RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

INTRODUCTION: Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation. METHODS AND ANALYSIS: This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300-400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised. ETHICS AND DISSEMINATION: The study has been approved by Yorkshire and The Humber - Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations. TRIAL REGISTRATION NUMBER: This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581).

The impact of transcatheter aortic valve implantation on quality of life: A mixed methods study.

OBJECTIVE: To provide an in-depth understanding of patients' views about the impact of transcatheter aortic valve implantation on self-reported quality of life. BACKGROUND: Transcatheter aortic valve implantation is considered to be the gold standard of care for inoperable patients diagnosed with severe symptomatic aortic stenosis. Mid- to long-term clinical outcomes are favourable and questionnaire data indicates improvements in quality of life but an in-depth understanding of how quality of life is altered by the intervention is missing. METHODS: A mixed methods study design with a total of 89 in-depth qualitative interviews conducted with participants (39% male; mean age 81.7 years), 1 and 3 months post TAVI, recruited from a regional centre in England. Data were triangulated with questionnaire data (SF-36 and EQ5D-VAS) collected, pre, 1 and 3 months post implantation. RESULTS: Participants' accounts were characterised by four key themes; shortened life, extended life, limited life and changed life. Quality of life was changed through two mechanisms. Most participants reported a reduced symptom burden and all explained that their life expectancy was improved. Questionnaire data supported interview data with gradual improvements in mean EQ-5D scores and SF-36 physical and mental domain scores at 1 and 3 months compared to baseline. CONCLUSION: Findings suggest that TAVI was of variable benefit, producing considerable improvements in either mental or physical health in many participants, while a smaller proportion continued to deteriorate.

Managing lifestyle change to reduce coronary risk: a synthesis of qualitative research on peoples' experiences.

BACKGROUND: Coronary heart disease is an incurable condition. The only approach known to slow its progression is healthy lifestyle change and concordance with cardio-protective medicines. Few people fully succeed in these daily activities so potential health improvements are not fully realised. Little is known about peoples' experiences of managing lifestyle change. The aim of this study was to synthesise qualitative research to explain how participants make lifestyle change after a cardiac event and explore this within the wider illness experience. METHODS: A qualitative synthesis was conducted drawing upon the principles of meta-ethnography. Qualitative studies were identified through a systematic search of 7 databases using explicit criteria. Key concepts were identified and translated across studies. Findings were discussed and diagrammed during a series of audiotaped meetings. RESULTS: The final synthesis is grounded in findings from 27 studies, with over 500 participants (56% male) across 8 countries. All participants experienced a change in their self-identity from what was 'familiar' to 'unfamiliar'. The transition process involved 'finding new limits and a life worth living' , 'finding support for self' and 'finding a new normal'. Analyses of these concepts led to the generation of a third order construct, namely an ongoing process of 'reassessing past, present and future lives' as participants considered their changed identity. Participants experienced a strong urge to get back to 'normal'. Support from family and friends could enable or constrain life change and lifestyle changes. Lifestyle change was but one small part of a wider 'life' change that occurred. CONCLUSIONS: The final synthesis presents an interpretation, not evident in the primary studies, of a person-centred model to explain how lifestyle change is situated within 'wider' life changes. The magnitude of individual responses to a changed health status varied. Participants experienced distress as their notion of self identity shifted and emotions that reflected the various stages of the grief process were evident in participants' accounts. The process of self-managing lifestyle took place through experiential learning; the level of engagement with lifestyle change reflected an individual's unique view of the balance needed to manage 'realistic change' whilst leading to a life that was perceived as 'worth living'. Findings highlight the importance of providing person centred care that aligns with both psychological and physical dimensions of recovery which are inextricably linked.

The role of the Sexual Assault Nurse Examiner in England: nurse experiences and perspectives.

