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• Published: 31 October 2020

Guidance for conducting feasibility and pilot studies for implementation trials

• Nicole Pearson   ORCID: orcid.org/0000-0003-2677-2327 1 , 2 ,
• Patti-Jean Naylor 3 ,
• Maureen C. Ashe 5 ,
• Maria Fernandez 4 ,
• Sze Lin Yoong 1 , 2 &
• Luke Wolfenden 1 , 2  

Pilot and Feasibility Studies volume  6 , Article number:  167 ( 2020 ) Cite this article

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Implementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials.

We convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies.

Conclusions

This paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.

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The failure to translate effective interventions for improving population and patient outcomes into policy and routine health service practice denies the community the benefits of investment in such research [ 1 ]. Improving the implementation of effective interventions has therefore been identified as a priority of health systems and research agencies internationally [ 2 , 3 , 4 , 5 , 6 ]. The increased emphasis on research translation has resulted in the rapid emergence of implementation science as a scientific discipline, with the goal of integrating effective medical and public health interventions into health care systems, policies and practice [ 1 ]. Implementation research aims to do this via the generation of new knowledge, including the evaluation of the effectiveness of implementation strategies [ 7 ]. The term “implementation strategies” is used to describe the methods or techniques (e.g. training, performance feedback, communities of practice) used to enhance the adoption, implementation and/or sustainability of evidence-based interventions (Fig. 1 ) [ 8 , 9 ].

Conceptual role of implementation strategies in improving intervention implementation and patient and public health outcomes

While there has been a rapid increase in the number of implementation trials over the past decade, the quality of trials has been criticised, and the effects of the strategies for such trials on implementation, patient or public health outcomes have been modest [ 11 , 12 , 13 ]. To improve the likelihood of impact, factors that may impede intervention implementation should be considered during intervention development and across each phase of the research translation process [ 2 ]. Feasibility and pilot studies play an important role in improving the conduct and quality of a definitive randomised controlled trial (RCT) for both intervention and implementation trials [ 10 ]. For clinical or public health interventions, pilot and feasibility studies may serve to identify potential refinements to the intervention, address uncertainties around the feasibility of intervention trial methods, or test preliminary effects of the intervention [ 10 ]. In implementation research, feasibility and pilot studies perform the same functions as those for intervention trials, however with a focus on developing or refining implementation strategies, refining research methods for an implementation intervention trial, or undertake preliminary testing of implementation strategies [ 14 , 15 ]. Despite this, reviews of implementation studies appear to suggest that few full implementation randomised controlled trials have undertaken feasibility and pilot work in advance of a larger trial [ 16 ].

A range of publications provides guidance for the conduct of feasibility and pilot studies for conventional clinical or public health efficacy trials including Guidance for Exploratory Studies of complex public health interventions [ 17 ] and the Consolidated Standards of Reporting Trials (CONSORT 2010) for Pilot and Feasibility trials [ 18 ]. However, given the differences between implementation trials and conventional clinical or public health efficacy trials, the field of implementation science has identified the need for nuanced guidance [ 14 , 15 , 16 , 19 , 20 ]. Specifically, unlike traditional feasibility and pilot studies that may include the preliminary testing of interventions on individual clinical or public health outcomes, implementation feasibility and pilot studies that explore strategies to improve intervention implementation often require assessing changes across multiple levels including individuals (e.g. service providers or clinicians) and organisational systems [ 21 ]. Due to the complexity of influencing behaviour change, the role of feasibility and pilot studies of implementation may also extend to identifying potential causal mechanisms of change and facilitate an iterative process of refining intervention strategies and optimising their impact [ 16 , 17 ]. In addition, where conventional clinical or public health efficacy trials are typically conducted under controlled conditions and directed mostly by researchers, implementation trials are more pragmatic [ 15 ]. As is the case for well conducted effectiveness trials, implementation trials often require partnerships with end-users and at times, the prioritisation of end-user needs over methods (e.g. random assignment) that seek to maximise internal validity [ 15 , 22 ]. These factors pose additional challenges for implementation researchers and underscore the need for guidance on conducting feasibility and pilot implementation studies.

Given the importance of feasibility and pilot studies in improving implementation strategies and the quality of full-scale trials of those implementation strategies, our aim is to provide practice guidance for those undertaking formative feasibility or pilot studies in the field of implementation science. Specifically, we seek to provide guidance pertaining to the three possible purposes of undertaking pilot and feasibility studies, namely (i) to inform implementation strategy development, (ii) to assess potential implementation strategy effects and (iii) to assess the feasibility of study methods.

A series of three facilitated group discussions were conducted with a group comprising of the 6 members from Canada, the U.S. and Australia (authors of the manuscript) that were mutually interested in the use of feasibility and pilot trials in implementation science. Members included international experts in implementation and behavioural science, public health and trial methods, and had considerable experience in conducting feasibility, pilot and/ or implementation trials. The group was responsible for developing the guidance document, including identification and synthesis of pertinent literature, and approving the final guidance.

To inform guidance development, a literature review was undertaken in electronic bibliographic databases and google, to identify and compile existing recommendations and guidelines for feasibility and pilot studies broadly. Through this process, we identified 30 such guidelines and recommendations relevant to our aim [ 2 , 10 , 14 , 15 , 17 , 18 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ]. In addition, seminal methods and implementation science texts recommended by the group were examined. These included the CONSORT 2010 Statement: extension to randomised pilot and feasibility trials [ 18 ], the Medical Research Council’s framework for development and evaluation of randomised controlled trials for complex interventions to improve health [ 2 ], the National Institute of Health Research (NIHR) definitions [ 39 ] and the Quality Enhancement Research Initiative (QUERI) Implementation Guide [ 4 ]. A summary of feasibility and pilot study guidelines and recommendations, and that of seminal methods and implementation science texts, was compiled by two authors. This document served as the primary discussion document in meetings of the group. Additional targeted searches of the literature were undertaken in circumstances where the identified literature did not provide sufficient guidance. The manuscript was developed iteratively over 9 months via electronic circulation and comment by the group. Any differences in views between reviewers was discussed and resolved via consensus during scheduled international video-conference calls. All members of the group supported and approved the content of the final document.

The broad guidance provided is intended to be used as supplementary resources to existing seminal feasibility and pilot study resources. We used the definitions of feasibility and pilot studies as proposed by Eldridge and colleagues [ 10 ]. These definitions propose that any type of study relating to the preparation for a main study may be classified as a “feasibility study”, and that the term “pilot” study represents a subset of feasibility studies that specifically look at a design feature proposed for the main trial, whether in part of in full, that is being conducted on a smaller scale [ 10 ]. In addition, when referring to pilot studies, unless explicitly stated otherwise, we will primarily focus on pilot trials using a randomised design. We focus on randomised trials as such designs are the most common trial design in implementation research, and randomised designs may provide the most robust estimates of the potential effect of implementation strategies [ 46 ]. Those undertaking pilot studies that employ non-randomised designs need to interpret the guidance provided in this context. We acknowledge, however, that using randomised designs can prove particularly challenging in the field of implementation science, where research is often undertaken in real-world contexts with pragmatic constraints.

We used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as the framework for conceptualising the application of feasibility testing of implementation interventions [ 47 ]. The typology makes an explicit distinction between the purpose and methods of implementation and conventional clinical (or public health efficacy) trials. Specifically, the first two of the three hybrid designs may be relevant for implementation feasibility or pilot studies. Hybrid Type 1 trials are those designed to test the effectiveness of an intervention on clinical or public health outcomes (primary aim) while conducting a feasibility or pilot study for future implementation via observing and gathering information regarding implementation in a real-world setting/situation (secondary aim) [ 47 ]. Hybrid Type 2 trials involve the simultaneous testing of both the clinical intervention and the testing or feasibility of a formed implementation intervention/strategy as co-primary aims. For this design, “testing” is inclusive of pilot studies with an outcome measure and related hypothesis [ 47 ]. Hybrid Type 3 trials are definitive implementation trials designed to test the effectiveness of an implementation strategy whilst also collecting secondary outcome data on clinical or public health outcomes on a population of interest [ 47 ]. As the implementation aim of the trial is a definitively powered trial, it was not considered relevant to the conduct of feasibility and pilot studies in the field and will not be discussed.

Embedding of feasibility and pilot studies within Type 1 and Type 2 effectiveness-implementation hybrid trials has been recommended as an efficient way to increase the availability of information and evidence to accelerate the field of implementation science and the development and testing of implementation strategies [ 4 ]. However, implementation feasibility and pilot studies are also undertaken as stand-alone exploratory studies and do not include effectiveness measures in terms of the patient or public health outcomes. As such, in addition to discussing feasibility and pilot trials embedded in hybrid trial designs, we will also refer to stand-alone implementation feasibility and pilot studies.

An overview of guidance (aims, design, measures, sample size and power, progression criteria and reporting) for feasibility and pilot implementation studies can be found in Table 1 .

Purpose (aims)

The primary objective of hybrid type 1 trial is to assess the effectiveness of a clinical or public health intervention (rather than an implementation strategy) on the patient or population health outcomes [ 47 ]. Implementation strategies employed in these trials are often designed to maximise the likelihood of an intervention effect [ 51 ], and may not be intended to represent the strategy that would (or could feasibly), be used to support implementation in more “real world” contexts. Specific aims of implementation feasibility or pilot studies undertaken as part of Hybrid Type 1 trials are therefore formative and descriptive as the implementation strategy has not been fully formed nor will be tested. Thus, the purpose of a Hybrid Type 1 feasibility study is generally to inform the development or refinement of the implementation strategy rather than to test potential effects or mechanisms [ 22 , 47 ]. An example of a Hybrid Type 1 trial by Cabassa and colleagues is provided in Additional file 1 [ 52 ].

In Hybrid Type 2 trial designs, there is a dual purpose to test: (i) the clinical or public health effectiveness of the intervention on clinical or public health outcomes (e.g. measure of disease or health behaviour) and (ii) test or measure the impact of the implementation strategy on implementation outcomes (e.g. adoption of health policy in a community setting) [ 53 ]. However, testing the implementation strategy on implementation outcomes may be a secondary aim in these trials and positioned as a pilot [ 22 ]. In Hybrid Type 2 trial designs, the implementation strategy is more developed than in Hybrid Type 1 trials, resembling that intended for future testing in a definitive implementation randomised controlled trial. The dual testing of the evidence-based intervention and implementation interventions or strategies in Hybrid Type 2 trial designs allows for direct assessment of potential effects of an implementation strategy and exploration of components of the strategy to further refine logic models. Additionally, such trials allow for assessments of the feasibility, utility, acceptability or quality of research methods for use in a planned definitive trial. An example of a Hybrid Type 2 trial design by Barnes and colleagues [ 54 ] is included in Additional file 2 .

Non-hybrid pilot implementation studies are undertaken in the absence of a broader effectiveness trial. Such studies typically occur when the effectiveness of a clinical or public health intervention is well established, but robust strategies to promote its broader uptake and integration into clinical or public health services remain untested [ 15 ]. In these situations, implementation pilot studies may test or explore specific trial methods for a future definitive randomised implementation trial. Similarly, a pilot implementation study may also be undertaken in a way that provides a more rigorous formative evaluation of hypothesised implementation strategy mechanisms [ 55 ], or potential impact of implementation strategies [ 56 ], using similar approaches to that employed in Hybrid Type 2 trials. Examples of potential aims for feasibility and pilot studies are outlined in Table 2 .

For implementation feasibility or pilot studies, as is the case for these types of studies in general, the selection of research design should be guided by the specific research question that the study is seeking to address [ 57 ]. Although almost any study design may be used, researchers should review the merits and potential threats to internal and external validity to help guide the selection of research design for feasibility/pilot testing [ 15 ].

As Hybrid Type 1 trials are primarily concerned with testing the effectiveness of an intervention (rather than implementation strategy), the research design will typically employ power calculations and randomisation procedures at the health outcome level to measure the effect on behaviour, symptoms, functional and/or other clinical or public health outcomes. Hybrid Type 1 feasibility studies may employ a variety of designs usually nested within the experimental group (those receiving the intervention and any form of an implementation support strategy) of the broader efficacy trial [ 47 ]. Consistent with the aims of Hybrid Type 1 feasibility and pilot studies, the research designs employed are likely to be non-comparative. Cross-sectional surveys, interviews or document review, qualitative research or mix methods approaches may be used to assess implementation contextual factors, such as barriers and enablers to implementation and/or the acceptability, perceived feasibility or utility of implementation strategies or research methods [ 47 ].

Pilot implementation studies as part of Hybrid Type 2 designs can make use of the comparative design of the broader effectiveness trial to examine the potential effects of the implementation strategy [ 47 ] and more robustly assess the implementation mechanisms, determinants and influence of broader contextual factors [ 53 ]. In this trial type, mixed method and qualitative methods may complement the findings of between group (implementation strategy arm versus comparison) quantitative comparisons, enable triangulation and provide more comprehensive evidence to inform implementation strategy development and assessment. Stand-alone implementation feasibility and pilot implementation studies are free from the constraints and opportunities of research embedded in broader effectiveness trials. As such, research can be designed in a way that best addresses the explicit implementation objectives of the study. Specifically, non-hybrid pilot studies can maximise the applicability of study findings for future definitive trials by employing methods to directly test trial methods such as recruitment or retention strategies [ 17 ], enabling estimates of implementation strategies effects [ 56 ] or capturing data to explicitly test logic models or strategy mechanisms.

The selection of outcome measures should be linked directly to the objectives of the feasibility or pilot study. Where appropriate, measures should be objective or have suitable psychometric properties, such as evidence of reliability and validity [ 58 , 59 ]. Public health evaluation frameworks often guide the choice of outcome measure in feasibility and pilot implementation work and include RE_AIM [ 60 ], PRECEDE_PROCEED [ 61 ], Proctor and colleagues framework on outcomes for implementation research [ 62 ] and more recently, the “Implementation Mapping” framework [ 63 ]. Recent work by McKay and colleagues suggests a minimum data set of implementation outcomes that includes measures of adoption, reach, dose, fidelity and sustainability [ 46 ]. We discuss selected measures below and provide a summary in Table 3 [ 46 ]. Such measures could be assessed using quantitative or qualitative or mixed methods [ 46 ].

Measures to assess potential implementation strategy effects

In addition to assessing the effects of an intervention on individual clinical or public health outcomes, Hybrid Type 2 trials (and some non-hybrid pilot studies) are interested in measures of the potential effects of an implementation strategy on desired organisational or clinician practice change such as adherence to a guideline, process, clinical standard or delivery of a program [ 62 ]. A range of potential outcomes that could be used to assess implementation strategy effects has been identified, including measures of adoption, reach, fidelity and sustainability [ 46 ]. These outcomes are described in Table 2 , including definitions and examples of how they may be applied to the implementation component of innovation being piloted. Standardised tools to assess these outcomes are often unavailable due to the unique nature of interventions being implemented and the variable (and changing) implementation context in which the research is undertaken [ 64 ]. Researchers may collect outcome data for these measures as part of environmental observations, self-completed checklists or administrative records, audio recording of client sessions or other methods suited to their study and context [ 62 ]. The limitations of such methods, however, need to be considered.

Measures to inform the design or development of the implementation strategy

Measures informing the design or development of the implementation strategy are potentially part of all types of feasibility and pilot implementation studies. An understanding of the determinants of implementation is critical to implementation strategy development. A range of theoretical determinant frameworks have been published which describe factors that may influence intervention implementation [ 65 ], and systematic reviews have been undertaken describing the psychometric properties of many of these measures [ 64 , 66 ]. McKay and colleagues have also identified a priority set of determinants for implementation trials that could be considered for use in implementation feasibility and pilot studies, including measures of context, acceptability, adaptability, feasibility, compatibility, cost, culture, dose, complexity and self-efficacy [ 46 ]. These determinants are described in Table 3 , including definitions and how such measures may be applied to an implementation feasibility or pilot study. Researchers should consider, however, the application of such measures to assess both the intervention that is being implemented (as in a conventional intervention feasibility and pilot study) and the strategy that is being employed to facilitate its implementation, given the importance of the interaction between these factors and implementation success [ 46 ]. Examples of the potential application of measures to both the intervention and its implementation strategies have been outlined elsewhere [ 46 ]. Although a range of quantitative tools could be used to measure such determinants [ 58 , 66 ], qualitative or mixed methods are generally recommended given the capacity of qualitative measures to provide depth to the interpretation of such evaluations [ 40 ].

Measures of potential implementation determinants may be included to build or enhance logic models (Hybrid Type 1 and 2 feasibility and pilot studies) and explore implementation strategy mechanisms (Hybrid Type 2 pilot studies and non-hybrid pilot studies) [ 67 ]. If exploring strategy mechanisms, a hypothesized logic model underpinning the implementation strategy should be articulated including strategy-mechanism linkages, which are required to guide the measurement of key determinants [ 55 , 63 ]. An important determinant which can complicate logic model specification and measurement is the process of adaptation—modifications to the intervention or its delivery (implementation), through the input of service providers or implementers [ 68 ]. Logic models should specify components of implementation strategies thought to be “core” to their effects and those which are thought to be “non-core” where adaptation may occur without adversely impacting on effects. Stirman and colleagues propose a method for assessing adaptations that could be considered for use in pilot and feasibility studies of implementation trials [ 69 ]. Figure 2 provides an example of some of the implementation logic model components that may be developed or refined as part of feasibility or pilot studies of implementation [ 15 , 63 ].

Example of components of an Implementation logic model

Measures to assess the feasibility of study methods

Measures of implementation feasibility and pilot study methods are similar to those of conventional studies for clinical or public health interventions. For example, standard measures of study participation and thresholds for study attrition (e.g. >20%) rates [ 73 ] can be employed in implementation studies [ 67 ]. Previous studies have also surveyed study data collectors to assess the success of blinding strategies [ 74 ]. Researchers may also consider assessing participation or adherence to implementation data collection procedures, the comprehension of survey items, data management strategies or other measures of feasibility of study methods [ 15 ].

Pilot study sample size and power

In effectiveness trials, power calculations and sample size decisions are primarily based on the detection of a clinically meaningful difference in measures of the effects of the intervention on the patient or public health outcomes such as behaviour, disease, symptomatology or functional outcomes [ 24 ]. In this context, the available study sample for implementation measures included in Hybrid Type 1 or 2 feasibility and pilot studies may be constrained by the sample and power calculations of the broader effectiveness trial in which they are embedded [ 47 ]. Nonetheless, a justification for the anticipated sample size for all implementation feasibility or pilot studies (hybrid or stand-alone) is recommended [ 18 ], to ensure that implementation measures and outcomes achieve sufficient estimates of precision to be useful. For Hybrid type 2 and relevant stand-alone implementation pilot studies, sample size calculations for implementation outcomes should seek to achieve adequate estimates of precision deemed sufficient to inform progression to a fully powered trial [ 18 ].

Progression criteria

Stating progression criteria when reporting feasibility and pilot studies is recommended as part of the CONSORT 2010 extension to randomised pilot and feasibility trials guidelines [ 18 ]. Generally, it is recommended that progression criteria should be set a priori and be specific to the feasibility measures, components and/or outcomes assessed in the study [ 18 ]. While little guidance is available, ideas around suitable progression criteria include assessment of uncertainties around feasibility, meeting recruitment targets, cost-effectiveness and refining causal hypotheses to be tested in future trials [ 17 ]. When developing progression criteria, the use of guidelines is suggested rather than strict thresholds [ 18 ], in order to allow for appropriate interpretation and exploration of potential solutions, for example, the use of a traffic light system with varying levels of acceptability [ 17 , 24 ]. For example, Thabane and colleagues recommend that, in general, the outcome of a pilot study can be one of the following: (i) stop—main study not feasible (red); (ii) continue, but modify protocol—feasible with modifications (yellow); (iii) continue without modifications, but monitor closely—feasible with close monitoring and (iv) continue without modifications (green) (44)p5.

As the goal of Hybrid Type 1 implementation component is usually formative, it may not be necessary to set additional progression criteria in terms of the implementation outcomes and measures examined. As Hybrid Type 2 trials test an intervention and can pilot an implementation strategy, criteria for these and non-hybrid pilot studies may set progression criteria based on evidence of potential effects but may also consider the feasibility of trial methods, service provider, organisational or patient (or community) acceptability, fit with organisational systems and cost-effectiveness [ 17 ]. In many instances, the progression of implementation pilot studies will often require the input and agreement of stakeholders [ 27 ]. As such, the establishment of progression criteria and the interpretation of pilot and feasibility study findings in the context of such criteria require stakeholder input [ 27 ].

Reporting suggestions

As formal reporting guidelines do not exist for hybrid trial designs, we would recommend that feasibility and pilot studies as part of hybrid designs draw upon best practice recommendations from relevant reporting standards such as the CONSORT extension for randomised pilot and feasibility trials, the Standards for Reporting Implementation Studies (STaRI) guidelines and the Template for Intervention Description and Replication (TIDieR) guide as well as any other design relevant reporting standards [ 48 , 50 , 75 ]. These, and further reporting guidelines, specific to the particular research design chosen, can be accessed as part of the EQUATOR (Enhancing the QUAility and Transparency Of health Research) network—a repository for reporting guidance [ 76 ]. In addition, researchers should specify the type of implementation feasibility or pilot study being undertaken using accepted definitions. If applicable, specification and justification behind the choice of hybrid trial design should also be stated. In line with existing recommendations for reporting of implementation trials generally, reporting on the referent of outcomes (e.g. specifying if the measure in relation to the specific intervention or the implementation strategy) [ 62 ], is also particularly pertinent when reporting hybrid trial designs.

Concerns are often raised regarding the quality of implementation trials and their capacity to contribute to the collective evidence base [ 3 ]. Although there have been many recent developments in the standardisation of guidance for implementation trials, information on the conduct of feasibility and pilot studies for implementation interventions remains limited, potentially contributing to a lack of exploratory work in this area and a limited evidence base to inform effective implementation intervention design and conduct [ 15 ]. To address this, we synthesised the existing literature and provide commentary and guidance for the conduct of implementation feasibility and pilot studies. To our knowledge, this work is the first to do so and is an important first step to the development of standardised guidelines for implementation-related feasibility and pilot studies.

Availability of data and materials

Not applicable.

Abbreviations

Randomised controlled trial

Consolidated Standards of Reporting Trials

Enhancing the QUAility and Transparency Of health Research

Standards for Reporting Implementation Studies

Strengthening the Reporting of Observational Studies in Epidemiology

Template for Intervention Description and Replication

National Institute of Health Research

Quality Enhancement Research Initiative

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Acknowledgements

Associate Professor Luke Wolfenden receives salary support from a NHMRC Career Development Fellowship (grant ID: APP1128348) and Heart Foundation Future Leader Fellowship (grant ID: 101175). Dr Sze Lin Yoong is a postdoctoral research fellow funded by the National Heart Foundation. A/Prof Maureen C. Ashe is supported by the Canada Research Chairs program.

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Example of a Hybrid Type 1 trial. Summary of publication by Cabassa et al.

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Example of a Hybrid Type 2 trial. Summary of publication by Barnes et al.

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Pearson, N., Naylor, PJ., Ashe, M.C. et al. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud 6 , 167 (2020). https://doi.org/10.1186/s40814-020-00634-w

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Pilot and Feasibility Studies

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What Is a Feasibility Study?

Understanding a feasibility study, how to conduct a feasibility study, the bottom line.

• Business Essentials

Feasibility Study

Yarilet Perez is an experienced multimedia journalist and fact-checker with a Master of Science in Journalism. She has worked in multiple cities covering breaking news, politics, education, and more. Her expertise is in personal finance and investing, and real estate.

A feasibility study is a detailed analysis that considers all of the critical aspects of a proposed project in order to determine the likelihood of it succeeding.

Success in business may be defined primarily by return on investment , meaning that the project will generate enough profit to justify the investment. However, many other important factors may be identified on the plus or minus side, such as community reaction and environmental impact.

Although feasibility studies can help project managers determine the risk and return of pursuing a plan of action, several steps should be considered before moving forward.

Key Takeaways

• A company may conduct a feasibility study when it’s considering launching a new business, adding a new product line, or acquiring a rival.
• A feasibility study assesses the potential for success of the proposed plan or project by defining its expected costs and projected benefits in detail.
• It’s a good idea to have a contingency plan on hand in case the original project is found to be infeasible.

Lara Antal / Investopedia

A feasibility study is an assessment of the practicality of a proposed plan or project. A feasibility study analyzes the viability of a project to determine whether the project or venture is likely to succeed. The study is also designed to identify potential issues and problems that could arise while pursuing the project.

As part of the feasibility study, project managers must determine whether they have enough of the right people, financial resources, and technology. The study must also determine the return on investment, whether this is measured as a financial gain or a benefit to society, the latter in the case of a nonprofit project.

The feasibility study might include a cash flow analysis, measuring the level of cash generated from revenue vs. the project’s operating costs . A risk assessment must also be completed to determine whether the return is enough to offset the risk of undergoing the venture.

When doing a feasibility study, it’s always good to have a contingency plan that is ready to test as a viable alternative if the first plan fails.

Benefits of a Feasibility Study

There are several benefits to feasibility studies, including helping project managers discern the pros and cons of undertaking a project before investing a significant amount of time and capital into it.

Feasibility studies can also provide a company’s management team with crucial information that could prevent them from entering into a risky business venture.

Such studies help companies determine how they will grow. They will know more about how they will operate, what the potential obstacles are, who the competition is, and what the market is.

Feasibility studies also help convince investors and bankers that investing in a particular project or business is a wise choice.

The exact format of a feasibility study will depend on the type of organization that requires it. However, the same factors will be involved even if their weighting varies.

Preliminary Analysis

Although each project can have unique goals and needs, there are some best practices for conducting any feasibility study:

• Conduct a preliminary analysis, which involves getting feedback about the new concept from the appropriate stakeholders.
• Analyze and ask questions about the data obtained in the early phase of the study to make sure that it’s solid.
• Conduct a market survey or market research to identify the market demand and opportunity for pursuing the project or business.
• Write an organizational, operational, or business plan, including identifying the amount of labor needed, at what cost, and for how long.
• Prepare a projected income statement, which includes revenue, operating costs, and profit .
• Prepare an opening day balance sheet .
• Identify obstacles and any potential vulnerabilities, as well as how to deal with them.
• Make an initial “go” or “no-go” decision about moving ahead with the plan.

Suggested Components

Once the initial due diligence has been completed, the real work begins. Components that are typically found in a feasibility study include the following:

• Executive summary : Formulate a narrative describing details of the project, product, service, plan, or business.
• Technological considerations : Ask what will it take. Do you have it? If not, can you get it? What will it cost?
• Existing marketplace : Examine the local and broader markets for the product, service, plan, or business.
• Marketing strategy : Describe it in detail.
• Required staffing : What are the human capital needs for this project? Draw up an organizational chart.
• Schedule and timeline : Include significant interim markers for the project’s completion date.
• Project financials
• Findings and recommendations : Break down into subsets of technology, marketing, organization, and financials.

Examples of a Feasibility Study

Below are two examples of a feasibility study. The first involves expansion plans for a university. The second is a real-world example conducted by the Washington State Department of Transportation with private contributions from Microsoft Inc.

A University Science Building

Officials at a university were concerned that the science building—built in the 1970s—was outdated. Considering the technological and scientific advances of the last 20 years, they wanted to explore the cost and benefits of upgrading and expanding the building. A feasibility study was conducted.

In the preliminary analysis, school officials explored several options, weighing the benefits and costs of expanding and updating the science building. Some school officials had concerns about the project, including the cost and possible community opposition. The new science building would be much larger, and the community board had earlier rejected similar proposals. The feasibility study would need to address these concerns and any potential legal or zoning issues.

The feasibility study also explored the technological needs of the new science facility, the benefits to the students, and the long-term viability of the college. A modernized science facility would expand the school’s scientific research capabilities, improve its curriculum, and attract new students.

Financial projections showed the cost and scope of the project and how the school planned to raise the needed funds, which included issuing a bond to investors and tapping into the school’s endowment . The projections also showed how the expanded facility would allow more students to be enrolled in the science programs, increasing revenue from tuition and fees.

The feasibility study demonstrated that the project was viable, paving the way to enacting the modernization and expansion plans of the science building.

Without conducting a feasibility study, the school administrators would never have known whether its expansion plans were viable.

A High-Speed Rail Project

The Washington State Department of Transportation decided to conduct a feasibility study on a proposal to construct a high-speed rail that would connect Vancouver, British Columbia, Seattle, Washington, and Portland, Oregon. The goal was to create an environmentally responsible transportation system to enhance the competitiveness and future prosperity of the Pacific Northwest.

The preliminary analysis outlined a governance framework for future decision making. The study involved researching the most effective governance framework by interviewing experts and stakeholders, reviewing governance structures, and learning from existing high-speed rail projects in North America. As a result, governing and coordinating entities were developed to oversee and follow the project if it was approved by the state legislature.

A strategic engagement plan involved an equitable approach with the public, elected officials, federal agencies, business leaders, advocacy groups, and Indigenous communities. The engagement plan was designed to be flexible, considering the size and scope of the project and how many cities and towns would be involved. A team of the executive committee members was formed and met to discuss strategies, as well as lessons learned from previous projects, and met with experts to create an outreach framework.

The financial component of the feasibility study outlined the strategy for securing the project’s funding, which explored obtaining funds from federal, state, and private investments. The project’s cost was estimated to be $24 billion to $42 billion. The revenue generated from the high-speed rail system was estimated to be $160 million to $250 million.

The report bifurcated the money sources between funding and financing. Funding referred to grants, appropriations from the local or state government, and revenue. Financing referred to bonds issued by the government, loans from financial institutions, and equity investments, which are essentially loans against future revenue that need to be paid back with interest.

The sources for the capital needed were to vary as the project moved forward. In the early stages, most of the funding would come from the government, and as the project developed, funding would come from private contributions and financing measures. Private contributors included Microsoft Inc.

The benefits outlined in the feasibility report show that the region would experience enhanced interconnectivity, allowing for better management of the population and increasing regional economic growth by $355 billion. The new transportation system would provide people with access to better jobs and more affordable housing. The high-speed rail system would also relieve congested areas from automobile traffic.

The timeline for the study began in 2016, when an agreement was reached with British Columbia to work together on a new technology corridor that included high-speed rail transportation. The feasibility report was submitted to the Washington State Legislature in December 2020.

What Is the Main Objective of a Feasibility Study?

A feasibility study is designed to help decision makers determine whether or not a proposed project or investment is likely to be successful. It identifies both the known costs and the expected benefits.

In business, “successful” means that the financial return exceeds the cost. In a nonprofit, success may be measured in other ways. A project’s benefit to the community it serves may be worth the cost.

What Are the Steps in a Feasibility Study?

A feasibility study starts with a preliminary analysis. Stakeholders are interviewed, market research is conducted, and a business plan is prepared. All of this information is analyzed to make an initial “go” or “no-go” decision.

If it’s a go, the real study can begin. This includes listing the technological considerations, studying the marketplace, describing the marketing strategy, and outlining the necessary human capital, project schedule, and financing requirements.

Who Conducts a Feasibility Study?

A feasibility study may be conducted by a team of the organization’s senior managers. If they lack the expertise or time to do the work internally, it may be outsourced to a consultant.

What Are the 4 Types of Feasibility?

The study considers the feasibility of four aspects of a project:

Technical : A list of the hardware and software needed, and the skilled labor required to make them work

Financial : An estimate of the cost of the overall project and its expected return

Market : An analysis of the market for the product or service, the industry, competition, consumer demand, sales forecasts, and growth projections

Organizational : An outline of the business structure and the management team that will be needed

Feasibility studies help project managers determine the viability of a project or business venture by identifying the factors that can lead to its success. The study also shows the potential return on investment and any risks to the success of the venture.

A feasibility study contains a detailed analysis of what’s needed to complete the proposed project. The report may include a description of the new product or venture, a market analysis, the technology and labor needed, and the sources of financing and capital. The report will also include financial projections, the likelihood of success, and ultimately, a “go” or “no-go” decision.

Washington State Department of Transportation. “ Ultra-High-Speed Rail Study .”

Washington State Department of Transportation. “ Cascadia Ultra High Speed Ground Transportation: Framework for the Future .”

Washington State Department of Transportation. “ Ultra-High-Speed Rail Study: Outcomes .”

Washington State Department of Transportation. “ Ultra-High-Speed Ground Transportation Business Case Analysis ,” Page ii (Page 3 of PDF).

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Here are some tips for structuring and presenting your findings with finesse:

• Keep your report succinct and to the point. Avoid unnecessary jargon or technical language.
• Use charts, graphs, and visuals to bring your data to life and make complex information more digestible.
• Provide actionable recommendations based on your analysis. Your final document is supposed to guide decision-makers on the path to success.

Step-by-Step Guide on How to Conduct a Feasibility Study

Clarify your mission and vision for the feasibility study. Define the scope of your study. Outline what you hope to achieve and the boundaries of your analysis.

Gather information from various sources—surveys, interviews, and existing research. Conduct thorough market research to understand your customer needs, market trends, and competitor landscapes.

Crunch the numbers and assess the financial feasibility of your project. Conduct a cost-benefit analysis to weigh the potential costs against the anticipated benefits of your venture.

Evaluate the operational feasibility of your project. Consider factors such as resource availability, technology requirements, and logistical challenges. Identify potential risks and develop risk management strategies to minimize their impact.

Compile your findings and recommendations into a comprehensive Feasibility Study report. Present your analysis, insights, and recommendations clearly and concisely, ensuring stakeholders can easily understand and act upon the information provided.

In conclusion, feasibility studies serve as a compass to guide businesses through the turbulent seas of uncertainty. Prioritizing these studies helps you chart a course towards success with confidence and clarity.

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What Is a Feasibility Study? How to Conduct One for Your Project

Why is a feasibility study so important in project management? For one, the feasibility study or feasibility analysis is the foundation upon which your project plan resides. That’s because the feasibility analysis determines the viability of your project. Now that you know the importance, read on to learn what you need to know about feasibility studies.

What Is a Feasibility Study?

A feasibility study is simply an assessment of the practicality of a proposed project plan or method. This is done by analyzing technical, economic, legal, operational and time feasibility factors. Just as the name implies, you’re asking, “Is this feasible?” For example, do you have or can you create the technology that accomplishes what you propose? Do you have the people, tools and resources necessary? And, will the project get you the ROI you expect?

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Feasibility study template

Use this free Feasibility Study Template for Word to manage your projects better.

What’s the Importance of a Feasibility Study?

A project feasibility study should be done during the project management life cycle after the business case has been completed. So, that’s the “what” and the “when” but how about the “why?” Why is it important to conduct a feasibility study?

An effective feasibility study points a project in the right direction by helping decision-makers have a holistic view of the potential benefits, disadvantages, barriers and constraints that could affect its outcome. The main purpose of a feasibility study is to determine whether the project can be not only viable but also beneficial from a technical, financial, legal and market standpoint.

What Is Included in a Feasibility Study Report?

The findings of your project feasibility study are compiled in a feasibility report that usually includes the following elements.

• Executive summary
• Description of product/service
• Technology considerations
• Product/service marketplace
• Marketing strategy
• Organization/staffing
• Financial projections
• Findings and recommendations

Free Feasibility Study Template

Use this free feasibility study template for Word to begin your own feasibility study. It has all the fundamental sections for you to get started, and it’s flexible enough to adapt to your specific needs. Download yours today.

Types of Feasibility Study

There are many things to consider when determining project feasibility, and there are different types of feasibility studies you might conduct to assess your project from different perspectives.

