Health technology assessment最新文献

{"title":"Clinical utility of biomarkers for outcomes prediction in adults with suspected sepsis presenting to the emergency department: a synthesis of current evidence.","authors":"Mari Imamura, Sinead N Duggan, Thenmalar Vadiveloo, Jamie G Cooper, Callum T Kaye, Paul Manson, Gianni Virgili, Lorna Aucott, Mike Clarke, Miriam Brazzelli","doi":"10.3310/GJMB1730","DOIUrl":"10.3310/GJMB1730","url":null,"abstract":"<p><strong>Background: </strong>Sepsis is characterised as life-threatening organ dysfunction due to a dysregulated host response to infection. It carries high mortality and is a major public health issue globally. Among adults presenting to the emergency department with features of suspected sepsis, rapid and accurate differentiation of those at high risk for prompt delivery of key therapies and escalation of care may improve outcomes.</p><p><strong>Objectives: </strong>To conduct a comprehensive evidence synthesis assessing the clinical utility of established and novel biomarkers - used individually or in combination - for predicting the risk of death or clinical deterioration in adults with clinically suspected sepsis presenting to the emergency department.</p><p><strong>Design and methods: </strong>Search strategies were designed to identify English-language studies published between 2013 and 2023 evaluating biomarker performance to predict mortality or clinical deterioration in adults with suspected sepsis. Eligible studies had to evaluate biomarker performance in patients with clinically suspected sepsis (as defined by study authors) at emergency department presentation. Outcomes of interest included all-cause mortality, critical care admission, septic shock and organ failure. A comprehensive search was conducted across multiple databases, including MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials (search date 5 July 2023). For each biomarker, used alone or in combination, risk ratios, hazard ratios, odds ratios and area under the receiver-operating characteristics curve values were extracted. Subgroup analyses were planned to compare patients in terms of age, presence of comorbidities, National Health Service or other health systems, and biomarker assessment timing. Methodological quality was evaluated using the Quality in Prognostic Factor Studies tool.</p><p><strong>Results: </strong>Of 1986 citations identified, 884 duplicates were removed, and 1102 were screened by title and abstract. Of the 430 full-text articles assessed, 377 were excluded as they did not meet the eligibility criteria, and 53 reports, related to 51 studies, were deemed suitable for inclusion. A total of 107 unique biomarkers or biomarker combinations were assessed across the included studies. However, due to limited data and clinical heterogeneity, only biomarkers commonly used in clinical practice (lactate, C-reactive protein and procalcitonin) were analysed through meta-analyses, and none effectively predicted adverse outcomes. Although novel biomarkers could not be pooled, several (Inflammatix Severity 2, mid-regional proadrenomedullin, neutrophil gelatinase-associated lipocalin, tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2, monocyte distribution width and neutrophil-to-lymphocyte ratio) showed potential for predicting mortality and admission to critical care. The","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"73-162"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13054664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147581164","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 polyhexanide, chlorhexidine with neomycin and mupirocin for nasal methicillin-resistant Staphylococcus aureus (MRSA) decolonisation: non-inferiority RCT (TIDE).","authors":"Elizabeth Cook, Sophie James, Joanne Laycock, Ashley Scrimshire, Alex Mitchell, Heather Leggett, Alison Booth, Karen Glerum-Brooks, Catriona McDaid, Paul Baker, Maria Cann, Vicky Hanlon, Mike Reed, Martin Kiernan, Arabella Scantlebury, Luke Strachan, David Tate, David J Torgerson, Catherine E Hewitt","doi":"10.3310/GJMR0715","DOIUrl":"10.3310/GJMR0715","url":null,"abstract":"<p><strong>Background: </strong>The bacterium <i>Staphylococcus aureus</i> is a leading cause of hospital-acquired infections. These infections are difficult to treat when there is increasing resistance to penicillin, known as methicillin-resistant <i>Staphylococcus aureus</i>. Patients who carry <i>Staphylococcus aureus</i> in the nose and skin are prone to developing infections and many patients admitted to hospital are routinely 'decolonised' to reduce this risk. The current standard treatment for nasal decolonisation is the antibiotic nasal mupirocin. There are concerns about over-reliance on a single treatment and the risk of mupirocin-resistant methicillin-resistant <i>Staphylococcus aureus</i>. Robust evidence for alternatives to mupirocin is required.