Health technology assessment最新文献

{"title":"Collagenase injection versus limited fasciectomy surgery to treat Dupuytren's contracture in adult patients in the UK: DISC, a non-inferiority RCT and economic evaluation.","authors":"Joseph Dias, Puvan Tharmanathan, Catherine Arundel, Charlie Welch, Qi Wu, Paul Leighton, Maria Armaou, Belen Corbacho, Nick Johnson, Sophie James, John Cooke, Christopher Bainbridge, Michael Craigen, David Warwick, Samantha Brady, Lydia Flett, Judy Jones, Catherine Knowlson, Michelle Watson, Ada Keding, Catherine Hewitt, David Torgerson","doi":"10.3310/KGXD8528","DOIUrl":"10.3310/KGXD8528","url":null,"abstract":"<p><strong>Background: </strong>Dupuytren's contracture is caused by nodules and cords which pull the fingers towards the palm of the hand. Treatments include limited fasciectomy surgery, collagenase injection and needle fasciotomy. There is limited evidence comparing limited fasciectomy with collagenase injection.</p><p><strong>Objectives: </strong>To compare whether collagenase injection is not inferior to limited fasciectomy when treating Dupuytren's contracture.</p><p><strong>Design: </strong>Pragmatic, two-arm, unblinded, randomised controlled non-inferiority trial with a cost-effectiveness evaluation and nested qualitative and photographic substudies.</p><p><strong>Setting: </strong>Thirty-one National Health Service hospitals in England and Scotland.</p><p><strong>Participants: </strong>Patients with Dupuytren's contracture of ≥ 30 degrees who had not received previous treatment in the same digit.</p><p><strong>Interventions: </strong>Collagenase injection with manipulation 1-7 days later was compared with limited fasciectomy.</p><p><strong>Main outcome measures: </strong>The primary outcome was the Patient Evaluation Measure score, with 1 year after treatment serving as the primary end point. A difference of 6 points in the primary end point was used as the non-inferiority margin. Secondary outcomes included: Unité Rhumatologique des Affections de la Main scale; Michigan Hand Outcomes Questionnaire; recurrence; extension deficit and total active movement; further care/re-intervention; complications; quality-adjusted life-year; resource use; and time to function recovery.</p><p><strong>Randomisation and blinding: </strong>Online central randomisation, stratified by the most affected joint, and with variable block sizes allocates participants 1 : 1 to collagenase or limited fasciectomy. Participants and clinicians were not blind to treatment allocation.</p><p><strong>Results: </strong>Between 31 July 2017 and 28 September 2021, 672 participants were recruited (<i>n</i> = 336 per group), of which 599 participants contributed to the primary outcome analysis (<i>n</i> = 285 limited fasciectomy; <i>n</i> = 314 collagenase). At 1 year (primary end point) there was little evidence to support rejection of the hypothesis that collagenase is inferior to limited fasciectomy. The difference in Patient Evaluation Measure score at 1 year was 5.95 (95% confidence interval 3.12 to 8.77; <i>p</i> = 0.49), increasing to 7.18 (95% confidence interval 4.18 to 10.88) at 2 years. The collagenase group had more complications (<i>n</i> = 267, 0.82 per participant) than the limited fasciectomy group (<i>n</i> = 177, 0.60 per participant), but limited fasciectomy participants had a greater proportion of 'moderate'/'severe' complications (5% vs. 2%). At least 54 participants (15.7%) had contracture recurrence and there was weak evidence suggesting that collagenase participants recurred more often than limited fasciectomy participants (odds ratio 1.39, 95% confidence","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 78","pages":"1-262"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11647555/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791513","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":"Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling.","authors":"Asra Asgharzadeh, Mubarak Patel, Martin Connock, Sara Damery, Iman Ghosh, Mary Jordan, Karoline Freeman, Anna Brown, Rachel Court, Sharin Baldwin, Fatai Ogunlayi, Chris Stinton, Ewen Cummins, Lena Al-Khudairy","doi":"10.3310/JYPL3536","DOIUrl":"10.3310/JYPL3536","url":null,"abstract":"<p><strong>Background: </strong>Hybrid closed-loop systems are a new class of technology to manage type 1 diabetes mellitus. The system includes a combination of real-time continuous glucose monitoring from a continuous glucose monitoring device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes mellitus and their families.