Pre-Feasibility Study

A pre-feasibility study, as its name suggests, it’s a process that’s undertaken before the feasibility study. It involves decision-makers and subject matter experts who will prioritize different project ideas or approaches to quickly determine whether the project has fundamental technical, financial, operational or any other evident flaws. If the project proposal is sound, a proper feasibility study will follow.

Technical Feasibility Study

A technical feasibility study consists in determining if your organization has the technical resources and expertise to meet the project requirements . A technical study focuses on assessing whether your organization has the necessary capabilities that are needed to execute a project, such as the production capacity, facility needs, raw materials, supply chain and other inputs. In addition to these production inputs, you should also consider other factors such as regulatory compliance requirements or standards for your products or services.

Economic Feasibility Study

Also called financial feasibility study, this type of study allows you to determine whether a project is financially feasible. Economic feasibility studies require the following steps:

• Before you can start your project, you’ll need to determine the seed capital, working capital and any other capital requirements, such as contingency capital. To do this, you’ll need to estimate what types of resources will be needed for the execution of your project, such as raw materials, equipment and labor.
• Once you’ve determined what project resources are needed, you should use a cost breakdown structure to identify all your project costs.
• Identify potential sources of funding such as loans or investments from angel investors or venture capitalists.
• Estimate the expected revenue, profit margin and return on investment of your project by conducting a cost-benefit analysis , or by using business forecasting techniques such as linear programming to estimate different future outcomes under different levels of production, demand and sales.
• Estimate your project’s break-even point.
• Conduct a financial benchmark analysis with industrial averages and specific competitors in your industry.
• Use pro forma cash flow statements, financial statements, balance sheets and other financial projection documents.

Legal Feasibility Study

Your project must meet legal requirements including laws and regulations that apply to all activities and deliverables in your project scope . In addition, think about the most favorable legal structure for your organization and its investors. Each business legal structure has advantages and disadvantages when it comes to liability for business owners, such as limited liability companies (LLCs) or corporations, which reduce the liability for each business partner.

Market Feasibility Study

A market feasibility study determines whether your project has the potential to succeed in the market. To do so, you’ll need to analyze the following factors:

• Industry overview: Assess your industry, such as year-over-year growth, identify key direct and indirect competitors, availability of supplies and any other trends that might affect the future of the industry and your project.
• SWOT analysis: A SWOT analysis allows organizations to determine how competitive an organization can be by examining its strengths, weaknesses and the opportunities and threats of the market. Strengths are the operational capabilities or competitive advantages that allow an organization to outperform its competitors such as lower costs, faster production or intellectual property. Weaknesses are areas where your business might be outperformed by competitors. Opportunities are external, such as an underserved market, an increased demand for your products or favorable economic conditions. Threats are also external factors that might affect your ability to do well in the market such as new competitors, substitute products and new technologies.
• Market research: The main purpose of market research is to determine whether it’s possible for your organization to enter the market or if there are barriers to entry or constraints that might affect your ability to compete. Consider variables such as pricing, your unique value proposition, customer demand, new technologies, market trends and any other factors that affect how your business will serve your customers. Use market research techniques to identify your target market, create buyer personas, assess the competitiveness of your niche and gauge customer demand, among other things.

7 Steps to Do a Feasibility Study

If you’re ready to do your own feasibility study, follow these 7 steps. You can use this free feasibility study template to help you get started.

1. Conduct a Preliminary Analysis

Begin by outlining your project plan . You should focus on an unserved need, a market where the demand is greater than the supply and whether the product or service has a distinct advantage. Then, determine if the feasibility factors are too high to clear (i.e. too expensive, unable to effectively market, etc.).

2. Prepare a Projected Income Statement

This step requires working backward. Start with what you expect the income from the project to be and then what project funding is needed to achieve that goal. This is the foundation of an income statement. Factor in what services are required and how much they’ll cost and any adjustments to revenues, such as reimbursements, etc.

Related: Free Project Management Templates

3. Conduct a Market Survey or Perform Market Research

This step is key to the success of your feasibility study, so make your market analysis as thorough as possible. It’s so important that if your organization doesn’t have the resources to do a proper one, then it is advantageous to hire an outside firm to do so.

Market research will give you the clearest picture of the revenues and return on investment you can realistically expect from the project. Some things to consider are the geographic influence on the market, demographics, analyzing competitors, the value of the market and what your share will be and if the market is open to expansion (that is, in response to your offer).

4. Plan Business Organization and Operations

Once the groundwork of the previous steps has been laid, it’s time to set up the organization and operations of the planned project to meet its technical, operational, economic and legal feasibility factors. This isn’t a superficial, broad-stroke endeavor. It should be thorough and include start-up costs, fixed investments and operating costs. These costs address things such as equipment, merchandising methods, real estate, personnel, supply availability, overhead, etc.

5. Prepare an Opening Day Balance Sheet

This includes an estimate of the assets and liabilities, one that should be as accurate as possible. To do this, create a list that includes items, sources, costs and available financing. Liabilities to consider are such things as leasing or purchasing land, buildings and equipment, financing for assets and accounts receivables.

6. Review and Analyze All Data

All of these steps are important, but the review and analysis are especially important to ensure that everything is as it should be and that nothing requires changing or tweaking. Take a moment to look over your work one last time.

Reexamine your previous steps, such as the income statement, and compare them with your expenses and liabilities. Is it still realistic? This is also the time to think about risk and come up with any contingency plans .

7. Make a Go/No-Go Decision

You’re now at the point to make a decision about whether or not the project is feasible. That sounds simple, but all the previous steps lead to this decision-making moment. A couple of other things to consider before making that binary choice are whether the commitment is worth the time, effort and money and whether it aligns with the organization’s strategic goals and long-term aspirations.

Feasibility Study Examples

Here are some simple feasibility study examples so you have a better idea of what a feasibility study is used for in different industries.

Construction Feasibility Study

For this construction feasibility study example, let’s imagine a large construction company that’s interested in starting a new project in the near future to generate profits.

• Pre-Feasibility Study: The first step is to conduct a preliminary feasibility study. It can be as simple as a meeting where decision-makers will prioritize projects and discuss different project ideas to determine which poses a bigger financial benefit for the organization.
• Technical Feasibility Study: Now it’s time to estimate what resources are needed to execute the construction project, such as raw materials, equipment and labor. If there’s work that can’t be executed by the company with its current resources, a subcontractor will be hired to fill the gap.
• Economic Feasibility Study: Once the construction project management team has established what materials, equipment and labor are needed, they can estimate costs. Cost estimators use information from past projects, construction drawings and documents such as a bill of quantities to come up with an accurate cost estimate. Then, based on this estimate, a profit margin and financial forecasts will be analyzed to determine if there’s economic feasibility.
• Legal Feasibility Study: Now the company needs to identify all potential regulations, building codes and laws that might affect the project. They’ll need to ask for approval from the local government so that they can begin the construction project .
• Market Feasibility Study: Market feasibility will be determined depending on the nature of the project. For this feasibility example, let’s assume a residential construction project will be built. To gauge market potential, they’ll need to analyze variables such as the average income of the households in the city, crime rate, population density and any trends in state migration.

Manufacturing Feasibility Study

Another industry that uses feasibility studies is manufacturing. It’s a test run of the steps in the manufacturing production cycle to ensure the process is designed properly. Let’s take a look at what a manufacturing feasibility study example would look like.

• Feasibility Study: The first step is to look at various ideas and decide which is the best one to pursue. You don’t want to get started and have to stop. That’s a waste of time, money and effort. Look at what you intend to manufacture, does it fill an unserved need, is the market able to support competition and can you manufacture a quality product on time and within your budget?
• Financial Feasibility Study: Find out if your estimated income from the sale of this product is going to cover your costs, both direct and indirect costs. Work backward from the income you expect to make and the expenses you’ll spend for labor, materials and production to determine if the manufacturing of this product is financially feasible.
• Market Feasibility Study: You’ve already determined that there’s a need that’s not being served, but now it’s time to dig deeper to get realistic projections of revenue. You’ll want to define your target demographic, analyze the competitive landscape, determine the total market volume and what your market share will be and estimate what market expansion opportunities there are.
• Technical Feasibility Study: This is where you’ll explore the production , such as what resources you’ll need to produce your product. These findings will inform your financial feasibility study as well as labor, material, equipment, etc., costs have to be within your budget. You’ll also figure out the processes you’ll use to produce and deliver your product to the market, including warehousing and retail distribution.

There could be other feasibility studies you’ll have to make depending on the product and the market, but these are the essential ones that all manufacturers have to look at before they can make an educated decision as to whether to go forward or abandon the idea.

Best Practices for a Feasibility Study

• Use project management software like ProjectManager to organize your data and work efficiently and effectively
• Use templates or any data and technology that gives you leverage
• Involve the appropriate stakeholders to get their feedback
• Use market research to further your data collection
• Do your homework and ask questions to make sure your data is solid

If your project is feasible, then the real work begins. ProjectManager helps you plan more efficiently. Our online Gantt chart organizes tasks, sets deadlines, adds priority and links dependent tasks to avoid delays. But unlike other Gantt software, we calculate the critical path for you and set a baseline to measure project variance once you move into the execution phase.

Watch a Video on Feasibility Studies

There are many steps and aspects to a project feasibility study. If you want yours to be accurate and forecast correctly whether your project is doable, then you need to have a clear understanding of all its moving parts.

Jennifer Bridges, PMP, is an expert on all aspects of project management and leads this free training video to help you get a firm handle on the subject.

Here’s a screenshot for your reference!

Pro tip: When completing a feasibility study, it’s always good to have a contingency plan that you test to make sure it’s a viable alternative.

ProjectManager Improves Your Feasibility Study

A feasibility study is a project, so get yourself a project management software that can help you execute it. ProjectManager is an award-winning software that can help you manage your feasibility study through every phase.

Once you have a plan for your feasibility study, upload that task list to our software and all your work is populated in our online Gantt chart. Now you can assign tasks to team members, add costs, create timelines, collect all the market research and attach notes at the task level. This gives people a plan to work off of, and a collaborative platform to collect ideas and comments.

If you decide to implement the project, you already have it started in our software, which can now help you monitor and report on its progress. Try it for yourself with this free 30-day trial.

Transcription

Today we’re talking about How to Conduct A Feasibility Study, but first of all, I want to start with clarifying what a feasibility study is.

Feasibility Analysis Definition

Basically, it’s an assessment of the practicality of a proposed plan or method. Basically, we’ll want to want to know, is this feasible. Some of the questions that may generate this or we can hear people asking are, “Do we have or can we create the technology to do this? Do we have the people resource who can produce this and will we get our ROI, our Return On Investment?”

When to Do a Feasibility Study

So when do we do the feasibility study? So it’s done during a project lifecycle and it’s done after the business case because the business case outlines what we’re proposing. Is it a product or service that we’re proposing?

So why do we do this? The reason we do this is that we need to determine the factors that will make the business opportunity a success.

How to Conduct a Feasibility Study

Well, let’s talk about a few steps that we do in order to conduct the feasibility study.

Well, first of all, we conduct a preliminary analysis of what all’s involved in the business case and what we’re analyzing and what we’re trying to determine is feasible.

Then we prepare a projected income statement. We need to know what are the income streams, how are we gonna make money on this. Where’s the revenue coming from? We also need to conduct a market survey.

We need to know, is this a demand? Is there a market for this? Are customers willing to use this product or use this service?

The fourth one is to plan the business organization and operations. What is the structure, what kind of resources do we need? What kind of staffing requirements do we have?

We also want to prepare an opening day balance sheet. What are the…how again, what are the expenses, what’s the revenue and to ensure that being able to determine if we’re gonna make our ROI.

So we want to review and analyze all of the data that we have and with that, we’re going to determine, we’re going to make a go, no-go decision. Meaning, are we going to do this project or this business opportunity or not.

Well, here are some of the best practices to use during your feasibility study.

One is to use templates, tools and surveys that exist today. The great news is, data is becoming more and more prevalent. There are all kinds of technologies. There are groups that they do nothing but research. Things that we can leverage today.

We want to involve the appropriate stakeholders to ensure that input is being considered from the different people involved.

We also want to use again the market research to ensure we’re bringing in good, reliable data.

Do your homework, meaning act like is if this is your project, if it’s your money. So do your homework and do it well and make sure you give credible data.

What Is a Feasibility Report?

So ultimately in the end what we’re doing is, we’re producing and we’re providing a feasibility report. So in that report, think of this is like a template.

So what you’re gonna do is give it an executive summary of the business opportunity that you’re evaluating and the description of the product or the service.

You want to look at different technology considerations. Is it technology that you’re going to use? Are you going to build the technology?

What kind of product and service marketplace and being able again, to identify the specific market you’re going to be targeting? Also, what is the marketing strategy you’re going to use to target the marketplace?

And also what’s the organizational structure? What are the staffing requirements? What people do you need to deliver the product or service and even support it?

So also we want to know the schedule to be able to have the milestones to ensure that as we’re building things, that as we’re spending money that we’re beginning to bring in income to pay and knowing when we’re going to start recuperating some of the funding. Again, which also ties into the financial projections.

Ultimately in this report, you’re going to provide the findings and the recommendations.

Again, we’ll probably talk about technology. Are you going to build it? Are you going to buy it? What are the marketing strategies for the specific marketplace organization? You may have some recommendations for whether you’re going to insource the staff, maybe you are going to outsource some staff and what that looks like and also financial recommendation.

If you’ve been looking for an all-in-one tool that can help with your feasibility study, consider ProjectManager. We offer five project views and countless features that make it seamless to plan projects, organize tasks and stay connected with your team. See what our software can do for you by taking this free 30-day trial.

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What is a Feasibility Study and How to Conduct It? (+ Examples)

Appinio Research · 26.09.2023 · 28min read

Are you ready to turn your project or business idea into a concrete reality but unsure about its feasibility? Whether you're a seasoned entrepreneur or a first-time project manager, understanding the intricate process of conducting a feasibility study is vital for making informed decisions and maximizing your chances of success.

This guide will equip you with the knowledge and tools to navigate the complexities of market, technical, financial, and operational feasibility studies. By the end, you'll have a clear roadmap to confidently assess, plan, and execute your project.

What is a Feasibility Study?

A feasibility study is a systematic and comprehensive analysis of a proposed project or business idea to assess its viability and potential for success. It involves evaluating various aspects such as market demand, technical feasibility, financial viability, and operational capabilities. The primary goal of a feasibility study is to provide you with valuable insights and data to make informed decisions about whether to proceed with the project.

Why is a Feasibility Study Important?

Conducting a feasibility study is a critical step in the planning process for any project or business. It helps you:

• Minimize Risks: By identifying potential challenges and obstacles early on, you can develop strategies to mitigate risks.
• Optimize Resource Allocation: A feasibility study helps you allocate your resources more efficiently, including time and money.
• Enhance Decision-Making: Armed with data and insights, you can make well-informed decisions about pursuing the project or exploring alternative options.
• Attract Stakeholders: Potential investors, lenders, and partners often require a feasibility study to assess the project's credibility and potential return on investment.

Now that you understand the importance of feasibility studies, let's explore the various types and dive deeper into each aspect.

Types of Feasibility Studies

Feasibility studies come in various forms, each designed to assess different aspects of a project's viability. Let's delve into the four primary types of feasibility studies in more detail:

1. Market Feasibility Study

Market feasibility studies are conducted to determine whether there is a demand for a product or service in a specific market or industry. This type of study focuses on understanding customer needs, market trends, and the competitive landscape. Here are the key elements of a market feasibility study:

• Market Research and Analysis: Comprehensive research is conducted to gather market size, growth potential , and customer behavior data. This includes both primary research (surveys, interviews) and secondary research (existing reports, data).
• Target Audience Identification: Identifying the ideal customer base by segmenting the market based on demographics, psychographics, and behavior. Understanding your target audience is crucial for tailoring your product or service.
• Competitive Analysis : Assessing the competition within the market, including identifying direct and indirect competitors, their strengths, weaknesses, and market share .
• Demand and Supply Assessment: Analyzing the balance between the demand for the product or service and its supply. This helps determine whether there is room for a new entrant in the market.

2. Technical Feasibility Study

Technical feasibility studies evaluate whether the project can be developed and implemented from a technical standpoint. This assessment focuses on the project's design, technical requirements, and resource availability. Here's what it entails:

• Project Design and Technical Requirements: Defining the technical specifications of the project, including hardware, software, and any specialized equipment. This phase outlines the technical aspects required for project execution.
• Technology Assessment: Evaluating the chosen technology's suitability for the project and assessing its scalability and compatibility with existing systems.
• Resource Evaluation: Assessing the availability of essential resources such as personnel, materials, and suppliers to ensure the project's technical requirements can be met.
• Risk Analysis: Identifying potential technical risks, challenges, and obstacles that may arise during project development. Developing risk mitigation strategies is a critical part of technical feasibility.

3. Financial Feasibility Study

Financial feasibility studies aim to determine whether the project is financially viable and sustainable in the long run. This type of study involves estimating costs, projecting revenue, and conducting financial analyses. Key components include:

• Cost Estimation: Calculating both initial and ongoing costs associated with the project, including capital expenditures, operational expenses, and contingency funds.
• Revenue Projections: Forecasting the income the project is expected to generate, considering sales, pricing strategies, market demand, and potential revenue streams.
• Investment Analysis: Evaluating the return on investment (ROI), payback period, and potential risks associated with financing the project.
• Financial Viability Assessment: Analyzing the project's profitability, cash flow, and financial stability to ensure it can meet its financial obligations and sustain operations.

4. Operational Feasibility Study

Operational feasibility studies assess whether the project can be effectively implemented within the organization's existing operational framework. This study considers processes, resource planning, scalability, and operational risks. Key elements include:

• Process and Workflow Assessment: Analyzing how the project integrates with current processes and workflows, identifying potential bottlenecks, and optimizing operations.
• Resource Planning: Determining the human, physical, and technological resources required for successful project execution and identifying resource gaps.
• Scalability Evaluation: Assessing the project's ability to adapt and expand to meet changing demands and growth opportunities, including capacity planning and growth strategies.
• Operational Risks Analysis: Identifying potential operational challenges and developing strategies to mitigate them, ensuring smooth project implementation.

Each type of feasibility study serves a specific purpose in evaluating different facets of your project, collectively providing a comprehensive assessment of its viability and potential for success.

How to Prepare for a Feasibility Study?

Before you dive into the nitty-gritty details of conducting a feasibility study, it's essential to prepare thoroughly. Proper preparation will set the stage for a successful and insightful study. In this section, we'll explore the main steps involved in preparing for a feasibility study.

1. Identify the Project or Idea

Identifying and defining your project or business idea is the foundational step in the feasibility study process. This initial phase is critical because it helps you clarify your objectives and set the direction for the study.

• Problem Identification: Start by pinpointing the problem or need your project addresses. What pain point does it solve for your target audience?
• Project Definition: Clearly define your project or business idea. What are its core components, features, or offerings?
• Goals and Objectives: Establish specific goals and objectives for your project. What do you aim to achieve in the short and long term?
• Alignment with Vision: Ensure your project aligns with your overall vision and mission. How does it fit into your larger strategic plan?

Remember, the more precisely you can articulate your project or idea at this stage, the easier it will be to conduct a focused and effective feasibility study.

2. Assemble a Feasibility Study Team

Once you've defined your project, the next step is to assemble a competent and diverse feasibility study team. Your team's expertise will play a crucial role in conducting a thorough assessment of your project's viability.

• Identify Key Roles: Determine the essential roles required for your feasibility study. These typically include experts in areas such as market research, finance, technology, and operations.
• Select Team Members: Choose team members with the relevant skills and experience to fulfill these roles effectively. Look for individuals who have successfully conducted feasibility studies in the past.
• Collaboration and Communication: Foster a collaborative environment within your team. Effective communication is essential to ensure everyone is aligned on objectives and timelines.
• Project Manager: Designate a project manager responsible for coordinating the study, tracking progress, and meeting deadlines.
• External Consultants: In some cases, you may need to engage external consultants or specialists with niche expertise to provide valuable insights.

Having the right people on your team will help you collect accurate data, analyze findings comprehensively, and make well-informed decisions based on the study's outcomes.

3. Set Clear Objectives and Scope

Before you begin the feasibility study, it's crucial to establish clear and well-defined objectives. These objectives will guide your research and analysis efforts throughout the study.

Steps to Set Clear Objectives and Scope:

• Objective Clarity: Define the specific goals you aim to achieve through the feasibility study. What questions do you want to answer, and what decisions will the study inform?
• Scope Definition: Determine the boundaries of your study. What aspects of the project will be included, and what will be excluded? Clarify any limitations.
• Resource Allocation: Assess the resources needed for the study, including time, budget, and personnel. Ensure that you allocate resources appropriately based on the scope and objectives.
• Timeline: Establish a realistic timeline for the feasibility study. Identify key milestones and deadlines for completing different phases of the study.

Clear objectives and a well-defined scope will help you stay focused and avoid scope creep during the study. They also provide a basis for measuring the study's success against its intended outcomes.

4. Gather Initial Information

Before you delve into extensive research and data collection , start by gathering any existing information and documents related to your project or industry. This initial step will help you understand the current landscape and identify gaps in your knowledge.

• Document Review: Review any existing project documentation, market research reports, business plans, or relevant industry studies.
• Competitor Analysis : Gather information about your competitors, including their products, pricing, market share, and strategies.
• Regulatory and Compliance Documents: If applicable, collect information on industry regulations, permits, licenses, and compliance requirements.
• Market Trends: Stay informed about current market trends, consumer preferences, and emerging technologies that may impact your project.
• Stakeholder Interviews: Consider conducting initial interviews with key stakeholders, including potential customers, suppliers, and industry experts, to gather insights and feedback.

By starting with a strong foundation of existing knowledge, you'll be better prepared to identify gaps that require further investigation during the feasibility study. This proactive approach ensures that your study is comprehensive and well-informed from the outset.

How to Conduct a Market Feasibility Study?

The market feasibility study is a crucial component of your overall feasibility analysis. It focuses on assessing the potential demand for your product or service, understanding your target audience, analyzing your competition, and evaluating supply and demand dynamics within your chosen market.

Market Research and Analysis

Market research is the foundation of your market feasibility study. It involves gathering and analyzing data to gain insights into market trends, customer preferences, and the overall business landscape.

• Data Collection: Utilize various methods such as surveys, interviews, questionnaires, and secondary research to collect data about the market. This data may include market size, growth rates, and historical trends.
• Market Segmentation: Divide the market into segments based on factors such as demographics, psychographics , geography, and behavior. This segmentation helps you identify specific target markets .
• Customer Needs Analysis: Understand the needs, preferences, and pain points of potential customers . Determine how your product or service can address these needs effectively.
• Market Trends: Stay updated on current market trends, emerging technologies, and industry innovations that could impact your project.
• SWOT Analysis: Conduct a SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis to identify internal and external factors that may affect your market entry strategy.

In today's dynamic market landscape, gathering precise data for your market feasibility study is paramount. Appinio offers a versatile platform that enables you to swiftly collect valuable market insights from a diverse audience.

With Appinio, you can employ surveys, questionnaires, and in-depth analyses to refine your understanding of market trends, customer preferences, and competition.

Enhance your market research and gain a competitive edge by booking a demo with us today!

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Target Audience Identification

Knowing your target audience is essential for tailoring your product or service to meet their specific needs and preferences.

• Demographic Analysis: Define the age, gender, income level, education, and other demographic characteristics of your ideal customers.
• Psychographic Profiling: Understand the psychographics of your target audience, including their lifestyle, values, interests, and buying behavior.
• Market Segmentation: Refine your target audience by segmenting it further based on shared characteristics and behaviors.
• Needs and Pain Points: Identify your target audience's unique needs, challenges, and pain points that your product or service can address.
• Competitor's Customers: Analyze the customer base of your competitors to identify potential opportunities for capturing market share.

Competitive Analysis

Competitive analysis helps you understand the strengths and weaknesses of your competitors, positioning your project strategically within the market.

• Competitor Identification: Identify direct and indirect competitors within your industry or market niche.
• Competitive Advantage: Determine the unique selling points (USPs) that set your project apart from competitors. What value can you offer that others cannot?
• SWOT Analysis for Competitors: Conduct a SWOT analysis for each competitor to assess their strengths, weaknesses, opportunities, and threats.
• Market Share Assessment: Analyze each competitor's market share and market penetration strategies.
• Pricing Strategies: Investigate the pricing strategies employed by competitors and consider how your pricing strategy will compare.

Leveraging the power of data collection and analysis is essential in gaining a competitive edge. With Appinio , you can efficiently gather critical insights about your competitors, their strengths, and weaknesses. Seamlessly integrate these findings into your market feasibility study, empowering your project with a strategic advantage.

Demand and Supply Assessment

Understanding supply and demand dynamics is crucial for gauging market sustainability and potential challenges.

• Market Demand Analysis: Estimate the current and future demand for your product or service. Consider factors like seasonality and trends.
• Supply Evaluation: Assess the availability of resources, suppliers, and distribution channels required to meet the expected demand.
• Market Saturation: Determine whether the market is saturated with similar offerings and how this might affect your project.
• Demand Forecasting: Use historical data and market trends to make informed projections about future demand.
• Scalability: Consider the scalability of your project to meet increased demand or potential fluctuations.

A comprehensive market feasibility study will give you valuable insights into your potential customer base, market dynamics, and competitive landscape. This information will be pivotal in shaping your project's direction and strategy.

How to Conduct a Technical Feasibility Study?

The technical feasibility study assesses the practicality of implementing your project from a technical standpoint. It involves evaluating the project's design, technical requirements, technological feasibility, resource availability, and risk analysis. Let's delve into each aspect in more detail.

1. Project Design and Technical Requirements

The project design and technical requirements are the foundation of your technical feasibility study. This phase involves defining the technical specifications and infrastructure needed to execute your project successfully.

• Technical Specifications: Clearly define the technical specifications of your project, including hardware, software, and any specialized equipment.
• Infrastructure Planning: Determine the physical infrastructure requirements, such as facilities, utilities, and transportation logistics.
• Development Workflow: Outline the workflow and processes required to design, develop, and implement the project.
• Prototyping: Consider creating prototypes or proof-of-concept models to test and validate the technical aspects of your project.

2. Technology Assessment

A critical aspect of the technical feasibility study is assessing the technology required for your project and ensuring it aligns with your goals.

• Technology Suitability: Evaluate the suitability of the chosen technology for your project. Is it the right fit, or are there better alternatives?
• Scalability and Compatibility: Assess whether the chosen technology can scale as your project grows and whether it is compatible with existing systems or software.
• Security Measures: Consider cybersecurity and data protection measures to safeguard sensitive information.
• Technical Expertise: Ensure your team or external partners possess the technical expertise to implement and maintain the technology.

3. Resource Evaluation

Resource evaluation involves assessing the availability of the essential resources required to execute your project successfully. These resources include personnel, materials, and suppliers.

• Human Resources: Evaluate whether you have access to skilled personnel or if additional hiring or training is necessary.
• Material Resources: Identify the materials and supplies needed for your project and assess their availability and costs.
• Supplier Relationships: Establish relationships with reliable suppliers and consistently assess their ability to meet your resource requirements.

4. Risk Analysis

Risk analysis is a critical component of the technical feasibility study, as it helps you anticipate and mitigate potential technical challenges and setbacks.

• Identify Risks: Identify potential technical risks, such as hardware or software failures, technical skill gaps, or unforeseen technical obstacles.
• Risk Mitigation Strategies: Develop strategies to mitigate identified risks, including contingency plans and resource allocation for risk management.
• Cost Estimation for Risk Mitigation: Assess the potential costs associated with managing technical risks and incorporate them into your project budget.

By conducting a thorough technical feasibility study, you can ensure that your project is technically viable and well-prepared to overcome technical challenges. This assessment will also guide decision-making regarding technology choices, resource allocation, and risk management strategies.

How to Conduct a Financial Feasibility Study?

The financial feasibility study is a critical aspect of your overall feasibility analysis. It focuses on assessing the financial viability of your project by estimating costs, projecting revenue, conducting investment analysis, and evaluating the overall financial health of your project. Let's delve into each aspect in more detail.

1. Cost Estimation

Cost estimation is the process of calculating the expenses associated with planning, developing, and implementing your project. This involves identifying both initial and ongoing costs.

• Initial Costs: Calculate the upfront expenses required to initiate the project, including capital expenditures, equipment purchases, and any development costs.
• Operational Costs: Estimate the ongoing operating expenses, such as salaries, utilities, rent, marketing, and maintenance.
• Contingency Funds: Allocate funds for unexpected expenses or contingencies to account for unforeseen challenges.
• Depreciation: Consider the depreciation of assets over time, as it impacts your financial statements.

2. Revenue Projections

Revenue projections involve forecasting the income your project is expected to generate over a specific period. Accurate revenue projections are crucial for assessing the project's financial viability.

• Sales Forecasts: Estimate your product or service sales based on market demand, pricing strategies, and potential growth.
• Pricing Strategy: Determine your pricing strategy, considering factors like competition, market conditions, and customer willingness to pay.
• Market Penetration: Analyze how quickly you can capture market share and increase sales over time.
• Seasonal Variations: Account for any seasonal fluctuations in revenue that may impact your cash flow.

3. Investment Analysis

Investment analysis involves evaluating the potential return on investment (ROI) and assessing the attractiveness of your project to potential investors or stakeholders.

• Return on Investment (ROI): Calculate the expected ROI by comparing the project's net gains against the initial investment.
• Payback Period: Determine how long it will take for the project to generate sufficient revenue to cover its initial costs.
• Risk Assessment: Consider the level of risk associated with the project and whether it aligns with investors' risk tolerance.
• Sensitivity Analysis: Perform sensitivity analysis to understand how changes in key variables, such as sales or costs, affect the investment's profitability.

4. Financial Viability Assessment

A financial viability assessment evaluates the project's ability to sustain itself financially in the long term. It considers factors such as profitability, cash flow, and financial stability.

• Profitability Analysis: Assess whether the project is expected to generate profits over its lifespan.
• Cash Flow Management: Analyze the project's cash flow to ensure it can cover operating expenses, debt payments, and other financial obligations.
• Break-Even Analysis: Determine the point at which the project's revenue covers all costs, resulting in neither profit nor loss.
• Financial Ratios: Calculate key financial ratios, such as debt-to-equity ratio and return on equity, to evaluate the project's financial health.

By conducting a comprehensive financial feasibility study, you can gain a clear understanding of the project's financial prospects and make informed decisions regarding its viability and potential for success.

How to Conduct an Operational Feasibility Study?

The operational feasibility study assesses whether your project can be implemented effectively within your organization's operational framework. It involves evaluating processes, resource planning, scalability, and analyzing potential operational risks.

1. Process and Workflow Assessment

The process and workflow assessment examines how the project integrates with existing processes and workflows within your organization.

• Process Mapping: Map out current processes and workflows to identify areas of integration and potential bottlenecks.
• Workflow Efficiency: Assess the efficiency and effectiveness of existing workflows and identify opportunities for improvement.
• Change Management: Consider the project's impact on employees and plan for change management strategies to ensure a smooth transition.

2. Resource Planning

Resource planning involves determining the human, physical, and technological resources needed to execute the project successfully.

• Human Resources: Assess the availability of skilled personnel and consider whether additional hiring or training is necessary.
• Physical Resources: Identify the physical infrastructure, equipment, and materials required for the project.
• Technology and Tools: Ensure that the necessary technology and tools are available and up to date to support project implementation.

3. Scalability Evaluation

Scalability evaluation assesses whether the project can adapt and expand to meet changing demands and growth opportunities.

• Scalability Factors: Identify factors impacting scalability, such as market growth, customer demand, and technological advancements.
• Capacity Planning: Plan for the scalability of resources, including personnel, infrastructure, and technology.
• Growth Strategies: Develop strategies for scaling the project, such as geographic expansion, product diversification, or increasing production capacity.

4. Operational Risk Analysis

Operational risk analysis involves identifying potential operational challenges and developing mitigation strategies.

• Risk Identification: Identify operational risks that could disrupt project implementation or ongoing operations.
• Risk Mitigation: Develop risk mitigation plans and contingency strategies to address potential challenges.
• Testing and Simulation: Consider conducting simulations or testing to evaluate how the project performs under various operational scenarios.
• Monitoring and Adaptation: Implement monitoring and feedback mechanisms to detect and address operational issues as they arise.

Conducting a thorough operational feasibility study ensures that your project aligns with your organization's capabilities, processes, and resources. This assessment will help you plan for a successful implementation and minimize operational disruptions.

How to Write a Feasibility Study?

The feasibility study report is the culmination of your feasibility analysis. It provides a structured and comprehensive document outlining your study's findings, conclusions, and recommendations. Let's explore the key components of the feasibility study report.

1. Structure and Components

The structure of your feasibility study report should be well-organized and easy to navigate. It typically includes the following components:

• Executive Summary: A concise summary of the study's key findings, conclusions, and recommendations.
• Introduction: An overview of the project, the objectives of the study, and a brief outline of what the report covers.
• Methodology: A description of the research methods , data sources, and analytical techniques used in the study.
• Market Feasibility Study: Detailed information on market research, target audience, competitive analysis, and demand-supply assessment.
• Technical Feasibility Study: Insights into project design, technical requirements, technology assessment, resource evaluation, and risk analysis.
• Financial Feasibility Study: Comprehensive information on cost estimation, revenue projections, investment analysis, and financial viability assessment.
• Operational Feasibility Study: Details on process and workflow assessment, resource planning, scalability evaluation, and operational risks analysis.
• Conclusion: A summary of key findings and conclusions drawn from the study.

Recommendations: Clear and actionable recommendations based on the study's findings.

2. Write the Feasibility Study Report

When writing the feasibility study report, it's essential to maintain clarity, conciseness, and objectivity. Use clear language and provide sufficient detail to support your conclusions and recommendations.

• Be Objective: Present findings and conclusions impartially, based on data and analysis.
• Use Visuals: Incorporate charts, graphs, and tables to illustrate key points and make the report more accessible.
• Cite Sources: Properly cite all data sources and references used in the study.
• Include Appendices: Attach any supplementary information, data, or documents in appendices for reference.

3. Present Findings and Recommendations

When presenting your findings and recommendations, consider your target audience. Tailor your presentation to the needs and interests of stakeholders, whether they are investors, executives, or decision-makers.

• Highlight Key Takeaways: Summarize the most critical findings and recommendations upfront.
• Use Visual Aids: Create a visually engaging presentation with slides, charts, and infographics.
• Address Questions: Be prepared to answer questions and provide additional context during the presentation.
• Provide Supporting Data: Back up your findings and recommendations with data from the feasibility study.

4. Review and Validation

Before finalizing the feasibility study report, conducting a thorough review and validation process is crucial. This ensures the accuracy and credibility of the report.

• Peer Review: Have colleagues or subject matter experts review the report for accuracy and completeness.
• Data Validation: Double-check data sources and calculations to ensure they are accurate.
• Cross-Functional Review: Involve team members from different disciplines to provide diverse perspectives.
• Stakeholder Input: Seek input from key stakeholders to validate findings and recommendations.

By following a structured approach to creating your feasibility study report, you can effectively communicate the results of your analysis, support informed decision-making, and increase the likelihood of project success.

Feasibility Study Examples

Let's dive into some real-world examples to truly grasp the concept and application of feasibility studies. These examples will illustrate how various types of projects and businesses undergo the feasibility assessment process to ensure their viability and success.

