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
<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
{"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":"https://doi.org/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":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Leanne Heathcote, Amanda E Perry, Ellie Thompson, Jennifer Shaw, Jane Senior, Seena Fazel
Background: Rates of self-harm and suicide in prisoners in England and Wales are high, exceeding rates observed in the general population, of similar age and gender. Assessment, Care in Custody and Teamwork (ACCT) is the prison service's self-harm monitoring process. Closure of this process is a high-risk time where people may be at risk of self-harm. Mechanisms to manage risk, particularly following closure of the ACCT management process, mean that many people subsequently self-harm while not being monitored. This creates an opportunity to evaluate the examination of a new tool that could be used to assess ongoing risk after an incident of self-harm and closure of ACCT, and bridge ongoing support.
Objective: To assess the acceptability of a new risk tool to clinicians, prison officers and people in custody, and subsequently, develop an operational implementation pathway to embed the risk tool in practice.
Design: A qualitative study using action learning groups.
Results: A total of five action learning groups were conducted in four male and one female prison sites. These included participation from six staff and eight people in custody. Four themes emerged from the thematic analysis, including establishing an effective implementation process, consistent administration and scoring, purposeful follow-up procedure, and meaningful engagement with people in custody. Two exemplar operational pathways were presented to identify how the risk tool could be incorporated into routine practice.
Limitations: Although this qualitative study used transparent and systematic methods, our sample size was small and may not be representative.
Conclusion: Suicidal thoughts, behaviours and attempts in people in prison continue to be common, and there is a need for a structured approach to reduce repetition. Action learning methods identified barriers, potential solutions and how a new tool could work alongside existing risk management. Future research should focus on the development of the exemplar pathways. In the first instance, a stakeholder working group could review the tool to make initial refinements, followed by a wider implementation study to develop the processes of how the tool could work in practice.
Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/159/09.
{"title":"Understanding barriers and facilitators of implementing a new assessment and bridging tool to support those at risk of repeat self-harm in prison: the qualitative RAPPS study.","authors":"Leanne Heathcote, Amanda E Perry, Ellie Thompson, Jennifer Shaw, Jane Senior, Seena Fazel","doi":"10.3310/GJSF0930","DOIUrl":"https://doi.org/10.3310/GJSF0930","url":null,"abstract":"<p><strong>Background: </strong>Rates of self-harm and suicide in prisoners in England and Wales are high, exceeding rates observed in the general population, of similar age and gender. <i>Assessment, Care in Custody and Teamwork</i> (ACCT) is the prison service's self-harm monitoring process. Closure of this process is a high-risk time where people may be at risk of self-harm. Mechanisms to manage risk, particularly following closure of the ACCT management process, mean that many people subsequently self-harm while not being monitored. This creates an opportunity to evaluate the examination of a new tool that could be used to assess ongoing risk after an incident of self-harm and closure of ACCT, and bridge ongoing support.</p><p><strong>Objective: </strong>To assess the acceptability of a new risk tool to clinicians, prison officers and people in custody, and subsequently, develop an operational implementation pathway to embed the risk tool in practice.</p><p><strong>Design: </strong>A qualitative study using action learning groups.</p><p><strong>Results: </strong>A total of five action learning groups were conducted in four male and one female prison sites. These included participation from six staff and eight people in custody. Four themes emerged from the thematic analysis, including establishing an effective implementation process, consistent administration and scoring, purposeful follow-up procedure, and meaningful engagement with people in custody. Two exemplar operational pathways were presented to identify how the risk tool could be incorporated into routine practice.</p><p><strong>Limitations: </strong>Although this qualitative study used transparent and systematic methods, our sample size was small and may not be representative.</p><p><strong>Conclusion: </strong>Suicidal thoughts, behaviours and attempts in people in prison continue to be common, and there is a need for a structured approach to reduce repetition. Action learning methods identified barriers, potential solutions and how a new tool could work alongside existing risk management. Future research should focus on the development of the exemplar pathways. In the first instance, a stakeholder working group could review the tool to make initial refinements, followed by a wider implementation study to develop the processes of how the tool could work in practice.</p><p><strong>Funding: </strong>This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/159/09.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-18"},"PeriodicalIF":4.0,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147498709","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}
