Programme Grants for Applied Research最新文献

{"title":"Identifying and managing psoriasis-associated comorbidities: the IMPACT research programme","authors":"L. Cordingley, P. Nelson, L. Davies, D. Ashcroft, C. Bundy, C. Chew‐Graham, A. Chisholm, Jamie Elvidge, M. Hamilton, R. Hilton, K. Kane, C. Keyworth, A. Littlewood, K. Lovell, M. Lunt, H. McAteer, D. Ntais, R. Parisi, C. Pearce, M. Rutter, D. Symmons, H. Young, C. Griffiths","doi":"10.3310/lvuq5853","DOIUrl":"https://doi.org/10.3310/lvuq5853","url":null,"abstract":"\u0000 \u0000 Psoriasis is a common, lifelong inflammatory skin disease, the severity of which can range from limited disease involving a small body surface area to extensive skin involvement. It is associated with high levels of physical and psychosocial disability and a range of comorbidities, including cardiovascular disease, and it is currently incurable.\u0000 \u0000 \u0000 \u0000 To (1) confirm which patients with psoriasis are at highest risk of developing additional long-term conditions and identify service use and costs to patient, (2) apply knowledge about risk of comorbid disease to the development of targeted screening services to reduce risk of further disease, (3) learn how patients with psoriasis cope with their condition and about their views of service provision, (4) identify the barriers to provision of best care for patients with psoriasis and (5) develop patient self-management resources and staff training packages to improve the lives of people with psoriasis.\u0000 \u0000 \u0000 \u0000 Mixed methods including two systematic reviews, one population cohort study, one primary care screening study, one discrete choice study, four qualitative studies and three mixed-methodology studies.\u0000 \u0000 \u0000 \u0000 Primary care, secondary care and online surveys.\u0000 \u0000 \u0000 \u0000 People with psoriasis and health-care professionals who manage patients with psoriasis.\u0000 \u0000 \u0000 \u0000 Prevalence rates for psoriasis vary by geographical location. Incidence in the UK was estimated to be between 1.30% and 2.60%. Knowledge about the cost-effectiveness of therapies is limited because high-quality clinical comparisons of interventions have not been done or involve short-term follow-up. After adjusting for known cardiovascular risk factors, psoriasis (including severe forms) was not found to be an independent risk factor for major cardiovascular events; however, co-occurrence of inflammatory arthritis was a risk factor. Traditional risk factors were high in patients with psoriasis. Large numbers of patients with suboptimal management of known risk factors were found by screening patients in primary care. Risk information was seldom discussed with patients as part of screening consultations, meaning that a traditional screening approach may not be effective in reducing comorbidities associated with psoriasis. Gaps in training of health-care practitioners to manage psoriasis effectively were identified, including knowledge about risk factors for comorbidities and methods of facilitating behavioural change. Theory-based, high-design-quality patient materials broadened patient understanding of psoriasis and self-management. A 1-day training course based on motivational interviewing principles was effective in increasing practitioner knowledge and changing consultation styles. The primary economic analysis indicated a high level of uncertainty. Sensitivity analysis indicated some situations when the interventions may be cost-effective. The interventions need to be assessed for long-term (cost-)effectiveness.\u0000 \u0000 \u0000 \u0000 The duration of pa","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81020374","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}

