Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs)
1 School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK
2 Department of Medical Psychology, Academic Medical Center/University of Amsterdam, Meibergdreef 5, Amsterdam NL 1105 AZ, Netherlands
3 Department of Public Health, Erasmus MC, P.O. Box 2040, Rotterdam NL 3000 CA, Netherlands
4 Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Level 3, Dolphin House, Bristol Royal Infirmary, Marlborough Street, Bristol BS2 8HW, UK
Trials 2014, 15:49 doi:10.1186/1745-6215-15-49Published: 5 February 2014
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.
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.
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.
This study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.