Programme Grants for Applied Research最新文献

{"title":"Crisis resolution teams for people experiencing mental health crises: the CORE mixed-methods research programme including two RCTs","authors":"B. Lloyd-Evans, Marina Christoforou, D. Osborn, G. Ambler, L. Marston, Danielle Lamb, O. Mason, N. Morant, S. Sullivan, C. Henderson, R. Hunter, S. Pilling, F. Nolan, R. Gray, T. Weaver, K. Kelly, Nicky Goater, A. Milton, Elaine Johnston, Kate Fullarton, M. Lean, Beth Paterson, Jonathan Piotrowski, Michael Davidson, Rebecca Forsyth, L. Mosse, M. Leverton, Puffin O’Hanlon, E. Mundy, T. Mundy, E. Brown, Sarah Fahmy, Emma Burgess, A. Churchard, C. Wheeler, Hannah Istead, D. Hindle, Sonia Johnson","doi":"10.3310/PGFAR07010","DOIUrl":"https://doi.org/10.3310/PGFAR07010","url":null,"abstract":"\u0000 \u0000 Crisis resolution teams (CRTs) seek to avert hospital admissions by providing intensive home treatment for people experiencing a mental health crisis. The CRT model has not been highly specified. CRT care is often experienced as ending abruptly and relapse rates following CRT discharge are high.\u0000 \u0000 \u0000 \u0000 The aims of CORE (Crisis resolution team Optimisation and RElapse prevention) workstream 1 were to specify a model of best practice for CRTs, develop a measure to assess adherence to this model and evaluate service improvement resources to help CRTs implement the model with high fidelity. The aim of CORE workstream 2 was to evaluate a peer-provided self-management programme aimed at reducing relapse following CRT support.\u0000 \u0000 \u0000 \u0000 Workstream 1 was based on a systematic review, national CRT manager survey and stakeholder qualitative interviews to develop a CRT fidelity scale through a concept mapping process with stakeholders (n = 68). This was piloted in CRTs nationwide (n = 75). A CRT service improvement programme (SIP) was then developed and evaluated in a cluster randomised trial: 15 CRTs received the SIP over 1 year; 10 teams acted as controls. The primary outcome was service user satisfaction. Secondary outcomes included CRT model fidelity, catchment area inpatient admission rates and staff well-being. Workstream 2 was a peer-provided self-management programme that was developed through an iterative process of systematic literature reviewing, stakeholder consultation and preliminary testing. This intervention was evaluated in a randomised controlled trial: 221 participants recruited from CRTs received the intervention and 220 did not. The primary outcome was re-admission to acute care at 1 year of follow-up. Secondary outcomes included time to re-admission and number of days in acute care over 1 year of follow-up and symptoms and personal recovery measured at 4 and 18 months’ follow-up.\u0000 \u0000 \u0000 \u0000 Workstream 1 – a 39-item CRT fidelity scale demonstrated acceptability, face validity and promising inter-rater reliability. CRT implementation in England was highly variable. The SIP trial did not produce a positive result for patient satisfaction [median Client Satisfaction Questionnaire score of 28 in both groups at follow-up; coefficient 0.97, 95% confidence interval (CI) –1.02 to 2.97]. The programme achieved modest increases in model fidelity. Intervention teams achieved lower inpatient admission rates and less inpatient bed use. Qualitative evaluation suggested that the programme was generally well received. Workstream 2 – the trial yielded a statistically significant result for the primary outcome, in which rates of re-admission to acute care over 1 year of follow-up were lower in the intervention group than in the control group (odds ratio 0.66, 95% CI 0.43 to 0.99; p = 0.044). Time to re-admission was lower and satisfaction with care was greater in the intervention group at 4 months’ follow-up. There were no other significant differences betw","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80164896","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":"Patient involvement in improving the evidence base on mental health inpatient care: the PERCEIVE programme","authors":"T. Wykes, E. Csipke, D. Rose, T. Craig, P. McCrone, P. Williams, L. Koeser, Stephen Nash","doi":"10.3310/PGFAR06070","DOIUrl":"https://doi.org/10.3310/PGFAR06070","url":null,"abstract":"Despite the movement towards care in the community, 40% of the NHS budget on mental health care is still attributed to inpatient services. However, long before the Francis Report highlighted grave shortcomings in inpatient care, there were reports by service user groups on the poor quality of these services in mental health. The programme provides a particular focus on the inclusion of the patient’s perspective in the development and evaluation of evidence.To understand how changes to inpatient care affect the perceptions of the ward by service users and staff by using stakeholder participatory methods.The programme consisted of four work packages (WPs). (1) Lasting Improvements for Acute Inpatient SEttings (LIAISE): using participatory methods we developed two new scales [Views On Therapeutic Environment (VOTE) for staff and Views On Inpatient CarE (VOICE) for