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• W2012321375 abstract "HomeCirculationVol. 128, No. 16Variable Impact of State Legislative Advocacy on Registry Participation and Regional Systems of Care Implementation Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBVariable Impact of State Legislative Advocacy on Registry Participation and Regional Systems of Care ImplementationA Policy Statement From the American Heart Association Ivan C. Rokos, MD, FAHA, Chair, Lee H. Schwamm, MD, FAHA, Madeleine Konig, MPH, Mary-Beth Malcarney, JD, MPH, Katie B. Horton, RN, MPH, JD, Jeffrey Ranous, A. Gray Ellrodt, MD, Steven A. Farmer, MD, PhD, Michael R. Frankel, MD, T. Bruce Ferguson, MD, FAHA, David C. GoffJr, MD, PhD, FAHA, Loren Hiratzka, MD, FAHA and Alice K. Jacobs, MD, FAHA Ivan C. RokosIvan C. Rokos Search for more papers by this author , Lee H. SchwammLee H. Schwamm Search for more papers by this author , Madeleine KonigMadeleine Konig Search for more papers by this author , Mary-Beth MalcarneyMary-Beth Malcarney Search for more papers by this author , Katie B. HortonKatie B. Horton Search for more papers by this author , Jeffrey RanousJeffrey Ranous Search for more papers by this author , A. Gray EllrodtA. Gray Ellrodt Search for more papers by this author , Steven A. FarmerSteven A. Farmer Search for more papers by this author , Michael R. FrankelMichael R. Frankel Search for more papers by this author , T. Bruce FergusonT. Bruce Ferguson Search for more papers by this author , David C. GoffJrDavid C. GoffJr Search for more papers by this author , Loren HiratzkaLoren Hiratzka Search for more papers by this author and Alice K. JacobsAlice K. Jacobs Search for more papers by this author Search for more papers by this author and on behalf of the American Heart Association Advocacy Coordinating Committee Originally published16 Sep 2013https://doi.org/10.1161/CIR.0b013e3182a8fc62Circulation. 2013;128:1799–1809Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2013: Previous Version 1 IntroductionRegionalization, systems of care design, and quality improvement (QI) registry participation all promote the widespread dissemination of guideline-based evidence into actual practice. As a result, policy statements from the American Heart Association/American Stroke Association (AHA/ASA) advocate for the creation of regional systems of care for various time-critical diagnoses, including ST-elevation myocardial infarction (STEMI), out-of-hospital cardiac arrest resuscitation, and acute stroke.1–3 Creation of these regional networks requires multidisciplinary collaboration to implement 5 mutually reinforcing core elements4 that build each system: (1) Designation of certain hospitals with special treatment capabilities as Receiving Centers for STEMI, resuscitation, or stroke; (2) emergency medical services (EMS) destination protocols that allow for direct transport of certain patients identified by explicit triage criteria to a designated Receiving Center, thus allowing for bypass of closer hospitals if they lack the needed specialty service; (3) organized interhospital transfer and transport protocols to a Receiving Center for appropriate patients who initially self-present or are mistriaged to a Referral Hospital; (4) communication or telemedicine options to provide real-time expert consultation as needed from a Receiving Center to its associated Referral Hospitals or EMS providers; and (5) participation in a regional and/or national QI registry to track relevant process-of-care metrics and meaningful risk-adjusted clinical outcomes.Within each of the 50 states, unique challenges exist for stakeholders attempting to implement the 5 aforementioned core elements of regional or statewide systems of care. In particular, substantial variation exists with regard to the starting point for these initiatives. For example, some states already have sufficient regulatory authority within their EMS agency or state department of health (DOH) to regionalize care of time-critical diagnoses, whereas other states require new legislation to create coordinated systems.In October 2011, the Advocacy Coordinating Committee of the AHA convened a multispecialty task force to assess the effects of state legislative activity on regional systems of care. The resulting AHA policy statement reflects a combination of expert consensus and mixed methods5 research. Semiquantitative analyses were used to study various state legislative efforts and evaluate their subsequent impact on QI registry participation, because this provided a practical and objective surrogate marker for the magnitude of regional systems implementation. In some states, existing regulatory authority allowed for avoidance of de novo legislation. Qualitative analyses were used to explore various supporting themes and lessons learned from each state’s experience with de novo legislation versus existing regulatory authority in promoting