The CONSORT Statement: Revised Recommendation for Improving the Quality of Reports of Parallel-group Randomised Trials_Chinese Journal of Evidence-Based Medicine

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David Moher , Kenneth F

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要正确理解随机对照试验(randomized controlled trial, RCT)的结果,读者必须了解其设计方案、实施过程、分析方法和结果解释.为达此目的,要求作者必须完整清晰地将这些内容表述出来.虽然经过数十年的教育,RCT的报告方法仍然需要改进.一些研究人员和编辑为此编写了CONSORT(Consolidated Standards of Reporting Trials, 临床试验报告的统一标准)声明第一版,采用清单和流程图的方式帮助作者提高报告质量.本文根据读者对第一版的反馈对CONSORT声明进行了修改,并补充了新的证据.清单条目分为题目、摘要、引言、方法、结果和评论共6个部分.修订版清单包括了22项条目,均为经验证据证明如不报告就会导致疗效估计偏倚的信息或作以判断结果可靠性和相关性的基本信息,配以流程图来描述受试者参与RCT的过程.修订版流程图描述了试验的4个步骤(包括登记、干预的分配、随访和分析),并明确注明了原始数据分析中各干预组人数.读者可通过人数判断作者是否进行了意向性分析(ITT).总之,CONSORT声明旨在改进RCT的报告质量,方便读者了解研究实施情况并判断其结果的真实性.

Citation： David Moher,Kenneth F,Schulz,Douglas G,Altman. The CONSORT Statement: Revised Recommendation for Improving the Quality of Reports of Parallel-group Randomised Trials. Chinese Journal of Evidence-Based Medicine, 2005, 05(9): 702-707. doi: Copy

1.	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[J]. JAMA, 1995; 273(5):408-412.
2.	Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P. Does the quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses[J]? Lancet,1998; 352(9128):609-613.
3.	Jadad AR, Boyle M, Cunningham C, Kim M, Schachar R. Treatment of Attention-Deficit/Hyperactivity Disorder[M]. Evidence Report/Technology Assessment No.11 (Prepared by McMaster University under Contract No. 290-97-0017), 2000.
4.	Thornley B and Adams CE. Content and quality of 2000 controlled trials in schizophrenia over 50 years[J]. BMJ, 1998; 317(7167): 1181-1184.
5.	Hotopf M, Lewis G, Normand C. Putting trials on trial-the costs and consequences of small trials in depression: a systematic review of methodology[J]. J Epidemiol Community Health, 1997; 51(4): 354-358.
6.	Dickinson K, Bunn F, Wentz R, Edwards P, Roberts I. Size and quality of randomised controlled trials in head injury: review of published studies[J]. BMJ, 2000; 320(7245): 1308-1311.
7.	Begg CB, Cho MK, Eastwood S, Horton R, Moher D, Olkin I, Rennie D, Schulz KF, Simel DL., Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement[J]. JAMA, 1996; 276(8):637-639.
8.	Freemantle N, Mason JM, Haines A, Eccles MP. CONSORT: an important step toward evidence-based health care[J]. Ann Intern Med,1997; 126(1): 81-83.
9.	Altman DG. Better reporting of randomized controlled trials: the CONSORT statement[J]. BMJ,1996; 313(7057): 570-571.
10.	Schulz KF. The quest for unbiased research: randomized clinical trials and the CONSORT reporting guidelines[J]. Ann Neurol,1997; 41(5): 569-573.
11.	Huston P, Hoey J. CMAJ endorses the CONSORT statement[J]. CMAJ, 1996; 155(9): 1277-1279.
12.	Davidoff F. News from the International Committee of Medical Journal Editors[J]. Ann Intern Med, 2000; 133(3): 229-231.
13.	http://www.consort-statement.org.
14.	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[J]? JAMA, 2001; 285(15): 1992-1995.
15.	Egger M, Juni P, Bartlett C, for the CONSORT Group. The value of patient flow charts in reports of randomized controlled trials: bibliographic study[J]. JAMA, 2001;285:1996-1999.
16.	Meinert CL. Beyond CONSORT: Need for improved reporting standards for clinical trials[J]. JAMA, 1998; 279(18):1487-1489.
17.	Chalmers I. Current Controlled Trials: an opportunity to help improve the quality of clinical research[J]. Curr Control Trials Cardiovasc Med, 2000; 1(1): 3-8.
18.	Bailer JC III, Mosteller F. Guidelines for statistical reporting in articles for medical journals: amplifications and explanations[J]. Ann Intern Med, 1988; 108(2): 266-273.
19.	Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T, for the CONSORT group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Annals of Internal Medicine, 2001; 134(8): 663-694.
20.	Elbourne DR, Campbell MK. Extending the CONSORT statement to cluster randomised trials: for discussion[J]. Stats Med, 2001;20:489-496.
21.	Hollis S, Campbell F. What is meant by intention-to-treat analysis? Survey of published randomized controlled trials[J]. BMJ, 1999; 319(7211): 670-674.
22.	Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention-to-treat analysis is related to methodological quality[J]. BMJ, 2000; 320(7240): 1007.
23.	Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option[J]? Stat Med, 1991; 10(10): 1595-1605.
24.	Bentzen SM. Towards evidence based radiation oncology: improving the design, analysis, and reporting of clinical outcome studies in radiotherapy[J]. Radiother Oncol, 1998; 46(1): 5-18.
25.	O’Toole LB. MRC uses checklist similar to CONSORTs[J]. BMJ, 1997;314:1127.
26.	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 randomized controlled trials: the QUOROM statement[J]. Lancet, 1999; 354(9193): 1896-1900.
27.	Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting[J]. JAMA, 2000; 283(15): 2008-2012.
28.	Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analysis[J]. JAMA, 1996; 276(16): 1339-1341.
29.	Neumann PJ, Stone PW, Chapman RH, Sandberg EA, Bell CM. The Quality of Reporting in Published Cost-Utility Analyses, 1976-1997[J]. Ann Intern Med, 2000; 132(12):964-972.
30.	Altman DG. The scandal of poor medical research[J]. BMJ, 1994; 308(6924): 283-284.

