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Related Experiment Video

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Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs).

Rhiannon C Macefield1, Marc Jacobs, Ida J Korfage

  • 1School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK. r.macefield@bristol.ac.uk.

Trials
|February 6, 2014
PubMed
Summary
This summary is machine-generated.

Developing a core outcome set for clinical trials is challenging due to varied patient-reported outcome measures (PROMs). This study presents a method to identify health domains from PROMs, aiding core outcome set development for consistent data synthesis.

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Area of Science:

  • Health Services Research
  • Clinical Trials Methodology
  • Patient-Reported Outcomes

Background:

  • Synthesizing patient-reported outcome (PRO) data is complex due to the heterogeneity of available PRO measures (PROMs).
  • Existing PROMs vary in terminology, content, and structure, hindering data aggregation and comparison.
  • Core outcome sets can standardize measurement but require methods for selecting relevant PRO domains.

Purpose of the Study:

  • To examine existing PROMs used in oesophageal cancer trials.
  • To describe a methodology for identifying and categorizing health domains from PROMs.
  • To inform the development of a core outcome set for clinical trials.

Main Methods:

  • Systematic literature searches identified validated PROMs for oesophageal cancer radical treatment.
  • PROM scale and item names were recorded verbatim; content was analyzed for conceptual meaning.
  • Expert clinicians, methodologists, and patient advocates categorized items into health domains.

Main Results:

  • Identified 21 PROMs with 116 scales and 32 single items, featuring 94 unique names.
  • Found repeated use of identical or similar scale names, often with non-comparable component items.
  • Categorized 606 individual items into 32 distinct health domains.

Conclusions:

  • Outlined a systematic methodology for identifying candidate PRO domains from existing PROMs.
  • This approach facilitates the development of core outcome sets for clinical trials.
  • Standardizing PRO domain selection can improve data synthesis and comparability in research.