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Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research 实用临床试验附带结果的识别和管理:当前的理解和未来研究的方向
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100586
Stephanie R. Morain , Debra J.H. Mathews , Gail Geller , Juli Bollinger , Kevin Weinfurt , Jeffrey G. Jarvik , Elizabeth May , Jeremy Sugarman

While the embedded nature of pragmatic clinical trials (PCTs) can improve the efficiency and relevance of research for multiple stakeholders, embedding research into ongoing clinical care can also involve ethical and regulatory challenges. An emergent challenge is the management of pragmatic clinical trial collateral findings (PCT-CFs). While PCT-CFs share some features with incidental or secondary findings that are encountered in conventional clinical trials and clinical care, the PCT context differs in ethically relevant ways that complicate PCT-CF identification and management. We report on the results of a two-year multi-method investigation of PCT-CFs. Overall, five core themes emerged: 1) the liminal nature of PCTs and the implications of this for PCT-CFs; 2) the context-specific nature of PCT-CF management; 3) the centrality of institutions; 4) the importance of prospective planning; and 5) patient expectations. Among the central lessons of this work are that prior ethics guidance from other settings cannot easily be adapted to address PCT-CFs, nor can a single approach readily accommodate all PCT-CFs. Moving forward, stakeholders, including researchers, institutions, ethics oversight bodies, and funders, should anticipate and plan for PCT-CFs in the design, conduct, and analysis of PCTs. Future scholarship is needed to examine experiences with PCT-CFs, and the practical and conceptual issues they raise for the future conduct of PCTs.

虽然实用临床试验(pct)的嵌入性质可以提高多个利益相关者的研究效率和相关性,但将研究嵌入正在进行的临床护理也可能涉及伦理和监管挑战。一个新出现的挑战是管理实用的临床试验附带发现(PCT-CFs)。虽然PCT- cf与传统临床试验和临床护理中遇到的偶发或继发发现有一些共同特征,但PCT背景在伦理相关方面有所不同,这使PCT- cf的识别和管理复杂化。我们报告了一项为期两年的PCT-CFs多方法调查的结果。总体而言,出现了五个核心主题:1)pct的有限性质及其对PCT-CFs的影响;2) PCT-CF管理的具体情况;3)制度的中心地位;4)前瞻性规划的重要性;还有耐心的期待。这项工作的主要教训之一是,以前来自其他环境的道德指导不能轻易适用于PCT-CFs,单一方法也不能轻易适用于所有PCT-CFs。今后,包括研究人员、机构、伦理监督机构和资助者在内的利益攸关方应在pct的设计、实施和分析中预测和规划PCT-CFs。今后需要研究pct - cf的经验,以及它们为今后开展pct提出的实际和概念问题。
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引用次数: 1
Improving smoking history documentation in the electronic health record for lung cancer risk assessment and screening in primary care: A case study 改善初级保健中肺癌风险评估和筛查电子健康记录中的吸烟史记录:一个案例研究
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100578
Elizabeth Peterson , Kathryn Harris , Farhood Farjah , Nkem Akinsoto , Leah M. Marcotte

Improving risk factor documentation in the electronic health record (EHR) is important in order to determine patient eligibility for lung cancer screening.

System-level prioritization combined with a clinic-level initiative can improve risk factor documentation rates.

Multi-faceted interventions that include training, process improvement, data management, and continuous performance feedback are effective and can be integrated into existing workflows.

改善电子健康记录(EHR)中的风险因素记录对于确定患者是否有资格进行肺癌筛查非常重要。系统级的优先级与临床级的主动性相结合可以提高风险因素的记录率。包括培训、流程改进、数据管理和持续的绩效反馈在内的多方面干预是有效的,并且可以集成到现有的工作流程中。
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引用次数: 4
STAT: Mobile app helps clinicians manage inpatient emergencies STAT:移动应用程序帮助临床医生管理住院紧急情况
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100590
Andrew L. Chu , Joshua C. Ziperstein , Blake A. Niccum , Melvin G. Joice , Eric M. Isselbacher , Jared Conley

In response to the unprecedented surge of patients with COVID-19, Massachusetts General Hospital created both repurposed and de-novo COVID-19 inpatient general medicine and intensive care units. The clinicians staffing these new services included those who typically worked in these care settings (e.g., medicine residents, hospitalists, intensivists), as well as others who typically practice in other care environments (e.g., re-deployed outpatient internists, medical subspecialists, and other physician specialties). These surge clinicians did not have extensive experience managing low frequency, high acuity emergencies, such as those that might result from COVID-19. Physician-innovators, in collaboration with key hospital stakeholders, developed a comprehensive strategy to design, develop, and distribute a digital health solution to address this problem. MGH STAT is an intuitive mobile application that empowers clinicians to respond to medical emergencies by providing immediate access to up-to-date clinical guidelines, consultants, and code-running tools at the point-of-care. 100% of surveyed physicians found STAT to be easy to use and would recommend it to others. Approximately 1100 clinicians have downloaded the app, and it continues to enjoy consistent use over a year after the initial COVID-19 surge. These results suggest that STAT has helped clinicians manage life threatening emergencies during and after the pandemic, although formal studies are necessary to evaluate its direct impact on patient care.

