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Interview protocol design

On this page you will find our recommendations for creating an interview protocol for both structured and semi-structured interviews. Your protocol can be viewed as a guide for the interview: what to say at the beginning of the interview to introduce yourself and the topic of the interview, how to collect participant consent, interview questions, and what to say when you end the interview. These tips have been adapted from  Jacob and Furgerson’s (2012) guide to writing interview protocols and conducting interviews for those new to qualitative research. Your protocol may have more questions if you are planning a structured interview. However, it may have fewer and more open-ended questions if you are planning a semi-structured interview, in order to allow more time for participants to elaborate on their responses and for you to ask follow-up questions.

Interview protocol design accordion widget

Use a script to open and close the interview.

This will allow you to share all of the relevant information about your study and critical details about informed consent before you begin the interview. It will also allow a space to close the interview and give the participant an opportunity to share additional thoughts that haven’t yet been discussed in the interview.

Collect informed consent

The most common (and encouraged) means of gaining informed consent is by giving the participant a participant information sheet as well as an informed consent form to read through and then sign before you begin the interview. You can find the template for participant information sheets  and informed consent form on the Imperial College London Education Ethics Review Process (EERP) webpage . Other resources for the EERP process can also be found on this website.

Start with the basics

To help build rapport and a comfortable space for the participant, start out with questions that ask for some basic background information. This could include asking their name, their course year, how they are doing, whether they have any interesting things happening at the moment, their likes and interests etc. (although be careful not to come across as inauthentic). This will help both you and the participant to have an open conversation throughout the interview.

Create open-ended questions

Open-ended questions enable more time and space for the participant to open up and share more detail about their experiences. Using phrases like “Tell me about…” rather than “Did you ever experience X?” will be less likely to elicit only “yes” or “no” answers, which do not provide rich data. If a participant does give a “yes” or “no” answer, but you would like to know more, you can ask, “Can you tell me why?” or “Could you please elaborate on that answer a bit more?” For example, if you are interviewing a student about their sense of belonging at Imperial, you could ask, “Can you tell me about a time when you felt a real sense that you belonged at Imperial College London?”

Ensure your questions are informed by existing research

Before creating your interview questions, conduct a thorough review of the literature about the topic you are investigating through interviews. For example, research on the topic of “students’ sense of belonging” has emphasised the importance of students feeling respected by other members of the university. Therefore, it would be a good idea to include a question about “respect” if you are interested in your students’ sense of belonging at Imperial or within their departments and study areas (e.g. the classroom). See our sense of belonging interview protocol for an idea.

Begin with questions that are easier to answer, then move to more difficult or abstract questions

Be aware that even if you have explained your topic to the participant, you should not assume that they have the same understanding of the topic as you. Resist the temptation to simply ask your research questions to your participants directly, particularly at the beginning of the interview, as these will often be too conceptual and abstract for them to answer easily. Asking abstract questions too early on can alienate your participant. By asking more concrete questions that participants can answer easily, you will build rapport and trust more quickly. Start by asking questions about concrete experiences, preferably ones that are very recent or ongoing. For example, if you are interested in students’ sense of belonging, do not start by asking whether a student “belongs” or how they perceive their “belonging.” Rather, try asking about how they have felt in recent modules to give them the opportunity to raise any positive or negative experiences themselves. Later, you can ask questions which specifically address concepts related to sense of belonging, for example whether they always feel “respected” (to follow on from our earlier example). Then, at the end of the interview, you could ask your participant to reflect more directly and generally on your topic. For example, it may be good to end an interview by asking the participant to summarise the extent to which they feel they ‘belong’ and what the main factors are. Note that this advice is particularly important if dealing with topics that may be difficult to form an opinion on, such as topics which require students to remember things from the distant past, or which deal with controversial topics.  

Use prompts

If you are asking open-ended questions, the intention is that the participant will use that as an opportunity to provide you with rich qualitative detail about their experiences and perceptions. However, participants sometimes need prompts to get them going. Try to anticipate what prompts you could give to help someone answer each of your open-ended questions (Jacob & Furgerson, 2012). For example, if you are investigating sense of belonging and the participant is struggling to respond to the question “What could someone see about you that would show them that you felt like you belonged?”, you might prompt them to think about their clothes or accessories (for example do they wear or carry anything with the Imperial College London logo) or their activities (for example membership in student groups), and what meaning they attach to these. 

Be prepared to revise your protocol during and after the interview

During the interview, you may notice that some additional questions might pop into your mind, or you might need to re-order the questions, depending on the response of the participant and the direction in which the interview is going. This is fine, as it probably means the interview is flowing like a natural conversation. You might even find that this new order of questions should be adopted for future interviews, and you can adjust the protocol accordingly.

Be mindful of how much time the interview will take

When designing the protocol, keep in mind that six to ten well-written questions may make for an interview lasting approximately one hour. Consider who you are interviewing, and remember that you are asking people to share their experiences and their time with you, so be mindful of how long you expect the interview to last.

Pilot test your questions with a colleague

Pilot testing your interview protocol will help you to assess whether your interview questions make sense. Pilot testing gives you the chance to familiarise yourself with the order and flow of the questions out loud, which will help you to feel more comfortable when you begin conducting the interviews for your data collection.

Jacob, S. A., & Furgerson, S. P. (2012). Writing Interview Protocols and Conducting Interviews: Tips for Students New to the Field of Qualitative Research. The Qualitative Report, 17 (2), 1-10.

Welch, C., & Piekkari, R. (2006). Crossing Language Boundaries:. Management International Review, 46 , 417-437. Retrieved from https://link.springer.com/content/pdf/10.1007%2Fs11575-006-0099-1.pdf

Prompts, Not Questions: Four Techniques for Crafting Better Interview Protocols

• Published: 05 June 2021
• Volume 44 , pages 507–528, ( 2021 )

Cite this article

• Tomás R. Jiménez 1 &
• Marlene Orozco 2  

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A Correction to this article was published on 05 August 2023

This article has been updated

We offer effective ways to write interview protocol “prompts” that are generative of the most critical types of information researchers wish to learn from interview respondents: salience of events, attributes, and experiences; the structure of what is normal; perceptions of cause and effect; and views about sensitive topics. We offer tips for writing and putting into practice protocol prompts that we have found to be effective at obtaining each of these kinds of information. In doing so, we encourage researchers to think of an interview protocol as a series of prompts, rather than a list of questions, for respondents to talk about certain topics related to the main research question(s). We provide illustrative examples from our own research and that of our students and professional colleagues to show how generally minor tweaks to typical interview prompts result in richer interview data.

