James Richards, Dominic Summers, Anna Sidders, Elisa Allen, Mohammed Ayaz Hossain, Subhankar Paul, Matthew Slater, Matthew Bartlett, Regin Lagaac, Emma Laing, Valerie Hopkins, Chloe Fitzpatrick-Creamer, Cara Hudson, Joseph Parsons, Samuel Turner, Andrew Tambyraja, Subash Somalanka, James Hunter, Sam Dutta, Neil Hoye, Sarah Lawman, Tracey Salter, Mohammed Farid Aslam, Atul Bagul, Rajesh Sivaprakasam, George E Smith, Helen L Thomas, Zia Moinuddin, Simon R Knight, Nicholas Barnett, Reza Motallebzadeh, Gavin J Pettigrew
<p><strong>Background: </strong>Arteriovenous fistulas are considered the best option for haemodialysis provision, but as many as 30% fail to mature or suffer early failure.</p><p><strong>Objective: </strong>To assess the feasibility of performing a randomised controlled trial that examines whether, by informing early and effective salvage intervention of fistulas that would otherwise fail, Doppler ultrasound surveillance of developing arteriovenous fistulas improves longer-term arteriovenous fistula patency.</p><p><strong>Design: </strong>A prospective multicentre observational cohort study (the 'SONAR' study).</p><p><strong>Setting: </strong>Seventeen haemodialysis centres in the UK.</p><p><strong>Participants: </strong>Consenting adults with end-stage renal disease who were scheduled to have an arteriovenous fistula created.</p><p><strong>Intervention: </strong>Participants underwent Doppler ultrasound surveillance of their arteriovenous fistulas at 2, 4, 6 and 10 weeks after creation, with clinical teams blinded to the ultrasound surveillance findings.</p><p><strong>Main outcome measures: </strong>Fistula maturation at week 10 defined according to ultrasound surveillance parameters of representative venous diameter and blood flow (wrist arteriovenous fistulas: ≥ 4 mm and > 400 ml/minute; elbow arteriovenous fistulas: ≥ 5 mm and > 500 ml/minute). Mixed multivariable logistic regression modelling of the early ultrasound scan data was used to predict arteriovenous fistula non-maturation by 10 weeks and fistula failure at 6 months.</p><p><strong>Results: </strong>A total of 333 arteriovenous fistulas were created during the study window (47.7% wrist, 52.3% elbow). By 2 weeks, 37 (11.1%) arteriovenous fistulas had failed (thrombosed), but by 10 weeks, 219 of 333 (65.8%) of created arteriovenous fistulas had reached maturity (60.4% wrist, 67.2% elbow). Persistently lower flow rates and venous diameters were observed in those fistulas that did not mature. Models for arteriovenous fistulas' non-maturation could be optimally constructed using the week 4 scan data, with fistula venous diameter and flow rate the most significant variables in explaining wrist fistula maturity failure (positive predictive value 60.6%, 95% confidence interval 43.9% to 77.3%), whereas resistance index and flow rate were most significant for elbow arteriovenous fistulas (positive predictive value 66.7%, 95% confidence interval 48.9% to 84.4%). In contrast to non-maturation, both models predicted fistula maturation much more reliably [negative predictive values of 95.4% (95% confidence interval 91.0% to 99.8%) and 95.6% (95% confidence interval 91.8% to 99.4%) for wrist and elbow, respectively]. Additional follow-up and modelling on a subset (<i>n</i> = 192) of the original SONAR cohort (the SONAR-12M study) revealed the rates of primary, assisted primary and secondary patency arteriovenous fistulas at 6 months were 76.5, 80.7 and 83.3, respectively. Fistula vein size, flow r
{"title":"Doppler ultrasound surveillance of recently formed haemodialysis arteriovenous fistula: the SONAR observational cohort study.","authors":"James Richards, Dominic Summers, Anna Sidders, Elisa Allen, Mohammed Ayaz Hossain, Subhankar Paul, Matthew Slater, Matthew Bartlett, Regin Lagaac, Emma Laing, Valerie Hopkins, Chloe Fitzpatrick-Creamer, Cara Hudson, Joseph Parsons, Samuel Turner, Andrew Tambyraja, Subash Somalanka, James Hunter, Sam Dutta, Neil Hoye, Sarah Lawman, Tracey Salter, Mohammed Farid Aslam, Atul Bagul, Rajesh Sivaprakasam, George E Smith, Helen L Thomas, Zia Moinuddin, Simon R Knight, Nicholas Barnett, Reza Motallebzadeh, Gavin J Pettigrew","doi":"10.3310/YTBT4172","DOIUrl":"10.3310/YTBT4172","url":null,"abstract":"<p><strong>Background: </strong>Arteriovenous fistulas are considered the best option for haemodialysis provision, but as many as 30% fail to mature or suffer early failure.