Sexual Assault Nurse Examiners (SANEs) were introduced in the United Kingdom in 2001, but there is a lack of knowledge about their role and the services they provide. The aim of this study was to explore the role of SANEs currently working in England. Qualitative semistructured interviews explored the training experiences, roles, and working practices of five SANEs in a variety of settings. The findings identified three categories: training and qualifications, SANE care, and working within multidisciplinary teams (MDT). SANEs have complex roles that involve patient care as well as collection of forensic evidence. There was variation in service provision and training of SANEs interviewed and differences in how they felt their role was regarded by members of the MDT. The findings suggest that SANE services need further evaluation to determine a model of practice that can be consistently implemented to provide both optimal patient care and reliable forensic evidence.

Quality of life in older adults with aortic stenosis: a narrative review.

BACKGROUND: Aortic stenosis in older adults can lead to symptoms of breathlessness, dizziness, syncope and angina. While surgical AVR is the optimum treatment, it is not suitable for frail older people who may have other significant comorbidities. TAVI provides a safer alternative. There is evidence that aortic valve replacement reduces mortality and morbidity, but less is known about its effect on quality of life (QoL) in older adults. AIMS AND OBJECTIVES: To carry out a narrative review of the existing literature on quality of life (QoL) after surgical aortic valve replacement (AVR) or transcatheter aortic valve replacement (TAVI) with the aim of identifying what is known about QoL pre- and postvalve replacement. CONCLUSIONS: There is some evidence that QoL improves after aortic valve replacement, but there are significant gaps in our knowledge. There are no studies that compare QoL after TAVI vs. surgical AVR; thus, we do not know the relative effect of the different procedures on QoL. The literature does not adequately explore why some people have improved QoL after aortic valve replacement and others do not. There appears to be some evidence that the existence of comorbidities may negatively influence QoL after valve replacement, but there is not enough consistent data on comorbidities to explore this further. Study designs are heterogeneous and prevent any meta-analysis of findings. IMPLICATIONS FOR PRACTICE: Decision-making processes regarding the suitability of patients for aortic valve replacement should include an assessment of the potential effects on overall QoL, rather than just relief of cardiac-related symptoms. Consideration of patients' social, emotional and physical needs both before and after valve replacement is essential if health services are serious about improving QoL as well as mortality and morbidity.

Pharmaceutical interventions for emotionalism after stroke.

BACKGROUND: Antidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004. OBJECTIVES: To determine whether pharmaceutical treatment reduces the frequency of emotional displays in people with emotionalism after stroke. SEARCH STRATEGY: We searched the trials registers of the Cochrane Stroke Group and the Cochrane Depression Anxiety and Neurosis Group (last searched August 2009). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2009), MEDLINE (1966 to May 2008), EMBASE (1980 to May 2008), CINAHL (1982 to May 2008), PsycINFO (1967 to May 2008), Arts and Humanities Index (1991 to May 2008), BIOSIS Previews (2002 to May 2008), Science Citation Index (1992 to May 2008), Social Sciences Citation Index (1991 to May 2008), Sociological Abstract/Sociofile (1974 to May 2008), ISI Web of Science (2002 to May 2008), reference lists, clinical trials registers, conference proceedings and dissertation abstracts. We also contacted authors, researchers and pharmaceutical companies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability or pathological crying and laughing). DATA COLLECTION AND ANALYSIS: We obtained data for people who no longer met the criteria for emotionalism, and on reduction in frequency of crying. Primary analyses were the proportion of patients who met the criteria for emotionalism at the end of treatment. Secondary outcomes included emotionalism and depression scores, cognitive function, death, activities of daily living and adverse effects. MAIN RESULTS: We included seven trials involving 239 participants. Data were available for five trials with 213 participants. Five trials showed large effects of treatment: 50% reduction in emotionalism, diminished tearfulness, improvements (reduction) in lability, tearfulness and scores on the Pathological Laughter and Crying Scale. However, confidence intervals were wide indicating that treatment may have had only a small positive effect, or even a small negative effect (in one trial). Only two studies systematically reported adverse events; no discernible differences were seen between groups. AUTHORS' CONCLUSIONS: Antidepressants can reduce the frequency and severity of crying or laughing episodes. The effect does not seem specific to one drug or class of drugs. Our conclusions must be qualified by several methodological deficiencies in the studies. More reliable data are required before recommendations can be made about the treatment of post-stroke emotionalism.

