Inflammation, endothelial injury, and the acute respiratory distress syndrome after out-of-hospital cardiac arrest.

Background: Acute respiratory distress syndrome (ARDS) is often seen in patients resuscitated from out-of-hospital cardiac arrest (OHCA). We aim to test whether inflammatory or endothelial injury markers are associated with the development of ARDS in patients hospitalized after OHCA. Methods: We conducted a prospective, cohort, pilot study at an urban academic medical center in 2019 that included a convenience sample of adults with non-traumatic OHCA. Blood and pulmonary edema fluid (PEF) were collected within 12 hours of hospital arrival. Samples were assayed for cytokines (interleukin [IL]-1, tumor necrosis factor-α [TNF-α], tumor necrosis factor receptor1 [TNFR1], IL-6), epithelial injury markers (pulmonary surfactant-associated protein D), endothelial injury markers (Angiopoietin-2 [Ang-2] and glycocalyx degradation products), and other proteins (matrix metallopeptidase-9 and myeloperoxidase). Patients were followed for 7 days for development of ARDS, as adjudicated by 3 blinded reviewers, and through hospital discharge for mortality and neurological outcome. We examined associations between biomarker concentrations and ARDS, hospital mortality, and neurological outcome using multivariable logistic regression. Latent phase analysis was used to identify distinct biological classes associated with outcomes. Results: 41 patients were enrolled. Mean age was 58 years, 29% were female, and 22% had a respiratory etiology for cardiac arrest. Seven patients (17%) developed ARDS within 7 days. There were no significant associations between individual biomarkers and development of ARDS in adjusted analyses, nor survival or neurologic status after adjusting for use of targeted temperature management (TTM) and initial cardiac arrest rhythm. Elevated Ang-2 and TNFR-1 were associated with decreased survival (RR = 0.6, 95% CI = 0.3-1.0; RR = 0.5, 95% CI = 0.3-0.9; respectively), and poor neurologic status at discharge (RR = 0.4, 95% CI = 0.2-0.8; RR = 0.4, 95% CI = 0.2-0.9) in unadjusted associations. Conclusion: OHCA patients have markedly elevated plasma and pulmonary edema fluid biomarker concentrations, indicating widespread inflammation, epithelial injury, and endothelial activation. Biomarker concentrations were not associated with ARDS development, though several distinct biological phenotypes warrant further exploration. Latent phase analysis demonstrated that patients with low biomarker levels aside from TNF-α and TNFR-1 (Class 2) fared worse than other patients. Future research may benefit from considering other tools to predict and prevent development of ARDS in this population.

Home-based versus centre-based cardiac rehabilitation.

