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• Random Assignment in Experiments | Introduction & Examples

Random Assignment in Experiments | Introduction & Examples

Published on March 8, 2021 by Pritha Bhandari . Revised on June 22, 2023.

In experimental research, random assignment is a way of placing participants from your sample into different treatment groups using randomization.

With simple random assignment, every member of the sample has a known or equal chance of being placed in a control group or an experimental group. Studies that use simple random assignment are also called completely randomized designs .

Random assignment is a key part of experimental design . It helps you ensure that all groups are comparable at the start of a study: any differences between them are due to random factors, not research biases like sampling bias or selection bias .

Table of contents

Why does random assignment matter, random sampling vs random assignment, how do you use random assignment, when is random assignment not used, other interesting articles, frequently asked questions about random assignment.

Random assignment is an important part of control in experimental research, because it helps strengthen the internal validity of an experiment and avoid biases.

In experiments, researchers manipulate an independent variable to assess its effect on a dependent variable, while controlling for other variables. To do so, they often use different levels of an independent variable for different groups of participants.

This is called a between-groups or independent measures design.

You use three groups of participants that are each given a different level of the independent variable:

• a control group that’s given a placebo (no dosage, to control for a placebo effect ),
• an experimental group that’s given a low dosage,
• a second experimental group that’s given a high dosage.

Random assignment to helps you make sure that the treatment groups don’t differ in systematic ways at the start of the experiment, as this can seriously affect (and even invalidate) your work.

If you don’t use random assignment, you may not be able to rule out alternative explanations for your results.

• participants recruited from cafes are placed in the control group ,
• participants recruited from local community centers are placed in the low dosage experimental group,
• participants recruited from gyms are placed in the high dosage group.

With this type of assignment, it’s hard to tell whether the participant characteristics are the same across all groups at the start of the study. Gym-users may tend to engage in more healthy behaviors than people who frequent cafes or community centers, and this would introduce a healthy user bias in your study.

Although random assignment helps even out baseline differences between groups, it doesn’t always make them completely equivalent. There may still be extraneous variables that differ between groups, and there will always be some group differences that arise from chance.

Most of the time, the random variation between groups is low, and, therefore, it’s acceptable for further analysis. This is especially true when you have a large sample. In general, you should always use random assignment in experiments when it is ethically possible and makes sense for your study topic.

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Random sampling and random assignment are both important concepts in research, but it’s important to understand the difference between them.

Random sampling (also called probability sampling or random selection) is a way of selecting members of a population to be included in your study. In contrast, random assignment is a way of sorting the sample participants into control and experimental groups.

While random sampling is used in many types of studies, random assignment is only used in between-subjects experimental designs.

Some studies use both random sampling and random assignment, while others use only one or the other.

Random sampling enhances the external validity or generalizability of your results, because it helps ensure that your sample is unbiased and representative of the whole population. This allows you to make stronger statistical inferences .

You use a simple random sample to collect data. Because you have access to the whole population (all employees), you can assign all 8000 employees a number and use a random number generator to select 300 employees. These 300 employees are your full sample.

Random assignment enhances the internal validity of the study, because it ensures that there are no systematic differences between the participants in each group. This helps you conclude that the outcomes can be attributed to the independent variable .

• a control group that receives no intervention.
• an experimental group that has a remote team-building intervention every week for a month.

You use random assignment to place participants into the control or experimental group. To do so, you take your list of participants and assign each participant a number. Again, you use a random number generator to place each participant in one of the two groups.

To use simple random assignment, you start by giving every member of the sample a unique number. Then, you can use computer programs or manual methods to randomly assign each participant to a group.

• Random number generator: Use a computer program to generate random numbers from the list for each group.
• Lottery method: Place all numbers individually in a hat or a bucket, and draw numbers at random for each group.
• Flip a coin: When you only have two groups, for each number on the list, flip a coin to decide if they’ll be in the control or the experimental group.
• Use a dice: When you have three groups, for each number on the list, roll a dice to decide which of the groups they will be in. For example, assume that rolling 1 or 2 lands them in a control group; 3 or 4 in an experimental group; and 5 or 6 in a second control or experimental group.

This type of random assignment is the most powerful method of placing participants in conditions, because each individual has an equal chance of being placed in any one of your treatment groups.

Random assignment in block designs

In more complicated experimental designs, random assignment is only used after participants are grouped into blocks based on some characteristic (e.g., test score or demographic variable). These groupings mean that you need a larger sample to achieve high statistical power .

For example, a randomized block design involves placing participants into blocks based on a shared characteristic (e.g., college students versus graduates), and then using random assignment within each block to assign participants to every treatment condition. This helps you assess whether the characteristic affects the outcomes of your treatment.

In an experimental matched design , you use blocking and then match up individual participants from each block based on specific characteristics. Within each matched pair or group, you randomly assign each participant to one of the conditions in the experiment and compare their outcomes.

Sometimes, it’s not relevant or ethical to use simple random assignment, so groups are assigned in a different way.

When comparing different groups

Sometimes, differences between participants are the main focus of a study, for example, when comparing men and women or people with and without health conditions. Participants are not randomly assigned to different groups, but instead assigned based on their characteristics.

In this type of study, the characteristic of interest (e.g., gender) is an independent variable, and the groups differ based on the different levels (e.g., men, women, etc.). All participants are tested the same way, and then their group-level outcomes are compared.

