Health technology assessment最新文献

{"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":"https://doi.org/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":4.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Manualised package intervention to achieve treatment adherence in people with tuberculosis: the IMPACT pilot cluster-RCT.","authors":"Marc Lipman, Ibrahim Abubakar, Colin Nj Campbell, Caroline Clarke, Andrew J Copas, Patricia Costello, Marcia Darvell, Robert Horne, Rachael M Hunter, Annie Sk Jones, Aaron S Karat, Karina Kielmann, Ayşenur Kılıç, Heinke Kunst, Mike Mandelbaum, Zoe Moon, Al Story, Jing Yi Weng, Helen R Stagg","doi":"10.3310/GJML0604","DOIUrl":"10.3310/GJML0604","url":null,"abstract":"<p><strong>Background and objectives: </strong>Tuberculosis remains a United Kingdom health concern. It occurs predominantly in people who have lived in tuberculosis endemic countries or have links there. Adherence to anti-tuberculosis treatment can be challenging, especially for people who experience severe side effects or social marginalisation. Poor adherence can lead to treatment failure. Current adherence support interventions make little difference to outcome. We identified the need for a 'manualised' approach to (1) improve case-managers' ability to detect people likely to non-adhere and (2) guide targeted adherence support.</p><p><strong>Objectives: </strong>Synthesise knowledge on drivers and interventions to support anti-tuberculosis treatment adherence Apply the Perceptions and Practicalities framework to understand poor adherence Develop a manualised intervention to identify adherence-related risks, modifiable barriers and support mechanisms Pilot the intervention and assess feasibility of data collection Evaluate implementation through fidelity and reach, and assess impact on adherence Assess intervention delivery costs to guide a full trial plus economic evaluation.</p><p><strong>Methods: </strong>The study ran April 2018-September 2022. Formative work included scoping reviews of adherence literature; National Health Service patients, caregivers, and health worker interviews; and clinic observations. A multidisciplinary group, including people with lived experience of tuberculosis, healthcare professionals, and researchers, coproduced the intervention package. We performed a (1 : 1) pilot cluster-randomised trial (<i>N</i> = 79 participants evaluated), randomising four London tuberculosis clinics, in preparation for a definitive cluster-randomised trial. Participants in control clinics received standard care. The primary outcome was adherence, doses taken of a possible 168 measured using evriMED boxes and other sources. We recorded treatment outcomes and changes in participants' needs, health-related beliefs and perceptions, costs, and health status. We conducted a mixed-methods process evaluation, using questionnaires, interviews, case-report forms, checklists and clinic observations.</p><p><strong>At intervention sites, additional resources were: </strong>Electronic tuberculosis needs assessment completed at all visits. Two animated videos to increase motivation and ability to take treatment. Interactive treatment guide designed around the Perceptions and Practicalities framework. Detailed manual for case managers.</p><p><strong>Results: </strong>We developed a tuberculosis needs assessment for tuberculosis services. This appeared better than standard care at identifying people requiring adherence support [e.g. at baseline 21/36 (58.3%) intervention vs. 4/43 (9.3%) control] and social support (over 24 weeks, on 29 vs. 6 occasions respectively). Cumulative dose-taking was high across the study population at 24 weeks [84% (95% confi","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 28","pages":"1-138"},"PeriodicalIF":4.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13112134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147721945","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 novel methodology using direct patient contact and UK national registries to collect long-term data from randomised trials: TARGIT-X - an extended follow-up study of the TARGIT-A trial of targeted intraoperative radiotherapy for breast cancer.","authors":"Jayant S Vaidya, Norman R Williams, Max Bulsara, Chris Brew-Graves, Ingrid Potyka, Nicholas Roberts, Julie Lindsay, Siobhan Laws, Sanjay Raj, Michael Douek, Mary Falzon, Gloria Petralia, Sarah Needleman, Anu Malhotra, Marcelle Bernstein, Jeffrey S Tobias","doi":"10.3310/GJJV2820","DOIUrl":"10.3310/GJJV2820","url":null,"abstract":"<p><strong>Background: </strong>Many diseases, including breast cancer, have a long natural history; therefore, longer-term effects of treatments are important for patients and for their full evaluation. However, trial follow-up data are collected by specific staff and are funded for a relatively short duration.</p><p><strong>Objective: </strong>We evaluated whether we could collect follow-up information for patients in a breast cancer randomised clinical trial by direct patient contact and data from national registries.