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December 2, 2019

Clarifying the Meaning of Clinically Meaningful Benefit in Clinical Research: Noticeable Change vs Valuable Change

Author Affiliations
  • 1Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina
JAMA. 2019;322(24):2381-2382. doi:10.1001/jama.2019.18496

Recent years have witnessed an increasing focus on the input of patients, their caregivers, or both to inform the selection, measurement, and interpretation of outcomes in clinical trials. One important issue for which their participation is sought is the question of what constitutes a clinically meaningful benefit, especially when patient-reported outcome measures (PROMs) are used to assess how patients feel and function. There is an extensive literature describing and appraising methods for defining minimally important differences and related terms and concepts.1-5 Several advances have been made in this field, including the recognition that the meaningfulness of differences for a person over time is distinct from differences between groups over time.6 Still, among researchers and manufacturers of drugs and devices, uncertainty remains about how best to determine clinically meaningful change in clinical research.