When it’s not ethically permissible

When studying unhealthy or dangerous behaviors, it’s not possible to use random assignment. For example, if you’re studying heavy drinkers and social drinkers, it’s unethical to randomly assign participants to one of the two groups and ask them to drink large amounts of alcohol for your experiment.

When you can’t assign participants to groups, you can also conduct a quasi-experimental study . In a quasi-experiment, you study the outcomes of pre-existing groups who receive treatments that you may not have any control over (e.g., heavy drinkers and social drinkers). These groups aren’t randomly assigned, but may be considered comparable when some other variables (e.g., age or socioeconomic status) are controlled for.

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

• Student’s  t -distribution
• Normal distribution
• Null and Alternative Hypotheses
• Chi square tests
• Confidence interval
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• Reproducibility vs Replicability
• Peer review
• Prospective cohort study

Research bias

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

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.

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.

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.

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6.2 Experimental Design

Learning objectives.

• Explain the difference between between-subjects and within-subjects experiments, list some of the pros and cons of each approach, and decide which approach to use to answer a particular research question.
• Define random assignment, distinguish it from random sampling, explain its purpose in experimental research, and use some simple strategies to implement it.
• Define what a control condition is, explain its purpose in research on treatment effectiveness, and describe some alternative types of control conditions.
• Define several types of carryover effect, give examples of each, and explain how counterbalancing helps to deal with them.

In this section, we look at some different ways to design an experiment. The primary distinction we will make is between approaches in which each participant experiences one level of the independent variable and approaches in which each participant experiences all levels of the independent variable. The former are called between-subjects experiments and the latter are called within-subjects experiments.

Between-Subjects Experiments

In a between-subjects experiment , each participant is tested in only one condition. For example, a researcher with a sample of 100 college students might assign half of them to write about a traumatic event and the other half write about a neutral event. Or a researcher with a sample of 60 people with severe agoraphobia (fear of open spaces) might assign 20 of them to receive each of three different treatments for that disorder. It is essential in a between-subjects experiment that the researcher assign participants to conditions so that the different groups are, on average, highly similar to each other. Those in a trauma condition and a neutral condition, for example, should include a similar proportion of men and women, and they should have similar average intelligence quotients (IQs), similar average levels of motivation, similar average numbers of health problems, and so on. This is a matter of controlling these extraneous participant variables across conditions so that they do not become confounding variables.

Random Assignment

The primary way that researchers accomplish this kind of control of extraneous variables across conditions is called random assignment , which means using a random process to decide which participants are tested in which conditions. Do not confuse random assignment with random sampling. Random sampling is a method for selecting a sample from a population, and it is rarely used in psychological research. Random assignment is a method for assigning participants in a sample to the different conditions, and it is an important element of all experimental research in psychology and other fields too.

In its strictest sense, random assignment should meet two criteria. One is that each participant has an equal chance of being assigned to each condition (e.g., a 50% chance of being assigned to each of two conditions). The second is that each participant is assigned to a condition independently of other participants. Thus one way to assign participants to two conditions would be to flip a coin for each one. If the coin lands heads, the participant is assigned to Condition A, and if it lands tails, the participant is assigned to Condition B. For three conditions, one could use a computer to generate a random integer from 1 to 3 for each participant. If the integer is 1, the participant is assigned to Condition A; if it is 2, the participant is assigned to Condition B; and if it is 3, the participant is assigned to Condition C. In practice, a full sequence of conditions—one for each participant expected to be in the experiment—is usually created ahead of time, and each new participant is assigned to the next condition in the sequence as he or she is tested. When the procedure is computerized, the computer program often handles the random assignment.

One problem with coin flipping and other strict procedures for random assignment is that they are likely to result in unequal sample sizes in the different conditions. Unequal sample sizes are generally not a serious problem, and you should never throw away data you have already collected to achieve equal sample sizes. However, for a fixed number of participants, it is statistically most efficient to divide them into equal-sized groups. It is standard practice, therefore, to use a kind of modified random assignment that keeps the number of participants in each group as similar as possible. One approach is block randomization . In block randomization, all the conditions occur once in the sequence before any of them is repeated. Then they all occur again before any of them is repeated again. Within each of these “blocks,” the conditions occur in a random order. Again, the sequence of conditions is usually generated before any participants are tested, and each new participant is assigned to the next condition in the sequence. Table 6.2 “Block Randomization Sequence for Assigning Nine Participants to Three Conditions” shows such a sequence for assigning nine participants to three conditions. The Research Randomizer website ( http://www.randomizer.org ) will generate block randomization sequences for any number of participants and conditions. Again, when the procedure is computerized, the computer program often handles the block randomization.

Table 6.2 Block Randomization Sequence for Assigning Nine Participants to Three Conditions

Random assignment is not guaranteed to control all extraneous variables across conditions. It is always possible that just by chance, the participants in one condition might turn out to be substantially older, less tired, more motivated, or less depressed on average than the participants in another condition. However, there are some reasons that this is not a major concern. One is that random assignment works better than one might expect, especially for large samples. Another is that the inferential statistics that researchers use to decide whether a difference between groups reflects a difference in the population takes the “fallibility” of random assignment into account. Yet another reason is that even if random assignment does result in a confounding variable and therefore produces misleading results, this is likely to be detected when the experiment is replicated. The upshot is that random assignment to conditions—although not infallible in terms of controlling extraneous variables—is always considered a strength of a research design.

