H. Plappert, R. Byng, S. Reilly, Charley Hobson-Merrett, Jon Allard, Elina Baker, N. Britten, M. Calvert, Mike Clark, S. Creanor, Linda M Davies, Rebecca Denyer, Julia Frost, Linda Gask, Bliss Gibbons, John Gibson, Laura Gill, Ruth Gwernan-Jones, Joanne Hosking, Peter Huxley, Alison Jeffery, Benjamin Jones, T. Keeley, R. Laugharne, S. Marwaha, C. Planner, T. Rawcliffe, A. Retzer, Debra Richards, Ruth Sayers, Lynsey Williams, V. Pinfold, Maximillian Birchwood
Individuals living with severe mental illness such as schizophrenia and bipolar can have significant emotional, cognitive, physical and social challenges. Most people with severe mental illness in the United Kingdom do not receive specialist mental health care. Collaborative care is a system of support that combines clinical and organisational components to provide integrated and person-centred care. It has not been tested for severe mental illness in the United Kingdom. We aimed to develop and evaluate a primary care-based collaborative care model (PARTNERS) designed to improve quality of life for people with diagnoses of schizophrenia, bipolar or other psychoses when compared with usual care. Phase 1 included studies to (1) understand context: an observational retrospective study of primary and secondary care medical records and an update of the Cochrane review ‘Collaborative care approaches for people with severe mental illness’; (2) develop and formatively evaluate the PARTNERS intervention: a review of literature on collaborative care and recovery, interviews with key leaders in collaborative care and recovery, focus groups with service users and a formative evaluation of a prototype intervention model; and (3) develop trial science work in this area: a core outcome set for bipolar and recruitment methods. In phase 2 we conducted a cluster randomised controlled trial measuring quality of life using the Manchester Short Assessment of Quality of Life and secondary outcomes including time use, recovery and mental well-being; a cost-effectiveness study; and a mixed-methods process evaluation. Public involvement underpinned all of the workstream activity through the study Lived Experience Advisory Panel and the employment of service user researchers in the project team. The study of records showed that care for individuals under secondary care is variable and substantial and that people are seen every 2 weeks on average. The updated Cochrane review showed that collaborative care interventions were highly variable, and no reliable conclusions can be drawn about effectiveness. The PARTNERS model incorporated change at organisational, practitioner and individual levels. Coaching was selected as the main form of support for individuals’ personal goals. In the formative evaluation, we showed that more intensive supervision and ‘top-up’ training were needed to achieve the desired shifts in practice. A core outcome set was developed for bipolar, and measures were selected for the trial. We developed a stepped approach to recruitment including initial approach and appointment. The trial was conducted in four areas. In total, 198 participants were recruited from 39 practices randomised. Participants received either the PARTNERS intervention or usual care. The follow-up rate was 86% at 9–12 months. The mean change in overall Manchester Short Assessment Quality of Life score did not differ between the groups [0.25 (standard deviation 0.73) for interv
{"title":"Collaborative care intervention for individuals with severe mental illness: the PARTNERS2 programme including complex intervention development and cluster RCT","authors":"H. Plappert, R. Byng, S. Reilly, Charley Hobson-Merrett, Jon Allard, Elina Baker, N. Britten, M. Calvert, Mike Clark, S. Creanor, Linda M Davies, Rebecca Denyer, Julia Frost, Linda Gask, Bliss Gibbons, John Gibson, Laura Gill, Ruth Gwernan-Jones, Joanne Hosking, Peter Huxley, Alison Jeffery, Benjamin Jones, T. Keeley, R. Laugharne, S. Marwaha, C. Planner, T. Rawcliffe, A. Retzer, Debra Richards, Ruth Sayers, Lynsey Williams, V. Pinfold, Maximillian Birchwood","doi":"10.3310/yaet7368","DOIUrl":"https://doi.org/10.3310/yaet7368","url":null,"abstract":"\u0000Individuals living with severe mental illness such as schizophrenia and bipolar can have significant emotional, cognitive, physical and social challenges. Most people with severe mental illness in the United Kingdom do not receive specialist mental health care. Collaborative care is a system of support that combines clinical and organisational components to provide integrated and person-centred care. It has not been tested for severe mental illness in the United Kingdom. We aimed to develop and evaluate a primary care-based collaborative care model (PARTNERS) designed to improve quality of life for people with diagnoses of schizophrenia, bipolar or other psychoses when compared with usual care.\u0000\u0000\u0000Phase 1 included studies to (1) understand context: an observational retrospective study of primary and secondary care medical records and an update of the Cochrane review ‘Collaborative care approaches for people with severe mental illness’; (2) develop and formatively evaluate the PARTNERS intervention: a review of literature on collaborative care and recovery, interviews with key leaders in collaborative care and recovery, focus groups with service users and a formative evaluation of a prototype intervention model; and (3) develop trial science work in this area: a core outcome set for bipolar and recruitment methods. In phase 2 we conducted a cluster randomised controlled trial measuring quality of life using the Manchester Short Assessment of Quality of Life and secondary outcomes including time use, recovery and mental well-being; a cost-effectiveness study; and a mixed-methods process evaluation. Public involvement underpinned all of the workstream activity through the study Lived Experience Advisory Panel and the employment of service user researchers in the project team.\u0000\u0000\u0000The study of records showed that care for individuals under secondary care is variable and substantial and that people are seen every 2 weeks on average. The updated Cochrane review showed that collaborative care interventions were highly variable, and no reliable conclusions can be drawn about effectiveness. The PARTNERS model incorporated change at organisational, practitioner and individual levels. Coaching was selected as the main form of support for individuals’ personal goals. In the formative evaluation, we showed that more intensive supervision and ‘top-up’ training were needed to achieve the desired shifts in practice. A core outcome set was developed for bipolar, and measures were selected for the trial. We developed a stepped approach to recruitment including initial approach and appointment.\u0000\u0000\u0000The trial was conducted in four areas. In total, 198 participants were recruited from 39 practices randomised. Participants received either the PARTNERS intervention or usual care. The follow-up rate was 86% at 9–12 months. The mean change in overall Manchester Short Assessment Quality of Life score did not differ between the groups [0.25 (standard deviation 0.73) for interv","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141850036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ricky Mullis, Maria Raisa Jessica Aquino, E. Kreit, V. Johnson, Julie Grant, E. Blatchford, Mark A. Pilling, Francesco Fusco, Jonathan Mant
It is recognised that longer-term needs after stroke may not be well addressed by current services. The aim of this programme of research was to develop a novel primary care model to address these needs and to evaluate this new approach. The work was divided into three workstreams: development of a primary care model development of a ‘Managing Life After Stroke’ programme (including self-management) for people with stroke evaluation of the effectiveness and cost effectiveness of these interventions. The development of the primary care model involved information gathering in the form of literature reviews, patient and public involvement workshops, qualitative studies (interviews and focus groups), a consensus study and a pilot study, all feeding into a multidisciplinary intervention development group that approved the final primary care model. In parallel, a further literature review, consultation workshops with healthcare professionals and patients and public involvement fed into the iterative development of the ‘My Life After Stroke’ programme. In the final phase of the programme, the two interventions were evaluated in a cluster randomised controlled trial, which included a process evaluation and within-trial cost-effectiveness analysis. General practices in the East of England and East Midlands. People with a history of stroke identified from general practice stroke registers. The Improving Primary Care After Stroke model of primary care delivery. This comprised five components: a structured review; a