</p><p><strong>Objective: </strong>To assess the feasibility of performing a randomised controlled trial that examines whether, by informing early and effective salvage intervention of fistulas that would otherwise fail, Doppler ultrasound surveillance of developing arteriovenous fistulas improves longer-term arteriovenous fistula patency.</p><p><strong>Design: </strong>A prospective multicentre observational cohort study (the 'SONAR' study).</p><p><strong>Setting: </strong>Seventeen haemodialysis centres in the UK.</p><p><strong>Participants: </strong>Consenting adults with end-stage renal disease who were scheduled to have an arteriovenous fistula created.</p><p><strong>Intervention: </strong>Participants underwent Doppler ultrasound surveillance of their arteriovenous fistulas at 2, 4, 6 and 10 weeks after creation, with clinical teams blinded to the ultrasound surveillance findings.</p><p><strong>Main outcome measures: </strong>Fistula maturation at week 10 defined according to ultrasound surveillance parameters of representative venous diameter and blood flow (wrist arteriovenous fistulas: ≥ 4 mm and > 400 ml/minute; elbow arteriovenous fistulas: ≥ 5 mm and > 500 ml/minute). Mixed multivariable logistic regression modelling of the early ultrasound scan data was used to predict arteriovenous fistula non-maturation by 10 weeks and fistula failure at 6 months.</p><p><strong>Results: </strong>A total of 333 arteriovenous fistulas were created during the study window (47.7% wrist, 52.3% elbow). By 2 weeks, 37 (11.1%) arteriovenous fistulas had failed (thrombosed), but by 10 weeks, 219 of 333 (65.8%) of created arteriovenous fistulas had reached maturity (60.4% wrist, 67.2% elbow). Persistently lower flow rates and venous diameters were observed in those fistulas that did not mature. Models for arteriovenous fistulas' non-maturation could be optimally constructed using the week 4 scan data, with fistula venous diameter and flow rate the most significant variables in explaining wrist fistula maturity failure (positive predictive value 60.6%, 95% confidence interval 43.9% to 77.3%), whereas resistance index and flow rate were most significant for elbow arteriovenous fistulas (positive predictive value 66.7%, 95% confidence interval 48.9% to 84.4%). In contrast to non-maturation, both models predicted fistula maturation much more reliably [negative predictive values of 95.4% (95% confidence interval 91.0% to 99.8%) and 95.6% (95% confidence interval 91.8% to 99.4%) for wrist and elbow, respectively]. Additional follow-up and modelling on a subset (<i>n</i> = 192) of the original SONAR cohort (the SONAR-12M study) revealed the rates of primary, assisted primary and secondary patency arteriovenous fistulas at 6 months were 76.5, 80.7 and 83.3, respectively. Fistula vein size, flow r","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 24","pages":"1-54"},"PeriodicalIF":3.5,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11145465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070876","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}
Rebecca Kearney, David Ellard, Helen Parsons, Aminul Haque, James Mason, Henry Nwankwo, Helen Bradley, Steve Drew, Chetan Modi, Howard Bush, David Torgerson, Martin Underwood
<p><strong>Background: </strong>The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy.</p><p><strong>Objective: </strong>The primary objective was to quantify and draw inferences about observed differences in the Oxford Shoulder Instability Score between the trial treatment groups 6 months post randomisation, in adults with a first-time traumatic shoulder dislocation.</p><p><strong>Design: </strong>A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study.</p><p><strong>Setting: </strong>Forty-one hospitals in the UK NHS.</p><p><strong>Participants: </strong>Adults with a radiologically confirmed first-time traumatic anterior shoulder dislocation, being managed non-operatively. People with neurovascular complications or bilateral dislocations, and those unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or who had previously been randomised, were excluded.