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Background Health research teams increasingly partner with stakeholders to produce research that is relevant, accessible, and widely used. Previous work has covered stakeholder group identification. Objective We aimed to develop factors for health research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership, with the aim of forming equitable and informed teams. Design Consensus development. Participants We involved 16 stakeholders from the international Multi-Stakeholder Engagement (MuSE) Consortium, including patients and the public, providers, payers of health services/purchasers, policy makers, programme managers, peer review editors, and principal investigators. Approach We engaged stakeholders in factor development and as co-authors of this manuscript. Using a modified Delphi approach, we gathered stakeholder views concerning a preliminary list of 18 factors. Over two feedback rounds, using qualitative and quantitative analysis, we concentrated these into ten factors. Key Results We present seven highly desirable factors: ‘expertise or experience’, ‘ability and willingness to represent the stakeholder group’, ‘inclusivity (equity, diversity and intersectionality)’, ‘communication skills’, ‘commitment and time capacity’, ‘financial and non-financial relationships and activities, and conflict of interest’, ‘training support and funding needs’. Additionally, three factors are desirable: ‘influence’, ‘research relevant values’, ‘previous stakeholder engagement’. Conclusions We present factors for research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership. Policy makers and guideline developers may benefit from considering the factors in stakeholder identification and invitation. Research funders may consider stipulating consideration of the factors in funding applications. We outline how these factors can be implemented and exemplify how their use has the potential to improve the quality and relevancy of health research.

Objectives To enhance the generalizability of the evidence it reviews, the US Food and Drug Administration (FDA) has encouraged manufacturers to expand the submission of real-world evidence (RWE). The extent to which this evidence, which is generated outside of research settings, can support decision making remains unclear. We described the current use of RWE for medical devices, assessed manufacturers’ challenges in generating and using it for regulatory and coverage decisions, and identified opportunities to expand its use. Methods We conducted 27 solo and group interviews with FDA officials and representatives of device manufacturers, payers, and health technology assessment organizations. All interviews used a semistructured protocol and were transcribed to allow thematic analysis. Results Accessing and linking real-world data sources, identifying unique devices, capturing longitudinal data, limited staff expertise, and uncertain return on investment have hampered efforts to use real-world data. Many companies in our sample were conducting research using real-world data, but none had submitted RWE as the primary evidence supporting a premarket approval. FDA guidance was helpful, but regulatory requirements remained ambiguous and examples of successful regulatory decisions based on RWE were limited. Payers mainly used RWE to supplement experimental evidence in coverage decisions, evaluated both types of evidence in similar ways, and had concerns about the rigor of RWE. Conclusions Technical challenges may slow efforts to generate and use RWE in the near term. Additional regulatory guidance and examples, greater use of rigorous study designs and analytic methods, and continued stakeholder engagement could accelerate the use of RWE.

To improve health insurance literacy, the Centers for Medicaid and Medicare Services launched From Coverage to Care (C2C) to help individuals translate health insurance into appropriate healthcare ...

Aim: Research regarding decisions patients make about total knee arthroplasty, apart from having the procedure or not, are limited. Understanding patient decision making and related information needs is essential for shared decision making. Methods: Focus groups with an online community-based sample identified decisions about total knee arthroplasty beyond the decision to have the surgery itself. An online survey was used to determine relative importance of five major decisions and evaluate related information available. Results: Patients did not feel they have enough information to make important decisions of surgeon, device type, surgical approach, facility, or timing, for their total knee arthroplasty. Conclusion: Although further research is needed to generalize these findings, physicians should consider these questions during shared decision making with patients considering total knee arthroplasty.

