Guidelines for designing and reporting clinical trials in vitiligo

Abstract

Objective: To create guidelines for randomized controlled trials (RCTs) investigating interventions used in the management of vitiligo.

Participants: Guideline developers included authors (clinicians, patient representatives, and a statistician) of the Cochrane systematic review "Interventions for Vitiligo" plus the coordinator of the vitiligo priority-setting partnership at the Centre of Evidence-Based Dermatology at the University of Nottingham.

Evidence: The guidelines are based on the assessment of the quality of design and reporting of RCTs evaluating interventions for vitiligo included in the 2010 update of the Cochrane systematic review "Interventions for Vitiligo."

Consensus process: We reviewed and commented on the sources of bias in existing RCTs on interventions for vitiligo (selection bias, blinding assessment, attrition bias, characteristics of participants, interventions, and outcomes) based on the findings of the Cochrane review, and we used open discussion on guideline drafts focusing on the study question (participants, interventions, and outcomes), study design (research methods), and reporting.

Conclusions: Much opportunity exists for improving the design and reporting of vitiligo clinical trials. The proposed guidelines will help overcome methodologic challenges faced when conducting RCTs to answer treatment questions.