The Development of the CONSORT Explanatory Document_Chinese Journal of Evidence-Based Medicine

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Centre for Statistics in Medicine, Wolfson College, Linton Road, Oxford OX2 6UD, UK;

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CONSORT statement; CONSORT explanatory ducument

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Citation： Douglas G Altman. The Development of the CONSORT Explanatory Document. Chinese Journal of Evidence-Based Medicine, 2005, 05(9): 708-711. doi: Copy

1.	Dunn HL. Application of statistical methods in physiology[J]. Physiol Rev, 1929; 9: 275-398.
2.	Hill AB. Short textbook of medical statistics[M]. 11th ed. London: Hodder and Stoughton, 1984.
3.	Altman DG. Better reporting of randomised controlled trials: the CONSORT statement[J]. BMJ, 1996; 313(7057): 570-571.
4.	Egger M, Jüni P, Bartlett C, Holenstein F, Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study[J]. Health Technol. Assess, 2003; 7(1): 1-76.
5.	Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement[J]. JAMA, 1996; 276(8): 637-639.
6.	Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials[J]. JAMA, 1994; 272(24): 1926-1931.
7.	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[J]. Ann Intern Med, 1994; 121(11): 894-895.
8.	DerSimonian R, Charette LJ, McPeek B, Mosteller F. Reporting on methods in clinical trials[J]. N Engl J Med, 1982; 306(22): 1332-1337.
9.	Simon R, Wittes RE. Methodologic guidelines for reports of clinical trials[J]. Cancer Treat Rep, 1985; 69(1):1-3.
10.	Moher D, Schulz KF, Altman DG for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials[J]. Lancet, 2001; 357(9263): 1191-1194.
11.	Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gtzsche PC, Lang T for the CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Ann Intern Med, 2001; 134(8): 663-694.
12.	Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist[J]. Control Clin Trials, 2002; 23(4): 380-388.
13.	Doig GS, Simpson F, Delaney A. A review of the true methodological quality of nutritional support trials conducted in the critically ill: time for improvement[J]. Anesth Analg, 2005; 100(2): 527-533.
14.	Mills EJ, Wu P, Gagnier J, Devereaux PJ.The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement[J]. Contemp Clin Trials, 2005; 26(4): 480-487.
15.	Altman DG. Endorsement of the CONSORT statement by high impact medical journals: a survey of instructions for authors[J]. BMJ, 2005; 330(7499): 1056-1057.
16.	Lao L. Recommendations for enhancing the quality of traditional Chinese medicine clinical research reporting[J]. (in Chinese) Zhong Xi Yi Jie He Xue Bao (J Chin Integr Med), 2004; 2(6): 402-406.
17.	Liang C, Chen N. Analysis of randomized controlled trials on otorhinolaryngological diseases in China[J]. (in Chinese) Zhonghua Er Bi Yan Hou Ke Za Zhi (Chin J Otorhinolaryngol), 2002; 37(1): 60-63.
18.	Liu YL, Xu K, Bai JP, Li LN, Yang XB. Qualitative evaluation on literatures related with treatment of lung cancer with combined use of chemotherapy and Chinese herbs[J]. (in Chinese) Zhongguo Zhong Xi Yi Jie He Za Zhi (Chin J Integr Med), 2005; 25(2): 123-125.
19.	Liu XM, Zhang MM, Du L. Quality of methodology and reporting of randomized controlled trials of acupuncture for obesity[J]. (in Chinese) Zhongguo Yi Xue Ke Xue Yuan Xue Bao (Acta Academiae Medicinae Sinicae), 2004; 26(2): 192-194.
20.	Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF for the QUOROM Group. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses[J]. Lancet, 1999; 354(9193): 1896-1900.
21.	Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative[J]. Clin Chem, 2003; 49(1):1-6.
22.	McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM; Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics. REporting recommendations for tumor MARKer prognostic studies (REMARK)[J]. J Natl Cancer Inst, 2005; 97(16): 1180-1184.
23.	MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations[J]. Complement Ther Med, 2001; 9(4): 246-249.
24.	Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Improving the quality of reporting of randomised controlled trials evaluating herbal interventions: implementing the CONSORT statement. Submitted.
25.	Campbell MK, Elbourne DR, Altman DG for the CONSORT Group. CONSORT statement: extension to cluster randomised trials[J]. BMJ, 2004; 328(7441): 702-708.
26.	Rennie D. CONSORT revised-improving the reporting of randomized trials[J]. JAMA, 2001; 285(15): 2006-2007.

