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Biopharmaceutical pipeline funded by venture capital firms, 2014 to 2024. 2014 年至 2024 年风险投资公司资助的生物制药项目。
Pub Date : 2024-10-04 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae124
So-Yeon Kang, Mingqian Liu, Jeromie Ballreich, Ravi Gupta, Gerard Anderson

Venture capital (VC) firms fund biopharmaceutical research and development (R&D) while incurring substantial financial risk. VC firms seek to invest in clinical areas with the greatest potential for financial return. Using a combination of data for clinical trials and VC investment deals between January 2014 and March 2024, we found that approximately 75% of VC investments were allocated to clinical trials studying small-molecule drugs compared to biologics or gene therapies, without substantial changes over the study period. Most of VC firms' investment in biopharmaceutical R&D was concentrated in phase 1 and phase 2 clinical trials. This trend has increased in recent years, with phase 1 trials accounting for nearly half of total deals and capital investments in 2023. VC investments were concentrated in several therapeutic areas, including cancer.

风险投资(VC)公司在为生物制药研发(R&D)提供资金的同时,也承担着巨大的财务风险。风险投资公司寻求投资于最具经济回报潜力的临床领域。利用 2014 年 1 月至 2024 年 3 月期间临床试验和风险投资交易的综合数据,我们发现,与生物制剂或基因疗法相比,大约 75% 的风险投资被分配给了研究小分子药物的临床试验,而且在研究期间没有发生重大变化。风险投资公司对生物制药研发的投资大多集中在 1 期和 2 期临床试验。这一趋势近年来有所上升,到 2023 年,1 期临床试验将占交易和资本投资总额的近一半。风险投资主要集中在几个治疗领域,包括癌症。
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引用次数: 0
Understanding the factors that impact federal rulemaking: a survey of former EPA regulators. 了解影响联邦规则制定的因素:对前 EPA 监管者的调查。
Pub Date : 2024-10-03 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae125
Rachel J Topazian, Emma E McGinty, Shelley A Hearne

While federal rulemaking is an essential part of American governance, it is not well understood by researchers and advocates. We surveyed 115 former regulators at the Environmental Protection Agency to understand their views on the kinds of information they valued most and their communication preferences (June-August 2023). Respondents highly valued information about the scope of a problem (96%), legal analysis (97%), technology assessments (96%), and impacts of a proposed rule (99%). Regulators had difficulty accessing several kinds of information: 16% of respondents viewed racial equity information as easy to access and 30% thought financial information was easy to access. Respondents valued communications that provided data (99% viewed as effective), made compelling arguments (97%) or technical recommendations (93%), and storytelling (88%). Respondents indicated that the content of comment letters was important: 94% viewed letters containing data as important and 90% valued technical recommendations. Only 22% thought that repetition of the same comments across letters was important. Our findings reveal opportunities for researchers and advocates to help fill information gaps and identify communication strategies that might resonate with federal regulators.

虽然联邦规则制定是美国治理的重要组成部分,但研究人员和倡导者对其了解不多。我们对环境保护局的 115 名前监管者进行了调查,以了解他们对最重视的信息类型的看法以及他们的沟通偏好(2023 年 6 月至 8 月)。受访者高度重视有关问题范围(96%)、法律分析(97%)、技术评估(96%)和拟议规则影响(99%)的信息。监管者在获取几种信息方面存在困难:16% 的受访者认为种族公平信息易于获取,30% 的受访者认为财务信息易于获取。受访者重视提供数据(99% 认为有效)、提出有说服力的论点(97%)或技术建议(93%)以及讲故事(88%)的沟通方式。受访者表示意见书的内容很重要:94% 的受访者认为包含数据的意见书很重要,90% 的受访者重视技术建议。只有 22% 的受访者认为信件中重复相同的意见很重要。我们的调查结果显示,研究人员和倡导者有机会帮助填补信息空白,并确定可能与联邦监管机构产生共鸣的沟通策略。
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引用次数: 0
Primary care telehealth utilization by access-challenged populations in Medicare Advantage. 医疗保险优势计划(Medicare Advantage)中有就医困难的人群利用初级保健远程医疗的情况。
Pub Date : 2024-09-28 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae120
Emily Boudreau, Amanda Sutherland, Debra Bozzi, Melanie Canterberry, Gosia Sylwestrzak

