Multilevel models are applicable to both the quantitative data and categorical variables. We used the methods, including the multilevel models, analysis of covariance and CMH chi-square test, to analyse different types of data, to explore the application of multilevel models in the analysis of the multicenter clinical trial center effect. The results showed that the analysis of covariance is more sensitive to find the center effect for quantitative data, while multilevel models are more sensitive to categorical variables. It can be seen that results with different analytical methods for center effect are not the same, and the most appropriate method should be selected in accordance with the characteristics of data, the objective of research, and the applicable conditions of the various methods in practical use.
Citation：
FUJin, HEJia, DULiang, LIUGuanjian. Multilevel Models in the Analysis of Center Effect in Clinical Trials. Journal of Biomedical Engineering, 2014, 31(3): 632-636. doi: 10.7507/1001-5515.20140118
Copy
Copyright © the editorial department of Journal of Biomedical Engineering of West China Medical Publisher. All rights reserved
| 1. |
化学药物和生物制品临床试验的生物统计学技术指导原则/生物统计指导原则[S]. 2002.
|
| 2. |
PETRINCO M, PAGANO E, DESIDERI A, et al. Information on center characteristics as costs' determinants in multicenter clinical trials:is modeling center effect worth the effort?[J]. Value in Health, 2009,12(2):325-330.
|
| 3. |
FALISSARD B, CHAVANCE M. The center effect in multicenter studies:fixed or random?[J]. Rev Epidemiol Sante Publique, 1996,44(5):455-464.
|
| 4. |
林洁,魏永越,陈峰,等. 中心效应及中心间样本不均衡对临床疗效评价的影响[J].中国临床药理学与治疗学,2012,17(4):428-432.
|
| 5. |
马丽媛,王文. 大规模临床研究的质量控制[J].中国临床药理学与治疗学,2010, 15(1):106-109.
|
| 6. |
BLAKELY T A, WOODWARD A J. Ecological effects in multi-level studies[J]. J Epidemiol Community Health, 2000, 54(5):367-374.
|
| 7. |
任仕泉,陈峰,杨树琴.多水平统计模型在多中心临床试验评价中的应用[J].中国卫生统计,2000,17(4):108-110.
|
| 8. |
于浩,陈锋. 临床试验中中心效应的评价及处理方法[J]. 中国临床药理学与治疗学, 2004, 9(9):1073-1075.
|
| 9. |
SULLIVAN LM, D'AGOSTINO R B Sr. Robustness and power of analysis of covariance applied to ordinal scaled data as arising in randomized controlled trials[J]. Stat Med, 2003, 22(8):1317-1334.
|
| 10. |
陈峰,任仕泉,陆守曾. 非独立计量数据的内部相关性研究[J]. 现代预防医学, 1998, 25:269-271.
|
| 11. |
杨珉,李晓松.医学和公共卫生研究常用多水平统计模型[M].北京:北京大学医学出版社, 2007:1-4.
|
| 12. |
郑建中,张岩波. 有序分类重复测量数据的多水平模型分析[J]. 现代预防医学, 2003, 30(1):6-14.
|
| 13. |
GOLDSTEIN H, BROWNE W, RASBASH J. Multilevel modeling of medical data[J]. Stat Med, 2002, 21(21):3291-3315.
|
- 1. 化学药物和生物制品临床试验的生物统计学技术指导原则/生物统计指导原则[S]. 2002.
- 2. PETRINCO M, PAGANO E, DESIDERI A, et al. Information on center characteristics as costs' determinants in multicenter clinical trials:is modeling center effect worth the effort?[J]. Value in Health, 2009,12(2):325-330.
- 3. FALISSARD B, CHAVANCE M. The center effect in multicenter studies:fixed or random?[J]. Rev Epidemiol Sante Publique, 1996,44(5):455-464.
- 4. 林洁,魏永越,陈峰,等. 中心效应及中心间样本不均衡对临床疗效评价的影响[J].中国临床药理学与治疗学,2012,17(4):428-432.
- 5. 马丽媛,王文. 大规模临床研究的质量控制[J].中国临床药理学与治疗学,2010, 15(1):106-109.
- 6. BLAKELY T A, WOODWARD A J. Ecological effects in multi-level studies[J]. J Epidemiol Community Health, 2000, 54(5):367-374.
- 7. 任仕泉,陈峰,杨树琴.多水平统计模型在多中心临床试验评价中的应用[J].中国卫生统计,2000,17(4):108-110.
- 8. 于浩,陈锋. 临床试验中中心效应的评价及处理方法[J]. 中国临床药理学与治疗学, 2004, 9(9):1073-1075.
- 9. SULLIVAN LM, D'AGOSTINO R B Sr. Robustness and power of analysis of covariance applied to ordinal scaled data as arising in randomized controlled trials[J]. Stat Med, 2003, 22(8):1317-1334.
- 10. 陈峰,任仕泉,陆守曾. 非独立计量数据的内部相关性研究[J]. 现代预防医学, 1998, 25:269-271.
- 11. 杨珉,李晓松.医学和公共卫生研究常用多水平统计模型[M].北京:北京大学医学出版社, 2007:1-4.
- 12. 郑建中,张岩波. 有序分类重复测量数据的多水平模型分析[J]. 现代预防医学, 2003, 30(1):6-14.
- 13. GOLDSTEIN H, BROWNE W, RASBASH J. Multilevel modeling of medical data[J]. Stat Med, 2002, 21(21):3291-3315.