</p><p><strong>Aim: </strong>The aim of this appraisal was to assess the clinical effectiveness and cost-effectiveness of hybrid closed-loop systems for managing glucose in people who have type 1 diabetes mellitus and are having difficulty managing their condition despite prior use of at least one of the following technologies: continuous subcutaneous insulin infusion, real-time continuous glucose monitoring or flash glucose monitoring (intermittently scanned continuous glucose monitoring).</p><p><strong>Methods: </strong>A systematic review of clinical effectiveness and cost-effectiveness evidence following predefined inclusion criteria informed by the aim of this review. An independent economic assessment using iQVIA CDM to model cost-effectiveness.</p><p><strong>Results: </strong>The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval -0.34 to -0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of -7.2 (95% confidence interval -8.89 to -5.51), but did not significantly affect per cent of  time below range (< 3.9 mmol/l)]. Comparator arms showed improvements, but these were smaller than in the hybrid closed-loop arm. Outcomes were superior in the hybrid closed-loop arm compared with the comparator arm. The cost-effectiveness search identified six studies that were included in the systematic review. Studies reported subjective cost-effectiveness that was influenced by the willingness-to-pay thresholds. Economic evaluation showed that the published model validation papers suggest that an earlier version of the iQVIA CDM tended to overestimate the incidences of the complications of diabetes, this being particularly important for severe visual loss and end-stage renal disease. Overall survival's medium-term modelling appeared good, but there was uncertainty about its longer-term modelling. Costs provided by the National Health Service Supply Chain suggest that hybrid closed loop is around an annual average of £1500 more expensive than continuous subcutaneous insulin infusion + continuous glucose monitoring, this being a ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 80","pages":"1-190"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824073","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":"Assessing long-term effectiveness and cost-effectiveness of statin therapy in the UK: a modelling study using individual participant data sets.","authors":"Borislava Mihaylova, Runguo Wu, Junwen Zhou, Claire Williams, Iryna Schlackow, Jonathan Emberson, Christina Reith, Anthony Keech, John Robson, Richard Parnell, Jane Armitage, Alastair Gray, John Simes, Colin Baigent","doi":"10.3310/KDAP7034","DOIUrl":"10.3310/KDAP7034","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease has declined but remains a major disease burden across developed countries.</p><p><strong>Objective: </strong>To assess the effectiveness and cost-effectiveness of statin therapy across United Kingdom population categories.</p><p><strong>Design: </strong>The cardiovascular disease microsimulation model, developed using Cholesterol Treatment Trialists' Collaboration data and the United Kingdom Biobank cohort, projected cardiovascular events, mortality, quality of life and healthcare costs using participant characteristics.</p><p><strong>Setting: </strong>United Kingdom primary health care.</p><p><strong>Participants: </strong>A total of 117,896 participants in 16 statin trials in the Cholesterol Treatment Trialists' Collaboration; 501,854 United Kingdom Biobank participants by previous cardiovascular disease status, sex, age (40-49, 50-59 and 60-70 years), 10-year cardiovascular disease risk [QRISK<sup>®</sup>3 (%): < 5, 5-10, 10-15, 15-20 and ≥ 20] and low-density lipoprotein cholesterol level (< 3.4, 3.4-4.1 and ≥ 4.1 mmol/l); 20,122 United Kingdom Biobank and Whitehall II participants aged ≥ 70 years by previous cardiovascular disease status, sex and low-density lipoprotein cholesterol (< 3.4, 3.4-4.1 and ≥ 4.1 mmol/l).</p><p><strong>Interventions: </strong>Lifetime standard (35-45% low-density lipoprotein cholesterol reduction) or higher-intensity (≥ 45% reduction) statin.</p><p><strong>Main outcome measures: </strong>Quality-adjusted life-years and incremental cost per quality-adjusted life-year gained from the United Kingdom healthcare perspective.