Treatment and Control Conditions

Between-subjects experiments are often used to determine whether a treatment works. In psychological research, a treatment is any intervention meant to change people’s behavior for the better. This includes psychotherapies and medical treatments for psychological disorders but also interventions designed to improve learning, promote conservation, reduce prejudice, and so on. To determine whether a treatment works, participants are randomly assigned to either a treatment condition , in which they receive the treatment, or a control condition , in which they do not receive the treatment. If participants in the treatment condition end up better off than participants in the control condition—for example, they are less depressed, learn faster, conserve more, express less prejudice—then the researcher can conclude that the treatment works. In research on the effectiveness of psychotherapies and medical treatments, this type of experiment is often called a randomized clinical trial .

There are different types of control conditions. In a no-treatment control condition , participants receive no treatment whatsoever. One problem with this approach, however, is the existence of placebo effects. A placebo is a simulated treatment that lacks any active ingredient or element that should make it effective, and a placebo effect is a positive effect of such a treatment. Many folk remedies that seem to work—such as eating chicken soup for a cold or placing soap under the bedsheets to stop nighttime leg cramps—are probably nothing more than placebos. Although placebo effects are not well understood, they are probably driven primarily by people’s expectations that they will improve. Having the expectation to improve can result in reduced stress, anxiety, and depression, which can alter perceptions and even improve immune system functioning (Price, Finniss, & Benedetti, 2008).

Placebo effects are interesting in their own right (see Note 6.28 “The Powerful Placebo” ), but they also pose a serious problem for researchers who want to determine whether a treatment works. Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” shows some hypothetical results in which participants in a treatment condition improved more on average than participants in a no-treatment control condition. If these conditions (the two leftmost bars in Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” ) were the only conditions in this experiment, however, one could not conclude that the treatment worked. It could be instead that participants in the treatment group improved more because they expected to improve, while those in the no-treatment control condition did not.

Figure 6.2 Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions

Fortunately, there are several solutions to this problem. One is to include a placebo control condition , in which participants receive a placebo that looks much like the treatment but lacks the active ingredient or element thought to be responsible for the treatment’s effectiveness. When participants in a treatment condition take a pill, for example, then those in a placebo control condition would take an identical-looking pill that lacks the active ingredient in the treatment (a “sugar pill”). In research on psychotherapy effectiveness, the placebo might involve going to a psychotherapist and talking in an unstructured way about one’s problems. The idea is that if participants in both the treatment and the placebo control groups expect to improve, then any improvement in the treatment group over and above that in the placebo control group must have been caused by the treatment and not by participants’ expectations. This is what is shown by a comparison of the two outer bars in Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” .

Of course, the principle of informed consent requires that participants be told that they will be assigned to either a treatment or a placebo control condition—even though they cannot be told which until the experiment ends. In many cases the participants who had been in the control condition are then offered an opportunity to have the real treatment. An alternative approach is to use a waitlist control condition , in which participants are told that they will receive the treatment but must wait until the participants in the treatment condition have already received it. This allows researchers to compare participants who have received the treatment with participants who are not currently receiving it but who still expect to improve (eventually). A final solution to the problem of placebo effects is to leave out the control condition completely and compare any new treatment with the best available alternative treatment. For example, a new treatment for simple phobia could be compared with standard exposure therapy. Because participants in both conditions receive a treatment, their expectations about improvement should be similar. This approach also makes sense because once there is an effective treatment, the interesting question about a new treatment is not simply “Does it work?” but “Does it work better than what is already available?”

The Powerful Placebo

Many people are not surprised that placebos can have a positive effect on disorders that seem fundamentally psychological, including depression, anxiety, and insomnia. However, placebos can also have a positive effect on disorders that most people think of as fundamentally physiological. These include asthma, ulcers, and warts (Shapiro & Shapiro, 1999). There is even evidence that placebo surgery—also called “sham surgery”—can be as effective as actual surgery.

Medical researcher J. Bruce Moseley and his colleagues conducted a study on the effectiveness of two arthroscopic surgery procedures for osteoarthritis of the knee (Moseley et al., 2002). The control participants in this study were prepped for surgery, received a tranquilizer, and even received three small incisions in their knees. But they did not receive the actual arthroscopic surgical procedure. The surprising result was that all participants improved in terms of both knee pain and function, and the sham surgery group improved just as much as the treatment groups. According to the researchers, “This study provides strong evidence that arthroscopic lavage with or without débridement [the surgical procedures used] is not better than and appears to be equivalent to a placebo procedure in improving knee pain and self-reported function” (p. 85).

Research has shown that patients with osteoarthritis of the knee who receive a “sham surgery” experience reductions in pain and improvement in knee function similar to those of patients who receive a real surgery.

Army Medicine – Surgery – CC BY 2.0.

Within-Subjects Experiments

In a within-subjects experiment , each participant is tested under all conditions. Consider an experiment on the effect of a defendant’s physical attractiveness on judgments of his guilt. Again, in a between-subjects experiment, one group of participants would be shown an attractive defendant and asked to judge his guilt, and another group of participants would be shown an unattractive defendant and asked to judge his guilt. In a within-subjects experiment, however, the same group of participants would judge the guilt of both an attractive and an unattractive defendant.

The primary advantage of this approach is that it provides maximum control of extraneous participant variables. Participants in all conditions have the same mean IQ, same socioeconomic status, same number of siblings, and so on—because they are the very same people. Within-subjects experiments also make it possible to use statistical procedures that remove the effect of these extraneous participant variables on the dependent variable and therefore make the data less “noisy” and the effect of the independent variable easier to detect. We will look more closely at this idea later in the book.

