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Clinical Research's Intangible Return on Investment on Clinicians, Institutions, and Communities. 临床研究对临床医生、机构和社区的无形投资回报。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.55770
Helen Burstin
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引用次数: 0
Financial Toxicity, Hope, and Satisfaction With Life in Patients Receiving Ambulatory Cancer Care. 接受癌症门诊治疗患者的财务毒性、希望和生活满意度。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.57328
Grace L Smith, David B Feldman, Hilary Ma, Christina Checka, Michael E Roth, James C Tucker, Cynthia Anderson, Marin Xavier, Jodi Kagihara, Ethan B Ludmir, Chi-Fang Wu, Edna Paredes, Kathrin Milbury, Benjamin W Corn
<p><strong>Importance: </strong>Financial toxicity significantly affects individuals with cancer, impacting not only treatment adherence and outcomes but also psychological dimensions such as satisfaction with life (SWL). Identifying mediators of psychological outcomes of financial toxicity, including hopefulness and social support, is critical for informing interventions to mitigate financial toxicity burdens.</p><p><strong>Objective: </strong>To examine the association of financial toxicity with hopefulness, social support, and SWL in patients with cancer, and to test the roles of hopefulness and social support in the association between financial toxicity and SWL.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional analysis assessed baseline patient-reported financial toxicity from participants of the prospective, multisite Economic Strain and Resilience in Cancer-II (ENRICh-II) study who enrolled from August 2020 to December 2022. Included patients were adults receiving ambulatory cancer care for various malignant neoplasm types diagnosed in the year prior from academic, community-based, and federally qualified health centers across 6 oncology clinics. Data were primarily analyzed between January and June 2024.</p><p><strong>Exposure: </strong>Financial toxicity was assessed using the ENRICh instrument, which measures global financial toxicity burden and financial toxicity-related material, coping, and psychological distress burden subdomain scores.</p><p><strong>Main outcomes and measures: </strong>The Satisfaction with Life Scale measured life satisfaction. Hypothesized mediators were measured using the State Hope Scale and Medical Outcomes Study Social Support Survey. A bootstrapping approach to multiple mediation was applied, controlling for demographic and clinical covariates.</p><p><strong>Results: </strong>A total of 519 participants were surveyed (mean [SD] age, 52.0 [15.2] years; 349 female [67.2%]; 49 Black [9.4%], 137 Hispanic [26.4%], 278 White [53.6%]). The most common cancers included breast (202 [38.9%]); colon, rectum, and anal (111 [21.4%]); biliary, liver, pancreatic, and stomach (65 [12.5%]); and leukemia, lymphoma, and other hematologic malignant neoplasms (53 [10.2%]). Higher financial toxicity was significantly associated with lower SWL (r = -0.34, P < .001). Hopefulness and social support each partially mediated this association (social support, -0.03 [95% CI, -0.06 to -0.01]; hope, -0.08, [95% CI, -0.12 to -0.03]). The combined multiple mediation path was significant (-0.02 [95% CI, -0.04 to -0.01]). These associations also existed for the material, coping, and psychological distress financial toxicity domains.</p><p><strong>Conclusions and relevance: </strong>In this multisite, cross-sectional study, greater financial toxicity burden was associated with lower life satisfaction; individuals' hopefulness and perceived social support levels-representing dimensions of psychosocial resilience-sta
重要性:财务毒性对癌症患者有显著影响,不仅影响治疗依从性和结果,还影响心理维度,如生活满意度(SWL)。确定金融毒性心理结果的中介因素,包括希望和社会支持,对于告知干预措施以减轻金融毒性负担至关重要。目的:探讨癌症患者的金融毒性与希望、社会支持和自愿行为的关系,并检验希望和社会支持在金融毒性与自愿行为的关系中的作用。设计、环境和参与者:本横断面分析评估了2020年8月至2022年12月入组的前瞻性、多地点癌症ii期经济压力和恢复力(enrici - ii)研究参与者的基线患者报告的财务毒性。纳入的患者是在6个肿瘤诊所的学术、社区和联邦合格的健康中心接受门诊癌症治疗的各种恶性肿瘤类型的成年人。数据主要分析于2024年1月至6月之间。暴露:使用ENRICh工具评估金融毒性,该工具测量全球金融毒性负担和金融毒性相关材料、应对和心理困扰负担子域得分。主要结果和测量方法:生活满意度量表测量生活满意度。使用国家希望量表和医疗结果研究社会支持调查来测量假设的中介。在控制人口统计学和临床协变量的情况下,对多重中介采用了自举方法。结果:共调查519名参与者(平均[SD]年龄52.0[15.2]岁,女性349人[67.2%],黑人49人[9.4%],西班牙裔137人[26.4%],白人278人[53.6%])。最常见的癌症包括乳腺癌(202例[38.9%]);结肠、直肠和肛门(111例[21.4%]);胆道、肝脏、胰腺和胃(65例[12.5%]);白血病、淋巴瘤和其他血液恶性肿瘤(53例[10.2%])。较高的财务毒性与较低的SWL显著相关(r = -0.34, P)。结论和相关性:在这项多地点、横断面研究中,较高的财务毒性负担与较低的生活满意度相关;个体的希望和感知到的社会支持水平(代表社会心理弹性的维度)在统计上介导了这种关联。这些结果支持一种方法,该方法将纳入加强心理社会恢复力因素的战略,并结合当前的财政援助,以帮助减轻与癌症相关的财政毒性的下游影响。
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引用次数: 0
Cerebral Oximetry-Guided Treatment and Cerebral Oxygenation in Extremely Preterm Infants: A Randomized Clinical Trial. 脑氧测量指导治疗和极早产儿脑氧合:一项随机临床试验。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.57620
Pranav R Jani, Traci-Anne Goyen, Kiran Kumar Balegar, Rajesh Maheshwari, Maria Saito-Benz, Tim Schindler, James Moore, Manelle Merhi, Melinda Cruz, Yang Song, Hayley McDonagh, Melissa Luig, Mark Tracy, Daphne D'Cruz, Aldo Perdomo, Stephanie Morakeas, Vishnu Dasireddy, Mihaela Culcer, Vijay Shingde, Karen Bennington, Joanna Michalowski, Andreja Fucek, Jennifer Querim, Sean Stevens, James Santanelli, James Elhindi, Brian Gloss, Robert Halliday, Dharmesh Shah, Himanshu Popat