{"title":"Electronic self-reporting of adverse events for patients undergoing cancer treatment: the eRAPID research programme including two RCTs","authors":"G. Velikova, K. Absolom, J. Hewison, P. Holch, L. Warrington, K. Avery, H. Richards, J. Blazeby, B. Dawkins, C. Hulme, R. Carter, L. Glidewell, Ann Henry, K. Franks, G. Hall, S. Davidson, K. Henry, C. Morris, M. Conner, L. McParland, K. Walker, E. Hudson, Julia M. Brown","doi":"10.3310/fdde8516","DOIUrl":"https://doi.org/10.3310/fdde8516","url":null,"abstract":"\u0000 \u0000 Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) and is frequently associated with adverse events that affect treatment delivery and quality of life. Regular adverse event reporting could improve care and safety through timely detection and management. Information technology provides a feasible monitoring model, but applied research is needed. This research programme developed and evaluated an electronic system, called eRAPID, for cancer patients to remotely self-report adverse events.\u0000 \u0000 \u0000 \u0000 The objectives were to address the following research questions: is it feasible to collect adverse event data from patients’ homes and in clinics during cancer treatment? Can eRAPID be implemented in different hospitals and treatment settings? Will oncology health-care professionals review eRAPID reports for decision-making? When added to usual care, will the eRAPID intervention (i.e. self-reporting with tailored advice) lead to clinical benefits (e.g. better adverse event control, improved patient safety and experiences)? Will eRAPID be cost-effective?\u0000 \u0000 \u0000 \u0000 Five mixed-methods work packages were conducted, incorporating co-design with patients and health-care professionals: work package 1 – development and implementation of the electronic platform across hospital centres; work package 2 – development of patient-reported adverse event items and advice (systematic and scoping reviews, patient interviews, Delphi exercise); work package 3 – mapping health-care professionals and care pathways; work package 4 – feasibility pilot studies to assess patient and clinician acceptability; and work package 5 – a single-centre randomised controlled trial of systemic treatment with a full health economic assessment.\u0000 \u0000 \u0000 \u0000 The setting was three UK cancer centres (in Leeds, Manchester and Bristol).\u0000 \u0000 \u0000 \u0000 The intervention was developed and evaluated with patients and clinicians. The systemic randomised controlled trial included 508 participants who were starting treatment for breast, colorectal or gynaecological cancer and 55 health-care professionals. The radiotherapy feasibility pilot recruited 167 patients undergoing treatment for pelvic cancers. The surgical feasibility pilot included 40 gastrointestinal cancer patients.\u0000 \u0000 \u0000 \u0000 eRAPID is an online system that allows patients to complete adverse event/symptom reports from home or hospital. The system provides immediate severity-graded advice based on clinical algorithms to guide self-management or hospital contact. Adverse event data are transferred to electronic patient records for review by clinical teams. Patients complete an online symptom report every week and whenever they experience symptoms.\u0000 \u0000 \u0000 \u0000 In systemic treatment, the primary outcome was Functional Assessment of Cancer Therapy – General, Physical Well-Being score assessed at 6, 12 and 18 weeks (primary end point). Secondary outcomes included cost-effectiveness assessed through the comparison of health-ca","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75705008","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}

{"title":"Pain self-management interventions for community-based patients with advanced cancer: a research programme including the IMPACCT RCT","authors":"M. Bennett, M. Allsop, Peter Allen, Christine Allmark, B. Bewick, K. Black, A. Blenkinsopp, Julia M. Brown, S. Closs, Zoe Edwards, K. Flemming, Marie Fletcher, R. Foy, M. Godfrey, Julia Hackett, G. Hall, S. Hartley, Daniel Howdon, N. Hughes, C. Hulme, Richard Jones, D. Meads, M. Mulvey, J. O’Dwyer, S. Pavitt, P. Rainey, Diana Robinson, Sally Taylor, Angelina W. Wray, A. Wright-Hughes, L. Ziegler","doi":"10.3310/pgfar09150","DOIUrl":"https://doi.org/10.3310/pgfar09150","url":null,"abstract":"\u0000 \u0000 Each year in England and Wales, 150,000 people die from cancer, of whom 110,000 will suffer from cancer pain. Research highlights that cancer pain remains common, severe and undertreated, and may lead to hospital admissions.\u0000 \u0000 \u0000 \u0000 To develop and evaluate pain self-management interventions for community-based patients with advanced cancer.\u0000 \u0000 \u0000 \u0000 A programme of mixed-methods intervention development work leading to a pragmatic multicentre randomised controlled trial of a multicomponent intervention for pain management compared with usual care, including an assessment of cost-effectiveness.