Improving the quality of reporting of randomized controlled trials: The CONSORT statement

Journal of the American Medical Association

Volumn 276, Issue 8, 1996, Pages 637-639

  Begg, Colin ^a   Cho, Mildred ^b   Eastwood, Susan ^c   Horton, Richard ^d   Moher, David ^e,k   Olkin, Ingram ^f   Pitkin, Roy ^g   Rennie, Drummond ^h   Schulz, Kenneth F ⁱ   Simel, David ^j   Stroup, Donna F ⁱ  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d THE LANCET   (United Kingdom)

^e UNIVERSITY OF OTTAWA   (Canada)

^f STANFORD UNIVERSITY   (United States)

^g Obstetrics and Gynecology   (United States)

^h JAMA   (United States)

ⁱ CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^j DURHAM VA MEDICAL CENTER   (United States)

^k OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; HEALTH CARE QUALITY; HUMAN; MEDICAL LITERATURE; MEDICAL RESEARCH; PATIENT CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

GUIDELINES; PERIODICALS; PUBLISHING; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIALS;

EID: 9444255722     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.276.8.637     Document Type: Article

References (31)

1. Freiman JA, Chalmers TC, Smith H Jr, Kuebler RR. The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: survey of 71 'negative' trials. N Engl J Med, 1978;299:690-694.
2. Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994;272:122-124.
3. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA. 1994;272:1926-1931. Correction: JAMA. 1995;273:776.
4. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature: a position paper. Ann Intern Med. 1994;121: 894-895.
5. Rennie D. Reporting randomized controlled trials: an experiment and a call for responses from readers. JAMA. 1995;273:1054-1055.
6. Williams JW Jr, Holleman DR Jr, Samsa GP, Simel DL. Randomized controlled trial of 3 vs 10 days of trimethoprim/sulfamethoxazole for acute maxillary sinusitis. JAMA. 1995;273:1015-1021.
7. Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for systematic reviews, BMJ. 1994; 309:1286-1291.
8. Ad Hoc Working Group for Critical Appraisal of the Medical Literature. A proposal for more informative abstracts of clinical studies. Ann Intern Med. 1987;106:598-604.
9. Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR. Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association. Can Med Assoc J. 1994;150:1611-1615.
10. Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Ann Intern Med. 1992;116:78-84.
11. Godfrey K. Statistics in practice: comparing the means of several groups. N Engl J Med. 1985;313: 1450-1456.
12. Gardner MJ, Bond J. An exploratory study of statistical assessment of papers published in the British Medical Journal. JAMA. 1990;263:1355-1357.
13. Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option? Stat Med. 1991;10: 1595-1605.
14. Pocock SJ. When to stop a clinical trial. BMJ. 1992;305:235-240.
15. Donner A, Brown KS, Brasher P. A methodological review of nontherapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol. 1990;19:795-800.
16. Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA. 1994;72:125-128.
17. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273: 408-412.
18. Schulz KF. Subverting randomization in controlled trials. JAMA. 1995;274:1456-1468.
19. Schulz KP, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ. 1996;312:742-744.
20. Karlowski TR, Chalmers TC, Frenkel LD, Kapikian AZ, Lewis TL, Lynch JM. Ascorbic acid for the common cold: a prophylactic and therapeutic trial. JAMA. 1975;231:1038-1042.
21. Pocock SJ. Clinical Trials: A Practical Approach. Chichester, England: John Wiley & Sons Inc; 1983:182-186.
22. Bailar JC, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Ann Intern Med. 1988;108:266-273.
23. Gardner MJ, Altman DG. Confidence intervals rather than P values: estimation rather than hypothesis testing. BMJ. 1986;292:746-750.
24. Evans M, Pollock AV. Trials on trial: a review of trials of antibiotic prophylaxis. Arch Surg. 1984; 119:109-113.
25. Gardner MJ, Machin D, Campbell MJ. Use of check lists in assessing the statistical content of medical studies. In: Gardner MJ, Altman DG, eds. Statistics With Confidence - Confidence Intervals and Statistical Guidelines. London, England: BMJ; 1989:101-108.
26. Fletcher RH, Fletcher SW. Clinical research in general medical journals: a 30-year perspective. N Engl J Med. 1979;301:180-183.
27. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1-12.
28. Altman DG. The scandal of poor medical research: we need less research, better research, and research done for the right reasons. BMJ. 1994; 308:283-284.
29. Altman DG, Doré C. Randomisation and baseline comparisons in clinical trials, Lancet. 1990;335: 149-153.
30. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials: a survey of three medical journals. N Engl J Med. 1987;317: 426-432.
31. Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal anti-inflammatory drugs in rheumatoid arthritis. Control Clin Trials. 1989;10:31-56. Correction: Control Clin Trials. 1989;10:356.