</p><p><strong>Data sources: </strong>Cholesterol Treatment Trialists' Collaboration and United Kingdom Biobank data informed risk equations. United Kingdom primary and hospital care data informed healthcare costs (2020-1 Great British pounds); £1.10 standard or £1.68 higher-intensity generic statin therapy per 28 tablets; and Health Survey for England data informed health-related quality of life. Meta-analyses of trials and cohort studies informed the effects of statin therapies on cardiovascular events, incident diabetes, myopathy and rhabdomyolysis.</p><p><strong>Results: </strong>Across categories of participants 40-70 years old, lifetime use of standard statin therapy resulted in undiscounted 0.20-1.09 quality-adjusted life-years gained per person, and higher-intensity statin therapy added a further 0.03-0.20 quality-adjusted life-years per person. Among participants aged ≥ 70 years, lifetime standard statin was estimated to increase quality-adjusted life-years by 0.24-0.70 and higher-intensity statin by a further 0.04-0.13 quality-adjusted life-years per person. Benefits were larger among participants at higher cardiovascular disease risk or with higher low-density lipoprotein cholesterol. Standard statin therapy was cost-effective across all categories of people 40-70 years old, with incremental costs per quality-adjusted life-year gaine","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 79","pages":"1-134"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11647556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791515","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":"Cervical ripening at home or in hospital during induction of labour: the CHOICE prospective cohort study, process evaluation and economic analysis.","authors":"Mairead Black, Cassandra Yuill, Mairi Harkness, Sayem Ahmed, Linda Williams, Kathleen A Boyd, Maggie Reid, Amar Bhide, Neelam Heera, Jane Huddleston, Neena Modi, John Norrie, Dharmintra Pasupathy, Julia Sanders, Gordon C S Smith, Rosemary Townsend, Helen Cheyne, Christine McCourt, Sarah Stock","doi":"10.3310/LPYT7894","DOIUrl":"10.3310/LPYT7894","url":null,"abstract":"<p><strong>Background: </strong>Around one in three pregnant women undergoes induction of labour in the United Kingdom, usually preceded by in-hospital cervical ripening to soften and open the cervix.</p><p><strong>Objectives: </strong>This study set out to determine whether cervical ripening at home is within an acceptable safety margin of cervical ripening in hospital, is effective, acceptable and cost-effective from both National Health Service and service user perspectives.</p><p><strong>Design: </strong>The CHOICE study comprised a prospective multicentre observational cohort study using routinely collected data (CHOICE cohort), a process evaluation comprising a survey and nested case studies (qCHOICE) and a cost-effectiveness analysis. The CHOICE cohort set out to compare outcomes of cervical ripening using dinoprostone (a prostaglandin) at home with in-hospital cervical ripening from 39 weeks of gestation. Electronic maternity record data were collected from 26 maternity units. Following pilot analysis, the primary comparison was changed to ensure feasibility and to reflect current practice, comparing home cervical ripening using a balloon catheter with in-hospital cervical ripening using any prostaglandin from 37 weeks of gestation. Analysis involved multiple logistic regression for the primary outcome and descriptive statistics for all other outcomes. The qCHOICE study reported descriptive statistics of quantitative survey data and thematic analysis of focus group and interview data. The economic analysis involved a decision-analytic model from a National Health Service and Personal Social Services perspective, populated with CHOICE cohort and published data. Secondary analysis explored the patient perspective utilising cost estimates from qCHOICE data.</p><p><strong>Setting: </strong>Twenty-six United Kingdom maternity units.</p><p><strong>Participants: </strong>Women with singleton pregnancies at or beyond 37 weeks of gestation having induction with details of cervical ripening method and location recorded.</p><p><strong>Main outcome measures: </strong>Neonatal unit admission within 48 hours of birth for 48 hours or more.</p><p><strong>Qchoice: </strong>Maternal and staff experience of cervical ripening.</p><p><strong>Economic analysis: </strong>Incremental cost per neonatal unit admission within 48 hours of birth avoided.