Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review

Hogg

et al. 2015

Eye

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.controlledtrials.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.

Section: Discussionsupporting

confidence: 67%

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

Hogg

et al. 2015

Eye

Graefes Arch Clin Exp Ophthalmol

“…However it only measures a single dimension of glaucoma care and it is acknowledged that IOP is an inadequate outcome measure used alone. 10 Similarly for VF a consensus on measurement of VF outcomes is also helpful as multiple different measurement options exist for evaluating visual fields reported in clinical trials 6 In this study panellists agreed on the easiest to collect data-global VF measures.…”

Section: Discussionmentioning

confidence: 99%

“…A Delphi study, using a modified version of the Research ANd Development (RAND)/University of California Los Angeles (UCLA) appropriateness method 5 was administered via Survey Monkey. Potential important audit outcomes for glaucoma were identified from the literature 6,7 . Panellists were asked to rate each potential outcome for importance for inclusion in a set of glaucoma surgery audit outcomes.…”

Section: Methodsmentioning

confidence: 99%

Consensus generation of a minimum set of outcome measures for auditing glaucoma surgery outcomes—a Delphi exercise

Somner

Ismail

Froud

et al. 2018

“…To reduce this variety, ideally one validated instrument should be nominated as a standard and then used uniformly in each AMD RCT. Such an instrument would be included in a core outcome set (COS) for AMD RCTs 6 22. For instance, NEI-VFQ-25 is perceived as a potential core outcome measure in terms of PROMs in AMD trials.…”

Section: Discussionmentioning

confidence: 99%

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

2015

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