</p><p><strong>Setting: </strong>The TARGIT-A randomised clinical trials of targeted intraoperative radiotherapy during lumpectomy versus whole-breast external beam radiotherapy (n=2298), and delayed TARGIT-IORT vs. external beam radiotherapy (<i>n</i> = 1153), recruited women with early breast cancer diagnosed in 33 centres in 12 countries, between March 2000 and June 2012. We planned to recruit all United Kingdom patients from the TARGIT-A trials for extended follow-up. These were the first randomised trials of intraoperative radiotherapy for breast cancer.</p><p><strong>Methods: </strong>We assessed the feasibility of recording whether patients are alive and their current health status, including events related to breast cancer, and effects of radiotherapy such as lung cancer diagnoses, by direct patient contact and data from NHS Digital (health episodes, diagnoses and death). Patients were consented in collaboration with the recruiting site and were then contacted annually, if appropriate, directly by the trial centre. We calculated the proportion of eligible patients whose status could be ascertained, contacted, consented and provided follow-up information via direct patient contact and/or NHS Digital data. We estimated the additional years of follow-up and its cost.</p><p><strong>Results: </strong>Six hundred and seven of 714 United Kingdom patients originally recruited in the TARGIT-A trials were initially eligible. We ascertained the current status or reason for non-participation of 574 (94.5%); 87% (502/574) of these patients' health status could be determined. Of these, 73% (366/502) or 60.3% of the total (366/607) were found to be in good health, provided valid consent for TARGIT-X and their health status. One hundred and thirty-six patients did not participate in TARGIT-X because: 105/136 (77%) were too unwell or had died, and for 6 patients, the consent was either incomplete or the physical form could not be traced. Less than 5% (25/502) of patients were unwilling to participate: 23 declined and 2 withdrew. We recorded an additional 103 deaths, more than doubling the initial number to 203. The quality of data returned by patients was very good [e.g. mismatch rate for recording date < 0.1% (1/1470 forms)]. Patients who participated increased their follow-up by a median 6 years [to 14 years (interquartile range 13-16)]. We found a much lower incidence of lung cancer diagnoses with TARGIT-IORT compared with EBRT (16-year","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 29","pages":"1-32"},"PeriodicalIF":4.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13112128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728880","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 description of Early Stroke Specialist Vocational Rehabilitation delivered in the RETAKE trial.","authors":"Kathryn A Radford, Mary I Grant, Jain A Holmes, Julie Phillips, Kathryn Powers, Rachel L Chambers, Kristelle Craven, Brian Bell, Christopher McKevitt, David Clarke, Amanda Farrin, Diane Trusson, Caroline Watkins, Audrey Bowen, Ellen Thompson, Alexandra Wright-Hughes","doi":"10.3310/GJKR0715","DOIUrl":"10.3310/GJKR0715","url":null,"abstract":"<p><strong>Objective: </strong>This paper describes the development of an Early Stroke Specialist Vocational Rehabilitation intervention to support return to work following stroke and its delivery in the RETAKE trial.</p><p><strong>Methods: </strong>Iterative three stage, target population approach to intervention development and evaluation informed by the Medical Research Council Framework. Stage 1 (Initial codevelopment): interviews with key stakeholder service providers and users' and mapping of services supporting return to work after stroke to identify and explore barriers to and unmet needs for support; intervention codevelopment with experts and patient and public involvement (PPI). Stage 2 (Refinement): expert panel codevelopment workshops and systematic review to identify vocational rehabilitation intervention mechanisms of change in supporting return to work after stroke. Stage 3 (Testing): intervention piloting in two case studies, feasibility testing in a randomised controlled trial, acceptability interviews with stroke and employer participants. Further intervention refinement following delivery in the RETAKE randomised controlled trial.