Background: African Americans in the United States have worse end-of-life care and cancer outcomes than whites. Palliative care may improve this disparity. Community Health Workers may provide a means to improve palliative care disparities. Methods: Semistructured in-depth interviews (five) and stakeholder focus groups (four) were conducted with cancer patients, caregivers, health care administrators, oncologists, and community health workers (CHWs). Patients were recruited through snowball sampling. Three raters coded interviews independently. Data were analyzed using interpretative phenomenological analysis. Results: Seventy-one individuals were contacted to participate with 24 stakeholders (34%) participating in individual interviews or across 4 stakeholder engagements. Eleven constructs were identified and grouped in three broader themes: “hub of the wheel,” understanding palliative care, and patient–provider relationships. Participants felt that the role of a CHW should be central, bridging patients with their providers, information, and resources, including psychosocial support and advance care planning documents. They also placed an emphasis on the background of CHWs, saying individuals selected should be familiar with the history, culture, and norms of the communities from which they operate. Stakeholders reported that a CHW could activate a patient to contact their primary care physician or oncologist who may refer to or provide palliative care. Stakeholders reported that given the barriers to palliative care, a CHW could contribute to patient-centered multidisciplinary care while addressing palliative care domains with patients and families in a culturally sensitive manner. Conclusion: Based on feedback from patients, caregivers, and providers, a culturally adapted CHW intervention may improve palliative care use for African American patients with advanced malignancies.

The World Trade Center Health Program (WTCHP) has a research mission to identify physical and mental health conditions that may be related to the 9/11 terrorist attacks as well as effective diagnostic procedures and treatments for WTC-related health conditions. The ability of the WTCHP to serve its members and realize positive impacts on all of its stakeholders depends on effective translation of research findings. As part of an ongoing assessment of the translational impact of World Trade Center (WTC)-related research, we applied the National Institute of Environmental Health Sciences (NIEHS) translational framework to two case studies: WTC-related research on post-traumatic stress disorder (PTSD) and cancer. We conducted a review of 9/11 health-related research in the peer-reviewed literature through October 2017, grey literature, and WTCHP program documentation. We mapped peer-reviewed studies in the literature to the NIEHS framework and used WTCHP program documentation and grey literature to find evidence of translation of research into clinical practice and policy. Using the NIEHS framework, we identified numerous translational milestones and bridges, as well as areas of opportunity, within each case study. This application demonstrates the utility of the NIEHS framework for documenting progress toward public health impact and for setting future research goals.

A formal definition of “stakeholder” is “any individual or organization who is responsible for or affected by health-related decisions that can be informed by evidence.” In this chapter, we describe a fit-for-purpose approach to stakeholder engagement throughout the planning, development, and use of evidence from pragmatic clinical trials (pRCTs). We offer guidance on how to identify the aims of engagement, the stakeholders who will be involved, the roles in which they will participate, and by what modes they will interact with others on the team. We have seen growing commitments to stakeholder-engaged research in part because we believe it can help us create new evidence that is relevant to patients and other decision makers, research methods that are more transparent to decision makers, and findings that are useable in a wider range of settings. These beliefs need to be put to the test with carefully designed evaluations that assess what has been done in engagement work, how well it has been done, and what impact it has had.

Aim: Despite broad interest in advancing personalized medicine, most evidence is currently derived from average results of clinical trials that may obscure heterogeneity of trial participants. Little is known currently about how patients view heterogeneity in trials and whether they can participate in methodological discussions about this concept. Materials & methods: In structured discussions with three focus groups involving 22 participants, we assessed how representatives of patient communities have used research to guide individual treatment decisions. Discussion themes were organized into a framework describing patient decision-making in four steps: decisions patients make in the course of care; information used to make decisions; sources for information; and quality of information. Results/conclusion: Patients prioritize information that reflects their own characteristics, preferences and values. They struggle applying clinical research to their own case.

Background Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. Methods This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. Discussion We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.

IntroductionStakeholder engagement can play an important role in increasing public trust and the understanding of scientific research and its impact. Frameworks for stakeholder identification exist, but these frameworks may not apply well to basic science and early stage translational research.MethodsFour Clinical and Translational Science Award (CTSA) hubs led six focus groups and two semi-structured interviews using a semi-structured discussion guide to learn from basic science researchers about stakeholder engagement in their work. The 24 participants represented fourteen clinical and academic disciplines.ResultsEarly stage translational researchers reported engagement with a broad array of stakeholders. Those whose research has a clinical focus reported working with a more diverse range of stakeholders than those whose work did not. Common barriers to stakeholder engagement were grouped into three major themes: a poor definition of concepts, absence of guidance, and limited resources.DiscussionThe National Center for Advancing Translational Sciences (NCATS), the consortium of CTSAs, and the individual CTSA "hubs" are three actors that can help early stage translational researchers develop shared terms of reference, build the necessary skills, and assemble the appropriate resources for engaging stakeholders in Clinical and Translational Research. Getting this right will involve a coordinated push by all three entities.

