Reporting of harm and safety results in randomized controlled trials published in 5 dermatology journals - 14/12/17
, Odette Berline Sigha, MD a, Bénédicte Lebrun-Vignes, MD b, c, Olivier Chosidow, MD, PhD a, b, Laurence Fardet, MD, PhD a, bAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : adverse events, CONSORT, Dermatology, quality of harm report, randomized controlled trials, report of harm, report of harm severity, safety
Abbreviations used : BJD, CONSORT, JAAD, JAMA, JEADV, JID, OR, RCT
Plan
| Funding sources: None. |
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| Conflicts of interest: None declared. |
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| Reprints not available from the authors. |
Vol 77 - N° 1
P. 98 - juillet 2017 Retour au numéro
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