Abi J Hall, Friederike Ziegler, Matthew Prescott, Victoria A Goodwin, Claire Hulme, Amanda J Farrin, Ellen Thompson, Anne Forster, Andrew Clegg, David Clarke
<p><strong>Background: </strong>Frailty is an especially significant consequence of ageing with resulting physical decline. Some studies suggest that exercise can reduce the deleterious effects of ageing and have a positive impact on functional ability and quality of life. Further research was required to determine the clinical effectiveness and cost-effectiveness of extended community-based rehabilitation for older people following acute illness or injury. The Home-based Extended Rehabilitation for Older people trial included an embedded process evaluation and compared provision of a home-based graded exercise programme plus usual care (the Home-based Older People's Exercise intervention) versus usual care alone for community-dwelling older people with frailty.</p><p><strong>Methods: </strong>Qualitative mixed-methods process evaluation incorporating non-participant observations, semistructured interviews and analysis of therapy records and participants' exercise diaries. Primary aims of the process evaluation were to explore fidelity and acceptability in intervention delivery. Data analysis was based on thematic analysis and was underpinned by Normalisation Process Theory.</p><p><strong>Results: </strong>Data were generated in 10 community services in England. Non-participant observations of 10 staff training sessions, 61 intervention delivery sessions and 8 staff trial update sessions were completed. Semistructured interviews were conducted with 10 therapy service managers, 19 therapists and 4 therapy assistants. Thirty-five interviews were conducted with intervention participants, with some including supporting carers, and 19 with usual care only participants. There was evidence of fidelity to the intervention protocol, with no significant variation between sites. Less experienced therapists were sometimes less confident in making judgements about what exercises could be adapted and tailored to the individual while maintaining intervention fidelity. Most therapists utilised planned behaviour change techniques to engage participants and sustain their involvement in the exercise programme. Intervention acceptability was generally good, with therapy staff and participants noting potential and actual benefits of the intervention and associated physical improvements for participants completing the 24-week intervention. Usual care only participant interviews provided no evidence of engagement with or perceived benefit from community-based programmes provided by the National Health Service or private providers which were equivalent to the Home-based Older People's Exercise intervention. Therapists and therapy service managers noted the value of the Home-based Older People's Exercise intervention as an addition to existing programmes that were designed to reduce the likelihood of older people with frailty requiring hospital admission. However, they felt that embedding the intervention in routine service provision would prove to be challenging within
{"title":"Process evaluation exploring implementation and delivery of a home-based extended exercise intervention for older people with frailty: the HERO trial.","authors":"Abi J Hall, Friederike Ziegler, Matthew Prescott, Victoria A Goodwin, Claire Hulme, Amanda J Farrin, Ellen Thompson, Anne Forster, Andrew Clegg, David Clarke","doi":"10.3310/GJAC2501","DOIUrl":"10.3310/GJAC2501","url":null,"abstract":"<p><strong>Background: </strong>Frailty is an especially significant consequence of ageing with resulting physical decline. Some studies suggest that exercise can reduce the deleterious effects of ageing and have a positive impact on functional ability and quality of life. Further research was required to determine the clinical effectiveness and cost-effectiveness of extended community-based rehabilitation for older people following acute illness or injury. The Home-based Extended Rehabilitation for Older people trial included an embedded process evaluation and compared provision of a home-based graded exercise programme plus usual care (the Home-based Older People's Exercise intervention) versus usual care alone for community-dwelling older people with frailty.</p><p><strong>Methods: </strong>Qualitative mixed-methods process evaluation incorporating non-participant observations, semistructured interviews and analysis of therapy records and participants' exercise diaries. Primary aims of the process evaluation were to explore fidelity and acceptability in intervention delivery. Data analysis was based on thematic analysis and was underpinned by Normalisation Process Theory.</p><p><strong>Results: </strong>Data were generated in 10 community services in England. Non-participant observations of 10 staff training sessions, 61 intervention delivery sessions and 8 staff trial update sessions were completed. Semistructured interviews were conducted with 10 therapy service managers, 19 therapists and 4 therapy assistants. Thirty-five interviews were conducted with intervention participants, with some including supporting carers, and 19 with usual care only participants. There was evidence of fidelity to the intervention protocol, with no significant variation between sites. Less experienced therapists were sometimes less confident in making judgements about what exercises could be adapted and tailored to the individual while maintaining intervention fidelity. Most therapists utilised planned behaviour change techniques to engage participants and sustain their involvement in the exercise programme. Intervention acceptability was generally good, with therapy staff and participants noting potential and actual benefits of the intervention and associated physical improvements for participants completing the 24-week intervention. Usual care only participant interviews provided no evidence of engagement with or perceived benefit from community-based programmes provided by the National Health Service or private providers which were equivalent to the Home-based Older People's Exercise intervention. Therapists and therapy service managers noted the value of the Home-based Older People's Exercise intervention as an addition to existing programmes that were designed to reduce the likelihood of older people with frailty requiring hospital admission. However, they felt that embedding the intervention in routine service provision would prove to be challenging within ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-26"},"PeriodicalIF":4.0,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12720193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742496","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}
Abril Seyahian, Martin Taylor-Rowan, Clareece Nevill, Ryan Mulholland, Campbell Roxburgh, Susan Brunskill, Nicola Cooper, Anna Noel-Storr, Alex J Sutton, Olivia Wu, Terry J Quinn
<p><strong>Background: </strong>United Kingdom blood shortages necessitate better prediction of surgical blood requirement. We sought to assess the predictive accuracy of tools designed to identify those patients requiring blood transfusion within the perioperative period.</p><p><strong>Methods: </strong>We searched the Cochrane library, EMBASE, MEDLINE, ClinicalTrials.gov and WHO trials portal, 2000-July 2023. We included studies that developed and/or validated prediction tools for blood requirement during the early perioperative period (48 hours). Risk of bias was evaluated using the Prediction model Risk Of Bias Assessment Tool. We pooled area under receiver operating curve and calibration data via random effects meta-analysis. We evaluated certainty of evidence of any estimates using the Grading of Recommendations Assessment, Development and Evaluation framework. We used meta-regression to describe associations between included variables/tool characteristics with tool accuracy.</p><p><strong>Results: </strong>We included 50 papers, describing 67 unique prediction tools. Most tools were at high risk of bias, with limited external validation. Discrimination (area under receiver operating curve) of prognostic models ranged from 0.49 to 0.96. Only two surgery-specific tools, the McClusky Index (liver transplant surgery) and Papworth Bleeding Risk Score (cardiothoracic surgery), had sufficient data to enable pooling of discrimination measures. The McClusky Index's pooled area under receiver operating curve: 0.74 (95% CI 0.61 to 0.84) and Bleeding Risk Score's area under receiver operating curve: 0.68 (95% CI 0.49 to 0.82) were both rated 'very low' certainty by Grading of Recommendations Assessment, Development and Evaluation. Pooling calibration data was not possible for any prediction tools. Meta-regression suggested that fewer included variables, longer time from surgery and independent validation studies were all associated with lower accuracy.</p><p><strong>Limitations: </strong>There were insufficient studies to assess overall tool performance via meta-analysis in other surgical subgroups beyond cardiothoracic surgery and liver transplant. Our study population is also predominantly made up of elective surgeries which may make our results less generalisable to emergency settings.</p><p><strong>Future work: </strong>Implementation and cost-effectiveness studies are needed to evaluate how promising tools could be applied to clinical practice and the economic impact such tools could have upon the service.</p><p><strong>Conclusions: </strong>Despite the availability of multiple potential tools, available data suggest none are currently suitable for predicting blood transfusion in surgical practice. Our summary of the data comes with caveats around the quality of the included papers and the limited number of tools with more than one reported external validation.</p><p><strong>Funding: </strong>This article presents independent research funded by t