To support health care resource allocation decisionmaking during the COVID-19 crisis, the authors created the Core Guidance Checklist from a discussion process with bioethicists, health system leaders, clinicians, patient advocates, and representatives of affected communities. It is intended for use by decisionmakers within health systems, as well as state-level policymakers, to improve resource allocation policy development and implementation.

Substantially engaging stakeholders in research involves making extensive changes to the full life cycle of research, from the initial stage of selecting research priorities to the final stages of dissemination and implementation. Recent scholarship has explored logistical and methodological challenges, including the time, training and resources required for engagement. However, inadequate attention has been given to the intended ends or goals of engagement – what do we want engagement to achieve? An examination of historical case studies can yield important insights regarding engagement and its intended ends. Using historical perspective methods, we explore how clarity about the ends of engagement can inform the design of engagement efforts and lead to better outcomes. We present several lessons for improving stakeholder-engaged research.

From Coverage to Care launched in 2014 with the dual goals of helping consumers understand their health insurance coverage and connect to care and supporting organizations in the community as they assist consumers at various points in this process. In this report, the authors present the results of their analysis of From Coverage to Care's effectiveness in meeting these goals.

Background Despite national guidelines promoting hepatitis C virus (HCV) testing in prisons, there is substantial heterogeneity on the implementation of HCV testing in jails. We sought to better understand barriers and opportunities for HCV testing by interviewing a broad group of stakeholders involved in HCV testing and treatment policies and procedures in Massachusetts jails. Methods We conducted semi-structured interviews with people incarcerated in Middlesex County Jail (North Billerica, MA), clinicians working in jail and community settings, corrections administrators, and representatives from public health, government, and industry between November 2018—April 2019. Results 51/120 (42%) of people agreed to be interviewed including 21 incarcerated men (mean age 32 [IQR 25, 39], 60% non-White). Themes that emerged from these interviews included gaps in knowledge about HCV testing and treatment opportunities in jail, the impact of captivity and transience, and interest in improving linkage to HCV care after release. Many stakeholders discussed stigma around HCV infection as a factor in reluctance to provide HCV testing or treatment in the jail setting. Some stakeholders expressed that stigma often led decisionmakers to estimate a lower “worth” of incarcerated individuals living with HCV and therefore to decide against paying for HCV testing.”. Conclusion All stakeholders agreed that HCV in the jail setting is a public health issue that needs to be addressed. Exploring stakeholders’ many ideas about how HCV testing and treatment can be approached is the first step in developing feasible and acceptable strategies.

With the increase in patient and consumer activism through the late twentieth century and into this century, patient roles in research evolved into a new model of research engagement, with patients serving as active advisors and co-leading or leading clinical research. By requiring active engagement of patients and other stakeholders, several government research funders have advanced this model, particularly in Canada, the United States (US), United Kingdom (UK), and Australia. A consortium of individuals from these countries formed a Multi-Stakeholder Engagement (MuSE) consortium to examine critical issues in engaged research, establish consensus on definitions, and provide guidance for the field, beginning with an overview of how to involve stakeholders in health research (Concannon et al. J Gen Intern Med. 2019;34(3):458-463) and continuing here with an examination of definitions of research engagement. The political and advocacy roots of engaged research are reflected in definitions. Engagement is conceptualized with reference to research project goals, from informing specific clinical decisions to informing health-system level decisions. Political and cultural differences across countries are evident. Some of these government funders focus on empirical rather than ethical rationales. In countries with centralized health technology assessment, the link between societal values and engaged research is explicit. Ethical rationales for engagement are explicit in most of the published literature on research engagement. Harmonization of definitions is recommended so that research engagement elements, methods, and outcomes and impacts can be clearly examined and understood, and so that the field of research engagement can proceed from a clear conceptual foundation. Specific recommendations for terminology definitions are provided. Placing engaged research on a continuum from specific clinical decisions to more global public and social justice concerns clarifies the type of engaged research, supports appropriate comparisons, and improves the rigor of engaged research methods. The results help identify knowledge gaps in this growing field. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-019-05436-2) contains supplementary material, which is available to authorized users.