service users]. (2) Client Services Receipt Inventory – Inpatient (CITRINE): working with nurses and service users we developed a health economic measure of the amount of contact service users have with staff. The self-report measure records interactions with staff as well as the number of therapeutic activities attended. (3) Delivering Opportunities for Recovery (DOORWAYS): a stepped-wedge randomised controlled trial to test if training ward nurses to deliver therapeutic group activities would improve the perception of the ward by service users and staff. A total of 16 wards were progressively randomised and we compared the VOICE, VOTE and CITRINE measures before and after the intervention. A total of 1108 service users and 539 staff participated in this trial. (4) Bringing Emergency TreatmenT to Early Resolution (BETTER PATHWAYS) was an observational study comparing two service systems. The first was a ‘triage’ system in which service users were admitted to the triage ward and then either transferred to their locality wards or discharged back into the community within 7 days. The second system was routine care. We collected data from 454 service users and 284 nurses on their perceptions of the wards.The main outcomes for the DOORWAYS and BETTER project were service user and staff perceptions of the ward (VOICE and VOTE, respectively) and the health economic measure was CITRINE. All were developed in WPs 1 and 2.We developed reliable and valid measures of (1) the perceptions of inpatient care from the perspectives of service users and nurses (VOICE and VOTE) and (2) costs of interactions that were valued by service users (CITRINE). In the DOORWAYS project, after adjusting for legal status, we found weak evidence for benefit (standardised effect of –0.18, 95% CI 0.38 improvement to 0.01 deterioration;p = 0.062). There was only a significant benefit for involuntary patients following the staff training (N582, standardised effect of –0.35, 95% CI –0.57 to –0.12;p = 0.002; interactionp-value 0.006). VOTE scores did not change over time (standardised effect size of 0.04, 95% CI –0.09 to 0.18;p","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79126135","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":"A web-based self-management programme for people with type 2 diabetes: the HeLP-Diabetes research programme including RCT","authors":"E. Murray, J. Ross, K. Pal, Jinshuo Li, C. Dack, F. Stevenson, M. Sweeting, S. Parrott, M. Barnard, L. Yardley, S. Michie, C. May, D. Patterson, G. Alkhaldi, B. Fisher, A. Farmer, O. O’Donnell","doi":"10.3310/PGFAR06050","DOIUrl":"https://doi.org/10.3310/PGFAR06050","url":null,"abstract":"\u0000 \u0000 In the UK, 6% of the UK population have diabetes mellitus, 90% of whom have type 2 diabetes mellitus (T2DM). Diabetes mellitus accounts for 10% of NHS expenditure (£14B annually). Good self-management may improve health outcomes. NHS policy is to refer all people with T2DM to structured education, on diagnosis, to improve their self-management skills, with annual reinforcement thereafter. However, uptake remains low (5.6% in 2014–15). Almost all structured education is group based, which may not suit people who work, who have family or other caring commitments or who simply do not like group-based formats. Moreover, patient needs vary with time and a single education session at diagnosis is unlikely to meet these evolving needs. A web-based programme may increase uptake.\u0000 \u0000 \u0000 \u0000 Our aim was to develop, evaluate and implement a web-based self-management programme for people with T2DM at any stage of their illness journey, with the goal of improving access to, and uptake of, self-management support, thereby improving health outcomes in a cost-effective manner. Specific objectives were to (1) develop an evidence-based theoretically informed programme that was acceptable to patients and health-care professionals (HCPs) and that could be readily implemented within routine NHS care, (2) determine the clinical effectiveness and cost-effectiveness of the programme compared with usual care and (3) determine how best to integrate the programme into routine care.\u0000 \u0000 \u0000 \u0000 There were five linked work packages (WPs). WP A determined patient requirements and WP B determined HCP requirements for the self-management programme. WP C developed and user-tested the Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) programme. WP D was an individually randomised controlled trial in primary care with a health economic analysis. WP E used a mixed-methods and case-study design to study the potential for implementing the HeLP-Diabetes programme within routine NHS practice.\u0000 \u0000 \u0000 \u0000 English primary care.\u0000 \u0000 \u0000 \u0000 People with T2DM (WPs A, D and E) or HCPs caring for people with T2DM (WPs B, C and E).\u0000 \u0000 \u0000 \u0000 The HeLP-Diabetes programme; an evidence-based theoretically informed web-based self-management programme for people with T2DM at all stages of their illness journey, developed using participatory design principles.