Nicholas James, Sarah Pirrie, Wenyu Liu, James Catto, Kieran Jefferson, Prashant Patel, Ana Hughes, Ann Pope, Veronica Nanton, Harriet P Mintz, Allen Knight, Jean Gallagher, Richard T Bryan
<p><strong>Background: </strong>Transurethral resection of bladder tumour has been the mainstay of bladder cancer staging for > 60 years. Staging inaccuracies are commonplace, leading to delayed treatment of muscle-invasive bladder cancer. Multiparametric magnetic resonance imaging offers rapid, accurate and non-invasive staging of muscle-invasive bladder cancer, potentially reducing delays to radical treatment.</p><p><strong>Objectives: </strong>To assess the feasibility and efficacy of the introducing multiparametric magnetic resonance imaging ahead of transurethral resection of bladder tumour in the staging of suspected muscle-invasive bladder cancer.</p><p><strong>Design: </strong>Open-label, multistage randomised controlled study in three parts: feasibility, intermediate and final clinical stages. The COVID pandemic prevented completion of the final stage.</p><p><strong>Setting: </strong>Fifteen UK hospitals.</p><p><strong>Participants: </strong>Newly diagnosed bladder cancer patients of age ≥ 18 years.</p><p><strong>Interventions: </strong>Participants were randomised to Pathway 1 or 2 following visual assessment of the suspicion of non-muscle-invasive bladder cancer or muscle-invasive bladder cancer at the time of outpatient cystoscopy, based upon a 5-point Likert scale: Likert 1-2 tumours considered probable non-muscle-invasive bladder cancer; Likert 3-5 possible muscle-invasive bladder cancer. In Pathway 1, all participants underwent transurethral resection of bladder tumour. In Pathway 2, probable non-muscle-invasive bladder cancer participants underwent transurethral resection of bladder tumour, and possible muscle-invasive bladder cancer participants underwent initial multiparametric magnetic resonance imaging. Subsequent therapy was determined by the treating team and could include transurethral resection of bladder tumour.</p><p><strong>Main outcome measures: </strong>Feasibility stage: proportion with possible muscle-invasive bladder cancer randomised to Pathway 2 which correctly followed the protocol. Intermediate stage: time to correct treatment for muscle-invasive bladder cancer.</p><p><strong>Results: </strong>Between 31 May 2018 and 31 December 2021, of 638 patients approached, 143 participants were randomised; 52.1% were deemed as possible muscle-invasive bladder cancer and 47.9% probable non-muscle-invasive bladder cancer. Feasibility stage: 36/39 [92% (95% confidence interval 79 to 98%)] muscle-invasive bladder cancer participants followed the correct treatment by pathway. Intermediate stage: median time to correct treatment was 98 (95% confidence interval 72 to 125) days for Pathway 1 versus 53 (95% confidence interval 20 to 89) days for Pathway 2 [hazard ratio 2.9 (95% confidence interval 1.0 to 8.1)], <i>p</i> = 0.040. Median time to correct treatment for all participants was 37 days for Pathway 1 and 25 days for Pathway 2 [hazard ratio 1.4 (95% confidence interval 0.9 to 2.0)].</p><p><strong>Limitations: </strong>For pa
{"title":"Image directed redesign of bladder cancer treatment pathways: the BladderPath RCT.","authors":"Nicholas James, Sarah Pirrie, Wenyu Liu, James Catto, Kieran Jefferson, Prashant Patel, Ana Hughes, Ann Pope, Veronica Nanton, Harriet P Mintz, Allen Knight, Jean Gallagher, Richard T Bryan","doi":"10.3310/DEHT5407","DOIUrl":"10.3310/DEHT5407","url":null,"abstract":"<p><strong>Background: </strong>Transurethral resection of bladder tumour has been the mainstay of bladder cancer staging for > 60 years. Staging inaccuracies are commonplace, leading to delayed treatment of muscle-invasive bladder cancer. Multiparametric magnetic resonance imaging offers rapid, accurate and non-invasive staging of muscle-invasive bladder cancer, potentially reducing delays to radical treatment.</p><p><strong>Objectives: </strong>To assess the feasibility and efficacy of the introducing multiparametric magnetic resonance imaging ahead of transurethral resection of bladder tumour in the staging of suspected muscle-invasive bladder cancer.</p><p><strong>Design: </strong>Open-label, multistage randomised controlled study in three parts: feasibility, intermediate and final clinical stages. The COVID pandemic prevented completion of the final stage.</p><p><strong>Setting: </strong>Fifteen UK hospitals.</p><p><strong>Participants: </strong>Newly diagnosed bladder cancer patients of age ≥ 18 years.</p><p><strong>Interventions: </strong>Participants were randomised to Pathway 1 or 2 following visual assessment of the suspicion of non-muscle-invasive bladder cancer or muscle-invasive bladder cancer at the time of outpatient cystoscopy, based upon a 5-point Likert scale: Likert 1-2 tumours considered probable non-muscle-invasive bladder cancer; Likert 3-5 possible muscle-invasive bladder cancer. In Pathway 1, all participants underwent transurethral resection of bladder tumour. In Pathway 2, probable non-muscle-invasive bladder cancer participants underwent transurethral resection of bladder tumour, and possible muscle-invasive bladder cancer participants underwent initial multiparametric magnetic resonance imaging. Subsequent therapy was determined by the treating team and could include transurethral resection of bladder tumour.</p><p><strong>Main outcome measures: </strong>Feasibility stage: proportion with possible muscle-invasive bladder cancer randomised to Pathway 2 which correctly followed the protocol. Intermediate stage: time to correct treatment for muscle-invasive bladder cancer.</p><p><strong>Results: </strong>Between 31 May 2018 and 31 December 2021, of 638 patients approached, 143 participants were randomised; 52.1% were deemed as possible muscle-invasive bladder cancer and 47.9% probable non-muscle-invasive bladder cancer. Feasibility stage: 36/39 [92% (95% confidence interval 79 to 98%)] muscle-invasive bladder cancer participants followed the correct treatment by pathway. Intermediate stage: median time to correct treatment was 98 (95% confidence interval 72 to 125) days for Pathway 1 versus 53 (95% confidence interval 20 to 89) days for Pathway 2 [hazard ratio 2.9 (95% confidence interval 1.0 to 8.1)], <i>p</i> = 0.040. Median time to correct treatment for all participants was 37 days for Pathway 1 and 25 days for Pathway 2 [hazard ratio 1.4 (95% confidence interval 0.9 to 2.0)].</p><p><strong>Limitations: </strong>For pa","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 42","pages":"1-65"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403381/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153873","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}
Thomas Frederick Crocker, Natalie Lam, Joie Ensor, Magda Jordão, Ram Bajpai, Matthew Bond, Anne Forster, Richard D Riley, Deirdre Andre, Caroline Brundle, Alison Ellwood, John Green, Matthew Hale, Jessica Morgan, Eleftheria Patetsini, Matthew Prescott, Ridha Ramiz, Oliver Todd, Rebecca Walford, John Gladman, Andrew Clegg
