Elspeth Guthrie, Bethan Copsey, Alexandra Wright-Hughes, Aaron Dowse, Chris Bojke, Richard Mattock, Florence Day, Judith Horrocks, Gina Bianco, Cathy Brennan, Marsha McAdam, Michael Crawford, Navneet Kapur, Catherine Fernandez, Petra Bijsterveld, Amanda Farrin
<p><strong>Background: </strong>There are over 200,000 hospital attendances for self-harm per annum in the United Kingdom at an estimated annual cost of £133-162M. Systematic reviews prior to commencing the study suggested that brief psychological interventions are effective in reducing psychological distress after self-harm and reduce repetition of self-harm.</p><p><strong>Objective: </strong>The SafePIT trial was designed to evaluate the effectiveness and cost-effectiveness of self-harm-focused psychological therapy plus standard care versus standard care alone.</p><p><strong>Design: </strong>Pragmatic, multicentre individually randomised controlled trial of brief psychodynamic-interpersonal therapy compared with standard care with internal pilot, cost-effectiveness and process evaluation.</p><p><strong>Setting and participants: </strong>People aged over 18 years who attend hospital after intentional self-harm with a history of ≤ 3 episodes in the last 12 months.</p><p><strong>Intervention: </strong>Individual psychodynamic-interpersonal therapy, delivered face to face or by video conferencing by liaison mental health nurses, over four (or fewer by mutual agreement) 50-minute weekly sessions with two optional boosters.</p><p><strong>Main outcome measures: </strong>The primary outcome was time from randomisation to first repetition of self-harm leading to hospital attendance. Secondary outcomes (at 6 and 12 months) included rate of repetition of self-harm leading to hospital attendance; self-reported self-harm using questionnaires and Short Message Service; psychological distress and clinically significant improvement (Clinical Outcomes in Routine Evaluation - Outcome Measure); anxiety (Generalised Anxiety Disorder-7); hopelessness (Beck Hopelessness Scale); interpersonal function (Inventory of Interpersonal Problems-32) and quality of life (EuroQol-5 Dimensions, five-level version; Recovering Quality of Life; Clinical Outcomes in Routine Evaluation-6D).</p><p><strong>Results: </strong>The planned sample size was 770 participants. The trial closed to recruitment early in January 2023 at the end of the 12-month internal pilot, with 22 randomised participants, 12 allocated to psychodynamic-interpersonal therapy and 10 to standard care. Due to the early trial closure, trial follow-up was curtailed to 6 months, and analyses are restricted to descriptive statistics. Seven of 12 participants allocated to psychodynamic-interpersonal therapy started therapy, and four completed therapy. Participant-reported secondary outcomes were completed for nine (40.9%) participants at 6 months. Repetition of self-harm leading to hospital presentation could be assessed for 18 participants and occurred in two participants in the psychodynamic-interpersonal therapy arm (18.2%) and no participants in the standard care arm within 6 months of randomisation. Economic findings indicated no substantive changes in health-related quality of life, or primary and secondary care
{"title":"Brief psychodynamic-interpersonal therapy for adults with a history of self-harm: the SafePIT RCT.","authors":"Elspeth Guthrie, Bethan Copsey, Alexandra Wright-Hughes, Aaron Dowse, Chris Bojke, Richard Mattock, Florence Day, Judith Horrocks, Gina Bianco, Cathy Brennan, Marsha McAdam, Michael Crawford, Navneet Kapur, Catherine Fernandez, Petra Bijsterveld, Amanda Farrin","doi":"10.3310/TNGF8545","DOIUrl":"10.3310/TNGF8545","url":null,"abstract":"<p><strong>Background: </strong>There are over 200,000 hospital attendances for self-harm per annum in the United Kingdom at an estimated annual cost of £133-162M. Systematic reviews prior to commencing the study suggested that brief psychological interventions are effective in reducing psychological distress after self-harm and reduce repetition of self-harm.</p><p><strong>Objective: </strong>The SafePIT trial was designed to evaluate the effectiveness and cost-effectiveness of self-harm-focused psychological therapy plus standard care versus standard care alone.</p><p><strong>Design: </strong>Pragmatic, multicentre individually randomised controlled trial of brief psychodynamic-interpersonal therapy compared with standard care with internal pilot, cost-effectiveness and process evaluation.</p><p><strong>Setting and participants: </strong>People aged over 18 years who attend hospital after intentional self-harm with a history of ≤ 3 episodes in the last 12 months.</p><p><strong>Intervention: </strong>Individual psychodynamic-interpersonal therapy, delivered face to face or by video conferencing by liaison mental health nurses, over four (or fewer by mutual agreement) 50-minute weekly sessions with two optional boosters.</p><p><strong>Main outcome measures: </strong>The primary outcome was time from randomisation to first repetition of self-harm leading to hospital attendance. Secondary outcomes (at 6 and 12 months) included rate of repetition of self-harm leading to hospital attendance; self-reported self-harm using questionnaires and Short Message Service; psychological distress and clinically significant improvement (Clinical Outcomes in Routine Evaluation - Outcome Measure); anxiety (Generalised Anxiety Disorder-7); hopelessness (Beck Hopelessness Scale); interpersonal function (Inventory of Interpersonal Problems-32) and quality of life (EuroQol-5 Dimensions, five-level version; Recovering Quality of Life; Clinical Outcomes in Routine Evaluation-6D).</p><p><strong>Results: </strong>The planned sample size was 770 participants. The trial closed to recruitment early in January 2023 at the end of the 12-month internal pilot, with 22 randomised participants, 12 allocated to psychodynamic-interpersonal therapy and 10 to standard care. Due to the early trial closure, trial follow-up was curtailed to 6 months, and analyses are restricted to descriptive statistics. Seven of 12 participants allocated to psychodynamic-interpersonal therapy started therapy, and four completed therapy. Participant-reported secondary outcomes were completed for nine (40.9%) participants at 6 months. Repetition of self-harm leading to hospital presentation could be assessed for 18 participants and occurred in two participants in the psychodynamic-interpersonal therapy arm (18.2%) and no participants in the standard care arm within 6 months of randomisation. Economic findings indicated no substantive changes in health-related quality of life, or primary and secondary care ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-42"},"PeriodicalIF":4.0,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12683462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145632593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Leanne M Aitken, Lydia M Emerson, Kalliopi Kydonaki, Bronagh Blackwood, Ben Creagh-Brown, Nazir Lone, Cathrine McKenzie, Richard Parker, Michael C Reade, Christopher J Weir, Matt P Wise, Timothy S Walsh
<p><strong>Background: </strong>Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required.</p><p><strong>Aim and objectives: </strong>The aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care.</p><p><strong>Design and methods: </strong>A mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention's fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial's logic model, lasted 45-60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial.</p><p><strong>Results: </strong>Site intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient
