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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要正確理解隨機對照試驗(randomized controlled trial, RCT)的結果,讀者必須了解其設計方案、實施過程、分析方法和結果解釋.為達此目的,要求作者必須完整清晰地將這些內容表述出來.雖然經過數十年的教育,RCT的報告方法仍然需要改進.一些研究人員和編輯為此編寫了CONSORT(Consolidated Standards of Reporting Trials, 臨床試驗報告的統一標準)聲明第一版,采用清單和流程圖的方式幫助作者提高報告質量.本文根據讀者對第一版的反饋對CONSORT聲明進行了修改,并補充了新的證據.清單條目分為題目、摘要、引言、方法、結果和評論共6個部分.修訂版清單包括了22項條目,均為經驗證據證明如不報告就會導致療效估計偏倚的信息或作以判斷結果可靠性和相關性的基本信息,配以流程圖來描述受試者參與RCT的過程.修訂版流程圖描述了試驗的4個步驟(包括登記、干預的分配、隨訪和分析),并明確注明了原始數據分析中各干預組人數.讀者可通過人數判斷作者是否進行了意向性分析(ITT).總之,CONSORT聲明旨在改進RCT的報告質量,方便讀者了解研究實施情況并判斷其結果的真實性.

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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