Carryover Effects and Counterbalancing

The primary disadvantage of within-subjects designs is that they can result in carryover effects. A carryover effect is an effect of being tested in one condition on participants’ behavior in later conditions. One type of carryover effect is a practice effect , where participants perform a task better in later conditions because they have had a chance to practice it. Another type is a fatigue effect , where participants perform a task worse in later conditions because they become tired or bored. Being tested in one condition can also change how participants perceive stimuli or interpret their task in later conditions. This is called a context effect . For example, an average-looking defendant might be judged more harshly when participants have just judged an attractive defendant than when they have just judged an unattractive defendant. Within-subjects experiments also make it easier for participants to guess the hypothesis. For example, a participant who is asked to judge the guilt of an attractive defendant and then is asked to judge the guilt of an unattractive defendant is likely to guess that the hypothesis is that defendant attractiveness affects judgments of guilt. This could lead the participant to judge the unattractive defendant more harshly because he thinks this is what he is expected to do. Or it could make participants judge the two defendants similarly in an effort to be “fair.”

Carryover effects can be interesting in their own right. (Does the attractiveness of one person depend on the attractiveness of other people that we have seen recently?) But when they are not the focus of the research, carryover effects can be problematic. Imagine, for example, that participants judge the guilt of an attractive defendant and then judge the guilt of an unattractive defendant. If they judge the unattractive defendant more harshly, this might be because of his unattractiveness. But it could be instead that they judge him more harshly because they are becoming bored or tired. In other words, the order of the conditions is a confounding variable. The attractive condition is always the first condition and the unattractive condition the second. Thus any difference between the conditions in terms of the dependent variable could be caused by the order of the conditions and not the independent variable itself.

There is a solution to the problem of order effects, however, that can be used in many situations. It is counterbalancing , which means testing different participants in different orders. For example, some participants would be tested in the attractive defendant condition followed by the unattractive defendant condition, and others would be tested in the unattractive condition followed by the attractive condition. With three conditions, there would be six different orders (ABC, ACB, BAC, BCA, CAB, and CBA), so some participants would be tested in each of the six orders. With counterbalancing, participants are assigned to orders randomly, using the techniques we have already discussed. Thus random assignment plays an important role in within-subjects designs just as in between-subjects designs. Here, instead of randomly assigning to conditions, they are randomly assigned to different orders of conditions. In fact, it can safely be said that if a study does not involve random assignment in one form or another, it is not an experiment.

There are two ways to think about what counterbalancing accomplishes. One is that it controls the order of conditions so that it is no longer a confounding variable. Instead of the attractive condition always being first and the unattractive condition always being second, the attractive condition comes first for some participants and second for others. Likewise, the unattractive condition comes first for some participants and second for others. Thus any overall difference in the dependent variable between the two conditions cannot have been caused by the order of conditions. A second way to think about what counterbalancing accomplishes is that if there are carryover effects, it makes it possible to detect them. One can analyze the data separately for each order to see whether it had an effect.

When 9 Is “Larger” Than 221

Researcher Michael Birnbaum has argued that the lack of context provided by between-subjects designs is often a bigger problem than the context effects created by within-subjects designs. To demonstrate this, he asked one group of participants to rate how large the number 9 was on a 1-to-10 rating scale and another group to rate how large the number 221 was on the same 1-to-10 rating scale (Birnbaum, 1999). Participants in this between-subjects design gave the number 9 a mean rating of 5.13 and the number 221 a mean rating of 3.10. In other words, they rated 9 as larger than 221! According to Birnbaum, this is because participants spontaneously compared 9 with other one-digit numbers (in which case it is relatively large) and compared 221 with other three-digit numbers (in which case it is relatively small).

Simultaneous Within-Subjects Designs

So far, we have discussed an approach to within-subjects designs in which participants are tested in one condition at a time. There is another approach, however, that is often used when participants make multiple responses in each condition. Imagine, for example, that participants judge the guilt of 10 attractive defendants and 10 unattractive defendants. Instead of having people make judgments about all 10 defendants of one type followed by all 10 defendants of the other type, the researcher could present all 20 defendants in a sequence that mixed the two types. The researcher could then compute each participant’s mean rating for each type of defendant. Or imagine an experiment designed to see whether people with social anxiety disorder remember negative adjectives (e.g., “stupid,” “incompetent”) better than positive ones (e.g., “happy,” “productive”). The researcher could have participants study a single list that includes both kinds of words and then have them try to recall as many words as possible. The researcher could then count the number of each type of word that was recalled. There are many ways to determine the order in which the stimuli are presented, but one common way is to generate a different random order for each participant.

Between-Subjects or Within-Subjects?

Almost every experiment can be conducted using either a between-subjects design or a within-subjects design. This means that researchers must choose between the two approaches based on their relative merits for the particular situation.

Between-subjects experiments have the advantage of being conceptually simpler and requiring less testing time per participant. They also avoid carryover effects without the need for counterbalancing. Within-subjects experiments have the advantage of controlling extraneous participant variables, which generally reduces noise in the data and makes it easier to detect a relationship between the independent and dependent variables.