Importance: Preterm infants are at high risk of developing brain injury, and near-infrared spectroscopy (NIRS) offers the ability to measure cerebral oxygenation. The impact of using a standardized treatment guideline combined with a single NIRS device manufacturer (Nonin Medical Inc) and neonatal sensor on cerebral oxygenation has not been previously examined.

Objective: To investigate whether cerebral oximetry with a dedicated treatment guideline improves cerebral oxygenation stability.

Design, setting, and participants: This was a single-blinded, 2-arm randomized clinical trial conducted from October 2021 to July 2024 at 5 tertiary neonatal intensive care units across Australia, New Zealand, and the US. Infants born at less than 29 weeks' gestation and aged younger than 6 hours underwent 1:1 random allocation stratified by gestational age (<26 weeks and ≥26 weeks) and study site.

Intervention: The intervention group received cerebral oximetry and dedicated guideline-based treatment when cerebral oxygenation was outside the range of 65% to 90%. The control group had blinded cerebral oximetry and treatment guided by standard clinical monitoring.

Main outcomes and measures: The burden of cerebral hypoxia and hyperoxia during the first 5 days after birth expressed as percentage hours was the primary outcome. Key secondary outcomes were mortality, morbidities before discharge, and NIRS-related skin injury.

Results: Of 149 screened infants (53 randomized to the intervention and 51 randomized to standard care), 100 infants were included in the final analysis (median [IQR] gestational age, 27 [25-28] weeks; 48 male [48.0%]). The median (IQR) birth weight was 883 (709-1079) g. The intervention group (50 infants) had a significantly lower median (IQR) burden of hypoxia and hyperoxia of 5.7% hours (2.8% hours to 15.0% hours) compared with 39.6% hours (6.5% hours to 82.3% hours) in the standard care group (50 infants), with an adjusted reduction of 42.8% hours (95% CI, 35.6% hours to 53.3% hours; P < .001). Mortality, morbidities before discharge, and safety outcomes were comparable between groups.

Conclusions and relevance: In this study, treatment guided by cerebral oximetry with a single device manufacturer and a neonatal sensor significantly improved the stability of cerebral oxygenation in extremely preterm infants. Larger multicenter trials are warranted to determine if this finding leads to improved survival without brain injury.

Trial registration: Australian New Zealand Clinical Trials Registry registration number ACTRN12621000778886.

