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Public Understanding of Risk and Benefit of Mifepristone: A Randomized Clinical Trial.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.60236
Tamar Krishnamurti, Gianna White, Barry Dewitt, Elizabeth Mosley, Baruch Fischhoff
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引用次数: 0
Cardiometabolic Trajectories Preceding Dementia in Community-Dwelling Older Individuals.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.58591
Zimu Wu, Lachlan Cribb, Rory Wolfe, Raj C Shah, Suzanne G Orchard, Alice Owen, Robyn L Woods, Swarna Vishwanath, Trevor T-J Chong, Kerry M Sheets, Anne M Murray, Joanne Ryan
<p><strong>Importance: </strong>Poor cardiometabolic health is a risk factor associated with cognitive impairment in later life, but it remains unclear whether cardiometabolic trajectories can serve as early markers associated with dementia.</p><p><strong>Objective: </strong>To compare cardiometabolic trajectories that precede dementia diagnosis with those among individuals without dementia.</p><p><strong>Design, setting, and participants: </strong>This case-control study analyzed a sample drawn from community-dwelling participants in the Aspirin in Reducing Events in the Elderly (ASPREE) study. Recruitment through primary care physicians occurred between March 2010 and December 2014, with participants followed up for a maximum of 11 years. Dementia cases were matched on sociodemographic characteristics and time of diagnosis to dementia-free controls. Data analysis was performed between February and June 2024.</p><p><strong>Exposures: </strong>Body mass index (BMI), waist circumference, systolic and diastolic blood pressure, glucose levels, high- and low-density lipoprotein (HDL and LDL) and total cholesterol levels, and triglyceride levels were measured repeatedly between 2010 and 2022.</p><p><strong>Main outcomes and measures: </strong>Dementia (Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition] criteria) was adjudicated by an international expert panel.</p><p><strong>Results: </strong>Among 5390 participants (mean [SD] age, 76.9 [4.8] years; 2915 women [54.1%]), there were 2655 individuals (49.3%) with less than 12 years of education. The study included 1078 dementia cases and 4312 controls. Up to a decade before diagnosis, dementia cases compared with controls had lower BMI for all years from -7 years (marginal estimate, 27.52 [95% CI, 27.24 to 27.79] vs 28.00 [95% CI, 27.86 to 28.14]; contrast P = 002) to 0 years (marginal estimate, 26.09 [95% CI, 25.81 to 26.36] vs 27.22 [95% CI, 27.09 to 27.36]; contrast P < .001) and lower waist circumference for all years from -10 years (marginal estimate, 95.45 cm [95% CI, 94.33 to 96.57 cm] vs 97.35 cm [95% CI, 96.79 to 97.92 cm]; contrast P = .003) to 0 years (marginal estimate, 93.90 [95% CI, 93.15 cm to 94.64 cm] vs 96.67 cm [95% CI, 96.30 to 97.05 cm]; contrast P < .001); cases also had a faster decline in BMI (linear change β, -0.13 [95% CI, -0.19 to -0.08]) and waist circumference (linear change β, -0.30 cm [95% CI, -0.51 to -0.08 cm]). Compared with controls, cases generally had higher HDL levels, in particular from 5 years (marginal estimate, 62.57 mg/dL [95% CI, 61.59 to 63.56 mg/dL] vs 60.84 mg/dL [95% CI, 60.35 to 61.34 mg/dL]; contrast P = .002) to 3 years (marginal estimate, 62.78 mg/dL [95% CI, 61.82 to 63.74 mg/dL] vs 61.08 mg/dL [95% CI, 60.60 to 61.56 mg/dL]; contrast P = .002) before dementia but with a decline in levels just before diagnosis (linear change β, -0.47 mg/dL [95% CI, -0.86 to -0.07 mg/dL]). Dementia cases had lower systolic blood pressure and triglyce
{"title":"Cardiometabolic Trajectories Preceding Dementia in Community-Dwelling Older Individuals.","authors":"Zimu Wu, Lachlan Cribb, Rory Wolfe, Raj C Shah, Suzanne G Orchard, Alice Owen, Robyn L Woods, Swarna Vishwanath, Trevor T-J Chong, Kerry M Sheets, Anne M Murray, Joanne Ryan","doi":"10.1001/jamanetworkopen.2024.58591","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2024.58591","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Poor cardiometabolic health is a risk factor associated with cognitive impairment in later life, but it remains unclear whether cardiometabolic trajectories can serve as early markers associated with dementia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To compare cardiometabolic trajectories that precede dementia diagnosis with those among individuals without dementia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This case-control study analyzed a sample drawn from community-dwelling participants in the Aspirin in Reducing Events in the Elderly (ASPREE) study. Recruitment through primary care physicians occurred between March 2010 and December 2014, with participants followed up for a maximum of 11 years. Dementia cases were matched on sociodemographic characteristics and time of diagnosis to dementia-free controls. Data analysis was performed between February and June 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposures: &lt;/strong&gt;Body mass index (BMI), waist circumference, systolic and diastolic blood pressure, glucose levels, high- and low-density lipoprotein (HDL and LDL) and total cholesterol levels, and triglyceride levels were measured repeatedly between 2010 and 2022.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Dementia (Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition] criteria) was adjudicated by an international expert panel.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 5390 participants (mean [SD] age, 76.9 [4.8] years; 2915 women [54.1%]), there were 2655 individuals (49.3%) with less than 12 years of education. The study included 1078 dementia cases and 4312 controls. Up to a decade before diagnosis, dementia cases compared with controls had lower BMI for all years from -7 years (marginal estimate, 27.52 [95% CI, 27.24 to 27.79] vs 28.00 [95% CI, 27.86 to 28.14]; contrast P = 002) to 0 years (marginal estimate, 26.09 [95% CI, 25.81 to 26.36] vs 27.22 [95% CI, 27.09 to 27.36]; contrast P &lt; .001) and lower waist circumference for all years from -10 years (marginal estimate, 95.45 cm [95% CI, 94.33 to 96.57 cm] vs 97.35 cm [95% CI, 96.79 to 97.92 cm]; contrast P = .003) to 0 years (marginal estimate, 93.90 [95% CI, 93.15 cm to 94.64 cm] vs 96.67 cm [95% CI, 96.30 to 97.05 cm]; contrast P &lt; .001); cases also had a faster decline in BMI (linear change β, -0.13 [95% CI, -0.19 to -0.08]) and waist circumference (linear change β, -0.30 cm [95% CI, -0.51 to -0.08 cm]). Compared with controls, cases generally had higher HDL levels, in particular from 5 years (marginal estimate, 62.57 mg/dL [95% CI, 61.59 to 63.56 mg/dL] vs 60.84 mg/dL [95% CI, 60.35 to 61.34 mg/dL]; contrast P = .002) to 3 years (marginal estimate, 62.78 mg/dL [95% CI, 61.82 to 63.74 mg/dL] vs 61.08 mg/dL [95% CI, 60.60 to 61.56 mg/dL]; contrast P = .002) before dementia but with a decline in levels just before diagnosis (linear change β, -0.47 mg/dL [95% CI, -0.86 to -0.07 mg/dL]). Dementia cases had lower systolic blood pressure and triglyce","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2458591"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interoperable Models for Identifying Critically Ill Children at Risk of Neurologic Morbidity.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.57469
