Related Experiment Videos
Can the randomized controlled trial literature generalize to nonrandomized patients?
Shannon Wiltsey Stirman1, Robert J Derubeis, Paul Crits-Christoph
1Department of Psychology, University of Pennsylvania, Philadelphia, PA 19104-6196, USA. sws@psych.upenn.edu
Journal of Consulting and Clinical Psychology
|February 16, 2005
Summary
Most outpatients meet criteria for psychotherapy randomized controlled trials (RCTs). However, eligibility for substance use and social anxiety disorders is limited by remission status, symptom severity, medication, and primary diagnosis, impacting generalizability.
Area of Science:
- Clinical Psychology
- Psychiatric Research
- Evidence-Based Practice
Background:
- Randomized controlled trials (RCTs) are crucial for establishing psychotherapy efficacy.
- Generalizability of psychotherapy RCT findings to real-world clinical populations is a persistent concern.
- Understanding patient characteristics that limit RCT eligibility is vital for improving research and practice.
Purpose of the Study:
- To assess the generalizability of psychotherapy RCTs to a diverse outpatient sample.
- To identify specific patient characteristics and diagnostic groups with limited RCT eligibility.
- To inform future research designs and clinical practice guidelines.
Main Methods:
- Chart data from screened-out outpatients were matched against inclusion/exclusion criteria of published psychotherapy RCTs.
- Eligibility was assessed for patients with primary diagnoses common in RCT literature.
- Common reasons for ineligibility were systematically documented.
Main Results:
- Most outpatients were eligible for at least one relevant psychotherapy RCT.
- Significant eligibility limitations were observed for patients with substance use disorders and social anxiety disorder.
- Key exclusion factors included partial remission, insufficient symptom severity/duration, concurrent antidepressant medication use, and non-primary disorder status.
Conclusions:
- While many outpatients align with psychotherapy RCT criteria, specific populations face considerable barriers to inclusion.
- Findings highlight the need to broaden RCT eligibility criteria to enhance representativeness.
- Implications exist for refining research methodologies and adapting clinical practice to better serve diverse patient needs.