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A Yellow Book for Medical Devices—A Proposal for Public Health 医疗器械黄皮书——公共卫生建议
Pub Date : 2026-01-29 DOI: 10.1001/jama.2025.27042
David A. Simon, Michael K. Paasche-Orlow, Hooman Noorchashm
This Viewpoint proposes that the US Food and Drug Administration create a patent database for medical devices, the Yellow Book, similar to the Orange Book’s database of drug-related patents.
本观点建议美国食品和药物管理局创建一个医疗器械专利数据库,即黄皮书,类似于橙皮书的药物相关专利数据库。
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引用次数: 0
AI Use in Research and the Need for Continued Guidance. 人工智能在研究中的应用和对持续指导的需求。
Pub Date : 2026-01-28 DOI: 10.1001/jama.2025.26845
Preeti N Malani,Joseph S Ross
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引用次数: 0
US State-Level Prevalence of Adult Obesity by Race and Ethnicity From 1990 to 2022 and Forecasted to 2035. 从1990年到2022年并预测到2035年美国各州按种族和民族划分的成人肥胖患病率。
Pub Date : 2026-01-28 DOI: 10.1001/jama.2025.26817
Nicole K DeCleene,Ethan Kahn,Chun-Wei Yuan,Emmanuela Gakidou,Ali H Mokdad,Christopher J L Murray,Catherine O Johnson,Gregory A Roth
ImportanceThe prevalence of obesity in the US has risen steeply over the past decades, representing a large public health burden with substantial variation by population. There is a lack of detailed population-level estimates and projections of obesity necessary for informing health policy and reducing disparities.ObjectiveTo estimate US obesity prevalence from 1990 to 2022 and predict trends through 2035 by race and ethnicity, state, sex, and age (≥20 years).Design, Setting, and ParticipantsAnalysis of measured body mass index data from the National Health and Nutrition Examination Survey and bias-corrected body mass index values calculated from self-reported height and weight data from the Behavioral Risk Factor Surveillance System and Gallup Daily Survey using spatiotemporal gaussian process regression and an ensemble of annualized rate of change and meta-regression bayesian spline models. Surveys for input data were conducted using population-based sampling by state and by race and ethnicity group with a total of 11 315 421 US participants. Results are reported for Hispanic, any race; non-Hispanic Black; and non-Hispanic White populations.Main Outcomes and MeasuresObesity prevalence (BMI ≥30).ResultsIn 2022, there were an estimated 107 (95% uncertainty interval [UI], 101-113) million adults living with obesity in the US (42.5% [95% UI, 40.2%-45.0%] of the adult population), an increase from 34.7 (95% UI, 31.1-38.3) million in 1990 (19.3% [95% UI, 17.3%-21.3%] of the adult population). By 2035, this is projected to increase to 126 (95% UI, 118-134) million (46.9% [95% UI, 43.9%-49.9%] of the adult population). Nationally, age-standardized prevalence by race and ethnicity group and sex in 2022 ranged from 40.1% (95% UI, 37.8%-42.5%) for non-Hispanic White males to 56.9% (95% UI, 54.1%-59.9%) for non-Hispanic Black females. There were substantial state-level differences, with prevalence highest in Midwestern and Southern states, as well as within-state disparities by race and ethnicity, which were larger for females than males. Prevalence also varied by age, with obesity prevalence highest among middle-aged adults and large increases in the youngest adult ages, especially for females.Conclusions and RelevanceWhile there are large differences by race and ethnicity, sex, age, and state, the prevalence of obesity is high and forecasted to continue increasing for all groups.
