Health technology assessment最新文献

{"title":"A community-based rehabilitation package following hip fracture: FEMuR III a multi-centre RCT, economic and process evaluation.","authors":"Nefyn H Williams, Monica Busse, Rachael Cooper, Jacob Davies, Susanna Dodd, Shanaz Dorkenoo, Kodchawan Doungsong, Rhiannon Tudor Edwards, Victory Ezeofor, Miriam Golding-Day, Jessica Green, Ben Hardwick, Kathryn Harvey, Sophie Hennessy, Andrew B Lemmey, Phillipa Logan, Val Morrison, Penelope Ralph, Catherine Sackley, Ben Smith, Toby O Smith, Llinos H Spencer, Suzanne Temple","doi":"10.3310/RBGD4741","DOIUrl":"10.3310/RBGD4741","url":null,"abstract":"<p><strong>Background: </strong>Proximal femoral (hip) fracture is common, serious and costly. An enhanced community rehabilitation intervention (Fracture in the Elderly Multidisciplinary Rehabilitation) was codeveloped with patients, carers and therapists. Trial methods have been tested previously in a feasibility study.</p><p><strong>Objective: </strong>To determine the effectiveness and cost-effectiveness of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention compared with usual NHS rehabilitation care. To determine the mechanisms and processes that explain the implementation and impacts of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention.</p><p><strong>Design and methods: </strong>Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1 : 1 allocation ratio. Concurrent economic and process evaluations.</p><p><strong>Setting: </strong>Participant recruitment in 13 hospitals across England and Wales, with the Fracture in the Elderly Multidisciplinary Rehabilitation intervention delivered in the community.</p><p><strong>Participants: </strong>Patients aged over 60 years, with mental capacity, recovering from surgical treatment for proximal femoral fracture, and living in their own home prior to fracture.</p><p><strong>Interventions: </strong>Usual rehabilitation care (control) was compared with usual rehabilitation care plus the Fracture in the Elderly Multidisciplinary Rehabilitation intervention, which comprised a patient-held workbook and goal-setting diary aimed at improving self-efficacy, and six additional therapy sessions delivered in the community (intervention), to increase the practice of exercise and activities of daily living.</p><p><strong>Primary and secondary outcome measures: </strong>Primary effectiveness outcome was the Nottingham Extended Activities of Daily Living scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy - International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Economic outcomes were EuroQol EQ-5D-3L and Client Service Receipt Inventory.</p><p><strong>Results: </strong>In total, 205 participants were randomised (<i>n</i> = 104 experimental; <i>n</i> = 101 control). Trial processes were adversely affected by the coronavirus disease discovered in 2019 pandemic and the target sample of 446 was not met. By 52 weeks, the intervention group had worse Nottingham Extended Activities of Daily Living scores than the control group (mean difference: -1.9; 95% confidence interval: -3.7 to -0.1), which was not clinically important. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values, removed the apparent inferiority of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention with a mean difference of 0.1 (95% confidence interval: -1.1 to 1.3). There was no st","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 67","pages":"1-29"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12746194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804272","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}