regional systems of care development and QI registry participation. Qualitative study methods are particularly useful when investigating the most relevant real-world factors in complex nonlinear processes.5MethodsThe AHA/ASA Office of State Advocacy continually monitors legislative activities in all states across the nation. At the time the present task force was convened (2011), 5 “case” states existed that had passed systems-of-care legislation that was also designed to encourage QI registry participation. These included Maryland, New Jersey, North Dakota, Rhode Island, and Tennessee during the years 2008 and 2009. For New Jersey, the 2009 law built on an initial hospital designation regulation from its Stroke Center Act of 2004. The fifth state, Maryland, instituted both stroke (2006) and STEMI (2010) registries via regulation under broad EMS authority from a prior trauma systems law that permitted the designation of hospitals as specialty centers and the development of clinical registries to monitor performance.Two illustrative “control” states, Pennsylvania and Indiana, were chosen because they lacked a legislative mandate to create a statewide stroke or STEMI registry, had not created a system of care via other mechanisms, and were not the recipients of federal monies aimed at the creation of voluntary registries. Pennsylvania and Indiana thus provided a comparison for registry participation in states without targeted AHA/ASA advocacy efforts.The semiquantitative analysis in the present study evaluated both the number of participating hospitals and the number of patient records submitted to state registries, stratified by key time points in system development: Prelegislation (2 years and 6 months prior), at legislation enactment (date of passage), at implementation date (effective date of legislation), and postimplementation (6 months, 1 year, and 2 years later). Simple unadjusted descriptive statistics were used to show trends over time. For stroke, the cross-sectional data queries for each time point were performed on the basis of data submitted by hospitals participating in the AHA’s Get With The Guidelines (GWTG)-Stroke program * in each of the 5 case and 2 control states. In these states, participation in GWTG-Stroke is voluntary and represents a convenience sample of hospitals. Although the New Jersey state system officially uses its own registry platform modified from the Coverdell QI registry, many New Jersey hospitals also continue to use GWTG-Stroke for collection and reporting of these data. For STEMI, a cross-sectional query of the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry–Get With The Guidelines (ACTION-GWTG) was performed for Maryland only, because it was the only state in the present study that had a STEMI registry. The rationale and registry design of both GWTG-Stroke and ACTION-GWTG have been described previously.6,7 Also, for each state, the ratio of registry-participating hospitals to total number of hospitals per a Medicare Web site8 was determined.For the qualitative evaluation, a 2-person policy research team conducted in-depth telephone interviews in each of the 5 case states and the 2 control states. Researchers interviewed at least 3 individuals in each state, selecting representatives from regulatory agencies, hospitals, and local AHA staff to assess how the QI registry data were being collected and used, barriers to implementation, and the overall impact on systems of care across each state. Table 1 provides more detail on those interviewed and demonstrates the equal distribution of categories for all studied states. The interviews focused primarily on stroke registries, because Maryland was the only state in the present study with a STEMI system. As per standard qualitative methodology,5 the conversations were dynamic yet organized around 7 key themes from a predetermined discussion guide (listed below); distinct concepts were cataloged by the constant comparative method; and interviews continued until theoretical saturation (the point at which no new concepts emerged):Table 1. Qualitative Evaluation: Details on Study IntervieweesInterviewee CategoryStateState Agency RepresentativeHospital RepresentativeState DOHAHA QIAHA AdvocacyCase states MarylandXXXX New JerseyXXXX North DakotaXXXXX Rhode IslandXXXXX TennesseeXXXXControl states IndianaXXXX PennsylvaniaXXXAHA indicates American Heart Association; DOH, Department of Health; and QI, quality improvement.Pathway to legislation in each stateDesignation of “centers” and organization of regional systemsRegistry implementationCurrent use of registry dataKeys to successful implementation of registryChallenges to implementationNext stepsResults of Semiquantitative AnalysesFigures 1 through 7 illustrate trends over time for stroke in the 5 case states and 2 control states. Both the number of participating hospitals and total number of patient records are displayed and span the period from 