A good rule of thumb, then, is that if it is possible to conduct a within-subjects experiment (with proper counterbalancing) in the time that is available per participant—and you have no serious concerns about carryover effects—this is probably the best option. If a within-subjects design would be difficult or impossible to carry out, then you should consider a between-subjects design instead. For example, if you were testing participants in a doctor’s waiting room or shoppers in line at a grocery store, you might not have enough time to test each participant in all conditions and therefore would opt for a between-subjects design. Or imagine you were trying to reduce people’s level of prejudice by having them interact with someone of another race. A within-subjects design with counterbalancing would require testing some participants in the treatment condition first and then in a control condition. But if the treatment works and reduces people’s level of prejudice, then they would no longer be suitable for testing in the control condition. This is true for many designs that involve a treatment meant to produce long-term change in participants’ behavior (e.g., studies testing the effectiveness of psychotherapy). Clearly, a between-subjects design would be necessary here.

Remember also that using one type of design does not preclude using the other type in a different study. There is no reason that a researcher could not use both a between-subjects design and a within-subjects design to answer the same research question. In fact, professional researchers often do exactly this.

Key Takeaways

• Experiments can be conducted using either between-subjects or within-subjects designs. Deciding which to use in a particular situation requires careful consideration of the pros and cons of each approach.
• Random assignment to conditions in between-subjects experiments or to orders of conditions in within-subjects experiments is a fundamental element of experimental research. Its purpose is to control extraneous variables so that they do not become confounding variables.
• Experimental research on the effectiveness of a treatment requires both a treatment condition and a control condition, which can be a no-treatment control condition, a placebo control condition, or a waitlist control condition. Experimental treatments can also be compared with the best available alternative.

Discussion: For each of the following topics, list the pros and cons of a between-subjects and within-subjects design and decide which would be better.

• You want to test the relative effectiveness of two training programs for running a marathon.
• Using photographs of people as stimuli, you want to see if smiling people are perceived as more intelligent than people who are not smiling.
• In a field experiment, you want to see if the way a panhandler is dressed (neatly vs. sloppily) affects whether or not passersby give him any money.
• You want to see if concrete nouns (e.g., dog ) are recalled better than abstract nouns (e.g., truth ).
• Discussion: Imagine that an experiment shows that participants who receive psychodynamic therapy for a dog phobia improve more than participants in a no-treatment control group. Explain a fundamental problem with this research design and at least two ways that it might be corrected.

Birnbaum, M. H. (1999). How to show that 9 > 221: Collect judgments in a between-subjects design. Psychological Methods, 4 , 243–249.

Moseley, J. B., O’Malley, K., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., … Wray, N. P. (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. The New England Journal of Medicine, 347 , 81–88.

Price, D. D., Finniss, D. G., & Benedetti, F. (2008). A comprehensive review of the placebo effect: Recent advances and current thought. Annual Review of Psychology, 59 , 565–590.

Shapiro, A. K., & Shapiro, E. (1999). The powerful placebo: From ancient priest to modern physician . Baltimore, MD: Johns Hopkins University Press.

Research Methods in Psychology Copyright © 2016 by University of Minnesota is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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• v.43(2); Mar-Apr 2008

Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials

Minsoo kang.

1 Middle Tennessee State University, Murfreesboro, TN

Brian G Ragan

2 University of Northern Iowa, Cedar Falls, IA

Jae-Hyeon Park

3 Korea National Sport University, Seoul, Korea

To review and describe randomization techniques used in clinical trials, including simple, block, stratified, and covariate adaptive techniques.

Background:

Clinical trials are required to establish treatment efficacy of many athletic training procedures. In the past, we have relied on evidence of questionable scientific merit to aid the determination of treatment choices. Interest in evidence-based practice is growing rapidly within the athletic training profession, placing greater emphasis on the importance of well-conducted clinical trials. One critical component of clinical trials that strengthens results is random assignment of participants to control and treatment groups. Although randomization appears to be a simple concept, issues of balancing sample sizes and controlling the influence of covariates a priori are important. Various techniques have been developed to account for these issues, including block, stratified randomization, and covariate adaptive techniques.

Advantages:

Athletic training researchers and scholarly clinicians can use the information presented in this article to better conduct and interpret the results of clinical trials. Implementing these techniques will increase the power and validity of findings of athletic medicine clinical trials, which will ultimately improve the quality of care provided.

Outcomes research is critical in the evidence-based health care environment because it addresses scientific questions concerning the efficacy of treatments. Clinical trials are considered the “gold standard” for outcomes in biomedical research. In athletic training, calls for more evidence-based medical research, specifically clinical trials, have been issued. 1 , 2

The strength of clinical trials is their superior ability to measure change over time from a treatment. Treatment differences identified from cross-sectional observational designs rather than experimental clinical trials have methodologic weaknesses, including confounding, cohort effects, and selection bias. 3 For example, using a nonrandomized trial to examine the effectiveness of prophylactic knee bracing to prevent medial collateral ligament injuries may suffer from confounders and jeopardize the results. One possible confounder is a history of knee injuries. Participants with a history of knee injuries may be more likely to wear braces than those with no such history. Participants with a history of injury are more likely to suffer additional knee injuries, unbalancing the groups and influencing the results of the study.