direct point of contact; improving communication between primary and secondary care; local service mapping; and training of primary care professionals. The ‘My Life After Stroke’ self-management programme for people with stroke comprised an initial individual session, four weekly group-based sessions and a final individual session. The coprimary end points for the trial were two subscales (emotion and participation) of the Stroke Impact Scale v3.0 at 12 months after randomisation. Secondary outcomes included the Stroke Impact Scale Short Form, the EuroQol-5 Dimension, five level questionnaire, the ICEpop CAPability measure for Adults, the Southampton Stroke Self-Management Questionnaire and the Health Literacy Questionnaire. General practice records for health economic costing data. Patient questionnaires for outcomes. Trial: 46 clusters (general practices) were randomised with 1040 participants. At 12 months, there was a 0.64 (97.5% confidence interval −1.7 to +2.8) improvement in the emotion outcome in the intervention arm compared to the control arm and a 1.3 (97.5% confidence interval −2.0 to +4.6) increase in the participation outcome in the intervention arm compared to control. There was also no evidence of effect of the intervention on short form Stroke Impact Scale, quality of life (EuroQol 5 Dimension 5 level questionnaire), well-being (ICEpop CAPability measure for Adults), Southampton Stroke Self-Management questionn
{"title":"Developing primary care services for stroke survivors: the Improving Primary Care After Stroke (IPCAS) research programme","authors":"Ricky Mullis, Maria Raisa Jessica Aquino, E. Kreit, V. Johnson, Julie Grant, E. Blatchford, Mark A. Pilling, Francesco Fusco, Jonathan Mant","doi":"10.3310/ayhw3622","DOIUrl":"https://doi.org/10.3310/ayhw3622","url":null,"abstract":"\u0000It is recognised that longer-term needs after stroke may not be well addressed by current services. The aim of this programme of research was to develop a novel primary care model to address these needs and to evaluate this new approach.\u0000\u0000\u0000The work was divided into three workstreams:\u0000\u0000development of a primary care model\u0000development of a ‘Managing Life After Stroke’ programme (including self-management) for people with stroke\u0000evaluation of the effectiveness and cost effectiveness of these interventions.\u0000\u0000\u0000\u0000The development of the primary care model involved information gathering in the form of literature reviews, patient and public involvement workshops, qualitative studies (interviews and focus groups), a consensus study and a pilot study, all feeding into a multidisciplinary intervention development group that approved the final primary care model. In parallel, a further literature review, consultation workshops with healthcare professionals and patients and public involvement fed into the iterative development of the ‘My Life After Stroke’ programme. In the final phase of the programme, the two interventions were evaluated in a cluster randomised controlled trial, which included a process evaluation and within-trial cost-effectiveness analysis.\u0000\u0000\u0000General practices in the East of England and East Midlands.\u0000\u0000\u0000People with a history of stroke identified from general practice stroke registers.\u0000\u0000\u0000The Improving Primary Care After Stroke model of primary care delivery. This comprised five components: a structured review; a direct point of contact; improving communication between primary and secondary care; local service mapping; and training of primary care professionals.\u0000The ‘My Life After Stroke’ self-management programme for people with stroke comprised an initial individual session, four weekly group-based sessions and a final individual session.\u0000\u0000\u0000The coprimary end points for the trial were two subscales (emotion and participation) of the Stroke Impact Scale v3.0 at 12 months after randomisation.\u0000Secondary outcomes included the Stroke Impact Scale Short Form, the EuroQol-5 Dimension, five level questionnaire, the ICEpop CAPability measure for Adults, the Southampton Stroke Self-Management Questionnaire and the Health Literacy Questionnaire.\u0000\u0000\u0000General practice records for health economic costing data. Patient questionnaires for outcomes.\u0000\u0000\u0000Trial: 46 clusters (general practices) were randomised with 1040 participants. At 12 months, there was a 0.64 (97.5% confidence interval −1.7 to +2.8) improvement in the emotion outcome in the intervention arm compared to the control arm and a 1.3 (97.5% confidence interval −2.0 to +4.6) increase in the participation outcome in the intervention arm compared to control. There was also no evidence of effect of the intervention on short form Stroke Impact Scale, quality of life (EuroQol 5 Dimension 5 level questionnaire), well-being (ICEpop CAPability measure for Adults), Southampton Stroke Self-Management questionn","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140464862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Steve Gillard, R. Foster, Sarah White, Andrew Healey, Stephen Bremner, Sarah Gibson, L. Goldsmith, Mike Lucock, J. Marks, R. Morshead, Akshaykumar Patel, Shalini Patel, Julie Repper, Miles Rinaldi, Alan Simpson, M. Ussher, Jessica Worner, Stefan Priebe
Rates of readmission are high following discharge from psychiatric inpatient care. Evidence suggests that transitional interventions incorporating peer support might improve outcomes. Peer support is rapidly being introduced into mental health services, typically delivered by peer workers (people with experiences of mental health problems trained to support others with similar problems). Evidence for the effectiveness of peer support remains equivocal, and the quality of randomised controlled trials to date is often poor. There is an absence of formal cost-effectiveness studies of peer support in mental health services. This programme aimed to develop, pilot and trial a peer support intervention to reduce readmission to inpatient psychiatric care in the year post-discharge. The programme also developed a peer support fidelity index and evaluated the impact of peer support on peer workers. Linked work packages comprised: (1) systematic review and stakeholder consensus work to develop a peer support for discharge intervention; (2) development and psychometric testing of a peer support fidelity index; (3) pilot trial; (4) individually randomised controlled trial of the intervention, including mixed methods process evaluation and economic evaluation; (5) mixed method cohort study to evaluate the impact of peer support on peer workers. The research team included: two experienced service user researchers who oversaw patient and public involvement; service user researchers employed to develop and undertake data collection and analysis; a Lived Experience Advisory Group that informed all stages of the research. The programme took place in inpatient and community mental health services in seven mental health National Health Service trusts in England. Participants included 590 psychiatric inpatients who had had at least one previous admission in the preceding 2 years; 32 peer workers who delivered the intervention; and 8 peer workers’ supervisors. Participants randomised to peer support were offered at least one session of manualised peer support for discharge prior to discharge and then approximately weekly for 4 months post-discharge. The primary outcome for the trial was readmission (formal or informal) to psychiatric inpatient care (readmitted or not) within 1 year of discharge from the index admission. Secondary outcomes included inpatient and emergency mental health service use at 1 year post discharge, plus standardised measures of psychiatric symptom severity and psychosocial outcomes, measured at end of intervention (4 months post discharge). Service use data were collected from electronic patient records, standardised measures of outcome and qualitative data were collected by interview. We produced two systematic reviews of one-to-one peer support for adults in mental health services. The first included studies of all designs and identified components of peer support interventions; the second was restricted to randomised controlle