{"title":"An exploration of the factors influencing successful implementation, delivery and outcomes in an intensive care sedation study: process evaluation of the A2B RCT.","authors":"Leanne M Aitken, Lydia M Emerson, Kalliopi Kydonaki, Bronagh Blackwood, Ben Creagh-Brown, Nazir Lone, Cathrine McKenzie, Richard Parker, Michael C Reade, Christopher J Weir, Matt P Wise, Timothy S Walsh","doi":"10.3310/GJTW0620","DOIUrl":"10.3310/GJTW0620","url":null,"abstract":"<p><strong>Background: </strong>Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required.</p><p><strong>Aim and objectives: </strong>The aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care.</p><p><strong>Design and methods: </strong>A mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention's fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial's logic model, lasted 45-60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial.</p><p><strong>Results: </strong>Site intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-18"},"PeriodicalIF":4.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12683464/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145523346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sara Kenyon, Tracey Johnston, Jason Waugh, Kim Hinshaw, Julia Sanders, Andrew Ewer, Lee Middleton, Clive Stubbs, Versha Cheed, Hannah Summers, Ruth Hewston, Adrian Wilcockson, Kate Siddall, Dee Wherton, Peter Brocklehurst
<p><strong>Background: </strong>Delay in the first stage of labour occurs in approximately 20% of nulliparous women. Recommended treatment is intravenous oxytocin, which shortens labour but does not affect the mode of birth. There is some evidence that a higher dose regimen may decrease the need for caesarean section.</p><p><strong>Objective: </strong>The primary objective was to establish if a high-dose regimen of oxytocin compared to the current standard-dose regimen reduced the need for caesarean section for nulliparous women with confirmed delay in the first stage of labour.</p><p><strong>Design: </strong>Multicentre, randomised double-blind controlled trial.</p><p><strong>Setting: </strong>Twenty-one maternity units in the United Kingdom.</p><p><strong>Participants: </strong>Consenting nulliparous women who had a singleton cephalic pregnancy, gestation of 37-41 weeks inclusive, confirmed delay in labour in first stage, ruptured membranes and for whom the clinical decision has been made to prescribe oxytocin.</p><p><strong>Interventions: </strong>Standard-dose regimen of oxytocin (2 mU/min increasing every 30 minutes to a maximum of 32 mU/min) compared with high-dose regimen (4 mU/min increasing every 30 minutes to a maximum of 64 mU/min).</p><p><strong>Main outcome measures: </strong>The primary outcome was the rate of caesarean section. Secondary outcomes included maternal and neonatal birth outcomes and safety.</p><p><strong>Results: </strong>One hundred and eighteen women were successfully randomised via third-party minimisation from an intended sample size of 1500 between 30 June 2017 and 14 November 2022. The caesarean section rate in the standard-dose group was 34% (20/58) and 27% (16/60) in the high-dose group. The intervention was provided as intended in 96% (113/118) of participants. There was no obvious suggestion that the high-dose regime was unsafe (all neonates were discharged home with mother), but this size of sample prohibited any definitive conclusions.</p><p><strong>Limitations: </strong>The trial did not meet its intended sample size due to a number of challenges. It was difficult for busy clinical staff to recruit women in labour in this acute, but not emergency, situation. The legislative requirements of undertaking research using interventional medicinal products imposed further constraints, and we encountered challenges in the production, blinding and monitoring required. Changes in clinical practice since trial design and commencement 10 years ago have resulted in fewer women going into spontaneous labour (reduced from 66% to 47%), and therefore potentially becoming eligible, due to more women having labour induced (22%-33%) or elective caesarean sections (12%-20%). These challenges were further compounded by a falling birth rate and the impact of the COVID-19 pandemic.</p><p><strong>Conclusions: </strong>The question of the optimum dose of oxytocin for nulliparous women delayed in the first stage of spontaneous labou
{"title":"High or low dose oxytocin for nulliparous women delayed in the first stage of labour: the HOLDS RCT.","authors":"Sara Kenyon, Tracey Johnston, Jason Waugh, Kim Hinshaw, Julia Sanders, Andrew Ewer, Lee Middleton, Clive Stubbs, Versha Cheed, Hannah Summers, Ruth Hewston, Adrian Wilcockson, Kate Siddall, Dee Wherton, Peter Brocklehurst","doi":"10.3310/MALP6685","DOIUrl":"10.3310/MALP6685","url":null,"abstract":"<p><strong>Background: </strong>Delay in the first stage of labour occurs in approximately 20% of nulliparous women. Recommended treatment is intravenous oxytocin, which shortens labour but does not affect the mode of birth. There is some evidence that a higher dose regimen may decrease the need for caesarean section.</p><p><strong>Objective: </strong>The primary objective was to establish if a high-dose regimen of oxytocin compared to the current standard-dose regimen reduced the need for caesarean section for nulliparous women with confirmed delay in the first stage of labour.</p><p><strong>Design: </strong>Multicentre, randomised double-blind controlled trial.</p><p><strong>Setting: </strong>Twenty-one maternity units in the United Kingdom.</p><p><strong>Participants: </strong>Consenting nulliparous women who had a singleton cephalic pregnancy, gestation of 37-41 weeks inclusive, confirmed delay in labour in first stage, ruptured membranes and for whom the clinical decision has been made to prescribe oxytocin.</p><p><strong>Interventions: </strong>Standard-dose regimen of oxytocin (2 mU/min increasing every 30 minutes to a maximum of 32 mU/min) compared with high-dose regimen (4 mU/min increasing every 30 minutes to a maximum of 64 mU/min).</p><p><strong>Main outcome measures: </strong>The primary outcome was the rate of caesarean section. Secondary outcomes included maternal and neonatal birth outcomes and safety.</p><p><strong>Results: </strong>One hundred and eighteen women were successfully randomised via third-party minimisation from an intended sample size of 1500 between 30 June 2017 and 14 November 2022. The caesarean section rate in the standard-dose group was 34% (20/58) and 27% (16/60) in the high-dose group. The intervention was provided as intended in 96% (113/118) of participants. There was no obvious suggestion that the high-dose regime was unsafe (all neonates were discharged home with mother), but this size of sample prohibited any definitive conclusions.</p><p><strong>Limitations: </strong>The trial did not meet its intended sample size due to a number of challenges. It was difficult for busy clinical staff to recruit women in labour in this acute, but not emergency, situation. The legislative requirements of undertaking research using interventional medicinal products imposed further constraints, and we encountered challenges in the production, blinding and monitoring required. Changes in clinical practice since trial design and commencement 10 years ago have resulted in fewer women going into spontaneous labour (reduced from 66% to 47%), and therefore potentially becoming eligible, due to more women having labour induced (22%-33%) or elective caesarean sections (12%-20%). These challenges were further compounded by a falling birth rate and the impact of the COVID-19 pandemic.</p><p><strong>Conclusions: </strong>The question of the optimum dose of oxytocin for nulliparous women delayed in the first stage of spontaneous labou","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-23"},"PeriodicalIF":4.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12683681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145523410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joanne Euden, Mahableshwar Albur, Rebecca Bestwick, Stuart Bond, Lucy Brookes-Howell, Paul Dark, Sarah Gerver, Detelina Grozeva, Ryan Hamilton, Margaret Heginbothom, Thomas Hellyer, Josie Henley, Russell Hope, Susan Hopkins, Philip Howard, Daniel Howdon, Natalie King, Chikezie Knox-Macaulay, Martin Llewelyn, Wakunyambo Maboshe, Iain McCullagh, Margaret Ogden, Philip Pallmann, Helena Parsons, David Partridge, Neil Powell, Graham Prestwich, Colin Richman, Dominick Shaw, Bethany Shinkins, Tamas Szakmany, Emma Thomas-Jones, Stacy Todd, Edward Webb, Robert West, Enitan Carrol, Jonathan Sandoe
