Reporting of harm and safety results in randomized controlled trials published in 5 dermatology journals

Publication date: Available online 14 March 2017
Source:Journal of the American Academy of Dermatology
Author(s): Cynthia Haddad, Odette Berline Sigha, Bénédicte Lebrun-Vignes, Olivier Chosidow, Laurence Fardet
BackgroundRandomized controlled trials (RCTs) are considered the gold standard for assessing efficacy and short-term harm of medicines. However, several studies have come to the conclusion that harm is less well reported than efficacy outcomes.ObjectiveTo describe harm reporting in publications on dermatological RCTs and assess parameters that could influence the quality of harm reporting.MethodsMethodologic systematic review of dermatologic RCTs published from 2010 to 2014 in 5 dermatological journals.ResultsAmong 110 assessed publications on RCTs, 80 (73%) adequately reported harm and 52% adequately reported its severity. Overall, 40% of the assessed manuscripts perfectly reported and discussed harm. The adequate reporting of harm was significantly associated with the type of trial (odds ratio [OR] 4.41, 95% confidence interval [CI] 1.60-12.35 for multicenter compared with monocentric trials) and having a predefined method for collecting harm data (OR 5.93, 95% CI 2.26-15.56). Reporting of harm severity was better in pharmacologic trials (OR 6.48, 95% CI 2.00-21.0) compared with nonpharmacologic trials and in trials for which a method for collecting harm (OR 5.65, 95% CI 2.00-16.4) and its severity (OR 3.60, 95% CI 1.00-12.8) was defined before the study onset.LimitationsAssessment was restricted to RCTs and 5 dermatological journals.ConclusionHarm is quite well reported in dermatologic journals. Efforts should be made on reporting severity of harm.



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