Quality Assessment Instruments of Clinical Trials and Their Application_Chinese Journal of Evidence-Based Medicine

Authors：

GUO Xinfeng ¹ , WEN Zehuai ¹ , LAO Ying rong ² , LAI Shilong ¹

1. National DME Train ing Center; Guangzhou University of Traditional Chinese Medicine; Guangzhou 510 405; China2. Research and Applying Unit of Clinical Epidemiology; the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine （Gua ngdong Provincial Hospital of Traditional Chinese Medicine）;

Corresponding author：

Keywords：

Clinical t rials; Methodology; Evaluation instrument

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The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.

Citation： GUO Xinfeng,WEN Zehuai,LAO Ying rong,LAI Shilong. Quality Assessment Instruments of Clinical Trials and Their Application. Chinese Journal of Evidence-Based Medicine, 2004, 04(7): 484-487. doi: Copy

1.	［1］Moher D，Pham B，Jones A，Cook DJ，Jaded AR，Moher M，Tugwell P.Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses[J].Lancet，1998; 352(9 128):609-613.
2.	［2］Moher D，Jadad AR，Nichol G，Penman M，Tugwell P，Walsh S.Assessing the quality of randomized controlled trials:an annotated bibliography of scales and checklists[J].Control Clin Trials，1995; 21(16):62-73.
3.	［3］Jadad AR，Moore RA，Carroll D，Jenkinson C，ReynoldsDJ，Gavaghan DJ，McQuay HJ.Assessing the quality of reports of randomized clinical trials:Is blinding necessary[J].Control Clin Trials，1996，12(17):1-12.
4.	［4］Chalmers TC，Smith H，Blackburn B，Silverman B，Schroeder B，Reitman D，Ambroz A.A method for assessing the quality of a randomized control trial[J].Controlled Clin Trials，1981;2(3):31-49.
5.	［5］Ma B.Quality analysis and recommendations of randomized controlled trials on treating Alzheimer’s Disease by Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Liaonin Province，2004.31(3):203-204.
6.	马斌.中医药治疗老年痴呆-随机对照资料的质量分析和建议[J].辽宁中医杂志，2004.31(3):203～204.
7.	［6］Liu JP，Ling TJ，Assessment of the clinical literatures on treating the viral hepatitis in recent eight years[J].Journal of Disease Control，1998;2(3):188-190.
8.	刘建平，冷泰俊.病毒性肝炎临床治疗试验八年文献评价[J].疾病控制杂志，1998;2(3):188～190.
9.	［7］Wang X，Liu Q，Yue XQ，Hou FG，Deng WZ，Gu W，Shen XB.Quality assessment of clinical studies on treating the primary carcinoma of liver with Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Hunan College，2003;23(4):50-52.
10.	王喜，刘庆，岳小强，侯凤刚，邓伟哲，顾伟，沈旭波.对中医药治疗原发性肝癌临床研究的方法学评价[J].湖南中医学院学报，2003;23(4):50～52.
11.	［8］Teng DH，Lu YP，Wang L，Li X，Wei Q，Xin YP，Liu XD，Yang YR.Quality assessment of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].West China Medicine，2004;19(1):2～3.
12.	滕东海，卢一平，王莉，李响，魏强，辛宇鹏，刘孝东，杨宇如.中医药治疗慢性前列腺炎临床随机对照试验的方法学质量评价[J].华西医学，2004;19(1):2～3.
13.	［9］Wang T，Wu TX，Liu GJ.Quality assessment of randomized controlled trials on treating the unstable angina pectoris with Traditional Chinese Medicine[J].J Chengdu Univ of TCM，2003;26(2):52-55.
14.	王覃，吴泰相，刘关键.关于不稳定型心绞痛的中医药临床随机对照试验质量的评价[J].成都中医药大学学报，2003;26(2):52～55.
15.	［10］Sun DZ，Xu L，Jiang LD，Wei PK.Quality assessment of clinical studies on treating the carcinoma of stomach with Traditional Chinese Medicine[J].Chinese Clinical Medicine.2003;10(6):833-835.
16.	孙大志，许玲，姜林娣，魏品康.中医药治疗胃癌临床研究文献质量的调查评价[J].中国临床医学，2003;10(6):833～835.
