Discrepancies Between Prespecified and Reported Outcomes
Authors: Eirion Slade, Henry Drysdale, Ben Goldacre
Journal: Annals of Internal Medicine (2015)

Letters22 December 2015Discrepancies Between Prespecified and Reported OutcomesEirion Slade, MPhys, Henry Drysdale, BSc, and Ben Goldacre, MBBS, on behalf of the COMPare TeamEirion Slade, MPhysFrom COMPare and the Centre for Evidence-Based Medicine, Oxford University, Oxford, United Kingdom., Henry Drysdale, BScFrom COMPare and the Centre for Evidence-Based Medicine, Oxford University, Oxford, United Kingdom., and Ben Goldacre, MBBSFrom COMPare and the Centre for Evidence-Based Medicine, Oxford University, Oxford, United Kingdom., on behalf of the COMPare TeamAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L15-0614 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Gepner and colleagues' article (1) reports outcomes that differ from those initially registered (2). One prespecified primary outcome was reported incorrectly as a secondary outcome. In addition, the article reports 5 "primary outcomes" and 9 secondary outcomes that were not prespecified without flagging them as such. One prespecified secondary outcome also was not reported anywhere in the article.Annals of Internal Medicine endorses the CONSORT (Consolidated Standards of Reporting Trials) guidelines (3) on best practice in trial reporting. To reduce the risk for selective outcome reporting, CONSORT includes a commitment that all prespecified primary and secondary outcomes ...References1. Gepner Y, Golan R, Harman-Boehm I, Henkin Y, Schwarzfuchs D, Shelef I, et al. Effects of initiating moderate alcohol intake on cardiometabolic risk in adults with type 2 diabetes: a 2-year randomized, controlled trial. Ann Intern Med. 2015;163:569-79. [PMID: 26458258]. doi:10.7326/M14-1650 LinkGoogle Scholar2. The Cardiovascular Diabetes and Ethanol (CASCADE) trial. ClinicalTrials.gov: NCT00784433. Accessed at https://clinicaltrials.gov/ct2/show/NCT00784433 on 9 November 2015. Google Scholar3. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. [PMID: 20332511] doi:10.1136/bmj.c869 CrossrefMedlineGoogle Scholar4. Centre for Evidence-Based Medicine Outcome Monitoring Project. Tracking switched outcomes in clinical trials. Accessed at www.COMPare-Trials.org on 9 November 2015. Google Scholar Author, Article, and Disclosure InformationAuthors: Eirion Slade, MPhys; Henry Drysdale, BSc; Ben Goldacre, MBBSAffiliations: From COMPare and the Centre for Evidence-Based Medicine, Oxford University, Oxford, United Kingdom.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L15-0614.This article was published at www.annals.org on 22 December 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEffects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes Yftach Gepner , Rachel Golan , Ilana Harman-Boehm , Yaakov Henkin , Dan Schwarzfuchs , Ilan Shelef , Ronen Durst , Julia Kovsan , Arkady Bolotin , Eran Leitersdorf , Shoshana Shpitzen , Shai Balag , Elad Shemesh , Shula Witkow , Osnat Tangi-Rosental , Yoash Chassidim , Idit F. Liberty , Benjamin Sarusi , Sivan Ben-Avraham , Anders Helander , Uta Ceglarek , Michael Stumvoll , Matthias Blüher , Joachim Thiery , Assaf Rudich , Meir J. Stampfer , and Iris Shai Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain Hugh MacPherson , Helen Tilbrook , Stewart Richmond , Julia Woodman , Kathleen Ballard , Karl Atkin , Martin Bland , Janet Eldred , Holly Essex , Catherine Hewitt , Ann Hopton , Ada Keding , Harriet Lansdown , Steve Parrott , David Torgerson , Aniela Wenham , and Ian Watt Discrepancies Between Prespecified and Reported OutcomesThe Editors Metrics Cited byIntent to share Annals of Internal Medicine's trial data was not associated with data re-useResearch Study DesignOn the Design of a Blockchain Platform for Clinical Trial and Precision MedicineHow blockchain-timestamped protocols could improve the trustworthiness of medical scienceHow blockchain-timestamped protocols could improve the trustworthiness of medical scienceHow blockchain-timestamped protocols could improve the trustworthiness of medical science 1 March 2016Volume 164, Issue 5 Page: 374 Keywords Decision making Disclosure Evidence based medicine Risk management ePublished: 22 December 2015 Issue Published: 1 March 2016 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...