observational and experimental studies examples

Observational vs. Experimental Study: A Comprehensive Guide

Explore the fundamental disparities between experimental and observational studies in this comprehensive guide by Santos Research Center, Corp. Uncover concepts such as control group, random sample, cohort studies, response variable, and explanatory variable that shape the foundation of these methodologies. Discover the significance of randomized controlled trials and case control studies, examining causal relationships and the role of dependent variables and independent variables in research designs.

This enlightening exploration also delves into the meticulous scientific study process, involving survey members, systematic reviews, and statistical analyses. Investigate the careful balance of control group and treatment group dynamics, highlighting how researchers meticulously assign variables and analyze statistical patterns to discern meaningful insights. From dissecting issues like lung cancer to understanding sleep patterns, this guide emphasizes the precision of controlled experiments and controlled trials, where variables are isolated and scrutinized, paving the way for a deeper comprehension of the world through empirical research.

Introduction to Observational and Experimental Studies

These two studies are the cornerstones of scientific inquiry, each offering a distinct approach to unraveling the mysteries of the natural world.

Observational studies allow us to observe, document, and gather data without direct intervention. They provide a means to explore real-world scenarios and trends, making them valuable when manipulating variables is not feasible or ethical. From surveys to meticulous observations, these studies shed light on existing conditions and relationships.

Experimental studies , in contrast, put researchers in the driver's seat. They involve the deliberate manipulation of variables to understand their impact on specific outcomes. By controlling the conditions, experimental studies establish causal relationships, answering questions of causality with precision. This approach is pivotal for hypothesis testing and informed decision-making.

At Santos Research Center, Corp., we recognize the importance of both observational and experimental studies. We employ these methodologies in our diverse research projects to ensure the highest quality of scientific investigation and to answer a wide range of research questions.

Observational Studies: A Closer Look

In our exploration of research methodologies, let's zoom in on observational research studies—an essential facet of scientific inquiry that we at Santos Research Center, Corp., expertly employ in our diverse research projects.

What is an Observational Study?

Observational research studies involve the passive observation of subjects without any intervention or manipulation by researchers. These studies are designed to scrutinize the relationships between variables and test subjects, uncover patterns, and draw conclusions grounded in real-world data.

Researchers refrain from interfering with the natural course of events in controlled experiment. Instead, they meticulously gather data by keenly observing and documenting information about the test subjects and their surroundings. This approach permits the examination of variables that cannot be ethically or feasibly manipulated, making it particularly valuable in certain research scenarios.

Types of Observational Studies

Now, let's delve into the various forms that observational studies can take, each with its distinct characteristics and applications.

Cohort Studies:  A cohort study is a type of observational study that entails tracking one group of individuals over an extended period. Its primary goal is to identify potential causes or risk factors for specific outcomes or treatment group. Cohort studies provide valuable insights into the development of conditions or diseases and the factors that influence them.

Case-Control Studies:  Case-control studies, on the other hand, involve the comparison of individuals with a particular condition or outcome to those without it (the control group). These studies aim to discern potential causal factors or associations that may have contributed to the development of the condition under investigation.

Cross-Sectional Studies:  Cross-sectional studies take a snapshot of a diverse group of individuals at a single point in time. By collecting data from this snapshot, researchers gain insights into the prevalence of a specific condition or the relationships between variables at that precise moment. Cross-sectional studies are often used to assess the health status of the different groups within a population or explore the interplay between various factors.

Advantages and Limitations of Observational Studies

Observational studies, as we've explored, are a vital pillar of scientific research, offering unique insights into real-world phenomena. In this section, we will dissect the advantages and limitations that characterize these studies, shedding light on the intricacies that researchers grapple with when employing this methodology.

Advantages: One of the paramount advantages of observational studies lies in their utilization of real-world data. Unlike controlled experiments that operate in artificial settings, observational studies embrace the complexities of the natural world. This approach enables researchers to capture genuine behaviors, patterns, and occurrences as they unfold. As a result, the data collected reflects the intricacies of real-life scenarios, making it highly relevant and applicable to diverse settings and populations.

Moreover, in a randomized controlled trial, researchers looked to randomly assign participants to a group. Observational studies excel in their capacity to examine long-term trends. By observing one group of subjects over extended periods, research scientists gain the ability to track developments, trends, and shifts in behavior or outcomes. This longitudinal perspective is invaluable when studying phenomena that evolve gradually, such as chronic diseases, societal changes, or environmental shifts. It allows for the detection of subtle nuances that may be missed in shorter-term investigations.

Limitations: However, like any research methodology, observational studies are not without their limitations. One significant challenge of statistical study lies in the potential for biases. Since researchers do not intervene in the subjects' experiences, various biases can creep into the data collection process. These biases may arise from participant self-reporting, observer bias, or selection bias in random sample, among others. Careful design and rigorous data analysis are crucial for mitigating these biases.

Another limitation is the presence of confounding variables. In observational studies, it can be challenging to isolate the effect of a specific variable from the myriad of other factors at play. These confounding variables can obscure the true relationship between the variables of interest, making it difficult to establish causation definitively. Research scientists must employ statistical techniques to control for or adjust these confounding variables.

Additionally, observational studies face constraints in their ability to establish causation. While they can identify associations and correlations between variables, they cannot prove causality or causal relationship. Establishing causation typically requires controlled experiments where researchers can manipulate independent variables systematically. In observational studies, researchers can only infer potential causation based on the observed associations.

Experimental Studies: Delving Deeper

In the intricate landscape of scientific research, we now turn our gaze toward experimental studies—a dynamic and powerful method that Santos Research Center, Corp. skillfully employs in our pursuit of knowledge.

What is an Experimental Study?

While some studies observe and gather data passively, experimental studies take a more proactive approach. Here, researchers actively introduce an intervention or treatment to an experiment group study its effects on one or more variables. This methodology empowers researchers to manipulate independent variables deliberately and examine their direct impact on dependent variables.

Experimental research are distinguished by their exceptional ability to establish cause-and-effect relationships. This invaluable characteristic allows researchers to unlock the mysteries of how one variable influences another, offering profound insights into the scientific questions at hand. Within the controlled environment of an experimental study, researchers can systematically test hypotheses, shedding light on complex phenomena.

Key Features of Experimental Studies

Central to statistical analysis, the rigor and reliability of experimental studies are several key features that ensure the validity of their findings.

Randomized Controlled Trials:  Randomization is a critical element in experimental studies, as it ensures that subjects are assigned to groups in a random assignment. This randomly assigned allocation minimizes the risk of unintentional biases and confounding variables, strengthening the credibility of the study's outcomes.

Control Groups:  Control groups play a pivotal role in experimental studies by serving as a baseline for comparison. They enable researchers to assess the true impact of the intervention being studied. By comparing the outcomes of the intervention group to those of survey members of the control group, researchers can discern whether the intervention caused the observed changes.

Blinding:  Both single-blind and double-blind techniques are employed in experimental studies to prevent biases from influencing the study or controlled trial's outcomes. Single-blind studies keep either the subjects or the researchers unaware of certain aspects of the study, while double-blind studies extend this blindness to both parties, enhancing the objectivity of the study.

These key features work in concert to uphold the integrity and trustworthiness of the results generated through experimental studies.

Advantages and Limitations of Experimental Studies

As with any research methodology, this one comes with its unique set of advantages and limitations.

Advantages:  These studies offer the distinct advantage of establishing causal relationships between two or more variables together. The controlled environment allows researchers to exert authority over variables, ensuring that changes in the dependent variable can be attributed to the independent variable. This meticulous control results in high-quality, reliable data that can significantly contribute to scientific knowledge.

Limitations:  However, experimental ones are not without their challenges. They may raise ethical concerns, particularly when the interventions involve potential risks to subjects. Additionally, their controlled nature can limit their real-world applicability, as the conditions in experiments may not accurately mirror those in the natural world. Moreover, executing an experimental study in randomized controlled, often demands substantial resources, with other variables including time, funding, and personnel.

Observational vs Experimental: A Side-by-Side Comparison

Having previously examined observational and experimental studies individually, we now embark on a side-by-side comparison to illuminate the key distinctions and commonalities between these foundational research approaches.

Key Differences and Notable Similarities

Methodologies

• Observational Studies : Characterized by passive observation, where researchers collect data without direct intervention, allowing the natural course of events to unfold.
• Experimental Studies : Involve active intervention, where researchers deliberately manipulate variables to discern their impact on specific outcomes, ensuring control over the experimental conditions.
• Observational Studies : Designed to identify patterns, correlations, and associations within existing data, shedding light on relationships within real-world settings.
• Experimental Studies : Geared toward establishing causality by determining the cause-and-effect relationships between variables, often in controlled laboratory environments.
• Observational Studies : Yield real-world data, reflecting the complexities and nuances of natural phenomena.
• Experimental Studies : Generate controlled data, allowing for precise analysis and the establishment of clear causal connections.

Observational studies excel at exploring associations and uncovering patterns within the intricacies of real-world settings, while experimental studies shine as the gold standard for discerning cause-and-effect relationships through meticulous control and manipulation in controlled environments. Understanding these differences and similarities empowers researchers to choose the most appropriate method for their specific research objectives.

When to Use Which: Practical Applications

The decision to employ either observational or experimental studies hinges on the research objectives at hand and the available resources. Observational studies prove invaluable when variable manipulation is impractical or ethically challenging, making them ideal for delving into long-term trends and uncovering intricate associations between certain variables (response variable or explanatory variable). On the other hand, experimental studies emerge as indispensable tools when the aim is to definitively establish causation and methodically control variables.

At Santos Research Center, Corp., our approach to both scientific study and methodology is characterized by meticulous consideration of the specific research goals. We recognize that the quality of outcomes hinges on selecting the most appropriate method of research study. Our unwavering commitment to employing both observational and experimental research studies further underscores our dedication to advancing scientific knowledge across diverse domains.

Conclusion: The Synergy of Experimental and Observational Studies in Research

In conclusion, both observational and experimental studies are integral to scientific research, offering complementary approaches with unique strengths and limitations. At Santos Research Center, Corp., we leverage these methodologies to contribute meaningfully to the scientific community.

Explore our projects and initiatives at Santos Research Center, Corp. by visiting our website or contacting us at (813) 249-9100, where our unwavering commitment to rigorous research practices and advancing scientific knowledge awaits.

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Statistics By Jim

Making statistics intuitive

What is an Observational Study: Definition & Examples

By Jim Frost 10 Comments

What is an Observational Study?

An observational study uses sample data to find correlations in situations where the researchers do not control the treatment, or independent variable, that relates to the primary research question. The definition of an observational study hinges on the notion that the researchers only observe subjects and do not assign them to the control and treatment groups. That’s the key difference between an observational study vs experiment. These studies are also known as quasi-experiments and correlational studies .

True experiments assign subject to the experimental groups where the researchers can manipulate the conditions. Unfortunately, random assignment is not always possible. For these cases, you can conduct an observational study.

In this post, learn about the types of observational studies, why they are susceptible to confounding variables, and how they compare to experiments. I’ll close this post by reviewing a published observational study about vitamin supplement usage.

Observational Study Definition

In an observational study, the researchers only observe the subjects and do not interfere or try to influence the outcomes. In other words, the researchers do not control the treatments or assign subjects to experimental groups. Instead, they observe and measure variables of interest and look for relationships between them. Usually, researchers conduct observational studies when it is difficult, impossible, or unethical to assign study participants to the experimental groups randomly. If you can’t randomly assign subjects to the treatment and control groups, then you observe the subjects in their self-selected states.

Observational Study vs Experiment

Randomized experiments provide better results than observational studies. Consequently, you should always use a randomized experiment whenever possible. However, if randomization is not possible, science should not come to a halt. After all, we still want to learn things, discover relationships, and make discoveries. For these cases, observational studies are a good alternative to a true experiment. Let’s compare the differences between an observational study vs. an experiment.

Random assignment in an experiment reduces systematic differences between experimental groups at the beginning of the study, which increases your confidence that the treatments caused any differences between groups you observe at the end of the study. In contrast, an observational study uses self-formed groups that can have pre-existing differences, which introduces the problem of confounding variables. More on that later!

In a randomized experiment, randomization tends to equalize confounders between groups and, thereby, prevents problems. In my post about random assignment , I describe that process as an elegant solution for confounding variables. You don’t need to measure or even know which variables are confounders, and randomization will still mitigate their effects. Additionally, you can use control variables in an experiment to keep the conditions as consistent as possible. For more detail about the differences, read Observational Study vs. Experiment .

If you’re looking for a middle ground choice between observational studies vs experiments, consider using a quasi-experimental design. These methods don’t require you to randomly assign participants to the experimental groups and still allow you to draw better causal conclusions about an intervention than an observational study. Learn more about Quasi-Experimental Design Overview & Examples .

Related posts : Experimental Design: Definition and Examples , Randomized Controlled Trials (RCTs) , and Control Groups in Experiments

Observational Study Examples

Consider using an observational study when random assignment for an experiment is problematic. This approach allows us to proceed and draw conclusions about effects even though we can’t control the independent variables. The following observational study examples will help you understand when and why to use them.

For example, if you’re studying how depression affects performance of an activity, it’s impossible to assign subjects to the depression and control group randomly. However, you can have subjects with and without depression perform the activity and compare the results in an observational study.

Or imagine trying to assign subjects to cigarette smoking and non-smoking groups randomly?! However, you can observe people in both groups and assess the differences in health outcomes in an observational study.

Suppose you’re studying a treatment for a disease. Ideally, you recruit a group of patients who all have the disease, and then randomly assign them to the treatment and control group. However, it’s unethical to withhold the treatment, which rules out a control group. Instead, you can compare patients who voluntarily do not use the medicine to those who do use it.

In all these observational study examples, the researchers do not assign subjects to the experimental groups. Instead, they observe people who are already in these groups and compare the outcomes. Hence, the scientists must use an observational study vs. an experiment.

Types of Observational Studies

The observational study definition states that researchers only observe the outcomes and do not manipulate or control factors . Despite this limitation, there various types of observational studies.

The following experimental designs are three standard types of observational studies.

• Cohort Study : A longitudinal observational study that follows a group who share a defining characteristic. These studies frequently determine whether exposure to risk factor affects an outcome over time.
• Case-Control Study : A retrospective observational study that compares two existing groups—the case group with the condition and the control group without it. Researchers compare the groups looking for potential risk factors for the condition.
• Cross-Sectional Study : Takes a snapshot of a moment in time so researchers can understand the prevalence of outcomes and correlations between variables at that instant.

Qualitative research studies are usually observational in nature, but they collect non-numeric data and do not perform statistical analyses.

Retrospective studies must be observational.

Later in this post, we’ll closely examine a quantitative observational study example that assesses vitamin supplement consumption and how that affects the risk of death. It’s possible to use random assignment to place each subject in either the vitamin treatment group or the control group. However, the study assesses vitamin consumption in 40,000 participants over the course of two decades. It’s unrealistic to enforce the treatment and control protocols over such a long time for so many people!

Drawbacks of Observational Studies

While observational studies get around the inability to assign subjects randomly, this approach opens the door to the problem of confounding variables. A confounding variable, or confounder, correlates with both the experimental groups and the outcome variable. Because there is no random process that equalizes the experimental groups in an observational study, confounding variables can systematically differ between groups when the study begins. Consequently, confounders can be the actual cause for differences in outcome at the end of the study rather than the primary variable of interest. If an experiment does not account for confounding variables, confounders can bias the results and create spurious correlations .

Performing an observational study can decrease the internal validity of your study but increase the external validity. Learn more about internal and external validity .

Let’s see how this works. Imagine an observational study that compares people who take vitamin supplements to those who do not. People who use vitamin supplements voluntarily will tend to have other healthy habits that exist at the beginning of the study. These healthy habits are confounding variables. If there are differences in health outcomes at the end of the study, it’s possible that these healthy habits actually caused them rather than the vitamin consumption itself. In short, confounders confuse the results because they provide alternative explanations for the differences.

Despite the limitations, an observational study can be a valid approach. However, you must ensure that your research accounts for confounding variables. Fortunately, there are several methods for doing just that!

Learn more about Correlation vs. Causation: Understanding the Differences .

Accounting for Confounding Variables in an Observational Study

Because observational studies don’t use random assignment, confounders can be distributed disproportionately between conditions. Consequently, experimenters need to know which variables are confounders, measure them, and then use a method to account for them. It involves more work, and the additional measurements can increase the costs. And there’s always a chance that researchers will fail to identify a confounder, not account for it, and produce biased results. However, if randomization isn’t an option, then you probably need to consider an observational study.

Trait matching and statistically controlling confounders using multivariate procedures are two standard approaches for incorporating confounding variables.

Related post : Causation versus Correlation in Statistics

Matching in Observational Studies

Matching is a technique that involves selecting study participants with similar characteristics outside the variable of interest or treatment. Rather than using random assignment to equalize the experimental groups, the experimenters do it by matching observable characteristics. For every participant in the treatment group, the researchers find a participant with comparable traits to include in the control group. Matching subjects facilitates valid comparisons between those groups. The researchers use subject-area knowledge to identify characteristics that are critical to match.

For example, a vitamin supplement study using matching will select subjects who have similar health-related habits and attributes. The goal is that vitamin consumption will be the primary difference between the groups, which helps you attribute differences in health outcomes to vitamin consumption. However, the researchers are still observing participants who decide whether they consume supplements.

Matching has some drawbacks. The experimenters might not be aware of all the relevant characteristics they need to match. In other words, the groups might be different in an essential aspect that the researchers don’t recognize. For example, in the hypothetical vitamin study, there might be a healthy habit or attribute that affects the outcome that the researchers don’t measure and match. These unmatched characteristics might cause the observed differences in outcomes rather than vitamin consumption.

Learn more about Matched Pairs Design: Uses & Examples .

Using Multiple Regression in Observational Studies

Random assignment and matching use different methods to equalize the experimental groups in an observational study. However, statistical techniques, such as multiple regression analysis , don’t try to equalize the groups but instead use a model that accounts for confounding variables. These studies statistically control for confounding variables.

In multiple regression analysis, including a variable in the model holds it constant while you vary the variable/treatment of interest. For information about this property, read my post When Should I Use Regression Analysis?

As with matching, the challenge is to identify, measure, and include all confounders in the regression model. Failure to include a confounding variable in a regression model can cause omitted variable bias to distort your results.

Next, we’ll look at a published observational study that uses multiple regression to account for confounding variables.

Related post : Independent and Dependent Variables in a Regression Model

Vitamin Supplement Observational Study Example

Murso et al. (2011)* use a longitudinal observational study that ran 22 years to assess differences in death rates for subjects who used vitamin supplements regularly compared to those who did not use them. This study used surveys to record the characteristics of approximately 40,000 participants. The surveys asked questions about potential confounding variables such as demographic information, food intake, health details, physical activity, and, of course, supplement intake.

Because this is an observational study, the subjects decided for themselves whether they were taking vitamin supplements. Consequently, it’s safe to assume that supplement users and non-users might be different in other ways. From their article, the researchers found the following pre-existing differences between the two groups:

Supplement users had a lower prevalence of diabetes mellitus, high blood pressure, and smoking status; a lower BMI and waist to hip ratio, and were less likely to live on a farm. Supplement users had a higher educational level, were more physically active and were more likely to use estrogen replacement therapy. Also, supplement users were more likely to have a lower intake of energy, total fat, and monounsaturated fatty acids, saturated fatty acids and to have a higher intake of protein, carbohydrates, polyunsaturated fatty acids, alcohol, whole grain products, fruits, and vegetables.

Whew! That’s a long list of differences! Supplement users were different from non-users in a multitude of ways that are likely to affect their risk of dying. The researchers must account for these confounding variables when they compare supplement users to non-users. If they do not, their results can be biased.

This example illustrates a key difference between an observational study vs experiment. In a randomized experiment, the randomization would have equalized the characteristics of those the researchers assigned to the treatment and control groups. Instead, the study works with self-sorted groups that have numerous pre-existing differences!

Using Multiple Regression to Statistically Control for Confounders

To account for these initial differences in the vitamin supplement observational study, the researchers use regression analysis and include the confounding variables in the model.

The researchers present three regression models. The simplest model accounts only for age and caloric intake. Next, are two models that include additional confounding variables beyond age and calories. The first model adds various demographic information and seven health measures. The second model includes everything in the previous model and adds several more specific dietary intake measures. Using statistical significance as a guide for specifying the correct regression model , the researchers present the model with the most variables as the basis for their final results.