背景：英国血液短缺需要更好地预测手术用血需求。我们试图评估用于识别围手术期需要输血的患者的工具的预测准确性。方法：检索Cochrane图书馆、EMBASE、MEDLINE、ClinicalTrials.gov和WHO试验门户网站，检索时间为2000- 2023年7月。我们纳入了开发和/或验证围手术期早期（48小时）血液需求预测工具的研究。使用预测模型偏倚风险评估工具评估偏倚风险。我们通过随机效应荟萃分析合并了受试者工作曲线下的面积和校准数据。我们使用建议分级评估、发展和评估框架评估任何估计证据的确定性。我们使用元回归来描述包含变量/工具特征与工具精度之间的关联。结果：我们纳入了50篇论文，描述了67种独特的预测工具。大多数工具存在高偏倚风险，外部验证有限。预后模型的鉴别（受试者工作曲线下面积）范围为0.49 ~ 0.96。只有麦克卢斯基指数（McClusky Index，肝移植手术）和帕普沃斯出血风险评分（Papworth Bleeding Risk Score，心胸外科手术）这两种手术专用工具有足够的数据来汇集区分措施。麦克拉斯基指数在受者操作曲线下的合并面积：0.74 （95% CI 0.61至0.84）和出血风险评分在受者操作曲线下的合并面积：0.68 （95% CI 0.49至0.82）均被推荐评估、发展和评估分级评为“非常低”确定性。任何预测工具都不可能汇集校准数据。meta回归表明，纳入变量较少、手术时间较长和独立验证研究均与较低的准确性相关。局限性：没有足够的研究通过荟萃分析来评估除心胸外科和肝移植以外的其他手术亚组的总体工具性能。我们的研究人群也主要由选择性手术组成，这可能使我们的结果不太适用于急诊情况。未来工作：需要进行实施和成本效益研究，以评估有希望的工具如何应用于临床实践以及这些工具对服务的经济影响。结论：尽管有多种潜在的工具可用，但现有数据表明，目前没有一种工具适合预测外科手术中的输血。我们的数据总结附带了关于所纳入论文质量的警告，以及具有多个外部验证报告的有限数量的工具。资助：本文介绍了由国家卫生与保健研究所（NIHR）卫生技术评估计划资助的独立研究，奖励号为NIHR159933。
{"title":"Risk assessment tools for predicting transfusion in surgery: a systematic review and meta-analysis.","authors":"Abril Seyahian, Martin Taylor-Rowan, Clareece Nevill, Ryan Mulholland, Campbell Roxburgh, Susan Brunskill, Nicola Cooper, Anna Noel-Storr, Alex J Sutton, Olivia Wu, Terry J Quinn","doi":"10.3310/GJAS1620","DOIUrl":"10.3310/GJAS1620","url":null,"abstract":"<p><strong>Background: </strong>United Kingdom blood shortages necessitate better prediction of surgical blood requirement. We sought to assess the predictive accuracy of tools designed to identify those patients requiring blood transfusion within the perioperative period.</p><p><strong>Methods: </strong>We searched the Cochrane library, EMBASE, MEDLINE, ClinicalTrials.gov and WHO trials portal, 2000-July 2023. We included studies that developed and/or validated prediction tools for blood requirement during the early perioperative period (48 hours). Risk of bias was evaluated using the Prediction model Risk Of Bias Assessment Tool. We pooled area under receiver operating curve and calibration data via random effects meta-analysis. We evaluated certainty of evidence of any estimates using the Grading of Recommendations Assessment, Development and Evaluation framework. We used meta-regression to describe associations between included variables/tool characteristics with tool accuracy.</p><p><strong>Results: </strong>We included 50 papers, describing 67 unique prediction tools. Most tools were at high risk of bias, with limited external validation. Discrimination (area under receiver operating curve) of prognostic models ranged from 0.49 to 0.96. Only two surgery-specific tools, the McClusky Index (liver transplant surgery) and Papworth Bleeding Risk Score (cardiothoracic surgery), had sufficient data to enable pooling of discrimination measures. The McClusky Index's pooled area under receiver operating curve: 0.74 (95% CI 0.61 to 0.84) and Bleeding Risk Score's area under receiver operating curve: 0.68 (95% CI 0.49 to 0.82) were both rated 'very low' certainty by Grading of Recommendations Assessment, Development and Evaluation. Pooling calibration data was not possible for any prediction tools. Meta-regression suggested that fewer included variables, longer time from surgery and independent validation studies were all associated with lower accuracy.</p><p><strong>Limitations: </strong>There were insufficient studies to assess overall tool performance via meta-analysis in other surgical subgroups beyond cardiothoracic surgery and liver transplant. Our study population is also predominantly made up of elective surgeries which may make our results less generalisable to emergency settings.</p><p><strong>Future work: </strong>Implementation and cost-effectiveness studies are needed to evaluate how promising tools could be applied to clinical practice and the economic impact such tools could have upon the service.</p><p><strong>Conclusions: </strong>Despite the availability of multiple potential tools, available data suggest none are currently suitable for predicting blood transfusion in surgical practice. Our summary of the data comes with caveats around the quality of the included papers and the limited number of tools with more than one reported external validation.</p><p><strong>Funding: </strong>This article presents independent research funded by t","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-38"},"PeriodicalIF":4.0,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145687386","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}
Nishant Jaiswal, Rebecca Gregg, Neil Hawkins, Sahar Sharif-Hurst, Alison Avenell, Louisa Ells, Sandra Jayacodi, Ruth Mackenzie, Sharon Anne Simpson, Olivia Wu, Jennifer Logue
<p><strong>Background: </strong>Behavioural weight management interventions are the primary treatment for obesity in the United Kingdom. These interventions focus on diet, physical activity and behaviour change, and are typically delivered over a period of 12 weeks. Although National Institute for Health and Care Excellence guidance makes recommendations on the content of behavioural weight management interventions, there are substantial variations in practice. As a result, what constitutes the most effective composition of behavioural weight management interventions is unclear.</p><p><strong>Objective: </strong>To determine the effectiveness of different types of behavioural weight management interventions in achieving weight loss, using individual participant data from randomised controlled trials and real-world services.</p><p><strong>Design: </strong>A network meta-analysis of individual participant data.</p><p><strong>Setting: </strong>Behavioural weight management interventions delivered in the community.</p><p><strong>Participants: </strong>Anonymous individual participant data of adults (> 18 years), living in the United Kingdom and attending behavioural weight management interventions in the real world (<i>n</i> = 76,201) and randomised controlled trial's (<i>n</i> = 4051).</p><p><strong>Main outcome measure: </strong>Mean change in weight at 12 weeks.</p><p><strong>Methods: </strong>Two-staged Bayesian network meta-analysis of individual participant data from included randomised controlled trials and real-world services was performed. Risk of bias was assessed for randomised controlled trials using Cochrane Risk of Bias 2.0. Prior to analysis, received data were checked, for consistency with the requests and cleaned for all anomalies.</p><p><strong>Results: </strong>All behavioural weight management interventions resulted in weight loss compared to usual care. In the randomised controlled trials, the 52-week weightloss programme referrals for adults in primary care (WRAP) with participants attending intervention achieved the greatest weight reduction at 12 weeks (mean difference = -2.58 kg, 95% credible interval -3.19 to -1.96). However, when a male-only intervention (football fans in training) was included in a sensitivity analysis, it demonstrated the largest short-term weight loss (mean difference = -4.65 kg, credible interval -5.24 to -4.07). In the real-world services, several programmes achieved substantial weight loss, with greater programme attendance associated with improved outcomes.</p><p><strong>Conclusions: </strong>The behavioural weight management intervention in both real-world services and randomised controlled trials are effective for weight loss, but there is a variation in the weight loss achieved at the end of active weight loss period depending upon the structure of intervention and participant engagement.</p><p><strong>Future work: </strong>Dismantling the interventions into component parts will help determine whi