Christopher M Horvat, Amie J Barda, Eddie Perez Claudio, Alicia K Au, Andrew Bauman, Qingyang Li, Ruoting Li, Neil Munjal, Mark S Wainwright, Tanupat Boonchalermvichien, Harry Hochheiser, Robert S B Clark
<p><strong>Importance: </strong>Decreasing mortality in the field of pediatric critical care medicine has shifted practicing clinicians' attention to preserving patients' neurodevelopmental potential as a main objective. Earlier identification of critically ill children at risk for incurring neurologic morbidity would facilitate heightened surveillance that could lead to timelier clinical detection, earlier interventions, and preserved neurodevelopmental trajectory.</p><p><strong>Objectives: </strong>To develop machine-learning models for identifying acquired neurologic morbidity in hospitalized pediatric patients with critical illness and assess correlation with contemporary serum-based, brain injury-derived biomarkers.</p><p><strong>Design, setting, and participants: </strong>This prognostic study used data from all children admitted to a quaternary pediatric intensive care unit in a large, freestanding children's hospital in Western Pennsylvania between January 1, 2010, and December 31, 2022. External model validation used data from children admitted between January 1, 2018, and December 31, 2023, to a quaternary pediatric intensive care unit in a large, freestanding children's hospital that serves as a referral center for the 5-state region of Washington, Wyoming, Alaska, Montana, and Idaho.</p><p><strong>Exposures: </strong>Critical illness.</p><p><strong>Main outcomes and measures: </strong>The outcome was neurologic morbidity, defined according to a computable, composite definition at the development site or an order for neurocritical care consultation at the validation site. Models were developed using varying time windows for temporal feature engineering and varying censored time horizons between the last feature and the identified neurologic morbidity. A generalizable model created at the development site was optimized and assessed at an external validation site. Correlation was assessed between development site model predictions and measurements of brain biomarkers from a convenience cohort.</p><p><strong>Results: </strong>After exclusions, there were 18 568 encounters from 2010 to 2022 in the development site generalizable model cohort (median age, 70 [IQR, 18-161] months; 8325 [45%] female). There were 6825 encounters from 2018 to 2021 at the external validation site (median age, 96 [IQR 18-171] months; 3159 [46%] female). A generalizable extreme gradient boosted model with a 24-hour time horizon and 48-hour feature engineering window demonstrated an F1 score of 0.37 (95% CI, 0.33-0.40), area under the receiver operating characteristics curve of 0.81 (95% CI, 0.78-0.83), and number needed to alert of 4 at the validation site. After recalibration at the validation site, the Brier score was 0.04. Serum levels of the brain injury biomarker glial fibrillary acidic protein significantly correlated with model output (rs = 0.34; P = .007).</p><p><strong>Conclusions and relevance: </strong>This prognostic study of prediction models for detec
重要性:儿科危重症医学领域死亡率的降低已使临床医生将注意力转移到以保护患者神经发育潜能为主要目标。尽早识别有神经系统发病风险的重症患儿将有助于加强监测,从而更及时地进行临床检测、更早地采取干预措施并保护神经系统的发育轨迹:开发机器学习模型,用于识别住院儿科危重症患者的获得性神经系统发病率,并评估其与当代基于血清的脑损伤生物标志物的相关性:这项预后研究使用了宾夕法尼亚州西部一家大型独立儿童医院四级儿科重症监护病房 2010 年 1 月 1 日至 2022 年 12 月 31 日期间收治的所有患儿的数据。外部模型验证使用的数据来自 2018 年 1 月 1 日至 2023 年 12 月 31 日期间入住一家大型独立儿童医院四级儿科重症监护病房的儿童,该医院是华盛顿州、怀俄明州、阿拉斯加州、蒙大拿州和爱达荷州 5 个州的转诊中心:危重病:主要结果和测量指标:结果为神经系统发病率,根据开发地点的可计算复合定义或验证地点的神经重症护理咨询订单进行定义。在开发模型时,使用了不同的时间窗进行时间特征工程,并在最后一个特征和确定的神经系统发病率之间使用了不同的删减时间范围。在外部验证站点对开发站点创建的通用模型进行了优化和评估。对开发基地的模型预测与便利队列的脑生物标志物测量结果之间的相关性进行了评估:排除其他因素后,从 2010 年到 2022 年,开发基地可推广模型队列中有 18 568 人次(中位年龄 70 [IQR, 18-161] 个月;女性 8325 [45%])。外部验证地点在 2018 年至 2021 年期间共有 6825 例患者(中位年龄为 96 [IQR, 18-171] 个月;女性为 3159 [46%])。在验证地点,一个具有 24 小时时间跨度和 48 小时特征工程窗口的可普适性极端梯度增强模型的 F1 得分为 0.37(95% CI,0.33-0.40),接收器操作特征曲线下面积为 0.81(95% CI,0.78-0.83),警戒所需人数为 4。在验证地点重新校准后,布赖尔评分为 0.04。脑损伤生物标志物胶质纤维酸性蛋白的血清水平与模型输出结果显著相关(rs = 0.34; P = .007):这项用于检测重症儿童神经系统发病率的预测模型预后研究表明,模型组合具有良好的生物分子确证作用。有必要对儿科危重症的生物标记物耦合风险模型进行前瞻性评估和改进。
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引用次数: 0
Alzheimer Disease Blood Biomarkers and Cognition Among Individuals With Diabetes and Overweight or Obesity.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.58149
Michelle M Mielke, Joni K Evans, Rebecca H Neiberg, Doris P Molina-Henry, Santica M Marcovina, Karen C Johnson, Owen T Carmichael, Stephen R Rapp, Bonnie C Sachs, Jingzhong Ding, Heather M Shappell, Jose A Luchsinger, Mark A Espeland, Kathleen M Hayden
<p><strong>Importance: </strong>Blood-based biomarkers (BBMs) are clinically available to aid in the diagnosis of Alzheimer disease (AD) and AD-related dementias (ADRD), but their association with cognition among older adults with specific chronic conditions has not been examined.</p><p><strong>Objective: </strong>To longitudinally examine associations between baseline AD and ADRD BBMs and change in BBMs with cognition among participants with type 2 diabetes (T2D) and overweight or obesity.</p><p><strong>Design, setting, and participants: </strong>The Look AHEAD (Action for Health in Diabetes) study was a clinical trial of older adults with T2D and overweight or obesity randomized to a 10-year intensive lifestyle intervention for weight loss or a diabetes support and education condition. Participants were recruited and followed up at 16 clinical sites across the US. Enrollment occurred from January 1, 2001, to December 31, 2004. The primary intervention spanned the first 4 years after participants' enrollment (January 1, 2008, to December 31, 2011). The clinical trial was stopped in September 2012 and was converted to an observational study. Blood samples were drawn at baseline and 8 to 12 years later. Cognitive assessments were performed from January 1, 2013, to December 31, 2014, and from January 1, 2018, to December 31, 2020. Data for the present cohort study were analyzed between January and August 2024.