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

Krezel, Aniela; Hogg, Ruth; Krezel, S; Fallis, Richard; Azuara‐Blanco, Augusto

doi:10.1038/eye.2015.132

Cited by 5 publications

(3 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These findings have the potential to help reduce the variability previously observed in outcome selection in GA trials. 4,10 Several reviews highlighted lack of standardisation in outcome selection for GA and AMD trials 4,5,10,11 and a few studies attempted to prioritize outcomes for research associated with AMD treatment 17 and everyday practice 18 , yet our work is the first to focus on identifying a set of optimum outcomes for GA trials. It takes into consideration different stakeholder groups and compares information from consensus exercises with qualitative interviews.…”

Section: Discussionmentioning

confidence: 99%

“…To identify GA-COS we followed the approach recommended by the COMET initiative, 10,11 using mixed methods including: Delphi consensus surveys with AMD patients and retina experts, parallel focus groups and interviews with AMD patients, family members, and workers supporting patients.…”

Section: Methodsmentioning

confidence: 99%

“…To gather patient consensus, we used two Delphi rounds of mailed questionnaires. The Round 1 consisted of eight questions about clinical outcomes domains and five questions on quality of life, that were selected based on systematic literature reviews 10,11 and a review of quality of life measures for AMD 12 . The format and content of the questionnaire were reviewed and approved by volunteers with visual impairment and members of the Macular Society and Royal National Institute for Blind, Northern Ireland (RNIB-NI), UK-based patient support organisations.…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Core outcomes for geographic atrophy trials

et al. 2019

View full text Add to dashboard Cite

Background/AimsOngoing and recent clinical trials for geographic atrophy (GA) have used different outcomes. The goal of this study was to identify a core outcome set (COS) important for patients, clinicians and researchers, and to propose the use of COS in the design of future GA trials.MethodsFive-component project including: Delphi method with patients and experts, focus groups and interviews with patients, relatives and workers supporting patients. Three hundred and one patients (301) with age-related macular degeneration participated in round 1 of a Delphi exercise. Most subjects had GA; 183 patients (61%) were females and the median (range) age was 77 (50–99) years. In round 2, of the 301 of the first round, 100 participants were randomly selected of whom 76 agreed to take part. In a parallel Delphi exercise, panellists comprised a mix of non-clinical scientists and clinicians (43 in the initial and 21 in the final round). In addition, interviews and focus groups consisting of patients (n=20), family members (n=4) and support workers (n=5) were undertaken.ResultsCore outcomes identified as important for age-related macular degeneration trials were the health of the outer retina, multimodal estimation of lesion size, reading speed, best corrected distance and near acuity, low luminance visual acuity, patient reported visual performance and safety.ConclusionThis study identified a set of core outcomes that should be used in GA trials. The COS include patient-reported outcome measures, near visual acuity, reading speed and assessment of the outer retina.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Core outcomes for geographic atrophy trials

et al. 2019

View full text Add to dashboard Cite

show abstract

Systematic review of sample size calculations and reporting in randomized controlled trials in ophthalmology over a 20-year period

2023

View full text Add to dashboard Cite

Decreased Visual Function Scores on a Low Luminance Questionnaire Is Associated with Impaired Dark Adaptation

et al. 2017

View full text Add to dashboard Cite

This cross-sectional analysis demonstrates associations of patient-reported functional deficits, as assessed on the LLQ, with both reduced DA and reduced choroidal thickness, in a population of older adults with varying degrees of AMD severity and good visual acuity in at least 1 eye. These analyses suggest that local functional measurements of DA testing (RIT) and choroidal thickness are associated with patient-reported functional deficits.

show abstract

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

Cited by 5 publications

References 24 publications

Core outcomes for geographic atrophy trials

Core outcomes for geographic atrophy trials

Systematic review of sample size calculations and reporting in randomized controlled trials in ophthalmology over a 20-year period

Decreased Visual Function Scores on a Low Luminance Questionnaire Is Associated with Impaired Dark Adaptation

Contact Info

Product

Resources

About