</p><p><strong>Data sources: </strong>Electronic maternity records from 26 maternity units; survey and interviews with service users/maternity staff; focus groups with maternity staff; published literature on economic aspects.</p><p><strong>Results: </strong>CHOICE cohort: A total of 515 women underwent balloon cervical ripening at home and 4332 underwent in-hospital cervical ripening using prostaglandin in hospitals that did not offer home cervical ripening. Neonatal unit admission within 48 hours of birth for 48 hours or more following home cervical ripening with balloon was not increased compared with in-hospital c","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 81","pages":"1-142"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11683663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871914","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 high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis.","authors":"Nicola Curry, Ross Davenport, Helen Thomas, Erin Fox, Joanne Lucas, Amy Evans, Efthalia Massou, Rupa Sharma, Shaminie Shanmugaranjan, Claire Rourke, Alice Newton, Alison Deary, Nikki Dallas, Chloe Fitzpatrick-Creamer, Jeanette M Podbielski, Charles E Wade, Antoinette Edwards, Jonathan Benger, Stephen Morris, Bryan A Cotton, James Piercy, Laura Green, Karim Brohi, Simon Stanworth","doi":"10.3310/JYTR6938","DOIUrl":"10.3310/JYTR6938","url":null,"abstract":"<p><strong>Background: </strong>Traumatic haemorrhage is common after severe injury, leading to disability and death. Cryoprecipitate, a source of fibrinogen, may improve outcomes for patients with traumatic haemorrhage.</p><p><strong>Objective: </strong>To investigate the effects of early fibrinogen supplementation in the form of 3 pools (15 units, approximately 6 g of fibrinogen) of cryoprecipitate on 28-day mortality.</p><p><strong>Design: </strong>A randomised, parallel-group, unblinded, multicentre, international trial and economic evaluation. Patients were randomised to either the intervention (early cryoprecipitate) or the comparator (standard major haemorrhage protocol) arm via opaque, sealed envelopes in the emergency department or the transfusion laboratory/blood bank. All analyses were performed on an intention-to-treat basis. A cost-effectiveness analysis was undertaken.</p><p><strong>Setting: </strong>Twenty-five major trauma centres in the UK and one level 1 trauma centre in the USA.</p><p><strong>Participants: </strong>Adults who had traumatic haemorrhage following severe injury requiring activation of the major haemorrhage protocol and had received a blood transfusion.</p><p><strong>Intervention: </strong>Early cryoprecipitate - 3 pools (equivalent to 15 single units of cryoprecipitate or 6 g of fibrinogen supplementation), infused as rapidly as possible, within 90 minutes of arrival at hospital in addition to standard major haemorrhage protocol or standard major haemorrhage protocol only.</p><p><strong>Main outcome measures: </strong>The primary outcome was all-cause mortality at 28 days. The secondary outcomes were all-cause mortality at 6 hours, 24 hours, 6 months and 12 months from admission; death from bleeding at 6 hours and 24 hours; transfusion requirements at 24 hours from admission; destination of participant at discharge; quality-of-life measurements (EuroQol-5 Dimensions, five-level version and Glasgow Outcome Scale) at discharge/day 28 and 6 months after injury; and hospital resource use up to discharge or day 28 (including ventilator-days, hours spent in critical care and inpatient stays).</p><p><strong>Results: </strong>Eight hundred and five patients were randomised to receive the standard major haemorrhage protocol (control arm). Seven hundred and ninety-nine patients were randomised to receive an additional three pools of cryoprecipitate in addition to standard care (intervention arm). Baseline characteristics appeared well matched. Patients had a median age of 39 (interquartile range 26-55) years, and the majority (79%) were male. All-cause 28-day mortality (<i>n</i> = 1531 patients; intention to treat) was 25.3% in the intervention arm compared with 26.1% in the control arm (odds ratio 0.96; <i>p</i> = 0.74).</p><p><strong>Limitations: </strong>There was variability in the timing of cryoprecipitate administration, with overlap between the treatment arms, limiting the degree of intervention separation.