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

• Published in: Journal of the American Academy of Dermatology 2017-07, Vol.77 (1), p.98-104.e1
• Main Authors: Haddad, Cynthia, PharmD, MSc, Sigha, Odette Berline, MD, Lebrun-Vignes, Bénédicte, MD, Chosidow, Olivier, MD, PhD, Fardet, Laurence, MD, PhD
• Format: Article
• Language: English
• Subjects: adverse events; CONSORT; Dermatology; Humans; Patient Safety; Periodicals as Topic; Publishing; quality of harm report; randomized controlled trials; Randomized Controlled Trials as Topic; report of harm; report of harm severity; Research Report; safety
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2017.01.011

Background Randomized 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. Objective To describe harm reporting in publications on dermatological RCTs and assess parameters that could influence the quality of harm reporting. Methods Methodologic systematic review of dermatologic RCTs published from 2010 to 2014 in 5 dermatological journals. Results Among 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. Limitations Assessment was restricted to RCTs and 5 dermatological journals. Conclusion Harm is quite well reported in dermatologic journals. Efforts should be made on reporting severity of harm.