Health technology assessment最新文献

{"title":"Alpha2 agonists for sedation to produce better outcomes for adults with critical illness: a synopsis of the A2B RCT with cost-effectiveness and process evaluation.","authors":"Timothy S Walsh, Richard A Parker, Leanne M Aitken, Lydia Emerson, Cathrine A McKenzie, Julia Boyd, Alix MacDonald, Gayle Beveridge, Annabel Giddings, David Hope, Sîan Irvine, Sharon Tuck, Nazir I Lone, Kalliopi Kydonaki, John Norrie, Benedict Creagh-Brown, Daniel F McAuley, Paul Dark, Matt P Wise, Anthony C Gordon, Gavin D Perkins, Michael C Reade, Bronagh Blackwood, Alasdair MacLullich, Robert Glen, Valerie J Page, Stephen Morris, Christopher J Weir","doi":"10.3310/GJTW3820","DOIUrl":"10.3310/GJTW3820","url":null,"abstract":"<p><strong>Background: </strong>Most mechanically ventilated intensive care unit patients require sedation and analgesia for comfort. Current usual care is propofol-based sedation plus an opioid analgesic. The alpha2 agonists dexmedetomidine and clonidine are potential alternative sedatives, but their clinical and cost-effectiveness are uncertain.</p><p><strong>Objective(s): </strong>To evaluate the clinical and cost-effectiveness and safety of alpha2 agonists (dexmedetomidine and clonidine) compared with propofol for sedating adult intensive care unit patients.</p><p><strong>Design and methods: </strong>Pragmatic open-label three-arm trial. Embedded process and economic evaluation.</p><p><strong>Setting and participants: </strong>Forty-one intensive care units in the UK. Recruitment from December 2018 to October 2023. Participants were 1437 adults within 48 hours of starting mechanical ventilation expected to require ≥ 48 hours of mechanical ventilation [analysis population: propofol (<i>N</i> = 471), dexmedetomidine (<i>N</i> = 457), and clonidine-based (<i>N</i> = 476) sedation]. Median time from intubation to randomisation was 21.0 (first, third quartile: 13.2, 31.3) hours.</p><p><strong>Interventions: </strong>In all groups, bedside algorithms targeted a Richmond Agitation Sedation Scale of -2 to + 1 unless clinicians requested deeper sedation. Intervention groups' algorithms supported alpha2-agonist up-titration and propofol down-titration followed by sedation primarily with allocated alpha2 agonist. Supplemental propofol was permitted if required.</p><p><strong>Outcomes: </strong>Primary outcome was time to successful extubation, analysed allowing for death as a competing risk. Secondary outcomes included mortality, sedation quality, rates of delirium and cardiovascular adverse events. Long-term outcomes included: experience of intensive care unit care; anxiety, depression and post-traumatic stress; cognitive function; health-related quality of life.</p><p><strong>Results: </strong>Mean (standard deviation) patient age was 59.2 (14.9) years; 901 (65%) male. The sub-distribution hazard ratio for time to successful extubation for dexmedetomidine versus propofol was 1.09 (95% confidence interval 0.96 to 1.25; <i>p</i> = 0.20) and for clonidine versus propofol was 1.05 (0.95 to 1.17; <i>p</i> = 0.34), with hazard ratio > 1 favouring alpha2 agonist. Median (95% confidence interval) hours from randomisation to successful extubation was: propofol 162 (136 to 170); dexmedetomidine 136 (117 to 150); and clonidine 146 (124 to 168). There was no effect interaction with age, sepsis status, median Sequential Organ Failure Assessment Score, or median Prediction of Delirium in intensive care unit patients' delirium risk score. Delirium rates were similar, but agitation occurred at higher rate than propofol with both alpha2 agonists [dexmedetomidine vs. propofol risk ratio (95% confidence intervals) 1.54 (1.21 to 1.97); clonidine vs. propofol 1.55 (1.22 t","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 48","pages":"1-94"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13334535/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148360421","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":"Ethical implications of the use of AI-based technologies for medical image classification systems in screening: a qualitative systematic review.","authors":"Melina Vasileiou, Victoria Wakefield, Clare Dadswell, Steven J Edwards","doi":"10.3310/GJSE4912","DOIUrl":"10.3310/GJSE4912","url":null,"abstract":"<p><strong>Background: </strong>The integration of artificial intelligence in medical image classification for screening has the potential to enhance efficiency, diagnostic accuracy and accessibility. However, ethical concerns such as accountability, bias, transparency and the impact on healthcare professionals remain critical. This review synthesises qualitative evidence on the ethical considerations surrounding artificial intelligence adoption in screening programmes.