</p><p><st","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 76","pages":"1-69"},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638748","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":"Point-of-care tests for urinary tract infections to reduce antimicrobial resistance: a systematic review and conceptual economic model.","authors":"Eve Tomlinson, Mary Ward, Chris Cooper, Rachel James, Christina Stokes, Samina Begum, Jessica Watson, Alastair D Hay, Hayley E Jones, Howard Thom, Penny Whiting","doi":"10.3310/PTMV8524","DOIUrl":"10.3310/PTMV8524","url":null,"abstract":"<p><strong>Background: </strong>Urinary tract infections are diagnosed by general practitioners based on symptoms, dipstick tests in some and laboratory urine culture. Patients may be given inappropriate antibiotics. Point-of-care tests can diagnose urinary tract infection in near-patient settings quicker than standard culture. Some can identify the causative pathogen or antimicrobial sensitivity.</p><p><strong>Objective: </strong>To assess whether point-of-care tests for people with suspected urinary tract infection have the potential to be clinically effective and cost-effective to the NHS.</p><p><strong>Design: </strong>Systematic review and conceptual economic model.</p><p><strong>Results: </strong>Two randomised controlled trials evaluated Flexicult Human (one against standard care; one against ID Flexicult). One trial found no evidence of a difference between groups in concordant antibiotic use (odds ratio 0.84, 95% confidence interval 0.58 to 1.20), and the other found no difference in appropriate antibiotic prescribing (odds ratio 1.44, 95% confidence interval 1.03 to 1.99). Compared with standard care, Flexicult was associated with reduced antibiotic prescribing at initial consultation (odds ratio 0.56, 95% confidence interval 0.35 to 0.88). No difference was found for other outcomes. Sixteen studies reported test accuracy data. Most were rated as being at unclear or high risk of bias. We identified data on three rapid tests (results < 40 minutes). Lodestar DX (<i>n</i> = 1) had good sensitivity (86%, 95% confidence interval 74% to 99%) and specificity (88%, 95% confidence interval 83% to 94%) for detecting <i>Escherichia coli.</i> Uriscreen (<i>n</i> = 4) had modest summary sensitivity (74%, 95% confidence interval 59% to 84%) and specificity (64%, 95% confidence interval 41% to 82%). UTRiPLEX (<i>n</i> = 1) had poor sensitivity (21%) and good specificity (94%). Twelve studies evaluated culture-based tests (results 24 hours). Laboratory-based studies found Dipstreak (<i>n</i> = 2) and Uricult (<i>n</i> = 1) to be highly accurate, but there were limitations with these studies. Uricult Trio (<i>n</i> = 3) had more modest summary sensitivity (73%, 95% confidence interval 63% to 82%) and specificity (70%, 95% confidence interval 52% to 84%). Summary sensitivity for Flexicult Human (<i>n</i> = 4) and ID Flexicult (<i>n</i> = 2) was 79% (95% confidence interval 72% to 85%) and 89% (95% confidence interval 84% to 93%). Summary specificity was 67% (95% confidence interval 30% to 90%) and 70% (95% confidence interval 52% to 84%). Caution is needed in interpreting findings because of heterogeneity and limited data. Five studies evaluated technical performance (Flexicult Human, <i>n</i> = 3; Uricult Trio, <i>n</i> = 2). Limited data suggested that they are easier to use and interpret than standard culture. A conceptual economic model estimated the cost-effectiveness of point-of-care tests for urinary tract infection diagnosis, pathogen identificat","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 77","pages":"1-109"},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11647557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791511","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 accuracy of point-of-care tests for acute respiratory infection: a systematic review of reviews.","authors":"Katie E Webster, Tom Parkhouse, Sarah Dawson, Hayley E Jones, Emily L Brown, Alastair D Hay, Penny Whiting, Christie Cabral, Deborah M Caldwell, Julian Pt Higgins","doi":"10.3310/JLCP4570","DOIUrl":"https://doi.org/10.3310/JLCP4570","url":null,"abstract":"<p><strong>Background: </strong>Acute respiratory infections are a common reason for consultation with primary and emergency healthcare services. Identifying individuals with a bacterial infection is crucial to ensure appropriate treatment. However, it is also important to avoid overprescription of antibiotics, to prevent unnecessary side effects and antimicrobial resistance. We conducted a systematic review to summarise evidence on the diagnostic accuracy of symptoms, signs and point-of-care tests to diagnose bacterial respiratory tract infection in adults, and to diagnose two common respiratory viruses, influenza and respiratory syncytial virus.