</p><p><strong>Interventions: </strong>All participants received the same initial shoulder examination followed by advice to aid self-management, lasting up to 1 hour and administered by a physiotherapist (control). Participants randomised to receive an additional programme of physiotherapy were offered sessions lasting for up to 30 minutes, over a maximum duration of 4 months from the date of randomisation (intervention).</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the Oxford Shoulder Instability Score. This is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (worst function) to 48 (best function). Measurements were collected at 6 weeks, 3 months, 6 months and 12 months by postal questionnaire; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was the quality-adjusted life-year, in accordance with National Institute of Health and Care Excellence guidelines.</p><p><strong>Results: </strong>Between 14 November 2018 and 14 March 2022, 482 participants were randomised to advice (<i>n</i> = 240) or advice and a programme of physiotherapy (<i>n</i> = 242). Participants were 34% female, with a mean age of 45 years, and treatment arms were balanced at baseline. There was not a statistically significant difference in the primary outcome between advice only and advice plus a programme of physiotherapy at 6 months for the primary intention-to-treat adjusted analysis (favours physiotherapy: 1.5, 95% confidence interval -0.3 to 3.5) or at earlier 3-month and 6-week time points on the Oxford Shoulder Instability Score (0-48; higher scores indicate better function). The probability of physiotherapy being cost-effective at a willingness-to-pay threshold of £30,0
{"title":"Advice only versus advice and a physiotherapy programme for acute traumatic anterior shoulder dislocation: the ARTISAN RCT.","authors":"Rebecca Kearney, David Ellard, Helen Parsons, Aminul Haque, James Mason, Henry Nwankwo, Helen Bradley, Steve Drew, Chetan Modi, Howard Bush, David Torgerson, Martin Underwood","doi":"10.3310/CMYW9226","DOIUrl":"10.3310/CMYW9226","url":null,"abstract":"<p><strong>Background: </strong>The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy.</p><p><strong>Objective: </strong>The primary objective was to quantify and draw inferences about observed differences in the Oxford Shoulder Instability Score between the trial treatment groups 6 months post randomisation, in adults with a first-time traumatic shoulder dislocation.</p><p><strong>Design: </strong>A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study.</p><p><strong>Setting: </strong>Forty-one hospitals in the UK NHS.</p><p><strong>Participants: </strong>Adults with a radiologically confirmed first-time traumatic anterior shoulder dislocation, being managed non-operatively. People with neurovascular complications or bilateral dislocations, and those unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or who had previously been randomised, were excluded.</p><p><strong>Interventions: </strong>All participants received the same initial shoulder examination followed by advice to aid self-management, lasting up to 1 hour and administered by a physiotherapist (control). Participants randomised to receive an additional programme of physiotherapy were offered sessions lasting for up to 30 minutes, over a maximum duration of 4 months from the date of randomisation (intervention).</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the Oxford Shoulder Instability Score. This is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (worst function) to 48 (best function). Measurements were collected at 6 weeks, 3 months, 6 months and 12 months by postal questionnaire; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was the quality-adjusted life-year, in accordance with National Institute of Health and Care Excellence guidelines.