Example 1: Local Restaurant

Imagine you're passionate about opening a new restaurant in a bustling urban area. Before investing significant capital, you'd want to conduct a thorough feasibility study. Here's how it might unfold:

• Market Feasibility: You research the local dining scene, identify target demographics, and assess the demand for your cuisine. Market surveys reveal potential competitors, dining preferences, and pricing expectations.
• Technical Feasibility: You design the restaurant layout, plan the kitchen setup, and assess the technical requirements for equipment and facilities. You consider factors like kitchen efficiency, safety regulations, and adherence to health codes.
• Financial Feasibility: You estimate the initial costs for leasing or purchasing a space, kitchen equipment, staff hiring, and marketing. Revenue projections are based on expected foot traffic, menu pricing, and seasonal variations.
• Operational Feasibility: You create kitchen and service operations workflow diagrams, considering staff roles and responsibilities. Resource planning includes hiring chefs, waitstaff, and kitchen personnel. Scalability is evaluated for potential expansion or franchising.
• Risk Analysis: Potential operational risks are identified, such as food safety concerns, labor shortages, or location-specific challenges. Risk mitigation strategies involve staff training, quality control measures, and contingency plans for unexpected events.

Example 2: Software Development Project

Now, let's explore the feasibility study process for a software development project, such as building a mobile app:

• Market Feasibility: You analyze the mobile app market, identify your target audience, and assess the demand for a solution in a specific niche. You gather user feedback and conduct competitor analysis to understand the competitive landscape.
• Technical Feasibility: You define the technical requirements for the app, considering platforms (iOS, Android), development tools, and potential integrations with third-party services. You evaluate the feasibility of implementing specific features.
• Financial Feasibility: You estimate the development costs, including hiring developers, designers, and ongoing maintenance expenses. Revenue projections are based on app pricing, potential in-app purchases, and advertising revenue.
• Operational Feasibility: You map out the development workflow, detailing the phases from concept to deployment. Resource planning includes hiring developers with the necessary skills, setting up development environments, and establishing a testing framework.
• Risk Analysis: Potential risks like scope creep, technical challenges, or market saturation are assessed. Mitigation strategies involve setting clear project milestones, conducting thorough testing, and having contingency plans for technical glitches.

These examples demonstrate the versatility of feasibility studies across diverse projects. Whatever type of venture or endeavor you want to embark on, a well-structured feasibility study guides you toward informed decisions and increased project success.

In conclusion, conducting a feasibility study is a crucial step in your project's journey. It helps you assess the viability and potential risks, providing a solid foundation for informed decision-making. Remember, a well-executed feasibility study not only enables you to identify challenges but also uncovers opportunities that can lead to your project's success.

By thoroughly examining market trends, technical requirements, financial aspects, and operational considerations, you are better prepared to embark on your project confidently. With this guide, you've gained the knowledge and tools needed to navigate the intricate terrain of feasibility studies.

How to Conduct a Feasibility Study in Minutes?

Speed and precision are paramount for feasibility studies, and Appinio delivers just that. As a real-time market research platform, Appinio empowers you to seamlessly conduct your market research in a matter of minutes, putting actionable insights at your fingertips.

Here's why Appinio stands out as the go-to tool for feasibility studies:

• Rapid Insights: Appinio's intuitive platform ensures that anyone, regardless of their research background, can effortlessly navigate and conduct research, saving valuable time and resources.
• Lightning-Fast Responses: With an average field time of under 23 minutes for 1,000 respondents, Appinio ensures that you get the answers you need when you need them, making it ideal for time-sensitive feasibility studies.
• Global Reach: Appinio's extensive reach spans over 90 countries, allowing you to define the perfect target group from a pool of 1,200+ characteristics and gather insights from diverse markets.

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What Is a Feasibility Study? How It Ensures Project Success

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What is the purpose of a feasibility study?

Types of feasibility studies.

• How to conduct a feasibility study?

Shark Tank was invented for a reason. A famous quote goes along these lines - "Execution is more important than planning. Planning is more important than ideas." 

There can be multiple interpretations of the saying (as with any quote), but the essence of it seems to be the importance of coming up with an idea that has a clear return on investment (ROI) and is implemented in a way that sets the business up for success.

Think of feasibility studies as an approach that boosts the value of an idea and prepares it to perform at its optimal level, thus leaving the essence of our quote intact. Feasibility studies are an integral part of the ideation, planning, and execution process, and when combined with technology like project management software , every project delivers on its objectives.

What is a feasibility study?

A feasibility study consists of research conducted before the approval of a project. It is essential to the project life cycle development as it helps determine the likelihood of success before you’ve spent your resources on a potential lost cause. 

The study helps determine a project's viability by looking at cost, resource requirements, return on investment, and necessary business factors to ensure its practicality and use cases.

You have an incredible project idea but are unsure whether it aligns with current business goals - so do you give up? No! You get to workshop your idea through a feasibility study to identify the project's strengths, weaknesses, and overall outcomes.

The aim of feasibility studies is to assess project objectives and opportunity costs to help choose the best alternative action. Before executing any business proposition, it is critical to check whether the plan can be achieved by the organization. Feasibility studies simplify project estimation and potential roadblocks by considering various factors, such as available resources, competencies, costs, and time frames.

By analyzing business performance and predicted outcomes, feasibility studies reduce the risk of failures and help bridge gaps in existing business models. Additionally, they force stakeholders to think through every idea in detail to make it easier to secure investment, improve performance, and make a strong case for the proposition.

Want to learn more about Project Management Software? Explore Project Management products.

Feasibility studies are essential to determine the opportunities and threats associated with the proposed business idea. Since the scope of evaluation can depend on the project and type and size of the company, feasibility studies are categorized into four main types.

• Technical feasibility:  This study answers the question, "Are the resources this project requires accessible?" The technical feasibility study lists the tools and labor needed to execute the idea successfully. Some projects require while complex ideas may benefit from visualizations like Gantt charts.
• Financial feasibility: The cost evaluation study answers the question, "How much will the resources for the project cost?" Assessing financial feasibility is critical to understanding the estimated income from the project, managing budgets , and determining the true cost of the project you hope to undertake.
• Market feasibility: A market assessment study answers questions like, "Who is the target audience for this project?" and "Is this the right market environment to launch this project?" Carrying out market research surveys minimizes the risk investments, helps identify trends, and is key to staying ahead of competitors when implementing new strategies.
• Organizational feasibility: This part of a feasibility study seeks to answer the question, "Who is working on this project, and in what role?" Outlining the organizational structure of a project is important to evaluate the ability of the company's management team and their areas of interest and expertise.

How to conduct a feasibility study

Feasibility studies consider all project factors to determine the likelihood of a team achieving its goals successfully. They help in answering questions such as:

• Is the project cost-efficient?
• Will the current state of the economy allow for success?
• Does it make sense to pursue this venture at this particular time?

Having these answers helps assess whether your proposed project or strategy is a necessary and practical solution.

To conduct a feasibility study, there are 3 main steps.

1. Define project goals

Start your feasibility study by defining the project and outlining its goal and deliverables.  A best practice to follow is to use the goal-setting process to evaluate necessary project steps.

Depending on where your company puts the feasibility study in the project life cycle, your project sponsors may have to choose between several studies to decide which ones to execute. By clearly describing your proposed solution, you can increase the chances of stakeholders picking your suggested course of action.

2. Run a preliminary study 

The most important aspect of a feasibility study is to determine the project's true feasibility  by conducting preliminary research.

For example, let's assume you are trying to get buy-in from senior leadership on redesigning the website. Before diving head first into setting up meetings with the C-suite, take a few steps back and analyze the various requirements for the venture. Make a detailed plan regarding the rationale behind the redesign, headcount required to help the project, necessary tools, and estimated time and cost.

Collect as much data as possible in the early stages of the study to create a strong value proposition . Make sure to note any risk factors and obstacles identified, along with probable solutions to nudge stakeholders towards giving you the green flag to proceed.

One of the biggest business considerations when launching new ideas is financial. This is why it is imperative that the preliminary analyses include a projected revenue that takes into account operating costs and net profits .

3. Perform a business analysis

There can be a thousand incredible ideas, but if only 5 of those can be achieved and implemented with the resources and goals of the business at a particular time, those are your projects.

When thinking of new ideas and endeavors, it may be helpful to assess whether the project aligns with the greater business goals or is more suited to a specific team's roadmaps. Projects impacting the organization's bottom line are more likely to be moved forward rather than ideas that benefit a small group. For example, a new product launch strategy will receive more attention than the request for an expensive tool set for a single department.

Things to consider during a business analysis

• Executive summary : Detailed description of the project, proposition, or plan.
• Project financials : Provide information regarding project costs and expected ROIs through financial analyses.
• Marketing strategy : Outline target personas, plans, and tools required to market the project.
• Staffing requirements : Draft an organizational plan detailing human capital needs for the project.
• Schedule and timeline : Include project milestones and interim markers for project completion.

Focus on what's feasible

Back to why Shark Tank was invented - to stop well-meaning people from draining their funds on impractical ventures that can't be scaled.

Taking a few extra moments to analyze an idea in detail and determine the best way to move forward is sometimes the only way to ensure success. Feasibility studies are powerful tools for project management and can help inculcate critical thinking and problem-solving for everyday tasks.

The first step to diving deep into small and big ideas is to conduct a feasibility study. Ready to bring your project to life? Start with the tried and tested project management methodologies . 

Grace Pinegar

Grace Pinegar is a lifelong storyteller with an extensive background in various forms such as acting, journalism, improv, research, and content marketing. She was raised in Texas, educated in Missouri, worked in Chicago, and is now a proud New Yorker. (she/her/hers)

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What is a Feasibility Study?

Steps in a feasibility study, contents of a feasibility report, types of feasibility study, more resources, feasibility study.

An assessment of the practicality of a proposed project/plan

A feasibility study, as the name suggests, is designed to reveal whether a project/plan is feasible. It is an assessment of the practicality of a proposed project/plan.

A feasibility study is part of the initial design stage of any project/plan. It is conducted in order to objectively uncover the strengths and weaknesses of a proposed project or an existing business. It can help to identify and assess the opportunities and threats present in the natural environment, the resources required for the project, and the prospects for success. It is conducted in order to find answers to the following questions:

• Does the company possess the required resources and technology?
• Will the company receive a sufficiently high return on its investment?

Conducting a feasibility study involves the following steps:

• Conduct preliminary analyses.
• Prepare a projected income statement . What are the possible revenues that the project can generate?
• Conduct a market survey. Does the project create a good or service that is in demand in the market? What price are consumers willing to pay for the good or service?
• Plan the organizational structure of the new project. What are the staffing requirements? How many workers are needed? What other resources are needed?
• Prepare an opening day balance of projected expenses and revenue
• Review and analyze the points of vulnerability that are internal to the project and that can be controlled or eliminated.
• Decide whether to go on with the plan/project.

A feasibility report should include the following sections:

• Executive Summary
• Description of the Product/Service
• Technology Considerations
• Product/ Service Marketplace
• Identification of the Specific Market
• Marketing Strategy
• Organizational Structure
• Financial Projections

1. Technical feasibility

• Technical: Hardware and software
• Existing or new technology
• Site analysis
• Transportation

2. Financial feasibility

• Initial investment
• Resources to procure capital: Banks, investors, venture capitalists
• Return on investment

3. Market feasibility

• Type of industry
• Prevailing market
• Future market growth
• Competitors and potential customers
• Projection of sales

4. Organizational feasibility

• The organizational structure of the business
• Legal structure of the business or the specific project
• Management team’s competency, professional skills, and experience

The practice of companies blindly following available templates comes with enormous risks. Whether companies design or copy certain business models, it is necessary to conduct a feasibility study using models to reduce the risk of failure. A feasibility study of the business model should be centered on the organization’s value-creation processes.

Thank you for reading CFI’s guide on Feasibility Study. To keep learning and advancing your career, the additional CFI resources below will be useful:

• Cross-Sectional Data Analysis
• Financial Statements Examples – Amazon Case Study
• Market Planning
• See all management & strategy resources

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How to conduct a feasibility study: Template and examples

Editor’s note : This article was last updated on 27 August 2024 to bolster the step-by-step guide with more detailed instructions, more robust examples, and a downloadable, customizable template.

Opportunities are everywhere. Some opportunities are small and don’t require many resources. Others are massive and need further analysis and evaluation.

One of your key responsibilities as a product manager is to evaluate the potential success of those opportunities before investing significant money, time, and resources. A feasibility study, also known as a feasibility assessment or feasibility analysis, is a critical tool that can help product managers determine whether a product idea or opportunity is viable, feasible, and profitable.

So, what is a feasibility analysis? Why should product managers use it? And how do you conduct one?

Click here to download our customizable feasibility study template .

What is a feasibility study?

A feasibility study is a systematic analysis and evaluation of a product opportunity’s potential to succeed. It aims to determine whether a proposed opportunity is financially and technically viable, operationally feasible, and commercially profitable.

A feasibility study typically includes an assessment of a wide range of factors, including the technical requirements of the product, resources needed to develop and launch the product, the potential market gap and demand, the competitive landscape, and economic and financial viability. These factors can be broken down into different types of feasibility studies:

• Technical feasibility — Evaluates the technical resources and expertise needed to develop the product and identifies any technical challenges that could arise
• Financial feasibility — Analyzes the costs involved, potential revenue, and overall financial viability of the opportunity
• Market feasibility — Assesses the demand for the product, market trends, target audience, and competitive landscape
• Operational feasibility — Looks at the organizational structure, logistics, and day-to-day operations required to launch and sustain the product
• Legal feasibility — Examines any legal considerations, including regulations, patents, and compliance requirements that could affect the opportunity

Based on the analysis’s findings, the product manager and their product team can decide whether to proceed with the product opportunity, modify its scope, or pursue another opportunity and solve a different problem.

Conducting a feasibility study helps PMs ensure that resources are invested in opportunities that have a high likelihood of success and align with the overall objectives and goals of the product strategy .

What are feasibility analyses used for?

Feasibility studies are particularly useful when introducing entirely new products or verticals. Product managers can use the results of a feasibility study to:

• Assess the technical feasibility of a product opportunity — Evaluate whether the proposed product idea or opportunity can be developed with the available technology, tools, resources, and expertise
• Determine a project’s financial viability — By analyzing the costs of development, manufacturing, and distribution, a feasibility study helps you determine whether your product is financially viable and can generate a positive return on investment (ROI)
• Evaluate customer demand and the competitive landscape — Assessing the potential market size, target audience, and competitive landscape for the product opportunity can inform decisions about the overall product positioning, marketing strategies, and pricing
• Identify potential risks and challenges — Identify potential obstacles or challenges that could impact the success of the identified opportunity, such as regulatory hurdles, operational and legal issues, and technical limitations
• Refine the product concept — The insights gained from a feasibility study can help you refine the product’s concept, make necessary modifications to the scope, and ultimately create a better product that is more likely to succeed in the market and meet users’ expectations

How to conduct a feasibility study

The activities involved in conducting a feasibility study differ from one organization to another. Also, the threshold, expectations, and deliverables change from role to role. However, a general set of guidelines can help you get started.

Here are some basic steps to conduct and report a feasibility study for major product opportunities or features:

1. Clearly define the opportunity

Imagine your user base is facing a significant problem that your product doesn’t solve. This is an opportunity. Define the opportunity clearly, support it with data, talk to your stakeholders to understand the opportunity space, and use it to define the objective.

2. Define the objective and scope

Each opportunity should be coupled with a business objective and should align with your product strategy.

Determine and clearly communicate the business goals and objectives of the opportunity. Align those objectives with company leaders to make sure everyone is on the same page. Lastly, define the scope of what you plan to build.

3. Conduct market and user research

Now that you have everyone on the same page and the objective and scope of the opportunity clearly defined, gather data and insights on the target market.

Include elements like the total addressable market (TAM) , growth potential, competitors’ insights, and deep insight into users’ problems and preferences collected through techniques like interviews, surveys, observation studies, contextual inquiries, and focus groups.

4. Analyze technical feasibility

Suppose your market and user research have validated the problem you are trying to solve. The next step should be to, alongside your engineers, assess the technical resources and expertise needed to launch the product to the market.

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Dig deeper into the proposed solution and try to comprehend the technical limitations and estimated time required for the product to be in your users’ hands. A detailed assessment might include:

• Technical requirements — What technology stack is needed? Does your team have the necessary expertise? Are there any integration challenges?
• Development timeline — How long will it take to develop the solution? What are the critical milestones?
• Resource allocation — What resources (hardware, software, personnel) are required? Can existing resources be repurposed?

5. Assess financial viability

If your company has a product pricing team, work closely with them to determine the willingness to pay (WTP) and devise a monetization strategy for the new feature.

Conduct a comprehensive financial analysis, including the total cost of development, revenue streams, and the expected return on investment (ROI) based on the agreed-upon monetization strategy. Key elements to include:

• Cost analysis — Breakdown of development, production, and operational costs
• Revenue projections — Estimated revenue from different pricing models
• ROI calculation — Expected return on investment and payback period

6. Evaluate potential risks

Now that you have almost a complete picture, identify the risks associated with building and launching the opportunity. Risks may include things like regulatory hurdles, technical limitations, and any operational risks.

A thorough risk assessment should cover:

• Technical risks — Potential issues with technology, integration, or scalability.
• Market risks — Changes in market conditions, customer preferences, or competitive landscape.
• Operational risks — Challenges in logistics, staffing, or supply chain management.
• Regulatory risks — Legal or compliance issues that could affect the product’s launch. For more on regulatory risks, check out this Investopedia article .

7. Decide, prepare, and share

Based on the steps above, you should end up with a comprehensive report that helps you decide whether to pursue the opportunity, modify its scope, or explore alternative options. Here’s what you should do next:

• Prepare your report — Compile all your findings, including the feasibility analysis, market research, technical assessment, financial viability, and risk analysis into a detailed report. This document should provide a clear recommendation on whether to move forward with the project
• Create an executive summary — Summarize the key findings and recommendations in a concise executive summary , tailored for stakeholders such as the C-suite. The executive summary should capture the essence of your report, focusing on the most critical points
• Present to stakeholders — Share your report with stakeholders, ensuring you’re prepared to discuss the analysis and defend your recommendations. Make sure to involve key stakeholders early in the process to build buy-in and address any concerns they may have
• Prepare for next steps — Depending on the decision, be ready to either proceed with the project, implement modifications, or pivot to another opportunity. Outline the action plan, resource requirements, and timeline for the next phase

Feasibility study template

The following feasibility study report template is designed to help you evaluate the feasibility of a product opportunity and provide a comprehensive report to inform decision-making and guide the development process.

Note: You can customize this template to fit your specific needs. Click here to download and customize this feasibility study report template .

Feasibility study example

Imagine you’re a product manager at a company that specializes in project management tools. Your team has identified a potential opportunity to expand the product offering by developing a new AI-powered feature that can automatically prioritize tasks for users based on their deadlines, workload, and importance.

A feasibility study can help you assess the viability of this opportunity. Here’s how you might approach it according to the template above:

• Opportunity description — The opportunity lies in creating an AI-powered feature that automatically prioritizes tasks based on user-defined parameters such as deadlines, workload, and task importance. This feature is expected to enhance user productivity by helping teams focus on high-priority tasks and ensuring timely project completion
• Problem statement — Many users of project management tools struggle with managing and prioritizing tasks effectively, leading to missed deadlines and project delays. Current solutions often require manual input or lack sophisticated algorithms to adjust priorities dynamically. The proposed AI-powered feature aims to solve this problem by automating the prioritization process, thereby reducing manual effort and improving overall project efficiency
• Business objective — The primary objective is to increase user engagement and satisfaction by offering a feature that addresses a common pain point. The feature is also intended to increase customer retention by providing added value and driving user adoption
• Scope — The scope includes the development of an AI algorithm capable of analyzing task parameters (e.g., deadlines, workload) and dynamically prioritizing tasks. The feature will be integrated into the existing project management tool interface, with minimal disruption to current users. Additionally, the scope covers user training and support for the new feature

Market analysis:

• Total addressable market (TAM)  — The TAM for this feature includes all users who actively manage projects and could benefit from enhanced task prioritization
• Competitor analysis — Competitor products such as Asana and Trello offer basic task prioritization features, but none use advanced AI algorithms. This presents a unique opportunity to differentiate this product by offering a more sophisticated solution
• User pain points — Surveys and interviews with current users reveal that 65 percent struggle with manual task prioritization, leading to inefficiencies and missed deadlines. Users expressed a strong interest in an automated solution that could save time and improve project outcomes

Technical requirements:

• AI algorithm development — The core of the feature is an AI algorithm that can analyze multiple factors to prioritize tasks. This requires expertise in machine learning, data processing, and AI integration
• Integration with existing infrastructure — The feature must seamlessly integrate with the existing architecture without causing significant disruptions. This includes data compatibility, API development, and UI/UX considerations
• Data handling and privacy — The feature will process sensitive project data, so robust data privacy and security measures must be implemented to comply with regulations like GDPR

Development timeline:

• Phase 1 (3 months) — Research and development of the AI algorithm, including training with sample datasets
• Phase 2 (2 months) — Integration with the platform, including UI/UX design adjustments
• Phase 3 (1 month) — Testing, quality assurance, and bug fixing
• Phase 4 (1 month) — User training materials and documentation preparation

Resource allocation:

• Development team  — Two AI specialists, three backend developers, two frontend developers, one project manager
• Hardware/software  — Additional cloud computing resources for AI processing, development tools for machine learning, testing environments

Cost analysis:

• Development costs — Estimated at $300,000, including salaries, cloud computing resources, and software licenses
• Marketing and launch costs  — $50,000 for promotional activities, user onboarding, and initial support
• Operational costs  — $20,000/year for maintenance, AI model updates, and ongoing support

Revenue projections:

• Pricing model — The AI-powered feature will be offered as part of a premium subscription tier, with an additional monthly fee of $10/user
• User adoption — Based on user surveys, an estimated 25 percent of the current user base (10,000 users) is expected to upgrade to the premium tier within the first year
• Projected revenue — First-year revenue is projected at $1.2 million, with an expected growth rate of 10 percent annually

ROI calculation:

• Break-even point — The project is expected to break even within 6 months of launch
• Five-year ROI — The feature is projected to generate a 200% ROI over five years, driven by increased subscription fees and user retention

Technical risks:

• AI algorithm complexity — Developing an accurate and reliable AI algorithm is challenging and may require multiple iterations
• Integration issues — There is a risk that integrating the new feature could disrupt the existing platform, leading to user dissatisfaction

Market risks:

• User adoption — There’s a risk that users may not perceive sufficient value in the AI feature to justify the additional cost, leading to lower-than-expected adoption rates

Operational risks:

• Support and maintenance — Maintaining the AI feature requires continuous updates and monitoring, which could strain the development and support teams

Regulatory risks:

• Data privacy compliance — Handling sensitive project data requires strict adherence to data privacy regulations. Noncompliance could lead to legal challenges and damage to the company’s reputation
• Decision — Based on the comprehensive analysis, the recommendation is to proceed with the development and launch of the AI-powered task prioritization feature. The potential for increased user engagement, differentiation from competitors, and positive ROI justifies the investment
• Prepare the report — A detailed report will be compiled, including all findings from the feasibility study, cost-benefit analysis, and risk assessments. This report will be presented to key stakeholders for approval
• Create an executive summary — A concise executive summary will be prepared for the C-suite, highlighting the key benefits, expected ROI, and strategic alignment with the company’s goals
• Next steps — Upon approval, the project will move into the development phase, following the timeline and resource allocation outlined in the study. Continuous monitoring and iterative improvements will be made based on user feedback and performance metrics

8. Executive summary

This feasibility study evaluates the potential for developing and launching an AI-powered task prioritization feature within our project management tool. The feature is intended to automatically prioritize tasks based on deadlines, workload, and task importance, thus improving user productivity and project efficiency. The study concludes that the feature is both technically and financially viable, with a projected ROI of 200 percent over five years. The recommendation is to proceed with development, as the feature offers a significant opportunity for product differentiation and user satisfaction.

Mock feasibility study report

Now let’s see what a feasibility study report based on the above example scenario would look like ( download an example here ):

Introduction

The purpose of this feasibility study is to assess the viability of introducing an AI-powered task prioritization feature into our existing project management software. This feature aims to address the common user challenge of manually prioritizing tasks, which often leads to inefficiencies and missed deadlines. By automating this process, we expect to enhance user productivity, increase customer retention, and differentiate our product in a competitive market.

Market and user research

The total addressable market (TAM) for this AI-powered task prioritization feature includes all current and potential users of project management tools who manage tasks and projects regularly. Based on market analysis, the current user base primarily consists of mid-sized enterprises and large organizations, where task management is a critical component of daily operations.

• Competitor analysis  — Key competitors in the project management space, such as Asana and Trello, offer basic task prioritization features. However, these solutions lack advanced AI capabilities that dynamically adjust task priorities based on real-time data. This gap in the market presents an opportunity for us to differentiate our product by offering a more sophisticated, AI-driven solution
• User pain points — Surveys and interviews conducted with our current user base reveal that 65 percent of users experience challenges with manual task prioritization. Common issues include difficulty in maintaining focus on high-priority tasks, inefficient use of time, and the tendency to miss deadlines due to poor task management. Users expressed a strong interest in an automated solution that could alleviate these challenges, indicating a high demand for the proposed feature

Technical feasibility

• AI algorithm development — The core component of the feature is an AI algorithm capable of analyzing multiple task parameters, such as deadlines, workload, and task importance. The development of this algorithm requires expertise in machine learning, particularly in natural language processing (NLP) and predictive analytics. Additionally, data processing capabilities will need to be enhanced to handle the increased load from real-time task prioritization
• Integration with existing infrastructure — The AI-powered feature must be integrated into our existing project management tool with minimal disruption. This includes ensuring compatibility with current data formats, APIs, and the user interface. The integration will also require modifications to the UI/UX to accommodate the new functionality while maintaining ease of use for existing features
• Data handling and privacy — The feature will process sensitive project data, making robust data privacy and security measures critical. Compliance with regulations such as GDPR is mandatory, and the data flow must be encrypted end-to-end to prevent unauthorized access. Additionally, user consent will be required for data processing related to the AI feature
• Phase 1 (3 months) — Research and development of the AI algorithm, including dataset acquisition, model training, and initial testing
• Phase 2 (2 months) — Integration with the existing platform, focusing on backend development and UI/UX adjustments
• Phase 3 (1 month) — Extensive testing, quality assurance, and bug fixing to ensure stability and performance
• Phase 4 (1 month) — Development of user training materials, documentation, and preparation for the product launch

Financial analysis

• Development costs — Estimated at $300,000, covering salaries, cloud computing resources, machine learning tools, and necessary software licenses
• Marketing and launch costs — $50,000 allocated for promotional campaigns, user onboarding programs, and initial customer support post-launch
• Operational costs — $20,000 annually for ongoing maintenance, AI model updates, and customer support services
• Pricing model — The AI-powered task prioritization feature will be included in a premium subscription tier, with an additional monthly fee of $10 per user
• User adoption — Market research suggests that approximately 25% of the current user base (estimated at 10,000 users) is likely to upgrade to the premium tier within the first year
• Projected revenue — First-year revenue is estimated at $1.2 million, with an anticipated annual growth rate of 10% as more users adopt the feature
• Break-even point — The project is expected to reach its break-even point within 6 months of the feature’s launch
• Five-year ROI — Over a five-year period, the feature is projected to generate a return on investment (ROI) of 200 percent, driven by steady subscription revenue and enhanced user retention

Risk assessment

• AI algorithm complexity — Developing a sophisticated AI algorithm poses significant technical challenges, including the risk of inaccuracies in task prioritization. Multiple iterations and extensive testing will be required to refine the algorithm
• Integration issues — Integrating the new feature into the existing platform could potentially cause compatibility issues, resulting in performance degradation or user dissatisfaction
• User adoption — There is a possibility that users may not perceive enough value in the AI-powered feature to justify the additional cost, leading to lower-than-expected adoption rates and revenue
• Support and maintenance — The ongoing support and maintenance required for the AI feature, including regular updates and monitoring, could place a significant burden on the development and customer support teams, potentially leading to resource constraints
• Data privacy compliance — Handling sensitive user data for AI processing necessitates strict adherence to data privacy regulations such as GDPR. Failure to comply could result in legal repercussions and damage to the company’s reputation

Conclusion and recommendations

The feasibility study demonstrates that the proposed AI-powered task prioritization feature is both technically and financially viable. The feature addresses a significant user pain point and has the potential to differentiate the product in a competitive market. With an estimated ROI of 200 percent over five years and strong user interest, it is recommended that the project move forward into the development phase.

Next steps include finalizing the development plan, securing approval from key stakeholders, and initiating the development process according to the outlined timeline and resource allocation. Continuous monitoring and iterative improvements will be essential to ensure the feature meets user expectations and achieves the projected financial outcomes.

Overcoming stakeholder management challenges

The ultimate challenge that faces most product managers when conducting a feasibility study is managing stakeholders .

Stakeholders may interfere with your analysis, jumping to conclusions that your proposed product or feature won’t work and deeming it a waste of resources. They may even try to prioritize your backlog for you.

Here are some tips to help you deal with even the most difficult stakeholders during a feasibility study:

• Use hard data to make your point — Never defend your opinion based on your assumptions. Always show them data and evidence based on your user research and market analysis
• Learn to say no — You are the voice of customers, and you know their issues and how to monetize them. Don’t be afraid to say no and defend your team’s work as a product manager
• Build stakeholder buy-in early on — Engage stakeholders from the beginning of the feasibility study process by involving them in discussions and seeking their input. This helps create a sense of ownership and ensures that their concerns and insights are considered throughout the study
• Provide regular updates and maintain transparency — Keep stakeholders informed about the progress of the feasibility study by providing regular updates and sharing key findings. This transparency can help build trust, foster collaboration, and prevent misunderstandings or misaligned expectations
• Leverage stakeholder expertise — Recognize and utilize the unique expertise and knowledge that stakeholders bring to the table. By involving them in specific aspects of the feasibility study where their skills and experience can add value, you can strengthen the study’s outcomes and foster a more collaborative working relationship

Final thoughts

A feasibility study is a critical tool to use right after you identify a significant opportunity. It helps you evaluate the potential success of the opportunity, analyze and identify potential challenges, gaps, and risks in the opportunity, and provides a data-driven approach in the market insights to make an informed decision.

By conducting a feasibility study, product teams can determine whether a product idea is profitable, viable, feasible, and thus worth investing resources into. It is a crucial step in the product development process and when considering investments in significant initiatives such as launching a completely new product or vertical.

For a more detailed approach and ready-to-use resources, consider using the feasibility study template provided in this post. If you’re dealing with challenging stakeholders, remember the importance of data-driven decisions, maintaining transparency, and leveraging the expertise of your team.

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Peer-reviewed

Research Article

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

* E-mail: [email protected]

Affiliation Centre for Primary Care and Public Health, Queen Mary University of London, London, United Kingdom

Affiliation Department of Mathematics and Statistics, Lancaster University, Lancaster, Lancashire, United Kingdom

Affiliation School of Health and Related Research, University of Sheffield, Sheffield, South Yorkshire, United Kingdom

Affiliation Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

Affiliation Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, Oxfordshire, United Kingdom

Affiliation Centre of Academic Primary Care, University of Aberdeen, Aberdeen, Scotland, United Kingdom

• Sandra M. Eldridge, 
• Gillian A. Lancaster, 
• Michael J. Campbell, 
• Lehana Thabane, 
• Sally Hopewell, 
• Claire L. Coleman, 
• Christine M. Bond

• Published: March 15, 2016
• https://doi.org/10.1371/journal.pone.0150205
• Reader Comments

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

Citation: Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, et al. (2016) Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS ONE 11(3): e0150205. https://doi.org/10.1371/journal.pone.0150205

Editor: Chiara Lazzeri, Azienda Ospedaliero-Universitaria Careggi, ITALY

Received: August 13, 2015; Accepted: February 10, 2016; Published: March 15, 2016

Copyright: © 2016 Eldridge et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: Due to a requirement by the ethics committee that the authors specified when the data will be destroyed, the authors are not able to give unlimited access to the Delphi study quantitative data. These data are available from Professor Sandra Eldridge. Data will be available upon request to all interested researchers. Qualitative data from the Delphi study are not available because the authors do not have consent from participants for wider distribution of this more sensitive data.

Funding: The authors received small grants from Queen Mary University of London (£7495), University of Sheffield (£8000), NIHR RDS London (£2000), NIHR RDS South East (£2400), Chief Scientist Office Scotland (£1000). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: All authors have completed the ICMJE disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare support from the following organisations that might have an interest in the submitted work – Queen Mary University of London, Sheffield University, NIHR, Chief Scientist Office Scotland; financial relationships with NIHR, MRC, EC FP7, Canadian Institute for Health Research, Wiley, who might have an interest in the submitted work in the previous three years. No other relationships or activities have influenced the submitted work. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Introduction

There is a large and growing number of studies in the literature that authors describe as feasibility or pilot studies. In this paper we focus on feasibility and pilot studies conducted in preparation for a future definitive randomised controlled trial (RCT) that aims to assess the effect of an intervention. We are primarily concerned with stand-alone studies that are completed before the start of such a definitive RCT, and do not specifically cover internal pilot studies which are designed as the early stage of a definitive RCT; work on the conduct of internal pilot studies is currently being carried out by the UK MRC Network of Hubs for Trials Methodology Research. One motivating factor for the work reported in this paper was the inconsistent use of terms. For example, in the context of RCTs ‘pilot study’ is sometimes used to refer to a study addressing feasibility in preparation for a larger RCT, but at other times it is used to refer to a small scale, often opportunistic, RCT which assesses efficacy or effectiveness.

A second, related, motivating factor was the lack of agreement in the research community about the use of the terms ‘pilot’ and ‘feasibility’ in relation to studies conducted in preparation for a future definitive RCT. In a seminal paper in 2004 reviewing the literature in relation to pilot and feasibility studies conducted in preparation for an RCT [ 1 ], Lancaster et al reported that they could find no formal guidance as to what constituted a pilot study. In the updated UK Medical Research Council (MRC) guidance on designing and evaluating complex interventions published four years later, feasibility and pilot studies are explicitly recommended, particularly in relation to identifying problems that might occur in an ensuing RCT of a complex intervention [ 2 ]. However, while the guidance suggests possible aims of such studies, for example, testing procedures for their acceptability, estimating the likely rates of recruitment and retention of subjects, and the calculation of appropriate sample sizes, no explicit definitions of a ‘pilot study’ or ‘feasibility study’ are provided. In 2010, Thabane and colleagues presented a number of definitions of pilot studies taken from various health related websites [ 3 ]. While these definitions vary, most have in common the idea of conducting a study in advance of a larger, more comprehensive, investigation. Thabane et al also considered the relationship between pilot and feasibility, suggesting that feasibility should be the main emphasis of a pilot study and that ‘a pilot study is synonymous with a feasibility study intended to guide the planning of a large scale investigation’. However, at about the same time, the UK National Institute for Health Research (NIHR) developed definitions of pilot and feasibility studies that are mutually exclusive, suggesting that feasibility studies occurred slightly earlier in the research process and that pilot studies are ‘a version of the main study that is run in miniature to test whether the components of the main study can all work together’. Arain et al . felt that the NIHR definitions were helpful, and showed that studies identified using the keyword ‘feasibility’ had different characteristics from those identified as ‘pilot’ studies [ 4 ]. The NIHR wording for pilot studies has been changed more recently to ‘a smaller version of the main study used to test whether the components of the main study can all work together’ ( Fig 1 ). Nevertheless, it still contrasts with the MRC framework guidance that explicitly states: ‘A pilot study need not be a “scale model” of the planned main-stage evaluation, but should address the main uncertainties that have been identified in the development work’ [ 2 ]. These various, sometimes conflicting, approaches to the interpretation of the terms ‘pilot’ and ‘feasibility’ exemplify differences in current usage and opinion in the research community.

