Health technology assessment最新文献

{"title":"Thromboprophylaxis during pregnancy and the puerperium: a systematic review and economic evaluation to estimate the value of future research.","authors":"Sarah Davis, Abdullah Pandor, Fiona C Sampson, Jean Hamilton, Catherine Nelson-Piercy, Beverley J Hunt, Jahnavi Daru, Steve Goodacre, Rosie Carser, Gill Rooney, Mark Clowes","doi":"10.3310/DFWT3873","DOIUrl":"10.3310/DFWT3873","url":null,"abstract":"<p><strong>Background: </strong>Pharmacological prophylaxis to prevent venous thromboembolism is currently recommended for women assessed as being at high risk of venous thromboembolism during pregnancy or in the 6 weeks after delivery (the puerperium). The decision to provide thromboprophylaxis involves weighing the benefits, harms and costs, which vary according to the individual's venous thromboembolism risk. It is unclear whether the United Kingdom's current risk stratification approach could be improved by further research.</p><p><strong>Objectives: </strong>To quantify the current decision uncertainty associated with selecting women who are pregnant or in the puerperium for thromboprophylaxis and to estimate the value of one or more potential future studies that would reduce that uncertainty, while being feasible and acceptable to patients and clinicians.</p><p><strong>Methods: </strong>A decision-analytic model was developed which was informed by a systematic review of risk assessment models to predict venous thromboembolism in women who are pregnant or in the puerperium. Expected value of perfect information analysis was used to determine which factors are associated with high decision uncertainty and should be the target of future research. To find out whether future studies would be acceptable and feasible, we held workshops with women who have experienced a blood clot or have been offered blood-thinning drugs and surveyed healthcare professionals. Expected value of sample information analysis was used to estimate the value of potential future research studies.</p><p><strong>Results: </strong>The systematic review included 17 studies, comprising 19 unique externally validated risk assessment models and 1 internally validated model. Estimates of sensitivity and specificity were highly variable ranging from 0% to 100% and 5% to 100%, respectively. Most studies had unclear or high risk of bias and applicability concerns. The decision analysis found that there is substantial decision uncertainty regarding the use of risk assessment models to select high-risk women for antepartum prophylaxis and obese postpartum women for postpartum prophylaxis. The main source of decision uncertainty was uncertainty around the effectiveness of thromboprophylaxis for preventing venous thromboembolism in women who are pregnant or in the puerperium. We found that a randomised controlled trial of thromboprophylaxis in obese postpartum women is likely to have substantial value and is more likely to be acceptable and feasible than a trial recruiting women who have had a previous venous thromboembolism. In unselected postpartum women and women following caesarean section, the poor performance of risk assessment models meant that offering prophylaxis based on these models had less favourable cost effectiveness with lower decision uncertainty.</p><p><strong>Limitations: </strong>The performance of the risk assessment model for obese postpartum women has not been ext","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 9","pages":"1-176"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140109863","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 switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis: the EASI-SWITCH RCT.","authors":"Vicky Coyle, Caroline Forde, Richard Adams, Ashley Agus, Rosemary Barnes, Ian Chau, Mike Clarke, Annmarie Doran, Margaret Grayson, Danny McAuley, Cliona McDowell, Glenn Phair, Ruth Plummer, Dawn Storey, Anne Thomas, Richard Wilson, Ronan McMullan","doi":"10.3310/RGTP7112","DOIUrl":"10.3310/RGTP7112","url":null,"abstract":"<p><strong>Background: </strong>Neutropenic sepsis is a common complication of systemic anticancer treatment. There is variation in practice in timing of switch to oral antibiotics after commencement of empirical intravenous antibiotic therapy.</p><p><strong>Objectives: </strong>To establish the clinical and cost effectiveness of early switch to oral antibiotics in patients with neutropenic sepsis at low risk of infective complications.</p><p><strong>Design: </strong>A randomised, multicentre, open-label, allocation concealed, non-inferiority trial to establish the clinical and cost effectiveness of early oral switch in comparison to standard care.