</p><p><strong>Methods: </strong>A systematic search of qualitative studies, from June 2020 to September 2024, was conducted across multiple databases: MEDLINE, EMBASE, PsycInfo<sup>®</sup> (American Psychological Association, Washington, DC, USA) and Cumulative Index to Nursing and Allied Health Literature. Primary qualitative studies exploring healthcare professionals', patients' and other stakeholders' perspectives on artificial intelligence in screening were included. Thematic analysis was performed, and findings were assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative Research approach to evaluate confidence in the evidence.</p><p><strong>Results: </strong>Fourteen qualitative studies were included, covering perspectives from clinicians, radiologists, artificial intelligence developers, policy-makers and patients. Key ethical concerns identified included: (1) the necessity of human oversight to ensure that artificial intelligences diagnostic recommendations are appropriate; (2) challenges in assigning liability when artificial intelligence errors occur; (3) risks of algorithmic bias due to discrepancies between training data sets and real-world populations; (4) concerns over data privacy, cybersecurity and informed consent in artificial intelligence-driven decision-making; (5) the need for transparency in artificial intelligence decision-making processes to build trust and (6) potential deskilling of healthcare professionals and shifts in professional responsibilities. While artificial intelligence was seen as a valuable tool to augment clinical decision-making, stakeholders emphasised that ethical frameworks must guide its implementation to maintain public trust and patient safety.</p><p><strong>Conclusion: </strong>This review highlights the critical considerations that must be addressed to ensure the responsible integration of artificial intelligence in medical screening. Policy-makers, healthcare institutions and developers should prioritise human oversight, robust regulatory frameworks and strategies to mitigate bias and ensure transparency. Future research should focus on disease-specific artificial intelligence applications and long-term ethical implications.</p><p><strong>Study registration: </strong>The protocol for this study is registered on PROSPERO as CRD42024599536.</p><p><strong>Funding: </strong>This award was funded by the National Institute for Health and Care Research (NI","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 51","pages":"1-89"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13358767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148360474","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":"Effects and costs of a group-based educational intervention to reduce opioid use in people with chronic pain: I-WOTCH RCT.","authors":"Harbinder K Sandhu, Katie Booth, Sheeja Manchira Krishnan, Charles Abraham, Sharisse Alleyne, Shyam Balasubramanian, Lauren Betteley, Tom Bromilow, Dawn Carnes, Andrea D Furlan, Vijay S Gc, Kirstie L Haywood, Maddy Hill, Cynthia P Iglesias-Urrutia, Ranjit Lall, Andrea Manca, Dipesh Mistry, Joe We Moss, Sian Newton, Vivien P Nichols, Jennifer Noyes, Emma Padfield, Anisur Rahman, Kate Seers, Jane Shaw, Nicole Ky Tang, Stephanie Jc Taylor, Colin Tysall, Martin Underwood, Sam Eldabe","doi":"10.3310/GJHS2715","DOIUrl":"10.3310/GJHS2715","url":null,"abstract":"<p><strong>Background: </strong>The long-term use of strong opioids for chronic non-cancer pain puts people at risk of serious harm.</p><p><strong>Objectives: </strong>To test the effectiveness and cost-effectiveness of a multicomponent intervention targeting opioid use for the treatment of chronic pain.</p><p><strong>Design: </strong>A multicentred randomised controlled trial with embedded process evaluation.</p><p><strong>Setting: </strong>Primary care.</p><p><strong>Participants: </strong>Adults using strong opioids for non-malignant chronic.</p><p><strong>Interventions: </strong>Participants were randomised 1 : 1 (using a minimisation programme stratified by geographical locality, baseline pain intensity score and baseline morphine equivalent dose) to either usual care (an educational booklet and relaxation compact disc) or usual care plus the I-WOTCH intervention; 3 day-long group sessions delivered by a nurse and lay facilitator, plus a one-to-one session and ongoing telephone contact from the nurse to support opioid tapering.</p><p><strong>Main outcome measures: </strong>The two primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A), and proportion using no opioids, at 12 months.