Although telehealth utilization in primary care has decreased markedly since 2020, it remains higher than before the COVID-19 pandemic. There is debate about its role in a post-pandemic healthcare system, particularly for certain groups of patients that may experience greater access challenges related to in-person care. To inform this debate, we examined the use of audiovisual telehealth for primary care as a share of total primary care outpatient visits among Medicare Advantage beneficiaries with and without 3 characteristics associated with potential access challenges (low-income status, disability, and frailty). Primary care visits when the beneficiary was frail were 39.4% (OR: 1.39 [95% CI, 1.37-1.42]) more likely to be telehealth; when the beneficiary was disabled or low-income status, visits were 20.1% (OR: 1.20 [95% CI, 1.18-1.22]) and 8.3% (OR: 1.08 [95% CI, 1.05-1.12]) more likely to be telehealth, respectively. The differential use of telehealth among beneficiaries with low-income status or disability, compared with those without, was significantly larger among providers with a 2-sided risk contract compared with fee for service (low-income status: OR: 1.19 [95% CI, 1.04-1.35]; disability: OR: 1.07 [95% CI, 1.01-1.13]).

尽管自 2020 年以来远程医疗在初级保健中的使用率明显下降,但仍高于 COVID-19 大流行之前。关于远程医疗在大流行后医疗保健系统中的作用,特别是对于某些可能会面临更多亲自就医挑战的患者群体而言,还存在争议。为了给这一争论提供信息,我们研究了视听远程医疗在医疗保险优势受益人初级保健门诊总就诊人次中所占的比例,无论受益人是否具有与潜在就诊挑战相关的三个特征(低收入状况、残疾和体弱)。当受益人体弱时,39.4%(OR:1.39 [95% CI,1.37-1.42])的初级保健门诊更有可能采用远程保健;当受益人残疾或低收入时,20.1%(OR:1.20 [95% CI,1.18-1.22])和 8.3%(OR:1.08 [95% CI,1.05-1.12])的门诊更有可能采用远程保健。与收费服务相比,在签订了双面风险合同的医疗服务提供者中,低收入或残疾受益人与非低收入或残疾受益人使用远程医疗的差异明显更大(低收入状况:OR:1.19 [95% CI];非低收入状况:OR:1.19 [95% CI]):OR: 1.19 [95% CI, 1.04-1.35]; disability:OR:1.07 [95% CI,1.01-1.13])。
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引用次数: 0
Assessing the feasibility and likelihood of policy options to lower specialty drug costs. 评估降低特殊药品成本的政策方案的可行性和可能性。
Pub Date : 2024-09-27 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae118
Erin A Taylor, Dmitry Khodyakov, Zachary Predmore, Christine Buttorff, Alice Kim

Specialty drugs are high-cost medications often used to treat complex chronic conditions. Even with insurance coverage, patients may face very high out-of-pocket costs, which in turn may restrict access. While the Inflation Reduction Act of 2022 included policies designed to reduce specialty drug costs, relatively few policies have been enacted during the past decade. In 2022-2023, we conducted a scoping literature review to identify a range of policy options and selected a set of 9 that have been regularly discussed or recently considered to present to an expert stakeholder panel to seek consensus on (1) the feasibility of implementing each policy and (2) its likely impact on drug costs. Experts rated only 1 policy highly on both feasibility and impact: grouping originator biologics and biosimilars under the same Medicare Part B reimbursement code. They rated 3 policies focused on setting payment limits as likely to have positive (downward) impact on costs but of uncertain feasibility. They considered 4 policies as uncertain on both criteria. Experts rated capping monthly out-of-pocket costs as feasible but unlikely to reduce specialty drug costs. Based on these results, we offer 4 recommendations to policymakers considering ways to reduce specialty drug costs.