BACKGROUND: Cardiovascular disease is the most common cause of death globally. Traditionally, centre-based cardiac rehabilitation programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based and technology-supported cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation, especially during the SARS-CoV-2 pandemic. This is an update of a review previously published in 2009, 2015, and 2017. OBJECTIVES: To compare the effect of home-based (which may include digital/telehealth interventions) and supervised centre-based cardiac rehabilitation on mortality and morbidity, exercise-capacity, health-related quality of life, and modifiable cardiac risk factors in patients with heart disease SEARCH METHODS: We updated searches from the previous Cochrane Review by searching the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid) and CINAHL (EBSCO) on 16 September 2022. We also searched two clinical trials registers as well as previous systematic reviews and reference lists of included studies. No language restrictions were applied. SELECTION CRITERIA: We included randomised controlled trials that compared centre-based cardiac rehabilitation (e.g. hospital, sports/community centre) with home-based programmes (± digital/telehealth platforms) in adults with myocardial infarction, angina, heart failure, or who had undergone revascularisation. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all identified references for inclusion based on predefined inclusion criteria. Disagreements were resolved through discussion or by involving a third review author. Two authors independently extracted outcome data and study characteristics and assessed risk of bias. Certainty of evidence was assessed using GRADE. MAIN RESULTS: We included three new trials in this update, bringing a total of 24 trials that have randomised a total of 3046 participants undergoing cardiac rehabilitation. A further nine studies were identified and are awaiting classification. Manual searching of trial registers until 16 September 2022 revealed a further 14 clinical trial registrations - these are ongoing. Participants had a history of acute myocardial infarction, revascularisation, or heart failure. Although there was little evidence of high risk of bias, a number of studies provided insufficient detail to enable assessment of potential risk of bias; in particular, details of generation and concealment of random allocation sequencing and blinding of outcome assessment were poorly reported. No evidence of a difference was seen between home- and centre-based cardiac rehabilitation in our primary outcomes up to 12 months of follow-up: total mortality (risk ratio [RR] = 1.19, 95% confidence interval [CI] 0.65 to 2.16; participants = 1647; studies = 12/comparisons = 14; low-certainty evidence) or exercise capacity (standardised mean difference (SMD) = -0.10, 95% CI -0.24 to 0.04; participants = 2343; studies = 24/comparisons = 28; low-certainty evidence). The majority of evidence (N=71 / 77 comparisons of either total or domain scores) showed no significant difference in health-related quality of life up to 24 months follow-up between home- and centre-based cardiac rehabilitation. Trials were generally of short duration, with only three studies reporting outcomes beyond 12 months (exercise capacity: SMD 0.11, 95% CI -0.01 to 0.23; participants = 1074; studies = 3; moderate-certainty evidence). There was a similar level of trial completion (RR 1.03, 95% CI 0.99 to 1.08; participants = 2638; studies = 22/comparisons = 26; low-certainty evidence) between home-based and centre-based participants. The cost per patient of centre- and home-based programmes was similar. AUTHORS' CONCLUSIONS: This update supports previous conclusions that home- (± digital/telehealth platforms) and centre-based forms of cardiac rehabilitation formally supported by healthcare staff seem to be similarly effective in improving clinical and health-related quality of life outcomes in patients after myocardial infarction, or revascularisation, or with heart failure. This finding supports the continued expansion of healthcare professional supervised home-based cardiac rehabilitation programmes (± digital/telehealth platforms), especially important in the context of the ongoing global SARS-CoV-2 pandemic that has much limited patients in face-to-face access of hospital and community health services. Where settings are able to provide both supervised centre- and home-based programmes, consideration of the preference of the individual patient would seem appropriate. Although not included in the scope of this review, there is an increasing evidence base supporting the use of hybrid models that combine elements of both centre-based and home-based cardiac rehabilitation delivery. Further data are needed to determine: (1) whether the short-term effects of home/digital-telehealth and centre-based cardiac rehabilitation models of delivery can be confirmed in the longer term; (2) the relative clinical effectiveness and safety of home-based programmes for other heart patients, e.g. post-valve surgery and atrial fibrillation.

Adherence to physical rehabilitation delivered via tele-rehabilitation for people with multiple sclerosis: a scoping review protocol.

INTRODUCTION: Using tele-rehabilitation methods to deliver exercise, physical activity (PA) and behaviour change interventions for people with multiple sclerosis (pwMS) has increased in recent years, especially since the SARS-CoV-2 pandemic. This scoping review aims to provide an overview of the literature regarding adherence to therapeutic exercise and PA delivered via tele-rehabilitation for pwMS. METHODS AND ANALYSIS: Frameworks described by Arksey and O'Malley and Levac et al underpin the methods. The following databases will be searched from 1998 to the present: Medline (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Health Management Information Consortium Database, ProQuest Dissertations and Theses Global, Pedro, Cochrane Central Register of Controlled Trials, US National Library of Medicine Registry of Clinical Trials, WHO International Clinical Trials Registry Platform portal and The Cochrane Database of Systematic Reviews. To identify papers not included in databases, relevant websites will be searched. Searches are planned for 2023. With the exception of study protocols, papers on any study design will be included. Papers reporting information regarding adherence in the context of prescribed therapeutic exercise and PA delivered via tele-rehabilitation for pwMS will be included. Information relating to adherence may comprise; methods of reporting adherence, adherence levels (eg, exercise diaries, pedometers), investigation of pwMS' and therapists' experiences of adherence or a discussion of adherence. Eligibility criteria and a custom data extraction form will be piloted on a sample of papers. Quality assessment of included studies will use Critical Appraisal Skills Programme checklists. Data analysis will involve categorisation, enabling findings relating to study characteristics and research questions to be presented in narrative and tabular format. ETHICS AND DISSEMINATION: Ethical approval was not required for this protocol. Findings will be submitted to a peer-reviewed journal and presented at conferences. Consultation with pwMS and clinicians will help to identify other dissemination methods.