Emerging health care research paradigms such as comparative effectiveness research (CER), patient-centered outcome research (PCOR), and precision medicine (PM) share one ultimate goal: constructing evidence to provide the right treatment to the right patient at the right time. We argue that to succeed at this goal, it is crucial to have both timely access to individual-level data and fine geographic granularity in the data. Existing data will continue to be an important resource for observational studies as new data sources are developed. We examined widely used publicly funded health databases and population-based survey systems and found four ways they could be improved to better support the new research paradigms: (1) finer and more consistent geographic granularity, (2) more complete geographic coverage of the US population, (3) shorter time from data collection to data release, and (4) improved environments for restricted data access. We believe that existing data sources, if utilized optimally, and newly developed data infrastructures will both play a key role in expanding our insight into what treatments, at what time, work for each patient.

Stakeholder engagement is increasingly common in health research, with protocols for engaging multiple stakeholder groups becoming normative in patient-centered outcomes research. Previous work has focused on identifying relevant stakeholder groups with whom to work and on working with stakeholders in evidence implementation. This paper draws on the expertise of a team from four countries—Canada, Australia, the UK, and the USA—to provide researchers with practical guidance for carrying out multi-stakeholder–engaged projects: we present a list of questions to assist in selecting appropriate roles and modes of engagement; we introduce a matrix to help summarize engagement activities; and we provide a list of online resources. This guidance, matrix, and list of resources can assist researchers to consider more systematically which stakeholder groups to involve, in what study roles, and by what modes of engagement. By documenting how stakeholders are paired up with specific roles, the matrix also provides a potential structure for evaluating the impact of stakeholder engagement. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-018-4738-6) contains supplementary material, which is available to authorized users.

The Center for Medicare and Medicaid Innovation within the Centers for MedicareMedicaid Services (CMS) has funded 108 Health Care Innovation Awards, funded through the Affordable Care Act, for applicants who proposed compelling new models of service delivery or payment improvements that promise to deliver better health, better health care, and lower costs through improved quality of care for Medicare, Medicaid, and Children's Health Insurance Program enrollees. CMS is also interested in learning how new models would affect subpopulations of beneficiaries (e.g., those eligible for Medicare and Medicaid and complex patients) who have unique characteristics or health care needs that could be related to poor outcomes. In addition, the initiative seeks to identify new models of workforce development and deployment, as well as models that can be rapidly deployed and have the promise of sustainability. This article describes a strategy for evaluating the results. The goal for the evaluation design process is to create standardized approaches for answering key questions that can be customized to similar groups of awardees and that allow for rapid and comparable assessment across awardees. The evaluation plan envisions that data collection and analysis will be carried out on three levels: at the level of the individual awardee, at the level of the awardee grouping, and as a summary evaluation that includes all awardees. Key dimensions for the evaluation framework include implementation effectiveness, program effectiveness, workforce issues, impact on priority populations, and context. The ultimate goal is to identify strategies that can be employed widely to lower cost while improving care.

In 2010, 15 percent of Americans older than age 70 had dementia, and the number of new dementia cases among those 65 and older is expected to double by the year 2050. As the baby boomer generation ages, many older adults will require dementia-related long-term services and supports (LTSS). This blueprint is the only national document to date that engages local, state, and national stakeholders to specifically focus on policy options at the intersection of dementia and LTSS. The authors undertook five major tasks that resulted in a prioritized list of policy options and research directions to help decisionmakers improve the dementia LTSS delivery system, workforce, and financing. These were to (1) identify weaknesses in the LTSS system that may be particularly severe for persons with dementia; (2) review national and state strategies addressing dementia or LTSS policy; (3) identify policy options from the perspective of a diverse group of stakeholders; (4) evaluate the policy options; and (5) prioritize policy options by impact and feasibility. Stakeholders identified 38 policy options. RAND researchers independently evaluated these options against prespecified criteria, settling on 25 priority options. These policy options can be summarized into five objectives for the dementia LTSS system: (1) increase public awareness of dementia to reduce stigma and promote earlier detection; (2) improve access to and use of LTSS; (3) promote high-quality, person- and caregiver-centered care; (4) provide better support for family caregivers of people with dementia; and (5) reduce the burden of dementia LTSS costs on individuals and families. This policy blueprint provides a foundation upon which to build consensus among a larger set of stakeholders to set priorities and the sequencing of policy recommendations.

