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Development and Preliminary Validation of the Chinese Medicine Interventional Clinical Trials Research Question
Ting Cheng1,2, Dongdong Yu1, Xingying Qiu1
1Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Objective:
Evidence-based medicine emphasizes clinical research driven by important questions, yet Chinese medicine lacks practical quantitative tools to identify such questions. We developed the Chinese Medicine Interventional Clinical Trials Research Question Importance Tool (CMICT-RQIT) to support topic selection and provide transparent criteria for proposal review, promoting high-quality clinical research in Chinese medicine.
Methods:
This study followed internationally accepted procedures of conceptualization and operationalization. Using a mixed-methods approach-including a literature review, qualitative interviews, Delphi surveys, expert consensus meetings, and the analytic hierarchy process-we developed the CMICT-RQIT. CMICT-RQIT was prespecified and interpreted as a formative/composite multicriteria decision-support tool.
Results:
Following a standardized development process comprising three stages-framework construction, tool development, and tool evaluation-the CMICT-RQIT V1.0 was established. It consists of four domains, 10 facets, and 24 items, each with corresponding composite weights, item explanations, scoring criteria, and an operations manual. Exploratory traditional psychometric analyses showed limited internal consistency and poor structural fit, consistent with the formative/composite nature of the tool and should not be interpreted as evidence that all items measure a single latent trait.
Conclusions:
CMICT-RQIT V1.0 can assist researchers in selecting research topics, with its greatest value lying in providing a concise summary of the importance of research question along with a comprehensive 24-item checklist for clinical investigators. At the same time, it offers reviewers transparent criteria for assessing the importance of research questions, thereby promoting the objectivity and fairness of evaluations. CMICT-RQIT V1.0 should be used primarily as a structured checklist and decision-support index.
