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Advancing a National Infrastructure for Clinical Trials. 推进国家临床试验基础设施建设。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-06 DOI: 10.1001/jamahealthforum.2024.4383
Melinda B Buntin, Otis W Brawley, Joshua M Sharfstein
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引用次数: 0
Confirmatory Trials for Drugs Granted Conditional Approval by the Chinese National Medical Products Administration. 中国国家药品监督管理局有条件批准药品的验证性试验。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-06 DOI: 10.1001/jamahealthforum.2024.4601
Yun Tian, Xiaoyong Liu, Xingyu Liu, Jinwei Zhang, Shuchen Hu, Caijun Yang, Yu Fang
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引用次数: 0
Will Cash Price Transparency Benefit Patients?: State Insurance Regulation Matters. 现金价格透明会让患者受益吗?:国家保险监管事宜。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-06 DOI: 10.1001/jamahealthforum.2024.4322
David Hyman, Sunjay Letchuman, Ge Bai
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引用次数: 0
US Tobacco 21 Policies and Potential Mortality Reductions by State. 美国烟草政策和各州潜在的死亡率降低。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-06 DOI: 10.1001/jamahealthforum.2024.4445
Jamie Tam, Alyssa Crippen, Abigail Friedman, Jihyoun Jeon, David C Colston, Nancy L Fleischer, Catherine A Vander Woude, Megan A Boelter, Theodore R Holford, David T Levy, Rafael Meza

Importance: Research shows that Tobacco 21 (T21) policies with a minimum legal access age for tobacco products of 21 years reduce smoking, yet their impact varies across US states due to differences in smoking behaviors, mortality rates, and policy coverage.

Objective: To quantify potential reductions in smoking-attributable mortality associated with Tobacco 21 policies for each of the 50 states and Washington, DC.

Design, setting, and participants: The Cancer Intervention Surveillance and Modeling Network (CISNET) Tobacco Control Policy Model of smoking was used with detailed state-specific data on smoking initiation, smoking cessation and mortality rates as they vary by age, gender, and birth cohort for 50 US states and the District of Columbia. This was integrated with comprehensive data on T21 policy coverage at the local and state levels from 2005 to 2024, and then T21 policy effects from quasi-experimental studies were applied to simulate each state's experience of T21 policies, quantifying potential mortality reductions from 2005 to 2100.

Exposures: Cigarette smoking.

Main outcomes and measures: Estimated smoking-attributable deaths averted and life-years gained compared with a baseline scenario.

Results: Early statewide T21 adoption in California, combined with its large population, was associated with more than 27 000 premature deaths averted through 2100, whereas statewide implementation in Kentucky was associated with 15 000 averted premature deaths. In Massachusetts, T21 policies were associated with 8000 averted premature deaths, largely attributed to municipal T21 policies covering most residents. Wisconsin-lacking state or local policies-requires enforcement of federal T21 to prevent up to 10 000 premature deaths. Across the country, comprehensive enforcement of federal, state, and local T21 laws were associated with up to 526 000 premature deaths averted and 13.3 million life-years gained by 2100. Enforcement of only state and local policies was associated with 442 000 premature deaths averted.

Conclusions and relevance: This study found that early adoption and implementation of T21 policies maximizes potential premature mortality reductions. However, the strength of T21 policies and enforcement varies widely across states. Enforcement of the federal T21 law is critical in the 8 states without state-level T21 cigarette policies of their own.