为了应对前所未有的COVID-19患者激增,马萨诸塞州总医院(Massachusetts General Hospital)创建了经过改造和改造的COVID-19住院普通内科和重症监护病房。配备这些新服务的临床医生包括那些通常在这些护理环境中工作的人(例如,住院医生、医院医生、重症监护医生),以及其他通常在其他护理环境中工作的人(例如,重新部署的门诊内科医生、医学专科医生和其他专科医生)。这些激增的临床医生没有管理低频率、高急性度紧急情况的丰富经验,例如可能由COVID-19引起的紧急情况。医生创新者与医院的主要利益相关者合作,制定了一项全面战略,设计、开发和分发数字健康解决方案,以解决这一问题。MGH STAT是一个直观的移动应用程序,通过提供即时访问最新的临床指南、顾问和代码运行工具,使临床医生能够应对医疗紧急情况。100%的受访医生认为STAT易于使用,并会推荐给其他人使用。大约1100名临床医生下载了这款应用程序,在最初的COVID-19激增一年后,它仍在持续使用。这些结果表明,STAT帮助临床医生在大流行期间和之后管理危及生命的紧急情况,尽管有必要进行正式研究以评估其对患者护理的直接影响。
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引用次数: 0
Association of Social Vulnerability, COVID-19 vaccine site density, and vaccination rates in the United States 美国社会脆弱性协会,COVID-19疫苗站点密度和疫苗接种率
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100583
Nitya Thakore , Rohan Khazanchi , E. John Orav , Ishani Ganguli

The COVID-19 pandemic has disproportionately impacted Americans in socially vulnerable areas. Unfortunately, these groups are also experiencing lower vaccination rates. To understand how strategic vaccine site placement may benefit high vulnerability populations, we extracted vaccine site locations for 26 U.S. states and linked these data to county-level adult vaccination rates and the CDC 2018 Social Vulnerability Index rankings. We fit quasi-Poisson regression models to compare vaccine site density between the highest and lowest SVI domain quartiles, and assessed whether greater vaccine site density mediated or modified the relationship between social vulnerability and vaccination rates. We found that high vulnerability counties by socioeconomic status had more vaccine sites per 10,000 residents, yet this higher vaccine site density did not reduce socioeconomic disparities in vaccination rates. Persistent vaccination inequities may reflect other structural barriers to access. Our results suggest that targeted vaccine site placement in high vulnerability counties may be necessary but insufficient for the goal of widespread, equitable vaccination.

COVID-19大流行对社会脆弱地区的美国人造成了不成比例的影响。不幸的是,这些群体的疫苗接种率也较低。为了了解战略性疫苗站点放置如何使高易感人群受益,我们提取了美国26个州的疫苗站点位置,并将这些数据与县级成人疫苗接种率和CDC 2018年社会脆弱性指数排名联系起来。我们拟合准泊松回归模型来比较SVI域最高和最低四分位数之间的疫苗站点密度,并评估更大的疫苗站点密度是否介导或修改了社会脆弱性与疫苗接种率之间的关系。我们发现,按社会经济地位划分的高易感县每10,000名居民拥有更多的疫苗站点,但这种较高的疫苗站点密度并没有减少疫苗接种率的社会经济差异。持续的疫苗接种不公平现象可能反映了其他结构性障碍。我们的研究结果表明,在高易感县有针对性的疫苗站点放置可能是必要的,但不足以实现广泛,公平的疫苗接种目标。
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引用次数: 16
Breaking the cycle: A public-private partnership to combat the American opioid epidemic 打破循环:与美国阿片类药物流行作斗争的公私伙伴关系
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100592
Derek Soled , Nishant Uppal , Scott G. Weiner

There has been an increased focus on the opioid epidemic in the United States, yet policy-based interventions such as prescription limits, restrictions on doctor shopping, and notification programs for high-volume prescribers have had no significant impact. In this paper, the authors explore a novel public health policy: a joint public-private partnership between the federal government and hospitals to establish long-term treatment centers for patients admitted to the emergency department after an overdose. These centers would provide medication for opioid use disorder, give individuals the necessary support for recovery, and reduce healthcare expenditures. Similar longitudinal strategies may be used in other areas of public health.

