Adherence reporting in randomized controlled trials

Clin Trials: December 19, 2013

Background Treatment adherence may influence the therapeutic effect that is observed in a randomized controlled trial (RCT). Adherence may also be an indicator of research quality and treatment acceptance by participants. Despite the importance of adherence in RCT research, little is known about current practices for its measurement and reporting.

Purpose The objective of this study was to determine and evaluate adherence measurement and reporting practices in RCTs involving oral pharmacologic interventions published in high impact factor journals.

Methods We conducted a systematic review of RCTs involving oral pharmacotherapy published during 2010 in 10 high-impact general medicine and subspecialty journals. Two investigators independently abstracted data regarding trial characteristics, adherence monitoring, and adherence reporting. Differences were reconciled in conference. Descriptive statistics were calculated, statistical comparisons were made using chi-square analysis, and associations assessed using Spearman’s rank correlation coefficient. Read More