It’s instructive to compare the raw results and the final regression results.

Raw results

The raw differences in death risks for consumers of folic acid, vitamin B6, magnesium, zinc, copper, and multivitamins are NOT statistically significant. However, the raw results show a significant reduction in the death risk for users of B complex, C, calcium, D, and E.

However, those are the raw results for the observational study, and they do not control for the long list of differences between the groups that exist at the beginning of the study. After using the regression model to control for the confounding variables statistically, the results change dramatically.

Adjusted results

Of the 15 supplements that the study tracked in the observational study, researchers found consuming seven of these supplements were linked to a statistically significant INCREASE in death risk ( p-value < 0.05): multivitamins (increase in death risk 2.4%), vitamin B6 (4.1%), iron (3.9%), folic acid (5.9%), zinc (3.0%), magnesium (3.6%), and copper (18.0%). Only calcium was associated with a statistically significant reduction in death risk of 3.8%.

In short, the raw results suggest that those who consume supplements either have the same or lower death risks than non-consumers. However, these results do not account for the multitude of healthier habits and attributes in the group that uses supplements.

In fact, these confounders seem to produce most of the apparent benefits in the raw results because, after you statistically control the effects of these confounding variables, the results worsen for those who consume vitamin supplements. The adjusted results indicate that most vitamin supplements actually increase your death risk!

This research illustrates the differences between an observational study vs experiment. Namely how the pre-existing differences between the groups allow confounders to bias the raw results, making the vitamin consumption outcomes look better than they really are.

In conclusion, if you can’t randomly assign subjects to the experimental groups, an observational study might be right for you. However, be aware that you’ll need to identify, measure, and account for confounding variables in your experimental design.

Jaakko Mursu, PhD; Kim Robien, PhD; Lisa J. Harnack, DrPH, MPH; Kyong Park, PhD; David R. Jacobs Jr, PhD; Dietary Supplements and Mortality Rate in Older Women: The Iowa Women’s Health Study ; Arch Intern Med . 2011;171(18):1625-1633.

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Reader Interactions

December 30, 2023 at 5:05 am

I see, but our professor required us to indicate what year it was put into the article. May you tell me what year was this published originally? <3

December 30, 2023 at 3:40 pm

December 29, 2023 at 10:46 am

Hi, may I use your article as a citation for my thesis paper? If so, may I know the exact date you published this article? Thank you!

December 29, 2023 at 2:13 pm

Definitely feel free to cite this article! 🙂

When citing online resources, you typically use an “Accessed” date rather than a publication date because online content can change over time. For more information, read Purdue University’s Citing Electronic Resources .

November 18, 2021 at 10:09 pm

Love your content and has been very helpful!

Can you please advise the question below using an observational data set:

I have three years of observational GPS data collected on athletes (2019/2020/2021). Approximately 14-15 athletes per game and 8 games per year. The GPS software outputs 50+ variables for each athlete in each game, which we have narrowed down to 16 variables of interest from previous research.

2 factors 1) Period (first half, second half, and whole game), 2) Position (two groups with three subgroups in each – forwards (group 1, group 2, group 3) and backs (group 1, group 2, group 3))

16 variables of interest – all numerical and scale variables. Some of these are correlated, but not all.

My understanding is that I can use a oneway ANOVA for each year on it’s own, using one factor at a time (period or position) with post hoc analysis. This is fine, if data meets assumptions and is normally distributed. This tells me any significant interactions between variables of interest with chosen factor. For example, with position factor, do forwards in group 1 cover more total running distance than forwards in group 2 or backs in group 3.

However, I want to go deeper with my analysis. If I want to see if forwards in group 1 cover more total running distance in period 1 than backs in group 3 in the same period, I need an additional factor and the oneway ANOVA does not suit. Therefore I can use a twoway ANOVA instead of 2 oneway ANOVA’s and that solves the issue, correct?

This is complicated further by looking to compare 2019 to 2020 or 2019 to 2021 to identify changes over time, which would introduce a third independent variable.

I believe this would require a threeway ANOVA for this observational data set. 3 factors – Position, Period, and Year?

Are there any issues or concerns you see at first glance?

I appreciate your time and consideration.

April 12, 2021 at 2:02 pm

Could an observational study use a correlational design.

e.g. measuring effects of two variables on happiness, if you’re not intervening.

April 13, 2021 at 12:14 am

Typically, with observational studies, you’d want to include potential confounders, etc. Consequently, I’ve seen regression analysis used more frequently for observational studies to be able to control for other things because you’re not using randomization. You could use correlation to observe the relationship. However, you wouldn’t be controlling for potential confounding variables. Just something to consider.

April 11, 2021 at 1:28 pm

Hi, If I am to administer moderate doses of coffee for a hypothetical experiment, does it raise ethical concerns? Can I use random assignment for it?

April 11, 2021 at 4:06 pm

I don’t see any inherent ethical problems here as long as you describe the participant’s experience in the experiment including the coffee consumption. They key with human subjects is “informed consent.” They’re agreeing to participate based on a full and accurate understanding of what participation involves. Additionally, you as a researcher, understand the process well enough to be able to ensure their safety.

In your study, as long as subject know they’ll be drinking coffee and agree to that, I don’t see a problem. It’s a proven safe substance for the vast majority of people. If potential subjects are aware of the need to consume coffee, they can determine whether they are ok with that before agreeing to participate.

June 17, 2019 at 4:51 am

Really great article which explains observational and experimental study very well. It presents broad picture with the case study which helped a lot in understanding the core concepts. Thanks

Comments and Questions Cancel reply

Introduction to Data Science I & II

Observational versus experimental studies, observational versus experimental studies #.

In most research questions or investigations, we are interested in finding an association that is causal (the first scenario in the previous section ). For example, “Is the COVID-19 vaccine effective?” is a causal question. The researcher is looking for an association between receiving the COVID-19 vaccine and contracting (symptomatic) COVID-19, but more specifically wants to show that the vaccine causes a reduction in COVID-19 infections (Baden et al., 2020) 1 .

Experimental Studies #

There are 3 necessary conditions for showing that a variable X (for example, vaccine) causes an outcome Y (such as not catching COVID-19):

Temporal Precedence : We must show that X (the cause) happened before Y (the effect).

Non-spuriousness : We must show that the effect Y was not seen by chance.

No alternate cause : We must show that no other variable accounts for the relationship between X and Y .

If any of the three is not present, the association cannot be causal. If the proposed cause did not happen before the effect, it cannot have caused the effect. In addition, if the effect was seen by chance and cannot be replicated, the association is spurious and therefore not causal. Lastly, if there is another phenomenon that accounts for the association seen, then it cannot be a causal association. These conditions are therefore, necessary to show causality.

The best way to show all three necessary conditions is by conducting an experiment . Experiments involve controllable factors which are measured and determined by the experimenter, uncontrollable factors which are measured but not determined by the experimentor, and experimental variability or noise which is unmeasured and uncontrolled. Controllable factors that the experimenter manipulates in his or her experiment are known as independent variables . In our vaccination example, the independent variable is receipt of vaccine. Uncontrollable factors that are hypothesized to depend on the independent variable are known as dependent variables. The dependent variable in the vaccination example is contraction of COVID-19. The experimentor cannot control whether participants catch the disease, but can measure it, and it is hypothesized that catching the disease is dependent on vaccination status.

Control Groups #

When conducting an experiment, it is important to have a comparison or control group . The control group is used to better understand the effect of the independent variable. For example, if all patients are given the vaccine, it would be impossible to measure whether the vaccine is effective as we would not know the outcome if patients had not received the vaccine. In order to measure the effect of the vaccine, the researcher must compare patients who did not receive the vaccine to patients that did receive the vaccine. This comparison group of patients who did not receive the vaccine is the control group for the experiment. The control group allows the researcher to view an effect or association. When scientists say that the COVID-19 vaccine is 94% effective, this does not mean that only 6% of people who got the vaccine in their study caught COVID-19 (the number is actually much lower!). That would not take into account the rate of catching COVID-19 for those without a vaccine. Rather, 94% effective refers to having 94% lower incidence of infection compared to the control group.

Let’s illustrate this using data from the efficacy trial by Baden and colleagues in 2020. In their primary analysis, 14,073 participants were in the placebo group and 14,134 in the vaccine group. Of these participants, a total of 196 were diagnosed with COVID-19 during the 78 day follow-up period: 11 in the vaccine group and 186 in the placebo group. This means, 0.08% of those in the vaccine group and 1.32% of those in the placebo group were diagnosed with COVID-19. Dividing 0.08 by 1.32, we see that the proportion of cases in the vaccine group was only 6% of the proportion of cases in the placebo group. Therefore, the vaccine is 94% effective.

Chicago has a population of almost 3,000,000. Extrapolating using the numbers from above, without the vaccine, 39,600 people would be expected to catch COVID-19 in the period between 14 and 92 days after their second vaccine. If everyone were vaccinated, the expected number would drop to 2,400. This is a large reduction! However, it is important that the researcher shows this effect is non-spurious and therefore important and significant. One way to do this is through replication : applying a treatment independently across two or more experimental subjects. In our example, researchers conducted many similar experiments for multiple groups of patients to show that the effect can be seen reliably.

Randomization #

A researcher must also be able to show there is no alternate cause for the association in order to prove causality. This can be done through randomization : random assignment of treatment to experimental subjects. Consider a group of patients where all male patients are given the treatment and all female patients are in the control group. If an association is found, it would be unclear whether this association is due to the treatment or the fact that the groups were of differing sex. By randomizing experimental subjects to groups, researchers ensure there is no systematic difference between groups other than the treatment and therefore no alternate cause for the relationship between treatment and outcome.

Another way of ensuring there is no alternate cause is by blocking : grouping similar experimental units together and assigning different treatments within such groups. Blocking is a way of dealing with sources of variability that are not of primary interest to the experimenter. For example, a researcher may block on sex by grouping males together and females together and assigning treatments and controls within the different groups. Best practices are to block the largest and most salient sources of variability and randomize what is difficult or impossible to block. In our example blocking would account for variability introduced by sex whereas randomization would account for factors of variability such as age or medical history which are more difficult to block.

Observational Studies #

Randomized experiments are considered the “Gold Standard” for showing a causal relationship. However, it is not always ethical or feasible to conduct a randomized experiment. Consider the following research question: Does living in Northern Chicago increase life expectancy? It would be infeasible to conduct an experiment which randomly allocates people to live in different parts of the city. Therefore, we must turn to observational data to test this question. Where experiments involve one or more variables controlled by the experimentor (dose of a drug for example), in observational studies there is no effort or intention to manipulate or control the object of study. Rather, researchers collect data without interfering with the subjects. For example, researchers may conduct a survey gathering both health and neighborhood data, or they may have access to administrative data from a local hospital. In these cases, the researchers are merely observing variables and outcomes.

There are two types of observational studies: retrospective studies and prospective studies. In a retrospective study , data is collected after events have taken place. This may be through surveys, historical data, or administrative records. An example of a retrospective study would be using administrative data from a hospital to study incidence of disease. In contrast, a prospective study identifies subjects beforehand and collects data as events unfold. For example, one might use a prospective study to evaluate how personality traits develop in children, by following a predetermined set of children through elementary school and giving them personality assessments each year.

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. New England journal of medicine. 2020 Dec 30.

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3.4 - experimental and observational studies.

Now that Jaylen can weigh the different sampling strategies, he might want to consider the type of study he is conduction. As a note, for students interested in research designs, please consult STAT 503 for a much more in-depth discussion. However, for this example, we will simply distinguish between experimental and observational studies.

Now that we know how to collect data, the next step is to determine the type of study. The type of study will determine what type of relationship we can conclude.

There are predominantly two different types of studies: 

Let's say that there is an option to take quizzes throughout this class. In an  observational study , we may find that better students tend to take the quizzes and do better on exams. Consequently, we might conclude that there may be a relationship between quizzes and exam scores.

In an experimental study , we would randomly assign quizzes to specific students to look for improvements. In other words, we would look to see whether taking quizzes causes higher exam scores.

Causation Section  

It is very important to distinguish between observational and experimental studies since one has to be very skeptical about drawing cause and effect conclusions using observational studies. The use of random assignment of treatments (i.e. what distinguishes an experimental study from an observational study) allows one to employ cause and effect conclusions.

Ethics is an important aspect of experimental design to keep in mind. For example, the original relationship between smoking and lung cancer was based on an observational study and not an assignment of smoking behavior.

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An introduction to different types of study design

Posted on 6th April 2021 by Hadi Abbas

Study designs are the set of methods and procedures used to collect and analyze data in a study.

Broadly speaking, there are 2 types of study designs: descriptive studies and analytical studies.

Descriptive studies

• Describes specific characteristics in a population of interest
• The most common forms are case reports and case series
• In a case report, we discuss our experience with the patient’s symptoms, signs, diagnosis, and treatment
• In a case series, several patients with similar experiences are grouped.

Analytical Studies

Analytical studies are of 2 types: observational and experimental.

Observational studies are studies that we conduct without any intervention or experiment. In those studies, we purely observe the outcomes.  On the other hand, in experimental studies, we conduct experiments and interventions.

Observational studies

Observational studies include many subtypes. Below, I will discuss the most common designs.

Cross-sectional study:

• This design is transverse where we take a specific sample at a specific time without any follow-up
• It allows us to calculate the frequency of disease ( p revalence ) or the frequency of a risk factor
• This design is easy to conduct
• For example – if we want to know the prevalence of migraine in a population, we can conduct a cross-sectional study whereby we take a sample from the population and calculate the number of patients with migraine headaches.

Cohort study:

• We conduct this study by comparing two samples from the population: one sample with a risk factor while the other lacks this risk factor
• It shows us the risk of developing the disease in individuals with the risk factor compared to those without the risk factor ( RR = relative risk )
• Prospective : we follow the individuals in the future to know who will develop the disease
• Retrospective : we look to the past to know who developed the disease (e.g. using medical records)
• This design is the strongest among the observational studies
• For example – to find out the relative risk of developing chronic obstructive pulmonary disease (COPD) among smokers, we take a sample including smokers and non-smokers. Then, we calculate the number of individuals with COPD among both.

Case-Control Study:

• We conduct this study by comparing 2 groups: one group with the disease (cases) and another group without the disease (controls)
• This design is always retrospective
•  We aim to find out the odds of having a risk factor or an exposure if an individual has a specific disease (Odds ratio)
•  Relatively easy to conduct
• For example – we want to study the odds of being a smoker among hypertensive patients compared to normotensive ones. To do so, we choose a group of patients diagnosed with hypertension and another group that serves as the control (normal blood pressure). Then we study their smoking history to find out if there is a correlation.

Experimental Studies

• Also known as interventional studies
• Can involve animals and humans
• Pre-clinical trials involve animals
• Clinical trials are experimental studies involving humans
• In clinical trials, we study the effect of an intervention compared to another intervention or placebo. As an example, I have listed the four phases of a drug trial:

I:  We aim to assess the safety of the drug ( is it safe ? )

II: We aim to assess the efficacy of the drug ( does it work ? )

III: We want to know if this drug is better than the old treatment ( is it better ? )

IV: We follow-up to detect long-term side effects ( can it stay in the market ? )

• In randomized controlled trials, one group of participants receives the control, while the other receives the tested drug/intervention. Those studies are the best way to evaluate the efficacy of a treatment.

Finally, the figure below will help you with your understanding of different types of study designs.

References (pdf)

You may also be interested in the following blogs for further reading:

An introduction to randomized controlled trials

Case-control and cohort studies: a brief overview

Cohort studies: prospective and retrospective designs

Prevalence vs Incidence: what is the difference?

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you are amazing one!! if I get you I’m working with you! I’m student from Ethiopian higher education. health sciences student

Very informative and easy understandable

You are my kind of doctor. Do not lose sight of your objective.

Wow very erll explained and easy to understand

I’m Khamisu Habibu community health officer student from Abubakar Tafawa Balewa university teaching hospital Bauchi, Nigeria, I really appreciate your write up and you have make it clear for the learner. thank you

well understood,thank you so much

Well understood…thanks

Simply explained. Thank You.

Thanks a lot for this nice informative article which help me to understand different study designs that I felt difficult before

That’s lovely to hear, Mona, thank you for letting the author know how useful this was. If there are any other particular topics you think would be useful to you, and are not already on the website, please do let us know.

it is very informative and useful.

thank you statistician

Fabulous to hear, thank you John.

Thanks for this information

Thanks so much for this information….I have clearly known the types of study design Thanks

That’s so good to hear, Mirembe, thank you for letting the author know.

Very helpful article!! U have simplified everything for easy understanding

I’m a health science major currently taking statistics for health care workers…this is a challenging class…thanks for the simified feedback.

That’s good to hear this has helped you. Hopefully you will find some of the other blogs useful too. If you see any topics that are missing from the website, please do let us know!

Hello. I liked your presentation, the fact that you ranked them clearly is very helpful to understand for people like me who is a novelist researcher. However, I was expecting to read much more about the Experimental studies. So please direct me if you already have or will one day. Thank you

Dear Ay. My sincere apologies for not responding to your comment sooner. You may find it useful to filter the blogs by the topic of ‘Study design and research methods’ – here is a link to that filter: https://s4be.cochrane.org/blog/topic/study-design/ This will cover more detail about experimental studies. Or have a look on our library page for further resources there – you’ll find that on the ‘Resources’ drop down from the home page.

However, if there are specific things you feel you would like to learn about experimental studies, that are missing from the website, it would be great if you could let me know too. Thank you, and best of luck. Emma

Great job Mr Hadi. I advise you to prepare and study for the Australian Medical Board Exams as soon as you finish your undergrad study in Lebanon. Good luck and hope we can meet sometime in the future. Regards ;)

You have give a good explaination of what am looking for. However, references am not sure of where to get them from.

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10 Observational Research Examples

Dave Cornell (PhD)

Dr. Cornell has worked in education for more than 20 years. His work has involved designing teacher certification for Trinity College in London and in-service training for state governments in the United States. He has trained kindergarten teachers in 8 countries and helped businessmen and women open baby centers and kindergartens in 3 countries.

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Observational research involves observing the actions of people or animals, usually in their natural environments.

For example, Jane Goodall famously observed chimpanzees in the wild and reported on their group behaviors. Similarly, many educational researchers will conduct observations in classrooms to gain insights into how children learn.

Examples of Observational Research

1. jane goodall’s research.

Jane Goodall is famous for her discovery that chimpanzees use tools. It is one of the most remarkable findings in psychology and anthropology .

Her primary method of study involved simply entering the natural habitat of her research subjects, sitting down with pencil and paper, and making detailed notes of what she observed.

Those observations were later organized and transformed into research papers that provided the world with amazing insights into animal behavior.

When she first discovered that chimpanzees use twigs to “fish” for termites, it was absolutely stunning. The renowned Louis Leakey proclaimed: “we must now redefine tool, redefine man, or accept chimps as humans.”

2. Linguistic Development of Children

Answering a question like, “how do children learn to speak,” can only be answered by observing young children at home.

By the time kids get to first grade, their language skills have already become well-developed, with a vocabulary of thousands of words and the ability to use relatively complex sentences.

Therefore, a researcher has to conduct their study in the child’s home environment. This typically involves having a trained data collector sit in a corner of a room and take detailed notes about what and how parents speak to their child.

Those observations are later classified in a way that they can be converted into quantifiable measures for statistical analysis.

For example, the data might be coded in terms of how many words the parents spoke, degree of sentence complexity, or emotional dynamic of being encouraging or critical. When the data is analyzed, it might reveal how patterns of parental comments are linked to the child’s level of linguistic development.

Related Article: 15 Action Research Examples

3. Consumer Product Design  

Before Apple releases a new product to the market, they conduct extensive analyses of how the product will be perceived and used by consumers.

The company wants to know what kind of experience the consumer will have when using the product. Is the interface user-friendly and smooth? Does it fit comfortably in a person’s hand?

Is the overall experience pleasant?

So, the company will arrange for groups of prospective customers come to the lab and simply use the next iteration of one of their great products. That lab will absolutely contain a two-way mirror and a team of trained observers sitting behind it, taking detailed notes of what the test groups are doing. The groups might even be video recorded so their behavior can be observed again and again.

That will be followed by a focus group discussion , maybe a survey or two, and possibly some one-on-one interviews.  

4. Satellite Images of Walmart

Observational research can even make some people millions of dollars. For example, a report by NPR describes how stock market analysts observe Walmart parking lots to predict the company’s earnings.