<p><strong>Background: </strong>Early in the COVID-19 pandemic, there was concern about potentially unnecessary antibiotic prescribing in the National Health Service. Procalcitonin testing was being used in some hospitals to guide antibiotic use. This study aimed to investigate the impact of procalcitonin testing on United Kingdom's antibiotic prescribing and health outcomes.</p><p><strong>Methods: </strong>Mixed-methods study comprising quantitative, qualitative and health economic work packages, including a: survey of National Health Service hospitals to understand procalcitonin use retrospective, controlled, interrupted time series analysis of aggregated, organisation-level data, including antibiotic dispensing, hospital activity and procalcitonin testing from acute hospital trusts/hospitals in England/Wales. Primary outcome: change in level and/or trend of antibiotic prescribing rates following introduction of procalcitonin multicentre, retrospective, cohort study of 5960 patients using patient-level clinical data from 11 trusts/health boards to determine the difference in early antibiotic prescribing between COVID-19 patients who did/did not have baseline procalcitonin testing by using propensity score matching. Primary outcome: days of early antibiotic therapy qualitative study exploring the decision-making process around antibiotic use for inpatients with COVID-19 pneumonia to identify the contextual factors, feasibility and acceptability of procalcitonin testing algorithms health economic analysis evaluating the cost-effectiveness of baseline procalcitonin testing using the matched data within a decision-analytic model.</p><p><strong>Setting: </strong>Acute hospital trusts/health boards in England/Wales.</p><p><strong>Participants: </strong>Inpatients ≥ 16 years, admitted to participating trusts/health boards and with a confirmed positive COVID-19 test between 1 February 2020 and 30 June 2020, National Health Service healthcare workers.</p><p><strong>Results: </strong>Early in the COVID-19 pandemic, procalcitonin use was expanded/introduced in many National Health Service hospitals, with variation in guidance and interpretation of results. The number of hospitals using procalcitonin in emergency/acute admissions rose from 17 (11%) to 74/146 (50.7%), and its use in intensive care unit increased from 70 (47.6%) to 124/147 (84.4%). Introduction of procalcitonin testing in emergency departments/acute medical admission units was associated with a statistically significant decrease in antibiotic use, which was not sustained. Patient-level data showed that baseline procalcitonin testing was associated with an average reduction in early antibiotic prescribing of 0.43 days (95% confidence interval: 0.22 to 0.64 days, <i>p</i> < 0.001) and a reduction of 0.72 days (95% confidence interval: 0.06 to 1.38 days, <i>p</i> = 0.03) in total antibiotic prescribing, with no increased mortality/hospital length of stay. Interviews revealed concerns about seco
背景：在COVID-19大流行早期，人们担心国民医疗服务体系中可能存在不必要的抗生素处方。一些医院使用降钙素原检测来指导抗生素的使用。本研究旨在调查降钙素原测试对英国抗生素处方和健康结果的影响。方法：混合方法研究，包括定量、定性和健康经济工作包，包括对国家卫生服务医院的调查，以了解降钙素原的使用情况，对汇总的组织级数据进行回顾性、对照、中断时间序列分析，包括抗生素配药、医院活动和降钙素原测试，这些数据来自英格兰/威尔士的急性医院信托/医院。主要结局：引入降钙素原后抗生素处方率水平和/或趋势的变化，多中心，回顾性，队列研究5960例患者使用来自11个信托/健康委员会的患者水平临床数据，通过倾向评分匹配确定有/没有基线降钙素原检测的COVID-19患者早期抗生素处方的差异。主要结局：早期抗生素治疗天数定性研究探索COVID-19肺炎住院患者抗生素使用的决策过程，以确定降钙素原检测算法的背景因素、可行性和可接受性健康经济分析评估基线降钙素原检测的成本效益，使用决策分析模型中的匹配数据。环境：英格兰/威尔士急性医院信托/健康委员会。参与者：≥16岁的住院患者，在2020年2月1日至2020年6月30日期间入住参与信托/卫生委员会并确认COVID-19检测呈阳性，国家卫生服务保健工作者。结果：在COVID-19大流行早期，许多国家卫生服务医院扩大/引入了降钙素原的使用，但对结果的指导和解释存在差异。急诊/急症住院使用降钙素原的医院从17家（11%）增加到74家/146家（50.7%），重症监护病房的使用从70家（47.6%）增加到124家/147家（84.4%）。在急诊科/急诊住院单位引入降钙素原检测与抗生素使用的统计学显著减少相关，但这种减少并没有持续下去。患者水平的数据显示，基线降钙素原检测与总抗生素处方中早期抗生素处方平均减少0.43天（95%可信区间：0.22至0.64天，p p = 0.03）相关，且死亡率/住院时间没有增加。采访显示，对继发性细菌感染的担忧导致COVID-19患者抗生素处方增加。随着经验的增加，临床医生区分COVID-19单独感染和细菌共感染的能力也在提高。抗生素处方决策受高层支持、情境因素和组织影响等因素的影响。卫生经济分析的结论是，基线降钙素原检测更有可能具有成本效益，尽管存在一些不确定性。结论：基线降钙素原检测似乎是大流行第一波期间有效的抗菌素管理工具，在无危害证据的情况下减少了抗生素处方。局限性：回顾性、基于医院记录的研究受到数据缺失、错误记录信息和缺乏随机化的限制。与临床医生的访谈是在第一波之后一年多进行的，这可能会导致回忆偏差。未来工作：本研究强调了在常规引入临床实践之前，需要进行适应性、包容性、广泛影响的感染诊断试验和实施研究，以评估临床效用。资助：本摘要介绍了由国家卫生与保健研究所（NIHR）卫生技术评估计划资助的独立研究，奖励号为NIHR132254。
{"title":"Procalcitonin evaluation of antibiotic use in COVID-19 hospitalised patients: The PEACH mixed methods study.","authors":"Joanne Euden, Mahableshwar Albur, Rebecca Bestwick, Stuart Bond, Lucy Brookes-Howell, Paul Dark, Sarah Gerver, Detelina Grozeva, Ryan Hamilton, Margaret Heginbothom, Thomas Hellyer, Josie Henley, Russell Hope, Susan Hopkins, Philip Howard, Daniel Howdon, Natalie King, Chikezie Knox-Macaulay, Martin Llewelyn, Wakunyambo Maboshe, Iain McCullagh, Margaret Ogden, Philip Pallmann, Helena Parsons, David Partridge, Neil Powell, Graham Prestwich, Colin Richman, Dominick Shaw, Bethany Shinkins, Tamas Szakmany, Emma Thomas-Jones, Stacy Todd, Edward Webb, Robert West, Enitan Carrol, Jonathan Sandoe","doi":"10.3310/GGFF9393","DOIUrl":"10.3310/GGFF9393","url":null,"abstract":"<p><strong>Background: </strong>Early in the COVID-19 pandemic, there was concern about potentially unnecessary antibiotic prescribing in the National Health Service. Procalcitonin testing was being used in some hospitals to guide antibiotic use. This study aimed to investigate the impact of procalcitonin testing on United Kingdom's antibiotic prescribing and health outcomes.</p><p><strong>Methods: </strong>Mixed-methods study comprising quantitative, qualitative and health economic work packages, including a: survey of National Health Service hospitals to understand procalcitonin use retrospective, controlled, interrupted time series analysis of aggregated, organisation-level data, including antibiotic dispensing, hospital activity and procalcitonin testing from acute hospital trusts/hospitals in England/Wales. Primary outcome: change in level and/or trend of antibiotic prescribing rates following introduction of procalcitonin multicentre, retrospective, cohort study of 5960 patients using patient-level clinical data from 11 trusts/health boards to determine the difference in early antibiotic prescribing between COVID-19 patients who did/did not have baseline procalcitonin testing by using propensity score matching. Primary outcome: days of early antibiotic therapy qualitative study exploring the decision-making process around antibiotic use for inpatients with COVID-19 pneumonia to identify the contextual factors, feasibility and acceptability of procalcitonin testing algorithms health economic analysis evaluating the cost-effectiveness of baseline procalcitonin testing using the matched data within a decision-analytic model.</p><p><strong>Setting: </strong>Acute hospital trusts/health boards in England/Wales.</p><p><strong>Participants: </strong>Inpatients ≥ 16 years, admitted to participating trusts/health boards and with a confirmed positive COVID-19 test between 1 February 2020 and 30 June 2020, National Health Service healthcare workers.</p><p><strong>Results: </strong>Early in the COVID-19 pandemic, procalcitonin use was expanded/introduced in many National Health Service hospitals, with variation in guidance and interpretation of results. The number of hospitals using procalcitonin in emergency/acute admissions rose from 17 (11%) to 74/146 (50.7%), and its use in intensive care unit increased from 70 (47.6%) to 124/147 (84.4%). Introduction of procalcitonin testing in emergency departments/acute medical admission units was associated with a statistically significant decrease in antibiotic use, which was not sustained. Patient-level data showed that baseline procalcitonin testing was associated with an average reduction in early antibiotic prescribing of 0.43 days (95% confidence interval: 0.22 to 0.64 days, <i>p</i> < 0.001) and a reduction of 0.72 days (95% confidence interval: 0.06 to 1.38 days, <i>p</i> = 0.03) in total antibiotic prescribing, with no increased mortality/hospital length of stay. Interviews revealed concerns about seco","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 52","pages":"1-32"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12666610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145488552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Eve Tomlinson, Mary Ward, Josephine Walker, Melissa Benevente, Hanyu Wang, Chris Cooper, Hayley E Jones, Amanda Owen-Smith, Catalina Lopez Manzano, Sara James, Dietmar Hank, Nicky J Welton, Penny Whiting