</p><p><strong>Methods: </strong>The primary approach was an overview of existing systematic reviews. We conducted literature searches (22 May 2023) to identify systematic reviews of the diagnostic accuracy of point-of-care tests. Where multiple reviews were identified, we selected the most recent and comprehensive review, with the greatest overlap in scope with our review question. Methodological quality was assessed using the Risk of Bias in Systematic Reviews tool. Summary estimates of diagnostic accuracy (sensitivity, specificity or area under the curve) were extracted. Where no systematic review was identified, we searched for primary studies. We extracted sufficient data to construct a 2 × 2 table of diagnostic accuracy, to calculate sensitivity and specificity. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 tool. Where possible, meta-analyses were conducted. We used GRADE to assess the certainty of the evidence from existing reviews and new analyses.</p><p><strong>Results: </strong>We identified 23 reviews which addressed our review question; 6 were selected as the most comprehensive and similar in scope to our review protocol. These systematic reviews considered the following tests for bacterial respiratory infection: individual symptoms and signs; combinations of symptoms and signs (in clinical prediction models); clinical prediction models incorporating C-reactive protein; and biological markers related to infection (including C-reactive protein, procalcitonin and others). We also identified systematic reviews that reported the accuracy of specific tests for influenza and respiratory syncytial virus. No reviews were found that assessed the diagnostic accuracy of white cell count for bacterial respiratory infection, or multiplex tests for influenza and respiratory syncytial virus. We therefore conducted searches for primary studies, and carried out meta-analyses for these index tests. Overall, we found that symptoms and signs have poor diagnostic accuracy for bacterial respiratory infection (sensitivity ranging from 9.6% to 89.1%; specificity ranging from 13.4% to 95%). Accuracy of biomarkers was slightly better, particularly when combinations of biomarkers were used (sensitivity 80-90%, specificity 82-93%). The sensitivity and specifici","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-75"},"PeriodicalIF":3.5,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142365067","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":"Strategies for older people living in care homes to prevent urinary tract infection: the StOP UTI realist synthesis.","authors":"Jacqui Prieto, Jennie Wilson, Alison Tingle, Emily Cooper, Melanie Handley, Jo Rycroft-Malone, Jennifer Bostock, Lynne Williams, Heather Loveday","doi":"10.3310/DADT3410","DOIUrl":"10.3310/DADT3410","url":null,"abstract":"<p><strong>Background: </strong>Urinary tract infection is the most diagnosed infection in older people. It accounts for more than 50% of antibiotic prescriptions in care homes and is a frequent reason for care home residents being hospitalised.</p><p><strong>Objective: </strong>This realist review developed and refined programme theories for preventing and recognising urinary tract infection, exploring what works, for whom and in what circumstances.</p><p><strong>Design: </strong>The review used realist synthesis to explore existing literature on the detection and prevention of urinary tract infection, complemented by stakeholder consultation. It applies to the UK context, although other healthcare systems may identify synergies in our findings.</p><p><strong>Data sources: </strong>Bibliographic databases searched included MEDLINE, CINAHL, EMBASE, Cochrane Library, Web of Science Core Collection (including the Social Sciences Citation Index), Sociological Abstracts, Bibliomap and National Institute for Health and Care Research Journals Library.</p><p><strong>Data selection and extraction: </strong>Title and abstract screening were undertaken by two researchers independently of each other. Selection and assessment were based on relevance and rigour and cross-checked by a second researcher. Data extracted from the included studies were explored for explanations about how the interventions were considered to work (or not). Evidence tables were constructed to enable identification of patterns across studies that offered insight about the features of successful interventions.