</p><p><strong>Results: </strong>Stage 1: service mapping and 25 stakeholder interviews identified service gaps and unmet needs relating to early identification of employed stroke survivors, mild stroke, and hidden disabilities. Access to timely support relied on geographical proximity to a specialist hub and tacit knowledge of complex health, education and employment services and provider roles. Return to work issues reported by stroke survivors informed Early Stroke Specialist Vocational Rehabilitation prototype design objectives. Iterative developments following piloting included fatigue management, involvement of general practitioners, work simulation and liaison with other healthcare services. Interviews with 12 recipient stroke survivors and 6 employers identified additional features including occupational therapist negotiation skills, ability to respond to changing needs over time and patient empowerment to self-re-refer. The review corroborated intervention components and mechanisms and identified additional mechanisms, for example, peer support, supported self-management. Intervention mechanisms identified across the three stages were early intervention, understanding the impact of stroke on the person, their job and work environment, vocational goal setting, implementing workplace accommodations, individual tailoring, work preparation, colocation, case co-ordination, Multidisciplinary Team (MDT) working, employer engagement and education, and responsiveness, which involved monitoring work stability, providing feedback, and responding to changing needs over time and participant self-re-referral. In RETAKE, Early Stroke Specialist Vocational Rehabilitation was successfully delivered to 95.4% of allocated participants with 75.3% compliance. Intervention commenced a median 38 days (interquartile","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-64"},"PeriodicalIF":4.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13071780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147608798","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 novel approach to the assessment of repeat self-harm in prisoners: development and validation of a tool to bridge assessment and treatment (RAPSS).","authors":"Seena Fazel, Leanne Heathcote, Leen Farouki, Jane Senior, Amanda Perry, Thomas Fanshawe, Jenny Shaw","doi":"10.3310/GJSF1605","DOIUrl":"https://doi.org/10.3310/GJSF1605","url":null,"abstract":"<p><strong>Background: </strong>Repetition of self-harm in prisoners is common but approaches to assess and manage risk of repetition are inconsistent and unstructured.</p><p><strong>Objective: </strong>To develop and validate a risk model for repeat self-harm in people in prison, and test feasibility and acceptability.</p><p><strong>Methods: </strong>In seven English prisons, we identified 754 people aged over 17 who had been placed on a suicide risk management plan (known as an Assessment, Care in Custody and Teamwork) after a self-harm episode or elevated risk. We developed a multivariable model to estimate risk of repeat suicidality at 3 months using routinely collected sociodemographic, clinical and prison-related factors, which were tested using Cox proportional hazards models. We tested 25 potential risk factors comprising sociodemographic factors, clinical history and treatment, and criminal records using routinely collected information. In a prospective validation sample of 390 people from 13 prisons, we tested this model to assess risk of repeat suicidality at 3 months across a range of performance measures. TRIPOD guidelines were followed for the design and reporting of this work. In a parallel study, we qualitatively ran separate focus groups for prison staff and people in prison to examine practical issues relating to the potential use of a new tool, and synthesised themes.</p><p><strong>Findings: </strong>In the overall final sample of 1144 people in prison [966 (84%) men, mean age 33 years], 22% had the outcome of repeat suicidality over 3 months. The final risk model consisted of 9 factors, including sex, calendar age, and features of recent suicidal behaviour. Calibration and discrimination were similar in both development and validation samples, with O:E ratio = 1.09 (95% confidence interval 0.88 to 1.35) and c-statistic = 0.66 (95% confidence interval 0.60 to 0.72) in external validation. At a 25% cut-off, sensitivity was 58% (50-66%) and specificity 72% (68-75%) in external validation. The tool (Risk Assessment for people in Prison at risk of Self-harm and Suicide or RAPSS) is available as an online risk calculator at https://oxrisk.com/rapsstrial/ and could be used towards the end or on completion of an existing suicide risk management plan. The qualitative study, conducted with multidisciplinary staff groups and two prisoner groups (one male and one female), led to eight themes being identified. Two prominent ones were staff saying that they would be keen to use the tool as a way to identify needs and signpost to other services, and people in prison explaining that any risk tool could help build rapport with their offender manager and support them to access psychological treatments and other services.</p><p><strong>Conclusions: </strong>We have developed and externally validated a brief structured tool that could act as a therapeutic bridge between the closure of a suicide risk management plan and aftercare provision for peo","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 30","pages":"1-38"},"PeriodicalIF":4.