The analysts purchase satellite images of selected parking lots across the country, maybe even worldwide. That data is combined with what they know about customer purchasing habits, broken down by time of day and geographic region.

Over time, a detailed set of calculations are performed that allows the analysts to predict the company’s earnings with a remarkable degree of accuracy .

This kind of observational research can result in substantial profits.

5. Spying on Farms

Similar to the example above, observational research can also be implemented to study agriculture and farming.

By using infrared imaging software from satellites, some companies can observe crops across the globe. The images provide measures of chlorophyll absorption and moisture content, which can then be used to predict yields. Those images also allow analysts to simply count the number of acres being planted for specific crops across the globe.

In commodities such as wheat and corn, that prediction can lead to huge profits in the futures markets.

It’s an interesting application of observational research with serious monetary implications.

6. Decision-making Group Dynamics  

When large corporations make big decisions, it can have serious consequences to the company’s profitability, or even survival.

Therefore, having a deep understanding of decision-making processes is essential. Although most of us think that we are quite rational in how we process information and formulate a solution, as it turns out, that’s not entirely true.

Decades of psychological research has focused on the function of statements that people make to each other during meetings. For example, there are task-masters, harmonizers, jokers, and others that are not involved at all.

A typical study involves having professional, trained observers watch a meeting transpire, either from a two-way mirror, by sitting-in on the meeting at the side, or observing through CCTV.

By tracking who says what to whom, and the type of statements being made, researchers can identify weaknesses and inefficiencies in how a particular group engages the decision-making process.

See More: Decision-Making Examples

7. Case Studies

A case study is an in-depth examination of one particular person. It is a form of observational research that involves the researcher spending a great deal of time with a single individual to gain a very detailed understanding of their behavior.

The researcher may take extensive notes, conduct interviews with the individual, or take video recordings of behavior for further study.

Case studies give a level of detailed information that is not available when studying large groups of people. That level of detail can often provide insights into a phenomenon that could lead to the development of a new theory or help a researcher identify new areas of research.

Researchers sometimes have no choice but to conduct a case study in situations in which the phenomenon under study is “rare and unusual” (Lee & Saunders, 2017). Because the condition is so uncommon, it is impossible to find a large enough sample of cases to study with quantitative methods.

Go Deeper: Pros and Cons of Case Study Research

8. Infant Attachment

One of the first studies on infant attachment utilized an observational research methodology . Mary Ainsworth went to Uganda in 1954 to study maternal practices and mother/infant bonding.  

Ainsworth visited the homes of 26 families on a bi-monthly basis for 2 years, taking detailed notes and interviewing the mothers regarding their parenting practices.

Her notes were then turned into academic papers and formed the basis for the Strange Situations test that she developed for the laboratory setting.

The Strange Situations test consists of 8 situations, each one lasting no more than a few minutes. Trained observers are stationed behind a two-way mirror and have been trained to make systematic observations of the baby’s actions in each situation.

9. Ethnographic Research  

Ethnography is a type of observational research where the researcher becomes part of a particular group or society.

The researcher’s role as data collector is hidden and they attempt to immerse themselves in the community as a regular member of the group.

By being a part of the group and keeping one’s purpose hidden, the researcher can observe the natural behavior of the members up-close. The group will behave as they would naturally and treat the researcher as if they were just another member. This can lead to insights into the group dynamics , beliefs, customs and rituals that could never be studied otherwise.

10. Time and Motion Studies

Time and motion studies involve observing work processes in the work environment. The goal is to make procedures more efficient, which can involve reducing the number of movements needed to complete a task.

Reducing the movements necessary to complete a task increases efficiency, and therefore improves productivity. A time and motion study can also identify safety issues that may cause harm to workers, and thereby help create a safer work environment.

The two most famous early pioneers of this type of observational research are Frank and Lillian Gilbreth.  

Lilian was a psychologist that began to study the bricklayers of her husband Frank’s construction company. Together, they figured out a way to reduce the number of movements needed to lay bricks from 18 to 4 (see original video footage here ).

The couple became quite famous for their work during the industrial revolution and

Lillian became the only psychologist to appear on a postage stamp (in 1884).

Why do Observational Research?

Psychologists and anthropologists employ this methodology because:

• Psychologists find that studying people in a laboratory setting is very artificial. People often change their behavior if they know it is going to be analyzed by a psychologist later.
• Anthropologists often study unique cultures and indigenous peoples that have little contact with modern society. They often live in remote regions of the world, so, observing their behavior in a natural setting may be the only option.
• In animal studies , there are lots of interesting phenomenon that simply cannot be observed in a laboratory, such as foraging behavior or mate selection. Therefore, observational research is the best and only option available.

Read Also: Difference Between Observation and Inference

Observational research is an incredibly useful way to collect data on a phenomenon that simply can’t be observed in a lab setting. This can provide insights into human behavior that could never be revealed in an experiment (see: experimental vs observational research ).

Researchers employ observational research methodologies when they travel to remote regions of the world to study indigenous people, try to understand how parental interactions affect a child’s language development, or how animals survive in their natural habitats.

On the business side, observational research is used to understand how products are perceived by customers, how groups make important decisions that affect profits, or make economic predictions that can lead to huge monetary gains.

Ainsworth, M. D. S. (1967). Infancy in Uganda . Baltimore: Johns Hopkins University Press.

Ainsworth, M. D. S., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment: A

psychological study of the Strange Situation. Hillsdale: Erlbaum.

Crowe, S., Cresswell, K., Robertson, A., Huby, G., Avery, A., & Sheikh, A. (2011). The case study approach. BMC Medical Research Methodology , 11 , 100. https://doi.org/10.1186/1471-2288-11-100

d’Apice, K., Latham, R., & Stumm, S. (2019). A naturalistic home observational approach to children’s language, cognition, and behavior. Developmental Psychology, 55 (7),1414-1427. https://doi.org/10.1037/dev0000733

Lee, B., & Saunders, M. N. K. (2017).  Conducting Case Study Research for Business and Management Students.  SAGE Publications.

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Observational and interventional study design types; an overview

The appropriate choice in study design is essential for the successful execution of biomedical and public health research. There are many study designs to choose from within two broad categories of observational and interventional studies. Each design has its own strengths and weaknesses, and the need to understand these limitations is necessary to arrive at correct study conclusions.

Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods. Observational study designs include ecological designs, cross sectional, case-control, case-crossover, retrospective and prospective cohorts. An important subset of observational studies is diagnostic study designs, which evaluate the accuracy of diagnostic procedures and tests as compared to other diagnostic measures. These include diagnostic accuracy designs, diagnostic cohort designs, and diagnostic randomized controlled trials.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease. Each study design has specific outcome measures that rely on the type and quality of data utilized. Additionally, each study design has potential limitations that are more severe and need to be addressed in the design phase of the study. This manuscript is meant to provide an overview of study design types, strengths and weaknesses of common observational and interventional study designs.

Introduction

Study design plays an important role in the quality, execution, and interpretation of biomedical and public health research ( 1 – 12 ). Each study design has their own inherent strengths and weaknesses, and there can be a general hierarchy in study designs, however, any hierarchy cannot be applied uniformly across study design types ( 3 , 5 , 6 , 9 ). Epidemiological and interventional research studies include three elements; 1) definition and measure of exposure in two or more groups, 2) measure of health outcome(s) in these same groups, and 3) statistical comparison made between groups to assess potential relationships between the exposure and outcome, all of which are defined by the researcher ( 1 – 4 , 8 , 13 ). The measure of exposure in epidemiologic studies may be tobacco use (“Yes” vs . “No”) to define the two groups and may be the treatment (Active drug vs . placebo) in interventional studies. Health outcome(s) can be the development of a disease or symptom (e.g. lung cancer) or curing a disease or symptom (e.g. reduction of pain). Descriptive studies, which are not epidemiological or interventional, lack one or more of these elements and have limited application. High quality epidemiological and interventional studies contain detailed information on the design, execution and interpretation of results, with methodology clearly written and able to be reproduced by other researchers.

Research is generally considered as primary or secondary research. Primary research relies upon data gathered from original research expressly for that purpose ( 1 , 3 , 5 ). Secondary research focuses on single or multiple data sources that are not collected for a single research purpose ( 14 , 15 ). Secondary research includes meta-analyses and best practice guidelines for treatments. This paper will focus on the study designs and their strengths, weaknesses, and common statistical outcomes of primary research.

The choice of a study design hinges on many factors, including prior research, availability of study participants, funding, and time constraints. One common decision point is the desire to suggest causation. The most common causation criteria are proposed by Hill ( 16 ). Of these, demonstrating temporality is the only mandatory criterion for suggesting temporality. Therefore, prospective studies that follow study participants forward through time, including prospective cohort studies and interventional studies, are best suited for suggesting causation. Causal conclusions cannot be proven from an observational study. Additionally, causation between an exposure and an outcome cannot be proven by one study alone; multiple studies across different populations should be considered when making causation assessments ( 17 ).

Primary research has been categorized in different ways. Common categorization schema include temporal nature of the study design (retrospective or prospective), usability of the study results (basic or applied), investigative purpose (descriptive or analytical), purpose (prevention, diagnosis or treatment), or role of the investigator (observational or interventional). This manuscript categorizes study designs by observational and interventional criteria, however, other categorization methods are described as well.

Observational and interventional studies

Within primary research there are observational studies and interventional studies. Observational studies, also called epidemiological studies, are those where the investigator is not acting upon study participants, but instead observing natural relationships between factors and outcomes. Diagnostic studies are classified as observational studies, but are a unique category and will be discussed independently. Interventional studies, also called experimental studies, are those where the researcher intercedes as part of the study design. Additionally, study designs may be classified by the role that time plays in the data collection, either retrospective or prospective. Retrospective studies are those where data are collected from the past, either through records created at that time or by asking participants to remember their exposures or outcomes. Retrospective studies cannot demonstrate temporality as easily and are more prone to different biases, particularly recall bias. Prospective studies follow participants forward through time, collecting data in the process. Prospective studies are less prone to some types of bias and can more easily demonstrate that the exposure preceded the disease, thereby more strongly suggesting causation. Table 1 describes the broad categories of observational studies: the disease measures applicable to each, the appropriate measures of risk, and temporality of each study design. Epidemiologic measures include point prevalence, the proportion of participants with disease at a given point in time, period prevalence, the proportion of participants with disease within a specified time frame, and incidence, the accumulation of new cases over time. Measures of risk are generally categorized into two categories: those that only demonstrate an association, such as an odds ratio (and some other measures), and those that demonstrate temporality and therefore suggest causation, such as hazard ratio. Table 2 outlines the strengths and weaknesses of each observational study design.

Observational study design measures of disease, measures of risk, and temporality.

Observational study design strengths and weaknesses.

Observational studies

Ecological study design.

The most basic observational study is an ecological study. This study design compares clusters of people, usually grouped based on their geographical location or temporal associations ( 1 , 2 , 6 , 9 ). Ecological studies assign one exposure level for each distinct group and can provide a rough estimation of prevalence of disease within a population. Ecological studies are generally retrospective. An example of an ecological study is the comparison of the prevalence of obesity in the United States and France. The geographic area is considered the exposure and the outcome is obesity. There are inherent potential weaknesses with this approach, including loss of data resolution and potential misclassification ( 10 , 11 , 13 , 18 , 19 ). This type of study design also has additional weaknesses. Typically these studies derive their data from large databases that are created for purposes other than research, which may introduce error or misclassification ( 10 , 11 ). Quantification of both the number of cases and the total population can be difficult, leading to error or bias. Lastly, due to the limited amount of data available, it is difficult to control for other factors that may mask or falsely suggest a relationship between the exposure and the outcome. However, ecological studies are generally very cost effective and are a starting point for hypothesis generation.

Proportional mortality ratio study design

Proportional mortality ratio studies (PMR) utilize the defined well recorded outcome of death and subsequent records that are maintained regarding the decedent ( 1 , 6 , 8 , 20 ). By using records, this study design is able to identify potential relationships between exposures, such as geographic location, occupation, or age and cause of death. The epidemiological outcomes of this study design are proportional mortality ratio and standardized mortality ratio. In general these are the ratio of the proportion of cause-specific deaths out of all deaths between exposure categories ( 20 ). As an example, these studies can address questions about higher proportion of cardiovascular deaths among different ethnic and racial groups ( 21 ). A significant drawback to the PMR study design is that these studies are limited to death as an outcome ( 3 , 5 , 22 ). Additionally, the reliance on death records makes it difficult to control for individual confounding factors, variables that either conceal or falsely demonstrate associations between the exposure and outcome. An example of a confounder is tobacco use confounding the relationship between coffee intake and cardiovascular disease. Historically people often smoked and drank coffee while on coffee breaks. If researchers ignore smoking they would inaccurately find a strong relationship between coffee use and cardiovascular disease, where some of the risk is actually due to smoking. There are also concerns regarding the accuracy of death certificate data. Strengths of the study design include the well-defined outcome of death, the relative ease and low cost of obtaining data, and the uniformity of collection of these data across different geographical areas.

Cross-sectional study design

Cross-sectional studies are also called prevalence studies because one of the main measures available is study population prevalence ( 1 – 12 ). These studies consist of assessing a population, as represented by the study sample, at a single point in time. A common cross-sectional study type is the diagnostic accuracy study, which is discussed later. Cross-sectional study samples are selected based on their exposure status, without regard for their outcome status. Outcome status is obtained after participants are enrolled. Ideally, a wider distribution of exposure will allow for a higher likelihood of finding an association between the exposure and outcome if one exists ( 1 – 3 , 5 , 8 ). Cross-sectional studies are retrospective in nature. An example of a cross-sectional study would be enrolling participants who are either current smokers or never smokers, and assessing whether or not they have respiratory deficiencies. Random sampling of the population being assessed is more important in cross-sectional studies as compared to other observational study designs. Selection bias from non-random sampling may result in flawed measure of prevalence and calculation of risk. The study sample is assessed for both exposure and outcome at a single point in time. Because both exposure and outcome are assessed at the same time, temporality cannot be demonstrated, i.e. it cannot be demonstrated that the exposure preceded the disease ( 1 – 3 , 5 , 8 ). Point prevalence and period prevalence can be calculated in cross-sectional studies. Measures of risk for the exposure-outcome relationship that can be calculated in cross-sectional study design are odds ratio, prevalence odds ratio, prevalence ratio, and prevalence difference. Cross-sectional studies are relatively inexpensive and have data collected on an individual which allows for more complete control for confounding. Additionally, cross-sectional studies allow for multiple outcomes to be assessed simultaneously.

Case-control study design

Case-control studies were traditionally referred to as retrospective studies, due to the nature of the study design and execution ( 1 – 12 , 23 , 24 ). In this study design, researchers identify study participants based on their case status, i.e. diseased or not diseased. Quantification of the number of individuals among the cases and the controls who are exposed allow for statistical associations between exposure and outcomes to be established ( 1 – 3 , 5 , 8 ). An example of a case control study is analysing the relationship between obesity and knee replacement surgery. Cases are participants who have had knee surgery, and controls are a random sampling of those who have not, and the comparison is the relative odds of being obese if you have knee surgery as compared to those that do not. Matching on one or more potential confounders allows for minimization of those factors as potential confounders in the exposure-outcome relationship ( 1 – 3 , 5 , 8 ). Additionally, case-control studies are at increased risk for bias, particularly recall bias, due to the known case status of study participants ( 1 – 3 , 5 , 8 ). Other points of consideration that have specific weight in case-control studies include the appropriate selection of controls that balance generalizability and minimize bias, the minimization of survivor bias, and the potential for length time bias ( 25 ). The largest strength of case-control studies is that this study design is the most efficient study design for rare diseases. Additional strengths include low cost, relatively fast execution compared to cohort studies, the ability to collect individual participant specific data, the ability to control for multiple confounders, and the ability to assess multiple exposures of interest. The measure of risk that is calculated in case-control studies is the odds ratio, which are the odds of having the exposure if you have the disease. Other measures of risk are not applicable to case-control studies. Any measure of prevalence and associated measures, such as prevalence odds ratio, in a case-control study is artificial because the researcher arbitrarily sets the proportion of cases to non-cases in this study design. Temporality can be suggested, however, it is rarely definitively demonstrated because it is unknown if the development of the disease truly preceded the exposure. It should be noted that for certain outcomes, particularly death, the criteria for demonstrating temporality in that specific exposure-outcome relationship are met and the use of relative risk as a measure of risk may be justified.

Case-crossover study design

A case-crossover study relies upon an individual to act as their own control for comparison issues, thereby minimizing some potential confounders ( 1 , 5 , 12 ). This study design should not be confused with a crossover study design which is an interventional study type and is described below. For case-crossover studies, cases are assessed for their exposure status immediately prior to the time they became a case, and then compared to their own exposure at a prior point where they didn’t become a case. The selection of the prior point for comparison issues is often chosen at random or relies upon a mean measure of exposure over time. Case-crossover studies are always retrospective. An example of a case-crossover study would be evaluating the exposure of talking on a cell phone and being involved in an automobile crash. Cases are drivers involved in a crash and the comparison is that same driver at a random timeframe where they were not involved in a crash. These types of studies are particularly good for exposure-outcome relationships where the outcome is acute and well defined, e.g. electrocutions, lacerations, automobile crashes, etc. ( 1 , 5 ). Exposure-outcome relationships that are assessed using case-crossover designs should have health outcomes that do not have a subclinical or undiagnosed period prior to becoming a “case” in the study ( 12 ). The exposure is cell phone use during the exposure periods, both before the crash and during the control period. Additionally, the reliance upon prior exposure time requires that the exposure not have an additive or cumulative effect over time ( 1 , 5 ). Case-crossover study designs are at higher risk for having recall bias as compared with other study designs ( 12 ). Study participants are more likely to remember an exposure prior to becoming a case, as compared to not becoming a case.

Retrospective and prospective cohort study design

Cohort studies involve identifying study participants based on their exposure status and either following them through time to identify which participants develop the outcome(s) of interest, or look back at data that were created in the past, prior to the development of the outcome. Prospective cohort studies are considered the gold standard of observational research ( 1 – 3 , 5 , 8 , 10 , 11 ). These studies begin with a cross-sectional study to categorize exposure and identify cases at baseline. Disease-free participants are then followed and cases are measured as they develop. Retrospective cohort studies also begin with a cross-sectional study to categorize exposure and identify cases. Exposures are then measured based on records created at that time. Additionally, in an ideal retrospective cohort, case status is also tracked using historical data that were created at that point in time. Occupational groups, particularly those that have regular surveillance or certifications such as Commercial Truck Drivers, are particularly well positioned for retrospective cohort studies because records of both exposure and outcome are created as part of commercial and regulatory purposes ( 8 ). These types of studies have the ability to demonstrate temporality and therefore identify true risk factors, not associated factors, as can be done in other types of studies.

Cohort studies are the only observational study that can calculate incidence, both cumulative incidence and an incidence rate ( 1 , 3 , 5 , 6 , 10 , 11 ). Also, because the inception of a cohort study is identical to a cross-sectional study, both point prevalence and period prevalence can be calculated. There are many measures of risk that can be calculated from cohort study data. Again, the measures of risk for the exposure-outcome relationship that can be calculated in cross-sectional study design of odds ratio, prevalence odds ratio, prevalence ratio, and prevalence difference can be calculated in cohort studies as well. Measures of risk that leverage a cohort study’s ability to calculate incidence include incidence rate ratio, relative risk, risk ratio, and hazard ratio. These measures that demonstrate temporality are considered stronger measures for demonstrating causation and identification of risk factors.

Diagnostic testing and evaluation study designs

A specific study design is the diagnostic accuracy study, which is often used as part of the clinical decision making process. Diagnostic accuracy study designs are those that compare a new diagnostic method with the current “gold standard” diagnostic procedure in a cross-section of both diseased and healthy study participants. Gold standard diagnostic procedures are the current best-practice for diagnosing a disease. An example is comparing a new rapid test for a cancer with the gold standard method of biopsy. There are many intricacies to diagnostic testing study designs that should be considered. The proper selection of the gold standard evaluation is important for defining the true measures of accuracy for the new diagnostic procedure. Evaluations of diagnostic test results should be blinded to the case status of the participant. Similar to the intention-to-treat concept discussed later in interventional studies, diagnostic tests have a procedure of analyses called intention to diagnose (ITD), where participants are analysed in the diagnostic category they were assigned, regardless of the process in which a diagnosis was obtained. Performing analyses according to an a priori defined protocol, called per protocol analyses (PP or PPA), is another potential strength to diagnostic study testing. Many measures of the new diagnostic procedure, including accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio can be calculated. These measures of the diagnostic test allow for comparison with other diagnostic tests and aid the clinician in determining which test to utilize.