\u0000 \u0000 \u0000 \u0000 WPs A and B provided data on user ‘wants and needs’, including factors that would improve the uptake and accessibility of the HeLP-Diabetes programme. The outcome for WP C was the HeLP-Diabetes programme itself. The trial (WP D) had two outcomes measures: glycated haemoglobin (HbA1c) level and diabetes mellitus-related distress, as measured with the Problem Areas in Diabetes (PAID) scale. The implementation outcomes (WP E) were the adoption and uptake at clinical commissioning group, general practice and patient levels and the identification of key barriers and facilitators.\u0000 \u0000 \u0000 \u0000 Data from WPs A and B supported our holistic approach and add","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81068253","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":"Reducing relapse and suicide in bipolar disorder: practical clinical approaches to identifying risk, reducing harm and engaging service users in planning and delivery of care – the PARADES (Psychoeducation, Anxiety, Relapse, Advance Directive Evaluation and Suicidality) programme","authors":"S. Jones, L. Riste, C. Barrowclough, P. Bartlett, C. Clements, L. Davies, F. Holland, N. Kapur, F. Lobban, R. Long, R. Morriss, S. Peters, C. Roberts, E. Camacho, L. Gregg, D. Ntais","doi":"10.3310/PGFAR06060","DOIUrl":"https://doi.org/10.3310/PGFAR06060","url":null,"abstract":"Bipolar disorder (BD) costs £5.2B annually, largely as a result of incomplete recovery after inadequate treatment.A programme of linked studies to reduce relapse and suicide in BD.There were five workstreams (WSs): a pragmatic randomised controlled trial (RCT) of group psychoeducation (PEd) versus group peer support (PS) in the maintenance of BD (WS1); development and feasibility RCTs of integrated psychological therapy for anxiety in bipolar disorder (AIBD) and integrated for problematic alcohol use in BD (WS2 and WS3); survey and qualitative investigations of suicide and self-harm in BD (WS4); and survey and qualitative investigation of service users’ (SUs) and psychiatrists’ experience of the Mental Capacity Act 2005 (MCA), with reference to advance planning (WS5).Participants were from England; recruitment into RCTs was limited to certain sites [East Midlands and North West (WS1); North West (WS2 and WS3)].Aged ≥ 18 years. In WS1–3, participants had their diagnosis of BD confirmed by the Structural Clinical Interview for theDiagnostic and Statistical Manual of Mental Disorders.In WS1, group PEd/PS; in WS3 and WS4, individual psychological therapy for comorbid anxiety and alcohol use, respectively.In WS1, time to relapse of bipolar episode; in WS2 and WS3, feasibility and acceptability of interventions; in WS4, prevalence and determinants of suicide and self-harm; and in WS5, professional training and support of advance planning in MCA, and SU awareness and implementation.Group PEd and PS could be routinely delivered in the NHS. The estimated median time to first bipolar relapse was 67.1 [95% confidence interval (CI) 37.3 to 90.9] weeks in PEd, compared with 48.0 (95% CI 30.6 to 65.9) weeks in PS. The adjusted hazard ratio was 0.83 (95% CI 0.62 to 1.11; likelihood ratio testp = 0.217). The interaction between the number of previous bipolar episodes (1–7 and 8–19, relative to 20+) and treatment arm was significant (χ2 = 6.80, degrees of freedom = 2;p = 0.034): PEd with one to seven episodes showed the greatest delay in time to episode. A primary economic analysis indicates that PEd is not cost-effective compared with PS. A sensitivity analysis suggests potential cost-effectiveness if decision-makers accept a cost of £37,500 per quality-adjusted life-year. AIBD and motivational interviewing (MI) cognitive–behavioural therapy (CBT) trials were feasible and acceptable in achieving recruitment and retention targets (AIBD:n = 72, 72% retention to follow-up; MI-CBT:n = 44, 75% retention) and in-depth qualitative interviews. There were no significant differences in clinical outcomes for either trial overall. The factors associated with risk of suicide and self-harm (longer duration of illness, large number of periods of inpatient care, and problems establishing diagnosis) could inform improved clinical care and specific interventions. Qualitative interviews suggested that suicide risk had been underestimated, that care needs to be more collaborative a","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87530210","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":"Optimal primary care management of clinical osteoarthritis and joint pain in older people: a mixed-methods programme of systematic reviews, observational and qualitative studies, and randomised controlled trials","authors":"E. Hay, K. Dziedzic, N. Foster, G. Peat, D. Windt, B. Bartlam, M. Blagojevic-Bucknall, J. Edwards, E. Healey, M. Holden, R. Hughes, C. Jinks, K. Jordan, S. Jowett, Martyn Lewis, C. Mallen, A. Morden, E. Nicholls, B. N. Ong, M. Porcheret, J. Wulff, J. Kigozi, Raymond Oppong, Z. Paskins, P. Croft","doi":"10.3310/PGFAR06040","DOIUrl":"https://doi.org/10.3310/PGFAR06040","url":null,"abstract":"Osteoarthritis (OA) is the most common long-term condition managed in UK general