ABSTRACT
As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
Subject(s)
Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional/methods , Outcome Assessment, Health Care , Reference Standards , Reproducibility of Results , Research Design , Clinical Trials as TopicABSTRACT
After a discussion of how to abstract and summarize the literature novelty points, how to use the retrieval words and how to write the conclusion in assessment of scientific literature novelty, the major factors influencing the assessment of scientific literature novelty were analyzed with suggestions put forward for improving the assessment of scientific literature novelty.
ABSTRACT
The use of literature novelty assessment reports in medical researchers of Guizhou Province and its in-fluencing factors were investigated with questionnaires combined with interview, and measures were put forward for improving the use and level of literature novelty assessment reports, and service for scientific research.