</p><p><strong>Results: </strong>We randomised 608 people. At 12 months, there was no between-group difference in Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A) scores; mean difference, -0.52 (95% confidence interval -1.94 to 0.89). At 12 months, 65/225 (29%) of people in the intervention group and 15/208 (7%) of people in usual-care group reported using no opioids [odds ratio 5.55 (95% confidence interval 2.80 to 10.99)], absolute difference, 21.7% (95% confidence interval 14.8 to 28.6). Over a lifetime horizon, I-WOTCH is on average associated with an incremental cost of £9277 per person, and provides an additional 0.314 quality-adjusted life-years. The deterministic incremental cost per quality-adjusted life-year gained was £29,543. The I-WOTCH intervention may be cost-effective compared to best usual care. The process evaluation suggested group support and shared experience were important to those trying to taper.</p><p><strong>Limitations: </strong>The opioid use analysis is based solely on participant self-report. The findings only apply to people willing to consider opioid reduction and may not apply to a more complex secondary care population. The results may not be applicable to people using very high opioid doses.</p><p><strong>Conclusions: </strong>The I-WOTCH intervention helps substantially more people stop opioids than best usual care without adversely affecting pain interference.</p><p><strong>Future work: </strong>The I-WOTCH intervention should be tested in different healthcare settings and other populations.</p><p><strong>Trial registration: </strong>This trial is registered as Current Controlled Trials ISRCTN49470934.</p><p><strong>Funding: </str","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 35","pages":"1-174"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13200030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147947588","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 negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention: the SWHSI 2 pragmatic RCT.","authors":"Catherine Arundel, Laura Mandefield, Caroline Fairhurst, Kalpita Baird, Pedro Saramago, Athanasios Gkekas, Rhiannon Macefield, Jane Blazeby, Belen Corbacho, Stephen Dixon, Jo Dumville, Josie Hatfield, Catherine Hewitt, Matthew Lee, Andrew Mott, Angela Oswald, Thomas Pinkney, Nikki Stubbs, Samantha Swan, David Torgerson, Jacqueline Wilkinson, Lyn Wilson, Sabeen Zahra, Ian Chetter","doi":"10.3310/GJIC1716","DOIUrl":"10.3310/GJIC1716","url":null,"abstract":"<p><strong>Background: </strong>Surgical wounds healing by secondary intention occur if a surgical wound is not closed or dehisces following primary closure. Surgical wounds healing by secondary intention are common and adversely affect patients' quality of life. Treatment is often prolonged, complex and expensive. Negative pressure wound therapy applies a controlled vacuum to the wound and is increasingly used to promote surgical wound healing by secondary intention despite limited rigorous evidence for the clinical and cost-effectiveness of negative pressure wound therapy to augment surgical wound healing by secondary intention.</p><p><strong>Objective: </strong>Assess the clinical and cost-effectiveness of negative pressure wound therapy versus usual care (no negative pressure wound therapy) in treating surgical wounds healing by secondary intention.</p><p><strong>Design and methods: </strong>A pragmatic, two-arm, parallel-group, randomised controlled superiority trial. Twenty-eight UK NHS Trusts randomised adult patients with a surgical wounds healing by secondary intention to receive negative pressure wound therapy or usual care (no negative pressure wound therapy). The planned sample size was 696 participants. Participants were followed up for 12 months via weekly telephone contact to collect the primary outcome (time to healing: full cover with no scab in days since randomisation) and clinical secondary outcomes: wound healing, surgical site infection, pain, hospital re-admission, current treatment and reasons for treatment change (if applicable), reoperation, amputation, antibiotic use, death. Patient-reported outcomes (pain, health-related quality of life and resource use) were collected by postal questionnaire at 3, 6 and 12 months. Validation of the Bluebelle Wound Healing Questionnaire, a patient-reported measure of surgical site infection, was also undertaken. A cost-effectiveness decision model considering all available evidence, and a within-trial cost-utility analysis, was also undertaken to evaluate the cost-effectiveness of negative pressure wound therapy against usual care. Neither participants nor the investigators were blind to treatment allocation.