在过去的几十年里,美国的肥胖患病率急剧上升,这是一个巨大的公共卫生负担,人口差异很大。目前缺乏为卫生政策提供信息和缩小差距所必需的详细的人口肥胖水平估计和预测。目的估计1990年至2022年美国肥胖症患病率,并根据种族、民族、州、性别和年龄(≥20岁)预测到2035年的趋势。设计、设置和参与者使用时空高斯过程回归、年化变化率和元回归贝叶斯样条模型,分析来自国家健康和营养检查调查的测量体重指数数据,以及来自行为风险因素监测系统和盖洛普每日调查的自我报告身高和体重数据计算的偏差校正体重指数值。输入数据的调查采用基于人口的抽样方式,按州和种族进行,共有11名 315 421名美国参与者。报告了西班牙裔,任何种族的结果;非西班牙裔黑人;以及非西班牙裔白人。主要结局和测量指标:肥胖患病率(BMI≥30)。结果2022年,美国估计有107亿(95%不确定区间[UI], 1.01 - 1.13)万成年人患有肥胖症(占成年人口的42.5% [95% UI, 40.2%-45.0%]),比1990年的34.7万人(95% UI, 31.1- 3830)万人(19.3% [95% UI, 17.3%-21.3%])有所增加。到2035年,这一数字预计将增加到1.26亿(95% UI, 1.18 - 1.34亿)(占成年人口的46.9% [95% UI, 43.9%-49.9%])。在全国范围内,2022年按种族、民族和性别划分的年龄标准化患病率从非西班牙裔白人男性的40.1% (95% UI, 37.8%-42.5%)到非西班牙裔黑人女性的56.9% (95% UI, 54.1%-59.9%)。各州的差异很大,中西部和南部各州的患病率最高,州内的种族和民族差异也很大,女性的差异大于男性。肥胖率也因年龄而异,中年人的肥胖率最高,最年轻的成年人(尤其是女性)的肥胖率大幅上升。结论和相关性虽然在种族、民族、性别、年龄和州之间存在很大差异,但肥胖的患病率很高,预计所有人群的肥胖患病率都将继续上升。
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引用次数: 0
Self-Disclosed Use of AI in Research Submissions to BMJ Journals. 在向BMJ期刊提交的研究报告中自我披露使用人工智能。
Pub Date : 2026-01-28 DOI: 10.1001/jama.2025.25688
Isamme AlFayyad,Maurice P Zeegers,Lex Bouter,Helen Macdonald,Sara Schroter
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引用次数: 0
Author Disclosure of Use of AI in Submissions to 13 JAMA Network Journals. 作者在提交给13个JAMA网络期刊的文章中披露了人工智能的使用。
Pub Date : 2026-01-28 DOI: 10.1001/jama.2025.25300
Roy H Perlis,Annette Flanagin,Jacob Kendall-Taylor,Michael Berkwits,Kirsten Bibbins-Domingo
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引用次数: 0
Win Ratio Method for Hierarchical Composite Outcomes in Randomized Clinical Trials. 随机临床试验中分层综合结果的赢比方法。
Pub Date : 2026-01-28 DOI: 10.1001/jama.2025.25686
John M Cunningham,Stephen Fuest,Harry Burke
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引用次数: 0
When Nutrition Science Is Ignored: Potential Public Health Cost of the 2025 Dietary Guidelines. 当营养科学被忽视:2025年膳食指南的潜在公共卫生成本。
Pub Date : 2026-01-28 DOI: 10.1001/jama.2026.0832
Kim A Williams,Lily N Dastmalchi,Neal D Barnard
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引用次数: 0
Donation After Circulatory Death Heart Transplant Without Preimplant Reanimation Using Rapid Ultraoxygenated Recovery 循环死亡心脏移植后无植入前复苏的捐赠
Pub Date : 2026-01-26 DOI: 10.1001/jama.2025.25169
Aaron M. Williams, John Trahanas, Swaroop Bommareddi, Kevin C. McGann, Awab Ahmad, Brian Lima, Chen Chia Wang, Mark Petrovic, Stephen Devries, Joshua Lowman, Tarek Absi, Eric Quintana, Hasan Siddiqi, Kaushik Amancherla, Marshall Brinkley, Stacy Tsai, Jonathan N. Menachem, Dawn Pedrotty, Aniket S. Rali, Suzanne Sacks, Sandip Zalawadiya, Joey Lepore, Mias Pretorious, Kelly Schlendorf, Matthew Bacchetta, Ashish S. Shah
Importance Rapid recovery with extended ultraoxygenated preservation (REUP) has shown promise in adult donation after circulatory death (DCD) heart transplant when used in younger donor populations (aged 16-30 years) and/or for hearts with shorter ischemic times (<4 hours). Objective To assess the feasibility of the REUP technique in adult DCD heart transplant, without regard to donor age or anticipated ischemic time. Design, Setting, and Participants Case series of 24 patients to undergo REUP-recovered DCD adult heart transplant at a single high-volume heart transplant center in the United States from November 2024 to July 2025. Exposure REUP used for DCD cardiac allograft recovery without preimplant donor heart reanimation or machine perfusion. Main Outcomes and Measures Severe primary graft dysfunction, 30-day survival, and acute rejection on first endomyocardial biopsy. Results Twenty-four REUP-recovered DCD hearts were transplanted, with a mean donor age of 32 years and 9 donors (38%) older than 40 years. Fifty percent of recipients had prior sternotomy. The mean time from initial declaration of donor death to flush was 9 minutes. Fifteen donor hearts (60%) had a total ischemic time longer than 4 hours, including 1 that was 8 hours. Among recipients, 30-day survival was 96%. Only 1 patient (4%) had severe primary graft dysfunction, and 1 other patient (4%) had secondary graft dysfunction. On initial endomyocardial biopsy, 1 patient (4%) had acute cellular rejection grade 2R; no cases of antibody-mediated rejection were observed. Conclusions and Relevance This study demonstrates the safety, feasibility, and efficacy of REUP for DCD heart recovery without donor heart reanimation in a broad population of donors and recipients and without regard to anticipated ischemic time. Given the high cost and complexity of current DCD heart recovery strategies, as well as ethical concerns surrounding normothermic regional perfusion, REUP may prove to be a promising procurement method. Further study is required to support continued expansion of this novel technique.
