An Acceptance and Commitment Therapy Prototype Mobile Program for Individuals With a Visible Difference: Mixed Methods Feasibility Study.

BACKGROUND: Mobile apps may offer a valuable platform for delivering evidence-based psychological interventions for individuals with atypical appearances, or visible differences, who experience psychosocial appearance concerns such as appearance-based social anxiety and body dissatisfaction. Before this study, researchers and stakeholders collaboratively designed an app prototype based on acceptance and commitment therapy (ACT), an evidence-based form of cognitive behavioral therapy that uses strategies such as mindfulness, clarification of personal values, and value-based goal setting. The intervention also included social skills training, an established approach for increasing individuals' confidence in managing social interactions, which evoke appearance-based anxiety for many. OBJECTIVE: In this study, the authors aim to evaluate the feasibility of an ACT-based app prototype via the primary objectives of user engagement and acceptability and the secondary feasibility objective of clinical safety and preliminary effectiveness. METHODS: To address the feasibility objectives, the authors used a single-group intervention design with mixed methods in a group of 36 participants who have a range of visible differences. The authors collected quantitative data via measures of program use, satisfaction ratings, and changes over 3 time points spanning 12 weeks in outcomes, including selected ACT process measures (experiential avoidance, cognitive defusion, and valued action), scales of appearance concerns (appearance-based life disengagement, appearance-fixing behaviors, appearance self-evaluation, and fear of negative appearance evaluation), and clinical well-being (depression and anxiety). Semistructured exit interviews with a subsample of 12 participants provided qualitative data to give a more in-depth understanding of participants' views and experiences of the program. RESULTS: In terms of user engagement, adherence rates over 6 sessions aligned with the upper boundary of those reported across mobile mental health apps, with over one-third of participants completing all sessions over 12 weeks, during which a steady decline in adherence was observed. Time spent on sessions matched design intentions, and engagement frequencies highlighted semiregular mindfulness practice, mixed use of value-based goal setting, and high engagement with social skills training. The findings indicate a good overall level of program acceptability via satisfaction ratings, and qualitative interview findings offer positive feedback as well as valuable directions for revisions. Overall, testing for clinical safety and potential effectiveness showed encouraging changes over time, including favorable changes in appearance-related life disengagement, appearance-fixing behaviors, and selected ACT measures. No iatrogenic effects were indicated for depression or anxiety. CONCLUSIONS: An ACT-based mobile program for individuals struggling with visible differences shows promising proof of concept in addressing appearance concerns, although further revisions and development are required before further development and more rigorous evaluation.

The pros and cons of the implementation of a chronic care model in European rural primary care: the points of view of European rural general practitioners.

INTRODUCTION: This article describes the views of European rural general practitioners regarding the strengths, weaknesses, opportunities and threats (SWOT) of the implementation of a chronic care model (CCM) in European rural primary care. METHODS: This was a mixed-methods online survey. Data were collected from 227 general practitioners between May and December 2017. Categorical data were analysed using descriptive methods while free-text responses were analysed using qualitative methods. The setting was rural primary care in nine European countries (including Central and Eastern Europe). Main outcomes measures were respondents' evaluations of a chronic care model in their rural healthcare settings in terms of SWOT. RESULTS: The SWOT analysis showed that the expertise of healthcare professionals and the strength of relationships and communications between professionals, caregivers and patients are positive components of the CCM system. However, ensuring adequate staffing levels and staff competency are issues that would need to be addressed. Opportunities included the need to enable patients to participate in decision making by ensuring adequate health literacy. CONCLUSION: The CCM could certainly have benefits for health care in rural settings but staffing levels and staff competency would need to be addressed before implementation of CCM in such settings. Improving health literacy among patients and their carers will be essential to ensure their full participation in the implementation of a successful CCM.

An individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal: the TABLE trial protocol.