Hospital care and repetition following self-harm: multicentre comparison of self-poisoning and self-injury.

BACKGROUND: Quantitative research about self-harm largely deals with self-poisoning, despite the high incidence of self-injury. AIMS: We compared patterns of hospital care and repetition associated with self-poisoning and self-injury. METHOD: Demographic and clinical data were collected in a multicentre, prospective cohort study, involving 10,498 consecutive episodes of self-harm at six English teaching hospitals. RESULTS: Compared with those who self-poisoned, people who cut themselves were more likely to have self-harmed previously and to have received support from mental health services, but they were far less likely to be admitted to the general hospital or receive a psychosocial assessment. Although only 17% of people repeated self-harm during the 18 months of study, survival analysis that takes account of all episodes revealed a repetition rate of 33% in the year following an episode: 47% after episodes of self-cutting and 31% after self-poisoning (P<0.001). Of those who repeated, a third switched method of self-harm. CONCLUSIONS: Hospital services offer less to people who have cut themselves, although they are far more likely to repeat, than to those who have self-poisoned. Attendance at hospital should result in psychosocial assessment of needs regardless of method of self-harm.

Psychosocial assessment following self-harm: results from the multi-centre monitoring of self-harm project.

BACKGROUND: Psychosocial assessment is central to the management of self-harm, but not all individuals receive an assessment following presentation to hospital. Research exploring the factors associated with assessment and non-assessment is sparse. It is unclear how assessment relates to subsequent outcome. METHODS: We identified episodes of self-harm presenting to six hospitals in the UK cities of Oxford, Leeds, and Manchester over an 18-month period (1st March 2000 to 31st August 2001). We used established monitoring systems to investigate: the proportion of episodes resulting in a specialist assessment in each hospital; the factors associated with assessment and non-assessment; the relationship between assessment and repetition of self-harm. RESULTS: A total of 7344 individuals presented with 10,498 episodes of self-harm during the study period. Overall, 60% of episodes resulted in a specialist psychosocial assessment. Factors associated with an increased likelihood of assessment included age over 55 years, current psychiatric treatment, admission to a medical ward, and ingestion of antidepressants. Factors associated with a decreased likelihood of assessment included unemployment, self-cutting, attending outside normal working hours, and self-discharge. We found no overall association between assessment and self-harm repetition, but there were differences between hospitals--assessments were protective in one hospital but associated with an increased risk of repetition in another. LIMITATIONS: Some data may have been more likely to be recorded if episodes resulted in a specialist assessment. This was a non-experimental study and so the findings relating specialist assessment to repetition should be interpreted cautiously. CONCLUSION: Many people who harm themselves, including potentially vulnerable individuals, do not receive an adequate assessment while at hospital. Staff should be aware of the organizational and clinical factors associated with non-assessment. Identifying the active components of psychosocial assessment may help to inform future interventions for self-harm.

Self-harm in England: a tale of three cities. Multicentre study of self-harm.