在较年轻的供体人群(16-30岁)和/或缺血时间较短的心脏(4小时)中使用,延长超氧保存(REUP)快速恢复在循环死亡(DCD)心脏移植后的成人捐献中显示出前景。目的评价REUP技术在成人DCD心脏移植中的可行性,不考虑供体年龄和预期缺血时间。设计、环境和参与者:2024年11月至2025年7月,在美国一个大容量心脏移植中心,24例患者接受reup恢复的DCD成人心脏移植。暴露REUP用于无移植前供体心脏复苏或机器灌注的DCD异体心脏移植恢复。主要结果和测量:严重的原发性移植物功能障碍,30天存活率,第一次心内膜活检急性排斥反应。结果24例经reup恢复的DCD心脏移植,平均供者年龄32岁,年龄大于40岁的9例(38%)。50%的接受者之前做过胸骨切开术。从最初宣布供体死亡到冲洗的平均时间为9分钟。供体心脏总缺血时间超过4小时15例(60%),其中1例为8小时。在受者中,30天生存率为96%。只有1例(4%)患者有严重的原发性移植物功能障碍,另外1例(4%)患者有继发性移植物功能障碍。在最初的心内膜活检中,1例患者(4%)出现2R级急性细胞排斥反应;未观察到抗体介导的排斥反应。本研究在广泛的供体和受体人群中证明了REUP用于无供体心脏复苏的DCD心脏恢复的安全性、可行性和有效性,且不考虑预期的缺血时间。考虑到目前DCD心脏恢复策略的高成本和复杂性,以及围绕常温区域灌注的伦理问题,REUP可能被证明是一种很有前途的采购方法。需要进一步的研究来支持这种新技术的持续扩展。
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引用次数: 0
IgA Nephropathy in Adults 成人IgA肾病
Pub Date : 2026-01-26 DOI: 10.1001/jama.2025.25020
Sinead Stoneman, Jia Wei Teh, Michelle Marie O’Shaughnessy
Importance IgA nephropathy (IgAN) is a chronic kidney disease involving deposition of IgA-containing immune complexes in the glomerulus, causing glomerular inflammation and scarring. It is the most common immune-mediated glomerular disease worldwide, and affects an estimated 198 887 to 208 184 persons in the US. Up to 50% of patients with IgAN develop kidney failure within 10 years of diagnosis. Observations IgAN typically presents with nephritic syndrome and usually occurs in younger adults, with a mean age at diagnosis of 34 to 45 years. Incidence is highest in East Asia. Approximately 60% of cases are detected incidentally with hematuria or proteinuria on urinalysis. Up to 30% of patients present with episodic visible hematuria, often concomitantly with an upper respiratory or gastrointestinal tract infection (synpharyngitic hematuria). Less common presentations include nephrotic syndrome (<5%) and rapidly progressive glomerulonephritis (<5%). When IgAN is suspected (due to hematuria, proteinuria, or reduced kidney function), initial workup should include quantification of proteinuria and assessment for other causes of nephritic syndrome (eg, lupus nephritis). Adults with suspected IgAN and proteinuria greater than or equal to 0.5 g per day should undergo kidney biopsy. The diagnosis of primary IgAN is based on presence of IgA-dominant immune deposits in the glomerular mesangium after excluding other causes of this histologic appearance, ie, IgA vasculitis, IgA-dominant infection-related glomerulonephritis, and secondary IgAN from diseases such as cirrhosis, inflammatory bowel disease, celiac disease, infection (eg, viral hepatitis), and autoimmune diseases (eg, axial spondyloarthritis). Based on the Kidney Disease: Improving Global Outcomes 2025 clinical practice guideline for the management of IgAN, treatment for patients