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Related Experiment Videos

Patient-reported outcomes: conceptual issues.

Margaret L Rothman1, Philippe Beltran, Joseph C Cappelleri

  • 1Johnson & Johnson Pharmaceutical Services LLC, Raritan, NJ, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|November 13, 2007
PubMed
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Establishing a strong conceptual basis for patient-reported outcome (PRO) assessment is crucial for drug development. This ensures the patient

Area of Science:

  • Health outcomes research
  • Clinical trial methodology
  • Regulatory science

Background:

  • Patient-reported outcomes (PROs) are increasingly emphasized in healthcare and drug development.
  • Formalization of PRO assessment is critical, especially with evolving regulatory guidance.
  • A strong conceptual foundation is needed for PRO measurement in drug labeling claims.

Purpose of the Study:

  • To address challenges in constructing conceptual foundations for PRO assessment.
  • To guide the selection of PRO instruments and psychometric analyses.
  • To ensure the patient's perspective is incorporated into regulatory decisions.

Main Methods:

  • Discussion of PRO concepts and measurement frameworks.
  • Examination of consequences of PRO instrument selection without a conceptual basis.

Related Experiment Videos

  • Illustration using a hypothetical example of claim development and conceptual models.

    • Main Results:

    • Highlights the interplay between product claims, conceptual models, and measurement frameworks.
    • Demonstrates the importance of a well-established conceptual framework for PRO assessment.
    • Underscores the need for clear rationales in PRO measurement.

    Conclusions:

    • Incorporating the patient's perspective is imperative for regulatory decisions impacting quality of life.
    • A consensus on articulating the conceptual basis of PRO measurement is emerging.
    • Conceptual issues in PRO assessment evolve with product development phases.