<p><strong>Background: </strong>Sustaining independence is important for older people, but there is insufficient guidance about which community health and care services to implement.</p><p><strong>Objectives: </strong>To synthesise evidence of the effectiveness of community services to sustain independence for older people grouped according to their intervention components, and to examine if frailty moderates the effect.</p><p><strong>Review design: </strong>Systematic review and network meta-analysis.</p><p><strong>Eligibility criteria: </strong>Studies: Randomised controlled trials or cluster-randomised controlled trials. Participants: Older people (mean age 65+) living at home. Interventions: community-based complex interventions for sustaining independence. Comparators: usual care, placebo or another complex intervention.</p><p><strong>Main outcomes: </strong>Living at home, instrumental activities of daily living, personal activities of daily living, care-home placement and service/economic outcomes at 1 year.</p><p><strong>Data sources: </strong>We searched MEDLINE (1946-), Embase (1947-), CINAHL (1972-), PsycINFO (1806-), CENTRAL and trial registries from inception to August 2021, without restrictions, and scanned reference lists.</p><p><strong>Review methods: </strong>Interventions were coded, summarised and grouped. Study populations were classified by frailty. A random-effects network meta-analysis was used. We assessed trial-result risk of bias (Cochrane RoB 2), network meta-analysis inconsistency and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation for network meta-analysis).</p><p><strong>Results: </strong>We included 129 studies (74,946 participants). Nineteen intervention components, including 'multifactorial-action' (multidomain assessment and management/individualised care planning), were identified in 63 combinations. The following results were of low certainty unless otherwise stated. For living at home, compared to no intervention/placebo, evidence favoured: multifactorial-action and review with medication-review (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty) multifactorial-action with medication-review (odds ratio 2.55, 95% confidence interval 0.61 to 10.60) cognitive training, medication-review, nutrition and exercise (odds ratio 1.93, 95% confidence interval 0.79 to 4.77) and activities of daily living training, nutrition and exercise (odds ratio 1.79, 95% confidence interval 0.67 to 4.76). Four intervention combinations may reduce living at home. For instrumental activities of daily living, evidence favoured multifactorial-action and review with medication-review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living. For personal activities of daily living, evidence favoured exercise, multifactorial-action and review with medication-review and sel
{"title":"Community-based complex interventions to sustain independence in older people, stratified by frailty: a systematic review and network meta-analysis.","authors":"Thomas Frederick Crocker, Natalie Lam, Joie Ensor, Magda Jordão, Ram Bajpai, Matthew Bond, Anne Forster, Richard D Riley, Deirdre Andre, Caroline Brundle, Alison Ellwood, John Green, Matthew Hale, Jessica Morgan, Eleftheria Patetsini, Matthew Prescott, Ridha Ramiz, Oliver Todd, Rebecca Walford, John Gladman, Andrew Clegg","doi":"10.3310/HNRP2514","DOIUrl":"10.3310/HNRP2514","url":null,"abstract":"<p><strong>Background: </strong>Sustaining independence is important for older people, but there is insufficient guidance about which community health and care services to implement.</p><p><strong>Objectives: </strong>To synthesise evidence of the effectiveness of community services to sustain independence for older people grouped according to their intervention components, and to examine if frailty moderates the effect.</p><p><strong>Review design: </strong>Systematic review and network meta-analysis.</p><p><strong>Eligibility criteria: </strong>Studies: Randomised controlled trials or cluster-randomised controlled trials. Participants: Older people (mean age 65+) living at home. Interventions: community-based complex interventions for sustaining independence. Comparators: usual care, placebo or another complex intervention.</p><p><strong>Main outcomes: </strong>Living at home, instrumental activities of daily living, personal activities of daily living, care-home placement and service/economic outcomes at 1 year.</p><p><strong>Data sources: </strong>We searched MEDLINE (1946-), Embase (1947-), CINAHL (1972-), PsycINFO (1806-), CENTRAL and trial registries from inception to August 2021, without restrictions, and scanned reference lists.</p><p><strong>Review methods: </strong>Interventions were coded, summarised and grouped. Study populations were classified by frailty. A random-effects network meta-analysis was used. We assessed trial-result risk of bias (Cochrane RoB 2), network meta-analysis inconsistency and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation for network meta-analysis).</p><p><strong>Results: </strong>We included 129 studies (74,946 participants). Nineteen intervention components, including 'multifactorial-action' (multidomain assessment and management/individualised care planning), were identified in 63 combinations. The following results were of low certainty unless otherwise stated. For living at home, compared to no intervention/placebo, evidence favoured: multifactorial-action and review with medication-review (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty) multifactorial-action with medication-review (odds ratio 2.55, 95% confidence interval 0.61 to 10.60) cognitive training, medication-review, nutrition and exercise (odds ratio 1.93, 95% confidence interval 0.79 to 4.77) and activities of daily living training, nutrition and exercise (odds ratio 1.79, 95% confidence interval 0.67 to 4.76). Four intervention combinations may reduce living at home. For instrumental activities of daily living, evidence favoured multifactorial-action and review with medication-review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living. For personal activities of daily living, evidence favoured exercise, multifactorial-action and review with medication-review and sel","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 48","pages":"1-194"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403382/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285842","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}
John Allotey, Lucinda Archer, Dyuti Coomar, Kym Ie Snell, Melanie Smuk, Lucy Oakey, Sadia Haqnawaz, Ana Pilar Betrán, Lucy C Chappell, Wessel Ganzevoort, Sanne Gordijn, Asma Khalil, Ben W Mol, Rachel K Morris, Jenny Myers, Aris T Papageorghiou, Basky Thilaganathan, Fabricio Da Silva Costa, Fabio Facchinetti, Arri Coomarasamy, Akihide Ohkuchi, Anne Eskild, Javier Arenas Ramírez, Alberto Galindo, Ignacio Herraiz, Federico Prefumo, Shigeru Saito, Line Sletner, Jose Guilherme Cecatti, Rinat Gabbay-Benziv, Francois Goffinet, Ahmet A Baschat, Renato T Souza, Fionnuala Mone, Diane Farrar, Seppo Heinonen, Kjell Å Salvesen, Luc Jm Smits, Sohinee Bhattacharya, Chie Nagata, Satoru Takeda, Marleen Mhj van Gelder, Dewi Anggraini, SeonAe Yeo, Jane West, Javier Zamora, Hema Mistry, Richard D Riley, Shakila Thangaratinam
<p><strong>Background: </strong>Fetal growth restriction is associated with perinatal morbidity and mortality. Early identification of women having at-risk fetuses can reduce perinatal adverse outcomes.</p><p><strong>Objectives: </strong>To assess the predictive performance of existing models predicting fetal growth restriction and birthweight, and if needed, to develop and validate new multivariable models using individual participant data.</p><p><strong>Design: </strong>Individual participant data meta-analyses of cohorts in International Prediction of Pregnancy Complications network, decision curve analysis and health economics analysis.</p><p><strong>Participants: </strong>Pregnant women at booking. External validation of existing models (9 cohorts, 441,415 pregnancies); International Prediction of Pregnancy Complications model development and validation (4 cohorts, 237,228 pregnancies).</p><p><strong>Predictors: </strong>Maternal clinical characteristics, biochemical and ultrasound markers.</p><p><strong>Primary outcomes: </strong>fetal growth restriction defined as birthweight <10th centile adjusted for gestational age and with stillbirth, neonatal death or delivery before 32 weeks' gestation birthweight.