重要性:早产儿发生脑损伤的风险很高,近红外光谱(NIRS)提供了测量脑氧合的能力。使用标准化治疗指南与单一NIRS设备制造商(Nonin Medical Inc)和新生儿传感器联合使用对脑氧合的影响此前尚未研究过。目的:探讨专用治疗指南下脑血氧测定是否能提高脑氧稳定性。设计、环境和参与者:这是一项单盲、双组随机临床试验,于2021年10月至2024年7月在澳大利亚、新西兰和美国的5个三级新生儿重症监护室进行。小于29周、小于6小时出生的婴儿按胎龄进行1:1随机分层(干预:干预组脑氧合在65% - 90%范围外时,接受脑氧饱和度测定和专门的基于指南的治疗)。对照组采用盲法脑血氧测定,在标准临床监测指导下治疗。主要观察指标:出生后5天脑缺氧和高氧负荷以百分比小时表示为主要观察指标。主要的次要结局是死亡率、出院前发病率和nirs相关的皮肤损伤。结果:在149名被筛选的婴儿中(53名随机分配到干预组,51名随机分配到标准护理组),有100名婴儿被纳入最终分析(中位[IQR]胎龄,27[25-28]周;48名男性[48.0%])。出生体重中位数(IQR)为883 (709-1079)g。干预组(50名婴儿)的低氧和高氧负担中位数(IQR)显著低于标准护理组(50名婴儿)的39.6%(6.5% - 82.3%)小时,调整后减少42.8%小时(95% CI, 35.6% - 53.3%);结论及相关性:在本研究中,在单一设备制造商和新生儿传感器的指导下,脑氧饱和度测量可显著改善极早产儿脑氧合的稳定性。需要更大规模的多中心试验来确定这一发现是否会提高无脑损伤的生存率。试验注册:澳大利亚新西兰临床试验注册中心注册号ACTRN12621000778886。
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引用次数: 0
National Support for Wealth-Building for Children From Low-Income Households. 国家对低收入家庭儿童致富的支持。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.58092
Catherine K Ettman, Andrew Anderson, Megan V Smith, David Radcliffe, Brian C Castrucci, Sandro Galea
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引用次数: 0
Comparative Safety of Advanced Therapies for Crohn Disease. 克罗恩病先进疗法的比较安全性
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.57922
Soo-Kyung Park, Dhruv Ahuja, Kuan-Hung Yeh, Sagar B Patel, Shane W Goodwin, Christopher Ma, Namrata Singh, Ashwin N Ananthakrishnan, Vipul Jairath, Ronghui Xu, Siddharth Singh
<p><strong>Importance: </strong>With the availability of multiple classes of advanced therapies for the treatment of Crohn disease (CD), understanding the comparative safety of different therapies can inform treatment positioning.</p><p><strong>Objective: </strong>To compare the risk of serious infections, venous thromboembolism (VTE), and major adverse cardiovascular events (MACE) with different advanced therapies in patients with CD.</p><p><strong>Design, setting, and participants: </strong>This retrospective comparative effectiveness research study was conducted between January 1, 2016, and December 31, 2022, with a mean (SD) follow-up of 26.9 (2.4) months until July 1, 2024. Using an administrative claims database (OptumLabs Data Warehouse), commercially insured patients with CD, who initiated treatment with tumor necrosis factor-α (TNF) antagonists, anti-integrin agents (vedolizumab), interleukin (IL)-12/23p40 antagonists (ustekinumab), IL-23p19 antagonists (primarily risankizumab), or Janus kinase inhibitors (upadacitinib) between 2016 and 2022 and had follow-up for at least 1 year before and after treatment initiation, were included.</p><p><strong>Exposure: </strong>TNF antagonists vs anti-integrin agents (vedolizumab) vs IL-12/23p40 antagonists (ustekinumab) vs IL-23p19 antagonists (risankizumab) vs Janus kinase inhibitors (upadacitinib).</p><p><strong>Main outcomes and measures: </strong>The risk of serious infections, VTE, and MACE was compared with various advanced therapies through multinomial propensity score-based inverse probability treatment weighting, with propensity scores estimated through generalized boosted models, accounting for disease characteristics, health care utilization, comorbidities, and prior and concomitant medications, and through competing risk of mortality. Cause-specific hazard ratios (HRs) and 95% CIs for multiple treatment comparisons were calculated.</p><p><strong>Results: </strong>This study included 12 245 patients with CD (mean [SD] age, 46.5 [17.5] years; 6642 females [54.2%]), who were treated with TNF antagonists (n = 5274), vedolizumab (n = 2716), ustekinumab (n = 3544), risankizumab (n = 559), or upadacitinib (n = 152). Serious infection incidence rates ranged from 5.46 (95% CI, 4.86-6.07) to 9.02 (95% CI, 6.38-11.89) per 100 person-years across therapies. After adjusting for confounding variables, there were no statistically significant differences in the risk of serious infections across different agents, including between risankizumab and ustekinumab (HR, 1.14 [95% CI, 0.78-1.67]), risankizumab and TNF antagonists (HR, 1.00 [95% CI, 0.68-1.47]), or ustekinumab and TNF antagonists (HR, 0.88 [95% CI, 0.74-1.04]). The incidence of VTE (incidence rate, 0.90 [95% CI, 0.71-1.10] to 2.33 [95% CI, 1.06-3.82] per 100 person-years) and MACE (0.68 [95% CI, 0.51-0.85] to 1.49 [95% CI, 0.43-2.76] per 100 person-years) was low, without any significant differences across agents.</p><p><strong>Conclusions and re