</p><p><strong>Objective: </strong>To investigate whether there are clinically and cost-effective alternatives to mupirocin for early nasal decolonisation of methicillin-resistant <i>Staphylococcus aureus</i> among adult hospital inpatients.</p><p><strong>Design and methods: </strong>We designed a multicentre, three-arm parallel-group, non-inferiority, randomised controlled trial with economic and qualitative evaluations, to recruit 3000 participants.</p><p><strong>Setting and participants: </strong>Adult hospital inpatients identified as being colonised with methicillin-resistant <i>Staphylococcus aureus</i> on routine hospital admission screening were eligible for inclusion.</p><p><strong>Interventions: </strong>Participants were randomised (ratio 1 : 1 : 1) to receive one of the following decolonisation treatments: mupirocin (2%) nasal ointment (3 g), polyhexanide (0.1%) nasal gel (30 ml) or chlorhexidine (0.1%) with neomycin (0.5%) nasal cream (15 g). Neither participants nor the investigators were blind to treatment allocation.</p><p><strong>Main outcome measures: </strong>The primary outcome was successful early nasal decolonisation, defined as a negative trial specific nasal methicillin-resistant <i>Staphylococcus aureus</i> swab taken 48 hours following treatment completion. Secondary outcomes included successful early nasal decolonisation of methicillin-resistant <i>Staphylococcus aureus</i> not fully susceptible to mupirocin, successful late nasal decolonisation, acceptability of treatment to patients, methicillin-resistant <i>Staphylococcus aureus</i> infections, length of hospital inpatient stays and re-admissions, adverse events and mortality. Outcomes were collected up to 4 weeks following treatment completion.</p><p><strong>Results: </strong>Recruitment and retention of participants were much lower than expected. In total, 297 patients were assessed for eligibility and 32 patients randomised. All participants received treatment as allocated. Seven participants withdrew from the study. The mean age was 73.8 years (standard deviation 16.6 years), with 62.5% (<i>n</i> = 20) of participants being male. Semistructured interviews were undertaken with patients (<i>N</i> = 5), clinical","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"543-576"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12968953/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147344009","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":"Duration of external neck stabilisation in the management of older and frail patients with a new odontoid fracture: the DENS RCT.","authors":"Paul M Brennan, Marta Adamczyk, Mia Closs, Phillip Copley, Gina Cranswick, Helen Eborall, Ellie Edlmann, Catriona Keerie, Kat Oatey, Sadaquate Khan, Julia Lawton, David Lowe, John Norrie, Angela Niven, Philip Rayson, Matthew Reed, Aryelly Rodriguez, Bea Selby, Himanshu Shekhar, Susan Shenkin, Pina Sorbara, Patrick Statham, Andrew Stoddart, James Tomlinson, Jennifer Waddell, Julie Woodfield","doi":"10.3310/GJPB0728","DOIUrl":"10.3310/GJPB0728","url":null,"abstract":"<p><strong>Background: </strong>Fractures of the cervical spine's odontoid process can result from low-impact falls in frail or older adults, and are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing often does not occur in older/frail adults and is not necessary for good outcomes. Further, hard collars can cause complications, such as skin pressure ulcers, and difficulties with swallowing or personal care.</p><p><strong>Objective: </strong>To examine whether management of odontoid process fractures without hard collar immobilisation is associated with improved quality of life in older/frail patients.</p><p><strong>Design and methods: </strong>The Duration of External Neck Stabilisation trial was a non-blinded randomised controlled trial with a nested qualitative study.</p><p><strong>Setting and participants: </strong>Aimed to recruit 887 participants from 25 United Kingdom hospitals, over 2 years. Eligible patients were aged ≥ 65 years, or with Rockwood Clinical Frailty Scale of ≥ 5.</p><p><strong>Interventions: </strong>Comparing early hard collar removal (intervention) with standard management in a hard collar for 12 weeks.