Objective To learn if appropriate methods and clinically relevant outcomes were used by analyzing methods of outcome assessment in Chinese acute stroke trials.
Method Randomised and quasi-randomised controlled trials on acute stroke published before March 2003 in 6 Chinese neurological journals were included. Types of outcome measures, blinding of outcome assessment, duration of follow up, statistical methods used for data analysis and the significance of the results were evaluated. Types of outcomes were classified as death and four levels: ① Pathology. ② Impairment. ③ Disability. ④ Handicap/quality of life.
Results Two hundreds and ten trials were included in this analysis. 57% of the trials used outcomes in pathology level, 77% in impairment level, 12% in disability level and none in the quality of life level. No dichotomous data was analyzed for disability measures. Only 16% of the trials reported number of death but few of them designed death as an outcome measure. Duration of follow up ranged from 3h to 3 years (median 17 d, interquartile range 14-30 d). Most trials did not assess outcomes blindly. Results in 95% of the trials were favorable to the tested interventions.
Conclusions In Chinese acute stroke trials, outcome measures used were mainly in pathology and impairment levels and very few trials used functional outcome or death. Blinding of outcome assessment was not commonly used. The average duration of follow up was short.
Citation：
LIU Ming,WU Bo,YUAN Qiang. Methods of Outcome Assessment in Chinese Acute Stroke Trials. Chinese Journal of Evidence-Based Medicine, 2004, 04(3): 164-166. doi:
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- 2. ［2］Wu B , Liu M . Trends of outcome measurement in stroke trias[ J ]. Chinese Journal of Neurology, 2002; 35 (3): 177-179.
- 3. 吴波,刘鸣.脑卒中临床试验疗效判定现状及趋势[J].中华神经科杂志,2002;35(3):177-179.
- 4. ［3］Zhao XL, Liu M, Yuan Q, He L, Wu B, Zhang SH. How to establish a chinese chnical controlled trials database of neurology[J]. Chinese J Evidence-based Medicine,, 2003; 3(4): 311-314,326.
- 5. 赵晓玲,刘鸣,袁强,何俐,吴波,张世洪.中文神经疾病临床对照试验数据库的建立[J].中国循证医学杂志,2003; 3(4) :311-314, 326.
- 6. ［4］Wang JL, editor-in-chief. Linchuang Liuxingbmg Xue-Linchuang Keyan Sheji, Henghang Yu Pingjia [ M ]. 2nd edition.Shanghai: Shanghai Science and Technology Press. 2001.
- 7. 王家良主编.临床流行病学--临床科研设计、衡量与评价.第二版.上海:上海科学技术出版社.2001.
- 8. ［5］Wade DT. Measurement in Neurological Rehabilitation. Oxford,England: Oxford University Press, 1996.
- 9. ［6］Roberts L , Counsell C. Assessment of Clinical Outcomes in Acute Stroke Trials[J]. Stroke,1998 ;29:986-991.
- 10. ［7］Van Gjn J. Evidence-based stroke medicine [J ]. Chinese J of Evidence-based Medicine, 2004 ;4 ( 3 ): 146-149Van Gjn J.
- 11. 循证卒中学.中国循证医学杂志[J],2004;4(3):146-149.