</p><p><strong>Exposures: </strong>Baseline and 8- to 12-year change in plasma levels of amyloid-β (Aβ)40, Aβ42, Aβ42/40 ratio, phosphorylated tau 181 (pTau-181), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL).</p><p><strong>Main outcomes and measures: </strong>Cognitive composite z score and adjudicated mild cognitive impairment or probable dementia.</p><p><strong>Results: </strong>The mean (SD) baseline age of 758 participants was 61.5 (6.1) years, and 424 participants [55.9%] were female. Mean (SD) body mass index was 34.8 (5.3). Of the participants, 373 were randomized to diabetes support and education and 385 to intensive lifestyle intervention. Increasing baseline BBM levels were not associated with any cognitive composite z score. Increasing levels of NfL (β = -0.032 [SE, 0.013]; P = .01) and GFAP (β = -0.087 [SE, 0.025]; P < .001), but not the Aβ42/40 ratio (β = 0.006 [SE, 0.040]; P = .88) or pTau-181 (β = 0.026 [SE, 0.025]; P = .31), were associated with worsening cognitive function and incident mild cognitive impairment or probable dementia. The intervention had no association with 8- to 12-year change in BBM levels.</p><p><strong>Conclusions and relevance: </strong>In this study of participants with T2D and overweight or obesity, increasing plasma NfL and GFAP levels over time, but not Aβ42/40 or pTau-181 levels, were associated with cognitive decline and incident cognitive impairment. These results suggest that plasma NfL and GFAP may be important biomarkers of cognitive change among this patient popula
{"title":"Alzheimer Disease Blood Biomarkers and Cognition Among Individuals With Diabetes and Overweight or Obesity.","authors":"Michelle M Mielke, Joni K Evans, Rebecca H Neiberg, Doris P Molina-Henry, Santica M Marcovina, Karen C Johnson, Owen T Carmichael, Stephen R Rapp, Bonnie C Sachs, Jingzhong Ding, Heather M Shappell, Jose A Luchsinger, Mark A Espeland, Kathleen M Hayden","doi":"10.1001/jamanetworkopen.2024.58149","DOIUrl":"10.1001/jamanetworkopen.2024.58149","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Blood-based biomarkers (BBMs) are clinically available to aid in the diagnosis of Alzheimer disease (AD) and AD-related dementias (ADRD), but their association with cognition among older adults with specific chronic conditions has not been examined.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To longitudinally examine associations between baseline AD and ADRD BBMs and change in BBMs with cognition among participants with type 2 diabetes (T2D) and overweight or obesity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;The Look AHEAD (Action for Health in Diabetes) study was a clinical trial of older adults with T2D and overweight or obesity randomized to a 10-year intensive lifestyle intervention for weight loss or a diabetes support and education condition. Participants were recruited and followed up at 16 clinical sites across the US. Enrollment occurred from January 1, 2001, to December 31, 2004. The primary intervention spanned the first 4 years after participants' enrollment (January 1, 2008, to December 31, 2011). The clinical trial was stopped in September 2012 and was converted to an observational study. Blood samples were drawn at baseline and 8 to 12 years later. Cognitive assessments were performed from January 1, 2013, to December 31, 2014, and from January 1, 2018, to December 31, 2020. Data for the present cohort study were analyzed between January and August 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposures: &lt;/strong&gt;Baseline and 8- to 12-year change in plasma levels of amyloid-β (Aβ)40, Aβ42, Aβ42/40 ratio, phosphorylated tau 181 (pTau-181), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Cognitive composite z score and adjudicated mild cognitive impairment or probable dementia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The mean (SD) baseline age of 758 participants was 61.5 (6.1) years, and 424 participants [55.9%] were female. Mean (SD) body mass index was 34.8 (5.3). Of the participants, 373 were randomized to diabetes support and education and 385 to intensive lifestyle intervention. Increasing baseline BBM levels were not associated with any cognitive composite z score. Increasing levels of NfL (β = -0.032 [SE, 0.013]; P = .01) and GFAP (β = -0.087 [SE, 0.025]; P &lt; .001), but not the Aβ42/40 ratio (β = 0.006 [SE, 0.040]; P = .88) or pTau-181 (β = 0.026 [SE, 0.025]; P = .31), were associated with worsening cognitive function and incident mild cognitive impairment or probable dementia. The intervention had no association with 8- to 12-year change in BBM levels.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this study of participants with T2D and overweight or obesity, increasing plasma NfL and GFAP levels over time, but not Aβ42/40 or pTau-181 levels, were associated with cognitive decline and incident cognitive impairment. These results suggest that plasma NfL and GFAP may be important biomarkers of cognitive change among this patient popula","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2458149"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Time to Act on a Growing Public Health Threat-Evidence of Elevated Mortality in Cannabis Use Disorder.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.57781
Laura J Bierut, Fang Fang
{"title":"Time to Act on a Growing Public Health Threat-Evidence of Elevated Mortality in Cannabis Use Disorder.","authors":"Laura J Bierut, Fang Fang","doi":"10.1001/jamanetworkopen.2024.57781","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2024.57781","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2457781"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exercise Interventions for Depression, Anxiety, and Quality of Life in Older Adults With Cancer: A Systematic Review and Meta-Analysis. 针对老年癌症患者抑郁、焦虑和生活质量的运动干预:系统回顾与元分析》。
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.57859
Rou Yi Soong, Chen Ee Low, Vanessa Ong, Isaac Sim, Charmaine Lee, Fattah Lee, Lucas Chew, Chun En Yau, Ainsley Ryan Yan Bin Lee, Matthew Zhixuan Chen