特药是高成本药物,通常用于治疗复杂的慢性疾病。即使有保险,患者也可能面临非常高昂的自付费用,这反过来又会限制患者的用药。虽然《2022 年通货膨胀削减法案》包含了旨在降低特药成本的政策,但过去十年间颁布的政策相对较少。在 2022-2023 年,我们进行了一次范围性文献回顾,以确定一系列政策选择,并选择了 9 项定期讨论或近期考虑的政策,提交给利益相关者专家小组,以就以下两点寻求共识:(1)实施每项政策的可行性;(2)其对药物成本可能产生的影响。专家们仅对一项政策的可行性和影响给予了高度评价:将原研生物制剂和生物仿制药归入同一医疗保险 B 部分报销代码。他们将 3 项侧重于设定支付限额的政策评为可能对成本产生积极(向下)影响,但可行性不确定。他们认为 4 项政策在这两个标准上都不确定。专家们认为为每月自付费用设定上限是可行的,但不太可能降低特药费用。基于上述结果,我们向考虑如何降低特药成本的政策制定者提出了 4 项建议。
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引用次数: 0
Disability inclusion in national surveys. 将残疾问题纳入国家调查。
Pub Date : 2024-09-26 eCollection Date: 2024-09-01 DOI: 10.1093/haschl/qxae117
Caroline Cerilli, Varshini Varadaraj, Jennifer Choi, Fiona Sweeney, Franz Castro, Scott D Landes, Bonnielin K Swenor

National surveys are important for understanding the disparities that disabled people experience across social determinants of health; however, limited research has examined the methods used to include disabled people in these surveys. This study reviewed nationally representative surveys administered by the Centers for Disease Control and Prevention (CDC) and the US Census Bureau that collected data in the past 5 years and sampled adults ≥18 years. Data from both publicly available online survey documents and a questionnaire emailed to survey administrators were used to determine whether surveys (1) oversampled disabled people, (2) had a data-accessibility protocol to support data collection, and (3) provided multiple data-collection modalities (eg, phone, paper). Of the 201 surveys identified, 30 met the inclusion criteria for the study. Of these 30 surveys, 1 oversampled disabled people, none had a data-collection accessibility protocol, and 21 provided multiple data-collection modalities. This study highlights barriers and opportunities to including disabled people in national surveys, which is essential for ensuring survey data are generalizable to the US population.

全国性调查对于了解残疾人在健康的社会决定因素方面所经历的差异非常重要;然而,对将残疾人纳入这些调查所使用的方法的研究却很有限。本研究回顾了由美国疾病控制与预防中心(CDC)和美国人口普查局在过去 5 年中进行的具有全国代表性的调查,这些调查收集了数据,并对年龄≥18 岁的成年人进行了抽样调查。从公开的在线调查文件和通过电子邮件发送给调查管理员的调查问卷中获取的数据被用来确定调查是否(1)对残疾人进行了过度采样,(2)具有支持数据收集的数据无障碍协议,以及(3)提供了多种数据收集方式(如电话、纸质)。在确定的 201 份调查中,有 30 份符合研究的纳入标准。在这 30 项调查中,1 项调查对残疾人进行了超额采样,没有一项调查制定了数据收集无障碍协议,21 项调查提供了多种数据收集方式。本研究强调了在全国性调查中纳入残疾人的障碍和机遇,这对于确保调查数据在美国人口中的普遍性至关重要。
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引用次数: 0
How are US hospitals adopting artificial intelligence? Early evidence from 2022. 美国医院如何采用人工智能?2022 年的早期证据。
Pub Date : 2024-09-26 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae123
Redwan Bin Abdul Baten

