Fidelity, pragmatism and the "grey line" in between-exploring the delivery of a pragmatic physical activity randomised controlled trial-a secondary analysis.

BACKGROUND: Intervention fidelity in health services research has been poor with a reported lack of understanding about what constitutes pragmatic adaptation of interventions and what constitutes failure to maintain intervention fidelity. However, the challenges facing those delivering such interventions have not been thoroughly explored. The aims of this study were to critically explore the challenges in maintaining fidelity experienced by physiotherapy staff and support workers when delivering a complex intervention for older people living with frailty. METHODS: This study is a secondary analysis of data from a process evaluation of a large randomised controlled trial (RCT). The process evaluation employed qualitative methodologies with mixed methods including a variety of data collection methods, including participant observation, semi-structured interviews and documentary analysis. Thematic analysis was used to make sense of the data. RESULTS: Many therapy staff felt ongoing confusion about what was acceptable to adapt and what needed to follow the protocol exactly. We found that some therapy staff were able to embrace the challenges of pragmatically adapting interventions while maintaining intervention fidelity, others stuck rigidly to the protocol and failed to adapt interventions where it was necessary. CONCLUSION: It was clear that the understanding of fidelity and pragmatism was poor. While pragmatic trials are vital to replicate real world clinical practice, further guidance may need to be developed in order to guide the level of adaptation that is acceptable before fidelity is undermined.

Older people's perception of being frail - a qualitative exploration.

BACKGROUND: Frailty is a suggested consequence of ageing, but with a variety of different definitions the understanding of what it means to be frail is challenging. There is a common belief that frailty results in a reduction of physical functioning and ability and therefore is likely to significantly affect a person's quality of life. The aim of this study was to explore the understanding of older people about the meaning of frailty and the potential consequences of being classified as frail. METHODS: This paper forms a secondary analysis of a process evaluation of a complex intervention that was embedded within the individually randomised Home-based Extended Rehabilitation of Older people (HERO) trial. A maximum variation, purposive sampling strategy sought to recruit participants with a wide range of characteristics. Data collection included observations of the delivery of the intervention, documentary analysis and semi-structured interviews with participants. Thematic analysis was used to make sense of the observational and interview data, adopting both inductive and deductive approaches. RESULTS: Ninety three HERO trial participants were sampled for the process evaluation with a total of 60 observational home visits and 35 interviews were undertaken. There was a wide range in perceptions about what it meant to be classified as frail with no clear understanding from our participants. However, there was a negative attitude towards frailty with it being considered something that needed to be avoided where possible. Frailty was seen as part of a negative decline that people struggled to associate with. There was discussion about frailty being temporary and that it could be reduced or avoided with sufficient physical exercise and activity. CONCLUSION: Our study provides insight into how older people perceive and understand the concept of frailty. Frailty is a concept that is difficult for patients to understand, with most associating the term with an extreme degree of physical and cognitive decline. Having a label of being "frail" was deemed to be negative and something to be avoided, suggesting the term needs to be used cautiously. TRIAL REGISTRATION: ISRCTN 13927531. Registered on April 19, 2017.

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.

Physical rehabilitation for people with advanced dementia who fracture their hip - expert consensus process.

PURPOSE: Hip fracture is common in older people - with prevalence even higher for people with dementia. Research often excludes people with dementia - especially those in the more advanced stages. Therefore, the most appropriate interventions remain unknown. The main aim of this study was to gain consensus about the core considerations needed to deliver a physical intervention for people with advanced dementia who fracture their hip. Materials and Methods: An expert consensus process was undertaken, using Nominal Group Technique, to explore the key considerations when delivering rehabilitation. Data collection was undertaken in January 2023 and involved an online group discussion followed by voting and off-line rating. Qualitative content analysis and quantitative analysis of consensus scoring was undertaken. An international group of seven highly specialised physiotherapists took part. RESULTS: 59 statements were agreed following the process. Content analysis was used to categorise these statements according to the International Classification of Functioning, Disability and Health. Although consensus levels were high, there was disagreement in several areas. CONCLUSION: The statements provide an overarching understanding of the multidisciplinary expertise that is needed to effectively deliver rehabilitation interventions to this population. People with dementia require highly skilled and trained professionals, providing holistic and person-centred approaches to deliver rehabilitation interventions.IMPLICATIONS FOR REHABILITATIONThe expert consensus provides an overarching understanding of the multidisciplinary expertise that is needed to effectively deliver rehabilitation interventions to this population.Physiotherapy - or other interventions - cannot be used in isolation.People with dementia require highly skilled and trained professionals, providing holistic and person-centred approaches to deliver rehabilitation interventions.While our focus was on hip fracture, we suggest these statements can be used for people with advanced dementia with a variety of other conditions.

Qualitative study exploring health care professionals' perceptions of providing rehabilitation for people with advanced dementia.