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147769893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and cost-effectiveness of targeted and population screening for osteoporosis in women: scoping review.","authors":"Kieran Becker, Morgan Weiland, Samantha Febrey, Michael Nunns, Jill Buckland, Rebecca Abbott, Rebecca Whear, Alison Bethel, Elizabeth Shaw, Kate Boddy, G J Melendez-Torres, Joanna Thompson Coon","doi":"10.3310/GJJT0804","DOIUrl":"10.3310/GJJT0804","url":null,"abstract":"<p><strong>Background: </strong>Osteoporosis is a systemic skeletal disorder characterised by bone tissue deterioration, leading to reduced bone density and increased susceptibility to fractures. Osteoporosis screening is the process of identifying people with an increased risk of osteoporosis by using risk assessment tools or medical imaging. The National Institute for Health and Care Excellence recommends opportunistic risk assessment in women over 65 years or under 65 years with risk factors, though this guideline was last updated in 2017. Regular surveillance of the available evidence is warranted to gauge the volume and type of evidence published on key issues relating to population-based and targeted screening for osteoporosis.</p><p><strong>Objectives: </strong>To identify and review the volume and type of evidence on effectiveness and cost-effectiveness of population-based and targeted osteoporosis screening in women and to explore the consideration of health equity in the evidence base.</p><p><strong>Design and methods: </strong>Two information specialists developed the search strategy in MEDLINE (via Ovid) and translated it to 10 other databases. The title and abstract then full text of each record were screened by two independent reviewers. Disagreements were resolved through discussion. Records found through supplementary searches were single-screened as were reference lists of relevant guidelines identified. One reviewer completed data extraction of included studies, with a second reviewer checking the accuracy.</p><p><strong>Setting and participants: </strong>Included studies were required to be experimental designs, systematic reviews or cost-effectiveness studies with a standard care comparator. Populations of interest were women over 65 years and women below 65 years with osteoporosis risk factors.</p><p><strong>Interventions: </strong>Any population or targeted screening intervention involving any combination of risk assessment and dual energy X-ray absorptiometry scan designed to identify women with, or at risk for, osteoporosis.</p><p><strong>Main outcome measures: </strong>Outcomes related to osteoporosis prevention (osteoporotic fractures, all-cause fractures and mortality), possible screening harms and cost-effectiveness.</p><p><strong>Data sources: </strong>Searches were conducted in 11 databases and were supplemented by forward and backward citation searching.</p><p><strong>Review methods: </strong>Study characteristics and equity considerations were tabulated and narratively described.</p><p><strong>Results: </strong>The 19 included studies consisted of 3 randomised controlled trials with 9 sibling papers, 1 non-concurrent cohort study and 6 reviews. The primary studies generally included women 65 years old and older, with interventions involving several risk assessment and screening methods. Most reviews investigated the general population and included either bone mineral density measurement or clinical risk assessment ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-27"},"PeriodicalIF":4.0,"publicationDate":"2026-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13051324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147581303","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 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":"1-90"},"PeriodicalIF":4.0,"publicationDate":"2026-03-25","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":"Diagnostic tools to establish the presence and severity of peripheral arterial disease in people with diabetes: a synopsis of the DM PAD prospective multicentre diagnostic accuracy study.","authors":"Laura Burgess, Pasha Normahani, John Norrie, Sharon Tuck, Catriona Graham, David Mark Epstein, Neghal Kandiyil, Athanasios Saratzis, Francine Heatley, Sasha Smith, Kamlesh Khunti, David Wingfield, Trusha Coward, Tim Hartshorne, Simon Ashwell, Joseph Shalhoub, Elizabeth Pigott, Alun H Davies, Usman Jaffer","doi":"10.3310/GJUJ2819","DOIUrl":"10.3310/GJUJ2819","url":null,"abstract":"<p><strong>Background: </strong>Peripheral arterial disease is a major cause of the development of diabetic foot ulcers, lower limb amputation and mortality in patients with diabetes. Diagnosing peripheral arterial disease is of clinical importance but is difficult in this cohort of patients. Several diagnostic bedside tests exist, but there is uncertainty as to which is the most accurate.