US hospitals are rapidly adopting artificial intelligence (AI), but there is a lack of knowledge about AI-adopting hospitals' characteristics, trends, and spread. This study aims to fill this gap by analyzing the 2022 American Hospital Association (AHA) data. The novel Hospital AI Adoption Model (HAIAM) is developed to categorize hospitals based on their AI adoption characteristics in the fields of (1) predicting patient demand, (2) optimizing workflow, (3) automating routine tasks, (4) staff scheduling, and (5) predicting staffing needs. Nearly one-fifth of US hospitals (1107 or 18.70%) have adopted some form of AI by 2022. The HAIAM shows that only 3.82% of hospitals are high adopters, followed by 6.22% moderate and 8.67% low adopters. Artificial intelligence adoption rates are highest in optimizing workflow (12.91%), while staff scheduling (9.53%) has the lowest growth rate. Hospitals with large bed sizes and outpatient surgical departments, private not-for-profit ownership, teaching status, and part of health systems are more likely to adopt different forms of AI. New Jersey (48.94%) is the leading hospital AI-adopting state, whereas New Mexico (0%) is the most lagging. These data can help policymakers better understand variations in AI adoption by hospitals and inform potential policy responses.

美国医院正在迅速采用人工智能(AI),但人们对采用人工智能的医院的特点、趋势和分布却缺乏了解。本研究旨在通过分析 2022 年美国医院协会(AHA)的数据来填补这一空白。我们开发了新颖的医院人工智能应用模型(HAIAM),根据医院在以下领域的人工智能应用特点对其进行分类:(1)预测患者需求;(2)优化工作流程;(3)自动化常规任务;(4)员工调度;(5)预测人员需求。到 2022 年,将近五分之一的美国医院(1107 家或 18.70%)采用了某种形式的人工智能。HAIAM 显示,只有 3.82% 的医院是高度采用者,其次是 6.22% 的中度采用者和 8.67% 的低度采用者。在优化工作流程方面,人工智能采用率最高(12.91%),而员工调度(9.53%)的增长率最低。拥有大型病床和门诊手术部、非营利性私营医院、教学医院和医疗系统的医院更有可能采用不同形式的人工智能。新泽西州(48.94%)在医院采用人工智能方面处于领先地位,而新墨西哥州(0%)则最为落后。这些数据可以帮助政策制定者更好地了解医院在采用人工智能方面的差异,并为潜在的政策应对措施提供参考。
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引用次数: 0
Exploring the geospatial variations in the public health workforce: implications for diversifying the supply of potential workers in governmental settings. 探索公共卫生工作人员的地理空间差异:对政府机构潜在工作人员供应多样化的影响。
Pub Date : 2024-09-17 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae116
Sezen O Onal, Skky Martin, Nicole M Weiss, Jonathon P Leider

The US public health workforce has markedly declined, falling from 500 000 individuals in 1980 to 239 000 by 2022, a trend exacerbated by economic instability and an aging demographic. There was a temporary surge in staffing through emergency hires during the COVID-19 pandemic, but the permanence of these positions remains uncertain. Concurrently, public health degree conferrals have sharply increased, creating a mismatch between the growing number of graduates and the actual needs of health departments. This study analyzes the distribution of the potential public health labor supply within a 50- and 150-mile radius of health departments, revealing a significant regional imbalance. Most regions experience substantial differences in the concentration of public health graduates when accounting for population size, reflecting geographic disparities in workforce distribution. These findings underscore the necessity for structured partnerships between health departments and educational institutions and advocacy for adaptive policy changes to align educational outputs with labor market demands, essential for a resilient public health workforce.