BACKGROUND: Leprosy is curable with multidrug therapy and treatment in the early stages can prevent disability. However, local nerve damage can lead to injury and consequently recurring and disfiguring ulcers. The aim of this study is to evaluate the treatment of leprosy ulcers using an autologous blood product; leukocyte and platelet-rich fibrin (L-PRF) to promote healing. METHODS: This is a single-centre study in the Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. Consenting patients (n=130) will be individually randomised in a single-blinded, controlled trial. Participants will be 18 years of age or older, admitted to the hospital with a clean, dry and infection-free chronic foot ulcer between 2 and 20 cm2 in size. If the ulcer is infected, it will be treated before enrolment into the study. The intervention involves the application of leukocyte and platelet-rich fibrin (L-PRF) matrix on the ulcer beds during twice-weekly dressing changes. Controls receive usual care in the form of saline dressings only during their twice-weekly dressing changes. Primary outcomes are the rate of healing assessed using standardised photographs by observers blind to allocated treatment, and time to complete re-epithelialization. Follow-up is at 6 months from randomisation. DISCUSSION: This research will provide valuable information on the clinical and cost-effectiveness of L-PRF in the treatment of leprosy ulcers. An additional benefit is the evaluation of the effects of treatment on quality of life for people living with leprosy ulcers. The results will improve our understanding of the scalability of this treatment across low-income countries for ulcer healing in leprosy and potentially other conditions such as diabetic ulcers. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN14933421 . Registered on 16 June 2020.

Evaluation of a self-help intervention to promote the health and wellbeing of marginalised people including those living with leprosy in Nepal: a prospective, observational, cluster-based, cohort study with controls.

BACKGROUND: People affected by leprosy are at increased risk of ulcers from peripheral nerve damage. This in turn can lead to visible impairments, stigmatisation and economic marginalisation. Health care providers suggest that patients should be empowered to self-manage their condition to improve outcomes and reduce reliance on services. Self-care involves carrying out personal care tasks with the aim of preventing disabilities or preventing further deterioration. Self-help, on the other hand, addresses the wider psychological, social and economic implications of leprosy and incorporates, for example, skills training and microfinance schemes. The aim of this study, known as SHERPA (Self-Help Evaluation for lepRosy and other conditions in NePAl) is to evaluate a service intervention called Integrated Mobilization of People for Active Community Transformation (IMPACT) designed to encourage both self-care and self-help in marginalised people including those affected by leprosy. METHODS: A mixed-method evaluation study in Province 5, Nepal comprising two parts. First, a prospective, cluster-based, non-randomised controlled study to evaluate the effectiveness of self-help groups on ulcer metrics (people affected by leprosy only) and on four generic outcome measures (all participants) - generic health status, wellbeing, social integration and household economic performance. Second, a qualitative study to examine the implementation and fidelity of the intervention. IMPACT: This research will provide information on the effectiveness of combined self-help and self-care groups, on quality of life, social integration and economic wellbeing for people living with leprosy, disability or who are socially and economically marginalised in low- and middle- income countries.

Interventions to prevent, delay or reverse frailty in older people: a journey towards clinical guidelines.

BACKGROUND: Age-related frailty is a multidimensional dynamic condition associated with adverse patient outcomes and high costs for health systems. Several interventions have been proposed to tackle frailty. This correspondence article describes the journey through the development of evidence- and consensus-based guidelines on interventions aimed at preventing, delaying or reversing frailty in the context of the FOCUS (Frailty Management Optimisation through EIP-AHA Commitments and Utilisation of Stakeholders Input) project (664367-FOCUS-HP-PJ-2014). The rationale, framework, processes and content of the guidelines are described. MAIN TEXT: The guidelines were framed into four questions - one general and three on specific groups of interventions - all including frailty as the primary outcome of interest. Quantitative and qualitative studies and reviews conducted in the context of the FOCUS project represented the evidence base. We followed the GRADE Evidence-to-Decision frameworks based on assessment of whether the problem is a priority, the magnitude of the desirable and undesirable effects, the certainty of the evidence, stakeholders' values, the balance between desirable and undesirable effects, the resource use, and other factors like acceptability and feasibility. Experts in the FOCUS consortium acted as panellists in the consensus process. Overall, we eventually recommended interventions intended to affect frailty as well as its course and related outcomes. Specifically, we recommended (1) physical activity programmes or nutritional interventions or a combination of both; (2) interventions based on tailored care and/or geriatric evaluation and management; and (3) interventions based on cognitive training (alone or in combination with exercise and nutritional supplementation). The panel did not support interventions based on hormone treatments or problem-solving therapy. However, all our recommendations were weak (provisional) due to the limited available evidence and based on heterogeneous studies of limited quality. Furthermore, they are conditional to the consideration of participant-, organisational- and contextual/cultural-related facilitators or barriers. There is insufficient evidence in favour of or against other types of interventions. CONCLUSIONS: We provided guidelines based on quantitative and qualitative evidence, adopting methodological standards, and integrating relevant stakeholders' inputs and perspectives. We identified the need for further studies of a higher methodological quality to explore interventions with the potential to affect frailty.

