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How to develop a condition-specific PROM.

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  • 1Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

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Summary
This summary is machine-generated.

This paper outlines creating new patient-reported outcome measures (PROMs) with face and content validity. A practical example demonstrates developing the Knee Numeric-Entity Evaluation Score (KNEES-ACL) for anterior cruciate ligament (ACL) injuries.

Keywords:
PROM developmentcondition-specificconstruct validitycontent validityface validity

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Area of Science:

  • Medical Informatics
  • Health Outcomes Research
  • Psychometrics

Background:

  • Developing new patient-reported outcome measures (PROMs) is crucial when existing measures are inadequate for clinical studies.
  • PROMs require face validity (relevance to clinicians/researchers) and content validity (relevance/coverage for patients).

Purpose of the Study:

  • To describe the systematic steps for creating PROMs with robust face and content validity for specific conditions.
  • To present a practical example of developing a condition-specific PROM.

Main Methods:

  • Face validity is established through literature reviews for item identification and generation.
  • Content validity is confirmed via iterative cognitive interviews with the target patient population.
  • A consensus-based pilot version of the PROM is generated through qualitative feedback.

Main Results:

  • The described methodology ensures items are clearly worded, understandable, and unambiguous.
  • The process facilitates the development of a reliable and relevant PROM for a specific patient group.
  • The Knee Numeric-Entity Evaluation Score (KNEES-ACL) was successfully developed for anterior cruciate ligament (ACL) deficient patients.

Conclusions:

  • The outlined methodology provides a framework for developing valid and reliable PROMs.
  • Cognitive interviewing is essential for ensuring patient understanding and relevance of PROM items.
  • The KNEES-ACL serves as a practical demonstration of this PROM development process for orthopedic conditions.