<p><strong>Background: </strong>Attention deficit hyperactivity disorder is characterised by inattention, impulsivity and hyperactivity. Diagnosis is complex and time-consuming. Medication requires careful selection and dose titration. Technologies for objective measures of attention deficit hyperactivity disorder that use motion sensors to measure hyperactivity ('sensor continuous performance tests') may help improve the diagnostic process and medication management when used in addition to clinical assessment.</p><p><strong>Objective: </strong>To determine whether sensor continuous performance tests are clinically effective and cost-effective to the National Health Service. Specific objectives were to determine the effectiveness of sensor continuous performance tests for: diagnosis of attention deficit hyperactivity disorder in people referred with suspected attention deficit hyperactivity disorder diagnosis of attention deficit hyperactivity disorder in people referred with suspected attention deficit hyperactivity disorder for whom current assessment cannot reach a diagnosis during initial dose titration and treatment decisions for people with attention deficit hyperactivity disorder evaluating treatment effectiveness during long-term treatment monitoring for people with attention deficit hyperactivity disorder.</p><p><strong>Design: </strong>Systematic review and economic model (searches completed 17 November 2023).</p><p><strong>Results: </strong>Objective 1 [29 studies - 25 QbTest (QbTech Ltd., Stockholm, Sweden), 2 EF Sim (Peili Vision, Oulu, Finland) and 2 Nesplora Kids (Giunti Psychometrics, Florence, Italy)]: most evidence was in children. The AQUA trial was the only study to evaluate the QbTest in combination with clinical assessment and included a comparison with clinical assessment alone. Accuracy was similar and there was no statistical evidence of a difference between groups (<i>p</i> = 0.14), but the study was at high risk of bias. The AQUA trial reported that adding QbTest to the diagnostic process resulted in fewer appointments to reach a diagnosis, reduced consultation time, greater clinician confidence and exclusion of the diagnosis in a more children. Findings were supported by limited data from uncontrolled before-after studies. Qualitative and survey data reported increased clinician confidence in clinical decision-making, reduced time to diagnostic decision and improved communication. Barriers to implementation included staffing, training, technology requirements and length and repetitive content of the test. We found that using QbTest in addition to clinical assessment was likely cost-effective due to the reduced time waiting for assessment, reduced appointments until diagnosis and a higher proportion receiving treatment benefits. Objective 3 (six studies): All evaluated QbTest and most had concerns with risk of bias. Qualitative and survey data suggested that healthcare staff and families valued the QbTest for dose titra
{"title":"Clinical and cost-effectiveness of technologies for the assessment of attention deficit hyperactivity disorder: a systematic review and economic model.","authors":"Eve Tomlinson, Mary Ward, Josephine Walker, Melissa Benevente, Hanyu Wang, Chris Cooper, Hayley E Jones, Amanda Owen-Smith, Catalina Lopez Manzano, Sara James, Dietmar Hank, Nicky J Welton, Penny Whiting","doi":"10.3310/DRDR7171","DOIUrl":"10.3310/DRDR7171","url":null,"abstract":"<p><strong>Background: </strong>Attention deficit hyperactivity disorder is characterised by inattention, impulsivity and hyperactivity. Diagnosis is complex and time-consuming. Medication requires careful selection and dose titration. Technologies for objective measures of attention deficit hyperactivity disorder that use motion sensors to measure hyperactivity ('sensor continuous performance tests') may help improve the diagnostic process and medication management when used in addition to clinical assessment.</p><p><strong>Objective: </strong>To determine whether sensor continuous performance tests are clinically effective and cost-effective to the National Health Service. Specific objectives were to determine the effectiveness of sensor continuous performance tests for: diagnosis of attention deficit hyperactivity disorder in people referred with suspected attention deficit hyperactivity disorder diagnosis of attention deficit hyperactivity disorder in people referred with suspected attention deficit hyperactivity disorder for whom current assessment cannot reach a diagnosis during initial dose titration and treatment decisions for people with attention deficit hyperactivity disorder evaluating treatment effectiveness during long-term treatment monitoring for people with attention deficit hyperactivity disorder.</p><p><strong>Design: </strong>Systematic review and economic model (searches completed 17 November 2023).</p><p><strong>Results: </strong>Objective 1 [29 studies - 25 QbTest (QbTech Ltd., Stockholm, Sweden), 2 EF Sim (Peili Vision, Oulu, Finland) and 2 Nesplora Kids (Giunti Psychometrics, Florence, Italy)]: most evidence was in children. The AQUA trial was the only study to evaluate the QbTest in combination with clinical assessment and included a comparison with clinical assessment alone. Accuracy was similar and there was no statistical evidence of a difference between groups (<i>p</i> = 0.14), but the study was at high risk of bias. The AQUA trial reported that adding QbTest to the diagnostic process resulted in fewer appointments to reach a diagnosis, reduced consultation time, greater clinician confidence and exclusion of the diagnosis in a more children. Findings were supported by limited data from uncontrolled before-after studies. Qualitative and survey data reported increased clinician confidence in clinical decision-making, reduced time to diagnostic decision and improved communication. Barriers to implementation included staffing, training, technology requirements and length and repetitive content of the test. We found that using QbTest in addition to clinical assessment was likely cost-effective due to the reduced time waiting for assessment, reduced appointments until diagnosis and a higher proportion receiving treatment benefits. Objective 3 (six studies): All evaluated QbTest and most had concerns with risk of bias. Qualitative and survey data suggested that healthcare staff and families valued the QbTest for dose titra","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 58","pages":"1-216"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12668258/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145495390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anette Schrag, Camille Carroll, Glyn Lewis, Marc Serfaty, Gordon Duncan, Sophie Molloy, John Whipps, Blair McLennan, Jing Yi Jessica Weng, Rachael M Hunter, Caroline S Clarke, Nicholas Freemantle, Andrew Embleton-Thirsk
<p><strong>Background: </strong>There is insufficient evidence on the effectiveness of different antidepressants in Parkinson's disease. This trial was commissioned to provide robust evidence regarding the effectiveness of a tricyclic and a selective serotonin reuptake inhibitor on depression in people with Parkinson's disease.</p><p><strong>Objectives: </strong>To evaluate the clinical effectiveness and cost-effectiveness of the tricyclic nortriptyline and the selective serotonin reuptake inhibitor escitalopram in addition to standard psychological care in the National Health Service in the treatment of depression in Parkinson's disease.</p><p><strong>Design: </strong>Forty-seven-month, multisite, three-arm, placebo-controlled, double-blind, randomised controlled trial, with an internal pilot phase. Four hundred and eight patients with a 1 : 1 : 1 randomisation between placebo, nortriptyline and escitalopram. The pilot study aimed to recruit 46 participants in the first 6 months from 10 sites to decide whether the trial is feasible.</p><p><strong>Interventions: </strong>Participants were treated with nortriptyline (target dose 100 mg in patients 65 and under, or 50 mg in patients over 65 or those with hepatic impairment), escitalopram (target dose 20 mg in patients 65 and under, or 10 mg in patients over 65 or those with hepatic impairment) or placebo, in addition to available standard psychological care.