A qualitative study examining everyday frailty management strategies adopted by Polish stakeholders.

Background: Frailty is a multidimensional clinical state that is common in older age and can be managed through intervention. Strategies to manage frailty have not been previously explored with stakeholders in Poland. This may stem from misperceptions about the nature and malleability of frailty, which has resulted in it being viewed as a lower priority healthcare concern.Objectives: To explore stakeholders' views to determine whether there are effective everyday strategies that they can adopt to reduce, reverse or prevent frailty.Methods: Semi-structured focus groups were conducted with five stakeholder groups (frail/pre-frail and robust older adults, health and social care professionals and family caregivers) in Poland (n = 44). Data was analysed using a reflexive thematic analysis approach.Results: Two themes were developed. The first emphasized both the positive everyday and more effortful strategies used by individuals to counter frailty; these included the adoption of healthy lifestyle behaviours, social engagement and shared experiences. Stakeholders perceived that older adults, even frail ones, might benefit from engaging in meaningful activities to build resilience against frailty. The second examined formal interventions delivered by health and social care professionals. Stakeholders noted the need to increase awareness of the malleability of frailty among professionals.Conclusion: Raising awareness of the malleability of frailty amongst health and social care professionals is critical. Further, information provision and personal support should be essential elements of health interventions aimed at older adults and family caregivers. Interventions to support resilience building in older adults should also be framed within a model of fostering self-efficacy.[Box: see text].

The use of technology in the context of frailty screening and management interventions: a study of stakeholders' perspectives.

BACKGROUND: Health and social care interventions show promise as a way of managing the progression of frailty in older adults. Information technology could improve the availability of interventions and services for older adults. The views of stakeholders on the acceptability of technological solutions for frailty screening and management have not been explored. METHODS: Focus groups were used to gather data from healthy and frail/pre-frail older adults, health and social care providers, and caregivers in three European countries - Italy, Poland and UK. Data were analysed using framework analysis in terms of facilitators or determinants of older adults' adoption of technology. RESULTS: Our findings clustered around the perceived value; usability, affordability and accessibility; and emotional benefits of frailty screening and management technology to stakeholders. We also noted issues relating to social support, previous experience of technology and confidence of stakeholders. CONCLUSIONS: Professionals and caregivers understand the benefits of technology to facilitate frailty care pathways but these views are tempered by concerns around social isolation. Frail older adults raised legitimate concerns about the accessibility and usability of technology, specifically around the potential for their personal information to be compromised. Solutions must be developed within a framework that addresses social contexts and avoids stigma around frailty and ageing.

Patient-centred access to health care: a framework analysis of the care interface for frail older adults.

BACKGROUND: The objective of this study was to explore the issues surrounding access to health and social care services for frail older adults with Polish stakeholders, including healthy and frail/pre-frail older adults, health care providers, social care providers, and caregivers, in order to determine their views and perspectives on the current system and to present suggestions for the future development of a more accessible and person-centred health and social care system. METHODS: Focus groups were used to gather qualitative data from stakeholders. Data were analysed using framework analysis according to five dimensions of accessibility to care: approachability, acceptability, availability and accommodation, affordability and appropriateness. RESULTS: Generally services were approachable and acceptable, but unavailable. Poor availability related to high staff turnover, staff shortages and a lack of trained personnel. There were problems of long waiting times for specialist care and rehabilitation services, and geographically remote clinics. Critically, there were shortages of long-term inpatient care places, social care workers and caregivers. The cost of treatments created barriers to care and inequities in the system. Participants described a lack of integration between health and social care systems with differing priorities and disconnected budgets. They described an acute medical system that was inappropriate for patients with complex needs, alongside a low functioning social care system, where bureaucratisation caused delays in providing services to the vulnerable. An integrated system with a care coordinator to improve connections between services and patients was suggested. CONCLUSIONS: There is an immediate need to improve access to health and social care systems for pre-frail and frail patients, as well as their caregivers. Health and social care services need to be integrated to reduce bureaucracy and increase the timeliness of treatment and care.