17.	［11］Wang XK，Cui XJ，Qiu YQ.Studies of quality of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].Chinese Journal of TCM information，2001;8(1):82-83.
18.	王玺坤，崔学教，邱云桥.中医药治疗慢性前列腺炎临床研究文献质量的调查研究[J].中国中医药信息杂志，2001;8(1):82～83.
19.	［12］Mao ZF，Yu MJ，Bi YY.Comment s on the Methodological Quality of Drug Therapeutic Concurrent Controlled Trials[J].Hunan Medicine，2000;17(6):401-403.
20.	毛宗福，余鸣娇，毕勇毅.药物防治性同期对照试验论著的方法学质量评价[J].湖南医学，2000;17(6):401～403.
21.	［13］Yu MJ，Bi YY，Mao ZF，He L.Investigation on the quality of the treaties about clinical medical treatment trials[J].Medicine and Society，2001;14(3):59-61.
22.	余鸣娇，毕勇毅，毛宗福，何立.临床药物治疗性研究论著质量的调查[J].医学与社会，2001;14(3):59～61.
23.	［14］Ran XW，Li N，Liu Y.Methodological Evaluation of Randomized Controlled Trials of Diabetic Peripheral Neuropathy Treatment by Chinese Medicine Herb.West China Medicine，2003;18(3):299-301.
24.	冉兴无，李宁，刘雅.中医药治疗糖尿病患者周围神经病变临床随机对照试验的方法学质量评估[J].华西医学，2003;18(3):299～301.
25.	［15］Guo XF，Lai SL，Yang XB，Li XT，Wen ZH，Liang WX.Quality Evaluation and Analysis of the Therapeutic Literature of Traditional Chinese Medicine on stroke[J].J Guangzhou Univ TCM，2000;17(1):15-19.
26.	郭新峰，赖世隆，杨小波，李先涛，温泽淮，梁伟雄.中医药治疗中风研究文献的质量评价[J].广州中医药大学学报.2000;17(1):15～19.
27.	［16］Zhang Y，Mao B，Li TQ.Assessment of the Thesis on Clinical Research in Shanghai Journal of Traditional Chinese Medicine[J].Shanghai J TCM，2000;34(11):46-48.
28.	张颖，毛兵，李廷谦.<上海中医药杂志>临床治疗研究论文评价[J].上海中医药杂志.2000;34(11):46～48.
29.	［17］Huang ZW，Yu YC，Wang L，Mao B.Evaluation of the Randomized Controlled Trials Papers Published in Jiangsu Journal of Traditional Chinese Medicine from 1980 to 1998[J].West China Medicine，2001;16(3):257-258.
30.	黄宗文，于迎春，王蕾，毛兵.<江苏中医>随机对照临床治疗试验文献评价1980-1998手检分析[J].华西医学.2001;16(3):257～258.
31.	［18］Nicolucci A; Grilli R; Alexanian AA，Apolone G，Torri V，Liberati.A.Quality，.
32.	evolution，and clinical implications of randomized，controlled trials on the treatment of lung cancer.A lost opportunity for meta-analysis[J].JAMA，1989 ; 262(15):2 101-2 107.
33.	［19］Powe NR，Kinnison ML，Steinberg EP.Quality assessment of randomized controlled trials of contrast media[J].Radiology.1989 ; 170(2):377-380.
34.	［20］S.Marsoni，W.Torri，A.Taiana，A.Gambino，R.Grilli，P.Liati，M.G.Franzosi，V.Pistotti，F.Parazzini，F.Focarile.Critical review of the quality and development of randomized clinical trials (RCTs) and their influence on the treatment of advanced epithelial ovarian cancer[J].Ann Oncol.1990 ; 1(5):343-350.
35.	［21］Koes BW，Bouter LM，vander Heijden GJ.Methodological quality of randomized clinical trials on treatment efficacy in low back pain[J].Spine.1995; 20(2):228-235.
36.	［22］Egglin TK，Horwitz RI.The case for better research standards in peripheral thrombolysis:poor quality of randomized trials during the past decade[J].Acad-Radiol.1996 ; 3(1):1-9.
37.	［23］Lent V，Langenbach A.A retrospective quality analysis of 102 randomized trials in four leading urological journals from 1984-1989[J].Urol-Res.1996; 24(2):119-122.
38.	［24］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.
39.	［25］Moher D，Jadad AR，Tugwell P.Assessing the quality of randomized controlled trials.Current issues and future directions[J].Int J Technol Assess Health Care.1996; 12(2):195-208.