The primary goal of comparative clinical trials is to provide comparisons of treatments with maximum precision and validity. 4 One critical component of clinical trials is random assignment of participants into groups. Randomizing participants helps remove the effect of extraneous variables (eg, age, injury history) and minimizes bias associated with treatment assignment. Randomization is considered by most researchers to be the optimal approach for participant assignment in clinical trials because it strengthens the results and data interpretation. 4 – , 9

One potential problem with small clinical trials (n < 100) 7 is that conventional simple randomization methods, such as flipping a coin, may result in imbalanced sample size and baseline characteristics (ie, covariates) among treatment and control groups. 9 , 10 This imbalance of baseline characteristics can influence the comparison between treatment and control groups and introduce potential confounding factors. Many procedures have been proposed for random group assignment of participants in clinical trials. 11 Simple, block, stratified, and covariate adaptive randomizations are some examples. Each technique has advantages and disadvantages, which must be carefully considered before a method is selected. Our purpose is to introduce the concept and significance of randomization and to review several conventional and relatively new randomization techniques to aid in the design and implementation of valid clinical trials.

What Is Randomization?

Randomization is the process of assigning participants to treatment and control groups, assuming that each participant has an equal chance of being assigned to any group. 12 Randomization has evolved into a fundamental aspect of scientific research methodology. Demands have increased for more randomized clinical trials in many areas of biomedical research, such as athletic training. 2 , 13 In fact, in the last 2 decades, internationally recognized major medical journals, such as the Journal of the American Medical Association and the BMJ , have been increasingly interested in publishing studies reporting results from randomized controlled trials. 5

Since Fisher 14 first introduced the idea of randomization in a 1926 agricultural study, the academic community has deemed randomization an essential tool for unbiased comparisons of treatment groups. Five years after Fisher's introductory paper, the first randomized clinical trial involving tuberculosis was conducted. 15 A total of 24 participants were paired (ie, 12 comparable pairs), and by a flip of a coin, each participant within the pair was assigned to either the control or treatment group. By employing randomization, researchers offer each participant an equal chance of being assigned to groups, which makes the groups comparable on the dependent variable by eliminating potential bias. Indeed, randomization of treatments in clinical trials is the only means of avoiding systematic characteristic bias of participants assigned to different treatments. Although randomization may be accomplished with a simple coin toss, more appropriate and better methods are often needed, especially in small clinical trials. These other methods will be discussed in this review.

Why Randomize?

Researchers demand randomization for several reasons. First, participants in various groups should not differ in any systematic way. In a clinical trial, if treatment groups are systematically different, trial results will be biased. Suppose that participants are assigned to control and treatment groups in a study examining the efficacy of a walking intervention. If a greater proportion of older adults is assigned to the treatment group, then the outcome of the walking intervention may be influenced by this imbalance. The effects of the treatment would be indistinguishable from the influence of the imbalance of covariates, thereby requiring the researcher to control for the covariates in the analysis to obtain an unbiased result. 16

Second, proper randomization ensures no a priori knowledge of group assignment (ie, allocation concealment). That is, researchers, participants, and others should not know to which group the participant will be assigned. Knowledge of group assignment creates a layer of potential selection bias that may taint the data. Schulz and Grimes 17 stated that trials with inadequate or unclear randomization tended to overestimate treatment effects up to 40% compared with those that used proper randomization. The outcome of the trial can be negatively influenced by this inadequate randomization.

Statistical techniques such as analysis of covariance (ANCOVA), multivariate ANCOVA, or both, are often used to adjust for covariate imbalance in the analysis stage of the clinical trial. However, the interpretation of this postadjustment approach is often difficult because imbalance of covariates frequently leads to unanticipated interaction effects, such as unequal slopes among subgroups of covariates. 18 , 19 One of the critical assumptions in ANCOVA is that the slopes of regression lines are the same for each group of covariates (ie, homogeneity of regression slopes). The adjustment needed for each covariate group may vary, which is problematic because ANCOVA uses the average slope across the groups to adjust the outcome variable. Thus, the ideal way of balancing covariates among groups is to apply sound randomization in the design stage of a clinical trial (before the adjustment procedure) instead of after data collection. In such instances, random assignment is necessary and guarantees validity for statistical tests of significance that are used to compare treatments.

How To Randomize?

Many procedures have been proposed for the random assignment of participants to treatment groups in clinical trials. In this article, common randomization techniques, including simple randomization, block randomization, stratified randomization, and covariate adaptive randomization, are reviewed. Each method is described along with its advantages and disadvantages. It is very important to select a method that will produce interpretable, valid results for your study.

Simple Randomization

Randomization based on a single sequence of random assignments is known as simple randomization. 10 This technique maintains complete randomness of the assignment of a person to a particular group. The most common and basic method of simple randomization is flipping a coin. For example, with 2 treatment groups (control versus treatment), the side of the coin (ie, heads  =  control, tails  =  treatment) determines the assignment of each participant. Other methods include using a shuffled deck of cards (eg, even  =  control, odd  =  treatment) or throwing a die (eg, below and equal to 3  =  control, over 3  =  treatment). A random number table found in a statistics book or computer-generated random numbers can also be used for simple randomization of participants.

This randomization approach is simple and easy to implement in a clinical trial. In large trials (n > 200), simple randomization can be trusted to generate similar numbers of participants among groups. However, randomization results could be problematic in relatively small sample size clinical trials (n < 100), resulting in an unequal number of participants among groups. For example, using a coin toss with a small sample size (n  =  10) may result in an imbalance such that 7 participants are assigned to the control group and 3 to the treatment group ( Figure 1 ).

