CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials

Letters15 February 2011CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized TrialsKenneth F. Schulz, PhD, MBA, Douglas G. Altman, DSc, and David Moher, PhDKenneth F. Schulz, PhD, MBAFrom Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada., Douglas G. Altman, DScFrom Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada., and David Moher, PhDFrom Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-154-4-201102150-00017 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Golomb and colleagues (1) write that in CONSORT 2010, “there is no requirement to stipulate the composition of the putative placebo or the inactive elements of the test treatment.” To the contrary, these are definitively “interventions” in CONSORT 2010, which explicitly requests a description of “the interventions for each group with sufficient details to allow replication” (2). To satisfy that replication criterion, the composition of the placebo or inactive elements would have to be described. Nevertheless, we appreciate that Golomb and colleagues have highlighted this issue. We should clarify our position and use their paper as a reference ...References1. Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. What's in placebos: who knows? Analysis of randomized, controlled trials. Ann Intern Med. 2010;153:532-5. PMID: 20956710 LinkGoogle Scholar2. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. PMID: 20332509 CrossrefMedlineGoogle 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 CrossrefMedlineGoogle Scholar4. Schulz KF, Altman DG, Moher D, Fergusson D. CONSORT 2010 changes and testing blindness in RCTs. Lancet. 2010;375:1144-6. PMID: 20338625 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Kenneth F. Schulz, PhD, MBA; Douglas G. Altman, DSc; David Moher, PhDAffiliations: From Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-0379. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials Kenneth F. Schulz , Douglas G. Altman , and David Moher , for the CONSORT Group* What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials Beatrice A. Golomb , Laura C. Erickson , Sabrina Koperski , Deanna Sack , Murray Enkin , and Jeremy Howick CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials Zhao-xiang Bian and Hong-cai Shang Metrics Cited byEffective behaviour change techniques for family and close friends: A systematic review and meta-analysis across the addictionsClinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical studyRandomized controlled phase 2 trial of hydroxychloroquine in childhood interstitial lung diseaseEffectiveness of a school-based mental health intervention for school teachers in urban Pakistan: a randomized controlled trialEfficacy of metacognitive training on symptom severity, neurocognition and social cognition in patients with schizophrenia: A single‐blind randomized controlled trialBasic demographic outcomes: additional findings of a single-blind, randomised, controlled trial on metacognitive training for psychosisEfficacy of Core Training in Swimming Performance and Neuromuscular Parameters of Young Swimmers: A Randomised Control TrialProspective Evaluation of Local Sustained Release of Celecoxib in Dogs with Low Back PainComparative study of combination therapy with non-steroidal anti inflammatory drugs and different doses of low level laser therapy in acute low back painIntervention Reporting of Published Trials Is Insufficient in Orthopaedic Surgery Journals: Application of the Template for Intervention Description and Replication ChecklistEffectiveness of a couple-based intervention on sexuality and intimacy among women in active cancer treatment: A quasi-experimental studyMobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)Can insights from placebo and nocebo mechanisms studies improve the randomized controlled trial?Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled studyTake A Breath: study protocol for a randomized controlled trial of an online group intervention to reduce traumatic stress in parents of children with a life threatening illness or injuryShenmai injection as an adjuvant treatment for chronic cor pulmonale heart failure: a systematic review and meta-analysis of randomized controlled trialsPrebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled TrialPsychiatric disorders and labour force activityEffects of Vegetable Consumption on Weight Loss: A Review of the Evidence with Implications for Design of Randomized Controlled TrialsShuganjieyu capsule for major depressive disorder (MDD) in adults: a systematic reviewSupporting Health Care Professionals to Improve the Processes of Shared Decision Making and Self-Management in a Web-Based Intervention: Randomized Controlled TrialStudy protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessationAre Interventions to Promote Sun-Protective Behaviors in Recreational and Tourist Settings Effective? A Systematic Review with Meta-analysis and Moderator Analysis 15 February 2011Volume 154, Issue 4Page: 291-292KeywordsBlindnessConflicts of interestDisclosureRandomized trialsReasoning ePublished: 15 February 2011 Issue Published: 15 February 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...