Socio-demographic features of participants in randomized con-trolled trials for major depression: generalizability and individu-alization.

Abstract

Rationale, Aims and Objectives: It is important for clinicians to know to what extent the results of randomized controlled trials (RCTs) are generalizable to their psychiatric practice, since RCTs are considered to be the most reliable source of evidence for treatment guideline development. Furthermore, it is important to know whether results from individual randomised controlled trials (RCTs) can be directly compared to each other. Socio-demographic and socio-economic (SES) features influence treatment-outcome in major depressive disorder (MDD). Differences in (reporting of) SES features of participants in RCTs will hamper comparison and jeopardise the external validity (generalizability) of their results. We explored the reporting of SES features in RCTs for depression. Methods: We selected 45 antidepressant efficacy trials (AETs) and 19 psychotherapy efficacy trials (PETs). We listed the reported socio-demographic and -economic features. Results: Reporting on SES-features was very diverse and often limited. Especially important SES features like educational level, socio-economic status and income were reported insufficiently. The mean age of RCT participants in MDD trials was 41 years. Participants are predominantly female (62%) and white (89%). Of the participants 61% were employed and 45% of the participants were married/cohabitating. Conclusions: Standardisation of reporting on socio-demographic and socio-economic status is needed to adequately judge the generalizability of RCTs to daily practice and to facilitate comparisons within the body of RCTs in order to move increasingly towards more individualized and person-centered models of clinical practice.