Quality measurement is critical to identifying high-quality care and improving the quality of care. The opportunities and challenges for consumers to engage in quality measurement warrant careful examination. This report explores the experience of consumer advocates in engaging with quality measurement, identifies barriers to effective consumer engagement, and suggests ways to address those barriers.

We conducted a review of the peer-reviewed literature since 2003 to catalogue reported methods of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research.We worked with stakeholders before, during and after the review was conducted to: define the primary and key research questions; conduct the literature search; screen titles, abstracts and articles; abstract data from the articles; and analyze the data. The literature search yielded 2,062 abstracts. The review was conducted on 70 articles that reported on stakeholder engagement in individual research projects or programs.Reports of stakeholder engagement are highly variable in content and quality. We found frequent engagement with patients, modestly frequent engagement with clinicians, and infrequent engagement with stakeholders in other key decision-making groups across the healthcare system. Stakeholder engagement was more common in earlier (prioritization) than in later (implementation and dissemination) stages of research. The roles and activities of stakeholders were highly variable across research and program reports.To improve on the quality and content of reporting, we developed a 7-Item Stakeholder Engagement Reporting Questionnaire. We recommend three directions for future research: 1) descriptive research on stakeholder-engagement in research; 2) evaluative research on the impact of stakeholder engagement on the relevance, transparency and adoption of research; and 3) development and validation of tools that can be used to support stakeholder engagement in future work.

To investigate the relationship between the framing of survival gains and the perceived value of cancer care.Through a population-based survey of 2040 US adults, respondents were randomized to one of the two sets of hypothetical scenarios, each of which described the survival benefit for a new treatment as either an increase in median survival time (median survival), or an increase in the probability of survival for a given length of time (landmark survival). Each respondent was presented with two randomly selected scenarios with different prognosis and survival improvements, and asked about their willingness to pay (WTP) for the new treatments.Predicted WTP increased with survival benefits and respondents' income, regardless of how survival benefits were described. Framing therapeutic benefits as improvements in landmark rather than median time survival increased the proportion of the population willing to pay for that gain by 11-35%, and the mean WTP amount by 42-72% in the scenarios we compared.How survival benefits are described may influence the value people place on cancer care.

Background— Evidence suggests that recent and projected future investments in percutaneous coronary intervention (PCI) programs at US hospitals fail to increase access to timely reperfusion for patients with ST-segment elevation myocardial infarction. Methods and Results— We set out to estimate the annual number and costs of new PCI programs in US hospitals from 2004 to 2008 and identify the characteristics of hospitals, neighborhoods, and states where new PCI programs have been introduced. We estimated a discrete-time hazard model to measure the influence of these characteristics on the decision of a hospital to introduce a new PCI program. In 2008, 1739 US hospitals were capable of performing PCI, a relative increase of 16.5% (251 hospitals) over 2004. The percentage of the US population with projected access to timely PCI grew by 1.8%. New PCI programs were more likely to be introduced in areas that already had a PCI program with more competition for market share, near populations with higher rates of private insurance, in states that had weak or no regulation of new cardiac catheterization laboratories, and in wealthier and larger hospitals. Conclusions— Our data show that new PCI programs were systematically duplicative of existing programs and did not help patients gain access to timely PCI. The total cost of recent US investments in new PCI programs is large and of questionable value for patients.

Background— In 2001, 1176 US hospitals were capable of performing primary percutaneous coronary intervention (PCI), and 79% of the population lived within 60-minute ground transport of these hospitals. We compared these estimates with data from 2006 to explore how hospital PCI capability and population access have changed over time. Methods and Results— We estimated the proportion of the population 18 years of age or older, living in 2006 within a 60-minute drive of a PCI-capable hospital, and we compared our estimate with a previously published report on 2001 data. Over the 5-year period, the number of PCI-capable hospitals grew from 1176 to 1695 hospitals, a relative increase of 44%; access to the procedure grew from 79.0% to 79.9% of the population, a relative increase of 1%. Conclusions— Our data indicate a large increase in the number of hospitals capable of performing PCI from 2001 to 2006, but this increase was not associated with an appreciable change in the proportion of the population with access to the procedure. In the future, more attention is needed on changes in PCI capacity over time and on the effects of these changes on outcomes of interest such as service utilization, expenditures, patient outcomes, and population health.