A realist review to understand the efficacy and outcomes of interventions designed to minimise, reverse or prevent the progression of frailty.

Interventions to minimise, reverse or prevent the progression of frailty in older adults represent a potentially viable route to improving quality of life and care needs in older adults. Intervention methods used across European Innovation Partnership on Active and Healthy Ageing collaborators were analysed, along with findings from literature reviews to determine 'what works for whom in what circumstances'. A realist review of FOCUS study literature reviews, 'real-world' studies and grey literature was conducted according to RAMESES (Realist and Meta-narrative Evidence Synthesis: Evolving Standards), and used to populate a framework analysis of theories of why frailty interventions worked, and theories of why frailty interventions did not work. Factors were distilled into mechanisms deriving from theories of causes of frailty, management of frailty and those based on the intervention process. We found that studies based on resolution of a deficiency in an older adult were only successful when there was indeed a deficiency. Client-centred interventions worked well when they had a theoretical grounding in health psychology and offered choice over intervention elements. Healthcare organisational interventions were found to have an impact on success when they were sufficiently different from usual care. Compelling evidence for the reduction of frailty came from physical exercise, or multicomponent (exercise, cognitive, nutrition, social) interventions in group settings. The group context appears to improve participants' commitment and adherence to the programme. Suggested mechanisms included commitment to co-participants, enjoyment and social interaction. In conclusion, initial frailty levels, presence or absence of specific deficits, and full person and organisational contexts should be included as components of intervention design. Strategies to enhance social and psychological aspects should be included even in physically focused interventions.

Effectiveness of interventions to prevent pre-frailty and frailty progression in older adults: a systematic review.

OBJECTIVE: To summarize the best available evidence regarding the effectiveness of interventions for preventing frailty progression in older adults. INTRODUCTION: Frailty is an age-related state of decreased physiological reserves characterized by an increased risk of poor clinical outcomes. Evidence supporting the malleability of frailty, its prevention and treatment, has been presented. INCLUSION CRITERIA: The review considered studies on older adults aged 65 and over, explicitly identified as pre-frail or frail, who had been undergoing interventions focusing on the prevention of frailty progression. Participants selected on the basis of specific illness or with a terminal diagnosis were excluded. The comparator was usual care, alternative therapeutic interventions or no intervention. The primary outcome was frailty. Secondary outcomes included: (i) cognition, quality of life, activities of daily living, caregiver burden, functional capacity, depression and other mental health-related outcomes, self-perceived health and social engagement; (ii) drugs and prescriptions, analytical parameters, adverse outcomes and comorbidities; (iii) costs, and/or costs relative to benefits and/or savings associated with implementing the interventions for frailty. Experimental study designs, cost effectiveness, cost benefit, cost minimization and cost utility studies were considered for inclusion. METHODS: Databases for published and unpublished studies, available in English, Portuguese, Spanish, Italian and Dutch, from January 2001 to November 2015, were searched. Critical appraisal was conducted using standardized instruments from the Joanna Briggs Institute. Data was extracted using the standardized tools designed for quantitative and economic studies. Data was presented in a narrative form due to the heterogeneity of included studies. RESULTS: Twenty-one studies, all randomized controlled trials, with a total of 5275 older adults and describing 33 interventions, met the criteria for inclusion. Economic analyses were conducted in two studies. Physical exercise programs were shown to be generally effective for reducing or postponing frailty but only when conducted in groups. Favorable effects on frailty indicators were also observed after the interventions, based on physical exercise with supplementation, supplementation alone, cognitive training and combined treatment. Group meetings and home visits were not found to be universally effective. Lack of efficacy was evidenced for physical exercise performed individually or delivered one-to-one, hormone supplementation and problem solving therapy. Individually tailored management programs for clinical conditions had inconsistent effects on frailty prevalence. Economic studies demonstrated that this type of intervention, as compared to usual care, provided better value for money, particularly for very frail community-dwelling participants, and had favorable effects in some of the frailty-related outcomes in inpatient and outpatient management, without increasing costs. CONCLUSIONS: This review found mixed results regarding the effectiveness of frailty interventions. However, there is clear evidence on the usefulness of such interventions in carefully chosen evidence-based circumstances, both for frailty itself and for secondary outcomes, supporting clinical investment of resources in frailty intervention. Further research is required to reinforce current evidence and examine the impact of the initial level of frailty on the benefits of different interventions. There is also a need for economic evaluation of frailty interventions.