Importance: Cancer and its treatment negatively impact the mental health of older adults. The potential of exercise interventions as a complementary treatment to alleviate the psychological impacts of cancer is promising, but there are gaps in the current literature.

Objective: To determine if exercise interventions are associated with improvements in psychological outcomes among older adults with cancer.

Data sources: PubMed, Embase, PsycINFO, and Cochrane databases were searched from database inception to November 5, 2024. Search terms used were geriatrics, cancer, depression, anxiety, quality of life, and exercise interventions.

Study selection: English-language randomized clinical trials (RCTs) that analyzed the association of various exercise interventions with at least 1 of 3 psychological outcomes (depression, anxiety, or health-related quality-of-life [HRQOL]) were included. The control groups were given usual care. Studies were included if the mean age of participants was older than 60 years and had participants with a diagnosis of any cancer regardless of comorbidities.

Data extraction and synthesis: Studies were screened, and data were extracted by 2 independent authors. Random-effects meta-analyses and meta-regressions were used for analysis. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline was followed.

Main outcomes and measures: The primary outcomes were depression, anxiety, and HRQOL. Standardized mean difference (SMD) was used to quantify the association of exercise interventions with outcomes.

Results: A total of 27 RCTs with 1929 participants were included. Meta-analyses observed an association of exercise with a significant reduction in levels of depression (SMD = -0.53; 95% CI, -0.79 to -0.28) and anxiety (SMD = -0.39; 95% CI, -0.66 to -0.12) and improvements in overall HRQOL (SMD = 0.63; 95% CI, 0.10 to 1.17). Subgroup analyses revealed that mind-body exercise interventions were significantly associated with improved depression (SMD = -0.89; 95% CI, -1.51 to -0.27) and anxiety levels (SMD = -0.77; 95% CI, -1.54 to -0.01) compared with conventional exercise interventions.

Conclusion: In this systematic review and meta-analysis of 27 RCTs, exercise interventions were found to be associated with significantly reduced levels of depression and anxiety and significantly improved HRQOL in older adults with cancer. These findings suggest that health care professionals and policymakers should focus more on implementing exercise interventions to improve mental health outcomes in this vulnerable population.

{"title":"Exercise Interventions for Depression, Anxiety, and Quality of Life in Older Adults With Cancer: A Systematic Review and Meta-Analysis.","authors":"Rou Yi Soong, Chen Ee Low, Vanessa Ong, Isaac Sim, Charmaine Lee, Fattah Lee, Lucas Chew, Chun En Yau, Ainsley Ryan Yan Bin Lee, Matthew Zhixuan Chen","doi":"10.1001/jamanetworkopen.2024.57859","DOIUrl":"10.1001/jamanetworkopen.2024.57859","url":null,"abstract":"<p><strong>Importance: </strong>Cancer and its treatment negatively impact the mental health of older adults. The potential of exercise interventions as a complementary treatment to alleviate the psychological impacts of cancer is promising, but there are gaps in the current literature.</p><p><strong>Objective: </strong>To determine if exercise interventions are associated with improvements in psychological outcomes among older adults with cancer.</p><p><strong>Data sources: </strong>PubMed, Embase, PsycINFO, and Cochrane databases were searched from database inception to November 5, 2024. Search terms used were geriatrics, cancer, depression, anxiety, quality of life, and exercise interventions.</p><p><strong>Study selection: </strong>English-language randomized clinical trials (RCTs) that analyzed the association of various exercise interventions with at least 1 of 3 psychological outcomes (depression, anxiety, or health-related quality-of-life [HRQOL]) were included. The control groups were given usual care. Studies were included if the mean age of participants was older than 60 years and had participants with a diagnosis of any cancer regardless of comorbidities.</p><p><strong>Data extraction and synthesis: </strong>Studies were screened, and data were extracted by 2 independent authors. Random-effects meta-analyses and meta-regressions were used for analysis. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline was followed.</p><p><strong>Main outcomes and measures: </strong>The primary outcomes were depression, anxiety, and HRQOL. Standardized mean difference (SMD) was used to quantify the association of exercise interventions with outcomes.</p><p><strong>Results: </strong>A total of 27 RCTs with 1929 participants were included. Meta-analyses observed an association of exercise with a significant reduction in levels of depression (SMD = -0.53; 95% CI, -0.79 to -0.28) and anxiety (SMD = -0.39; 95% CI, -0.66 to -0.12) and improvements in overall HRQOL (SMD = 0.63; 95% CI, 0.10 to 1.17). Subgroup analyses revealed that mind-body exercise interventions were significantly associated with improved depression (SMD = -0.89; 95% CI, -1.51 to -0.27) and anxiety levels (SMD = -0.77; 95% CI, -1.54 to -0.01) compared with conventional exercise interventions.</p><p><strong>Conclusion: </strong>In this systematic review and meta-analysis of 27 RCTs, exercise interventions were found to be associated with significantly reduced levels of depression and anxiety and significantly improved HRQOL in older adults with cancer. These findings suggest that health care professionals and policymakers should focus more on implementing exercise interventions to improve mental health outcomes in this vulnerable population.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2457859"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Financial Incentives for COVID-19 Vaccination: A Cluster Randomized Clinical Trial.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.58542
John Ternovski, Sebastian Jilke, Florian Keppeler, Dominik Vogel