Shared social identity and perceived social support among stroke groups during the COVID-19 pandemic: Relationship with psychosocial health.

Community-based peer support groups for stroke survivors are common in the United Kingdom and aim to support rehabilitation. This study of 260 stroke survivors across 118 groups nationally used an online survey format, completed on average 3 months into the pandemic. Analysis of both quantitative and open-ended responses provided insights into how stroke group members maintained contact during the COVID-19 pandemic and how the group processes of shared social identity and perceived social support related to psychosocial outcomes (self-esteem, well-being and loneliness). Group members adapted to the pandemic early through telephone calls (61.6% of participants) and internet-based contact (>70% of participants), although also showed a desire for greater contact with their groups. A stronger sense of shared social identity and perceptions of social support from the stroke groups were weakly associated with reductions in loneliness among members, and greater perceived social support was associated with higher self-esteem. However, having poor health and living alone were more strongly associated with more negative psychosocial outcomes. The discussion considers how barriers to contact during pandemics can be managed, including access and use of online communication, limitations imposed by stroke-related disability, and how the experience of feeling supported and social identification can be better nurtured within remote contexts.

Knowledge needs and use in long-term care homes for older people: A qualitative interview study of managers' views.

We explore the views of managers' knowledge needs and use to optimise care practices and enhance the life experience for older people living, and staff working, in long-term care homes (with and without nursing). This paper contributes to previous research by offering insights into the knowledge types drawn upon and used by managers to inform efforts to better support gaining and mobilising knowledge. Using a pragmatic qualitative approach, we undertook 19 semi-structured interviews with managers and leaders in 15 care homes in the South West of England, varying in geographical location, size and type of ownership. We did a thematic analysis of the data using Framework Analysis. Our interpretations were informed by the existing literature on knowledge types. We identified three themes from our analysis as to managers' knowledge needs and use when implementing changes. First, views about training and formal reports or "explicit knowledge" consisting of the two sub-themes "gaining explicit knowledge" and "research knowledge". Second, perspectives relating to practical experience or "tacit knowledge" and judging the use of knowledge in particular cases or "phronesis". Third, the role of emotion in managers' knowledge needs and use. We found that having knowledge was positively valued by managers and leaders for improving care practices and enhancing the lives of people residing in care homes. Tacit knowledge and phronesis were particularly highly valued and we note challenges with the perceived applicability, relevance and use of research evidence. We identify that emotions are an important component within knowledge use and a need to further understand how to support the emotional wellbeing of managers so they can support care staff and residents. Greater consideration is needed as to how to optimise gaining and mobilising all knowledge types - "know-what," "know-how," "know-when" and "know-feel" - to benefit people living, and staff working, in care homes.

Measurement of Shared Social Identity in Singing Groups for People With Aphasia.

Community groups are commonly used as a mode of delivery of interventions for promoting health and well-being. Research has demonstrated that developing a sense of shared social identity with other group members is a key mechanism through which the health benefits of group membership are realized. However, there is little understanding of how shared social identity emerges within these therapeutic settings. Understanding the emergence of shared social identity may help researchers optimize interventions and improve health outcomes. Group-based singing activities encourage coordination and a shared experience, and are a potential platform for the development of shared social identity. We use the "Singing for People with Aphasia" (SPA) group intervention to explore whether group cohesiveness, as a behavioral proxy for shared social identity, can be observed and tracked across the intervention. Video recordings of group sessions from three separate programmes were rated according to the degree of cohesiveness exhibited by the group. For all treatment groups, the final group session evidenced reliably higher levels of cohesiveness than the first session (t values ranged from 4.27 to 7.07; all p values < 0.003). As well as providing confidence in the design and fidelity of this group-based singing intervention in terms of its capacity to build shared social identity, this evaluation highlighted the value of observational methods for the analysis of shared social identity in the context of group-based singing interventions.

