Article type
Year
Abstract
Background: A well-designed randomized controlled trial (RCT) provides the most reliable evidence of the effectiveness of interventions – the gold standard for clinical trials. Many RCTs are published each year with either trivial or serious flaws. Some serious flaws lead to misleading conclusions or failure to provide important information to guide clinical decision making. The more flaws, the lower the quality of RCTs. A way to assess the quality of RCTs is to consider the reporting quality; the CONSORT (Consolidated Standards of Reporting Trials) statement is a tool. There is no research that evaluates the reporting quality of RCTs published in Thai healthcare Journals.
Objectives: To describe the quality of published RCTs in Thai healthcare journals.
Methods: We searched for Thai-language RCTs published in Thai healthcare Journals from January 2008 to December 2012 by using an Online Public Access Catalog (OPAC) of Khon Kaen University and Thai University Library Network of OPAC. For each full RCT text we assessed the reporting quality by means of a questionnaire based on the revised version of the CONSORT statement 2010 (a 25-main item checklist; consists of 37 items). We recorded the quality of reporting presented by each item of the CONSORT checklist, and also the overall quality of included RCTs.
Results: The search identified 757 RCTs, 35 of which met the inclusion criteria. Result by each item of CONSORT: 18 of 37 (48.6%) items were reported in at least 75%. Some important items were inadequately reported; item 7a sample size determination (40%) , item 8a sequence generation (57%), item 9a allocation concealment mechanism (43%), item 11a blinding (57%), item 13a participant flow (9%), items 17a and 17b reporting of estimated effect size and its precision (14%, 13%). The least reported items were item 23 registration number and name of trial registry (1/35), item 24 where the full trial protocol can be accessed (1/35), item 12b statistical methods for additional analyses (2/14). The overall quality was moderate; 28 RCTs reported on 19 to 27 items.
Conclusions: The quality of reporting RCTs in Thai healthcare journals needs to be improved.
Objectives: To describe the quality of published RCTs in Thai healthcare journals.
Methods: We searched for Thai-language RCTs published in Thai healthcare Journals from January 2008 to December 2012 by using an Online Public Access Catalog (OPAC) of Khon Kaen University and Thai University Library Network of OPAC. For each full RCT text we assessed the reporting quality by means of a questionnaire based on the revised version of the CONSORT statement 2010 (a 25-main item checklist; consists of 37 items). We recorded the quality of reporting presented by each item of the CONSORT checklist, and also the overall quality of included RCTs.
Results: The search identified 757 RCTs, 35 of which met the inclusion criteria. Result by each item of CONSORT: 18 of 37 (48.6%) items were reported in at least 75%. Some important items were inadequately reported; item 7a sample size determination (40%) , item 8a sequence generation (57%), item 9a allocation concealment mechanism (43%), item 11a blinding (57%), item 13a participant flow (9%), items 17a and 17b reporting of estimated effect size and its precision (14%, 13%). The least reported items were item 23 registration number and name of trial registry (1/35), item 24 where the full trial protocol can be accessed (1/35), item 12b statistical methods for additional analyses (2/14). The overall quality was moderate; 28 RCTs reported on 19 to 27 items.
Conclusions: The quality of reporting RCTs in Thai healthcare journals needs to be improved.