Abstract There is a significant and growing interest among both payers and producers of medical products for agreements that involve a “pay-for-performance” or “risk-sharing” element. These payment ...schemes—called “performance-based risk-sharing arrangements” (PBRSAs)—involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the amount or level of reimbursement is based on the health and cost outcomes achieved. There has always been considerable uncertainty at product launch about the ultimate real-world clinical and economic performance of new products, but this appears to have increased in recent years. PBRSAs represent one mechanism for reducing this uncertainty through greater investment in evidence collection while a technology is used within a health care system. The objective of this Task Force report was to set out the standards that should be applied to “good practices”—both research and operational—in the use of a PBRSA, encompassing questions around the desirability, design, implementation, and evaluation of such an arrangement. This report provides practical recommendations for the development and application of state-of-the-art methods to be used when considering, using, or reviewing PBRSAs. Key findings and recommendations include the following. Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring, and evaluation costs can be substantial. For good research practice in PBRSAs, it is critical to match the appropriate study and research design to the uncertainties being addressed. Good governance processes are also essential. The information generated as part of PBRSAs has public good aspects, bringing ethical and professional obligations, which need to be considered from a policy perspective. The societal desirability of a particular PBRSA is fundamentally an issue as to whether the cost of additional data collection is justified by the benefits of improved resource allocation decisions afforded by the additional evidence generated and the accompanying reduction in uncertainty. The ex post evaluation of a PBRSA should, however, be a multidimensional exercise that assesses many aspects, including not only the impact on long-term cost-effectiveness and whether appropriate evidence was generated but also process indicators, such as whether and how the evidence was used in coverage or reimbursement decisions, whether budget and time were appropriate, and whether the governance arrangements worked well. There is an important gap in the literature of structured ex post evaluation of PBRSAs. As an innovation in and of themselves, PBRSAs should also be evaluated from a long-run societal perspective in terms of their impact on dynamic efficiency (eliciting the optimal amount of innovation).
What will it take to bring disease-modifying therapy to clinical use in type 1 diabetes? Coordinated efforts of investigators involved in discovery, translational, and clinical research operating in ...partnership with funders and industry and in sync with regulatory agencies are needed. This Perspective describes one such effort, Type 1 Diabetes TrialNet, a National Institutes of Health-funded and JDRF-supported international clinical trials network that emerged from the Diabetes Prevention Trial-Type 1 (DPT-1). Through longitudinal natural history studies, as well as trials before and after clinical onset of disease combined with mechanistic and ancillary investigations to enhance scientific understanding and translation to clinical use, TrialNet is working to bring disease-modifying therapies to individuals with type 1 diabetes. Moreover, TrialNet uses its expertise and experience in clinical studies to increase efficiencies in the conduct of trials and to reduce the burden of participation on individuals and families. Herein, we highlight key contributions made by TrialNet toward a revised understanding of the natural history of disease and approaches to alter disease course and outline the consortium's plans for the future.
The vulnerability of postacute and long-term care (PA/LTC) facility residents to COVID-19 has manifested across the world with increasing facility outbreaks associated with high hospitalization and ...mortality rates. Systematic protocols to guide telehealth-centered interventions in response to COVID-19 outbreaks have yet to be delineated. This article is intended to inform PA/LTC facilities and neighboring health care partners how to collaboratively utilize telehealth-centered strategies to improve outcomes in facility outbreaks.
: The University of Virginia rapidly developed a multidisciplinary telehealth-centered COVID-19 facility outbreak strategy in response to a LTC facility outbreak in which 41 (out of 48) facility residents and 7 staff members tested positive. This strategy focused on supporting the facility team remotely using rapidly deployed technologic solutions. Goals included (1) early identification of patients who need their care escalated, (2) monitoring and treating patients deemed safe to remain in the facility, (3) care coordination to facilitate bidirectional transfers between the skilled nursing facility (SNF) and hospital, and (4) daily facility needs assessment related to technology, infection control, and staff well-being. To achieve these goals, a standardized approach centered on daily multidisciplinary virtual rounds and telemedicine consultation was provided.
Over a month since the outbreak began, 18 out of 48 (38%) facility residents required hospitalization and 6 (12.5%) died. Eleven facility residents have since returned back to the SNF after recovering from their hospitalization. No staff required hospitalization.
Interventions that reduce hospitalizations and mortality are a critical need during the COVID-19 pandemic. The mortality and hospitalization rates seen in this PA/LTC facility outbreak are significantly lower than has been documented in other facility outbreaks. Our multidisciplinary approach centered on telemedicine should be considered as other PA/LTC facilities partner with neighboring health care systems in responding to COVID-19 outbreaks. We have begun replicating these services to additional PA/LTC facilities facing COVID-19 outbreaks.