"It Makes You Feel That You Are There": Exploring the Acceptability of Virtual Reality Nature Environments for People with Memory Loss.

Aim: To report on the acceptability of virtual reality (VR) nature environments for people with memory loss at memory cafes, and explore the experiences and perceptions of carers and staff. Methods: A qualitative study was conducted between January and March 2019. Ten adults with memory loss, eight carers and six volunteer staff were recruited from two memory cafes, located in Cornwall, UK. There were 19 VR sessions which were audio recorded and all participants were interviewed at the end of the sessions. Framework analysis was used to identify patterns and themes in the data. Results: During the VR experience, participants were engaged to varying degrees, with engagement facilitated by the researcher, and in some cases, with the help of a carer. Participants responded positively to the nature scenes, finding them soothing and evoking memories. The VR experience was positive; many felt immersed in nature and saw it as an opportunity to 'go somewhere'. However, it was not always positive and for a few, it could be 'strange'. Participants reflected on their experience of the VR equipment, and volunteer staff and carers also shared their perceptions of VR for people with dementia in long-term care settings. Conclusions: The VR nature experience was an opportunity for people with memory loss to be immersed in nature and offered the potential to enhance their quality of life. Future work should build on lessons learned and continue to work with people with dementia in developing and implementing VR technology in long-term care settings.

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Indoor Nature Interventions for Health and Wellbeing of Older Adults in Residential Settings: A Systematic Review.

BACKGROUND AND OBJECTIVES: Having contact with nature can be beneficial for health and wellbeing, but many older adults face barriers with getting outdoors. We conducted a systematic review of quantitative studies on health and wellbeing impacts of indoor forms of nature (both real and simulated/artificial), for older adults in residential settings. RESEARCH DESIGN AND METHODS: Search terms relating to older adults and indoor nature were run in 13 scientific databases (MEDLINE, CINAHL, AgeLine, Environment Complete, AMED, PsychINFO, EMBASE, HMIC, PsychARTICLES, Global Health, Web of Knowledge, Dissertations and Theses Global, and ASSIA). We also pursued grey literature, global clinical trials registries, and a range of supplementary methods. RESULTS: Of 6,131 articles screened against eligibility criteria, 26 studies were accepted into the review, and were quality-appraised using the Effective Public Health Practice Project (EPHPP) tool. The participants were 930 adults aged over 60. Nature interventions and health/wellbeing outcomes were heterogeneous, which necessitated a narrative synthesis. The evidence base was generally weak, with 18 of 26 studies having a high risk of bias. However, several higher-quality studies found indoor gardening and horticulture programs were effective for cognition, psychological wellbeing, social outcomes, and life satisfaction. DISCUSSION AND IMPLICATIONS: There is inconsistent evidence that indoor nature exposures are beneficial for older care residents. We expect that successful interventions were, at least partly, facilitating social interaction, supporting feelings of autonomy/control, and promoting skill development, that is, factors not necessarily associated with nature per se. Higher-quality studies with improved reporting standards are needed to further elucidate these mechanisms.

Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial.

BACKGROUND: Unanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an embedded process evaluation to explore the impact participants may have on the study, but also unintended impacts the study may have on them. AIM: The aim of the study was to explore participants' experiences and the impact of trial involvement in a pilot RCT in order to inform the designing and delivery of a definitive RCT. METHODS: In-depth interviews with 20 participants (10 in the intervention and 10 in the control group) enrolled in a stroke rehabilitation pilot trial. A modified framework approach was used to analyse transcripts. RESULTS: Participation in the study was motivated partly by a desperation to receive further rehabilitation after discharge. Responses to allocation to the control group included an increased commitment to self-treatment, and negative psychological consequences were also described. Accounts of participants in both control and intervention groups challenge the presumption that they were neutral, or in equipoise, regarding group allocation prior to consenting to randomisation. CONCLUSIONS: Considering and exploring participant and participation effects, particularly in the control group, highlights numerous issues in the interpretation of trial studies, as well as the in ethics of RCTs more generally. While suggestions for a definitive trial design are given, further research is required to investigate the significant implications these findings may have for trial design, monitoring and funding. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02429180 . Registered on 29 April/2015.