</p><p><strong>Main outcome measures: </strong>Primary outcome measure: quality of life 12 weeks following randomisation. EuroQol-5 Dimensions, five-level version.</p><p><strong>Randomisation: </strong>Web-based randomisation system based on age, fracture type and frailty.</p><p><strong>Blinding: </strong>Participants not blinded. Outcome event adjudication committee blinded to treatment allocation.</p><p><strong>Results: </strong>The study was terminated prematurely because of slow recruitment. One hundred and thirty-eight patients were randomised with. 83.3% aged > 75 years old and. 72.5% of fractures being odontoid type 2. Mean number of days in collar 0.2 (standard deviation 1.4) for early removal of collar participants, and 55.5 days (standard deviation 38.0) for standard management participants; 15.6% of standard management participants crossed over, 3.0% of early removal of collar participants. Twenty-eight days after randomisation, 80 patients (61.5%) were not wearing a collar. Primary end-point assessment (EuroQol 5 dimension instrument five-level version at 12 weeks), based on intention-to-treat analysis, mean score 0.650 (standard error 0.039, 0.490 to 0.86) in early removal of collar group and 0.0667 (standard error 0.040, 0.51 to 0.89) in standard management group. Pre-specified subgroup analysis by fracture type (<i>p</i> = 0.3645), Rockwood score (<i>p</i> = 0.6593) and age (<i>p</i> = 0.4088) were non-significant. Qualitative study participants reported decreased autonomy following the fracture. Standard management patients reported additional negative impacts. There was need for better information about the injury, 'normal' recovery and return to activities. Seventeen patients died; 10 (17.2%) early removal of collar group, 7 (9.8%) standard management","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"121-156"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13181504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863885","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":"Learnings from the establishment and delivery of the UK Collaborative Paediatric Palliative Care Research Network.","authors":"George Peat, Emily Harrop, Anna-Karenia Anderson, Debbie Box, Fliss Murtagh, Richard Harding, Lucy Ziegler, Catherine Hewitt, Ian Wong, Joanna Elverson, Nicola Harris, Lorna K Fraser","doi":"10.3310/VRFT5679","DOIUrl":"10.3310/VRFT5679","url":null,"abstract":"<p><strong>Background: </strong>There are increasing numbers of children living with conditions that may threaten or shorten their lives. While child mortality has decreased in recent decades, it is estimated 4500 infants, children and young people (0-19 years) die in the United Kingdom every year. Despite a growing increase in clinical provision, there is a clear paucity in research evidence underpinning paediatric palliative care. To support research delivery, a United Kingdom-wide network composed of paediatric palliative care-sector organisations and academics with expertise in the area was developed. The network had a clear vision of establishing partnerships between academia and services delivering paediatric palliative care that would support increased research capacity and delivery in the sector.</p><p><strong>Objective(s): </strong>The overarching aim of the network was to deliver national high-quality research studies, education and materials, and build research capacity. Specific objectives included working closely with seven paediatric palliative care sites to develop guidance on the appropriate methods for undertaking research, the delivery of information and educational resources including a webinar series, offering of mentor opportunities, and the development of a minimum of two bids to National Institute for Health and Care Research related funding pathways.</p><p><strong>Design: </strong>A collaborative design underpinned the network. Network activity included continued partner engagement through online meetings and newsletters, scoping activity to identify research priorities, establishment of research themes, and active engagement and support from national organisations. Patient and public involvement was core to all network activity.</p><p><strong>Setting: </strong>Network engagement largely took place online. The network has a web page hosted on the website of the organisation Together for Short Lives.</p><p><strong>Partners: </strong>Seven paediatric palliative care sites in England and Scotland (six hospices and one National Health Service hospital site) formed the network with input from several academic partners.