</p><p><strong>Results: </strong>Between 14 November 2018 and 14 March 2022, 482 participants were randomised to advice (<i>n</i> = 240) or advice and a programme of physiotherapy (<i>n</i> = 242). Participants were 34% female, with a mean age of 45 years, and treatment arms were balanced at baseline. There was not a statistically significant difference in the primary outcome between advice only and advice plus a programme of physiotherapy at 6 months for the primary intention-to-treat adjusted analysis (favours physiotherapy: 1.5, 95% confidence interval -0.3 to 3.5) or at earlier 3-month and 6-week time points on the Oxford Shoulder Instability Score (0-48; higher scores indicate better function). The probability of physiotherapy being cost-effective at a willingness-to-pay threshold of £30,0","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 22","pages":"1-94"},"PeriodicalIF":3.5,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11089447/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140851355","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}
Matthew Maddocks, Lisa Jane Brighton, Louise Connell, Alison Cowley, Barry Laird, Guy Peryer, Carmine Petrasso, Lucy Ziegler, Rowan Harwood
<p><strong>Background: </strong>Functional loss, the inability to perform necessary or desired tasks, is a common consequence of life-limiting illnesses and associated symptoms (pain, fatigue, breathlessness, etc.) and causes suffering for patients and families. Rehabilitation, a set of interventions designed to address functional loss, is recognised as essential within palliative care, as it can improve quality of life and reduce care costs. However, not everyone has equal access to rehabilitation. Despite limited life expectancy or uncertain ability to benefit from interventions, palliative rehabilitation services are often absent. This is partly due to a lack of high-quality research around optimal models of rehabilitation. Research in this area is methodologically challenging and requires multidisciplinary and cross-speciality collaboration.</p><p><strong>Aim and objectives: </strong>We aimed to establish and grow a United Kingdom research partnership across diverse areas, commencing with partners from Edinburgh, East Anglia, Lancashire, Leeds, London and Nottingham, around the topic area of functional loss and rehabilitation in palliative and end-of-life care. The objectives were to (1) develop a multidisciplinary, cross-speciality research partnership, (2) generate high-priority unanswered research questions with stakeholders, (3) co-design and submit high-quality competitive research proposals, including (4) sharing topic and methodological expertise, and (5) to build capacity and capability to deliver nationally generalisable studies.</p><p><strong>Activities: </strong>The partnership was established with professionals from across England and Scotland with complementary areas of expertise including complex palliative and geriatric research, physiotherapy, nursing, palliative medicine and psychology. Research questions were generated through a modified version of the Child Health and Nutrition Research Initiative, which allowed for the collation and refinement of research questions relating to functional loss and rehabilitation towards the end of life. Partnership members were supported through a series of workshops to transform research ideas into proposals for submission to stage one calls by the National Institute for Health and Care Research. The partnership not only supported students, clinicians and public members with training opportunities but also supported clinicians in securing protected time from clinical duties to allow them to focus on developing local research initiatives.</p><p><strong>Reflections: </strong>Through our partnership we established a network that offered researchers, clinicians, students and public members the chance to develop novel skills and explore opportunities for personal and professional development around the topic area of functional loss and rehabilitation in palliative and end-of-life care. The partnership was crucial to foster collaboration and facilitate exchange of ideas, knowledge and experience
