Acceptability of intravitreal injections in geographic atrophy: protocol for a mixed-methods pilot study

Abstract

IntroductionAge-related macular degeneration (AMD) is a common cause of visual impairment, affecting central vision. Geographic atrophy (GA) is an advanced form of the non-neovascular (dry) type of AMD. Late-stage clinical trials suggest that intravitreal injections of novel therapeutics may slow down the rate of GA progression by up to 30% in 1 year, thus allowing people with GA to preserve central vision for a longer period. While intravitreal injections have become an established treatment modality for neovascular (wet) AMD, it is unknown whether patients with (more gradually progressing) GA would accept regular injections that slow down, but do not stop or reverse, vision loss. Therefore, this mixed-methods pilot study will aim to explore whether regular intravitreal injections will be acceptable as treatment for patients with GA, and the factors that may affect treatment acceptability.Methods and analysisA mixed-methods survey has been designed in collaboration with a GA patient advisory group. The survey comprises of structured questionnaires, semi-structured interview questions regarding patients’ perceptions of intravitreal injections and the burden of treatment, and a task eliciting preferences between different potential treatments. Due to COVID-19 restrictions, this study will be conducted remotely by telephone. Thirty individuals will be recruited from NHS Medical Retina clinics at Central Middlesex Hospital, London. Half of the participants will be naïve to intravitreal injections, while half will have previous experience of intravitreal injections for neovascular (wet) AMD. Qualitative data analysis will be conducted using the Framework Method of analysis to identify key themes from participants’ accounts.Ethics and disseminationThe study received Health Research Authority approval on 23 March 2021 (IRAS Project ID: 287824). Findings will be disseminated through peer-reviewed publications and conference presentations to the medical retina community, as well as through dialogue with patients and macular disease charities.

Exploring patient acceptability of a short‐stay care pathway in hospital post arthroplasty: A theory‐informed qualitative study

“… 14 , 15 , 16 It has also been applied in a small number of surgical contexts such as maternal–foetal surgery and intravitreal injections for macular degeneration. 17 , 18 The TFA has not yet been used in acceptability studies relating to arthroplasty or short‐stay models of care. Given that a short stay in hospital after arthroplasty was a new model of care in Australia, exploring acceptability to patients was important for informing the potential scalability of this care pathway.…”

“…The TFA has been used successfully in other (nonsurgical) contexts to identify components that could be addressed to enhance acceptability, such as nurse‐led reviews of inflammatory rheumatological conditions, postnatal exercise and infant feeding practices 14–16 . It has also been applied in a small number of surgical contexts such as maternal–foetal surgery and intravitreal injections for macular degeneration 17,18 . The TFA has not yet been used in acceptability studies relating to arthroplasty or short‐stay models of care.…”

Emotional and physical experiences of people with neovascular age-related macular degeneration during the injection process in Germany: a qualitative study

“…Treated patients will not sense any gain in vision 34. Enoch et al, for example, currently investigate how patients with atrophic AMD accept injections, what factors affect acceptability and how patients understand these treatment options 35. Based on the findings of our study, it seems crucial to provide adequate information of what patients with atrophic AMD may expect from the injections, and to improve the organisation of how the injections are delivered to minimise barriers and improve acceptance and adherence to injections.…”

Exploring patient acceptability of emerging intravitreal therapies for Geographic Atrophy: a mixed-methods study

“…This study employed a cross-sectional, mixed-methods design, 31 and full detail on methodological aspects is presented in the published study protocol. 32 In summary, it was deemed important to quantify participants’ attitudes to acceptability, but also to integrate qualitative data through open-ended questions, in order to explore participants’ perspectives in-depth and understand their beliefs, hopes and concerns regarding GA treatment within their unique contexts and circumstances.…”

“…This study employed a cross-sectional, mixed-methods design, 31 and full detail on methodological aspects is presented in the published study protocol. 32 In summary, it was deemed important to quantify participants' attitudes to acceptability, but also to integrate…”