</p><p><strong>Data analysis and synthesis: </strong>Programme theories were constructed through a four-stage process involving scoping workshops, examination of relevant extant theory, analysis and synthesis of primary research, teacher-learner interviews and a cross-system stakeholder event. A process of abductive and retroductive reasoning was used to construct context-mechanism-outcome configurations to inform programme theory.</p><p><strong>Results: </strong>The scoping review and stakeholder engagement identified three theory areas that address the prevention and recognition of urinary tract infection and show what is needed to implement best practice. Nine context-mechanism-outcome configurations provided an explanation of how interventions to prevent and recognise urinary tract infection might work in care homes. These were (1) recognition of urinary tract infection is informed by skills in clinical reasoning, (2) decision-support tools enable a whole care team approach to communication, (3) active monitoring is recognised as a legitimate care routine, (4) hydration is recognised as a care priority for all residents, (5) systems are in place to drive action that helps residents to drink more, (6) good infection prevention practice is applied to indwelling urinary catheters, (7) proactive strategies are in place to prevent recurrent urinary tract infection, (8) care home l","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 68","pages":"1-139"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11513742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463900","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":"Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCT.","authors":"Catherine A Moakes, Andrew W Bradbury, Zainab Abdali, Gareth R Bate, Jack Hall, Hugh Jarrett, Lisa Kelly, Jesse Kigozi, Suzanne Lockyer, Lewis Meecham, Smitaa Patel, Matthew Popplewell, Gemma Slinn, Jonathan J Deeks","doi":"10.3310/YTFV4524","DOIUrl":"10.3310/YTFV4524","url":null,"abstract":"<p><strong>Background: </strong>Chronic limb-threatening ischaemia with ischaemic pain and/or tissue loss.</p><p><strong>Objective: </strong>To examine the clinical and cost-effectiveness of a vein bypass-first compared to a best endovascular treatment-first revascularisation strategy in preventing major amputation or death.</p><p><strong>Design: </strong>Superiority, open, pragmatic, multicentre, phase III randomised trial.</p><p><strong>Setting: </strong>Thirty-nine vascular surgery units in the United Kingdom, and one each in Sweden and Denmark.</p><p><strong>Participants: </strong>Patients with chronic limb-threatening ischaemia due to atherosclerotic peripheral arterial disease who required an infra-popliteal revascularisation, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion.</p><p><strong>Interventions: </strong>A vein bypass-first or a best endovascular treatment-first infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation strategy.</p><p><strong>Main outcome measures: </strong>The primary outcome was amputation-free survival. Secondary outcomes included overall survival, major amputation, further revascularisation interventions, major adverse limb event, health-related quality of life and serious adverse events.</p><p><strong>Methods: </strong>Participants were randomised to a vein bypass-first or a best endovascular treatment-first revascularisation strategy. The original sample size of 600 participants (247 events) was based on a hazard ratio of 0.66 with amputation-free survival rates of 0.72, 0.62, 0.53, 0.47 and 0.35 in years 1-5 in the best endovascular treatment-first group with 90% power and alpha at <i>p</i> = 0.05. The sample size was revised to an event-based approach as a result of increased follow-up time due to slower than anticipated recruitment rates. Participants were followed up for a minimum of 2 years. A cost-effectiveness analysis was employed to estimate differences in total hospital costs and amputation-free survival between the groups. Additionally, a cost-utility analysis was carried out and the total cost and quality-adjusted life-years, 2 and 3 years after randomisation were used.