{"title":"Peer support for discharge from inpatient to community mental health care: the ENRICH research programme","authors":"Steve Gillard, R. Foster, Sarah White, Andrew Healey, Stephen Bremner, Sarah Gibson, L. Goldsmith, Mike Lucock, J. Marks, R. Morshead, Akshaykumar Patel, Shalini Patel, Julie Repper, Miles Rinaldi, Alan Simpson, M. Ussher, Jessica Worner, Stefan Priebe","doi":"10.3310/lqkp9822","DOIUrl":"https://doi.org/10.3310/lqkp9822","url":null,"abstract":"Rates of readmission are high following discharge from psychiatric inpatient care. Evidence suggests that transitional interventions incorporating peer support might improve outcomes. Peer support is rapidly being introduced into mental health services, typically delivered by peer workers (people with experiences of mental health problems trained to support others with similar problems). Evidence for the effectiveness of peer support remains equivocal, and the quality of randomised controlled trials to date is often poor. There is an absence of formal cost-effectiveness studies of peer support in mental health services. This programme aimed to develop, pilot and trial a peer support intervention to reduce readmission to inpatient psychiatric care in the year post-discharge. The programme also developed a peer support fidelity index and evaluated the impact of peer support on peer workers. Linked work packages comprised: (1) systematic review and stakeholder consensus work to develop a peer support for discharge intervention; (2) development and psychometric testing of a peer support fidelity index; (3) pilot trial; (4) individually randomised controlled trial of the intervention, including mixed methods process evaluation and economic evaluation; (5) mixed method cohort study to evaluate the impact of peer support on peer workers. The research team included: two experienced service user researchers who oversaw patient and public involvement; service user researchers employed to develop and undertake data collection and analysis; a Lived Experience Advisory Group that informed all stages of the research. The programme took place in inpatient and community mental health services in seven mental health National Health Service trusts in England. Participants included 590 psychiatric inpatients who had had at least one previous admission in the preceding 2 years; 32 peer workers who delivered the intervention; and 8 peer workers’ supervisors. Participants randomised to peer support were offered at least one session of manualised peer support for discharge prior to discharge and then approximately weekly for 4 months post-discharge. The primary outcome for the trial was readmission (formal or informal) to psychiatric inpatient care (readmitted or not) within 1 year of discharge from the index admission. Secondary outcomes included inpatient and emergency mental health service use at 1 year post discharge, plus standardised measures of psychiatric symptom severity and psychosocial outcomes, measured at end of intervention (4 months post discharge). Service use data were collected from electronic patient records, standardised measures of outcome and qualitative data were collected by interview. We produced two systematic reviews of one-to-one peer support for adults in mental health services. The first included studies of all designs and identified components of peer support interventions; the second was restricted to randomised controlle","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139301749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Williamson, M. Sanchez-Santos, I. Marian, M. Maredza, C. Srikesavan, Angela Garrett, Alana Morris, G. Boniface, Susan J Dutton, Frances Griffiths, Gary S Collins, Stavros Petrou, Julie Bruce, J. Fairbank, Z. Hansen, Karen Barker, Charles Hutchinson, C. Mallen, Lesley Ward, R. Gagen, Judith Fitch, David P French, S. E. Lamb
Back pain frequently affects older people. Knowledge about back pain in older people and evidence to inform clinical care was lacking, particularly for older people with neurogenic claudication due to spinal stenosis, which is a debilitating condition. To understand and reduce the burden of back pain on older people by increasing knowledge about back pain in older people and developing evidence-based treatment strategies. We completed six work packages. These were not undertaken chronologically as there was overlap between work packages. Work package 1: Refine a physiotherapy intervention for neurogenic claudication. Work package 2: Feasibility of the Oxford Pain Activity and Lifestyle cohort study and Better Outcomes for Older people with Spinal Trouble randomised controlled trial. Work package 3: Development of a prognostic tool to identify when older people are at risk of mobility decline using data from the Oxford Pain Activity and Lifestyle cohort study. Work package 4: A randomised controlled trial of physiotherapy for neurogenic claudication and nested longitudinal qualitative study (Better Outcomes for Older people with Spinal Trouble randomised controlled trial). Work package 5: Predictors of participants’ response to treatment – prespecified subgroup analyses. Work package 6: Implementation planning. Primary care and National Health Service Community and Secondary Care Trusts. Community-dwelling adults over the age of 65 years and registered with primary care practices. Better Outcomes for Older people with Spinal Trouble trial participants reported back and/or leg pain consistent with neurogenic claudication. The Better Outcomes for Older people with Spinal Trouble programme was a physiotherapy-delivered combined physical and psychological group intervention for older people with neurogenic claudication. The comparator was a physiotherapy assessment and tailored advice (best practice advice). The primary outcome for the Oxford Pain Activity and Lifestyle prognostic tool was mobility decline based on the EQ-5D-5L Mobility Question. The primary outcome for the Better Outcomes for Older people with Spinal Trouble trial was the Oswestry Disability Index at 12 months. Other outcomes included the Oswestry Disability Index walking item, 6-minute walk test and falls. The economic analyses used the EuroQol EQ-5D-5L to measure quality of life. Among Oxford Pain Activity and Lifestyle participants, 34% (1786/5304) reported back pain. A further 19.5% (1035/5304) reported back pain and associated leg pain, with 11.2% (n = 594/5304) reporting symptoms consistent with neurogenic claudication. Participants with back pain had worse quality of life compared to those without back pain and reported more adverse health states such as falls, frailty, low walking confidence and mobility decline. Those with neurogenic claudication were worst affected. At 2 years’ follow-up, among those reporting back pain at baseline, only 23% (489/2100) no lo
{"title":"Improving the understanding and management of back pain in older adults: the BOOST research programme including RCT and OPAL cohort","authors":"E. Williamson, M. Sanchez-Santos, I. Marian, M. Maredza, C. Srikesavan, Angela Garrett, Alana Morris, G. Boniface, Susan J Dutton, Frances Griffiths, Gary S Collins, Stavros Petrou, Julie Bruce, J. Fairbank, Z. Hansen, Karen Barker, Charles Hutchinson, C. Mallen, Lesley Ward, R. Gagen, Judith Fitch, David P French, S. E. Lamb","doi":"10.3310/lkwx3424","DOIUrl":"https://doi.org/10.3310/lkwx3424","url":null,"abstract":"Back pain frequently affects older people. Knowledge about back pain in older people and evidence to inform clinical care was lacking, particularly for older people with neurogenic claudication due to spinal stenosis, which is a debilitating condition. To understand and reduce the burden of back pain on older people by increasing knowledge about back pain in older people and developing evidence-based treatment strategies. We completed six work packages. These were not undertaken chronologically as there was overlap between work packages. Work package 1: Refine a physiotherapy intervention for neurogenic claudication. Work package 2: Feasibility of the Oxford Pain Activity and Lifestyle cohort study and Better Outcomes for Older people with Spinal Trouble randomised controlled trial. Work package 3: Development of a prognostic tool to identify when older people are at risk of mobility decline using data from the Oxford Pain Activity and Lifestyle cohort study. Work package 4: A randomised controlled trial of physiotherapy for neurogenic claudication and nested longitudinal qualitative study (Better Outcomes for Older people with Spinal Trouble randomised controlled trial). Work package 5: Predictors of participants’ response to treatment – prespecified subgroup analyses. Work package 6: Implementation planning. Primary care and National Health Service Community and Secondary Care Trusts. Community-dwelling adults over the age of 65 years and registered with primary care practices. Better Outcomes for Older people with Spinal Trouble trial participants reported back and/or leg pain consistent with neurogenic claudication. The Better Outcomes for Older people with Spinal Trouble programme was a physiotherapy-delivered combined physical and psychological group intervention for older people with neurogenic claudication. The comparator was a physiotherapy assessment and tailored advice (best practice advice). The primary outcome for the Oxford Pain Activity and Lifestyle prognostic tool was mobility decline based on the EQ-5D-5L Mobility Question. The primary outcome for the Better Outcomes for Older people with Spinal Trouble trial was the Oswestry Disability Index at 12 months. Other outcomes included the Oswestry Disability Index walking item, 6-minute walk test and falls. The economic analyses used the EuroQol EQ-5D-5L to measure quality of life. Among Oxford Pain Activity and Lifestyle participants, 34% (1786/5304) reported back pain. A further 19.5% (1035/5304) reported back pain and associated leg pain, with 11.2% (n = 594/5304) reporting symptoms consistent with neurogenic claudication. Participants with back pain had worse quality of life compared to those without back pain and reported more adverse health states such as falls, frailty, low walking confidence and mobility decline. Those with neurogenic claudication were worst affected. At 2 years’ follow-up, among those reporting back pain at baseline, only 23% (489/2100) no lo","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139295511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. Murtagh, Ping Guo, Alice M Firth, K.M. Yip, Christine Ramsenthaler, Abdel Douiri, Cathryn Pinto, S. Pask, M. Dzingina, J. Davies, Suzanne O’Brien, B. Edwards, E. I. Groeneveld, Mevhibe B. Hocaoglu, C. Bausewein, I. Higginson
