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
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. 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. 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. 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
{"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}
T. Wykes, E. Csipke, D. Rose, T. Craig, P. McCrone, P. Williams, L. Koeser, Stephen Nash
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
尽管朝着社区护理的方向发展，但国民保健制度用于精神保健的预算中仍有40%用于住院服务。然而，早在弗朗西斯报告强调住院治疗方面的严重缺陷之前，服务使用者群体就报告了这些精神卫生服务的质量很差。该方案提供了一个特别的重点，包括在证据的发展和评估患者的观点。通过使用利益相关者参与方法，了解住院护理的变化如何影响服务使用者和工作人员对病房的看法。该方案包括四个工作包。(1)急性住院环境的持续改善(LIAISE):使用参与式方法，我们开发了两个新的量表[对治疗环境的看法(投票)和对住院护理的意见(VOICE)的服务使用者]。(2)住院病人客户服务收据清单(CITRINE):我们与护士和服务使用者合作，制定了衡量服务使用者与工作人员接触次数的健康经济指标。自我报告测量记录了与工作人员的互动以及参加治疗活动的次数。(3)为康复提供机会(DOORWAYS):一项阶梯式随机对照试验，以测试培训病房护士提供治疗小组活动是否会提高服务用户和工作人员对病房的看法。共有16个病房被逐步随机化，我们比较了干预前后的VOICE、VOTE和CITRINE测量。共有1108名服务用户和539名工作人员参与了本次试验。(4) BETTER PATHWAYS (Bringing Emergency TreatmenT to Early Resolution)是比较两种服务系统的观察性研究。第一个是“分诊”系统，服务使用者进入分诊病房，然后在7天内转到他们所在的病房或出院回到社区。第二个系统是常规护理。我们收集了454名服务使用者和284名护士对病房的看法的数据。DOORWAYS和BETTER项目的主要结果是服务用户和工作人员对病房的看法(分别为VOICE和VOTE)，健康经济措施是CITRINE。所有病例均发生在WPs 1和WPs 2。我们开发了可靠和有效的测量方法(1)从服务使用者和护士的角度对住院护理的看法(VOICE和VOTE)和(2)服务使用者所重视的互动成本(CITRINE)。在DOORWAYS项目中，在调整了法律地位后，我们发现了微弱的效益证据(标准化效应为-0.18,95% CI 0.38改善到0.01恶化;p = 0.062)。只有非自愿接受医护人员培训的患者获益显著(N582，标准化效应为-0.35,95% CI为-0.57 ~ -0.12;p = 0.002;interactionp-value 0.006)。投票得分没有随时间变化(标准化效应值为0.04,95% CI为-0.09至0.18;p = 0.54)。我们没有发现成本效益改善的证据(估计效果为33英镑，95% CI - 91英镑至146英镑;p = 0.602)，但资源分配确实向患者认为有意义的接触者平均改变了12英镑(95% CI - 76英镑至98英镑;p = 0.774)。分诊模式和常规入院模式在服务使用者更好的认知(估计对分诊病房的VOICE评分提高0.77分;p = 0.68)或护士(估计对分诊病房的VOTE评分下降1.68分;p = 0.38)或所提供护理时间的成本(分诊增加391英镑;p = 0.77)方面没有显著差异。我们利用涉及服务使用者和精神卫生服务工作人员的方法制定了措施。这些措施是专门为急症住院服务制定的，因此不能假定对其他服务有用。例如，正在建设扩大这些措施，以便在母婴病房使用。BETTER PATHWAYS和DOORWAYS项目的优势在于大规模的数据收集。然而，我们正在测试基于内城地区的特定服务，并将其扩展到内城地区。可能在更多的农村社区或不同类型的住院治疗中会发现不同的效果。我们的数据库将用于发展的中介和调节因素的理解，以提高护理质量。当前对照试验ISRCTN06545047。本项目由国家卫生研究院应用研究计划资助，并将全文发表在《应用研究计划资助》上;第六卷第七期请参阅NIHR期刊图书馆网站了解更多项目信息。
{"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}
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
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. 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. 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. English primary care. People with T2DM (WPs A, D and E) or HCPs caring for people with T2DM (WPs B, C and E). 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. 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. Data from WPs A and B supported our holistic approach and add
{"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}
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
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
{"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}
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
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
{"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}
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
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.
{"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}
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
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
现代蛋白质组学技术正在鉴定与疾病活动和结果相关的蛋白质生物标志物。它们可能是简单、容易获得、廉价和安全的测试，可为诊断、预后、治疗选择、疾病活动监测和治疗提供信息，并可替代复杂、侵入性和昂贵的测试。然而，它们的潜力尚未实现。该研究由三个工作流程组成，以创建一个研究框架:工作流程1，方法-定义当前实践并探索用于监测疾病的生物标志物的方法创新;工作流程2，临床翻译-创建研究实践框架，高质量样本和相关临床数据，以评估蛋白质生物标志物的有效性和临床实用性;和工作流程3，揭示肝硬化作为可治疗事件诊断和行动指示的ELF (ELUCIDATE)随机对照试验(RCT) -已建立测试的典型RCT, ADVIA Centaur®增强肝纤维化(ELF)测试(西门子医疗诊断有限公司，英国Camberley)[由三个标记组成的面板-(1)血清透明质酸，(2)III型前胶原的氨基末端前肽和(3)金属蛋白酶组织抑制剂1]。确定其对肝硬化的诊断时机和肝硬化的管理及护理过程的影响，并改善预后。方法工作流程评估了使用前列腺特异性抗原监测患者的建议的质量，系统地回顾了监测策略的随机对照试验，回顾了监测生物标志物文献以及监测如何对结果产生影响。进行了模拟研究，以评估监测和改进医疗保健的优点。监测生物标志物的文献是适度的，可靠的结论很少。我们建议改进研究实践。患者强烈支持在这一领域进行强有力和结论性研究的必要性。临床翻译工作流程侧重于分析和临床有效性。为肾细胞癌(RCC)和肾移植(RT)建立队列，使用来自多个中心的样本和患者数据，作为评估生物标志物有效性的快速获取资源。从文献中确定RCC和RT的候选生物标志物，对其质量进行评估，并对选定的生物标志物进行优先排序。随访时间有限，但确定了可用于临床应用的生物标志物。在第三个工作流程中，ELUCIDATE试验注册了1303名患者，并从1000名目标患者中随机抽取了878名患者。试验开始较晚，最初招募较慢，但最终招募了具有良好统计能力的人来回答关键问题。ELF监测改变了患者的护理过程，并可能从早期引入干预措施和进一步随访中获益。ELUCIDATE试验是一个“范例”试验，证明了在“端到端”随机对照试验中评估生物标志物策略的挑战，并将为未来的研究设计提供信息。该项目的局限性主要在于，在收集和整理RCC和RT患者队列期间，商业和非商业研究中发现新生物标志物的速度比预期要慢，因此使用队列的结结性评估很少;然而，对于未来新的生物标志物，将保持对队列的访问。由于后期招募的激增，ELUCIDATE试验开始和招募的速度较慢，因此关于ELF测试对长期结果影响的最终结论有待进一步随访。来自三个工作流程的研究结果被用于综合未来生物标志物评估的策略和框架，包括研究设计、卫生经济学和卫生信息学方面的创新。当前对照试验ISRCTN74815110, UKCRN ID 9954和UKCRN ID 11930。本项目由国家卫生研究院应用研究计划资助，并将全文发表在《应用研究计划资助》上;第六卷第三期请参阅NIHR期刊图书馆网站了解更多项目信息。
{"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}
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