</p><p><strong>Analysis: </strong>First, we externally validated existing models using individual participant data meta-analysis. If needed, we developed and validated new International Prediction of Pregnancy Complications models using random-intercept regression models with backward elimination for variable selection and undertook internal-external cross-validation. We estimated the study-specific performance (<i>c</i>-statistic, calibration slope, calibration-in-the-large) for each model and pooled using random-effects meta-analysis. Heterogeneity was quantified using τ<sup>2</sup> and 95% prediction intervals. We assessed the clinical utility of the fetal growth restriction model using decision curve analysis, and health economics analysis based on National Institute for Health and Care Excellence 2008 model.</p><p><strong>Results: </strong>Of the 119 published models, one birthweight model (Poon) could be validated. None reported fetal growth restriction using our definition. Across all cohorts, the Poon model had good summary calibration slope of 0.93 (95% confidence interval 0.90 to 0.96) with slight overfitting, and underpredicted birthweight by 90.4 g on average (95% confidence interval 37.9 g to 142.9 g). The newly developed International Prediction of Pregnancy Complications-fetal growth restriction model included maternal age, height, parity, smoking status, ethnicity, and any history of hypertension, pre-eclampsia, previous stillbirth or small for gestational age baby and gestational age at delivery. This allowed predictions conditional on a range of assumed gestational ages at delivery. The pooled apparent <i>c</i>-statistic and calibration were 0.96 (95% confidence interval 0.51 to 1.0), and 0.95 (95% confidence interval 0.67
背景：胎儿生长受限与围产期发病率和死亡率有关。早期识别高危胎儿的妇女可减少围产期不良结局：评估现有胎儿生长受限和出生体重预测模型的预测性能，并在必要时利用个体参与者数据开发和验证新的多变量模型：设计：对国际妊娠并发症预测网络中的队列进行个体参与者数据荟萃分析、决策曲线分析和健康经济学分析：预约时的孕妇。现有模型的外部验证（9 个队列，441 415 例妊娠）；国际妊娠并发症预测模型的开发和验证（4 个队列，237 228 例妊娠）：主要结果：胎儿生长受限，定义为出生体重 分析：首先，我们利用个体参与者数据荟萃分析对现有模型进行外部验证。如有必要，我们使用随机截距回归模型和反向排除法选择变量，开发并验证了新的妊娠并发症国际预测模型，并进行了内部-外部交叉验证。我们估算了每个模型的研究特异性表现（c 统计量、校准斜率、大校准），并使用随机效应荟萃分析进行了汇总。异质性采用 τ2 和 95% 预测区间进行量化。我们使用决策曲线分析评估了胎儿生长受限模型的临床实用性，并根据美国国家健康与护理卓越研究所（National Institute for Health and Care Excellence 2008）的模型进行了健康经济学分析：在已发表的 119 个模型中，有一个出生体重模型（Poon）可以通过验证。根据我们的定义，没有一个模型报告了胎儿生长受限。在所有队列中，Poon 模型的校准斜率为 0.93（95% 置信区间为 0.90 至 0.96），具有良好的汇总校准斜率，但略有过拟合，出生体重平均低估了 90.4 克（95% 置信区间为 37.9 克至 142.9 克）。新开发的国际妊娠并发症预测-胎儿生长受限模型包括产妇年龄、身高、奇偶数、吸烟状况、种族、高血压病史、子痫前期、死胎或小于胎龄儿以及分娩时的胎龄。这样就可以根据一系列假定的分娩时胎龄进行预测。汇总的表观 c 统计量和校准值分别为 0.96（95% 置信区间为 0.51 至 1.0）和 0.95（95% 置信区间为 0.67 至 1.23）。预测概率阈值在 1%至 90%之间时，模型显示出正净效益。除了妊娠并发症国际预测-胎儿生长受限模型中的预测因素外，妊娠并发症国际预测-出生体重模型还包括产妇体重、糖尿病史和受孕方式。在内部-外部交叉验证中，各组群的平均校准斜率为 1.00（95% 置信区间为 0.78 至 1.23），没有过度拟合的迹象。出生体重平均被低估了 9.7 克（95% 置信区间为 -154.3 克至 173.8 克）：局限性：由于结果定义的不同，我们无法对大部分已发表的模型进行外部验证。国际妊娠并发症预测-胎儿生长受限模型的内部-外部交叉验证受到了所纳入队列中事件较少的限制。使用国家健康与护理卓越研究所公布的 2008 年模型进行的经济评估可能无法反映当前的实践，而且由于数据匮乏，无法进行全面的经济评估：国际妊娠并发症预测模型的性能需要在日常实践中进行评估，其对决策和临床结果的影响也需要评估：结论：妊娠并发症国际预测-胎儿生长受限模型和妊娠并发症国际预测-出生体重模型能准确预测不同假定孕龄分娩时的胎儿生长受限和出生体重。这些模型可用于对预约时的风险状况进行分层、计划监测和管理：本研究注册为 PROSPERO CRD42019135045：该奖项由美国国家健康与护理研究所（NIHR）健康技术评估项目资助（NIHR奖项编号：17/148/07），全文发表于《健康技术评估》第28卷第14期。如需了解更多奖项信息，请访问 NIHR Funding and Awards 网站。
{"title":"Development and validation of prediction models for fetal growth restriction and birthweight: an individual participant data meta-analysis.","authors":"John Allotey, Lucinda Archer, Dyuti Coomar, Kym Ie Snell, Melanie Smuk, Lucy Oakey, Sadia Haqnawaz, Ana Pilar Betrán, Lucy C Chappell, Wessel Ganzevoort, Sanne Gordijn, Asma Khalil, Ben W Mol, Rachel K Morris, Jenny Myers, Aris T Papageorghiou, Basky Thilaganathan, Fabricio Da Silva Costa, Fabio Facchinetti, Arri Coomarasamy, Akihide Ohkuchi, Anne Eskild, Javier Arenas Ramírez, Alberto Galindo, Ignacio Herraiz, Federico Prefumo, Shigeru Saito, Line Sletner, Jose Guilherme Cecatti, Rinat Gabbay-Benziv, Francois Goffinet, Ahmet A Baschat, Renato T Souza, Fionnuala Mone, Diane Farrar, Seppo Heinonen, Kjell Å Salvesen, Luc Jm Smits, Sohinee Bhattacharya, Chie Nagata, Satoru Takeda, Marleen Mhj van Gelder, Dewi Anggraini, SeonAe Yeo, Jane West, Javier Zamora, Hema Mistry, Richard D Riley, Shakila Thangaratinam","doi":"10.3310/DABW4814","DOIUrl":"10.3310/DABW4814","url":null,"abstract":"<p><strong>Background: </strong>Fetal growth restriction is associated with perinatal morbidity and mortality. Early identification of women having at-risk fetuses can reduce perinatal adverse outcomes.</p><p><strong>Objectives: </strong>To assess the predictive performance of existing models predicting fetal growth restriction and birthweight, and if needed, to develop and validate new multivariable models using individual participant data.</p><p><strong>Design: </strong>Individual participant data meta-analyses of cohorts in International Prediction of Pregnancy Complications network, decision curve analysis and health economics analysis.</p><p><strong>Participants: </strong>Pregnant women at booking. External validation of existing models (9 cohorts, 441,415 pregnancies); International Prediction of Pregnancy Complications model development and validation (4 cohorts, 237,228 pregnancies).</p><p><strong>Predictors: </strong>Maternal clinical characteristics, biochemical and ultrasound markers.</p><p><strong>Primary outcomes: </strong>fetal growth restriction defined as birthweight <10th centile adjusted for gestational age and with stillbirth, neonatal death or delivery before 32 weeks' gestation birthweight.</p><p><strong>Analysis: </strong>First, we externally validated existing models using individual participant data meta-analysis. If needed, we developed and validated new International Prediction of Pregnancy Complications models using random-intercept regression models with backward elimination for variable selection and undertook internal-external cross-validation. We estimated the study-specific performance (<i>c</i>-statistic, calibration slope, calibration-in-the-large) for each model and pooled using random-effects meta-analysis. Heterogeneity was quantified using τ<sup>2</sup> and 95% prediction intervals. We assessed the clinical utility of the fetal growth restriction model using decision curve analysis, and health economics analysis based on National Institute for Health and Care Excellence 2008 model.</p><p><strong>Results: </strong>Of the 119 published models, one birthweight model (Poon) could be validated. None reported fetal growth restriction using our definition. Across all cohorts, the Poon model had good summary calibration slope of 0.93 (95% confidence interval 0.90 to 0.96) with slight overfitting, and underpredicted birthweight by 90.4 g on average (95% confidence interval 37.9 g to 142.9 g). The newly developed International Prediction of Pregnancy Complications-fetal growth restriction model included maternal age, height, parity, smoking status, ethnicity, and any history of hypertension, pre-eclampsia, previous stillbirth or small for gestational age baby and gestational age at delivery. This allowed predictions conditional on a range of assumed gestational ages at delivery. The pooled apparent <i>c</i>-statistic and calibration were 0.96 (95% confidence interval 0.51 to 1.0), and 0.95 (95% confidence interval 0.67","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 47","pages":"1-119"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11404361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285841","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}
Nigel Fleeman, Rachel Houten, Sarah Nevitt, James Mahon, Sophie Beale, Angela Boland, Janette Greenhalgh, Katherine Edwards, Michelle Maden, Devarshi Bhattacharyya, Marty Chaplin, Joanne McEntee, Shien Chow, Tom Waddell