practice. However, care is suboptimal despite evidence that primary care and community-based interventions can reduce OA pain and disability.The overall aim was to improve primary care management of OA and the health of patients with OA. Four parallel linked workstreams aimed to (1) develop a health economic decision model for estimating the potential for cost-effective delivery of primary care OA interventions to improve population health, (2) develop and evaluate new health-care models for delivery of core treatments and support for self-management among primary care consulters with OA, and to investigate prioritisation and implementation of OA care among the public, patients, doctors, health-care professionals and NHS trusts, (3) determine the effectiveness of strategies to optimise specific components of core OA treatment using the example of exercise and (4) investigate the effect of interventions to tackle barriers to core OA treatment, using the example of comorbid anxiety and depression in persons with OA.The North Staffordshire Osteoarthritis Project database, held by Keele University, was the source of data for secondary analyses in workstream 1.Workstream 1 used meta-analysis and synthesis of published evidence about effectiveness of primary care treatments, combined with secondary analysis of existing longitudinal population-based cohort data, to identify predictors of poor long-term outcome (prognostic factors) and design a health economic decision model to estimate cost-effectiveness of different hypothetical strategies for implementing optimal primary care for patients with OA. Workstream 2 used mixed methods to (1) develop and test a ‘model OA consultation’ for primary care health-care professionals (qualitative interviews, consensus, training and evaluation) and (2) evaluate the combined effect of a computerised ‘pop-up’ guideline for general practitioners (GPs) in the consultation and implementing the model OA consultation on practice and patient outcomes (parallel group intervention study). Workstream 3 developed and investigated in a randomised controlled trial (RCT) how to optimise the effect of exercise in persons with knee OA by tailoring it to the individual and improving adherence. Workstream 4 developed and investigated in a cluster RCT the extent to which screening patients for comorbid anxiety and depression can improve OA outcomes. Public and patient involvement included proposal development, project steering and analysis. An OA forum involved public, patient, health professional, social care and researcher representatives to debate the results and formulate proposals for wider implementation and dissemination.This programme provides evidence (1) that economic modelling can be used in OA to extrapolate findings of cost-effectiveness beyond the short-term outcomes of clinical trials, (2) about ways of implementing support for self-manageme","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76588513","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":"Crossing the divide: a longitudinal study of effective treatments for people with autism and attention deficit hyperactivity disorder across the lifespan","authors":"D. Murphy, K. Glaser, H. Hayward, Hanna Eklund, T. Cadman, James L. Findon, Emma Woodhouse, K. Ashwood, J. Beecham, P. Bolton, F. McEwen, Ellie L. Wilson, C. Ecker, I. Wong, E. Simonoff, A. Russell, J. McCarthy, E. Chaplin, S. Young, P. Asherson","doi":"10.3310/PGFAR06020","DOIUrl":"https://doi.org/10.3310/PGFAR06020","url":null,"abstract":"Autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) frequently persist into adolescence and young adulthood. However, there are few clinical services that support those with these disorders through adulthood.Our aim was to determine if clinical services meet the needs of people with ASD and ADHD, who are ‘at transition’ from childhood to adulthood.A longitudinal study of individuals with ASD and ADHD, the impact of services and treatments.Our research methods included (1) interviewing > 180 affected individuals (and their families) with a confirmed diagnosis of ASD and/or ADHD, (2) screening for ASD and ADHD in approximately 1600 patients and (3) surveying general practitioner prescribing to 5651 ASD individuals across the UK. In addition, we tested the effectiveness of (1) new ASD diagnostic interview measures in 169 twins, 145 familes and 150 non-twins, (2) a magnetic resonance imaging-based diagnostic aid in 40 ASD individuals, (3) psychological treatments in 46 ASD individuals and (4) the feasability of e-learning in 28 clinicians.NHS clinical services and prisons.Focus – young people with ASD and ADHD as they ‘transition’ from childhood and adolescence into early adulthood.Testing the utility of diagnostic measures and services, web-based learning interventions, pharmacological prescribing and cognitive–behavioural treatments.Symptom severity, service provision and met/unmet need.People with ASD and ADHD have very significant unmet needs as they transition through adolescence and young adulthood. A major contributor to this is the presence of associated mental health symptoms. However, these