</p><p><strong>Setting: </strong>Nineteen UK oncology centres.</p><p><strong>Participants: </strong>Patients aged 16 years and over receiving systemic anticancer therapy with fever (≥ 38°C), or symptoms and signs of sepsis, and neutropenia (≤ 1.0 × 10<sup>9</sup>/l) within 24 hours of randomisation, with a Multinational Association for Supportive Care in Cancer score of ≥ 21 and receiving intravenous piperacillin/tazobactam or meropenem for < 24 hours were eligible. Patients with acute leukaemia or stem cell transplant were excluded.</p><p><strong>Intervention: </strong>Early switch to oral ciprofloxacin (750 mg twice daily) and co-amoxiclav (625 mg three times daily) within 12-24 hours of starting intravenous antibiotics to complete 5 days treatment in total. Control was standard care, that is, continuation of intravenous antibiotics for at least 48 hours with ongoing treatment at physician discretion.</p><p><strong>Main outcome measures: </strong>Treatment failure, a composite measure assessed at day 14 based on the following criteria: fever persistence or recurrence within 72 hours of starting intravenous antibiotics; escalation from protocolised antibiotics; critical care support or death.</p><p><strong>Results: </strong>The study was closed early due to under-recruitment with 129 patients recruited; hence, a definitive conclusion regarding non-inferiority cannot be made. Sixty-five patients were randomised to the early switch arm and 64 to the standard care arm with subsequent intention-to-treat and per-protocol analyses including 125 (intervention <i>n</i> = 61 and control <i>n</i> = 64) and 113 (intervention <i>n</i> = 53 and control <i>n</i> = 60) patients, respectively. In the intention-to-treat population the treatment failure rates were 14.1% in the control group and 24.6% in the intervention group, difference = 10.5% (95% confidence interval 0.11 to 0.22). In the per-protocol population the treatment failure rates were 13.3% and 17.7% in control and intervention groups, respectively; difference = 3.7% (95% confidence interval 0.04 to 0.148). Treatment failure predominantly consisted of persistence or recurrence of fever and/or physician-directed escalation from protocolised antibiotics with no critical care admissions or deaths. The median length of stay was shorter in the intervention group","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 14","pages":"1-101"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174466","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":"KardiaMobile 6L for measuring QT interval in people having antipsychotic medication to inform early value assessment: a systematic review.","authors":"Marie Westwood, Nigel Armstrong, Pawel Posadzki, Caro Noake","doi":"10.3310/TFHU0078","DOIUrl":"10.3310/TFHU0078","url":null,"abstract":"<p><strong>Background: </strong>The indication for this assessment is the use of the KardiaMobile six-lead electrocardiogram device for the assessment of QT interval-based cardiac risk in service users prior to the initiation of, or for the monitoring of, antipsychotic medications, which are associated with an established risk of QT interval prolongation.</p><p><strong>Objectives: </strong>To provide an early value assessment of whether KardiaMobile six-lead has the potential to provide an effective and safe alternative to 12-lead electrocardiogram for initial assessment and monitoring of QT interval-based cardiac risk in people taking antipsychotic medications.</p><p><strong>Review methods: </strong>Twenty-seven databases were searched to April/May 2022. Review methods followed published guidelines. Where appropriate, study quality was assessed using appropriate risk of bias tools. Results were summarised by research question; accuracy/technical performance; clinical effects (on cardiac and psychiatric outcomes); service user acceptability/satisfaction; costs of KardiaMobile six-lead.</p><p><strong>Results: </strong>We did not identify any studies which provided information about the diagnostic accuracy of KardiaMobile six-lead, for the detection of corrected QT-interval prolongation, in any population. All studies which reported information about agreement between QT interval measurements (corrected and/or uncorrected) with KardiaMobile six-lead versus 12-lead electrocardiogram were conducted in non-psychiatric populations, used cardiologists and/or multiple readers to interpret electrocardiograms. Where reported or calculable, the mean difference in corrected QT interval between devices (12-lead electrocardiogram vs. KardiaMobile six-lead) was generally small (≤ 10 ms) and corrected QT interval measured using