在美国,人们越来越关注阿片类药物的流行,但基于政策的干预措施,如处方限制、限制医生购物和对大量处方者的通知计划,并没有产生重大影响。在本文中,作者探索了一种新的公共卫生政策:联邦政府和医院之间的公私合作伙伴关系,为过量服药后入院的急诊科患者建立长期治疗中心。这些中心将为阿片类药物使用障碍提供药物,为个人提供必要的康复支持,并减少医疗支出。在公共卫生的其他领域也可采用类似的纵向战略。
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引用次数: 1
Moving the needle on primary care burnout: Using a driver diagram to accelerate impact 移动初级保健倦怠的指针:使用驱动图来加速影响
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100595
Erin E. Sullivan , Kathleen Dwiel , Lindsay Swain Hunt , Kathleen Conroy , Katherine Gergen Barnett

Prior to the COVID-19 pandemic, studies demonstrated an alarming prevalence of burnout in primary care. In the midst of the pandemic, primary care clinician wellbeing deteriorated and burnout rates increased, yet many organizational efforts to reduce burnout were put on hold due to the urgency of the pandemic. In this article, we present the “Reducing Burnout Driver Diagram” as a tool that clinical leaders and policy makers can use to address and mitigate primary care clinician burnout.

在2019冠状病毒病大流行之前,研究表明,初级保健中职业倦怠的普遍程度令人震惊。在大流行期间,初级保健临床医生的福祉恶化,倦怠率上升,但由于大流行的紧迫性,许多组织减少倦怠的努力被搁置。在这篇文章中,我们提出了“减少职业倦怠驱动图”,作为临床领导者和政策制定者可以用来解决和减轻初级保健临床医生职业倦怠的工具。
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引用次数: 3
Massachusetts General Hospital Revere Food Pantry: Addressing hunger and health at an academic medical center community clinic 马萨诸塞州总医院里维尔食品储藏室:在一个学术医疗中心社区诊所解决饥饿和健康问题
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100589
Jacob B. Mirsky , Rachel M. Zack , Seth A. Berkowitz , Lauren Fiechtner

Food insecurity is defined by limited access to adequate food. As a result, it is associated with chronic disease for millions of Americans. Healthcare systems take responsibility for improving patient health and thus are well positioned to create food security interventions that improve health. Given that dietary recommendations now emphasize plant-based foods (such as vegetables, fruits, legumes, and whole grains), interventions could prioritize distributing plant-based foods that promote health and reduce food insecurity. We developed a plant-based food pantry at the Massachusetts General Hospital Revere Healthcare Center, an academic medical center-affiliated community clinic that serves many patients with food insecurity. We partnered with a local food bank and used a color-coded nutrition ranking system to prioritize healthy foods. What began as a pilot program for patients with food insecurity and chronic disease expanded to serve the entire clinic population in response to rising community level food insecurity resulting from the COVID-19 pandemic. We developed and modified a workflow that provided an average of 384 recipients (i.e., patients and their household members) with food monthly during the 10-month study period. A total of 117,742 pounds of food was distributed. Next steps for the food pantry will include investigating health outcomes, assessing patient satisfaction with plant-based foods, and securing sustainable funding. Our experience can be used to guide other health organizations interested in the intersection of food security and chronic disease management.

粮食不安全的定义是获得充足粮食的机会有限。因此,它与数百万美国人的慢性疾病有关。卫生保健系统有责任改善病人的健康,因此在制定改善健康的粮食安全干预措施方面处于有利地位。鉴于现在的饮食建议强调植物性食物(如蔬菜、水果、豆类和全谷物),干预措施可以优先分配促进健康和减少粮食不安全的植物性食物。我们在马萨诸塞州总医院里维尔医疗中心开发了一个植物性食品储藏室,这是一个学术医疗中心附属的社区诊所,为许多食物不安全的病人提供服务。我们与当地的食品银行合作,使用颜色编码的营养排名系统来优先考虑健康食品。该项目最初是针对粮食不安全和慢性病患者的试点项目,后来扩大到服务于整个诊所人群,以应对2019冠状病毒病大流行导致的社区层面粮食不安全加剧。我们开发并修改了一个工作流程,在10个月的研究期间,每月平均为384名接受者(即患者及其家庭成员)提供食物。总共分发了117 742磅食物。食品储藏室的下一步工作将包括调查健康结果,评估患者对植物性食品的满意度,以及确保可持续的资金。我们的经验可用于指导其他对粮食安全和慢性病管理交叉领域感兴趣的卫生组织。
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引用次数: 7
Rapid analysis of local data to inform off-label tocilizumab use early in the COVID-19 pandemic 快速分析当地数据,以便在COVID-19大流行早期为适应症外用药提供信息
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100581
Camille E. Morgan , Casey A. Rimland , Griffin J. Bell , Min K. Kim , Tanner Hedrick , Ashley Marx , Brian Bramson , Heidi Swygard , Sonia Napravnik , John L. Schmitz , Shannon S. Carson , William A. Fischer , Joseph J. Eron , Cynthia L. Gay , Jonathan B. Parr