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
<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
{"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}
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
<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
{"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}
Alison O'Mara-Eves, Silvy Mathew, Rachael C Edwards, Katy Sutcliffe, Claire Stansfield, Hossein Dehdarirad, Sara-Jane McAteer, Sarah Markham, Dylan Kneale
<p><strong>Background: </strong>Diabetic retinopathy is a severe diabetes complication that can cause blindness. The United Kingdom's pioneering diabetic eye screening programme has decreased blindness by early detection and treatment. Enhancing diabetic eye screening uptake requires a deeper understanding of the programme implementation.</p><p><strong>Objectives: </strong>This study aimed to develop a logic model depicting diabetic eye screening programme implementation and to systematically map evidence on the implementation of diabetic eye screening in the United Kingdom and countries with similar health systems: Australia, Canada, Ireland and New Zealand.</p><p><strong>Methods: </strong>A logic model was coproduced with UK National Screening Committee members and public coproducers with living experience of diabetic eye screening, informed by existing models and group knowledge. We searched 14 discipline-focused bibliographic databases, 3 academic search engines (Google Scholar, Bielefeld Academic Search Engine and OpenAlex) and targeted websites that covered the time frame up to December 2023. Eligible studies, from 2003 onwards, involved diabetic eye programme implementation in the target countries, covering a range of outcomes. Data extracted were publication year, study location (country), aim of study, study evaluation design, reported data (effectiveness outcomes, implementation outcomes, views/experiences data, observational data or data on resources required), study population, screening stage, intervention strategies and health inequality considerations. Findings are displayed as an interactive evidence map and searchable database.</p><p><strong>Results: </strong>The coproduced logic model depicted factors that could be mapped: screening stage, intervention strategy and evidence type as well as 'black box' factors that would require an in-depth synthesis to address: points for improvement and mechanisms of action. One hundred and thirty-three records were included the interactive map. The largest subset of studies provided information relevant to the entire screening pathway or multiple parts of this system (<i>n</i> = 85), followed by interventions relating to delivery of the eye screening appointment (<i>n </i>= 36), while the fewest studies focused specifically on processes for identifying people eligible for screening. Few studies used experimental designs to evaluate the intervention effectiveness, and there were relatively few studies assessing how well interventions were implemented. Of the studies that reported the evaluation of some form of intervention, the most common type was environmental restructuring of the social and/or physical context (<i>n </i>= 40). The most common data types were observational (e.g. audit studies; <i>n = </i>69) and views or experiences (<i>n </i>= 51). Most studies provided data that can contribute to tackling health inequalities (<i>n</i> = 91).</p><p><strong>Limitations: </strong>We identified
{"title":"Implementation of eye screening programmes for patients with diabetes: a systematic map of evidence from five countries.","authors":"Alison O'Mara-Eves, Silvy Mathew, Rachael C Edwards, Katy Sutcliffe, Claire Stansfield, Hossein Dehdarirad, Sara-Jane McAteer, Sarah Markham, Dylan Kneale","doi":"10.3310/GJAO0707","DOIUrl":"10.3310/GJAO0707","url":null,"abstract":"<p><strong>Background: </strong>Diabetic retinopathy is a severe diabetes complication that can cause blindness. The United Kingdom's pioneering diabetic eye screening programme has decreased blindness by early detection and treatment. Enhancing diabetic eye screening uptake requires a deeper understanding of the programme implementation.</p><p><strong>Objectives: </strong>This study aimed to develop a logic model depicting diabetic eye screening programme implementation and to systematically map evidence on the implementation of diabetic eye screening in the United Kingdom and countries with similar health systems: Australia, Canada, Ireland and New Zealand.</p><p><strong>Methods: </strong>A logic model was coproduced with UK National Screening Committee members and public coproducers with living experience of diabetic eye screening, informed by existing models and group knowledge. We searched 14 discipline-focused bibliographic databases, 3 academic search engines (Google Scholar, Bielefeld Academic Search Engine and OpenAlex) and targeted websites that covered the time frame up to December 2023. Eligible studies, from 2003 onwards, involved diabetic eye programme implementation in the target countries, covering a range of outcomes. Data extracted were publication year, study location (country), aim of study, study evaluation design, reported data (effectiveness outcomes, implementation outcomes, views/experiences data, observational data or data on resources required), study population, screening stage, intervention strategies and health inequality considerations. Findings are displayed as an interactive evidence map and searchable database.