<p><strong>Importance: </strong>Prior studies found that financial incentives have small, positive direct effects in increasing COVID-19 vaccination rates, but unmeasured social spillovers (ie, changes in outcomes among untreated individuals who are socially exposed to policy beneficiaries) may diminish the overall effect of such policies.</p><p><strong>Objective: </strong>To assess the spillover effects of a COVID-19 vaccination financial incentive and assess whether incorporating estimates of spillover meaningfully affects broader evaluations of policy effectiveness.</p><p><strong>Design, setting, and participants: </strong>This population-level, address-cluster randomized clinical trial was conducted in November 2021. Participants were all adult (aged ≥18 years) residents of Ravensburg, Germany, who were randomly assigned to the treatment or control group. One resident in each address cluster was randomly selected to be an address-cluster representative. Address-cluster representatives in the treatment group received the treatment letter; all other cohabitants at that same address received the control letter. All individuals in addresses randomly assigned to the control group were mailed a control letter. Intention-to-treat data analysis was conducted from January 2022 to May 2024.</p><p><strong>Intervention: </strong>Control letters informed recipients about 7 upcoming free COVID-19 vaccination events. Treatment letters were identical to control letters, except they also offered €40 (US $41.46) for getting vaccinated at one of the events.</p><p><strong>Main outcome and measure: </strong>Primary and booster COVID-19 vaccination uptake was observed and recorded on site during the public vaccination events. Primary vaccinations were defined as either the first dose of a 1-dose vaccine or the first or second dose of a 2-doses vaccine. Boosters were defined as any dose after primary vaccination. Three types of commonly used treatment effects were analyzed: direct, spillover, and overall.</p><p><strong>Results: </strong>Among 41 548 Ravensburg residents (mean [SD] age, 49.96 [19.04] years; 51.3% female), 796 (1.9%) were vaccinated at 1 of the 7 public vaccination events. The direct, spillover, and overall effects of receiving a financial incentive on primary vaccinations were all nonsignificant. For booster vaccinations, the direct effect was negative but not statistically significant (-0.32 percentage points [95% CI, -0.77 to 0.14 percentage points]; P = .17), whereas the overall effect (-0.30 percentage points [95% CI, -0.51 to -0.09 percentage points]; P = .006) was significantly negative. The spillover effect was significantly negative (-0.29 percentage points [95% CI, -0.53 to -0.06 percentage points]; P = .01), but only for the first vaccination events.</p><p><strong>Conclusions and relevance: </strong>This trial found null direct effects on COVID-19 vaccination uptake and negative effects on booster uptake among individuals who did not recei
{"title":"Financial Incentives for COVID-19 Vaccination: A Cluster Randomized Clinical Trial.","authors":"John Ternovski, Sebastian Jilke, Florian Keppeler, Dominik Vogel","doi":"10.1001/jamanetworkopen.2024.58542","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2024.58542","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Prior studies found that financial incentives have small, positive direct effects in increasing COVID-19 vaccination rates, but unmeasured social spillovers (ie, changes in outcomes among untreated individuals who are socially exposed to policy beneficiaries) may diminish the overall effect of such policies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the spillover effects of a COVID-19 vaccination financial incentive and assess whether incorporating estimates of spillover meaningfully affects broader evaluations of policy effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This population-level, address-cluster randomized clinical trial was conducted in November 2021. Participants were all adult (aged ≥18 years) residents of Ravensburg, Germany, who were randomly assigned to the treatment or control group. One resident in each address cluster was randomly selected to be an address-cluster representative. Address-cluster representatives in the treatment group received the treatment letter; all other cohabitants at that same address received the control letter. All individuals in addresses randomly assigned to the control group were mailed a control letter. Intention-to-treat data analysis was conducted from January 2022 to May 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Intervention: &lt;/strong&gt;Control letters informed recipients about 7 upcoming free COVID-19 vaccination events. Treatment letters were identical to control letters, except they also offered €40 (US $41.46) for getting vaccinated at one of the events.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome and measure: &lt;/strong&gt;Primary and booster COVID-19 vaccination uptake was observed and recorded on site during the public vaccination events. Primary vaccinations were defined as either the first dose of a 1-dose vaccine or the first or second dose of a 2-doses vaccine. Boosters were defined as any dose after primary vaccination. Three types of commonly used treatment effects were analyzed: direct, spillover, and overall.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 41 548 Ravensburg residents (mean [SD] age, 49.96 [19.04] years; 51.3% female), 796 (1.9%) were vaccinated at 1 of the 7 public vaccination events. The direct, spillover, and overall effects of receiving a financial incentive on primary vaccinations were all nonsignificant. For booster vaccinations, the direct effect was negative but not statistically significant (-0.32 percentage points [95% CI, -0.77 to 0.14 percentage points]; P = .17), whereas the overall effect (-0.30 percentage points [95% CI, -0.51 to -0.09 percentage points]; P = .006) was significantly negative. The spillover effect was significantly negative (-0.29 percentage points [95% CI, -0.53 to -0.06 percentage points]; P = .01), but only for the first vaccination events.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;This trial found null direct effects on COVID-19 vaccination uptake and negative effects on booster uptake among individuals who did not recei","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2458542"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Age-Related Changes in Brain Structure in Pediatric Chronic Kidney Disease.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.57601
Ellen van der Plas, Eric Nelson, Brian Becknell, Anne E Dawson, Camille S Wilson, Jeffrey D Dawson, Joseph L Alge, Lyndsay A Harshman