美国的公共卫生人员数量明显减少,从 1980 年的 500 000 人减少到 2022 年的 239 000 人,经济不稳定和人口老龄化加剧了这一趋势。在 COVID-19 大流行期间,通过紧急招聘临时激增了人员,但这些职位的长期性仍不确定。与此同时,公共卫生学位授予人数急剧增加,造成了毕业生人数增长与卫生部门实际需求之间的不匹配。本研究分析了卫生部门 50 英里和 150 英里半径范围内潜在公共卫生劳动力供应的分布情况,揭示了严重的地区不平衡。在考虑人口数量的情况下,大多数地区的公共卫生专业毕业生的集中程度存在很大差异,这反映了劳动力分布的地域差异。这些发现突出表明,卫生部门与教育机构之间必须建立结构化的合作关系,并倡导适应性的政策变革,使教育产出与劳动力市场需求相一致,这对建立一支具有复原力的公共卫生队伍至关重要。
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引用次数: 0
Return on investments in social determinants of health interventions: what is the evidence? 健康问题社会决定因素干预措施的投资回报:证据是什么?
Pub Date : 2024-09-11 eCollection Date: 2024-09-01 DOI: 10.1093/haschl/qxae114
Sayeh Nikpay, Zhanji Zhang, Pinar Karaca-Mandic

There has been an increasing recognition of the importance and the value of addressing social determinants of health (SDOH) to improve population health outcomes, manage health care costs, and reduce health inequities. Despite the strong interest in investing in SDOH initiatives by various stakeholders, the literature on the return from such investments is scarce. The differences in study populations and methodologies, and the lack of data on SDOH intervention outcomes and/or costs, make it challenging to quantify and generalize outcomes for decision-making. We reviewed the literature on SDOH interventions focused on food and housing insecurity, and developed a methodology for estimating a key outcome: the return on investment (ROI), defined as the net returns from an intervention divided by its costs. The ROI estimates we report can be used by stakeholders to prioritize among alternative SDOH interventions for fundraising, investing, and implementing purposes. The average ROI for food-insecurity programs was 85% (ranging from 1% to 287%; except for 1 study's ROI, -31%) and for housing-insecurity programs was 50% (ranging from 5% to 224%; except for 1 ROI, -38%). In addition, these estimates can serve as key inputs for designing and employing innovative financing and policy solutions to increase the use of these interventions.

越来越多的人认识到,解决健康的社会决定因素(SDOH)问题对于改善人口健康状况、控制医疗成本和减少健康不公平现象具有重要意义和价值。尽管各利益相关方对投资 SDOH 举措兴趣浓厚,但有关此类投资回报的文献却很少。研究人群和方法的差异,以及 SDOH 干预结果和/或成本数据的缺乏,使得量化和归纳决策结果具有挑战性。我们回顾了有关以食物和住房不安全为重点的 SDOH 干预措施的文献,并开发了一种估算关键成果的方法:投资回报率 (ROI),其定义为一项干预措施的净回报除以其成本。利益相关者可以利用我们报告的投资回报率估算结果,在可供选择的 SDOH 干预措施中确定优先次序,以达到筹资、投资和实施的目的。食品不安全项目的平均投资回报率为 85%(从 1%到 287%不等;只有一项研究的投资回报率为-31%),住房不安全项目的平均投资回报率为 50%(从 5%到 224%不等;只有一项研究的投资回报率为-38%)。此外,这些估算可作为设计和采用创新性融资和政策解决方案的关键投入,以增加这些干预措施的使用。
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引用次数: 0
Public deliberation on health gain measures. 公众对健康增益措施的讨论。
Pub Date : 2024-09-09 eCollection Date: 2024-09-01 DOI: 10.1093/haschl/qxae111
Ching-Hsuan Lin, Tara A Lavelle, Marie C Phillips, Abigail G Riley, Daniel Ollendorf

Researchers and decision-makers use health gain measures to assess the value of health interventions. However, our current understanding of how these measures are understandable and accessible to the community is limited. This study examined a diverse group of stakeholders' attitudes and preferences for 9 commonly used health gain measures. We recruited 20 stakeholders, including patients, caregivers, pharmacists, allied health professionals, and citizens. We conducted 2 in-person deliberative meetings in which participants learned, discussed, deliberated on, and ranked 9 health gain measures. The final ranking conducted after unified deliberation showed the quality-adjusted life year (QALY) as the top-ranked measure, followed by the clinical benefit rating method used by the U.S. Preventive Services Task Force, and multicriteria decision analysis (MCDA). We identified 3 themes during deliberations: the importance of using patient values in population-based health gain measures, examining complementary measures together, and choosing measures that are intuitive and easy to understand. Future policymaking should consider incorporating the QALY, clinical benefit rating, and MCDA into prioritization decisions.