</p><p><strong>Results: </strong>The coproduced logic model depicted factors that could be mapped: screening stage, intervention strategy and evidence type as well as 'black box' factors that would require an in-depth synthesis to address: points for improvement and mechanisms of action. One hundred and thirty-three records were included the interactive map. The largest subset of studies provided information relevant to the entire screening pathway or multiple parts of this system (<i>n</i> = 85), followed by interventions relating to delivery of the eye screening appointment (<i>n </i>= 36), while the fewest studies focused specifically on processes for identifying people eligible for screening. Few studies used experimental designs to evaluate the intervention effectiveness, and there were relatively few studies assessing how well interventions were implemented. Of the studies that reported the evaluation of some form of intervention, the most common type was environmental restructuring of the social and/or physical context (<i>n </i>= 40). The most common data types were observational (e.g. audit studies; <i>n = </i>69) and views or experiences (<i>n </i>= 51). Most studies provided data that can contribute to tackling health inequalities (<i>n</i> = 91).</p><p><strong>Limitations: </strong>We identified","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-34"},"PeriodicalIF":4.0,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377109","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}
Sudha Sundar, Ridhi Agarwal, Katie Scandrett, Clare Davenport, Lauren Sturdy, Ryan Ottridge, Jon Deeks
<p><strong>Background: </strong>Ovarian cancer survival is stage-dependent: Stage I patients have 90% 5-year survival versus 15% for stage IV. Over 70% of patients worldwide are diagnosed at advanced stages. Ovarian cancer presents with non-specific symptoms (abdominal bloating, early satiety, discomfort/pain, bowel/urinary changes). Current National Institute for Health and Care Excellence guidelines recommend that symptomatic women presenting to primary care are tested with cancer antigen 125 and ultrasound, then referred to secondary care for further triage if these tests are abnormal. Current standard of care risk prediction model used to triage women in National Health Service secondary care is Risk of Malignancy Index 1 combining cancer antigen 125 and simple ultrasound features, which at 250 threshold has 70% sensitivity and 90% specificity. Newer models offer potential for improved sensitivity, earlier diagnosis and better survival outcomes.</p><p><strong>Objectives: </strong>To evaluate diagnostic strategies for ovarian cancer in women with non-specific symptoms through systematic review, United Kingdom Collaborative Trial of Ovarian Cancer Screening data set analysis, prospective studies and health economic evaluation comparing Risk of Malignancy Index 1 against newer approaches including Risk of Ovarian Malignancy Algorithm, Ovarian-Adnexal Reporting and Data System and International Ovarian Tumour Analysis models, including International Ovarian Tumour Analysis Assessment of Different NEoplasias in the adneXa.</p><p><strong>Methods: </strong>Four concurrent work packages: (1) Cochrane systematic review; (2) United Kingdom Collaborative Trial of Ovarian Cancer Screening data set model development; (3) prospective multicentre diagnostic accuracy study (ROCkeTS) with parallel pre/postmenopausal cohorts; and (4) cost-consequence analysis. Allied analyses investigated psychological impact and cancer outcomes from symptom-triggered pathways. ROCkeTS recruited 2453 women across 23 hospitals (2015-23) with symptoms, raised cancer antigen 125 and/or abnormal imaging. Women completed questionnaires, donated blood and underwent transvaginal ultrasound scored by International Ovarian Tumour Analysis terminology by certified National Health Service sonographers with quality assurance. Reference standard was histology for surgical cases or 12-month wellbeing ascertainment. Primary outcome: primary invasive ovarian cancer versus benign or normal.</p><p><strong>Results: </strong>The Cochrane systematic review (58 studies, 30,121 patients and 9061 ovarian cancer cases) demonstrated that most published diagnostic test accuracy studies failed to differentiate between pre- and postmenopausal women, and all were conducted in high-prevalence settings, limiting applicability to routine practice. In the ROCkeTS prospective study in premenopausal women, in the initial cohort recruited prior to protocol change (<i>n</i> = 857), Risk of Malignancy Index 1 at th