Importance: Pediatric patients with chronic kidney disease (CKD) exhibit reduced cerebellum volume, which is associated with neurocognitive deficits and a lower estimated glomerular filtration rate (eGFR), even before dialysis or transplantation. These differences have not been examined within the context of age-related brain changes during childhood to early adulthood.

Objective: To evaluate differences in age-related neurodevelopmental changes in patients with CKD compared with control participants and to investigate associations between regional neuroanatomy, functional outcomes, and disease-related variables.

Design, setting, and participants: Case-control study of individuals aged 6 through 21 years with and without CKD at an academic medical center in Iowa City, Iowa, from September 2016 to August 2024.

Exposures: Neurocognitive testing; 3-T magnetic resonance imaging.

Main outcomes and measures: Participants completed standardized neurocognitive assessments and quantitative neuroanatomical scans. Brain regions of interest (ROIs) were analyzed for volumetric differences using automated pipelines. Multivariable linear models assessed neurocognitive and neuroanatomical differences between groups, including an age × group interaction for ROI analyses.

Results: The sample included 124 individuals (mean [SD] age, 12.8 [4.5] years; 74 [59.7%] male), including 87 control participants (44 [50.6%] male) and 37 participants with CKD (30 [81.1%] male). The mean (SD) eGFR was 71.3 [25.5] mL/min/1.73 m2 for the CKD group. Participants with CKD scored lower than control participants on most neurocognitive measures included in the analyses. The CKD group showed differential age-related changes in cerebellar gray matter (β = -0.10; 95% CI, -0.18 to -0.01; Cohen f = 0.22) and white matter (β = -0.09; 95% CI, -0.19 to -0.00; Cohen f = 0.19). The age × group interaction approached but did not reach significance for amygdala volume (β = 0.09; 95% CI, -0.01 to 0.19; Cohen f = 0.18; P = .06). Volumetric variation in these regions was associated with proxy ratings of executive function in patients with CKD. A significant, positive association between cerebellar gray matter and eGFR was observed in the CKD group (β = 0.04; 95% CI, 0.00 to 0.02; P = .01).

Conclusions and relevance: In this case-control study, age-related neurodevelopmental differences were observed in pediatric patients with CKD compared with healthy peers. Reductions in cerebellar volume were associated with cognitive deficits and lower kidney function. These findings underscore the importance of monitoring neurodevelopmental trajectories in children with CKD, as early interventions may be necessary to mitigate cognitive impairments associated with CKD.