are mostly undiagnosed (and untreated) by clinical services. Furthermore, the largest determinant of service provision was age and not severity of symptoms. We provide new tools to help diagnose both the core disorders and their associated symptoms. We also provide proof of concept for the effectiveness of simple psychological interventions to treat obsessional symptoms, the potential to run treatment trials in prisons and training interventions.Our findings only apply to clinical service settings.As individuals ‘transition’ their contact with treatment and support services reduces significantly. Needs-led services are required, which can both identify individuals with the ‘core symptoms’ of ASD and ADHD and treat their residual symptoms and associated conditions.To test our new diagnostic measures and treatment approaches in larger controlled trials.Current Controlled Trials ISRCTN87114880.The National Institute for Health Research Programme Grants for Applied Research programme.","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80474223","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":"Methods for the evaluation of biomarkers in patients with kidney and liver diseases: multicentre research programme including ELUCIDATE RCT","authors":"P. Selby, R. Banks, W. Gregory, J. Hewison, W. Rosenberg, D. Altman, J. Deeks, C. McCabe, J. Parkes, C. Sturgeon, D. Thompson, M. Twiddy, J. Bestall, Joan Bedlington, Tilly Hale, J. Dinnes, Marc Jones, A. Lewington, M. Messenger, V. Napp, A. Sitch, S. Tanwar, N. Vasudev, P. Baxter, S. Bell, D. Cairns, N. Calder, N. Corrigan, F. del Galdo, P. Heudtlass, N. Hornigold, C. Hulme, Michelle Hutchinson, C. Lippiatt, Tobias Livingstone, R. Longo, M. Potton, S. Roberts, S. Sim, Sebastian Trainor, Matthew P Welberry Smith, J. Neuberger, D. Thorburn, P. Richardson, J. Christie, N. Sheerin, W. Mckane, P. Gibbs, Anusha Edwards, N. Soomro, A. Adeyoju, G. Stewart, D. Hrouda","doi":"10.3310/PGFAR06030","DOIUrl":"https://doi.org/10.3310/PGFAR06030","url":null,"abstract":"Protein biomarkers with associations with the activity and outcomes of diseases are being identified by modern proteomic technologies. They may be simple, accessible, cheap and safe tests that can inform diagnosis, prognosis, treatment selection, monitoring of disease activity and therapy and may substitute for complex, invasive and expensive tests. However, their potential is not yet being realised.The study consisted of three workstreams to create a framework for research: workstream 1, methodology – to define current practice and explore methodology innovations for biomarkers for monitoring disease; workstream 2, clinical translation – to create a framework of research practice, high-quality samples and related clinical data to evaluate the validity and clinical utility of protein biomarkers; and workstream 3, the ELF to Uncover Cirrhosis as an Indication for Diagnosis and Action for Treatable Event (ELUCIDATE) randomised controlled trial (RCT) – an exemplar RCT of an established test, the ADVIA Centaur® Enhanced Liver Fibrosis (ELF) test (Siemens Healthcare Diagnostics Ltd, Camberley, UK) [consisting of a panel of three markers – (1) serum hyaluronic acid, (2) amino-terminal propeptide of type III procollagen and (3) tissue inhibitor of metalloproteinase 1], for liver cirrhosis to determine its impact on diagnostic timing and the management of cirrhosis and the process of care and improving outcomes.The methodology workstream evaluated the quality of recommendations for using prostate-specific antigen to monitor patients, systematically reviewed RCTs of monitoring strategies and reviewed the monitoring biomarker literature and how monitoring can have an impact on outcomes. Simulation studies were conducted to evaluate monitoring and improve the merits of health care. The monitoring biomarker literature is modest and robust conclusions are infrequent. We recommend improvements in research practice. Patients strongly endorsed the need for robust and conclusive research in this area. The clinical translation workstream focused on analytical and clinical validity. Cohorts were established for renal cell carcinoma (RCC) and renal transplantation (RT), with samples and patient data from multiple centres, as a rapid-access resource to evaluate the validity of biomarkers. Candidate biomarkers for RCC and RT were identified from the literature and their quality was evaluated and selected biomarkers were prioritised. The duration of follow-up was a limitation but biomarkers were identified that may be taken forward for clinical utility. In the third workstream, the ELUCIDATE trial registered 1303 patients and randomised 878 patients out of a target of 1000. The trial started late and recruited slowly initially but ultimately recruited with good statistical power to answer the key questions. ELF monitoring altered the patient process of care and may show benefits from the early introduction of interventions with further follow-up. The ELUCIDATE trial wa","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79542381","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}