{"title":"Identifying the best diagnostic test for ovarian cancer - synopsis of Refining Ovarian Cancer Test accuracy Scores (ROCkeTS) research.","authors":"Sudha Sundar, Ridhi Agarwal, Katie Scandrett, Clare Davenport, Lauren Sturdy, Ryan Ottridge, Jon Deeks","doi":"10.3310/BDHS6485","DOIUrl":"10.3310/BDHS6485","url":null,"abstract":"<p><strong>Background: </strong>Ovarian cancer survival is stage-dependent: Stage I patients have 90% 5-year survival versus 15% for stage IV. Over 70% of patients worldwide are diagnosed at advanced stages. Ovarian cancer presents with non-specific symptoms (abdominal bloating, early satiety, discomfort/pain, bowel/urinary changes). Current National Institute for Health and Care Excellence guidelines recommend that symptomatic women presenting to primary care are tested with cancer antigen 125 and ultrasound, then referred to secondary care for further triage if these tests are abnormal. Current standard of care risk prediction model used to triage women in National Health Service secondary care is Risk of Malignancy Index 1 combining cancer antigen 125 and simple ultrasound features, which at 250 threshold has 70% sensitivity and 90% specificity. Newer models offer potential for improved sensitivity, earlier diagnosis and better survival outcomes.</p><p><strong>Objectives: </strong>To evaluate diagnostic strategies for ovarian cancer in women with non-specific symptoms through systematic review, United Kingdom Collaborative Trial of Ovarian Cancer Screening data set analysis, prospective studies and health economic evaluation comparing Risk of Malignancy Index 1 against newer approaches including Risk of Ovarian Malignancy Algorithm, Ovarian-Adnexal Reporting and Data System and International Ovarian Tumour Analysis models, including International Ovarian Tumour Analysis Assessment of Different NEoplasias in the adneXa.</p><p><strong>Methods: </strong>Four concurrent work packages: (1) Cochrane systematic review; (2) United Kingdom Collaborative Trial of Ovarian Cancer Screening data set model development; (3) prospective multicentre diagnostic accuracy study (ROCkeTS) with parallel pre/postmenopausal cohorts; and (4) cost-consequence analysis. Allied analyses investigated psychological impact and cancer outcomes from symptom-triggered pathways. ROCkeTS recruited 2453 women across 23 hospitals (2015-23) with symptoms, raised cancer antigen 125 and/or abnormal imaging. Women completed questionnaires, donated blood and underwent transvaginal ultrasound scored by International Ovarian Tumour Analysis terminology by certified National Health Service sonographers with quality assurance. Reference standard was histology for surgical cases or 12-month wellbeing ascertainment. Primary outcome: primary invasive ovarian cancer versus benign or normal.</p><p><strong>Results: </strong>The Cochrane systematic review (58 studies, 30,121 patients and 9061 ovarian cancer cases) demonstrated that most published diagnostic test accuracy studies failed to differentiate between pre- and postmenopausal women, and all were conducted in high-prevalence settings, limiting applicability to routine practice. In the ROCkeTS prospective study in premenopausal women, in the initial cohort recruited prior to protocol change (<i>n</i> = 857), Risk of Malignancy Index 1 at th","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 24","pages":"1-21"},"PeriodicalIF":4.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377251","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}
Gwenllian Wynne-Jones, Martyn Lewis, Gail Sowden, Ira Madan, Karen Walker-Bone, Carolyn A Chew-Graham, Kieran Bromley, Sue Jowett, Vaughan Parsons, Gemma Mansell, Kendra Cooke, Sarah A Lawton, Benjamin Saunders, Rosie Harrison, Simon Wathall, John Pemberton, Julia Hammond, Cyrus Cooper, Nadine E Foster
<p><strong>Background: </strong>Accessible occupational health advice is only available to approximately half the United Kingdom population. With rising sickness absence new models for delivering occupational health are required to support employees with health conditions to manage their condition at work.</p><p><strong>Aim: </strong>To determine, in patients consulting in general practice who receive a fit note, whether the addition of a vocational advice intervention to usual primary care leads to fewer days lost from work, and whether vocational advice is cost-effective.</p><p><strong>Design: </strong>Intervention development: Training development using mixed methods and the theoretical framework the Behaviour Change Wheel. Feasibility study: Mixed methods, single-arm feasibility study, with stop/go criteria to assist decision making about progression to full trial. Trial: Multi-centre, two-parallel arm, superiority, randomised controlled trial with health economic analysis and nested qualitative study.</p><p><strong>Setting: </strong>General practices in three geographic areas in England: West Midlands, South London and Wessex.</p><p><strong>Participants: </strong>Patients aged ≥ 18 years, currently in paid employment (full or part-time), current absence from work of at least 2 weeks but not more than 6 consecutive months, with a fit note for any health condition.</p><p><strong>Interventions: </strong>Vocational advice delivered by trained vocational support workers plus usual primary care (intervention arm), compared to usual primary care alone (control arm).</p><p><strong>Main outcome measures: </strong>The outcome of intervention development was a vocational advice intervention and training package. Feasibility study outcomes were ability to recruit and acceptability of the vocational advice intervention to participants. The trial primary outcome was number of days absent from work over 6 months.