Interventional study designs

Interventional study designs, also called experimental study designs, are those where the researcher intervenes at some point throughout the study. The most common and strongest interventional study design is a randomized controlled trial, however, there are other interventional study designs, including pre-post study design, non-randomized controlled trials, and quasi-experiments ( 1 , 5 , 13 ). Experimental studies are used to evaluate study questions related to either therapeutic agents or prevention. Therapeutic agents can include prophylactic agents, treatments, surgical approaches, or diagnostic tests. Prevention can include changes to protective equipment, engineering controls, management, policy or any element that should be evaluated as to a potential cause of disease or injury.

Pre-post study design

A pre-post study measures the occurrence of an outcome before and again after a particular intervention is implemented. A good example is comparing deaths from motor vehicle crashes before and after the enforcement of a seat-belt law. Pre-post studies may be single arm, one group measured before the intervention and again after the intervention, or multiple arms, where there is a comparison between groups. Often there is an arm where there is no intervention. The no-intervention arm acts as the control group in a multi-arm pre-post study. These studies have the strength of temporality to be able to suggest that the outcome is impacted by the intervention, however, pre-post studies do not have control over other elements that are also changing at the same time as the intervention is implemented. Therefore, changes in disease occurrence during the study period cannot be fully attributed to the specific intervention. Outcomes measured for pre-post intervention studies may be binary health outcomes such as incidence or prevalence, or mean values of a continuous outcome such as systolic blood pressure may also be used. The analytic methods of pre-post studies depend on the outcome being measured. If there are multiple treatment arms, it is also likely that the difference from beginning to end within each treatment arm are analysed.

Non-randomized trial study design

Non-randomized trials are interventional study designs that compare a group where an intervention was performed with a group where there was no intervention. These are convenient study designs that are most often performed prospectively and can suggest possible relationships between the intervention and the outcome. However, these study designs are often subject to many types of bias and error and are not considered a strong study design.

Randomized controlled trial study design

Randomized controlled trials (RCTs) are the most common type of interventional study, and can have many modifications ( 26 – 28 ). These trials take a homogenous group of study participants and randomly divide them into two separate groups. If the randomization is successful then these two groups should be the same in all respects, both measured confounders and unmeasured factors. The intervention is then implemented in one group and not the other and comparisons of intervention efficacy between the two groups are analysed. Theoretically, the only difference between the two groups through the entire study is the intervention. An excellent example is the intervention of a new medication to treat a specific disease among a group of patients. This randomization process is arguably the largest strength of an RCT ( 26 – 28 ). Additional methodological elements are utilized among RCTs to further strengthen the causal implication of the intervention’s impact. These include allocation concealment, blinding, measuring compliance, controlling for co-interventions, measuring dropout, analysing results by intention to treat, and assessing each treatment arm at the same time point in the same manner.

Crossover randomized controlled trial study design

A crossover RCT is a type of interventional study design where study participants intentionally “crossover” to the other treatment arm. This should not be confused with the observational case-crossover design. A crossover RCT begins the same as a traditional RCT, however, after the end of the first treatment phase, each participant is re-allocated to the other treatment arm. There is often a wash-out period in between treatment periods. This design has many strengths, including demonstrating reversibility, compensating for unsuccessful randomization, and improving study efficiency by not using time to recruit subjects.

Allocation concealment theoretically guarantees that the implementation of the randomization is free from bias. This is done by ensuring that the randomization scheme is concealed from all individuals involved ( 26 – 30 ). A third party who is not involved in the treatment or assessment of the trial creates the randomization schema and study participants are randomized according to that schema. By concealing the schema, there is a minimization of potential deviation from that randomization, either consciously or otherwise by the participant, researcher, provider, or assessor. The traditional method of allocation concealment relies upon sequentially numbered opaque envelopes with the treatment allocation inside. These envelopes are generated before the study begins using the selected randomization scheme. Participants are then allocated to the specific intervention arm in the pre-determined order dictated by the schema. If allocation concealment is not utilized, there is the possibility of selective enrolment into an intervention arm, potentially with the outcome of biased results.

Blinding in an RCT is withholding the treatment arm from individuals involved in the study. This can be done through use of placebo pills, deactivated treatment modalities, or sham therapy. Sham therapy is a comparison procedure or treatment which is identical to the investigational intervention except it omits a key therapeutic element, thus rendering the treatment ineffective. An example is a sham cortisone injection, where saline solution of the same volume is injected instead of cortisone. This helps ensure that patients do not know if they are receiving the active or control treatment. The process of blinding is utilized to help ensure equal treatment of the different groups, therefore continuing to isolate the difference in outcome between groups to only the intervention being administered ( 28 – 31 ). Blinding within an RCT includes patient blinding, provider blinding, or assessor blinding. In some situations it is difficult or impossible to blind one or more of the parties involved, but an ideal study would have all parties blinded until the end of the study ( 26 – 28 , 31 , 32 ).

Compliance is the degree of how well study participants adhere to the prescribed intervention. Compliance or non-compliance to the intervention can have a significant impact on the results of the study ( 26 – 29 ). If there is a differentiation in the compliance between intervention arms, that differential can mask true differences, or erroneously conclude that there are differences between the groups when one does not exist. The measurement of compliance in studies addresses the potential for differences observed in intervention arms due to intervention adherence, and can allow for partial control of differences either through post hoc stratification or statistical adjustment.

Co-interventions, interventions that impact the outcome other than the primary intervention of the study, can also allow for erroneous conclusions in clinical trials ( 26 – 28 ). If there are differences between treatment arms in the amount or type of additional therapeutic elements then the study conclusions may be incorrect ( 29 ). For example, if a placebo treatment arm utilizes more over-the-counter medication than the experimental treatment arm, both treatment arms may have the same therapeutic improvement and show no effect of the experimental treatment. However, the placebo arm improvement is due to the over-the-counter medication and if that was prohibited, there may be a therapeutic difference between the two treatment arms. The exclusion or tracking and statistical adjustment of co-interventions serves to strengthen an RCT by minimizing this potential effect.

Participants drop out of a study for multiple reasons, but if there are differential dropout rates between intervention arms or high overall dropout rates, there may be biased data or erroneous study conclusions ( 26 – 28 ). A commonly accepted dropout rate is 20% however, studies with dropout rates below 20% may have erroneous conclusions ( 29 ). Common methods for minimizing dropout include incentivizing study participation or short study duration, however, these may also lead to lack of generalizability or validity.

Intention-to-treat (ITT) analysis is a method of analysis that quantitatively addresses deviations from random allocation ( 26 – 28 ). This method analyses individuals based on their allocated intervention, regardless of whether or not that intervention was actually received due to protocol deviations, compliance concerns or subsequent withdrawal. By maintaining individuals in their allocated intervention for analyses, the benefits of randomization will be captured ( 18 , 26 – 29 ). If analysis of actual treatment is solely relied upon, then some of the theoretical benefits of randomization may be lost. This analysis method relies on complete data. There are different approaches regarding the handling of missing data and no consensus has been put forth in the literature. Common approaches are imputation or carrying forward the last observed data from individuals to address issues of missing data ( 18 , 19 ).

Assessment timing can play an important role in the impact of interventions, particularly if intervention effects are acute and short lived ( 26 – 29 , 33 ). The specific timing of assessments are unique to each intervention, however, studies that allow for meaningfully different timing of assessments are subject to erroneous results. For example, if assessments occur differentially after an injection of a particularly fast acting, short-lived medication the difference observed between intervention arms may be due to a higher proportion of participants in one intervention arm being assessed hours after the intervention instead of minutes. By tracking differences in assessment times, researchers can address the potential scope of this problem, and try to address it using statistical or other methods ( 26 – 28 , 33 ).

Randomized controlled trials are the principle method for improving treatment of disease, and there are some standardized methods for grading RCTs, and subsequently creating best practice guidelines ( 29 , 34 – 36 ). Much of the current practice of medicine lacks moderate or high quality RCTs to address what treatment methods have demonstrated efficacy and much of the best practice guidelines remains based on consensus from experts ( 28 , 37 ). The reliance on high quality methodology in all types of studies will allow for continued improvement in the assessment of causal factors for health outcomes and the treatment of diseases.

Standards of research and reporting

There are many published standards for the design, execution and reporting of biomedical research, which can be found in Table 3 . The purpose and content of these standards and guidelines are to improve the quality of biomedical research which will result in providing sound conclusions to base medical decision making upon. There are published standards for categories of study designs such as observational studies (e.g. STROBE), interventional studies (e.g. CONSORT), diagnostic studies (e.g. STARD, QUADAS), systematic reviews and meta-analyses (e.g. PRISMA ), as well as others. The aim of these standards and guideline are to systematize and elevate the quality of biomedical research design, execution, and reporting.

Published standard for study design and reporting.

• Consolidated Standards Of Reporting Trials (CONSORT, www.consort-statement.org ) are interventional study standards, a 25 item checklist and flowchart specifically designed for RCTs to standardize reporting of key elements including design, analysis and interpretation of the RCT.
• Strengthening the Reporting of Observational studies in Epidemiology (STROBE, www.strobe-statement.org ) is a collection of guidelines specifically for standardization and improvement of the reporting of observational epidemiological research. There are specific subsets of the STROBE statement including molecular epidemiology (STROBE-ME), infectious diseases (STROBE-ID) and genetic association studies (STREGA).
• Standards for Reporting Studies of Diagnos tic Accuracy (STARD, www.stard-statement.org ) is a 25 element checklist and flow diagram specifically designed for the reporting of diagnostic accuracy studies.
• Quality assessment of diagnostic accuracy studies (QUADAS, www.bris.ac.uk/quadas ) is a quality assessment of diagnostic accuracy studies.
• Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA, www.prisma-statement.org ) is a 27 element checklist and multiphase flow diagram to improve quality of reporting systematic reviews and meta-analyses. It replaces the QUOROM statement.
• Consolidated criteria for reporting qualitative research (COREQ) is a 32 element checklist designed for reporting of qualitative data from interviews and focus groups.
• Statistical Analyses and Methods in the Published Literature (SAMPL) is a guideline for statistical methods and analyses of all types of biomedical research.
• Consensus-based Clinical Case Reporting Guideline Development (CARE, www.carestatement.org ) is a checklist comprised of 13 elements and is designed only for case reports.
• Standards for Quality Improvement Reporting Excellence (SQUIRE, www.squire-statement.org ) are publication guidelines comprised of 19 elements, for authors aimed at quality improvement in health care reporting.
• Consolidated Health Economic Evaluation Reporting Standards (CHEERS) is a 24 element checklist of reporting practices for economic evaluations of interventional studies.
• Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) is a guideline specifically for standardizing and improving the reporting of qualitative biomedical research.

When designing or evaluating a study it may be helpful to review the applicable standards prior to executing and publishing the study. All published standards and guidelines are available on the web, and are updated based on current best practices as biomedical research evolves. Additionally, there is a network called “Enhancing the quality and transparency of health research” (EQUATOR, www.equator-network.org ) , which has guidelines and checklists for all standards reported in Table 3 and is continually updated with new study design or specialty specific standards.

The appropriate selection of a study design is only one element in successful research. The selection of a study design should incorporate consideration of costs, access to cases, identification of the exposure, the epidemiologic measures that are required, and the level of evidence that is currently published regarding the specific exposure-outcome relationship that is being assessed. Reviewing appropriate published standards when designing a study can substantially strengthen the execution and interpretation of study results.

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What is Observational Study Design and Types

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Most people think of a traditional experimental design when they consider research and published research papers. There is, however, a type of research that is more observational in nature, and it is appropriately referred to as “observational studies.”

There are many valuable reasons to utilize an observational study design. But, just as in research experimental design, different methods can be used when you’re considering this type of study. In this article, we’ll look at the advantages and disadvantages of an observational study design, as well as the 3 types of observational studies.

What is Observational Study Design?

An observational study is when researchers are looking at the effect of some type of intervention, risk, a diagnostic test or treatment, without trying to manipulate who is, or who isn’t, exposed to it.

This differs from an experimental study, where the scientists are manipulating who is exposed to the treatment, intervention, etc., by having a control group, or those who are not exposed, and an experimental group, or those who are exposed to the intervention, treatment, etc. In the best studies, the groups are randomized, or chosen by chance.

Any evidence derived from systematic reviews is considered the best in the hierarchy of evidence, which considers which studies are deemed the most reliable. Next would be any evidence that comes from randomized controlled trials. Cohort studies and case studies follow, in that order.

Cohort studies and case studies are considered observational in design, whereas the randomized controlled trial would be an experimental study.

Let’s take a closer look at the different types of observational study design.

The 3 types of Observational Studies

The different types of observational studies are used for different reasons. Selecting the best type for your research is critical to a successful outcome. One of the main reasons observational studies are used is when a randomized experiment would be considered unethical. For example, a life-saving medication used in a public health emergency. They are also used when looking at aetiology, or the cause of a condition or disease, as well as the treatment of rare conditions.

Case Control Observational Study

Researchers in case control studies identify individuals with an existing health issue or condition, or “cases,” along with a similar group without the condition, or “controls.” These two groups are then compared to identify predictors and outcomes. This type of study is helpful to generate a hypothesis that can then be researched.

Cohort Observational Study

This type of observational study is often used to help understand cause and effect. A cohort observational study looks at causes, incidence and prognosis, for example. A cohort is a group of people who are linked in a particular way, for example, a birth cohort would include people who were born within a specific period of time. Scientists might compare what happens to the members of the cohort who have been exposed to some variable to what occurs with members of the cohort who haven’t been exposed.

Cross Sectional Observational Study

Unlike a cohort observational study, a cross sectional observational study does not explore cause and effect, but instead looks at prevalence. Here you would look at data from a particular group at one very specific period of time. Researchers would simply observe and record information about something present in the population, without manipulating any variables or interventions. These types of studies are commonly used in psychology, education and social science.

Advantages and Disadvantages of Observational Study Design

Observational study designs have the distinct advantage of allowing researchers to explore answers to questions where a randomized controlled trial, or RCT, would be unethical. Additionally, if the study is focused on a rare condition, studying existing cases as compared to non-affected individuals might be the most effective way to identify possible causes of the condition. Likewise, if very little is known about a condition or circumstance, a cohort study would be a good study design choice.

A primary advantage to the observational study design is that they can generally be completed quickly and inexpensively. A RCT can take years before the data is compiled and available. RCTs are more complex and involved, requiring many more logistics and details to iron out, whereas an observational study can be more easily designed and completed.

The main disadvantage of observational study designs is that they’re more open to dispute than an RCT. Of particular concern would be confounding biases. This is when a cohort might share other characteristics that affect the outcome versus the outcome stated in the study. An example would be that people who practice good sleeping habits have less heart disease. But, maybe those who practice effective sleeping habits also, in general, eat better and exercise more.

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Frequently asked questions

What is the difference between an observational study and an experiment.

The key difference between observational studies and experimental designs is that a well-done observational study does not influence the responses of participants, while experiments do have some sort of treatment condition applied to at least some participants by random assignment .

Frequently asked questions: Methodology

Attrition refers to participants leaving a study. It always happens to some extent—for example, in randomized controlled trials for medical research.

Differential attrition occurs when attrition or dropout rates differ systematically between the intervention and the control group . As a result, the characteristics of the participants who drop out differ from the characteristics of those who stay in the study. Because of this, study results may be biased .

Action research is conducted in order to solve a particular issue immediately, while case studies are often conducted over a longer period of time and focus more on observing and analyzing a particular ongoing phenomenon.

Action research is focused on solving a problem or informing individual and community-based knowledge in a way that impacts teaching, learning, and other related processes. It is less focused on contributing theoretical input, instead producing actionable input.

Action research is particularly popular with educators as a form of systematic inquiry because it prioritizes reflection and bridges the gap between theory and practice. Educators are able to simultaneously investigate an issue as they solve it, and the method is very iterative and flexible.

A cycle of inquiry is another name for action research . It is usually visualized in a spiral shape following a series of steps, such as “planning → acting → observing → reflecting.”

To make quantitative observations , you need to use instruments that are capable of measuring the quantity you want to observe. For example, you might use a ruler to measure the length of an object or a thermometer to measure its temperature.

Criterion validity and construct validity are both types of measurement validity . In other words, they both show you how accurately a method measures something.

While construct validity is the degree to which a test or other measurement method measures what it claims to measure, criterion validity is the degree to which a test can predictively (in the future) or concurrently (in the present) measure something.

Construct validity is often considered the overarching type of measurement validity . You need to have face validity , content validity , and criterion validity in order to achieve construct validity.

Convergent validity and discriminant validity are both subtypes of construct validity . Together, they help you evaluate whether a test measures the concept it was designed to measure.

• Convergent validity indicates whether a test that is designed to measure a particular construct correlates with other tests that assess the same or similar construct.
• Discriminant validity indicates whether two tests that should not be highly related to each other are indeed not related. This type of validity is also called divergent validity .

You need to assess both in order to demonstrate construct validity. Neither one alone is sufficient for establishing construct validity.

• Discriminant validity indicates whether two tests that should not be highly related to each other are indeed not related

Content validity shows you how accurately a test or other measurement method taps  into the various aspects of the specific construct you are researching.

In other words, it helps you answer the question: “does the test measure all aspects of the construct I want to measure?” If it does, then the test has high content validity.

The higher the content validity, the more accurate the measurement of the construct.

If the test fails to include parts of the construct, or irrelevant parts are included, the validity of the instrument is threatened, which brings your results into question.

Face validity and content validity are similar in that they both evaluate how suitable the content of a test is. The difference is that face validity is subjective, and assesses content at surface level.

When a test has strong face validity, anyone would agree that the test’s questions appear to measure what they are intended to measure.

For example, looking at a 4th grade math test consisting of problems in which students have to add and multiply, most people would agree that it has strong face validity (i.e., it looks like a math test).

On the other hand, content validity evaluates how well a test represents all the aspects of a topic. Assessing content validity is more systematic and relies on expert evaluation. of each question, analyzing whether each one covers the aspects that the test was designed to cover.

A 4th grade math test would have high content validity if it covered all the skills taught in that grade. Experts(in this case, math teachers), would have to evaluate the content validity by comparing the test to the learning objectives.

Snowball sampling is a non-probability sampling method . Unlike probability sampling (which involves some form of random selection ), the initial individuals selected to be studied are the ones who recruit new participants.

Because not every member of the target population has an equal chance of being recruited into the sample, selection in snowball sampling is non-random.

Snowball sampling is a non-probability sampling method , where there is not an equal chance for every member of the population to be included in the sample .

This means that you cannot use inferential statistics and make generalizations —often the goal of quantitative research . As such, a snowball sample is not representative of the target population and is usually a better fit for qualitative research .

Snowball sampling relies on the use of referrals. Here, the researcher recruits one or more initial participants, who then recruit the next ones.

Participants share similar characteristics and/or know each other. Because of this, not every member of the population has an equal chance of being included in the sample, giving rise to sampling bias .

Snowball sampling is best used in the following cases:

• If there is no sampling frame available (e.g., people with a rare disease)
• If the population of interest is hard to access or locate (e.g., people experiencing homelessness)
• If the research focuses on a sensitive topic (e.g., extramarital affairs)

The reproducibility and replicability of a study can be ensured by writing a transparent, detailed method section and using clear, unambiguous language.

Reproducibility and replicability are related terms.

• Reproducing research entails reanalyzing the existing data in the same manner.
• Replicating (or repeating ) the research entails reconducting the entire analysis, including the collection of new data . 
• A successful reproduction shows that the data analyses were conducted in a fair and honest manner.
• A successful replication shows that the reliability of the results is high.

Stratified sampling and quota sampling both involve dividing the population into subgroups and selecting units from each subgroup. The purpose in both cases is to select a representative sample and/or to allow comparisons between subgroups.

The main difference is that in stratified sampling, you draw a random sample from each subgroup ( probability sampling ). In quota sampling you select a predetermined number or proportion of units, in a non-random manner ( non-probability sampling ).

Purposive and convenience sampling are both sampling methods that are typically used in qualitative data collection.