Physical activity, sleep, and fatigue in community dwelling Stroke Survivors.

Stroke can lead to physiological and psychological impairments and impact individuals' physical activity (PA), fatigue and sleep patterns. We analysed wrist-worn accelerometry data and the Fatigue Assessment Scale from 41 stroke survivors following a physical rehabilitation programme, to examine relationships between PA levels, fatigue and sleep. Validated acceleration thresholds were used to quantify time spent in each PA intensity/sleep category. Stroke survivors performed less moderate to vigorous PA (MVPA) in 10 minute bouts than the National Stroke guidelines recommend. Regression analysis revealed associations at baseline between light PA and fatigue (p = 0.02) and MVPA and sleep efficiency (p = 0.04). Light PA was positively associated with fatigue at 6 months (p = 0.03), whilst sleep efficiency and fatigue were associated at 9 months (p = 0.02). No other effects were shown at baseline, 6 or 9 months. The magnitude of these associations were small and are unlikely to be clinically meaningful. Larger trials need to examine the efficacy and utility of accelerometry to assess PA and sleep in stroke survivors.

Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility.

OBJECTIVES: To assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity. DESIGN: A two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations. SETTING: Community settings across two sites in Devon. PARTICIPANTS: Eligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation. INTERVENTIONS: ReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet. OUTCOME MEASURES: Candidate primary outcomes included functional mobility and physical activity. RESULTS: Forty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations. CONCLUSIONS: All objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable. TRIAL REGISTRATION NUMBER: NCT02429180; Results.

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial.

Background: Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9-10 years would prevent excessive weight gain after 24 months. Methods: This pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9-10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete. Findings: Between March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention-control) at 24 months was -0·02 (95% CI -0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator. Interpretation: Despite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches. Funding: UK National Institute for Health Research, Public Health Research Programme.

Why do GPs leave direct patient care and what might help to retain them? A qualitative study of GPs in South West England.

OBJECTIVE: To identify factors influencing general practitioners' (GPs') decisions about whether or not to remain in direct patient care in general practice and what might help to retain them in that role. DESIGN: Qualitative, in-depth, individual interviews exploring factors related to GPs leaving, remaining in and returning to direct patient care. SETTING: South West England, UK. PARTICIPANTS: 41 GPs: 7 retired; 8 intending to take early retirement; 11 who were on or intending to take a career break; 9 aged under 50 years who had left or were intending to leave direct patient care and 6 who were not intending to leave or to take a career break. Plus 19 stakeholders from a range of primary care-related professional organisations and roles. RESULTS: Reasons for leaving direct patient care were complex and based on a range of job-related and individual factors. Three key themes underpinned the interviewed GPs' thinking and rationale: issues relating to their personal and professional identity and the perceived value of general practice-based care within the healthcare system; concerns regarding fear and risk, for example, in respect of medical litigation and managing administrative challenges within the context of increasingly complex care pathways and environments; and issues around choice and volition in respect of personal social, financial, domestic and professional considerations. These themes provide increased understanding of the lived experiences of working in today's National Health Service for this group of GPs. CONCLUSION: Future policies and strategies aimed at retaining GPs in direct patient care should clarify the role and expectations of general practice and align with GPs' perception of their own roles and identity; demonstrate to GPs that they are valued and listened to in planning delivery of the UK healthcare; target GPs' concerns regarding fear and risk, seeking to reduce these to manageable levels and give GPs viable options to support them to remain in direct patient care.

Home-based versus centre-based cardiac rehabilitation.