KardiaMobile six-lead was consistently lower than that measured using 12-lead electrocardiogram. All information about the use of KardiaMobile six-lead, in the context of QT interval-based cardiac risk assessment for service users who require antipsychotic medication, was taken from retrospective surveys of staff and service users who had chosen to use KardiaMobile six-lead during pilots, described in two unpublished project reports. It is important to note that both these project reports relate to pilot studies which were not intended to be used in wider evaluations of KardiaMobile six-lead for use in the NHS. Both reports included survey results which indicated that the use of KardiaMobile six-lead may be associated with reductions in the time taken to complete an electrocardiogram and costs, relative to 12-lead electrocardiogram, and that KardiaMobile six-lead was preferred over 12-lead electrocardiogram by almost all responding staff and service users.</p><p><strong>Limitations: </strong>There was a lack of published evidence about the efficacy of KardiaMobile six-lead for initial assessment and monitoring of QT interval-based cardiac","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 19","pages":"1-94"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017144/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140318165","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":"Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease: the ALL-HEART RCT and economic evaluation.","authors":"Isla S Mackenzie, Christopher J Hawkey, Ian Ford, Nicola Greenlaw, Filippo Pigazzani, Amy Rogers, Allan D Struthers, Alan G Begg, Li Wei, Anthony J Avery, Jaspal S Taggar, Andrew Walker, Suzanne L Duce, Rebecca J Barr, Jennifer S Dumbleton, Evelien D Rooke, Jonathan N Townend, Lewis D Ritchie, Thomas M MacDonald","doi":"10.3310/ATTM4092","DOIUrl":"10.3310/ATTM4092","url":null,"abstract":"<p><strong>Background: </strong>Allopurinol is a xanthine oxidase inhibitor that lowers serum uric acid and is used to prevent acute gout flares in patients with gout. Observational and small interventional studies have suggested beneficial cardiovascular effects of allopurinol.</p><p><strong>Objective: </strong>To determine whether allopurinol improves major cardiovascular outcomes in patients with ischaemic heart disease.</p><p><strong>Design: </strong>Prospective, randomised, open-label, blinded endpoint multicentre clinical trial.</p><p><strong>Setting: </strong>Four hundred and twenty-four UK primary care practices.</p><p><strong>Participants: </strong>Aged 60 years and over with ischaemic heart disease but no gout.</p><p><strong>Interventions: </strong>Participants were randomised (1 : 1) using a central web-based randomisation system to receive allopurinol up to 600 mg daily that was added to usual care or to continue usual care.</p><p><strong>Main outcome measures: </strong>The primary outcome was the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes were non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, all-cause mortality, hospitalisation for heart failure, hospitalisation for acute coronary syndrome, coronary revascularisation, hospitalisation for acute coronary syndrome or coronary revascularisation, all cardiovascular hospitalisations, quality of life and cost-effectiveness. The hazard ratio (allopurinol vs. usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis.</p><p><strong>Results: </strong>From 7 February 2014 to 2 October 2017, 5937 participants were enrolled and randomised to the allopurinol arm (<i>n</i> = 2979) or the usual care arm (<i>n</i> = 2958). A total of 5721 randomised participants (2853 allopurinol; 2868 usual care) were included in the modified intention-to-treat analysis population (mean age 72.0 years; 75.5% male). There was no difference between the allopurinol and usual care arms in the primary endpoint, 314 (11.0%) participants in the allopurinol arm (2.47 events per 100 patient-years) and 325 (11.3%) in the usual care arm (2.37 events per 100 patient-years), hazard ratio 1.04 (95% confidence interval 0.89 to 1.21); <i>p</i> = 0.65. Two hundred and eighty-eight (10.1%) participants in the allopurinol arm and 303 (10.6%) participants in the usual care arm died, hazard ratio 1.02 (95% confidence interval 0.87 to 1.20); <i>p</i> = 0.77. The pre-specified health economic analysis plan was to perform a 'within trial' cost-utility analysis if there was no statistically significant difference in the primary endpoint, so NHS costs and quality-adjusted life-years were estimated over a 5-year period. The difference in costs between treatment arms was +£115 higher for allopurinol (95% confidence