</p><p><strong>Results: </strong>Between 15 May 2019 and 13 January 2023, 686 participants were recruited, randomised and included in the analysis (negative pressure wound therapy <i>n</i> = 349; usual care <i>n</i> = 337). Most participants had a single surgical wound healing by secondary intention (<i>n</i> = 622, 90.7%), located on the foot (<i>n</i> = 551, 80.3%) or leg (<i>n</i> = 69, 10.1%) arising following vascular surgery (<i>n</i> = 619, 90.2%). Most participants had comorbidities; diabetes (<i>n</i> = 549, 80.0%), cardiovascular disease (<i>n</i> = 446, 65.0%) and/or peripheral vascular disease (<i>n</i> = 349, 50.9%). Median time to healing was 187 days (negative pressure wound therapy) versus 195 days (usual care), with no evidence that negative pressure wound therapy ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 32","pages":"1-50"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13181503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856278","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":"A personalised health intervention to maintain independence in older people with mild frailty: a process evaluation within the HomeHealth RCT.","authors":"Rachael Frost, Yolanda Barrado-Martín, Louise Marston, Shengning Pan, Jessica Catchpole, Tasmin Rookes, Sarah Gibson, Jane Hopkins, Farah Mahmood, Benjamin Gardner, Rebecca L Gould, Claire Jowett, Rashmi Kumar, Rekha Elaswarapu, Christina Avgerinou, Paul Chadwick, Kalpa Kharicha, Vari M Drennan, Kate Walters","doi":"10.3310/MBCV1794","DOIUrl":"10.3310/MBCV1794","url":null,"abstract":"<p><strong>Background: </strong>Frailty is common in later life and can lead to adverse health outcomes. Services aimed at preventing decline in early stages of frailty may support older people to remain independent for longer. We developed and tested a new service, HomeHealth, in a randomised controlled trial. HomeHealth was a multidomain behaviour change service based in the voluntary sector in England targeting mobility, socialising, nutrition and psychological well-being.</p><p><strong>Objective: </strong>To describe the population reach, fidelity, acceptability, context and mechanisms of impact of the HomeHealth service.</p><p><strong>Design and methods: </strong>Mixed-methods process evaluation of a randomised trial.</p><p><strong>Setting and participants: </strong>HomeHealth trial participants (older people aged 65+ years with mild frailty) and service providers.</p><p><strong>Data sources and analysis: </strong>Population reach was evaluated through comparison to local census data. Fidelity of audio-recorded appointments was assessed by two independent raters using a structured checklist. Using data from appointments attended, types of goals set and progress towards goals, we described appointment characteristics, goals and signposting, and evaluated three mechanisms of impact: (1) effect of appointment attendance on independence, (2) effect of goal progress on independence and (3) whether selecting a particular goal type led to improvements in the corresponding intermediate outcome. We thematically analysed qualitative interviews with 49 older people, 7 HomeHealth workers and 8 stakeholders to explore acceptability and context.</p><p><strong>Results: </strong>HomeHealth participants were similar with regards to deprivation, education and housing status to the local older population but with lower rates of minority ethnic groups. HomeHealth was delivered with good fidelity (81.7%) in voluntary sector organisations. Appointments were well attended (mean 5.33 out of the 6 intended), but attendance was not associated with better independence scores at 12 months [mean difference 1.29 (-8.20 to 10.78)]. Participants varied in progress towards goals within appointments (mean progress 1.15/2.00), but greater goal progress was not associated with improved independence scores at 12 months [mean difference -0.40 (-2.38 to 1.58)]. Mobility goals were most frequently selected (49%), but type of goal had no impact on independence and little impact on intermediate outcomes. Forty-one per cent were signposted or referred to other supportive services, with ongoing support where needed throughout this process. Qualitative data indicated that HomeHealth was acceptable, empowering for those who saw a need for change and fitted well within host voluntary sector organisations.