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https://doi.org/10.1371/journal.pone.0150205.g001

While lack of agreement about definitions may not necessarily affect research quality, it can become problematic when trying to develop guidance for research conduct because of the need for clarity over what the guidance applies to and therefore what it should contain. Previous research has identified weaknesses in the reporting and conduct of pilot and feasibility studies [ 1 , 3 , 4 , 7 ], particularly in relation to studies conducted in preparation for a future definitive RCT assessing the effect of an intervention or therapy. While undertaking research to develop guidance to address some of the weaknesses in reporting these studies, we became convinced by the current interest in this area, the lack of clarity, and the differences of opinion in the research community, that a re-evaluation of the definitions of pilot and feasibility studies was needed. This paper describes the process and results of this re-evaluation and suggests a conceptual framework within which researchers can operate when designing and reporting pilot/feasibility studies. Since our work on reporting guidelines focused specifically on pilot and feasibility studies in preparation for an RCT assessing the effect of some intervention or therapy, we restrict our re-evaluation to these types of pilot and feasibility studies.

The process of developing and validating the conceptual framework for defining pilot and feasibility studies was, to a large extent, integral to the development of our reporting guidelines, the core components of which were a large Delphi study and an international expert consensus meeting focused on developing an extension of the 2010 CONSORT statement for RCTs [ 8 ] to randomised pilot studies. The reporting guidelines, Delphi study and consensus meeting are therefore referred to in this paper. However, the reporting guidelines will be reported separately; this paper focuses on our conceptual framework.

Developing a conceptual framework—Delphi study

Following research team discussion of our previous experience with, and research on, pilot and feasibility studies we initially produced mutually exclusive definitions of pilot and feasibility studies based on, but not identical to, the definitions used by the NIHR. We drew up two draft reporting checklists based on the 2010 CONSORT statement [ 8 ], one for what we had defined as feasibility studies and one for what we had defined as pilot studies. We constructed a Delphi survey, administered on-line by Clinvivo [ 9 ], to obtain consensus on checklist items for inclusion in a reporting guideline, and views on the definitions. Following user-testing of a draft version of the survey with a purposive sample of researchers active in the field of trials and pilot studies, and a workshop at the 2013 Society for Clinical Trials Conference in Boston, we further refined the definitions, checklists, survey introduction and added additional questions.

The first round of the main Delphi survey included: a description and explanation of our definitions of pilot and feasibility studies including examples (Figs 2 and 3 ); questions about participants’ characteristics; 67 proposed items for the two checklists and questions about overall appropriateness of the guidelines for feasibility or pilot studies; and four questions related to the definitions of feasibility and pilot studies: How appropriate do you think our definition for a pilot study conducted in preparation for an RCT is ? How appropriate do you think our definition for a feasibility study conducted in preparation for an RCT is ? How appropriate is the way we have distinguished between two different types of study conducted in preparation for an RCT ? How appropriate are the labels ‘pilot’ and ‘feasibility’ for the two types of study we have distinguished ? Participants were asked to rate their answers to the four questions on a nine-point scale from ‘not at all appropriate’ to ‘completely appropriate’. There was also a space for open comments about the definitions. The second round included results from the first round and again asked for further comments about the definitions.

https://doi.org/10.1371/journal.pone.0150205.g002

https://doi.org/10.1371/journal.pone.0150205.g003

Participants for the main survey were identified as likely users of the checklist including trialists, methodologists, statisticians, funders and journal editors. Three hundred and seventy potential participants were approached by email from the project team or directly from Clinvivo. These were individuals identified based on personal networks, authors of relevant studies in the literature, members of the Canadian Institute of Health Research, Biostatistics section of Statistics Society of Canada, and the American Statistical Society. The International Society for Clinical Biostatistics and the Society for Clinical Trials kindly forwarded our email to their entire membership. There was a link within the email to the on-line questionnaire. Each round lasted three weeks and participants were sent one reminder a week before the closure of each survey. The survey took place between August and October 2013. Ethical approval was granted by the ScHARR research ethics committee at the University of Sheffield.

Developing a conceptual framework—Open meeting and research team meetings

The results of the Delphi survey pertaining to the definitions of feasibility and pilot studies were presented to an open meeting at the 2 nd UK MRC Trials Methodology Conference in Edinburgh in November 2013 [ 13 ]. Attendees chose their preferred proposition from four propositions regarding the definitions, based variously on our original definitions, the NIHR and MRC views of pilot and feasibility studies and different views expressed in the Delphi survey. At a subsequent two-day research team meeting we collated the findings from the Delphi survey and the open meeting, and considered definitions of piloting and feasiblity outside the health research context found from on-line searches using the terms ‘pilot definition’, ‘feasiblity definition’, ‘pilot study definition’ and ‘feasibility study definition’ in Google. We expected all searches to give a very large number of hits and examined the first two pages of hits only from each search. From this, we developed a conceptual framework reflecting consensus about the definitions, types and roles of feasibility and pilot studies conducted in preparation for an RCT evaluating the effect of an intervention or therapy. To ensure we incorporated the views of all researchers likely to be conducting pilot/feasiblity studies, two qualitative researchers joined the second day of the meeting which focused on agreeing this framework. Throughout this process we continually referred back to examples that we had identified to check that our emerging definitions were workable.

Validating the conceptual framework—systematic review

To validate the proposed conceptual framework, we identified a selection of recently reported studies that fitted our definition of pilot and feasibility studies, and tested a number of hypotheses in relation to these studies. We expected that approximately 30 reports would be sufficient to test the hypotheses. We conducted a systematic review to identify studies that authors described as pilot or feasibility studies, by searching Medline via PubMed for studies that had the words ‘pilot’ or ‘feasibility’ in the title. To increase the likelihood that the studies would be those conducted in preparation for a randomised controlled trial of the effect of a therapy or intervention we limited our search to those that contained the word ‘trial’ in the title or abstract. For full details of the search strategy see S1 Fig .

To focus on current practice, we selected the 150 most recent studies from those identified by the electronic search. We did not exclude protocols since we were primarily interested in identifying the way researchers characterised their study and any possible future study and the relationship between them; we expected investigators to describe these aspects of their studies in a similar way in protocols and reports of findings. Two research team members independently reviewed study abstracts to assess whether each study fitted our working definition of a pilot or feasibility study in preparation for an RCT evaluating the effect of an intervention or therapy. Where reviewers disagreed, studies were classed as ‘possible inclusions’ and disagreements resolved by discussion with referral to the full text of the paper as necessary. Given the difficulty of interpreting some reports and to ensure that all research team members agreed on inclusion, the whole team then reviewed relevant extracted sections of the papers provisionally agreed for inclusion. We recognised that abstracts of some studies might not include appropriate information, and therefore that our initial abstract review could have excluded some relevant studies; we explored the extent of this potential omission of studies by reviewing the full texts of a random sample of 30 studies from the original 150. Since our prime goal was to identify a manageable number of relevant studies in order to test our hypotheses rather than identify all possible relevant studies we did not include any additional studies as a result of this exploratory study.

We postulated that the following hypotheses would support our conceptual framework:

• The words ‘pilot’ and ‘feasibility’ are both used in the literature to describe studies undertaken in preparation for an RCT evaluating the effect of an intervention or therapy
• It is possible to identify a subset of studies within the literature that are RCTs conducted in preparation for a larger RCT which evaluates the effect of an intervention or therapy. Authors do not use the term ‘pilot trial’ consistently in relation to these studies.
• Within the literature it is not possible to apply unique mutually exclusive definitions of pilot and feasibility studies in preparation for an RCT evaluating the effect of an intervention or therapy that are consistent with the way authors describe their studies.
• Amongst feasibility studies in preparation for an RCT which evaluates the effect of an intervention or therapy it is possible to identify some studies that are not pilot studies as defined within our conceptual framework, but are studies that acquire information about the feasibility of applying an intervention in a future study.

In order to explore these hypotheses, we categorised included studies into three groups that tallied with our framework (see results for details): randomised pilot studies, non-randomised pilot studies, feasibility studies that are not pilot studies. We also extracted data on objectives, and the phrases that indicated that the studies were conducted in preparation for a subsequent RCT.

Validating the conceptual framework—Consensus meeting

We also took an explanation and visual representation of our framework to an international consensus meeting primarily designed to reach consensus on an extension of the 2010 CONSORT statement to randomised pilot studies. There were 19 invited participants with known expertise, experience, or interest in pilot and feasibility studies, including representatives of CONSORT, funders, journal editors, and those who had been involved in writing the NIHR definitions of pilot and feasibility studies and the MRC guidance on designing and evaluating complex interventions. Thus this was an ideal forum in which to discuss the framework also. This project was not concerned with any specific disease, and was methodological in design; no patients or public were involved.

Ninety-three individuals, including chief investigators, statisticians, trial managers, clinicians, research assistants and a funder, participated in the first round of the Delphi survey and 79 in the second round. Over 70% of participants in the first round felt that our definitions, the way we had distinguished between pilot and feasibility studies, and the labels ‘pilot’ and ‘feasibility’ were appropriate. However, these four items had some of the lowest appropriateness ratings in the survey and there were a large number of comments both in direct response to our four survey items related to appropriateness of definitions, and in open comment boxes elsewhere in the survey. Some of these comments are presented in Fig 4 . Some participants commented favourably on the definitions we had drawn up (quote 1) but others were confused by them (quote 2). Several compared our definitions to the NIHR definitions pointing out the differences (quote 3) and suggesting this might make it particularly difficult for the research community to understand our definitions (quote 4). Some expressed their own views about the definitions (quote 5); largely these tallied with the NIHR definitions. Others noted that both the concept of feasibility and the word itself were often used in relation to studies which investigators referred to as pilot studies (quote 6). Others questioned whether it was practically and/or theoretically possible to make a distinction between pilot and feasibility studies (quote 6, quote 7), suggesting that the two terms are not mutually exclusive and that feasibility was more of an umbrella term for studies conducted prior to the main trial. Some participants felt that, using our definitions, feasibility studies would be less structured and more variable and therefore their quality would be less appropriately assessed via a checklist (quote 8). These responses regarding definitions mirrored what we had found in the user-testing of the Delphi survey, the Society for Clinical Trials workshop, and differences of opinion already apparent in the literature. In the second round of the survey there were few comments about definitions.

https://doi.org/10.1371/journal.pone.0150205.g004

There was a wide range of participants in the open meeting, including senior quantitative and qualitative methodologists, and a funding body representative. The four propositions we devised to cover different views about definitions of pilot and feasibility studies are shown in Fig 5 . Fourteen out of the fifteen attendees who voted on these propositions preferred propositions 3 or 4, based on comments from the Delphi survey and the MRC guidance on designing and evaluating complex interventions respectively. Neither of these propositions implied mutually exclusive definitions of pilot and feasibility studies.

https://doi.org/10.1371/journal.pone.0150205.g005

Definitions of feasibility outside the health research context focus on the likelihood of being able to do something. For example, the Oxford on-line dictionary defines feasibility as: ‘The state or degree of being easily or conveniently done’ [ 14 ] and a feasibility study as: ‘An assessment of the practicality of a proposed plan or method’ [ 15 ]. Some definitions also suggest that a feasibility study should help with decision making, for example [ 16 ]: ‘The feasibility study is an evaluation and analysis of the potential of a proposed project. It is based on extensive investigation and research to support the process of decision making’. Outside the health research context the word ‘pilot’ has several different meanings but definitions of pilot studies usually focus on an experiment, project or development undertaken in advance of a future wider experiment, project or development. For example the Oxford on-line dictionary describes a pilot study as: ‘Done as an experiment or test before being introduced more widely’ [ 17 ]. Several definitions carry with them ideas that the purpose of a pilot study is also to facilitate decision making, for example ‘a small-scale experiment or set of observations undertaken to decide how and whether to launch a full-scale project’ [ 18 ] and some definitions specifically mention feasibility, for example: ‘a small scale preliminary study conducted in order to evaluate feasibility’ [ 19 ].

In keeping with these definitions not directly related to the health research context, we agreed that feasiblity is a concept encapsulating ideas about whether it is possible to do something and that a feasibility study asks whether something can be done , should we proceed with it , and if so , how . While piloting is also concerned with whether something can be done and whether and how we should proceed with it, it has a further dimension; piloting is implementing something, or part of something, in a way you intend to do it in future to see whether it can be done in practice. We therefore agreed that a pilot study is a study in which a future study or part of a future study , is conducted on a smaller scale to ask the question whether something can be done , should we proceed with it , and if so , how . The corollary of these definitions is that all pilot studies are feasibility studies but not all feasibility studies are pilot studies. Within the context of RCTs, the focus of our research, the ‘something’ in the definitions can be replaced with ‘a future RCT evaluating the effect of an intervention or therapy’. Studies that address the question of whether the RCT can be done, should we proceed with it and if so how, can then be classed as feasibility or pilot studies. Some of these studies may, of course, have other objectives but if they are mainly focusing on feasiblity of the future RCT we would include them as feasiblity studies. All three studies used as examples in our Delphi survey [ 10 – 12 ] satisfy the definition of a feasiblity study. However, a study by Piot et al , that we encountered while developing the Delphi study, does not. This study is described as a pilot trial in the abstract but the authors present only data on effectiveness and although they state that their results require confirmation in a larger study it is not clear that their pilot study was conducted in preparation for such a larger study [ 20 ]. On the other hand, Palmer et al ‘performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI [femoroacetabular impingement]’ [ 12 ]. Heazell et al describe the aim of their randomised study as ‘to address whether a randomised controlled trial (RCT) of the management of RFM [reduced fetal movement] was feasible’ [ 10 ]. Their study was piloting many of the aspects they hoped to implement in a larger trial of RFM, thus making this also a pilot study, whereas the study conducted by Palmer et al , which comprised a questionnare to clinicians and seeking patient opinion, is not a pilot study but is a feasibility study.

Within our framework, some important studies conducted in advance of a future RCT to evaluate the effect of a therapy or intervention are not feasibility studies. For example, a systematic review, usually an essential pre-requisite for such an RCT, normally addresses whether the future RCT is necessary or desirable , not whether it is feasible . To reflect this, we developed a comprehensive diagrammatical representation of our framework for studies conducted in preparation for an RCT which, for completeness, includes, on the left hand side, early studies that are not pilot and feasibility studies, such as systematic reviews and, along the bottom, details of existing or planned reporting guidelines for different types of study ( S2 Fig ).

Validating the conceptual framework—Systematic review

From the 150 most recent studies identified by our electronic search, we identified 27 eligible reports ( Fig 6 ). In keeping with our working definition of a pilot or feasibility study, to be included the reports had to show evidence that investigators were addressing at least some feasibility objectives and that the study was in preparation for a future RCT evaluating the effect of an intervention. Ideally we would have stipulated that the primary objective of the study should be a feasibility objective but, given the nature of the reporting of most of these studies, we felt this would be too restrictive.

https://doi.org/10.1371/journal.pone.0150205.g006

The 27 studies are reported in Table 1 and results relating to terminology that authors used summarised in Table 2 . Results in Table 2 support our first hypothesis that the words ‘pilot’ and ‘feasibility’ are both used in the literature to describe studies undertaken in preparation for a randomised controlled trial of effectiveness; 63% (17/27) used both terms somewhere in the title or abstract. The table also supports our second hypothesis that amongst the subset of feasibility studies in preparation for an RCT that are themselves RCTs, authors do not use the term ‘pilot trial’ consistently in relation to these studies; of the 18 randomised studies only eight contained the words ‘pilot’ and ‘trial’ in the title. Our third hypothesis, namely that it is not possible to apply unique mutually exclusive definitions of pilot and feasibility studies in preparation for an RCT that are consistent with the way authors describe their studies, is supported by the characteristics of studies presented in Table 1 and summarised in Table 2 . We could find no design or other features (such as randomisation or presence of a control group) that distinguished between those that investigators called feasibility studies and those that they called pilot studies. However, the fourth hypothesis, that amongst studies in preparation for an RCT evaluating the effect of an intervention or therapy it is possible to identify some studies that explore the feasibility of a certain intervention or acquire related information about the feasibility of applying an intervention in a future study but are not pilot studies, was not supported; we identified no such studies amongst those reported in Table 1 . Nevertheless, we had identified two prior to carrying out the review [ 10 , 15 ].

https://doi.org/10.1371/journal.pone.0150205.t001

https://doi.org/10.1371/journal.pone.0150205.t002

Out of our exploratory sample of 30 study reports for which we reviewed full texts rather than only titles and abstracts, we identified 10 that could be classed as pilot or feasibility studies using our framework. We had already identified four of these in our sample reported in Table 1 , but had failed to identify the other six. As expected, this was because key information to identify them as pilot or feasiblity studies such as the fact that they were in preparation for a larger RCT, or that the main objectives were to do with feasiblity were not included in the abstract. Thus our assumption that an initial screen using only abstracts resulted in the omission of some pilot and feasiblity studies was correct.

International consensus meeting participants agreed with the general tenets of our conceptual framework including the ideas that all pilot studies are feasibility studies but that some feasibility studies are not pilot studies. They suggested that any definitive diagrammatic representation should more strongly reflect non-linearity in the ordering of feasibility studies. As a result of their input we produced a new, simplified, diagrammatical representation of the framework ( Fig 7 ) which focuses on the key elements represented inside an oval shape on our original diagram, omits the wider context outside this shape, and highlights some features, including the non-linearity, more clearly.

https://doi.org/10.1371/journal.pone.0150205.g007

The finalised framework

Fig 7 represents the framework. The figure indicates that where there is uncertainty about future RCT feasibility, a feasibility study is appropriate. Feasibility is thus an overarching concept within which we distinguish between three distinct types of study. Randomised pilot studies are those studies in which the future RCT, or parts of it, including the randomisation of participants, is conducted on a smaller scale (piloted) to see if it can be done. Thus randomised pilot studies can include studies that for the most part reflect the design of a future definitive trial but, if necessary due to remaining uncertainty, may involve trying out alternative strategies, for example, collecting an outcome variable via telephone for some participants and on-line for others. Within the framework randomised pilot studies could also legitimately be called randomised feasibility studies. Two-thirds of the studies presented in Table 1 are of this type.

Non-randomised pilot studies are similar to randomised pilot studies; they are studies in which all or part of the intervention to be evaluated and other processes to be undertaken in a future trial is/are carried out (piloted) but without randomisation of participants. These could also legitimately be called by the umbrella term, feasibility study. These studies cover a wide range from those that are very similar to randomised pilot studies except that the intervention and control groups have not been randomised, to those in which only the intervention, and no other trial processes, are piloted. One-third of studies presented in Table 1 are of this type.

Feasibility studies that are not pilot studies are those in which investigators attempt to answer a question about whether some element of the future trial can be done but do not implement the intervention to be evaluated or other processes to be undertaken in a future trial, though they may be addressing intervention development in some way. Such studies are rarer than the other types of feasibility study and, in fact, none of the studies in Table 1 were of this type. Nevertheless, we include these studies within the framework because they do exist; the Palmer study [ 15 ] in which surgeons and patients were asked about the feasibility of randomisation is one such example. Other examples might be interviews to ascertain the acceptability of an intervention, or questionnaires to assess the types of outcomes participants might think important. Within the framework these studies can be called feasibility studies but cannot be called pilot studies since no part of the future randomised controlled trial is being conducted on a smaller scale.

Investigators may conduct a number of studies to assess feasibility of an RCT to test the effect of any intervention or therapy. While it may be most common to carry out what we have referred to as feasibility studies that are not pilot studies before non-randomised pilot studies , and non-randomised pilot studies prior to randomised pilot studies , the process of feasibility work is not necessarily linear and such studies can in fact be conducted in any order. For completeness the diagram indicates the location of internal pilot studies.

There are diverse views about the definitions of pilot and feasibility studies within the research community. We reached consensus over a conceptual framework for the definitions of these studies in which feasibility is an overarching concept for studies assessing whether a future study, project or development can be done. For studies conducted in preparation for a RCT assessing the effect of a therapy or intervention, three distinct types of study come under the umbrella of feasibility studies: randomised pilot studies, non-randomised pilot studies, feasibility studies that are not pilot studies. Thus pilot studies are a subset of feasibility studies. A review of the literature confirmed that it is not possible to apply mutually exclusive definitions of pilot and feasibility studies in preparation for such an RCT that are consistent with the way authors describe their studies. For example Lee et al [ 31 ], Boogerd et al [ 22 ] and Wolf et al [ 38 ] all describe randomised studies exploring the feasibility of introducing new systems (brain computer interface memory training game, on-line interactive treatment environment, bed-exit alarm respectively) but Lee et al describe their study as a ‘A Randomized Control Pilot Study’, with the word ‘feasibility’ used in the abstract and text, while the study by Boogerd et al . is titled ‘Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes’, and Wolf at al describe their study as a pilot study without using the word ‘feasibility’.

Our re-evaluation of the definitions of pilot and feasibility studies was conducted over a period of time with input via a variety of media by multi-disciplinary and international researchers, publishers, editors and funders. It was to some extent a by-product of our work developing reporting guidelines for such studies. Nevertheless, we were able to gather a wide range of expert views, and the iterative nature of the development of our thinking has been an important part of obtaining consensus. Other parallel developments, including the recent establishment of the new Pilot and Feasibility Studies journal [ 48 ], suggest that our work is, indeed, timely. We encountered several difficulties in reviewing empirical study reports. Firstly, it was sometimes hard to assess whether studies were planned in preparation for an RCT or whether the authors were conducting a small study and simply commenting on the fact that a larger RCT would be useful. Secondly, objectives were sometimes unclear, and/or effectiveness objectives were often emphasised in spite of recommendations that pilot and feasibility studies should not be focusing on effectiveness [ 1 , 4 ]. In identifying relevant studies we erred on the side of inclusiveness, acknowledging that getting these studies published is not easy and that there are, as yet, no definitive reporting guidelines for investigators to follow. Lastly, our electronic search was unable to identify any feasibility studies that were not pilot studies according to our definitions. Subsequent discussion with qualitative researchers suggested that this is because such studies are often not described as feasibility studies in the title or abstract.

Our framework is compatible with the UK MRC guidance on complex interventions which suggests a ‘feasibility and piloting’ phase as part of the work to design and evaluate such interventions without any explicit distinction between pilot and feasibility studies. In addition, although our framework has a different underlying principle from that adopted by UK NIHR, the NIHR definition of a pilot study is not far from the subset of studies we have described as randomised pilot studies. Although there appears to be increasing interest in pilot and feasibility studies, as far as we are aware no other funding bodies specifically address the nature of such studies. The National Institute for Health in the USA does, however, routinely require published pilot studies before considering funding applications for certain streams, and the Canadian Institutes of Health Research routinely have calls for pilot or feasibility studies in different clinical areas to gather evidence necessary to determine the viability of new research directions determined by their strategic funding plans. These approaches highlight the need for clarity regarding what constitutes a pilot study.

There are several previous reviews of empirical pilot and feasibility studies [ 1 , 4 , 7 ]. In the most recent, reviewing studies published between 2000 and 2009 [ 7 ], the authors identified a large number of studies, described similar difficulty in identifying whether a larger study was actually being planned, and similar lack of consistency in the way the terms ‘pilot’ and ‘feasibility’ are used. Nevertheless, in methodological work, many researchers have adopted fairly rigid definitions of pilot and feasibility studies. For example, Bugge et al in developing the ADEPT framework refer to the NIHR definitions and suggest that feasibility studies ask questions about ‘whether the study can be done’ while pilot trials are ‘(a miniature version of the main trial), which aim to test aspects of study design and processes for the implementation of a larger main trial in the future’ [ 49 ]. Although not explicitly stated, the text seems to suggest that pilot and feasibility studies are mutually exclusive. Our work indicates that this is neither necessary nor desirable. There is, however, general agreement in the literature about the purpose of pilot and feasibility studies. For example, pilot trials are ‘to provide sufficient assurance to enable a larger definitive trial to be undertaken’ [ 50 ], and pilot studies are ‘designed to test the performance characteristics and capabilities of study designs, measures, procedures, recruitment criteria, and operational strategies that are under consideration for use in a subsequent, often larger, study’ [ 51 ], and ‘play a pivotal role in the planning of large-scale and often expensive investigations’ [ 52 ]. Within our framework we define all studies aiming to assess whether a future RCT is do-able as ‘feasibility studies’. Some might argue that the focus of their study in preparation for a future RCT is acceptability rather than feasibility, and indeed, in other frameworks, such as the RE-AIM framework [ 53 ], feasibility and acceptability are seen as two different concepts. However, it is perfectly possible to explore the acceptability of an intervention, of a data collection process or of randomisation in order to determine the feasibility of a putative larger RCT. Thus the use of the term ‘feasibility study’ for a study in preparation for a future RCT is not incompatible with the exploration of issues other than feasibility within the study itself.

There are numerous previous studies in which the investigators review the literature and seek the counsel of experts to develop definitions and clarify terminology. Most of these relate to clinical or physiological definitions [ 54 – 56 ]. A few explorations of definitions relate to concepts such as quality of life [ 57 ]. Implicit in much of this work is that from time to time definitions need rethinking as knowledge and practice moves on. From an etymological point of view this makes sense. In fact, the use of the word ‘pilot’ to mean something that is a prototype of something else only appears to emerge in the middle of the twentieth century and the first use of the word in relation to research design that we could find was in 1947—a pilot survey [ 58 ]. Thus we do not have to look very far back to see changes in the use of one of the words we have been dealing with in developing our conceptual framework. We hope what we are proposing here is helpful in the early twenty-first century to clarify the use of the words ‘pilot’ and ‘feasibility’ in a health research context.

We suggest that researchers view feasibility as an overarching concept, with all studies done in preparation for a main study open to being called feasibility studies, and with pilot studies as a subset of feasibility studies. All such studies should be labelled ‘pilot’ and/or ‘feasibility’ as appropriate, preferably in the title of a report, but if not certainly in the abstract. This recommendation applies to all studies that contribute to an assessment of the feasibility of an RCT evaluating the effect of an intervention. Using either of the terms in the title will be most helpful for those conducting future electronic searches. However, we recognise that for qualitative studies, authors may find it convenient to use the terms in the abstract rather than the title. Authors also need to describe objectives and methods well, reporting clearly if their study is in preparation for a future RCT to evaluate the effect of an intervention or therapy.

Though the focus of this work was on the definitions of pilot and feasibility studies and extensive recommendations for the conduct of these studies is outside its scope, we suggest that in choosing what type of feasibility study to conduct investigators should pay close attention to the major uncertainties that exist in relation to trial or intervention. A randomised pilot study may not be necessary to address these; in some cases it may not even be necessary to implement an intervention at all. Similarly, funders should look for a justification for the type of feasibility study that investigators propose. We have has also highlighted the need for better reporting of these studies. The CONSORT extension for randomised pilot studies that our group has developed are important in helping to address this need and will be reported separately. Nevertheless, further work will be necessary to extend or adapt these reporting guidelines for use for non-randomised pilot studies and for feasibility studies that are not pilot studies. There is also more work to be done in developing good practice guidance for the conduct of pilot and feasibility studies.

Supporting Information

S1 fig. search strategy to identify studies that authors described as pilot or feasibility studies..

https://doi.org/10.1371/journal.pone.0150205.s001

S2 Fig. Initial comprehensive diagrammatic representation of framework.

https://doi.org/10.1371/journal.pone.0150205.s002

Acknowledgments

We thank Alicia O’Cathain and Pat Hoddinot for discussions about the reporting of qualitative studies, and consensus participants for their views on our developing framework. Claire Coleman was funded by a National Institute for Health Research (NIHR) Research Methods Fellowship. This article presents independent research funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Author Contributions

Conceived and designed the experiments: SE GL MC LT SH CB. Performed the experiments: SE GL MC LT SH CB CC. Analyzed the data: SE GL MC LT SH CB CC. Contributed reagents/materials/analysis tools: SE GL MC LT SH CB. Wrote the paper: SE GL MC LT SH CB CC.

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Why Feasibility Studies Matter (With Examples)

Published: November 11, 2022

As a business leader, you want your projects to generate a return on investment. So before you begin any new venture, it’s a good idea to complete a feasibility study.

Feasibility studies help to determine the success (or failure) of your proposed project or plan. These types of studies help you make better, informed business decisions. As a result, you can save time and money by starting a plan or a project that you know has a high ROI.

Here, you’ll learn how to run feasibility studies. This post includes:

What is a feasibility study?

Feasibility study benefits, types of feasibility studies, how to write a feasibility study, feasibility study examples.

A feasibility study analyzes a potential project’s benefits, risks, costs, and potential outcomes. After completing a feasibility study, you and your team will have enough information to determine if the proposed project is a worthy investment.

Two types of sales forecasting data are appropriate for feasibility studies:

• Quantitative forecasting uses historical business data to predict trends.
• Qualitative sales forecasting data takes customers’ opinions, market research, and survey results into account.

The type of feasibility study you run determines which type of data you will need. Consider using qualitative forecasting data to determine how well your audience might receive your product. Quantitative data can help you predict revenue.

As a team leader, it’s your job to ensure your team hits yearly sales revenue goals. That may include deciding to take on a project based on projected sales forecasting data.

However, you do not want to take on a proposed plan or project without being sure the project will benefit your organization. Companies with accurate forecasts are 10% more likely to increase revenue yearly , according to Intangent.

That’s why feasibility studies matter. Combine sales forecasting data with the insight from a feasibility report, and you’ll be able to gauge the success rate of your proposed plan before you start.

Other feasibility benefits include:

• Determining if the project is appropriate for your team.
• Making sound decisions for your team.
• Avoiding mistakes.
• Narrowing the focus of the project.
• Determining project and team needs.
• Determining which departments need to be involved in the project.
• Calculating the amount and source of appropriate funding.
• Assessing the success or failure rate of your project.
• Estimating ROI.

Not only do feasibility studies help determine if a proposed plan or project is viable, but they also help narrow the focus of the project. Overall, feasibility studies can help keep your project on track from the start.

Now that you understand the benefits of feasibility studies, it’s time to determine which kind of feasibility study is best for your team.

Technical Feasibility Study

A technical feasibility study looks at your project’s technical aspects. This type of study answers the question: do you have the specialized resources and capabilities to carry out this project?

You might have the appropriate funding for a project, but a technical feasibility study will help you determine if you have the right processes, systems, and staffing for the job.

Best for: Software development teams and project development teams

Financial or Economic Feasibility Study

Financial feasibility studies can help you determine if you have the funding for your project. Plus, you’ll learn the venture is an overall good investment for your team and your company. These kinds of feasibility studies ask: is the allotted funding amount appropriate for this project?

By completing a financial feasibility study, you’ll have already identified funding sources, expenses, your budget, any potential risks, and expected revenue.

Best for: Financial managers and project managers

Operational Feasibility Study

As the name suggests, an operational feasibility study analyzes whether or not your team is equipped to carry out the proposed plan or project. This feasibility study answers the questions:

• Does your team have the means to complete the project?
• Will the project add value for your team or your customers?

Consider conducting an operational feasibility study if you have developed a solution for a potential problem. This kind of study will help you determine if the solution solves the problem or creates more issues.

Best for: Project managers and stakeholders

Legal Feasibility Study

This feasibility study should be performed to determine if your proposed project is legal and ethical. Legal feasibility studies are designed to keep you and your team aligned with local, state, and federal laws.

If you are unsure if your project is unethical or unlawful, a legal feasibility study will help you make the appropriate decision before you begin.

Best for: Legal departments and project managers

Scheduling Feasibility Study

When starting a new project, you’ll often be asked, “When can we reasonably expect this project to be completed?”

If you and your team are working for clients and are on a deadline, a scheduling feasibility study looks at the project’s timeline. That can help your team determine a reasonable completion date.

After completing a scheduling feasibility study, you might find the plan requires more time than you thought. This is helpful to know before you begin a project.

Best for: Stakeholders, project managers, and their teams

If you are wondering how to write a feasibility study, look no further than our feasibility study template .

Before you jump into writing your own study with our feasibility study template, take a minute to familiarize yourself with each section of the template. Keep in mind, the feasibility study temple can be customized to fit the needs of you and your team.

1. Executive Summary

Your executive summary should be a one-page summary of the entire study. Make sure to include the following:

• The project name.
• A description of the project.
• The goals of the project or plan.
• The target market.

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2. Business Explanation

This section of the feasibility study is your space to introduce the business concept of your project or plan. Consider discussing:

• The purpose of the project or plan.
• Products or services.
• Competitive advantages.
• Experience of its founders.

If your project is feasible, you’ll want to be as specific as possible in this section and discuss the project’s projected success.

3. Market Overview

This section of your feasibility study should discuss your target market and why your project or plan will (or will not) succeed. You’ll want to discuss your target market in-depth, its pain points, and how your proposed product or service will solve the problems.

You’ll want to include valid data in this section. Consider featuring:

• The market size and demographics.
• The market psychographics.
• Competitors and substitutes.

4. Financial Projections

Every good business endeavor is meant to make a profit. Your feasibility study should determine if the project or plan is a financially wise investment. The financial projections section of the feasibility template outlines and discusses critical financial metrics.

Considering including and discussing:

• Capital needs.
• Projected revenue and expenses.
• Projected revenue needed to break even.

5. Feasibility Assessment and Conclusion

In your conclusion, be as clear and specific about your proposed project or plan as possible. Use statements like, “Based on our assessment of (X), we have deemed this business project feasible.”

Feasibility studies can be helpful across your entire organization — from the sales team to the product development team. Here are a few examples of feasibility studies conducted in various industries.

Howard County Public School System

The Howard County Public School System’s feasibility study dives into projected student enrollment over a 10-year period.

What we love: The school system offers an excellent example of a brief, but thorough, executive summary. In this section, Howard County Public Schools also includes specific historical data used throughout the study.

Town of Walpole, Massachusetts

This feasibility study from the Walpole, Massachusetts’ explores the town’s recreation programming and facilities. Throughout, the document includes program recommendations with data that explains how the researchers came to this conclusion.

What we love: This document combines several different types of feasibility studies (financial, technical, and operational) into one comprehensive study. Remember, you can mold your feasibility study to fit your organization’s needs best.

U.S. Fish and Wildlife Service

In this example, the U.S. Fish and Wildlife Service explores the feasibility of reintroducing sea otters to areas of the Pacific coast. This study also provides a model for structuring the objectives section of this document. A good feasibility study is clear and to the point in each section.

What we love: Here, the U.S. Fish and Wildlife Service distinguishes what the study covers (potential options for reintroduction), and what it cannot accomplish (projected population growth from reintroduction).

While your feasibility study seeks to assess a project’s viability, your document will have a limited scope. If you’ll need to gather additional information moving forward, mention that in your feasibility study.

Holdrege Area Public Library

Your feasibility study doesn’t need to be all text. The Holdrege Area Public Library makes use of graphics and charts to convey information in its feasibility study.

What we love: Infographics are easy to read. You can absorb important information with a quick skim.

Running Your Feasibility Study

Accurately predicting the success of a project might seem like a daunting task. But it doesn’t have to be. There are many ways to conduct a feasibility study. Stary by leveraging the tools you already have, like HubSpot’s Forecasting Software and our feasibility study template.