The hospice movement has provided an excellent model of specialist palliative care for those with advanced illness approaching the end of life. However, there are marked inequities in provision of this care, and major geographical variations in the resourcing of palliative care, often resulting in a poor match between the needs of a patient/family and resources provided to meet those needs. To develop/test a casemix classification to accurately capture the complex needs of patients with advanced disease, better quantify those needs and more fairly allocate resources to meet them. A ‘casemix classification’ groups patients into classes according to differing care needs to help inform the resources needed to meet those care needs. Workstream 1 comprised the validating and refining of patient-centred measures of health status and well-being. In workstream 2, stakeholder interviews with patients, families, policy-makers, service providers and commissioners were carried out to understand complexity/casemix and models of specialist palliative care. In workstream 2 the casemix classification was developed through a multicentre cohort study. Workstream 4 comprised a longitudinal mixed-methods study to test the casemix classification, with a nested qualitative study to explore experiences of transitions between care settings. Voluntary sector and NHS specialist palliative care services across England. Patients ≥ 18 years receiving specialist palliative care, their families and the professionals delivering this care. For the Integrated Palliative care Outcome Scale validation: data from 376 patient participants and 161 clinicians showed this measure has a strong ability to distinguish between clinically relevant groups, good internal consistency (α = 0.77), and acceptable-to-good test–retest reliability (60% of items kw > 0.60). The Phase of Illness measure showed function and symptoms/concerns varied significantly by Phase of Illness, but Phase of Illness reflected additional construct(s) and so is important for casemix (workstream 1 conducted 2013–15). To gain stakeholder perspectives, 65 participants were interviewed. Based on emergent themes, we developed a theoretical framework to conceptualise complexity in specialist palliative care. This framework emphasises that considering physical, psychological and social needs is not enough to characterise complexity. Number, severity and range of needs all need to be considered in the development of a meaningful casemix classification. To understand models of care, semistructured interviews were conducted with 14 participants, 54 further participants took part in a two-round Delphi survey and interviews were conducted with 21 service leads. Twenty criteria were adopted to define/distinguish models of specialist palliative care (workstream 2 conducted 2014–16). For the development of the casemix classification, a total of 2469 patients were recruited, providing data on 2968 episodes of specialist pal
我们制定了：（1）一个基于证据的框架，将姑息关怀需求的复杂性概念化；（2）确定了标准，以描述/区分专科姑息关怀的模式；（3）制定了专科姑息关怀的病例组合分类。每一个需要专科姑息关怀的人都是不同的，都有不同程度的复杂需求。现在，我们有了病例组合分类法，可以系统地、大规模地了解和把握这一点，用于实践、政策和研究。这有可能帮助解决不平等问题，为所有需要姑息关怀的人提供更公平的专科姑息关怀。未来还需要开展研究，包括进一步验证测量方法、对照护模式进行更详细的研究以及进一步测试病例组合分类。 该试验的注册号为 ISRCTN90752212。 该奖项由英国国家健康与护理研究所（NIHR）应用研究项目资助，全文发表于《应用研究项目资助》（Programme Grants for Applied Research）第11卷第7期。欲了解更多获奖信息，请访问英国国家健康与护理研究所的 "资助与奖励 "网站。该项目还得到了国王学院医院 NHS 基金会信托基金会的 NIHR 南伦敦应用研究合作组织（NIHR ARC South London，前身为应用健康研究与护理领导力合作组织）的支持。
{"title":"A casemix classification for those receiving specialist palliative care during their last year of life across England: the C-CHANGE research programme","authors":"F. Murtagh, Ping Guo, Alice M Firth, K.M. Yip, Christine Ramsenthaler, Abdel Douiri, Cathryn Pinto, S. Pask, M. Dzingina, J. Davies, Suzanne O’Brien, B. Edwards, E. I. Groeneveld, Mevhibe B. Hocaoglu, C. Bausewein, I. Higginson","doi":"10.3310/plrp4875","DOIUrl":"https://doi.org/10.3310/plrp4875","url":null,"abstract":"The hospice movement has provided an excellent model of specialist palliative care for those with advanced illness approaching the end of life. However, there are marked inequities in provision of this care, and major geographical variations in the resourcing of palliative care, often resulting in a poor match between the needs of a patient/family and resources provided to meet those needs. To develop/test a casemix classification to accurately capture the complex needs of patients with advanced disease, better quantify those needs and more fairly allocate resources to meet them. A ‘casemix classification’ groups patients into classes according to differing care needs to help inform the resources needed to meet those care needs. Workstream 1 comprised the validating and refining of patient-centred measures of health status and well-being. In workstream 2, stakeholder interviews with patients, families, policy-makers, service providers and commissioners were carried out to understand complexity/casemix and models of specialist palliative care. In workstream 2 the casemix classification was developed through a multicentre cohort study. Workstream 4 comprised a longitudinal mixed-methods study to test the casemix classification, with a nested qualitative study to explore experiences of transitions between care settings. Voluntary sector and NHS specialist palliative care services across England. Patients ≥ 18 years receiving specialist palliative care, their families and the professionals delivering this care. For the Integrated Palliative care Outcome Scale validation: data from 376 patient participants and 161 clinicians showed this measure has a strong ability to distinguish between clinically relevant groups, good internal consistency (α = 0.77), and acceptable-to-good test–retest reliability (60% of items kw > 0.60). The Phase of Illness measure showed function and symptoms/concerns varied significantly by Phase of Illness, but Phase of Illness reflected additional construct(s) and so is important for casemix (workstream 1 conducted 2013–15). To gain stakeholder perspectives, 65 participants were interviewed. Based on emergent themes, we developed a theoretical framework to conceptualise complexity in specialist palliative care. This framework emphasises that considering physical, psychological and social needs is not enough to characterise complexity. Number, severity and range of needs all need to be considered in the development of a meaningful casemix classification. To understand models of care, semistructured interviews were conducted with 14 participants, 54 further participants took part in a two-round Delphi survey and interviews were conducted with 21 service leads. Twenty criteria were adopted to define/distinguish models of specialist palliative care (workstream 2 conducted 2014–16). For the development of the casemix classification, a total of 2469 patients were recruited, providing data on 2968 episodes of specialist pal","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139299311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Simon Harding, Ayesh Alshukri, Duncan Appelbe, Deborah Broadbent, Philip Burgess, Paula Byrne, Christopher Cheyne, Antonio Eleuteri, Anthony Fisher, Marta García-Fiñana, Mark Gabbay, Marilyn James, James Lathe, Tracy Moitt, Mehrdad Mobayen Rahni, John Roberts, Christopher Sampson, Daniel Seddon, Irene Stratton, Clare Thetford, Pilar Vazquez-Arango, Jiten Vora, Amu Wang, Paula Williamson
