How Well Are Randomized Controlled Trials Reported in the Dermatology Literature?

K. Adetugbo · Hywel C Williams

126 citations0/0 files storedArchives of Dermatology

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Pharmaceutical industry and healthcare

Abstract

OBJECTIVE: To assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal. DESIGN AND DATA SOURCES: In 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 MEASURES: Direct and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis. RESULTS: Hand 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. CONCLUSIONS: Hand 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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References

1995Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials 1996Improving the quality of reporting of randomized controlled trials. The CONSORT statement 1998The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials 1994Assessing the Quality of Randomization From Reports of Controlled Trials Published in Obstetrics and Gynecology Journals 1982Reporting on Methods in Clinical Trials 1996The Importance of Quality of Primary Studies in Producing Unbiased Systematic Reviews 1986A quality assessment of randomized control trials of primary treatment of breast cancer.

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