Your job as a sales leader is to help your team increase your organization’s bottom line. With the use of sales forecasting data and feasibility studies, you’ll be able to pursue the projects that will yield the highest ROI.

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A free template to help you prove your project's feasibility.

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From Idea to Innovation: What Is a Feasibility Study In Research

Learn the process behind feasibility study in research, how it helps research projects, and the factors that make up a successful project.

Have you ever thought of doing something but wondered whether it’s doable or not? Obviously, there will be several constraints when we wish to do something unique. To understand all these constraints and to check whether the idea that we have in our mind is beneficial or not, we do this preparatory work called a feasibility study.

A feasibility study is like a reality check for your idea, helping you determine if it’s really worth pursuing. In this article, we will discuss what is a feasibility study in research , various aspects of the feasibility study, how it is engaged, how it has to be checked, and how it helps us create a perfect model for our idea.

What is a Feasibility Study in Research? 

A feasibility study is an in-depth assessment conducted to determine the practicality and viability of a proposed project or idea. It involves evaluating various factors such as technical, economic, legal, operational, and scheduling aspects to ascertain whether the project can be successfully implemented.

The purpose of a feasibility study is to provide objective and unbiased information to decision-makers, enabling them to make informed choices regarding the project’s future. It helps identify potential risks, challenges, and opportunities associated with the undertaking, allowing stakeholders to gauge its potential outcomes.

By conducting a feasibility study, decision-makers can determine if the project aligns with organizational goals, identify potential hurdles, and develop contingency plans. This systematic assessment ensures that resources are allocated efficiently and that projects with a high chance of success are pursued.  

What is the Purpose of the Feasibility Study?

A feasibility study serves as a vital tool for assessing the practicality and viability of a proposed project or initiative before committing significant resources to its implementation. It is a comprehensive evaluation that considers various factors such as technical, economic, legal, operational, and scheduling aspects, providing stakeholders with crucial insights to make informed decisions.

First and foremost, a feasibility study helps identify the project’s objectives and determine whether they align with the organization’s overall goals. It allows stakeholders to assess the project’s potential benefits and weigh them against the associated risks. By conducting a feasibility study, decision-makers can gain a clearer understanding of the project’s potential impact on the organization’s resources, capabilities, and market position.

Examination of technical feasibility

One key aspect of a feasibility study is the examination of technical feasibility. This involves evaluating whether the proposed project can be implemented using available technology, infrastructure, and expertise. It helps identify potential technical constraints or challenges that may arise during project execution and allows for appropriate contingency planning.

Furthermore, a feasibility study evaluates the economic viability of a project. It involves conducting a detailed cost-benefit analysis to determine the financial implications associated with the project. This analysis helps stakeholders understand the potential return on investment, project profitability, and the timeline for cost recovery.

Related Article: What is Geospatial Analysis? The Plan Before the Actual Plan

Types of Feasibility Studies

There are several types of feasibility studies, each with its own specific focus and objectives. Some of the most common types of feasibility studies include:

• Technical feasibility study: This type of study assesses whether the proposed project can be implemented using available technology, infrastructure, and expertise. It identifies potential technical constraints or challenges that may arise during project execution and allows for appropriate contingency planning.
• Economic feasibility study: This type of study involves conducting a detailed cost-benefit analysis to determine the financial implications associated with the project. It helps stakeholders understand the potential return on investment, project profitability, and the timeline for cost recovery.
• Legal feasibility study: This type of study examines the legal and regulatory requirements associated with the project. By identifying any legal hurdles or compliance issues early on, organizations can ensure that the project aligns with legal frameworks and minimizes the risk of legal complications down the line.
• Operational feasibility study: This type of study assesses whether the project can be smoothly integrated into existing systems and processes. It examines factors such as staffing requirements, training needs, and potential impacts on day-to-day operations.
• Scheduling feasibility study: This type of study helps establish a realistic timeline for project completion. It considers the availability of resources, dependencies, and potential bottlenecks, allowing stakeholders to develop a well-structured project plan and set achievable milestones.
• Market feasibility study: This type of study evaluates the potential demand for the proposed project in the marketplace. It examines factors such as customer preferences, competition, and market trends to determine whether the project is likely to be successful.
• Environmental feasibility study: This type of study assesses the potential environmental impacts of the proposed project. It examines factors such as air and water quality, habitat destruction, and waste management to ensure that the project is sustainable and environmentally responsible.

Overall, the type of feasibility study conducted will depend on the specific objectives of the proposed project and the information needed to make informed decisions about its implementation.

How to Conduct a Feasibility Study?

A feasibility study is an important step in evaluating the viability of a proposed project or business venture. The study is typically conducted before any significant investment is made to determine whether the project is feasible, both financially and operationally. Here are the general steps to conduct a feasibility study:

Step 1 – Define the scope of the study

Clearly define the objectives of the feasibility study and the specific questions that need to be answered. Identify the stakeholders who will be involved in the study and their roles and responsibilities.

Step 2 – Conduct market research

Research the market and competition to determine the potential demand for the product or service, as well as the size and characteristics of the target market. Analyze the existing competition and identify any gaps in the market that the proposed project could fill.

Step 3 – Evaluate the operational feasibility

Assess the operational feasibility of the proposed project, including the availability of resources, skills, and expertise needed to execute the project.

Step 4 – Identify potential risks

Identify potential risks and challenges that could impact the success of the proposed project. Develop contingency plans to mitigate these risks.

Step 5 – Make recommendations

Based on the results of the feasibility study, make recommendations about whether or not to move forward with the proposed project and, if so, what steps should be taken to ensure its success.

It’s important to note that the specific steps and level of detail required for a feasibility study may vary depending on the nature and complexity of the project. A feasibility study is a critical step in the decision-making process and should be conducted thoroughly and objectively to ensure that all aspects of the proposed project have been evaluated.

How to Write a Feasibility Study?

Writing a feasibility study involves conducting a systematic analysis to determine the viability and potential success of a proposed project or initiative. Here are the steps to help you write a feasibility study: 

• Executive Summary: Provide a brief overview of the project, its objectives, and the purpose of the feasibility study.
• Introduction : Describe the background and context of the project, including its goals, scope, and any relevant background information.
• Project Description: Provide a detailed description of the project, outlining its objectives, deliverables, and expected outcomes. Include information on the target audience or beneficiaries.
• Market Analysis: Assess the market conditions and demand for the proposed project. Identify the target market, competitors, and potential customers. Analyze market trends, growth prospects, and any potential challenges or risks.
• Technical Feasibility: Evaluate the technical aspects of the project, such as the required infrastructure, technology, resources, and expertise. Determine if the necessary resources and capabilities are available or can be acquired within the project’s constraints.
• Financial Feasibility: Conduct a thorough financial analysis of the project. Estimate the initial investment costs, operational expenses, and projected revenues. Evaluate the project’s profitability, return on investment (ROI), payback period, and other financial indicators. Consider potential funding sources and financing options.
• Organizational Feasibility: Assess the project’s compatibility with the existing organizational structure and capabilities. Evaluate the availability of skilled personnel, management support, and any potential impact on the organization’s operations. Consider any legal, regulatory, or compliance requirements.
• Risk Analysis: Identify and evaluate potential risks and uncertainties associated with the project. Analyze both internal and external factors that may impact the project’s success. Develop risk mitigation strategies and contingency plans.
• Implementation Plan: Outline a detailed plan for implementing the project. Define the necessary steps, timelines, and responsibilities. Consider resource allocation, project management methodologies, and any potential challenges during the implementation phase.
• Summarize your findings: Write a clear and concise summary of your findings and conclusions. This should include an assessment of the project’s overall feasibility, a description of any risks or challenges, and a recommendation on whether or not to proceed with the project.

Examples of Feasibility Studies

It typically examines various aspects such as technical, economic, legal, operational, and scheduling factors. Here are some examples of feasibility studies conducted for different purposes: 

• New Business Venture: A study to determine the feasibility of opening a new restaurant, including analysis of market demand, location suitability, competition, and financial projections.
• Real Estate Development: An evaluation of the feasibility of constructing a shopping mall, considering factors such as land availability, market demand, construction costs, potential tenants, and expected return on investment.
• Renewable Energy Project: Assessing the feasibility of establishing a solar power plant, including examination of solar resources, land requirements, grid connectivity, financial analysis, and environmental impact.
• Information Technology System: A study to determine the feasibility of implementing a new software system within an organization, analyzing factors like system requirements, compatibility, cost-benefit analysis, and potential impact on existing operations.

These are some examples of feasibility studies and it is very important to note that though the process looks the same for every domain of work, the concept will be different for each one of them so it is important to analyze the domain before getting to work on it.

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About Sowjanya Pedada

Sowjanya is a passionate writer and an avid reader. She holds MBA in Agribusiness Management and now is working as a content writer. She loves to play with words and hopes to make a difference in the world through her writings. Apart from writing, she is interested in reading fiction novels and doing craftwork. She also loves to travel and explore different cuisines and spend time with her family and friends.

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Table of Contents

What is a feasibility study, understanding a feasibility study, types of feasibility study, importance of feasibility study, benefits of a feasibility study, what is included in a feasibility study report, tools for conducting a feasibility study, examples of a feasibility study, what is the purpose of a feasibility study, how do you write a feasibility study, 7 steps to do a feasibility study, how to conduct a feasibility study, feasibility study vs. business plan, reasons to do or not to do a feasibility study, enroll today with these pgp on project management to enhance your skills, what is a feasibility study a comprehensive guide.

Reviewed and fact-checked by Sayantoni Das

The growth and recognition of project management training have changed significantly over the past few years, and these changes are expected to continue and expand. And with the rise of project management comes the need for a feasibility study.

It can be thrilling to start a complex, large-scale project with a significant impact on your company. You are creating real change. Failure can be scary.  This article will help you get started if you have never done a feasibility study on project management.

Getting certified as a project management professional is simple with Simplilearn's PMP Certification . Take advantage of this opportunity by enrolling now.

A feasibility study is a comprehensive evaluation of a proposed project that evaluates all factors critical to its success in order to assess its likelihood of success. Business success can be defined primarily in terms of ROI, which is the amount of profits that will be generated by the project.

A feasibility study evaluates a project's or system's practicality. As part of a feasibility study, the objective and rational analysis of a potential business or venture is conducted to determine its strengths and weaknesses, potential opportunities and threats, resources required to carry out, and ultimate success prospects. Two criteria should be considered when judging feasibility: the required cost and expected value.

As the name implies, a feasibility analysis is used to determine the viability of an idea, such as ensuring a project is legally and technically feasible as well as economically justifiable. It tells us whether a project is worth the investment—in some cases, a project may not be doable. There can be many reasons for this, including requiring too many resources, which not only prevents those resources from performing other tasks but also may cost more than an organization would earn back by taking on a project that isn’t profitable.

A well-designed study should offer a historical background of the business or project, such as a description of the product or service, accounting statements, details of operations and management, marketing research and policies, financial data, legal requirements, and tax obligations. Generally, such studies precede technical development and project implementation.

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Project management is the process of planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives. A feasibility study is a preliminary exploration of a proposed project or undertaking to determine its merits and viability. A feasibility study aims to provide an independent assessment that examines all aspects of a proposed project, including technical, economic, financial, legal, and environmental considerations. This information then helps decision-makers determine whether or not to proceed with the project.

The feasibility study results can also be used to create a realistic project plan and budget. Without a feasibility study, it cannot be easy to know whether or not a proposed project is worth pursuing.

A feasibility analysis evaluates the project’s potential for success; therefore, perceived objectivity is an essential factor in the credibility of the study for potential investors and lending institutions. There are five types of feasibility study—separate areas that a feasibility study examines, described below.

1. Technical Feasibility

This assessment focuses on the technical resources available to the organization. It helps organizations determine whether the technical resources meet capacity and whether the technical team is capable of converting the ideas into working systems. Technical feasibility also involves the evaluation of the hardware, software, and other technical requirements of the proposed system. As an exaggerated example, an organization wouldn’t want to try to put Star Trek’s transporters in their building—currently, this project is not technically feasible.

2. Economic Feasibility

This assessment typically involves a cost/ benefits analysis of the project, helping organizations determine the viability, cost, and benefits associated with a project before financial resources are allocated. It also serves as an independent project assessment and enhances project credibility—helping decision-makers determine the positive economic benefits to the organization that the proposed project will provide.

3. Legal Feasibility

This assessment investigates whether any aspect of the proposed project conflicts with legal requirements like zoning laws, data protection acts or social media laws. Let’s say an organization wants to construct a new office building in a specific location. A feasibility study might reveal the organization’s ideal location isn’t zoned for that type of business. That organization has just saved considerable time and effort by learning that their project was not feasible right from the beginning.

4. Operational Feasibility

This assessment involves undertaking a study to analyze and determine whether—and how well—the organization’s needs can be met by completing the project. Operational feasibility studies also examine how a project plan satisfies the requirements identified in the requirements analysis phase of system development.

5. Scheduling Feasibility

This assessment is the most important for project success ; after all, a project will fail if not completed on time. In scheduling feasibility, an organization estimates how much time the project will take to complete.

When these areas have all been examined, the feasibility analysis helps identify any constraints the proposed project may face, including:

• Internal Project Constraints: Technical, Technology, Budget, Resource, etc.
• Internal Corporate Constraints: Financial, Marketing, Export, etc.
• External Constraints: Logistics, Environment, Laws, and Regulations, etc.

The importance of a feasibility study is based on organizational desire to “get it right” before committing resources, time, or budget. A feasibility study might uncover new ideas that could completely change a project’s scope. It’s best to make these determinations in advance, rather than to jump in and to learn that the project won’t work. Conducting a feasibility study is always beneficial to the project as it gives you and other stakeholders a clear picture of the proposed project. 

Below are some key benefits of conducting a feasibility study:

• Improves project teams’ focus
• Identifies new opportunities
• Provides valuable information for a “go/no-go” decision
• Narrows the business alternatives
• Identifies a valid reason to undertake the project
• Enhances the success rate by evaluating multiple parameters
• Aids decision-making on the project
• Identifies reasons not to proceed

Apart from the approaches to feasibility study listed above, some projects also require other constraints to be analyzed -

Preparing a project's feasibility study is an important step that may assist project managers in making informed decisions about whether or not to spend time and money on the endeavor. Feasibility studies may also help a company's management avoid taking on a tricky business endeavor by providing them with critical information.

An additional advantage of doing a feasibility study is that it aids in the creation of new ventures by providing information on factors such as how a company will work, what difficulties it could face, who its competitors are, and how much and where it will get its funding from. These marketing methods are the goal of feasibility studies, which try to persuade financiers and banks whether putting money into a certain company venture makes sense.

When starting a business, one of the most important steps is to conduct a feasibility study. This study will help to determine if your business idea is viable and has the potential to be successful. Several factors need to be considered when conducting a feasibility study, including the marketability of your product or service, the competition, the financial stability of your company, and more. A feasibility study should cover the amount of technology, resources required, and ROI.

The results of your feasibility studies study are summarized in a feasibility report, which typically comprises the following sections.

• Executive summary
• Specifications of the item or service
• Considerations for the future of technology
• The marketplace for goods and services
• Approach to marketing
• Organization/staffing
• The financial forecasts
• Recommendations based on research

Suggested Best Practices

While every project has its own goals and needs, the following are best practices for conducting a feasibility study.

• Do a preliminary analysis. This includes getting feedback from relevant stakeholders on the new project. Also, look for other business scenarios.
• To ensure that the data is solid, determine and ask queries about it in the initial phase.
• Take a market survey to identify market demand and opportunities for the new concept or business.
• Create an organizational, operational, or business plan. This includes identifying how much labor is required, what costs, and how long.
• Make a projected income statement that involves revenue, operating expenses, and profit.
• Create an opening day balance sheet.
• You will need to identify and address any vulnerabilities or obstacles.
• Take an initial decision to go ahead with the plan.

Suggested Components

Here are the some suggested components for conducting a feasibility study:

• Executive Summary: Write a narrative describing the project, product, or service.
• Technological considerations: Ask yourself what it will take. Are you able to afford it? How much will it cost?
• Current marketplace: Find out the market for your product, service, or plan in the local and global markets.
• Marketing strategy: Define in the detailed description.
• Required staff: What human resources are needed for this project?
• Timeline and schedule: Use important interim markers to indicate when the project will be completed.
• Project financials. Project financials are the different ways managers can account for money spent and earned on projects. One of the most important aspects of financial management is creating and tracking accurate project financials.

A local university was concerned about the state of the science building, which was built in the 1970s. School officials sought to determine the costs and benefits of expanding and upgrading the building, given the scientific and technological advances over the past 20 years. A feasibility study was therefore conducted.

School officials looked at several options and weighed the costs and benefits of updating and expanding the science building. There were concerns expressed by school officials about the project's cost and public reaction. The proposed new science building will be larger than the current one. The community board rejected similar proposals in the past. The feasibility study will address these concerns and any possible legal or zoning issues.

The feasibility study examined the technology requirements of the proposed concept(new science building), the potential benefits for students, and its long-term viability. Modernizing the science facility will increase the scientific research potential and ameliorate its modules. It also would allure new students.

Financial projections provided information about the scope & cost of this project and also provided information on raising funds. This covers issuing an investor's bonds and tapping into its endowment. Projections also help determine how the new science program attracts more fresh students to enroll in offered programs, increasing tuition and fees revenue.

The feasibility study proved that the proposed concept was feasible, which allowed for the expansion and modernization of the science building. The feasibility study would not have allowed school administrators to know if the expansion plans were feasible without it.

A feasibility study is an important first step in starting a new business. It is a detailed examination of whether or not a proposed business venture is likely to be successful. A feasibility study aims to provide information that will help business owners make informed decisions about their new venture.

The feasibility study will answer important questions about the proposed business, including:

• What is the target market for this business?
• Who are the competitors?
• What are the costs associated with starting and running this business?
• What are the potential risks and rewards associated with this venture?
• How much revenue can this business generate?
• What are the estimated profits and losses for this business?
• What is the potential for growth in this industry?

This feasibility study will outline why your business idea is worth pursuing and will also help you identify any potential risks or problems that could occur. When writing a feasibility study, there are a few key things to keep in mind:

• Outline your target market and how you plan to reach them.
• Discuss your product or service in detail and explain why it is unique and needed.
• Outline your financial projections and explain how you plan to make a profit.

1. Conduct a Preliminary Analysis

A preliminary investigation is necessary to determine whether a full feasibility study is warranted. During this stage, key information will be gathered to assess the project's potential and make a preliminary decision about its feasibility. This should include a review of relevant documents, interviews with key personnel, and surveys of potential customers or users.

2. Prepare a Projected Income Statement

To do a feasibility study, you must create a projected income statement. Your projected income statement will show how much money your business is expected to make in the coming year. It will include both your estimated revenue and your estimated expenses. This document will be essential in helping you make informed decisions about your business.

3. Conduct a Market Survey, or Perform Market Research

Conducting market research is an important step in any feasibility study. By understanding the needs and wants of your potential customers, you can determine if there is a market for your product or service. You can also get an idea of what your competition is doing and how to best position your business to meet the needs of your target market.

There are a variety of ways to conduct market research. One popular method is to conduct a survey. You can survey potential customers directly or use data from secondary sources such as surveys conducted by other organizations. You can also use focus groups or interviews to get feedback from potential customers.

Once you have gathered your data, you can use it to create a profile of your ideal customer. This will help you understand your target market and how to reach them.

4. Plan Business Organization and Operations

When starting a business, one of the first things you need is to plan your organization and operations. This involves creating a structure for your company and figuring out the logistics of how you will run it. There are many factors to consider when planning your organization and operations, such as:

• Company Structure: What type of company will you be (sole proprietorship, partnership, corporation, etc.)? What will the hierarchy look like?
• Location: Where will your business be located? Will you have a physical storefront or operate online only?
• Marketing: How will you promote your business?

5. Prepare an Opening Day Balance Sheet

The opening day balance sheet is a snapshot of the company's financial position at the beginning of the business venture. The purpose of the opening day balance sheet is to give an idea of the amount of money that the company has to work with and track its expenses and income as they occur. This information is vital to making sound business decisions. The opening day balance sheet will include the following:

• Cash on hand
• Accounts receivable
• Prepaid expenses
• Fixed assets
• Accounts payable
• Notes payable
• Long-term liabilities

6. Review and Analyze All Data

The feasibility study should include reviewing and analyzing all data relevant to the proposed project. The data collected should be verified against source documentation, and any discrepancies should be noted. The purpose of the feasibility study is to provide a basis for making a decision, and the data should be sufficient to support that decision.

The analysis should consider both the positive and negative aspects of the proposed project. The financial analysis should be thorough, and all assumptions should be documented. The risk assessment should identify any potential risks and mitigation strategies. The team assigned to the project should review the feasibility study and recommend the organization's leadership.

Organizational leadership should decide whether to proceed with the project based on the feasibility study's findings. If the project is approved, the organization should develop a project plan that includes a detailed budget and timeline

7. Make a Go/No-Go Decision

It is important to know when to cut your losses when starting a business. The go/no-go decision in a feasibility study comes in. The go/no-go decision is a key part of a feasibility study, and it can help you determine whether or not your business idea is worth pursuing.

Making the go/no-go decision is all about risk assessment. You need to weigh the risks and rewards of starting your business and decide whether the potential rewards are worth the risks. If the risks are too high, you may want to reconsider your business idea.

Now, let's discuss a few of the steps we take in order to do the feasibility study.

• To begin, we do a preliminary study of the business case to define what is included and what we are examining and attempting to find is realistic.
• Following that, we generate a forecasted income statement. We need to understand the revenue sources; how are we going to profit from this? Where does the income originate? Additionally, we must do a market study.
• We need to find out whether this is a demand for our product. How much demand does this have? Is there a market for this product or service?
• Plan your company's structure and operations, which is the fourth step. Specifically, what type of organization do we need, and what resources do we have? Do we have any specific personnel needs?
• We also plan to generate a balance sheet on the first day. What are the income and expenses, and how can we be confident we'll be able to decide whether we're going to make our ROI?
• As a result, we plan to go through and examine all of our data before making a final decision on whether or not to go forward. In other words, are we going to pursue this project or business opportunity?

When starting a business, you must create two very important documents: a feasibility study and a business plan. While they may seem similar, they are two different things with different purposes.

A feasibility study is a preliminary document that assesses the feasibility of a proposed business. It looks at the market potential, the competition, the costs and benefits of starting the business, and the risks and rewards involved.

On the other hand, a business plan is a more detailed document that outlines how a business will be run and what its goals are. It includes information about its mission statement, its products and services, its target market, its finances, and its management team.

There are many factors to consider when deciding whether or not to conduct a feasibility study. The most important question is whether the study will help you make a better decision.

Some reasons to do a feasibility study include:

• You are considering a major change or investment
• You want to assess the viability of a new business or product
• You need to understand the risks and potential rewards associated with a project

On the other hand, some reasons not to do a feasibility study include:

• You are pressed for time and don't think the study will provide enough value to justify the time commitment.
• You are confident that your idea is feasible, and a study will only confirm what you already believe.
• The change or investment is not significant enough to warrant the study.
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This article introduces the concept of a feasibility study and provides a few tips on conducting one. A feasibility study is an important tool for evaluating a project before starting it. By understanding the feasibility of a project, you can make better decisions about whether to move forward.

We hope this helped you understand the concept of feasibility study better. To learn more about similar project management concepts , explore our library of Project Management articles or check out our Post Graduate Program in Project Management that covers new trends, emerging practices, tailoring considerations, and core competencies required of a Project Management professional .

Q1. What Is the Main Objective of a Feasibility Study?

Feasibility study helps decision makers to determine the success or failure of a proposed project or investment. It evaluates the predicted cost and benefits of the proposed project. 

Q2. What Are the Steps in a Feasibility Study?

The first step in a feasibility study is to conduct the primary analysis and create the projected income statement. Followed by doing a market survey and accordingly planning business operations. The last step is to create a balance sheet to review and analyze data. Based on your analysis, you can decide whether to go or not go ahead with the proposed statement. 

Q3. Who Conducts a Feasibility Study?

Feasibility study is done by the senior management of the organization. Sometimes, they take help from mid-senior employees to complete the analysis in short span of time. 

Q4. What Are the 5 Types of Feasibility?

The 5 types of feasibility study are Scheduling Feasibility, Operational Feasibility, Legal Feasibility, Economic Feasibility, and Technical Feasibility. 

Q5. Why is a Feasibility Study Important?

A feasibility study helps in identifying the financial, market and logistical challenges of a proposed project. It is done by evaluating the estimated funds for the project and return of investment.

Q6. When is the Feasibility Study Done?

The feasibility study is done before the business plan is created. 

Q7. What is the Primary Purpose of Conducting a Feasibility Analysis?

The objective of feasibility study is to assess the financial viability of developed plan and whether it will be successful or not.

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Feasibility Studies: What They Are, How They Are Done, and What We Can Learn From Them

Anne M. Kolenic

Nursing clinical research is a growing field, and as more nurses become engaged in conducting clinical research, feasibility studies may be their first encounter. Understanding what they are, how to conduct them, and the importance of properly reporting their outcomes is vital to the continued advancement of nursing science.

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What Is a Feasibility Study? 6 Types and Practical Tips

A feasibility study is an analysis to determine the practicality of a proposed project or business venture—but there’s more than just one type.

Here’s a business idea: Everyone prefers to keep a perfect body temperature no matter the weather, so why not create clothing that maintains comfort in both hot and cold temperatures? The problem is it would require built-in heating and cooling mechanisms, adding weight, bulk, and electricity needs. In other words, it’s an intriguing idea, but it’s not feasible.

Decision makers and project managers must constantly assess if great ideas are truly feasible in the real world. To do this, they might conduct a feasibility study to determine if there’s a practical way to bring these ideas to life. Feasibility studies consider things like cost, resource availability, technical capacity, and potential risks.

Here’s an overview of feasibility studies, with tips on how to conduct your own feasibility analysis.

What is a feasibility study?

A feasibility study is a preliminary analysis to determine the viability and practicality of a proposed project or new business venture. It can be commissioned by a government, a business organization, or an individual during an analysis phase. Feasibility studies help stakeholders understand potential risks, benefits, costs, and challenges to predict whether a project should be pursued, modified, or simply abandoned.

A typical feasibility study evaluates timelines, budgeting, market research , supply chain information, technological considerations, and legal requirements. Assessing these feasibility factors in the early stages helps determine if the proposed project is a worthwhile investment of your time, money, and resources.

A study usually culminates in a feasibility report you can present to business owners and project leaders. The report centralizes your findings and makes a declaration about the new project or business’s viability.

Benefits of feasibility studies

Informed decision-making, financial viability assessment, risk assessment, resource management, stakeholder confidence.

Conducting a feasibility study helps determine how likely your idea or venture is to succeed. Here are the five main benefits of a feasibility assessment:

A successful business or project feasibility study helps you make informed decisions based on data and analysis rather than assumptions or guesswork. Your proposed business venture should rely on concrete numbers, not gut instinct or anecdotal evidence.

Does a market survey show there’s a viable customer base? Do your financial projections suggest the project can become profitable? Does your project management team think you have the technical resources to execute your plan? A proper feasibility study report answers these questions with solid data.

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Many great business ideas are derailed by a project’s cost. A feasibility study helps you understand if you have the financial resources to see your project through. This can prevent costly investments in projects unlikely to yield expected returns and protect your organization’s financial health.

A feasibility study can warn your management team of potential risks in a business plan. It can identify potential challenges related to money, market size, technical abilities, and legal risks. Addressing these challenges early can spare you from severe consequences, saving time, money, and resources.

Implementing a proposed plan typically requires time, physical resources, human effort, and capital. A full-scale feasibility study takes a holistic look at the resources needed to realize a particular project and determines if your organization has or can allocate and manage these resources effectively.

A well-conducted feasibility study shows stakeholders—like investors, partners, managers, and employees—that you’ve thoroughly evaluated your project before diving in. You can show them your project plan, the risks involved, the resources required, and your predicted likelihood of success. Showing your partners what lies under the hood of your project can inspire emotional and capital investment.

6 types of feasibility studies

• Operational
• Environmental

Different initiatives succeed or fail because of various factors, so feasibility studies address distinct topics. Here are six of the most commonly commissioned feasibility studies:

A market feasibility study assesses the demand for a product or service within a target market. It analyzes the total addressable market (TAM) , target customers, competition , market trends, and potential market share. Note that this type of market analysis doesn’t involve creating a marketing strategy; it determines whether there’s even a viable market to begin with.

2. Technical

A technical feasibility study examines the technical resources needed to complete a project, including the required technology, equipment, and expertise. It then assesses whether the organization has achieved the technical development required to achieve tactical or business success.

A legal feasibility study aims to identify the legal factors affecting your project, ensuring it complies with relevant laws and regulations, including zoning laws, licensing, permits, and intellectual property .

4. Financial

A financial feasibility study—or economic feasibility study—analyzes a project’s costs, revenues, and profitability to assess its economic viability and funding. This type of study often includes a business plan , projected income statement , and overall financial analysis. Some lending institutions require this study for loan approval.

5. Operational

An operational feasibility study aims to assess whether you have the operational capacity to implement the proposed project considering your physical assets, human resources, organizational structure , company culture, and workflows.

6. Environmental

An environmental feasibility study assesses a project’s potential environmental impact and outlines measures to mitigate negative effects. It also ensures alignment with environmental regulations and your organization’s sustainability goals.

How to conduct a feasibility study

• Define the project and its scope
• Conduct preliminary analysis
• Evaluate market feasibility
• Assess technical and operational feasibility
• Analyze financial feasibility
• Review legal and environmental considerations
• Prepare the final report

Using this feasibility study template to guide your process, here’s how to conduct a comprehensive feasibility study:

1. Define the project and its scope

Clearly outline your project's objectives, goals, and key deliverables. This includes identifying the problem or opportunity the project aims to address and setting specific criteria for success, including key performance indicators (KPIs) .

For example, Gloria Hwang conceived of her idea for a bike helmet company, Thousand , after her friend tragically died in a cycling accident. Her goal: Create a stylish helmet for commuters. As she explains on an episode of Shopify Masters , “If you can make a helmet people actually want to wear, you can help save lives.” Her company’s very name references her mission to save 1,000 bike riders’ lives—a key deliverable she reached in 2023.

2. Conduct preliminary analysis

A preliminary analysis provides a general assessment to determine if your project is worth pursuing. Roughly evaluate the potential market, technical requirements, financial costs, and legal constraints to identify any major obstacles. If the project clears this initial requirements analysis phase, you can dive deeper into all these topics.

When Gloria set out to research her business idea, she found that most bike helmet companies catered to high-tech riders or cycling enthusiasts—not casual riders.

“From my perspective, it was just [about] trying to find and make a product that was driven by consumer insights,” says Gloria.

Knowing that the product she wanted didn’t exist inspired her to dig deeper into research and development.

3. Evaluate market feasibility

Assuming your preliminary analysis suggests the project is viable, proceed with a comprehensive market assessment . Analyze the demand for your product or service. Profile target customers , estimate market size, size up the competition , and identify market trends.

Gloria, for example, sent out 50 surveys to people she knew with an interest in biking or skateboarding and asked what they would like to see in a helmet. In the responses, it became clear there was demand for the type of helmet she wanted to make. People expressed their primary concerns were about safety, convenience, and price—data Gloria used to refine her product’s value proposition .

4. Assess technical and operational feasibility

If a viable market exists, decide whether your organization is equipped to serve it. Examine the technical requirements of your project, including technology, resources, and expertise. Assess your organization’s capacity for implementation and operation, paying special attention to human resources, infrastructure, and company culture.

For example, Gloria knew she needed to design a helmet that had never existed before on a budget that wouldn’t allow her to hire an expensive product development firm.

“Thankfully [my dad] happened to be a former NASA engineer,” Gloria says.

5. Analyze financial feasibility

Take a hard look at whether you have the financial means to execute the project. Develop a detailed financial analysis, including cost estimates, revenue projections, and funding sources. What will the opening day balance sheet look like? When will the project be profitable? Consider creating financial models to assess the project’s profitability, return on investment (ROI) , and break-even point .

One tip: Gloria recommends finding mid-sized manufacturers to help you make your business a reality since the largest, most well-known companies may not prioritize your small business’s needs.

“Finding someone who's in it with you from a partnership perspective, I think is the best thing to do,” she says.

6. Review legal and environmental considerations

Your project will only succeed if it complies with applicable laws, regulations, and environmental standards. Determine what permits and licenses you need, and whether an environmental impact assessment is necessary.

For Gloria, this meant making sure her designs met the safety standards set for cycling and skateboarding helmets so her customers could wear her helmets for both use cases.

7. Prepare the final report

Compile your findings into a detailed report covering all aspects of the feasibility study. Start with an executive summary outlining potential business scenarios based on the information you’ve amassed. Present the report to stakeholders, highlighting key insights and recommendations. Your team can then make an informed decision about whether to proceed with the project, pursue business alternatives, or scrap the endeavor altogether.

For Gloria, the time she spent researching and refining her concept paid off. She’s reached her goal of saving lives with her helmets while getting people who never wore helmets before to start prioritizing their safety—without sacrificing style.

“It’s all centered around this idea of, ‘How can products help you express your personal style?’” Gloria says.

Because when your bike helmet expresses your style, you’re more likely to wear it.

Feasibility study FAQ

How do you write a feasibility study.

To write a feasibility study, define your project scope, conduct thorough analyses of market, technical, financial, legal, and operational factors, and compile the findings into a comprehensive report with recommendations for decision-making.

What should a feasibility study include?

A feasibility study should include an assessment of your project's market potential, technical requirements, financial viability, legal considerations, and operational capacity.

What is the average cost of a feasibility study?

The cost of a feasibility study varies tremendously based on the scope and nature of your project. Some business veterans estimate a study should be about 1% of your project’s total cost. For example, if you’re planning a $100,000 project, your feasibility study might cost around $1,000 to conduct.

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• Open access
• Published: 04 September 2024

Exploring the feasibility and acceptability of community paramedicine programs in achieving vaccination equity: a qualitative study

• Monica L. Kasting 1 , 2 ,
• Alfu Laily 1 ,
• Sidney J. Smith 1 ,
• Sathveka Sembian 3 ,
• Katharine J. Head 4 ,
• Bukola Usidame 1 ,
• Gregory D. Zimet 5 &
• Laura M. Schwab-Reese 1  

BMC Health Services Research volume  24 , Article number:  1022 ( 2024 ) Cite this article

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Mobile Integrated Health-Community Paramedicine (MIH-CP) is a novel approach that may reduce the rural-urban disparity in vaccination uptake in the United States. MIH-CP providers, as physician extenders, offer clinical follow-up and wrap-around services in homes and communities, uniquely positioning them as trusted messengers and vaccine providers. This study explores stakeholder perspectives on feasibility and acceptability of community paramedicine vaccination programs.

We conducted semi-structured qualitative interviews with leaders of paramedicine agencies with MIH-CP, without MIH-CP, and state/regional leaders in Indiana. Interviews were audio recorded, transcribed verbatim, and analyzed using content analysis.

