Appropriate primary endpoints in randomized controlled trials (RCTs) improve the quality of the measurement and enable comparison of the findings with those of other trials.
We aimed to assess the quality of reporting primary endpoints in RCTs recently published in dermatology journals.
We identified 134 primary reports of RCTs among original articles in four dermatology journals published from January 2016 to December 2018. Details were extracted from articles, supplements, and trial registries. A multivariable logistic regression analysis was conducted to identify factors associated with adequate primary endpoint reporting.
Out of the 134 RCTs, adequate primary endpoint reporting was conducted in 56.7% (n = 76). Nine missed definition of primary endpoints and 13 did not define the timing of primary endpoints in the publications. Among 113 RCTs reporting primary endpoints explicitly in the articles, 16 showed discrepancies between registration and publication, and 21 were not able to valuate pre-specification of primary endpoints. Multicenter studies and sponsor-initiated trials were significantly associated with adequate reporting quality after adjusting for covariates.
Pre-specification was evaluated based on comparison of the article and registry.
Quality of primary endpoint reporting, particularly in pre-specification, have remained unsatisfactory in the recent dermatology literature.
Copyright © 2020. Published by Elsevier Inc.