\u0000 \u0000 \u0000 \u0000 Patients, including those with metastatic solid cancer (histological, cytological or radiological evidence) and/or those receiving anti-cancer therapy with palliative intent, and health professionals involved in the delivery of community-based palliative care.\u0000 \u0000 \u0000 \u0000 For the randomised controlled trial, patients were recruited from oncology outpatient clinics and were randomly allocated to intervention or control and followed up at home.\u0000 \u0000 \u0000 \u0000 The Supported Self-Management intervention comprised an educational component called Tackling Cancer Pain, and an eHealth component for routine pain assessment and monitoring called PainCheck.\u0000 \u0000 \u0000 \u0000 The primary outcome was pain severity (measured using the Brief Pain Inventory). The secondary outcomes included pain interference (measured using the Brief Pain Inventory), participants’ pain knowledge and experience, and cost-effectiveness. We estimated costs and health-related quality-of-life outcomes using decision modelling and a separate within-trial economic analysis. We calculated incremental cost-effectiveness ratios per quality-adjusted life-year for the trial period.\u0000 \u0000 \u0000 \u0000 Work package 1 – We found barriers to and variation in the co-ordination of advanced cancer care by oncology and primary care professionals. We identified that the median time between referral to palliative care services and death for 42,758 patients in the UK was 48 days. We identified key components for self-management and developed and tested our Tackling Cancer Pain resource for acceptability. Work package 2 – Patients with advanced cancer and their health professionals recognised the benefits of an electronic system to monitor pain, but had reservations about how such a system might work in practice. We developed and tested a prototype PainCheck system. Work package 3 – We found that strong opioids were prescribed for 48% of patients in the last year of life at a median of 9 weeks before death. We delivered Medicines Use Reviews to patients, in which many medicines-related problems were identified. Work package 4 – A total of 161 oncology outpatients were randomised in our clinical trial, receiving either supported self-management (n = 80) or usual care (n = 81); their median survival from randomisation was 53 weeks. Primary and sensitivity analyses found no significant treatment differences for the primary outcome or for other ","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86452851","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}

{"title":"Case-finding and improving patient outcomes for chronic obstructive pulmonary disease in primary care: the BLISS research programme including cluster RCT","authors":"P. Adab, R. Jordan, D. Fitzmaurice, J. Ayres, K. Cheng, B. Cooper, A. Daley, A. Dickens, A. Enocson, Sheila M. Greenfield, Shamil Haroon, K. Jolly, S. Jowett, Tosin Lambe, James Martin, Martin R. Miller, K. Rai, R. Riley, S. Sadhra, A. Sitch, S. Siebert, R. Stockley, A. Turner","doi":"10.3310/pgfar09130","DOIUrl":"https://doi.org/10.3310/pgfar09130","url":null,"abstract":"\u0000 \u0000 Chronic obstructive pulmonary disease is a major contributor to morbidity, mortality and health service costs but is vastly underdiagnosed. Evidence on screening and how best to approach this is not clear. There are also uncertainties around the natural history (prognosis) of chronic obstructive pulmonary disease and how it impacts on work performance.\u0000 \u0000 \u0000 \u0000 Work package 1: to evaluate alternative methods of screening for undiagnosed chronic obstructive pulmonary disease in primary care, with clinical effectiveness and cost-effectiveness analyses and an economic model of a routine screening programme. Work package 2: to recruit a primary care chronic obstructive pulmonary disease cohort, develop a prognostic model [Birmingham Lung Improvement StudieS (BLISS)] to predict risk of respiratory hospital admissions, validate an existing model to predict mortality risk, address some uncertainties about natural history and explore the potential for a home exercise intervention. Work package 3: to identify which factors are associated with employment, absenteeism, presenteeism (working while unwell) and evaluate the feasibility of offering formal occupational health assessment to improve work performance.