Quality of Reporting Randomized Controlled Trials in Thai Health Care Journals: A Systematic Review

Abstract

Backgroundand Objective: A well designed randomized controlled trial (RCT) provides the most reliable evidence on the effectiveness of interventions, the gold standard for a clinical trial. A way to assess the quality of RCTs is to consider the reporting quality; The CONSORT Statement is a tool. The Objective of this study were to describe the quality of reporting RCTs in Thai Health Care Journals

Methods: Thai-language RCT reports published in Thai Health Care Journals between 2008 and 2012 were searched by using Online Public Access Catalog (OPAC) of Khon Kaen University and Thai University Library Network of OPAC. Reporting quality of RCTs was assessed by using adapted CONSORT Statement; a standard data collection form of a 25-main-item checklist (37 items). Quality of reporting is presented for each item, and also the overall.

Results: The search identified 757 RCTs. Thirty-five RCTs met the inclusion criteria. Results for each item of the CONSORT Statement; 18 of 37 (48.6%) items were reported in at least 75%. Some important items were inadequately reported; sample size determination (40%), sequence generation (57%), allocation concealment mechanism (43%), blinding (57%), participant flow (9%), reporting of estimated effect size and its precision (14%, 13%). The least reported items were registration number and name of trial registry (1/35), where the full trial protocol can be accessed (1/35) and statistical methods for additional analyses (2/14). The overall quality was moderate; 28 RCTs were reported in 18 to 26 items.

Conclusions :The quality of reporting RCTs  published in Thai Health Care Journals needs to be improved.