Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
10.13422/j.cnki.syfjx.20240422
- VernacularTitle:中医观察性研究中混杂因素识别及控制的方法及挑战
- Author:
Guozhen ZHAO
1
;
Ziheng GAO
2
;
Chen ZHAO
1
;
Huizhen LI
1
;
Ning LIANG
1
;
Bin LIU
1
;
Qianzi CHE
1
;
Haili ZHANG
1
;
Yixiang LI
1
;
Feng ZHOU
2
;
He LI
3
;
Bo LI
2
;
Nannan SHI
1
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences， Beijing 100700，China
2. Beijing Evidence-Based Chinese Medicine Center，Beijing Traditional Chinese Medicine Hospital，Capital Medical University/ Beijing Institute of Chinese Medicine，Beijing 100010，China
3. First School of Clinical Medicine，Beijing University of Chinese Medicine，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
confounding factors;
cohort study;
observational study;
real-world study;
traditional Chinese medicine （TCM）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(22):120-126
- CountryChina
- Language:Chinese
-
Abstract:
As a supplement to randomized controlled trials， observational studies can provide evidence for the effectiveness of traditional Chinese medicine （TCM） treatment measures. They can also study influencing factors of diseases， etiology， and prognosis. However， there is a confounding effect due to the lack of randomization， which seriously affects the causal inference between the study factors and the outcome， resulting in confounding bias. Therefore， identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory， confounding factors can be categorized into measured and unmeasured confounding factors. In addition， attention must be paid to identifying confounding factors and intermediate variables， as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors， measured confounding factors can be controlled by stratification， multifactor analysis， propensity scores， and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods， difference-in-difference methods， and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups， and confounding bias can be reduced. In addition， methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM， observational studies of TCM face unique challenges in identifying and controlling confounding factors， including the ever-changing TCM treatment measures received by patients， the often-overlooked confounding effects in the four diagnostic information of TCM， and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues， providing a methodological basis for conducting higher-quality TCM observational studies， so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