BACKGROUND: Self-harm is a major healthcare problem in the United Kingdom, but monitoring of hospital presentations has largely been done separately in single centres. Multicentre monitoring of self-harm has been established as a result of the National Suicide Prevention Strategy for England. METHOD: Data on self-harm presentations to general hospitals in Oxford (one hospital), Manchester (three hospitals) and Leeds (two hospitals), collected through monitoring systems in each centre, were analysed for the 18-month period March 2000 to August 2001. RESULTS: The findings were based on 7344 persons who presented following 10,498 episodes of self-harm. Gender and age patterns were similar in the three centres, 57.0% of patients being female and two-thirds (62.9%) under 35 years of age. The largest numbers by age groups were 15-19 year-old females and 20-24 year-old males. The female to male ratio decreased with age. Rates of self-harm were higher in Manchester than Oxford or Leeds, in keeping with local suicide rates. The proportion of patients receiving a specialist psychosocial assessment varied between centres and was strongly associated with admission to the general hospital. Approximately 80% of self-harm involved self-poisoning. Overdoses of paracetamol, the most frequent method, were more common in younger age groups, antidepressants in middle age groups, and benzodiazepines and sedatives in older age groups. Alcohol was involved in more than half (54.9%) of assessed episodes. The most common time of presentation to hospital was between 10 pm and 2 am. CONCLUSIONS: Multicentre monitoring of self-harm in England has demonstrated similar overall patterns of self-harm in Oxford, Manchester and Leeds, with some differences reflecting local suicide rates. Diurnal variation in time of presentation to hospital and the need for assessment of non-admitted patients have implications for service provision.

Self-injury attendances in the accident and emergency department: Clinical database study.

BACKGROUND: Self-injury is a neglected area of self-harm research and we know little about its epidemiology, hospital care and outcome. Aims To provide epidemiological data on self-injury and compare hospital management of self-injury with that for self-poisoning. METHOD: Data were collected on all self-harm attendances to the general hospitals in Leeds over an 18-month period. RESULTS: People attending hospital for self-injury or self-poisoning do not form mutually exclusive groups. There were higher proportions of self-injury episodes compared with self-poisoning, where a history of self-harm or contact with mental health services had been recorded. Fewer psychosocial assessments were carried out after episodes of self-injury compared with self-poisoning but, when they were, follow-up was recommended more often. CONCLUSIONS: The clinical importance of self-injury is not mirrored by the level of psychosocial assessment and after-care provided.

Assessment and management of self-harm in older adults attending accident and emergency: a comparative cross-sectional study.

OBJECTIVE: Older people who undertake self-harm are at higher suicide risk than are younger patients. This study examines whether this greater risk is reflected in the assessment and after-care that older patients receive when they attend accident and emergency. METHOD: This cross-sectional study, set in the two accident and emergency departments in a large industrial city in Northern England, compared 141 consecutive attendances due to self-harm among older patients (aged 55 years and over) with a random sample of 125 attendances of younger people (aged 15-54) attending because of self-harm. Data were drawn from accident and emergency records and from psychiatric and general hospital casenotes. RESULTS: Compared with the younger group, older patients were significantly more likely to be admitted from accident and emergency to the general hospital, to receive a specialist assessment whilst at the hospital, and to be offered psychiatric after-care-either as a psychiatric in-patient or an out-patient. CONCLUSIONS: Fortunately, older people attending accident and emergency following self-harm seemed likely to receive psychosocial assessment from a mental health specialist, and they were much more likely than younger patients to be offered after-care. Hospitals will need to monitor accident and emergency and other records if they are to check that their services are responding to the high risks seen in older patients.

Fatal and non-fatal repetition of self-harm. Systematic review.

BACKGROUND: Non-fatal self-harm frequently leads to non-fatal repetition and sometimes to suicide. We need to quantify these two outcomes of self-harm to help us to develop and test effective interventions. AIMS: To estimate rates of fatal and non-fatal repetition of self-harm. METHOD: A systematic review of published follow-up data, from observational and experimental studies. Four electronic databases were searched and 90 studies met the inclusion criteria. RESULTS: Eighty per cent of studies found were undertaken in Europe, over one-third in the UK. Median proportions for repetition 1 year later were: 16% non-fatal and 2% fatal; after more than 9 years, around 7% of patients had died by suicide. The UK studies found particularly low rates of subsequent suicide. CONCLUSIONS: After 1 year, non-fatal repetition rates are around 15%. The strong connection between self-harm and later suicide lies somewhere between 0.5% and 2% after 1 year and above 5% after 9 years. Suicide risk among self-harm patients is hundreds of times higher than in the general population.