The interleukin-6 receptor antagonist tocilizumab became widely used early in the coronavirus disease 2019 (COVID-19) pandemic based on small observational studies that suggested clinical benefit in COVID-19 patients with a hyperinflammatory state. To inform our local treatment algorithms in the absence of randomized clinical trial results, we performed a rapid analysis of the first 11 hospitalized COVID-19 patients treated with tocilizumab at our academic medical center. We report their early clinical outcomes and describe the process by which we assembled a team of diverse trainees and stakeholders to extract, analyze, and disseminate data during a time of clinical uncertainty.

基于小型观察性研究,白细胞介素-6受体拮抗剂托珠单抗在2019冠状病毒病(COVID-19)大流行的早期被广泛使用,这些研究表明对高炎症状态的COVID-19患者有临床益处。为了在缺乏随机临床试验结果的情况下为我们的本地治疗算法提供信息,我们对在我们的学术医疗中心接受tocilizumab治疗的前11名住院的COVID-19患者进行了快速分析。我们报告了他们的早期临床结果,并描述了我们在临床不确定时期组建了一个由不同的学员和利益相关者组成的团队来提取、分析和传播数据的过程。
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引用次数: 1
Whose value is it anyway? Reconciling conflicting perceptions of patients and payers 它到底有谁的价值?调和患者和支付者之间相互矛盾的看法
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100596
Matthew L. Maciejewski , Abby Hoffman , Jeffrey T. Kullgren

A promising pathway to achieving greater value in health care is to increase use of “high-value” services and decrease use of “low-value” services. Sometimes the value judgments of patients and payers are well-aligned, creating opportunities for policymakers to more forcefully influence use of services for which perceived value is concordant. More difficult situations arise when patients and payers have discordant value perceptions. We propose a novel framework for navigating situations where payers and patients agree or disagree on the relative value of services, and potential solutions for improving value under different conditions.

实现医疗保健更大价值的一个有希望的途径是增加使用"高价值"服务,减少使用"低价值"服务。有时,患者和付款人的价值判断是一致的,这为政策制定者创造了机会,可以更有力地影响感知价值一致的服务的使用。当患者和付款人的价值观不一致时,就会出现更困难的情况。我们提出了一个新的框架,用于引导支付者和患者对服务的相对价值达成一致或不一致的情况,以及在不同条件下提高价值的潜在解决方案。
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引用次数: 0
The development and implementation of a “B-Team” (buprenorphine team) to treat hospitalized patients with opioid use disorder 建立和实施“b组”(丁丙诺啡组)治疗住院阿片类药物使用障碍患者
IF 2.5 4区 医学 Q3 HEALTH POLICY & SERVICES Pub Date : 2021-12-01 DOI: 10.1016/j.hjdsi.2021.100579
Richard Bottner , Jillian B. Harvey , Amber N. Baysinger , Kirsten Mason , Snehal Patel , Alanna Boulton , Nicholaus Christian , Blair Walker , Christopher Moriates

Implementation insights

  • Hospitalization is a reachable moment to address opioid and other substance use disorders. This includes initiation of pharmacotherapy such as buprenorphine, which is the standard of care but not frequently offered.

  • Initiating pharmacotherapy for interested patients with opioid use disorder (OUD) during hospitalization does not require a formal addiction consultation service and can be accomplished by any in-hospital prescriber, aided by interprofessional and multidisciplinary teams with support from senior leadership.

  • Barriers to widespread adoption include lack of education; stigma towards people with substance use disorders; inadequate outpatient capacity to address OUD; regulatory requirements; and challenges to modifying electronic health record algorithms, clinical workflows, and institutional policies.

•住院是解决阿片类药物和其他物质使用障碍的一个可触及的时刻。这包括开始药物治疗,如丁丙诺啡,这是标准的护理,但不经常提供。•在住院期间,对有兴趣的阿片类药物使用障碍(OUD)患者启动药物治疗不需要正式的成瘾咨询服务,可由任何住院开处方者在高级领导的支持下,在跨专业和多学科团队的协助下完成。•广泛采用的障碍包括缺乏教育;对物质使用障碍患者的污名;治疗OUD的门诊能力不足;监管要求;以及修改电子健康记录算法、临床工作流程和机构政策的挑战。
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引用次数: 4
期刊
Healthcare-The Journal of Delivery Science and Innovation
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