Quality of Reporting in Randomized Trials Published in High-Quality Surgical Journals Sidhartha Sinha, MBBChir, MRCS, Shrestha Sinha, BSc, Elizabeth Ashby, MBBChir, MRCS, Raja Jayaram, MBBS, MD, FCARCSI, Michael PW Grocott, MBBS, MRCP, FRCA BACKGROUND: Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Ade- quate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonphar- macologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements. STUDY DESIGN: We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year.We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic method- ologic, adverse-event-related, and specific nonpharmacologic criteria. RESULTS: Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score 3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event-related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively. CONCLUSIONS: Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharma- cologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria. (J Am Coll Surg 2009;209:565–571. © 2009 by the American College of Surgeons) Randomized controlled trials (RCTs) provide high-quality evidence on efficacy of health care interventions only if they are well-designed and appropriately executed. 1 Inter- pretation of the strengths and limitations of an RCT relies on clear reporting of trial methodology. 2 Inadequate reporting can mask deficient methodology and lend false credence to biased results.The Consolidated Standards of ReportingTrials (CONSORT) statement was developed by an international group of clinicians, statisticians, and biomedical editors in the mid-1990s in an attempt to remedy persistent deficiencies in reporting of trial methodology. 3 The CONSORT statement provides a standardized framework to help authors prepare reports of their trial findings in a complete and transparent manner. Revised in 2001, the CONSORT statement is sup- ported by a growing number of biomedical journals and health care groups. 2,4 Unfortunately, despite evidence suggest- ing that adherence to CONSORT guidelines substantially improves quality of trial reporting, compliance remains low among surgical journals. 5 It is acknowledged that RCTs involving nonpharmaco- logic interventions, such as operations, face additional Disclosure Information: Nothing to disclose. This work was undertaken, in part, at University College London Hospital/ University College London Comprehensive Biomedical Research Centre, which receives a proportion of funding from the UK Department of Health’s National Institute for Health Research Biomedical Research Centres funding scheme. Received March 9, 2009; Revised June 17, 2009; Accepted July 1, 2009. From the Department of General Surgery, North Middlesex University Hos- pital, London (Sidhartha Sinha); University College London Medical School, London (Shrestha Sinha); Department of Orthopaedic Surgery, Barnet and Chase Farm Hospitals National Health ServiceTrust, London (Ashby); De- partment of Anaesthetics, John Radcliffe Hospital, Oxford, UK (Jayaram); and Surgical Outcomes Research Centre, Joint University College London Hospital/University College London Comprehensive Biomedical Research Centre, London, UK (Grocott). Correspondence address: Sidhartha Sinha, MRCS, 27 Aylmer Rd, London, N2 0BS, UK. email: sid261@hotmail.com 565 © 2009 by the American College of Surgeons ISSN 1072-7515/09/$36.00 Published by Elsevier Inc. doi:10.1016/j.jamcollsurg.2009.07.019