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.
| [1] |
G. Curfman, “Integrating Clinical Trials and Practice: A New JAMA Series and Call for Papers,” JAMA 332, no. 2 (2024): 111.
|
| [2] |
P. Ravaud, P. Créquit, H. C. Williams, J. Meerpohl, J. C. Craig, and I. Boutron, “Future of Evidence Ecosystem Series: 3. From an Evidence Synthesis Ecosystem to an Evidence Ecosystem,” Journal of Clinical Epidemiology 123 (2020): 153–161.
|
| [3] |
V. Carande-Kulis, R. W. Elder, and D. M. Koffman, “Standards Required for the Development of CDC Evidence-Based Guidelines,” MMWR Supplements 71, no. 1 (2022): 1–6.
|
| [4] |
J. He, Z. Jin, and D. Yu, “Statistical Reporting in Chinese Biomedical Journals,” Lancet 373, no. 9681 (2009): 2091–2093.
|
| [5] |
X. Y. Zang and H. C. Shang, “Current Situation and Problems of Clinical Research on Traditional Chinese Medicine in China in Recent 10 Years,” Journal of Traditional Chinese Medicine 59, no. 21 (2018): 1808–1811.
|
| [6] |
J. Y. Hu, X. Y. Zhang, Y. Jiang, et al., “Developing Status of Clinical Research in China and the Existing Problems, Strategies and Practices of Clinical Research of Traditional Chinese Medicine,” World Science and Technology – Modernization of Traditional Chinese Medicine 20, no. 8 (2018): 1417–1421.
|
| [7] |
X. X. Peng, “Understand the Key Points of Innovation and Improve the Level of Innovation on Clinical Research,” National Medical Journal of China 100, no. 44 (2020): 3479–3483.
|
| [8] |
J. Zhang and G. Q. Chen, “Enrich Science Funding System by Focusing on Key Clinical Scientific Issues,” National Natural Science Foundation of China 38, no. 2 (2024): 308–313.
|
| [9] |
X. Y. Zhang, R. J. Qiu, C. Y. Li, et al., “Clinical Research Priority Setting for Traditional Chinese Medicine,” Chinese Journal of Evidence-Based Medicine 19, no. 3 (2019): 373–376.
|
| [10] |
The Lancet, China's Research Renaissance, Lancet 393, no. 10179 (2019): 1385.
|
| [11] |
X. X. Zhang, X. H. He, Z. H. Fang, et al., “Analyzing the Highlights and Trends of Traditional Chinese Medicine Academic Development Based on the “Top10 Academic Advances in TCM From 2020 to 2023”,” Scientia Sinica Vitae 55 (2025): 267–281.
|
| [12] |
L. Li, “Promoting International Acceptance of Clinical Studies About Traditional Chinese Medicine Interventions,” Science of Traditional Chinese Medicine 3, no. 1 (2025): 1–7.
|
| [13] |
V. M. Ravindra and J. R. W. Kestle, “Writing a Clinical Research Question,” Neurosurgery 84, no. 1 (2019): 12–16.
|
| [14] |
H. J. Luijendijk, “How to Create PICO Questions About Diagnostic Tests,” BMJ Evidence-Based Medicine 26, no. 4 (2021): 155–157.
|
| [15] |
Y. Chen, Y. Sun, X. Luo, and X. Yu, “The Core Methods and Key Models in Evidence-Based Medicine,” Medical Journal of Peking Union Medical College Hospital 14, no. 1 (2023): 1–8.
|
| [16] |
The Working Group on Priority Setting. Priority Setting for Health Research: Lessons From Developing Countries, Health Policy and Planning 15, no. 2 (2000): 130–136.
|
| [17] |
M. N. Yang, K. Zhao, X. R. Qi, et al., “Determining the Priority Issues of Health Policy Based on CHNRI,” Chinese Journal of Health Policy 8, no. 1 (2015): 74–79.
|
| [18] |
X. F. Kang, R. Lyu, F. Y. Zhang, et al., “Prioritizing Topics of Nursing Practice Guideline of Acute Heart Failure,” Chinese Nursing Management 16, no. 9 (2016): 1191–1195.
|
| [19] |
Z. T. Hu, Y. X. Chen, H. L. Zhang, et al., “Evidence-Based Construction of Evaluation Items for Selecting Priority Clinical Questions of Traditional Chinese Medicine Guidelines,” Chinese Journal of Evidence-Based Medicine 25, no. 2 (2025): 134–140.
|
| [20] |
C. Y. Jing, X. Wu, L. Zhang, et al., “Introduction to Health Research Priority Setting Methods and Application Recommendations of Methods in Field of Traditional Chinese Medicine,” Chinese Journal of Experimental Traditional Medical Formulae 29, no. 6 (2023): 167–175.
|
| [21] |
S. Aslam and P. Emmanuel, “Formulating a Researchable Question: A Critical Step for Facilitating Good Clinical Research,” Indian Journal of Sexually Transmitted Diseases and AIDS 31, no. 1 (2010): 47–50.
|
| [22] |
W. J. Taylor, R. Willink, D. A. O'Connor, et al., “Which Clinical Research Questions Are the Most Important? Development and preliminary validation of the Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network Research Question Importance Tool (ANZMUSC-RQIT),” PLoS ONE 18, no. 3 (2023): e0281308.
|
| [23] |
T. Cheng, L. J. Song, Q. Tang, et al., “Research Question Importance Tool and Its Exploratory Application in the Field of Chinese Medicine,” Chinese Journal of Evidence-Based Medicine 25, no. 5 (2025): 550–554.
|
| [24] |
K. Chappell, R. ElChamaa, D. Jeong, et al., “Conceptualization and Operationalization of Certification in the US and Canadian Nursing Literature,” Journal of Nursing Administration 48, no. 5 (2018): 238–246.
|
| [25] |
M. Khalil, H. Ravaghi, D. Samhouri, et al., “What Is “Hospital Resilience”? A Scoping Review on Conceptualization, Operationalization, and Evaluation,” Frontiers in Public Health 10 (2022): 1009400.
|
| [26] |
D. D. King, G. Lopiano, and E. S. M. Fattoracci, “A Stigma-Conscious Framework for Resilience and Posttraumatic Change,” American Psychologist 79, no. 8 (2024): 1155–1170.
|
| [27] |
N. McMeekin, O. Wu, E. Germeni, and A. Briggs, “How Methodological Frameworks Are Being Developed: Evidence From a Scoping Review,” BMC Medical Research Methodology 20, no. 1 (2020): 173.
|
| [28] |
Y. Chun Tie, M. Birks, and K. Francis, “Grounded Theory Research: A Design Framework for Novice Researchers,” SAGE Open Medicine 7 (2019): 2050312118822927.
|
| [29] |
J. R. Cutcliffe, “Methodological Issues in Grounded Theory,” Journal of Advanced Nursing 31, no. 6 (2000): 1476–1484.
|
Rights & permissions
2026 The Author(s). Journal of Evidence-Based Medicine published by Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.
PDF
(842KB)