重要性:随着克罗恩病(CD)治疗的多种先进疗法的可用性,了解不同疗法的相对安全性可以为治疗定位提供信息。目的:比较不同先进治疗方法对cd患者严重感染、静脉血栓栓塞(VTE)和主要心血管不良事件(MACE)的风险。设计、环境和参与者:这项回顾性比较疗效研究于2016年1月1日至2022年12月31日进行,平均(SD)随访26.9(2.4)个月,直至2024年7月1日。使用行政索赔数据库(OptumLabs数据仓库),纳入了商业保险的CD患者,这些患者在2016年至2022年间开始接受肿瘤坏死因子-α (TNF)拮抗剂、抗整合素(vedolizumab)、白细胞介素(IL)-12/23p40拮抗剂(ustekinumab)、IL-23p19拮抗剂(主要是risankizumab)或Janus激酶抑制剂(upadacitinib)治疗,并在治疗开始前后随访至少1年。暴露:TNF拮抗剂vs抗整合素药物(vedolizumab) vs IL-12/23p40拮抗剂(ustekinumab) vs IL-23p19拮抗剂(risankizumab) vs Janus激酶抑制剂(upadacitinib)。主要结局和措施:通过多项倾向评分为基础的逆概率治疗加权,比较各种先进疗法的严重感染、静脉血栓栓塞和MACE的风险,通过广义增强模型估计倾向评分,考虑疾病特征、医疗保健利用、合并症、既往和伴随用药,并通过竞争死亡风险。计算多种治疗比较的病因特异性风险比(hr)和95% ci。结果:本研究纳入12 245例CD患者(平均[SD]年龄46.5[17.5]岁;6642例女性[54.2%]),接受TNF拮抗剂(n = 5274)、vedolizumab (n = 2716)、ustekinumab (n = 3544)、risankizumab (n = 559)或upadacitinib (n = 152)治疗。不同治疗方法的严重感染发生率为每100人年5.46 (95% CI, 4.86-6.07)至9.02 (95% CI, 6.38-11.89)。在调整混杂变量后,不同药物之间严重感染的风险无统计学差异,包括利桑单抗和乌斯特金单抗(HR, 1.14 [95% CI, 0.78-1.67]),利桑单抗和TNF拮抗剂(HR, 1.00 [95% CI, 0.68-1.47]),或乌斯特金单抗和TNF拮抗剂(HR, 0.88 [95% CI, 0.74-1.04])。静脉血栓栓塞发生率(0.90 [95% CI, 0.71-1.10]至2.33 [95% CI, 1.06-3.82] / 100人年)和MACE发生率(0.68 [95% CI, 0.51-0.85]至1.49 [95% CI, 0.43-2.76] / 100人年)较低,各药物间无显著差异。结论和相关性:在这项针对CD患者的比较疗效研究中,各种先进治疗方法在严重感染、静脉血栓栓塞或MACE的风险方面没有发现显著差异。这些发现支持对大多数个体乳糜泻患者选择先进疗法的临床决策主要由比较治疗效果驱动,而不是由对严重不良事件的担忧驱动。
{"title":"Comparative Safety of Advanced Therapies for Crohn Disease.","authors":"Soo-Kyung Park, Dhruv Ahuja, Kuan-Hung Yeh, Sagar B Patel, Shane W Goodwin, Christopher Ma, Namrata Singh, Ashwin N Ananthakrishnan, Vipul Jairath, Ronghui Xu, Siddharth Singh","doi":"10.1001/jamanetworkopen.2025.57922","DOIUrl":"10.1001/jamanetworkopen.2025.57922","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;With the availability of multiple classes of advanced therapies for the treatment of Crohn disease (CD), understanding the comparative safety of different therapies can inform treatment positioning.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To compare the risk of serious infections, venous thromboembolism (VTE), and major adverse cardiovascular events (MACE) with different advanced therapies in patients with CD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This retrospective comparative effectiveness research study was conducted between January 1, 2016, and December 31, 2022, with a mean (SD) follow-up of 26.9 (2.4) months until July 1, 2024. Using an administrative claims database (OptumLabs Data Warehouse), commercially insured patients with CD, who initiated treatment with tumor necrosis factor-α (TNF) antagonists, anti-integrin agents (vedolizumab), interleukin (IL)-12/23p40 antagonists (ustekinumab), IL-23p19 antagonists (primarily risankizumab), or Janus kinase inhibitors (upadacitinib) between 2016 and 2022 and had follow-up for at least 1 year before and after treatment initiation, were included.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposure: &lt;/strong&gt;TNF antagonists vs anti-integrin agents (vedolizumab) vs IL-12/23p40 antagonists (ustekinumab) vs IL-23p19 antagonists (risankizumab) vs Janus kinase inhibitors (upadacitinib).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The risk of serious infections, VTE, and MACE was compared with various advanced therapies through multinomial propensity score-based inverse probability treatment weighting, with propensity scores estimated through generalized boosted models, accounting for disease characteristics, health care utilization, comorbidities, and prior and concomitant medications, and through competing risk of mortality. Cause-specific hazard ratios (HRs) and 95% CIs for multiple treatment comparisons were calculated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study included 12 245 patients with CD (mean [SD] age, 46.5 [17.5] years; 6642 females [54.2%]), who were treated with TNF antagonists (n = 5274), vedolizumab (n = 2716), ustekinumab (n = 3544), risankizumab (n = 559), or upadacitinib (n = 152). Serious infection incidence rates ranged from 5.46 (95% CI, 4.86-6.07) to 9.02 (95% CI, 6.38-11.89) per 100 person-years across therapies. After adjusting for confounding variables, there were no statistically significant differences in the risk of serious infections across different agents, including between risankizumab and ustekinumab (HR, 1.14 [95% CI, 0.78-1.67]), risankizumab and TNF antagonists (HR, 1.00 [95% CI, 0.68-1.47]), or ustekinumab and TNF antagonists (HR, 0.88 [95% CI, 0.74-1.04]). The incidence of VTE (incidence rate, 0.90 [95% CI, 0.71-1.10] to 2.33 [95% CI, 1.06-3.82] per 100 person-years) and MACE (0.68 [95% CI, 0.51-0.85] to 1.49 [95% CI, 0.43-2.76] per 100 person-years) was low, without any significant differences across agents.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and re","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"9 2","pages":"e2557922"},"PeriodicalIF":9.7,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12881986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131779","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
Trends in Nonsurgical Management for Low-Risk, Hormone Receptor-Positive Ductal Carcinoma In Situ. 低风险、激素受体阳性导管原位癌的非手术治疗趋势。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.58248
Yu Matsui, Jincong Q Freeman, Sarah Poland, Frederick M Howard, Nan Chen, Olufunmilayo I Olopade, Dezheng Huo
