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Background The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved. The aim of this study was to develop a generic TFA questionnaire that can be adapted to assess acceptability of any healthcare intervention. Methods Two intervention-specific acceptability questionnaires based on the TFA were developed using a 5-step pre-validation method for developing patient-reported outcome instruments: 1) item generation; 2) item de-duplication; 3) item reduction and creation; 4) assessment of discriminant content validity against a pre-specified framework (TFA); 5) feedback from key stakeholders. Next, a generic TFA-based questionnaire was developed and applied to assess prospective and retrospective acceptability of the COVID-19 vaccine. A think-aloud method was employed with two samples: 10 participants who self-reported intention to have the COVID-19 vaccine, and 10 participants who self-reported receiving a first dose of the vaccine. Results 1) The item pool contained 138 items, identified from primary papers included in an overview of reviews. 2) There were no duplicate items. 3) 107 items were discarded; 35 new items were created to maximise coverage of the seven TFA constructs. 4) 33 items met criteria for discriminant content validity and were reduced to two intervention-specific acceptability questionnaires, each with eight items. 5) Feedback from key stakeholders resulted in refinement of item wording, which was then adapted to develop a generic TFA-based questionnaire. For prospective and retrospective versions of the questionnaire, no participants identified problems with understanding and answering items reflecting four TFA constructs: affective attitude, burden, perceived effectiveness, opportunity costs. Some participants encountered problems with items reflecting three constructs: ethicality, intervention coherence, self-efficacy. Conclusions A generic questionnaire for assessing intervention acceptability from the perspectives of intervention recipients was developed using methods for creating participant-reported outcome measures, informed by theory, previous research, and stakeholder input. The questionnaire provides researchers with an adaptable tool to measure acceptability across a range of healthcare interventions.

Background It is increasingly acknowledged that ‘acceptability’ should be considered when designing, evaluating and implementing healthcare interventions. However, the published literature offers little guidance on how to define or assess acceptability. The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospective (i.e. anticipated) and retrospective (i.e. experienced) acceptability from the perspective of intervention delivers and recipients. Methods Two methods were used to select the component constructs of acceptability. 1) An overview of reviews was conducted to identify systematic reviews that claim to define, theorise or measure acceptability of healthcare interventions. 2) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework. Steps included (1) defining acceptability; (2) describing its properties and scope and (3) identifying component constructs and empirical indicators. Results From the 43 reviews included in the overview, none explicitly theorised or defined acceptability. Measures used to assess acceptability focused on behaviour (e.g. dropout rates) (23 reviews), affect (i.e. feelings) (5 reviews), cognition (i.e. perceptions) (7 reviews) or a combination of these (8 reviews). From the methods described above we propose a definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The theoretical framework of acceptability (TFA) consists of seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Conclusion Despite frequent claims that healthcare interventions have assessed acceptability, it is evident that acceptability research could be more robust. The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions.

Background Health-related quality of life (HRQoL) is important in determining surgical success, particularly from the patients’ perspective. Aims To identify predictors for HRQoL outcome after cardiac surgery in order to identify potentially modifiable factors where interventions to improve patient outcomes could be targeted. Methods Electronic databases (including MEDLINE, CINAHL, Embase) were searched between January 2001 and December 2020 for studies determining predictors of HRQoL (using a recognised and validated tool) in adult patients undergoing cardiac surgery. Data extraction and quality assessments were undertaken and data was summarised using descriptive statistics and narrative synthesis, as appropriate. Results Overall, 3924 papers were screened with 41 papers included in the review. Considerable methodological heterogeneity between studies was observed. Most were single-centre (75.6%) prospective observational studies (73.2%) conducted in patients undergoing coronary artery bypass graft (CABG) (n = 51.2%) using a version of the SF-36 (n = 63.4%). Overall, 103 independent predictors (62 pre-operative, five intra-operative and 36 post-operative) were identified, where 34 (33.0%) were reported in more than one study. Potential pre-operative modifiable predictors include alcohol use, BMI/weight, depression, pre-operative quality of life and smoking while in the post-operative period pain and strategies to reduce post-operative complications and intensive care and hospital length of stay are potential therapeutic targets. Conclusion Despite a lack of consistency across studies, several potentially modifiable predictors were identified that could be targeted in interventions to improve patient or treatment outcomes. This may contribute to delivering more person-centred care involving shared decision-making to improve patient HRQoL after cardiac surgery.