We interviewed 24 individuals who represented EMS organizations with MIH-CP programs (MIH-CP; n  = 10), EMS organizations without MIH-CP programs (non-MIH-CP; n  = 9), and state/regional administrators (SRA; n  = 5). Overall, the sample included professionals with an average of 19.6 years in the field (range: 1–42 years). Approximately 75% ( n  = 14) were male, and all identified as non-Hispanic white. MIH-CPs reported they initiated a vaccine program to reach underserved areas, operating as a health department extension. Some MIH-CPs integrated existing services, such as food banks, with vaccine clinics, while other MIH-CPs focused on providing vaccinations as standalone initiatives. Key barriers to vaccination program initiation included funding and vaccinations being a low priority for MIH-CP programs. However, participants reported support for vaccine programs, particularly as they provided an opportunity to alleviate health disparities and improve community health. MIH-CPs reported low vaccine hesitancy in the community when community paramedics administered vaccines. Non-CP agencies expressed interest in launching vaccine programs if there is clear guidance, sustainable funding, and adequate personnel.

Conclusions

Our study provides important context on the feasibility and acceptability of implementing an MIH-CP program. Findings offer valuable insights into reducing health disparities seen in vaccine uptake through community paramedics, a novel and innovative approach to reduce health disparities in rural communities.

Peer Review reports

Introduction

Mobile integrated health-community paramedicine (MIH-CP) is a rapidly evolving patient-centered healthcare delivery model within the domain of emergency medical services (EMS) [ 1 , 2 ]. Community Paramedics (CP)s, a large portion of the MIH-CP workforce, expand the traditional role of EMS personnel to be physician extenders, delivering non-urgent but key medical services such as vaccinations. This is particularly important considering the existing vaccination inequities.

The COVID-19 pandemic highlighted these systemic health inequities, exacerbated existing health disparities, and broadened the gap in access to care. For example, many healthcare visits during the COVID-19 pandemic took place virtually using telemedicine and research shows that low socioeconomic status (SES), rural, and minority populations received less access to telehealth during the pandemic [ 3 , 4 ]. Furthermore, a study of Rural Health Clinics (RHCs) found that the clinics reported high levels of financial concerns and challenges obtaining personal protective equipment, resulting in them providing fewer preventive services during the pandemic [ 5 ].

Vaccination rates also dropped during the pandemic, with early reports suggesting some childhood vaccination rates dropping by as much as 70% in the beginning of the pandemic [ 6 , 7 ]. These reductions in vaccine uptake are multifactorial and are associated not only with lack of access to care, but also higher levels of mistrust in the medical system and medical establishment among underrepresented minorities as well as people living in rural areas [ 7 ]. A potential solution to address these disparities is through trusted messengers, who have the opportunity to change previously held beliefs and increase awareness and acceptability of vaccinations [ 8 ]. One example of a trusted messenger is a CP.

CPs are evolving to be a blend of community health workers, social workers, and non-emergency health care providers [ 1 , 2 , 9 ]. Approximately 18 states in the United States (U.S.) have CPs, but the roles vary in scope, training, and authority [ 1 , 10 ]. Studies have shown that they are positively accepted and reviewed across the quadruple aim framework used to assess the effectiveness of a health care system (i.e., improved patient satisfaction, improved provider satisfaction, reducing healthcare costs, and improved population health outcomes) [ 1 , 11 ]. While there are limited studies encompassing all of the quadruple aims, review papers have shown that MIH-CP programs are generally perceived positively as a means of bridging the healthcare delivery gap, especially within communities with healthcare shortages, such as rural areas, and can potentially reduce existing disparities [ 1 , 2 , 9 , 10 , 12 , 13 , 14 , 15 ].

This positive reception and patient satisfaction suggests MIH-CP may be a novel approach to address health disparities and improve uptake of preventive health services, including vaccinations [ 1 , 14 , 15 ]. MIH-CP programs are often able to administer vaccines [ 16 , 17 , 18 , 19 , 20 , 21 , 22 ], but there are few studies specifically examining the impact of this service. Currently, Indiana has more than a dozen MIH-CP programs [ 23 ], including many that provide vaccination services. More research is needed to understand program effectiveness and the potential usefulness in improving health equity through these programs. In addition, it is unclear whether community paramedics are receptive to including vaccine administration in their scope of care, which may cause implementation challenges. Therefore, the aim of this study was to determine perceived barriers, facilitators, attitudes, and beliefs of relevant stakeholders (i.e., MIH-CP/EMS providers, leaders, and administrators) regarding implementation of MIH-CP-based adult vaccination services in the state of Indiana.

This study was reviewed and approved as exempt by the Institutional Review Boards at both Purdue University and Indiana University.

Setting, design, sample, and recruitment

We conducted one-time interviews with three groups of participants: leaders of paramedicine agencies with registered MIH-CP programs (10 interviews), leaders of paramedicine agencies without MIH-CP programs (9 interviews), and state/regional administrators (SRA; 5 interviews). Below we describe how each group was identified and recruited.

The Indiana Department of Homeland Security (DHS), which oversees EMS in Indiana, provided a list of registered MIH-CP programs as of January 2023. Team members contacted the administrators of these programs via email or phone to confirm whether the MIH-CP program was active. Of the 16 registered agencies with an active MIH-CP program, 10 (63%) completed interviews.

To identify non-MIH-CP providers, we used targeted recruitment and identified counties that were demographically similar to the counties served by the MIH-CP interviewees, specifically focusing on rurality (within 4% rurality of MIH-CP interviewees) and average resident age (mean age within 2 years of MIH-CP interviewees). Then, we identified the hospital-based, governmental, paid fire, and private paramedicine agencies in those counties from a registry of ambulance service providers from DHS. We excluded volunteer organizations, as they are quite different in scope and function than organizations with employees. Of the 18 programs identified and contacted, 9 (50%) completed an interview.

Finally, we contacted the state MIH-CP administrators and regional EMS administrators, based on the contact information provided on the DHS website [ 24 ]. Approximately half (i.e., 5 of 9) of the state and reginal administrators contacted by the team completed an interview.

All interviews were conducted by study team members (MLK, AL, SJS) trained in qualitative interviewing and were recorded via Zoom. One interviewer (MLK) is a faculty member with a PhD and two are graduate students (AL, SJS). All interviewers are female. No one else was present in the interviews besides the participants and research team members. The interview guides are included as Additional File 1 (leaders of paramedicine agencies) and Additional File 2 (state/regional administrators). The audio files were transcribed in three rounds, one by artificial-intelligence transcriber through happyscribe.com, then verified by two rounds of manual transcriptions carried out by team members with training in qualitative methods (AL, SJS, SS). Following the interview, participants completed an anonymous survey about their demographic characteristics and beliefs about the COVID-19 vaccine. Survey items were adapted from previously validated surveys [ 25 , 26 , 27 ], where applicable. The survey codebook is included as Additional File 3. All participants were offered a $50 gift card in appreciation of their time, although many declined due to agency restrictions on accepting gifts.

Interviews started with introductory questions about the participants’ roles within their agency to build rapport, better understand the participants’ experience in EMS, and describe the goals of the research project. The rest of the interview questions focused on MIH-CP program history and functions. However, the questions were tailored to the participants’ experiences with MIH-CP and whether they had vaccination programs. For MIH-CP interviews, the subsequent questions focused on their overall MIH-CP programs as well as their vaccination programs, emphasizing how the programs started, barriers to implementation, operational barriers, and lessons learned. Non-MIH-CP interviews emphasized similar topics except that the questions were framed around their opinions and perspectives on MIH-CP as someone without a program. State/regional administrator interviews focused on higher-level administration of MIH-CP programs.

Data analysis

We used qualitative content analysis, as described by Schreier, to analyze the transcripts [ 28 ]. First, two authors (LMSR, AL) completed an exhaustive and comprehensive review of the transcripts to ensure a thorough understanding of all the data. During these reviews, they took notes on content that was repeated across interviews and areas that were unique to each interview. After gaining familiarity with the material, each author reviewed the transcripts for a second time, specifically focusing on content that was not noted in the first review. Then, each author organized their notes into a first draft of a codebook. This approach is most similar to the codebook development strategy described by Schrier as summarization. As part of our note-taking process, we paraphrased relevant passages. As we developed the codebook, we deleted paraphrases that were superfluous and combined related paraphrases. Then, we used the paraphrases to generate the main category and subcategory names. Although we did not generate the main categories prior to codebook development, our draft codebooks were closely aligned with our objectives because the semi-structured interview guide used to collect data was aligned with our objectives.

Based on these initial drafts, two members of the research team (LMSR, MLK) reviewed the draft codebooks, combined the codebook drafts into a single comprehensive codebook (Additional File 4), and pilot-coded a transcript together. Then, one member of the team (LMSR) applied the codebook to the transcripts. Finally, two members of the team (LMSR, MLK) met to review the coded materials and assess for disagreement in the code application. However, the codebook is quite straightforward and descriptive, so there were no disagreements.

Saturation has multiple meanings in qualitative methods. In qualitative content analysis, as described by Schreier, saturation occurs when each subcategory has at least one code segment (i.e., no subcategory is ‘empty’). Because we used a data-driven approach to develop our codebook, we automatically met the criterion of saturation. That is, if the content was not present in the data, it was not present in our coding framework. Data analyses were conducted using MAXQDA.

Sample characteristics

We interviewed 24 individuals who represented EMS organizations with MIH-CP programs (MIH-CP; n  = 10), EMS organizations without MIH-CP programs (non-MIH-CP; n  = 9), and state/regional administrators (SRA; n  = 5). Interviews lasted an average of 41 min (range: 14–75 min). Of the 24 interviewees, 19 responded to the survey provided at the end of the interview. Overall, the sample included highly experienced EMS professionals with an average of 19.6 years in the field (range: 1–42 years). Approximately 75% ( n  = 14) of respondents were male, and all identified as non-Hispanic white. Nearly two-thirds of respondents were fully vaccinated for COVID-19 and had received at least one booster shot ( n  = 12). Another quarter were fully vaccinated without a booster shot ( n  = 5). One respondent received one dose of the COVID-19 vaccine, and one was not vaccinated.

When asked if their programs ever distributed vaccines, more than 75% of agencies reported doing so. This was significantly different between MIH-CP (10 out of 10 distributed vaccines) and non-MIH-CP (5 out of 9 distributed vaccines) programs ( p  < 0.05). Most programs ( n  = 11) discussed distributing COVID-19 vaccines during the pandemic. Flu vaccines were the second most commonly administered vaccine ( n  = 7). Other vaccines included Tetanus, Hepatitis A, and childhood vaccines. Some agencies partnered with other organizations (i.e., primary care providers, health departments, and schools) and were willing to give any vaccines requested by these partners. These partnerships and structures are further discussed in the next section.

Vaccine program structure and organization

All vaccine programs fit into one of three structures: outreach for a separate agency, extension of existing MIH-CP services, or standalone programs focused on vaccine distribution.

Outreach for Separate Agencies

Most vaccine programs were outreach for a separate agency, generally the county health department during the COVID-19 pandemic. In Indiana, many county health departments sponsored mass vaccine clinics and/or provided in-home vaccines for individuals unable to leave their homes. EMS agencies provided staffing for both approaches. One individual shared that during the COVID-19 mass clinics “ the state said that anywhere they were administering vaccines , they had to have a paramedic on site.” (Non-MIH-CP-15). Some agencies allowed their staff to go during normal work hours, while others treated it as volunteer/non-work time. Generally, the MIH-CP programs were more focused on providing in-home services, although a couple of non-MIH-CP programs also provided these services. As one participant explained, “ Let’s do what paramedicine’s meant to do , and it’s to be mobile… ” (MIH-CP-08). Generally, these programs followed the same administrative processes:

“So basically, county health nurse will identify Mrs. Smith at 1234 North Main Street, needs a vaccine. Can you do it on this date? Sure, we’ll do it. We’ll send all the information back to the county health nurse and then she’ll enter it in [the state vaccine registry]. And that’s kind of the partnership we have is we’re the boots on the ground and they’re the paperwork side of things, which is obviously the least fun part.” (MIH-CP-05).

At least one program continued partnering with the county health department beyond the COVID-19 vaccine clinics, including providing vaccines to students in schools and routine vaccines in people’s homes. These arrangements had several benefits for EMS agencies: reduced administrative burden, financial compensation, and relationship building with community organizations. As discussed above, the health department was responsible for procuring and storing the vaccines, managing the schedule, and documenting the distribution with the state vaccine registry. This administrative oversight was particularly helpful when the storage and maintenance of multiple COVID-19 vaccines became complicated. As one participant explained:

“It got crazy. Like you had to order your patients in such a way to where your vaccines weren’t expiring. So, we had a fridge inside of the vehicle, but it does not get to cold storage temperatures. So, it’s only maintaining. So yeah, you had to schedule your Johnson and Johnson’s first and then your Modernas and then your Pfizers…” (MIH-CP-10).

Providing vaccines as an extension of the health department was also financially beneficial for some agencies. All agencies were eligible for reimbursement for vaccine administration as part of a state-wide program. One individual explained, “ We got compensated for all those. I think we got like seventy-five dollars- seventy five to one hundred dollars for- per dose.” (MIH-CP-04). However, some agencies preferred to use the opportunity to build relationships. One individual described their motivation as “ just to help the health department.” (MIH-CP-09). For many agencies, these programs ended when the mass COVID-19 vaccine clinics ended. Some, including non-MIH-CP programs, used the existing processes and relationships as an opportunity to continue the partnerships, including “ a vaccine clinic at our school.” (Non-MIH-CP-12).

Extension of Current Services

Some MIH-CP programs also provided vaccines as an extension of their current services. Several programs offered vaccines to all existing MIH-CP patients. A primary care provider or health department was responsible for vaccine storage and documentation in these instances. Other extensions reflected the uniqueness of the MIH-CP programs. For example, one MIH-CP program operated out of a community center that hosted a weekly food bank. As demand for the food bank increased, MIH-CP personnel decided to pilot a vaccine clinic, which became the basis for mass vaccine drive-through clinics in the state:

“We tied it into the food distribution. So, people were already here, they were already in line. They would get their food, and as they drove through, we flagged the ones that would like- you know, they said, ‘yeah, we’ll do a flu shot as well.’ It was a simple- it started off with a post-it note on their windshield. And as they came through the food distribution, we’d flag them into the other part of the parking lot, and they would stay in their car, roll down their window, we would vaccinate them, and then we’d move them off just to the side to stay there for their 15 minutes to make sure that they weren’t having a reaction. Their instructions were, if you start feeling funny or ill in any way, honk your horn, turn on your flashers, we’ll be right there.” (MIH-CP-06).

Another MIH-CP program was integrated into an occupational health program and had provided vaccines to their patients since 2013. Generally, this consisted of on-site vaccine clinics, particularly for employers who mandated the vaccines. For other employers, program staff “ just made ourselves available. ” (MIH-CP-07). During the pandemic, this program expanded its vaccine services to other MIH-CP programs. For example, they regularly held clinics at Salvation Army and transitional housing centers. During these events, they started “ providing vaccines at every single one of those community events. And that was just simple walk up.” (MIH-CP-07).

Because these programs were unique, the relative benefits and challenges were also unique. Some agencies acted as independent vaccine providers, while others’ administrative structure was more similar to that of the agencies acting as outreach (i.e., purchasing, storage, and documentation were managed by a separate agency). Agencies acting as independent vaccine providers did not frame purchasing, storage, or documentation as challenging. However, these agencies had a history of vaccine administration before the COVID-19 pandemic, meaning they had built sufficient infrastructure (e.g., staff, space, and financial resources) for their day-to-day operations.

Standalone Program

Only one MIH-CP program had a standalone program focused exclusively on vaccines, which started in 2020. The goal was to provide vaccines in schools for staff and students, with a particular emphasis on vaccines required to attend school. During the pandemic, the program shifted to “ a lot more work with COVID vaccines and testing ” (MIH-CP-08). After schools began reopening, the team learned that a local hospital had started providing a traveling nurse to schools to provide vaccines, which duplicated their service. They decided to shift the focus to “ really just finding those gaps and needs.” (MIH-CP-08). For this community, that looked like:

“Let’s do what paramedicine’s meant to do, and it’s to be mobile, right, to go out and fill that fill that gap. So if we have students that are getting to that point where school is going to kick them out because they haven’t met their mandated vaccines, we’ll go out and do that. We’ll put clinics together and fill that piece….We have some vaccinations- for HPV and meningitis I believe - that we needed to- we knew that was the right age, so we connected with the school nurse there and did clinics for the [the local college] students.” (MIH-CP-08).

For this program, vaccine storage and documentation were not reported as challenges. The primary challenge was finding the right partnerships and gaps, although there were also financial challenges. Because they operated as a standalone program, they also managed purchasing the vaccines. The administrator described one related issue as, “ You have to be very strategic about it. And we run into that. You know , there are a few where we’ve had some expire because we haven’t got shots in arms and you eat that cost. ” (MIH-CP-08).

Vaccine program challenges

When talking about challenges related to providing vaccines through an MIH-CP program, participants reported a range of challenges, including concerns about funding, vaccine hesitancy in communities, and vaccines as a low priority for MIH-CP.

One participant described the funding issue as “ Vaccines aren’t sexy. It’s not a big money maker. It’s just- It’s one of those things that has to be done .” (MIH-CP-08). During the COVID-19 pandemic, the state had a program for reimbursing vaccines. Since that program expired, there has been no funding for vaccine distribution through MIH-CP. Without this funding, the biggest barrier for many agencies was “ really just having the money to cover the supplies and the uh cost of actually getting the money out there to do it.” (MIH-CP-01). Even if funding was available, the administrative burden can be overwhelming. One participant described their program’s decision to stop providing vaccines as:

“But there’s just too much already on a day-to-day basis to where even just that minor ask that they’re trying to ask for it’s becoming too burdensome….it would be fantastic if everyone in our organization also had a secretary, right? I mean, that would be- just someone to help. I’m talking about interns or whatever….you’re sacrificing a lot of your personal time in order to do that, because it’s just not- the reimbursement is just not there to really build up the workforce how it needs to be.” (MIH-CP-10).

The lack of established funding mechanisms was perceived by some participant as evidence that it was not a high priority for the state. As one participant said, “ I’m here to serve my community. So , I don’t mind going out there and helping somebody and administering that. But if that was something the health care field thought we should do all the time , then there have to be some kind of funding mechanism for that. ” (Non-MIH-CP-16).

In discussing funding challenges, a few other participants discussed how the lack of MIH-CP infrastructure and state policies impeded reimbursement and billing mechanisms. A state/regional administrator explained that many state agencies oversee vaccine regulations. The “ Department of Health , because they regulate vaccines. They have reimbursed for some of it” , “ the FFSA [Family and Social Services Administration] was covering [MIH-CP vaccines] for Medicaid” and the Department of Homeland Security play roles in who is allowed to administer vaccines and reimbursement (SRA-21). Some MIH-CP administrators believed that the lack of policies governing MIH-CP contributed to the limited reimbursement opportunities. One participant said,

“We just don’t have a standard documented [reimbursement policy] in the state of Indiana….I mean, there are other states that have it out there. I think Minnesota is a prime example, but yeah. What does that look like for the state of Indiana? And let’s get it written into policy, and it’s been talked about for the last several years, and it’s supposed to be coming up, but it’s just nature of how that works.” (MIH-CP-08).

Vaccine Hesitancy

Because most of the programs provided vaccines to individuals who requested them, vaccine hesitancy was not a primary challenge. As one participant described, “ I mean , because we’re not beating their door down and jabbing them without their permission , right? So if we’re there for a service that they’ve requested , uh , I don’t see there being any divide. Uh , I don’t see there being any issue.” (Non-MIH-CP-15). However, many of the participants described wide-spread vaccine hesitancy in their communities. One explained that, “ Yeah , there’s always hesitant , not because we’re doing it. The hesitancy exists because of the vaccine , the misinformation from the vaccines. Um , when the vaccines became a political issue and a political fireball to use , that created a hesitancy . ” (Non-MIH-CP-13).

Some people saw addressing vaccine hesitancy as within the scope of paramedicine. Many felt “ comfortable communicating with people” about vaccines (MIH-CP-01). One went further and said that to address vaccine hesitancy, “ I mean , what do you do? You know , you can talk to individuals. ” (MIH-CP-06). Others wanted to avoid the “ political involvement ” with vaccines (Non-MIH-CP-18). One participant further explained that “ We see them when they’re sick , whether they’re vaccinated or not with COVID or whatever…If they don’t want it , they don’t want it. We as an agency , don’t push that to outside people.” (Non-MIH-CP-13).

These differences in opinions may be related to participants’ own feelings about vaccines. In the open-ended question at the end of the post-interview survey, one participant said that,

“Combating misinformation has been required in our vaccination program. Not only with patients but with healthcare providers. More information to healthcare workers delivered in a manner they will digest such as 1-to-2-minute videos would be beneficial. So much information was given, but ultimately ignored during COVID, and I believe the delivery of the information could have been improved. Asking how do we get all our Healthcare providers speaking comfortably, confidently and competently while delivering the same talking points I believe will be critical to build public trust.” (Post-Interview Survey, anonymous).

This view was also shared by another participant who said, “ And even amongst healthcare workers , the number of them that just outright refuse for whatever reason is pretty , pretty impressive. ” (Non-MIH-CP-17). This division was evident in our post-interview survey questions about vaccine hesitancy. We asked participants how strongly they agreed or disagreed with 12 statements describing vaccine hesitancy like, “Getting a COVID-19 vaccine is a good way to protect me from coronavirus disease.” and “I think COVID-19 vaccines might cause lasting health problems for me.” For all questions, there were individuals who answered “Strongly Agree” and individuals who answered “Strongly Disagree,” respectively. The overall mean score of the 12 items on a scale of 1–5 (with higher numbers indicating more confidence in vaccines) was 3.6 out of 5. However, the anonymous nature of the study precluded us from connecting their interview data with their survey responses.

Vaccines as a Low Priority for MIH-CP

A few participants with MIH-CP programs thought vaccines could be a component of their services, but the other services were more critical: “ We were very protective of our Medics because they see only chronic disease patients , right - the highest risk patients…So we didn’t- we don’t really do , we’re not high-volume vaccines comparatively to some of our other peer programs .” (MIH-CP-02). Although this view was less commonly described in the interviews, several voiced it in the post-interview survey. One said:

“We should be asking if this is the best way to utilize community paramedics. There are much more beneficial tasks (fall prevention, home modification, collection of health information in case of emergency, risk mitigation) that should be prioritized over vaccines. The vaccinations could be a portion of a holistic health picture but is relatively low priority when it comes to the numbers and severity of those impacted.” (Post-Interview Survey, anonymous).

Some participants perceived vaccines to be a low priority for MIH-CP because EMTs could provide the same service. One participant stated, “ I guess when I think community paramedicine , I think more of an advanced scope than vaccine distribution. Um , and here in the state of Indiana , EMT Basics are eligible to distribute vaccinations. ” (Non-MIH-CP-11). However, one of the state administrators clarified that EMTs can “ do influenza and COVID. We added that to their scope of practice. Anything else would have to be a paramedic for vaccination.” (SRA-21).

Vaccine program opportunities

Despite the challenges, many participants felt there were benefits to providing vaccines through MIH-CP and that their programs were successful. Many people viewed vaccines as “ beneficial ” (MIH-CP-01) and that MIH-CP could be an important part of reducing health disparities saying, “ I think that leans into a large ability to see the patient as a whole. And certainly , vaccines are within that ability to go into the home and do and make sure that everybody has equal access. ” (Non-MIH-CP-18). Agencies that had COVID-19 programs reported that they were successful. One said that, “ we ended up doing hundreds of vaccines. I can’t remember how many , but it was a lot of them .” (MIH-CP-10). Another described the response to their services as:

“Oh, incredibly successful. You know, the whole concept was it wasn’t just the clinics that were successful. I say clinic and that’s kind of a broad term ….And so part of these clinics were us going to these individuals homes and giving them these vaccinations on site in their own homes. And that part of this was just, you know, I thought, wildly successful too. Because, you know, here we are taking care to people who otherwise wouldn’t have a means of getting there. And I think that that’s the kind of health care system we need to start moving towards in a lot of respects, not just in vaccinations.” (MIH-CP-07).

In this qualitative study examining implementation of MIH-CP vaccination programs, participants reported a wide variety of vaccination program structure and functions. Overall, vaccine programs were described as very successful and have the potential to serve as an effective way to improve access to underserved areas. The largest overall challenge reported was funding for the program, and the lack of funding had a ripple effect, affecting multiple functions within the organization, resulting in a lack of dedicated staff for vaccines and a perception that vaccinations were a low priority for the organization. Some participants commented on upstream causes of the lack of funding, including that there are not state-wide and federal policies governing MIH-CP, which limits reimbursement opportunities and limits the implementation of broader vaccination programs. Most participants described their vaccination programs as very successful and a way to reach people who were homebound or otherwise unable to access vaccines within their communities. The overall sentiment was that while vaccine hesitancy was not a barrier with the patient population they were serving, they did express discomfort at the prospect of being perceived as “pushing” or advocating for vaccines.

When discussing the feasibility of implementing an MIH-CP vaccine program, the main barrier described was funding. This was described as a barrier at multiple levels, including gaining initial funding, maintaining funding, and having dedicated staffing when sustained funding is not guaranteed. This same barrier has been reported in the literature for community health workers (CHWs), with one study also conducted in Indiana specifically reporting on the difficulties maintaining personnel with uncertain funding mechanisms and a cumbersome and confusing structure to apply for Medicaid reimbursement [ 29 ]. Like our findings, the CHW study reported that inconsistent funding jeopardizes CHW programs and recommended clarifying the existing Medicaid reimbursement policies. Recently, Indiana county health departments have received an influx of public health funding from the state that increased funding for public health in the state by 1500% [ 30 ]. Some of these funds are being used to expand the geographic reach of existing MIH-CP programs. This increased funding should alleviate the barriers discussed by our participants. Future work should examine the effects of this funding on alleviating disparities in the expanded areas.

Overall, CP vaccination programs were perceived as acceptable across EMS organizations. Our participants also reported they believed community members would be supportive of receiving vaccines from a CP. However, there have been limited studies examining patient perceptions of the acceptability of CP vaccine provision, particularly in the U.S [ 2 ]. Similar studies examining patient acceptability of the CHW-model has shown overall positive perceptions and high acceptability both in the U.S [ 31 ], and abroad [ 32 , 33 ]. Future studies should examine community perceptions of CP acceptability to determine whether this might be a model that could be implemented more broadly to address health disparities.

While CPs in our study did report they felt comfortable giving vaccines, most also expressed that they would not want to advocate for vaccines or be seen as “pushing” vaccines on their patients. Even though they did not report any personal vaccination hesitancy in the qualitative interviews, the answers on the anonymous survey did indicate a significant level of vaccination hesitancy in this group of providers. This sentiment is seen across health professionals with one publication finding that nearly one-third of US healthcare providers were hesitant about vaccinations [ 34 ]. This is not a new phenomenon and vaccine hesitant providers existed before the COVID-19 pandemic and continue to exist after the pandemic [ 35 ]. Thus, there is a pressing need not only to educate healthcare providers to reduce vaccination hesitancy among this group, but also to give providers across the spectrum adequate training to effectively communicate with patients so that they feel comfortable combatting existing misinformation to improve vaccination uptake.

This study is among the first to examine feasibility and acceptability of implementing vaccination programs within MIH-CP programs. The findings can be used to inform implementation of other programs and to improve existing programs. However, the results should be interpreted in light of several limitations. First, the participants in this study are from a single state and the findings may be different in other geographic locations. Second, there were counties within the state that had no EMS services, and we were not able to gain perspectives of professionals working in those counties. Third, while the qualitative nature of our study allowed us to gain an in-depth understanding of the existing programs, we did not have quantitative data assessing program effectiveness and we are unable to determine if the implemented programs have had an impact on the health of the community.

This study provides important context on the feasibility and acceptability of implementing an MIH-CP vaccination program. Major barriers to implementing and maintaining these programs are lack of sustained funding and unclear policies governing the programs. While participants in our study did not describe vaccine hesitancy as a major problem in their communities, they also expressed discomfort in advocating for vaccines, should people express hesitancy. They also described vaccines as a lower priority for their agencies than other services they provide, like managing chronic diseases. However, many did describe vaccines as beneficial and an important part of reducing health disparities in their communities. Future research should conduct rigorous evaluations of MIH-CP programs to determine program effectiveness and examine patient perceptions of the acceptability of receiving a vaccine from a CP. Using CP to deliver vaccinations to underserved communities has the potential to reduce health disparities and improve health outcomes for these communities.

Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Community health worker

Community paramedics

Department of Homeland Security

Emergency Medical Services

Mobile integrated health-community paramedicine

Rural health clinics

Socioeconomic Status

State/regional administrators

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Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Alicia o’cathain.

1 Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Street, Sheffield, S1 4DA UK

Pat Hoddinott

2 Primary Care, Nursing Midwifery and Allied Health Professionals Research Unit, University of Stirling, Stirling, FK9 4LA Scotland UK

Simon Lewin

3 Global Health Unit, Norwegian Knowledge Centre for the Health Services, Oslo, Norway

4 Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa

Kate J. Thomas

Bridget young.

5 Institute of Psychology, Health and Society, University of Liverpool, Waterhouse Building, Block B, Brownlow Street, Liverpool, L69 3GL UK

Joy Adamson

6 Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD UK

Yvonne JFM. Jansen

7 Behavioural and Societal Sciences, Work, Health & Care, Schoemakerstraat 97 (Gebouw A), Delft, 2628 VK Netherlands

Nicola Mills

8 School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK

Graham Moore

9 Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement, Cardiff University, Cardiff, CF10 3XQ UK

Jenny L. Donovan

Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

Introduction

The United Kingdom Medical Research Council (UK MRC) guidance on the development and evaluation of complex interventions recommends an early phase of assessing feasibility prior to a full evaluation [ 1 ]. In this feasibility and pilot phase, researchers can identify and address problems which might undermine the acceptability and delivery of the intervention or the conduct of the evaluation. When the outcome evaluation is a randomised controlled trial, this feasibility phase increases the chances of researchers evaluating the optimum intervention using the most appropriate and efficient recruitment practices and trial design. Alternatively, at the feasibility phase, researchers may identify fundamental problems with the intervention or trial conduct and return to the development phase rather than proceed to a full trial. The feasibility phase thus has the potential to ensure that money is not wasted on an expensive trial which produces a null result due to problems with recruitment, retention or delivery of the intervention [ 2 ].

Feasibility studies for randomised controlled trials can draw on a range of methods. Some feasibility studies use quantitative methods only. For example, researchers concerned about whether they could recruit to a trial, and whether the intervention was acceptable to health professionals and patients, undertook a pilot trial with outcomes related to recruitment and surveys to measure the acceptability of the intervention [ 3 ]. Increasingly, qualitative or mixed methods are being used within feasibility studies for randomised controlled trials. A review of 296 journal articles reporting the use of qualitative research with trials published between 2008 and 2010 identified that 28 % of articles reported qualitative research undertaken prior to the full trial [ 4 ]. Qualitative research was not only undertaken with trials of complex interventions but was also used with trials of drugs and devices where researchers recognised the complexity of the patient group receiving the intervention or the complexity of the environment in which the trial was to be undertaken [ 5 ]. Yet, there is little guidance available on how to use qualitative methods within feasibility studies for trials. Here, we offer guidance in order to help researchers maximise the opportunities of this endeavour.

Getting the language right: feasibility studies, pilot studies and pilot trials

Before offering guidance on using qualitative methods at the feasibility phase of a trial, we first need to be clear about the meaning of the term ‘feasibility study’ because the language used to describe the preparatory phase for a trial is inconsistent [ 6 ]. These types of studies can be called feasibility or pilot studies, with researchers making no clear distinction between the two when reporting their studies in journal articles [ 7 ]. The MRC guidance for developing and evaluating complex interventions describes this as the ‘feasibility and piloting’ stage. The UK funding body, the National Institute for Health Research (NIHR), offers definitions of feasibility and pilot studies, distinguishing between the two [ 8 ]. A feasibility study is undertaken to address the question ‘can the planned evaluation be done?’. In contrast, pilot studies are miniature versions of the main study. In the case of a randomised controlled trial, the pilot study is a pilot trial. A feasibility study for a randomised controlled trial does not necessarily involve a pilot randomised controlled trial [ 1 ] but may do so, and indeed, some researchers have described their studies as a ‘feasibility study and pilot trial’ in the titles of their journal articles [ 9 ]. Other terms may be used to describe a feasibility study for a trial, for example a ‘formative’ study as part of ‘evidence-based planning’ [ 10 ] or an exploratory pilot study [ 11 ] or a process evaluation with a pilot trial [ 12 ]. In this guidance, we use the term ‘feasibility study’ to describe any study that addresses the question of whether the planned evaluation trial can be done regardless of the labels other researchers might use.

The need for guidance on using qualitative methods in feasibility studies for randomised controlled trials

With the use of qualitative research in feasibility studies for randomised controlled trials becoming increasingly common, guidance on how to do this would be useful to both researchers and those commissioning and reviewing this research. Guidance is available or emerging in areas related to feasibility studies for trials. Guidance exists for undertaking quantitative pilot studies [ 13 , 14 ], and a Consolidated Standards of Reporting Trials (CONSORT) statement for reporting feasibility studies (rather than undertaking them) is under development [ 6 ]. UK MRC guidance has recently been developed for process evaluations undertaken alongside randomised controlled trials [ 15 ]. This new guidance recommends that, in most cases, it is useful to use both qualitative and quantitative methods concurrently with a pilot or full trial. It also states that as feasibility studies will usually aim to refine understanding of how the intervention works, and facilitate ongoing adaptation of intervention and evaluation design in preparation for a full trial, qualitative data will likely be of particular value at this stage. However, that guidance does not address in any depth issues specific to the use of qualitative research during the feasibility phase of a trial. There is also guidance for writing proposals for using qualitative research with trials [ 16 ] and reporting qualitative research undertaken with trials [ 5 ]. However, the feasibility phase of a trial is unique in that it may involve the ongoing adaptation of plans for conducting the trial and of the intervention in preparation for the full trial. Therefore, our guidance complements recent and upcoming guidance by focusing on the role of qualitative research specifically rather than the overall feasibility study and by addressing the iterative nature of research that may occur in feasibility studies for trials.

The focus of the guidance

This guidance focuses on how to use qualitative research within a feasibility study undertaken prior to a fully randomised controlled trial where the aim is to improve the intervention or trial conduct for the full trial. Appropriate and well-conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. The guidance presented here may help researchers to consider the full range of possible contributions that qualitative research can make in relation to their particular trial and reflect on the utility of this research in practice, so that others can decide when and how best to use qualitative research in their studies. Prior to presenting the guidance, we clarify six issues about the scope of the guidance:

• A feasibility study may or may not include a pilot randomised controlled trial.
• The feasibility phase follows the development phase of an intervention, in which qualitative methods may also be used [ 1 ]. Although there may be overlap between the development of the intervention and the feasibility phase of the trial, this guidance assumes that an intervention has been developed, but that it might need further modification, including assessment of its practicability in the health care setting.
• Qualitative methods can be used alone or in conjunction with quantitative methods, such as modelling and surveys, in the feasibility phase [ 1 ].
• The definition of qualitative research is the explicit use of both qualitative data collection and analysis methods. This is distinguished from trialists’ reflective reports on the problems that they encountered in running a feasibility study and from the use of methods that may draw on qualitative approaches but do not meet our definition. For example, some researchers report using ‘observation’ and ‘field notes’ but show no evidence of qualitative data collection or analysis in their article and do not label these as qualitative research [ 8 ]. Reflective practice by trialists and intervention deliverers is important for learning about trial conduct but is not the focus of the guidance presented here.
• The guidance focuses on maximising the opportunities of qualitative research by presenting options, rather than delineating required actions. This is based on the understanding that the strengths of qualitative research are its flexibility and responsiveness to emerging issues from the field.
• The guidance may be used by researchers when writing proposals and undertaking or reporting qualitative research within feasibility studies. If the feasibility study includes a pilot randomised controlled trial, reporting should follow the CONSORT statement that is currently under development [ 6 ].

