Process evaluation of a New psychosocial goal-setting and manualised support intervention for Independence in Dementia (NIDUS-Family).

INTRODUCTION: We report a mixed-methods process evaluation embedded within a randomised controlled trial. We aimed to test and refine a theory of change model hypothesising key causal assumptions to understand how the New Interventions for Independence in Dementia Study (NIDUS)-Family (a manualised, multimodal psychosocial intervention), was effective relative to usual care, on the primary outcome of Goal Attainment Scaling (GAS) over 1 year. METHODS: In 2021-2022, intervention-arm dyads completed an acceptability questionnaire developed to test causal assumptions. We conducted qualitative interviews with dyads and intervention facilitators, purposively selected for diverse follow-up GAS scores. We collected observational data from intervention session recordings. We thematically analysed data, then integrated qualitative and quantitative data. RESULTS: 174/204 (85.3%) dyads allocated to NIDUS-Family, fully completed it, 18 partially completed, while 12 received no intervention. We interviewed 27/192 (14%) of dyads receiving any sessions, and 9/10 facilitators; and observed 12 sessions. 47/192 (24.5%) of carers completed the acceptability questionnaire. We identified four themes: (A) 'Someone to talk to helps dyads feel supported'; (B) 'NIDUS-Family helps carers change their perspective'; (C) 'Personalisation helps people living with dementia maintain their identity' and (D) 'Small steps help dyads move forward'. CONCLUSION: Key causal pathway mechanisms were: a respectful, trusting and impartial relationship with the facilitator: supporting the development of meaningful goals and support to find manageable solutions. Core implementation factors were delivery of the modules from a consistent facilitator across regular sessions. Core contextual factors influencing these mechanisms were dyadic participation and understanding of abilities.

How might secondary dementia prevention programs work in practice: a pre-implementation study of the APPLE-Tree program.

BACKGROUND: Over 850,000 people in the UK currently have dementia, and that number is expected to grow rapidly. One approach that may help slow or prevent this growth is personalized dementia prevention. For most people, this will involve targeted lifestyle changes. These approaches have shown promise in trials, but as of yet, the evidence for how to scale them to a population level is lacking. In this pre-implementation study, we aimed to explore stakeholder perspectives on developing system-readiness for dementia prevention programs. We focused on the APPLE-Tree program, one of several low-intensity, lifestyle-based dementia prevention interventions currently in clinical trials. METHODS: We conducted semi-structured interviews with health and social care professionals without previous experience with the APPLE-Tree program, who had direct care or managerial experience in services for older adults with memory concerns, without a dementia diagnosis. We used the Consolidated Framework for Implementation Research to guide interviews and thematic analysis. RESULTS: We interviewed 26 stakeholders: commissioners and service managers (n = 15) and frontline workers (n = 11) from eight NHS and 11 third sector organizations throughout England. We identified three main themes: (1) favorable beliefs in the effectiveness of dementia prevention programs in enhancing cognition and wellbeing and their potential to fill a service gap for people with memory concerns, (2) challenges related to funding and capacity to deliver such programs at organizations without staff capacity or higher prioritization of dementia services, and (3) modifications to delivery and guidance required for compatibility with organizations and patients. CONCLUSION: This study highlights likely challenges in scale-up if we are to make personalized dementia prevention widely available. This will only be possible with increased funding of dementia prevention activities; integrated care systems, with their focus on prevention, may enable this. Scale-up of dementia prevention programs will also require clear outlines of their core and adaptable components to fit funding, patient, and facilitator needs.

A systematic review of process evaluations for psychosocial interventions designed to improve the wellbeing and quality of life of community-dwelling people with dementia and their carers.

