The quest for unbiased research: Randomized clinical trials and the CONSORT reporting guidelines

Annals of Neurology

Volumn 41, Issue 5, 1997, Pages 569-573

  Schulz, Kenneth F ^a  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; HUMAN; MEDICAL LITERATURE; MEDICAL RESEARCH; META ANALYSIS; METHODOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL;

BIAS (EPIDEMIOLOGY); DOUBLE-BLIND METHOD; GUIDELINES; PUBLISHING; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS; RESEARCH; RESEARCH DESIGN; UNITED STATES;

EID: 0030909098     PISSN: 03645134     EISSN: None     Source Type: Journal    
DOI: 10.1002/ana.410410504     Document Type: Article

References (25)

1. Schultz KF. Subverting randomization in controlled trials. JAMA 1995;274:1456-1458
2. Schulz KF. Unbiased research and the human spirit: the challenges of randomized controlled trials. Can Med Assoc J 1995; 153:783-786
3. Schulz KF. Randomized trials, human nature, and reporting guidelines. Lancet 1996;348:596-598
4. Altman DG, Doré CJ. Randomization and baseline comparisons in clinical trials. Lancet 1990;335:149-153
5. 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;272: 125-128
6. Moher D, Fortin P, Jadad AR, et al. Assessing the completeness of reporting of trials published in languages other than English: implications for the conduct and reporting of systematic reviews. Lancet 1996;347:363-366
7. Williams DH, Davis CE. Reporting of assignment methods in clinical trials. Control Clin Trials 1994;15:294-298
8. Sonis J, Joines J. The quality of clinical trials published in The Journal of Family Practice. J Fam Pract 1994;39:225-235
9. Mosteller F, Gilbert JP, McPeek B. Reporting standards and research strategies for controlled trials: agenda for the editor. Control Clin Trials 1980;1:37-58
10. DerSimonian R, Charette LJ, McPeek B, Mosteller F. Reporting on methods in clinical trials. N Engl J Med 1982;306: 1332-1337
11. Tyson JE, Furzan JA, Reisch JS, Mize SG. An evaluation of the quality of therapeutic studies in perinatal medicine. J Pediatr 1983;102:10-13
12. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637-639
13. 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
14. Pocock SJ. Statistical aspects of clinical trial design. Statistician 1982;31:1-18
15. Chalmers TC, Levin H, Sacks HS, et al. Meta-analysis of clinical trials as a scientific discipline. I: control of bias and comparison with large co-operative trials. Stat Med 1987;6:315-325
16. Khan KS, Daya S, Jadad AR. The importance of quality of primary studies in producing unbiased systematic reviews. Arch Intern Med 1996;156:661-666
17. Khan KS, Daya S, Collins JA, Walter SD. Empirical evidence of bias in infertility research: overestimation of treatment effect in crossover trials using pregnancy as the outcome measure. Fertil Steril 1996;65:939-945
18. Carleton RA, Sanders CA, Burack WR. Heparin administration after acute myocardial infarction. N Engl J Med 1960;263: 1002-1004
19. Schulz KF, Chalmers I, Altman DG, et al. The methodologic quality of randomization as assessed from reports of trials in specialist and general medical journals. Online J Curr Clin Trials [serial online] 1995 August 26;4(Doc No 197)
20. Schulz KF, 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
21. Gøtzsche PC. Multiple publication of reports of drug trials. Eur J Clin Pharmacol 1989;36:429-432
22. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA 1994; 272:1926-1931
23. 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. Ann Intern Med 1994;121:894-895
24. Rennie D. Reporting randomized controlled trials: an experiment and a call for responses from readers. JAMA 1995;273: 1054-1055
25. Medical Research Council. Streptomycin treatment of pulmonary tuberculosis. BMJ 1948;2:769-782