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Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example

Kevin P Weinfurt1

  • 1Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.

Clinical Trials (London, England)
|February 1, 2022
PubMed
Summary

Modern validity theory provides a framework for evaluating clinical outcome assessments (COAs) used in clinical trials. This argument-based approach ensures COA scores accurately reflect patient health by requiring evidence for underlying assumptions.

Keywords:
Patient-centered outcomesargument-based approach to validityclinical outcome assessmentendpointsmeasurementperformance outcomesreliabilityvalidityvalidity theory

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Area of Science:

  • Clinical trial methodology
  • Psychometric validation
  • Patient-reported outcomes

Background:

  • Clinical outcome assessments (COAs) are crucial for measuring patient-reported outcomes in clinical trials.
  • Ensuring the validity of COAs is challenging but essential for accurate health assessments.
  • Modern validity theory offers a structured approach to COA validation.

Purpose of the Study:

  • To describe the argument-based approach to validity using a specific performance outcome measure.
  • To illustrate the process of evaluating assumptions underlying a COA's interpretation and use.
  • To provide a practical example of a validity rationale for a COA.

Main Methods:

  • Utilized the argument-based approach to validity theory.
  • Applied the approach to the Multi-luminance Mobility Test (MLMT), a performance outcome measure.
  • Examined key assumptions and supporting evidence for the MLMT's use in inherited retinal dystrophy.

Main Results:

  • Presented an example of a validity rationale for the Multi-luminance Mobility Test.
  • Demonstrated the application of the argument-based approach to COA evaluation.
  • Highlighted challenges in providing evidence for certain validity rationale components.

Conclusions:

  • The argument-based approach enhances the clarity and efficiency of COA validation.
  • Aligning COA validation with modern validity theory supports patient-centered endpoints.
  • Improved validation practices facilitate clearer communication among investigators, sponsors, and regulators.