<p><strong>Importance: </strong>Active surveillance has emerged as a deescalation strategy for low-risk ductal carcinoma in situ (DCIS) to reduce overtreatment while maintaining favorable outcomes. Emerging data in low-risk DCIS, eg, the COMET trial, have highlighted growing interest in surveillance-based management for carefully selected patients. However, recent clinical adoption and national trends in managing low-risk, hormone receptor (HR)-positive DCIS have not been evaluated in the US.</p><p><strong>Objective: </strong>To examine trends and sociodemographic variations in nonsurgical management and other treatment modalities for low-risk, HR-positive DCIS.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study analyzed data from the National Cancer Database from January 1, 2004, to December 31, 2022, and included patients aged 18 years or older with grade 1 to 2, HR-positive DCIS and at least 12 months of follow-up since initial diagnosis. Analyses were performed between January 10 and August 31, 2025.</p><p><strong>Exposures: </strong>Year of diagnosis and sociodemographic characteristics.</p><p><strong>Main outcomes and measures: </strong>Nonsurgical management, lumpectomy alone, lumpectomy plus adjuvant radiotherapy, unilateral mastectomy, bilateral mastectomy, and endocrine therapy were measured using descriptive statistics.</p><p><strong>Results: </strong>A total of 316 590 female patients were included (mean [SD] age, 60.8 [12.0] years; 5.8% Asian or Pacific Islander, 13.9% Black, 6.1% Hispanic, 73.3% White, and 0.9% other race and ethnicity). From 2004 to 2022, nonsurgical management increased from 2.1% to 3.5%, bilateral mastectomy increased from 4.1% to 8.7%, and lumpectomy increased from 22.0% to 25.1%, while lumpectomy plus adjuvant radiotherapy decreased from 50.9% to 45.6% and unilateral mastectomy decreased from 20.9% to 17.1%. Nonsurgical management was more common among Black patients and patients with no insurance. Bilateral mastectomy was common in younger, White, and privately insured patients and those who lived in higher-income areas. Endocrine therapy use increased from 2004 to 2020 but declined thereafter. Endocrine therapy was highest after lumpectomy plus adjuvant radiotherapy (69.6%), followed by lumpectomy alone (43.9%), unilateral mastectomy (35.3%), and nonsurgical management (29.2%), with the lowest use in patients younger than 50 years in the no surgery (15.2%) and lumpectomy alone (38.6%) groups. Since 2018, radiotherapy use has increased and become progressively more risk adapted, with increasing use with higher Oncotype DX DCIS scores (low risk, 34.5%; intermediate risk, 63.9%; high risk, 73.1%).</p><p><strong>Conclusions and relevance: </strong>This cross-sectional study highlights increasing trends and socioeconomic disparities in the nonsurgical management of and the need for precision-based, patient-centered care for low-risk DCIS. Precision prevention may enhance the ident
重要性:主动监测已成为低风险导管原位癌(DCIS)的降级策略,以减少过度治疗,同时保持良好的结果。低风险DCIS的新数据,如COMET试验,突出了对精心挑选的患者进行基于监视的管理的兴趣。然而,最近的临床采用和国家趋势管理低风险,激素受体(HR)阳性DCIS尚未在美国进行评估。目的:探讨低风险hr阳性DCIS的非手术治疗和其他治疗方式的趋势和社会人口统计学差异。设计、环境和参与者:本横断面研究分析了2004年1月1日至2022年12月31日来自国家癌症数据库的数据,包括年龄在18岁或以上的1至2级、hr阳性DCIS患者,自初次诊断以来随访至少12个月。分析在2025年1月10日至8月31日之间进行。暴露:诊断年份和社会人口特征。主要结果和测量方法:采用描述性统计方法对非手术治疗、单纯乳房肿瘤切除术、乳房肿瘤切除术加辅助放疗、单侧乳房切除术、双侧乳房切除术和内分泌治疗进行测量。结果:共纳入316 590名女性患者(平均[SD]年龄60.8[12.0]岁;亚洲或太平洋岛民5.8%,黑人13.9%,西班牙裔6.1%,白人73.3%,其他种族和民族0.9%)。从2004年到2022年,非手术治疗从2.1%上升到3.5%,双侧乳房切除术从4.1%上升到8.7%,乳房肿瘤切除术从22.0%上升到25.1%,乳房肿瘤切除加辅助放疗从50.9%下降到45.6%,单侧乳房切除术从20.9%下降到17.1%。非手术治疗在黑人患者和没有保险的患者中更为常见。双侧乳房切除术在年轻、白人、私人保险患者和生活在高收入地区的患者中很常见。从2004年到2020年,内分泌治疗的使用有所增加,但此后有所下降。内分泌治疗在乳房肿瘤切除术加辅助放疗后最高(69.6%),其次是单独乳房肿瘤切除术(43.9%)、单侧乳房切除术(35.3%)和非手术治疗(29.2%),年龄小于50岁的患者中最低的是不手术组(15.2%)和单独乳房肿瘤切除术组(38.6%)。自2018年以来,放疗的使用有所增加,并逐渐变得更加适应风险,随着使用的增加,Oncotype DX DCIS评分更高(低风险,34.5%;中风险,63.9%;高风险,73.1%)。结论和相关性:本横断面研究强调了低风险DCIS非手术治疗的增长趋势和社会经济差异,以及对精确、以患者为中心的护理的需求。精确的预防可以加强对那些可以从预防性手术、长期内分泌治疗或治疗降级中获益最多的患者的识别,为个性化策略铺平道路。
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引用次数: 0
Error in Figure Keys. 图键错误。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2026.0872
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引用次数: 0
Disability and Relapse Risk in Late-Onset Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease. 迟发性髓鞘少突胶质细胞糖蛋白抗体相关疾病的残疾和复发风险
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.59471
Hyunjin Ju, Ki Hoon Kim, Sook Young Woo, Yeon Hak Chung, Ho Jin Kim, Hyunjin Kim, Eun-Jae Lee, Young-Min Lim, Woohee Ju, Sung-Min Kim, Young Nam Kwon, Seung Woo Kim, Ha Young Shin, In Soo Joo, Sohyeon Kim, Hung Youl Seok, Jeong Bin Bong, Byeol-A Yoon, Jong Kuk Kim, You-Ri Kang, Tai-Seung Nam, Sooyoung Kim, Eunhee Sohn, Woojun Kim, Jin Myoung Seok, Hyung-Soo Lee, Sun-Young Oh, Suk-Won Ahn, Sukyoon Lee, Tae-Kyeong Lee, Hye Lim Lee, Nam-Hee Kim, Jeeyoung Oh, Jee-Eun Kim, Soonwook Kwon, Seong-Il Oh, Min Su Park, Jong Seok Bae, Wookyung Kim, Jin-Woo Park, Byung-Jo Kim, Jiwon Yang, Su-Hyun Kim, Ju-Hong Min