Block Randomization

The block randomization method is designed to randomize participants into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group assignments, which keeps the numbers of participants in each group similar at all times. According to Altman and Bland, 10 the block size is determined by the researcher and should be a multiple of the number of groups (ie, with 2 treatment groups, block size of either 4 or 6). Blocks are best used in smaller increments as researchers can more easily control balance. 7 After block size has been determined, all possible balanced combinations of assignment within the block (ie, equal number for all groups within the block) must be calculated. Blocks are then randomly chosen to determine the participants' assignment into the groups.

For a clinical trial with control and treatment groups involving 40 participants, a randomized block procedure would be as follows: (1) a block size of 4 is chosen, (2) possible balanced combinations with 2 C (control) and 2 T (treatment) subjects are calculated as 6 (TTCC, TCTC, TCCT, CTTC, CTCT, CCTT), and (3) blocks are randomly chosen to determine the assignment of all 40 participants (eg, one random sequence would be [TTCC / TCCT / CTTC / CTTC / TCCT / CCTT / TTCC / TCTC / CTCT / TCTC]). This procedure results in 20 participants in both the control and treatment groups ( Figure 2 ).

Although balance in sample size may be achieved with this method, groups may be generated that are rarely comparable in terms of certain covariates. 6 For example, one group may have more participants with secondary diseases (eg, diabetes, multiple sclerosis, cancer) that could confound the data and may negatively influence the results of the clinical trial. Pocock and Simon 11 stressed the importance of controlling for these covariates because of serious consequences to the interpretation of the results. Such an imbalance could introduce bias in the statistical analysis and reduce the power of the study. 4 , 6 , 8 Hence, sample size and covariates must be balanced in small clinical trials.

Stratified Randomization

The stratified randomization method addresses the need to control and balance the influence of covariates. This method can be used to achieve balance among groups in terms of participants' baseline characteristics (covariates). Specific covariates must be identified by the researcher who understands the potential influence each covariate has on the dependent variable. Stratified randomization is achieved by generating a separate block for each combination of covariates, and participants are assigned to the appropriate block of covariates. After all participants have been identified and assigned into blocks, simple randomization occurs within each block to assign participants to one of the groups.

The stratified randomization method controls for the possible influence of covariates that would jeopardize the conclusions of the clinical trial. For example, a clinical trial of different rehabilitation techniques after a surgical procedure will have a number of covariates. It is well known that the age of the patient affects the rate of healing. Thus, age could be a confounding variable and influence the outcome of the clinical trial. Stratified randomization can balance the control and treatment groups for age or other identified covariates.

For example, with 2 groups involving 40 participants, the stratified randomization method might be used to control the covariates of sex (2 levels: male, female) and body mass index (3 levels: underweight, normal, overweight) between study arms. With these 2 covariates, possible block combinations total 6 (eg, male, underweight). A simple randomization procedure, such as flipping a coin, is used to assign the participants within each block to one of the treatment groups ( Figure 3 ).

Although stratified randomization is a relatively simple and useful technique, especially for smaller clinical trials, it becomes complicated to implement if many covariates must be controlled. 20 For example, too many block combinations may lead to imbalances in overall treatment allocations because a large number of blocks can generate small participant numbers within the block. Therneau 21 purported that a balance in covariates begins to fail when the number of blocks approaches half the sample size. If another 4-level covariate was added to the example, the number of block combinations would increase from 6 to 24 (2 × 3 × 4), for an average of fewer than 2 (40 / 24  =  1.7) participants per block, reducing the usefulness of the procedure to balance the covariates and jeopardizing the validity of the clinical trial. In small studies, it may not be feasible to stratify more than 1 or 2 covariates because the number of blocks can quickly approach the number of participants. 10

Stratified randomization has another limitation: it works only when all participants have been identified before group assignment. This method is rarely applicable, however, because clinical trial participants are often enrolled one at a time on a continuous basis. When baseline characteristics of all participants are not available before assignment, using stratified randomization is difficult. 7

Covariate Adaptive Randomization

Covariate adaptive randomization has been recommended by many researchers as a valid alternative randomization method for clinical trials. 9 , 22 In covariate adaptive randomization, a new participant is sequentially assigned to a particular treatment group by taking into account the specific covariates and previous assignments of participants. 9 , 12 , 18 , 23 , 24 Covariate adaptive randomization uses the method of minimization by assessing the imbalance of sample size among several covariates. This covariate adaptive approach was first described by Taves. 23

The Taves covariate adaptive randomization method allows for the examination of previous participant group assignments to make a case-by-case decision on group assignment for each individual who enrolls in the study. Consider again the example of 2 groups involving 40 participants, with sex (2 levels: male, female) and body mass index (3 levels: underweight, normal, overweight) as covariates. Assume the first 9 participants have already been randomly assigned to groups by flipping a coin. The 9 participants' group assignments are broken down by covariate level in Figure 4 . Now the 10th participant, who is male and underweight, needs to be assigned to a group (ie, control versus treatment). Based on the characteristics of the 10th participant, the Taves method adds marginal totals of the corresponding covariate categories for each group and compares the totals. The participant is assigned to the group with the lower covariate total to minimize imbalance. In this example, the appropriate categories are male and underweight, which results in the total of 3 (2 for male category + 1 for underweight category) for the control group and a total of 5 (3 for male category + 2 for underweight category) for the treatment group. Because the sum of marginal totals is lower for the control group (3 < 5), the 10th participant is assigned to the control group ( Figure 5 ).