interval £17 to £210) with no difference in quality-adjusted life-years (95% confide","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 18","pages":"1-55"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140318164","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":"Software with artificial intelligence-derived algorithms for analysing CT brain scans in people with a suspected acute stroke: a systematic review and cost-effectiveness analysis.","authors":"Marie Westwood, Bram Ramaekers, Sabine Grimm, Nigel Armstrong, Ben Wijnen, Charlotte Ahmadu, Shelley de Kock, Caro Noake, Manuela Joore","doi":"10.3310/RDPA1487","DOIUrl":"10.3310/RDPA1487","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence-derived software technologies have been developed that are intended to facilitate the review of computed tomography brain scans in patients with suspected stroke.</p><p><strong>Objectives: </strong>To evaluate the clinical and cost-effectiveness of using artificial intelligence-derived software to support review of computed tomography brain scans in acute stroke in the National Health Service setting.</p><p><strong>Methods: </strong>Twenty-five databases were searched to July 2021. The review process included measures to minimise error and bias. Results were summarised by research question, artificial intelligence-derived software technology and study type. The health economic analysis focused on the addition of artificial intelligence-derived software-assisted review of computed tomography angiography brain scans for guiding mechanical thrombectomy treatment decisions for people with an ischaemic stroke. The de novo model (developed in R Shiny, R Foundation for Statistical Computing, Vienna, Austria) consisted of a decision tree (short-term) and a state transition model (long-term) to calculate the mean expected costs and quality-adjusted life-years for people with ischaemic stroke and suspected large-vessel occlusion comparing artificial intelligence-derived software-assisted review to usual care.</p><p><strong>Results: </strong>A total of 22 studies (30 publications) were included in the review; 18/22 studies concerned artificial intelligence-derived software for the interpretation of computed tomography angiography to detect large-vessel occlusion. No study evaluated an artificial intelligence-derived software technology used as specified in the inclusion criteria for this assessment. For artificial intelligence-derived software technology alone, sensitivity and specificity estimates for proximal anterior circulation large-vessel occlusion were 95.4% (95% confidence interval 92.7% to 97.1%) and 79.4% (95% confidence interval 75.8% to 82.6%) for Rapid (iSchemaView, Menlo Park, CA, USA) computed tomography angiography, 91.2% (95% confidence interval 77.0% to 97.0%) and 85.0 (95% confidence interval 64.0% to 94.8%) for Viz LVO (Viz.ai, Inc., San Fransisco, VA, USA) large-vessel occlusion, 83.8% (95% confidence interval 77.3% to 88.7%) and 95.7% (95% confidence interval 91.0% to 98.0%) for Brainomix (Brainomix Ltd, Oxford, UK) e-computed tomography angiography and 98.1% (95% confidence interval 94.5% to 99.3%) and 98.2% (95% confidence interval 95.5% to 99.3%) for Avicenna CINA (Avicenna AI, La Ciotat, France) large-vessel occlusion, based on one study each. These studies were not considered appropriate to inform cost-effectiveness modelling but formed the basis by which the accuracy of artificial intelligence plus human reader could be elicited by expert opinion. Probabilistic analyses based on the expert elicitation to inform the sensitivity of the diagnostic pathway indicated that the add","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 11","pages":"1-204"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174463","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":"Prehospital early warning scores for adults with suspected sepsis: the PHEWS observational cohort and decision-analytic modelling study.","authors":"Steve Goodacre, Laura Sutton, Kate Ennis, Ben Thomas, Olivia Hawksworth, Khurram Iftikhar, Susan J Croft, Gordon Fuller, Simon Waterhouse, Daniel Hind, Matt Stevenson, Mike J Bradburn, Michael Smyth, Gavin D Perkins, Mark Millins, Andy Rosser, Jon Dickson, Matthew Wilson","doi":"10.3310/NDTY2403","DOIUrl":"10.3310/NDTY2403","url":null,"abstract":"<p><strong>Background: </strong>Guidelines for sepsis recommend treating those at highest risk within 1 hour. The emergency care system can only achieve this if sepsis is recognised and prioritised. Ambulance services can use prehospital early warning scores alongside paramedic diagnostic impression to prioritise patients for treatment or early assessment in the emergency department.