{"title":"Establishing a research partnership to investigate functional loss and rehabilitation towards the end of life.","authors":"Matthew Maddocks, Lisa Jane Brighton, Louise Connell, Alison Cowley, Barry Laird, Guy Peryer, Carmine Petrasso, Lucy Ziegler, Rowan Harwood","doi":"10.3310/PTHC7598","DOIUrl":"10.3310/PTHC7598","url":null,"abstract":"<p><strong>Background: </strong>Functional loss, the inability to perform necessary or desired tasks, is a common consequence of life-limiting illnesses and associated symptoms (pain, fatigue, breathlessness, etc.) and causes suffering for patients and families. Rehabilitation, a set of interventions designed to address functional loss, is recognised as essential within palliative care, as it can improve quality of life and reduce care costs. However, not everyone has equal access to rehabilitation. Despite limited life expectancy or uncertain ability to benefit from interventions, palliative rehabilitation services are often absent. This is partly due to a lack of high-quality research around optimal models of rehabilitation. Research in this area is methodologically challenging and requires multidisciplinary and cross-speciality collaboration.</p><p><strong>Aim and objectives: </strong>We aimed to establish and grow a United Kingdom research partnership across diverse areas, commencing with partners from Edinburgh, East Anglia, Lancashire, Leeds, London and Nottingham, around the topic area of functional loss and rehabilitation in palliative and end-of-life care. The objectives were to (1) develop a multidisciplinary, cross-speciality research partnership, (2) generate high-priority unanswered research questions with stakeholders, (3) co-design and submit high-quality competitive research proposals, including (4) sharing topic and methodological expertise, and (5) to build capacity and capability to deliver nationally generalisable studies.</p><p><strong>Activities: </strong>The partnership was established with professionals from across England and Scotland with complementary areas of expertise including complex palliative and geriatric research, physiotherapy, nursing, palliative medicine and psychology. Research questions were generated through a modified version of the Child Health and Nutrition Research Initiative, which allowed for the collation and refinement of research questions relating to functional loss and rehabilitation towards the end of life. Partnership members were supported through a series of workshops to transform research ideas into proposals for submission to stage one calls by the National Institute for Health and Care Research. The partnership not only supported students, clinicians and public members with training opportunities but also supported clinicians in securing protected time from clinical duties to allow them to focus on developing local research initiatives.</p><p><strong>Reflections: </strong>Through our partnership we established a network that offered researchers, clinicians, students and public members the chance to develop novel skills and explore opportunities for personal and professional development around the topic area of functional loss and rehabilitation in palliative and end-of-life care. The partnership was crucial to foster collaboration and facilitate exchange of ideas, knowledge and experience","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-12"},"PeriodicalIF":3.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11070894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140854536","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}
Peter J Hutchinson, Ellie Edlmann, John G Hanrahan, Diederik Bulters, Ardalan Zolnourian, Patrick Holton, Nigel Suttner, Kevin Agyemang, Simon Thomson, Ian A Anderson, Yahia Al-Tamimi, Duncan Henderson, Peter Whitfield, Monica Gherle, Paul M Brennan, Annabel Allison, Eric P Thelin, Silvia Tarantino, Beatrice Pantaleo, Karen Caldwell, Carol Davis-Wilkie, Harry Mee, Elizabeth A Warburton, Garry Barton, Aswin Chari, Hani J Marcus, Sarah Pyne, Andrew T King, Antonio Belli, Phyo K Myint, Ian Wilkinson, Thomas Santarius, Carole Turner, Simon Bond, Angelos G Kolias