</p><p><strong>Results: </strong>The network achieved several outputs related to objectives including the submission of two National Institute for Health and Care Research applications for funding, the delivery of five educational webinars, the establishment of an online research toolkit and the development of a research nurse group.</p><p><strong>Conclusions: </strong>Prior to the establishment of the network, there was no national mechanism for co-ordination for research in paediatric palliative care. In bringing together seven partner organisations and clinical and research expertise, the network has supported the foundations upon which to deliver high-quality research in the sector.</p><p><strong>Future work: </strong>Future work is required to support the sustainability of the network including obtaining nece","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"633-642"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11891940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523191","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":"Development and evaluation of the electronic frailty index+ (eFI+) tool for older people: prognostic prediction modelling with integrated decision curve and health economic analysis.","authors":"Lucinda Archer, Samuel D Relton, Ashley Akbari, Kate Best, Rebecca Bestwick, Milica Bucknall, Simon Conroy, Miriam Hattle, Joe Hollinghurst, Daniel Howdon, Claire Hulme, Sara Humphrey, Ronan A Lyons, Silviya Nikolova, Mar Pujades Rodriguez, Suzanne Richards, Kate Walters, Robert West, Danielle Van der Windt, Richard D Riley, Andrew Clegg","doi":"10.3310/GJAC1008","DOIUrl":"10.3310/GJAC1008","url":null,"abstract":"<p><strong>Background: </strong>Our aim was to develop and evaluate the electronic frailty index+, a prognostic tool, including four integrated prognostic-decision models, to stratify older people into subgroups for targeting key interventions.</p><p><strong>Methods: </strong>Prognostic model development, internal validation and external validation using large data sets and longitudinal cohort study data, with decision curve and health economic analysis.</p><p><strong>Population: </strong>Patients aged 65+ years.</p><p><strong>Key outcomes: </strong>The 12-month outcomes for prognostic models: new home care package care home admission emergency department attendance/hospitalisation with fall/fracture all-cause mortality.</p><p><strong>Statistical methods: </strong>We developed and internally validated models for our key outcomes in one large data set. We used internal-external cross-validation for the home care model and full external validation for the remaining three models in a second large data set. We used CARE75+ to investigate additional predictive value of clinical measures practical for primary care.</p><p><strong>Decision curve analysis: </strong>We translated the prognostic models into a framework to support clinical decision-making.</p><p><strong>Health economic evaluation: </strong>We integrated the falls prediction models with effect size estimates from network meta-analysis to examine potential cost savings.</p><p><strong>Results: </strong>We used data from 660,417 patients in SAIL, 88,947 in Connected Bradford and 252 CARE75+ participants. Model performance was promising in internal-external cross-validation, with average calibration slope 1.00 (95% confidence interval 0.99 to 1.01), average calibration-in-the-large -0.01 (95% confidence interval -0.02 to 0.01), average observed/expected ratio 0.99 (95% confidence interval 0.98 to 1.01) and average C-statistic 0.81 (95% confidence interval 0.81 to 0.81).</p><p><strong>Emergency department attendance/hospitalisation with fall/fracture: </strong>Model performance was promising on internal and external validation, although with some evidence for overprediction of falls risk, with calibration slope 1.25 (95% confidence interval 1.24 to 1.27), calibration-in-the-large -0.931 (95% confidence interval -0.938 to -0.920), observed/expected ratio 0.43 (95% confidence interval 0.42 to 0.44), C-statistic 0.83 (0.82 to 0.83).</p><p><strong>Care home admission: </strong>Model performance was promising on internal validation, but it showed some miscalibration on external validation, with calibration slope 0.75 (95% CI 0.74 to 0.76), calibration-in-the-large -1.60 (-1.62 to -1.58) and observed/expected ratio 0.25 (95% CI 0.24 to 0.25), C-statistic of 0.86 (95% CI 0.86 to 0.86).