\u0000 \u0000 \u0000 \u0000 Work package 1: a cluster randomised controlled trial with household-level randomised comparison of two alternative case-finding approaches in the intervention arm. Work package 2: cohort study – focus groups. Work package 3: subcohort – feasibility study.\u0000 \u0000 \u0000 \u0000 Primary care settings in West Midlands, UK.\u0000 \u0000 \u0000 \u0000 Work package 1: 74,818 people who have smoked aged 40–79 years without a previous chronic obstructive pulmonary disease diagnosis from 54 general practices. Work package 2: 741 patients with previously diagnosed chronic obstructive pulmonary disease from 71 practices and participants from the work package 1 randomised controlled trial. Twenty-six patients took part in focus groups. Work package 3: occupational subcohort with 248 patients in paid employment at baseline. Thirty-five patients took part in an occupational health intervention feasibility study.\u0000 \u0000 \u0000 \u0000 Work package 1: targeted case-finding – symptom screening questionnaire, administered opportunistically or additionally by post, followed by diagnostic post-bronchodilator spirometry. The comparator was routine care. Work package 2: twenty-three candidate variables selected from literature and expert reviews. Work package 3: sociodemographic, clinical and occupational characteristics; occupational health assessment and recommendations.\u0000 \u0000 \u0000 \u0000 Work package 1: yield (screen-detected chronic obstructive pulmonary disease) and cost-effectiveness of case-finding; effectiveness of screening on respiratory hospitalisation and mortality after approximately 4 years. Work package 2: respiratory hospitalisation within 2 years, and barriers to and facilitators of physical activity. Work package 3: work performance – feasibility and acceptability of the occupational health intervention a","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76776918","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}

{"title":"Specialist cancer services for teenagers and young adults in England: BRIGHTLIGHT research programme","authors":"R. Taylor, L. Fern, J. Barber, F. Gibson, S. Lea, N. Patel, Stephen Morris, J. Álvarez-Gálvez, R. Feltbower, L. Hooker, A. Martins, D. Stark, R. Raine, J. Whelan","doi":"10.3310/pgfar09120","DOIUrl":"https://doi.org/10.3310/pgfar09120","url":null,"abstract":"\u0000 \u0000 When cancer occurs in teenagers and young adults, the impact is far beyond the physical disease and treatment burden. The effect on psychological, social, educational and other normal development can be profound. In addition, outcomes including improvements in survival and participation in clinical trials are poorer than in younger children and older adults with similar cancers. These unique circumstances have driven the development of care models specifically for teenagers and young adults with cancer, often focused on a dedicated purpose-designed patient environments supported by a multidisciplinary team with expertise in the needs of teenagers and young adults. In England, this is commissioned by NHS England and delivered through 13 principal treatment centres. There is a lack of evaluation that identifies the key components of specialist care for teenagers and young adults, and any improvement in outcomes and costs associated with it.\u0000 \u0000 \u0000 \u0000 To determine whether or not specialist services for teenagers and young adults with cancer add value.\u0000 \u0000 \u0000 \u0000 A series of multiple-methods studies centred on a prospective longitudinal cohort of teenagers and young adults who were newly diagnosed with cancer.\u0000 \u0000 \u0000 \u0000 Multiple settings, including an international Delphi study of health-care professionals, qualitative observation in specialist services for teenagers and young adults, and NHS trusts.\u0000 \u0000 \u0000 \u0000 A total of 158 international teenage and young adult experts, 42 health-care professionals from across England, 1143 teenagers and young adults, and 518 caregivers.\u0000 \u0000 \u0000 \u0000 The main outcomes were specific to each project: key areas of competence for the Delphi survey; culture of teenagers and young adults care in the case study; and unmet needs from the caregiver survey. The primary outcome for the cohort participants was quality of life and the cost to the NHS and patients in the health economic evaluation.