BACKGROUND: Psychosocial interventions improve the wellbeing and quality of life of People Living with Dementia (PLWD) and their family carers; but due to their complexity it can be challenging to identify mechanisms of action. We reviewed process evaluations that have sought to elucidate how these interventions work, to inform their implementation. METHOD: We systematically reviewed process evaluations of studies evaluating psychosocial interventions for PLWD in their own home and/or their family carers. We rated study quality using the Mixed Methods Appraisal Tool. We described, with reference to Medical Research Council (2015) process evaluation guidance, how implementation, mechanisms of impact and contextual factors were investigated; and describe commonalities in the mechanisms of action identified across studies. RESULTS: Twenty four included studies evaluated the processes of 22 interventions. These studies collectively applied five frameworks; almost all frameworks' advised evaluations were theory-based and used mixed-methods analyses, but only 5/24 evaluation designs were informed by the intervention theory and 8/24 used mixed methods. 8/24 evaluations considered contextual factors in their design, though 20/24 cited contextual factors in findings. Interventions were more successful where PLWD were motivated and aware of potential benefits, and when carers could support engagement and were themselves supported by the intervention. How the intervention aligned with participants' current needs and stage of dementia were key influencing factors. CONCLUSION: Knowing how interventions can influence change for community-dwelling people with dementia and their family carer's will improve translation of trial findings into practice. Robust, theory-driven process evaluations can enable this.

The economic impact of cancer diagnosis to individuals and their families: a systematic review.

BACKGROUND: The effect of a cancer diagnosis is wide-ranging with the potential to affect income, employment and risk of poverty. The aim of this systematic review is to identify the economic impact of a cancer diagnosis for patients and their families/caregivers. METHODS: The search covered peer-reviewed journals using MEDLINE, EMBASE, CINAHL, Cochrane Library, Epistemonikos and PsycINFO databases. Quality appraisal was undertaken using CASP tools. Monetary values were converted to US Dollars/2019 using a purchasing power parities (PPP) conversion factor. The review included articles up to and including January 2020, written in English language, for patients with cancer aged ≥ 18 years and focused on the costs up to 5 years following a cancer diagnosis. RESULTS: The search was run in January 2020 and updated in November 2021. Of the 7973 articles identified, 18 met the inclusion criteria. Studies were undertaken in the USA, Ireland, Canada, Australia, France, UK, Malaysia, Pakistan, China and Sri Lanka. The majority were cohort studies. Twelve reported out-of-pocket costs (range US$16-US$2523/month per patient/caregiver) consisting of medical expenses (e.g. surgery, radiotherapy and chemotherapy) and non-medical expenses (e.g. travel, food and childcare). Fourteen studies reported patient/caregiver loss of income and lost productivity (range 14-57.8%). CONCLUSIONS: A high percentage of cancer patients and their families/caregivers experience out-of-pocket expenditure, loss of income and lost productivity. Future research is needed to observe the effects of continuing changes to healthcare policies and social protections on the economic burden among cancer patients and their families/caregivers.

Reflections on a personalized cognitive rehabilitation intervention: Experiences of people living with dementia and their carers participating in the GREAT trial.

Cognitive rehabilitation for people living with early-stage dementia improves functional ability in areas targeted in the therapy, but little is known about how participants experience this intervention. This qualitative paper investigates participants' views about a cognitive rehabilitation intervention in a randomized controlled trial (the GREAT trial) and aims to help explain and interpret the findings and to inform further intervention development. Using in-depth thematic analysis, 43 semi-structured interviews (35 individual and 8 dyadic) were conducted with 25 people living with dementia and 26 family carers from three sites. The person-centred, individualized approach was valued. Some participants' views about dementia were questioned as a consequence of taking part in the therapy; they considered the effectiveness of the intervention in the context of the progressive nature of the condition. Certain participants continued to be doubtful, focussing on the inevitability of decline, rather than the possibility of reablement. Such views may have influenced engagement. The therapeutic relationship played a vital role as it was how personalized care was provided and participants' views had changed positively. Therapists engendered greater confidence and reduced anxiety and social isolation. Positive responses support personalized rehabilitative care to address the specific needs of people living with dementia.

Interventions to support recovery following an episode of delirium: A realist synthesis.