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Acknowledgements

We would like to thank our colleagues who supported this work and provided examples from their research: Emily Carian, Molly King, Tagart Sobotka, and Chloe Hart. Special thanks to Forrest Stuart for his input on several drafts. We would also like to thank the participants of the Migration, Ethnicity, Race and Nation workshop at Stanford for their comments on the manuscript.

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Jiménez, T.R., Orozco, M. Prompts, Not Questions: Four Techniques for Crafting Better Interview Protocols. Qual Sociol 44 , 507–528 (2021). https://doi.org/10.1007/s11133-021-09483-2

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Prompts, Not Questions: Four Techniques for Crafting Better Interview Protocols

We offer effective ways to write interview protocol “prompts” that are generative of the most common types of information researchers wish to learn from interview respondents: the salience of events, attributes, and experiences; the structure of what is normal; perceptions of cause and effect; and views about sensitive topics. We offer tips for writing and putting into practice protocol prompts that we have found to be effective at obtaining each of these kinds of information. In doing so, we encourage researchers to think of an interview protocol as a series of prompts, rather than a list of questions, for respondents to talk about certain topics related to the main research question(s). We provide illustrative examples from our own research to show how generally minor tweaks to typical interview prompts result in richer interview data.

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• Types of Interviews in Research | Guide & Examples

Types of Interviews in Research | Guide & Examples

Published on March 10, 2022 by Tegan George . Revised on June 22, 2023.

An interview is a qualitative research method that relies on asking questions in order to collect data . Interviews involve two or more people, one of whom is the interviewer asking the questions.

There are several types of interviews, often differentiated by their level of structure.

• Structured interviews have predetermined questions asked in a predetermined order.
• Unstructured interviews are more free-flowing.
• Semi-structured interviews fall in between.

Interviews are commonly used in market research, social science, and ethnographic research .

Table of contents

What is a structured interview, what is a semi-structured interview, what is an unstructured interview, what is a focus group, examples of interview questions, advantages and disadvantages of interviews, other interesting articles, frequently asked questions about types of interviews.

Structured interviews have predetermined questions in a set order. They are often closed-ended, featuring dichotomous (yes/no) or multiple-choice questions. While open-ended structured interviews exist, they are much less common. The types of questions asked make structured interviews a predominantly quantitative tool.

Asking set questions in a set order can help you see patterns among responses, and it allows you to easily compare responses between participants while keeping other factors constant. This can mitigate   research biases and lead to higher reliability and validity. However, structured interviews can be overly formal, as well as limited in scope and flexibility.

• You feel very comfortable with your topic. This will help you formulate your questions most effectively.
• You have limited time or resources. Structured interviews are a bit more straightforward to analyze because of their closed-ended nature, and can be a doable undertaking for an individual.
• Your research question depends on holding environmental conditions between participants constant.

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Semi-structured interviews are a blend of structured and unstructured interviews. While the interviewer has a general plan for what they want to ask, the questions do not have to follow a particular phrasing or order.

Semi-structured interviews are often open-ended, allowing for flexibility, but follow a predetermined thematic framework, giving a sense of order. For this reason, they are often considered “the best of both worlds.”

However, if the questions differ substantially between participants, it can be challenging to look for patterns, lessening the generalizability and validity of your results.

• You have prior interview experience. It’s easier than you think to accidentally ask a leading question when coming up with questions on the fly. Overall, spontaneous questions are much more difficult than they may seem.
• Your research question is exploratory in nature. The answers you receive can help guide your future research.

An unstructured interview is the most flexible type of interview. The questions and the order in which they are asked are not set. Instead, the interview can proceed more spontaneously, based on the participant’s previous answers.

Unstructured interviews are by definition open-ended. This flexibility can help you gather detailed information on your topic, while still allowing you to observe patterns between participants.

However, so much flexibility means that they can be very challenging to conduct properly. You must be very careful not to ask leading questions, as biased responses can lead to lower reliability or even invalidate your research.

• You have a solid background in your research topic and have conducted interviews before.
• Your research question is exploratory in nature, and you are seeking descriptive data that will deepen and contextualize your initial hypotheses.
• Your research necessitates forming a deeper connection with your participants, encouraging them to feel comfortable revealing their true opinions and emotions.

A focus group brings together a group of participants to answer questions on a topic of interest in a moderated setting. Focus groups are qualitative in nature and often study the group’s dynamic and body language in addition to their answers. Responses can guide future research on consumer products and services, human behavior, or controversial topics.

Focus groups can provide more nuanced and unfiltered feedback than individual interviews and are easier to organize than experiments or large surveys . However, their small size leads to low external validity and the temptation as a researcher to “cherry-pick” responses that fit your hypotheses.

• Your research focuses on the dynamics of group discussion or real-time responses to your topic.
• Your questions are complex and rooted in feelings, opinions, and perceptions that cannot be answered with a “yes” or “no.”
• Your topic is exploratory in nature, and you are seeking information that will help you uncover new questions or future research ideas.

Depending on the type of interview you are conducting, your questions will differ in style, phrasing, and intention. Structured interview questions are set and precise, while the other types of interviews allow for more open-endedness and flexibility.

Here are some examples.

• Semi-structured
• Unstructured
• Focus group
• Do you like dogs? Yes/No
• Do you associate dogs with feeling: happy; somewhat happy; neutral; somewhat unhappy; unhappy
• If yes, name one attribute of dogs that you like.
• If no, name one attribute of dogs that you don’t like.
• What feelings do dogs bring out in you?
• When you think more deeply about this, what experiences would you say your feelings are rooted in?

Interviews are a great research tool. They allow you to gather rich information and draw more detailed conclusions than other research methods, taking into consideration nonverbal cues, off-the-cuff reactions, and emotional responses.

However, they can also be time-consuming and deceptively challenging to conduct properly. Smaller sample sizes can cause their validity and reliability to suffer, and there is an inherent risk of interviewer effect arising from accidentally leading questions.