</p><p><strong>Outcomes: </strong>The primary outcome measure was the Beck Depression Inventory-II at 8 weeks. Secondary outcomes included clinician- and patient-reported outcomes, with safety summaries.</p><p><strong>Results: </strong>Fifty-two patients were recruited and randomised to receive either nortriptyline, escitalopram, or a placebo-matched tablet. This was effectively the internal pilot period, with the trial being truncated at this point. There was a reduction in Beck Depression Inventory-II scores between baseline to week 8 in all arms. In the placebo arm, this was from a mean of 24.3 (SD 7.8) at baseline to 15.7 (SD 5.8) at week 8, in the nortriptyline arm from 20.5 (SD 3.8) to 12.6 (SD 8.1), and in the escitalopram arm from 23.3 (SD 8.0) to 14.6 (SD 8.4). The reduction in Beck Depression Inventory-II scores was not significantly different between either of the two active arms and the placebo arm, with a mean change of -3.1 (95% confidence interval -8.66 to 2.53, <i>p</i> = 0.28) in the nortriptyline versus placebo comparison, and a mean change of -0.7 (-6.11 to 4.70, <i>p</i> = 0.80) in the escitalopram versus placebo comparison. There was however a statistically significant difference in reduction of Patient Health Questionnaire-9 items scores between the nortriptyline and the placebo arm (<i>p</i> = 0.01) but not the escitalopram compared to the placebo arm (<i>p</i> = 0.33). There were no differences in adverse events, Movement Disorders Society Unified Parkinson's Disease Rating Scale scores or Montreal Cognitive Assessment sc
{"title":"Effectiveness of Escitalopram and Nortriptyline on Depressive Symptoms in Parkinson's disease: the ADepT-PD RCT pilot.","authors":"Anette Schrag, Camille Carroll, Glyn Lewis, Marc Serfaty, Gordon Duncan, Sophie Molloy, John Whipps, Blair McLennan, Jing Yi Jessica Weng, Rachael M Hunter, Caroline S Clarke, Nicholas Freemantle, Andrew Embleton-Thirsk","doi":"10.3310/HFDO7575","DOIUrl":"10.3310/HFDO7575","url":null,"abstract":"<p><strong>Background: </strong>There is insufficient evidence on the effectiveness of different antidepressants in Parkinson's disease. This trial was commissioned to provide robust evidence regarding the effectiveness of a tricyclic and a selective serotonin reuptake inhibitor on depression in people with Parkinson's disease.</p><p><strong>Objectives: </strong>To evaluate the clinical effectiveness and cost-effectiveness of the tricyclic nortriptyline and the selective serotonin reuptake inhibitor escitalopram in addition to standard psychological care in the National Health Service in the treatment of depression in Parkinson's disease.</p><p><strong>Design: </strong>Forty-seven-month, multisite, three-arm, placebo-controlled, double-blind, randomised controlled trial, with an internal pilot phase. Four hundred and eight patients with a 1 : 1 : 1 randomisation between placebo, nortriptyline and escitalopram. The pilot study aimed to recruit 46 participants in the first 6 months from 10 sites to decide whether the trial is feasible.</p><p><strong>Interventions: </strong>Participants were treated with nortriptyline (target dose 100 mg in patients 65 and under, or 50 mg in patients over 65 or those with hepatic impairment), escitalopram (target dose 20 mg in patients 65 and under, or 10 mg in patients over 65 or those with hepatic impairment) or placebo, in addition to available standard psychological care.</p><p><strong>Outcomes: </strong>The primary outcome measure was the Beck Depression Inventory-II at 8 weeks. Secondary outcomes included clinician- and patient-reported outcomes, with safety summaries.</p><p><strong>Results: </strong>Fifty-two patients were recruited and randomised to receive either nortriptyline, escitalopram, or a placebo-matched tablet. This was effectively the internal pilot period, with the trial being truncated at this point. There was a reduction in Beck Depression Inventory-II scores between baseline to week 8 in all arms. In the placebo arm, this was from a mean of 24.3 (SD 7.8) at baseline to 15.7 (SD 5.8) at week 8, in the nortriptyline arm from 20.5 (SD 3.8) to 12.6 (SD 8.1), and in the escitalopram arm from 23.3 (SD 8.0) to 14.6 (SD 8.4). The reduction in Beck Depression Inventory-II scores was not significantly different between either of the two active arms and the placebo arm, with a mean change of -3.1 (95% confidence interval -8.66 to 2.53, <i>p</i> = 0.28) in the nortriptyline versus placebo comparison, and a mean change of -0.7 (-6.11 to 4.70, <i>p</i> = 0.80) in the escitalopram versus placebo comparison. There was however a statistically significant difference in reduction of Patient Health Questionnaire-9 items scores between the nortriptyline and the placebo arm (<i>p</i> = 0.01) but not the escitalopram compared to the placebo arm (<i>p</i> = 0.33). There were no differences in adverse events, Movement Disorders Society Unified Parkinson's Disease Rating Scale scores or Montreal Cognitive Assessment sc","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 57","pages":"1-78"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12668257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145495426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Enoch F Akowuah, Rebecca H Maier, Helen C Hancock, Janelle Wagnild, Luke Vale, Cristina Fernandez-Garcia, Ehsan Kharati, Emmanuel Ogundimu, Ayesha Mathias, Zoe Walmsley, Nicola Howe, Richard Graham, Karen Ainsworth, Joseph Zacharias
<p><strong>Background: </strong>The safety, effectiveness and cost-effectiveness of mitral valve repair via thoracoscopically guided minithoracotomy compared with conventional median sternotomy (Sternotomy) in patients with degenerative mitral valve regurgitation is uncertain and widely debated.</p><p><strong>Objectives: </strong>To determine if Mini was more effective than Sternotomy in terms of physical functioning and associated return to usual activities and was cost-effective compared with Sternotomy.</p><p><strong>Design: </strong>A pragmatic, multicentre, expertise-based, superiority, randomised trial.</p><p><strong>Participants: </strong>Adults with degenerative mitral valve regurgitation undergoing mitral valve repair surgery.</p><p><strong>Setting: </strong>Ten tertiary care institutions in the United Kingdom.</p><p><strong>Intervention: </strong>Mini or Sternotomy mitral valve repair performed by an expert surgeon.</p><p><strong>Blinding: </strong>Primary outcome measure [Short Form 36-item Health Survey, version 2 (SF-36v2) physical functioning score] was measured by an independent assessor, blinded to allocation. Echocardiographic findings were measured in a core laboratory, blinded to allocation.</p><p><strong>Outcome measures: </strong>Primary outcomes were physical functioning and associated return to usual activities measured by change from baseline in SF-36v2 physical function domain at 12 weeks following index surgery. The primary economic measure was incremental cost per quality-adjusted life-year over the year following surgery. Secondary outcomes included recurrent mitral regurgitation grade, physical activity and quality of life measured at time points to 1 year. Safety outcomes included death, repeat mitral valve surgery or heart failure hospitalisation up to 1 year.</p><p><strong>Results: </strong>Between November 2016 and January 2021, 330 participants were randomised; 166 to Mini and 164 to Sternotomy. Of these, 309 underwent surgery and 294 reported the primary outcome. Thirty per cent were female. At 12 weeks, mean difference between groups in the change in SF-36v2 physical function <i>T</i>-scores was 0.68 (95% confidence interval -1.89 to 3.26). Valve repair rates (96%) were similar in both groups. Echocardiography demonstrated mitral regurgitation severity as none or mild for 92% of participants at 1 year in both groups. The composite safety outcome occurred in 5.4% (9/166) of Mini and 6.1% (10/163) of Sternotomy participants at 1 year. On average, Mini was more costly £29,424 (95% confidence interval 26,909 to 31,940) versus £27,397 (95% confidence interval 25,172 to 29,620) and more effective 0.81 quality-adjusted life-years (95% confidence interval 0.78 to 0.84) versus 0.78 (95% confidence interval 0.75 to 0.81) than Sternotomy. The adjusted incremental cost-effectiveness ratio was £74,863 per quality-adjusted life-year for the comparison between Mini and Sternotomy. Mini has a probability of < 50% of being cost