</p><p><strong>Objectives: </strong>To determine the accuracy, impact and cost-effectiveness of using early warning scores alongside paramedic diagnostic impression to identify sepsis requiring urgent treatment.</p><p><strong>Design: </strong>Retrospective diagnostic cohort study and decision-analytic modelling of operational consequences and cost-effectiveness.</p><p><strong>Setting: </strong>Two ambulance services and four acute hospitals in England.</p><p><strong>Participants: </strong>Adults transported to hospital by emergency ambulance, excluding episodes with injury, mental health problems, cardiac arrest, direct transfer to specialist services, or no vital signs recorded.</p><p><strong>Interventions: </strong>Twenty-one early warning scores used alongside paramedic diagnostic impression, categorised as sepsis, infection, non-specific presentation, or other specific presentation.</p><p><strong>Main outcome measures: </strong>Proportion of cases prioritised at the four hospitals; diagnostic accuracy for the sepsis-3 definition of sepsis and receiving urgent treatment (primary reference standard); daily number of cases with and without sepsis prioritised at a large and a small hospital; the minimum treatment effect associated with prioritisation at which each strategy would be cost-effective, compared to no prioritisation, assuming willingness to pay £20,000 per quality-adjusted life-year gained.</p><p><strong>Results: </strong>Data from 95,022 episodes involving 71,204 patients across four hospitals showed that most early warning scores operating at their pre-specified thresholds would prioritise more than 10% of cases when applied to non-specific attendances or all attendances. Data from 12,870 episodes at one hospital identified 348 (2.7%) with the primary reference standard. The National Early Warning Score, version 2 (NEWS2), had the highest area under the receiver operating characteristic curve when applied only to patients with a paramedic diagnostic impression of sepsis or infection (0.756, 95% confidence interval 0.729 to 0.783) or sepsis alone (0.655, 95% confidence interval 0.63 to 0.68). None of the strategies provided high sensitivity (> 0.8) with acceptable positive predictive value (> 0.15). NEWS2 provided combinations of sensitivity and specificity that were similar or superior to all other early warning scores. Applying NEWS2 to paramedic diagnostic impression of sepsis or infection with thresholds of > 4, > 6 and > 8 respectively provided sensitivities and positive predictive values (95% confidence interval) of 0.522 (0.469 to 0.574) and 0.216 (","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 16","pages":"1-93"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140318162","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":"Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.","authors":"Jo Worthington, Jessica Frost, Emily Sanderson, Madeleine Cochrane, Jessica Wheeler, Nikki Cotterill, Stephanie J MacNeill, Sian Noble, Miriam Avery, Samantha Clarke, Mandy Fader, Hashim Hashim, Lucy McGeagh, Margaret Macaulay, Jonathan Rees, Luke Robles, Gordon Taylor, Jodi Taylor, Joanne Thompson, J Athene Lane, Matthew J Ridd, Marcus J Drake","doi":"10.3310/GVBC3182","DOIUrl":"10.3310/GVBC3182","url":null,"abstract":"<p><strong>Background: </strong>Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery.</p><p><strong>Objective: </strong>The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care.</p><p><strong>Design: </strong>This was a two-arm cluster randomised controlled trial.</p><p><strong>Setting: </strong>The trial was set in 30 NHS general practice sites in England.</p><p><strong>Participants: </strong>Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms.</p><p><strong>Interventions: </strong>Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention.</p><p><strong>Main outcome measures: </strong>The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms.</p><p><strong>Results: </strong>A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (<i>n</i> = 17) and 553 in sites randomised to the control arm (<i>n</i> = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 13","pages":"1-162"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017146/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174465","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":"Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation.","authors":"Tony Kendrick, Christopher Dowrick, Glyn Lewis, Michael Moore, Geraldine M Leydon, Adam Wa Geraghty, Gareth Griffiths, Shihua Zhu, Guiqing Lily Yao, Carl May, Mark Gabbay, Rachel Dewar-Haggart, Samantha Williams, Lien Bui, Natalie Thompson, Lauren Bridewell, Emilia Trapasso, Tasneem Patel, Molly McCarthy, Naila Khan, Helen Page, Emma Corcoran, Jane Sungmin Hahn, Molly Bird, Mekeda X Logan, Brian Chi Fung Ching, Riya Tiwari, Anna Hunt, Beth Stuart","doi":"10.3310/PLRQ4216","DOIUrl":"10.3310/PLRQ4216","url":null,"abstract":"<p><strong>Background: </strong>Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes.</p><p><strong>Objective: </strong>To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback.</p><p><strong>Design: </strong>Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control.</p><p><strong>Setting: </strong>UK primary care (141 group general practices in England and Wales).</p><p><strong>Inclusion criteria: </strong>Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations.</p><p><strong>Exclusions: </strong>Current depression treatment, dementia, psychosis, substance misuse and risk of suicide.</p><p><strong>Intervention: </strong>Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10-35 days later, compared with usual care.</p><p><strong>Primary outcome: </strong>Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks.</p><p><strong>Secondary outcomes: </strong>Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events.</p><p><strong>Sample size: </strong>The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure.</p><p><strong>Randomisation: </strong>Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location.</p><p><strong>Blinding: </strong>Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation.</p><p><strong>Analysis: </strong>Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks.</p><p><strong>Qualitative interviews: </strong>Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework.</p><p><strong>Results: </strong>Three hundred and two patients were recruited in intervention arm practices and 227 patients we","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 17","pages":"1-95"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140318163","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":"Surgical versus non-surgical management of lateral compression type-1 pelvic fracture in adults 60 years and older: the L1FE RCT.","authors":"Elizabeth Cook, Joanne Laycock, Dhanupriya Sivapathasuntharam, Camila Maturana, Catherine Hilton, Laura Doherty, Catherine Hewitt, Catriona McDaid, David Torgerson, Peter Bates","doi":"10.3310/LAPW3412","DOIUrl":"10.3310/LAPW3412","url":null,"abstract":"<p><strong>Background: </strong>Lateral compression type-1 pelvic fractures are a common fragility fracture in older adults. Patients who do not mobilise due to ongoing pain are at greater risk of immobility-related complications. Standard treatment in the United Kingdom is provision of pain relief and early mobilisation, unlike fragility hip fractures, which are usually treated surgically based on evidence that early surgery is associated with better outcomes. Currently there is no evidence on whether patients with lateral compression type-1 fragility fractures would have a better recovery with surgery than non-surgical management.</p><p><strong>Objectives: </strong>To assess the clinical and cost effectiveness of surgical fixation with internal fixation device compared to non-surgical management of lateral compression type-1 fragility fractures in older adults.</p><p><strong>Design: </strong>Pragmatic, randomised controlled superiority trial, with 12-month internal pilot; target sample size was 600 participants. Participants were randomised between surgical and non-surgical management (1 : 1 allocation ratio). An economic evaluation was planned.</p><p><strong>Setting: </strong>UK Major Trauma Centres.</p><p><strong>Participants: </strong>Patients aged 60 years or older with a lateral compression type-1 pelvic fracture, arising from a low-energy fall and unable to mobilise independently to a distance of 3 m and back due to pelvic pain 72 hours after injury.</p><p><strong>Interventions: </strong>Internal fixation device surgical fixation and non-surgical management. Participants, surgeons and outcome assessors were not blinded to treatment allocation.</p><p><strong>Main outcome measures: </strong>Primary outcome - average patient health-related quality of life, over 6 months, assessed by the EuroQol-5 Dimensions, five-level version utility score. Secondary outcomes (over the 6 months following injury) - self-rated health, physical function, mental health, pain, delirium, displacement of pelvis, mortality, complications and adverse events, and resource use data for the economic evaluation.