{"title":"Tele-ophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease: HERMES cluster randomised trial with a diagnostic accuracy study.","authors":"Anitta Sharma, Rima Hussain, Annastazia E Learoyd, Angela Aristidou, Taha Soomro, Ann Blandford, John G Lawrenson, Gabriela Grimaldi, Abdel Douiri, Ashleigh Kernohan, Tomos Robinson, Najmeh Moradi, Christiana Dinah, Evangelos Minos, Dawn Sim, Tariq Aslam, Avinash Manna, Alastair K Denniston, Praveen J Patel, Pearse A Keane, Catey Bunce, Luke Vale, Konstantinos Balaskas","doi":"10.3310/QNDF3325","DOIUrl":"10.3310/QNDF3325","url":null,"abstract":"<p><strong>Background: </strong>Community-based optometrists, a major provider of primary eye care in the United Kingdom, are the main source of referrals to hospital eye services. The widespread introduction of optical coherence tomography devices in community practices provides community-based optometrists with an opportunity to identify a broader range of treatable diseases. Standard referral pathways do not effectively filter unnecessary referrals, with misclassification of urgency, and erroneous diagnoses.</p><p><strong>Objectives: </strong>To assess the effectiveness of a teleophthalmology referral pathway between community-based optometrists and hospital eye services for retinal diseases. To measure the accuracy of an artificial intelligence decision support system for diagnosis and referral management of retinal disease.</p><p><strong>Design: </strong>A multicentre, superiority cluster randomised controlled trial to assess the effectiveness of a teleophthalmology referral pathway. A prospective, observational diagnostic accuracy study to measure the performance of artificial intelligence decision support system. A comprehensive economic evaluation was conducted.</p><p><strong>Settings: </strong>United Kingdom-based community optometry practices with an optical coherence tomography device and hospital eye services.</p><p><strong>Participants: </strong>Adults requiring referral for retinal disease at the opinion of the community-based optometrists.</p><p><strong>Interventions: </strong>Community optometry practices were randomised 1 : 1 to standard care or teleophthalmology. Referrals sent via the teleophthalmology platform were remotely reviewed by human experts based at the corresponding hospital eye services. A referral decision was provided within 48 hours. Suitable optical coherence tomography scans were solely processed by artificial intelligence decision support system (the 'Octane' model).</p><p><strong>Main outcome measures: </strong>Cluster randomised controlled trial's primary outcome was the proportion of false-positive referrals (not required or not urgent) per arm in overall participants and in referred-only participants against an independent reference standard. Secondary outcomes included the proportion of wrong diagnosis, wrong referral urgency, false-negative referrals, safely triaged referrals for rare diseases, time from referral to consultation and treatment and cost-effectiveness of teleophthalmology. Primary outcome for the artificial intelligence study was the sensitivity and specificity of artificial intelligence referral decisions against the reference standard.</p><p><strong>Results: </strong>Teleophthalmology significantly reduces the proportion of false-positive urgent referrals by 59% compared to standard care in referred participants. Due to the observed low event rate for false positive referrals, teleophthalmology's role for reducing false positives overall was inconclusive. No significant difference between","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 69","pages":"1-113"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12746195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804255","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}

{"title":"Cost-effectiveness of endoscopic treatments for obesity: a clinical evidence map and systematic review to inform a model-based cost-effectiveness analysis.","authors":"Esther Albon, Nafsika Afentou, Janine Dretzke, James Hall, Chidubem Okeke Ogwulu, Malcolm J Price, Ken Clare, Rishi Singhal, Abd Tahrani, Emma Frew, David J Moore","doi":"10.3310/PWKQ2310","DOIUrl":"10.3310/PWKQ2310","url":null,"abstract":"<p><strong>Background: </strong>Bariatric surgery is the most effective treatment for obesity, but access is limited. Endoscopic obesity treatments are potentially cheaper and less invasive options, which may be similarly effective. There is currently a lack of evidence to inform decisions on whether such treatments should be considered for people living with obesity.</p><p><strong>Objective(s): </strong>What is the current evidence for the clinical and cost-effectiveness of endoscopic treatments compared to alternative weight management interventions for obesity?</p><p><strong>Methods: </strong>Comprehensive searches were undertaken to January 2023 and a searchable evidence map of all quantitative studies (<i>n</i> > 2) on endoscopic treatments was constructed. The map was used where possible to inform the economic models. Indirect comparisons were undertaken where relevant direct evidence for the model was not available. A systematic review of cost-effectiveness studies was undertaken. Targeted searches were undertaken to identify additional evidence to inform model parameters. Three economic (Markov) models were designed to estimate the cost-effectiveness of endoscopic therapies compared to alternative weight management interventions from a United Kingdom National Health Service and Personal Social Services perspective.</p><p><strong>Results: </strong>The evidence map included over 1500 records of studies of endoscopic therapies, most of which related to intragastric balloons and endoscopic sleeve gastrectomy. Three cost-utility analyses were identified, one of which was set in the United Kingdom and was used to inform the models. Laparoscopic sleeve gastrectomy is likely cost-effective compared with endoscopic sleeve gastroplasty for patients' obesity class II and III (£10,593 per quality-adjusted life-year-gained). Endoscopic sleeve gastroplasty is likely cost-effective compared with semaglutide for patients' obesity class I and II (£7267 per quality-adjusted life-year-gained). Semaglutide is dominant (cheaper and more effective) than intragastric balloon in patients' obesity class I and II. Probabilistic sensitivity analysis found a degree of confidence in the estimates. The 5-year time horizon may not capture longer-term benefits from endoscopic sleeve gastroplasty or laparoscopic sleeve gastrectomy.</p><p><strong>Limitations and conclusions: </strong>The effectiveness evidence base was greater and more wide-ranging than anticipated. However, for the interventions compared within the economic models, there were no randomised controlled trials and either limited, or an absence of, direct comparative evidence. There was also limited long-term data on interventions. These limitations necessitated the use of assumptions in modelling.</p><p><strong>Future work: </strong>Future research should focus on longer-term effectiveness of endoscopic treatments, studies directly comparing endoscopic therapies against semaglutide or other emerging weight ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 68","pages":"1-196"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12746199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804318","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}

