ZHANG Tong, HE Wenting, FEI Yutong, et al. Bias Control of Interventional Cohort Study and the Particularity in the Field of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2019, 60(11): 923-927.
ZHANG Tong, HE Wenting, FEI Yutong, et al. Bias Control of Interventional Cohort Study and the Particularity in the Field of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2019, 60(11): 923-927.DOI: 10.13288/j.11-2166/r.2019.11.006.
interventional cohort study has good external authenticity
whose evidence level is lower only than randomized controlled trials(RCTs)
but its greatest controversy is bias. This paper discussed how to control common biases from the perspective of research design
implementation and statistical analysis. In controlling selective bias
the author emphasizes that the researcher is an observer and should not interfere with the intervention assignment. Exposure factors and intensity should be clearly defined to help researchers to determine the final exposure attribution of subjects. In some special cases
the randomization principle can reduce the occurrence of selective bias. Matching method can increase the balance between groups. In controlling information bias
it is suggested to use objective and quantitative indicators to collect data. If this is difficult to achieve
then "blinded"data collection method shall be used. For wide collection of information
the content should be clear and easy to understand
in order to avoid too cumbersome to create non-response bias. In controlling compounding bias
it is necessary to properly and clearly set the inclusion and exclusion criteria. The clear confounding factors can be excluded to reduce the occurrence of confounding bias. In the analysis phase
the correction analysis
subgroup analysis
multivariate regression analysis
and propensity scores are commonly used for controlling bias. In addition
the interventional cohort study of traditional Chinese medicine has its own particularity. When choosing sub-centers
researchers should focus on the match of different regions
as well as traditional Chinese medicine hospitals
western medicine hospitals and general hospitals. The author expects to improve the internal authenticity and evidence level of interventional cohort studies by controlling bias and optimizing design. Researchers can change research ideas in case of such individualized and complicated intervention systems like traditional Chinese medicine treatment
which does not allow randomization
and often with ethical issues
and let more patients benefit from clinical trials.