1. 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[J]. JAMA, 1995; 273(5):408-412.
2. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P. Does the quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses[J]? Lancet,1998; 352(9128):609-613.
3. Jadad AR, Boyle M, Cunningham C, Kim M, Schachar R. Treatment of Attention-Deficit/Hyperactivity Disorder[M]. Evidence Report/Technology Assessment No.11 (Prepared by McMaster University under Contract No. 290-97-0017), 2000.
4. Thornley B and Adams CE. Content and quality of 2000 controlled trials in schizophrenia over 50 years[J]. BMJ, 1998; 317(7167): 1181-1184.
5. Hotopf M, Lewis G, Normand C. Putting trials on trial-the costs and consequences of small trials in depression: a systematic review of methodology[J]. J Epidemiol Community Health, 1997; 51(4): 354-358.
6. Dickinson K, Bunn F, Wentz R, Edwards P, Roberts I. Size and quality of randomised controlled trials in head injury: review of published studies[J]. BMJ, 2000; 320(7245): 1308-1311.
7. Begg CB, Cho MK, Eastwood S, Horton R, Moher D, Olkin I, Rennie D, Schulz KF, Simel DL., Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement[J]. JAMA, 1996; 276(8):637-639.
8. Freemantle N, Mason JM, Haines A, Eccles MP. CONSORT: an important step toward evidence-based health care[J]. Ann Intern Med,1997; 126(1): 81-83.
9. Altman DG. Better reporting of randomized controlled trials: the CONSORT statement[J]. BMJ,1996; 313(7057): 570-571.
10. Schulz KF. The quest for unbiased research: randomized clinical trials and the CONSORT reporting guidelines[J]. Ann Neurol,1997; 41(5): 569-573.
11. Huston P, Hoey J. CMAJ endorses the CONSORT statement[J]. CMAJ, 1996; 155(9): 1277-1279.
12. Davidoff F. News from the International Committee of Medical Journal Editors[J]. Ann Intern Med, 2000; 133(3): 229-231.
13. http://www.consort-statement.org.
14. 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[J]? JAMA, 2001; 285(15): 1992-1995.
15. Egger M, Juni P, Bartlett C, for the CONSORT Group. The value of patient flow charts in reports of randomized controlled trials: bibliographic study[J]. JAMA, 2001;285:1996-1999.
16. Meinert CL. Beyond CONSORT: Need for improved reporting standards for clinical trials[J]. JAMA, 1998; 279(18):1487-1489.
17. Chalmers I. Current Controlled Trials: an opportunity to help improve the quality of clinical research[J]. Curr Control Trials Cardiovasc Med, 2000; 1(1): 3-8.
18. Bailer JC III, Mosteller F. Guidelines for statistical reporting in articles for medical journals: amplifications and explanations[J]. Ann Intern Med, 1988; 108(2): 266-273.
19. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T, for the CONSORT group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Annals of Internal Medicine, 2001; 134(8): 663-694.
20. Elbourne DR, Campbell MK. Extending the CONSORT statement to cluster randomised trials: for discussion[J]. Stats Med, 2001;20:489-496.
21. Hollis S, Campbell F. What is meant by intention-to-treat analysis? Survey of published randomized controlled trials[J]. BMJ, 1999; 319(7211): 670-674.
22. Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention-to-treat analysis is related to methodological quality[J]. BMJ, 2000; 320(7240): 1007.
23. Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option[J]? Stat Med, 1991; 10(10): 1595-1605.
24. Bentzen SM. Towards evidence based radiation oncology: improving the design, analysis, and reporting of clinical outcome studies in radiotherapy[J]. Radiother Oncol, 1998; 46(1): 5-18.
25. O’Toole LB. MRC uses checklist similar to CONSORTs[J]. BMJ, 1997;314:1127.
26. 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 randomized controlled trials: the QUOROM statement[J]. Lancet, 1999; 354(9193): 1896-1900.
27. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting[J]. JAMA, 2000; 283(15): 2008-2012.
28. Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analysis[J]. JAMA, 1996; 276(16): 1339-1341.
29. Neumann PJ, Stone PW, Chapman RH, Sandberg EA, Bell CM. The Quality of Reporting in Published Cost-Utility Analyses, 1976-1997[J]. Ann Intern Med, 2000; 132(12):964-972.
30. Altman DG. The scandal of poor medical research[J]. BMJ, 1994; 308(6924): 283-284.

Chinese Journal of Evidence-Based Medicine

The CONSORT Statement: Revised Recommendation for Improving the Quality of Reports of Parallel-group Randomised Trials

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