BACKGROUND: Cardiovascular disease is the most common cause of death globally. Traditionally, centre-based cardiac rehabilitation programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation. This is an update of a review previously published in 2009 and 2015. OBJECTIVES: To compare the effect of home-based and supervised centre-based cardiac rehabilitation on mortality and morbidity, exercise-capacity, health-related quality of life, and modifiable cardiac risk factors in patients with heart disease. SEARCH METHODS: We updated searches from the previous Cochrane Review by searching the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid) and CINAHL (EBSCO) on 21 September 2016. We also searched two clinical trials registers as well as previous systematic reviews and reference lists of included studies. No language restrictions were applied. SELECTION CRITERIA: We included randomised controlled trials, including parallel group, cross-over or quasi-randomised designs) that compared centre-based cardiac rehabilitation (e.g. hospital, gymnasium, sports centre) with home-based programmes in adults with myocardial infarction, angina, heart failure or who had undergone revascularisation. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all identified references for inclusion based on pre-defined inclusion criteria. Disagreements were resolved through discussion or by involving a third review author. Two authors independently extracted outcome data and study characteristics and assessed risk of bias. Quality of evidence was assessed using GRADE principles and a Summary of findings table was created. MAIN RESULTS: We included six new studies (624 participants) for this update, which now includes a total of 23 trials that randomised a total of 2890 participants undergoing cardiac rehabilitation. Participants had an acute myocardial infarction, revascularisation or heart failure. A number of studies provided insufficient detail to enable assessment of potential risk of bias, in particular, details of generation and concealment of random allocation sequencing and blinding of outcome assessment were poorly reported.No evidence of a difference was seen between home- and centre-based cardiac rehabilitation in clinical primary outcomes up to 12 months of follow up: total mortality (relative risk (RR) = 1.19, 95% CI 0.65 to 2.16; participants = 1505; studies = 11/comparisons = 13; very low quality evidence), exercise capacity (standardised mean difference (SMD) = -0.13, 95% CI -0.28 to 0.02; participants = 2255; studies = 22/comparisons = 26; low quality evidence), or health-related quality of life up to 24 months (not estimable). Trials were generally of short duration, with only three studies reporting outcomes beyond 12 months (exercise capacity: SMD 0.11, 95% CI -0.01 to 0.23; participants = 1074; studies = 3; moderate quality evidence). However, there was evidence of marginally higher levels of programme completion (RR 1.04, 95% CI 1.00 to 1.08; participants = 2615; studies = 22/comparisons = 26; low quality evidence) by home-based participants. AUTHORS' CONCLUSIONS: This update supports previous conclusions that home- and centre-based forms of cardiac rehabilitation seem to be similarly effective in improving clinical and health-related quality of life outcomes in patients after myocardial infarction or revascularisation, or with heart failure. This finding supports the continued expansion of evidence-based, home-based cardiac rehabilitation programmes. The choice of participating in a more traditional and supervised centre-based programme or a home-based programme may reflect local availability and consider the preference of the individual patient. Further data are needed to determine whether the effects of home- and centre-based cardiac rehabilitation reported in the included short-term trials can be confirmed in the longer term and need to consider adequately powered non-inferiority or equivalence study designs.

Is Pelvic-Floor Muscle Training a Physical Therapy or a Behavioral Therapy? A Call to Name and Report the Physical, Cognitive, and Behavioral Elements.

This perspective article explores whether pelvic-floor muscle training (PFMT) for the management of female urinary incontinence and prolapse is a physical therapy or a behavioral therapy. The primary aim is to demonstrate that it is both. A secondary aim is to show that the plethora of terms used for PFMT is potentially confusing and that current terminology inadequately represents the full intent, content, and delivery of this complex intervention. While physical therapists may be familiar with exercise terms, the details are often incompletely reported; furthermore, physical therapists are less familiar with the terminology used in accurately representing cognitive and behavioral therapy interventions, which results in these elements being even less well reported. Thus, an additional aim is to provide greater clarity in the terminology used in the reporting of PFMT interventions, specifically, descriptions of the exercise and behavioral elements. First, PFMT is described as a physical therapy and as an exercise therapy informed predominantly by the discipline of physical therapy. However, effective implementation requires use of the cognitive and behavioral perspectives of the discipline of psychology. Second, the theoretical underpinning of the psychology-informed elements of PFMT is summarized. Third, to address some identified limitations and confusion in current terminology and reporting, recommendations for ways in which physical therapists can incorporate the psychology-informed elements of PFMT alongside the more familiar exercise therapy-informed elements are made. Fourth, an example of how both elements can be described and reported in a PFMT intervention is provided. In summary, this perspective explores the underlying concepts of PFMT to demonstrate that it is both a physical intervention and a behavioral intervention and that it can and should be described as such, and an example of the integration of these elements into clinical practice is provided.

Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain).

INTRODUCTION: The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. METHODS AND ANALYSIS: A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. ETHICS AND DISSEMINATION: National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases. TRIAL REGISTRATION NUMBER: NCT02429180; Pre-results.

Home-based cardiac rehabilitation for people with heart failure: A systematic review and meta-analysis.

AIMS: To assess the effectiveness of home-based cardiac rehabilitation (CR) for heart failure compared to either usual medical care (i.e. no CR) or centre-based CR on mortality, morbidity, exercise capacity, health-related quality of life, drop out, adherence rates, and costs. METHODS: Randomised controlled trials were initially identified from previous systematic reviews of CR. We undertook updated literature searches of MEDLINE, EMBASE, CINAHL, PsycINFO and Cochrane Library to December 2015. A total of 19 trials with median follow up of 3months were included - 17 comparisons of home-based CR to usual care (995 patients) and four comparing home and centre-based CR (295 patients). RESULTS: Compared to usual care, home-based CR improved VO2max (mean difference: 1.6ml/kg/min, 0.8 to 2.4) and total Minnesota Living with Quality of Life score (-3.3, -7.5 to 1.0), with no difference in mortality, hospitalisation or study drop out. Outcomes and costs were similar between home-based and centre-based CR with the exception of higher levels of trial completion in the home-based group (relative risk: 1.2, 1.0 to 1.3). CONCLUSIONS: Home-based CR results in short-term improvements in exercise capacity and health-related quality of life of heart failure patients compared to usual care. The magnitude of outcome improvement is similar to centre-based CR. Home-based CR appears to be safe with no evidence of increased risk of hospitalisation or death. These findings support the provision of home-based CR for heart failure as an evidence-based alternative to the traditional centre-based model of provision.

Goal setting and strategies to enhance goal pursuit in adult rehabilitation: summary of a Cochrane systematic review and meta-analysis.

INTRODUCTION: Goal setting is considered an essential part of rehabilitation, but approaches to goal setting vary with no consensus regarding the best approach. The aim of this systematic review and meta-analysis was to assess the effects of goal setting and strategies to enhance the pursuit of goals on improving outcomes in adult rehabilitation. EVIDENCE ACQUISITION: We searched CENTRAL, MEDLINE, EMBASE, four other databases and three trial registries for randomized control trials (RCTs), cluster RCTs, or quasi-RCTs published before December 2013. Two reviewers independently screened all search results, then critically appraised and extracted data on all included studies. We identified 39 trials, which differed in clinical context, participant populations, research question related to goal use, and outcomes measured. Eighteen studies compared goal setting, with or without strategies to enhance goal pursuit, to no goal setting. EVIDENCE SYNTHESIS: These 18 studies provided very low-quality evidence for a moderate effect size that any type of goal setting is better than no goal setting for improving health-related quality of life or self-reported emotional status (N.=446, standard mean difference [SMD]=0.53, 95% confidence interval [CI]: 0.17 to 0.88), and very low-quality evidence of a large effect size for self-efficacy (N.=108, SMD=1.07, 95% CI: 0.64 to 1.49). Fourteen studies compared a structured approach to goal setting to "usual care" goal setting, where some goals may have been set but no structured approach was followed. These studies provided very low-quality evidence for a small effect size that more structured goal setting results in higher patient self-efficacy (N.=134, SMD=0.37, 95% CI: 0.02 to 0.71). No conclusive evidence was found to support the notion that goal setting, or structured goal setting in comparison to "usual care" goal setting, changes outcomes for patients for measures of participation, activity, or engagement in rehabilitation programs. CONCLUSIONS: This review found a large and increasing amount of research being conducted on goal setting in rehabilitation. However, problems with study design and diversity in methods used means the quality of evidence to support estimated effect sizes is poor. Further research is highly likely to change reported estimates of effect size arising from goal setting in rehabilitation.