</p><p><strong>Results: </strong>A vocational advice intervention and training package designed for delivery in primary care using case management and stepped care to support patients absent from work for 2 weeks to 6 months. The feasibility study recruited 19 participants demonstrating the vocational advice intervention could be delivered and was acceptable to participants. Recommendations around automated recruitment and data collection were made which were implemented in the trial. The randomised controlled trial sample size was 720; 130 participants were recruited (66 intervention/64 control) before closing early due to recruitment difficulties. There was no statistically significant difference in days absent over 6 months with a mean of 37 (standard deviation 48) days absence (vocational advice intervention) compared to a mean of 42 (standard deviation 57) days absence (usual primary care alone) and an adjusted incidence rate ratio of 0.913 (80% confidence interval 0.653 to 1.276). Health economic analysis found that productivity losses were a
{"title":"The work and vocational advice intervention for adults in full or part-time employment: a synopsis of the WAVE feasibility study and RCT.","authors":"Gwenllian Wynne-Jones, Martyn Lewis, Gail Sowden, Ira Madan, Karen Walker-Bone, Carolyn A Chew-Graham, Kieran Bromley, Sue Jowett, Vaughan Parsons, Gemma Mansell, Kendra Cooke, Sarah A Lawton, Benjamin Saunders, Rosie Harrison, Simon Wathall, John Pemberton, Julia Hammond, Cyrus Cooper, Nadine E Foster","doi":"10.3310/DSRW9113","DOIUrl":"10.3310/DSRW9113","url":null,"abstract":"<p><strong>Background: </strong>Accessible occupational health advice is only available to approximately half the United Kingdom population. With rising sickness absence new models for delivering occupational health are required to support employees with health conditions to manage their condition at work.</p><p><strong>Aim: </strong>To determine, in patients consulting in general practice who receive a fit note, whether the addition of a vocational advice intervention to usual primary care leads to fewer days lost from work, and whether vocational advice is cost-effective.</p><p><strong>Design: </strong>Intervention development: Training development using mixed methods and the theoretical framework the Behaviour Change Wheel. Feasibility study: Mixed methods, single-arm feasibility study, with stop/go criteria to assist decision making about progression to full trial. Trial: Multi-centre, two-parallel arm, superiority, randomised controlled trial with health economic analysis and nested qualitative study.</p><p><strong>Setting: </strong>General practices in three geographic areas in England: West Midlands, South London and Wessex.</p><p><strong>Participants: </strong>Patients aged ≥ 18 years, currently in paid employment (full or part-time), current absence from work of at least 2 weeks but not more than 6 consecutive months, with a fit note for any health condition.</p><p><strong>Interventions: </strong>Vocational advice delivered by trained vocational support workers plus usual primary care (intervention arm), compared to usual primary care alone (control arm).</p><p><strong>Main outcome measures: </strong>The outcome of intervention development was a vocational advice intervention and training package. Feasibility study outcomes were ability to recruit and acceptability of the vocational advice intervention to participants. The trial primary outcome was number of days absent from work over 6 months.</p><p><strong>Results: </strong>A vocational advice intervention and training package designed for delivery in primary care using case management and stepped care to support patients absent from work for 2 weeks to 6 months. The feasibility study recruited 19 participants demonstrating the vocational advice intervention could be delivered and was acceptable to participants. Recommendations around automated recruitment and data collection were made which were implemented in the trial. The randomised controlled trial sample size was 720; 130 participants were recruited (66 intervention/64 control) before closing early due to recruitment difficulties. There was no statistically significant difference in days absent over 6 months with a mean of 37 (standard deviation 48) days absence (vocational advice intervention) compared to a mean of 42 (standard deviation 57) days absence (usual primary care alone) and an adjusted incidence rate ratio of 0.913 (80% confidence interval 0.653 to 1.276). Health economic analysis found that productivity losses were a","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 21","pages":"1-36"},"PeriodicalIF":4.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147389848","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}
Michael D Jenkinson, Helen Bulbeck, Jade Carruthers, Jacqueline Burns, Sarah Lessels, Richard Dobbie, Rachael Watson, Ciara Gribben, Alasdair G Rooney, Gerard Thompson, Tomos Robinson, Luke Vale, Sara Erridge, Colin Watts, Anthony G Marson, Robin Grant