1. Dunn HL. Application of statistical methods in physiology[J]. Physiol Rev, 1929; 9: 275-398.
2. Hill AB. Short textbook of medical statistics[M]. 11th ed. London: Hodder and Stoughton, 1984.
3. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement[J]. BMJ, 1996; 313(7057): 570-571.
4. Egger M, Jüni P, Bartlett C, Holenstein F, Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study[J]. Health Technol. Assess, 2003; 7(1): 1-76.
5. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement[J]. JAMA, 1996; 276(8): 637-639.
6. Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials[J]. JAMA, 1994; 272(24): 1926-1931.
7. 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[J]. Ann Intern Med, 1994; 121(11): 894-895.
8. DerSimonian R, Charette LJ, McPeek B, Mosteller F. Reporting on methods in clinical trials[J]. N Engl J Med, 1982; 306(22): 1332-1337.
9. Simon R, Wittes RE. Methodologic guidelines for reports of clinical trials[J]. Cancer Treat Rep, 1985; 69(1):1-3.
10. Moher D, Schulz KF, Altman DG for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials[J]. Lancet, 2001; 357(9263): 1191-1194.
11. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gtzsche PC, Lang T for the CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Ann Intern Med, 2001; 134(8): 663-694.
12. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist[J]. Control Clin Trials, 2002; 23(4): 380-388.
13. Doig GS, Simpson F, Delaney A. A review of the true methodological quality of nutritional support trials conducted in the critically ill: time for improvement[J]. Anesth Analg, 2005; 100(2): 527-533.
14. Mills EJ, Wu P, Gagnier J, Devereaux PJ.The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement[J]. Contemp Clin Trials, 2005; 26(4): 480-487.
15. Altman DG. Endorsement of the CONSORT statement by high impact medical journals: a survey of instructions for authors[J]. BMJ, 2005; 330(7499): 1056-1057.
16. Lao L. Recommendations for enhancing the quality of traditional Chinese medicine clinical research reporting[J]. (in Chinese) Zhong Xi Yi Jie He Xue Bao (J Chin Integr Med), 2004; 2(6): 402-406.
17. Liang C, Chen N. Analysis of randomized controlled trials on otorhinolaryngological diseases in China[J]. (in Chinese) Zhonghua Er Bi Yan Hou Ke Za Zhi (Chin J Otorhinolaryngol), 2002; 37(1): 60-63.
18. Liu YL, Xu K, Bai JP, Li LN, Yang XB. Qualitative evaluation on literatures related with treatment of lung cancer with combined use of chemotherapy and Chinese herbs[J]. (in Chinese) Zhongguo Zhong Xi Yi Jie He Za Zhi (Chin J Integr Med), 2005; 25(2): 123-125.
19. Liu XM, Zhang MM, Du L. Quality of methodology and reporting of randomized controlled trials of acupuncture for obesity[J]. (in Chinese) Zhongguo Yi Xue Ke Xue Yuan Xue Bao (Acta Academiae Medicinae Sinicae), 2004; 26(2): 192-194.
20. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF for the QUOROM Group. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses[J]. Lancet, 1999; 354(9193): 1896-1900.
21. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative[J]. Clin Chem, 2003; 49(1):1-6.
22. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM; Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics. REporting recommendations for tumor MARKer prognostic studies (REMARK)[J]. J Natl Cancer Inst, 2005; 97(16): 1180-1184.
23. MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations[J]. Complement Ther Med, 2001; 9(4): 246-249.
24. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Improving the quality of reporting of randomised controlled trials evaluating herbal interventions: implementing the CONSORT statement. Submitted.
25. Campbell MK, Elbourne DR, Altman DG for the CONSORT Group. CONSORT statement: extension to cluster randomised trials[J]. BMJ, 2004; 328(7441): 702-708.
26. Rennie D. CONSORT revised-improving the reporting of randomized trials[J]. JAMA, 2001; 285(15): 2006-2007.

Chinese Journal of Evidence-Based Medicine

The Development of the CONSORT Explanatory Document

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