2 years before legislation (or regulation) enactment for the case states to December 2011 (except Rhode Island). For the 2 control states, the graphs span January 2007 to December 2011.Download figureDownload PowerPointFigure 1. Maryland: GWTG-Stroke. Participation by hospital and number of patient records by month before regulation enactment, after regulation enactment, and after regulation implementation. GWTG indicates Get With The Guidelines.Download figureDownload PowerPointFigure 2. New Jersey: GWTG-Stroke. Participation by hospital and number of patient records by month before legislation enactment, after legislation enactment, and after legislation implementation. GWTG indicates Get With The Guidelines.Download figureDownload PowerPointFigure 3. North Dakota: GWTG-Stroke. Participation by hospital and number of patient records by month before legislation enactment, after legislation enactment, and after legislation implementation. GWTG indicates Get With The Guidelines.Download figureDownload PowerPointFigure 4. Rhode Island: GWTG-Stroke. Participation by hospital and number of patient records by month before and after legislation enactment. GWTG indicates Get With The Guidelines.Download figureDownload PowerPointFigure 5. Tennessee: GWTG-Stroke. Participation by hospital and number of patient records by month before legislation enactment, after legislation enactment, and after legislation implementation. GWTG indicates Get With The Guidelines.Download figureDownload PowerPointFigure 6. Indiana: GWTG-Stroke. Number of hospitals and patient records by month. GWTG indicates Get With The Guidelines.Download figureDownload PowerPointFigure 7. Pennsylvania: GWTG-Stroke. Number of hospitals and patient records by month. GWTG indicates Get With The Guidelines.For all 5 case states, participation by hospitals (blue line) and the total number of patient records (red line) in the registries increased consistently over time. The upward slope of both lines began before legislation enactment, but the positive trend in hospital participation (blue line) accelerated around the time of legislation for all case states except Rhode Island. Specifically, for Maryland and Tennessee, it occurred during the legislation period, whereas it accelerated in New Jersey during the 6 months before legislation enactment and accelerated in North Dakota ≈6 months after legislation implementation began. Although analysis of the 2 control states also demonstrated a positive trend for both hospital participation and number of patient records, the slope was consistently gradual and without any obvious inflection point. Across all 7 graphs, minor slope changes may be seen around the beginning of the year, indicative of the annual contract renewal cycle that occurs within the GWTG program.Table 2 summarizes the maximum number of stroke registry–participating hospitals in each state during the study period. Most states had ≈50% of hospitals voluntarily participating in the stroke system of care when the denominator was the total number of both acute care hospitals and critical access hospitals (CAHs) on the Medicare Web site8 (Veterans Health Administration hospitals excluded). Among the case states, Tennessee had the lowest proportion (11%) and New Jersey had the highest proportion (69%). For the 2 control states, Indiana had a 28% and Pennsylvania a 47% rate of participation.Table 2. Maximum Number of Stroke Registry–Participating Hospitals in Each State During the Study PeriodStatePrimary StrokeCenters, n*Total Hospitals in Each State’s Stroke Registry, nTotal Hospitals per CMS, Stratified by Acute Care vs Critical Access, n (x, y)Registry ParticipationRate by State, %†Case states Maryland172745 (45, 0)60 New Jersey314464 (64, 0)69 North Dakota22444 (8, 36)55 Rhode Island4311 (11, 0)27 Tennessee1113114 (99, 15)11Control states Indiana1334123 (88, 35)28 Pennsylvania4178165 (152, 13)47CMS indicates Centers for Medicare & Medicaid Services.*Certified by The Joint Commission.†Although hospital data submissions to the quality improvement registry were mandatory in most states, the initial decision by each hospital to join the stroke network was voluntary.Maryland (using existing regulatory authority) was the only state in the present study to implement a STEMI system, with 25 (56%) of 45 hospitals participating in ACTION-GWTG by the end of the study period. In Figure 8, a particularly steep upward slope (blue line) reflects the rapid response by hospitals in the 2-month period after regulation enactment and leading up to regulation implementation.Download figureDownload PowerPointFigure 8. Maryland: ACTION-GWTG. Participation by hospital and number of patient records by month before and after legislation enactment. GWTG indicates Get With The Guidelines.Results of Qualitative AnalysesTable 3 provides a summary of recurrent themes and key findings. Section 1 highlights important clinical registry policies, and section 2 lists supportive state policies. The narrative below provides a more in-depth discussion of each item in Table 3.Table 3. Summary of Qualitative Findings1. Clinical registry policies 1A. Hospitals are most likely to submit data to a stroke clinical registry when state policies require mandatory data collection as part of stroke center designation. 