title: An introduction to patient-reported outcome measures in ophthalmic research.
abstract: Clinical outcomes, such as quantifying the extent of visual field loss by automated perimetry, are valued highly by health professionals, but such measures do not capture the impact of the condition on a patient's life. Patient-reported outcomes describe any report or measure of health reported by the patient, without external interpretation by a clinician or researcher. In this review, we discuss the value of the measures that capture this information (patient-reported outcome measures; PROMs), and why they are important to both the clinician and the researcher. We also consider issues around developing or selecting a PROM for ophthalmic research, the emerging challenges around conducting and reporting PROMs in clinical trials and highlight best practice for their use. Search terms for this review comprised: (1) (patient-reported outcomes OR patient-reported outcome measures) AND (2) randomised controlled trials AND (3) limited to ophthalmic conditions. These terms were expanded as follows: ((('patients'(MeSH Terms) OR 'patients'(All Fields) OR 'patient'(All Fields)) AND ('research report'(MeSH Terms) OR ('research'(All Fields) AND 'report'(All Fields)) OR 'research report'(All Fields) OR 'reported'(All Fields)) AND outcomes(All Fields)) OR (('patients'(MeSH Terms) OR 'patients'(All Fields) OR 'patient'(All Fields)) AND ('research report'(MeSH Terms) OR ('research'(All Fields) AND 'report'(All Fields)) OR 'research report'(All Fields) OR 'reported'(All Fields) AND ('outcome assessment (health care)'(MeSH Terms) OR ('outcome'(All Fields) AND 'assessment'(All Fields) AND '(health'(All Fields) AND 'care)'(All Fields)) OR 'outcome assessment (health care)'(All Fields) OR ('outcome'(All Fields) AND 'measures'(All Fields)) OR 'outcome measures'(All Fields)))) AND ('randomized controlled trial'(Publication Type) OR 'randomized controlled trials as topic'(MeSH Terms) OR 'randomised controlled trials'(All Fields) OR 'randomized controlled trials'(All Fields)) AND (ophth*(All Fields)). The authors also utilised the extensive non-ophthalmic literature and online resources relating to PROs and PROMs to inform this review.
authors.affiliation: 1] Centre for Translational Inflammation Research, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, UK [2] Department of Ophthalmology, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
authors.forename: A K
authors.identifier: 0000000178490087
authors.initials: AK
authors.lastname: Denniston
authors.affiliation: Patient Reported Outcomes Research Group, School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: D
authors.initials: D
authors.lastname: Kyte
authors.affiliation: 1] Patient Reported Outcomes Research Group, School of Health and Population Sciences, University of Birmingham, Birmingham, UK [2] MRC Midland Hub for Trials Methodology Research, University of Birmingham, Birmingham, UK.
authors.forename: M
authors.initials: M
authors.lastname: Calvert
authors.affiliation: 1] School of Medicine, University of St Andrews, Fife, UK [2] NIHR Biomedical Research Centre for Ophthalmology, University College London, London, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Burr
mesh_terms: D035843:Biomedical Research; D018849:Controlled Clinical Trials as Topic; D006801:Humans; D009885:Ophthalmology; D063868:Patient Outcome Assessment