CONSORT: An Important Step toward Evidence-Based Health Care

Editorials1 January 1997CONSORT: An Important Step toward Evidence-Based Health CareNick Freemantle, MA, James M. Mason, PhD, Andrew Haines, MD, and Martin P. Eccles, MDNick Freemantle, MAUniversity of York, Heslington, York Y01 5DD, United Kingdom.University College London Medical School and Royal Free Hospital School of Medicine, London NW3 2PF, United Kingdom.University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, United Kingdom., James M. Mason, PhDUniversity of York, Heslington, York Y01 5DD, United Kingdom.University College London Medical School and Royal Free Hospital School of Medicine, London NW3 2PF, United Kingdom.University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, United Kingdom., Andrew Haines, MDUniversity of York, Heslington, York Y01 5DD, United Kingdom.University College London Medical School and Royal Free Hospital School of Medicine, London NW3 2PF, United Kingdom.University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, United Kingdom., and Martin P. Eccles, MDUniversity of York, Heslington, York Y01 5DD, United Kingdom.University College London Medical School and Royal Free Hospital School of Medicine, London NW3 2PF, United Kingdom.University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, United Kingdom.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-126-1-199701010-00011 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The recent publication of the Consolidated Standards of Reporting Trials (CONSORT) guidelines lines for the reporting of randomized trials [1] marks a welcome convergence of advice from the Standards of Reporting Trials (SORT) Group [2] and the Asilomar Working Group on Recommendations for the Reporting of Clinical Trials in the Biomedical Literature, which examine clinical efficacy [3]. Authors who submit papers to Annals are now being asked to adhere to the principles embodied in the sensible recommendations from these two similar but until recently largely independent projects [4]. The Lancet, JAMA, and BMJ are also adopting these recommendations. The goal ...References1. Begg C, Cho M, Eastwod S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized, controlled trials. The CONSORT statement. JAMA. 1996; 276:637-9. Google Scholar2. A proposal for structured reporting of randomized, controlled trials. The Standards of Reporting Trials Group. JAMA. 1994; 272:1926-31. Google Scholar3. Checklist of information for inclusion in reports of clinical trials. The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med. 1996; 124:741-3. Google Scholar4. Information for authors. Ann Intern Med. 1997; 127:1-11. Google Scholar5. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care. 1996; 12:209-37 Google Scholar6. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement [Editorial]. BMJ. 1996; 313:570-1. Google Scholar7. Mosteller F, Colditz GA. Understanding research synthesis (meta-analysis). Annu Rev Public Health. 1996; 17:1-23. Google Scholar8. Begg CB, Berlin JA. Publication bias: a problem in interpreting medical data. Journal of the Royal Statistical Society. 1988; 151:419-63. Google Scholar9. Song F, Freemantle N, Sheldon TA, House A, Watson P, Long A, et al. Selective serotonin reuptake inhibitors: meta-analysis of efficacy and acceptability. BMJ. 1993; 306:683-7. Google Scholar10. Baum M. New approach for recruitment into randomised controlled trials. Lancet. 1993; 341:812-3. Google Scholar11. Jeng GT, Scott JR, Burmeister LF. A comparison of meta-analytic results using literature vs individual patient data: paternal cell immunization for recurrent miscarriage. JAMA. 1995; 274:830-6. Google Scholar12. Stewart LA, Parmar MK. Meta analysis of the literature or of individual patient data: Is there a difference? Lancet. 1993; 341:418-22. Google Scholar13. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet. 1991; 337:867-72. Google Scholar14. Goetzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Controlled Clin Trials. 1989; 10:31-56. Google Scholar15. Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust; 1972. Google Scholar16. Freemantle N, Drummond MF. Should clinical trials with concurrent economic analyses be blinded? JAMA. 1997; [In press]. Google Scholar17. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ. 1996; 313:275-83. Google Scholar18. Rennie D. Reporting randomized, controlled trials: an experiment and a call or responses from readers [Editorial]. JAMA. 1995; 273:1054-5. Google Scholar Author, Article, and Disclosure InformationAuthors: Nick Freemantle, MA; James M. Mason, PhD; Andrew Haines, MD; Martin P. Eccles, MDAffiliations: University of York, Heslington, York Y01 5DD, United Kingdom.University College London Medical School and Royal Free Hospital School of Medicine, London NW3 2PF, United Kingdom.University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, United Kingdom.Corresponding Author: Nick Freemantle, MA, Centre for Health Economics, University of York, Heslington, York Y01 5DD, United Kingdom. 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Altman, DSc, for the CONSORT Group*The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trialsImpact of presentation of research results on likelihood of prescribing medications to patients with left ventricular dysfunctionEvaluation of clinical studies of the efficacy of therapeutic apheresisReport & Commentary: The NKF‐DOQI Anemia Guidelines: Not Appropriate as Performance Measures for Peritoneal DialysisChoosing an Appropriate Unit of Analysis in Trials of Interventions That Attempt to Influence PracticeEvidence-Based Medicine: A New Paradigm for the Teaching and Practice of MedicineDoes quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?Randomized controlled trials in cancer: Improving the quality of their reports will also facilitate better conductClinical trials in urogynecologyPrinted educational materials: effects on professional practice and health care outcomes 1 January 1997Volume 126, Issue 1Page: 81-83KeywordsClinical trial reportingClinical trialsEmotionsForecastingGuinea pigsHealth carePatientsRandomized trialsResearch designStatistical data ePublished: 15 August 2000 Issue Published: 1 January 1997 Copyright & PermissionsCopyright © 1997 by American College of Physicians. 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