01 · The Question
What If the People Available for Your Study Are Not the Population You Planned to Study?
A study may begin with a clearly defined population and then encounter an uncomfortable practical reality: those are not the people you can actually recruit.
Perhaps the planned population is less accessible than expected. One subgroup rarely responds. A participating institution withdraws. Recruitment succeeds mainly among younger, healthier, more experienced, more motivated, or otherwise different participants. You may discover that the accessible population has characteristics that were not anticipated when the study was designed.
The obvious solution is often to recruit whoever is available and adjust the description later. That can create a mismatch between the question the study claims to answer and the people from whom its evidence actually comes.
The central issue is therefore whether the recruitable population is sufficiently aligned with the population relevant to your research question, and what claims remain justified if it is not.
03 · What You Need to Know
Separate the Population You Want to Understand From the People You Can Actually Study
Target Population, Accessible Population, and Study Sample Are Not the Same Thing
Several populations can sit between a research question and the final dataset. Terminology varies somewhat across disciplines, but the distinction is methodologically useful.
| Concept |
Practical meaning |
Question to ask |
| Target population |
The population about which the research aims to draw conclusions |
Who is the research question fundamentally about? |
| Source or accessible population |
The population from which participants can realistically be identified or recruited |
Who actually has a chance of entering the study? |
| Eligible population |
People within the recruitment source who satisfy the study's eligibility criteria |
Who qualifies under the protocol? |
| Study sample |
The participants who ultimately enter the study and provide the relevant data |
Who actually contributed evidence? |
These groups rarely correspond perfectly. That alone is not necessarily a flaw. Most empirical studies investigate a sample rather than every member of the population of interest. The important issue is whether the pathway from the target population to the observed sample permits the intended inference.
First Determine How the Recruitable Population Differs
“Different population” can mean many things. The accessible participants may differ in age, socioeconomic circumstances, geographic location, disease severity, educational background, institutional setting, prior exposure, language, motivation, technology access, or another characteristic relevant to the study.
Some differences may be largely incidental to the research question. Others may be directly related to the exposure, intervention, outcome, measurement process, or mechanism being studied.
Do not therefore ask only whether the populations are statistically different on some characteristics. Ask whether the differences are scientifically consequential for the inference you intend to make.
External Validity Is About Applying Findings to a Specified Population
Generalizability, often discussed under external validity, concerns whether findings can reasonably be applied beyond the particular participants studied. It is not an all-or-nothing property of a study.
STROBE guidance emphasizes that judgments about generalizability depend on the study setting, participant characteristics, exposures, outcomes, recruitment period, and other contextual features. This is why transparent descriptions of setting, eligibility criteria, recruitment, and participants matter.
The question should therefore be specific. Rather than asking, “Is this study generalizable?” ask, “Are these findings reasonably applicable to the population I originally intended to understand, given the differences between that population and the people who were actually studied?”
A Different Sample Is Not Automatically a Biased Sample
Researchers sometimes use “not representative” and “biased” as though they were interchangeable. They are not.
Difference in composition
The recruited sample has different characteristics from the intended population.
Selection bias
The processes determining participation or inclusion produce a systematic distortion of the association, effect, or other quantity the study aims to estimate.
A sample can differ demographically from a target population without every study estimate necessarily being biased. Conversely, a sample that appears similar on several descriptive characteristics can still be affected by selection processes related to the exposure and outcome.
The methodological question is not solved by comparing a few demographic percentages. You need to understand how participants entered the study and whether the factors distinguishing participants from nonparticipants matter for the target inference.
Changing Eligibility Criteria Changes Who the Study Is About
If recruitment difficulties arise because few available participants satisfy the eligibility criteria, researchers may consider broadening those criteria. Sometimes this is defensible. Sometimes it substantially changes the study population.
Before removing an eligibility criterion, return to its rationale. Was it included for participant safety? To define the condition or phenomenon of interest? To reduce a known source of heterogeneity? To ensure that participants could meaningfully receive the intervention or complete the measurement? Or was it included largely by convention without a strong scientific reason?
The consequences of removing it depend on the answer.
Watch Out
Do not broaden eligibility criteria solely until enough people qualify. A larger sample drawn from the wrong population does not solve the original recruitment problem; it may replace it with a mismatch between the evidence and the research question.
If eligibility or recruitment changes are being considered primarily because enrolment is falling behind, first diagnose the underlying participant recruitment problem rather than assuming that the population definition must change.
Changing Recruitment Settings Can Also Change the Population
Suppose a study planned to recruit from public secondary schools but recruitment succeeds only after private schools are added. Or a health study designed around community clinics begins recruiting primarily from a specialist hospital. The eligibility criteria might remain identical, yet the source population can change meaningfully.
Settings influence who becomes available for recruitment. Institutions may serve populations with different resources, severity profiles, referral pathways, practices, exposures, or opportunities. Moving or expanding recruitment therefore deserves the same conceptual question as changing formal eligibility criteria: are the newly accessible participants still appropriate for the research question?
Underrepresentation Does Not Always Require Redesigning the Study
Suppose the target population contains several important subgroups, but one participates at a lower rate. Whether that requires changing the study depends on the research objective and sampling design.
If subgroup representation is essential to estimating a population quantity, the imbalance may be serious. If the research question concerns a relationship expected to operate similarly across groups, the implications may be different, although that similarity should not simply be assumed. In some designs, weighting, stratified recruitment, oversampling, model-based adjustment, or other approaches may be relevant, provided they are methodologically appropriate and supported by the required information.
No statistical adjustment can automatically manufacture evidence about a population that was effectively absent from the study. Analytical methods depend on assumptions and available data, so they should not be treated as substitutes for recruitment.
Changing the Population May Change More Than Generalizability
A population shift is often described only as an external-validity issue. Sometimes it reaches deeper.
If the intervention works differently according to participant characteristics, a changed population can alter the effect being estimated. If measurement behaves differently across groups, the validity of the instrument may change. If the exposure is distributed differently, the study may contain less informative variation. If contextual conditions shape the phenomenon, moving to another setting may change what is being studied.
This is why a major population change can become a design change rather than merely a limitation. At some point, you may need to ask whether changing the research sample turns the project into a different study.
Be Prepared to Narrow the Population Named in Your Conclusions
Sometimes the study itself remains methodologically useful, but the original generalization does not.
Suppose a project intended to study university students nationally but ultimately recruited participants almost entirely from urban institutions with particular characteristics. The appropriate conclusion may be narrower than the original ambition. The findings might still be informative for the observed settings or sufficiently similar populations while providing weaker evidence for students in settings that were poorly represented.
Narrowing the claim is not an admission that the data are useless. It is often the methodologically appropriate response to evidence whose reach is narrower than planned.
Population Changes Should Remain Visible in the Study Record
If the target, source population, eligibility criteria, recruitment settings, or sampling procedures change after the study begins, preserve the original plan and document the modification. Record why it occurred, when it took effect, and how it may affect the resulting sample and interpretation.
STROBE recommends reporting eligibility criteria, sources and methods of participant selection, study setting, relevant participant characteristics, and limitations concerning external validity. These details allow readers to judge how the study sample relates to populations of interest.
If the population change is unplanned, maintain a clear record of how and why the research change occurred rather than rewriting the final methods as though the revised population had always been intended.