<p><strong>Background: </strong>Renal cell carcinoma is the most common type of kidney cancer, comprising approximately 85% of all renal malignancies. Patients with advanced renal cell carcinoma are the focus of this National Institute for Health and Care Excellence multiple technology appraisal. A patient's risk of disease progression depends on a number of prognostic risk factors; patients are categorised as having intermediate/poor risk or favourable risk of disease progression.</p><p><strong>Objectives: </strong>The objectives of this multiple technology appraisal were to appraise the clinical effectiveness and cost-effectiveness of lenvatinib plus pembrolizumab versus relevant comparators listed in the final scope issued by the National Institute for Health and Care Excellence: sunitinib, pazopanib, tivozanib, cabozantinib and nivolumab plus ipilimumab.</p><p><strong>Methods: </strong>The assessment group carried out clinical and economic systematic reviews and assessed the clinical and cost-effectiveness evidence submitted by Eisai, Hatfield, Hertfordshire, UK (the manufacturer of lenvatinib) and Merck Sharp & Dohme, Whitehouse Station, NJ, USA (the manufacturer of pembrolizumab). The assessment group carried out fixed-effects network meta-analyses using a Bayesian framework to generate evidence for clinical effectiveness. As convergence issues occurred due to sparse data, random-effects network meta-analysis results were unusable. The assessment group did not develop a de novo economic model, but instead modified the partitioned survival model provided by Merck Sharp & Dohme.</p><p><strong>Results: </strong>The assessment group clinical systematic review identified one relevant randomised controlled trial (CLEAR trial). The CLEAR trial is a good-quality, phase III, multicentre, open-label trial that provided evidence for the efficacy and safety of lenvatinib plus pembrolizumab compared with sunitinib. The assessment group progression-free survival network meta-analysis results for all three risk groups should not be used to infer any statistically significant difference (or lack of statistically significant difference) for any of the treatment comparisons owing to within-trial proportional hazards violations or uncertainty regarding the validity of the proportional hazards assumption. The assessment group overall survival network meta-analysis results for the intermediate-/poor-risk subgroup suggested that there was a numerical, but not statistically significant, improvement in the overall survival for patients treated with lenvatinib plus pembrolizumab compared with patients treated with cabozantinib or nivolumab plus ipilimumab. Because of within-trial proportional hazards violations or uncertainty regarding the validity of the proportional hazards assumption, the assessment group overall survival network meta-analysis results for the favourable-risk subgroup and the all-risk population should not be used to infer any statistically signi
研究注册：本研究注册为 PROSPERO CRD4202128587：该奖项由国家健康与护理研究所（NIHR）证据综合项目（NIHR奖项编号：NIHR134985）资助，全文发表于《健康技术评估》（Health Technology Assessment）第28卷第49期。更多奖项信息请参阅 NIHR Funding and Awards 网站。
{"title":"Lenvatinib plus pembrolizumab for untreated advanced renal cell carcinoma: a systematic review and cost-effectiveness analysis.","authors":"Nigel Fleeman, Rachel Houten, Sarah Nevitt, James Mahon, Sophie Beale, Angela Boland, Janette Greenhalgh, Katherine Edwards, Michelle Maden, Devarshi Bhattacharyya, Marty Chaplin, Joanne McEntee, Shien Chow, Tom Waddell","doi":"10.3310/TRRM4238","DOIUrl":"https://doi.org/10.3310/TRRM4238","url":null,"abstract":"<p><strong>Background: </strong>Renal cell carcinoma is the most common type of kidney cancer, comprising approximately 85% of all renal malignancies. Patients with advanced renal cell carcinoma are the focus of this National Institute for Health and Care Excellence multiple technology appraisal. A patient's risk of disease progression depends on a number of prognostic risk factors; patients are categorised as having intermediate/poor risk or favourable risk of disease progression.</p><p><strong>Objectives: </strong>The objectives of this multiple technology appraisal were to appraise the clinical effectiveness and cost-effectiveness of lenvatinib plus pembrolizumab versus relevant comparators listed in the final scope issued by the National Institute for Health and Care Excellence: sunitinib, pazopanib, tivozanib, cabozantinib and nivolumab plus ipilimumab.</p><p><strong>Methods: </strong>The assessment group carried out clinical and economic systematic reviews and assessed the clinical and cost-effectiveness evidence submitted by Eisai, Hatfield, Hertfordshire, UK (the manufacturer of lenvatinib) and Merck Sharp & Dohme, Whitehouse Station, NJ, USA (the manufacturer of pembrolizumab). The assessment group carried out fixed-effects network meta-analyses using a Bayesian framework to generate evidence for clinical effectiveness. As convergence issues occurred due to sparse data, random-effects network meta-analysis results were unusable. The assessment group did not develop a de novo economic model, but instead modified the partitioned survival model provided by Merck Sharp & Dohme.</p><p><strong>Results: </strong>The assessment group clinical systematic review identified one relevant randomised controlled trial (CLEAR trial). The CLEAR trial is a good-quality, phase III, multicentre, open-label trial that provided evidence for the efficacy and safety of lenvatinib plus pembrolizumab compared with sunitinib. The assessment group progression-free survival network meta-analysis results for all three risk groups should not be used to infer any statistically significant difference (or lack of statistically significant difference) for any of the treatment comparisons owing to within-trial proportional hazards violations or uncertainty regarding the validity of the proportional hazards assumption. The assessment group overall survival network meta-analysis results for the intermediate-/poor-risk subgroup suggested that there was a numerical, but not statistically significant, improvement in the overall survival for patients treated with lenvatinib plus pembrolizumab compared with patients treated with cabozantinib or nivolumab plus ipilimumab. Because of within-trial proportional hazards violations or uncertainty regarding the validity of the proportional hazards assumption, the assessment group overall survival network meta-analysis results for the favourable-risk subgroup and the all-risk population should not be used to infer any statistically signi","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 49","pages":"1-190"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11404358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David Cottrell, Alex Wright-Hughes, Amanda Farrin, Rebecca Walwyn, Faraz Mughal, Alex Truscott, Emma Diggins, Donna Irving, Peter Fonagy, Dennis Ougrin, Daniel Stahl, Judy Wright
Background: Self-harm is common in adolescents and a major public health concern. Evidence for effective interventions is lacking. An individual patient data meta-analysis has the potential to provide more reliable estimates of the effects of therapeutic interventions for self-harm than conventional meta-analyses, to explore which treatments are best suited to certain groups.
Method: A systematic review and individual patient data meta-analysis of randomised controlled trials of therapeutic interventions to reduce repeat self-harm in adolescents who had a history of self-harm and presented to clinical services. Primary outcome was repetition of self-harm. The methods employed for searches, study screening and selection, and risk of bias assessment are described, with an overview of the outputs of the searching, selection and quality assessment processes. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance is followed.