with proteinuria greater than 0.5 g per day includes behavioral modifications (eg, dietary sodium <2 g/d, smoking cessation, weight control, exercise), antihypertensive medications for goal blood pressure less than 120/70 mm Hg, and therapies to reduce the formation of IgA-containing immune complexes (eg, targeted-release budesonide), decrease glomerular injury (eg, systemic glucocorticoids, iptacopan), and manage existing IgAN-induced nephron loss (eg, renin-angiotensin system inhibitor or dual endothelin angiotensin receptor antagonist [eg, sparsentan] alone or in combination with a sodium-glucose cotransporter 2 inhibitor). Conclusions and Relevance IgAN is the leading cause of immune-mediated glomerular disease worldwide. Patients with suspected IgAN and proteinuria greater than or equal to 0.5 g per day should undergo kidney biopsy to confirm the diagnosis. Treatment of IgAN includes behavioral modifications, blood pressure management, and therapies to decrease formation of IgA-containing immune complexes (eg, targeted-release budesonide), reduce immune complex–mediated glomerular injur
IgA肾病(IgAN)是一种慢性肾脏疾病,涉及肾小球中含有IgA的免疫复合物沉积,引起肾小球炎症和瘢痕形成。它是世界上最常见的免疫介导的肾小球疾病,在美国估计有198887至208184人受到影响。高达50%的IgAN患者在确诊后10年内发生肾衰竭。IgAN通常表现为肾病综合征,通常发生在较年轻的成年人,诊断时的平均年龄为34至45岁。发病率在东亚最高。大约60%的病例在尿液分析中偶然发现血尿或蛋白尿。高达30%的患者表现为偶发性可见血尿,常伴有上呼吸道或胃肠道感染(咽喉性血尿)。不太常见的表现包括肾病综合征(<5%)和快速进展的肾小球肾炎(<5%)。当怀疑IgAN(由于血尿、蛋白尿或肾功能下降)时,最初的检查应包括蛋白尿的量化和肾病综合征(如狼疮性肾炎)的其他原因的评估。成人疑似IgAN和蛋白尿大于或等于每天0.5 g应进行肾活检。原发性IgAN的诊断是基于肾小球系膜中存在IgA显性免疫沉积,排除了这种组织学表现的其他原因,即IgA血管炎、IgA显性感染相关的肾小球肾炎,以及肝硬化、炎症性肠病、乳糜泻、感染(如病毒性肝炎)和自身免疫性疾病(如轴性脊柱炎)引起的继发性IgAN。根据肾脏疾病:改善全球结局2025年IgAN管理临床实践指南,蛋白尿超过每天0.5 g的患者的治疗包括行为改变(例如,饮食钠和lt;2 g/d,戒烟,控制体重,运动),目标血压低于120/70 mm Hg的降压药物,以及减少含iga免疫复合物形成的治疗(例如,靶向释放布地奈德),减少肾小球损伤(例如,全身糖皮质激素,伊普他科潘),以及控制现有的igan诱导的肾素损失(例如,肾素-血管紧张素系统抑制剂或双重内皮素-血管紧张素受体拮抗剂)。斯巴sentan]单独或与钠-葡萄糖共转运蛋白2抑制剂联合使用)。IgAN是世界范围内免疫介导肾小球疾病的主要原因。疑似IgAN和蛋白尿大于或等于每天0.5 g的患者应进行肾活检以确认诊断。IgAN的治疗包括行为改变、血压管理和减少含有iga的免疫复合物形成的治疗(如靶向释放布地奈德)、减少免疫复合物介导的肾小球损伤(如全身糖皮质激素、伊普他科潘)和控制IgAN诱导的肾素损失(如肾素-血管紧张素系统抑制剂、双重内皮素-血管紧张素受体拮抗剂和钠-葡萄糖共转运蛋白2抑制剂)。
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引用次数: 0
Reimagining Transplant Center Incentives Beyond the CMS IOTA Model 重新构想移植中心的激励机制,超越CMS IOTA模型
Pub Date : 2026-01-26 DOI: 10.1001/jama.2025.26194
Alex Chan, Alvin E. Roth
This Viewpoint discusses the Centers for Medicare & Medicaid Services’ (CMS) Increasing Organ Transplant Access (IOTA) model and how its focus should be less on volume than patient-centered quality-of-life outcomes.
这一观点讨论了医疗保险中心医疗补助服务(CMS)增加器官移植准入(IOTA)模型,以及它的重点如何应该少以数量为中心,多以患者为中心的生活质量结果。
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引用次数: 0
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