Here are some advantages and disadvantages of each type of interview that can help you decide if you’d like to utilize this research method.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Student’s  t -distribution
• Normal distribution
• Null and Alternative Hypotheses
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Data cleansing
• Reproducibility vs Replicability
• Peer review
• Prospective cohort study

Research bias

• Implicit bias
• Cognitive bias
• Placebo effect
• Hawthorne effect
• Hindsight bias
• Affect heuristic
• Social desirability bias

The four most common types of interviews are:

• Structured interviews : The questions are predetermined in both topic and order. 
• Semi-structured interviews : A few questions are predetermined, but other questions aren’t planned.
• Unstructured interviews : None of the questions are predetermined.
• Focus group interviews : The questions are presented to a group instead of one individual.

The interviewer effect is a type of bias that emerges when a characteristic of an interviewer (race, age, gender identity, etc.) influences the responses given by the interviewee.

There is a risk of an interviewer effect in all types of interviews , but it can be mitigated by writing really high-quality interview questions.

Social desirability bias is the tendency for interview participants to give responses that will be viewed favorably by the interviewer or other participants. It occurs in all types of interviews and surveys , but is most common in semi-structured interviews , unstructured interviews , and focus groups .

Social desirability bias can be mitigated by ensuring participants feel at ease and comfortable sharing their views. Make sure to pay attention to your own body language and any physical or verbal cues, such as nodding or widening your eyes.

This type of bias can also occur in observations if the participants know they’re being observed. They might alter their behavior accordingly.

A focus group is a research method that brings together a small group of people to answer questions in a moderated setting. The group is chosen due to predefined demographic traits, and the questions are designed to shed light on a topic of interest. It is one of 4 types of interviews .

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

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PSY 411 Spring 2018

Seminar in user experience research, sample interview protocol.

System: Yelp

Aspect of system being focused on: Reviews of restaurants

[Introduction]

Hi, my name is Todd Haskell, and the purpose of this interview is to learn how you make use of Yelp. In particular, I’d like to know how you use reviews on Yelp, and how you identify reviews that you find useful. We’ll do that by going through a series of questions, which will take approximately 1 hour. During the interview, please imagine you’re describing how you use Yelp to someone who isn’t familiar with Yelp.

Before we get started, there are a few things that you should know. First, when I write my report, I may want to quote things that you have said, but I will not include your name or any other information that might identify who you are. If there’s anything in particular that you really don’t want to be quoted, please let me know.

Also, this interview is completely voluntary – if for any reason you want to stop, please just let me know. We can end the interview at that point with no negative consequences for you, and you will still be paid for the time you have already spent. I can also discard anything you’ve told me up to that point.

Third, if you would like, I can provide you with the final report once it is completed.

Finally, would it be okay if I audiorecord our conversation? This is just so I don’t miss anything – no one else will have access to the recording, and I will transcribe what you say before sharing it with anyone else.

Do you have any questions for me? Okay, let’s get started.

How long have you been using Yelp? Do you remember approximately when you first started using it?

Currently, about how often do you use Yelp? (If they don’t understand the question: daily, weekly, monthly, etc.)

What do you use Yelp for?

[Core Questions]

• I’d like you to think back to the last time you used Yelp to try to find a place to eat. Can you first tell me a little about the situation you were in and how you ended up deciding to use Yelp?
• Were you in a city you were already familiar with, or an unfamiliar city?
• Were you in a group or on your own?
• What were you hoping to accomplish by using Yelp?
• What requirements/constraints were you working with in finding a restaurant? In other words, if you had to finish the sentence, “This restaurant would be a good choice if…”, how would you finish that sentence?
• Were price, location, hours, or overall rating a factor in your decision? (NOTE: these are things that you can find on Yelp without reading reviews)
• Were there other considerations, like good service, nice décor, not too long of a wait? (NOTE: these are things you would need to read reviews to learn about)
• How much time/energy were you willing to put into choosing a restaurant? Did you want to find something in 2 minutes, or were you prepared to spend 20 minutes?
• Once you decided to use Yelp, could you walk me through how you did that? What you did first, what you did next, etc.?
• What kind of device were you using? (like smartphone, laptop, etc.)
• Were you using the Yelp web site or the Yelp app?
• If necessary, ask them to describe what they did in terms of the interface; if they say “I started by pulling up restaurants in Cleveland,” ask them “How did you do that?”
• How did you use the reviews to help you choose a restaurant? (if they say they didn’t use the reviews, ask if they can think of another time they used Yelp when they did use the reviews)
• About how many reviews did you read?
• How did you choose which reviews to read?
• Did you read each review carefully, or skim it to get a general impression?
• Did you use the reviews to form a general impression of the restaurant, or were you looking for specific pieces of information? If the latter, what were you looking for?
• Did you share the reviews with other people in your group, or discuss the reviews with them?
• Did you learn anything by looking at specific reviews that you did not learn from looking at the general information that came up when you first clicked/tapped on the restaurant in the result list? If so, what?
• Was there specific information that you were looking for that you were able to find in the reviews?
• Did you find information in the reviews that you were not specifically looking for, but which you found useful? If so, what was that information?
• Were there specific pieces of information you were looking for that you did not find? If so, what couldn’t you find?
• What were your overall feelings about the reviews you read?
• Were there any reviews that you found particularly helpful? If so, why?
• Were there any reviews that you found particularly unhelpful? If so, why?
• What strategies did you use to try to find useful reviews?
• Did you use the review snippets at the top? (where they show words/phrases that came up in many reviews?
• Did you use the “Search within reviews” feature? If so, how?
• Did you use the “Yelp sort” feature? If so, how?
• Did you have any frustrations or challenges that came up when using the reviews?
• Did you find the interface for finding/viewing reviews easy or difficult to use? Why?
• Were you pleased or displeased with the content of the reviews? (i.e., the information contained in them) Why?
• Were you pleased or displeased with the quality of the reviews? (i.e., how credible you found the reviewer, did they seem to have a strong bias or agenda) Why?
• Were there any reviews you thought should not be on the site? (i.e., Yelp should have removed them)
• What functionality or features would you like to see for using Yelp reviews that isn’t currently available on Yelp?
• How would you complete the sentence, “For me, the perfect review would be…”?
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• Volume 14, Issue 9
• Physiotherapy rehabilitation experiences of people with shoulder dislocation in ARTISAN study: a qualitative study
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• http://orcid.org/0000-0001-5504-7189 Seyran Naghdi 1 ,
• http://orcid.org/0000-0002-2992-048X David R Ellard 1 , 2 ,
• Rebecca Kearney 3
• on behalf of the ARTISAN team
• 1 Warwick Clinical Trials Unit , University of Warwick , Coventry , UK
• 2 University Hospitals Coventry and Warwickshire , Coventry , UK
• 3 Bristol Trials Centre , University of Bristol , Bristol , UK
• Correspondence to Seyran Naghdi; Seyran.Naghdi{at}warwick.ac.uk