</p><p><strong>Results: </strong>Between 22 July 2014 and 30 November 2020, 345 participants were randomised, 172 to vein bypass-first and 173 to best endovascular treatment-first. Non-amputation-free survival occurred in 108 (63%) of 172 patients in the vein bypass-first group and 92 (53%) of 173 patients in the best endovascular treatment-first group [adjusted hazard ratio 1.35 (95% confidence interval 1.02 to 1.80); <i>p</i> = 0.037]. Ninety-one (53%) of 172 patients in the vein bypass-first group and 77 (45%) of 173 patients in the best endovascular treatment-first group died [adjusted hazard ratio 1.37 (95% confidence interval 1.00 to 1.87)]. Over follow-up, the economic evaluation discounted results showed that best endovascula","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 65","pages":"1-72"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463897","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":"Alitretinoin versus phototherapy as the first-line treatment in adults with severe chronic hand eczema: the ALPHA RCT.","authors":"Miriam Wittmann, Isabelle L Smith, Sarah Tess Brown, Anna Berekméri, Armando Vargas-Palacios, Lesley Sunderland, Amy Barker, Fiona Cowdell, Steven Ersser, Rachael Gilberts, Cathy Green, Philip Hampton, Catherine Smith, Jane Nixon","doi":"10.3310/TWQC0141","DOIUrl":"10.3310/TWQC0141","url":null,"abstract":"<p><strong>Background: </strong>Hand eczema is common and a cause of morbidity and occupational disability. When education, irritant/contact allergen avoidance, moisturisation and topical corticosteroids are insufficient to control chronic hand eczema, ultraviolet therapy or systemic immune-modifying drugs are used. There is no treatment pathway generally accepted by UK dermatologists.</p><p><strong>Primary objective: </strong>Compare alitretinoin and ultraviolet therapy as first-line therapy in terms of disease activity at 12 weeks post planned start of treatment.</p><p><strong>Design: </strong>Prospective, multicentre, open-label, two-arm parallel group, adaptive randomised controlled trial with one planned interim analysis, and an economic evaluation.</p><p><strong>Setting: </strong>UK secondary care dermatology outpatient clinics.</p><p><strong>Participants: </strong>Patients with severe chronic hand eczema unresponsive to at least 4 weeks of treatment with potent topical corticosteroids.</p><p><strong>Primary end point: </strong>Natural logarithm of the Hand Eczema Severity Index + 1, 12 weeks post planned start of treatment.</p><p><strong>Randomisation: </strong>Participants randomised 1 : 1 by minimisation to alitretinoin or ultraviolet therapy for 12 to 24 weeks.</p><p><strong>Blinding: </strong>Blinded primary end-point assessor.</p><p><strong>Results: </strong>Intention-to-treat population: 441 (100.0%) participants; 220 (49.9%) alitretinoin and 221 (50.1%) ultraviolet therapy. At least one dose was received by 212 (96.4%) alitretinoin and 196 (88.7%) ultraviolet therapy participants.</p><p><strong>Primary outcome: </strong>The unadjusted median (interquartile range) relative change in hand eczema severity index at 12 weeks was 30% (10-70%) of that at baseline for alitretinoin compared with 50% (20-100%) for ultraviolet therapy. There was a statistically significant benefit of alitretinoin compared with ultraviolet therapy at 12 weeks, with an estimated fold change or relative difference (95% confidence interval) = 0.66 (0.52 to 0.82), <i>p</i> = 0.0003 at 12 weeks. There was no evidence of a difference at 24 or 52 weeks, with the estimated fold change (95% confidence interval) equal to 0.92 (0.798 to 1.08) and 1.27 (0.97 to 1.67), respectively.</p><p><strong>Primary analysis results were consistent for secondary end points: </strong>Fifty-nine per cent allocated to alitretinoin and 61% allocated to ultraviolet therapy achieved a clear/almost clear assessment during the trial period. Differential treatment compliance observed: 145 (65.9%) alitretinoin and 53 (24.0%) ultraviolet therapy participants confirmed compliance (≥ 80% received, no treatment breaks > 7 days during first 12 weeks). High levels of missing data were observed.</p><p><strong>Safety: </strong>One hundred and thirty-five reportable adverse events across 79 participants, 55 (25.0%) alitretinoin and 24 (10.9%) ultraviolet therapy. Four serious adverse events (two alitreti","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 59","pages":"1-123"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371696","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}