Processes used to develop the guidance

This guidance is based on the experience of the authors of this paper. The authors came together in a workshop to write this guidance after meeting to discuss a study of how to maximise the value of qualitative research with randomised controlled trials which had been undertaken by two of the authors of this guidance (AOC, KJT) [ 4 , 5 ]. That study involved undertaking a systematic mapping review of journal articles reporting qualitative research undertaken with randomised controlled trials and interviews with qualitative researchers and trialists; some of these articles are referenced to illustrate points made. Towards the end of this study, the UK MRC Hubs for Trials Methodology Research funded a conference to disseminate the findings from this study and a related 1-day workshop to develop guidance for using qualitative research with trials. The nine workshop members, all of whom are authors of this guidance, were identified for their experience in using qualitative research with trials. One member had also published a review of the use of qualitative research alongside trials of complex interventions [ 17 ].

The workshop focused on feasibility studies because these were identified as an underdeveloped aspect of trial methodology. The workshop members put forward items for the guidance, based on their experience and expert knowledge. Discussion took place about the importance of items and the different viewpoints within each item. Draft guidance was produced by AOC after the workshop. Subsequent development of the guidance was undertaken by email correspondence and meetings between sub-groups of the workshop membership. A draft of the guidance was then presented at a meeting of an MRC Methodology Hub for researchers with experience in undertaking qualitative research in feasibility studies for trials. Attendees viewed the guidance as helpful, and further insights emerged from this process, particularly around the analysis domain of the guidance.

The guidance

The guidance is detailed below and summarised in Table  1 . The structure follows the stages of a research project from identifying research questions to reporting findings and consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Although the table presents a neat and linear process, in practice, this research is likely to be messy and iterative, with researchers moving backwards and forwards between steps as insights emerge and the priority of different research questions changes. Figure  1 shows how the guidance meshes with this more dynamic process. We illustrate some of the items in the guidance using case studies of published qualitative research undertaken within feasibility studies for trials. Some items tend not to be visible in publications, particularly those on teamworking, and therefore are not illustrated in these case studies.

• When designing the feasibility study, consider the full range of questions that could be addressed. Then, consider those best addressed by qualitative research.

Guidance for using qualitative research in feasibility studies for trials

Key steps for qualitative research in a feasibility study for a trial

Some researchers have produced lists of questions that could be addressed in feasibility studies for trials, focusing on the conduct of the trial and on the intervention [ 8 ]. A review of feasibility and pilot trials identified the range of questions actually addressed in a subset of feasibility studies that included a randomised controlled trial, [ 18 ] although it was not clear which questions were actually addressed by qualitative research. Other researchers have identified frameworks or typologies of questions for feasibility studies. For example, a description of feasibility studies for cancer prevention in the USA identified a typology of the questions addressed and some of the methodologies used [ 19 ]. Qualitative research was identified as useful for issues concerning acceptability, implementation, practicality and expansion (in terms of understanding use of a known intervention in a different sub-group). There is also a framework for the work undertaken by qualitative research with trials [ 4 ]. Using the latter framework, we drew on the literature cited here and our own experience of feasibility studies to identify the range of issues qualitative research can address in a feasibility study for a trial (Table  2 ). Although not noted explicitly in Table  2 , the context in which the intervention is delivered is relevant to a large number of the questions identified in Table  2 and should be considered during a feasibility study as well as in the full trial [ 15 ]. The important role of context within complex intervention trials was highlighted in a recent study which found that contextual threats to trial conduct were often subtle, idiosyncratic and complex [ 20 ], and therefore best explored using qualitative research.

• (b) Prioritise the questions for the qualitative research by identifying key uncertainties.

Questions that qualitative research a can address in a feasibility study for a randomised controlled trial

a Mixed methods research could also be used

Many questions can be addressed in a feasibility study, but resource limitations require that these are prioritised. The whole team will need to identify the key uncertainties that the feasibility study should address. Thereafter, a search of the evidence base for systematic reviews (including mixed reviews based on both qualitative and quantitative researches) relevant to these uncertainties may yield useful insights. Where no systematic reviews exist, and there is no resource to undertake them, studies of similar interventions or similar types of trials may be helpful. Questions on which there is currently little or no existing evidence can then be prioritised for new primary qualitative research.

• (c) Consider often overlooked questions.

Researchers commonly use qualitative research to address the acceptability and feasibility of the intervention [ 10 , 21 – 24 ] or its perceived benefits [ 11 , 22 ]. During our workshop, we identified four important questions that can be overlooked and are worth considering:

• (i) How do the intervention components and delivery processes work in the real world?

Guidance for process evaluations recommends developing a logic model or explanatory model of the intervention [ 15 ]. This logic model includes the intervention components and pathways to delivering desired outcomes. However, even if trialists, intervention deliverers, patients and the public, and qualitative researchers have been involved in developing this logic model, some aspects of the intervention in practice may be hidden or not understood, and these hidden aspects may be the key to delivering outcomes. For example, intervention deliverers may adapt the intervention in unanticipated ways in order to deliver it in their local context. Qualitative research, including non-participant observation and interviews with intervention deliverers and recipients, may be helpful in identifying how and why they have done this. This may facilitate replication of the intervention in the subsequent trial or rollout and also raise questions about the most appropriate trial design required. In addition, it may offer insights into which aspects of the intervention should be fixed or flexible in the full trial [ 25 ] and how the intervention needs to be tailored to different contexts. The wider context in which the trial operates may also affect the implementation of the intervention, the control or the trial, for example staff shortages, media scares or the economic climate. Intervention vignettes can be a helpful tool in qualitative interviews to talk potential participants through each step of an intervention in a concrete way [ 26 ].

• (ii) How does the choice of comparator affect the trial?

The focus of qualitative research undertaken with trials tends to be on the intervention, but qualitative research can also help to understand the control. Interventions can be compared with active controls or usual care, and there may be issues to explore regarding the comparability of an active control and the intervention or the extent to which the trial may change usual care [ 27 ]. Such research may help the trial team to consider whether there is sufficient difference between the groups being compared in any trial. For instance, the planned intervention may not be that different from usual care in some settings and may need to be enhanced prior to use in the full trial. Differences between the intervention and usual care will have implications for the relative effectiveness of the intervention and the transferability of the trial findings to other contexts.

Understanding usual care is also important because it represents a key feature of the context in which the new intervention will be implemented. Where a new intervention represents a fundamental change from usual practice, one would perhaps expect to encounter greater challenges in implementation and would need to pay more attention to the resources and structures required to achieve change compared to where the intervention represents a more incremental change.

• (iii) To what degree does equipoise exist?

Key stakeholders may not be in equipoise around the intervention [ 28 ]. These stakeholders include the trial designers, recruiters, patient and public representatives and participants, as well as health care staff who are not directly involved in the trial but will use the evidence produced by it. A lack of equipoise amongst stakeholders may lead to poor recruitment practices, low recruitment rates or a lack of utility of the evidence in the real world [ 29 ]. Consideration of the question of equipoise at the feasibility phase can offer opportunities to address this, for example through education, increasing awareness and enabling open discussion of the issues, or highlight the option of not progressing to an expensive full trial [ 30 , 31 ]. This has been highlighted as a particular problem for behavioural intervention trials, with recommendations to explore this issue at the pilot stage of a trial [ 32 ].

• Consider the range of qualitative methods that might be used to address the key feasibility questions, including dynamic or iterative approaches which allow learning from early qualitative research findings to be implemented before further qualitative research is undertaken as part of the feasibility study.

When undertaking qualitative research in feasibility studies for trials, it is common for researchers to undertake a cross-sectional interview study with intervention deliverers and recipients and not to specify explicitly an approach or design [ 12 , 21 , 22 , 24 ]. Although sometimes it may be important to mirror closely the expected approach of the planned full trial in terms of recruitment practices, it may be helpful for the research team to take a flexible approach to the qualitative research. The team may make changes during the feasibility study itself, based on findings from the qualitative research, and then assess the impact of these changes [ 33 ]. This is sometimes called a ‘dynamic approach’. Such changes could include taking action to modify the pilot trial conduct, as well as working with intervention stakeholders to feedback and resolve difficulties in implementing the intervention. Further qualitative research can then be undertaken to inform further improvements throughout the feasibility study. This can help to optimise trial conduct or an intervention rather than simply identify problems with it. Case study 1 describes an example of this dynamic approach to data collection [ 33 ].

Other approaches suitable for feasibility studies include iterative ‘rapid ethnographic assessment’ which has been used to adapt and tailor interventions to the different contexts in which the trial was planned [ 34 ]. This approach applies a range of methods including participant observation, focus groups, interviews and social mapping [ 34 ]. Other researchers have used ‘mixed methods formative research’ at the feasibility stage [ 10 ] and action research where potential participants and practitioners are actively involved in the research to assess the feasibility of an intervention and to ensure a good intervention-context fit [ 35 , 36 ]. For instance, a participatory approach informed by the principles of action research was used to design, implement and evaluate the FEeding Support Team (FEST) intervention [ 35 , 36 ].

A dynamic or iterative approach to qualitative research in a feasibility study, where concurrent changes are made to the intervention or trial conduct, would not be suitable for a full trial where care is taken to protect the experiment. In a fully randomised controlled trial, researchers may be concerned that an excessive volume or intensity of qualitative research may contaminate the experiment by acting as an intervention [ 37 ]. Or, they may be concerned about early reporting of findings of the qualitative research detrimentally affecting staff delivering the intervention or the trial [ 38 ]. Any risks will depend on the size and type of the trial and the qualitative research and may be far outweighed by the benefits in practice of undertaking the qualitative research throughout the full trial. These concerns are less relevant during the feasibility phase.

• (b) Select from a range of appropriate qualitative methods to address the feasibility questions and provide a rationale for the choices made; non-participant observation may be an important consideration.

Researchers need to select from a range of qualitative methods including telephone and face-to-face interviews, focus groups, non-participant observation, paper/audio/video diaries, case notes kept by health professionals and discussions in online chat rooms and social media. Decisions on data collection and analysis methods should depend on the research questions posed and the context in which data will be collected. To date, feasibility studies for trials have often tended to rely solely upon interviews or focus group discussions with participants and intervention deliverers and have not drawn on the wider range of methods available [ 21 – 24 ]. Researchers tend also to use focus groups and may do this because they think they are cheap and quick when in practice, they are challenging to both organise and analyse. Some researchers are explicit about why focus groups are the best approach for their study. For example, in a randomised trial on the use of diaphragms to prevent sexually transmitted infection, the research team conducted 12 focus groups with women before and after they received the intervention to consider its acceptability and feasibility. This data collection approach was justified on the basis that the researchers felt focus groups would generate more open discussion [ 10 ]. However, focus groups may be problematic in a feasibility study because they tend towards consensus and can mask dissenting views, with the possibility of premature conceptual closure. It may also be the case that participants who are prepared to talk openly within a group setting may differ from the target population for a trial as, in general, focus groups tend to attract more educated and confident individuals [ 39 ].

Non-participant observation, including the use of audio or video recordings of intervention delivery or recruitment sessions, can help to identify implementation constraints at the feasibility phase. Observation has also proved to be very useful when exploring recruitment practices for a full trial [ 33 , 40 ]. ‘Think aloud’ protocols may also be helpful—for example, in one feasibility study of a technology to deliver behaviour change, the approach was used to allow users to talk about the strengths and weaknesses of the technology as they attempted to use it [ 41 ].

• (c) Pay attention to diversity when sampling participants, groups, sites and stage of intervention.

All of the different approaches to sampling in qualitative research—such as purposive, key informant and snowballing—are relevant to feasibility studies. A particular challenge for sampling within the feasibility phase is the need to address the wide range of uncertainties about the full trial or the intervention within the resource limitations of the study.

It can be difficult to decide when enough has been learnt about the trial intervention or the conduct of the trial (or when data saturation has occurred) to recommend moving on to the full trial. Researchers will need to make pragmatic decisions on which emerging analysis themes warrant more data collection and where sufficient data are available. In practice, sample sizes for qualitative research in feasibility studies are usually small (typically between 5 and 20 individuals [ 10 , 12 , 22 – 24 ]). This may be reasonable, given that simulations suggest that 10 users will identify a minimum of 80 % of the problems with the technology during usability testing, and 20 users will identify 95 % of the problems [ 42 ]. However, sample size will be dependent on the study; for example, there may be therapist effects to consider and a need to sample a range of patients using different therapists or a range of contexts.

Diversity of sampling is probably more important at the feasibility phase than the number of interviews or focus groups conducted, and some researchers have rightly highlighted as a limitation the lack of diversity in the sampling process for their qualitative feasibility study [ 20 ]. Paying attention to the diversity of sampling needed may be important for identifying the wide range of problems likely to be faced by the group/s to which the intervention is directed. Including a diverse range of health professionals and patients (for an individual-level trial) and sites (for a cluster trial) can be beneficial. In individual-level multicentre trials, including more than one centre at the feasibility stage can reduce the chance of refining an intervention or trial that will only work within that single centre. As in other forms of qualitative research, sampling may be very broad at the start of the feasibility study, when there are lots of questions and uncertainty, with later sampling focusing on disconfirming cases to test emerging findings.

• (d) Appreciate the difference between qualitative research and public and patient involvement.

In the UK and many other settings, it is considered good practice to have public and patient involvement in health research [ 43 ]. This is highly relevant to a feasibility study where patients and the public can contribute to prioritising which key uncertainties to address and are therefore involved at an early stage of the design of the full trial. Indeed, there is guidance available on patient and public involvement in trials, showing how service users can be involved at the feasibility/pilot stage of a trial by being members of the management group, steering committee and research team and by contributing to the design, analysis and reporting of the feasibility study [ 44 ]. A potential concern is that some researchers conflate qualitative research and public and patient involvement; this may be more common during a feasibility study if the public or patient involvement group is asked to provide feedback on the intervention. Although patient and public representatives on research teams can provide helpful feedback on the intervention, this does not constitute qualitative research and may not result in sufficiently robust data to inform the appropriate development of the intervention. That is, qualitative research is likely to be necessary in conjunction with any patient and public involvement. Case study 2 describes an example of a qualitative study undertaken with patient involvement [ 45 ].

• Consider the timing of analysis, which might be in stages in a dynamic approach.

For many types of qualitative research, it is suggested that data are analysed as they are collected so that the sampling for the next round of data collection benefits from the analysis of these earlier data. If a dynamic approach is applied in a feasibility study, it is important to have available sufficient resources to analyse the data collected early in the study in order to feed findings back to the wider team and allow changes to be made to the intervention and trial conduct prior to the next set of data collection. This can be quite different from using qualitative research in the full trial, where all data might be collected prior to any formal analysis and sharing of findings with the wider team.

• (b) Many different approaches to analysis can be used, including framework, thematic and grounded theory-informed analysis.

Many different approaches can be used to analyse qualitative data in the context of a feasibility study, and the approach should be chosen based on the research question and the skills of the research team. Some researchers simply describe the steps they take within their analysis rather than citing a named approach [ 12 ]. Other researchers use combinations of known approaches such as framework analysis and grounded theory [ 36 ].

• (c) Data can cover a breadth of issues, but the analysis may focus on a few key issues.

An important challenge for analysis may be the specificity of the questions that need to be addressed by a qualitative feasibility study, in order to inform trial development. Analysis will need to focus on the questions prioritised at the beginning, or those emerging throughout the feasibility study, from the large amounts of qualitative data generated. The analysis process needs to consider ‘fatal flaws’ that may require tailoring or refining of the intervention or trial conduct, as well as the mechanisms of action for the intervention.

• Have a qualitative researcher as part of feasibility study design team.

Planning the feasibility study needs qualitative expertise to determine what can be done, how long it might take, how it is best done and the resources needed. It is therefore important that an expert in qualitative methods be included in both the planning and delivery teams for the feasibility study.

• (b) Consider relationships between the qualitative researchers and the wider feasibility study team.

How the qualitative researchers interact with the wider feasibility study team is an important concern. If study participants view the qualitative researchers as closely aligned with the team delivering the intervention or conducting the pilot trial, then participants may feel less able to offer honest criticisms of the intervention or trial conduct. On the other hand, where qualitative researchers work too independently from the wider team, they may not develop a deep understanding of the needs of the trial and the implications of their findings for the trial.

Qualitative researchers may identify issues that are uncomfortable for the rest of the research team. For example, they may consider that an intervention does not simply need refining but has a fundamental flaw or weakness in the context in which it is being tested. This may be particularly difficult if the intervention developer is part of the team. Indeed, some members of the team may not be in equipoise about the intervention (see earlier); they may have strong prior beliefs about its feasibility, acceptability and effectiveness and be unable to acknowledge any weaknesses. However, without openness to change, the qualitative research is unlikely to reach its potential for impact on the full trial. On the other hand, the wider team may need to challenge the findings of the qualitative research to ensure that any proposed changes are necessary. Qualitative researchers may also identify problems with the trial conduct that the rest of the team do not see as important because, for example, the recruitment statistics are adequate or it is an effort to change plans. There may also be tensions between what the trial design team need and what the qualitative researcher sees as important. For instance, the trial team may want to understand the feasibility of the intervention whilst the qualitative researcher is more interested in understanding mechanisms of action of the intervention. The team will need to discuss these differences as they plan and undertake the research. The only solution to these tensions is open communication between team members throughout the feasibility study.

• (c) Consider who will make changes to the intervention or trial conduct.

Qualitative researchers can identify strengths and weaknesses of the intervention or the conduct of the trial. However, they are usually not responsible for redesigning the intervention or trial either during the feasibility study (if a dynamic approach is taken) or at the end of the feasibility study when the full trial is being considered and planned. It is helpful to be explicit about who is responsible for making changes based on the qualitative findings and how and when they will do this.

• Publish feasibility studies where possible because they help other researchers to consider the feasibility of similar interventions or trials.

Other researchers can learn from feasibility studies, and where this is likely to be the case, we recommend publishing them in peer-reviewed journal articles. Other researchers might be willing to take forward to full trial an intervention that the original researchers were unable or unwilling to take beyond the feasibility study. Or, other researchers might learn how to develop better interventions or trials within the same field or understand which qualitative methods are most fruitful in different contexts. Publishing what went wrong within a feasibility study can be as helpful as publishing what went right. Explicit description of how decisions were made about which research questions and uncertainties were prioritised may help others to understand how to make these types of decisions in their future feasibility studies.

Researchers may choose to publish the qualitative findings in the same article as the findings from the pilot trial or quantitative study or may publish them separately if there are detailed and different stories to tell. For example, Hoddinott and colleagues published separate articles related to the outcome evaluation and the process evaluation of a feasibility study of a breastfeeding intervention for women in disadvantaged areas [ 35 , 36 ]. Feasibility studies may generate multiple papers, each of which will need to tell one part of a coherent whole story. Regardless of how many articles are published from a single feasibility study, identifying each one as a feasibility study in the article title will help other researchers to locate them.

• (b) Describe the qualitative analysis and findings in detail.

When publishing qualitative research used with trials, researchers sometimes offer very limited description of the qualitative methods, analysis and findings or rely on limited data collection [ 5 , 17 ]. This ‘qual-lite’ approach limits the credibility of the qualitative research because other researchers and research users cannot assess the quality of the methods and interpretation. This may be due to the word limits of journal articles, especially if a range of quantitative and qualitative methods are reported in the same journal article. Electronic journals allowing longer articles, and the use of supplementary tables, can facilitate the inclusion of both more detail on the methods used and a larger number of illustrative data extracts [ 12 ]. Researchers may wish to draw on guidelines for the reporting of qualitative research [ 46 ].

• (c) Be explicit about the learning for a future trial or a similar body of interventions or generic learning for trials.

Qualitative research in a feasibility study for a trial can identify useful learning for the full trial and for researchers undertaking similar trials or evaluating similar interventions. This makes it important to be explicit about that learning in any report or article. Reporting the impact of the qualitative research on the trial, and potential learning for future trials, in the abstract of any journal article can make it easier for other researchers to learn from the qualitative research findings [ 12 ]. Examples of the impact that qualitative research in feasibility studies can have on the full trial include changes in the information given to participants in the full trial [ 10 ], recruitment procedures [ 21 , 28 ], intervention content or delivery [ 12 , 22 , 24 ], trial design [ 23 ] or outcome measures to be used [ 47 ]. For example, in the ProtecT trial, initial expectations were that only a two-arm trial comparing radical treatments would be possible, but following the qualitative research, an active monitoring arm that was acceptable was developed and included in the main trial [ 21 ]. Learning from the qualitative research may be unexpected. For example, the aim of the qualitative research in one feasibility study was to explore the acceptability of the intervention, but in practice, it identified issues about the perceived benefits of the intervention which affected the future trial design [ 23 ]. See case study 3 for an example of qualitative research undertaken with a pilot trial where the learning for the full trial is explicitly reported in the published paper [ 47 ]

Once a feasibility study is complete, researchers must make the difficult decision of whether to progress to the full trial or publish why a full trial cannot be undertaken. There is guidance on how to make this decision, which encourages the systematic identification and appraisal of problems and potential solutions and improves the transparency of decision-making processes [ 48 ]. Too often, progression criteria are framed almost entirely in quantitative terms and it is unclear the extent to which qualitative data may or not play a direct role in informing the decision on whether to proceed to a full trial. For example, if researchers fall just short of a quantitative criterion, but have a sufficient qualitative understanding of why this happened and how to improve it, then it might be possible to proceed. Related to this, qualitative research may identify potential harms at the feasibility stage; the intervention could be modified to avoid these in the full trial, or a decision could be made not to proceed to a full trial even if progression criteria were met.

Conclusions

Exploring uncertainties before a full trial is underway can enable trialists to address problems or optimise the intervention or conduct of the trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research in feasibility studies. This guidance consists of 16 items framed around five research domains: research questions, data collection, analysis, teamwork and reporting. A strength of the guidance is that it is based on a combination of experiences from both published feasibility studies and researchers from eight universities in three countries. A limitation is that the guidance was not developed using consensus methods. The guidance is not meant as a straitjacket but as a way of helping researchers to reflect on their practice. A useful future exercise would be to develop worked examples of how research teams have used the guidance to plan and undertake their qualitative research within feasibility studies for trials. This would help to highlight the strengths and limitations of the guidance in different contexts. Using qualitative research with trials is still a developing area, and so, we present this guidance as a starting point for others to build on, as understanding of the importance of this vital stage of preparation for randomised controlled trials grows. Researchers may also wish to reflect on the utility of different qualitative methods and approaches within their studies to help other researchers make decisions about their future feasibility studies.

Acknowledgements

The workshop was funded by the MRC North West and ConDuCT Hubs for Trial Methodology. This work was undertaken with the support of the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures—MR/K025643/1). We would like to thank attendees at the ConDuCT-II Hub workshop on feasibility studies held at the University of Bristol in October 2014 who discussed and commented on a presentation of an earlier version of this guidance. JLD is a NIHR Senior Investigator. SL is supported by funding from the South African Medical Research Council.

Abbreviations

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

AOC, JLD, KJT, BY and SL developed the idea and obtained the funding for the workshop. AOC, PH, KJT, BY, JA, YJFMJ, SL, GM and JLD attended the workshop where the core content of the guidance was developed. AOC wrote the first draft of the manuscript. AOC, PH and NM presented the guidance to the researchers engaged in this type of work to further develop the guidance. All authors commented on the drafts of the manuscript and read and approved the final manuscript.

Contributor Information

Alicia O’Cathain, Email: [email protected] .

Pat Hoddinott, Email: [email protected] .

Simon Lewin, Email: [email protected] .

Kate J. Thomas, Email: [email protected] .

Bridget Young, Email: [email protected] .

Joy Adamson, Email: [email protected] .

Yvonne JFM. Jansen, Email: [email protected] .

Nicola Mills, Email: [email protected] .

Graham Moore, Email: ku.ca.ffidrac@GerooM .

Jenny L. Donovan, Email: [email protected] .

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• Volume 14, Issue 9
• Evaluation of a digital therapy programme for the treatment of primary arterial hypertension: eXPLORE – study protocol for a fully decentralised randomised controlled feasibility study
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• Jenny Schlichtiger 1 , 2 ,
• Anna Strüven 1 , 2 ,
• Steffen Massberg 1 , 2 ,
• Georges von Degenfeld 3 ,
• Alexander Leber 4 ,
• Paul Weyh 5 ,
• Julia Meyer 5 ,
• Stefan Brunner 1 , 2 ,
• http://orcid.org/0000-0002-6404-1421 Christopher Stremmel 1 , 2
• 1 Medizinische Klinik und Poliklinik 1 , LMU Klinikum der Universität München , Munich , Germany
• 2 DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance , LMU Klinikum der Universität München , Munich , Germany
• 3 I. Medizinische Klinik , Universitätsklinikum Augsburg , Augsburg , Germany
• 4 Isar Herzzentrum , Munich , Germany
• 5 iATROS GmbH , Munich , Germany
• Correspondence to Dr Christopher Stremmel; christopher.stremmel{at}med.uni-muenchen.de

Introduction Hypertension is a major cause of premature death worldwide as it is an important risk factor for coronary artery disease, myocardial infarction, heart failure and stroke. Although an estimated 1.3 billion adults suffer from hypertension, less than half of them are diagnosed correctly and therefore receive sufficient treatment. Furthermore, only one fifth of those treated reach the therapy target of normotension. This significant deficit underlines the need for new therapy concepts to improve long-term health outcomes. Several studies have shown positive effects of digital health programmes in the disease management of ambulatory, long-term hypertension treatment. More research is needed to explore the abilities of digital health programmes as an innovative pathway in ambulatory healthcare.

The eXPLORE study aims to evaluate the feasibility of a clinical trial on the impact of a supplementary digital therapy programme for the treatment of primary arterial hypertension.

Methods and analyses The eXPLORE study collects data in the setting of a prospective randomised controlled trial to evaluate methodological feasibility for larger-scaled follow-up research. The study compares a digital therapy programme using a smartphone application that is based on functions and algorithms creating tasks and recommendations based on individual health data to standard care for the treatment of primary arterial hypertension. The study period is 180 days, with a 90-day in-life phase followed by a 90-day follow-up phase. Baseline and follow-up data (3 months, 6 months follow-up) of all participants included is collected via questionnaire surveys as well as self-administered blood pressure monitoring. Patient inclusion, initial data acquisition and follow-up were carried out in an innovative remote setting. The study was initiated in November 2022 and is currently ongoing. Study outcome measures are changes in mean blood pressure, health literacy and self-sufficient health behaviour.

Ethics and dissemination The eXPLORE study is carried out in accordance with all applicable legal regulations. Cost-effectiveness is assured by continuous evaluation and documentation over the course of the study. All health-relevant data from the eXPLORE study will be provided for analyses and publication to the investigators of LMU Hospital. The study was approved by the local ethics committee of LMU Munich (project nr.: 22–0115).

Trial registration NCT05580068 . Protocol Version: 1.5, 28.08.2023.

• Hypertension
• Blood Pressure
• Adult cardiology
• Clinical Trial
• Health Education

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2023-081347

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Strengths and limitations of this study

Testing a new methodological approach that simplifies data collection and could result in an improvement of response rates, a reduction in loss to follow-up and dropout rates.

Facilitates the inclusion of subjects beyond regional borders even without a multicentre study approach, which might improve generalisability of study results and reduce systematic bias.

The study aims to test for methodological feasibility of conducting a clinical study on a digital treatment programme for arterial hypertension; therefore, the study sample is comparably small (n=100).

The mode of therapy delivery via smartphone application could lead to selection bias especially with regard to age.

Introduction

With every third adult being affected by primary arterial hypertension, it is one of the most prevalent diseases in industrialised countries, accountable for over 7 million deaths per year worldwide. 1 2 Although the course of the disease frequently remains unrecognised for several years, untreated hypertension causes serious complications, like coronary artery disease, myocardial infarction, heart failure and stroke. Additionally, therapeutic measures like lifestyle changes and medication intake are often characterised by low patient compliance. 3 Early detection and consistent treatment have a significant impact, not only on the individual health status but also in terms of global health economics. 4 5 Therefore, it is important to establish a concept that facilitates long-term adherence to the therapy regime for patients and physicians.

Today, there are numerous devices for digital self-administered blood pressure measurements. In general, digital blood pressure recordings have proven to optimise treatment in medically underserved areas and to facilitate the transition from inpatient to outpatient care. 6–10 First systems implementing the use of digital blood pressure recordings, mostly in combination with telemedical consultations, have shown an additional lowering of systolic blood pressure by 4 mm Hg while optimising health economic costs at the same time. 11–13 Furthermore, several studies concluded that digital health programmes including, but not limited to self-administered measurings, not only have the ability to positively impact the individual health but might also have the ability to transform the pathways of disease management. 14–16 Digital health applications have the potential to implement the latest guideline-based recommendations into the patients’ therapy regimes without actively consulting a physician. In addition, recommendations can be adjusted to the individual needs and might be able to improve compliance. 14 15 However, studies on this comparably new topic are rare and often investigate rather small samples. 14 Besides the individual health benefits, digital disease management programmes provide the possibility of data processing using artificial intelligence, which introduces new and innovative strategies for risk stratification and potentially early detection based on individualised patient data. 10

The eXPLORE study (Trial Registration: ClinicalTrials.gov NCT05580068 ) aims to evaluate the feasibility of a clinical study on the impact of a supplementary digital therapy programme (iATROS digital therapy programme) for the treatment of primary arterial hypertension. Furthermore, the dispersion of the outcome measure serves as data basis for the power analyses of following larger-scaled trials. Therefore, no a priori research hypotheses were established due to the explorative approach of the study. Subsequent data analyses aim to generate research hypotheses for upcoming trials.

Methods and analysis

Study background.

The eXPLORE study is a cooperative project of the Department of Cardiology at Ludwig-Maximilians-University (LMU) in Munich, Germany and the company iATROS (Munich, Germany). Data collection and handling were exclusively performed by registered study physicians at LMU Munich, Germany. The company iATROS only had access to pseudonymised data. The study was approved by the local ethics committee of LMU Munich (project nr.: 22–0115).

The iATROS digital therapy programme

The technical platform consists of an electronic health record connected on the patient’s side to a smartphone app and on the physician’s side to a dashboard for the staff of the telemedicine centre (iATROS, Munich, Germany, with technical functions provided by DocCirrus, Berlin, Germany). The platform is a CE-certified medicinal product and complies with the German and European Union data protection regulations. The app serves as the interface between the patient and the platform and includes the following functions: (1) manually entering blood pressure data as well as other vital parameters (option to connect bluetooth blood pressure measurement device if available), (2) feedback on blood pressure data, (3) displaying educational content such as videos, texts and short messages, (4) generating tasks such as reminders to measure blood pressure, watch a video, take medication, perform exercise or follow nutritional advice and (5) scheduling appointments for videoconsultations with a Telemedicine Centre physician (iATROS, Munich, Germany).

The dashboard for staff and physicians of the telemedicine centre displays blood pressure and all other medical information that the patient has entered, the documentation of previous teleconsultations, and information on which tasks were performed and skipped by the patient (iATROS, Munich, Germany).

A core function of the system is to display the educational content of the digital health programme to treat hypertension which consists of >100 elements over 180 days to the patient over the app. The education programme includes content on health literacy (disease, diagnosis and treatment) and lifestyle education including nutrition and sports (iATROS, Munich, Germany). Remote technical assistance and telemedicine consultation via video or phone are provided initially at the start of the programme and thereafter, when booked by the patient (Deutsche Telemedizin, Duisburg, Germany).

The programme is designed to provide patient support in accordance with the current European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines on arterial hypertension. 17

Home-based blood pressure (BP) measurement : the guidelines generally recommend measurement of BP at home rather than in office, as this method provides more reproducible BP data, is more closely related to hypertension-mediated organ dysfunction and left ventricular hypertrophy, appears to better predict morbidity and mortality, and to have positive effects on medication adherence. 18–21

Education on self-measurement : the training content in the digital health programme to treat hypertension teaches the patient to measure blood pressure according to the ESC/ESH guidelines: taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1–2 min apart. 22

Education of lifestyle optimisation, including nutrition and exercise : healthy lifestyle is recommended to prevent or delay the onset of hypertension and reduce cardiovascular risk, and can augment the efficacy of blood pressure-lowering medication. 17 23 Recommendations that the patients receive through the programme via the app include restriction of dietary salt, moderation of alcohol consumption, high consumption of vegetables and fruits, maintaining an ideal body weight and regular physical activity.

Telemedicine : The possibility to book an appointment with a telemedicine doctor gives the patient the possibility to get high-urgency medical attention.

This study is the first to evaluate the efficacy of the digital health programme to treat hypertension in a randomised controlled trial. Internal systematic analyses of real-world data with the platform have shown that blood pressure can be significantly reduced. Moreover, recent research has shown additional benefits in the combination of different therapeutic measures for lowering of blood pressure in patients with hypertension. In a meta-analysis investigating the relationship between blood pressure lowering and care intensity, reduction of up to 6 mm Hg was observed. 24 Consequently, the intervention was designed to combine the different therapy elements of home blood pressure measurements, measurement value feedback, patient education and telemedical care by physicians.

Study design and setting

The eXPLORE study is a prospective randomised controlled feasibility study exploring the changes in blood pressure of an intervention group (iATROS digital therapy programme) vs standard care therapy.

The intervention group receives access to the iATROS digital therapy programme which serves as an outpatient therapy programme to optimise lifestyle factors and improve compliance. Furthermore, patients have the opportunity to book teleconsultations. Participants are required to enter data on blood pressure and heart frequency three times a day (08:00 a.m., 12:00 p.m. and 6:00 p.m.). Push messages serve as a reminder to ensure the data entry at standardised time points. Participants that are randomised into the standard care group do not need to take any additional actions but they are free to do so at their own discretion.

For inclusion in the eXPLORE study, participants had to meet the following criteria:

Inclusion criteria

Age ≥18 years

Diagnosed arterial hypertension (ICD 10 diagnosis: I10.- to I13.-)

Mean systolic blood pressure between 130 mm Hg and 170 mm Hg in a 24-hour long-term blood pressure measurement. respectively between 135 mm Hg and 175 mm Hg in a 7-day at-home measure. Since the recruitment numbers turned out to be temporarily limited by the availability of 24 hours measuring devices, the methodological approach of data collection was extended: in addition to the ambulatory 24 hours blood pressure measure (ABPM), all participants must document their blood pressure for 7 days in a standardised RR-diary (three times a day, two consecutive measures). If no 24 hours blood pressure device is available, the mean value of all 7 days at-home measures (HBPM) serves as screening and subsequently follow-up tool

Usage of a smartphone capable of running the iATROS application

Physical and mental abilities to operate the digital tool

Exclusion criteria

Missing capability to give informed consent

Age <18 years

No use of a smartphone

Lack of physical and mental abilities to operate the digital tool

Pre-existing usage of the iATROS app

Participation in any other clinical study that may impact the compliance of the app usage or may bias the study results

If ESC guideline classification for blood pressure is not applicable

Substance abuse

Medical contraindications:

Pre-existing illness with a limited life expectation under 1 year

Immune suppression

Underlying disease that restricts participation

Pregnancy and nursing

Secondary hypertension

Systolic blood pressure at baseline: ABPM >170 mm Hg, HBPM >175 mm Hg

Stroke within the last 3 months

Transitory ischaemic attack within the last 3 months

Recruitment and data collection

Recruitment started in November 2022 and will be continued until the enrolment of 100 individuals who completed the entire follow-up. Patients are recruited via public advertisement for the eXPLORE study, for example, newspaper, online marketing and poster advertising. As a second strain of recruitment, former patients of the Medical Clinic I (Cardiology) of the LMU Hospital of the Ludwigs Maximilians University within 2021 to 2023 who had a confirmed diagnosis of arterial hypertension are selectively informed via letter. Since this is a feasibility study, different strains of recruitment are pursued and evaluated during the recruitment process.