Background Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN) was a large trial comparing the clinical and cost-effectiveness of two rehabilitation interventions in adults with a first-time traumatic shoulder dislocation. Participants were allocated to receive either a single session of advice (ARTISAN) or a single session of advice and a programme of physiotherapy (ARTISAN plus). Trial results illustrated that additional physiotherapy after an initial session was not superior in improving functional outcomes for participants.

Objectives In this study, we aim to explore the experiences of a purposive sample of participants from both the ARTISAN and ARTISAN plus groups regarding their rehabilitation journey.

Design This is a semistructured interview-based study.

Setting The study was conducted in the United Kingdom.

Participants Thirty-one participants of ARTISAN trial: 16 participants from ARTISAN group and 15 from ARTISAN plus group.

Outcome measures and analysis The study follows the consolidated criteria for reporting qualitative research. The framework analysis was used to synthesise the participants’ experiences. The interviews were coded through NVivo 12.6.1.

Results Three dominant and interrelated topics emerged from the interview data: (1) feelings about their shoulder rehabilitation outcome, (2) judgement of ARTISAN rehabilitation materials, (3) assessment of shoulder rehabilitation service provision.

Conclusion Both forms of intervention have some merit for some individuals. Thus, it may be appropriate to look at the patients’ preference for offering treatment to them. Recognising and facilitating this will be of benefit to both the patients and healthcare as a whole.

• qualitative research
• physical therapy modalities

Data availability statement

Data are available upon reasonable request. All codes and quotations can be found in the supplementary file.

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-2024-083975

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STRENGTHS AND LIMITATIONS OF THIS STUDY

The study used semistructured interviews, allowing in-depth exploration of participants’ experiences.

Interviewers used prompts and rephrased questions to mitigate recall issues among older participants.

Due to the COVID-19 pandemic, the methodology was adapted from face-to-face interviews to telephone interviews and the planned return of transcripts to participants for checking was not done (due to remote working).

The shift to telephone interviews could have affected the depth of understanding of participants’ feelings and reactions.

The sample size and specific context may limit the transferability of the findings.

Introduction

The UK, National Institute for Health and Care Research, Health Technology Assessment-funded Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN) trial took place between November 2018 and March 2022. The trial aimed to compare the clinical and cost-effectiveness of two rehabilitation interventions in adults with a first-time traumatic shoulder dislocation. 1 Participants, presenting with first-time traumatic shoulder dislocation, meeting the inclusion criteria, were randomly allocated to receive either a single session of advice or a single session of advice and a programme of physiotherapy, delivered by trained physiotherapists; 482 participants were randomised and screened from 41 NHS Trusts. 2

The trial reports that there was no evidence of a difference in the primary outcome (Oxford Shoulder Instability Score) at the primary endpoint (6 months) between the two groups. 2 Additionally, there were no statistically significant differences observed in the QuickDASH (a self-completed shortened version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire) scores, nor were there consistent differences in the EQ-5D-5L secondary outcomes. 2 Noting that the offer of additional physiotherapy after an initial session was not superior in improving functional outcomes for participants. 2

Embedded within the ARTISAN trial were a cost-effectiveness study and a qualitative interview study. 1 Understanding patient perspectives is essential for achieving successful treatment of anterior shoulder instability. 3 Patient adherence to rehabilitation protocols, their personal experiences and perceived barriers and facilitators play a significant role in influencing treatment outcomes. 4 Here, in this paper, we present the results of the ARTISAN interviews exploring their findings alongside the findings from the clinical effectiveness trial. 2 The results from the interview study, which were analysed before the effectiveness results were revealed, are presented here and provide insight into possible reasons for the outcome.

This is a qualitative study, exploring the experiences and reality of participants, via individual semistructured interviews. This study is in accordance with the consolidated criteria for reporting qualitative research 5 (see online supplemental appendix 1, table 1 ).

Supplemental material

Participants.

All participants, on consenting to participate in the trial, were informed about the interview substudy, and asked if they would be willing to be potentially contacted. A purposive sample was used, to ensure a diverse range of characteristics including location, treatment allocation, gender, age, of those who expressed an interest in participating. 6 7 Up to 50 interviews were planned to capture a comprehensive range of experiences related to shoulder dislocation rehabilitation. The decision to set the sample at around 50 was based on researchers’ experience and represented over 10% of the randomised population. Potential participants were contacted by the researcher (ZL), who confirmed their interest, provided information and arranged interviews at the 12-month postrandomisation timepoint. This was for two reasons, first it allowed participants sufficient time to undergo their rehabilitation journey and reflect on their experiences comprehensively, but second, and more importantly for the trial, we set it at this point in time, so that interviews were carried out outside of trial data collection and thus did not bias the main results. The interviewer was not known to the participants prior to the study and was centrally based.

Data collection

Semistructured interviews of participants from both arms were undertaken by a researcher (ZL) experienced in qualitative research methods. The interview schedule is presented in online supplemental appendix 2 . The interview topics were generated through a combination of literature review, expert input and patient feedback with pilot testing conducted to ensure reliability and validity. 8 Interviews were planned to be face-to-face, but the COVID-19 pandemic required the team to conduct most of these interviews by telephone. This shift to remote working away from the office meant that we had to adapt and while our protocol stated we would return transcripts to participants for checking this was not done. Three interviews were conducted in the participants’ homes, one at the participant’s workplace and the rest through telephone. All interviews were done between 11 February 2020 and 1 February 2021. The approximate time for each interview was 45 min. Field notes were written up as soon as possible after the interviews to record the interviewers’ immediate impressions. Interviews were digitally recorded, subjected to permission of each participant, and they transcribed verbatim by an independent university-approved transcription company and anonymised. All transcription interviews from audios were checked by another researcher (SN).