</p><p><strong>Limitations: </strong>Census data were only available for all adults aged over 65 in local areas rather than a mildly frail population, who are likely to be older, female ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"23-46"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11995243/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788267","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 intensive community care services for adolescents with acute psychiatric emergencies: findings from a feasibility multi-centre, parallel-group, single-blinded RCT.","authors":"Dennis Ougrin, Thilipan Thaventhiran, Ben Wong, Izabela Pilecka, Sabine Landau, Sarah Byford, Petrina Chu, Margaret Heslin, Emma Tassie, Paula Reavey, Opeyemi Olusegun Atanda, Tauseef Mehdi, Mandy Wait, Toby Zundel, Jovanka Tolmac, Joe Clacey, Leon Wehncke, Veronika Dobler, Ebony Baker, Jessica Collier, Rhys Bevan-Jones, Hassan Jafari, Ruth Woolhouse","doi":"10.3310/GJDO2425","DOIUrl":"10.3310/GJDO2425","url":null,"abstract":"<p><strong>Background: </strong>Adolescents experiencing psychiatric emergencies often require intensive interventions to prevent hospitalisation and support their return to education, employment or training. Intensive Community Care Services aim to provide an alternative to inpatient care.</p><p><strong>Aims: </strong>To evaluate the effectiveness of Intensive Community Care Services compared to treatment as usual in reducing the time to start or return to education, employment or training for young people with psychiatric emergencies.</p><p><strong>Method: </strong>A multicentre, parallel-group, single-blinded, randomised controlled trial, including an internal feasibility phase, across seven NHS trusts in the United Kingdom. Adolescents aged 12-17 were randomised to receive either Intensive Community Care Services or treatment as usual. The primary outcome was the time to start or return to education, employment or training within a 6-month observation period. Secondary outcomes included clinical symptoms, functioning and service satisfaction. Process evaluation used semistructured visual interviews followed by thematic decomposition analysis. The impact of COVID-19 and the importance of continuity of care were explored in a series of cohort studies based in emergency departments. A consensus meeting was held to define the features of Intensive Community Care Services.</p><p><strong>Results: </strong>Of the approximately 977 adolescents screened, 36 were randomised in a 1 : 1 ratio using a web-based randomisation system stratified by the NHS trust using variable block sizes to receive either Intensive Community Care Services or treatment as usual. A key reason for poor recruitment was the absence of an alternative to Intensive Community Care Services. The recruitment rate did not meet pre-specified progression criteria (<i>n</i> = 55 by the first 6 months of recruitment), and conducting a full evaluation trial was deemed not feasible. Thirty participants from the pilot sample (83.3%) returned to education, employment or training during the 6-month follow-up period, with a median time to education, employment or training of 9 days (interquartile range 1-49). The median time to education, employment or training was lower in the Intensive Community Care Services group (6 days) compared to the treatment-as-usual group (12 days), with a hazard ratio of 1.34 (95% confidence interval 0.63 to 2.86). Estimated effect sizes for secondary outcomes were also in the direction of a benefit under Intensive Community Care Services, with higher satisfaction with services and improvements in clinical symptoms and functioning. There was a greater total average cost for the treatment-as-usual group at £15,155 (standard deviation 31,560), compared to £7063 (standard deviation 10,605) for Intensive Community Care Services. Due to the small sample size, no inferences regarding Intensive Community Care Services effectiveness or cost-effectiveness can be drawn. Fourte","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 40","pages":"1-32"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13223881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963570","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":"Early stroke specialist vocational rehabilitation for REturn To work After stroKE: a synopsis from the RETAKE RCT.","authors":"Kate Radford, Alexandra Wright-Hughes, David Clarke, Julie Phillips, Jain Holmes, Katie Powers, Diane Trusson, Kristelle Craven, Ellen Thompson, Caroline Watkins, Audrey Bowen, Christopher McKevitt, Judith Stevens, John Murray, Rory O'Connor, Sarah Pyne, Helen Risebro, Rory Cameron, Tracey Sach, Florence Day, Amanda Farrin","doi":"10.3310/LAKP6585","DOIUrl":"10.3310/LAKP6585","url":null,"abstract":"<p><strong>Background: </strong>Return to work is achieved by < 50% stroke survivors. Evidence on support for return to work is lacking.</p><p><strong>Objective: </strong>To determine whether Early Stroke Specialist Vocational Rehabilitation is more clinically effective and cost-effective at supporting return to work 12 months after stroke than usual care.