Background Systematic annual screening for sight-threatening diabetic retinopathy is established in several countries but is resource intensive. Personalised (individualised) medicine offers the opportunity to extend screening intervals for people at low risk of progression and to target high-risk groups. However, significant concern exists among all stakeholders around the safety of changing programmes. Evidence to guide decisions is limited, with, to the best of our knowledge, no randomised controlled trials to date. Objectives To develop an individualised approach to screening for sight-threatening diabetic retinopathy and test its acceptability, safety, efficacy and cost-effectiveness. To estimate the changing incidence of patient-centred outcomes. Design A risk calculation engine; a randomised controlled trial, including a within-trial cost-effectiveness study; a qualitative acceptability study; and an observational epidemiological cohort study were developed. A patient and public group was involved in design and interpretation. Setting A screening programme in an English health district of around 450,000 people. Participants People with diabetes aged ≥ 12 years registered with primary care practices in Liverpool. Interventions The risk calculation engine estimated each participant’s risk at each visit of progression to screen-positive diabetic retinopathy (individualised intervention group) and allocated their next appointment at 6, 12 or 24 months (high, medium or low risk, respectively). Main outcome measures The randomised controlled trial primary outcome was attendance at first follow-up assessing the safety of individualised compared with usual screening. Secondary outcomes were overall attendance, rates of screen-positive and sight-threatening diabetic retinopathy, and measures of visual impairment. Cost-effectiveness outcomes were cost/quality-adjusted life year and incremental cost savings. Cohort study outcomes were rates of screen-positive diabetic retinopathy and sight-threatening diabetic retinopathy. Data sources Local screening programme (retinopathy), primary care (demographic, clinical) and hospital outcomes. Methods A seven-person patient and public involvement group was recruited. Data were linked into a purpose-built dynamic data warehouse. In the risk assessment, the risk calculation engine used patient-embedded covariate data, a continuous Markov model, 5-year historical local population data, and most recent individual demographic, retina and clinical data to predict risk of future progression to screen-positive. The randomised controlled trial was a masked, two-arm, parallel assignment, equivalence randomised controlled trial, with an independent trials unit and 1 : 1 allocation to individualised screening (6, 12 or 24 months, determined by risk calculation engine at each visit) or annual screening (control). Cost-effectiveness was assessed using a within-trial analysis over a 2-year time horizon, including NHS and so
背景:一些国家建立了威胁视力的糖尿病视网膜病变的系统年度筛查，但这是一项资源密集的工作。个体化药物为低进展风险人群提供了延长筛查间隔的机会，并针对高危人群。然而，所有利益相关者都对改变方案的安全性存在重大关切。指导决策的证据有限，据我们所知，迄今为止还没有随机对照试验。目的建立一种个体化的糖尿病视网膜病变筛查方法，并检验其可接受性、安全性、有效性和成本效益。估计以患者为中心的结局发生率的变化。设计风险计算引擎;随机对照试验，包括试验内成本-效果研究;定性可接受性研究;并开展了一项观察性流行病学队列研究。一个病人和公众团体参与了设计和解释。在英国一个约45万人的卫生区开展筛查项目。参与者在利物浦初级保健机构登记的年龄≥12岁的糖尿病患者。风险计算引擎估计每个参与者在每次就诊时进展为筛查阳性糖尿病视网膜病变的风险(个体化干预组)，并在6个月、12个月或24个月分配他们的下一次预约(分别为高、中或低风险)。主要结局指标:随机对照试验的主要结局是第一次随访时的出席率，评估个体化筛查与常规筛查的安全性。次要结果是总体出勤率，筛查阳性和视力威胁的糖尿病视网膜病变率，以及视力损害的测量。成本效益结果为成本/质量调整生命年和增量成本节约。队列研究的结果是筛查阳性的糖尿病视网膜病变和威胁视力的糖尿病视网膜病变的发生率。数据来源当地筛查方案(视网膜病变)、初级保健(人口统计、临床)和医院结果。方法招募7人患者及公众参与组。数据被链接到一个专门构建的动态数据仓库中。在风险评估中，风险计算引擎使用患者嵌入的协变量数据、连续马尔可夫模型、5年历史当地人口数据以及最近的个人人口统计学、视网膜和临床数据来预测未来进展为筛检阳性的风险。该随机对照试验是一项隐蔽、双臂、平行分配、等效随机对照试验，具有独立试验单元和1:1分配，分别为个体化筛查(6、12或24个月，由每次就诊时的风险计算引擎决定)或年度筛查(对照)。成本效益评估使用2年时间范围的试验内分析，包括NHS和社会观点以及随机对照试验中直接观察到的成本。通过对60名糖尿病患者和21名医疗保健专业人员进行有目的抽样，采用半结构化访谈对可接受性进行评估;这是一种不断比较的方法，直到饱和。该队列是一个11年回顾性/前瞻性筛查人群数据集。结果在随机对照试验中，4534名受试者被随机分配:个体化组2265名受试者中有2097名(92.6%)，对照组2269名受试者中有2224名(98.0%)在停药后仍然存在。首次随访时的出勤率相等(个体化83.6%，对照组84.7%)(差异-1.0%，95%可信区间-3.2%至1.2%)。威胁视力的糖尿病视网膜病变的检出率也不差:个体化1.4%，对照组1.7%(差异-0.3%，95%可信区间-1.1%至0.5%)。在成本-效果分析中，全病例质量调整生命年(EuroQol-5维度，5级版本和健康效用指数标记3)的平均差异从零到零没有显著差异。从NHS的角度来看，不包括治疗费用的人均增量成本节约为17.34英镑(置信区间为17.02英镑至17.67英镑)，从社会的角度来看为23.11英镑(置信区间为22.73英镑至23.53英镑)。在个体化治疗组中，需要的筛查预约减少了43.2%。在可接受性方面，对于大多数糖尿病患者和保健专业人员来说，改变为可变间隔是可以接受的。每年的筛查被认为是不可持续的，而且是对资源的低效利用。许多糖尿病患者和医疗保健专业人员表示担心，两年的筛查间隔可能会太晚发现可参考的眼病，并可能对出勤和糖尿病护理的重要性产生负面影响。6个月的间隔被认为是积极的。 在痴呆症患者中，对与眼科相关的预约和护理存在相当大的误解。在队列研究中，11年来参与者人数(总共28384人)有所增加(2006/7,n = 6637;2016/17, n = 14,864)。年发病率范围如下:筛查阳性4.4-10.6%，糖尿病视网膜病变2.3-4.6%，威胁视力的糖尿病视网膜病变1.3-2.2%。筛查阳性比例稳步下降，但威胁视力的糖尿病视网膜病变比例保持稳定。我们的发现适用于一个城市范围内建立的英语筛查项目，主要是白人糖尿病患者。成本效益分析是针对一种长期疾病的短时间内进行的;然而，这项研究的目的是测试筛查方案的安全性和有效性，而不是筛查与不筛查的成本效益。队列数据的收集在一定程度上是回顾性的:无法获得2013年之前患有威胁视力的糖尿病视网膜病变或死亡的人的数据。结论:我们的随机对照试验可以让参与糖尿病护理的利益相关者放心，延长间隔和个性化筛查是可行的，数据链接是可能的，并且可以安全地引入已建立的筛查计划，与每年筛查相比，可能节省成本。筛检阳性的糖尿病视网膜病变和威胁视力的糖尿病视网膜病变的发病率很低，并随时间持续下降。患者参与研究对成功至关重要。未来的工作未来的工作可能包括与其他项目的外部验证，然后在研究环境之外扩大个性化筛查的规模，并在2年的时间范围内建立经济模型。本试验注册号为ISRCTN87561257。本项目由国家卫生和保健研究所(NIHR)应用研究方案资助，并将全文发表在应用研究方案资助上;第十一卷第六期请参阅NIHR期刊图书馆网站了解更多项目信息。
{"title":"Individualised variable-interval risk-based screening in diabetic retinopathy: the ISDR research programme including RCT","authors":"Simon Harding, Ayesh Alshukri, Duncan Appelbe, Deborah Broadbent, Philip Burgess, Paula Byrne, Christopher Cheyne, Antonio Eleuteri, Anthony Fisher, Marta García-Fiñana, Mark Gabbay, Marilyn James, James Lathe, Tracy Moitt, Mehrdad Mobayen Rahni, John Roberts, Christopher Sampson, Daniel Seddon, Irene Stratton, Clare Thetford, Pilar Vazquez-Arango, Jiten Vora, Amu Wang, Paula Williamson","doi":"10.3310/hrfa3155","DOIUrl":"https://doi.org/10.3310/hrfa3155","url":null,"abstract":"Background Systematic annual screening for sight-threatening diabetic retinopathy is established in several countries but is resource intensive. Personalised (individualised) medicine offers the opportunity to extend screening intervals for people at low risk of progression and to target high-risk groups. However, significant concern exists among all stakeholders around the safety of changing programmes. Evidence to guide decisions is limited, with, to the best of our knowledge, no randomised controlled trials to date. Objectives To develop an individualised approach to screening for sight-threatening diabetic retinopathy and test its acceptability, safety, efficacy and cost-effectiveness. To estimate the changing incidence of patient-centred outcomes. Design A risk calculation engine; a randomised controlled trial, including a within-trial cost-effectiveness study; a qualitative acceptability study; and an observational epidemiological cohort study were developed. A patient and public group was involved in design and interpretation. Setting A screening programme in an English health district of around 450,000 people. Participants People with diabetes aged ≥ 12 years registered with primary care practices in Liverpool. Interventions The risk calculation engine estimated each participant’s risk at each visit of progression to screen-positive diabetic retinopathy (individualised intervention group) and allocated their next appointment at 6, 12 or 24 months (high, medium or low risk, respectively). Main outcome measures The randomised controlled trial primary outcome was attendance at first follow-up assessing the safety of individualised compared with usual screening. Secondary outcomes were overall attendance, rates of screen-positive and sight-threatening diabetic retinopathy, and measures of visual impairment. Cost-effectiveness outcomes were cost/quality-adjusted life year and incremental cost savings. Cohort study outcomes were rates of screen-positive diabetic retinopathy and sight-threatening diabetic retinopathy. Data sources Local screening programme (retinopathy), primary care (demographic, clinical) and hospital outcomes. Methods A seven-person patient and public involvement group was recruited. Data were linked into a purpose-built dynamic data warehouse. In the risk assessment, the risk calculation engine used patient-embedded covariate data, a continuous Markov model, 5-year historical local population data, and most recent individual demographic, retina and clinical data to predict risk of future progression to screen-positive. The randomised controlled trial was a masked, two-arm, parallel assignment, equivalence randomised controlled trial, with an independent trials unit and 1 : 1 allocation to individualised screening (6, 12 or 24 months, determined by risk calculation engine at each visit) or annual screening (control). Cost-effectiveness was assessed using a within-trial analysis over a 2-year time horizon, including NHS and so","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136167901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
N. Foster, K. Dunn, J. Protheroe, Jonathan C Hill, Martyn Lewis, B. Saunders, S. Jowett, S. Hennings, P. Campbell, K. Bromley, B. Bartlam, O. Babatunde, S. Wathall, Raymond Oppong, J. Kigozi, A. Chudyk
Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and reducing potential harm or unnecessary interventions. This programme developed a new prognostic stratified primary care approach, where treatments are matched to a patient’s risk of future persistent pain and disability based on a prognostic tool, and compared this with usual care. In four linked work packages, we refined and validated a prognostic tool [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to identify risk of poor outcome and defined cut-off scores to distinguish patient risk subgroups (work package 1); defined and agreed new matched treatment options for each risk subgroup and developed a support package for delivery of stratified care (work package 2); tested the feasibility of delivering the stratified approach through a pilot randomised controlled trial and externally validated the prognostic tool (work package 3); and tested the effectiveness of the approach by comparing the clinical effectiveness and cost-effectiveness of stratified primary care with that of usual care through a cluster randomised controlled trial with embedded health economic and qualitative studies (work package 4). General practices and linked musculoskeletal services in the West Midlands of England, UK. Adults registered with participating practices consulting with back, neck, shoulder, knee or multisite musculoskeletal pain, and clinicians involved in managing these patients. The programme included the following work packages: work package 1 – a prospective cohort study in 12 practices; work package 2 – an evidence synthesis, consensus group workshops and qualitative studies; work package 3 – a cluster feasibility and pilot trial in eight practices; and work package 4 – a main cluster randomised controlled trial in 24 practices, with health economic analyses and process evaluation. Stratified care comprised training general practitioners to use the tool and match patients to treatment options depending on their risk subgroup. Usual care comprised usual non-stratified primary care without formal stratification tools. Cohort primary end points included function (Short Form questionnaire-36 items physical component score) and pain intensity (numerical rating scale). The trial primary end point for patient outcomes was pain intensity (monthly for 6 months) (0–10 numerical rating scale). An audit of primary care electronic medical records evaluated the impact of stratified care on clinical decision-making regarding patient management. Work package 1 – the cohort study (n = 1890 patients) refined and validated a new 10-item tool with which to stratify patients with the five most common musculoskeletal pain presentations. The tool subgroups patients into three strata with diffe
{"title":"Stratified primary care for adults with musculoskeletal pain: the STarT MSK research programme including RCTs","authors":"N. Foster, K. Dunn, J. Protheroe, Jonathan C Hill, Martyn Lewis, B. Saunders, S. Jowett, S. Hennings, P. Campbell, K. Bromley, B. Bartlam, O. Babatunde, S. Wathall, Raymond Oppong, J. Kigozi, A. Chudyk","doi":"10.3310/fbvx4177","DOIUrl":"https://doi.org/10.3310/fbvx4177","url":null,"abstract":"\u0000Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and reducing potential harm or unnecessary interventions. This programme developed a new prognostic stratified primary care approach, where treatments are matched to a patient’s risk of future persistent pain and disability based on a prognostic tool, and compared this with usual care.\u0000\u0000\u0000In four linked work packages, we refined and validated a prognostic tool [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to identify risk of poor outcome and defined cut-off scores to distinguish patient risk subgroups (work package 1); defined and agreed new matched treatment options for each risk subgroup and developed a support package for delivery of stratified care (work package 2); tested the feasibility of delivering the stratified approach through a pilot randomised controlled trial and externally validated the prognostic tool (work package 3); and tested the effectiveness of the approach by comparing the clinical effectiveness and cost-effectiveness of stratified primary care with that of usual care through a cluster randomised controlled trial with embedded health economic and qualitative studies (work package 4).\u0000\u0000\u0000General practices and linked musculoskeletal services in the West Midlands of England, UK.\u0000\u0000\u0000Adults registered with participating practices consulting with back, neck, shoulder, knee or multisite musculoskeletal pain, and clinicians involved in managing these patients.\u0000\u0000\u0000The programme included the following work packages: work package 1 – a prospective cohort study in 12 practices; work package 2 – an evidence synthesis, consensus group workshops and qualitative studies; work package 3 – a cluster feasibility and pilot trial in eight practices; and work package 4 – a main cluster randomised controlled trial in 24 practices, with health economic analyses and process evaluation.\u0000\u0000\u0000Stratified care comprised training general practitioners to use the tool and match patients to treatment options depending on their risk subgroup. Usual care comprised usual non-stratified primary care without formal stratification tools.\u0000\u0000\u0000Cohort primary end points included function (Short Form questionnaire-36 items physical component score) and pain intensity (numerical rating scale). The trial primary end point for patient outcomes was pain intensity (monthly for 6 months) (0–10 numerical rating scale). An audit of primary care electronic medical records evaluated the impact of stratified care on clinical decision-making regarding patient management.\u0000\u0000\u0000Work package 1 – the cohort study (n = 1890 patients) refined and validated a new 10-item tool with which to stratify patients with the five most common musculoskeletal pain presentations. The tool subgroups patients into three strata with diffe","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85594036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Wenborn, G. Mountain, E. Moniz-Cook, F. Poland, M. King, R. Omar, A. O’Keeffe, S. Morris, Elena Pizzo, S. Michie, M. Vernooij-Dassen, M. Graff, Jane Hill, D. Challis, I. Russell, C. Sackley, S. Hynes, N. Crellin, Jacqueline Mundy, J. Burgess, T. Swinson, L. Di Bona, B. Field, C. Hart, J. Stansfeld, H. Walton, S. Rooks, R. Ledgerd, M. Orrell
People with dementia find it increasingly difficult to carry out daily activities (activities of daily living), and may require increasing support from family carers. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia intervention, which was delivered in 10 1-hour sessions over 5 weeks to people with dementia and their family carers at home. Community Occupational Therapy in Dementia was found to be clinically effective and cost-effective. Translate and adapt Community Occupational Therapy in Dementia to develop the Community Occupational Therapy in Dementia - the UK version intervention and training programme and to optimise its suitability for use within the UK. To estimate the clinical effectiveness and cost-effectiveness of Community Occupational Therapy in Dementia - the UK version for people with mild to moderate dementia and their family carers compared with treatment as usual. The development phase used mixed methods to develop Community Occupational Therapy in Dementia - the UK version: translation, expert review, and adaptation of the manual and training materials; training occupational therapists; focus groups and interviews, including occupational therapists, managers, people with dementia and family carers; consensus conference; and an online survey of occupational therapists to scope UK practice. A multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial was preceded by an internal pilot. Pairs were randomly allocated between Community Occupational Therapy in Dementia - the UK version and treatment as usual. A cost–utility analysis, fidelity study and qualitative study were also completed. Community services for people with dementia across England. People with mild to moderate dementia recruited in pairs with a family carer/supporter. Community Occupational Therapy in Dementia - the UK version is an activity-based, goal-setting approach for people with dementia and family carers, and is delivered at home by an occupational therapist for 10 hours over 10 weeks. Treatment as usual comprised the usual local service provision, which may or may not include standard occupational therapy. Data were collected through interviews conducted in person with dyads at baseline and at 12 and 26 weeks post randomisation, and then over the telephone with a reduced sample of just carers at 52 and 78 weeks post randomisation. The primary outcome was the Bristol Activities of Daily Living Scale at 26 weeks. The secondary outcomes were as follows: person with dementia – cognition, activities of daily living, quality of life and mood; carer – sense of competence, quality of life and mood; all participants – social contacts, leisure activities and serious adverse events. The Community Occupational Therapy in Dementia manual and training materials were translated and reviewed. In total, 44 occupational therapists were trained and delivered Community Occupational Therapy in