<p><strong>Background: </strong>Chronic subdural haematoma is a collection of 'old blood' and its breakdown products in the subdural space and predominantly affects older people. Surgical evacuation remains the mainstay in the management of symptomatic cases.</p><p><strong>Objective: </strong>The Dex-CSDH (DEXamethasone in Chronic SubDural Haematoma) randomised trial investigated the clinical effectiveness and cost-effectiveness of dexamethasone in patients with a symptomatic chronic subdural haematoma.</p><p><strong>Design: </strong>This was a parallel, superiority, multicentre, pragmatic, randomised controlled trial. Assigned treatment was administered in a double-blind fashion. Outcome assessors were also blinded to treatment allocation.</p><p><strong>Setting: </strong>Neurosurgical units in the UK.</p><p><strong>Participants: </strong>Eligible participants included adults (aged ≥ 18 years) admitted to a neurosurgical unit with a symptomatic chronic subdural haematoma confirmed on cranial imaging.</p><p><strong>Interventions: </strong>Participants were randomly assigned in a 1 : 1 allocation to a 2-week tapering course of dexamethasone or placebo alongside standard care.</p><p><strong>Main outcome measures: </strong>The primary outcome was the Modified Rankin Scale score at 6 months dichotomised to a favourable (score of 0-3) or an unfavourable (score of 4-6) outcome. Secondary outcomes included the Modified Rankin Scale score at discharge and 3 months; number of chronic subdural haematoma-related surgical interventions undertaken during the index and subsequent admissions; Barthel Index and EuroQol 5-Dimension 5-Level utility index score reported at discharge, 3 months and 6 months; Glasgow Coma Scale score reported at discharge and 6 months; mortality at 30 days and 6 months; length of stay; discharge destination; and adverse events. An economic evaluation was also undertaken, during which the net monetary benefit was estimated at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year.</p><p><strong>Results: </strong>A total of 748 patients were included after randomisation: 375 were assigned to dexamethasone and 373 were assigned to placebo. The mean age of the patients was 74 years and 94% underwent evacuation of their chronic subdural haematoma during the trial period. A total of 680 patients (91%) had 6-month primary outcome data available for analysis: 339 in the placebo arm and 341 in the dexamethasone arm. On a modified intention-to-treat analysis of the full study population, there was an absolute reduction in the proportion of favourable outcomes of 6.4% (95% confidence interval 11.4% to 1.4%; <i>p</i> = 0.01) in the dexamethasone arm compared with the control arm at 6 months. At 3 months, the between-group difference was also in favour of placebo (-8.2%, 95% confidence interval -13.3% to -3.1%). Serious adverse events occurred in 60 out of 375 (16.0%) in the dexamethasone arm and 24 out of 373 (6.4%) in the placeb
{"title":"A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma (Dex-CSDH trial).","authors":"Peter J Hutchinson, Ellie Edlmann, John G Hanrahan, Diederik Bulters, Ardalan Zolnourian, Patrick Holton, Nigel Suttner, Kevin Agyemang, Simon Thomson, Ian A Anderson, Yahia Al-Tamimi, Duncan Henderson, Peter Whitfield, Monica Gherle, Paul M Brennan, Annabel Allison, Eric P Thelin, Silvia Tarantino, Beatrice Pantaleo, Karen Caldwell, Carol Davis-Wilkie, Harry Mee, Elizabeth A Warburton, Garry Barton, Aswin Chari, Hani J Marcus, Sarah Pyne, Andrew T King, Antonio Belli, Phyo K Myint, Ian Wilkinson, Thomas Santarius, Carole Turner, Simon Bond, Angelos G Kolias","doi":"10.3310/XWZN4832","DOIUrl":"10.3310/XWZN4832","url":null,"abstract":"<p><strong>Background: </strong>Chronic subdural haematoma is a collection of 'old blood' and its breakdown products in the subdural space and predominantly affects older people. Surgical evacuation remains the mainstay in the management of symptomatic cases.</p><p><strong>Objective: </strong>The Dex-CSDH (DEXamethasone in Chronic SubDural Haematoma) randomised trial investigated the clinical effectiveness and cost-effectiveness of dexamethasone in patients with a symptomatic chronic subdural haematoma.</p><p><strong>Design: </strong>This was a parallel, superiority, multicentre, pragmatic, randomised controlled trial. Assigned treatment was administered in a double-blind fashion. Outcome assessors were also blinded to treatment allocation.</p><p><strong>Setting: </strong>Neurosurgical units in the UK.