HIV infection during pregnancy and breastfeeding has implications for maternal health. Between May- November 2018, we explored prospective acceptability of two novel HIV Pre-exposure Prophylaxis (PrEP) products, oral pills and vaginal rings, through focus group discussions with 65 pregnant and breastfeeding women in Malawi, South Africa, Uganda, Zimbabwe. Qualitative analysis was completed, guided by the Theoretical Framework of Acceptability (TFA). First, a deductive thematic analysis was applied to relevant coded data, into the seven TFA constructs (Affective Attitude; Burden; Ethicality, Intervention Coherence; Opportunity Costs; Perceived Effectiveness; Self-efficacy). Next, an iterative analysis was completed to generate themes within each of the TFA constructs. Women’s positive attitudes towards daily oral PrEP highlighted the familiarity of taking pills, understanding the purpose of taking pills, and the perception that it is an effective method to protect mothers and babies from HIV during pregnancy and breastfeeding. Women emphasized the ease of using the ring given its monthly duration that lowers burden on the user, its discreetness and invisibility once in place. The TFA analysis highlighted how acceptability of both methods could be enhanced by focusing on perceptions of the end users (i.e. the women) and not just the products themselves. This approach provided insights into how to refine the intervention materials and plans for implementation.

IntroductionGeographic atrophy (GA) is the advanced form of the non-neovascular (‘dry’) type of age-related macular degeneration (AMD). Previously untreatable, complement inhibitors delivered by regular intravitreal injections have recently been demonstrated to slow down the progression of GA lesions in phase 3 trials. One such treatment, Syfovre (pegcetacoplan), was approved by the US Food and Drug Administration in February 2023. These therapies slow down, but do not stop or reverse, the progression of GA; they may also increase the risk of developing the neovascular (‘wet’) type of AMD. In light of these developments, this study aims to quantify the acceptability of these new intravitreal injection treatments to patients with GA in the UK and explore factors that may influence the acceptability of these treatments.Methods and analysisIn this cross-sectional, non-interventional study, the primary objective is to determine the proportion of patients with GA that find regular intravitreal therapy acceptable for slowing the progression of GA. We will use a validated acceptability questionnaire in order to quantify the acceptability of new treatments among patients with GA. The correlation between acceptability and functional and structural biomarkers of GA will be established. We will also explore demographic, general health and ocular factors that may influence acceptability. 180 individuals with a diagnosis of GA will be recruited from 7 to 8 participating National Health Service trusts across the UK. Multiple regression analysis will be conducted to determine the simultaneous effects of multiple factors on patient acceptability.Ethics and disseminationThe study received ethical approval from the Health Research Authority on 14 March 2023 (IRAS Project ID: 324854). 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.

Objective Geographic Atrophy (GA) is the advanced form of the non-neovascular (‘dry’) type of age-related macular degeneration (AMD) and responsible for one-quarter of legal blindness in the UK. New therapies delivered by intravitreal injection are in late-stage development, and two such therapies (pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay)) have now been approved for clinical use by the US Food and Drug Administration. These therapies slow down, but do not stop or reverse, progression of GA and they may also increase the risk of developing the neovascular (‘wet’) type of AMD. Within a larger study exploring the acceptability of these new treatments to people living with GA, we developed a forced-choice exercise to evaluate how participants weigh up benefits and drawbacks of different treatment regimens. This research note reports quantitative and qualitative findings from this exercise. Results Twenty-eight participants took part in this exercise. The exercise demonstrated that participants were generally, although not unanimously, in favour of less frequent treatment for GA that was slightly less efficacious in terms of preserving visual function but presented a lower risk of developing wet AMD. Even among a small sample, the exercise demonstrated the highly personal and idiosyncratic decision-making processes influencing participants’ choices of preferred hypothetical GA treatment.

Geographic atrophy (GA) is the advanced form of the non-neovascular (dry) type of age-related macular degeneration. Presently, GA cannot be treated. However, new therapies administered by intravitreal injection are in late-stage development. These can slow down, but do not stop or reverse, GA progression. The acceptability of these emerging therapies to people with GA is currently unknown. The present case study explores the perspectives of a person living with GA who took part in the terminated Phase 3 clinical trial of Lampalizumab, a candidate intravitreal treatment for GA. We explored this patient's perspective on the retrospective acceptability of regular Lampalizumab injections, and the prospective acceptability of future intravitreal therapies for GA. A 78-year-old woman living in the UK was recruited as part of a mixed-methods pilot study and interviewed by telephone, regarding: her experience of the Lampalizumab trial injections; and her thoughts regarding emerging intravitreal therapies for GA. The Framework Method was used for initial inductive analysis of the interview transcript. Subsequently, deductive analysis was undertaken, informed by the Theoretical Framework of Acceptability (TFA). For this participant, intravitreal injections in the Lampalizumab trial were acceptable, although streamlining processes within the clinic would have improved the patient experience. Regarding prospective acceptability of new intravitreal therapies, the participant considered a delay in progression of GA a valuable goal. Potential discomfort, anxiety and inconvenience associated with regular intravitreal injections would be acceptable in the context of preserving her vision for as long as possible. Analysis of one participant's experience demonstrates the value of exploring GA patients' unique views on the acceptability of new intravitreal treatments. Larger prospective studies will provide more insight that help to optimise treatment design and delivery, thereby maximising likelihood of adherence and persistence when these therapies eventually arrive in clinic.