1. ［1］Moher D，Pham B，Jones A，Cook DJ，Jaded AR，Moher M，Tugwell P.Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses[J].Lancet，1998; 352(9 128):609-613.
2. ［2］Moher D，Jadad AR，Nichol G，Penman M，Tugwell P，Walsh S.Assessing the quality of randomized controlled trials:an annotated bibliography of scales and checklists[J].Control Clin Trials，1995; 21(16):62-73.
3. ［3］Jadad AR，Moore RA，Carroll D，Jenkinson C，ReynoldsDJ，Gavaghan DJ，McQuay HJ.Assessing the quality of reports of randomized clinical trials:Is blinding necessary[J].Control Clin Trials，1996，12(17):1-12.
4. ［4］Chalmers TC，Smith H，Blackburn B，Silverman B，Schroeder B，Reitman D，Ambroz A.A method for assessing the quality of a randomized control trial[J].Controlled Clin Trials，1981;2(3):31-49.
5. ［5］Ma B.Quality analysis and recommendations of randomized controlled trials on treating Alzheimer’s Disease by Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Liaonin Province，2004.31(3):203-204.
6. 马斌.中医药治疗老年痴呆-随机对照资料的质量分析和建议[J].辽宁中医杂志，2004.31(3):203～204.
7. ［6］Liu JP，Ling TJ，Assessment of the clinical literatures on treating the viral hepatitis in recent eight years[J].Journal of Disease Control，1998;2(3):188-190.
8. 刘建平，冷泰俊.病毒性肝炎临床治疗试验八年文献评价[J].疾病控制杂志，1998;2(3):188～190.
9. ［7］Wang X，Liu Q，Yue XQ，Hou FG，Deng WZ，Gu W，Shen XB.Quality assessment of clinical studies on treating the primary carcinoma of liver with Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Hunan College，2003;23(4):50-52.
10. 王喜，刘庆，岳小强，侯凤刚，邓伟哲，顾伟，沈旭波.对中医药治疗原发性肝癌临床研究的方法学评价[J].湖南中医学院学报，2003;23(4):50～52.
11. ［8］Teng DH，Lu YP，Wang L，Li X，Wei Q，Xin YP，Liu XD，Yang YR.Quality assessment of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].West China Medicine，2004;19(1):2～3.
12. 滕东海，卢一平，王莉，李响，魏强，辛宇鹏，刘孝东，杨宇如.中医药治疗慢性前列腺炎临床随机对照试验的方法学质量评价[J].华西医学，2004;19(1):2～3.
13. ［9］Wang T，Wu TX，Liu GJ.Quality assessment of randomized controlled trials on treating the unstable angina pectoris with Traditional Chinese Medicine[J].J Chengdu Univ of TCM，2003;26(2):52-55.
14. 王覃，吴泰相，刘关键.关于不稳定型心绞痛的中医药临床随机对照试验质量的评价[J].成都中医药大学学报，2003;26(2):52～55.
15. ［10］Sun DZ，Xu L，Jiang LD，Wei PK.Quality assessment of clinical studies on treating the carcinoma of stomach with Traditional Chinese Medicine[J].Chinese Clinical Medicine.2003;10(6):833-835.
16. 孙大志，许玲，姜林娣，魏品康.中医药治疗胃癌临床研究文献质量的调查评价[J].中国临床医学，2003;10(6):833～835.
17. ［11］Wang XK，Cui XJ，Qiu YQ.Studies of quality of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].Chinese Journal of TCM information，2001;8(1):82-83.
18. 王玺坤，崔学教，邱云桥.中医药治疗慢性前列腺炎临床研究文献质量的调查研究[J].中国中医药信息杂志，2001;8(1):82～83.
19. ［12］Mao ZF，Yu MJ，Bi YY.Comment s on the Methodological Quality of Drug Therapeutic Concurrent Controlled Trials[J].Hunan Medicine，2000;17(6):401-403.
20. 毛宗福，余鸣娇，毕勇毅.药物防治性同期对照试验论著的方法学质量评价[J].湖南医学，2000;17(6):401～403.