{"title":"Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: the UK Mini Mitral multicentre RCT.","authors":"Enoch F Akowuah, Rebecca H Maier, Helen C Hancock, Janelle Wagnild, Luke Vale, Cristina Fernandez-Garcia, Ehsan Kharati, Emmanuel Ogundimu, Ayesha Mathias, Zoe Walmsley, Nicola Howe, Richard Graham, Karen Ainsworth, Joseph Zacharias","doi":"10.3310/PKOT2391","DOIUrl":"10.3310/PKOT2391","url":null,"abstract":"<p><strong>Background: </strong>The safety, effectiveness and cost-effectiveness of mitral valve repair via thoracoscopically guided minithoracotomy compared with conventional median sternotomy (Sternotomy) in patients with degenerative mitral valve regurgitation is uncertain and widely debated.</p><p><strong>Objectives: </strong>To determine if Mini was more effective than Sternotomy in terms of physical functioning and associated return to usual activities and was cost-effective compared with Sternotomy.</p><p><strong>Design: </strong>A pragmatic, multicentre, expertise-based, superiority, randomised trial.</p><p><strong>Participants: </strong>Adults with degenerative mitral valve regurgitation undergoing mitral valve repair surgery.</p><p><strong>Setting: </strong>Ten tertiary care institutions in the United Kingdom.</p><p><strong>Intervention: </strong>Mini or Sternotomy mitral valve repair performed by an expert surgeon.</p><p><strong>Blinding: </strong>Primary outcome measure [Short Form 36-item Health Survey, version 2 (SF-36v2) physical functioning score] was measured by an independent assessor, blinded to allocation. Echocardiographic findings were measured in a core laboratory, blinded to allocation.</p><p><strong>Outcome measures: </strong>Primary outcomes were physical functioning and associated return to usual activities measured by change from baseline in SF-36v2 physical function domain at 12 weeks following index surgery. The primary economic measure was incremental cost per quality-adjusted life-year over the year following surgery. Secondary outcomes included recurrent mitral regurgitation grade, physical activity and quality of life measured at time points to 1 year. Safety outcomes included death, repeat mitral valve surgery or heart failure hospitalisation up to 1 year.</p><p><strong>Results: </strong>Between November 2016 and January 2021, 330 participants were randomised; 166 to Mini and 164 to Sternotomy. Of these, 309 underwent surgery and 294 reported the primary outcome. Thirty per cent were female. At 12 weeks, mean difference between groups in the change in SF-36v2 physical function <i>T</i>-scores was 0.68 (95% confidence interval -1.89 to 3.26). Valve repair rates (96%) were similar in both groups. Echocardiography demonstrated mitral regurgitation severity as none or mild for 92% of participants at 1 year in both groups. The composite safety outcome occurred in 5.4% (9/166) of Mini and 6.1% (10/163) of Sternotomy participants at 1 year. On average, Mini was more costly £29,424 (95% confidence interval 26,909 to 31,940) versus £27,397 (95% confidence interval 25,172 to 29,620) and more effective 0.81 quality-adjusted life-years (95% confidence interval 0.78 to 0.84) versus 0.78 (95% confidence interval 0.75 to 0.81) than Sternotomy. The adjusted incremental cost-effectiveness ratio was £74,863 per quality-adjusted life-year for the comparison between Mini and Sternotomy. Mini has a probability of < 50% of being cost","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 55","pages":"1-121"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12666603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145488547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Helen Mossop, Sarah Al Ashmori, Tumi Sotire, Emma Clark, Gillian Watson, Miles Witham, Luke Vale, Naomi McGregor, Julia Phillipson, James Ms Wason, Alison J Yarnall, Helen Hancock, Rose Anne Kenny, James Frith
<p><strong>Background: </strong>Orthostatic hypotension is a significant drop in blood pressure upon standing upright. It is very common and can result in symptoms such as postural dizziness, fainting and falls. Within the United Kingdom National Health Service, there are three principal treatments: non-drug therapies, and two medications - fludrocortisone or midodrine. Despite this we do not know which treatments are the most effective, nor whether they are cost-effective.</p><p><strong>Objective: </strong>Evaluate the feasibility of a randomised trial to evaluate the clinical and cost-effectiveness of fludrocortisone and midodrine in comparison to non-drug therapies for the treatment of orthostatic hypotension.</p><p><strong>Design: </strong>A 10-month pilot of a pragmatic, open-label, randomised, prospective, superiority, multiarm, multistage clinical trial. The pilot evaluated recruitment, attrition, crossover and quality of outcomes.</p><p><strong>Setting: </strong>Falls and Syncope, Movement Disorder, Geriatrics, and Cardiology clinics in United Kingdom National Health Service secondary care.</p><p><strong>Participants: </strong>Adults with symptomatic orthostatic hypotension.</p><p><strong>Interventions: </strong>Control: Non-drug therapies (conservative management). Interventions: Conservative management plus fludrocortisone (50-400 mcg daily) or conservative management plus midodrine (5-30 mg daily).</p><p><strong>Main outcome measures: </strong>Recruitment: Target was 40-64 participants from 14 sites. Attrition target: ≤ 15% participants withdraw before the primary end point. Crossover: To determine the rates of crossover between intervention arms. Outcome data: Assess the quality and completeness of outcomes. Other important outcomes included feedback via questionnaire and interview from sites and participants.</p><p><strong>Results: </strong>Two hundred and eighty-two patients were screened for eligibility during the pilot; of these, 13 were recruited from 4 of 9 open sites. Current or recent use of one of the study medications accounted for 120 (52%) exclusions due to ineligibility. At the primary end point of 6 months, 10 of the 13 participants (77%) remained in the study. Of those, completion rates for primary and secondary outcomes were 100%, except for the falls diaries, which was 60%. Feedback from sites revealed that redeployment of clinical and research staff due to COVID-19 negatively impacted on site opening and screening for eligible participants. Adapting the protocol to make it more flexible for remote clinics and more pragmatic for clinical use did not improve recruitment.</p><p><strong>Limitations: </strong>The sample size is too small to provide a reliable estimate of attrition and crossover rates for future studies.</p><p><strong>Conclusions: </strong>This study was not feasible in its current design. COVID-19 had an impact on staffing and site opening, while the exclusion criteria limited recruitment.</p><p><strong>F