<p><strong>Background: </strong>In patients with a glioma, 50-80% will have seizures during their lifetime and half of these will be drug resistant. Seizure risk is increased perioperatively (around the time of surgery) at tumour progression and shortly before death. In seizure-naive patients with glioma undergoing surgery, existing guidelines do not recommend routine use of prophylactic antiseizure medication. Despite this, an antiseizure medication, levetiracetam, is frequently prescribed perioperatively in many neurosurgical units.</p><p><strong>Objectives: </strong>To determine whether in seizure-naive, newly diagnosed cerebral glioma patients undergoing surgery, prophylactic levetiracetam, pre-operatively and for at least 1 year post operatively, produces a meaningful (> 50%) reduction in the risk of developing seizures when compared with standard care (no prophylaxis) and is cost-effective.</p><p><strong>Design and methods: </strong>We undertook a two-arm, multicentre phase III randomised trial in 14 neurosurgery units across England and Scotland, with an embedded health economic evaluation, comparing 12 months of prophylactic antiseizure medication (levetiracetam) versus no antiseizure medication (comparator) in patients with suspected cerebral glioma undergoing surgery. The target samples size was 804 participants.</p><p><strong>Outcome measures: </strong>The primary outcome was the occurrence of a seizure within 12 months of randomisation. The secondary outcomes were time to first seizure, time to first tonic-clonic seizure, time to death (overall survival) and time to tumour recurrence (progression-free survival). The impact of prophylactic levetiracetam on mood, personality, fatigue and memory, severity of first seizure if it occurred and quality of life were assessed. The planned health economic outcomes were costs to the National Health Service and Personal Social Services and incremental cost per quality-adjusted life-year at 12 months and modelled over estimated survival. Analyses were carried out using the intention-to-treat principle.</p><p><strong>Results: </strong>Between 9 October 2019 and 30 August 2022, 94 patients were recruited, from 24 to 79 years of age and randomised to prophylactic levetiracetam (<i>n</i> = 49) or no prophylaxis (<i>n</i> = 45). Due to slow accrual, the trial closed early. Thirteen patients in the prophylactic levetiracetam arm and 9 in the no prophylaxis group died within 1 year of randomisation and did not have a seizure. Of the patients who survived for at least 1 year, 17 (47%) of 36 prophylactic levetiracetam patients had a seizure when compared with 15 (41%) of 36 no prophylaxis patients (odds ratio 1.25, 95% confidence interval 0.49 to 3.21, <i>p</i> = 0.64). Median time to first seizure was 5.0 months in the prophylactic levetiracetam group and 2.5 months in the no prophylaxis group. In the prophylactic levetiracetam group, 20 (41%) of 49 patients died within 12 months (median overall survival
{"title":"Seizure prophylaxis in glioma surgery: a synopsis from the SPRING RCT.","authors":"Michael D Jenkinson, Helen Bulbeck, Jade Carruthers, Jacqueline Burns, Sarah Lessels, Richard Dobbie, Rachael Watson, Ciara Gribben, Alasdair G Rooney, Gerard Thompson, Tomos Robinson, Luke Vale, Sara Erridge, Colin Watts, Anthony G Marson, Robin Grant","doi":"10.3310/GJMJ1815","DOIUrl":"10.3310/GJMJ1815","url":null,"abstract":"<p><strong>Background: </strong>In patients with a glioma, 50-80% will have seizures during their lifetime and half of these will be drug resistant. Seizure risk is increased perioperatively (around the time of surgery) at tumour progression and shortly before death. In seizure-naive patients with glioma undergoing surgery, existing guidelines do not recommend routine use of prophylactic antiseizure medication. Despite this, an antiseizure medication, levetiracetam, is frequently prescribed perioperatively in many neurosurgical units.</p><p><strong>Objectives: </strong>To determine whether in seizure-naive, newly diagnosed cerebral glioma patients undergoing surgery, prophylactic levetiracetam, pre-operatively and for at least 1 year post operatively, produces a meaningful (> 50%) reduction in the risk of developing seizures when compared with standard care (no prophylaxis) and is cost-effective.</p><p><strong>Design and methods: </strong>We undertook a two-arm, multicentre phase III randomised trial in 14 neurosurgery units across England and Scotland, with an embedded health economic evaluation, comparing 12 months of prophylactic antiseizure medication (levetiracetam) versus no antiseizure medication (comparator) in patients with suspected cerebral glioma undergoing surgery. The target samples size was 804 participants.</p><p><strong>Outcome measures: </strong>The primary outcome was the occurrence of a seizure within 12 months of randomisation. The secondary outcomes were time to first seizure, time to first tonic-clonic seizure, time to death (overall survival) and time to tumour recurrence (progression-free survival). The impact of prophylactic levetiracetam on mood, personality, fatigue and memory, severity of first seizure if it occurred and quality of life were assessed. The planned health economic outcomes were costs to the National Health Service and Personal Social Services and incremental cost per quality-adjusted life-year at 12 months and modelled over estimated survival. Analyses were carried out using the intention-to-treat principle.