Importance: The impact of late onset in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is still controversial.

Objective: To investigate the association of late onset MOGAD with moderate disability and relapse in Korean patients.

Design, setting, and participants: This nationwide, multicenter, retrospective cohort study included adult patients with a diagnosis of MOGAD according to the 2023 international diagnostic criteria between August 2018 and September 2024 across 28 hospitals in South Korea.

Exposure: Age at onset of MOGAD, categorized into adult-onset MOGAD (AO-MOGAD; 18-49 years) and late-onset MOGAD (LO-MOGAD; ≥50 years).

Main outcomes and measures: The primary outcomes were time to first relapse in patients with a disease duration of 12 or more months and moderate disability, defined as Expanded Disability Status Scale (EDSS) score of 3 or greater at last follow-up.

Results: A total of 350 patients (mean [SD] age at onset, 43.2 [15.0] years; 189 female [54.0%]) with a median (IQR) baseline EDSS of 3.0 (2.0-4.0) were included, with 124 patients (35.4%) with LO-MOGAD and 226 patients (64.6%) with AO-MOGAD. The LO-MOGAD group had less frequent brain involvement than the AO-MOGAD group at onset (26 patients [21.0%] vs 75 patients [33.2%]; P = .02) and during the disease course (28 patients [22.6%] vs 95 patients [42.0%]; P < .001), while optic neuritis or myelitis was comparable between the 2 groups. The LO-MOGAD group showed more frequent monophasic course (55 of 95 patients [57.9%] vs 75 of 188 patients [39.9%]; P = .004), but higher EDSS score at last follow-up (median [IQR], 2.0 [1.0-2.0] vs 1.0 [0.0-2.0]; P < .001) compared with those in the AO-MOGAD group. However, late onset was not significantly associated with the time to first relapse in multivariable analysis (adjusted hazard ratio, 0.72; 95% CI, 0.48-1.08; P = .11), which was consistent after propensity score matching. By contrast, late onset was associated with a significantly higher risk of moderate disability at the last follow-up (adjusted odds ratio, 2.84; 95% CI, 1.39-5.80; P = .004).

Conclusions and relevance: In this cohort study of MOGAD, late onset was not associated with a risk of relapse but with a higher risk of moderate disability at follow-up. Prospective studies with longer follow-up periods are warranted to better understand and manage patients with late-onset disease.