{"title":"Behavioural weight management interventions for the treatment of obesity: network meta-analysis of trial and real-world individual participant data.","authors":"Nishant Jaiswal, Rebecca Gregg, Neil Hawkins, Sahar Sharif-Hurst, Alison Avenell, Louisa Ells, Sandra Jayacodi, Ruth Mackenzie, Sharon Anne Simpson, Olivia Wu, Jennifer Logue","doi":"10.3310/GJJL0404","DOIUrl":"10.3310/GJJL0404","url":null,"abstract":"<p><strong>Background: </strong>Behavioural weight management interventions are the primary treatment for obesity in the United Kingdom. These interventions focus on diet, physical activity and behaviour change, and are typically delivered over a period of 12 weeks. Although National Institute for Health and Care Excellence guidance makes recommendations on the content of behavioural weight management interventions, there are substantial variations in practice. As a result, what constitutes the most effective composition of behavioural weight management interventions is unclear.</p><p><strong>Objective: </strong>To determine the effectiveness of different types of behavioural weight management interventions in achieving weight loss, using individual participant data from randomised controlled trials and real-world services.</p><p><strong>Design: </strong>A network meta-analysis of individual participant data.</p><p><strong>Setting: </strong>Behavioural weight management interventions delivered in the community.</p><p><strong>Participants: </strong>Anonymous individual participant data of adults (> 18 years), living in the United Kingdom and attending behavioural weight management interventions in the real world (<i>n</i> = 76,201) and randomised controlled trial's (<i>n</i> = 4051).</p><p><strong>Main outcome measure: </strong>Mean change in weight at 12 weeks.</p><p><strong>Methods: </strong>Two-staged Bayesian network meta-analysis of individual participant data from included randomised controlled trials and real-world services was performed. Risk of bias was assessed for randomised controlled trials using Cochrane Risk of Bias 2.0. Prior to analysis, received data were checked, for consistency with the requests and cleaned for all anomalies.</p><p><strong>Results: </strong>All behavioural weight management interventions resulted in weight loss compared to usual care. In the randomised controlled trials, the 52-week weightloss programme referrals for adults in primary care (WRAP) with participants attending intervention achieved the greatest weight reduction at 12 weeks (mean difference = -2.58 kg, 95% credible interval -3.19 to -1.96). However, when a male-only intervention (football fans in training) was included in a sensitivity analysis, it demonstrated the largest short-term weight loss (mean difference = -4.65 kg, credible interval -5.24 to -4.07). In the real-world services, several programmes achieved substantial weight loss, with greater programme attendance associated with improved outcomes.</p><p><strong>Conclusions: </strong>The behavioural weight management intervention in both real-world services and randomised controlled trials are effective for weight loss, but there is a variation in the weight loss achieved at the end of active weight loss period depending upon the structure of intervention and participant engagement.</p><p><strong>Future work: </strong>Dismantling the interventions into component parts will help determine whi","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-42"},"PeriodicalIF":4.0,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145687327","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}
Nishant Jaiswal, Rebecca Gregg, Neil Hawkins, Sahar Sharif-Hurst, Alison Avenell, Louisa Ells, Sandra Jayacodi, Ruth Mackenzie, Sharon Anne Simpson, Olivia Wu, Jennifer Logue
<p><strong>Background: </strong>Behavioural weight management interventions are complex interventions having several coexisting components designed to facilitate weight loss. Existing evidence has shown behavioural weight management interventions to be effective; however, the magnitude of weight loss varies among programmes. There is value in understanding whether differences in the intervention components influence the overall effectiveness of the interventions. The current study is the first attempt to explore the effects of individual components of interventions using data from both randomised controlled trials and real-world services based in the United Kingdom.</p><p><strong>Objective: </strong>To deconstruct behavioural weight management interventions into constituent components and identify the effectiveness of individual components for weight loss.</p><p><strong>Design: </strong>A component network meta-analysis of data from randomised controlled trials and real-world services.</p><p><strong>Setting: </strong>Real-world services and randomised controlled trials based in the United Kingdom for weight management in adults.</p><p><strong>Participants: </strong>Adults over 18 years of age, living in the United Kingdom and attending behavioural weight management interventions in the real world (<i>n</i> = 76,201) or participating in randomised controlled trials (<i>n</i> = 4051).</p><p><strong>Main outcome measure: </strong>Mean change in weight after 12 weeks of active weight loss sessions.</p><p><strong>Methods: </strong>Bayesian two-staged component network meta-analysis using an additive model.</p><p><strong>Results: </strong>In the analysis of randomised controlled trials, significant weight loss was associated with components tailoring (mean difference -5.54 kg; 95% credible interval -7.72 to -3.35), flexibility in attendance (mean difference -3.18 kg; 95% credible interval -4.29 to -2.07) and multimodal referral (mean difference -2.57 kg; 95% credible interval -4.89 to -0.25). In real-world services, the components associated with significant weight loss included multimodal referral (mean difference -2.01, 95% credible interval -2.13 to -1.88), personalised dietary advice (mean difference -1.22, 95% credible interval -1.33 to -1.11), flexibility (mean difference -0.41, 95% credible interval -0.47 to -0.35) and in-person delivery (mean difference -0.45, 95% credible interval -0.52 to -0.38). However, co-design (mean difference 3.46 kg; 95% credible interval 2.12 to 4.82) in randomised controlled trials, and added extras (mean difference 0.99 kg; 95% credible interval 0.88 to 1.10) and tailoring (mean difference 0.33 kg; 95% credible interval 0.27 to 0.40) in real-world services, were not shown to be effective in short-term weight loss.</p><p><strong>Conclusions: </strong>The findings from this study highlight the importance of understanding the impact of intervention components such as accessibility, flexibility, tailoring and dietary ad
{"title":"Dismantling behavioural weight management interventions: component network meta-analysis of randomised controlled trials and real-world services.","authors":"Nishant Jaiswal, Rebecca Gregg, Neil Hawkins, Sahar Sharif-Hurst, Alison Avenell, Louisa Ells, Sandra Jayacodi, Ruth Mackenzie, Sharon Anne Simpson, Olivia Wu, Jennifer Logue","doi":"10.3310/GJJL0630","DOIUrl":"10.3310/GJJL0630","url":null,"abstract":"<p><strong>Background: </strong>Behavioural weight management interventions are complex interventions having several coexisting components designed to facilitate weight loss. Existing evidence has shown behavioural weight management interventions to be effective; however, the magnitude of weight loss varies among programmes. There is value in understanding whether differences in the intervention components influence the overall effectiveness of the interventions. The current study is the first attempt to explore the effects of individual components of interventions using data from both randomised controlled trials and real-world services based in the United Kingdom.</p><p><strong>Objective: </strong>To deconstruct behavioural weight management interventions into constituent components and identify the effectiveness of individual components for weight loss.</p><p><strong>Design: </strong>A component network meta-analysis of data from randomised controlled trials and real-world services.</p><p><strong>Setting: </strong>Real-world services and randomised controlled trials based in the United Kingdom for weight management in adults.</p><p><strong>Participants: </strong>Adults over 18 years of age, living in the United Kingdom and attending behavioural weight management interventions in the real world (<i>n</i> = 76,201) or participating in randomised controlled trials (<i>n</i> = 4051).</p><p><strong>Main outcome measure: </strong>Mean change in weight after 12 weeks of active weight loss sessions.</p><p><strong>Methods: </strong>Bayesian two-staged component network meta-analysis using an additive model.