Evolution of methodological standards in surgical trials

ANZ Journal of Surgery

Volumn 75, Issue 10, 2005, Pages 874-877

  Ellis, Carleen ^a   Hall, Jane L ^a   Khalil, Alizan ^a   Hall, John C ^a,b  

^a UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^b ROYAL PERTH HOSPITAL   (Australia)

Author keywords

Biostatistics; Clinical trials; Methodological standards; Surgery

Indexed keywords

ARTICLE; BIOSTATISTICS; CLINICAL TRIAL; MEDICAL LITERATURE; METHODOLOGY; RANDOMIZATION; SAMPLE SIZE; AUSTRALIA; BIOMETRY; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; EVALUATION; HUMAN; NEW ZEALAND; PRACTICE GUIDELINE; PUBLICATION; PUBLISHING; RANDOMIZED CONTROLLED TRIAL; STANDARD; SURGERY; TREATMENT OUTCOME; UNITED KINGDOM;

AUSTRALIA; BIOMETRY; CLINICAL TRIALS; GREAT BRITAIN; GUIDELINE ADHERENCE; HUMANS; NEW ZEALAND; PERIODICALS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS; SURGICAL PROCEDURES, OPERATIVE; TREATMENT OUTCOME;

EID: 33644823930     PISSN: 14451433     EISSN: 14452197     Source Type: Journal    
DOI: 10.1111/j.1445-2197.2005.03554.x     Document Type: Article

References (16)

1. Clunie G, Ludbrook J, Farris I. The reporting of randomized clinical trials and the Cochrane Collaboration. Aust. N.Z. J. Surg. 1995; 65: 461 2.
2. The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Checklist of information for inclusion in reports of clinical trials. Ann. Intern. Med. 1996; 124: 741 3.
3. Begg C, Cho M, Eastwood S et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637 9.
4. Altman DG, Schulz KF, Moher D et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann. Intern. Med. 2001; 134: 663 94 (http://www.consort-statement.org).
5. Hall JC, Mills B, Nuygen H, Hall JL. Methodological standards in surgical trials. Surgery 1996; 119: 466 72.
6. Hall JC, Platell C, Hall JL. Surgery on trial: an account of clinical trials evaluating operations. Surgery 1998; 124: 22 7.
7. Dickersin K, Chan S, Chalmers TC, Sacks HS, Smith HJR. Publication bias and clinical trials. Control. Clin. Trials 1987; 8: 343 53.
8. Kelly MJ, Wadsworth J. What price inconclusive trials? Ann. R. Coll. Surg. Engl. 1993; 75: 145 6.
9. Dewan PA, Van Rij AM, Robinson RG, Skeggs GB, Fergus M. The use of an iodophor-impregated plastic incise drape in abdominal surgery: a controlled clinical trial. Aust. N.Z. J. Surg. 1987; 57: 859 63.
10. Baum M. Publishing surgery. Lancet. 2000; 355: 1466.
11. Moher D, Jones A, Lepage L for the CONSORT group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before and after evaluation? JAMA 2001; 285: 1992 5.
12. 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 randomised control trial. N. Engl. J. Med. 1978; 299: 690 4.
13. Hall JC. The other side of statistical significance: a review of Type II errors in the Australian medical literature. Aust. N.Z. J. Med. 1982; 12: 7 9.
14. Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann. Intern. Med. 1994; 121: 200 5.
15. Diamond GA, Forrester JS. Trials and statistical verdicts: probable grounds for appeal. Ann. Intern. Med. 1983; 98: 385 94.
16. Soares HP, Daniels S, Kumar A et al. Radiation Therapy Oncology Group. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 2004; 328: 22 4.