重要性:迟发性髓鞘少突胶质细胞糖蛋白抗体相关疾病(MOGAD)的影响仍有争议。目的:探讨韩国迟发性MOGAD与中度残疾和复发的关系。设计、环境和参与者:这项全国性、多中心、回顾性队列研究纳入了2018年8月至2024年9月韩国28家医院中根据2023年国际诊断标准诊断为MOGAD的成年患者。暴露:MOGAD发病年龄,分为成年性MOGAD (AO-MOGAD, 18-49岁)和迟发性MOGAD (LO-MOGAD,≥50岁)。主要结局和测量方法:主要结局是疾病持续12个月及以上且中度残疾的患者首次复发的时间,定义为最后随访时扩展残疾状态量表(EDSS)得分为3分或更高。结果:共纳入350例患者(平均[SD]发病年龄43.2[15.0]岁;189例女性[54.0%]),基线EDSS中位数(IQR)为3.0(2.0-4.0),其中LO-MOGAD患者124例(35.4%),AO-MOGAD患者226例(64.6%)。LO-MOGAD组发病时脑受累频率低于AO-MOGAD组(26例[21.0%]vs 75例[33.2%];P =。结论和相关性:在这项MOGAD队列研究中,晚发与复发风险无关,但随访时出现中度残疾的风险较高。为了更好地了解和管理迟发性疾病患者,有必要进行更长随访期的前瞻性研究。
{"title":"Disability and Relapse Risk in Late-Onset Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease.","authors":"Hyunjin Ju, Ki Hoon Kim, Sook Young Woo, Yeon Hak Chung, Ho Jin Kim, Hyunjin Kim, Eun-Jae Lee, Young-Min Lim, Woohee Ju, Sung-Min Kim, Young Nam Kwon, Seung Woo Kim, Ha Young Shin, In Soo Joo, Sohyeon Kim, Hung Youl Seok, Jeong Bin Bong, Byeol-A Yoon, Jong Kuk Kim, You-Ri Kang, Tai-Seung Nam, Sooyoung Kim, Eunhee Sohn, Woojun Kim, Jin Myoung Seok, Hyung-Soo Lee, Sun-Young Oh, Suk-Won Ahn, Sukyoon Lee, Tae-Kyeong Lee, Hye Lim Lee, Nam-Hee Kim, Jeeyoung Oh, Jee-Eun Kim, Soonwook Kwon, Seong-Il Oh, Min Su Park, Jong Seok Bae, Wookyung Kim, Jin-Woo Park, Byung-Jo Kim, Jiwon Yang, Su-Hyun Kim, Ju-Hong Min","doi":"10.1001/jamanetworkopen.2025.59471","DOIUrl":"10.1001/jamanetworkopen.2025.59471","url":null,"abstract":"<p><strong>Importance: </strong>The impact of late onset in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is still controversial.</p><p><strong>Objective: </strong>To investigate the association of late onset MOGAD with moderate disability and relapse in Korean patients.</p><p><strong>Design, setting, and participants: </strong>This nationwide, multicenter, retrospective cohort study included adult patients with a diagnosis of MOGAD according to the 2023 international diagnostic criteria between August 2018 and September 2024 across 28 hospitals in South Korea.</p><p><strong>Exposure: </strong>Age at onset of MOGAD, categorized into adult-onset MOGAD (AO-MOGAD; 18-49 years) and late-onset MOGAD (LO-MOGAD; ≥50 years).</p><p><strong>Main outcomes and measures: </strong>The primary outcomes were time to first relapse in patients with a disease duration of 12 or more months and moderate disability, defined as Expanded Disability Status Scale (EDSS) score of 3 or greater at last follow-up.</p><p><strong>Results: </strong>A total of 350 patients (mean [SD] age at onset, 43.2 [15.0] years; 189 female [54.0%]) with a median (IQR) baseline EDSS of 3.0 (2.0-4.0) were included, with 124 patients (35.4%) with LO-MOGAD and 226 patients (64.6%) with AO-MOGAD. The LO-MOGAD group had less frequent brain involvement than the AO-MOGAD group at onset (26 patients [21.0%] vs 75 patients [33.2%]; P = .02) and during the disease course (28 patients [22.6%] vs 95 patients [42.0%]; P < .001), while optic neuritis or myelitis was comparable between the 2 groups. The LO-MOGAD group showed more frequent monophasic course (55 of 95 patients [57.9%] vs 75 of 188 patients [39.9%]; P = .004), but higher EDSS score at last follow-up (median [IQR], 2.0 [1.0-2.0] vs 1.0 [0.0-2.0]; P < .001) compared with those in the AO-MOGAD group. However, late onset was not significantly associated with the time to first relapse in multivariable analysis (adjusted hazard ratio, 0.72; 95% CI, 0.48-1.08; P = .11), which was consistent after propensity score matching. By contrast, late onset was associated with a significantly higher risk of moderate disability at the last follow-up (adjusted odds ratio, 2.84; 95% CI, 1.39-5.80; P = .004).</p><p><strong>Conclusions and relevance: </strong>In this cohort study of MOGAD, late onset was not associated with a risk of relapse but with a higher risk of moderate disability at follow-up. Prospective studies with longer follow-up periods are warranted to better understand and manage patients with late-onset disease.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"9 2","pages":"e2559471"},"PeriodicalIF":9.7,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12905660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146179935","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
Pancreatic Cystic Neoplasm Risk Among Individuals With Diabetes. 糖尿病患者患胰腺囊性肿瘤的风险
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2025.56951
In Rae Cho, Sung Hoon Chang, Sang Hyub Lee, Kyung-Do Han, Kwang Hyun Chung, Min Woo Lee, Jin Ho Choi, Woo Hyun Paik, Ji Kon Ryu