1B. Initial state funding to assist hospitals in registry participation is often a determining factor of hospital engagement with a stroke registry. 1C. DOH management over the stroke clinical registry and adequate resources for data analysis are important for full registry implementation and continued stakeholder engagement. 1D. Engaging critical access hospitals in the stroke clinical registry is important for rural states. 1E. Strong data confidentiality policies are critically important to drive hospital participation in stroke registries.2. State policies that reinforce clinical registry participation 2A. Leadership and consensus from an independent or state-sponsored stroke task force were often integral to the establishment of a state’s stroke registry. 2B. State leadership on designating primary stroke centers may be important. 2C. A state-operated primary stroke center designation process may reduce barriers to hospital participation compared with The Joint Commission accreditation. 2D. Efforts to address complex stroke cases are a critical component in the stroke system of care. 2E. EMS bypass policies likely reinforce the initial stroke center designation process, thereby increasing stroke clinical registry participation. 2F. A statewide stroke coordinator network may be important for stroke registry participation. 2G. Broad regulatory authority may be helpful for implementation but may not be feasible in all states. 2H. Registry data collection and dissemination promotes continuous quality improvement activities.DOH indicates Department of Health; and EMS, emergency medical services.1. Clinical Registry Policies1A. Hospitals Are Most Likely to Submit Data to a Stroke Clinical Registry When State Policies Require Mandatory Data Collection as Part of Stroke Center DesignationFour of the 5 case states evaluated have a mandatory registry policy: By law or regulation, each hospital in the state that voluntarily decides to become stroke center certified must submit data to the state stroke clinical registry. Interviewees observed that the mandatory nature of a state’s stroke registry policy serves 2 important functions: (1) Mandatory registries ensure robust data submission from certified stroke centers, and (2) these policies tend to signal to hospital administrators that the state is taking stroke QI seriously. As a result, many hospitals in these states have become more motivated to focus on stroke within their institutions, often giving them the impetus to become stroke center certified in the first place. In the case states where a mandatory reporting policy is in place, ≥50% of eligible hospitals in the state are certified as stroke centers. By contrast, in Tennessee (the only case state where reporting to the stroke clinical registry is voluntary), only 11% of hospitals in the state have sought stroke center certification.1B. Initial State Funding to Assist Hospitals in Registry Participation Is Often a Determining Factor of Hospital Engagement With a Stroke RegistryIn all case states, interviewees described the challenges for hospitals to submit data to the state stroke clinical registry, including the cost of purchasing stroke registry software and salaries for data-entry personnel. To address some of these cost concerns, most states implemented regulations that selected the GWTG-Stroke registry as the official clinical registry platform, given that many hospitals were already familiar with the program and its relatively low annual subscription cost.New Jersey is unique because the state’s legislation requires registry reporting through a state-specific stroke clinical registry, the New Jersey Acute Stroke Registry. Many hospitals initially found it difficult to adapt to the alternative registry format and had to dedicate more staff resources to the submission of new data points. Interestingly, many New Jersey hospitals also continued to participate in GWTG-Stroke because they wanted to compare their performance against national trends. Despite these burdens, 69% percent of hospitals in New Jersey participate in the New Jersey Acute Stroke Registry. In addition to waiving any data submission fees for registry participation, the state has established a grant-making program to assist some hospitals with developing the infrastructure necessary to become stroke center certified and registry-submission ready.Other case states implemented smaller funding programs with similar success. For example, North Dakota has established a grant program to assist CAHs in the state to purchase GWTG-Stroke, train