Approaches of measuring the minimum clinically important differences in clinical trial studies in the field of health and treatment: A narrative review of concepts and methods

Document Type : Review article

Authors

1 Ph.D. candidate, Department of Exercise Rehabilitation, Faculty of Sport Sciences, Bu-Ali Sina University, Hamedan, Iran

2 Professor, Department of Exercise Rehabilitation, Faculty of Sport Sciences, Bu-Ali Sina University, Hamedan, Iran

10.22084/rsr.2024.28872.1728

Abstract

Background and aim: In recent years, statistical significance alone cannot determine the impact of interventions in RCT studies, and the minimum clinically important difference (MCID) is used to check the real value of an intervention to enter the treatment and health system. The present study is a narrative review of the concepts and methods of MCID calculation in clinical trial studies to understand this diagnostic approach better.
Methods: Researchers searched Google Scholar, Web of Science, and PubMed by combining the keywords "MCID","distribution-based approach","anchor-based approach" and "minimum clinically important difference" in English. , and reviewed more than a thousand studies related to the determination and calculation of MCID, and finally the general concept of MCID and related methods were identified and the basic assumptions, statistical biases, and shortcomings of each method were examined in detail.
Results: Two acceptable methods compared to other methods were identified, distribution-based and anchor-based. Also, the general limitations in the exact determination of an identified MCID were: the number and difference of scores obtained from different methods of MCID calculation, the loss of the patient's perspective, and the relationship between the change scores before and after treatment.
Conclusion: The purpose of MCID calculation is to determine the most optimal treatment method both in terms of time and cost for patients. In recent years, the importance of this issue seems more and more; Therefore, researchers and specialists in clinical fields can use these methods cautiously to measure the performance of their interventions in the work and study environment.

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