OBJECTIVES: The aim of this study was to explore healthcare professionals' principles for providing and delivering rehabilitation interventions for people with advanced dementia. DESIGN: This was a qualitative study with three focus groups undertaken virtually. The data were analysed using a process of reflexive thematic analysis in order to gain an in-depth understanding of rehabilitation principles for this population. SETTING AND PARTICIPANTS: 20 healthcare professionals who were specialists in treating and rehabilitating people with advanced dementia were recruited. These healthcare professionals had a wide range of experience in a variety of different settings including primary care, secondary care as well as specialist mental health teams. Purposive sampling focused on the requirement for participants to have significant experience of treating people with dementia. Participants were from the UK and Denmark. Data collection was undertaken during August and September 2022. RESULTS: Three overarching themes were developed following analysis-organisational culture, knowledge and personal values of the healthcare professional. The first explored how the culture of an organisation affects a person with advanced dementia as well as the healthcare professional. The organisation needed to promote positive approaches to person-centred care and provide effective situational leadership to embed such approaches. Knowledge was a key consideration and was closely linked to the personal values of the healthcare professional, which formed the final theme. This study suggests that the interrelationship of these three factors influences the outcomes for the person with dementia and effective outcomes required consideration of all domains. CONCLUSIONS: Effective interventions for people with advanced dementia require the healthcare professional to have the knowledge about dementia and positive personal values, but the culture of the organisation is also key to ensure that the healthcare professional is able to deliver successful interventions.

Key Considerations When Providing Physical Rehabilitation for People with Advanced Dementia.

Dementia is a growing global challenge with numbers set to increase rapidly in the coming years. Evidence suggests that exercise can be effective in improving cognitive functioning, but the evidence does not yet support improvements in other key domains such as quality of life or physical ability. The aim of this study was to explore the key components that needed to be considered when providing physical rehabilitation to people with advanced dementia. The study used a qualitative approach involving semi-structured focus groups with health care professionals who are experts in delivering interventions to people with advanced dementia. As a pragmatic study seeking to inform the development of interventions, a thematic coding approach was used to make sense of the data. We collected data from 20 healthcare professionals who reported that key considerations needed to be considered from both an assessment and an intervention perspective. The assessment needed to be person centred and, with the right people engaged and using outcome measures that were meaningful to the patient. The actual intervention also needed to follow the principles of person-centred care, with emphasis placed on the importance of taking time to build a rapport with the person, but also reducing any of the barriers that would prevent effective engagement, such as unsuitable environments. Our study suggests that while there are barriers and challenges to providing interventions and rehabilitation to people with advanced dementia, appropriate person-centred, tailored interventions can be effective and therefore should be offered.

Physical interventions for people with more advanced dementia - a scoping review.

BACKGROUND: Dementia is a neuro-degenerative condition resulting in cognitive and physical decline over time. In the early stages of the condition, physical decline may be slow, but in the later stages, it may become more pronounced. Physical interventions may be employed to try and reduce the physical decline that people experience, yet it is unclear what interventions may be effective. The aim of this study was to explore the breadth and quantity of evidence that exists in relation to the delivery of physical interventions for people with advanced dementia. METHODS: We undertook a scoping review in order to map the current literature. All types of study design were included in the search in order to gain a comprehensive scope of the literature. We searched a variety of databases from inception until March 2021, focusing on physical interventions. Double screening and data extraction were employed in order to increase the reliability of the results. RESULTS: Our review found four studies which focused on physical interventions aimed at improving physical outcomes for people with more advanced dementia. The majority of studies were excluded as their interventions were not specific to people with advanced dementia. The studies that were included incorporated functional activities and, despite small sample sizes, suggested statistically significant improvements in outcomes for people with advanced dementia. CONCLUSION: There is currently limited evidence relating to physical rehabilitation interventions for people with more advanced dementia, however, the evidence we presented suggests potential benefits for physical outcomes. Future research should focus on robust research to determine the most effective and cost-effective interventions that meet the needs of this population.

Synthesis and crystal structure of a heterobimetallic nickel-manganese 12-metallacrown-4 methanol disolvate monohydrate compound.

The synthesis and crystal structure of the title compound [systematic name: di-µ-acetato-tetra-kis-(µ4-N,2-dioxido-benzene-1-carboximidato)hexa-methano-ltetra-manganese(III)nickel(II) methanol disolvate monohydrate], [Mn4Ni(C7H4NO3)4(C2H3O2)2(CH4O)6]·2CH4O·H2O or Ni(OAc)2[12-MCMn(III)N(shi)-4](CH3OH)6·2CH3OH·H2O, where MC is metallacrown, -OAc is acetate, and shi3- is salicyl-hydroximate, are reported. The macrocyclic metallacrown is positioned on an inversion center located on the NiII ion that resides in the central MC cavity. The macrocycle consists of an MnIII-N-O repeat unit that recurs four times to generate an overall square-shaped mol-ecule. Both the NiII and MnIII ions are six-coordinate with an octa-hedral geometry. In addition, the MnIII ions possess an elongated Jahn-Teller distortion along the z-axis of the coordination environment. The inter-stitial water mol-ecule is slightly offset from and disordered about an inversion center.