Home-based versus centre-based cardiac rehabilitation.

BACKGROUND: Cardiovascular disease is the most common cause of death globally. Traditionally, centre-based cardiac rehabilitation programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation. This is an update of a review originally published in 2009. OBJECTIVES: To compare the effect of home-based and supervised centre-based cardiac rehabilitation on mortality and morbidity, health-related quality of life, and modifiable cardiac risk factors in patients with heart disease. SEARCH METHODS: To update searches from the previous Cochrane review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 9, 2014), MEDLINE (Ovid, 1946 to October week 1 2014), EMBASE (Ovid, 1980 to 2014 week 41), PsycINFO (Ovid, 1806 to October week 2 2014), and CINAHL (EBSCO, to October 2014). We checked reference lists of included trials and recent systematic reviews. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared centre-based cardiac rehabilitation (e.g. hospital, gymnasium, sports centre) with home-based programmes in adults with myocardial infarction (MI), angina, heart failure or who had undergone revascularisation. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the eligibility of the identified trials and data were extracted by a single author and checked by a second. Authors were contacted where possible to obtain missing information. MAIN RESULTS: Seventeen trials included a total of 2172 participants undergoing cardiac rehabilitation following an acute MI or revascularisation, or with heart failure. This update included an additional five trials on 345 patients with heart failure. Authors of a number of included trials failed to give sufficient detail to assess their potential risk of bias, and details of generation and concealment of random allocation sequence were particularly poorly reported. In the main, no difference was seen between home- and centre-based cardiac rehabilitation in outcomes up to 12 months of follow up: mortality (relative risk (RR) = 0.79, 95% confidence interval (CI) 0.43 to 1.47, P = 0.46, fixed-effect), cardiac events (data not poolable), exercise capacity (standardised mean difference (SMD) = -0.10, 95% CI -0.29 to 0.08, P = 0.29, random-effects), modifiable risk factors (total cholesterol: mean difference (MD) = 0.07 mmol/L, 95% CI -0.24 to 0.11, P = 0.47, random-effects; low density lipoprotein cholesterol: MD = -0.06 mmol/L, 95% CI -0.27 to 0.15, P = 0.55, random-effects; systolic blood pressure: mean difference (MD) = 0.19 mmHg, 95% CI -3.37 to 3.75, P = 0.92, random-effects; proportion of smokers at follow up (RR = 0.98, 95% CI 0.79 to 1.21, P = 0.83, fixed-effect), or health-related quality of life (not poolable). Small outcome differences in favour of centre-based participants were seen in high density lipoprotein cholesterol (MD = -0.07 mmol/L, 95% CI -0.11 to -0.03, P = 0.001, fixed-effect), and triglycerides (MD = -0.18 mmol/L, 95% CI -0.34 to -0.02, P = 0.03, fixed-effect, diastolic blood pressure (MD = -1.86 mmHg; 95% CI -0.76 to -2.95, P = 0.0009, fixed-effect). In contrast, in home-based participants, there was evidence of a marginally higher levels of programme completion (RR = 1.04, 95% CI 1.01 to 1.07, P = 0.009, fixed-effect) and adherence to the programme (not poolable). No consistent difference was seen in healthcare costs between the two forms of cardiac rehabilitation. AUTHORS' CONCLUSIONS: This updated review supports the conclusions of the previous version of this review that home- and centre-based forms of cardiac rehabilitation seem to be equally effective for improving the clinical and health-related quality of life outcomes in low risk patients after MI or revascularisation, or with heart failure. This finding, together with the absence of evidence of important differences in healthcare costs between the two approaches, supports the continued expansion of evidence-based, home-based cardiac rehabilitation programmes. The choice of participating in a more traditional and supervised centre-based programme or a home-based programme should reflect the preference of the individual patient. Further data are needed to determine whether the effects of home- and centre-based cardiac rehabilitation reported in these short-term trials can be confirmed in the longer term. A number of studies failed to give sufficient detail to assess their risk of bias.