staff, and receive reimbursement for data entry activities. Before the grant program, no CAHs were submitting data to a stroke registry; today, the majority of CAHs submit stroke registry data to the state. Interviews in several states revealed that when hospitals do not receive supportive funding from their state, stroke coordinators face greater challenges convincing their hospital administrators to promote stroke improvement initiatives.1C. DOH Management Over the Stroke Clinical Registry and Adequate Resources for Data Analysis Are Important for Full Registry Implementation and Continued Stakeholder EngagementThe experience from Maryland and New Jersey highlights that developing a stroke clinical registry with robust data analysis requires DOH leadership and dedicated resources. Both of these states have the capacity to evaluate stroke data and issue quarterly reports, largely because of the considerable resources each state DOH devotes to the stroke effort.Other case states have struggled to implement their stroke registries because of a lack of dedicated resources or prioritization at the DOH. For example, insufficient DOH resources in Rhode Island have delayed the state’s implementation of its stroke registry by almost 4 years. In North Dakota, although hospitals were able to submit data to the registry relatively soon after passage of the implementing law, the DOH has not yet had the ability to conduct a comprehensive analysis of incoming data, because it lacked sufficient funds to hire a full-time employee dedicated to the stroke registry. The Tennessee DOH determined that operation of a stroke registry was cost-prohibitive, so the registry was placed within one of the state’s universities; however, some interviewees are now apprehensive about the university-model registry because it does not appear sufficiently responsive to stakeholder or DOH needs.1D. Engaging CAHs in the Stroke Clinical Registry Is Important for Rural StatesGiven the rural nature of North Dakota, CAHs (small, rural hospitals with <25 beds) dominate the state’s healthcare landscape. The state has 36 CAHs compared with just 8 acute care hospitals. Although individual CAHs encounter few cases of stroke, collectively, North Dakota’s network of CAHs sees a significant number of stroke patients. Accordingly, regulations implementing the stroke registry in North Dakota allow CAHs to voluntarily submit data, and interviewees anticipate that CAH registry data will be critical in understanding and improving the stroke system of care for the state’s rural residents.Indiana (a control state) engages CAHs in stroke registry participation through the use of “telestroke” consultations with tertiary hospitals. In addition to building telestroke capacity, the program provides support to Indiana CAHs to enable them to submit data to GWTG-Stroke. Even in less rural states, engaging smaller community hospitals is critical to program success, because ideally all hospitals in the state will participate in some manner within the stroke systems-of-care model.1E. Strong Data Confidentiality Policies Are Critically Important to Drive Hospital Participation in Stroke RegistriesNearly every hospital employee interviewed emphasized the importance of data confidentiality, because hospitals want to be assured that any publicly reported stroke registry data are only reported in the aggregate. This QI approach fosters a truthful, accurate, and comprehensive evaluation of each hospital’s strengths and weaknesses. Case states vary in how they address registry data privacy. Maryland regulations outline specific standards for how the DOH can use any data collected through the registry and set strong protections that limit public reporting of hospital-identifiable data. New Jersey does not have a formal registry privacy policy, but the DOH has stated that it does not intend to publicly report hospital stroke registry data.In contrast, the first report from the Tennessee stroke registry contained hospital-specific information, even though the state’s statute specifically precluded reporting of hospital-identifiable data. The lapse in privacy protection has since been resolved, but some hospitals have dropped out the registry and are hesitant to rejoin without stronger privacy regulations. Similarly, in Pennsylvania, hospitals have been reluctant to support state efforts to implement a stroke clinical registry because respondents believed that the state had a history of reporting hospital-identifiable stroke information publicly.2. State Policies That Reinforce Clinical Registry ParticipationA stroke clinical registry is just 1 of the 5 major components (described in the introduction to this statement) needed to create a statewide system of care. Interviews were rich with information on other aspects of the stroke system of care that contribute to (or detract from) clinical registry efforts. The following discussion outlines several