Understanding frailty: a qualitative study of European healthcare policy-makers' approaches to frailty screening and management.

OBJECTIVE: To elicit European healthcare policy-makers' views, understanding and attitudes about the implementation of frailty screening and management strategies and responses to stakeholders' views. DESIGN: Thematic analysis of semistructured qualitative interviews. SETTING: European healthcare policy departments. PARTICIPANTS: Seven European healthcare policy-makers representing the European Union (n=2), UK (n=2), Italy (n=1), Spain (n=1) and Poland (n=1). Participants were sourced through professional networks and the European Commission Authentication Service website and were required to be in an active healthcare policy or decision-making role. RESULTS: Seven themes were identified. Our findings reveal a 'knowledge gap', around frailty and awareness of the malleability of frailty, which has resulted in restricted ownership of frailty by specialists. Policy-makers emphasised the need to recognise frailty as a clinical syndrome but stressed that it should be managed via an integrated and interdisciplinary response to chronicity and ageing. That is, through social co-production. This would require a culture shift in care with redeployment of existing resources to deliver frailty management and intervention services. Policy-makers proposed barriers to a culture shift, indicating a need to be innovative with solutions to empower older adults to optimise their health and well-being, while still fully engaging in the social environment. The cultural acceptance of an integrated care system theme described the complexities of institutional change management, as well as cultural issues relating to working democratically, while in signposting adult care, the need for a personal navigator to help older adults to access appropriate services was proposed. Policy-makers also believed that screening for frailty could be an effective tool for frailty management. CONCLUSIONS: There is potential for frailty to be managed in a more integrated and person-centred manner, overcoming the challenges associated with niche ownership within the healthcare system. There is also a need to raise its profile and develop a common understanding of its malleability among stakeholders, as well as consistency in how and when it is measured.

From Mixing methods to the logic(s) of inquiry: taking a fresh look at developing mixed design studies.

Objective: This invited paper offers an innovative framework for mixed methods research design. Method: We propose the adoption of the Model of Disciplined Inquiry, a five-component model that focuses on the research question(s) rather than the type(s) of data collected. This pluralist model firmly anchors the research design and paradigm assumptions in the research question(s). Decisions about an appropriate research strategy are made in line with those assumptions. We propose three logics of inquiry to help articulate the processes involved in making sense of findings and their relationship to theory. Results: The Model of Disciplined Inquiry is demonstrated by applying it to the framework to a longitudinal study and describe our decision-making processes at each component stage. The results support the arguement in favour of shifting the focus away from the types of data generated (i.e. qualitative or quantitative) and relatedly a move away from mixed methods research to mixed design research. Conclusion: We conclude the paper with some challenges experienced in the example study and some challenges yet to be resolved.

The effect of age, gender and attitudes on self-regulation in driving.

Self-regulation in driving has primarily been studied as a precursor to driving cessation in older people, who minimise driving risk and compensate for physical and cognitive decline by avoiding driving in challenging circumstances, e.g. poor weather conditions, in the dark and at busy times. This research explores whether other demographic groups of drivers adopt self-regulatory behaviours and examines the effects of affective and instrumental attitudes on self-regulation across the lifespan. Quantitative data were collected from 395 drivers. Women were significantly more likely than men to engage in self-regulation, and to be negatively influenced by their emotions (affective attitude). A quadratic effect of age on self-regulation was determined such that younger and older drivers reported higher scores for self-regulation than middle-years' drivers. However, this effect was affected by experience such that when experience was controlled for, self-regulation increased with age. Nevertheless, anxious driving style and negative affective attitude were independent predictors of self-regulation behaviours. Results suggest that self-regulation behaviours are present across the driving lifespan and may occur as a result of driving anxiety or low confidence rather than as an effect of ageing.