\u0000 \u0000 \u0000 \u0000 Multiple sources were used, including responses from health-care professionals through a Delphi survey and face-to-face interviews, interview data from teenagers and young adults, the BRIGHTLIGHT survey to collect patient-reported data, patient-completed cost records, hospital clinical records, routinely collected NHS data and responses from primary caregivers.\u0000 \u0000 \u0000 \u0000 Competencies associated with specialist care for teenagers and young adults were identified from a Delphi study. The key to developing a culture of teenage and young adult care was time and commitment. An exposure variable, the teenagers and young adults Cancer Specialism Scale, was derived, allowing categorisation of patients to three groups, which were defined by the time spent in a principal treatment centre: SOME (some care in a principal treatment centre for teenagers and young adults, and the rest of their care in either a children’s or an adult cancer unit), ALL (all care in a principal treatment centre for teenagers and young adults) or NONE (no care in a principal treatm","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81294916","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}

{"title":"An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT","authors":"M. Wildman, A. O’Cathain, D. Hind, Chin Maguire, M. Arden, M. Hutchings, J. Bradley, S. Walters, P. Whelan, J. Ainsworth, P. Tappenden, I. Buchan, R. Elliott, J. Nicholl, S. Elborn, S. Michie, L. Mandefield, L. Sutton, Z. Hoo, S. Drabble, E. Lumley, D. Beever, A. Navega Biz, Anne Scott, S. Waterhouse, L. Robinson, Mónica Hernández Alava, A. Sasso","doi":"10.3310/pgfar09110","DOIUrl":"https://doi.org/10.3310/pgfar09110","url":null,"abstract":"\u0000 \u0000 People with cystic fibrosis frequently have low levels of adherence to inhaled medications.\u0000 \u0000 \u0000 \u0000 The objectives were to develop and evaluate an intervention for adults with cystic fibrosis to improve adherence to their inhaled medication.\u0000 \u0000 \u0000 \u0000 We used agile software methods to develop an online platform. We used mixed methods to develop a behaviour change intervention for delivery by an interventionist. These were integrated to become the CFHealthHub intervention. We undertook a feasibility study consisting of a pilot randomised controlled trial and process evaluation in two cystic fibrosis centres. We evaluated the intervention using an open-label, parallel-group randomised controlled trial with usual care as the control. Participants were randomised in a 1 : 1 ratio to intervention or usual care. Usual care consisted of clinic visits every 3 months. We undertook a process evaluation alongside the randomised controlled trial, including a fidelity study, a qualitative interview study and a mediation analysis. We undertook a health economic analysis using both a within-trial and model-based analysis.\u0000 \u0000 \u0000 \u0000 The randomised controlled trial took place in 19 UK cystic fibrosis centres.\u0000 \u0000 \u0000 \u0000 Participants were people aged ≥ 16 years with cystic fibrosis, on the cystic fibrosis registry, not post lung transplant or on the active transplant list, who were able to consent and not using dry-powder inhalers.\u0000 \u0000 \u0000 \u0000 People with cystic fibrosis used a nebuliser with electronic monitoring capabilities. This transferred data automatically to a digital platform. People with cystic fibrosis and clinicians could monitor adherence using these data, including through a mobile application (app). CFHealthHub displayed graphs of adherence data as well as educational and problem-solving information. A trained interventionist helped people with cystic fibrosis to address their adherence.\u0000 \u0000 \u0000 \u0000 Randomised controlled trial – adjusted incidence rate ratio of pulmonary exacerbations meeting the modified Fuchs criteria over a 12-month follow-up period (primary outcome); change in percentage adherence; and per cent predicted forced expiratory volume in 1 second (key secondary outcomes). Process evaluation – percentage fidelity to intervention delivery, and participant and interventionist perceptions of the intervention. Economic modelling – incremental cost per quality-adjusted life-year gained.\u0000 \u0000 \u0000 \u0000 Randomised controlled trial – 608 participants were randomised to the intervention (n = 305) or usual care (n = 303). To our knowledge, this was the largest randomised controlled trial in cystic fibrosis undertaken in the UK. The adjusted rate of exacerbations per year (primary outcome) was 1.63 in the intervention and 1.77 in the usual-care arm (incidence rate ratio 0.96, 95% confidence interval 0.83 to 1.12; p = 0.638) after adjustment for covariates. The adjusted difference in mean weekly normative adherence was 9.5% (95% confidence interval 8.6% to 10.4%) across 1","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77948846","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}