Results: We identified a total 39 eligible studies, from 10 countries, where we sought Individual Patient Data (IPD), of which the full sample of participants were eligible in 18 studies and a partial sample of participants were eligible in 21 studies. We obtained IPD from 26 studies of 3448 eligible participants. For our primary outcome, repetition of self-harm, only 6 studies were rated as low risk of bias with 10 rated as high risk (although 2 of these were for secondary outcomes only).
Conclusions: Obtaining individual patient data for meta-analyses is possible but very time-consuming, despite clear guidance from funding bodies that researchers should share their data appropriately. More attention needs to be paid to seeking appropriate consent from study participants for (pseudo) anonymised data-sharing and institutions need to collaborate on agreeing template data-sharing agreements. Researchers and funders need to consider issues of research design more carefully. Our next step is to analyse all the data we have collected to see if it will tell us more about how we might prevent repetition of self-harm in young people.
Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/117/11. A plain language summary of this research article is available on the NIHR Journals Library Website https://doi.org/10.3310/GTNT6331.
{"title":"Reducing self-harm in adolescents: the RISA-IPD individual patient data meta-analysis and systematic review.","authors":"David Cottrell, Alex Wright-Hughes, Amanda Farrin, Rebecca Walwyn, Faraz Mughal, Alex Truscott, Emma Diggins, Donna Irving, Peter Fonagy, Dennis Ougrin, Daniel Stahl, Judy Wright","doi":"10.3310/GTNT6331","DOIUrl":"https://doi.org/10.3310/GTNT6331","url":null,"abstract":"<p><strong>Background: </strong>Self-harm is common in adolescents and a major public health concern. Evidence for effective interventions is lacking. An individual patient data meta-analysis has the potential to provide more reliable estimates of the effects of therapeutic interventions for self-harm than conventional meta-analyses, to explore which treatments are best suited to certain groups.</p><p><strong>Method: </strong>A systematic review and individual patient data meta-analysis of randomised controlled trials of therapeutic interventions to reduce repeat self-harm in adolescents who had a history of self-harm and presented to clinical services. Primary outcome was repetition of self-harm. The methods employed for searches, study screening and selection, and risk of bias assessment are described, with an overview of the outputs of the searching, selection and quality assessment processes. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance is followed.</p><p><strong>Results: </strong>We identified a total 39 eligible studies, from 10 countries, where we sought Individual Patient Data (IPD), of which the full sample of participants were eligible in 18 studies and a partial sample of participants were eligible in 21 studies. We obtained IPD from 26 studies of 3448 eligible participants. For our primary outcome, repetition of self-harm, only 6 studies were rated as low risk of bias with 10 rated as high risk (although 2 of these were for secondary outcomes only).</p><p><strong>Conclusions: </strong>Obtaining individual patient data for meta-analyses is possible but very time-consuming, despite clear guidance from funding bodies that researchers should share their data appropriately. More attention needs to be paid to seeking appropriate consent from study participants for (pseudo) anonymised data-sharing and institutions need to collaborate on agreeing template data-sharing agreements. Researchers and funders need to consider issues of research design more carefully. Our next step is to analyse all the data we have collected to see if it will tell us more about how we might prevent repetition of self-harm in young people.</p><p><strong>Funding: </strong>This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/117/11. A plain language summary of this research article is available on the NIHR Journals Library Website https://doi.org/10.3310/GTNT6331.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-42"},"PeriodicalIF":3.5,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shuo Feng, Julie McLellan, Nicola Pidduck, Nia Roberts, Julian Pt Higgins, Yoon Choi, Alane Izu, Mark Jit, Shabir A Madhi, Kim Mulholland, Andrew J Pollard, Simon Procter, Beth Temple, Merryn Voysey
<p><strong>Background: </strong>Vaccination of infants with pneumococcal conjugate vaccines is recommended by the World Health Organization. Evidence is mixed regarding the differences in immunogenicity and efficacy of the different pneumococcal vaccines.</p><p><strong>Objectives: </strong>The primary objective was to compare the immunogenicity of pneumococcal conjugate vaccine-10 versus pneumococcal conjugate vaccine-13. The main secondary objective was to compare the seroefficacy of pneumococcal conjugate vaccine-10 versus pneumococcal conjugate vaccine-13.</p><p><strong>Methods: </strong>We searched the Cochrane Library, EMBASE, Global Health, MEDLINE, ClinicalTrials.gov and trialsearch.who.int up to July 2022. Studies were eligible if they directly compared either pneumococcal conjugate vaccine-7, pneumococcal conjugate vaccine-10 or pneumococcal conjugate vaccine-13 in randomised trials of children under 2 years of age, and provided immunogenicity data for at least one time point. Individual participant data were requested and aggregate data used otherwise. Outcomes included the geometric mean ratio of serotype-specific immunoglobulin G and the relative risk of seroinfection. Seroinfection was defined for each individual as a rise in antibody between the post-primary vaccination series time point and the booster dose, evidence of presumed subclinical infection. Each trial was analysed to obtain the log of the ratio of geometric means and its standard error. The relative risk of seroinfection ('seroefficacy') was estimated by comparing the proportion of participants with seroinfection between vaccine groups. The log-geometric mean ratios, log-relative risks and their standard errors constituted the input data for evidence synthesis. For serotypes contained in all three vaccines, evidence could be synthesised using a network meta-analysis. For other serotypes, meta-analysis was used. Results from seroefficacy analyses were incorporated into a mathematical model of pneumococcal transmission dynamics to compare the differential impact of pneumococcal conjugate vaccine-10 and pneumococcal conjugate vaccine-13 introduction on invasive pneumococcal disease cases. The model estimated the impact of vaccine introduction over a 25-year time period and an economic evaluation was conducted.</p><p><strong>Results: </strong>In total, 47 studies were eligible from 38 countries. Twenty-eight and 12 studies with data available were included in immunogenicity and seroefficacy analyses, respectively. Geometric mean ratios comparing pneumococcal conjugate vaccine-13 versus pneumococcal conjugate vaccine-10 favoured pneumococcal conjugate vaccine-13 for serotypes 4, 9V and 23F at 1 month after primary vaccination series, with 1.14- to 1.54-fold significantly higher immunoglobulin G responses with pneumococcal conjugate vaccine-13. Risk of seroinfection prior to the time of booster dose was lower for pneumococcal conjugate vaccine-13 for serotype 4, 6B, 9V, 18C an