</p><p><strong>Design and methods: </strong>Pragmatic, observer-blind, multicentre superiority randomised controlled trial with embedded health economic evaluation. Participants were individually randomised, 5 : 4, to receive occupational therapy-led Early Stroke Specialist Vocational Rehabilitation + usual care. Questionnaire follow-up at 3, 6 and 12 months post randomisation. Mixed-methods process evaluation explored intervention experience, fidelity, compliance and implementation.</p><p><strong>Setting: </strong>Twenty-one NHS stroke services in England and Wales.</p><p><strong>Participants: </strong>Patients with new stroke within 12 weeks, aged ≥ 18, in paid/unpaid work at stroke onset. People not intending to return to work excluded.</p><p><strong>Intervention: </strong>Occupational therapists assessed stroke impact on participants and their job; co-ordinated NHS/employer/other stakeholders' support; negotiated job accommodations, monitored return to work and explored alternatives if return to work were unfeasible. Usual care involved NHS rehabilitation provided by community teams and medical follow-up.</p><p><strong>Main outcome measures: </strong>Primary outcome: self-reported return to work for ≥ 2 hours/week 12 months post randomisation. Secondary outcomes: mood, functional ability, participation, productivity, work self-efficacy, health-related quality of life, confidence, mortality, carer strain, cost-consequences, COVID-19 impact.</p><p><strong>Results: </strong>Between 1 June 2018 and 7 March 2022, 583 participants [mean age 54 years (standard deviation 11.1), 69.0% male, mean 29.9 days (standard deviation 20.0) post stroke, 452 (82.8%) ischaemic stroke] were randomised to Early Stroke Specialist Vocational Rehabilitation (<i>n</i> = 324) or usual care (<i>n</i> = 259). Primary and secondary outcome data were available for 454 (77.9%) and 316 (54.2%) participants, respectively. Intention-to-treat analysis showed no statistically significant difference in return to work between groups at 12 months [165/257 (64.2%) Early Stroke Specialist Vocational Rehabilitation vs. 117/197 (59.4%) usual-care, adjusted odds ratio 1.12 (95% confidence interval 0.8 to 1.87), <i>p</i> = 0.3582]. Similar proportions of adverse events occurred in both groups [40/241 (16.6%) attended accident and emergency, 24/244 (9.1%) hospital admissions, 6/266 (2.3%) work accidents at 12 months]. Exploratory subgroup analyses indicated Early Stroke Specialist Vocational Rehabilitation potentially benefits older people (60+), and those with two or more post-stroke impairments. Health economic outcomes were consistent ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 31","pages":"1-64"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13181502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147873888","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":"Fenofibrate and progression of retinopathy in adults with diabetes: the randomised placebo-controlled LENS trial.","authors":"David Preiss, Jennifer Logue, Emily Sammons, Mohammed Zayed, Graham Scotland, Mekazin Tsehaye, Jonathan Emberson, Rachel Wade, Karl Wallendszus, Will Stevens, Rosanna Cretney, Simon Harding, Graham Leese, Gemma Currie, Caroline Styles, And Jane Armitage","doi":"10.3310/AAPH5610","DOIUrl":"10.3310/AAPH5610","url":null,"abstract":"<p><strong>Background: </strong>Diabetic retinopathy is a leading cause of visual loss. Hypothesis-generating data from cardiovascular outcome trials suggest that fenofibrate therapy may reduce the progression of diabetic retinopathy.</p><p><strong>Objective: </strong>To determine whether treatment with fenofibrate reduces the progression of diabetic retinopathy.</p><p><strong>Design and methods: </strong>We conducted a parallel-group, double-masked, placebo-controlled clinical trial of fenofibrate. A web-based algorithm allocated participants to treatment arms by minimisation.</p><p><strong>Setting and participants: </strong>The trial was positioned within NHS Scotland's Diabetic Eye Screening Programme. Adults with diabetes and non-referable retinopathy or maculopathy (based on Diabetic Eye Screening retinal image grading) were eligible.</p><p><strong>Interventions: </strong>Study treatment was mailed to participants' homes. Participants who were eligible at the screening assessment entered an active pre-randomisation run-in during which they took 145 mg fenofibrate. After randomisation, participants received 145 mg fenofibrate tablets or placebo. Study treatment was taken daily in those with normal renal function, or on alternate days in those with impaired renal function.