The eXPLORE study is entirely based on a remote concept. The advertisement and information letters include a link for scheduling an initial information session (via Webex software) with a study physician. For participation, informed consent has to be signed digitally ( https://app.pandadoc.com/ ), followed by a short survey on patients’ sociodemographic data as well as medical history and a self-administered 24 hours long-term blood pressure measurement (custo med GmbH, Germany). If eligible, participants are randomised 1:1 via an iATROS proprietary online tool matching for the range of the mean systolic blood pressure at baseline (130–140 mm Hg; 141–150 mm Hg; 151–169 mm Hg). After inclusion into the study, the general practitioner of every practitioner was informed about the participation and study objective of the eXPLORE study. Importantly, the general practitioner was also provided with the full results of the baseline 24 hours long-term blood pressure measurement, which shows hypertensive values, and was instructed that the study protocol imposes no restrictions to treat her/his patient according to best medical practice.

The total study period is 180 days, containing 90 days in-live phase and an additional 90 days follow-up phase ( online supplemental material 1 ). Data of all participants was collected at baseline, after 90 days (3 months follow-up) and 180 days (6 months follow-up), including

Supplemental material

(1) an interview-based questionnaire survey ( online supplemental material 2 ) on (serious) adverse events, medical data and lifestyle changes performed by a study physician via Webex conference call, (2) a self-administered 24 hours long-term blood pressure measurement and a 7 days at-home blood pressure monitoring (if no 24 hours blood pressure tool was available, only HBPM needs to be performed; subsequently, also the follow-up measures need to be HBPM), and (3) an online questionnaire on health literacy (HLQ-questionnaire) and self-sufficient health behaviour (PAM-13 questionnaire) that was sent to the participants after each meeting via email.

After inclusion into the eXPLORE study participants, general practitioner is informed about the study participation. The iATROS digital therapy programme does not make suggestions on alterations of the existing antihypertensive medication, but alterations in medication can be made whenever medically necessary. Patients in the intervention group using the iATROS digital therapy programme have a reminder function for drug intake and the opportunity to book telemedicine consultations, in which the medication can be adjusted if medically necessary. These patients receive a doctor’s note and revised medication plan to inform their general practitioner. In any case, information on changes in the medication is documented during the prescheduled follow-up visits (3 months/6 months follow-up).

Study endpoints

For the methodological feasibility of the study, the primary endpoint was the evaluation of

Usage of the iATROS App under controlled study conditions

Compliance, dropout rates, loss-to-follow-up rates

Testing of various advertising measures for recruitment

Recruitment process

Estimation of sample size

Secondary endpoints were defined as follows:

Evaluation of systolic blood pressure at baseline, 90 days and 180 days within the intervention group (iATROS digital therapy programme) and the control group (standard care)

Evaluation of changes in health literacy

Evaluation of changes in self-sufficient health behaviour

Sample size

For the eXPLORE feasibility study, a sample size of 100 participants (n=50 intervention group vs n=50 control group) to complete the follow-up was predetermined as the primary goal was to evaluate the feasibility of the study concept. Additionally, the collected data provides information about the spread of the blood pressure data which will be considered for the power calculation of larger-scaled follow-up studies. The present investigation was not powered to detect blood pressure differences between the groups.

Data analyses

Feasability outcomes.

Since the study aims to test for methodological feasibility, follow-up rates achieved via different recruitment strategies will be analysed. For process optimisation, all members of the study group are requested to regularly report about their experiences, problems and suggestions. Furthermore, participants are asked for their feedback on the study process in a standardised questionnaire (1) at baseline (information on the recruitment process) and (2) at the end of the follow-up, including:

Baseline questionnaire

Comprehensability of the main subject of the study, the timeline and the outcome measures

Quality and contentment of information delivery and explanations

Remaining questions before inclusion into the study

Sufficient and satisfactory supply of information

Follow-up questionnaire (Study Participant Feedback Questionnaire) 25

Contentment with information and support during the follow-up period

Primary and secondary endpoints

In accordance with the primary endpoints response rates will be analysed stratified for different advertisement strategies, as well as dropout and loss-to-follow-up counts.

The analyses on the dispersion of the outcome ‘changes in mean blood pressure’ will serve for power calculation of larger-scaled follow-up surveys.

All secondary endpoints will be examined in an explorative approach; analyses aim to generate research hypotheses in order to establish a reliable concept for larger-scaled follow-up trials.

For the analyses of the differences between the groups, 1 intergroup comparisons will be calculated, including data on sociodemographics, health and lifestyle data as well as blood pressure measures for every timepoint (baseline, 90 days, 180 days). Additionally, 2 intragroup comparisons will be analysed aiming to detect changes within the study groups.

For descriptive analyses, measures of central tendency and dispersion will be calculated. Statistics on the group comparisons will be derived according to the scaling of the variables and the dispersion of the data.

All analyses above can only serve to generate hypothesis since the study was not powered for these analyses.

Data monitoring

Data monitoring is carried out at the study site by an independent body at predefined study milestones:

Monitoring 1: after completion of in-life phase of 10 patients

Monitoring 2: after completion of in-life and follow-up phase of 80 patients

The monitoring is commissioned by the sponsor who receives a monitoring report and is informed about any violations of the study protocol.

Patient and public involvement

Patient and members of the public were involved at several stages of the trial, including the design, management and conduct of the trial. The entirely remote concept of this study is a result of several informal patient discussions as well as evaluations of the study team to facilitate recruitment and enhance patient comfort. In a preliminary phase, the iATROS App was tested and improved on continuous patient feedback. Public involvement was further strengthened by public advertisement campaigns. We intend to disseminate the main results to trial participants and will seek patient and public involvement in the development of an appropriate method of dissemination.

Ethics and dissemination

The study was approved by the local ethics committee of LMU Munich (project nr.: 22–0115). A positive cost-benefit ratio is ensured by the continuous evaluation of the study. Adverse events were predefined and classified according to intensity and duration (serious adverse event vs adverse event). As a part of the survey, all (serious) adverse events are documented and reported to the responsible authority within a statutory deadline where applicable, taking all relevant legal regulations into account.

In general, the eXPLORE study investigates a non-invasive approach for the ambulant management of arterial hypertension via a novel non-invasive digital healthcare tool that aims to improve patient compliance and enhance the management of lifestyle adjustments. Since the measure of participation in a digital health programme is non-invasive, no study-related disadvantages are expected. The control group still receives the standard care treatment; no study-related changes will be made.

Therefore, to the investigators’ best knowledge, no ethical concerns in connection to the study approach are anticipated.

For the dissemination, all health-relevant data from the eXPLORE study will be provided for analyses and publication to the investigators of LMU Hospital. The authorisation to authorship demands a substantial contribution to the conception of the study, data collection and analyses as well as the preparation of a publication manuscript; additionally, the specific requirements for authorship of the respective journal have to be met.

Interim results

Recruitment and data collection are currently ongoing, within the time frame of 1 year, n=162 individuals signed up for an online information appointment; of these, 50% (n=81) wanted to participate in the study. From 81 potential participants, 62% (n=50) were eligible and subsequently included in the study.

In July 2023, the recruitment was stopped for the period of 6 months since at-home blood pressure measurements were included into the study and changes in the study protocol had to be approved by the ethics committee.

Considering the participation rates, the study is expected to reach the sample size goal of 100 participants to complete the follow-up by March 2025. Up to now, no serious adverse events related to the iATROS digital therapy programme were observed.

Detailed study data will not be published until the completion of the eXPLORE study.

The eXPLORE study was designed to test for methodological feasibility of a remote approach for recruitment and data collection. This new approach could have an impact beyond the present study since it simplifies especially the process of data collection which could result in an improvement of response rates and a reduction in loss to follow-up and dropout rates. Additionally, the remote design facilitates the inclusion of subjects beyond regional borders even without a multicentre study approach which might improve generalisability of study results and reduce systematic bias.

Due to temporal limitations in the availability of 24 hours blood pressure measuring devices (ABPM), we included an alternative approach of repetitive 7 days at-home measurements (HBPM) in our recruitment process and adapted the study protocol. In fact, a majority of our patients performed both measurements in parallel and ABPM device limitations were only rare. This dual measurement will potentially allow us to establish the optimal methodology for measuring blood pressure in the subsequent larger-scaled trials. Indeed, the current ESC guidelines on hypertension give both methods an equivalent (class I C) recommendation. 17

While the present feasibility study is not powered to measure health improvements of study participants, it nevertheless forms a first basis for the evaluation of combined smartphone-delivered therapy acceptance and feasibility. As this mode of patient-centric treatment will likely continue to gain traction in healthcare, it warrants the investigation of its advantages and drawbacks.

In the long run, the eXPLORE study aims to establish a new approach in the treatment of arterial hypertension. A beneficial usage of digital health programmes to improve lifestyle factors could have a great impact on cardiovascular disease management since it would impact primary as well as secondary disease prevention. Therefore, it would not only positively impact the individual’s health but might also reduce health costs that arise from secondary diseases caused by hypertension.

The eXPLORE study aims to introduce a promising methodical concept of data collection in clinical feasibility study settings. Additionally, the collected data serves as a basis for larger-scaled trials to evaluate an innovative treatment strategy of arterial hypertension that could potentially serve as a therapeutic concept apart from medication.

Ethics statements

Patient consent for publication.

Not applicable.

• World Health Organisation
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SB and CS contributed equally.

Contributors Conceptualisation, JS, SM, GvD, AL, PW, JM, SB and CS; methodology, JS, GvD, AL, PW, JM, SB and CS; validation, JS, AS, SM, PW, JM, SB and CS; formal analysis, AS, SM, SB and CS; investigation, JS, AS, SB and CS; resources, SM, SB and CS; data curation, AS, SB and CS; writing—original draft preparation, JS and CS; writing—review and editing, JS, AS, SM, SB and CS; project administration, SB and CS. All authors have read and agreed to the published version of the manuscript. CS acted as guarantor.

Funding This work was supported by funding from Zentrales Innovationsprogramm Mittelstand to iAtros, grant number KK5334701 (AP1).

Competing interests PW is an employee of iATROS.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Feature-Based vs. Deep-Learning Fusion Methods for the In Vivo Detection of Radiation Dermatitis Using Optical Coherence Tomography, a Feasibility Study

• Open access
• Published: 04 September 2024

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• Christos Photiou   ORCID: orcid.org/0000-0002-5843-4288 1 ,
• Constantina Cloconi   ORCID: orcid.org/0000-0002-9126-8082 2 &
• Iosif Strouthos   ORCID: orcid.org/0000-0001-6229-5471 2  

Acute radiation dermatitis (ARD) is a common and distressing issue for cancer patients undergoing radiation therapy, leading to significant morbidity. Despite available treatments, ARD remains a distressing issue, necessitating further research to improve prevention and management strategies. Moreover, the lack of biomarkers for early quantitative assessment of ARD impedes progress in this area. This study aims to investigate the detection of ARD using intensity-based and novel features of Optical Coherence Tomography (OCT) images, combined with machine learning. Imaging sessions were conducted twice weekly on twenty-two patients at six neck locations throughout their radiation treatment, with ARD severity graded by an expert oncologist. We compared a traditional feature-based machine learning technique with a deep learning late-fusion approach to classify normal skin vs. ARD using a dataset of 1487 images. The dataset analysis demonstrates that the deep learning approach outperformed traditional machine learning, achieving an accuracy of 88%. These findings offer a promising foundation for future research aimed at developing a quantitative assessment tool to enhance the management of ARD.

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Introduction

Radiation therapy is routinely used to treat cancer with more than half of all cancer patients receiving some form of radiation treatment during the course of their disease. Unfortunately, radiation can have serious side effects, including acute radiation dermatitis (ARD). ARD, a skin inflammatory condition that develops in reaction to radiation, can be uncomfortable and painful [ 1 , 2 , 3 , 4 ]. The location of the tumor, the radiation technique, the overall dose, the volume and frequency of radiation, concurrent systemic therapy, concomitant diseases, as well as the patient's individual radiation sensitivity and genetic susceptibility, can all affect the severity of ARD [ 5 , 6 ]. For patients to benefit fully from radiation therapy, it is crucial to monitor and manage ARD symptoms that include swelling, redness, pain, burning, and itching. Furthermore, pigmentary modifications and loss of hair follicle stem cells are possible. Ulceration and fibrosis could also occur in some unusual cases [ 7 , 8 , 9 ]. Despite improvements in radiation therapy configurations and planning strategies, skin toxicity is still a concern, especially for those patients receiving radiation for head and neck cancers [ 10 , 11 ]. Although the frequency and severity of skin toxicity have decreased over the years, it is still an important clinical challenge for some populations [ 12 ].

ARD evaluation and grading, which is usually based on standardized criteria like RTOG and CTCAE, is crucial for clinical therapy. These standards, however, are inherently constrained by subjectivity, unpredictability, and the intricacy of skin reactions. Such visual inspection-based approaches of assessment have significant limitations, for patients with head and neck cancer in particular [ 13 , 14 ]. First, only descriptive terms describing ARD symptoms are used in the grading guidelines (e.g., the RTOG grading criteria for skin toxicity). Since the rater's experience plays a major role in the visual assessment, there are sometimes large interrater discrepancies. Second, regular ARD evaluation will greatly increase the workload of doctors and will be resource intensive. To address these issues with the present ARD evaluation approach and enhance both ARD management and the overall treatment outcome for patients, it is therefore desirable to develop an automated system for ARD assessment. Assessment accuracy and consistency could be further improved by incorporating machine learning capabilities. By offering standardized, trustworthy criteria, these tools have the potential to lessen subjective diversity among clinicians. Furthermore, research in the management and treatment of ARD could benefit from systems that could enable a more quantitative evaluation and monitoring.

Skin biomarker assessments, thermography, and digital photography, combined with image processing, are among the modalities used to evaluate ARD. While thermography is helpful in identifying inflammation, it is non-specific [ 15 ]. Digital photography is constrained by lighting and surface-only views [ 16 ]. Skin biomarker assessment, which involves the study of proteins and other molecules, can offer insights into the molecular processes behind dermatitis [ 17 ]. Even though machine and deep learning have been used to evaluate skin abnormalities, radiation therapy toxic effects have been relatively less studied. Castanedo et al. presented various data analysis methods for image processing, segmentation, feature extraction, and classification using infrared images that could be used for ARD detection [ 18 ]. Another study showed that early thermal markers are predictive of radiation-induced skin toxicity in breast radiotherapy with an accuracy of 87% [ 19 ]. Park et al., developed an image-based radiation dermatitis assessment system using a convolutional neural network (CNN) and digital images. The average sensitivity and specificity were 61% and 91%, respectively, in early radiation dermatitis and 78% and 96%, respectively, in severe cases [ 20 ]. In addition, using 2263 digital images, another study developed deep CNNs for automatic classification of radiation induced dermatitis. For a two-class problem of normal skin (grade 0) versus dermatitis (grade ≥ 1), the models produced an accuracy of ~ 70%, with sensitivity and specificity of 67–72% and 72–83% [ 21 ]. Ruijan et al., demonstrated a deep learning method for automatic assessment of ARD severity in patients with nasopharyngeal carcinoma using 1205 digital images. The overall classification accuracy was 83.0% [ 16 ]. It is therefore apparent that further developments are needed both in the hardware, datasets, and algorithms for the detection of ARD. Ideally, the goal should be to predict the appearance of ARD before that even occurs. However, this does not appear to be within the reach of current technologies.

OCΤ is a powerful optical imaging technique that enables non-invasive, real-time, visualization of skin microstructure and microcirculation. OCT can provide high-resolution images, comparable to histopathology (~ 10 μm resolution) in real-time. Furthermore, OCT is non-invasive, enabling imaging of already-injured skin without any contact. Its penetration depth of approximately ~ 2 mm allows visualization of the skin's stratum corneum and epidermis, making it well-suited for ARD diagnosis. In dermatology, OCT has already been investigated for its diagnostic ability, with promising results in the evaluation of basal cell carcinomas, psoriasis, and allergic dermatitis in humans, as well as detecting radiation effects [ 22 , 23 , 24 , 25 , 26 ]. In all these studies, the sensitivity and specificity reached 80% to 96%. However, visual interpretation of OCT images can be challenging, even for skilled evaluators [ 27 ]. To overcome this limitation, investigators have attempted to extract various features from OCT images, such as intensity and texture-based features [ 28 , 29 ], to serve as biomarkers of disease. Recently, novel biomarkers, including group velocity dispersion, scatterer size, and index of refraction, have also been estimated from OCT data and were shown to correlate with malignancy. These new biomarkers reflect both microstructural and biochemical changes of disease and could increase the diagnostic relevance [ 30 , 31 , 32 , 33 , 34 ] of the OCT images. Based on recent experience in the application of OCT in radio-oncology [ 35 , 36 , 37 , 38 ], establishing diagnostic algorithms that provide objective and actionable management decisions is also essential in order to address the challenges of manually evaluating OCT images. By providing quantitative assessment of skin changes, OCT combined with machine learning, could provide a tool for a more precise and personalized approach to ARD management as well as provide unbiased evaluation of new experimental methods.

In order to determine the feasibility of identifying ARD using OCT, in vivo skin images were acquired from patients undergoing radiation therapy for head and neck cancer. A fully automated algorithm for image segmentation and feature extraction and selection was developed to provide diagnostically relevant information. Traditional (intensity, texture, and fractal) and novel (scatterer size and optical dispersion) imaging biomarkers and machine and deep learning methods were compared for their ability to differentiate normal skin from ARD. This pilot study has produced the first evidence of the potential of in vivo OCT imaging of head and neck ARD in humans with encouraging insights that warrant further investigation.

Theory and Methods

To achieve the goals of this study, image acquisition, preprocessing, feature extraction, and classification with both machine learning and deep learning was performed (Fig.  1 ).

Flow chart of the study showing the two different classification procedures used. After image acquisition and segmentation, feature based ML with feature extraction was applied. Alternatively, feature HSV and pseudocolor images were created, followed by Deep Learning with late fusion

Clinical Study and Image Acquisition

Twenty-two head and neck cancer patients who were scheduled to receive radiation therapy at the German Oncology Center (GOC) in Limassol, Cyprus, participated in this proof-of-concept trial. The trial has received bioethics approval from the Cyprus National Bioethics Committee. Patients with disabilities, expectant women, those who had recently undergone radiation therapy in the same area, and patients with autoimmune diseases were excluded from the study. All study participants were over 16 years of age. Specifically, one patient was within the range of 30–40 years of age, two were between 40–50 years old, six patients were in the range of 50–60 years, seven fell between 60–70, three between 70–80 age range, and another three were in the 80–90 age range. The mean patient age was 62.3 years with a standard deviation of 12.5. The participants provided the informed consent form prior to the study. After informed consent, the irradiated side of the neck of the subjects was imaged with OCT (Fig.  2 ). Six images were acquired at 1 cm intervals, covering the region from the mandibular angle to the clavicle. In order to assure proper image spacing, a paper grid guide was used to assist the clinician. Additionally, a photograph of the same area was captured using a digital camera. Imaging was repeated prior to every radiation therapy session, twice per week, until the conclusion of the therapy. The duration of the therapy (6 ± 1 weeks) was determined by the treating physician, resulting in a dataset of 1487 images. Although adjacent images collected from the same patient might be similar, they are not completely redundant since skin microstructure varies from superior to inferior position. Furthermore, the additional images serve as a form of data augmentation to improve the performance of the algorithm. This is further discussed in the results.

A Digital photo of a patient presenting with two different grades of ARD. The top black box encloses an area of Grade 1 ARD whereas the lower black box outlines an area of Grade 2b ARD. B Three of the six OCT images acquired from the Grade 1 ARD area. ( C ) Another three OCT images from the Grade 2b ARD area

During each visit, the patient's ARD grade, at each of the imaging sites, was determined and recorded by the same senior oncologist, with more than eight years of experience. The grade of ARD was determined based on the RTOG scale (grade 0: absence of perceptive lesions, grade I: presence of mild erythema, dry peeling, grade II: presence of moderate to-mild erythema, irregular wet peeling, confined mainly to skin folds and wrinkles, moderate edema, grade III: presence of wet peeling in areas other than skin folds or wrinkles, bleeding induced by minor trauma or abrasion and grade IV: presence of skin necrosis or ulcers) [ 13 , 14 ]. The images at day 0 (i.e., before the appearance of ARD) were used as the normal dataset of each patient. The imaging was performed with a swept-source OCT system (Santec IVS300), with a center wavelength of 1300 nm, a lateral resolution of 22 μm, an axial resolution of 12 μm in tissue, and an A-scan rate of 40 kHz. Each image consisted of 500 A-Scans, sampling a range of 5 mm. The data were saved in raw interferometric format and subsequently convert to intensity images by FFT and logarithmic processing.

Image Processing and Feature Extraction

An automated algorithm was developed to segment the OCT images of the skin by finding the top surface of each image and subsequently isolating a segment containing the epidermis and part of the dermis (Fig.  3 A, between the green lines, and Fig.  3 B). The depth was determined by optimizing the classification results. The algorithm used automatic thresholding, with Otsu’s method, and morphological processing of the binary image to determine the borders of the tissue. Morphological processing included image normalization and filtering (median), along with image open and close functions in Matlab to remove redundant and misleading information. Subsequently, several features were extracted either from individual neighborhoods of the image (Fig.  3 B, purple squares) or from strips at various depths (Fig.  3 C, yellow rectangles). The details regarding each feature are explained below. The value of each feature at each image location was used to create both a pseudo-color image (where each pixel was assigned a color based on the value of the feature) or a colorized image where the value of the feature was overlaid as color over the intensity image (i.e., the hue in a hue-saturation-value (HSV) image, for example Fig.  3 D.

A In vivo OCT image of human skin in the neck region. The automated algorithm segmented a given depth of skin (in this example 0.650mm in air (or approximately 0.450 mm in tissue), outlined by the green lines). The vertical red lines mark the portion of the image used (in this case the entire image). B The flattened segmented portion which was used to calculate intensity, texture, fractal, and scatterer size features at each distinct-window neighborhood (purple squares). C The same image as in ( B ), was used to determine the optical group velocity (GVD) dispersion based on the speckle resolution degradation at progressively increasing depths (yellow rectangles). D For each feature, a new image was created where the value of the features (in this example, scatterer size) was overlaid on the intensity as HSV color

Features were extracted from the segmented portion of each image. Various neighborhood sizes were evaluated and the optimal for classification was selected. For each neighborhood in the image, the following features were extracted:

First order intensity statistics : Extraction of various first-order intensity statistics, such as the mean, standard deviation, variance, skewness, median, kurtosis, minimum, mode and maximum of the intensity were calculated from each neighborhood of each segmented portion of the images. These features provide valuable textural information. For the purposes of feature-based machine learning, the statistics of each feature over the entire image were also calculated resulting in 90 features per image.

Gray Level Co-occurrence Matrix (GLCM) : The Gray Level Co-occurrence Matrix (GLCM), is used to effectively measure perceptual texture image qualities. Four essential characteristics, the correlation, contrast, homogeneity, and energy, can be estimated using this approach. The correlation coefficient gauges how closely two pixels in an image are related to one another. While a low correlation suggests that the two pixels tend to have different values, a high correlation suggests that they are closer together. Contrast quantifies the contrast differences between neighboring pixels. A low contrast implies a small change between neighboring pixel values whereas a high contrast suggests a significant difference. The degree of similarity between adjacent pixels in an image is measured by homogeneity. When homogeneity is high, values of adjacent pixels are comparable. In contrast, when homogeneity is low, values of adjacent pixels are different. Finally, energy quantifies the overall level of uniformity in the neighborhood and indicates a more uniform distribution. Each GLCM feature was extracted at four directions (0, 45, 90 and 135 degrees) and for three different offsets (1, 3, and 5 pixels) from the center of the neighborhood. When the statistics of each were calculated over the entire image, the result was 600 features for feature-based machine learning.

Fractal Dimension (FD) : An effective measure of the complexity and irregularity of image structures is the fractal dimension. It is especially useful in medical imaging due to its capacity of identifying the increased irregularities often associated with disease. The box counting approach is used in this work to calculate the statistics of the FD distribution for all the neighborhoods of each image [ 29 ]. For feature-based machine learning, the statistics over the entire image resulted in an additional 90 features.

Novel feature – Group Velocity Dispersion (GVD) : Dispersion, an indicator of the wavelength dependency of the index of refraction, has recently been investigated as a useful biomarker of disease. Since changes in tissue dispersion are a result of compositional/biochemical alterations, this metric can be an invaluable complement to the micro-structural information offered by the features above. By examining the speckle patterns in OCT images, the resolution degradation brought about by GVD as a function of depth, can be measured in situ and in vivo [ 31 ]. As with the previous features, the calculation of the statistics over the entire image resulted in 10 additional features.

Novel feature – Scatterer Size (SS) : In addition to the intensity information, which is the source of the micro-structural images, the OCT interferograms contain spectral information that, most often, remains unused. However, according to the Mie theory of light scattering, oscillatory patterns in the spectrum are related to the size of the scatterer. A novel metric, the bandwidth of the correlation of the derivative (COD) of the OCT spectrum, has been formulated to estimate the mean size of the scatterers, in this case the nuclei of the cells, in vivo [ 32 ]. Calculating the statistics of the COD and SS over the entire image resulted in another 20 features for the feature-based machine learning.

Feature-Based Classification

The images were segmented at a depth of 0.375 mm in air (or approximately 0.260 mm in tissue) since that was empirically shown to provide the most accurate classification results. This is not unexpected since this depth includes the top portion of the epidermis where some ARD early signs (e.g. desquamation) first appear. The segmented image sections were processed to extract the features from each 21 × 21 pixel (0.21 × 0.063 mm) neighborhood of the 1487 images. Given the large number of features (810 in total) and the fact that many of those attributes are correlated, the processes of feature-based machine learning classification began with feature selection. First, the features were ranked in order of significance using a combination of hypothesis t-test and mutual information Maximum Relevance—Minimum Redundancy (MRMR) algorithms. The final number of features used was selected manually to optimize the classification accuracy, in decreasing order of significance. The feature vectors were normalized prior to classification. In addition, to address the issue of an imbalanced dataset, Synthetic Minority Oversampling Technique (SMOTE) was used to increase the minority class by 20% in order to prevent overfitting of the majority class. SMOTE is a data augmentation approach which selects the instances closer to the feature space and creates new samples at points between the existing ones. Various classifiers were evaluated to differentiate normal skin vs. ARD. The classifiers tested included Linear Discriminant Analysis (LDA), with a pseudolinear discriminant type, Support Vector Machine (SVM), with a linear kernel, k-Nearest Neighbor (k-NN), with 11 nearest neighbors, Naïve-Bayes (NB), and Decision Tree (DT) classifiers. The classifiers were compared in terms of accuracy in a leave-one-patient-out (LOPO) cross-validation scheme to ensure unbiased results. Each image was classified using leave-one-patient-out (LOPO) cross-validation, i.e. all the images from all time points of a patient were included in the test set, to avoid training with correlated images.

Classification Using Multi-feature Deep Learning with Late Fusion (MFDLF)

A deep learning methodology was also applied to differentiate between normal skin and ARD. Segmentation and feature extraction were performed as described in Sect. 2.3. For the 80 most significant features, based on the feature ranking in 2.3, a pseudo color and an overlay image were created (a total of 237,920 images from the 22 patients) As mentioned above, pseudocolor and HSV images were created for each feature (Fig.  4 ). These images were rescaled to 227 × 227 × 3 pixels to be adapted to the network architecture. Data augmentation was implemented by applying a set of augmentation operations to the original images during training, generating augmented versions of the images as they pass through the network. The augmentation techniques applied included rotation as well as translation in the x and y scale for each image. A pre-trained ResNet101 neural network was utilized, with the modification of the last layers to incorporate a fully connected layer for two-class classification, followed by a "Softmax" activation, and finally the classification layer. A pre-trained network was selected due to the small number of patients included in this study. The Adam optimizer was utilized with a batch size of 128. The learning rate was set to 0.001 and the network was trained for 35 epochs. The dataset of images corresponding to each feature were classified using a separate network (a total of 160 networks). A new feature vector for each image was created by combining the results of the classification of each of the different feature datasets. Finally, various conventional classifiers were evaluated to combine the results into a final classification of each image (Fig.  5 ). Each image was classified using leave-one-patient-out (LOPO) cross-validation, i.e. all the images from all time points of a patient were included in the test set, to avoid training with correlated images.

From each OCT imaging location, several feature images are created. First order intensity statistics (IS), GLCM second order statistics, group velocity dispersion (GVD) and fractal dimension (FD) images are created from the intensity image. The spectrally dependent properties of scatterer size (SS) and the bandwidth of the correlation of the derivative (COD BW) are extracted from the spectral content of each raw interferogram

Training flow of the proposed multi-featured deep learning method. Each feature dataset passes through a separate ResNet101 neural network, and the resulting classes are combined into a feature vector which is then passed as the input to a traditional machine learning classifier to produce the final result

A Visual examination of the digital photograph and the OCT images of different grades of ARD (Fig.  2 ), reveals that despite the obvious changes between the two grades in the digital photo, i.e., flaking and redness, distinguishing details that could identify ARD are not easily discernible in the OCT images. This limitation highlights the necessity for computational assistance but also underscores the challenges in detecting ARD from the OCT images.

Feature-Based Classification Results

The segmented regions from each image were used to extract features for feature-based classification as described above. A window size 21 × 21 pixel (0.21 × 0.063 mm) and a segmentation depth (0.375mm) were selected since they resulted in the best accuracy, after assessing several options (depth up to 0.750 mm and window sizes up to 31 × 31). Fourteen first and second order intensity statistics along with the GVD and SS appeared to be the most significant features resulting in optimal classification. The Linear Discriminant Analysis (LDA) classifier provided the best results for the classification between normal vs ARD classification, with a sensitivity of 86%, specificity of 77% and accuracy of 85% (Table  1 ). Based on the calculated statistics the LDA classifier provided the best performance, an improvement which was statically significant from the second classifier (SVM) with a p-value of 1.32e-17 [ 39 ].

Deep Learning Classification Results

As a baseline, the performance of deep learning classification of standard intensity images was evaluated. Using a ResNet101 model the classification accuracy was 70.74% with 83.62% sensitivity and 50.81% specificity. When only three images per patient per session were used, the accuracy was 67.21%. This highlights the importance of augmenting the dataset with additional images. Furthermore, to evaluate the inter-patient variability, the accuracy per patient was considered. In the case of standard intensity images, the individual accuracy varied with a standard deviation ± 10.25%. This is an indication of the extend of inter-patient variability, which implies that an increased dataset could further improve the algorithm’s performance.

For the proposed deep learning method with late fusion, the networks were optimized as described above, resulting in a new feature vector with 160 components for each image. Various combinations of these 160 deep-learning-derived features were evaluated to achieve the highest possible accuracy during the final classification procedure. The optimal choice incorporated 21 of those features, which included the ResNet outputs for the images of five statistics of the fractal dimension, the GVD, as well as sixteen first- and second-order intensity statistics. The list of features, as well as the image format used, is shown in Table  2 . A comparison of the results from the various fusion classifiers is shown in Table  3 . The Naïve Bayes (NB) classifier, assuming a normal distribution, provided the best discrimination between normal vs. ARD, with a sensitivity of 89%, specificity of 80%, accuracy of 88% and Area Under the Curve (AUC) of 0.85. Based on the calculated statistics the Naïve Bayes (NB) classifier provided the best performance, an improvement which was statically significant from the second classifier (LDA) with a p-value of 4.19e-07 [ 39 ].

Conclusions

Radiation induced dermatitis is a common and undesirable side effect of radiation therapy that can severely impair a patient's quality of life. To ensure appropriate and timely intervention, active monitoring and precise assessment of the skin condition are necessary. In this study, traditional and novel imaging features and machine and deep learning methods were compared for their ability to differentiate normal skin from ARD. The results of this in vivo pilot study demonstrate that, despite the limitation of having no visually discernible, distinguishing, microstructural characteristics in the OCT images, carefully selected features and machine learning have the potential to provide accurate classification of ARD. The proposed multi-feature deep learning with late fusion algorithm provided the most accurate results, differentiating normal skin tissue from ARD with an accuracy of 88% (89% sensitivity and 80% specificity). This is an improvement compared to other attempts to automatically detect ARD from photographs of the affected regions.

Although promising, these preliminary results demonstrate that more research is necessary to address the shortcomings of the current study and enhance the algorithms' performance in the use of OCT imaging for ARD diagnosis. One issue with the data generation is that the microscale imaging of OCT makes it exceedingly difficult to precisely localize the scan position. This has minimal effect when skin is normal, therefore relatively uniform, but may affect the images of areas where ARD is not uniform. In a future study, better localization and, perhaps, volume imaging could be used.

One of the main limitations influencing the performance of the proposed method is the small sample size. Data augmentation is a data-space technique to partially address the issue of limited data and, at the same time, balance the data. In the current study, we employed geometric transformations such as rotation and translation for each image. The data imbalance is a result of the fact that only about 20% of patients with radiation-treated head and neck cancer develop severe ARD, out of the 80% to 90% of patients who develop ARD [ 40 ]. A clinical study with more participants would be the optimal approach to address these limitations. In addition, more advanced and precise classification techniques can be developed when a larger dataset is gathered. Customized neural networks with earlier and more efficient fusion strategies can be explored, building on the experience of pattern recognition and semantic segmentation of multi-spectral images. Such systems are necessary to both efficiently predict the onset of ARD but also more precisely identify the ARD grade, especially when considering higher grades which may require more urgent medical attention [ 9 ].

This study lays the foundation for further investigation in the use of OCT for ARD imaging and may have significant implications for the early diagnosis and management of ARD in patients undergoing radiation therapy. If a tool is successfully developed, it could guide ARD management as well as enable new research that will ultimately improve patient prognosis and quality of life. Furthermore, the application of multi-feature deep learning could be applied to other OCT imaging classification challenges where the microstructure alone does not provide adequate information for an accurate and robust diagnosis.

Data Availability

The dataset used and analyzed during the current study is available at: https://zenodo.org/record/8238140 .

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Open access funding provided by the Cyprus Libraries Consortium (CLC). This study is funded by the European Union’s Horizon 2020 research and innovation program under grant agreement No 739551 (KIOS CoE) and from the Republic of Cyprus through the Directorate General for European Programs, Coordination and Development.

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All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Christos Photiou and Constantina Cloconi. Image examination and annotation performed by Iosif Strouthos. The first draft of the manuscript was written by Christos Photiou. All authors read and approved the final manuscript.

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Photiou, C., Cloconi, C. & Strouthos, I. Feature-Based vs. Deep-Learning Fusion Methods for the In Vivo Detection of Radiation Dermatitis Using Optical Coherence Tomography, a Feasibility Study. J Digit Imaging. Inform. med. (2024). https://doi.org/10.1007/s10278-024-01241-4

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Received : 23 May 2024

Revised : 07 August 2024

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Published : 04 September 2024

DOI : https://doi.org/10.1007/s10278-024-01241-4

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