Data analysis

Data were analysed thematically using the Framework method, as follows: data familiarisation, identifying a thematic framework, indexing, charting, mapping and interpretation. 6 7 The analysis was conducted by researchers with extensive expertise in qualitative research methods. SN, who joined the trial team after the interviews were recorded, listened to the audio recordings to check the accuracy. She became familiar with the data. The transcripts were imported to the NVivo release V.12.6.1 9 to facilitate coding data and mapping them. SN generated initial relevant codes/topic; these were generally based around the specific questions asked of participants. The next analysis stage involved DRE collating the codes to note meaningful patterns in the data that were relevant to the research question. DRE and SN created themes and subthemes that captured the essence of the participants’ voices. Themes and subthemes are presented using quotes to illustrate the participant view.

Rigour was enhanced during the process by coding the first five transcriptions by two independent, experienced researchers (ZHL and SN). Discrepancies were addressed by DRE, who has extensive experience in process evaluation and played a key role as a coapplicant for the ARTISAN trial, contributing to its design. SN independently coded all transcripts and discussed them in detail with DRE. The results were presented before releasing a statistical and health economics result. Reflexivity was maintained throughout the analysis process, with researchers reflecting on their own biases and preconceptions, thereby enhancing the credibility, transferability and dependability of the findings. 10

The qualitative analyses and results were prepared and presented to the Chief Investigator, RK, who is a leading expert in the physiotherapy with extensive experience in randomised controlled trials, before the main trial results were known.

Patient and public involvement

Patient representatives provided input on study design, intervention development and dissemination plans, ensuring a comprehensive approach. Detailed patient and public involvement activities are outlined in the ARTISAN trial report. 11

A total of 102 participants, who had expressed an interest in involvement in the qualitative study at the time of consenting to be in the ARTISAN trial, were contacted. Seventeen declined to participate, and 54 did not respond. A total of 31 participants consented and were interviewed from both arms of the trial, ARTISAN and ARTISAN plus (see table 1 ). The participants were from 17 different trial sites in the UK. Of them, 16 participants were allocated to the ARTISAN’s arm, and 15 participants were allocated to the ARTISAN plus arm.

• View inline

Demographic characteristics of ARTISAN interview study participants

Baseline characteristics

The majority of the participants in the ARTISAN plus arm were men (11 out of 15), while there was a balance between participants (eight men and eight women) in the ARTISAN’s arm. The participants’ means (SD) of age were 49 (21) and 59 (17) for the ARTISAN and ARTISAN plus arms, respectively. Five participants in the ARTISAN’s arm and four in the ARTISAN plus arm stated they were involved in sporting activities that needed high levels of physical activity. Most of them described no difficulties with their shoulder before the injury. Only two and three participants in the ARTISAN and ARTISAN plus had a previous problem that goes back many years ago. There was a wide variety of the injury caused; however, seven participants (four in the ARTISAN plus arm and three in the ARTISAN’s arm) got an injury while doing sports activities such as football, rugby, weightlifting and riding a bike. The injury in the three participants in the ARTISAN group resulted in a fractured shoulder in addition to dislocation. The practitioner team decided to perform shoulder surgery for one participant in the ARTISAN plus arm due to pre-existing arthritis. Most participants in both groups believed they were provided the Ambulance and Emergency (A&E) services straightforwardly and quickly, while one participant in the ARTISAN’s arm faced a delay because he needed to be transferred from a small unit to another hospital with an A&E department. A shoulder dislocation for all participants was diagnosed by X-rays. After putting the shoulder back, they received painkillers to relieve the pain and were recommended to wear a sling for at least a week.

Theme identification and common themes

Our findings (detailed below) illustrate participants’ experiences of receiving and interacting with rehabilitation services.

Three dominant and interrelated topics emerged from the interview data questions: (1) feelings about their shoulder rehabilitation outcome, (2) judgement of ARTISAN rehabilitation materials, (3) assessment of shoulder rehabilitation services provision

Themes and their subthemes, within each of these topics, are reported below comparing and contrasting responses from both arms of the trial ((ARTISAN) advise only and those from (ARTISAN plus) advise plus a programme of physiotherapy). Quotations are used as exemplars of themes with each quote linked to a particular participant denoted by the arm of the trial, they were involved in AP=ARTISAN plus arm or A=ARTISAN followed by their id number (see table 1 ), their gender (m or f) and age (eg, A11, m, 31). See Appendix 3 for additional quotations.

Feelings about their shoulder rehabilitation outcome

This topic breaks down into several themes/subthemes, providing an insight into the assessment of their feelings about their recovery including movement and use of their shoulder and being able to get back to their previous activities or not. Noting that within the ARTISAN arm, fewer participants expressed satisfaction with their shoulder movement levels.

Shoulder status (How they feel their shoulder is now postrehabilitation)

Participants who received ARTISAN plus report improvement in returning to their normal life and working activities. Almost all of them expressed the status of their shoulder as ‘better’.

I feel good now, and then I can…I’m back to doing all the jobs I could do before (AP13, m 59), I think I'm back at 100 now (AP25, m,72), Probably getting up to 100% I guess. (AP27, m,72).

A few did still feel that they still a little way to go.

I would say yeah, probably 70% now. Yeah, around about that. Yes, yeah (AP3, m, 65), Like maybe more 60 than 50 in terms of movements (AP28, m, 36).

Compared with the ARTISAN arm where there were fewer participants who believed their shoulder was at a good level of movement.

…had almost complete range of movement (A21, f, 65). It’s absolutely fine… (A26, f, 68).

Satisfaction

Interestingly, most participants who had received ARTISAN plus apparently liked to recommend it to the others with the same problem because they were very satisfied with the result from having multiphysiotherapy sessions.

Yeah, I would recommend, I would definitely recommend anybody to go do that what I did, yeah, definitely. Definitely, yeah (AP12, f, 62).

The other source of satisfaction from the result for most of them was receiving positive reinforcement from the physiotherapist about outcomes and being told that they were doing the exercise correctly.

