Improving the quality of reporting of randomized controlled trials the CONSORT statement;Mejora de la calidad de los informes de los ensayos clinicos aleatorios controlados. Recomendaciones del grupo de trabajo CONSORT

Revista Espanola de Salud Publica

Volumn 72, Issue 1, 1998, Pages 5-11

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

^a Memorial Sloan Cancer Center

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d THE LANCET   (United Kingdom)

^e UNIVERSITY OF OTTAWA   (Canada)

^f Departamento de Estadísticas   (United States)

^g Obstetricia y Ginecología   (United States)

^h JAMA   (United States)

ⁱ Ctro Contr Prevencion las Enferm   (United States)

^j Servicios Sanitarios Atencion P

^k Centro Médico para Veteranos

^l OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

more..

Author keywords

Controlled Clinical Trial; Delphi Method; Work Group

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; REVIEW; STANDARD;

EID: 6844266277     PISSN: 11355727     EISSN: None     Source Type: Journal    
DOI: 10.1590/S1135-57271998000100002     Document Type: Review

References (31)

1. Freiman JA, Chalmers TC, Smith la 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 Int 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. Wilbams JW Jr, Holleman DR Jr, Sarnsa GP, Simel DL. Randomized controlled trial of 3 vs 10 days of trimethopim/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 abstract of clinical studies. Ann Intern Med 1987,106:598-604.
9. Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einaron 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 JAMA, August 28, Vol 276, No. 8 subgroup analyses. Ann Int 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 assesment of papers published in the British Medical Journal. JAMA 1990:263:1355-1357.
13. Lee YJ, Ellenberg JH, Flirtz DG, Nelon 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, Brom-n KS, Brasher P A methodological review of nontherapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epideimiol. 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 obstetries and ginecology journals JAMA 1994;272:125-128.
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;274:1456-1458.
19. Schulz KF, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomized controlled trials: survey of published parallel group trials in obstetrics and ginaecology. 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, Moistener F. Guidelines for statistical reporting in articles for medical journals Ann Inttern 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 sstudies. 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 medicine 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;385: 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. Gotzsche 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;10 856.