OBJECTIVES: Persistent delirium is associated with poor outcomes in older adults but little is known about how to support longer-term recovery from delirium. The aim of this review was to identify and synthesise literature to understand mechanisms of recovery from delirium as a basis for designing an intervention that enables more effective recovery. METHODS: A systematic search of literature relevant to the research question was conducted in two phases. Phase one focused on studies evaluating the efficacy of interventions to support recovery from delirium, and stage two used a wider search strategy to identify other relevant literature including similar patient groups and wider methodologies. Synthesis of the literature followed realist principles. RESULTS: Phase one identified four relevant studies and stage two identified a further forty-six studies. Three interdependent recovery domains and four recovery facilitators were identified. Recovery domains were 1) support for physical recovery through structured exercise programmes; 2) support for cognitive recovery through reality orientation and cognitive stimulation; 3) support for emotional recovery through talking with skilled helpers. Recovery facilitators were 1) involvement and support of carers; 2) tailoring intervention to individual needs, preferences and abilities; 3) interpersonal connectivity and continuity in relationships and; 4) facilitating positive expressions of self. CONCLUSIONS: Multicomponent interventions with elements that address all recovery domains and facilitators may have the most promise. Future research should build on this review and explore patients', carers', and professionals' tacit theories about the persistence of delirium or recovery from delirium in order to inform an effective intervention.

"Falling through the cracks"; Stakeholders' views around the concept and diagnosis of mild cognitive impairment and their understanding of dementia prevention.

OBJECTIVES: Many people live with an awareness of mild cognitive changes that increase their dementia risk. Previous authors describe the uncertainties of this liminal state, between cognitive health and dementia, where being "at risk" can itself be an illness. We ask how services respond to people with memory concerns currently, and how a future, effective and inclusive dementia prevention intervention might be structured for people with memory concerns. METHODS/DESIGN: We conducted qualitative interviews with 18 people aged 60+ years with subjective or objective memory problems, six family members, 10 health and social care professionals and 11 third sector workers. Interviews were audio-recorded, transcribed and analysed using an inductive thematic approach. RESULTS: Three main themes were identified: (1) acknowledging the liminal state, compounded by current, discordant health service responses: medicalising memory concerns yet situating responsibilities for their management with patients and families; (2) enabling change in challenging contexts of physical and cognitive frailty and social disengagement and (3) building on existing values, cultures and routines. CONCLUSIONS: Effective dementia prevention must empower individuals to make lifestyle changes within challenging contexts. Programmes must be evidence based yet sufficiently flexible to allow new activities to be fitted into people's current lives; and mindful of the risks of pathologising memory concerns. Most current memory services are neither commissioned, financially or clinically resourced to support people with memory concerns without dementia. Effective, large scale dementia prevention will require a broad societal response.

APPLE-Tree (Active Prevention in People at risk of dementia: Lifestyle, bEhaviour change and Technology to REducE cognitive and functional decline) programme: Protocol.

BACKGROUND: Observational studies indicate that approximately a third of dementia cases are attributable to modifiable cardiometabolic, physical and mental health, and social and lifestyle risk factors. There is evidence that intensive behaviour change interventions targeting these factors can reduce cognitive decline. [Figure: see text] METHODS AND ANALYSIS: We will design and test a low intensity, secondary dementia-prevention programme (Active Prevention in People at risk of dementia: Lifestyle, bEhaviour change and Technology to REducE cognitive and functional decline, "APPLE-Tree") to slow cognitive decline in people with subjective cognitive decline with or without objective cognitive impairment. We will embed our work within social science research to understand how dementia prevention is currently delivered and structured. We will carry out systematic reviews and around 50 qualitative interviews with stakeholders, using findings to coproduce the APPLE-Tree intervention. We plan a 10-session group intervention, involving personalised goal-setting, with individual sessions for those unable or unwilling to attend groups, delivered by psychology assistants who will be trained and supervised by clinical psychologists. The coproduction group (including public and patient involvement [PPI], academic and clinical/third-sector professional representatives) will use the Behaviour Change Wheel theoretical framework to develop it. We will recruit and randomly allocate 704 participants, 1:1 to the intervention: informational control group. This sample size is sufficient to detect a between-group difference at 2 years of 0.15 on the primary outcome (cognition: modified neuropsychological test battery; 90% power, 5% significance, effect size 0.25, SD 0.6). DISSEMINATION: We will work with Public Health England and third-sector partners to produce an effective national implementation approach, so that if our intervention works, it is used in practice.