</p><p><strong>Results: </strong>The trial closed early, at the end of the internal pilot, due to low recruitment. The internal pilot was undertaken in two separate phases because of a pause in recruitment due to the coronavirus disease 2019 pandemic. The planned statistical and health economic analyses were not conducted. Outcome data were summarised descriptively. Eleven sites opened for recruitment for a combined total of 92 months. Three-hundred and sixteen patients were assessed for eligibility, of whom 43 were eligible (13.6%). The main reason for ineligibility was that the patient was able to mobilise independently to 3 m and back (<i>n</i> = 161). Of the 43 eligible participants, 36 (83.7%) were approached for consent, of whom 11 (30.6%) provided consent. The most common reason for eligible patients not consenting to take part was that they were unwilling","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 15","pages":"1-67"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174467","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":"Use of selective gut decontamination in critically ill children: PICnIC a pilot RCT and mixed-methods study.","authors":"Alanna Brown, Paloma Ferrando-Vivas, Mariana Popa, Gema Milla de la Fuente, John Pappachan, Brian H Cuthbertson, Laura Drikite, Richard Feltbower, Theodore Gouliouris, Isobel Sale, Robert Shulman, Lyvonne N Tume, John Myburgh, Kerry Woolfall, David A Harrison, Paul R Mouncey, Kathryn Rowan, Nazima Pathan","doi":"10.3310/HDKV1008","DOIUrl":"10.3310/HDKV1008","url":null,"abstract":"<p><strong>Background: </strong>Healthcare-associated infections are a major cause of morbidity and mortality in critically ill children. In adults, data suggest the use of selective decontamination of the digestive tract may reduce the incidence of healthcare-associated infections. Selective decontamination of the digestive tract has not been evaluated in the paediatric intensive care unit population.</p><p><strong>Objectives: </strong>To determine the feasibility of conducting a multicentre, cluster-randomised controlled trial in critically ill children comparing selective decontamination of the digestive tract with standard infection control.</p><p><strong>Design: </strong>Parallel-group pilot cluster-randomised controlled trial with an integrated mixed-methods study.</p><p><strong>Setting: </strong>Six paediatric intensive care units in England.</p><p><strong>Participants: </strong>Children (> 37 weeks corrected gestational age, up to 16 years) requiring mechanical ventilation expected to last for at least 48 hours were eligible for the PICnIC pilot cluster-randomised controlled trial. During the ecology periods, all children admitted to the paediatric intensive care units were eligible. Parents/legal guardians of recruited patients and healthcare professionals working in paediatric intensive care units were eligible for inclusion in the mixed-methods study.</p><p><strong>Interventions: </strong>The interventions in the PICnIC pilot cluster-randomised controlled trial included administration of selective decontamination of the digestive tract as oro-pharyngeal paste and as a suspension given by enteric tube during the period of mechanical ventilation.</p><p><strong>Main outcome measures: </strong>The decision as to whether a definitive cluster-randomised controlled trial is feasible is based on multiple outcomes, including (but not limited to): (1) willingness and ability to recruit eligible patients; (2) adherence to the selective decontamination of the digestive tract intervention; (3) acceptability of the definitive cluster-randomised controlled trial; (4) estimation of recruitment rate; and (5) understanding of potential clinical and ecological outcome measures.</p><p><strong>Results: </strong>A total of 368 children (85% of all those who were eligible) were enrolled in the PICnIC pilot cluster-randomised controlled trial across six paediatric intensive care units: 207 in the baseline phase (Period One) and 161 in the intervention period (Period Two). In sites delivering selective decontamination of the digestive tract, the majority (98%) of children received at least one dose of selective decontamination of the digestive tract, and of these, 68% commenced within the first 6 hours. Consent for the collection of additional swabs was low (44%), though data completeness for potential outcomes, including microbiology data from routine clinical swab testing, was excellent. Recruited children were representative of the wider paediatric intensiv","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 8","pages":"1-84"},"PeriodicalIF":3.5,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989802","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}