The CONSORT Statement: Explanation and Elaboration
Authors: Kenneth M. Kessler
Journal: Annals of Internal Medicine (2002)

Letters18 June 2002The CONSORT Statement: Explanation and ElaborationKenneth M. Kessler, MDKenneth M. Kessler, MDUniversity of Miami; Miami, FL 33101Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-136-12-200206180-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Despite the rigor of the CONSORT statement (1, 2), in reality the results of most clinical trials are reduced to a single number: some expression of the treatment effect. The CONSORT statement primarily recommends the reporting of treatment effect as a representation of relative risk. However, relative risk may seriously overestimate treatment effect whenever the outcome prevalence is significantly less than 100% (3, 4). The CONSORT statement secondarily recommends using the number needed to treat (NNT), a value that reflects outcome prevalence as well as treatment effect. The NNT seems to have become popular because it is ...References1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-62. [PMID: 11304106] LinkGoogle Scholar2. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al . The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663-94. [PMID: 11304107] LinkGoogle Scholar3. Naylor CD, Chen E, Strauss B. Measured enthusiasm: does the method of reporting trial results alter perceptions of therapeutic effectiveness? Ann Intern Med. 1992;117:916-21. [PMID: 1443954] LinkGoogle Scholar4. Kessler KM, Kessler DK. Definition and axioms of net treatment benefit. Clin Pharmacol Ther. 2001;69:1-6. [PMID: 11180032] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: University of Miami; Miami, FL 33101 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials David Moher , Kenneth F. Schulz , Douglas G. Altman , and The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration Douglas G. Altman , Kenneth F. Schulz , David Moher , Matthias Egger , Frank Davidoff , Diana Elbourne , Peter C. Gøtzsche , Thomas Lang , and The CONSORT Statement: Explanation and Elaboration Matthias Egger , Douglas G. Altman , and Kenneth G. Schulz The CONSORT Statement: Explanation and Elaboration Hidemichi Yuasa Metrics Cited byMulti-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis planUpdate of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis planDetailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restrictionSystemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis planRoutine postoperative administration of vitamin D and calcium after total thyroidectomy: a meta-analysisProphylactic platelet transfusion for haemorrhage after chemotherapy and stem cell transplantation 18 June 2002Volume 136, Issue 12Page: 926KeywordsAbsolute risk reductionAdverse eventsClinical trialsNumber needed to harmNumber needed to treatRelative riskRisk management ePublished: 18 June 2002 Issue Published: 18 June 2002 Copyright & PermissionsCopyright © 2002 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...