The dynamics of decision-making in weight loss and maintenance: a qualitative enquiry.

BACKGROUND: Behavioural approaches to weight loss are often initially successful but less so in the longer term, as some people maintain the necessary behaviour changes while others do not. This study aimed to derive possible explanations for this using a qualitative approach with a view to improving intervention effectiveness. METHODS: Thirty-six participants in a development and feasibility study for a weight loss and maintenance intervention (called SkiM) were interviewed three times over 18 months regarding their experiences before, during and after the intervention. Data were analysed thematically. The accounts of those who were more and less successful in terms of longer term weight loss were compared, and a conceptual model linking the main analytic themes was developed. RESULTS: Five interpretative themes were generated: encountering and managing key situations; the impact of emotion; the source of control; personal values; and acquiring knowledge and skills. These themes were linked through a model of decision-making during key situations. In this model, behavioural decisions emerge from a dynamic interplay between several drivers: emotional state and needs, perceived control, personal values, the individual's knowledge and skills, and their existing habits. The individual's response in key situations generates experiential learning that can influence decisional dynamics in similar situations in future. These dynamics appeared to differ between participants, and between those who were more and less successful in weight management. CONCLUSIONS: Our analysis and model of decision-making during weight-management have implications for the development and delivery of behavioural weight management interventions. By helping individuals to identify the drivers of their decision-making in key situations, and equipping them to manage these drivers, programmes may enhance their capacity to sustain the behaviour changes needed for long-term weight loss.

Pre-implementation planning for a new personalised, dementia post-diagnostic support intervention: exploring the perspective of professional stakeholders.

BACKGROUND: Only a third of people with dementia receive a diagnosis and post-diagnostic support. An eight session, manualised, modular post-diagnostic support system (New Interventions for Independence in Dementia Study (NIDUS) - family), delivered remotely by non-clinical facilitators is the first scalable intervention to improve personalised goal attainment for people with dementia. It could significantly improve care quality. AIMS: We aimed to explore system readiness for NIDUS-family, a scalable, personalised post-diagnostic support intervention. METHOD: We conducted semi-structured interviews with professionals from dementia care services; the Consolidated Framework for Implementation Research guided interviews and their thematic analysis. RESULTS: From 2022 to 2023, we interviewed a purposive sample of 21 professionals from seven English National Health Service, health and social care services. We identified three themes: (1) potential value of a personalised intervention - interviewees perceived the capacity for choice and supporting person-centred care as relative advantages over existing resources; (2) compatibility and deliverability with existing systems - the NIDUS-family intervention model was perceived as compatible with service goals and clients' needs, but current service infrastructures, financing and commissioning briefs constraining resources to those at greatest need were seen as barriers to providing universal, post-diagnostic care; (3) fit with current workforce skills - the intervention model aligned well with staff development plans; delivery by non-clinically qualified staff was considered an advantage over current care options. CONCLUSIONS: Translating evidence for scalable and effective post-diagnostic care into practice will support national policies to widen access to support and upskill support workers, but requires a greater focus on prevention in commissioning briefs and resource planning.

Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial.

Objectives: Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced intracapsular fractures on postoperative mobility and function compared with a standard lateral approach. Design: Pragmatic, superiority, multicenter, parallel-group, randomized controlled trial (with internal pilot). Participants, ward staff, and research staff conducting postoperative assessments were blinded to allocation. A CTU allocated treatments centrally using computer-generated lists. Setting: Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022. Participants: 244 adults (≥60 years) requiring hip hemiarthroplasty (122 allocated to each approach). 90 and 85 participants allocated to SPAIRE and lateral, respectively, had primary outcome data within the prespecified data collection window. Interventions: Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation. Main outcome measure: Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3 days), pain (3 days, 120 days), discharge destination, length of hospital stay, complications and mortality (within 120 days), quality of life and place of residence (120 days). Results: Participants' mean age was 84.6 years (SD 7.2); 168 (69%) were women. Primary outcome: little evidence of a difference in OHS at 120 days; adjusted mean difference (SPAIRE-lateral) -1.23 (95% CI -3.96 to 1.49, p=0.37). Secondary outcomes: indication of lower participant-reported pain at 3 days in SPAIRE arm; no differences between arms for remaining outcomes. Conclusions: Participants' mobility and function are similar in the short term (3 days) and longer term (120 days), whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to prefracture residence, survival within 120 days, or quality of life at 120 days. Participants receiving SPAIRE approach may experience less pain in the early postoperative period. Modifying the posterior approach in hip hemiarthroplasty to the SPAIRE approach gives equivalent patient outcomes to the lateral approach within 120 days. Trial registration number: NCT04095611.

Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN.

INTRODUCTION: Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual's overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia. METHOD AND ANALYSIS: This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes. ETHICS AND DISSEMINATION: The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16413728.

"It's a lot more complicated than it seems": physiotherapists' experiences of using compensation strategies in people with Parkinson's.

Background: Gait disturbances often result in functional limitations in daily activities and negatively impact the quality of life in people with Parkinson's disease. Physiotherapists often employ compensation strategies in an attempt to improve patients' walking. However, little is known about physiotherapists' experiences in this regard. We evaluated how physiotherapists adopt compensation strategies and what they draw on to inform their clinical decision-making. Methods: We carried out semi-structured online interviews with 13 physiotherapists with current or recent experience working with people with Parkinson's disease in the United Kingdom. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was utilized. Results: Two main themes were developed from the data. The first theme, optimizing compensation strategies through personalized care, shows how physiotherapists accounted for the individual needs and characteristics of people with Parkinson's, which resulted in them individually tailoring compensation strategies. The second theme, delivering compensation strategies effectively, considers the available support and perceived challenges with work settings and experience that impact physiotherapists' ability to deliver compensation strategies. Discussion: Although physiotherapists strived to optimize compensation strategies, there was a lack of formal training in this area, and their knowledge was primarily acquired from peers. Furthermore, a lack of specific knowledge on Parkinson's can impact physiotherapists' confidence in maintaining person-centered rehabilitation. However, the question that remains to be answered is what accessible training could address the knowledge-practice gap to contribute to the delivery of better-personalized care for people with Parkinson's.

Nature As a "Lifeline": The Power of Photography When Exploring the Experiences of Older Adults Living With Memory Loss and Memory Concerns.

The visual is an underutilized modality through which to investigate experiences of memory loss in older people. We describe a visual ethnography with older adults experiencing subjective or objective memory loss, receiving a cognitive well-being group intervention designed to prevent cognitive decline and dementia (APPLE-Tree program). We aimed to explore lived experiences of people with memory concerns, how participants engaged with this photography and codesign project, and how collaboration with an artist/photographer enhanced this process. Nineteen participants shared photographs reflecting what they valued in their daily lives, their experiences of memory concerns, and the intervention. Fourteen participated in qualitative photo-elicitation interviews, and 13 collaborated with a professional artist/photographer to cocreate an exhibition, in individual meetings and workshops, during which a researcher took ethnographic field notes. Eight participants were reinterviewed after the exhibition launch.We contextualize images produced by participants in relation to discourses around the visual and aging and highlight their relationship with themes developed through thematic analysis that interconnects photographic, observational, and interview data. We present themes around the use of photographs to: (1) celebrate connections to nature as a lifeline; (2) anchor lives within the context of relationships with family; and (3) reflect on self and identity, enduring through aging, memory concerns, pandemic, and aging stereotypes. We explore visual research as a powerful tool for eliciting meaningful accounts from older adults experiencing cognitive change and to connect the arts and social sciences within aging studies.

Practitioners' ability to remotely develop understanding for personalised care and support planning: a thematic analysis of multiple data sources from the feasibility phase of the Dementia Personalised Care Team (D-PACT) intervention.

