Reporting of harm severity in dermatology trials needs improvement
Studies in dermatology journals report harm quite well, according to a systematic review, adding that efforts should be made on reporting harm severity.
Researchers conducted a methodologic systematic review of dermatologic randomized controlled trials (RCTs) published from 2010 to 2014 in five dermatology journals to describe harm reporting and assess parameters that could influence the quality of harm reporting.
A total of 110 publications on RCTs were included. Of these, 80 (73 percent) adequately reported harm and 52 percent adequately reported its severity.
The type of trial (odds ratio [OR], 4.41; 95 percent CI, 1.60 to 12.35 for multicentre vs monocentric trials) and having a predefined method for collecting harm data (OR, 5.93; 2.26 to 15.56) were significantly associated with the adequate reporting of harm.
Reporting of harm severity was better in pharmacologic trials (OR, 6.48; 2.00 to 21.0) vs nonpharmacologic trials and in trials for which a method for collecting harm (OR, 5.65; 2.00 to 16.4) and its severity (OR, 3.60; 1.00 to 12.8) was defined prior to the commencement of the study.
This systematic review was limited by the assessment of RCTs and five dermatology journals only.
RCTs are regarded as the “gold standard” for evaluating efficacy and short-term harm of medicines, according to researchers.
In a previous study that evaluated RCTs (n=98) published in two dermatology journals pre- and post-CONSORT (Consolidated Standards for Reporting Trials) adoption, researchers found that the reporting quality of such RCTs needs improvement. Pharmaceutical industry funding was one of the factors associated with a good methodological quality. [Br J Dermatol 2009;161:1159-65]