</p><p><strong>Objective(s): </strong>To determine the diagnostic accuracy of five index tests (audible waveform assessment, visual waveform assessment, toe-brachial pressure index, ankle-brachial pressure index and exercise ankle-brachial pressure index) for the diagnosis of peripheral arterial disease in patients with diabetes as determined by a reference test (computed tomography angiography or magnetic resonance angiography). In selected sites, to evaluate the performance of a sixth test, the Podiatry Ankle Duplex scan, a new point-of-care duplex ultrasound scan.</p><p><strong>Design and methods: </strong>Prospective multicentre diagnostic accuracy study.</p><p><strong>Setting: </strong>Primary (general practice and community clinics) and secondary care National Health Service hospitals (inpatient and outpatient) in the United Kingdom.</p><p><strong>Participants: </strong>Patients were eligible for inclusion if they were aged ≥ 18 years and had a known history of diabetes. Exclusion criteria included contraindications to computed tomography angiography or magnetic resonance angiography, if their peripheral arterial disease status was known on imaging, or they had a known history of peripheral arterial disease intervention.</p><p><strong>Interventions: </strong>Participants underwent all bedside tests (Podiatry Ankle Duplex scan performed in three centres only), which were performed in a logical sequence to reduce the risk of bias. The reference scan was to be performed within 6 weeks of the index tests.</p><p><strong>Main outcome measures: </strong>The primary outcome measure of diagnostic performance is test sensitivity. Secondary outcomes included specificity, likelihood ratios, predictive values and diagnostic odds ratio, as well as patient acceptability of tests, technical success and health economic outcomes.</p><p><strong>Results: </strong>Based on the 573 reference tests performed, 222 (39%) participants had evidence of peripheral arterial disease. All routinely used index tests showed relatively low sensitivities: audible waveform 36%, 99% confidence interval 27% to 45%; visual waveform 42%, confidence interval 33% to 51%; toe-brachial pressure index 55%, confidence interval 46% to 64%; ankle-brachial pressure index 41%, confidence interval 32% to 50%; and exercise ankle-brachial pressure index 41%, confidence interval 31% to 51%. The Podiatry Ankle Duplex scan had a higher sensitivity 89%, confidence interval 74% to 100%, as compared to all other index tests.</p><p><strong>Limitations: </strong>A large proportion of reference scans were performed ou","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-22"},"PeriodicalIF":4.0,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13034846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147498725","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":"Prophylactic antibiotics to prevent chest infections in children with neurological impairment: the PARROT RCT.","authors":"Paul S McNamara, Ashley Paul Jones, Anne Chang, Kieran Crabtree, Kylie Crompton, Sepideh Dehghani, Helen Eccleson, Jo Fothergill, Jonathan Grigg, Paul Gringras, Adrienne Harvey, Michelle Heys, Dyfrig Arwyn Hughes, Gabrielle McCallum, Kim McLennan, Christopher Morris, Amy Nuttall, Jeremy Parr, Yankier Pijeira Perez, Dinah Reddihough, Malcolm Gracie Semple, Hayley Smallman, Mandy Wan, Katrina Williams","doi":"10.3310/GJPM1930","DOIUrl":"10.3310/GJPM1930","url":null,"abstract":"<p><strong>Background: </strong>Improvements in neonatal and paediatric care in recent decades have increased the survival of children with non-progressive neurological impairment. Respiratory disease in children with neurological impairment is common, with symptoms difficult to manage and lower respiratory tract infection occurring frequently. To reduce these, prophylactic antibiotics are being increasingly used, but the type, duration and dose of antibiotics can vary considerably, and there is limited evidence about their effectiveness in children and young people. A joint United Kingdom and Australia multicentre, randomised, double-blind, placebo-controlled trial comparing 52 weeks of azithromycin to placebo in children and young people with neurological impairment at risk of lower respiratory tract infection (PARROT) was planned to address this gap. PARROT was a multicentre, parallel group, blinded, pragmatic randomised controlled trial of 52-week duration with a planned sample size of 500 (250 in each arm) participants with neurological impairment. The primary outcome was the proportion of children and young people hospitalised with lower respiratory tract infection over the 52-week period.