</p><p><strong>All-cause mortality: </strong>The model showed excellent performance across the full range of predicted risks on external validation, with average calibration slope 1.00 (0.98 to 1.01), average calibration-in","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 61","pages":"1-154"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13478932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701158","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":"Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model.","authors":"Catalina Lopez Manzano, Ayman Sadek, Chris Cooper, Eve Tomlinson, Hanyu Wang, Claire Rice, Emma Tallantyre, Ananya Rao-Middleton, Penny Whiting, Howard Thom","doi":"10.3310/GJHT1811","DOIUrl":"10.3310/GJHT1811","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis is an immune-mediated inflammatory disease, causing long-term disability in young adults. Most cases begin as relapsing-remitting multiple sclerosis. Some people have a form of relapsing-remitting multiple sclerosis known as highly active relapsing-remitting multiple sclerosis, defined as multiple sclerosis with unchanged or increased disease activity despite prior treatment with at least one disease-modifying therapy.</p><p><strong>Objectives: </strong>To appraise the clinical and cost-effectiveness of natalizumab [Tysabri<sup>®</sup> (Biogen, Cambridge, MA, USA)] and natalizumab biosimilar [Tyruko<sup>®</sup> (Sandoz)] for treating highly active relapsing-remitting multiple sclerosis compared to other disease-modifying therapy.</p><p><strong>Design: </strong>Systematic review with network meta-analysis and economic model. Searches last updated in April 2024.</p><p><strong>Results: </strong>We included 42 studies (22,409 participants): 40 in people with relapsing-remitting multiple sclerosis and 2 in highly active relapsing-remitting multiple sclerosis. Six studies also reported data separately for highly active relapsing-remitting multiple sclerosis. Only four studies evaluated natalizumab or natalizumab biosimilar; none provided data on those with highly active relapsing-remitting multiple sclerosis. Follow-up ranged from 4 to 36 (median 24) months. Most interventions reduced relapses (39 studies, 17 interventions) and magnetic resonance imaging lesions (19 studies, 11 interventions for gadolinium enhancing lesions and 17 studies, 12 interventions for T2-weighted lesions) compared to placebo. Alemtuzumab, ocrelizumab, cladribine, natalizumab, fingolimod and peginterferon beta-1a reduced disease progression compared to placebo (15 studies, 12 interventions). There were no differences in any adverse events (24 studies, 16 interventions), serious adverse events (31 studies, 15 interventions) or treatment-related adverse events (8 studies, no network meta-analysis) for any intervention compared to placebo. Fingolimod, glatiramer acetate, interferon beta-1a, interferon beta-1b and peginterferon beta-1a were associated with an increased treatment discontinuation (29 studies, 13 interventions). There was little evidence for a difference in quality of life. There was no evidence of a difference between natalizumab and natalizumab biosimilar for relapse rates [rate ratio 0.65 (95% credible interval 0.33 to 1.23], gadolinium enhancing lesions [hazard ratio 1.29 (0.69 to 2.37)], T2-weighted lesions [hazard ratio 1.07 (0.73 to 1.57)], any adverse events [hazard ratio 1.06 (0.77 to 1.46)] or treatment discontinuation [hazard ratio 0.48 (0.13 to 1.76)]. Data in highly active relapsing-remitting multiple sclerosis were available for fingolimod, ocrelizumab, alemtuzumab, cladribine, interferon beta, autologous haematopoietic stem cell treatment and placebo. We also included one study on natalizumab conducted ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 60","pages":"1-290"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13478935/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148712662","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":"Establishing palliative care research partnerships in Northern Ireland.","authors":"Julie McMullan, Clare McVeigh, Peter O'Halloran","doi":"10.3310/QUTP1946","DOIUrl":"10.3310/QUTP1946","url":null,"abstract":"<p><strong>Background: </strong>The National Institute for Health and Care Research call for research partnerships was designed to build research capacity in palliative and end-of-life care and to ensure that the research of the National Institute for Health and Care Research is conducted in areas of greatest need and where there are historically low levels of research. Northern Ireland has high levels of need, relatively underdeveloped services, and comparatively low levels of research.