Patient-reported outcomes in randomised controlled trials on age-related macular degeneration.
OBJECTIVE
The purpose of this systematic review was to identify the frequency and type of patient-reported outcome measures (PROMs) used in recent randomised controlled trials (RCTs) for age-related macular degeneration (AMD).


METHODS
The authors conducted a systematic search between January 2010 and November 2013 in MEDLINE, EMBASE, Scopus, Cochrane Library (Central) and the clinical trials registries (http://www.controlled-trials.com and http://www.ClinicalTrials.gov) according to defined inclusion criteria (RCTs on AMD in English). Two independent reviewers evaluated studies for inclusion. One reviewer extracted data of included studies, and a second masked reviewer assessed 10% to confirm accuracy in data collection. Reference lists of included papers and appendices of relevant Cochrane systematic reviews were scanned to identify other relevant RCTs. Information collected on extracted outcomes was analysed using descriptive statistics.


RESULTS
Literature and registry search yielded 3816 abstracts of journal articles and 493 records from trial registries. A total of 177 RCTs were deemed to have met inclusion criteria. Of the 858 outcomes reported, 38 outcomes were identified as PROMs (4.4%). Of the 177 RCTs examined, PROMs were used in 25 trials (14.1%). The National Eye Institute Visual Function Questionnaire-25 was the most frequently used PROM instrument (64% of RCTs with PROMs included).


CONCLUSIONS
This review highlights that a small proportion of AMD RCTs included PROMs as outcome measures and that there was a variety in the instruments used.


BACKGROUND
The systematic review was registered in the PROSPERO database for systematic reviews, registration number CRD42014010040.
Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Aniela K
AK
Krezel
Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Ruth E
RE
Hogg
Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Augusto
A
Azuara-Blanco
D006801:Humans; D008268:Macular Degeneration / Q000503:physiopathology / Q000523:psychology*; D063868:Patient Outcome Assessment; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology*
Macula