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

Autor: Haddad C; Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France; Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France. Electronic address: Cynthia_had@yahoo.fr., Sigha OB; Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France., Lebrun-Vignes B; Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France; Pharmacovigilance Center, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France., Chosidow O; Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France; Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France., Fardet L; Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France; Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France.
Jazyk: angličtina
Zdroj: Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2017 Jul; Vol. 77 (1), pp. 98-104.e1. Date of Electronic Publication: 2017 Mar 14.
DOI: 10.1016/j.jaad.2017.01.011
Abstrakt: 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.
(Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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