A convenience sample is drawn from a source that is conveniently accessible to the researcher. Convenience sampling does not distinguish characteristics among the participants. On the other hand, purposive sampling focuses on selecting participants possessing characteristics associated with the research study.

The findings of studies based on either convenience or purposive sampling can only be generalized to the (sub)population from which the sample is drawn, and not to the entire population.

Random sampling or probability sampling is based on random selection. This means that each unit has an equal chance (i.e., equal probability) of being included in the sample.

On the other hand, convenience sampling involves stopping people at random, which means that not everyone has an equal chance of being selected depending on the place, time, or day you are collecting your data.

Convenience sampling and quota sampling are both non-probability sampling methods. They both use non-random criteria like availability, geographical proximity, or expert knowledge to recruit study participants.

However, in convenience sampling, you continue to sample units or cases until you reach the required sample size.

In quota sampling, you first need to divide your population of interest into subgroups (strata) and estimate their proportions (quota) in the population. Then you can start your data collection, using convenience sampling to recruit participants, until the proportions in each subgroup coincide with the estimated proportions in the population.

A sampling frame is a list of every member in the entire population . It is important that the sampling frame is as complete as possible, so that your sample accurately reflects your population.

Stratified and cluster sampling may look similar, but bear in mind that groups created in cluster sampling are heterogeneous , so the individual characteristics in the cluster vary. In contrast, groups created in stratified sampling are homogeneous , as units share characteristics.

Relatedly, in cluster sampling you randomly select entire groups and include all units of each group in your sample. However, in stratified sampling, you select some units of all groups and include them in your sample. In this way, both methods can ensure that your sample is representative of the target population .

A systematic review is secondary research because it uses existing research. You don’t collect new data yourself.

An observational study is a great choice for you if your research question is based purely on observations. If there are ethical, logistical, or practical concerns that prevent you from conducting a traditional experiment , an observational study may be a good choice. In an observational study, there is no interference or manipulation of the research subjects, as well as no control or treatment groups .

It’s often best to ask a variety of people to review your measurements. You can ask experts, such as other researchers, or laypeople, such as potential participants, to judge the face validity of tests.

While experts have a deep understanding of research methods , the people you’re studying can provide you with valuable insights you may have missed otherwise.

Face validity is important because it’s a simple first step to measuring the overall validity of a test or technique. It’s a relatively intuitive, quick, and easy way to start checking whether a new measure seems useful at first glance.

Good face validity means that anyone who reviews your measure says that it seems to be measuring what it’s supposed to. With poor face validity, someone reviewing your measure may be left confused about what you’re measuring and why you’re using this method.

Face validity is about whether a test appears to measure what it’s supposed to measure. This type of validity is concerned with whether a measure seems relevant and appropriate for what it’s assessing only on the surface.

Statistical analyses are often applied to test validity with data from your measures. You test convergent validity and discriminant validity with correlations to see if results from your test are positively or negatively related to those of other established tests.

You can also use regression analyses to assess whether your measure is actually predictive of outcomes that you expect it to predict theoretically. A regression analysis that supports your expectations strengthens your claim of construct validity .

When designing or evaluating a measure, construct validity helps you ensure you’re actually measuring the construct you’re interested in. If you don’t have construct validity, you may inadvertently measure unrelated or distinct constructs and lose precision in your research.

Construct validity is often considered the overarching type of measurement validity ,  because it covers all of the other types. You need to have face validity , content validity , and criterion validity to achieve construct validity.

Construct validity is about how well a test measures the concept it was designed to evaluate. It’s one of four types of measurement validity , which includes construct validity, face validity , and criterion validity.

There are two subtypes of construct validity.

• Convergent validity : The extent to which your measure corresponds to measures of related constructs
• Discriminant validity : The extent to which your measure is unrelated or negatively related to measures of distinct constructs

Naturalistic observation is a valuable tool because of its flexibility, external validity , and suitability for topics that can’t be studied in a lab setting.

The downsides of naturalistic observation include its lack of scientific control , ethical considerations , and potential for bias from observers and subjects.

Naturalistic observation is a qualitative research method where you record the behaviors of your research subjects in real world settings. You avoid interfering or influencing anything in a naturalistic observation.

You can think of naturalistic observation as “people watching” with a purpose.

A dependent variable is what changes as a result of the independent variable manipulation in experiments . It’s what you’re interested in measuring, and it “depends” on your independent variable.

In statistics, dependent variables are also called:

• Response variables (they respond to a change in another variable)
• Outcome variables (they represent the outcome you want to measure)
• Left-hand-side variables (they appear on the left-hand side of a regression equation)

An independent variable is the variable you manipulate, control, or vary in an experimental study to explore its effects. It’s called “independent” because it’s not influenced by any other variables in the study.

Independent variables are also called:

• Explanatory variables (they explain an event or outcome)
• Predictor variables (they can be used to predict the value of a dependent variable)
• Right-hand-side variables (they appear on the right-hand side of a regression equation).

As a rule of thumb, questions related to thoughts, beliefs, and feelings work well in focus groups. Take your time formulating strong questions, paying special attention to phrasing. Be careful to avoid leading questions , which can bias your responses.

Overall, your focus group questions should be:

• Open-ended and flexible
• Impossible to answer with “yes” or “no” (questions that start with “why” or “how” are often best)
• Unambiguous, getting straight to the point while still stimulating discussion
• Unbiased and neutral

A structured interview is a data collection method that relies on asking questions in a set order to collect data on a topic. They are often quantitative in nature. Structured interviews are best used when: 

• You already have a very clear understanding of your topic. Perhaps significant research has already been conducted, or you have done some prior research yourself, but you already possess a baseline for designing strong structured questions.
• You are constrained in terms of time or resources and need to analyze your data quickly and efficiently.
• Your research question depends on strong parity between participants, with environmental conditions held constant.

More flexible interview options include semi-structured interviews , unstructured interviews , and focus groups .

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.

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.

A semi-structured interview is a blend of structured and unstructured types of interviews. Semi-structured interviews are best used when:

• You have prior interview experience. Spontaneous questions are deceptively challenging, and it’s easy to accidentally ask a leading question or make a participant uncomfortable.
• Your research question is exploratory in nature. Participant answers can guide future research questions and help you develop a more robust knowledge base for future research.

An unstructured interview is the most flexible type of interview, but it is not always the best fit for your research topic.

Unstructured interviews are best used when:

• You are an experienced interviewer and have a very strong background in your research topic, since it is challenging to ask spontaneous, colloquial questions.
• Your research question is exploratory in nature. While you may have developed hypotheses, you are open to discovering new or shifting viewpoints through the interview process.
• You are seeking descriptive data, and are ready to ask questions that will deepen and contextualize your initial thoughts and hypotheses.
• Your research depends on forming connections with your participants and making them feel comfortable revealing deeper emotions, lived experiences, or thoughts.

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.

Deductive reasoning is commonly used in scientific research, and it’s especially associated with quantitative research .

In research, you might have come across something called the hypothetico-deductive method . It’s the scientific method of testing hypotheses to check whether your predictions are substantiated by real-world data.

Deductive reasoning is a logical approach where you progress from general ideas to specific conclusions. It’s often contrasted with inductive reasoning , where you start with specific observations and form general conclusions.

Deductive reasoning is also called deductive logic.

There are many different types of inductive reasoning that people use formally or informally.

Here are a few common types:

• Inductive generalization : You use observations about a sample to come to a conclusion about the population it came from.
• Statistical generalization: You use specific numbers about samples to make statements about populations.
• Causal reasoning: You make cause-and-effect links between different things.
• Sign reasoning: You make a conclusion about a correlational relationship between different things.
• Analogical reasoning: You make a conclusion about something based on its similarities to something else.

Inductive reasoning is a bottom-up approach, while deductive reasoning is top-down.

Inductive reasoning takes you from the specific to the general, while in deductive reasoning, you make inferences by going from general premises to specific conclusions.

In inductive research , you start by making observations or gathering data. Then, you take a broad scan of your data and search for patterns. Finally, you make general conclusions that you might incorporate into theories.

Inductive reasoning is a method of drawing conclusions by going from the specific to the general. It’s usually contrasted with deductive reasoning, where you proceed from general information to specific conclusions.

Inductive reasoning is also called inductive logic or bottom-up reasoning.

A hypothesis states your predictions about what your research will find. It is a tentative answer to your research question that has not yet been tested. For some research projects, you might have to write several hypotheses that address different aspects of your research question.

A hypothesis is not just a guess — it should be based on existing theories and knowledge. It also has to be testable, which means you can support or refute it through scientific research methods (such as experiments, observations and statistical analysis of data).

Triangulation can help:

• Reduce research bias that comes from using a single method, theory, or investigator
• Enhance validity by approaching the same topic with different tools
• Establish credibility by giving you a complete picture of the research problem

But triangulation can also pose problems:

• It’s time-consuming and labor-intensive, often involving an interdisciplinary team.
• Your results may be inconsistent or even contradictory.

There are four main types of triangulation :

• Data triangulation : Using data from different times, spaces, and people
• Investigator triangulation : Involving multiple researchers in collecting or analyzing data
• Theory triangulation : Using varying theoretical perspectives in your research
• Methodological triangulation : Using different methodologies to approach the same topic

Many academic fields use peer review , largely to determine whether a manuscript is suitable for publication. Peer review enhances the credibility of the published manuscript.

However, peer review is also common in non-academic settings. The United Nations, the European Union, and many individual nations use peer review to evaluate grant applications. It is also widely used in medical and health-related fields as a teaching or quality-of-care measure. 

Peer assessment is often used in the classroom as a pedagogical tool. Both receiving feedback and providing it are thought to enhance the learning process, helping students think critically and collaboratively.

Peer review can stop obviously problematic, falsified, or otherwise untrustworthy research from being published. It also represents an excellent opportunity to get feedback from renowned experts in your field. It acts as a first defense, helping you ensure your argument is clear and that there are no gaps, vague terms, or unanswered questions for readers who weren’t involved in the research process.

Peer-reviewed articles are considered a highly credible source due to this stringent process they go through before publication.

In general, the peer review process follows the following steps: 

• First, the author submits the manuscript to the editor.
• Reject the manuscript and send it back to author, or 
• Send it onward to the selected peer reviewer(s) 
• Next, the peer review process occurs. The reviewer provides feedback, addressing any major or minor issues with the manuscript, and gives their advice regarding what edits should be made. 
• Lastly, the edited manuscript is sent back to the author. They input the edits, and resubmit it to the editor for publication.

Exploratory research is often used when the issue you’re studying is new or when the data collection process is challenging for some reason.

You can use exploratory research if you have a general idea or a specific question that you want to study but there is no preexisting knowledge or paradigm with which to study it.

Exploratory research is a methodology approach that explores research questions that have not previously been studied in depth. It is often used when the issue you’re studying is new, or the data collection process is challenging in some way.

Explanatory research is used to investigate how or why a phenomenon occurs. Therefore, this type of research is often one of the first stages in the research process , serving as a jumping-off point for future research.

Exploratory research aims to explore the main aspects of an under-researched problem, while explanatory research aims to explain the causes and consequences of a well-defined problem.

Explanatory research is a research method used to investigate how or why something occurs when only a small amount of information is available pertaining to that topic. It can help you increase your understanding of a given topic.

Clean data are valid, accurate, complete, consistent, unique, and uniform. Dirty data include inconsistencies and errors.

Dirty data can come from any part of the research process, including poor research design , inappropriate measurement materials, or flawed data entry.

Data cleaning takes place between data collection and data analyses. But you can use some methods even before collecting data.

For clean data, you should start by designing measures that collect valid data. Data validation at the time of data entry or collection helps you minimize the amount of data cleaning you’ll need to do.

After data collection, you can use data standardization and data transformation to clean your data. You’ll also deal with any missing values, outliers, and duplicate values.

Every dataset requires different techniques to clean dirty data , but you need to address these issues in a systematic way. You focus on finding and resolving data points that don’t agree or fit with the rest of your dataset.

These data might be missing values, outliers, duplicate values, incorrectly formatted, or irrelevant. You’ll start with screening and diagnosing your data. Then, you’ll often standardize and accept or remove data to make your dataset consistent and valid.

Data cleaning is necessary for valid and appropriate analyses. Dirty data contain inconsistencies or errors , but cleaning your data helps you minimize or resolve these.

Without data cleaning, you could end up with a Type I or II error in your conclusion. These types of erroneous conclusions can be practically significant with important consequences, because they lead to misplaced investments or missed opportunities.

Data cleaning involves spotting and resolving potential data inconsistencies or errors to improve your data quality. An error is any value (e.g., recorded weight) that doesn’t reflect the true value (e.g., actual weight) of something that’s being measured.

In this process, you review, analyze, detect, modify, or remove “dirty” data to make your dataset “clean.” Data cleaning is also called data cleansing or data scrubbing.

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

In multistage sampling , you can use probability or non-probability sampling methods .

For a probability sample, you have to conduct probability sampling at every stage.

You can mix it up by using simple random sampling , systematic sampling , or stratified sampling to select units at different stages, depending on what is applicable and relevant to your study.

Multistage sampling can simplify data collection when you have large, geographically spread samples, and you can obtain a probability sample without a complete sampling frame.

But multistage sampling may not lead to a representative sample, and larger samples are needed for multistage samples to achieve the statistical properties of simple random samples .

These are four of the most common mixed methods designs :

• Convergent parallel: Quantitative and qualitative data are collected at the same time and analyzed separately. After both analyses are complete, compare your results to draw overall conclusions. 
• Embedded: Quantitative and qualitative data are collected at the same time, but within a larger quantitative or qualitative design. One type of data is secondary to the other.
• Explanatory sequential: Quantitative data is collected and analyzed first, followed by qualitative data. You can use this design if you think your qualitative data will explain and contextualize your quantitative findings.
• Exploratory sequential: Qualitative data is collected and analyzed first, followed by quantitative data. You can use this design if you think the quantitative data will confirm or validate your qualitative findings.

Triangulation in research means using multiple datasets, methods, theories and/or investigators to address a research question. It’s a research strategy that can help you enhance the validity and credibility of your findings.

Triangulation is mainly used in qualitative research , but it’s also commonly applied in quantitative research . Mixed methods research always uses triangulation.

In multistage sampling , or multistage cluster sampling, you draw a sample from a population using smaller and smaller groups at each stage.

This method is often used to collect data from a large, geographically spread group of people in national surveys, for example. You take advantage of hierarchical groupings (e.g., from state to city to neighborhood) to create a sample that’s less expensive and time-consuming to collect data from.

No, the steepness or slope of the line isn’t related to the correlation coefficient value. The correlation coefficient only tells you how closely your data fit on a line, so two datasets with the same correlation coefficient can have very different slopes.

To find the slope of the line, you’ll need to perform a regression analysis .

Correlation coefficients always range between -1 and 1.

The sign of the coefficient tells you the direction of the relationship: a positive value means the variables change together in the same direction, while a negative value means they change together in opposite directions.

The absolute value of a number is equal to the number without its sign. The absolute value of a correlation coefficient tells you the magnitude of the correlation: the greater the absolute value, the stronger the correlation.

These are the assumptions your data must meet if you want to use Pearson’s r :

• Both variables are on an interval or ratio level of measurement
• Data from both variables follow normal distributions
• Your data have no outliers
• Your data is from a random or representative sample
• You expect a linear relationship between the two variables

Quantitative research designs can be divided into two main categories:

• Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
• Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

The priorities of a research design can vary depending on the field, but you usually have to specify:

• Your research questions and/or hypotheses
• Your overall approach (e.g., qualitative or quantitative )
• The type of design you’re using (e.g., a survey , experiment , or case study )
• Your sampling methods or criteria for selecting subjects
• Your data collection methods (e.g., questionnaires , observations)
• Your data collection procedures (e.g., operationalization , timing and data management)
• Your data analysis methods (e.g., statistical tests  or thematic analysis )

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

Questionnaires can be self-administered or researcher-administered.

Self-administered questionnaires can be delivered online or in paper-and-pen formats, in person or through mail. All questions are standardized so that all respondents receive the same questions with identical wording.

Researcher-administered questionnaires are interviews that take place by phone, in-person, or online between researchers and respondents. You can gain deeper insights by clarifying questions for respondents or asking follow-up questions.

You can organize the questions logically, with a clear progression from simple to complex, or randomly between respondents. A logical flow helps respondents process the questionnaire easier and quicker, but it may lead to bias. Randomization can minimize the bias from order effects.

Closed-ended, or restricted-choice, questions offer respondents a fixed set of choices to select from. These questions are easier to answer quickly.

Open-ended or long-form questions allow respondents to answer in their own words. Because there are no restrictions on their choices, respondents can answer in ways that researchers may not have otherwise considered.

A questionnaire is a data collection tool or instrument, while a survey is an overarching research method that involves collecting and analyzing data from people using questionnaires.

The third variable and directionality problems are two main reasons why correlation isn’t causation .

The third variable problem means that a confounding variable affects both variables to make them seem causally related when they are not.

The directionality problem is when two variables correlate and might actually have a causal relationship, but it’s impossible to conclude which variable causes changes in the other.

Correlation describes an association between variables : when one variable changes, so does the other. A correlation is a statistical indicator of the relationship between variables.

Causation means that changes in one variable brings about changes in the other (i.e., there is a cause-and-effect relationship between variables). The two variables are correlated with each other, and there’s also a causal link between them.

While causation and correlation can exist simultaneously, correlation does not imply causation. In other words, correlation is simply a relationship where A relates to B—but A doesn’t necessarily cause B to happen (or vice versa). Mistaking correlation for causation is a common error and can lead to false cause fallacy .

Controlled experiments establish causality, whereas correlational studies only show associations between variables.

• In an experimental design , you manipulate an independent variable and measure its effect on a dependent variable. Other variables are controlled so they can’t impact the results.
• In a correlational design , you measure variables without manipulating any of them. You can test whether your variables change together, but you can’t be sure that one variable caused a change in another.

In general, correlational research is high in external validity while experimental research is high in internal validity .

A correlation is usually tested for two variables at a time, but you can test correlations between three or more variables.

A correlation coefficient is a single number that describes the strength and direction of the relationship between your variables.

Different types of correlation coefficients might be appropriate for your data based on their levels of measurement and distributions . The Pearson product-moment correlation coefficient (Pearson’s r ) is commonly used to assess a linear relationship between two quantitative variables.

A correlational research design investigates relationships between two variables (or more) without the researcher controlling or manipulating any of them. It’s a non-experimental type of quantitative research .

A correlation reflects the strength and/or direction of the association between two or more variables.

• A positive correlation means that both variables change in the same direction.
• A negative correlation means that the variables change in opposite directions.
• A zero correlation means there’s no relationship between the variables.

Random error  is almost always present in scientific studies, even in highly controlled settings. While you can’t eradicate it completely, you can reduce random error by taking repeated measurements, using a large sample, and controlling extraneous variables .

You can avoid systematic error through careful design of your sampling , data collection , and analysis procedures. For example, use triangulation to measure your variables using multiple methods; regularly calibrate instruments or procedures; use random sampling and random assignment ; and apply masking (blinding) where possible.

Systematic error is generally a bigger problem in research.

With random error, multiple measurements will tend to cluster around the true value. When you’re collecting data from a large sample , the errors in different directions will cancel each other out.

Systematic errors are much more problematic because they can skew your data away from the true value. This can lead you to false conclusions ( Type I and II errors ) about the relationship between the variables you’re studying.

Random and systematic error are two types of measurement error.

Random error is a chance difference between the observed and true values of something (e.g., a researcher misreading a weighing scale records an incorrect measurement).

Systematic error is a consistent or proportional difference between the observed and true values of something (e.g., a miscalibrated scale consistently records weights as higher than they actually are).

On graphs, the explanatory variable is conventionally placed on the x-axis, while the response variable is placed on the y-axis.

• If you have quantitative variables , use a scatterplot or a line graph.
• If your response variable is categorical, use a scatterplot or a line graph.
• If your explanatory variable is categorical, use a bar graph.

The term “ explanatory variable ” is sometimes preferred over “ independent variable ” because, in real world contexts, independent variables are often influenced by other variables. This means they aren’t totally independent.

Multiple independent variables may also be correlated with each other, so “explanatory variables” is a more appropriate term.

The difference between explanatory and response variables is simple:

• An explanatory variable is the expected cause, and it explains the results.
• A response variable is the expected effect, and it responds to other variables.