重要性:研究表明,21岁烟草(T21)政策将烟草制品的最低合法获取年龄定为21岁,减少了吸烟,但由于吸烟行为、死亡率和政策覆盖范围的差异,其影响在美国各州有所不同。目的:量化与50个州和华盛顿特区的烟草21政策相关的吸烟导致死亡率的潜在降低。设计、环境和参与者:使用癌症干预监测和建模网络(CISNET)烟草控制政策吸烟模型,并结合美国50个州和哥伦比亚特区的年龄、性别和出生队列不同的吸烟开始、戒烟和死亡率的详细州特定数据。结合2005年至2024年地方和州一级T21政策覆盖范围的综合数据,然后应用准实验研究的T21政策效应来模拟各州的T21政策经验,量化2005年至2100年期间潜在的死亡率降低。暴露:吸烟。主要结果和措施:与基线情景相比,估计可避免吸烟导致的死亡和增加的生命年。结果:加州早期在全州范围内采用T21,结合其庞大的人口,到2100年避免了超过27 000例过早死亡,而肯塔基州在全州范围内实施T21,避免了15 000例过早死亡。在马萨诸塞州,T21政策与8000例避免过早死亡有关,这在很大程度上归功于覆盖大多数居民的市政T21政策。威斯康星州缺乏州或地方政策,要求执行联邦T21,以防止多达10,000 000人过早死亡。在全国范围内,联邦、州和地方T21法律的全面执行与到2100年避免多达526 000例过早死亡和增加1330万生命年有关。仅执行州和地方政策可避免44.2 000例过早死亡。结论和相关性:本研究发现,早期采用和实施T21政策可最大限度地降低过早死亡率。然而,各州的T21政策和执行力度差别很大。在没有自己的州一级T21香烟政策的8个州,联邦T21法律的执行至关重要。
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引用次数: 0
Flavored E-Cigarette Sales Restrictions and Young Adult Tobacco Use. 调味电子烟销售限制和青少年烟草使用。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-06 DOI: 10.1001/jamahealthforum.2024.4594
Abigail S Friedman, Michael F Pesko, Travis R Whitacre

Importance: More than one-quarter of US residents live in states or localities that restrict sales of flavored electronic nicotine delivery systems (ENDS), often as a means to reduce youth vaping. Yet, how these policies affect young adult vaping and smoking remains unclear.

Objective: To estimate the effects of ENDS flavor restrictions on ENDS use and cigarette smoking among young adults (age 18-29 years) in the US.

Design, participants, and setting: This quasi-experimental analysis used annual survey data from the 2016 to 2023 Behavioral Risk Factor Surveillance System (BRFSS), a series of nationally- and state-representative, repeated cross-sectional surveys of noninstitutionalized civilian adults in the US. Two-way fixed-effects specifications were estimated to assess how ENDS flavor restrictions affect young adults' use of ENDS and cigarettes. Analyses were adjusted for potential confounders including concurrent tobacco control policies, respondent demographic characteristics, and socioeconomic factors. Data analyses were conducted in November 2023 and repeated in October 2024 to incorporate newly released 2023 survey data.

Main outcomes and measures: Current and daily use of ENDS and of cigarettes as measured in the BRFSS.

Results: Balanced panel analyses of 242 154 individuals aged 18 to 29 years consistently found that state ENDS flavor restrictions were associated with statistically significant reductions in daily vaping and increases in daily cigarette smoking. Estimates were similar across robustness checks, with the main specification showing 3.6 (95% CI, -5.0 to -2.1) percentage point (ppt) reductions in daily vaping and 2.2 ppt increases in daily cigarette smoking (95% CI, 1.0 to 3.4) relative to changes in states without restrictions. These estimates are equivalent to an 80% reduction in daily vaping and 22% increase in daily smoking compared with 2018 mean rates.

Conclusions and relevance: The findings of this quasi-experimental analysis of BRFSS survey data indicate that state restrictions on flavored ENDS sales were associated with reduced vaping among young adults but may have unintentionally increased cigarette smoking, potentially offsetting public health gains. These findings suggest that alleviating the burden of tobacco-related disease will require regulatory strategies that balance reducing vaping with preventing increases in more lethal, combustible tobacco use.