The Pocock and Simon method 11 of covariate adaptive randomization is similar to the method Taves 23 described. The difference in this approach is the temporary assignment of participants to both groups. This method uses the absolute difference between groups to determine group assignment. To minimize imbalance, the participant is assigned to the group determined by the lowest sum of the absolute differences among the covariates between the groups. For example, using the previous situation in assigning the 10th participant to a group, the Pocock and Simon method would (1) assign the 10th participant temporarily to the control group, resulting in marginal totals of 3 for male category and 2 for underweight category; (2) calculate the absolute difference between control and treatment group (males: 3 control – 3 treatment  =  0; underweight: 2 control – 2 treatment  =  0) and sum (0 + 0  =  0); (3) temporarily assign the 10th participant to the treatment group, resulting in marginal totals of 4 for male category and 3 for underweight category; (4) calculate the absolute difference between control and treatment group (males: 2 control – 4 treatment  =  2; underweight: 1 control – 3 treatment  =  2) and sum (2 + 2  =  4); and (5) assign the 10th participant to the control group because of the lowest sum of absolute differences (0 < 4).

Pocock and Simon 11 also suggested using a variance approach. Instead of calculating absolute difference among groups, this approach calculates the variance among treatment groups. Although the variance method performs similarly to the absolute difference method, both approaches suffer from the limitation of handling only categorical covariates. 25

Frane 18 introduced a covariate adaptive randomization for both continuous and categorical types. Frane used P values to identify imbalance among treatment groups: a smaller P value represents more imbalance among treatment groups.

The Frane method for assigning participants to either the control or treatment group would include (1) temporarily assigning the participant to both the control and treatment groups; (2) calculating P values for each of the covariates using a t test and analysis of variance (ANOVA) for continuous variables and goodness-of-fit χ 2 test for categorical variables; (3) determining the minimum P value for each control or treatment group, which indicates more imbalance among treatment groups; and (4) assigning the participant to the group with the larger minimum P value (ie, try to avoid more imbalance in groups).

Going back to the previous example of assigning the 10th participant (male and underweight) to a group, the Frane method would result in the assignment to the control group. The steps used to make this decision were calculating P values for each of the covariates using the χ 2 goodness-of-fit test represented in the Table . The t tests and ANOVAs were not used because the covariates in this example were categorical. Based on the Table , the lowest minimum P values were 1.0 for the control group and 0.317 for the treatment group. The 10th participant was assigned to the control group because of the higher minimum P value, which indicates better balance in the control group (1.0 > 0.317).

Probabilities From χ 2 Goodness-of-Fit Tests for the Example Shown in Figure 5 (Frane 18 Method)

Covariate adaptive randomization produces less imbalance than other conventional randomization methods and can be used successfully to balance important covariates among control and treatment groups. 6 Although the balance of covariates among groups using the stratified randomization method begins to fail when the number of blocks approaches half the sample size, covariate adaptive randomization can better handle the problem of increasing numbers of covariates (ie, increased block combinations). 9

One concern of these covariate adaptive randomization methods is that treatment assignments sometimes become highly predictable. Investigators using covariate adaptive randomization sometimes come to believe that group assignment for the next participant can be readily predicted, going against the basic concept of randomization. 12 , 26 , 27 This predictability stems from the ongoing assignment of participants to groups wherein the current allocation of participants may suggest future participant group assignment. In their review, Scott et al 9 argued that this predictability is also true of other methods, including stratified randomization, and it should not be overly penalized. Zielhuis et al 28 and Frane 18 suggested a practical approach to prevent predictability: a small number of participants should be randomly assigned into the groups before the covariate adaptive randomization technique being applied.

The complicated computation process of covariate adaptive randomization increases the administrative burden, thereby limiting its use in practice. A user-friendly computer program for covariate adaptive randomization is available (free of charge) upon request from the authors (M.K., B.G.R., or J.H.P.). 29

Conclusions

Our purpose was to introduce randomization, including its concept and significance, and to review several randomization techniques to guide athletic training researchers and practitioners to better design their randomized clinical trials. Many factors can affect the results of clinical research, but randomization is considered the gold standard in most clinical trials. It eliminates selection bias, ensures balance of sample size and baseline characteristics, and is an important step in guaranteeing the validity of statistical tests of significance used to compare treatment groups.

Before choosing a randomization method, several factors need to be considered, including the size of the clinical trial; the need for balance in sample size, covariates, or both; and participant enrollment. 16 Figure 6 depicts a flowchart designed to help select an appropriate randomization technique. For example, a power analysis for a clinical trial of different rehabilitation techniques after a surgical procedure indicated a sample size of 80. A well-known covariate for this study is age, which must be balanced among groups. Because of the nature of the study with postsurgical patients, participant recruitment and enrollment will be continuous. Using the flowchart, the appropriate randomization technique is covariate adaptive randomization technique.

Simple randomization works well for a large trial (eg, n > 200) but not for a small trial (n < 100). 7 To achieve balance in sample size, block randomization is desirable. To achieve balance in baseline characteristics, stratified randomization is widely used. Covariate adaptive randomization, however, can achieve better balance than other randomization methods and can be successfully used for clinical trials in an effective manner.

Acknowledgments

This study was partially supported by a Faculty Grant (FRCAC) from the College of Graduate Studies, at Middle Tennessee State University, Murfreesboro, TN.

Minsoo Kang, PhD; Brian G. Ragan, PhD, ATC; and Jae-Hyeon Park, PhD, contributed to conception and design; acquisition and analysis and interpretation of the data; and drafting, critical revision, and final approval of the article.