OBJECTIVES/SPECIFIC AIMS: Stakeholder and community engagement (SCE) is a national priority for the National Center for Advancing Translational Science (NCATS). An established framework for stakeholder engagement exists for the latter stages (T2-T4) of translational, but no such framework currently exists for early stages of translational science (T1). Four Clinical and Translational Science Award (CTSA) hubs launched a collaboration to develop a new framework for engaging communities and stakeholders in T1 research. METHODS/STUDY POPULATION: We led structured individual and group discussions with T1 investigators to learn about: (1) the health decisions they seek to inform with research evidence, (2) the actors who make those decisions, and (3) the individuals and organizations that are affected by those decisions. In total, 18 individuals connected to 4 CTSA hubs participated in the discussions. Participants came from the fields ranging from basic chemistry and drug development to infectious disease and pediatrics and represented both methodological and topical experts. Focus groups lasted, on average, 1 hour, were audio recorded. Interviews lasted ~30 minutes. Audio recordings were transcribed and deidentified, and transcripts were coded using Dedoose™. We used a deductive-inductive procedure to develop the framework for stakeholder engagement in T1 research. A deductive codebook was development from the focus group and interview guides; emergent themes were added and the codebook was revised after preliminary inductive analysis. Two coders analyzed all transcripts using a constant comparison approach. We used an inductive process to identify themes and form them into a framework that could be used by T1 researchers in their work. The framework was developed through sequential reviews with coauthors and research participants. RESULTS/ANTICIPATED RESULTS: Preliminary findings suggest that stakeholders in early stage translational research (T1) do not fit into the same framework as those further down the translational spectrum (T2-T4). Basic scientists can identify stakeholders, however, and would like more guidance on who, how, and when to engage them in their research. DISCUSSION/SIGNIFICANCE OF IMPACT: By showing T1 researchers how to identify and involve their stakeholders in (1) defining research questions, (2) carrying out research activities, and (3) disseminating research evidence, this work has the potential to improve the use of basic science evidence in latter stages of translation from bench to bedside.

Background— Primary percutaneous coronary intervention (PCI) is more effective on average than fibrinolytic therapy in the treatment of ST-segment–elevation myocardial infarction. Yet, most US hospitals are not equipped for PCI, and fibrinolytic therapy is still widely used. This study evaluated the comparative effectiveness of ST-segment–elevation myocardial infarction regionalization strategies to increase the use of PCI against standard emergency transport and care. Methods and Results— We estimated incremental treatment costs and quality-adjusted life expectancies of 2000 patients with ST-segment–elevation myocardial infarction who received PCI or fibrinolytic therapy in simulations of emergency care in a regional hospital system. To increase access to PCI across the system, we compared a base case strategy with 12 hospital-based strategies of building new PCI laboratories or extending the hours of existing laboratories and 1 emergency medical services–based strategy of transporting all patients with ST-segment–elevation myocardial infarction to existing PCI-capable hospitals. The base case resulted in 609 (95% CI, 569–647) patients getting PCI. Hospital-based strategies increased the number of patients receiving PCI, the costs of care, and quality-adjusted life years saved and were cost-effective under a variety of conditions. An emergency medical services–based strategy of transporting every patient to an existing PCI facility was less costly and more effective than all hospital expansion options. Conclusion— Our results suggest that new construction and staffing of PCI laboratories may not be warranted if an emergency medical services strategy is both available and feasible.