{"title":"Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension: CONFORM-OH pilot RCT and economic evaluation.","authors":"Helen Mossop, Sarah Al Ashmori, Tumi Sotire, Emma Clark, Gillian Watson, Miles Witham, Luke Vale, Naomi McGregor, Julia Phillipson, James Ms Wason, Alison J Yarnall, Helen Hancock, Rose Anne Kenny, James Frith","doi":"10.3310/HGRW7249","DOIUrl":"10.3310/HGRW7249","url":null,"abstract":"<p><strong>Background: </strong>Orthostatic hypotension is a significant drop in blood pressure upon standing upright. It is very common and can result in symptoms such as postural dizziness, fainting and falls. Within the United Kingdom National Health Service, there are three principal treatments: non-drug therapies, and two medications - fludrocortisone or midodrine. Despite this we do not know which treatments are the most effective, nor whether they are cost-effective.</p><p><strong>Objective: </strong>Evaluate the feasibility of a randomised trial to evaluate the clinical and cost-effectiveness of fludrocortisone and midodrine in comparison to non-drug therapies for the treatment of orthostatic hypotension.</p><p><strong>Design: </strong>A 10-month pilot of a pragmatic, open-label, randomised, prospective, superiority, multiarm, multistage clinical trial. The pilot evaluated recruitment, attrition, crossover and quality of outcomes.</p><p><strong>Setting: </strong>Falls and Syncope, Movement Disorder, Geriatrics, and Cardiology clinics in United Kingdom National Health Service secondary care.</p><p><strong>Participants: </strong>Adults with symptomatic orthostatic hypotension.</p><p><strong>Interventions: </strong>Control: Non-drug therapies (conservative management). Interventions: Conservative management plus fludrocortisone (50-400 mcg daily) or conservative management plus midodrine (5-30 mg daily).</p><p><strong>Main outcome measures: </strong>Recruitment: Target was 40-64 participants from 14 sites. Attrition target: ≤ 15% participants withdraw before the primary end point. Crossover: To determine the rates of crossover between intervention arms. Outcome data: Assess the quality and completeness of outcomes. Other important outcomes included feedback via questionnaire and interview from sites and participants.</p><p><strong>Results: </strong>Two hundred and eighty-two patients were screened for eligibility during the pilot; of these, 13 were recruited from 4 of 9 open sites. Current or recent use of one of the study medications accounted for 120 (52%) exclusions due to ineligibility. At the primary end point of 6 months, 10 of the 13 participants (77%) remained in the study. Of those, completion rates for primary and secondary outcomes were 100%, except for the falls diaries, which was 60%. Feedback from sites revealed that redeployment of clinical and research staff due to COVID-19 negatively impacted on site opening and screening for eligible participants. Adapting the protocol to make it more flexible for remote clinics and more pragmatic for clinical use did not improve recruitment.</p><p><strong>Limitations: </strong>The sample size is too small to provide a reliable estimate of attrition and crossover rates for future studies.</p><p><strong>Conclusions: </strong>This study was not feasible in its current design. COVID-19 had an impact on staffing and site opening, while the exclusion criteria limited recruitment.</p><p><strong>F","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 54","pages":"1-21"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12666604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145488626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E Andrea Nelson, Colin C Everett, Henrietta Konwea, Angela Oates, Sarah T Brown, Chris Bojke, Michael Backhouse, Howard Collier, Joanna Dennett, Rachael Gilberts, Benjamin A Lipsky, Michelle M Lister, Jane Nixon, David Russell, Tim Sloan, Fran Game
<p><strong>Background: </strong>Foot ulcers affecting people with diabetes (diabetic foot ulcers) often become infected, potentially leading to amputation. Suspected diabetic foot ulcer infection is treated with immediate empiric antimicrobials, with wound samples for culture and sensitivity collected to optimise antibiotic therapy. Collecting samples with swabs is easier than obtaining tissue, but this reports fewer pathogens and more contaminants. Compared with standard culture and sensitivity laboratory methods, molecular microbiology identifies more organisms. How these differences affect clinical decisions or outcomes is currently unknown. To determine if taking tissue samples versus swabs from suspected infected diabetic foot ulcer affects ulcer healing, antibiotic prescribing, costs of care and patient safety.</p><p><strong>Substudy 1: </strong>To determine the agreement between microbiology results from culture and sensitivity versus molecular techniques and to assess whether intention of prescribers to change antimicrobials differs based on sampling methods.</p><p><strong>Substudy 2: </strong>A health-economic perspective of the expected application of empiric and/or targeted treatment regimens and the cost consequences of treatment decisions based on substudy 1.</p><p><strong>Substudy 3: </strong>To compare questionnaire response rates for theoretically informed versus standard participant letters.</p><p><strong>Substudy 4: </strong>To explore clinician perspectives on diabetic foot ulcer sampling and processing techniques.</p><p><strong>Design: </strong>Randomised controlled trial of results of performing tissue sampling versus swabbing of wounds in people with suspected mild or moderate infected diabetic foot ulcer. Individually randomised (allocation concealed), 1 : 1, tissue or swab sampling for suspected diabetic foot ulcer infection. Follow-up is 12-24 months. A priori sample size estimate is 730.</p><p><strong>Substudy 1: </strong>Cross-sectional agreement study of microbiology results from molecular versus culture and sensitivity techniques and virtual clinic. Diabetic foot ulcers sampled for standard microbiology and central laboratory analysis (molecular).</p><p><strong>Substudy 2: </strong>Exploratory cost-consequence analysis of molecular processing and the likelihood of empiric and targeted treatment based on treatment decisions from substudy 1.</p><p><strong>Substudy 3: </strong>Randomised trial of theoretically informed versus standard participant letters.</p><p><strong>Substudy 4: </strong>Qualitative study explored clinicians' perspectives regarding sampling and processing techniques.</p><p><strong>Setting and participants: </strong>Twenty-one United Kingdom diabetic foot ulcer clinics. Participants with suspected mild or moderate infected diabetic foot ulcers. Time to ulcer healing (primary outcome blinded assessment), proportion of ulcers healed, antibiotic usage, ulcer area reduction at 4 weeks, hospitalisation durat
{"title":"Swabs versus tissue samples for infected diabetic foot ulcers: the CODIFI2 RCT.","authors":"E Andrea Nelson, Colin C Everett, Henrietta Konwea, Angela Oates, Sarah T Brown, Chris Bojke, Michael Backhouse, Howard Collier, Joanna Dennett, Rachael Gilberts, Benjamin A Lipsky, Michelle M Lister, Jane Nixon, David Russell, Tim Sloan, Fran Game","doi":"10.3310/KKPP0404","DOIUrl":"10.3310/KKPP0404","url":null,"abstract":"<p><strong>Background: </strong>Foot ulcers affecting people with diabetes (diabetic foot ulcers) often become infected, potentially leading to amputation. Suspected diabetic foot ulcer infection is treated with immediate empiric antimicrobials, with wound samples for culture and sensitivity collected to optimise antibiotic therapy. Collecting samples with swabs is easier than obtaining tissue, but this reports fewer pathogens and more contaminants. Compared with standard culture and sensitivity laboratory methods, molecular microbiology identifies more organisms. How these differences affect clinical decisions or outcomes is currently unknown. To determine if taking tissue samples versus swabs from suspected infected diabetic foot ulcer affects ulcer healing, antibiotic prescribing, costs of care and patient safety.</p><p><strong>Substudy 1: </strong>To determine the agreement between microbiology results from culture and sensitivity versus molecular techniques and to assess whether intention of prescribers to change antimicrobials differs based on sampling methods.</p><p><strong>Substudy 2: </strong>A health-economic perspective of the expected application of empiric and/or targeted treatment regimens and the cost consequences of treatment decisions based on substudy 1.</p><p><strong>Substudy 3: </strong>To compare questionnaire response rates for theoretically informed versus standard participant letters.</p><p><strong>Substudy 4: </strong>To explore clinician perspectives on diabetic foot ulcer sampling and processing techniques.</p><p><strong>Design: </strong>Randomised controlled trial of results of performing tissue sampling versus swabbing of wounds in people with suspected mild or moderate infected diabetic foot ulcer. Individually randomised (allocation concealed), 1 : 1, tissue or swab sampling for suspected diabetic foot ulcer infection. Follow-up is 12-24 months. A priori sample size estimate is 730.</p><p><strong>Substudy 1: </strong>Cross-sectional agreement study of microbiology results from molecular versus culture and sensitivity techniques and virtual clinic. Diabetic foot ulcers sampled for standard microbiology and central laboratory analysis (molecular).