The quality of reporting randomized controlled trials in the dermatology literature in an era where the CONSORT statement is a standard

摘要

Background The quality of reporting randomized controlled trials (RCTs) in the dermatology literature has not received much consideration since the late 2000s. Objectives We aimed to assess the quality of recently reported RCTs published in dermatology journals, focusing on randomization processes, blinding and trial registration. Methods We reviewed 2042 original articles and identified 141 primary reports of RCTs in four dermatology journals (Journal of the American Academy of Dermatology, JAMA Dermatology, Journal of Investigative Dermatology and British Journal of Dermatology) from January 2015 to December 2017. Details were extracted from articles, supplements and public trial registries. A multivariable logistic regression analysis was conducted to identify factors associated with optimal reporting quality. Results Among the 141 RCTs, 99 (70 center dot 2%), 82 (58 center dot 2%) and 69 (48 center dot 9%) described methods used for randomization, allocation concealment and implementation, respectively. Most trials (126, 89 center dot 4%) reported blinding status; however, one-third did not state the similarity of the intervention. Furthermore, 52 RCTs (36 center dot 9%) were not registered prospectively. Trials published in the British Journal of Dermatology and using central randomization were significantly associated with optimal reporting quality after adjusting for covariates. Conclusions Several critical items in reporting RCTs, including allocation concealment, similarity of interventions in blinded trials and prospective trial registration, have remained unsatisfactory in the recent dermatology literature.