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Quality of Reporting of Randomized Controlled Trials in General Endocrinology Literature

Father Sean O’Sullivan Research Centre (L.P.R., A.O., L.T.) St. Joseph’s Healthcare Hamilton, Hamilton Ontario, L8N 4A6 Canada; and Department of Clinical Epidemiology and Biostatistics (A.O., L.T.) and Department of Medicine (L.P.R.) and Bachelor of Health Sciences Program (M.O.M., M.O.R.), Faculty of Health Science, McMaster University, Hamilton, Ontario, L8N 3Z5 Canada

Address all correspondence and requests for reprints to: Lehana Thabane, Biostatistics/FSORC, 3rd Floor Martha, Room H325, St. Joseph’s Healthcare Hamilton, 50 Charlton Avenue East, Hamilton, Ontario, L8N 4A6 Canada. E-mail: ThabanL{at}mcmaster.ca.

Context: The reporting quality of randomized controlled trials (RCTs) is poor in general medicine and several areas of specialization but unknown in endocrinology.

Objective: Our aim was to assess the reporting quality of RCTs in general endocrinology. A secondary objective was to identify predictors for better reporting quality.

Design and Setting: We systematically reviewed RCTs published in three general endocrinology journals between January 2005 and December 2006.

Participants: We included parallel-design RCTs that addressed a question of treatment or prevention. Article selection and data abstraction were conducted by two reviewers independently, and disagreements were resolved by consensus.

Main Outcomes: There were two main outcomes: 1) a 15-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials (CONSORT); and 2) a 3-point key score, based on allocation concealment, blinding, and use of intention-to-treat analysis.

Results: Eighty nine RCTs were included. The median OQS was 10 (interquartile range = 2). Allocation concealment, blinding, and analysis by intention to treat were reported in 10, 20, and 16 of the 89 RCTs, respectively. A multivariable regression analysis showed that complete industrial funding [incidence rate ratio (IRR) = 1.014; 95% confidence interval (CI), 1.010–1.018], journal of publication (IRR = 1.068; 95% CI, 1.007–1.132), and sample size (IRR = 1.048; 95% CI, 1.026–1.070) were significantly associated with a slightly better OQS.

Conclusions: The quality of RCT reporting in general endocrine literature is suboptimal. We discuss our results, highlight the areas where improvements are needed, and provide some recommendations.

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				D. C. Bauer Randomized Trial Reporting in General Endocrine Journals: The Good, the Bad, and the Ugly J. Clin. Endocrinol. Metab., October 1, 2008; 93(10): 3733 - 3734. [Full Text] [PDF]