Community physiotherapy for people with dementia following hip fracture: Fact or fiction? A qualitative study.

BACKGROUND: Physiotherapy is a core component of rehabilitation following a hip fracture. Approximately 40% of people sustaining a hip fracture will have dementia, but there is little evidence to guide physiotherapy interventions in this population. OBJECTIVE: This study forms part of a process evaluation seeking to explore reasons why people with dementia were not referred for physiotherapy following a hip fracture and challenges that are faced treating these people in the community. METHODS: We undertook a series of structured focus groups and interviews with physiotherapists based in community-rehabilitation services in the South West of England. Qualitative data sought to explain reasons why people with dementia were not being referred for onward physiotherapy following discharge from the acute setting after hip fracture. Framework analysis was used to make sense of the data. RESULTS: Four focus groups and interviews were undertaken with physiotherapists and assistants working in community settings. Three main themes were determined - beliefs, the importance of pathways of care and the effect of resources on decision making. DISCUSSION: Out data suggest that people with dementia were often labelled as having 'no rehabilitation potential' in the acute setting and this excluded them from receiving ongoing therapy in the community setting. It was also suggested that physiotherapists were judging this potential using biomedical measures of outcome which fails to recognise the importance of person centred care for this population. CONCLUSION: There was suggestion of therapeutic nihilism when considering rehabilitation for this population, whereby it is assumed that people with dementia cannot be rehabilitated, so they are not given the opportunity. It is unsurprising that outcomes for this population are poor considering the reluctance to provide physiotherapy to people with dementia following hip fracture.

Are physiotherapists employing person-centred care for people with dementia? An exploratory qualitative study examining the experiences of people with dementia and their carers.

BACKGROUND: People with dementia may receive physiotherapy for a variety of reasons. This may be for musculoskeletal conditions or as a result of falls, fractures or mobility difficulties. While previous studies have sought to determine the effectiveness of physiotherapy interventions for people with dementia, little research has focused on the experiences of people receiving such treatment. The aim of this study was to gain an in-depth understanding of people's experiences of receiving physiotherapy and to explore these experiences in the context of principles of person-centred care. METHODS: Semi-structured interviews were undertaken with people with dementia or their carers between September 2016 and January 2017. A purposive sampling strategy recruited participants with dementia from the South West of England who had recently received physiotherapy. We also recruited carers to explore their involvement in the intervention. Thematic analysis was used to analyse the data. RESULTS: A total of eleven participants were recruited to the study. Six people with dementia were interviewed and five interviews undertaken separately with carers of people with dementia. Three themes were identified. The first explores the factors that enable exercises to be undertaken successfully, the second deals with perceived resource pressures, and the final theme "the physiotherapy just vanished" explores the feeling of abandonment felt when goals and expectations of physiotherapy were not discussed. When mapped against the principles of person-centred care, our participants did not describe physiotherapy adopting such an approach. CONCLUSION: Lack of a person-centred care approach was evident by ineffective communication, thus failing to develop a shared understanding of the role and aims of physiotherapy. The incorporation of person-centred care may help reduce the frustration and feelings of dissatisfaction that some of our participants reported.

Orthotics and taping in the management of vertebral fractures in people with osteoporosis: a systematic review.

OBJECTIVE: To establish the current evidence base for the use of orthotics and taping for people with osteoporotic vertebral fracture (OVF). DESIGN: Systematic review of quantitative and qualitative studies. DATA SOURCES: Medline, Medline-In Process, EMBASE, AMED, CINAHL, PEDro, TRIP, EThOS, ProQuest Dissertations and Theses and Cochrane (CDSR, DARE, CMR, HTA, EED) plus Cochrane Central, UK Clinical Research Network portfolio, Controlled Clinical Trials register and the Australian and New Zealand Clinical Trials register. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: All study designs were considered if they reported in English and evaluated the impact of using an external support, such as a spinal brace, orthosis or postural tape, with adults with OVF. All outcomes were considered. RESULTS: Nine studies were included comprising two parallel-group randomised controlled trials, four randomised cross-over trials, two before-after (single arm) studies and a parallel group observational study. No qualitative studies were identified. A wide range of outcomes assessing impairments, activities and participation were assessed but the findings were mixed. The quality of studies was limited. CONCLUSIONS: The current evidence for using orthotic devices or taping for people with OVF is inconsistent and of limited quality and therefore careful consideration should be taken by clinicians before prescribing them in practice. SYSTEMATIC REVIEW REGISTRATION NUMBER: CRD42015020893.