<p><strong>Importance: </strong>With advancements in imaging technology and more frequent health evaluations, the incidence and prevalence of pancreatic cysts have gradually increased. Certain types of pancreatic cystic neoplasms are precancerous lesions associated with an increased risk of pancreatic cancer. Hence, identifying risk factors and preventing their occurrence are crucial. Nonetheless, population-based research on modifiable risk factors remains lacking.</p><p><strong>Objective: </strong>To investigate the association of diabetes and related factors with risk of developing pancreatic cysts.</p><p><strong>Design, setting, and participants: </strong>This population-based cohort study included adults (aged ≥20 years) who underwent health examinations in 2009 through medical institutions designated by the Korean National Health Insurance Service. Participants were followed up until December 31, 2020. Data were analyzed from March 23, 2023, to February 8, 2024.</p><p><strong>Exposure: </strong>All participants were categorized according to diabetes status as having normoglycemia, impaired fasting glucose, shorter diabetes duration (<5 years), or longer diabetes duration (≥5 years). Demographic characteristics, lifestyle factors, and comorbidities at the time of health examinations were investigated.</p><p><strong>Main outcomes and measures: </strong>Adjusted hazard ratios (AHRs) for pancreatic cyst occurrence for each diabetes status group were estimated using Cox proportional hazards regression models, adjusting for potential confounders.</p><p><strong>Results: </strong>Among the entire study population of 3 856 676 adults (mean [SD] age, 47.1 [14.0] years; 54.5% male), 330 138 (8.6%) had diabetes. The median observation period was 10.3 (IQR, 10.1-10.6) years. A total of 31 877 patients (0.8%) developed pancreatic cysts during the observation period. Compared with individuals with normoglycemia, AHRs for the development of pancreatic cysts were 1.06 (95% CI, 1.03-1.08) for those with impaired fasting glucose, 1.23 (1.18-1.28) for those with a shorter diabetes duration, and 1.37 (1.31-1.44) for those with a longer diabetes duration. Subgroup analyses showed higher AHRs for pancreatic cyst occurrence associated with diabetes among individuals younger than 60 years (AHR, 1.34 [95% CI, 1.27-1.40]), males (AHR, 1.32 [95% CI, 1.26-1.38]), and current smokers (AHR, 1.40 [95% CI, 1.30-1.51]) with diabetes compared with patients 60 years or older (AHR, 1.21 [95% CI, 1.16-1.27]), females (AHR, 1.20 [95% CI, 1.15-1.26]), never smokers (AHR, 1.22 [95% CI, 1.18-1.28]), and former smokers (AHR, 1.25 [95% CI, 1.16-1.35]) with diabetes.</p><p><strong>Conclusions and relevance: </strong>In this cohort study of 3 856 676 Korean adults, longer diabetes duration was associated with an increased risk of pancreatic cysts. The risk of pancreatic cyst occurrence was higher among younger male individuals with diabetes compared with their counterparts. Smoking ces
重要性:随着影像技术的进步和更频繁的健康评估,胰腺囊肿的发病率和患病率逐渐增加。某些类型的胰腺囊性肿瘤是与胰腺癌风险增加相关的癌前病变。因此,识别风险因素并预防其发生至关重要。然而,基于人群的可改变危险因素的研究仍然缺乏。目的:探讨糖尿病及其相关因素与胰腺囊肿发生的关系。设计、环境和参与者:这项以人群为基础的队列研究纳入了2009年通过韩国国民健康保险局指定的医疗机构进行健康检查的成年人(年龄≥20岁)。参与者被跟踪到2020年12月31日。数据分析时间为2023年3月23日至2024年2月8日。暴露:所有参与者根据糖尿病状态被分类为血糖正常、空腹血糖受损、糖尿病持续时间较短(主要结局和措施:使用Cox比例风险回归模型估计每个糖尿病状态组胰腺囊肿发生的调整风险比(AHRs),调整潜在混杂因素。结果:在整个研究人群中,3 856 676名成年人(平均[SD]年龄47.1[14.0]岁,男性54.5%),330 138(8.6%)患有糖尿病。中位观察期为10.3 (IQR, 10.1-10.6)年。观察期间共发生31 877例(0.8%)胰腺囊肿。与血糖正常的个体相比,空腹血糖受损患者胰腺囊肿发展的ahr为1.06 (95% CI, 1.03-1.08),糖尿病病程较短者为1.23(1.18-1.28),糖尿病病程较长者为1.37(1.31-1.44)。亚组分析显示,与60岁及以上的糖尿病患者(AHR, 1.21 [95% CI, 1.16-1.27])、男性(AHR, 1.32 [95% CI, 1.26-1.38])、当前吸烟者(AHR, 1.40 [95% CI, 1.30-1.51])、女性(AHR, 1.20 [95% CI, 1.15-1.26])、从不吸烟者(AHR, 1.22 [95% CI, 1.18-1.28])和既往吸烟者(AHR, 1.25 [95% CI, 1.16-1.35])相比,60岁及以上的糖尿病患者(AHR, 1.34 [95% CI, 1.27- 1.34])与糖尿病患者(AHR, 1.34 [95% CI, 1.27- 1.27])的AHR较高。结论和相关性:在这项涉及3 856 676名韩国成年人的队列研究中,糖尿病病程较长与胰腺囊肿风险增加相关。年轻男性糖尿病患者发生胰腺囊肿的风险高于同龄男性糖尿病患者。戒烟可以降低患胰腺囊肿的风险。需要进一步的研究结合影像学和纵向数据来阐明糖尿病患者胰腺囊肿的临床意义。
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引用次数: 0
Error in Commentary. 注释错误。
IF 9.7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-02 DOI: 10.1001/jamanetworkopen.2026.1505
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引用次数: 0
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JAMA Network Open
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