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

Rhiannon Macefield, Marc Jacobs, Ida Korfage, Joanna Nicklin, Robert Whistance, Sara Brookes, Mirjam Sprangers, Jane Blazeby

Research output: Contribution to journalArticle (Academic Journal)peer-review

98 Citations (Scopus)
199 Downloads (Pure)

Abstract

Background

Synthesis of patient-reported outcome (PRO) data is hindered by the range of available PRO measures (PROMs) composed of multiple scales and single items with differing terminology and content. The use of core outcome sets, an agreed minimum set of outcomes to be measured and reported in all trials of a specific condition, may improve this issue but methods to select core PRO domains from the many available PROMs are lacking. This study examines existing PROMs and describes methods to identify health domains to inform the development of a core outcome set, illustrated with an example.

Methods

Systematic literature searches identified validated PROMs from studies evaluating radical treatment for oesophageal cancer. PROM scale/single item names were recorded verbatim and the frequency of similar names/scales documented. PROM contents (scale components/single items) were examined for conceptual meaning by an expert clinician and methodologist and categorised into health domains. A patient advocate independently checked this categorisation.

Results

Searches identified 21 generic and disease-specific PROMs containing 116 scales and 32 single items with 94 different verbatim names. Identical names for scales were repeatedly used (for example, ‘physical function’ in six different measures) and others were similar (overlapping face validity) although component items were not always comparable. Based on methodological, clinical and patient expertise, 606 individual items were categorised into 32 health domains.

Conclusion

This study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.
Original languageEnglish
Article number49
Number of pages12
JournalTrials
Volume15
DOIs
Publication statusPublished - 5 Feb 2014

Structured keywords

  • Centre for Surgical Research

Keywords

  • Core outcome set
  • Patient reported outcome (PRO)
  • Patient reported outcome measure (PROM)
  • Randomised controlled trial (RCT)
  • Trial methodology
  • Health domains
  • Quality of life
  • Systematic review

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