</p><p><strong>Aims: </strong>To build palliative care and end-of-life research capacity in Northern Ireland, with a specific focus on less experienced sites, so that strong applications could be submitted to Part 2 of the National Institute for Health and Care Research Commissioned Call: building the evidence base. To create a sustained collaboration to support a programme of research focused on key areas of need in Northern Ireland that are also relevant to the rest of the United Kingdom.</p><p><strong>Methods: </strong>The Partners were: Queen's, Ulster and Open Universities; All Ireland Institute of Hospice and Palliative Care; Marie Curie Hospice Care; Patient and Client Council; Kidney Care UK; the three Health and Social Care Trusts covering areas with greatest need; Northern Ireland Clinical Trials Unit; Palliative Care Research Forum Northern Ireland; Public Health Agency; Department of Health; Health and Social Care Board. The Partnership was co-led by Drs Peter O'Halloran and Clare McVeigh, senior lecturers at Queen's University Belfast. A post-doctoral research assistant was employed 3 days a week in a support role. The Partners agreed the terms of reference for the Partnership and met six times over the following year. An expression of interest form was distributed to potential investigators, producing 13 responses. The Partnership then offered networking opportunities for investigators with specific partners, facilitated by the research assistant. The Partnership hosted a palliative care research conference on '<i>Cross-sector Partnerships for Palliative and End-of-life Care Research</i>'. This included presentations from the National Institute for Health and Care Research representatives on grant proposal preparation. A website and newsletter were published.</p><p><strong>Results: </strong>Nine introductory meetings took place, mostly with early career researchers. Topics included symptom management, accessing palliative care for vulnerable groups, perinatal bereavement care and advanced care planning. Draft proposals were reviewed by the Partnership and one was prepared for submission to Part 2 of the National Institute for Health and Care Research Commissioned Call: an evaluation of an intervention to improve the readiness of people with end-stage kidney disease, healthcare professionals, and surrogate decision-makers to engage with advance care planning.</p><p><strong>Conclusions: </strong>The Partnership took advantage of widespread interest and","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"643-654"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11891634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531327","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":"Lessons from the PROTECT-CH COVID-19 platform trial in care homes.","authors":"Philip M Bath, Jonathan Ball, Matthew Boyd, Heather Gage, Matthew Glover, Maureen Godfrey, Bruce Guthrie, Jonathan Hewitt, Robert Howard, Thomas Jaki, Edmund Juszczak, Daniel Lasserson, Paul Leighton, Val Leyland, Wei Shen Lim, Pip Logan, Garry Meakin, Alan Montgomery, Reuben Ogollah, Peter Passmore, Philip Quinlan, Caroline Rick, Simon Royal, Susan D Shenkin, Clare Upton, Adam L Gordon","doi":"10.3310/MTRS8833","DOIUrl":"10.3310/MTRS8833","url":null,"abstract":"<p><strong>Background: </strong>Coronavirus disease-2019 was associated with significant mortality and morbidity in care homes in 2020-1. Repurposed antiviral drugs might reduce morbidity and mortality through reducing viral transmission, infection, replication and inflammation. We aimed to compare the safety and efficacy of potential antiviral drugs in care home residents.</p><p><strong>Methods: </strong>We designed a cluster-randomised, open-label, blinded end-point platform trial to test drugs in a postexposure prophylaxis paradigm. Participants aged 65+ years from United Kingdom care homes, with or without nursing, were eligible for participation. Care homes were to be allocated at random by computer to administer 42 days of antiviral agent (ciclesonide or niclosamide) plus standard care versus standard care alone to residents. The primary outcome at 60 days after randomisation comprised the most serious outcome, which was defined as all-cause mortality, all-cause hospitalisation, severe acute respiratory syndrome coronavirus 2 infection or no infection. Analysis would be by intention to treat using ordinal logistic regression. Other outcomes included individual components of the primary outcome, transmission, plus health economic and process evaluation outcomes. The planned sample size was 300 care homes corresponding to 9600 residents. With ~40% of care homes predicted to develop an outbreak during the trial, we needed to recruit 750 homes/24,000 residents.