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

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Date

2012

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Volume Title

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Sri Lanka Medical Association

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.

Description

Poster Presentation Abstract (PP 138), 125th Anniversary Scientific Medical Congress, Sri Lanka Medical Association, June 2012 Colombo, Sri Lanka

Keywords

clinical trial

Citation

Sri Lanka Medical Association, 125th International Medical Congress. 2012;57 Supplement 1: 137

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Review

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