In a controlled experiment , all extraneous variables are held constant so that they can’t influence the results. Controlled experiments require:

• A control group that receives a standard treatment, a fake treatment, or no treatment.
• Random assignment of participants to ensure the groups are equivalent.

Depending on your study topic, there are various other methods of controlling variables .

There are 4 main types of extraneous variables :

• Demand characteristics : environmental cues that encourage participants to conform to researchers’ expectations.
• Experimenter effects : unintentional actions by researchers that influence study outcomes.
• Situational variables : environmental variables that alter participants’ behaviors.
• Participant variables : any characteristic or aspect of a participant’s background that could affect study results.

An extraneous variable is any variable that you’re not investigating that can potentially affect the dependent variable of your research study.

A confounding variable is a type of extraneous variable that not only affects the dependent variable, but is also related to the independent variable.

In a factorial design, multiple independent variables are tested.

If you test two variables, each level of one independent variable is combined with each level of the other independent variable to create different conditions.

Within-subjects designs have many potential threats to internal validity , but they are also very statistically powerful .

Advantages:

• Only requires small samples
• Statistically powerful
• Removes the effects of individual differences on the outcomes

Disadvantages:

• Internal validity threats reduce the likelihood of establishing a direct relationship between variables
• Time-related effects, such as growth, can influence the outcomes
• Carryover effects mean that the specific order of different treatments affect the outcomes

While a between-subjects design has fewer threats to internal validity , it also requires more participants for high statistical power than a within-subjects design .

• Prevents carryover effects of learning and fatigue.
• Shorter study duration.
• Needs larger samples for high power.
• Uses more resources to recruit participants, administer sessions, cover costs, etc.
• Individual differences may be an alternative explanation for results.

Yes. Between-subjects and within-subjects designs can be combined in a single study when you have two or more independent variables (a factorial design). In a mixed factorial design, one variable is altered between subjects and another is altered within subjects.

In a between-subjects design , every participant experiences only one condition, and researchers assess group differences between participants in various conditions.

In a within-subjects design , each participant experiences all conditions, and researchers test the same participants repeatedly for differences between conditions.

The word “between” means that you’re comparing different conditions between groups, while the word “within” means you’re comparing different conditions within the same group.

Random assignment is used in experiments with a between-groups or independent measures design. In this research design, there’s usually a control group and one or more experimental groups. Random assignment helps ensure that the groups are comparable.

In general, you should always use random assignment in this type of experimental design when it is ethically possible and makes sense for your study topic.

To implement random assignment , assign a unique number to every member of your study’s sample .

Then, you can use a random number generator or a lottery method to randomly assign each number to a control or experimental group. You can also do so manually, by flipping a coin or rolling a dice to randomly assign participants to groups.

Random selection, or random sampling , is a way of selecting members of a population for your study’s sample.

In contrast, random assignment is a way of sorting the sample into control and experimental groups.

Random sampling enhances the external validity or generalizability of your results, while random assignment improves the internal validity of your study.

In experimental research, random assignment is a way of placing participants from your sample into different groups using randomization. With this method, every member of the sample has a known or equal chance of being placed in a control group or an experimental group.

“Controlling for a variable” means measuring extraneous variables and accounting for them statistically to remove their effects on other variables.

Researchers often model control variable data along with independent and dependent variable data in regression analyses and ANCOVAs . That way, you can isolate the control variable’s effects from the relationship between the variables of interest.

Control variables help you establish a correlational or causal relationship between variables by enhancing internal validity .

If you don’t control relevant extraneous variables , they may influence the outcomes of your study, and you may not be able to demonstrate that your results are really an effect of your independent variable .

A control variable is any variable that’s held constant in a research study. It’s not a variable of interest in the study, but it’s controlled because it could influence the outcomes.

Including mediators and moderators in your research helps you go beyond studying a simple relationship between two variables for a fuller picture of the real world. They are important to consider when studying complex correlational or causal relationships.

Mediators are part of the causal pathway of an effect, and they tell you how or why an effect takes place. Moderators usually help you judge the external validity of your study by identifying the limitations of when the relationship between variables holds.

If something is a mediating variable :

• It’s caused by the independent variable .
• It influences the dependent variable
• When it’s taken into account, the statistical correlation between the independent and dependent variables is higher than when it isn’t considered.

A confounder is a third variable that affects variables of interest and makes them seem related when they are not. In contrast, a mediator is the mechanism of a relationship between two variables: it explains the process by which they are related.

A mediator variable explains the process through which two variables are related, while a moderator variable affects the strength and direction of that relationship.

There are three key steps in systematic sampling :

• Define and list your population , ensuring that it is not ordered in a cyclical or periodic order.
• Decide on your sample size and calculate your interval, k , by dividing your population by your target sample size.
• Choose every k th member of the population as your sample.

Systematic sampling is a probability sampling method where researchers select members of the population at a regular interval – for example, by selecting every 15th person on a list of the population. If the population is in a random order, this can imitate the benefits of simple random sampling .

Yes, you can create a stratified sample using multiple characteristics, but you must ensure that every participant in your study belongs to one and only one subgroup. In this case, you multiply the numbers of subgroups for each characteristic to get the total number of groups.

For example, if you were stratifying by location with three subgroups (urban, rural, or suburban) and marital status with five subgroups (single, divorced, widowed, married, or partnered), you would have 3 x 5 = 15 subgroups.

You should use stratified sampling when your sample can be divided into mutually exclusive and exhaustive subgroups that you believe will take on different mean values for the variable that you’re studying.

Using stratified sampling will allow you to obtain more precise (with lower variance ) statistical estimates of whatever you are trying to measure.

For example, say you want to investigate how income differs based on educational attainment, but you know that this relationship can vary based on race. Using stratified sampling, you can ensure you obtain a large enough sample from each racial group, allowing you to draw more precise conclusions.

In stratified sampling , researchers divide subjects into subgroups called strata based on characteristics that they share (e.g., race, gender, educational attainment).

Once divided, each subgroup is randomly sampled using another probability sampling method.

Cluster sampling is more time- and cost-efficient than other probability sampling methods , particularly when it comes to large samples spread across a wide geographical area.

However, it provides less statistical certainty than other methods, such as simple random sampling , because it is difficult to ensure that your clusters properly represent the population as a whole.

There are three types of cluster sampling : single-stage, double-stage and multi-stage clustering. In all three types, you first divide the population into clusters, then randomly select clusters for use in your sample.

• In single-stage sampling , you collect data from every unit within the selected clusters.
• In double-stage sampling , you select a random sample of units from within the clusters.
• In multi-stage sampling , you repeat the procedure of randomly sampling elements from within the clusters until you have reached a manageable sample.

Cluster sampling is a probability sampling method in which you divide a population into clusters, such as districts or schools, and then randomly select some of these clusters as your sample.

The clusters should ideally each be mini-representations of the population as a whole.

If properly implemented, simple random sampling is usually the best sampling method for ensuring both internal and external validity . However, it can sometimes be impractical and expensive to implement, depending on the size of the population to be studied,

If you have a list of every member of the population and the ability to reach whichever members are selected, you can use simple random sampling.

The American Community Survey  is an example of simple random sampling . In order to collect detailed data on the population of the US, the Census Bureau officials randomly select 3.5 million households per year and use a variety of methods to convince them to fill out the survey.

Simple random sampling is a type of probability sampling in which the researcher randomly selects a subset of participants from a population . Each member of the population has an equal chance of being selected. Data is then collected from as large a percentage as possible of this random subset.

Quasi-experimental design is most useful in situations where it would be unethical or impractical to run a true experiment .

Quasi-experiments have lower internal validity than true experiments, but they often have higher external validity  as they can use real-world interventions instead of artificial laboratory settings.

A quasi-experiment is a type of research design that attempts to establish a cause-and-effect relationship. The main difference with a true experiment is that the groups are not randomly assigned.

Blinding is important to reduce research bias (e.g., observer bias , demand characteristics ) and ensure a study’s internal validity .

If participants know whether they are in a control or treatment group , they may adjust their behavior in ways that affect the outcome that researchers are trying to measure. If the people administering the treatment are aware of group assignment, they may treat participants differently and thus directly or indirectly influence the final results.

• In a single-blind study , only the participants are blinded.
• In a double-blind study , both participants and experimenters are blinded.
• In a triple-blind study , the assignment is hidden not only from participants and experimenters, but also from the researchers analyzing the data.

Blinding means hiding who is assigned to the treatment group and who is assigned to the control group in an experiment .

A true experiment (a.k.a. a controlled experiment) always includes at least one control group that doesn’t receive the experimental treatment.

However, some experiments use a within-subjects design to test treatments without a control group. In these designs, you usually compare one group’s outcomes before and after a treatment (instead of comparing outcomes between different groups).

For strong internal validity , it’s usually best to include a control group if possible. Without a control group, it’s harder to be certain that the outcome was caused by the experimental treatment and not by other variables.

An experimental group, also known as a treatment group, receives the treatment whose effect researchers wish to study, whereas a control group does not. They should be identical in all other ways.

Individual Likert-type questions are generally considered ordinal data , because the items have clear rank order, but don’t have an even distribution.

Overall Likert scale scores are sometimes treated as interval data. These scores are considered to have directionality and even spacing between them.

The type of data determines what statistical tests you should use to analyze your data.

A Likert scale is a rating scale that quantitatively assesses opinions, attitudes, or behaviors. It is made up of 4 or more questions that measure a single attitude or trait when response scores are combined.

To use a Likert scale in a survey , you present participants with Likert-type questions or statements, and a continuum of items, usually with 5 or 7 possible responses, to capture their degree of agreement.

In scientific research, concepts are the abstract ideas or phenomena that are being studied (e.g., educational achievement). Variables are properties or characteristics of the concept (e.g., performance at school), while indicators are ways of measuring or quantifying variables (e.g., yearly grade reports).

The process of turning abstract concepts into measurable variables and indicators is called operationalization .

There are various approaches to qualitative data analysis , but they all share five steps in common:

• Prepare and organize your data.
• Review and explore your data.
• Develop a data coding system.
• Assign codes to the data.
• Identify recurring themes.

The specifics of each step depend on the focus of the analysis. Some common approaches include textual analysis , thematic analysis , and discourse analysis .

There are five common approaches to qualitative research :

• Grounded theory involves collecting data in order to develop new theories.
• Ethnography involves immersing yourself in a group or organization to understand its culture.
• Narrative research involves interpreting stories to understand how people make sense of their experiences and perceptions.
• Phenomenological research involves investigating phenomena through people’s lived experiences.
• Action research links theory and practice in several cycles to drive innovative changes.

Hypothesis testing is a formal procedure for investigating our ideas about the world using statistics. It is used by scientists to test specific predictions, called hypotheses , by calculating how likely it is that a pattern or relationship between variables could have arisen by chance.

Operationalization means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioral avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalize the variables that you want to measure.

When conducting research, collecting original data has significant advantages:

• You can tailor data collection to your specific research aims (e.g. understanding the needs of your consumers or user testing your website)
• You can control and standardize the process for high reliability and validity (e.g. choosing appropriate measurements and sampling methods )

However, there are also some drawbacks: data collection can be time-consuming, labor-intensive and expensive. In some cases, it’s more efficient to use secondary data that has already been collected by someone else, but the data might be less reliable.

Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by academics, governments, businesses, and other organizations.

There are several methods you can use to decrease the impact of confounding variables on your research: restriction, matching, statistical control and randomization.

In restriction , you restrict your sample by only including certain subjects that have the same values of potential confounding variables.

In matching , you match each of the subjects in your treatment group with a counterpart in the comparison group. The matched subjects have the same values on any potential confounding variables, and only differ in the independent variable .

In statistical control , you include potential confounders as variables in your regression .

In randomization , you randomly assign the treatment (or independent variable) in your study to a sufficiently large number of subjects, which allows you to control for all potential confounding variables.

A confounding variable is closely related to both the independent and dependent variables in a study. An independent variable represents the supposed cause , while the dependent variable is the supposed effect . A confounding variable is a third variable that influences both the independent and dependent variables.

Failing to account for confounding variables can cause you to wrongly estimate the relationship between your independent and dependent variables.

To ensure the internal validity of your research, you must consider the impact of confounding variables. If you fail to account for them, you might over- or underestimate the causal relationship between your independent and dependent variables , or even find a causal relationship where none exists.

Yes, but including more than one of either type requires multiple research questions .

For example, if you are interested in the effect of a diet on health, you can use multiple measures of health: blood sugar, blood pressure, weight, pulse, and many more. Each of these is its own dependent variable with its own research question.

You could also choose to look at the effect of exercise levels as well as diet, or even the additional effect of the two combined. Each of these is a separate independent variable .

To ensure the internal validity of an experiment , you should only change one independent variable at a time.

No. The value of a dependent variable depends on an independent variable, so a variable cannot be both independent and dependent at the same time. It must be either the cause or the effect, not both!

You want to find out how blood sugar levels are affected by drinking diet soda and regular soda, so you conduct an experiment .

• The type of soda – diet or regular – is the independent variable .
• The level of blood sugar that you measure is the dependent variable – it changes depending on the type of soda.

Determining cause and effect is one of the most important parts of scientific research. It’s essential to know which is the cause – the independent variable – and which is the effect – the dependent variable.

In non-probability sampling , the sample is selected based on non-random criteria, and not every member of the population has a chance of being included.

Common non-probability sampling methods include convenience sampling , voluntary response sampling, purposive sampling , snowball sampling, and quota sampling .

Probability sampling means that every member of the target population has a known chance of being included in the sample.

Probability sampling methods include simple random sampling , systematic sampling , stratified sampling , and cluster sampling .

Using careful research design and sampling procedures can help you avoid sampling bias . Oversampling can be used to correct undercoverage bias .

Some common types of sampling bias include self-selection bias , nonresponse bias , undercoverage bias , survivorship bias , pre-screening or advertising bias, and healthy user bias.

Sampling bias is a threat to external validity – it limits the generalizability of your findings to a broader group of people.

A sampling error is the difference between a population parameter and a sample statistic .

A statistic refers to measures about the sample , while a parameter refers to measures about the population .

Populations are used when a research question requires data from every member of the population. This is usually only feasible when the population is small and easily accessible.

Samples are used to make inferences about populations . Samples are easier to collect data from because they are practical, cost-effective, convenient, and manageable.

There are seven threats to external validity : selection bias , history, experimenter effect, Hawthorne effect , testing effect, aptitude-treatment and situation effect.

The two types of external validity are population validity (whether you can generalize to other groups of people) and ecological validity (whether you can generalize to other situations and settings).

The external validity of a study is the extent to which you can generalize your findings to different groups of people, situations, and measures.

Cross-sectional studies cannot establish a cause-and-effect relationship or analyze behavior over a period of time. To investigate cause and effect, you need to do a longitudinal study or an experimental study .

Cross-sectional studies are less expensive and time-consuming than many other types of study. They can provide useful insights into a population’s characteristics and identify correlations for further research.

Sometimes only cross-sectional data is available for analysis; other times your research question may only require a cross-sectional study to answer it.

Longitudinal studies can last anywhere from weeks to decades, although they tend to be at least a year long.

The 1970 British Cohort Study , which has collected data on the lives of 17,000 Brits since their births in 1970, is one well-known example of a longitudinal study .

Longitudinal studies are better to establish the correct sequence of events, identify changes over time, and provide insight into cause-and-effect relationships, but they also tend to be more expensive and time-consuming than other types of studies.

Longitudinal studies and cross-sectional studies are two different types of research design . In a cross-sectional study you collect data from a population at a specific point in time; in a longitudinal study you repeatedly collect data from the same sample over an extended period of time.

There are eight threats to internal validity : history, maturation, instrumentation, testing, selection bias , regression to the mean, social interaction and attrition .

Internal validity is the extent to which you can be confident that a cause-and-effect relationship established in a study cannot be explained by other factors.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
• If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

A confounding variable , also called a confounder or confounding factor, is a third variable in a study examining a potential cause-and-effect relationship.

A confounding variable is related to both the supposed cause and the supposed effect of the study. It can be difficult to separate the true effect of the independent variable from the effect of the confounding variable.

In your research design , it’s important to identify potential confounding variables and plan how you will reduce their impact.

Discrete and continuous variables are two types of quantitative variables :

• Discrete variables represent counts (e.g. the number of objects in a collection).
• Continuous variables represent measurable amounts (e.g. water volume or weight).

Quantitative variables are any variables where the data represent amounts (e.g. height, weight, or age).

Categorical variables are any variables where the data represent groups. This includes rankings (e.g. finishing places in a race), classifications (e.g. brands of cereal), and binary outcomes (e.g. coin flips).

You need to know what type of variables you are working with to choose the right statistical test for your data and interpret your results .

You can think of independent and dependent variables in terms of cause and effect: an independent variable is the variable you think is the cause , while a dependent variable is the effect .

In an experiment, you manipulate the independent variable and measure the outcome in the dependent variable. For example, in an experiment about the effect of nutrients on crop growth:

• The  independent variable  is the amount of nutrients added to the crop field.
• The  dependent variable is the biomass of the crops at harvest time.

Defining your variables, and deciding how you will manipulate and measure them, is an important part of experimental design .

Experimental design means planning a set of procedures to investigate a relationship between variables . To design a controlled experiment, you need:

• A testable hypothesis
• At least one independent variable that can be precisely manipulated
• At least one dependent variable that can be precisely measured

When designing the experiment, you decide:

• How you will manipulate the variable(s)
• How you will control for any potential confounding variables
• How many subjects or samples will be included in the study
• How subjects will be assigned to treatment levels

Experimental design is essential to the internal and external validity of your experiment.

I nternal validity is the degree of confidence that the causal relationship you are testing is not influenced by other factors or variables .

External validity is the extent to which your results can be generalized to other contexts.

The validity of your experiment depends on your experimental design .

Reliability and validity are both about how well a method measures something:

• Reliability refers to the  consistency of a measure (whether the results can be reproduced under the same conditions).
• Validity   refers to the  accuracy of a measure (whether the results really do represent what they are supposed to measure).

If you are doing experimental research, you also have to consider the internal and external validity of your experiment.

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

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.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

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Experiment vs Observational Study: A Deeper Look

When we read about research studies and reports, many are times that we fail to pay attention to the design of the study. For you to know the quality of the research findings, it is paramount to start by understanding some basics of research/study design.

The primary goal of doing a study is to evaluate the relationship between several variables. For example, does eating fast food result in teenagers being overweight? Or does going to college increase the chances of getting a job? Most studies fall into two main categories, observational and experimental studies, but what is the difference? Other widely accepted research types are cohort studies, randomized controls, and case-control studies, but these three are part of either experimental or observational study. Keep reading to understand the difference between observational study and experiment.

What Is An Observational Study?

To understand observational study vs experiment, let us start by looking at each of them.

So, what is an observational study ? This is a form of research where the measurement is done on the selected sample without running a control experiment. Therefore, the researcher observes the impact of a specific risk factor, such as treatment or intervention, without focusing on who is not exposed. It is simply a matter of observing what is happening.

When an observational report is released, it indicates that there might be a relationship between several variables, but this cannot be relied on. It is simply too weak or biased. We will demonstrate this with an example.

A study asking people how they liked a new film that was released a few months ago is a good example of an observational study. The researcher in the study does not have any control over the participants. Therefore, even if the study point to some relationship between the main variables, it is considered too weak. For example, the study did not factor in the possibility of viewers watching other films.

The main difference between an observational study and an experiment is that the latter is randomized . Again, unlike the observational study statistics, which are considered biased and weak, evidence from experimental research is stronger.

Advantages of Observational Studies

If you are thinking of carrying a research and have been wondering whether to go for randomized experiment vs observational study, here are some key advantages of the latter.

• Because the observational study does not require the use of control, it is inexpensive to undertake. Suppose you take the example of a study looking at the impact of introducing a new learning method into a school. In that case, all you need is to ask any interested students to participate in a survey with questions, such as “yes” and “no.”
• Doing observational research can also be pretty simple because you do not have to keep looking into multiple variables, and trying to control some groups.
• Sometimes the observational method is the only way to study some things, such as exposure to specific threats. For example, it might not be ethical to expose people to harmful variables, such as radiation. However, it is possible to study the exposed population living in affected areas using observational studies.

While the advantages of observational research might appear attractive, you need to weigh them against the cons. To run conclusive observational research, you might require a lot of time. Sometimes, this might run for years or decades.