{"title":"Age-Related Changes in Brain Structure in Pediatric Chronic Kidney Disease.","authors":"Ellen van der Plas, Eric Nelson, Brian Becknell, Anne E Dawson, Camille S Wilson, Jeffrey D Dawson, Joseph L Alge, Lyndsay A Harshman","doi":"10.1001/jamanetworkopen.2024.57601","DOIUrl":"10.1001/jamanetworkopen.2024.57601","url":null,"abstract":"<p><strong>Importance: </strong>Pediatric patients with chronic kidney disease (CKD) exhibit reduced cerebellum volume, which is associated with neurocognitive deficits and a lower estimated glomerular filtration rate (eGFR), even before dialysis or transplantation. These differences have not been examined within the context of age-related brain changes during childhood to early adulthood.</p><p><strong>Objective: </strong>To evaluate differences in age-related neurodevelopmental changes in patients with CKD compared with control participants and to investigate associations between regional neuroanatomy, functional outcomes, and disease-related variables.</p><p><strong>Design, setting, and participants: </strong>Case-control study of individuals aged 6 through 21 years with and without CKD at an academic medical center in Iowa City, Iowa, from September 2016 to August 2024.</p><p><strong>Exposures: </strong>Neurocognitive testing; 3-T magnetic resonance imaging.</p><p><strong>Main outcomes and measures: </strong>Participants completed standardized neurocognitive assessments and quantitative neuroanatomical scans. Brain regions of interest (ROIs) were analyzed for volumetric differences using automated pipelines. Multivariable linear models assessed neurocognitive and neuroanatomical differences between groups, including an age × group interaction for ROI analyses.</p><p><strong>Results: </strong>The sample included 124 individuals (mean [SD] age, 12.8 [4.5] years; 74 [59.7%] male), including 87 control participants (44 [50.6%] male) and 37 participants with CKD (30 [81.1%] male). The mean (SD) eGFR was 71.3 [25.5] mL/min/1.73 m2 for the CKD group. Participants with CKD scored lower than control participants on most neurocognitive measures included in the analyses. The CKD group showed differential age-related changes in cerebellar gray matter (β = -0.10; 95% CI, -0.18 to -0.01; Cohen f = 0.22) and white matter (β = -0.09; 95% CI, -0.19 to -0.00; Cohen f = 0.19). The age × group interaction approached but did not reach significance for amygdala volume (β = 0.09; 95% CI, -0.01 to 0.19; Cohen f = 0.18; P = .06). Volumetric variation in these regions was associated with proxy ratings of executive function in patients with CKD. A significant, positive association between cerebellar gray matter and eGFR was observed in the CKD group (β = 0.04; 95% CI, 0.00 to 0.02; P = .01).</p><p><strong>Conclusions and relevance: </strong>In this case-control study, age-related neurodevelopmental differences were observed in pediatric patients with CKD compared with healthy peers. Reductions in cerebellar volume were associated with cognitive deficits and lower kidney function. These findings underscore the importance of monitoring neurodevelopmental trajectories in children with CKD, as early interventions may be necessary to mitigate cognitive impairments associated with CKD.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2457601"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Error in the Byline, Abstract, and Results.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2025.0680
{"title":"Error in the Byline, Abstract, and Results.","authors":"","doi":"10.1001/jamanetworkopen.2025.0680","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.0680","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e250680"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perioperative Factor Xa Inhibitor Discontinuation for Patients Undergoing Procedures With Minimal or Low Bleeding Risk.
IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1001/jamanetworkopen.2024.58742
So-Ryoung Lee, Kyung-Yeon Lee, Jong-Sung Park, Young Soo Lee, Yong Seog Oh, Sang-Jin Han, June Namgung, Ji Hyun Lee, Woo-Hyun Lim, Min Soo Ahn, Soonil Kwon, Hyo-Jeong Ahn, Seil Oh, Gregory Y H Lip, Eue-Keun Choi
<p><strong>Importance: </strong>Discontinuation of oral anticoagulant treatment is common in clinical practice due to concerns about bleeding, even for procedures with minimal to low bleeding risk.</p><p><strong>Objective: </strong>To explore whether perioperative discontinuation of factor Xa inhibitors is associated with major bleeding and thromboembolic events in patients with atrial fibrillation (AF) undergoing procedures with minimal to low bleeding risk.</p><p><strong>Design, setting, and participants: </strong>This prospective, multicenter, single-arm cohort study conducted in Korea included patients with AF who planned to undergo a procedure with minimal to low bleeding risk between September 25, 2020, and April 5, 2024.</p><p><strong>Exposure: </strong>The PERIXa (Perioperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Undergoing Minimal to Low Bleed Risk Procedures) protocol recommending giving the last dose of factor Xa inhibitor (ie, apixaban, edoxaban, or rivaroxaban) 24 hours before the procedure (ie, endoscopy, dental procedure, or ocular surgery) and restarting treatment with the inhibitor the next day.