{"title":"Immunogenicity and seroefficacy of pneumococcal conjugate vaccines: a systematic review and network meta-analysis.","authors":"Shuo Feng, Julie McLellan, Nicola Pidduck, Nia Roberts, Julian Pt Higgins, Yoon Choi, Alane Izu, Mark Jit, Shabir A Madhi, Kim Mulholland, Andrew J Pollard, Simon Procter, Beth Temple, Merryn Voysey","doi":"10.3310/YWHA3079","DOIUrl":"10.3310/YWHA3079","url":null,"abstract":"<p><strong>Background: </strong>Vaccination of infants with pneumococcal conjugate vaccines is recommended by the World Health Organization. Evidence is mixed regarding the differences in immunogenicity and efficacy of the different pneumococcal vaccines.</p><p><strong>Objectives: </strong>The primary objective was to compare the immunogenicity of pneumococcal conjugate vaccine-10 versus pneumococcal conjugate vaccine-13. The main secondary objective was to compare the seroefficacy of pneumococcal conjugate vaccine-10 versus pneumococcal conjugate vaccine-13.</p><p><strong>Methods: </strong>We searched the Cochrane Library, EMBASE, Global Health, MEDLINE, ClinicalTrials.gov and trialsearch.who.int up to July 2022. Studies were eligible if they directly compared either pneumococcal conjugate vaccine-7, pneumococcal conjugate vaccine-10 or pneumococcal conjugate vaccine-13 in randomised trials of children under 2 years of age, and provided immunogenicity data for at least one time point. Individual participant data were requested and aggregate data used otherwise. Outcomes included the geometric mean ratio of serotype-specific immunoglobulin G and the relative risk of seroinfection. Seroinfection was defined for each individual as a rise in antibody between the post-primary vaccination series time point and the booster dose, evidence of presumed subclinical infection. Each trial was analysed to obtain the log of the ratio of geometric means and its standard error. The relative risk of seroinfection ('seroefficacy') was estimated by comparing the proportion of participants with seroinfection between vaccine groups. The log-geometric mean ratios, log-relative risks and their standard errors constituted the input data for evidence synthesis. For serotypes contained in all three vaccines, evidence could be synthesised using a network meta-analysis. For other serotypes, meta-analysis was used. Results from seroefficacy analyses were incorporated into a mathematical model of pneumococcal transmission dynamics to compare the differential impact of pneumococcal conjugate vaccine-10 and pneumococcal conjugate vaccine-13 introduction on invasive pneumococcal disease cases. The model estimated the impact of vaccine introduction over a 25-year time period and an economic evaluation was conducted.</p><p><strong>Results: </strong>In total, 47 studies were eligible from 38 countries. Twenty-eight and 12 studies with data available were included in immunogenicity and seroefficacy analyses, respectively. Geometric mean ratios comparing pneumococcal conjugate vaccine-13 versus pneumococcal conjugate vaccine-10 favoured pneumococcal conjugate vaccine-13 for serotypes 4, 9V and 23F at 1 month after primary vaccination series, with 1.14- to 1.54-fold significantly higher immunoglobulin G responses with pneumococcal conjugate vaccine-13. Risk of seroinfection prior to the time of booster dose was lower for pneumococcal conjugate vaccine-13 for serotype 4, 6B, 9V, 18C an","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 34","pages":"1-109"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11284620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751570","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}
Edward Cox, Ros Wade, Robert Hodgson, Helen Fulbright, Thai Han Phung, Nicholas Meader, Simon Walker, Claire Rothery, Mark Simmonds
<p><strong>Background: </strong>Parkinson's disease is a brain condition causing a progressive loss of co ordination and movement problems. Around 145,500 people have Parkinson's disease in the United Kingdom. Levodopa is the most prescribed treatment for managing motor symptoms in the early stages. Patients should be monitored by a specialist every 6-12 months for disease progression and treatment of adverse effects. Wearable devices may provide a novel approach to management by directly monitoring patients for bradykinesia, dyskinesia, tremor and other symptoms. They are intended to be used alongside clinical judgement.</p><p><strong>Objectives: </strong>To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson's disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON.</p><p><strong>Methods: </strong>We performed systematic reviews of all evidence on the five devices, outcomes included: diagnostic accuracy, impact on decision-making, clinical outcomes, patient and clinician opinions and economic outcomes. We searched MEDLINE and 12 other databases/trial registries to February 2022. Risk of bias was assessed. Narrative synthesis was used to summarise all identified evidence, as the evidence was insufficient for meta-analysis. One included trial provided individual-level data, which was re-analysed. A de novo decision-analytic model was developed to estimate the cost-effectiveness of Personal KinetiGraph and Kinesia 360 compared to standard of care in the UK NHS over a 5-year time horizon. The base-case analysis considered two alternative monitoring strategies: one-time use and routine use of the device.</p><p><strong>Results: </strong>Fifty-seven studies of Personal KinetiGraph, 15 of STAT-ON, 3 of Kinesia 360, 1 of KinesiaU and 1 of PDMonitor were included. There was some evidence to suggest that Personal KinetiGraph can accurately measure bradykinesia and dyskinesia, leading to treatment modification in some patients, and a possible improvement in clinical outcomes when measured using the Unified Parkinson's Disease Rating Scale. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical impact. The evidence for Kinesia 360, KinesiaU and PDMonitor is insufficient to draw any conclusions on their value in clinical practice. The base-case results for Personal KinetiGraph compared to standard of care for one-time and routine use resulted in incremental cost-effectiveness ratios of £67,856 and £57,877 per quality-adjusted life-year gained, respectively, with a beneficial impact of the Personal KinetiGraph on Unified Parkinson's Disease Rating Scale domains III and IV. The incremental cost-effectiveness ratio results for Kinesia 360 compared to standard of care for one-time and routine use were £38,828 and £67,203 per quality-adjusted life-year gained, respectively.</p><p><strong>Limitations: </strong>The evidence was limited i
{"title":"Devices for remote continuous monitoring of people with Parkinson's disease: a systematic review and cost-effectiveness analysis.","authors":"Edward Cox, Ros Wade, Robert Hodgson, Helen Fulbright, Thai Han Phung, Nicholas Meader, Simon Walker, Claire Rothery, Mark Simmonds","doi":"10.3310/YDSL3294","DOIUrl":"10.3310/YDSL3294","url":null,"abstract":"<p><strong>Background: </strong>Parkinson's disease is a brain condition causing a progressive loss of co ordination and movement problems. Around 145,500 people have Parkinson's disease in the United Kingdom. Levodopa is the most prescribed treatment for managing motor symptoms in the early stages. Patients should be monitored by a specialist every 6-12 months for disease progression and treatment of adverse effects. Wearable devices may provide a novel approach to management by directly monitoring patients for bradykinesia, dyskinesia, tremor and other symptoms. They are intended to be used alongside clinical judgement.</p><p><strong>Objectives: </strong>To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson's disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON.</p><p><strong>Methods: </strong>We performed systematic reviews of all evidence on the five devices, outcomes included: diagnostic accuracy, impact on decision-making, clinical outcomes, patient and clinician opinions and economic outcomes. We searched MEDLINE and 12 other databases/trial registries to February 2022. Risk of bias was assessed. Narrative synthesis was used to summarise all identified evidence, as the evidence was insufficient for meta-analysis. One included trial provided individual-level data, which was re-analysed. A de novo decision-analytic model was developed to estimate the cost-effectiveness of Personal KinetiGraph and Kinesia 360 compared to standard of care in the UK NHS over a 5-year time horizon. The base-case analysis considered two alternative monitoring strategies: one-time use and routine use of the device.