</p><p><strong>Results: </strong>We initiated the trial including protocol, approvals, insurance, website, database, data algorithms, intervention selection and training materials. We built a network of principal investigators and staff (91) and care homes (299) to support the trial. However, we never contracted care homes or general practitioners since the trial was stopped in September 2021, as vaccination in care homes had significantly reduced infections. Multiple delays significantly delayed the start date, such as: (1) reduced prioritisation of pandemic trials in 2021; (2) cumbersome mechanisms for choosing the investigational medicinal products; (3) contracting between National Institute for Health and Care Research and the investigational medicinal product manufacturers; (4) publicising the investigational medicinal products; (5) identification of sufficient numbers of care homes; (6) identification and contracting with several thousand general practitioners; (7) limited research nurse availability and (8) identification of adequate insurance to cover care homes for research. Generic challenges included working across the four home nations with their different structures and regulations.</p><p><strong>Limitations: </strong>The feasibility of contracting between the sponsor and the principal investigators, general practitioners and care homes; screening, consent and treatment of care home residents; data acquisition and the potential benefit of postexposure prophylaxis were never t","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"303-328"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12010236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990492","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 pragmatic, multicentre, placebo-controlled, 3-arm, double-blinded, randomised controlled trial, incorporating an internal pilot, to determine the role of bronchodilators in preventing exacerbations of bronchiectasis.","authors":"Nina Wilson, Miranda Morton, Tara Homer, Ann Breeze Konkoth, Richard Joyce, Anneka Kershaw, Hazel Wilde, Alison Liddle, James Wason, Laura Ternent, Maria Allen, Robert Lord, John Steer, Graham Devereux, James D Chalmers, Adam T Hill, Charles S Haworth, John R Hurst, And Anthony De Soyza","doi":"10.3310/GGCC1111","DOIUrl":"10.3310/GGCC1111","url":null,"abstract":"<p><strong>Background: </strong>Bronchiectasis is a long-term lung condition associated with bronchial dilatation, chronic inflammation and infection. Treatment is often empirical or extrapolated from other lung conditions, for example the use of inhaled therapies licensed for use in asthma or chronic obstructive pulmonary disease. Inhaled therapies, such as corticosteroids or long-acting bronchodilators (long-acting beta agonists or long-acting muscarinic antagonists), are commonly used in bronchiectasis despite scanty evidence on exacerbation reduction.</p><p><strong>Objective: </strong>To assess whether: dual bronchodilators (long-acting beta agonists/long-acting muscarinic antagonists) either as stand-alone therapy or in combination with inhaled corticosteroid are superior to placebo at reducing mean exacerbation rates over 12 months dual bronchodilators (long-acting beta agonists/long-acting muscarinic antagonists) are non-inferior to triple therapy (inhaled corticosteroid/long-acting beta agonists/long-acting muscarinic antagonists) at reducing mean exacerbation rates over 12 months.</p><p><strong>Design: </strong>Pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, prospective, randomised controlled trial incorporating a 12-month internal pilot.</p><p><strong>Target population: </strong>Six hundred adults with bronchiectasis and history of ≥ 2 exacerbations in any 12-month period within the preceding 2 years.</p><p><strong>Setting: </strong>United Kingdom National Health Service secondary care sites.</p><p><strong>Interventions: </strong>Twelve months, one puff daily of either dual therapy [55 μg umeclidinium (long-acting muscarinic antagonists) and 22 μg vilanterol (long-acting beta agonists)], triple therapy [dual therapy plus 92 μg fluticasone furoate (inhaled corticosteroid)] or matched placebo dry powder inhalers, randomised in a 2 : 2 : 1 ratio, respectively.