• K Adetugbo and H Williams.
• Cochrane Skin Group, Dermato-Epidemiology Unit, Queen's Medical Centre, University Hospital, Nottingham, England. adetugbo@hotmail.com
• Arch Dermatol. 2000 Mar 1;136(3):381-5.

ObjectiveTo assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal.Design And Data SourcesIn a survey of all published parallel group randomized controlled trials, we found 73 reports with allocation described as randomized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997.Main Outcome MeasuresDirect and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis.ResultsHand searching identified 73 randomized controlled trials, but only 31 of these were found by searching MEDLINE for the publication type clinical trials. Of the 73 randomized controlled trials, 68 contained sufficient information to include in the analysis. Only 1 study (1%) reported the method of random sequence generation, and only 5 studies (7%) reported adequate concealment of allocation. Among 38 trials that used simple randomization, the sample sizes in the comparison groups were identical in 22 occasions, raising the possibility that simple randomization might not have been adequately generated or concealed. Most trials (88%) excluded some randomized participants from their analysis. The median sample size was 23 per trial. Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis.ConclusionsHand searching is important for locating all relevant trials. There is the need for higher methodological quality in clinical trial reporting in dermatology journals. The adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.

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