研究人员和决策者使用健康收益衡量标准来评估健康干预措施的价值。然而,我们目前对这些衡量标准如何为社区所理解和使用的了解还很有限。本研究考察了不同利益相关者对 9 种常用健康收益指标的态度和偏好。我们招募了 20 名利益相关者,包括患者、护理人员、药剂师、专职医疗人员和市民。我们举行了两次面对面的商议会议,与会者在会上学习、讨论、商议了 9 项健康增益措施,并对其进行了排序。经过统一商议后进行的最终排名显示,质量调整生命年 (QALY) 是排名最靠前的衡量标准,其次是美国预防服务工作组使用的临床收益评级方法和多标准决策分析 (MCDA)。在讨论过程中,我们发现了 3 个主题:在基于人群的健康收益衡量标准中使用患者价值的重要性、共同研究互补性衡量标准以及选择直观易懂的衡量标准。未来的决策应考虑将 QALY、临床收益评级和 MCDA 纳入优先级决策中。
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引用次数: 0
Insurance acceptance and cash pay rates for psychotherapy in the US. 美国心理治疗的保险接受率和现金支付率。
Pub Date : 2024-09-09 eCollection Date: 2024-09-01 DOI: 10.1093/haschl/qxae110
Jane M Zhu, Aine Huntington, Simon Haeder, Courtney Wolk, K John McConnell

Cost and insurance coverage remain important barriers to mental health care, including psychotherapy and mental health counseling services ("psychotherapy"). While data are scant, psychotherapy services are often delivered in private practice settings, where providers frequently do not take insurance and instead rely on direct pay. In this cross-sectional analysis, we use a large national online directory of 175 083 psychotherapy providers to describe characteristics of private practice psychotherapy providers who accept and do not accept insurance, and assess self-reported private pay rates. Overall, about one-third of private practice psychotherapists did not accept insurance, with insurance acceptance varying substantially across states. We also found significant session rate differentials, with Medicaid rates being on average 40% lower than reported cash pay rates, which averaged $143.26 a session. Taken together, low insurance acceptance across a broad swath of mental health provider types means that access to care is disproportionately reliant on patients' ability to afford out-of-pocket payments-even when covered by insurance. While our findings are descriptive and may not be representative of all US psychotherapists, they add to scant existing knowledge about the cash pay market for an important mental health service that has experienced increased use and demand over time.

费用和保险范围仍然是心理健康护理的重要障碍,包括心理治疗和心理健康咨询服务("心理治疗")。虽然数据很少,但心理治疗服务通常是在私人诊所提供的,那里的服务提供者通常不接受保险,而是依靠直接支付。在这项横截面分析中,我们使用了一个包含 175 083 名心理治疗提供者的大型全国性在线目录,以描述接受和不接受保险的私人心理治疗提供者的特征,并评估自我报告的私人付费率。总体而言,约有三分之一的私人心理治疗师不接受保险,各州接受保险的情况大不相同。我们还发现了明显的疗程费率差异,医疗补助费率平均比报告的现金支付费率低 40%,平均为每次疗程 143.26 美元。综上所述,在众多心理健康服务提供者中,保险接受度低意味着患者能否获得医疗服务在很大程度上取决于其自付费用的能力--即使是在有保险的情况下。虽然我们的研究结果只是描述性的,可能并不代表所有的美国心理治疗师,但它们丰富了现有的关于现金支付市场的知识,而这种重要的心理健康服务的使用和需求随着时间的推移不断增加。
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