</p><p><strong>Participants: </strong>Eligible participants included adults (aged ≥ 18 years) admitted to a neurosurgical unit with a symptomatic chronic subdural haematoma confirmed on cranial imaging.</p><p><strong>Interventions: </strong>Participants were randomly assigned in a 1 : 1 allocation to a 2-week tapering course of dexamethasone or placebo alongside standard care.</p><p><strong>Main outcome measures: </strong>The primary outcome was the Modified Rankin Scale score at 6 months dichotomised to a favourable (score of 0-3) or an unfavourable (score of 4-6) outcome. Secondary outcomes included the Modified Rankin Scale score at discharge and 3 months; number of chronic subdural haematoma-related surgical interventions undertaken during the index and subsequent admissions; Barthel Index and EuroQol 5-Dimension 5-Level utility index score reported at discharge, 3 months and 6 months; Glasgow Coma Scale score reported at discharge and 6 months; mortality at 30 days and 6 months; length of stay; discharge destination; and adverse events. An economic evaluation was also undertaken, during which the net monetary benefit was estimated at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year.</p><p><strong>Results: </strong>A total of 748 patients were included after randomisation: 375 were assigned to dexamethasone and 373 were assigned to placebo. The mean age of the patients was 74 years and 94% underwent evacuation of their chronic subdural haematoma during the trial period. A total of 680 patients (91%) had 6-month primary outcome data available for analysis: 339 in the placebo arm and 341 in the dexamethasone arm. On a modified intention-to-treat analysis of the full study population, there was an absolute reduction in the proportion of favourable outcomes of 6.4% (95% confidence interval 11.4% to 1.4%; <i>p</i> = 0.01) in the dexamethasone arm compared with the control arm at 6 months. At 3 months, the between-group difference was also in favour of placebo (-8.2%, 95% confidence interval -13.3% to -3.1%). Serious adverse events occurred in 60 out of 375 (16.0%) in the dexamethasone arm and 24 out of 373 (6.4%) in the placeb","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 12","pages":"1-122"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174464","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}
Sean Carrie, Tony Fouweather, Tara Homer, James O'Hara, Nikki Rousseau, Leila Rooshenas, Alison Bray, Deborah D Stocken, Laura Ternent, Katherine Rennie, Emma Clark, Nichola Waugh, Alison J Steel, Jemima Dooley, Michael Drinnan, David Hamilton, Kelly Lloyd, Yemi Oluboyede, Caroline Wilson, Quentin Gardiner, Naveed Kara, Sadie Khwaja, Samuel Chee Leong, Sangeeta Maini, Jillian Morrison, Paul Nix, Janet A Wilson, M Dawn Teare
<p><strong>Background: </strong>The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking.</p><p><strong>Objective: </strong>The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum.</p><p><strong>Design: </strong>This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation.</p><p><strong>Setting: </strong>The trial was set in 17 NHS secondary care hospitals in the UK.</p><p><strong>Participants: </strong>A total of 378 eligible participants aged > 18 years were recruited.</p><p><strong>Interventions: </strong>Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery (<i>n</i> = 188) or (2) medical management with intranasal steroid spray and saline spray (<i>n</i> = 190).</p><p><strong>Main outcome measures: </strong>The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes - Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements - peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms.</p><p><strong>Results: </strong>At the 6-month time point, 307 participants provided primary outcome data (septoplasty, <i>n</i> = 152; medical management, <i>n</i> = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were -20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was