{"title":"Community Occupational Therapy in Dementia intervention for people with mild to moderate dementia and their family carers in the UK: the VALID research programme including RCT","authors":"J. Wenborn, G. Mountain, E. Moniz-Cook, F. Poland, M. King, R. Omar, A. O’Keeffe, S. Morris, Elena Pizzo, S. Michie, M. Vernooij-Dassen, M. Graff, Jane Hill, D. Challis, I. Russell, C. Sackley, S. Hynes, N. Crellin, Jacqueline Mundy, J. Burgess, T. Swinson, L. Di Bona, B. Field, C. Hart, J. Stansfeld, H. Walton, S. Rooks, R. Ledgerd, M. Orrell","doi":"10.3310/rgtj7429","DOIUrl":"https://doi.org/10.3310/rgtj7429","url":null,"abstract":"\u0000People with dementia find it increasingly difficult to carry out daily activities (activities of daily living), and may require increasing support from family carers. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia intervention, which was delivered in 10 1-hour sessions over 5 weeks to people with dementia and their family carers at home. Community Occupational Therapy in Dementia was found to be clinically effective and cost-effective.\u0000\u0000\u0000Translate and adapt Community Occupational Therapy in Dementia to develop the Community Occupational Therapy in Dementia - the UK version intervention and training programme and to optimise its suitability for use within the UK. To estimate the clinical effectiveness and cost-effectiveness of Community Occupational Therapy in Dementia - the UK version for people with mild to moderate dementia and their family carers compared with treatment as usual.\u0000\u0000\u0000The development phase used mixed methods to develop Community Occupational Therapy in Dementia - the UK version: translation, expert review, and adaptation of the manual and training materials; training occupational therapists; focus groups and interviews, including occupational therapists, managers, people with dementia and family carers; consensus conference; and an online survey of occupational therapists to scope UK practice. A multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial was preceded by an internal pilot. Pairs were randomly allocated between Community Occupational Therapy in Dementia - the UK version and treatment as usual. A cost–utility analysis, fidelity study and qualitative study were also completed.\u0000\u0000\u0000Community services for people with dementia across England.\u0000\u0000\u0000People with mild to moderate dementia recruited in pairs with a family carer/supporter.\u0000\u0000\u0000Community Occupational Therapy in Dementia - the UK version is an activity-based, goal-setting approach for people with dementia and family carers, and is delivered at home by an occupational therapist for 10 hours over 10 weeks. Treatment as usual comprised the usual local service provision, which may or may not include standard occupational therapy.\u0000\u0000\u0000Data were collected through interviews conducted in person with dyads at baseline and at 12 and 26 weeks post randomisation, and then over the telephone with a reduced sample of just carers at 52 and 78 weeks post randomisation. The primary outcome was the Bristol Activities of Daily Living Scale at 26 weeks. The secondary outcomes were as follows: person with dementia – cognition, activities of daily living, quality of life and mood; carer – sense of competence, quality of life and mood; all participants – social contacts, leisure activities and serious adverse events.\u0000\u0000\u0000The Community Occupational Therapy in Dementia manual and training materials were translated and reviewed. In total, 44 occupational therapists were trained and delivered Community Occupational Therapy in","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83212664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Martin Underwood, Felix Achana, Dawn Carnes, Sandra Eldridge, David R Ellard, Frances Griffiths, Kirstie Haywood, Siew Wan Hee, Helen Higgins, Dipesh Mistry, Hema Mistry, Sian Newton, Vivien Nichols, Chloe Norman, Emma Padfield, Shilpa Patel, Stavros Petrou, Tamar Pincus, Rachel Potter, Harbinder Sandhu, Kimberley Stewart, Stephanie JC Taylor, Manjit Matharu
Background Headaches are a leading cause of years lived with disability. For some people, headaches become chronic and disabling, with treatment options being primarily pharmaceutical. Non-pharmacological alternative treatment approaches are worthy of exploration. Aim To develop and test an educational and supportive self-management intervention for people with chronic headaches. Objectives To develop and evaluate a brief diagnostic interview to support diagnosis for people with chronic headaches, and then to develop and pilot an education and self-management support intervention for the management of common chronic headache disorders (the CHESS intervention). To select the most appropriate outcome measures for a randomised controlled trial of the CHESS intervention, and then to conduct a randomised controlled trial and economic evaluation of the CHESS intervention with an embedded process evaluation. Design Developmental and feasibility studies followed by a randomised controlled trial. Setting General practice and community settings in the Midlands and London, UK. Participants For our feasibility work, 14 general practices recruited 131 people with chronic headaches (headaches on ≥15 days per month for >3 months). People with chronic headaches and expert clinicians developed a telephone classification interview for chronic headache that we validated with 107 feasibility study participants. We piloted the CHESS intervention with 13 participants and refined the content and structure based on their feedback. People with chronic headaches contributed to the decisions about our primary outcome and a core outcome set for chronic and episodic migraine. For the randomised controlled trial, we recruited adults with chronic migraine or chronic tension-type headache and episodic migraine, with or without medication overuse headache, from general practices and via self-referral. Our main analyses were on people with migraine. Interventions The CHESS intervention consisted of two 1-day group sessions focused on education and self-management to promote behaviour change and support learning strategies to manage chronic headaches. This was followed by a one-to-one nurse consultation and telephone support. The control intervention consisted of feedback from classification interviews, headache management leaflet and a relaxation compact disc. Main outcome measures The primary outcome was headache-related quality of life measured using the Headache Impact Test-6 at 12 months. The secondary outcomes included the Chronic Headache Quality of Life Questionnaire; headache days, duration and severity; EuroQol-5 Dimensions, five-level version; Short Form Questionnaire-12 items; Hospital Anxiety and Depression Scale; and Pain Self-Efficacy Questionnaire scores. We followed up participants at 4, 8 and 12 months. Results Between April 2017 and March 2019, we randomised 736 participants from 164 general practices. Nine participants (1%) had chronic tension-type headache
{"title":"Non-pharmacological educational and self-management interventions for people with chronic headache: the CHESS research programme including a RCT","authors":"Martin Underwood, Felix Achana, Dawn Carnes, Sandra Eldridge, David R Ellard, Frances Griffiths, Kirstie Haywood, Siew Wan Hee, Helen Higgins, Dipesh Mistry, Hema Mistry, Sian Newton, Vivien Nichols, Chloe Norman, Emma Padfield, Shilpa Patel, Stavros Petrou, Tamar Pincus, Rachel Potter, Harbinder Sandhu, Kimberley Stewart, Stephanie JC Taylor, Manjit Matharu","doi":"10.3310/pljl1440","DOIUrl":"https://doi.org/10.3310/pljl1440","url":null,"abstract":"Background Headaches are a leading cause of years lived with disability. For some people, headaches become chronic and disabling, with treatment options being primarily pharmaceutical. Non-pharmacological alternative treatment approaches are worthy of exploration. Aim To develop and test an educational and supportive self-management intervention for people with chronic headaches. Objectives To develop and evaluate a brief diagnostic interview to support diagnosis for people with chronic headaches, and then to develop and pilot an education and self-management support intervention for the management of common chronic headache disorders (the CHESS intervention). To select the most appropriate outcome measures for a randomised controlled trial of the CHESS intervention, and then to conduct a randomised controlled trial and economic evaluation of the CHESS intervention with an embedded process evaluation. Design Developmental and feasibility studies followed by a randomised controlled trial. Setting General practice and community settings in the Midlands and London, UK. Participants For our feasibility work, 14 general practices recruited 131 people with chronic headaches (headaches on ≥15 days per month for >3 