重要性:超过四分之一的美国居民居住在限制销售调味电子尼古丁输送系统(ENDS)的州或地区,这通常是为了减少青少年吸电子烟。然而,这些政策对年轻人吸电子烟的影响尚不清楚。目的:评估ENDS口味限制对美国年轻人(18-29岁)使用ENDS和吸烟的影响。设计、参与者和环境:这项准实验分析使用了2016年至2023年行为风险因素监测系统(BRFSS)的年度调查数据,这是一系列具有全国和州代表性的美国非机构成年平民的重复横断面调查。估计双向固定效应规格,以评估ENDS口味限制如何影响年轻人使用ENDS和香烟。对潜在的混杂因素进行了分析调整,包括同时实施的烟草控制政策、被调查者的人口统计学特征和社会经济因素。数据分析于2023年11月进行,并于2024年10月重复进行,以纳入新发布的2023年调查数据。主要结果和措施:根据BRFSS测量,目前和每日使用ENDS和香烟的情况。结果:对242 154名年龄在18至29岁之间的人进行的平衡小组分析一致发现,州ENDS口味限制与统计上显着的每日电子烟减少和每日吸烟增加有关。稳健性检查的估计相似,主要规范显示,相对于没有限制的状态的变化,每日吸电子烟减少3.6个百分点(95% CI, -5.0至-2.1),每日吸烟增加2.2个百分点(95% CI, 1.0至3.4)。这些估计相当于与2018年的平均吸烟率相比,每日吸电子烟减少了80%,每日吸烟率增加了22%。结论和相关性:BRFSS调查数据的准实验分析结果表明,各州对调味电子烟销售的限制与年轻人吸电子烟的减少有关,但可能无意中增加了吸烟人数,潜在地抵消了公共健康收益。这些发现表明,减轻烟草相关疾病的负担将需要监管策略,以平衡减少电子烟与防止更致命的可燃烟草使用的增加。
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引用次数: 0
Changes in Adult Obesity Trends in the US. 美国成人肥胖趋势的变化。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-06 DOI: 10.1001/jamahealthforum.2024.3685
Benjamin Rader, Rebecca Hazan, John S Brownstein
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引用次数: 0
Populationwide Screening for Chronic Kidney Disease: A Cost-Effectiveness Analysis. 慢性肾脏病全民筛查:成本效益分析
IF 11.3 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.1001/jamahealthforum.2024.3892
Marika M Cusick, Rebecca L Tisdale, Glenn M Chertow, Douglas K Owens, Jeremy D Goldhaber-Fiebert, Joshua A Salomon

Importance: Sodium-glucose cotransporter-2 (SGLT2) inhibitors have changed clinical management of chronic kidney disease (CKD) and made populationwide screening for CKD a viable strategy. Optimal age of screening initiation has yet to be evaluated.

Objective: To compare the clinical benefits, costs, and cost-effectiveness of population-wide CKD screening at different initiation ages and screening frequencies.

Design, setting, and participants: This cost-effectiveness study used a previously published decision-analytic Markov cohort model that simulated progression of CKD among US adults from age 35 years and older and was calibrated to population-level data from the National Health and Nutrition Examination Survey (NHANES). Effectiveness of SGLT2 inhibitors was derived from the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial. Mortality, quality-of-life weights, and cost estimates were obtained from published cohort studies, randomized clinical trials, and US Centers for Medicare & Medicaid Services data. Analyses were performed from June 2023 through September 2024.

Exposures: One-time or periodic (every 10 or 5 years) screening for albuminuria, initiated at ages between 35 and 75 years, with and without addition of SGLT2 inhibitors to conventional CKD therapy (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers).

Main outcomes and measures: Cumulative incidence of kidney failure requiring kidney replacement therapy (KRT); life years, quality-adjusted life years (QALYs), lifetime health care costs (2024 US currency), and incremental cost-effectiveness ratios discounted at 3% annually.

Results: For those aged 35 years, starting screening at age 55 years, and continuing every 5 years through age 75 years, combined with SGLT2 inhibitors, decreased the cumulative incidence of kidney failure requiring KRT from 2.4% to 1.9%, increased life expectancy by 0.13 years, and cost $128 400 per QALY gained. Although initiation of screening every 5 years at age 35 or 45 years yielded greater gains in population-wide health benefits, these strategies cost more than $200 000 per additional QALY gained. The comparative values of starting screening at different ages were sensitive to the cost and effectiveness of SGLT2 inhibitors; if SGLT2 inhibitor prices drop due to patent expirations, screening at age 55 years continued to be cost-effective even if SGLT2 inhibitor effectiveness were 30% lower than in the base case.