</p><p><strong>Main outcome measures: </strong>The primary outcome was a composite of developing referable diabetic retinopathy or maculopathy, or requiring treatment for diabetic retinopathy or maculopathy. Incremental cost-effectiveness was assessed in terms of the primary outcome and per modelled quality-adjusted life-year gained.</p><p><strong>Data sources: </strong>Data were obtained from 6-monthly interviews by research nurses and linkage to national healthcare data sets. Selected adverse events were adjudicated by study clinicians masked to treatment allocation.</p><p><strong>Results: </strong>One thousand four hundred and eighty-four participants entered the pre-randomisation run-in, of whom 1151 were randomised. The primary outcome occurred in 131 (22.7%) of 576 participants assigned fenofibrate and 168 (29.2%) of 575 participants assigned placebo (hazard ratio 0.73; 95% confidence interval 0.58 to 0.91; <i>p</i> = 0.006) over a median of 4.0 years. Any progression of retinopathy or maculopathy, and development of macular oedema were also reduced. There was no effect on visual function, quality of life, or visual acuity. Fenofibrate use resulted in a non-significant reduction in 6-monthly health service costs (mean difference -£101, 95% confidence interval -£243 to £42), leading to dominance over standard care and a high probability of cost-effectiveness. Based on modelling (assuming no difference in background healthcare costs by treatment allocation), fenofibrate led to a small increase (£6) in cost for a small gain (0.02) in quality-adjusted life-years; incremental cost-effectiveness ratio £406 per quality-adjusted life-year gained. The probability of cost-effecti","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 41","pages":"1-70"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13200031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147873908","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":"Enabling health and maintaining independence for older people at home: the 'HomeHealth' Randomised Controlled Trial.","authors":"Kate Walters, Rachael Frost, Yolanda Barrado-Martín, Sarah Kalwarowsky, Louise Marston, Shengning Pan, Christina Avgerinou, Claire Goodman, Andrew Clegg, Benjamin Gardner, Jane Hopkins, Farah Mahmood, Rebecca L Gould, Rekha Elaswarapou, Claire Jowett, Dawn A Skelton, Vari M Drennan, Claudia Cooper, Kalpa Kharicha, Pip Logan, Matthew Prescot, Gillian Thornton, Tasmin Rookes, Jessica Catchpole, Rachael Hunter","doi":"10.3310/GJKW1909","DOIUrl":"10.3310/GJKW1909","url":null,"abstract":"<p><strong>Background: </strong>HomeHealth is a home-based, voluntary sector service supporting older people with mild frailty to maintain independence through behaviour change. Support workers discuss the person's priorities and enable setting/achieving goals around mobility, nutrition, socialising and/or psychological well-being.</p><p><strong>Aims: </strong>We tested clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty in a randomised controlled trial.</p><p><strong>Methods: </strong>Design: Single-blind, parallel randomised controlled trial open between 18 January 2021 and 4 July 2023, with mixed-methods process evaluation. Setting: Community-dwelling older people aged 65+ years with mild frailty from 27 general practices and community settings in London, Yorkshire and Hertfordshire. Randomisation: Participants were randomised 1 : 1 to receive HomeHealth or treatment as usual. Outcomes: Primary outcome was independence in activities of daily living (modified Barthel Index), analysed using linear mixed models. Secondary outcomes included frailty phenotype score, extended activities of daily living, well-being, psychological distress, loneliness, cognition, falls and mortality. Health economic outcomes included quality of life, capability and service use, including hospital admissions. Cost-effectiveness acceptability curves and cost-effectiveness planes were used to represent the probability of cost-effectiveness compared to treatment as usual. Process evaluation: We conducted semistructured interviews with participants receiving the intervention, HomeHealth workers and other stakeholders supporting service delivery. Interviews were thematically analysed. Fidelity of audio-recorded appointments was assessed by two independent raters. We evaluated potential mechanisms of impact using data from appointments attended, types of goals set and progress towards goals.