Patient-Reported Outcome Instrument Selection- Designing a Measurement Strategy

Nov 1, 2007, 00:00 AM
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Section Order : 9
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To discuss issues in the design of a measurement strategy related to the use of patient-reported outcomes (PROs) in support of a labelling claim.


In association with the release by the US Food and Drug Administration of its draft guidance on the use of PROs to support labeling claims, the Mayo/FDA Patient-Reported Outcomes Consensus Writing Group was formed. This paper, part of a series of manuscripts produced by the Writing Group, focuses on designing a PRO measurement strategy.


Developing a PRO measurement strategy begins with a clear statement about the proposed label claim that will derive from the PRO data. Investigators should identify the relevant domains to measure, develop a conceptual framework, identify alternative approaches for measuring the domains, and synthesize the information to design the measurement strategy.


A position of “reasonable pragmatism” is recommended such that the best available measurement strategy be considered as evidence for labeling.
HEOR Topics :
  • Approval & Labeling
  • Health Policy & Regulatory
  • Instrument Development, Validation, & Translation
  • Patient-Centered Research
  • Patient-reported Outcomes & Quality of Life Outcomes
Tags :
  • instrument selection
  • patient-reported outcomes
  • validation
Regions :
  • Global