Age Related Macular Degeneration Clinical Trial
Official title:
Development of Core Outcomes for Age-related Macular Degeneration (AMD)
This study will explore experience of AMD caregivers in order to develop a core outcome set
(COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying
to capture what research outcomes are important from their perspective.
People 18 years of age and older who have been AMD caregivers for at least 6 months may be
eligible for this study.
The aim is to conduct three focus groups lasting approximately one hour. The plan is to enrol
18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will be
involved in conducting the focus groups. A moderator will ensure fluid discussion, while the
second investigator will be taking notes and audio-recording the discussion.
Randomised controlled trials (RCTs) are widely employed interventional studies in medicine, yet many times their outcomes are presented inconsistently. The COMET Initiative (Core Outcome Measures for Effectiveness Trials) suggests that a solution for that issue would be preparation of a core outcome set (COS)a minimal group of outcome measures relevant to different group of stakeholders (e.g. clinicians, patients, carers) that would be implemented in each RCT in a particular area. The overall aim is to prepare a COS for age related-macular degeneration (AMD) RCTs. As first step to develop a COS for AMD, the investigators conducted a systematic review that confirmed variability in AMD trials' outcome selection. The current step encompasses involvement of different stakeholders' groups in focus groups: patients and caregivers (current project) such as family members and friends helping AMD patients with their everyday living. Knowledge of caregivers' perspective on living with, treatment and outcomes for AMD is a key consideration when building up a COS, because they may not only evaluate existing outcomes, but also their experience may be translate into new outcomes. In the current focus group study, caregivers will be invited for a one hour discussion. The investigators plan to arrange three focus groups with approximately 8 participants each. Two researchers will be present to help facilitate discussion. Participants will be asked about their experience related to their help brought to AMD patients, observations of living with and treatment of AMD as well as about AMD study outcomes and their importance. ;
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