</p><p><strong>Results: </strong>Fifty-seven studies of Personal KinetiGraph, 15 of STAT-ON, 3 of Kinesia 360, 1 of KinesiaU and 1 of PDMonitor were included. There was some evidence to suggest that Personal KinetiGraph can accurately measure bradykinesia and dyskinesia, leading to treatment modification in some patients, and a possible improvement in clinical outcomes when measured using the Unified Parkinson's Disease Rating Scale. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical impact. The evidence for Kinesia 360, KinesiaU and PDMonitor is insufficient to draw any conclusions on their value in clinical practice. The base-case results for Personal KinetiGraph compared to standard of care for one-time and routine use resulted in incremental cost-effectiveness ratios of £67,856 and £57,877 per quality-adjusted life-year gained, respectively, with a beneficial impact of the Personal KinetiGraph on Unified Parkinson's Disease Rating Scale domains III and IV. The incremental cost-effectiveness ratio results for Kinesia 360 compared to standard of care for one-time and routine use were £38,828 and £67,203 per quality-adjusted life-year gained, respectively.</p><p><strong>Limitations: </strong>The evidence was limited i","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 30","pages":"1-187"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11331379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633281","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}
Lucy E Bradshaw, Laura A Wyatt, Sara J Brown, Rachel H Haines, Alan A Montgomery, Michael R Perkin, Tracey H Sach, Sandra Lawton, Carsten Flohr, Matthew J Ridd, Joanne R Chalmers, Joanne Brooks, Richard Swinden, Eleanor J Mitchell, Stella Tarr, Nicola Jay, Kim S Thomas, Hilary Allen, Michael J Cork, Maeve M Kelleher, Eric L Simpson, Stella T Lartey, Susan Davies-Jones, Robert J Boyle, Hywel C Williams
<p><strong>Background: </strong>Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.</p><p><strong>Objectives: </strong>To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children.</p><p><strong>Design: </strong>A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.</p><p><strong>Setting: </strong>Twelve secondary and four primary care centres.</p><p><strong>Participants: </strong>Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.</p><p><strong>Interventions: </strong>Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation.</p><p><strong>Main outcome measures: </strong>Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness.</p><p><strong>Results: </strong>One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; <i>p</i> = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires.</p><p><strong>Limitations: </strong>Two emol
{"title":"Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.","authors":"Lucy E Bradshaw, Laura A Wyatt, Sara J Brown, Rachel H Haines, Alan A Montgomery, Michael R Perkin, Tracey H Sach, Sandra Lawton, Carsten Flohr, Matthew J Ridd, Joanne R Chalmers, Joanne Brooks, Richard Swinden, Eleanor J Mitchell, Stella Tarr, Nicola Jay, Kim S Thomas, Hilary Allen, Michael J Cork, Maeve M Kelleher, Eric L Simpson, Stella T Lartey, Susan Davies-Jones, Robert J Boyle, Hywel C Williams","doi":"10.3310/RHDN9613","DOIUrl":"10.3310/RHDN9613","url":null,"abstract":"<p><strong>Background: </strong>Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.</p><p><strong>Objectives: </strong>To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children.</p><p><strong>Design: </strong>A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.</p><p><strong>Setting: </strong>Twelve secondary and four primary care centres.</p><p><strong>Participants: </strong>Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.</p><p><strong>Interventions: </strong>Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation.</p><p><strong>Main outcome measures: </strong>Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness.</p><p><strong>Results: </strong>One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; <i>p</i> = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires.</p><p><strong>Limitations: </strong>Two emol","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 29","pages":"1-116"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11261424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633280","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}
Edmund J Lamb, Jonathan Barratt, Elizabeth A Brettell, Paul Cockwell, R Nei Dalton, Jon J Deeks, Gillian Eaglestone, Tracy Pellatt-Higgins, Philip A Kalra, Kamlesh Khunti, Fiona C Loud, Ryan S Ottridge, Aisling Potter, Ceri Rowe, Katie Scandrett, Alice J Sitch, Paul E Stevens, Claire C Sharpe, Bethany Shinkins, Alison Smith, Andrew J Sutton, Maarten W Taal
<p><strong>Background: </strong>Estimation of glomerular filtration rate using equations based on creatinine is widely used to manage chronic kidney disease. In the UK, the Chronic Kidney Disease Epidemiology Collaboration creatinine equation is recommended. Other published equations using cystatin C, an alternative marker of kidney function, have not gained widespread clinical acceptance. Given higher cost of cystatin C, its clinical utility should be validated before widespread introduction into the NHS.</p><p><strong>Objectives: </strong>Primary objectives were to: (1) compare accuracy of glomerular filtration rate equations at baseline and longitudinally in people with stage 3 chronic kidney disease, and test whether accuracy is affected by ethnicity, diabetes, albuminuria and other characteristics; (2) establish the reference change value for significant glomerular filtration rate changes; (3) model disease progression; and (4) explore comparative cost-effectiveness of kidney disease monitoring strategies.</p><p><strong>Design: </strong>A longitudinal, prospective study was designed to: (1) assess accuracy of glomerular filtration rate equations at baseline (<i>n</i> = 1167) and their ability to detect change over 3 years (<i>n</i> = 875); (2) model disease progression predictors in 278 individuals who received additional measurements; (3) quantify glomerular filtration rate variability components (<i>n</i> = 20); and (4) develop a measurement model analysis to compare different monitoring strategy costs (<i>n</i> = 875).</p><p><strong>Setting: </strong>Primary, secondary and tertiary care.</p><p><strong>Participants: </strong>Adults (≥ 18 years) with stage 3 chronic kidney disease.</p><p><strong>Interventions: </strong>Estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration and Modification of Diet in Renal Disease equations.</p><p><strong>Main outcome measures: </strong>Measured glomerular filtration rate was the reference against which estimating equations were compared with accuracy being expressed as P30 (percentage of values within 30% of reference) and progression (variously defined) studied as sensitivity/specificity. A regression model of disease progression was developed and differences for risk factors estimated. Biological variation components were measured and the reference change value calculated. Comparative costs of monitoring with different estimating equations modelled over 10 years were calculated.</p><p><strong>Results: </strong>Accuracy (P30) of all equations was ≥ 89.5%: the combined creatinine-cystatin equation (94.9%) was superior (<i>p</i> < 0.001) to other equations. Within each equation, no differences in P30 were seen across categories of age, gender, diabetes, albuminuria, body mass index, kidney function level and ethnicity. All equations showed poor (< 63%) sensitivity for detecting patients showing kidney function decline crossing clinically significant thresholds (e.g.