{"title":"Compression Hosiery to Avoid the Post-Thrombotic Syndrome: a synopsis of the CHAPS RCT.","authors":"Ankur Thapar, Rebecca Lawton, Imad Adamestam, John Norrie, Sarrah Peerbux, Alun H Davies","doi":"10.3310/THYD9865","DOIUrl":"10.3310/THYD9865","url":null,"abstract":"<p><strong>Background: </strong>Approximately half of adults diagnosed with deep vein thrombosis will develop the post-thrombotic syndrome leading to chronic symptoms - including leg pain, oedema, venous ectasia and, in 5% of cases, venous ulceration. Risk factors include older age, obesity, a history of blood clots, cancer and heart failure. Despite adequate anticoagulation, post-thrombotic syndrome remains a chronic health condition with significant financial burden for patients and health services. The effectiveness of compression stockings in preventing post-thrombotic syndrome is unclear and whether the risks and costs associated with compression stockings are justified.</p><p><strong>Design: </strong>The Compression Hosiery to Avoid Post-Thrombotic Syndrome study was a multicentre, pragmatic, assessor-blind, randomised controlled trial of adults with a first proximal deep vein thrombosis.</p><p><strong>Setting: </strong>Secondary care National Health Service hospitals in the United Kingdom.</p><p><strong>Participants: </strong>Patients ≥ 18 years, with imaging-confirmed, symptomatic presentation of first deep vein thrombosis in the lower limb (popliteal, femoral, iliac or combination), ≤ 3 weeks from diagnosis.</p><p><strong>Interventions: </strong>Participants were randomised 1 : 1 to standard care (anticoagulation as per local guidelines) or intervention (anticoagulation as per local guidelines and regular use of a graduated compression stocking).</p><p><strong>Primary outcome: </strong>The primary outcome was any incidence of post-thrombotic syndrome using the Villalta criteria over a median of 18-month follow-up (range 6-30 months). This was planned to be assessed on up to three occasions (6 and 12 months post randomisation and at study end), depending on when an individual was randomised.</p><p><strong>Secondary outcomes: </strong>Planned secondary outcomes: incidence of venous ulceration (measured by the validated Villalta criteria) employment status (change in the number of days working from baseline) change in disease-specific and generic quality of life - Venous Insufficiency Epidemiological and Economic Study (VEINES-QOL/Sym) and EuroQol-5 Dimensions scales from baseline over 6 months, 12 months and end of study visit adherence to stockings and anticoagulants (patient self-report) cost-effectiveness of stocking prescription - incremental cost-effectiveness ratio from the EuroQol-5 Dimensions questionnaire, with appropriate sensitivity analysis.</p><p><strong>Results: </strong>The trial closed early due to poor recruitment during the COVID-19 pandemic; and, of the planned sample size of 864, 152 participants were randomised. Post-thrombotic syndrome occurred in 51% of the control arm and in 30% of the intervention arm at last follow-up. No serious adverse events relating to stockings were recorded. Stocking adherence was a mean of 6 days (standard deviation 2) per week.</p><p><strong>Conclusions: </strong>The sample size was not re","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 66","pages":"1-13"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700723","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}

{"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}

{"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}

{"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}

{"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}

{"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}

{"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}