</p><p><strong>Results: </strong>In the analysis of randomised controlled trials, significant weight loss was associated with components tailoring (mean difference -5.54 kg; 95% credible interval -7.72 to -3.35), flexibility in attendance (mean difference -3.18 kg; 95% credible interval -4.29 to -2.07) and multimodal referral (mean difference -2.57 kg; 95% credible interval -4.89 to -0.25). In real-world services, the components associated with significant weight loss included multimodal referral (mean difference -2.01, 95% credible interval -2.13 to -1.88), personalised dietary advice (mean difference -1.22, 95% credible interval -1.33 to -1.11), flexibility (mean difference -0.41, 95% credible interval -0.47 to -0.35) and in-person delivery (mean difference -0.45, 95% credible interval -0.52 to -0.38). However, co-design (mean difference 3.46 kg; 95% credible interval 2.12 to 4.82) in randomised controlled trials, and added extras (mean difference 0.99 kg; 95% credible interval 0.88 to 1.10) and tailoring (mean difference 0.33 kg; 95% credible interval 0.27 to 0.40) in real-world services, were not shown to be effective in short-term weight loss.</p><p><strong>Conclusions: </strong>The findings from this study highlight the importance of understanding the impact of intervention components such as accessibility, flexibility, tailoring and dietary ad","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-27"},"PeriodicalIF":4.0,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145687322","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}
Evangelos Danopoulos, Nigel Armstrong, Kevin McDermott, Jiongyu Chen, Xiaoyu Tian, Caro Noake, Marie Westwood
<p><strong>Background: </strong>Smallness for gestational age has been associated with an increased risk of neonatal/fetal adverse outcomes. The Healthcare Safety Investigation Branch has issued a safety recommendation aimed at improving fetal growth monitoring strategies and reducing risk for babies.</p><p><strong>Objectives: </strong>The objective was to summarise available evidence to inform the Healthcare Safety Investigation Branch recommendation. The review comprised four research questions on: effects of fetal growth monitoring on neonatal/parental outcomes; effects of implementing fetal growth monitoring guidelines on neonatal/parental outcomes; accuracy of fetal growth monitoring strategies for predicting smallness for gestational age neonates/fetal growth restriction and factors affecting the accuracy of fetal growth monitoring strategies.</p><p><strong>Methods: </strong>Nineteen databases were searched from 2000 to March 2023 and were updated September 2023. Pregnant people with and without risk factors were included. Each review question had further eligibility criteria. For accuracy results, summary estimates of the sensitivity and specificity with 95% confidence intervals for the prediction of smallness for gestational age at delivery were calculated. Random-effects models were used for the meta-analysis of clinical outcomes. Further outcomes, including the results of risk of bias assessments, were summarised narratively.</p><p><strong>Results: </strong>Fifty-eight studies (78 publications) were included in the review. Q1 - Antenatal identification of smallness for gestational age pregnancies was associated with increased rates of intervention (two retrospective cohort studies, <i>n</i> = 100, 198 and 2928), but the available evidence did not support an effect on stillbirths or neonatal outcomes. Q2 - Meta-analysis (three observational studies and one randomised controlled trial, <i>n</i> = 318,523) indicated that implementation of the Growth Assessment Protocol was associated with a reduction in the risk of stillbirth and risk ratio of 0.79 (95% confidence interval 0.74 to 0.84). Meta-analyses (one observational study and one randomised controlled trial, <i>n</i> = 11,978) indicated that Growth Assessment Protocol implementation was associated with a reduction in the risk of 5-minute Apgar score < 7, risk ratio of 0.78 (95% confidence interval 0.64 to 0.95); however, the effect estimate for neonatal intensive care unit admission was highly uncertain, 0.59 (95% confidence interval 0.02 to 20.03). Q3 (53 studies) and Q4 (15 studies) - regarding accuracy, the highest sensitivity for both general and high-risk populations was achieved using a combination of estimated fetal weight and abdominal circumference tests, where the threshold was defined as either parameter < 10th percentile. No clear trends were observed for the type of reference charts, either for the use of general versus local reference charts (either the estimated fetal we
{"title":"Accuracy and clinical effectiveness of fetal growth monitoring strategies for the prediction of small for gestational age at birth: a systematic review and meta-analysis.","authors":"Evangelos Danopoulos, Nigel Armstrong, Kevin McDermott, Jiongyu Chen, Xiaoyu Tian, Caro Noake, Marie Westwood","doi":"10.3310/AJLK7403","DOIUrl":"10.3310/AJLK7403","url":null,"abstract":"<p><strong>Background: </strong>Smallness for gestational age has been associated with an increased risk of neonatal/fetal adverse outcomes. The Healthcare Safety Investigation Branch has issued a safety recommendation aimed at improving fetal growth monitoring strategies and reducing risk for babies.</p><p><strong>Objectives: </strong>The objective was to summarise available evidence to inform the Healthcare Safety Investigation Branch recommendation. The review comprised four research questions on: effects of fetal growth monitoring on neonatal/parental outcomes; effects of implementing fetal growth monitoring guidelines on neonatal/parental outcomes; accuracy of fetal growth monitoring strategies for predicting smallness for gestational age neonates/fetal growth restriction and factors affecting the accuracy of fetal growth monitoring strategies.</p><p><strong>Methods: </strong>Nineteen databases were searched from 2000 to March 2023 and were updated September 2023. Pregnant people with and without risk factors were included. Each review question had further eligibility criteria. For accuracy results, summary estimates of the sensitivity and specificity with 95% confidence intervals for the prediction of smallness for gestational age at delivery were calculated. Random-effects models were used for the meta-analysis of clinical outcomes. Further outcomes, including the results of risk of bias assessments, were summarised narratively.</p><p><strong>Results: </strong>Fifty-eight studies (78 publications) were included in the review. Q1 - Antenatal identification of smallness for gestational age pregnancies was associated with increased rates of intervention (two retrospective cohort studies, <i>n</i> = 100, 198 and 2928), but the available evidence did not support an effect on stillbirths or neonatal outcomes. Q2 - Meta-analysis (three observational studies and one randomised controlled trial, <i>n</i> = 318,523) indicated that implementation of the Growth Assessment Protocol was associated with a reduction in the risk of stillbirth and risk ratio of 0.79 (95% confidence interval 0.74 to 0.84). Meta-analyses (one observational study and one randomised controlled trial, <i>n</i> = 11,978) indicated that Growth Assessment Protocol implementation was associated with a reduction in the risk of 5-minute Apgar score < 7, risk ratio of 0.78 (95% confidence interval 0.64 to 0.95); however, the effect estimate for neonatal intensive care unit admission was highly uncertain, 0.59 (95% confidence interval 0.02 to 20.03). Q3 (53 studies) and Q4 (15 studies) - regarding accuracy, the highest sensitivity for both general and high-risk populations was achieved using a combination of estimated fetal weight and abdominal circumference tests, where the threshold was defined as either parameter < 10th percentile. No clear trends were observed for the type of reference charts, either for the use of general versus local reference charts (either the estimated fetal we","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 62","pages":"1-216"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700675","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 McCulloch, April Shaw, Gail Gilchrist, Catriona Matheson, Margaret Maxwell, Joanne Neale, Gareth Myring, Hugh McLeod, Matt Hickman, Peter Vickerman, Alison Munro, Steve MacGillivray