The results from observational studies are also open to a lot of criticism because of confounding biases. For example, a cohort study might conclude that most people who love to meditate regularly suffer less from heart issues. However, this alone might not be the only cause of low cases of heart problems. The people who medicate might also be following healthy diets and doing a lot of exercises to stay healthy.

Types of Observational Studies

Observational studies further branches into several categories, including cohort study, cross-sectional, and case-control. Here is a breakdown of these different types of studies:

• Cohort Study

For study purposes, a “cohort” is a team or group of people who are somehow linked. Example, people born within a specific period might be referred to as a “birth cohort.”

The concept of cohort study edges close to that of experimental research. Here, the researcher records whether every participant in the cohort is affected by the selected variables. In a medical setting, the researcher might want to know whether the cohort population in the study got exposed to a certain variable and if they developed the medical condition of interest. This is the most preferred method of study when urgent response, especially to a public health concern, such as a disease outbreak is reported.

It is important to appreciate that this is different from experimental research because the investigator simply observes but does not determine the exposure status of the participants.

• Case Control Study

In this type of study, the researcher enrolls people with a health issue and another without the problem. Then, the two groups are compared based on exposure. The control group is used to generate an estimate of the expected exposure in the population.

• Cross-Sectional Research

This is the third type of observational type of study, and it involves taking a sample from a population that is exposed to health risk and measuring them to establish the extent of the outcome. This study is very common in health settings when researchers want to know the prevalence of a health condition at any specific moment. For example, in a cross-sectional study, some of the selected persons might have lived with high blood pressure for years, while others might have started seeing the signs recently.

Experimental Studies

Now that you know the observational study definition, we will now compare it with experiment research. So, what is experimental research?

In experimental design, the researcher randomly assigns a selected part of the population some treatment to make a cause and effect conclusion. The random selection of samples is largely what makes the experiment different from the observational study design.

The researcher controls the environment, such as exposure levels, and then checks the response produced by the population. In science, the evidence generated by experimental studies is stronger and less contested compared to that produced by observational studies.

Sometimes, you might find experimental study design being referred to as a scientific study. Always remember that when using experimental studies, you need two groups, the main experiment group (part of the population exposed to a variable) and the control (another group that does not get exposed/ treatment by the researcher).

Benefits of Using Experimental Study Design

Here are the main advantages to expect for using experimental study vs observational experiment.

• Most experimental studies are shorter and smaller compared to observational studies.
• The study, especially the selected sample and control group, is monitored closely to ensure the results are accurate.
• Experimental study is the most preferred method of study when targeting uncontested results.

When using experimental studies, it is important to appreciate that it can be pretty expensive because you are essentially following two groups, the experiment sample and control. The cost also arises from the factor that you might need to control the exposure levels and closely follow the progress before drawing a conclusion.

Observational Study vs Experiment: Examples

Now that we have looked at how each design, experimental and observational, work, we will now turn to examples and identify their application.

To improve the quality of life, many people are trying to quit smoking by following different strategies, but it is true that quitting is not easy. So the methods that are used by smokers include:

• Using drugs to reduce addiction to nicotine.
• Using therapy to train smokers how to stop smoking.
• Combining therapy and drugs.
• Cold turkey (neither of the above).

The variable in the study is (I, II, III, IV), and the outcome or response is success or failure to quit the problem of smoking. If you select to use an observational method, the values of the variables (I, ii, iii, iv) would happen naturally, meaning that you would not control them. In an experimental study, values would be assigned by the researcher, implying that you would tell the participants the methods to use. Here is a demonstration:

• Observational Study: Here, you would imagine a population of people trying to quit smoking. Then, use a survey, such as online or telephone interviews, to reach the smokers trying to stop the habit. After a year later, you reach the same persons again, to enquire whether they were successful. Note that you do not run any control over the population.
• Experimental study: In this case, a representative sample of smokers trying to stop the habit is selected through a survey. Say you reach about 1000. Now, the number is divided into four groups of 250 persons, and each group is allocated one of the four methods above (i, ii, iii, or iv).

The results from the experimental study might be as shown below:

From the results of the experimental study, we can say that combining therapy and drugs method helped most smokers to quit the habit successfully. Therefore, a policy can be developed to adopt the most successful method for helping smokers quit the problem.

It is important to note that both studies commence with a random sample. The difference between an observational study and an experiment is that the sample is divided in the latter while it is not in the former. In the case of the experimental study, the researcher is controlling the main variables and then checking the relationship.

A researcher picked a random sample of learners in a class and asked them about their study habits at home. The data showed that students who used at least 30 minutes to study after school scored better grades than those who never studied at all.

This type of study can be classified as observational because the researcher simply asked the respondents about their study habits after school. Because there was no group given a particular treatment, the study cannot qualify as experimental.

In another study, the researcher randomly picked two groups of students in school to determine the effectiveness of a new study method. Group one was asked to follow the new method for a period of three months, while the other was asked to simply study the way they were used. Then, the researcher checked the scores between the two groups to determine if the new method is better.

So, is this an experimental or observational study? This type of study can be categorized as experimental because the researcher randomly picked two groups of respondents. Then, one group was given some treatment, and the other one was not.

In one of the studies, the researcher took a random sample of people and looked at their eating habits. Then, every member was classified as either healthy or at risk of developing obesity. The researcher also drew recommendations to help people at risk of developing overweight issues to avoid the problem.

This type of study is observational because the researcher took a random sample but did no accord any group a special treatment. The study simply observed the people’s eating habits and classified them.

In one of the studies done in Japan, the researcher wanted to know the levels of radioactive materials in people’s tissues after the bombing of Hiroshima and Nagasaki in 1945. Therefore, he took a random sample of 1000 people in the region and asked them to get checked to determine the levels of radiation in their tissues.

After the study, the researcher concluded that the level of radiation in people’s tissues is still very high and might be associated with different types of diseases being reported in the region. Can you determine what type of study design this is?

The research is an example observational study because it did not have any control. The researcher only observed the levels but did not have any type of control group. Again, there was no special treatment to one of the study populations.

Get Professional Help Whenever You Need It

If you are a researcher, it is very important to be able to define observational study and experiment research before commencing your work. This can help you to determine the different parameters and how to go about the study. As we have demonstrated, observational studies mainly involve gathering the findings from the field without trying to control the variables. Although this study’s results can be contested, it is the most recommended method when using other studies such as experimental design, is unfeasible or unethical.

Experimental studies giving the researcher greater control over the study population by controlling the variables. Although more expensive, it takes a relatively shorter time, and results are less biased.

Now, go ahead and design your study. Always remember that you can seek help from either your lecturer or an expert when designing the study. Once you understand the concept of observational study vs experiment well, research can become so enjoyable and fun.

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Controllable Preparation and Mechanism Study of Easy‑Peel High‑Density and Vertically Aligned Carbon Nanotube Forests

• Yan, Yongjie
• Feng, Qingqing
• Ni, Qingqing

The stripping of carbon nanotube forests (CNTF) is an urgent problem in terms of its application in thermal management and semiconductor devices. The easy‑peel and vertically aligned CNTF is prepared in a two‑step process of high vacuum magnetron sputtering and chemical vapor deposition. Based on the thick alumina buffer layer, CNTF with heights of 100 μm, 300 μm, and 500 μm was prepared by adjusting the magnetron sputtering power. Through SEM observation and calculation, the corresponding densities were 2.5 × 109 cm−2, 6.4 × 109 cm−2, and 1.21 × 1010 cm−2, with an average curvature of 1.64 × 102 m−1, 1.35 × 102 m−1 and 0.53 × 102 m‑−1, respectively. The TEM, XPS, Raman, and TGA were used to investigate the growth mechanism of CNTF. The experimental results show that the catalyst particles annealed under high sputtering power refined with high density can grow a low‑defect, well‑oriented, and high‑density CNTF, and confirm the tip growth route. Further analysis shows that the easy‑peel properties of CNTF depend on the thickness of the alumina layer, the tip growth route, and the tight entanglement between the nanotubes. This paper provides technical guidance and support for the preparation, stripping, and application of monolithic CNTF.

• Open access
• Published: 24 July 2024

Machine learning for accurate detection of small airway dysfunction-related respiratory changes: an observational study

• Wen-Jing Xu 1 ,
• Wen-Yi Shang 2 ,
• Jia-Ming Feng 3 ,
• Xin-Yue Song 1 ,
• Liang-Yuan Li 1 ,
• Xin-Peng Xie 4 ,
• Yan-Mei Wang 5 &
• Bin-Miao Liang 1  

Respiratory Research volume  25 , Article number:  286 ( 2024 ) Cite this article

126 Accesses

Metrics details

The use of machine learning(ML) methods would improve the diagnosis of small airway dysfunction(SAD) in subjects with chronic respiratory symptoms and preserved pulmonary function(PPF). This paper evaluated the performance of several ML algorithms associated with the impulse oscillometry(IOS) analysis to aid in the diagnostic of respiratory changes in SAD. We also find out the best configuration for this task.

IOS and spirometry were measured in 280 subjects, including a healthy control group ( n  = 78), a group with normal spirometry ( n  = 158) and a group with abnormal spirometry ( n  = 44). Various supervised machine learning (ML) algorithms and feature selection strategies were examined, such as Support Vector Machines (SVM), Random Forests (RF), Adaptive Boosting (ADABOOST), Navie Bayesian (BAYES), and K-Nearest Neighbors (KNN).

The first experiment of this study demonstrated that the best oscillometric parameter (BOP) was R5, with an AUC value of 0.642, when comparing a healthy control group(CG) with patients in the group without lung volume-defined SAD(PPFN). The AUC value of BOP in the control group was 0.769 compared with patients with spirometry defined SAD(PPFA) in the PPF population. In the second experiment, the ML technique was used. In CGvsPPFN, RF and ADABOOST had the best diagnostic results (AUC = 0.914, 0.915), with significantly higher accuracy compared to BOP ( p  < 0.01). In CGvsPPFA, RF and ADABOOST had the best diagnostic results (AUC = 0.951, 0.971) and significantly higher diagnostic accuracy ( p  < 0.01). In the third, fourth and fifth experiments, different feature selection techniques allowed us to find the best IOS parameters (R5, (R5-R20)/R5 and Fres). The results demonstrate that the performance of ADABOOST remained essentially unaltered following the application of the feature selector, whereas the diagnostic accuracy of the remaining four classifiers (RF, SVM, BAYES, and KNN) is marginally enhanced.

Conclusions

IOS combined with ML algorithms provide a new method for diagnosing SAD in subjects with chronic respiratory symptoms and PPF. The present study’s findings provide evidence that this combination may help in the early diagnosis of respiratory changes in these patients.

Two major chronic respiratory disorders that can affect the small airways include asthma and chronic obstructive pulmonary disease (COPD). Evidence from prospective studies indicates that asthma and COPD may occur before small airway dysfunction (SAD) [ 1 , 2 , 3 ]. Symptoms of COPD and asthma include coughing, producing phlegm, dyspnea, and wheezing. The following symptoms may indicate SAD in some subjects: negative airway hyperresponsiveness (AHR) or bronchial reversibility (BR), which means the subject does not meet the pulmonary function criteria for COPD or asthma, and preserved pulmonary function (PPF, forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio ≥ 0.70 [ 4 ]). According to a large-scale multi-stage stratified sampling survey, about 40% of Chinese individuals 20 years of age and older have spirometrically characterized SAD [ 5 ]. Owing to the severe impact of SAD, it was crucial to identify and treat the condition early.

The “quiet zone” is made up of small airways (with an inner diameter of less than 2 mm), which had a huge cross-sectional area and contribute very little to the total airway resistance. [ 6 ] In clinical practice, spirometry was the most widely used technique to assess small-airway function. The parameters that were employed include FVC50% (FEF50%), FVC75% at expiration (FEF75%), and forced expiratory flow between 25% and 75% of FVC (FEF25–75%). At least two of the three small airway markers (FEF25–75%, FEF50%, and FEF75%) had a projected value of less than 65%, which was the definition of spirometry SAD [ 5 ]. However, spirometry requires good cooperation of subjects, and the great variability of values makes its reliability not universally accepted [ 7 , 8 ]. An approach to measuring respiratory impedance based on the forced oscillation technique (FOT) is called impulse oscillometry (IOS). All that is needed for the IOS measurement is quiet tidal breathing, which is easy to do, appropriate for a broad spectrum of individuals, and yields a variety of respiratory physiological data. IOS is able to measure the respiratory mechanics during quiet tidal breathing, which sets it apart from spirometry. Because of externally overlaid oscillatory signals, it is independent of subject effort, unlike spirometry [ 9 ]. Furthermore, it appears to correlate better with small airway features and may be more sensitive in identifying SAD [ 10 , 11 , 12 ]. Since IOS can reflect the viscosity of the respiratory system through electrical resistance (RRS) and the elastic and inertial properties of the respiratory system through reactance (XRS), it can be combined with spirometry to gain more insight into individual pathological changes.

IOS was not currently frequently utilized in pulmonary function assessment, though. This approach’s drawback stems from the fact that it relied on electrical engineering ideas, which might be challenging to interpret in a clinical context. Another important consideration is the expensive inspection apparatus. Therefore, even though the IOS test is straightforward, a busy, inexperienced pulmonary function technician or primary care physician would find it challenging to interpret the resistance and reactance curves, as well as the derived values, without proper training and expertise. Furthermore, the analysis is challenging due to the findings for the IOS test values being dispersed. Consequently, machine learning (ML)-based computer-aided decision systems can enhance the functionality of IOS and support physicians in strengthening the diagnosis, monitoring, and treatment of chronic respiratory disorders, such as asthma and COPD.

In this context, we hypothesized that the use of ML methods in combination with IOS test would improve the diagnosis of small airway function in PPF populations. This study aims to evaluate the performance of several ML algorithms in diagnosing SAD in PPF population, and to find the best configuration.

Materials and methods

Study population.

This was a single-centered, observational study in the Pulmonary Function Laboratory of West China Hospital, Sichuan University. Subjects were recruited and tested from May 1st to September 1st, 2020.

Included were adult patients undergoing pulmonary function tests as a result of persistent respiratory complaints. In addition, participants must meet the PPF requirements (FEV1/FVC ≥ 0.70) [ 4 ]. The following conditions had to be met in order to be excluded: restrictive pulmonary diseases (FVC < 80% predicted), asthma, interstitial lung diseases, lung cancer, respiratory infection within two weeks, myocardial ischemia, history of pulmonary surgery, and incomplete IOS due to tongue position errors, vocal cord closures, or swallowing. As healthy controls, we also enrolled never-smokers (those with ≤ 1 pack-year of tobacco smoking history) with a normal chest radiograph, no active pulmonary conditions, and no unstable cardiovascular disorders. Basic demographic data was gathered, such as height, weight, age, sex, and body mass index (BMI). Subjects received IOS, spirometry, and completed a questionnaire covering qualitative and quantitative evaluation of symptoms. Also, bronchial provocation tests or bronchodilator tests were performed to exclude asthma. The study was approved by the ethics committee of West China Hospital, Sichuan University, and all participants signed an informed consent before the procedure.

Impulse oscillometry and parameters

In accordance with ERS guidelines, the respiratory resistance and reactance were measured using IOS equipment (MS-IOS Jaeger) [ 9 ]. Because forced expiration may alter airway tone, IOS was performed prior to spirometry [ 13 ]. Pressure oscillations generated by a loudspeaker were superimposed onto normal tidal breathing through a mouthpiece for 30 to 45 s, which ranged from 5 to 35 Hz in frequency. Sitting upright, subjects were asked to wear a nasal clip and exert manual compression on their faces to minimize the influence of cheek vibration and air leak.

The IOS parameters selected in this paper and their clinical significance are as follows:

(1) Respiratory resistance at 5 Hz (R5): reflects the total viscous resistance of the respiratory system, because it is mainly airway resistance, also known as total airway resistance.

(2) Respiratory resistance at 20 Hz (R20): reflects central airway resistance.

(3) The difference between R5 and R20 (R5–R20): reflects the frequency dependence of resistance, that is, peripheral airway resistance. That is, the change of respiratory system resistance when the oscillation frequency is gradually increased.

(4) (R5-R20)/R5(%): the ratio of peripheral airway resistance to total airway resistance.

(5) Reactance at 5 Hz (X5): reflects the total elastic resistance of the respiratory system. Because the elastic resistance of the lung and thorax is the main one, it is often called peripheral elastic resistance, and also includes gas compression in the airway and alveoli. X5 is generally negative, with higher negative values indicating greater elastic resistance.

(6) Reactance area (AX): The area enclosed by the Xrs f frequency curve between 5 Hz and Fres and the horizontal 0 axis. AX is the integration of the low frequency reactance.

(7) Resonant frequency (Fres): The inertial resistance and elastic resistance are in opposite directions. When the two are equal and cancel each other, the reactance of the respiratory system is zero.

Spirometry and parameters

Spirometry was performed by a full MasterScreen PFT System (Jaeger Corp. Germany) according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines [ 14 ]. FEV1, FVC, FEV1/ FVC, FEF25–75%, FEF50% and FEF75% were recorded as percentages of predicted values. The prediction equations are based on a large study of normal spirometry values in Chinese aged 4–80 years, which is recommended in the spirometry guideline in China [ 15 ].

The data collection used for the experiments included measurements from 280 participant groups. The data set contained information from the volunteers’ IOS test and lung function in addition to biological data like age, sex, height, and weight. The PPF patients without SAD (PPFN group) contributed 158 sets, the PPF patients with SAD (PPFA group) contributed 44 sets, and the healthy control group (CG group) contributed 78 sets. Using random sampling, the data set is split into training and test sets in a 7:3 ratio. All of the given results were from test sets. The adjustment of the hyperparameters was obtained by manual tuning, taking the hyperparameter with the best average result.

The studied classifiers

The discrete data measured by IOS can be thoroughly analyzed by ML algorithms to identify potential relationships. These ML algorithms were assessed in this study based on the findings of earlier research and pre-experiments:

(1) Random forests: A method of decision tree analysis in which a supervised algorithm works through “bagging” approach to create multiple decision trees with a random subset of the data. These decision trees are then merged to get a more accurate and stable prediction [ 16 ].

(2) Support vector machine: A supervised ML algorithm that classifies data points by finding the optimal hyperplane that maximally separates different classes in a high-dimensional space [ 17 ].

(3) Naive Bayes: A probabilistic classifier based on Bayes’ theorem [ 18 ].

(4) Adaptive Boosting (ADABOOST): A statistical classification algorithm that is frequently used with other “weaker” ML algorithms (e.g., decision tree) to improve their performance. [ 19 ]

(5) K-Nearest Neighbor (KNN): A common unsupervised ML method, in which unsupervised algorithms aim to group input vectors into k clusters based on k averages of points (i.e., centroids) without referring to known, or labeled outcomes [ 20 ].

In addition, this study conducted feature selection and investigated the use of SelectKBest, RFECV, and SelectFromModel algorithms in this experiment in order to find IOS parameters with a better correlation with the experimental results and minimize the complexity of the experimental data set.

(6) SelectKBest : A feature selection method based on statistical tests, which selects K features that are most relevant to the target variable according to some evaluation index. [ 21 ]

(7) RFECV: A Feature selection method in scikit-learn that combines Recursive Feature Elimination (RFE) and Cross-Validation (CV) to select the best feature subset [ 22 ].

(8) SelectFromModel: A feature selection method in scikit-learn, which selects the most relevant features based on the feature importance of the supervised learning model. [ 23 ]

Experiment design

This study involved the conduct of five experiments.

The first experiment’s goal was to assess each IOS parameter’s capacity to identify SAD in patients with PPF. The study’s criteria for diagnosing SAD were two out of the three small airway measurements (FEF25-75%, FEF50%, and FEF75%) having a predictive value of less than 65% according to spirometry. We examined two distinct scenarios: control versus PPF patients without SAD (CGvsPPFN) and control versus PPF patients with SAD (CGvsPPFA) in order to accurately assess the degree of airway blockage in patients with PPF. The two situations described were likewise assessed in the remaining studies.

The second experiment employed the ML algorithm and compared it to the results obtained using a single IOS parameter to ascertain whether the ML algorithm could achieve superior performance. The area under the ROC curve (AUC) was then selected as the performance evaluation metric. All IOS parameter characteristics for this experiment were included in the selection process.

In the third experiment, the effectiveness of SelectKBest as a feature selector for lowering complexity and determining the significance of various IOS parameters was evaluated. Five classifiers were used for training once SelectKBest had chosen the IOS parameters.