</p><p><strong>Results: </strong>In total, 90 children and young people (62 in Australia, 28 in the United Kingdom) aged 3-17 years, with a diagnosed non-progressive, non-neuromuscular neurological impairment, who had persistent respiratory symptoms were randomised (1 : 1) to receive azithromycin or placebo. Baseline demographic and clinical characteristics were relatively well balanced across the two treatment groups and countries. Overall, mean (standard deviation) age was 9.2 (4.4) years, with 64% of participants having cerebral palsy, 67% being non-ambulant and 54% being totally tube-fed. At baseline, mean (standard deviation) numbers of hospital admissions with lower respiratory tract infection in the preceding year were 1.8 (2.0)/year, and general practitioner attendances 3.3 (3.0)/year. The PARROT trial was closed early to recruitment due to challenges arising from the COVID-19 pandemic. Sixty-five (72%) participants (azithromycin <i>n</i> = 30, placebo <i>n</i> = 35) completed 52 weeks of treatment and were not withdrawn early from the trial. Regarding the primary outcome, 11 (36.7%) in the azithromycin group were hospitalised with lower respiratory tract infection and 9 (25.7%) in the placebo group [absolute risk reduction 0.11 (95% confidence interval -0.12 to 0.33), relative risk 1.43 (95% confidence interval 0.68 to 2.97)]. Analysis of secondary outcome data was limited by the number of missing data, but parent-reported quality of life for young person and parent, sleep amount/quality for young person and parent, and respiratory symptoms were similar between groups and countries.</p><p><strong>Limitations: </strong>As PARROT was stopped early and was consequently underpowered, it is not possible to say whether azithromycin prophylaxis is any mo","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-19"},"PeriodicalIF":4.0,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377175","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":"Surgery versus non-surgical splint treatment for proximal phalanx shaft finger fractures in adults: the POINT Randomised Controlled Trial.","authors":"Alexia Karantana, Jennifer White, Lucy Bradshaw, Tim R Davis, Maureen Godfrey, Marilyn James, Hugh Jarrett, Christina Jerosch-Herold, Reuben Ogollah, Cristina Roadevin, Jeremy Rodrigues, Kirsty Sprange, Ryan W Trickett, Matthew L Costa, Alan Montgomery","doi":"10.3310/GJAK6715","DOIUrl":"10.3310/GJAK6715","url":null,"abstract":"<p><strong>Background: </strong>Proximal phalanx finger shaft fractures are common and can impair hand function. There is controversy, but no high-quality evidence, on how they are best treated. We compared the clinical and cost-effectiveness of surgery versus non-surgical splint treatment.</p><p><strong>Objective: </strong>The primary objective was to compare hand function following surgical fixation with hand function following non-surgical splint treatment using the Hand Health Profile of the Patient Evaluation Measure at 6 months post randomisation.</p><p><strong>Design: </strong>Pragmatic multicentre, parallel superiority randomised (1 : 1) trial.</p><p><strong>Setting: </strong>Twenty-four acute hospitals in the United Kingdom National Health Service.</p><p><strong>Participants: </strong>Patients ≥ 16 years with one or more proximal phalanx shaft fracture(s), which can be treated via either surgery or non-surgical splint treatment. Patients with intra-articular, base-metaphyseal, neck, open proximal phalanx fractures, injury ≥ 14 days or unable to adhere to trial procedures/complete questionnaires were excluded.</p><p><strong>Interventions: </strong>Surgery was any mode of surgical fixation that was considered as appropriate by the treating specialist. Non-surgical splint treatment consisted of any technique/material used in routine care, which may involve manipulation of the fracture with analgesia or local anaesthetic, and subsequent bracing through an externally applied support, usually performed in a clinic or therapy room environment.</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the Hand Health Profile of the Patient Evaluation Measure (possible range 11-77, higher scores indicate worst function). Measurements were collected at 6 weeks, 3, 6 and 12 months; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was quality-adjusted life-years in accordance with National Institute for Health and Care Excellence guidelines.</p><p><strong>Results: </strong>Between 9 November 2020 and 2 February 2023, 113 participants were randomised to surgery (<i>n</i> = 56) or non-surgical treatment (<i>n</i> = 55); 2 were excluded. Participants were 60% male, with mean age of 38 years. Treatment arms were balanced. Fifty-three participants in the surgical and 46 in the non-surgical group were included in the primary analysis. At 6 months, the mean Patient Evaluation Measure was 27.1 (standard deviation = 13.6, <i>n</i> = 48) in the surgical group and 25 (standard deviation 12.4, <i>n</i> = 41) in the non-surgical group, with no clinically important difference between groups (adjusted difference in means for surgery vs. non-surgical groups 3, 95% confidence interval -1.6 to 7.7). There were no differences at 6 weeks and 3 months. There were more complications in the surgery group. Surgery was more expensive, resulting in an incremental cost-effectiveness ratio of £39,686 per qualit","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-41"},"PeriodicalIF":4.0,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12994879/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377268","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}