<p><strong>Background: </strong>The barriers and facilitators to engagement with Opiate Substitute Treatment and Needle and Syringe Provision need to be better understood to develop interventions to attract people into services.</p><p><strong>Objective(s): </strong>We conducted a multi-method realist evaluation to generate an in-depth theory of the factors that influence the optimal provision of services in terms of access, engagement, retention and successful exit.</p><p><strong>Design: </strong>Multi-method involving an online survey of United Kingdom drug and alcohol service commissioning leads and a meta-synthesis of qualitative literature (phase 1) to facilitate the development of an initial theory of optimal provision; and, in phase 2, a realist evaluation to test and refine the initial theory, involving in-depth interviews across three United Kingdom sites, with service commissioners, managers, staff and service users. We used routine treatment and staffing data to estimate the additional staff costs of implementing optimal service provision within one context of our refined theory.</p><p><strong>Results: </strong>Findings indicated that optimal provision could be understood with reference to five main contexts [(1) agency and empowerment, (2) self-esteem and respect, (3) knowledge and communication, (4) goals, needs and preferences and (5) resources and demands]. The analysis suggested that optimal provision could be facilitated via specific mechanisms of action, operating at the 'Systems level' (policy, legislation and funding) and 'Service level' (delivery of services, service pathways, staff roles and responsibilities and organisational culture). Our analysis also identified the potential importance of independent 'mediating mechanisms' (e.g. confidence, trust and self-efficacy) which can operate to increase the likelihood of successful service outcomes. A costing analysis estimated the costs associated with a smaller caseload for shared care workers and the implementation of a salary increment scheme at one of the study sites.</p><p><strong>Limitations: </strong>The survey sample size limited generalisability. There was a limited number of United Kingdom studies within the meta-synthesis. The findings of the realist evaluation highlight that provision was not optimised in the observed sites, limiting examples of best practice. However, the conceptual theory of optimal provision can direct future research to facilitate the development and implementation of optimal policy and practice.</p><p><strong>Conclusions: </strong>We have provided a rich understanding of the contexts, mechanisms and actions by which optimal delivery of Opiate Substitute Treatment and Needle and Syringe Provision services may increase the likelihood of successful service provision. A multiagency approach applying various mechanisms within the various contexts of optimal provision may need to be implemented to optimise the provision.</p><p><strong>Future work: </st
{"title":"Optimal provision of opiate substitution therapy and needle and syringe programmes: a multi-method realist evaluation.","authors":"Peter McCulloch, April Shaw, Gail Gilchrist, Catriona Matheson, Margaret Maxwell, Joanne Neale, Gareth Myring, Hugh McLeod, Matt Hickman, Peter Vickerman, Alison Munro, Steve MacGillivray","doi":"10.3310/HGDS4449","DOIUrl":"10.3310/HGDS4449","url":null,"abstract":"<p><strong>Background: </strong>The barriers and facilitators to engagement with Opiate Substitute Treatment and Needle and Syringe Provision need to be better understood to develop interventions to attract people into services.</p><p><strong>Objective(s): </strong>We conducted a multi-method realist evaluation to generate an in-depth theory of the factors that influence the optimal provision of services in terms of access, engagement, retention and successful exit.</p><p><strong>Design: </strong>Multi-method involving an online survey of United Kingdom drug and alcohol service commissioning leads and a meta-synthesis of qualitative literature (phase 1) to facilitate the development of an initial theory of optimal provision; and, in phase 2, a realist evaluation to test and refine the initial theory, involving in-depth interviews across three United Kingdom sites, with service commissioners, managers, staff and service users. We used routine treatment and staffing data to estimate the additional staff costs of implementing optimal service provision within one context of our refined theory.</p><p><strong>Results: </strong>Findings indicated that optimal provision could be understood with reference to five main contexts [(1) agency and empowerment, (2) self-esteem and respect, (3) knowledge and communication, (4) goals, needs and preferences and (5) resources and demands]. The analysis suggested that optimal provision could be facilitated via specific mechanisms of action, operating at the 'Systems level' (policy, legislation and funding) and 'Service level' (delivery of services, service pathways, staff roles and responsibilities and organisational culture). Our analysis also identified the potential importance of independent 'mediating mechanisms' (e.g. confidence, trust and self-efficacy) which can operate to increase the likelihood of successful service outcomes. A costing analysis estimated the costs associated with a smaller caseload for shared care workers and the implementation of a salary increment scheme at one of the study sites.</p><p><strong>Limitations: </strong>The survey sample size limited generalisability. There was a limited number of United Kingdom studies within the meta-synthesis. The findings of the realist evaluation highlight that provision was not optimised in the observed sites, limiting examples of best practice. However, the conceptual theory of optimal provision can direct future research to facilitate the development and implementation of optimal policy and practice.</p><p><strong>Conclusions: </strong>We have provided a rich understanding of the contexts, mechanisms and actions by which optimal delivery of Opiate Substitute Treatment and Needle and Syringe Provision services may increase the likelihood of successful service provision. A multiagency approach applying various mechanisms within the various contexts of optimal provision may need to be implemented to optimise the provision.</p><p><strong>Future work: </st","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 64","pages":"1-118"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700690","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}
Karoline Freeman, Jacqueline Dinnes, Bethany Shinkins, Corinna Clark, Inès Kander, Katie Scandrett, Shivashri Chockalingam, Aziza Osman, Naila Dracup, Rachel Court, Furqan Butt, Cristina Visintin, James R Bonham, David Elliman, Graham Shortland, Anne Mackie, Zosia Miedzybrodzka, Sian M Morgan, Felicity Boardman, Yemisi Takwoingi, Sian Taylor-Phillips
<p><strong>Background: </strong>Newborn screening using whole genome sequencing is being evaluated in numerous projects across the world, including Genomics England Limited's Generation Study. It presents considerable challenges for policy advisors, not least, given the logistics of simultaneously evaluating the evidence for the suggested 200 rare genetic conditions. The 'genotype-first' approach has the potential for harms through overdiagnosis, and benefits are uncertain.</p><p><strong>Objective: </strong>To assess different approaches to evaluating whole genome sequencing for newborn screening to inform the development of a robust method of evaluation for informing policy decisions.</p><p><strong>Methods: </strong>We approached the objective with systematic review methods for a sample of five conditions (considering gene penetrance, expressivity, accuracy and effectiveness of whole genome sequencing and effect of earlier treatment) (search inception to November 2023), evaluated the National Institutes of Health [US] Clinical Genome Resource (ClinGen) as an alternative evidence source for the five conditions and we compared this to a review of genomic studies of newborn screening cohorts reporting penetrance for pathogenic variants of any paediatric condition (search inception to February 2024). We undertook a methodological review of economic evaluations of whole genome sequencing/whole exome sequencing (search inception to January 2024) and explored public views on evaluating whole genome sequencing.</p><p><strong>Data sources: </strong>MEDLINE (Ovid), EMBASE (Ovid), Web of Science, Science Citation Index (via Clarivate), the Cochrane Library (via Wiley), cost-effectiveness analysis registry and American Economic Association electronic bibliography. Actionability reports and scores from the Clinical Genome Resource website (downloaded 30 April 2024).</p><p><strong>Results: </strong>The traditional review approach identified 268 studies reporting the genetic spectrum of individuals with the five conditions or benefits of earlier, symptomatic treatment. No evidence on the penetrance and expressivity or the accuracy or effectiveness of whole genome sequencing in newborns was identified. A review of 200 conditions would take a team of five reviewers 23 years to complete. Clinical Genome Resource reviews were available for four or five conditions. All four 'actionability' ratings disagreed with the findings of our reviews. Our review of 14 genomic studies of newborn screening cohorts found insufficient information to allow individual highly penetrant pathogenic variants for any condition to be identified. None of the 86 economic evaluations of whole genome sequencing or whole exome sequencing were set in a screening context. Some micro-costing studies are available that could help understand the resource use and costs associated with whole genome sequencing. Following a series of patient and public involvement meetings, attendees appreciated the u
