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, 15:49

First Online: 05 February 2014Received: 03 October 2013Accepted: 17 January 2014DOI: 10.1186-1745-6215-15-49

Cite this article as: Macefield, R.C., Jacobs, M., Korfage, I.J. et al. Trials 2014 15: 49. doi:10.1186-1745-6215-15-49


BackgroundSynthesis 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.

MethodsSystematic 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.

ResultsSearches 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.

ConclusionThis study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.

KeywordsCore outcome set Patient reported outcome PRO Patient reported outcome measure PROM Randomised controlled trial RCT Trial methodology Health domains Quality of life Systematic review AbbreviationsCOSCore outcome set

HRQLHealth-related quality of life

PROPatient-reported outcome

PROMPatient-reported outcome measure

RCTRandomised controlled trial.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-49 contains supplementary material, which is available to authorized users.

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Autor: Rhiannon C Macefield - Marc Jacobs - Ida J Korfage - Joanna Nicklin - Robert N Whistance - Sara T Brookes - Mirjam AG 


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