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was major bleeding, and the secondary outcome included a composite of thromboembolic events 30 days after the index procedure with minimal to low bleeding risk.</p><p><strong>Results: </strong>In total, 1902 patients were included in the modified intention-to-treat analysis set encompassing all patients who underwent the intended procedure (mean [SD] age, 70.4 [8.8] years; 1135 [59.7%] male; mean [SD] CHA2DS2-VASc [congestive heart failure, hypertension, age 75 years or older, diabetes, stroke, vascular disease, age 65-74 years, and female sex; range, 0-9, with higher scores indicating higher risk of stroke] score, 2.8 [1.3]; mean [SD] HAS-BLED [hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65 years, and drug or alcohol use; range, 0-9, with higher scores indicating higher risk of bleeding] score, 1.6 [0.7]). Among them, 921 (48.4%) were receiving apixaban, 616 (32.4%) were receiving edoxaban, and 365 (19.2%) were receiving rivaroxaban. Of the total procedures, 948 (49.8%) were endoscopy, 820 (43.1%) were dental procedures, and 120 (6.3%) were ocular surgery. The 30-day event rate of major bleeding was 0.1% (n = 2), and there were no composite thromboembolic events. The results were consistent in the per-protocol analysis, and no differences were observed by procedure category or factor Xa inhibitor type.</p><p><strong>Conclusions and relevance: </strong>In this cohort study, patients with AF receiving a factor Xa inhibitor and undergoing a procedure with minimal to low bleeding risk had low rates of major bleeding and thromboembolism when following the standardized PERIXa protocol for perioperative management of oral anticoagulant treatment, suggesting that this
{"title":"Perioperative Factor Xa Inhibitor Discontinuation for Patients Undergoing Procedures With Minimal or Low Bleeding Risk.","authors":"So-Ryoung Lee, Kyung-Yeon Lee, Jong-Sung Park, Young Soo Lee, Yong Seog Oh, Sang-Jin Han, June Namgung, Ji Hyun Lee, Woo-Hyun Lim, Min Soo Ahn, Soonil Kwon, Hyo-Jeong Ahn, Seil Oh, Gregory Y H Lip, Eue-Keun Choi","doi":"10.1001/jamanetworkopen.2024.58742","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2024.58742","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Discontinuation of oral anticoagulant treatment is common in clinical practice due to concerns about bleeding, even for procedures with minimal to low bleeding risk.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To explore whether perioperative discontinuation of factor Xa inhibitors is associated with major bleeding and thromboembolic events in patients with atrial fibrillation (AF) undergoing procedures with minimal to low bleeding risk.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This prospective, multicenter, single-arm cohort study conducted in Korea included patients with AF who planned to undergo a procedure with minimal to low bleeding risk between September 25, 2020, and April 5, 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposure: &lt;/strong&gt;The PERIXa (Perioperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Undergoing Minimal to Low Bleed Risk Procedures) protocol recommending giving the last dose of factor Xa inhibitor (ie, apixaban, edoxaban, or rivaroxaban) 24 hours before the procedure (ie, endoscopy, dental procedure, or ocular surgery) and restarting treatment with the inhibitor the next day.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The primary outcome was major bleeding, and the secondary outcome included a composite of thromboembolic events 30 days after the index procedure with minimal to low bleeding risk.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In total, 1902 patients were included in the modified intention-to-treat analysis set encompassing all patients who underwent the intended procedure (mean [SD] age, 70.4 [8.8] years; 1135 [59.7%] male; mean [SD] CHA2DS2-VASc [congestive heart failure, hypertension, age 75 years or older, diabetes, stroke, vascular disease, age 65-74 years, and female sex; range, 0-9, with higher scores indicating higher risk of stroke] score, 2.8 [1.3]; mean [SD] HAS-BLED [hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age &gt;65 years, and drug or alcohol use; range, 0-9, with higher scores indicating higher risk of bleeding] score, 1.6 [0.7]). Among them, 921 (48.4%) were receiving apixaban, 616 (32.4%) were receiving edoxaban, and 365 (19.2%) were receiving rivaroxaban. Of the total procedures, 948 (49.8%) were endoscopy, 820 (43.1%) were dental procedures, and 120 (6.3%) were ocular surgery. The 30-day event rate of major bleeding was 0.1% (n = 2), and there were no composite thromboembolic events. The results were consistent in the per-protocol analysis, and no differences were observed by procedure category or factor Xa inhibitor type.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this cohort study, patients with AF receiving a factor Xa inhibitor and undergoing a procedure with minimal to low bleeding risk had low rates of major bleeding and thromboembolism when following the standardized PERIXa protocol for perioperative management of oral anticoagulant treatment, suggesting that this","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 2","pages":"e2458742"},"PeriodicalIF":10.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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JAMA Network Open
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