In the fourth and fifth experiments, two model-dependent feature selection algorithms were employed to investigate the significance of the 7 IOS feature parameters in this study.Recursive Feature Elimination with Cross-Validation, or RFECV, was used in Experiment 4. RFECV fits a machine learning model to data, ranks features according to their weights or importance, recursively removes the least important features, and uses cross-validation to assess model performance in each iteration. RFECV creates a performance curve by recording the results of varying numbers of features removed in each round. Using SelectFromModel, the most pertinent characteristics were chosen in Experiment 5 based on the significance of the features in a supervised learning model. To increase model efficiency and generalization while preserving important information, the technique selects features over a threshold, computes feature importance scores, trains a supervised learning model, and then generates a new feature set.

Hypothesis testing is necessary to contrast ML algorithms. A wide variety of parametric tests are available, often based on t-tests. The Wilcoxon Rank-Sum Test, the Kruskal-Wallis Test, and the Mann-Whitney U Test are a few of the most often used nonparametric tests [ 24 , 25 , 26 ]. We used the permutation test to do hypothesis testing of AUCs in this work. [ 27 , 28 ].

Table  1 displays the individuals’ biological parameters, spirometry results, chronic respiratory complaints, and IOS data. There was no discernible difference between any of the three research groups’ biological characteristics. There was no discernible difference in symptoms between the groups with and without spirometer-defined SAD for individuals with persistent respiratory symptoms. PPFA patients exhibited considerably lower spirometry parameters ( p  < 0.05), as Table  1 illustrates.

(The last column describes the comparisons between groups, in which the dot means non-significant change, while the dash means significant change.)

Figure  1 ’s bar graphs display the distinct features of the IOS parameters for the CG, PPFN, and PPFA groups. The majority of IOS parameters were substantially different ( p  < 0.05) across the three groups, according to the analysis of variance (ANOVA). PPF patients showed higher R5 and R20 when compared to healthy people. PPF patients consequently had greater airway resistance. In the meantime, patients with SAD in the PPF group showed greater values of R5, R5-R20, AXV, and Fres. The three groups’ R5-R20/R5 and X5 levels were comparable.

Comparison of IOS parameters among the three groups. Bar charts represented Mean + SD (M + SD). * indicates that there is a statistically significant difference comparing to each IOS parameter for each group. * P  < 0.05, ** P  < 0.01, *** P  < 0.001, **** P  < 0.0001

The first experiment: diagnostic accuracy of IOS parameters.

Figure  2 presents the findings from Experiment 1. As can be observed, R5 was the best IOS parameter (BOP) for PPF patient diagnosis, with moderate diagnostic accuracy (AUC = 0.642, AUC = 0.769) for CG vs. PPFN and CG vs. PPFA scenarios.

Results of experiment 1, describing the diagnostic accuracy of Impulse oscillometry in subjects with chronic respiratory symptoms and preserved pulmonary function. More detailed tables and graphs regarding these results are available in the Additional file.(Additional file Figure S1 )

The second experiment of the study: diagnostic accuracy of the original IOS parameters associated with ML techniques.

Figure  3 presents the AUCs of the BOP, ML algorithm, and MIL classifier obtained in Experiment 2. It can be seen that the ML algorithm improves the AUC with high diagnostic accuracy in both cases, CGvsPPFN and CGvsPPFA. In the CGvsPPFN scenario, ADABOOST (AUC = 0.915) had the best performance, followed by RF (AUC = 0.914). Compared with BOP, RF, SVM, ADABOOST and KNN showed statistical differences. In the CGvsPPFA scenario, ADABOOST (AUC = 0.971) had the best performance, followed by RF (AUC = 0.951). Compared with BOP, RF, SVM, ADABOOST and KNN showed statistical differences.

Results of experiment 2, describing the diagnostic accuracy of Impulse oscillometry with ML algorithms in subjects with chronic respiratory symptoms and preserved pulmonary function. Also, * indicates that there a statistically significant difference comparing to BOP ( p  < 0.05). * P  < 0.05, ** P  < 0.01. More detailed tables and graphs regarding these results are available in the Additional file.(Additional file Figure S2 - S3 )

The third experiment: diagnostic accuracy of the best original IOS parameters associated with ML techniques.

The IOS parameters used for the two cases, CGvsPPFN and CGvsPPFA, respectively, utilizing SelectKBest as the feature selector, are shown in Table  2 .

Experiments 2 and 3 had superior AUC outcomes, as shown by the data in Fig.  4 . A similar pattern was seen in both cases when SelectKBest was used as the feature selector: as the number of features increased, the ML algorithm’s performance improved over time. When choosing 3/5 IOS feature parameters, the AUC value decreased slightly, but overall, the diagnostic performance was still better than BOP.

Summary of Experiment 2 and Experiment 3 (SelectKBest as a feature selector)—AUCs for the best oscillometric parameter (BOP), for the best ML algorithms in experiments 3, and the best ML algorithm with oscillometric parameters (ADABOOST). The figure indicates the best ML algorithm in each case. Also, * indicates that there a statistically significant difference comparing to BOP ( p  < 0.05). * P  < 0.05, ** P  < 0.01. More detailed tables and graphs regarding these results are available in the Additional file.(Additional file Figure S4 - S7 )

The fourth and fifth experiment: diagnostic accuracy of the IOS parameters associated with ML techniques.

The best AUC findings for Experiments 4 and 5 are shown in Fig.  5 . When compared to the full parameter, the IOS feature parameter’s diagnostic performance tends to be similar in both situations and to hold onto a high diagnostic value following feature selection.

The task configurations for each ML method classifier with the best performance across all experiments were summarized in Tables  3 and 4 . In the two scenarios of CGvsPPFN and CGvsPPFA, among them, RF, SVM, ADABOOST, and KNN may increase the AUC, and the difference was statistically significant. Furthermore, The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of various individual ML classifiers are also reported.

Summary of Experiment 4 and Experiment 5—AUCs for the best oscillometric parameter (BOP), for the best ML algorithms in experiments 4 and 5, and the best ML algorithm with oscillometric parameters. The figure indicates the best ML algorithm in each case. Also, * indicates that there a statistically significant difference comparing to BOP ( p  < 0.05). * P  < 0.05, ** P  < 0.01.More detailed tables and graphs regarding these results are available in the Additional file.(Additional file Figure S8 - S19 )

For the purpose of early screening and treatment of respiratory disorders, a number of chronic respiratory disease guidelines, including GINA 2023 and GOLD 2024, advise early monitoring of changes in small airway function. In our previous study, we found that IOS is more sensitive to detect SAD than spirometry in subjects with chronic respiratory symptoms and PPF, and it correlates better with symptoms. IOS could be an additional method for SAD detection in the early stage of diseases [ 29 ]. Other similar research has demonstrated the usefulness of small airway function monitoring with IOS for clinical diagnosis [ 30 , 31 , 32 ]. We found only four correlated IOS parameters, including R5, R5-R20, AX, and Fres, which had low diagnostic efficacy, with none of the AUC values exceeding 0.7.

In order to facilitate the diagnosis of respiratory disorders, this study describes the design of a classifier for SAD diseases in the PPF population.By using machine learning approaches, this work aims to improve the diagnostic value of IOS for small airway dysfunction. Additionally, the best set of parameters and algorithms for this task was determined. Compared to a single IOS measure, the results show that this approach increases diagnostic accuracy and streamlines the clinical assessment of IOS.

Similar to our previous study, we found that R5 had the best AUC value, better sensitivity and slightly lower specificity among all parameters. After the introduction of the machine learning algorithm, the AUC, sensitivity, and specificity of the prediction model were very significantly improved.The best performance in both CGvsPPFN and CGvsPPFA scenarios was achieved by R5, which was the single IOS parameter used in the first experiment. The finding supports the presence of elevated airway resistance in patients with SAD, as measured by various methods including CT scans and bronchoscopy. It is important to note that these results are based on objective measurements rather than subjective evaluations [ 33 , 34 ].

In the first case, it was more challenging to differentiate the control group from the patients with PPF who had preserved lung function. This was due to the small differences in IOS parameters. The AUC value was 0.642, indicating low diagnostic accuracy. In the second case, the increase in physiological abnormalities resulted in a greater difference in measured parameters, enabling R5 to easily distinguish between the two groups with an AUC of 0.769. These findings suggest that a single IOS parameter may not be sufficient to accurately identify the SAD situation in the PPF population.

The diagnostic accuracy was significantly enhanced through the utilization of RF, SVM, BAYES, ADABOOST, and KNN algorithms. It is clear that ADABOOST and RF produced the most favorable results followed by KNN, SVM and BYS.This breakthrough is mainly due to the use of ML algorithms.Similar to earlier research [ 35 , 36 , 37 , 38 ], feature selection permits the use of fewer characteristics without appreciably lowering performance. When SelectKBest was employed as a feature selector, the 3/5 relevant features were selected, respectively. Despite the final trend indicating that the results are superior when more parameters are used, the difference between using the least and most parameters is relatively minor. Furthermore, the results are superior when using the least parameters than when using BOP alone. This implies that feature selection can in fact result in good diagnostic value (AUC 0.948 and 0.967, respectively) with fewer IOS parameters. The most pertinent features are found through feature selection in both the CGvsPPFN and CGvsPPFA scenarios. Despite the fact that the approach only chose two sets of features, R20 and Fres had a significant intersection. This intersection is slightly different from the results of the ability of each single IOS parameter to diagnose SAD in patients with PPF, showing better diagnostic ability for R5 when using a single parameter. This suggests resonant frequency and central airway resistance, in addition to total airway resistance, have a significant role in the increased airway blockage observed in the PPF population.

Compared to the conventional classifier SelectFromModel, the RFECV method may produce superior results and has an efficient selection capability. While it does not increase the accuracy of diagnosis, it does display significant traits like R5, (R5-R20)/R5, and Fres. Feature selection was done to make the analysis easier to understand. We were able to discriminate between groups with clarity by using these three essential criteria. These results support the idea of a simple diagnostic model that can help explain the suggested medical decision support system’s findings and make it easier to apply in clinical settings.

Recent studies have shown that IOS is considered the most advanced technique for lung function analysis and is one of the most promising emerging techniques in the field [ 29 , 39 , 40 , 41 ]. Despite its advantages in providing detailed and direct examination, IOS has not yet been widely used. However, because interpreting the metrics—which are based on electrical modeling—requires knowledge and experience, their application is restricted. This study shows how ML algorithms can improve the diagnosis of associated diseases and simplify the use of IOS, therefore improving healthcare for patients with SAD.

Early detection of abnormal respiratory changes in SAD can facilitate timely interventions that may limit disease progression, alleviate adverse symptoms, improve overall health, prevent complications and comorbidities, and reduce premature mortality [ 5 , 42 ]. Since the 1980s, lung function analysis has been improved by artificial intelligence and machine learning techniques [ 43 , 44 , 45 , 46 , 47 , 48 ]. The present work expands on previous results by demonstrating that early aberrant respiratory alterations in SAD may be suggested by a combination of IOS measures and a clinical decision support system based on ML technology.

The algorithm presented in this work can be applied not just to SAD but to a variety of other conditions, including asthma, COPD, interstitial lung disease, and others. By establishing appropriate models and finding the best parameters, the relationship between physiological parameters and the development of the disease can be explored. This benefits the early screening of other respiratory diseases and the reduction of the disease burden on patients.

Clinical technology-wise, more thorough information can be obtained by combining IOS with other imaging modalities (such as MRI, CT, PET, etc.) and by developing real-time imaging technology and dynamic observation techniques. More information for clinical diagnosis and scientific study will be available with the improvement of image contrast and anatomical detail. [ 49 ] Concurrently, artificial intelligence and machine learning are integrated to analyse and interpret multiple data types, enhance the accuracy and credibility of clinical examination results, and develop automated and intelligent analysis tools. Encouraging data sharing and IOS standardization, creating a platform for data sharing and standardizing data formats, facilitating multi-center data comparison and analysis, and promoting the field’s progress are all crucial in the context of big data [ 50 ].

Finally, it is important to consider and clarify some significant limitations. Firstly, this study is limited to the Chinese population in a specific location. Therefore, it is not possible to ensure its generalisability to different populations. It is recommended that future studies investigate multi-centre data to expand the generalisability of the findings. The experimental design of this work followed globally recognised inclusion and exclusion criteria and was conducted in a typical clinical setting.

Additionally, it is important to note that the PPF population in China is relatively small due to low public health awareness. Many individuals do not seek medical attention promptly when experiencing clinical symptoms such as cough and chest tightness. Therefore, due to the relatively small size of the available dataset, it is necessary to carefully control the complexity of the ML model. In addition to the measures taken in this study to avoid overfitting, such as controlling hyperparameters, feature selection can also aid in controlling overfitting by reducing inputs. Another reason for using feature selection is that a smaller number of features can help simplify the analysis. Furthermore, utilising only three features enables the visualisation of group separation, aiding diagnostic interpretation.

In this work, a variety of machine learning algorithms were utilized to create a clinical auxiliary diagnosis system that can identify respiratory anomalies in patients with PPF. In the initial disease stage (CGvsPPFN), respiratory oscillation parameters achieved low diagnostic accuracy (AUC = 0.642), but ML classifiers significantly improved accuracy (AUC ≥ 0.9). In the progressive disease stage (CGvsPPFA), using oscillation parameters alone yielded moderate accuracy (AUC = 0.769), while ML algorithms greatly enhanced accuracy (AUC ≥ 0.9). The developed diagnostic system simplifies IOS application in PPF patients, utilizing key IOS parameters identified through feature selection. All things considered, combining ML algorithms with IOS examination improves pulmonary function assessment in PPF patients, indicating future improvements in patient care.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

Chronic obstructive pulmonary disease

• Small airway dysfunction
• Preserved pulmonary function
• Machine learning

Random Forests

Support Vector Machines

Navie Bayesian

Adaptive Boosting

K-Nearest Neighbors

The forced expiratory volume in 1st s

Forced vital capacity

Airway hyper-responsiveness

Bronchial reversibility

The forced expiratory flow between 25 and 75% of FVC; FEF50%:The forced expiratory flow when 50% of FVC has been exhaled

The forced expiratory flow when 75% of FVC has been exhaled

• Impulse oscillometry

Resistance of the respiratory system

Reactance of the respiratory system

Respiratory resistance at 5 Hz

Respiratory resistance at 20 Hz

The difference between R5 and R20

Reactance at 5 Hz

Resonant Frequency

Area under reactance curve between Fres and5 Hz

Best Oscillometric Parameter

American Thoracic Society

Europe Respiratory Society

Receiver Operator Characteristic

Area Under the Curve

Positive Predictive Value

Negative Predictive Value

Body Mass Index

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Acknowledgements

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This study was partly supported by the National Nature Science Foundation of China Grant (NSFC No.81800016), Sichuan Science and Technology Agency Grant (2019YFS0033). The funders had no roles in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Wen-Jing Xu, Xin-Yue Song, Liang-Yuan Li & Bin-Miao Liang

Machine Intelligence Laboratory, College of Computer Science, Sichuan University, Chengdu, 610065, China

Wen-Yi Shang

West China School of Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, P. R. China

Jia-Ming Feng

College of Electrical Engineering and Automation, Sichuan University, Chengdu, 610065, China

Xin-Peng Xie

Institute of Traditional Chinese Medicine of Sichuan Academy of Chinese Medicine Sciences(Sichuan Second Hospital of T.C.M), Chengdu, 610000, China

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XWJ contributed to study design, manuscript writing and data analysis. SWY contributed to data acquisition and analysis. SXY and LLY contributed to study design and data interpretation. XXP and WYM contributed to data acquisition and interpretation. LBM contributed to study design and manuscript revision. All authors Read and approved the final manuscript. FJM contributed to the linguistic embellishment of the article as well as proofreading of the manuscript.

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Xu, WJ., Shang, WY., Feng, JM. et al. Machine learning for accurate detection of small airway dysfunction-related respiratory changes: an observational study. Respir Res 25 , 286 (2024). https://doi.org/10.1186/s12931-024-02911-1

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A method to obtain frequency response functions of operating mechanical systems based on experimental modal analysis and operational modal analysis.

1. Introduction

2. problem description and the main assumption, 3. the proposed method, 3.1. the main idea and procedures, 3.2. the principal square root method for the third step, 3.3. the stability of condensed mass and countermeasures, 3.4. practical implementation.

• The number of measured DOFs m should be sufficient to reduce the likelihood that MAC matrix for different idle mode shapes has large elements, which may result in a high κ . The exact number should be determined comprehensively considering test demands and the complexity of the structure.
• Modes beyond the frequency band of interest in OFRF are needed. They will supplement upper and low residues beyond frequency band and thus promote estimation accuracy of OFRFs.
• The proposed method is derived based on normal modes. For structures with high damping, the accuracy may decrease.
• All approaches that improve EMA precision can benefit the identification of OFRFs. For instance, selecting appropriate frequencies as boundaries during EMA, and checking for reciprocity. FRFs that significantly violate reciprocity would affect the estimation of modal shape and ultimately cause trouble in the normalization of operational modes.

4. Case Studies

4.1. simulation example, 4.2. experimental example, 5. conclusions, supplementary materials, author contributions, data availability statement, acknowledgments, conflicts of interest.

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Shen, C.; Lu, C. A Method to Obtain Frequency Response Functions of Operating Mechanical Systems Based on Experimental Modal Analysis and Operational Modal Analysis. Machines 2024 , 12 , 516. https://doi.org/10.3390/machines12080516

Shen C, Lu C. A Method to Obtain Frequency Response Functions of Operating Mechanical Systems Based on Experimental Modal Analysis and Operational Modal Analysis. Machines . 2024; 12(8):516. https://doi.org/10.3390/machines12080516

Shen, Cunrui, and Chihua Lu. 2024. "A Method to Obtain Frequency Response Functions of Operating Mechanical Systems Based on Experimental Modal Analysis and Operational Modal Analysis" Machines 12, no. 8: 516. https://doi.org/10.3390/machines12080516

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Multi-frequency Oscillations in the Nonlinear Threshold Controlled Unidirectionally Coupled Oscillators

• Published: 29 July 2024

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• P. Yogamarish 1 &
• I. Raja Mohamed 1  

This work presents an experimental realization of a ring scheme of nonlinear threshold controlled unidirectionally coupled (N = 3) second-order autonomous type oscillating systems. The originality of this work lies in having the threshold controller as the nonlinear element of the dynamical system and as the coupling element to form a ring circuit using these systems. The advantage of this coupling is getting tuning of frequency (multi-frequency) of the ring from a few hertz to kilohertz along with the observation of a periodic rotating wave pattern by varying one of the parameter values of the system, in terms of either changing the resistor value (gain) in the coupling path or changing the threshold value of the threshold controller or both. The results explored through this experimental study are confirmed by numerically simulated results, obtained using MATLAB coding- simulink and MULTISIM software. The symmetrical and asymmetrical aspects of the flexible threshold coupling are also studied and the observed interesting experimental and numerical results are presented.

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Data availability

The datasets generated during and analysed during the current study are not publicly available from the corresponding author on reasonable request.

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Acknowledgements

The authors would like to thank Dr. K. Murali, Department of Physics, Anna University, Chennai, for his valuable guidance and support and Dr. A. Abudhahir, Department of EIE, BSA Crescent Institute of Science and Technology, Chennai, for the fruitful discussion in completing this work. P. Yogamarish acknowledge B. S. Abdur Rahman Crescent Institute of Science and Technology, Chennai-600 048, for the award of BSA - Junior Research Fellowship (File No.: Lr. No.475 / Dean (R) / 2023).

The authors declare that they did not receive any financial assistance, grands, or support while preparing this manuscript.

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All authors contributed equally to the study conception, design, material preparation, data collection and analysis were performed by P. Yogamarish and I. Raja Mohamed. The first draft of the manuscript was prepared by P. Yogamarish under the supervision of I. Raja Mohamed and the final draft of the manuscript was approved by the corresponding author (I. Raja Mohamed).

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Yogamarish, P., Mohamed, I.R. Multi-frequency Oscillations in the Nonlinear Threshold Controlled Unidirectionally Coupled Oscillators. Circuits Syst Signal Process (2024). https://doi.org/10.1007/s00034-024-02795-y

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Received : 14 March 2024

Revised : 11 July 2024

Accepted : 11 July 2024

Published : 29 July 2024

DOI : https://doi.org/10.1007/s00034-024-02795-y

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