背景：使用基于肌酐的公式估算肾小球滤过率被广泛用于慢性肾病的管理。在英国，慢性肾脏病流行病学协作组推荐使用肌酐方程。其他已公布的使用胱抑素 C（肾功能的替代标志物）的方程尚未获得广泛的临床认可。鉴于胱抑素 C 的成本较高，在广泛引入国家医疗服务系统之前，应先验证其临床实用性：主要目的是(目标：主要目标是：（1）比较基线和纵向肾小球滤过率方程对 3 期慢性肾脏病患者的准确性，并检验准确性是否受种族、糖尿病、白蛋白尿和其他特征的影响；（2）确定肾小球滤过率显著变化的参考变化值；（3）建立疾病进展模型；（4）探讨肾脏病监测策略的成本效益比较：设计：一项纵向前瞻性研究旨在(设计：这项纵向前瞻性研究旨在：（1）评估基线肾小球滤过率方程的准确性（n = 1167）及其检测 3 年变化的能力（n = 875）；（2）为接受额外测量的 278 人建立疾病进展预测模型；（3）量化肾小球滤过率变异成分（n = 20）；以及（4）开发测量模型分析，以比较不同监测策略的成本（n = 875）：环境：初级、二级和三级医疗机构：干预措施：采用慢性肾脏病流行病学协作组和肾脏病饮食调整方程估算肾小球滤过率：以测量的肾小球滤过率为参照，对估算方程进行比较，准确性以 P30（参照值 30% 以内的百分比）表示，进展情况（定义各异）以敏感性/特异性表示。建立了疾病进展回归模型，并估算了风险因素的差异。测量生物变异成分并计算参考变化值。计算了使用不同估算方程模拟 10 年的监测成本比较：所有方程的准确度（P30）均≥89.5%：肌酐-胱抑素联合方程（94.9%）更优（P 限制）：南亚和非洲-加勒比背景人群的招募低于研究目标：未来工作：应对胱抑素 C 作为慢性肾脏病风险标志物的价值进行前瞻性研究：结论：在肾小球滤过率估算公式中加入胱抑素 C 可略微提高准确性，但不能提高疾病进展的检测率。我们的数据不支持将胱抑素 C 用于监测慢性肾脏病三期患者的肾小球滤过率：该试验的注册号为 ISRCTN42955626：该奖项由美国国家健康与护理研究所（NIHR）健康技术评估项目资助（NIHR奖项编号：11/103/01），全文发表于《健康技术评估》（Health Technology Assessment）第28卷第35期。更多奖项信息请参阅 NIHR Funding and Awards 网站。
{"title":"Accuracy of glomerular filtration rate estimation using creatinine and cystatin C for identifying and monitoring moderate chronic kidney disease: the eGFR-C study.","authors":"Edmund J Lamb, Jonathan Barratt, Elizabeth A Brettell, Paul Cockwell, R Nei Dalton, Jon J Deeks, Gillian Eaglestone, Tracy Pellatt-Higgins, Philip A Kalra, Kamlesh Khunti, Fiona C Loud, Ryan S Ottridge, Aisling Potter, Ceri Rowe, Katie Scandrett, Alice J Sitch, Paul E Stevens, Claire C Sharpe, Bethany Shinkins, Alison Smith, Andrew J Sutton, Maarten W Taal","doi":"10.3310/HYHN1078","DOIUrl":"10.3310/HYHN1078","url":null,"abstract":"<p><strong>Background: </strong>Estimation of glomerular filtration rate using equations based on creatinine is widely used to manage chronic kidney disease. In the UK, the Chronic Kidney Disease Epidemiology Collaboration creatinine equation is recommended. Other published equations using cystatin C, an alternative marker of kidney function, have not gained widespread clinical acceptance. Given higher cost of cystatin C, its clinical utility should be validated before widespread introduction into the NHS.</p><p><strong>Objectives: </strong>Primary objectives were to: (1) compare accuracy of glomerular filtration rate equations at baseline and longitudinally in people with stage 3 chronic kidney disease, and test whether accuracy is affected by ethnicity, diabetes, albuminuria and other characteristics; (2) establish the reference change value for significant glomerular filtration rate changes; (3) model disease progression; and (4) explore comparative cost-effectiveness of kidney disease monitoring strategies.</p><p><strong>Design: </strong>A longitudinal, prospective study was designed to: (1) assess accuracy of glomerular filtration rate equations at baseline (<i>n</i> = 1167) and their ability to detect change over 3 years (<i>n</i> = 875); (2) model disease progression predictors in 278 individuals who received additional measurements; (3) quantify glomerular filtration rate variability components (<i>n</i> = 20); and (4) develop a measurement model analysis to compare different monitoring strategy costs (<i>n</i> = 875).</p><p><strong>Setting: </strong>Primary, secondary and tertiary care.</p><p><strong>Participants: </strong>Adults (≥ 18 years) with stage 3 chronic kidney disease.</p><p><strong>Interventions: </strong>Estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration and Modification of Diet in Renal Disease equations.</p><p><strong>Main outcome measures: </strong>Measured glomerular filtration rate was the reference against which estimating equations were compared with accuracy being expressed as P30 (percentage of values within 30% of reference) and progression (variously defined) studied as sensitivity/specificity. A regression model of disease progression was developed and differences for risk factors estimated. Biological variation components were measured and the reference change value calculated. Comparative costs of monitoring with different estimating equations modelled over 10 years were calculated.</p><p><strong>Results: </strong>Accuracy (P30) of all equations was ≥ 89.5%: the combined creatinine-cystatin equation (94.9%) was superior (<i>p</i> < 0.001) to other equations. Within each equation, no differences in P30 were seen across categories of age, gender, diabetes, albuminuria, body mass index, kidney function level and ethnicity. All equations showed poor (< 63%) sensitivity for detecting patients showing kidney function decline crossing clinically significant thresholds (e.g.","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 35","pages":"1-169"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11331378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758373","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, Eline Krijkamp, Mark Perry, Caro Noake, Apostolos Tsiachristas, Isaac Corro-Ramos
<p><strong>Background: </strong>The CaRi-Heart® device estimates risk of 8-year cardiac death, using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden and clinical risk factors.</p><p><strong>Objectives: </strong>To provide an Early Value Assessment of the potential of CaRi-Heart Risk to be an effective and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease, undergoing computed tomography coronary angiography. This assessment includes conceptual modelling which explores the structure and evidence about parameters required for model development, but not development of a full executable cost-effectiveness model.</p><p><strong>Data sources: </strong>Twenty-four databases, including MEDLINE, MEDLINE In-Process and EMBASE, were searched from inception to October 2022.</p><p><strong>Methods: </strong>Review methods followed published guidelines. Study quality was assessed using Prediction model Risk Of Bias ASsessment Tool. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. Exploratory searches were conducted to inform conceptual cost-effectiveness modelling.</p><p><strong>Results: </strong>The only included study indicated that CaRi-Heart Risk may be predictive of 8 years cardiac death. The hazard ratio, per unit increase in CaRi-Heart Risk, adjusted for smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume, was 1.04 (95% confidence interval 1.03 to 1.06) in the model validation cohort. Based on Prediction model Risk Of Bias ASsessment Tool, this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this Early Value Assessment. We did not identify any studies that reported information about the clinical effects or costs of using CaRi-Heart to assess cardiac risk. Exploratory searches, conducted to inform the conceptual cost-effectiveness modelling, indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation (e.g. fat attenuation index). A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart is described. A combination of a short-term diagnostic model component and a long-term model component that evaluates the downstream consequences is anticipated to capture the diagnosis and the progression of coronary artery disease.</p><p><strong>Limitations: </strong>The rapid review methods and pragmatic additional searches used to inform this Early Value Assessment mean that, although areas of potential uncertainty hav
{"title":"A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model.","authors":"Marie Westwood, Nigel Armstrong, Eline Krijkamp, Mark Perry, Caro Noake, Apostolos Tsiachristas, Isaac Corro-Ramos","doi":"10.3310/WYGC4096","DOIUrl":"10.3310/WYGC4096","url":null,"abstract":"<p><strong>Background: </strong>The CaRi-Heart® device estimates risk of 8-year cardiac death, using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden and clinical risk factors.</p><p><strong>Objectives: </strong>To provide an Early Value Assessment of the potential of CaRi-Heart Risk to be an effective and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease, undergoing computed tomography coronary angiography. This assessment includes conceptual modelling which explores the structure and evidence about parameters required for model development, but not development of a full executable cost-effectiveness model.</p><p><strong>Data sources: </strong>Twenty-four databases, including MEDLINE, MEDLINE In-Process and EMBASE, were searched from inception to October 2022.</p><p><strong>Methods: </strong>Review methods followed published guidelines. Study quality was assessed using Prediction model Risk Of Bias ASsessment Tool. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. Exploratory searches were conducted to inform conceptual cost-effectiveness modelling.</p><p><strong>Results: </strong>The only included study indicated that CaRi-Heart Risk may be predictive of 8 years cardiac death. The hazard ratio, per unit increase in CaRi-Heart Risk, adjusted for smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume, was 1.04 (95% confidence interval 1.03 to 1.06) in the model validation cohort. Based on Prediction model Risk Of Bias ASsessment Tool, this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this Early Value Assessment. We did not identify any studies that reported information about the clinical effects or costs of using CaRi-Heart to assess cardiac risk. Exploratory searches, conducted to inform the conceptual cost-effectiveness modelling, indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation (e.g. fat attenuation index). A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart is described. A combination of a short-term diagnostic model component and a long-term model component that evaluates the downstream consequences is anticipated to capture the diagnosis and the progression of coronary artery disease.</p><p><strong>Limitations: </strong>The rapid review methods and pragmatic additional searches used to inform this Early Value Assessment mean that, although areas of potential uncertainty hav","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 31","pages":"1-105"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11299050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633282","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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