Only the reassurance that everything was going fine (AP22, m, 67), So, I suppose I needed those sorts of reassurances before I got into heavier physiotherapy (AP12, f, 62).

On the other hand, most people in the ARTISAN arm have found the exercises as the most helpful part of rehabilitation to get back their abilities.

Yeah. I would…I would tell them, you need that physio exercise, yeah (A19, m, 48).

Setting short-term goals and identifying milestones were noted as helpful by some participants in both groups. Helping them have a realistic view of their shoulder progression.

the goals were…because I think it kind of helps you set a realistic view of you know, going on to next session that if you could do this” (A19, m, 48).“Yeah, the goals were…because I think it kind of helps you set a realistic view of, you know, going on to the next session that if you could do this, it was literally things like being able to reach something from one of the cupboards in the kitchen, kind of thing. So, I think it’s really good to just help set umm and be able to achieve, also to help set expectations (A19, m, 48). The main point was the face-to-face setting of goals between sessions (AP27, m, 72). I do find useful writing down, there was a sheet in one of the books where you wrote down what you achieve every day. And that really worked for me as well because you weren’t in this wilderness you were actually working step by step towards something… you know you can get a lot of resources but actually the biggest resource is your own determination (AP5, f, 71)

Participants’ judgement about ARTISAN rehabilitation materials

All of the trial participants had the opportunity to use the provided rehabilitation training materials in addition to the support given by the physiotherapist in the sessions they all had with them. These materials seem to be more important for the ARTISAN participants as they generally only had the one in-person session with the physiotherapist. However, it is also important to know to what extent the participants have used the materials and what their experience is in using them.

Material usefulness

Almost all participants in the ARTISAN arm report using the booklets while only half of the ARTISAN plus arm reported used them. In addition, none of the ARTISAN plus participants report having used the videos and website compared with around half of those in the ARTISAN arm. The ARTISAN plus participants who have not used the materials believed that they had gained enough from their in-person visits with the physiotherapist; therefore, they did not feel the need to refer to the training materials.

just after the first (physio) session, I had the chance to have a very quick look at the booklets, so, it was enough exercise and guidance from physiotherapist over the sessions, …, didn’t feel need them! (AP7, m, 37). I had time, was off from work, almost at home, and was keen on going through the booklets, but only booklets, no website, and videos, so I think it was quite helpful (AP15, m, 33). I got those stuff (training materials), …, but yea! I don’t remember using them! yea, didn’t look at them at all (A18, f, 72) (I) got the booklet and everything, I went on the website, saw the videos and, yeah (A32, F, 59).

Problems with study materials provided

The main reported source of difficulty in using the materials provided was in the ARTISAN arm where there were problems reported accessing the video and internet-based materials. A few of the participants from ARTISAN have reported some problems with the booklets provided. These problems are very low in the ARTISAN plus arm.

There was but I don't have the internet at my house… (A21, f, 65), I couldn't quite find…I couldn't follow the instructions on those. And I couldn't log into the website. So, I couldn't get any additional information”. I had a booklet. I didn't find them all easy to follow. There was a couple…I mean they did run through it with me, the fracture clinic, but they more demonstrated it I would say. But I didn't find everything in the booklet that easy to follow. I did with the hospital physiotherapist, I actually had to do it because my arm was in better shape (A32, f, 59). I think there was one [picture] that wasn't quite clear, but I checked it out with her the next time I went (AP22, m, 67). I suppose the booklet umm is in some ways misinterpreted because it is not in 3D you know so surely for a picture… a picture does not always give you the right angle or the right umm motion to use (AP5, f, 71).

Material comprehensiveness and consistency

The content of the materials was consistent with what had been provided in face-to-face rehabilitation sessions in view of almost participants. The materials were also reported to be comprehensive and to meet the needs of the participants in both arms.

From the ARTISAN participants:

It was very good because you get…further on, you’ve sort of got more exercises to do. So, you really need that leaflet to show you the different exercises you need to do (A26, f, 68). Yeah well, the exercises we did were the exercises in the pamphlet that I was given which I said to you, and hmmm the physio she did them all with me… 2 or three times (A2, m, 56).

From the ARTISAN plus participants

It was just giving me alternatives to do. It’s the same kind of stress on the shoulder, but it was a different exercise. But more or less, there were those like, you know (AP28, m, 36). She (the physiotherapist) did. She did go through the booklet with it and marked certain things, you know like she wrote in the book the few exercises that I should be doing (AP1, m, 27).

Participant’s assessment of rehabilitation service provision

This theme reflects participants feelings about the provision of physiotherapy/rehabilitation in terms of the accessibility to the providing rehabilitation centres, physiotherapist performance and then the form of sessions provided. This part of the participants’ experiences reflects insights about the barriers that can influence the participants getting to the centres, and to what extent participant believe the physiotherapists have been engaged in their rehabilitation/treatment process.

Accessibility to the rehabilitation services

Several of the participants in ARTISAN plus have experienced some physical difficulties in attending the rehabilitation sessions, such as problems with driving, finding a car park and a considerable distance to the physiotherapy clinic or hospital from their home.

Taking into account quite a long distance to travel and the roads aren’t that great, I have to be taken in by my wife obviously I was not driving (AP3, m, 62). Sort of 2 hours right around the hospital so if I wasn’t close it would be more difficult (AP1, m, 27).

Most of the people in this group stated that there are no difficulties to attend the physiotherapy sessions. They also mentioned that the health centres were flexible in providing suitable slots for appointments. In addition, there were positive comments about public transport and employers who were supportive.

Nothing whatsoever because I was able to get a time slot that suited me, which was earlyish morning. And there was no delay, you know. There was…it was all perfectly right for me (AP27, m, 72). No, no. Well, they were quite supportive at work (AP28, m, 36), No, you can get a bus to the hospital (AP15, m, 33).

Most of the participants in the ARTISAN group report not having experienced any obstacles or barriers to accessing rehabilitation services.

I didn't (have trouble to attend), but I walked attending…walked attending the physio (A23, f, 53), that’s fine (A26, f, 68).

However, some barriers remained for a small number of ARTISAN participants.