背景：使用全基因组测序的新生儿筛查正在世界各地的许多项目中进行评估，包括Genomics England Limited的Generation Study。这给政策顾问带来了相当大的挑战，尤其是考虑到同时评估所建议的200种罕见遗传条件的证据的后勤工作。“基因型优先”的方法有可能因过度诊断而造成危害，其益处也不确定。目的：评估评估新生儿筛查全基因组测序的不同方法，为制定可靠的评估方法提供信息，为政策决策提供信息。方法:我们采用系统评价方法对五个条件（考虑基因外显率、表达性、全基因组测序的准确性和有效性以及早期治疗的效果）的样本进行了研究（搜索开始至2023年11月）。评估了美国国立卫生研究院临床基因组资源（ClinGen）作为这五种疾病的替代证据来源，我们将其与新生儿筛查队列的基因组研究综述进行了比较，这些研究报告了任何儿科疾病致病变异的外显率（搜索开始至2024年2月）。我们对全基因组测序/全外显子组测序的经济评估进行了方法学回顾（检索开始至2024年1月），并探讨了公众对全基因组测序评估的看法。数据来源：MEDLINE （Ovid）、EMBASE （Ovid）、Web of Science、Science Citation Index（通过Clarivate）、Cochrane Library（通过Wiley）、cost-effectiveness analysis registry和American Economic Association电子书目。可操作性报告和评分来自临床基因组资源网站（下载于2024年4月30日）。结果：传统的回顾方法确定了268项研究，报告了具有五种疾病或早期对症治疗益处的个体的遗传谱。没有证据表明新生儿全基因组测序的外显率和表达性或准确性或有效性。对200项条件的审查将需要由5名审查人员组成的小组23年才能完成。临床基因组资源综述可用于四或五种情况。所有四个“可操作性”评级都与我们的审查结果不一致。我们回顾了14项新生儿筛查队列的基因组研究，发现信息不足，无法确定任何疾病的个体高渗透致病变异。86项全基因组测序或全外显子组测序的经济评估中没有一项是在筛选背景下进行的。一些微观成本研究可以帮助了解与全基因组测序相关的资源使用和成本。在一系列患者和公众参与会议之后，与会者认识到全基因组测序的不确定性。需要更广泛的利益相关者视角来为政策决策提供信息。局限性：虽然我们只深入研究了五种情况，但缺乏数据的一致性表明我们的结论是稳健的。结论：评价新生儿全基因组测序的系统评价方法缺乏高质量的证据。将审查扩展到所有200种情况是不可行的。目前，利用现有基因组资源和回顾新生儿筛查队列的基因组研究并不是可行的替代方法。全基因组测序在新生儿筛查中的成本效益尚不清楚。未来工作：需要大规模的合作研究来评估全基因组测序筛查新生儿的短期和长期危害、益处和经济意义。我们提出了一种分阶段的评估方法，只考虑具有高外显率的致病变异的条件，以尽量减少过度诊断的危害。研究注册：本研究注册号为PROSPERO CRD42023475529。资助：该奖项由美国国家卫生与保健研究所（NIHR）证据综合计划（NIHR奖励编号：NIHR159928）资助，全文发表在《卫生技术评估》上；第29卷，第65期。有关进一步的奖励信息，请参阅美国国立卫生研究院资助和奖励网站。
{"title":"Evaluating whole genome sequencing for rare diseases in newborn screening: evidence synthesis from a series of systematic reviews.","authors":"Karoline Freeman, Jacqueline Dinnes, Bethany Shinkins, Corinna Clark, Inès Kander, Katie Scandrett, Shivashri Chockalingam, Aziza Osman, Naila Dracup, Rachel Court, Furqan Butt, Cristina Visintin, James R Bonham, David Elliman, Graham Shortland, Anne Mackie, Zosia Miedzybrodzka, Sian M Morgan, Felicity Boardman, Yemisi Takwoingi, Sian Taylor-Phillips","doi":"10.3310/DJRF1124","DOIUrl":"10.3310/DJRF1124","url":null,"abstract":"<p><strong>Background: </strong>Newborn screening using whole genome sequencing is being evaluated in numerous projects across the world, including Genomics England Limited's Generation Study. It presents considerable challenges for policy advisors, not least, given the logistics of simultaneously evaluating the evidence for the suggested 200 rare genetic conditions. The 'genotype-first' approach has the potential for harms through overdiagnosis, and benefits are uncertain.</p><p><strong>Objective: </strong>To assess different approaches to evaluating whole genome sequencing for newborn screening to inform the development of a robust method of evaluation for informing policy decisions.</p><p><strong>Methods: </strong>We approached the objective with systematic review methods for a sample of five conditions (considering gene penetrance, expressivity, accuracy and effectiveness of whole genome sequencing and effect of earlier treatment) (search inception to November 2023), evaluated the National Institutes of Health [US] Clinical Genome Resource (ClinGen) as an alternative evidence source for the five conditions and we compared this to a review of genomic studies of newborn screening cohorts reporting penetrance for pathogenic variants of any paediatric condition (search inception to February 2024). We undertook a methodological review of economic evaluations of whole genome sequencing/whole exome sequencing (search inception to January 2024) and explored public views on evaluating whole genome sequencing.</p><p><strong>Data sources: </strong>MEDLINE (Ovid), EMBASE (Ovid), Web of Science, Science Citation Index (via Clarivate), the Cochrane Library (via Wiley), cost-effectiveness analysis registry and American Economic Association electronic bibliography. Actionability reports and scores from the Clinical Genome Resource website (downloaded 30 April 2024).</p><p><strong>Results: </strong>The traditional review approach identified 268 studies reporting the genetic spectrum of individuals with the five conditions or benefits of earlier, symptomatic treatment. No evidence on the penetrance and expressivity or the accuracy or effectiveness of whole genome sequencing in newborns was identified. A review of 200 conditions would take a team of five reviewers 23 years to complete. Clinical Genome Resource reviews were available for four or five conditions. All four 'actionability' ratings disagreed with the findings of our reviews. Our review of 14 genomic studies of newborn screening cohorts found insufficient information to allow individual highly penetrant pathogenic variants for any condition to be identified. None of the 86 economic evaluations of whole genome sequencing or whole exome sequencing were set in a screening context. Some micro-costing studies are available that could help understand the resource use and costs associated with whole genome sequencing. Following a series of patient and public involvement meetings, attendees appreciated the u","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 65","pages":"1-172"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700740","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}
Nefyn H Williams, Monica Busse, Rachael Cooper, Jacob Davies, Susanna Dodd, Shanaz Dorkenoo, Kodchawan Doungsong, Rhiannon Tudor Edwards, Victory Ezeofor, Miriam Golding-Day, Jessica Green, Ben Hardwick, Kathryn Harvey, Sophie Hennessy, Andrew B Lemmey, Phillipa Logan, Val Morrison, Penelope Ralph, Catherine Sackley, Ben Smith, Toby O Smith, Llinos H Spencer, Suzanne Temple
<p><strong>Background: </strong>Proximal femoral (hip) fracture is common, serious and costly. An enhanced community rehabilitation intervention (Fracture in the Elderly Multidisciplinary Rehabilitation) was codeveloped with patients, carers and therapists. Trial methods have been tested previously in a feasibility study.</p><p><strong>Objective: </strong>To determine the effectiveness and cost-effectiveness of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention compared with usual NHS rehabilitation care. To determine the mechanisms and processes that explain the implementation and impacts of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention.</p><p><strong>Design and methods: </strong>Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1 : 1 allocation ratio. Concurrent economic and process evaluations.</p><p><strong>Setting: </strong>Participant recruitment in 13 hospitals across England and Wales, with the Fracture in the Elderly Multidisciplinary Rehabilitation intervention delivered in the community.</p><p><strong>Participants: </strong>Patients aged over 60 years, with mental capacity, recovering from surgical treatment for proximal femoral fracture, and living in their own home prior to fracture.</p><p><strong>Interventions: </strong>Usual rehabilitation care (control) was compared with usual rehabilitation care plus the Fracture in the Elderly Multidisciplinary Rehabilitation intervention, which comprised a patient-held workbook and goal-setting diary aimed at improving self-efficacy, and six additional therapy sessions delivered in the community (intervention), to increase the practice of exercise and activities of daily living.</p><p><strong>Primary and secondary outcome measures: </strong>Primary effectiveness outcome was the Nottingham Extended Activities of Daily Living scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy - International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Economic outcomes were EuroQol EQ-5D-3L and Client Service Receipt Inventory.</p><p><strong>Results: </strong>In total, 205 participants were randomised (<i>n</i> = 104 experimental; <i>n</i> = 101 control). Trial processes were adversely affected by the coronavirus disease discovered in 2019 pandemic and the target sample of 446 was not met. By 52 weeks, the intervention group had worse Nottingham Extended Activities of Daily Living scores than the control group (mean difference: -1.9; 95% confidence interval: -3.7 to -0.1), which was not clinically important. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values, removed the apparent inferiority of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention with a mean difference of 0.1 (95% confidence interval: -1.1 to 1.3). There was no st