21. ［13］Yu MJ，Bi YY，Mao ZF，He L.Investigation on the quality of the treaties about clinical medical treatment trials[J].Medicine and Society，2001;14(3):59-61.
22. 余鸣娇，毕勇毅，毛宗福，何立.临床药物治疗性研究论著质量的调查[J].医学与社会，2001;14(3):59～61.
23. ［14］Ran XW，Li N，Liu Y.Methodological Evaluation of Randomized Controlled Trials of Diabetic Peripheral Neuropathy Treatment by Chinese Medicine Herb.West China Medicine，2003;18(3):299-301.
24. 冉兴无，李宁，刘雅.中医药治疗糖尿病患者周围神经病变临床随机对照试验的方法学质量评估[J].华西医学，2003;18(3):299～301.
25. ［15］Guo XF，Lai SL，Yang XB，Li XT，Wen ZH，Liang WX.Quality Evaluation and Analysis of the Therapeutic Literature of Traditional Chinese Medicine on stroke[J].J Guangzhou Univ TCM，2000;17(1):15-19.
26. 郭新峰，赖世隆，杨小波，李先涛，温泽淮，梁伟雄.中医药治疗中风研究文献的质量评价[J].广州中医药大学学报.2000;17(1):15～19.
27. ［16］Zhang Y，Mao B，Li TQ.Assessment of the Thesis on Clinical Research in Shanghai Journal of Traditional Chinese Medicine[J].Shanghai J TCM，2000;34(11):46-48.
28. 张颖，毛兵，李廷谦.<上海中医药杂志>临床治疗研究论文评价[J].上海中医药杂志.2000;34(11):46～48.
29. ［17］Huang ZW，Yu YC，Wang L，Mao B.Evaluation of the Randomized Controlled Trials Papers Published in Jiangsu Journal of Traditional Chinese Medicine from 1980 to 1998[J].West China Medicine，2001;16(3):257-258.
30. 黄宗文，于迎春，王蕾，毛兵.<江苏中医>随机对照临床治疗试验文献评价1980-1998手检分析[J].华西医学.2001;16(3):257～258.
31. ［18］Nicolucci A; Grilli R; Alexanian AA，Apolone G，Torri V，Liberati.A.Quality，.
32. evolution，and clinical implications of randomized，controlled trials on the treatment of lung cancer.A lost opportunity for meta-analysis[J].JAMA，1989 ; 262(15):2 101-2 107.
33. ［19］Powe NR，Kinnison ML，Steinberg EP.Quality assessment of randomized controlled trials of contrast media[J].Radiology.1989 ; 170(2):377-380.
34. ［20］S.Marsoni，W.Torri，A.Taiana，A.Gambino，R.Grilli，P.Liati，M.G.Franzosi，V.Pistotti，F.Parazzini，F.Focarile.Critical review of the quality and development of randomized clinical trials (RCTs) and their influence on the treatment of advanced epithelial ovarian cancer[J].Ann Oncol.1990 ; 1(5):343-350.
35. ［21］Koes BW，Bouter LM，vander Heijden GJ.Methodological quality of randomized clinical trials on treatment efficacy in low back pain[J].Spine.1995; 20(2):228-235.
36. ［22］Egglin TK，Horwitz RI.The case for better research standards in peripheral thrombolysis:poor quality of randomized trials during the past decade[J].Acad-Radiol.1996 ; 3(1):1-9.
37. ［23］Lent V，Langenbach A.A retrospective quality analysis of 102 randomized trials in four leading urological journals from 1984-1989[J].Urol-Res.1996; 24(2):119-122.
38. ［24］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.
39. ［25］Moher D，Jadad AR，Tugwell P.Assessing the quality of randomized controlled trials.Current issues and future directions[J].Int J Technol Assess Health Care.1996; 12(2):195-208.

Chinese Journal of Evidence-Based Medicine

Quality Assessment Instruments of Clinical Trials and Their Application

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