I couldn't drive. I got some free transport from the transport people. And then…and that stopped when I was told that…they had to tell me I must get on a bus because they have to keep it for people that are more seriously ill than me. And I was, therefore, trying to sort that out, and eventually, I got a friend to take me, across the road…. (After requiring additional physiotherapy sessions for frozen shoulder). (A21, f, 65) Parking. It’s terrible up there (A29, m, 26).

The physiotherapist’s performance

The physiotherapist was considered a valuable source of motivation in improving the injured shoulder by participants in both arms of the trial. All participants expressed that their physiotherapists went through the exercises and correct movement in detail as much as they could. Giving feedback and setting short and long-time goals by physiotherapists had a positive impact on the participants’ feelings, especially for ARTISAN plus.

It gave us confidence (AP10, f, 25). I don’t know who he (the physiotherapist) was, but it was a good job (AP13, m, 59). She (the physiotherapist) pretty much answered the questions anyway as we went along you know (AP20, m, 81).

The participants in the ARTISAN’s arm also found an excellent experience with their physiotherapists.

he (the physiotherapist) was a really, really, really good physio. Very straightforward, practical, on to work which I really like (A19, m, 48). He’s…he (the physiotherapist) was very, very positive attitude so that’s about all really. No, they're all very positive about what to do next (A21, f, 65). (Participant who was given additional physiotherapy session by the clinician).

Physiotherapy session formats

Almost all participants in the ARTISAN group found the physiotherapy session helpful and informative; a few expressed they may have preferred having multiple physiotherapy sessions. A number noted that they felt that they benefited from a single session.

Yes, was helpful. He (the physiotherapist) gave me a booklet, he gave me lots of things and did say that if I had problems, then I was to go back (A14, f, 74). It was informative. They gave me a few exercises to do, and they scanned through all different movements to see where I was sort of suffering with it (A29, m, 26).

One ARTISAN participant noted that she experienced group-based physiotherapy sessions (outside of that provided by the trial). She was keen on attending these sessions because she thought it was an excellent opportunity to get peer support, to understand the limitations and develop coping strategies for dealing with issues that may arise.

Although everybody is different it was nice to talk to other people and other people have different things, but it was still nice to speak to someone in the same situation as you (A2, f, 56).

Two participants in the ARTISAN arm have sought out additional treatments or programmes apart from the training materials to increase their chance of returning to their previous sports activities.

I’m lucky enough that the club that I play rugby for has a physio that they employ as well, he recommended that the Derby shoulder stability programme, so I went along, did some of those exercises on that, and that was good, got to all progressions that I was trying to get back to, and the exercise that was provided from like the ARTISAN from the hospital was kind of due to get me back to general life, it probably would’ve been perfectly fine, but yeah, I want to go back to rugby so I know I needed to get my shoulder back to like full strength (A9, m, 24). Almost to the year, it was almost to the year and my shoulder was absolutely killing. I couldn't drive. It almost felt like well, I didn't know what was wrong with it. It felt like a frozen shoulder, and I ended up in the…I ended up going to a chiropractor (A23, f, 53).

Most participants with ARTISAN plus multiphysiotherapy sessions pointed out that they had enough chances to visit their physiotherapist to assess their shoulder movement, achieve their goals and receive instructions on doing the exercises correctly.

If I was doing something wrong, they could correct me (AP15, m, 33).

The most emphasised point in this group was getting reassurance and feedback from the physiotherapist.

Well, I suppose it’s…the fact that you can do a certain exercise over a period of time, then you get some feedback with a consultant to tell you how you’re doing (AP13, m, 59).

Several of them expressed that communication with a professional member such as a physiotherapist psychologically impacts the rehabilitation journey.

It certainly helped mentally. It gave you support. You felt that somebody was interested in trying to help, which was as much benefit as the physical side of it (AP20, m, 81).

A participant from the ARTISAN arm who received additional physiotherapy sessions highlights again the reassurance of having the contact with a therapist.

The other benefit really was the reassurance because I think one of the things that you did…that you worry about is you know it’s going to dislocate again (A19, m, 48).

The interview substudy, seamlessly integrated within the broader framework of the ARTISAN trial, served as a crucial avenue to explore the nuanced experiences of participants undergoing the trial treatments. By adopting a qualitative approach, we aimed to unravel the intricacies of their rehabilitation journeys and illuminate the factors influencing their adherence to the prescribed interventions. Our endeavour was not merely to supplement the quantitative findings of the main trial but to enrich the understanding of the outcomes by capturing the subjective narratives of the participants. Through the lens of 31 in-depth interviews, we explored the multifaceted dimensions of their experiences, ranging from their feelings about shoulder rehabilitation outcomes to their assessments of the provided rehabilitation services.

While the outcome of the trial found no difference between the two groups, the participant experiences give an insight that is a little different. 2 Similar findings were observed in the REPOSE trial, where qualitative data provided valuable context and a deeper understanding of patient experiences that were not captured by the quantitative results. 12 More ARTISAN plus participants reported that their expectations about their rehabilitation were met than those in the ARTISAN group. There were those, however, in both groups, who felt that they did not return to the level of physical activities that they would have liked (eg, Sports). Indeed, even participants in the ARTISAN plus group who had a programme of physiotherapy felt they were not reaching their preinjury levels of activity. A recent paper highlights that fear of recurrent dislocation may be a contributing factor to participants feeling they are not returning to their normal levels of physical activity. 3

Participants who only received the advice session (the ARTISAN group) do seem to want more engagement and more actual physiotherapy sessions. Several of the younger participants in the ARTISAN group have sought out additional treatment options (eg, exercise programmes, chiropractic sessions) in addition to what was provided to increase their chance of returning preinjury levels of activities. While ARTISAN plus participants, it seems were less likely to go for additional treatments outside of that provided.

The interviews give us an insight into the participants’ experiences in their rehabilitation journey. Involving them in the improvement journey seems to have a positive influence on their sense of improvement. Regardless of the participant’s allocated group, sex, age and history of doing exercise, the physiotherapist’s advice and efforts to give reassurance appear to play a crucial role in the participants’ mindset and confidence. Following operative and non-operative treatment of shoulder instability, physiotherapists plays a key role in the recovery process, supporting the patient and building strength and trust. 3 This highlights the importance of clearly communicating with participants, providing them with clear information and reassurance about their rehabilitation journey. This approach ensures effective treatment and contributes to a better overall experience and outcome for participants. Cridland et al , in a recent article, looking at patient experiences and perceptions of rotator cuff related shoulder pain rehabilitation, highlight the importance of participants’ trust in the health professional providing the rehabilitation. They note that this facilitates adherence and increases the belief that the condition is being effectively treated. 13 Main et al also emphasise the critical role of the therapeutic relationship in rehabilitation success. 14

Those participants who have engaged with the materials provided have found them helpful regardless of their background factors (sex, age and history of doing sport) and allocated arms. Both groups of participants have used the booklets and expressed good experiences with it.

