The quality of controlled clinical trial reporting in five leading Sri Lankan medical journals

Abstract

INTRODUCTION: The Consolidated Standards of Reporting Trials (CONSORT) statement and the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) checklist help improve the quality of reporting of trials. Report quality is often used as a surrogate measure of methodological quality. AIMS: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals METHODS: Five medical journals published between 1982-2011 were hand searched for randomized (RCT) and non-randomized clinical trials (NRCT) conducted in humans. These were evaluated by two independent observers to assess them against a checklist developed based on CONSORT and TREND recommendations. Outcome measures were presence of checklist items in published reports. Results: Twenty two RCT and 16 parallel group NRCT from 160 journals were included. Out of them, Thirty six (94.7%) clearly described the objectives, 13 (34.2%) the periods of recruitment, 7(18.4%) sample size determination, 12(31.6%) the flow of participants through each stage,19 (50%) baseline demographic and clinical characteristics of each group. Twenty one (55.3%) used statistical methods to compare groups for primary outcome, 21(55.3%) effect size, 4 (10.5%) its precision. Twenty (52.6%) interpreted the results in the context of current evidence. Five (13.2%) described the generalizability of the findings. Of the 22 RCT, only one (4.5%) reported sequence generation, 3(13.6%) allocation concealment, 7(31.8%) blinding status of participants or investigators and 2(9.1%) intention to treat analysis. CONCLUSIONS: Reporting of several essential criteria of remain suboptimal. Awareness of the CONSORT and TREND statements may improve matters quality of reporting.