</p><p><strong>Substudy 2: </strong>Exploratory cost-consequence analysis of molecular processing and the likelihood of empiric and targeted treatment based on treatment decisions from substudy 1.</p><p><strong>Substudy 3: </strong>Randomised trial of theoretically informed versus standard participant letters.</p><p><strong>Substudy 4: </strong>Qualitative study explored clinicians' perspectives regarding sampling and processing techniques.</p><p><strong>Setting and participants: </strong>Twenty-one United Kingdom diabetic foot ulcer clinics. Participants with suspected mild or moderate infected diabetic foot ulcers. Time to ulcer healing (primary outcome blinded assessment), proportion of ulcers healed, antibiotic usage, ulcer area reduction at 4 weeks, hospitalisation durat","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 59","pages":"1-53"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12668260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145488649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kapil Sayal, Laura Wyatt, Louise Thomson, Grace Holt, Colleen Ewart, Anupam Bhardwaj, Bernadka Dubicka, Tamsin Marshall, Julia Gledhill, Alexandra Lang, Kirsty Sprange, Christopher Partlett, Kristina Newman, Sebastian Moody, Helen Bould, Clare Upton, Matthew Keane, Edward Cox, Marilyn James, Alan Montgomery
<p><strong>Background: </strong>Emotional disorders are common in children and young people and can significantly impair their quality of life. Evidence-based treatments require a timely and appropriate diagnosis. The utility of standardised diagnostic assessment tools may aid the detection of emotional disorders, but there is limited evidence of their clinical value.</p><p><strong>Objectives: </strong>To assess the clinical effectiveness and cost effectiveness of a standardised diagnostic assessment for children and young people with emotional difficulties referred to Child and Adolescent Mental Health Services. A nested qualitative process evaluation aimed to identify the barriers and facilitators to using a standardised diagnostic assessment tool in Child and Adolescent Mental Health Services.</p><p><strong>Design: </strong>A United Kingdom, multicentre, two-arm, parallel-group randomised controlled trial with a nested qualitative process evaluation.</p><p><strong>Setting: </strong>Eight National Health Service Trusts providing multidisciplinary specialist Child and Adolescent Mental Health Services.</p><p><strong>Participants: </strong>Children and young people aged 5-17 years with emotional difficulties referred to Child and Adolescent Mental Health Services, excluding emergency/urgent referrals that required an expedited assessment. In the qualitative process evaluation, 15 young people aged 16-17 years, 38 parents/carers and 56 healthcare professionals participated in semistructured interviews.</p><p><strong>Interventions: </strong>Participants were randomly assigned (1 : 1) following referral receipt to intervention (the development and well-being assessment) and usual care, or usual care only.</p><p><strong>Main outcome measures: </strong>Primary outcome was a clinician-made diagnosis decision about the presence of an emotional disorder within 12 months of randomisation, collected from Child and Adolescent Mental Health Services clinical records. Secondary outcomes collected from clinical records included referral acceptance, time to offer and start treatment/interventions and discharge. Data were also self-reported from participants through online questionnaires at baseline, 6 and 12 months post randomisation, and the cost effectiveness of the intervention was investigated.</p><p><strong>Results: </strong>One thousand two hundred and twenty-five (1225) children and young people were randomly assigned (1 : 1) to study groups between 27 August 2019 and 17 October 2021; 615 were assigned to the intervention and 610 were assigned to the control group. Adherence to the intervention (full/partial completion of the development and well-being assessment) was 80% (494/615). At 12 months, 68 (11%) participants in the intervention group received an emotional disorder diagnosis versus 72 (12%) in the control group [adjusted risk ratio 0.94 (95% confidence interval 0.70 to 1.28); <i>p</i> = 0.71]. Child and Adolescent Mental Health Services acceptan
{"title":"Clinical and cost-effectiveness of a standardised diagnostic assessment for children and adolescents with emotional difficulties: the STADIA multi-centre RCT.","authors":"Kapil Sayal, Laura Wyatt, Louise Thomson, Grace Holt, Colleen Ewart, Anupam Bhardwaj, Bernadka Dubicka, Tamsin Marshall, Julia Gledhill, Alexandra Lang, Kirsty Sprange, Christopher Partlett, Kristina Newman, Sebastian Moody, Helen Bould, Clare Upton, Matthew Keane, Edward Cox, Marilyn James, Alan Montgomery","doi":"10.3310/GJKS0519","DOIUrl":"10.3310/GJKS0519","url":null,"abstract":"<p><strong>Background: </strong>Emotional disorders are common in children and young people and can significantly impair their quality of life. Evidence-based treatments require a timely and appropriate diagnosis. The utility of standardised diagnostic assessment tools may aid the detection of emotional disorders, but there is limited evidence of their clinical value.</p><p><strong>Objectives: </strong>To assess the clinical effectiveness and cost effectiveness of a standardised diagnostic assessment for children and young people with emotional difficulties referred to Child and Adolescent Mental Health Services. A nested qualitative process evaluation aimed to identify the barriers and facilitators to using a standardised diagnostic assessment tool in Child and Adolescent Mental Health Services.</p><p><strong>Design: </strong>A United Kingdom, multicentre, two-arm, parallel-group randomised controlled trial with a nested qualitative process evaluation.</p><p><strong>Setting: </strong>Eight National Health Service Trusts providing multidisciplinary specialist Child and Adolescent Mental Health Services.</p><p><strong>Participants: </strong>Children and young people aged 5-17 years with emotional difficulties referred to Child and Adolescent Mental Health Services, excluding emergency/urgent referrals that required an expedited assessment. In the qualitative process evaluation, 15 young people aged 16-17 years, 38 parents/carers and 56 healthcare professionals participated in semistructured interviews.</p><p><strong>Interventions: </strong>Participants were randomly assigned (1 : 1) following referral receipt to intervention (the development and well-being assessment) and usual care, or usual care only.</p><p><strong>Main outcome measures: </strong>Primary outcome was a clinician-made diagnosis decision about the presence of an emotional disorder within 12 months of randomisation, collected from Child and Adolescent Mental Health Services clinical records. Secondary outcomes collected from clinical records included referral acceptance, time to offer and start treatment/interventions and discharge. Data were also self-reported from participants through online questionnaires at baseline, 6 and 12 months post randomisation, and the cost effectiveness of the intervention was investigated.</p><p><strong>Results: </strong>One thousand two hundred and twenty-five (1225) children and young people were randomly assigned (1 : 1) to study groups between 27 August 2019 and 17 October 2021; 615 were assigned to the intervention and 610 were assigned to the control group. Adherence to the intervention (full/partial completion of the development and well-being assessment) was 80% (494/615). At 12 months, 68 (11%) participants in the intervention group received an emotional disorder diagnosis versus 72 (12%) in the control group [adjusted risk ratio 0.94 (95% confidence interval 0.70 to 1.28); <i>p</i> = 0.71]. Child and Adolescent Mental Health Services acceptan","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 61","pages":"1-34"},"PeriodicalIF":4.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12641346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145523328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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