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Evidentiary Standards for Patient-Centered Core Impact (PC-CIS) Value Claims.
1Adjunct Professor, College of Pharmacy, University of Minnesota, Minneapolis MN.
Patient-centered core impact sets require rigorous adherence to fundamental measurement standards for relevance in healthcare decisions. Without established measurement criteria for clinical and patient outcomes, current proposals are premature.
Area of Science:
- Health economics and outcomes research
- Measurement theory
- Health services research
Background:
- Patient-centered core impact sets (PC-CIS) lack relevance for healthcare decisions without scientific rigor.
- Current proposals fail to meet fundamental measurement standards from physical sciences, economics, and health economics.
Purpose of the Study:
- To establish required standards for core impact patient-centric value claims.
- To outline a framework for evaluating these claims based on measurement principles.
Main Methods:
- Critically evaluate proposed core impact measures against standards of normal science and fundamental measurement.
- Delineate core impact elements: clinical, patient-centric, drug utilization, and resource utilization.
- Advocate for Rasch or modern measurement theory for calibrating patient-centric measures.
Main Results:
- PC-CIS proposals are premature due to weak evidentiary foundations and lack of agreed-upon measurement standards.
- Failure to recognize measurement constraints for patient populations will impede progress.
- Rasch or modern measurement theory is essential for patient-centric measures of latent traits.
Conclusions:
- Agreed-upon measurement standards for clinical, patient-centric, and resource utilization impacts are necessary before advancing PC-CIS.
- Implementing fundamental measurement principles is critical for the validity and utility of patient-centric value claims.
- Focusing on measurement rigor will ensure the relevance and reliability of core impact sets in healthcare.
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