The CONSORT Statement: Explanation and Elaboration
Authors: Matthias Egger, Douglas G. Altman, Kenneth G. Schulz
Journal: Annals of Internal Medicine (2002)

Letters18 June 2002The CONSORT Statement: Explanation and ElaborationMatthias Egger, MD, Douglas G. Altman, DSc, and Kenneth G. Schulz, PhD, MBAMatthias Egger, MDUniversity of Bristol; Bristol B58 2PR, United Kingdom (Egger)Institute of Health Sciences; Oxford OX3 7LF, United Kingdom (Altman)Family Health International; Research Triangle Park, NC 27709 (Schulz)Search for more papers by this author, Douglas G. Altman, DScUniversity of Bristol; Bristol B58 2PR, United Kingdom (Egger)Institute of Health Sciences; Oxford OX3 7LF, United Kingdom (Altman)Family Health International; Research Triangle Park, NC 27709 (Schulz)Search for more papers by this author, and Kenneth G. Schulz, PhD, MBAUniversity of Bristol; Bristol B58 2PR, United Kingdom (Egger)Institute of Health Sciences; Oxford OX3 7LF, United Kingdom (Altman)Family Health International; Research Triangle Park, NC 27709 (Schulz)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-136-12-200206180-00016 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Critical appraisal of the quality of controlled clinical trials is central to informed decision making in health care. Such appraisal is possible only if the design, conduct, and analysis of trials are comprehensively and accurately described. Unfortunately, the current quality of reporting of clinical trials in the medical literature is poor (1). The CONSORT statement aims to provide guidance to authors on how to improve the reporting of trials.The CONSORT statement focuses on items related to the two dimensions of study validity originally proposed in 1957 by the psychologist Campbell (2): internal validity (“Did in fact the ...References1. Schulz KF. Randomised trials, human nature, and reporting guidelines. Lancet. 1996;348:596-8. [PMID: 8774577] CrossrefMedlineGoogle Scholar2. Campbell DT. Factors relevant to the validity of experiments in social settings. Psychol Bull. 1957;54:297-312. CrossrefMedlineGoogle Scholar3. Cook TD, Campbell DT. Quasi-Experimentation: Design and Analysis Issues for Field Testing. Boston: Houghton Mifflin; 1979. Google Scholar4. . Last JM, eds. A Dictionary of Epidemiology. New York: Oxford Univ Pr; 2001. Google Scholar Author, Article, and Disclosure InformationAuthors: Matthias Egger, MD; Douglas G. Altman, DSc; Kenneth G. Schulz, PhD, MBAAffiliations: University of Bristol; Bristol B58 2PR, United Kingdom (Egger)Institute of Health Sciences; Oxford OX3 7LF, United Kingdom (Altman)Family Health International; Research Triangle Park, NC 27709 (Schulz) PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe 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 , and Thomas Lang , for the CONSORT GroupThe CONSORT Statement: Explanation and Elaboration Hidemichi Yuasa The CONSORT Statement: Explanation and Elaboration Kenneth M. Kessler Metrics 18 June 2002Volume 136, Issue 12Page: 926-927KeywordsAbsolute risk reductionHealth careMortalityOdds ratioPopulation statisticsPsychologyQuality improvementReproducibilityRisk managementRisk ratio ePublished: 18 June 2002 Issue Published: 18 June 2002 Copyright & PermissionsCopyright © 2002 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...