{"title":"Intensive therapy for moderate established rheumatoid arthritis: the TITRATE research programme","authors":"D. Scott, F. Ibrahim, H. Hill, B. Tom, L. Prothero, R. Baggott, A. Bosworth, J. Galloway, S. Georgopoulou, N. Martin, Isabel Neatrour, E. Nikiphorou, J. Sturt, A. Wailoo, F. Williams, Ruth Williams, H. Lempp","doi":"10.3310/pgfar09080","DOIUrl":"https://doi.org/10.3310/pgfar09080","url":null,"abstract":"\u0000 \u0000 Rheumatoid arthritis is a major inflammatory disorder and causes substantial disability. Treatment goals span minimising disease activity, achieving remission and decreasing disability. In active rheumatoid arthritis, intensive management achieves these goals. As many patients with established rheumatoid arthritis have moderate disease activity, the TITRATE (Treatment Intensities and Targets in Rheumatoid Arthritis ThErapy) programme assessed the benefits of intensive management.\u0000 \u0000 \u0000 \u0000 To (1) define how to deliver intensive therapy in moderate established rheumatoid arthritis; (2) establish its clinical effectiveness and cost-effectiveness in a trial; and (3) evaluate evidence supporting intensive management in observational studies and completed trials.\u0000 \u0000 \u0000 \u0000 Observational studies, secondary analyses of completed trials and systematic reviews assessed existing evidence about intensive management. Qualitative research, patient workshops and systematic reviews defined how to deliver it. The trial assessed its clinical effectiveness and cost-effectiveness in moderate established rheumatoid arthritis.\u0000 \u0000 \u0000 \u0000 Observational studies (in three London centres) involved 3167 patients. These were supplemented by secondary analyses of three previously completed trials (in centres across all English regions), involving 668 patients. Qualitative studies assessed expectations (nine patients in four London centres) and experiences of intensive management (15 patients in 10 centres across England). The main clinical trial enrolled 335 patients with diverse socioeconomic deprivation and ethnicity (in 39 centres across all English regions).\u0000 \u0000 \u0000 \u0000 Patients with established moderately active rheumatoid arthritis receiving conventional disease-modifying drugs.\u0000 \u0000 \u0000 \u0000 Intensive management used combinations of conventional disease-modifying drugs, biologics (particularly tumour necrosis factor inhibitors) and depot steroid injections; nurses saw patients monthly, adjusted treatment and provided supportive person-centred psychoeducation. Control patients received standard care.\u0000 \u0000 \u0000 \u0000 Disease Activity Score for 28 joints based on the erythrocyte sedimentation rate (DAS28-ESR)-categorised patients (active to remission). Remission (DAS28-ESR < 2.60) was the treatment target. Other outcomes included fatigue (measured on a 100-mm visual analogue scale), disability (as measured on the Health Assessment Questionnaire), harms and resource use for economic assessments.\u0000 \u0000 \u0000 \u0000 Evaluation of existing evidence for intensive rheumatoid arthritis management showed the following. First, in observational studies, DAS28-ESR scores decreased over 10–20 years, whereas remissions and treatment intensities increased. Second, in systematic reviews of published trials, all intensive management strategies increased remissions. Finally, patients with high disability scores had fewer remissions. Qualitative studies of rheumatoid arthritis patients, workshops and systematic reviews helped","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87762586","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}