Practitioner understanding of patients' preferences, wishes and needs is essential for personalised health care i.e., focusing on 'what matters' to people based on their individual life situation. To develop such an understanding, dementia practitioners need to use communication practices that help people share their experiences, preferences, and priorities. Following the COVID-19 pandemic, dementia support is likely to continue to be delivered both remotely and in-person. This study analysed multiple sources of qualitative data to examine the views of practitioners, people living with dementia and carers, and researchers on how an understanding of what matters to people living with dementia can be developed remotely via telephone and video call. Access to environmental stimuli, the remote use of visual tools, peoples' tendency to downplay or omit details about their troubles and carers' ability to disclose privately were interpreted, through thematic analysis, to be factors affecting how practitioners sought to develop understanding remotely. Cumulatively, findings show that while remote support created unique challenges to practitioners' ability to develop understanding for personalised care, practitioners developed adaptive strategies to overcome some of these challenges. Further research should examine how, when and for whom these adapted practices for remote personalised care work, informing the development of evidence-based guidance and training on how practitioners can remotely develop the understanding required for personalised care.

Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.

A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study.

BACKGROUND: Delirium affects over 20% of all hospitalised older adults. Delirium is associated with a number of adverse outcomes following hospital admission including cognitive decline, anxiety and depression, increased mortality and care needs. Previous research has addressed prevention of delirium in hospitals and care homes, and there are guidelines on short-term treatment of delirium during admission. However, no studies have addressed the problem of longer-term recovery after delirium and it is currently unknown whether interventions to improve recovery after delirium are effective and cost-effective. The primary objective of this feasibility study is to test a new, theory-informed rehabilitation intervention (RecoverED) in older adults delivered following a hospital admission complicated by delirium to determine whether (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible. METHODS: The study is a multi-centre, single-arm feasibility study of a rehabilitation intervention with an embedded process evaluation. Sixty participants with delirium (aged > 65 years old) and carer pairs will be recruited from six NHS acute hospitals across the UK. All pairs will be offered the intervention, with follow-up assessments conducted at 3 months and 6 months post-discharge home. The intervention will be delivered in participants' own homes by therapists and rehabilitation support workers for up to 10 intervention sessions over 12 weeks. The intervention will be tailored to individual needs, and the chosen intervention plan and goals will be discussed and agreed with participants and carers. Quantitative data on reach, retention, fidelity and dose will be collected and summarised using descriptive statistics. The feasibility outcomes that will be used to determine whether the study meets the criteria for progression to a definitive randomised controlled trial (RCT) include recruitment, delivery of the intervention, retention, data collection and acceptability of outcome measures. Acceptability of the intervention will be assessed using in-depth, semi-structured qualitative interviews with participants and healthcare professionals. DISCUSSION: Findings will inform the design of a pragmatic multi-centre RCT of the effectiveness and cost-effectiveness of the RecoverED intervention for helping the longer-term recovery of people with delirium compared to usual care. TRIAL REGISTRATION: The feasibility study was registered: ISRCTN15676570.

Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay.

BACKGROUND: Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. METHODS/DESIGN: The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6-7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars. DISCUSSION: The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children. TRIAL REGISTRATIONS: ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273.

Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol.

INTRODUCTION: New Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer's Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention's effectiveness. Findings will inform how the programme is implemented in practice. METHODS AND ANALYSIS: The process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level 'case studies', and a joint display for 'population' level analysis and interpretation. ETHICS AND DISSEMINATION: Ethical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer's Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy. TRIAL REGISTRATION NUMBER: ISRCTN11425138.

Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE.

BACKGROUND: The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-"Save Piriformis and Internus, Repairing Externus") in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes the detailed statistical analysis plan for the trial.  METHODS AND DESIGN: HemiSPAIRE is a definitive, pragmatic, superiority, multicentre, randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward staff and all research staff involved in post-operative assessments are blinded to allocation. This article describes in detail (1) the primary and secondary outcomes; (2) the statistical analysis principles, including a survivor average causal effect (SACE) method chosen specifically to address the issue of potential bias from differential survival between trial arms, which was seen from data review by the Trial Steering Committee, the participants that will be included in each analysis, the covariates that will be included in each analysis, and how the results will be presented; (3) planned main analysis of the primary outcome; (4) planned analyses of the secondary outcomes; and (5) planned additional analyses of the primary and secondary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04095611. Registered on 19 September 2019.