Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2014 Jun;28(6):637-45.
doi: 10.1038/eye.2014.41. Epub 2014 Mar 14.

An introduction to patient-reported outcome measures in ophthalmic research

Affiliations
Review

An introduction to patient-reported outcome measures in ophthalmic research

A K Denniston et al. Eye (Lond). 2014 Jun.

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.

PubMed Disclaimer

References

    1. Somner JEA, Sii F, Bourne RR, Cross V, Burr JM, Shah P. Moving from PROMs to POEMs for glaucoma care: a qualitative scoping exercise. Invest Ophthalmol Vis Sci. 2012;53 (9:5940–5947. - PubMed
    1. Rahi JS, Cumberland PM, Peckham CS. Visual impairment and vision-related quality of life in working-age adults. Ophthalmology. 2009;116 (2:270–274. - PubMed
    1. Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013;346:f167. - PubMed
    1. FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009. Available http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/... . Accessed 2013. - PMC - PubMed
    1. Hamzah JJC, Burr JMJ, Ramsay CRC, Azuara-Blanco AA, Prior MM. Choosing appropriate patient-reported outcomes instrument for glaucoma research: a systematic review of vision instruments. Qual Life Res. 2011;20 (7:1141–1158. - PubMed

Publication types

LinkOut - more resources