Abstract
BackgroundRandomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions. The reporting of these trials should be of high quality to allow readers’ appropriate interpretation and application.MethodsThe objectives of our study were to assess the extent to which the recent Otolaryngology – Head and Neck Surgery (ORL-HNS) randomized control trials in the top nine journals and in the top Canadian journal comply with the Consolidated Standards of Reporting Trials (CONSORT) statement, and to identify the CONSORT items most in need of improvement. Based on the impact factor and circulation number of 2014, the top nine Otolaryngology journals and the top Canadian Otolaryngology journal were selected and were searched to identify RCTs published in English and between 2010 and 2014. Two authors independently reviewed and extracted data using a standardized data extraction form constructed with the help of a medical librarian. Our outcome was to assess the adherence of articles reporting to the CONSORT items. Descriptive statistics were used.ResultsOne hundred and eighty-two Otolaryngologic RCTs were identified in the top nine international journals and in the top Canadian journal. The inter-rater reliability between two raters was 0.32. The extent of adherence to CONSORT Statement ranged from 25 to 93.5% with a mean of 59.0% and a median of 59.4%. Only 6.5% of RCTs described the individual responsible for enrolling and assigning subjects and method of randomization; 32.4% reported the estimated effect size and precision; 40.6% reported a sample size calculation and 32.4% mentioned external validity or implications of the findings.ConclusionFindings revealed that the reporting of RCTs in the top nine ORL-HNS journals and in the top Canadian ORL-HNS journal is suboptimal. The quality of reporting can be improved by addressing the three CONSORT items found most deficient in this study namely, sample size calculations, estimated effect size and precision, and external validity.
Highlights
Randomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions
Randomized Controlled Trials (RCTs) are the preferred study design for comparing therapeutic interventions in medicine; they are considered the cornerstone of evidencebased medicine
Selection of Otolaryngology – Head and Neck Surgery (ORL-HNS) journals On a review of the highest-ranking impact factor international ORL-HNS journals of 2014 with the highest number of circulation, top nine journals were chosen, and one top Canadian otolaryngology journal was included in our study to add on the national perspective
Summary
Randomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions. The reporting of these trials should be of high quality to allow readers’ appropriate interpretation and application. Randomized Controlled Trials (RCTs) are the preferred study design for comparing therapeutic interventions in medicine; they are considered the cornerstone of evidencebased medicine. Poor reporting of RCTs impedes adequate understanding of the clinical indications. Because biases can occur in all aspects of studies, poor reporting limits the reader’s appreciation of the result’s validity [1]. To improve clarity and transparency of reporting of RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was released in 1996 and revised in 2001 and in 2010. The CONSORT Statement and the corresponding checklist summarize the essential items that should be reported
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
