Discrepancies Between Prespecified and Reported Outcomes
Journal: Annals of Internal Medicine (2015)

Letters1 March 2016Discrepancies Between Prespecified and Reported OutcomesThe EditorsThe EditorsSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L15-0615 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:The Centre for Evidence-Based Medicine Outcome Monitoring Project (1) recently commented on Gepner and colleagues' article (2) and mentioned MacPherson and associates' trial (3) on their Web site. This watchdog group aims to monitor the reporting of prespecified outcomes in all clinical trials published in 5 top-tier medical journals, including Annals. Because these comments express concerns about “switched” or incompletely reported outcomes, we would like to describe our editorial process and potential reasons for the discrepancies noted by COMPare. We attempted to post a public comment on the group's Web site to express our concerns about their assessments, ...References1. Centre for Evidence-Based Medicine Outcome Monitoring Project. Tracking switched outcomes in clinical trials. Accessed at www.COMPare-Trials.org on 8 December 2015. Google Scholar2. 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 Scholar3. MacPherson H, Tilbrook H, Richmond S, Woodman J, Ballard K, Atkin K, et al. Alexander technique lessons or acupuncture sessions for persons with chronic neck pain: a randomized trial. Ann Intern Med. 2015;163:653-62. [PMID: 26524571]. doi:10.7326/M15-0667 LinkGoogle Scholar4. Goldacre B, Drysdale H, Heneghan C; Centre for Evidence-Based Medicine Outcome Monitoring Project. The Centre for Evidence Based Medicine Outcome Monitoring Project (COMPare) Protocol. Accessed at http://compare-trials.org/downloads/protocol.pdf on 8 December 2015. Google Scholar5. Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Ahrén B, Torffvit O, et al. Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial). BMJ. 2015;351:h5364. [PMID: 26512041] doi:10.1136/bmj.h5364 CrossrefMedlineGoogle Scholar6. Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Torffvit O, Pehrsson NG. Design and methods of a randomised double-blind trial of adding liraglutide to control HbA1c in patients with type 2 diabetes with impaired glycaemic control treated with multiple daily insulin injections (MDI-Liraglutide trial). Prim Care Diabetes. 2015;9:15-22. [PMID: 25175385] doi:10.1016/j.pcd.2014.07.010 CrossrefMedlineGoogle Scholar7. MacPherson H, Tilbrook HE, Richmond SJ, Atkin K, Ballard K, Bland M, et al. Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial. Trials. 2013;14:209. [PMID: 23841901] doi:10.1186/1745-6215-14-209 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.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 Outcomes Eirion Slade , Henry Drysdale , Ben Goldacre , and Metrics 1 March 2016Volume 164, Issue 5Page: 374-375KeywordsClinical trial reportingClinical trialsEvidence based medicineInformation retrievalInstitutional review boardsPeer reviewResearch quality assessmentScientific misconductStatistical dataStatistical methods ePublished: 22 December 2015 Issue Published: 1 March 2016 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...