</p><p><strong>Results: </strong>Between 9 October 2019 and 30 August 2022, 94 patients were recruited, from 24 to 79 years of age and randomised to prophylactic levetiracetam (<i>n</i> = 49) or no prophylaxis (<i>n</i> = 45). Due to slow accrual, the trial closed early. Thirteen patients in the prophylactic levetiracetam arm and 9 in the no prophylaxis group died within 1 year of randomisation and did not have a seizure. Of the patients who survived for at least 1 year, 17 (47%) of 36 prophylactic levetiracetam patients had a seizure when compared with 15 (41%) of 36 no prophylaxis patients (odds ratio 1.25, 95% confidence interval 0.49 to 3.21, <i>p</i> = 0.64). Median time to first seizure was 5.0 months in the prophylactic levetiracetam group and 2.5 months in the no prophylaxis group. In the prophylactic levetiracetam group, 20 (41%) of 49 patients died within 12 months (median overall survival ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 22","pages":"1-40"},"PeriodicalIF":4.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989904/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377254","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}
<p><strong>Background: </strong>Behavioural weight management interventions are the main treatment for obesity in the United Kingdom; however, there are limitations in the published evidence on their effectiveness which in turn affects the available guidance. This research aims to determine which individual components of behavioural weight management programmes are associated with greater attendance, intervention completion and weight loss.</p><p><strong>Objective(s): </strong>To map individual components of behavioural weight management interventions. To analyse individual participant data using network meta-analyses at the level of the intervention and component network meta-analysis to investigate the relative effectiveness of components of behavioural weight management interventions for weight loss outcomes.</p><p><strong>Design: </strong>A two-stage Bayesian network meta-analysis and component network meta-analysis of individual participant data from randomised controlled trials and real-world services.</p><p><strong>Setting: </strong>Data obtained from two separate scenarios: randomised controlled trials and real-world services.</p><p><strong>Participants: </strong>Anonymous individual participant data of adults over 18 years of age, living in the United Kingdom and attending behavioural weight management interventions in randomised controlled trials (<i>n</i> = 4051) and in the real world (<i>n</i> = 76,201).</p><p><strong>Interventions: </strong>Behavioural weight management interventions.</p><p><strong>Main outcome measures: </strong>Mean change in weight at 12 weeks of active weight loss session of both randomised controlled trials and real-world service data.</p><p><strong>Results: </strong>Mapping of participating services demonstrated variating between the two scenarios (randomised controlled trial and real-world service) despite all following National Institute for Health and Care Excellence guidance. At intervention level, network meta-analysis of randomised controlled trials found that all behavioural weight management interventions lead to weight loss at 12 weeks, with Football Fans in Training showing the greatest weight loss (mean difference -4.65, 95% credible intervals -5.24 to -4.07) compared with all other interventions. The intervention-level individual participant data network meta-analysis of real-world services included data from 19 services (<i>n</i> = 76,201). The analysis for change in weight (kg) showed that face-to-face intervention with weekly sessions on diet and physical activity was associated with the greatest weight loss (programme 1; mean difference -4.03, 95% credible interval -4.12 to -3.94) when compared with other programmes; while interventions of group-based weekly sessions focusing solely on physical activity was associated with very low weight loss (programme 7; mean difference -0.28, 95% credible interval -0.40 to -0.15). Network meta-analysis at component level showed that components associated wit
{"title":"BEhavioural Weight Management: COMponents of Effectiveness (BE:COME) Synopsis.","authors":"Rebecca Gregg, Nishant Jaiswal, Sahar Sharif, Alison Avenell, Louisa Ells, Sandra Jayacodi, Ruth Mackenzie, Sharon Simpson, Olivia Wu, Jennifer Logue","doi":"10.3310/GJJL1701","DOIUrl":"10.3310/GJJL1701","url":null,"abstract":"<p><strong>Background: </strong>Behavioural weight management interventions are the main treatment for obesity in the United Kingdom; however, there are limitations in the published evidence on their effectiveness which in turn affects the available guidance. This research aims to determine which individual components of behavioural weight management programmes are associated with greater attendance, intervention completion and weight loss.</p><p><strong>Objective(s): </strong>To map individual components of behavioural weight management interventions. To analyse individual participant data using network meta-analyses at the level of the intervention and component network meta-analysis to investigate the relative effectiveness of components of behavioural weight management interventions for weight loss outcomes.</p><p><strong>Design: </strong>A two-stage Bayesian network meta-analysis and component network meta-analysis of individual participant data from randomised controlled trials and real-world services.</p><p><strong>Setting: </strong>Data obtained from two separate scenarios: randomised controlled trials and real-world services.