{"title":"Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT.","authors":"Sean Carrie, Tony Fouweather, Tara Homer, James O'Hara, Nikki Rousseau, Leila Rooshenas, Alison Bray, Deborah D Stocken, Laura Ternent, Katherine Rennie, Emma Clark, Nichola Waugh, Alison J Steel, Jemima Dooley, Michael Drinnan, David Hamilton, Kelly Lloyd, Yemi Oluboyede, Caroline Wilson, Quentin Gardiner, Naveed Kara, Sadie Khwaja, Samuel Chee Leong, Sangeeta Maini, Jillian Morrison, Paul Nix, Janet A Wilson, M Dawn Teare","doi":"10.3310/MVFR4028","DOIUrl":"10.3310/MVFR4028","url":null,"abstract":"<p><strong>Background: </strong>The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking.</p><p><strong>Objective: </strong>The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum.</p><p><strong>Design: </strong>This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation.</p><p><strong>Setting: </strong>The trial was set in 17 NHS secondary care hospitals in the UK.</p><p><strong>Participants: </strong>A total of 378 eligible participants aged > 18 years were recruited.</p><p><strong>Interventions: </strong>Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery (<i>n</i> = 188) or (2) medical management with intranasal steroid spray and saline spray (<i>n</i> = 190).</p><p><strong>Main outcome measures: </strong>The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes - Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements - peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms.</p><p><strong>Results: </strong>At the 6-month time point, 307 participants provided primary outcome data (septoplasty, <i>n</i> = 152; medical management, <i>n</i> = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were -20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 10","pages":"1-213"},"PeriodicalIF":3.5,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140109862","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}
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
<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
{"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}
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
<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
{"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}
Marie Westwood, Nigel Armstrong, Pawel Posadzki, Caro Noake
<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
{"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}
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
<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
{"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}
Marie Westwood, Bram Ramaekers, Sabine Grimm, Nigel Armstrong, Ben Wijnen, Charlotte Ahmadu, Shelley de Kock, Caro Noake, Manuela Joore
<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
背景：已开发出人工智能衍生软件技术，旨在为疑似中风患者的计算机断层扫描脑部扫描复查提供便利：评估在国民健康服务环境中使用人工智能衍生软件支持对急性中风患者进行计算机断层扫描脑部扫描的临床和成本效益：检索了截至 2021 年 7 月的 25 个数据库。方法：检索了 25 个数据库，截止日期为 2021 年 7 月。结果按研究问题、人工智能衍生软件技术和研究类型进行了总结。健康经济分析的重点是增加人工智能衍生软件对计算机断层扫描血管成像脑部扫描的辅助审查，以指导缺血性中风患者的机械取栓治疗决策。新模型（在 R Shiny 中开发，R 基金会用于统计计算，奥地利维也纳）由决策树（短期）和状态转换模型（长期）组成，用于计算缺血性脑卒中和疑似大血管闭塞患者的平均预期成本和质量调整生命年，并将人工智能衍生的软件辅助复查与常规护理进行比较：共有 22 项研究（30 篇出版物）被纳入综述；18/22 项研究涉及人工智能衍生软件，用于解读计算机断层扫描血管造影以检测大血管闭塞。没有一项研究对本评估纳入标准中规定使用的人工智能衍生软件技术进行评估。仅就人工智能衍生软件技术而言，Rapid (iSchemaView, Menlo Park, CA, USA)计算机断层扫描血管造影检测近端前循环大血管闭塞的灵敏度和特异性估计值分别为 95.4%（95% 置信区间为 92.7% 至 97.1%）和 79.4%（95% 置信区间为 75.8% 至 82.6%），Viz LVO (Viz.ai, Inc., San Fransisco, VA, USA)计算机断层扫描血管造影检测近端前循环大血管闭塞的灵敏度和特异性估计值分别为 91.2%（95% 置信区间为 77.0% 至 97.0%）和 85.0（95% 置信区间为 64.0% 至 94.8%）、Viz LVO（Viz.ai, Inc., San Fransisco, VA, USA）的大血管闭塞率为 83.8%（95% 置信区间为 77.3% 至 88.7%），Brainomix（Brainomix Ltd, Oxford, UK）的电子计算机断层扫描血管造影率为 95.7%（95% 置信区间为 91.0% 至 98.0%）。根据一项研究，Avicenna CINA (Avicenna AI, La Ciotat, France) 的大血管闭塞率分别为 98.1%（95% 置信区间为 94.5% 至 99.3%）和 98.2%（95% 置信区间为 95.5% 至 99.3%）。这些研究被认为不适合作为成本效益建模的依据，但它们构成了人工智能加人类阅读器的准确性的专家意见基础。基于专家意见的概率分析为诊断路径的灵敏度提供了依据，结果表明，增加人工智能检测大血管闭塞可能更有效（质量调整生命年收益为0.003）、更昂贵（成本增加8.61英镑），在支付意愿阈值为每质量调整生命年3380英镑及以上时具有成本效益：现有证据不适合确定使用人工智能衍生软件支持急性卒中计算机断层扫描脑部扫描审查的临床有效性。经济分析没有提供证据表明人工智能衍生软件策略优于当前的临床实践。不过，结果表明，如果增加人工智能衍生软件辅助审查以指导机械取栓治疗决策，可提高诊断路径的敏感性（即降低未发现大血管闭塞的比例），则可认为具有成本效益：今后的工作：需要开展大型、最好是多中心的研究（针对所有人工智能衍生软件技术），以评估这些技术在临床实践中的应用情况：本研究已注册为 PROSPERO CRD42021269609：该奖项由国家健康与护理研究所（NIHR）的证据合成计划（NIHR奖项编号：NIHR133836）资助，全文发表于《健康技术评估》（Health Technology Assessment）第28卷第11期。如需了解更多奖项信息，请参阅 NIHR Funding and Awards 网站。
{"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}
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