</p><p><strong>Findings: </strong>We recruited 388 participants, mean age 81.4 years (standard deviation 6.5), 64% female and 94% White British/European. HomeHealth did not improve Barthel Index scores at 12 months (0.250, 95% confidence interval -0.932 to 1.432). At 6 months, we found small significant reductions in psychological distress (-1.237, 95% confidence interval -2.127 to -0.348), and frailty phenotype score (-0.252, 95% confidence interval -0.487 to -0.017). At 12 months, we found significant improvements in well-being (1.449, 95% confidence interval 0.124 to 2.775), reduced unplanned admissions (incidence rate ratio 0.65, 95% confidence interval 0.54 to 0.92) with lower associated costs (-£586/participant, 95% confidence interval -351 to -821). There were no differences in other outcomes. HomeHealth dominates treatment as usual with a negative point estimate for incremental costs (-796, 95% confidence interval -2016 to 424), positive point estimate for incremental quality-adjusted life-years (0.009, -0.021 to 0.039) and ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 43","pages":"1-22"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13202625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147972131","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":"Developing a national triage tool for use in NHS regional trauma networks: the MATTS mixed methods study.","authors":"Gordon W Fuller, James Baird, Joshua Miller, Richard Pilbery, Esther Herbert, Samuel Keating, Tia Callaghan, Daniel Pollard, Abdullah Pandor, Munira Essat, Di Charles, Robin Chatters, Fiona Sampson, Jaqui Long, Michael Smyth, Jason E Smith, Gavin D Perkins, Fiona Lecky, Janette Turner, Cindy Cooper","doi":"10.3310/ALPE8857","DOIUrl":"10.3310/ALPE8857","url":null,"abstract":"<p><strong>Background: </strong>There is currently wide variation in prehospital major trauma triage across the National Health Service, with regional ambulance services using different triage tools, varying in format, structure and variables.</p><p><strong>Objectives: </strong>To develop a national triage tool that is acceptable, usable, accurate, and optimises under- and over-triage.</p><p><strong>Design: </strong>A three-phase research programme, comprising Phase 1: development of a new triage tool by expert consensus informed by existing evidence, a systematic review of elderly triage, document analysis of current tools, decision-analytic modelling, expert consensus definition of a major trauma reference standard, and a qualitative examination of current triage; Phase 2: case-cohort study validating triage tools identified and developed in Phase 1, with identification of an optimally performing candidate triage tool; Phase 3: evaluation of the candidate triage tool following implementation, including cohort study investigating accuracy of triage decisions, cost-effectiveness analysis, and examination of user experiences.</p><p><strong>Setting: </strong>English regional trauma networks served by the South-Western, West Midlands, Yorkshire and London Ambulance Services. Phase 2 case-cohort study and Phase 3 cohort studies performed between 1 November 2019 and 28 February 2020, and 1 November 2021 and 15 May 2022, respectively.</p><p><strong>Participants: </strong>Injured patients presenting to ambulance services in participating regional trauma networks.</p><p><strong>Results: </strong>In Phase 1, document analysis identified 19 United Kingdom triage tools and 34 published international tools. The systematic review demonstrated limited diagnostic accuracy of triage tools in the elderly, with divergent real-life triage decisions. The reference standard included the need for critical trauma-related interventions, significant individual anatomical injuries, burden of multiple minor injuries and specific patient attributes. Decision-analytic modelling indicated that high-specificity triage tools were favoured. Triage tool simplicity and the option for clinical judgement were valued by stakeholders, but real-world triage was a multifaceted, nonlinear, dynamic and multiagency process. Following review of Phase 1 evidence, a three-step Major Trauma Triage Study candidate triage tool targeting relatively higher specificity was developed through expert consensus. The Phase 2 case-cohort sample included 2757 patients, with a weighted prevalence of major trauma of 3.1% (95% confidence interval 2.3% to 4.0%). The Major Trauma Triage Study tool performed optimally compared to under- and over-triage targets (sensitivity 37.3%, specificity 95.1%). In Phase 3, the newly implemented Major Trauma Triage Study triage tool was received favourably by stakeholders. Prehospital triage decisions using the new tool demonstrated a sensitivity of 55.3% (95% confidence in","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 34","pages":"1-222"},"PeriodicalIF":3.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13223880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147987257","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}