months). People with chronic headaches and expert clinicians developed a telephone classification interview for chronic headache that we validated with 107 feasibility study participants. We piloted the CHESS intervention with 13 participants and refined the content and structure based on their feedback. People with chronic headaches contributed to the decisions about our primary outcome and a core outcome set for chronic and episodic migraine. For the randomised controlled trial, we recruited adults with chronic migraine or chronic tension-type headache and episodic migraine, with or without medication overuse headache, from general practices and via self-referral. Our main analyses were on people with migraine. Interventions The CHESS intervention consisted of two 1-day group sessions focused on education and self-management to promote behaviour change and support learning strategies to manage chronic headaches. This was followed by a one-to-one nurse consultation and telephone support. The control intervention consisted of feedback from classification interviews, headache management leaflet and a relaxation compact disc. Main outcome measures The primary outcome was headache-related quality of life measured using the Headache Impact Test-6 at 12 months. The secondary outcomes included the Chronic Headache Quality of Life Questionnaire; headache days, duration and severity; EuroQol-5 Dimensions, five-level version; Short Form Questionnaire-12 items; Hospital Anxiety and Depression Scale; and Pain Self-Efficacy Questionnaire scores. We followed up participants at 4, 8 and 12 months. Results Between April 2017 and March 2019, we randomised 736 participants from 164 general practices. Nine participants (1%) had chronic tension-type headache ","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rachael Gooberman-Hill, Vikki Wylde, Wendy Bertram, Andrew J Moore, Rafael Pinedo-Villanueva, Emily Sanderson, Jane Dennis, Shaun Harris, Andrew Judge, Sian Noble, Andrew D Beswick, Amanda Burston, Tim J Peters, Julie Bruce, Christopher Eccleston, Stewart Long, David Walsh, Nicholas Howells, Simon White, Andrew Price, Nigel Arden, Andrew Toms, Candida McCabe, Ashley W Blom
Background The treatment of osteoarthritis with knee replacement aims to reduce pain and disability. However, some people experience chronic pain. Objectives To improve outcomes for people with chronic pain after knee replacement by identifying post-surgical predictors and effective interventions, characterising patient pathways and resource use, developing and evaluating a new care pathway, and exploring non-use of services. Design The programme comprised systematic reviews, national database analyses, a cohort study, intervention development, a randomised controlled trial, health economic analyses, qualitative studies and stakeholder engagement. Extensive and meaningful patient and public involvement underpinned all studies. Setting NHS, secondary care, primary care. Participants People with, or at risk of, chronic pain after knee replacement and health-care professionals involved in the care of people with pain. Interventions A care pathway for the management of people with pain at 3 months after knee replacement. Main outcome measures Patient-reported outcomes and cost-effectiveness over 12 months. Data sources Literature databases, the National Joint Registry, Hospital Episode Statistics, patient-reported outcomes, the Clinical Practice Research Datalink, the Clinical Outcomes in Arthroplasty Study, the Support and Treatment After joint Replacement randomised trial, interviews with 90 patients and 14 health-care professionals, and stakeholder events. Review methods Systematic reviews of cohort studies or randomised trials, using meta-analysis or narrative synthesis. Results In the Clinical Outcomes in Arthroplasty Study cohort, 14% of people experienced chronic pain 1 year after knee replacement. By 5 years, 65% reported no pain, 31% fluctuated and 4% remained in chronic pain. People with chronic pain had a worse quality of life, higher primary care costs, and more frequent analgesia prescriptions, particularly for opioids, than those not in chronic pain. People with chronic pain after knee replacement who made little or no use of services often felt nothing more could be done, or that further treatments may have no benefit or cause harm. People described a feeling of disconnection from their replaced knee. Analysis of UK databases identified risk factors for chronic pain after knee replacement. Pre-operative predictors were mild knee pain, smoking, deprivation, body mass index between 35 and 40 kg/m 2 and knee arthroscopy. Peri- and post-operative predictors were mechanical complications, infection, readmission, revision, extended hospital stay, manipulation under anaesthetic and use of opioids or antidepressants. In systematic reviews, pre-operative exercise and education showed no benefit in relation to chronic pain. Peri-operative interventions that merit further research were identified. Common peri-operative treatments were not associated with chronic pain. There was no strong evidence favouring specific post-operative physiotherapy co
{"title":"Better post-operative prediction and management of chronic pain in adults after total knee replacement: the multidisciplinary STAR research programme including RCT","authors":"Rachael Gooberman-Hill, Vikki Wylde, Wendy Bertram, Andrew J Moore, Rafael Pinedo-Villanueva, Emily Sanderson, Jane Dennis, Shaun Harris, Andrew Judge, Sian Noble, Andrew D Beswick, Amanda Burston, Tim J Peters, Julie Bruce, Christopher Eccleston, Stewart Long, David Walsh, Nicholas Howells, Simon White, Andrew Price, Nigel Arden, Andrew Toms, Candida McCabe, Ashley W Blom","doi":"10.3310/watm4500","DOIUrl":"https://doi.org/10.3310/watm4500","url":null,"abstract":"Background The treatment of osteoarthritis with knee replacement aims to reduce pain and disability. However, some people experience chronic pain. Objectives To improve outcomes for people with chronic pain after knee replacement by identifying post-surgical predictors and effective interventions, characterising patient pathways and resource use, developing and evaluating a new care pathway, and exploring non-use of services. Design The programme comprised systematic reviews, national database analyses, a cohort study, intervention development, a randomised controlled trial, health economic analyses, qualitative studies and stakeholder engagement. Extensive and meaningful patient and public involvement underpinned all studies. Setting NHS, secondary care, primary care. Participants People with, or at risk of, chronic pain after knee replacement and health-care professionals involved in the care of people with pain. Interventions A care pathway for the management of people with pain at 3 months after knee replacement. Main outcome measures Patient-reported outcomes and cost-effectiveness over 12 months. Data sources Literature databases, the National Joint Registry, Hospital Episode Statistics, patient-reported outcomes, the Clinical Practice Research Datalink, the Clinical Outcomes in Arthroplasty Study, the Support and Treatment After joint Replacement randomised trial, interviews with 90 patients and 14 health-care professionals, and stakeholder events. Review methods Systematic reviews of cohort studies or randomised trials, using meta-analysis or narrative synthesis. Results In the Clinical Outcomes in Arthroplasty Study cohort, 14% of people experienced chronic pain 1 year after knee replacement. By 5 years, 65% reported no pain, 31% fluctuated and 4% remained in chronic pain. People with chronic pain had a worse quality of life, higher primary care costs, and more frequent analgesia prescriptions, particularly for opioids, than those not in chronic pain. People with chronic pain after knee replacement who made little or no use of services often felt nothing more could be done, or that further treatments may have no benefit or cause harm. People described a feeling of disconnection from their replaced knee. Analysis of UK databases identified risk factors for chronic pain after knee replacement. Pre-operative predictors were mild knee pain, smoking, deprivation, body mass index between 35 and 40 kg/m 2 and knee arthroscopy. Peri- and post-operative predictors were mechanical complications, infection, readmission, revision, extended hospital stay, manipulation under anaesthetic and use of opioids or antidepressants. In systematic reviews, pre-operative exercise and education showed no benefit in relation to chronic pain. Peri-operative interventions that merit further research were identified. Common peri-operative treatments were not associated with chronic pain. There was no strong evidence favouring specific post-operative physiotherapy co","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136280875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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