Conclusions and relevance: This study found that, based on conventional benchmarks for cost-effectiveness in medicine, initiating population-wide CKD screening with SGLT2 inhibitors at age 55 years would be cost-effective.

重要性:钠-葡萄糖共转运体-2(SGLT2)抑制剂改变了慢性肾脏病(CKD)的临床治疗,使全民CKD筛查成为一项可行的策略。开始筛查的最佳年龄还有待评估:比较不同启动年龄和筛查频率下全人群 CKD 筛查的临床获益、成本和成本效益:这项成本效益研究使用了之前发表的决策分析马尔可夫队列模型,该模型模拟了美国 35 岁及以上成年人的 CKD 进展情况,并根据美国国家健康与营养调查(NHANES)的人群数据进行了校准。SGLT2 抑制剂的疗效来自达帕格列净和慢性肾脏病不良后果预防(DAPA-CKD)试验。死亡率、生活质量权重和成本估算来自已发表的队列研究、随机临床试验以及美国医疗保险和医疗补助服务中心的数据。分析时间为 2023 年 6 月至 2024 年 9 月:一次性或定期(每 10 年或 5 年)筛查白蛋白尿,年龄在 35 岁至 75 岁之间,在常规 CKD 治疗(血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂)的基础上加用或不加用 SGLT2 抑制剂:需要肾脏替代疗法(KRT)的肾衰竭累积发病率;生命年数、质量调整生命年数(QALYs)、终生医疗成本(2024 年美元币值)以及按每年 3% 的贴现率计算的增量成本效益比:对于 35 岁的人群,从 55 岁开始筛查,每隔 5 年筛查一次,直至 75 岁,同时使用 SGLT2 抑制剂,可将需要 KRT 的肾衰竭累积发病率从 2.4% 降至 1.9%,预期寿命延长 0.13 年,每获得 1 QALY 的成本为 128 400 美元。虽然在 35 岁或 45 岁时开始每 5 年进行一次筛查可为整个人群带来更大的健康益处,但每增加一个 QALY 的成本超过 20 万美元。在不同年龄开始筛查的比较值对 SGLT2 抑制剂的成本和有效性很敏感;如果 SGLT2 抑制剂的价格因专利到期而下降,即使 SGLT2 抑制剂的有效性比基础案例低 30%,55 岁开始筛查仍然具有成本效益:本研究发现,根据医学成本效益的传统基准,在 55 岁开始使用 SGLT2 抑制剂进行全人群 CKD 筛查将具有成本效益。
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引用次数: 0
Medicare's New Pathway for Transitional Coverage for Emerging Technologies. 医疗保险为新兴技术提供过渡性保险的新途径。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.1001/jamahealthforum.2024.3901
Steven A Farmer, Lori M Ashby, Jonathan D Blum
{"title":"Medicare's New Pathway for Transitional Coverage for Emerging Technologies.","authors":"Steven A Farmer, Lori M Ashby, Jonathan D Blum","doi":"10.1001/jamahealthforum.2024.3901","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.3901","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243901"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ways to Save Money in Health Care. 节省医疗费用的方法。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.1001/jamahealthforum.2024.4956
David M Cutler
{"title":"Ways to Save Money in Health Care.","authors":"David M Cutler","doi":"10.1001/jamahealthforum.2024.4956","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.4956","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244956"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142683357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Participation of Behavioral Health Facilities in Medicare Accountable Care Organizations. 行为健康机构参与医疗保险责任医疗组织。
IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.1001/jamahealthforum.2024.4022
Yucheng Hou, Susan H Busch, Helen Newton
{"title":"Participation of Behavioral Health Facilities in Medicare Accountable Care Organizations.","authors":"Yucheng Hou, Susan H Busch, Helen Newton","doi":"10.1001/jamahealthforum.2024.4022","DOIUrl":"10.1001/jamahealthforum.2024.4022","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244022"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11786226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142734577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
JAMA Health Forum
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