Background— In patients with a major cardiac event, the first priority is to minimize time to treatment. For many patients, first contact with the health system is through emergency medical services (EMS). We set out to identify patient-level and neighborhood-level factors that were associated with elapsed time in EMS. Methods and Results— A retrospective cohort study was conducted in 10 municipalities in Dallas County, Tex, from January 1 through December 31, 2004. The data set included 5887 patients with suspected cardiac-related symptoms. The region was served by 29 hospitals and 98 EMS depots. Multivariate models included measures of distance traveled, time of day, day of week, and patient and neighborhood characteristics. The main outcomes were elapsed time in EMS (continuous; in minutes) and delay in EMS (dichotomous; >15 minutes beyond median elapsed time). We found positive associations between patient characteristics and both average elapsed time and delay in EMS care. Variation in average elapsed time was not large enough to be clinically meaningful. However, approximately 11% (n=647) of patients were delayed ≥15 minutes. Women were more likely to be delayed (adjusted odds ratio, 1.52; 95% confidence interval, 1.32 to 1.74), and this association did not change after adjusting for other characteristics, including neighborhood socioeconomic composition. Conclusions— Compared with otherwise similar men, women have 50% greater odds of being delayed in the EMS setting. The determinants of delay should be a special focus of EMS studies in which time to treatment is a priority.

Primary percutaneous coronary intervention (PPCI) yields superior mortality outcomes compared with thrombolysis in ST-elevation acute myocardial infarction (STEMI) but takes longer to administer. Previous meta-regressions have estimated that a procedure-related delay of 60 minutes would nullify the benefits of PPCI on mortality. Using a combined database from randomized clinical trials and registries (n = 2,781) and an independently developed model of mortality risk in STEMI, we developed logistic regression models predicting 30-day mortality for PPCI and thrombolysis by examining the influence of baseline risk on the treatment effect of PPCI and on the hazard of treatment delay. We used these models to solve mathematically for "time interval to mortality equivalence," defined as the PPCI-related delay that would nullify its expected mortality benefit over thrombolysis, and to explore the influence of baseline risk on this value. As baseline risk increases, the relative benefit of PPCI compared with thrombolytic therapy significantly increases (p = 0.002); patients with STEMI at relatively low risk of mortality accrue little or no incremental mortality benefit from PPCI, but high-risk patients benefit greatly. However, as baseline risk increases, the hazard associated with longer treatment-related delay also increases (p = 0.007). These 2 effects are compensatory and yield a roughly uniform time interval to mortality equivalence of approximately 100 minutes in patients who have at least a moderate degree of mortality risk (> approximately 4%). In conclusion, the mortality benefits of PPCI and the hazard of PPCI-related delay depend on baseline risk. Previous meta-regressions appear to have underestimated the PPCI-related delay that would nullify the incremental benefits of PPCI.

Objective To examine the association between warfarin treatment and longitudinal outcomes after ischemic stroke in patients with atrial fibrillation in community practice. Design Observational study. Setting Hospitals (n=1487) participating in the Get With The Guidelines (GWTG)-Stroke program in the United States, from 2009 to 2011. Participants 12 552 warfarin naive atrial fibrillation patients admitted to hospital for ischemic stroke and treated with warfarin compared with no oral anticoagulant at discharge, linked to Medicare claims for longitudinal outcomes. Main outcome measures Major adverse cardiovascular events (MACE) and home time, a patient centered outcomes measure defined as the total number of days free from institutional care after discharge. A propensity score inverse probability weighting method was used to account for all differences in observed characteristics between treatment groups. Results Among 12 552 survivors of stroke, 11 039 (88%) were treated with warfarin at discharge. Warfarin treated patients were slightly younger and less likely to have a history of previous stroke or coronary artery disease but had similar severity of stroke as measured by the National Institutes of Health Stroke Scale. Relative to those not treated, patients treated with warfarin had more days at home (as opposed to institutional care) during the two years after discharge (adjusted home time difference 47.6 days, 99% confidence interval 26.9 to 68.2). Patients discharged on warfarin treatment also had a reduced risk of MACE (adjusted hazard ratio 0.87, 99% confidence interval 0.78 to 0.98), all cause mortality (0.72, 0.63 to 0.84), and recurrent ischemic stroke (0.63, 0.48 to 0.83). These differences were consistent among clinically relevant subgroups by age, sex, stroke severity, and history of previous coronary artery disease and stroke. Conclusions Among ischemic stroke patients with atrial fibrillation, warfarin treatment was associated with improved long term clinical outcomes and more days at home. Clinical trial registration Clinical trials NCT02146274.