Core Outcome Measures in Effectiveness Trials

Design characteristic of randomised controlled trials for geographic atrophy in age-related macular degeneration: selection of outcomes and sample size calculation

General Information

Abstract:
PURPOSE: The selection of suitable outcomes and sample size calculation are critical factors in the design of a randomised controlled trial (RCT). The goal of this study was to identify the range of outcomes and information on sample size calculation in RCTs on geographic atrophy (GA). METHODS: We carried out a systematic review of age-related macular degeneration (AMD) RCTs. We searched MEDLINE, EMBASE, Scopus, Cochrane Library, www.controlled-trials.com, and www.ClinicalTrials.gov. Two independent reviewers screened records. One reviewer collected data and the second reviewer appraised 10% of collected data. We scanned references lists of selected papers to include other relevant RCTs. RESULTS: Literature and registry search identified 3816 abstracts of journal articles and 493 records from trial registries. From a total of 177 RCTs on all types of AMD, 23 RCTs on GA were included. Eighty-one clinical outcomes were identified. Visual acuity (VA) was the most frequently used outcome, presented in 18 out of 23 RCTs and followed by the measures of lesion area. For sample size analysis, 8 GA RCTs were included. None of them provided sufficient Information on sample size calculations. CONCLUSIONS: This systematic review illustrates a lack of standardisation in terms of outcome reporting in GA trials and issues regarding sample size calculation. These limitations significantly hamper attempts to compare outcomes across studies and also perform meta-analyses.

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

Publication

Journal:
Eye (Lond)
Volume:
29
Issue:
11
Pages:
1458 - 63
Year:
2015
DOI:
Further Study Information

Date:
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

Stakeholders Involved

None

Study Type

Systematic review of outcome measures/measurement instruments
Systematic review of outcomes measured in trials

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