</p><p><strong>Outcome measures: </strong>Primary: number of participants reported bronchiectasis exacerbations requiring treatment with antibiotics during the 12-month treatment period. Primary economic: incremental cost per quality-adjusted life-year gained at 12 months.</p><p><strong>Results: </strong>Recruitment rates did not follow projections due to the COVID-19 pandemic; 85 potentially eligible patients were screened, of whom 33 (39%) were randomised. Of the randomised participants, 30 (91%) completed follow-up at 12 months; 3 participants withdrew [1/14 (7%) dual therapy, 1/12 (8%) triple therapy and 1/7 (14%) placebo]. Five participants discontinued therapy during the trial [1/14 (7%) dual therapy, 2/12 (17%) triple therapy and 2/7 (29%) placebo]. Given the small sample size, the statistical and economic analyses are descriptive and exploratory. Exacerbation data were available for 32/33 (97%) of randomised participants (13 dual therapy, 12 triple therapy and 7 placebo). The median number of exacerbations during the follow-up (the primary outcome) was 1","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"465-542"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13034087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146142375","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":"Interventions to reduce pain at dressing change of chronic wounds: a mixed-methods systematic review.","authors":"Fiona Campbell, Ruth Wong, Georgina Wilkins, Menghan Wang, Katie Twentyman, Richard Cooper, Andrew Kirkcaldy","doi":"10.3310/GJRC0808","DOIUrl":"10.3310/GJRC0808","url":null,"abstract":"<p><strong>Background: </strong>Pain during dressing changes is a major concern for individuals with chronic wounds, such as venous leg ulcers, diabetic foot ulcers and pressure sores. These procedures, often performed in community settings, can cause significant physical and emotional distress. Despite widespread recognition of this issue, there has been no comprehensive synthesis of evidence to guide effective pain management strategies during dressing changes.</p><p><strong>Objective: </strong>This mixed-methods systematic review aimed to evaluate interventions designed to reduce pain during dressing changes for chronic wounds and to explore the experiences of patients and healthcare professionals.</p><p><strong>Methods: </strong>Twenty-nine studies were included: 8 effectiveness studies, 11 surveys and 10 qualitative studies. Data were sourced from six electronic databases and analysed using a convergent segregated approach. Quantitative data were summarised using synthesis without meta-analysis guidance, while qualitative and survey data were analysed thematically. Findings were integrated using the preventing pain at dressing change pathway, a framework developed with stakeholder input to map interventions across the dressing change process.</p><p><strong>Results: </strong>Pain was found to be highly variable and influenced by wound type, healing stage and previous experiences. Non-adhesive and ibuprofen-releasing foam dressings consistently reduced pain, while gauze dressings were frequently associated with increased discomfort. Topical treatments, such as eutectic mixture of local anaesthetics cream and morphine gel, showed promise. Patients valued skilled, communicative nursing care and involvement in their own treatment. Distraction techniques and post-dressing pain relief were identified as important but under-researched. Pain assessment practices were inconsistent, and formal tools were rarely used.</p><p><strong>Limitations: </strong>The broad scope of eligible interventions increases the risk of missing relevant studies. Most studies were small and at moderate to high risk of bias.</p><p><strong>Future work: </strong>Future research should focus on evaluating underused interventions (e.g. distraction, patient involvement), improving pain assessment practices, and addressing equity gaps in pain management. Investment in nurse training and consistent care protocols is essential.</p><p><strong>Conclusions: </strong>Effective pain management during dressing changes requires a holistic, patient-centred approach. While some interventions show promise, many commonly used strategies lack robust evidence. The preventing pain at dressing change pathway offers a practical framework for guiding future practice, research and policy development.</p><p><strong>Funding: </strong>This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 59","pages":"1-57"},"PeriodicalIF":3.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13501245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701149","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}