The participants have raised some minor points regarding the difficulty with the booklets and the online materials were sometimes difficult to access. However, the participants in the ARTISAN plus group seem to have had a better chance of resolving this kind of problem because of having more contact with their therapist. Participants in both groups report using the videos and website less than the booklets. This is more obvious among the senior groups and women. Lack of internet access was an issue for several older participants, who struggled with digital materials. This underscores the need for alternative formats and enhanced support for digital resources to ensure all participants, regardless of their digital literacy or access to technology, can effectively engage with the provided materials. Addressing these aspects is crucial for improving the inclusivity and effectiveness of the future interventions. However, for those who viewed the video, it has given them a better idea of how to do the exercises correctly. The latter is more apparent among those participants at younger ages and with less severe injuries.

Strengths and limitations

It was found that some participants, especially elderly participants, faced challenges in recalling their rehabilitation journey experiences, potentially affecting the accuracy of their recall. To mitigate this issue, the interviewer used prompts as necessary and adjusted questions to improve understanding. The study also observed variations in recall accuracy among different demographic groups, indicating that the passage of time since their rehabilitation may impact memory differently. These findings underscore the importance of demographic considerations in qualitative research, ensuring a comprehensive understanding of participants’ experiences. In addition, because of the COVID-19 pandemic and lockdown, only the first four interviews were held face-to-face, and the rest were by telephone. This potentially could have some effects on understanding the participants’ feelings and reactions, as non-verbal cues and personal rapport are more challenging to capture over the phone. Despite these limitations, efforts were made to ensure comprehensive data collection by employing consistent interview techniques and maintaining a flexible approach to question phrasing.

While our study comprehensively explored the patient experience in the ARTISAN trial, we did not evaluate the perspectives of the healthcare practitioners delivering the intervention. Understanding the experiences and insights of physiotherapists could provide valuable context to our findings. Future research should consider their views on treatment implementation. This approach aligns with the current emphasis on shared decision-making models in healthcare, where the collaboration between patients and practitioners is crucial for optimal treatment outcomes. 15

While previous qualitative studies have explored the experiences of people with shoulder instability, this study provides an in-depth reflection on participants’ voices specifically with shoulder dislocation during their physiotherapy journey within the UK-based randomised trial. However, the transferability of findings may be limited.

The overall clinical trial outcome was very conclusive, in which extraphysiotherapy was not superior and thus may not be the best form of rehabilitation for those who experience a first-time traumatic shoulder dislocation. This interview study supports this finding in that it shows us that both forms of intervention have merit for some individuals. Thus, it may be that tailoring the treatment offered to the needs of the patient is appropriate here. Not all patients want regular clinic visits or indeed support from a health professional. Recognising and facilitating this will be of benefit to both the patients and healthcare as a whole.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

Ethical approval for the interview study was included in the ethical approval of the main trial (Wales REC 3, REC reference: 18/WA/0236, 2018). All participants gave written informed consent prior to taking part. Participants gave informed consent to participate in the study before taking part.

Acknowledgments

We would like to thank Ziheng Liew for conducting the interviews. We also would like to thank all the participants who attended the interview sessions. In addition, we acknowledge this paper is written on behalf of the ARTISAN Team, and we would like to acknowledge the expert support of the ARTISAN Team which comprised: Helen Parsons, Warwick Clinical Trials Unit, University of Warwick, Warwick, UK, ( https://orcid.org/0000-0002-2765-3728 ); Aminul Haque, Warwick Clinical Trials Unit, University of Warwick, Warwick, UK, ( https://orcid.org/0000-0003-3589-6751 ); James Mason, Warwick Clinical Trials Unit, University of Warwick, Warwick, UK, ( https://orcid.org/0000-0001-9210-4082 ); Henry Nwankwo, Warwick Clinical Trials Unit, University of Warwick, Warwick, UK, ( https://orcid.org/0000-0001-7401-1923 ), Helen Bradley, Warwick Clinical Trials Unit, University of Warwick, Warwick, UK, ( https://orcid.org/0009-0003-1663-4462 ); Stephen Drew, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, ( https://orcid.org/0000-0002-9523-682X ); Chetan Modi, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, ( https://orcid.org/0009-0008-3337-4419 ); Howard Bush, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, ( https://orcid.org/0000-0001-9360-0504 ); David Torgerson, York Clinical Trials Unit, University of York, York, UK, ( https://orcid.org/0000-0002-1667-4275 ); Martin Underwood, Warwick Clinical Trials Unit, University of Warwick, Warwick, UK, ( https://orcid.org/0000-0002-0309-1708 ).

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Contributors DRE and RK have designed the study. DRE and SN have analysed the data. All authors have contribution to drafting the manuscript and reviewed. SN is the corresponding author, and all authors are guarantors for the overall content of the manuscript.

Funding ARTISAN trial founded by NIHR, Health Technology Assessment (HTA) Programme, (16/167/56) 01/06/18. The University of Warwick and University Hospitals Coventry and Warwickshire NHS Trust are co-sponsorship for this trial.

Competing interests RK is co-chair of the NIHR Programme Grants for Applied Research (PGfAR) committee, a paid position in NIHR but unrelated to the trial. She is also a previous chair of the NIHR West Midlands Research for Patient Benefit (RfPB) committee and member of the NIHR Health Technology Assessment (HTA) Clinical Evaluation and Trials Committee and NIHR Integrated Clinical Academic (ICA) doctoral committee. RK, DRE, HP, AH, JM, HN, SD, CM, HB, DT, MU have all been awarded current and previous NIHR research grants. HP, MU and RK are co-investigators on grants funded by the Australian NHMRC and NIHR funded studies receiving additional support from Stryker Ltd.

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.

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