{"title":"Long-term monitoring in primary care for chronic kidney disease and chronic heart failure: a multi-method research programme","authors":"R. Perera, R. Stevens, J. Aronson, A. Banerjee, Julie Evans, B. Feakins, S. Fleming, P. Glasziou, C. Heneghan, F. R. Hobbs, L. Jones, M. Kurtinecz, D. Lasserson, L. Locock, J. Mclellan, B. Mihaylova, C. O'Callaghan, J. Oke, Nicola Pidduck, A. Plüddemann, N. Roberts, I. Schlackow, B. Shine, Claire L. Simons, C. Taylor, K. Taylor, J. Verbakel, C. Bankhead","doi":"10.3310/pgfar09100","DOIUrl":"https://doi.org/10.3310/pgfar09100","url":null,"abstract":"\u0000 \u0000 Long-term monitoring is important in chronic condition management. Despite considerable costs of monitoring, there is no or poor evidence on how, what and when to monitor. The aim of this study was to improve understanding, methods, evidence base and practice of clinical monitoring in primary care, focusing on two areas: chronic kidney disease and chronic heart failure.\u0000 \u0000 \u0000 \u0000 The research questions were as follows: does the choice of test affect better care while being affordable to the NHS? Can the number of tests used to manage individuals with early-stage kidney disease, and hence the costs, be reduced? Is it possible to monitor heart failure using a simple blood test? Can this be done using a rapid test in a general practitioner consultation? Would changes in the management of these conditions be acceptable to patients and carers?\u0000 \u0000 \u0000 \u0000 Various study designs were employed, including cohort, feasibility study, Clinical Practice Research Datalink analysis, seven systematic reviews, two qualitative studies, one cost-effectiveness analysis and one cost recommendation.\u0000 \u0000 \u0000 \u0000 This study was set in UK primary care.\u0000 \u0000 \u0000 \u0000 Data were collected from study participants and sourced from UK general practice and hospital electronic health records, and worldwide literature.\u0000 \u0000 \u0000 \u0000 The participants were NHS patients (Clinical Practice Research Datalink: 4.5 million patients), chronic kidney disease and chronic heart failure patients managed in primary care (including 750 participants in the cohort study) and primary care health professionals.\u0000 \u0000 \u0000 \u0000 The interventions were monitoring with blood and urine tests (for chronic kidney disease) and monitoring with blood tests and weight measurement (for chronic heart failure).\u0000 \u0000 \u0000 \u0000 The main outcomes were the frequency, accuracy, utility, acceptability, costs and cost-effectiveness of monitoring.\u0000 \u0000 \u0000 \u0000 Chronic kidney disease: serum creatinine testing has increased steadily since 1997, with most results being normal (83% in 2013). Increases in tests of creatinine and proteinuria correspond to their introduction as indicators in the Quality and Outcomes Framework. The Chronic Kidney Disease Epidemiology Collaboration equation had 2.7% greater accuracy (95% confidence interval 1.6% to 3.8%) than the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate. Estimated annual transition rates to the next chronic kidney disease stage are ≈ 2% for people with normal urine albumin, 3–5% for people with microalbuminuria (3–30 mg/mmol) and 3–12% for people with macroalbuminuria (> 30 mg/mmol). Variability in estimated glomerular filtration rate-creatinine leads to misclassification of chronic kidney disease stage in 12–15% of tests in primary care. Glycaemic-control and lipid-modifying drugs are associated with a 6% (95% confidence interval 2% to 10%) and 4% (95% confidence interval 0% to 8%) improvement in renal function, respectively. Neither estimated glomerular filtration rate-crea","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78601780","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}

{"title":"Strategies to enhance routine physical activity in care home residents: the REACH research programme including a cluster feasibility RCT","authors":"A. Forster, M. Godfrey, John Green, Nicola McMaster, Jennifer Airlie, B. Cundill, R. Lawton, R. Hawkins, C. Hulme, K. Birch, L. Brown, Robert Cicero, T. Crocker, B. Dawkins, D. Ellard, A. Ellwood, Joan Firth, Beverley Gallagher, Liz Graham, Louise Johnson, A. Lusambili, J. Marti, carolyn mccrorie, Vicki McLellan, I. Patel, A. Prashar, N. Siddiqi, D. Trépel, I. Wheeler, A. Wright, John Young, A. Farrin","doi":"10.3310/pgfar09090","DOIUrl":"https://doi.org/10.3310/pgfar09090","url":null,"abstract":"\u0000 \u0000 Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity.\u0000 \u0000 \u0000 \u0000 The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams.\u0000 \u0000 \u0000 \u0000 This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5).\u0000 \u0000 \u0000 \u0000 The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK.\u0000 \u0000 \u0000 \u0000 The participants were elderly residents, carers, managers and staff of care homes.\u0000 \u0000 \u0000 \u0000 The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines.\u0000 \u0000 \u0000 \u0000 The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5).\u0000 \u0000 \u0000 \u0000 Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and su","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84573944","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}

{"title":"Improving the diagnosis and management of Lewy body dementia: the DIAMOND-Lewy research programme including pilot cluster RCT","authors":"J. O'Brien, John-Paul Taylor, Alan J. Thomas, C. Bamford, L. Vale, Sarah R Hill, L. Allan, T. Finch, R. McNally, L. Hayes, A. Surendranathan, J. Kane, A. Chrysos, A. Bentley, S. Barker, J. Mason, D. Burn, I. McKeith","doi":"10.3310/PGFAR09070","DOIUrl":"https://doi.org/10.3310/PGFAR09070","url":null,"abstract":"\u0000 \u0000 \u0000 Lewy body dementia, comprising both dementia with Lewy bodies and Parkinson’s disease dementia, is the second commonest cause of neurodegenerative dementia. Existing evidence suggests that it is underdiagnosed and without a consistent approach to management.\u0000 \u0000 \u0000 \u0000 To improve the diagnosis and management of Lewy body dementia by (1) understanding current diagnostic practice for dementia with Lewy bodies and Parkinson’s disease dementia; (2) identifying barriers to and facilitators of diagnosis and management; (3) developing evidence-based assessment toolkits to improve diagnosis of dementia with Lewy bodies and Parkinson’s disease dementia; (4) producing a management toolkit to facilitate management; and (5) undertaking a pilot cluster randomised clinical trial.\u0000 \u0000 \u0000 \u0000 Work package 1 assessed clinical diagnostic rates from case notes for dementia with Lewy bodies and Parkinson’s disease dementia before and after (work package 1 repeated) introduction of an assessment toolkit. In work package 2, we developed a management toolkit for Lewy body dementia. In work package 3, we developed assessment toolkits for dementia with Lewy bodies and Parkinson’s disease dementia and piloted these and the management toolkit in a clinical service. In work package 4, we undertook a pilot study of 23 services in nine NHS trusts that were cluster randomised to receiving and using the management toolkit or standard care. Work package 5 comprised a series of qualitative studies, examining barriers to and facilitators of diagnosis and management.\u0000 \u0000 \u0000 \u0000 Secondary care memory assessment and movement disorder services in England.\u0000 \u0000 \u0000 \u0000 Assessment toolkits for Lewy body dementia consisted of questions for diagnostic symptoms, and management toolkits comprised 161 guidance statements grouped under five symptom domains.\u0000 \u0000 \u0000 \u0000 The systematic reviews of pharmacological and non-pharmacological management were based on published literature, with meta-analysis when possible, following a search of several electronic databases and the grey literature using terms related to Lewy body dementia, without restriction on time or language.\u0000 \u0000 \u0000 \u0000 Participants aged ≥ 50 years diagnosed with dementia with Lewy bodies or Parkinson’s disease dementia and, for work package 1 and work package 1 repeated, non-dementia with Lewy bodies and non-Parkinson’s disease dementia controls. The qualitative studies included people with Lewy body dementia, carers and professionals.\u0000 \u0000 \u0000 \u0000 For work packages 1 and 1 repeated, diagnostic rates for dementia with Lewy bodies and Parkinson’s disease dementia as a proportion of all dementia or Parkinson’s disease. For work packages 2 and 3, the production of diagnostic and management toolkits. For work package 4, feasibility of undertaking a cluster randomised trial of the toolkits, measured by number of participants recruited and use of the toolkits, assessed qualitatively.\u0000 \u0000 \u0000 \u0000 Work package 1 – 4.6% of dementia cases in secondary care received a demen","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89077670","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}