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


CONCLUSIONS
Assessment was restricted to RCTs and 5 dermatological journals.


CONCLUSIONS
Harm is quite well reported in dermatologic journals. Efforts should be made on reporting severity of harm.
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.
Cynthia
C
Haddad
Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France.
Odette Berline
OB
Sigha
Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France; Pharmacovigilance Center, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
Bénédicte
B
Lebrun-Vignes
Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France; Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France.
Olivier
O
Chosidow
Department of Dermatology, Henri Mondor Hospital, APHP, Créteil, France; Equipe d'accueil 7379 - EpiDermE, University Paris-Est Créteil, Créteil, France.
Laurence
L
Fardet
D003880:Dermatology; D006801:Humans; D061214:Patient Safety; D010506:Periodicals as Topic; D011643:Publishing; D016032:Randomized Controlled Trials as Topic; D058028:Research Report
CONSORT; Dermatology; adverse events; quality of harm report; randomized controlled trials; report of harm; report of harm severity; safety