findings on supportive state stroke system-of-care policies.2A. Leadership and Consensus From an Independent or State-Sponsored Stroke Task Force Were Often Integral to the Establishment of a State’s Stroke RegistryBefore implementation of stroke center designation, EMS protocols, or clinical registry policies, all of the case states depended on leadership from a statewide stroke task force. The Rhode Island and North Dakota task forces were established officially by law; in New Jersey, the state’s task force was convened by the DOH; and in Maryland and Tennessee, the task forces convened informally with leadership from the AHA and other stakeholders. Formal or informal, each of these stroke task forces is generally composed of state DOH officials and voluntary stakeholders from across the spectrum of stroke care (eg, healthcare providers, stroke survivors, and EMS personnel). Interviewees in the case states generally agreed that recommendations that came out of these consensus-driven multidisciplinary task forces carried weight with decision makers (state legislatures, DOH officials, and others) and were a pivotal part of getting legislative and regulatory stroke system reforms implemented.However, the existence of a stroke task force does not guarantee success. For example, Indiana has a stroke task force mandated by its general assembly and operated within the DOH. The task force has a similar makeup and goals as other stroke task forces in other states, yet Indiana has not been able to introduce legislation to implement a stroke registry in the state. The different outcome in Indiana (despite task force engagement) appears to be the task force’s limited ability to issue and enforce recommendations, as well as the Indiana DOH’s relative lack of resources put toward stroke QI efforts compared with case states.2B. State Leadership on Designating Primary Stroke Centers May Be ImportantIn 4 of the 5 case states examined, a formal statewide primary stroke center designation process forms the foundation of the state’s stroke clinical registry. Although it is voluntary for hospitals to apply to the state to become a designated primary stroke center, all hospitals that become designated stroke centers in Maryland, New Jersey, North Dakota, and Rhode Island must submit data to the state stroke registry and participate in QI activities. In each of the case states with a stroke center designation process, more than half of all hospitals have become designated. In contrast, Tennessee does not have a state designation program, and very few hospitals in the state have independently sought certification.2C. A State-Operated Primary Stroke Center Designation Process May Reduce Barriers to Hospital Participation Compared With Joint Commission AccreditationCriteria for primary stroke center designation differ between states. Although New Jersey conducts its own designation process through the state DOH, North Dakota and Rhode Island recognize hospitals as primary stroke centers only if they have obtained designation from The Joint Commission. Hospitals in Maryland can achieve designation either using their existing certification from The Joint Commission or by undergoing the state’s certification process. Interviewees described the cost of certification by The Joint Commission as a major barrier to participation in the stroke system in states that did not offer a DOH designation option. Hospitals in New Jersey and Maryland, however, noted that they still sought certification from The Joint Commission because it allowed national comparisons.2D. Efforts to Address Complex Stroke Cases Are a Critical Component in the Stroke System of CareTwo case states, New Jersey and Maryland, have promulgated regulations for designating comprehensive stroke centers. Comprehensive stroke centers are highly specialized facilities capable of delivering the full range of care needed for complex stroke patients, including advanced neuroimaging capabilities, a neurosurgical team, and onsite rehabilitation services. Since its inception in 2006, the natural distribution of primary and comprehensive stroke centers in New Jersey has formed a network in which each primary stroke center is linked to a comprehensive stroke center in a hub-and-spoke arrangement. Maryland is working toward a similar goal of comprehensive stroke center distribution across the state.2E. EMS Bypass Policies Likely Reinforce the Initial Stroke Center Designation Process, Thereby Increasing Stroke Clinical Registry ParticipationThree of the case study states (Maryland, New Jersey, and Rhode Island) have formal EMS bypass policies in place. These policies state that potential stroke patients identified by EMS via prehospital triage protocols must be transported to the nearest designated primary stroke center, thereby bypassing closer hospitals without stroke center designation" @default.
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