{"title":"A community-based rehabilitation package following hip fracture: FEMuR III a multi-centre RCT, economic and process evaluation.","authors":"Nefyn H Williams, Monica Busse, Rachael Cooper, Jacob Davies, Susanna Dodd, Shanaz Dorkenoo, Kodchawan Doungsong, Rhiannon Tudor Edwards, Victory Ezeofor, Miriam Golding-Day, Jessica Green, Ben Hardwick, Kathryn Harvey, Sophie Hennessy, Andrew B Lemmey, Phillipa Logan, Val Morrison, Penelope Ralph, Catherine Sackley, Ben Smith, Toby O Smith, Llinos H Spencer, Suzanne Temple","doi":"10.3310/RBGD4741","DOIUrl":"10.3310/RBGD4741","url":null,"abstract":"<p><strong>Background: </strong>Proximal femoral (hip) fracture is common, serious and costly. An enhanced community rehabilitation intervention (Fracture in the Elderly Multidisciplinary Rehabilitation) was codeveloped with patients, carers and therapists. Trial methods have been tested previously in a feasibility study.</p><p><strong>Objective: </strong>To determine the effectiveness and cost-effectiveness of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention compared with usual NHS rehabilitation care. To determine the mechanisms and processes that explain the implementation and impacts of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention.</p><p><strong>Design and methods: </strong>Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1 : 1 allocation ratio. Concurrent economic and process evaluations.</p><p><strong>Setting: </strong>Participant recruitment in 13 hospitals across England and Wales, with the Fracture in the Elderly Multidisciplinary Rehabilitation intervention delivered in the community.</p><p><strong>Participants: </strong>Patients aged over 60 years, with mental capacity, recovering from surgical treatment for proximal femoral fracture, and living in their own home prior to fracture.</p><p><strong>Interventions: </strong>Usual rehabilitation care (control) was compared with usual rehabilitation care plus the Fracture in the Elderly Multidisciplinary Rehabilitation intervention, which comprised a patient-held workbook and goal-setting diary aimed at improving self-efficacy, and six additional therapy sessions delivered in the community (intervention), to increase the practice of exercise and activities of daily living.</p><p><strong>Primary and secondary outcome measures: </strong>Primary effectiveness outcome was the Nottingham Extended Activities of Daily Living scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy - International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Economic outcomes were EuroQol EQ-5D-3L and Client Service Receipt Inventory.</p><p><strong>Results: </strong>In total, 205 participants were randomised (<i>n</i> = 104 experimental; <i>n</i> = 101 control). Trial processes were adversely affected by the coronavirus disease discovered in 2019 pandemic and the target sample of 446 was not met. By 52 weeks, the intervention group had worse Nottingham Extended Activities of Daily Living scores than the control group (mean difference: -1.9; 95% confidence interval: -3.7 to -0.1), which was not clinically important. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values, removed the apparent inferiority of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention with a mean difference of 0.1 (95% confidence interval: -1.1 to 1.3). There was no st","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 67","pages":"1-29"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12746194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804272","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}
Anitta Sharma, Rima Hussain, Annastazia E Learoyd, Angela Aristidou, Taha Soomro, Ann Blandford, John G Lawrenson, Gabriela Grimaldi, Abdel Douiri, Ashleigh Kernohan, Tomos Robinson, Najmeh Moradi, Christiana Dinah, Evangelos Minos, Dawn Sim, Tariq Aslam, Avinash Manna, Alastair K Denniston, Praveen J Patel, Pearse A Keane, Catey Bunce, Luke Vale, Konstantinos Balaskas
<p><strong>Background: </strong>Community-based optometrists, a major provider of primary eye care in the United Kingdom, are the main source of referrals to hospital eye services. The widespread introduction of optical coherence tomography devices in community practices provides community-based optometrists with an opportunity to identify a broader range of treatable diseases. Standard referral pathways do not effectively filter unnecessary referrals, with misclassification of urgency, and erroneous diagnoses.</p><p><strong>Objectives: </strong>To assess the effectiveness of a teleophthalmology referral pathway between community-based optometrists and hospital eye services for retinal diseases. To measure the accuracy of an artificial intelligence decision support system for diagnosis and referral management of retinal disease.</p><p><strong>Design: </strong>A multicentre, superiority cluster randomised controlled trial to assess the effectiveness of a teleophthalmology referral pathway. A prospective, observational diagnostic accuracy study to measure the performance of artificial intelligence decision support system. A comprehensive economic evaluation was conducted.</p><p><strong>Settings: </strong>United Kingdom-based community optometry practices with an optical coherence tomography device and hospital eye services.</p><p><strong>Participants: </strong>Adults requiring referral for retinal disease at the opinion of the community-based optometrists.</p><p><strong>Interventions: </strong>Community optometry practices were randomised 1 : 1 to standard care or teleophthalmology. Referrals sent via the teleophthalmology platform were remotely reviewed by human experts based at the corresponding hospital eye services. A referral decision was provided within 48 hours. Suitable optical coherence tomography scans were solely processed by artificial intelligence decision support system (the 'Octane' model).</p><p><strong>Main outcome measures: </strong>Cluster randomised controlled trial's primary outcome was the proportion of false-positive referrals (not required or not urgent) per arm in overall participants and in referred-only participants against an independent reference standard. Secondary outcomes included the proportion of wrong diagnosis, wrong referral urgency, false-negative referrals, safely triaged referrals for rare diseases, time from referral to consultation and treatment and cost-effectiveness of teleophthalmology. Primary outcome for the artificial intelligence study was the sensitivity and specificity of artificial intelligence referral decisions against the reference standard.</p><p><strong>Results: </strong>Teleophthalmology significantly reduces the proportion of false-positive urgent referrals by 59% compared to standard care in referred participants. Due to the observed low event rate for false positive referrals, teleophthalmology's role for reducing false positives overall was inconclusive. No significant difference between
{"title":"Tele-ophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease: HERMES cluster randomised trial with a diagnostic accuracy study.","authors":"Anitta Sharma, Rima Hussain, Annastazia E Learoyd, Angela Aristidou, Taha Soomro, Ann Blandford, John G Lawrenson, Gabriela Grimaldi, Abdel Douiri, Ashleigh Kernohan, Tomos Robinson, Najmeh Moradi, Christiana Dinah, Evangelos Minos, Dawn Sim, Tariq Aslam, Avinash Manna, Alastair K Denniston, Praveen J Patel, Pearse A Keane, Catey Bunce, Luke Vale, Konstantinos Balaskas","doi":"10.3310/QNDF3325","DOIUrl":"10.3310/QNDF3325","url":null,"abstract":"<p><strong>Background: </strong>Community-based optometrists, a major provider of primary eye care in the United Kingdom, are the main source of referrals to hospital eye services. The widespread introduction of optical coherence tomography devices in community practices provides community-based optometrists with an opportunity to identify a broader range of treatable diseases. Standard referral pathways do not effectively filter unnecessary referrals, with misclassification of urgency, and erroneous diagnoses.</p><p><strong>Objectives: </strong>To assess the effectiveness of a teleophthalmology referral pathway between community-based optometrists and hospital eye services for retinal diseases. To measure the accuracy of an artificial intelligence decision support system for diagnosis and referral management of retinal disease.</p><p><strong>Design: </strong>A multicentre, superiority cluster randomised controlled trial to assess the effectiveness of a teleophthalmology referral pathway. A prospective, observational diagnostic accuracy study to measure the performance of artificial intelligence decision support system. A comprehensive economic evaluation was conducted.</p><p><strong>Settings: </strong>United Kingdom-based community optometry practices with an optical coherence tomography device and hospital eye services.