Core Outcome Measures in Effectiveness Trials

Patient-reported outcomes in randomised controlled trials on age-related macular degeneration

General Information

Abstract:
BACKGROUND/AIMS: 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. TRIAL REGISTRATION NUMBER: The systematic review was registered in the PROSPERO database for systematic reviews, registration number CRD42014010040.

Authors:
Krezel, A. K. Hogg, R. E. Azuara-Blanco, A.

Publication

Journal:
Br J Ophthalmol
Volume:
99
Issue:
11
Pages:
1560 - 4
Year:
2015
DOI:
Further Study Information

Date:
Not applicable
Funding source(s):

Health Area

Disease Category
Eyes & vision

Disease Name
Age-related macular degeneration (AMD)

Target Population

Age Range
55 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Systematic review

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.controlledtrials.com and http://www.ClinicalTrials.gov) according to defined inclusion criteria (RCTs on AMD in English). Reference lists of included papers and appendices of relevant Cochrane systematic reviews were scanned to identify other relevant RCTs.


Stakeholders Involved

Study investigators

Study Type

Systematic review of outcome measures/measurement instruments

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