Background Awareness of the importance of patient and public involvement (PPI) in ophthalmology research is growing, ensuring studies align with patient priorities and experiences. However, there is limited literature exploring the practicalities and details of how PPI may be conducted within this field. In this case study of PPI within an ophthalmological research project, we aim to provide a transparent, in-depth illustration of how PPI was implemented and helped to shape the Acceptability of Geographic Atrophy INjections (AGAIN) study. The AGAIN study is focused on patients’ perspectives regarding the acceptability of new intravitreal (eye) injection treatments for Geographic Atrophy, an advanced form of age-related macular degeneration. Main text This commentary explores how PPI was undertaken to shape the design of the two work packages of the AGAIN study. In work package 1, the AGAIN pilot, we worked with a group of patient advisors to design materials for a mixed-methods questionnaire. This questionnaire consisted of Likert-type scale questions, semi-structured interview questions, and an elicitation task considering different hypothetical treatment scenarios. Eight patient advisors provided their input into the design of this questionnaire, and we discuss examples of the concrete changes to the research materials based on the advisors’ feedback. In work package 2, we carried out several rounds of consultation with patient advisors to develop a pre-validated quantitative questionnaire on Geographic Atrophy treatment acceptability. This involved using ‘think-aloud’ techniques to explore the questionnaire’s validity, clarity, and comprehensibility. We discuss some of the challenges that may arise when taking on board divergent points of view, and how to maximise comprehensibility without compromising fidelity to a validated questionnaire. Conclusions Our experience attests to the importance of listening to the insights of patients and those with lived experience in the early stages of designing research, while also ensuring that PPI remains continually integrated throughout the study lifecycle. Our PPI approach evolved in an ad-hoc fashion, and we suggest that given its beneficial impact for our study, PPI should be carefully planned for and adequately resourced in patient-centred ophthalmological research programmes. Plain English summary This article highlights the importance of involving patients and the public in eye health research, ensuring research addresses their concerns and experiences. In this article, we reflect on our experience of patient involvement, and the lessons we learned. We present a case study of how we involved patients as advisors on our study, the Acceptability of Geographic Atrophy INjections (AGAIN) study. The AGAIN study is exploring patient views on new eye injection treatments for Geographic Atrophy, a later stage form of age-related macular degeneration, which can cause sight loss among older adults. Our article is organised around the two different parts of the AGAIN study. In the first part, we reflect on how we worked with a group of patient advisors, who were people living with Geographic Atrophy, to design a study using surveys and interviews to understand views on Geographic Atrophy treatments. In the second part, we reflect in detail on working with patient advisors to design and refine a more formal questionnaire. This questionnaire aimed to assess how acceptable people living with Geographic Atrophy consider the treatments to be. In both parts of the AGAIN study, the patient advisors provided feedback that helped to improve the clarity and relevance of the questionnaire. Our article illustrates the value of patient input into eye health research. We also advocate involving patients from the start of research projects, and considering methods to balance conflicting viewpoints.

ObjectiveThe contribution of patient research partners (PRPs) is well established in EULAR recommendation development. However, in observational and registry studies, PRP involvement is not well-defined and remains limited.MethodsBased on a round table discussion during the EULAR Registries and Observational Drug Studies (RODS) meeting in 2019, a mixed methods study was undertaken, including a survey to RODS participants and EULAR PRPs and focus groups with volunteers from the survey. An inductive thematic analysis approach was applied to qualitative data and descriptive statistics to survey data.ResultsWe retrieved 45 survey responses and ran 3 focus groups with a total of 17 participants. The notion of PRP involvement in research was positively perceived by PRPs and the wider academic rheumatology community. There is universal agreement that PRP involvement in registry research is low and inclusion in different parts of the research cycle is limited. Potential benefits of PRP involvement include: input on the research objectives based on patients’ needs, advice and support regarding recruitment and retention strategies, obtaining patient views on analysis and interpretation, and assistance in disseminating results. Researchers and PRPs highlighted that education, inclusion of PRPs with diverse backgrounds and a welcoming environment as important facilitators for PRP involvement. On the other hand, preconceptions of researchers and insufficient budget allocation have been identified as barriers.ConclusionThere is an unmet need to involve PRPs in registries and observational studies and to better define their required input during all research stages. This study provides suggestions for successful PRP integration.

ObjectiveTo understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR).MethodsA systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies.ResultsOf 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid.ConclusionThere is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level.