16.3 Threats to External Validity

External validity concerns the extent to which findings generalize beyond the specific conditions of a study. A study may support a conclusion for one sample, setting, treatment version, or outcome measure, but that does not automatically mean the same conclusion holds elsewhere.

One way to think about external validity is through UTOS:

Common Threats to External Validity

Selection Biases

Selection biases occur when the sample differs from the population to which researchers want to generalize. This can happen because of recruitment methods, exclusion criteria, self-selection, attrition, or limited access to participants.

For example, a study of therapy outcomes based only on participants who can attend weekday daytime sessions may not generalize to people with different work schedules, caregiving responsibilities, or access barriers.

Treatment Variation

Findings may not generalize across different versions of a treatment or intervention. A treatment delivered by one highly trained provider in a controlled setting may not have the same effect when delivered by many providers in routine practice.

Outcome Variation

Findings may depend on how the outcome is measured. A study may show an effect on self-reported anxiety but not on clinician-rated anxiety, behavioral avoidance, or physiological indicators.

This overlaps with construct validity because generalizing across outcomes requires confidence that the outcome measures represent the intended construct.

Setting and Context

The “real world” may differ from the research setting in important ways. Laboratory studies can provide control, but findings may not always generalize to naturalistic settings. Similarly, field studies conducted in one organization, school, clinic, or community may not generalize to others.

Historical and Temporal Context

Findings may depend on when the study was conducted. Social norms, technology, policies, economic conditions, and major historical events can shape whether results generalize to later time periods.

Longer studies may also be influenced by changes that occur during the study itself. These issues can affect both external validity and, in some designs, internal validity.