</p><p><strong>Participants: </strong>Adults requiring referral for retinal disease at the opinion of the community-based optometrists.</p><p><strong>Interventions: </strong>Community optometry practices were randomised 1 : 1 to standard care or teleophthalmology. Referrals sent via the teleophthalmology platform were remotely reviewed by human experts based at the corresponding hospital eye services. A referral decision was provided within 48 hours. Suitable optical coherence tomography scans were solely processed by artificial intelligence decision support system (the 'Octane' model).</p><p><strong>Main outcome measures: </strong>Cluster randomised controlled trial's primary outcome was the proportion of false-positive referrals (not required or not urgent) per arm in overall participants and in referred-only participants against an independent reference standard. Secondary outcomes included the proportion of wrong diagnosis, wrong referral urgency, false-negative referrals, safely triaged referrals for rare diseases, time from referral to consultation and treatment and cost-effectiveness of teleophthalmology. Primary outcome for the artificial intelligence study was the sensitivity and specificity of artificial intelligence referral decisions against the reference standard.</p><p><strong>Results: </strong>Teleophthalmology significantly reduces the proportion of false-positive urgent referrals by 59% compared to standard care in referred participants. Due to the observed low event rate for false positive referrals, teleophthalmology's role for reducing false positives overall was inconclusive. No significant difference between","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 69","pages":"1-113"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12746195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804255","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}
Esther Albon, Nafsika Afentou, Janine Dretzke, James Hall, Chidubem Okeke Ogwulu, Malcolm J Price, Ken Clare, Rishi Singhal, Abd Tahrani, Emma Frew, David J Moore
<p><strong>Background: </strong>Bariatric surgery is the most effective treatment for obesity, but access is limited. Endoscopic obesity treatments are potentially cheaper and less invasive options, which may be similarly effective. There is currently a lack of evidence to inform decisions on whether such treatments should be considered for people living with obesity.</p><p><strong>Objective(s): </strong>What is the current evidence for the clinical and cost-effectiveness of endoscopic treatments compared to alternative weight management interventions for obesity?</p><p><strong>Methods: </strong>Comprehensive searches were undertaken to January 2023 and a searchable evidence map of all quantitative studies (<i>n</i> > 2) on endoscopic treatments was constructed. The map was used where possible to inform the economic models. Indirect comparisons were undertaken where relevant direct evidence for the model was not available. A systematic review of cost-effectiveness studies was undertaken. Targeted searches were undertaken to identify additional evidence to inform model parameters. Three economic (Markov) models were designed to estimate the cost-effectiveness of endoscopic therapies compared to alternative weight management interventions from a United Kingdom National Health Service and Personal Social Services perspective.</p><p><strong>Results: </strong>The evidence map included over 1500 records of studies of endoscopic therapies, most of which related to intragastric balloons and endoscopic sleeve gastrectomy. Three cost-utility analyses were identified, one of which was set in the United Kingdom and was used to inform the models. Laparoscopic sleeve gastrectomy is likely cost-effective compared with endoscopic sleeve gastroplasty for patients' obesity class II and III (£10,593 per quality-adjusted life-year-gained). Endoscopic sleeve gastroplasty is likely cost-effective compared with semaglutide for patients' obesity class I and II (£7267 per quality-adjusted life-year-gained). Semaglutide is dominant (cheaper and more effective) than intragastric balloon in patients' obesity class I and II. Probabilistic sensitivity analysis found a degree of confidence in the estimates. The 5-year time horizon may not capture longer-term benefits from endoscopic sleeve gastroplasty or laparoscopic sleeve gastrectomy.</p><p><strong>Limitations and conclusions: </strong>The effectiveness evidence base was greater and more wide-ranging than anticipated. However, for the interventions compared within the economic models, there were no randomised controlled trials and either limited, or an absence of, direct comparative evidence. There was also limited long-term data on interventions. These limitations necessitated the use of assumptions in modelling.</p><p><strong>Future work: </strong>Future research should focus on longer-term effectiveness of endoscopic treatments, studies directly comparing endoscopic therapies against semaglutide or other emerging weight
{"title":"Cost-effectiveness of endoscopic treatments for obesity: a clinical evidence map and systematic review to inform a model-based cost-effectiveness analysis.","authors":"Esther Albon, Nafsika Afentou, Janine Dretzke, James Hall, Chidubem Okeke Ogwulu, Malcolm J Price, Ken Clare, Rishi Singhal, Abd Tahrani, Emma Frew, David J Moore","doi":"10.3310/PWKQ2310","DOIUrl":"10.3310/PWKQ2310","url":null,"abstract":"<p><strong>Background: </strong>Bariatric surgery is the most effective treatment for obesity, but access is limited. Endoscopic obesity treatments are potentially cheaper and less invasive options, which may be similarly effective. There is currently a lack of evidence to inform decisions on whether such treatments should be considered for people living with obesity.</p><p><strong>Objective(s): </strong>What is the current evidence for the clinical and cost-effectiveness of endoscopic treatments compared to alternative weight management interventions for obesity?</p><p><strong>Methods: </strong>Comprehensive searches were undertaken to January 2023 and a searchable evidence map of all quantitative studies (<i>n</i> > 2) on endoscopic treatments was constructed. The map was used where possible to inform the economic models. Indirect comparisons were undertaken where relevant direct evidence for the model was not available. A systematic review of cost-effectiveness studies was undertaken. Targeted searches were undertaken to identify additional evidence to inform model parameters. Three economic (Markov) models were designed to estimate the cost-effectiveness of endoscopic therapies compared to alternative weight management interventions from a United Kingdom National Health Service and Personal Social Services perspective.</p><p><strong>Results: </strong>The evidence map included over 1500 records of studies of endoscopic therapies, most of which related to intragastric balloons and endoscopic sleeve gastrectomy. Three cost-utility analyses were identified, one of which was set in the United Kingdom and was used to inform the models. Laparoscopic sleeve gastrectomy is likely cost-effective compared with endoscopic sleeve gastroplasty for patients' obesity class II and III (£10,593 per quality-adjusted life-year-gained). Endoscopic sleeve gastroplasty is likely cost-effective compared with semaglutide for patients' obesity class I and II (£7267 per quality-adjusted life-year-gained). Semaglutide is dominant (cheaper and more effective) than intragastric balloon in patients' obesity class I and II. Probabilistic sensitivity analysis found a degree of confidence in the estimates. The 5-year time horizon may not capture longer-term benefits from endoscopic sleeve gastroplasty or laparoscopic sleeve gastrectomy.</p><p><strong>Limitations and conclusions: </strong>The effectiveness evidence base was greater and more wide-ranging than anticipated. However, for the interventions compared within the economic models, there were no randomised controlled trials and either limited, or an absence of, direct comparative evidence. There was also limited long-term data on interventions. These limitations necessitated the use of assumptions in modelling.</p><p><strong>Future work: </strong>Future research should focus on longer-term effectiveness of endoscopic treatments, studies directly comparing endoscopic therapies against semaglutide or other emerging weight ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 68","pages":"1-196"},"PeriodicalIF":4.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12746199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804318","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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