</p><p><strong>Participants: </strong>Anonymous individual participant data of adults over 18 years of age, living in the United Kingdom and attending behavioural weight management interventions in randomised controlled trials (<i>n</i> = 4051) and in the real world (<i>n</i> = 76,201).</p><p><strong>Interventions: </strong>Behavioural weight management interventions.</p><p><strong>Main outcome measures: </strong>Mean change in weight at 12 weeks of active weight loss session of both randomised controlled trials and real-world service data.</p><p><strong>Results: </strong>Mapping of participating services demonstrated variating between the two scenarios (randomised controlled trial and real-world service) despite all following National Institute for Health and Care Excellence guidance. At intervention level, network meta-analysis of randomised controlled trials found that all behavioural weight management interventions lead to weight loss at 12 weeks, with Football Fans in Training showing the greatest weight loss (mean difference -4.65, 95% credible intervals -5.24 to -4.07) compared with all other interventions. The intervention-level individual participant data network meta-analysis of real-world services included data from 19 services (<i>n</i> = 76,201). The analysis for change in weight (kg) showed that face-to-face intervention with weekly sessions on diet and physical activity was associated with the greatest weight loss (programme 1; mean difference -4.03, 95% credible interval -4.12 to -3.94) when compared with other programmes; while interventions of group-based weekly sessions focusing solely on physical activity was associated with very low weight loss (programme 7; mean difference -0.28, 95% credible interval -0.40 to -0.15). Network meta-analysis at component level showed that components associated wit","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 23","pages":"1-16"},"PeriodicalIF":4.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147389808","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}
David Wright, Hangjian Wu, Anthony King, Giovanni Montesano, Bethany Higgins, Gus Gazzard, James Morgan, Andy McNaught, Rani Sebastian, Faisal Ahmed, Chrysostomos Dimitriou, Madhu Nagar, Andrew Scott, Omar Rafiq, Robert Harper, David Crabb, Verity Watson, Rodolfo Hernández, Chris Cardwell, Yemisi Takwoingi, Augusto Azuara-Blanco
<p><strong>Background: </strong>Ocular hypertension, that is intraocular pressure > 21 mmHg, is a risk factor for glaucoma. A glaucoma risk predictor, the Ocular Hypertension Study-European Glaucoma Prevention Study model, is available.</p><p><strong>Objectives: </strong>(1) To validate and update the Ocular Hypertension Study-European Glaucoma Prevention Study risk prediction model in a United Kingdom population; (2) to assess the relative efficiency of alternative monitoring pathways according to glaucoma risk; (3) to determine the clinical and cost-effectiveness of treating people with ocular hypertension with intraocular pressure of 22 or 23 mmHg and (4) to elicit patient preferences for monitoring.</p><p><strong>Design: </strong>(1) Retrospective data analysis of electronic medical records of ocular hypertension patients attending hospital eye services. The influence of the Ocular Hypertension Study-European Glaucoma Prevention Study predictors and additional ocular and systematic factors was explored. Validation: the Ocular Hypertension Study-European Glaucoma Prevention Study prediction model was applied. Update: the model was refitted by re-estimating baseline hazard and regression coefficients. (2, 3) Predictor versus standard care, with deterministic and probabilistic sensitivity analyses. Subgroup analysis for people with 22-23 mmHg intraocular pressure. (4) Discrete choice experiment.</p><p><strong>Setting and participants: </strong>People with intraocular pressure 22-32 mmHg in either eye, at least four visual field tests, 5 years of follow-up, no significant ocular comorbidities. Data sourced from secondary clinical settings.</p><p><strong>Main outcome measures: </strong>Discriminative ability (c-index) and calibration (calibration slope) to predict conversion to glaucoma in 5 years. Quality-adjusted life-years, incremental cost-effectiveness ratio, preferences.</p><p><strong>Data sources: </strong>Electronic medical records of 10 hospitals in England.</p><p><strong>Results: </strong>(1) Of 9030 patients with ocular hypertension who fitted the inclusion criteria 1530 (16.9%) converted to glaucoma. The Ocular Hypertension Study-European Glaucoma Prevention Study model provided a pooled c-index of 0.61 (95% confidence interval: 0.60 to 0.63). The updated model had a pooled c-index of 0.67 (0.51 to 0.84). (2) In the economic model almost all (99%) patients were treated in the risk predictor strategy, and less than half (47%) in the standard care strategy. The risk predictor strategy produced higher costs, but also higher quality-adjusted life-years and is likely to be cost-effective compared with standard care. (3) Patients with ocular hypertension and intraocular pressure 22-23 mmHg had similar risk of conversion to the rest of the cohort. A treat-all strategy may not be cost-effective. (4) Three hundred and sixty patients were recruited from four NHS hospitals. Almost all respondents (92%) had experienced face-to-face monitoring at a
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