IMPORTANCE: Postacute care is thought to be a major source of wasteful spending. The extent to which accountable care organizations (ACOs) can limit postacute care spending has implications for the ...importance and design of other payment models that include postacute care. OBJECTIVE: To assess changes in postacute care spending and use of postacute care associated with provider participation as ACOs in the Medicare Shared Savings Program (MSSP) and the pathways by which they occurred. DESIGN, SETTING, AND PARTICIPANTS: With the use of fee-for-service Medicare claims from a random 20% sample of beneficiaries with 25 544 650 patient-years, 8 395 426 hospital admissions, and 1 595 352 stays in skilled nursing facilities (SNFs) from January 1, 2009, to December 31, 2014, difference-in-difference comparisons of beneficiaries served by ACOs with beneficiaries served by local non-ACO health care professionals (control group) were performed before vs after entry into the MSSP. Differential changes were estimated separately for cohorts of ACOs entering the MSSP in 2012, 2013, and 2014. EXPOSURES: Patient attribution to an ACO in the MSSP. MAIN OUTCOMES AND MEASURES: Postacute spending, discharge to a facility, length of SNF stays, readmissions, use of highly rated SNFs, and mortality, adjusted for patient characteristics. RESULTS: For the 2012 cohort of 114 ACOs, participation in the MSSP was associated with an overall reduction in postacute spending (differential change in 2014 for ACOs vs control group, −$106 per beneficiary 95% CI, –$176 to –$35, or −9.0% of the precontract unadjusted mean of $1172; P = .003) that was driven by differential reductions in acute inpatient care, discharges to facilities rather than home (−0.6 percentage points 95% CI, –1.1 to 0.0, or −2.7% of the unadjusted precontract mean of 22.6%; P = .03), and length of SNF stays (−0.60 days per stay 95% CI, –0.99 to –0.22, or −2.2% of the precontract unadjusted mean of 27.07 days; P = .002). Reductions in use of SNFs and length of stay were largely due to within-hospital or within-SNF changes in care specifically for ACO patients. Participation in the MSSP was associated with smaller significant reductions in SNF spending in 2014 for the 2013 ACO cohort (–$27 per beneficiary 95% CI, –$49 to –$6, or –3.3% of the precontract unadjusted mean of $813; P = .01) but not in the 2013 or 2014 cohort’s first year of participation (–$13 per beneficiary 95% CI, –$33 to $6; P = .19; and $4 per beneficiary 95% CI, –$15 to $24; P = .66). Estimates were similar for ACOs with and without financial ties to hospitals. Participation in the MSSP was not associated with significant changes in 30-day readmissions, use of highly rated SNFs, or mortality. CONCLUSIONS AND RELEVANCE: Participation in the MSSP has been associated with significant reductions in postacute spending without ostensible deterioration in quality of care. Spending reductions were more consistent with clinicians working within hospitals and SNFs to influence care for ACO patients than with hospital-wide initiatives by ACOs or use of preferred SNFs.
A third of the world's population does not engage in recommended levels of physical activity (PA), leading to substantial health and economic burdens. The healthcare sector offers a variety of ...resources that can help counsel, refer and deliver PA promotion programmes for purposes of primordial, primary, secondary and tertiary prevention. Substantial evidence already exists in support of multipronged PA counselling, prescription and referral strategies, in particular those linking healthcare and community-based resources.
The Exercise is Medicine (EIM) initiative was introduced in 2007 to advance the implementation of evidence-based strategies to elevate the status of PA in healthcare. In this article, we describe the evolution and global expansion of the EIM initiative, its components, their implementation, an evaluation framework and future initiative activities.
Until now, EIM has a presence in 39 countries with EIM Regional Centers established in North America, Latin America, Europe, Africa, Southeast Asia, China and Australasia. The EIM Global Health Initiative is transitioning from its initial phase of infrastructure and awareness building to a phase of programme implementation, with an emphasis in low-to-middle income countries, where 80% of deaths due to non-communicable diseases already occur, but where a large gap in research and implementation of PA strategies exists.
Broad implementation of PA counselling and referral systems, as clinical practice standard of care, has the potential to improve PA at the population level by complementing and leveraging other efforts and to contribute to achieving global targets for the reduction of inactivity and related morbidity and mortality.
Building on decades of research on the proactivity of individual performers, this study integrates research on goal setting and trust in leadership to examine manager proactivity and business unit ...sales performance in one of the largest sales organizations in the United States. Results of a moderated-mediation model suggest that proactive senior managers establish more challenging goals for their business units (N = 50), which in turn are associated with higher sales performance. We further found that employees' trust in the manager is a critical contingency variable that facilitates the relationship between challenging sales goals and subsequent sales performance. This research contributes to growing literatures on trust in leadership and proactivity by studying their joint effects at a district-unit level of analysis while identifying district managers' tendency to set challenging goals as a process variable that helps translate their proactivity into the collective performance of their units.
Worldwide, leaders are implementing nonpharmaceutical interventions to slow transmission of the novel coronavirus while pursuing vaccines that confer immunity to severe acute respiratory syndrome ...coronavirus-2 (SARS-CoV-2) infection. In this article we describe lessons learned from past pandemics and vaccine campaigns about the path to successful vaccine delivery. The historical record suggests that to have a widely immunized population, leaders must invest in evidence-based vaccine delivery strategies that generate demand, allocate and distribute vaccines, and verify coverage. To generate demand, there must be an understanding of the roots of vaccine hesitancy, involvement of trusted sources of authority in advocacy for vaccination, and commitment to longitudinal engagement with communities. To allocate vaccines, qualified organizations and expert coalitions must be allowed to determine evidence-based vaccination approaches and generate the political will to ensure the cooperation of local and national governments. To distribute vaccines, the people and organizations with expertise in manufacturing, supply chains, and last-mile distribution must be positioned to direct efforts. To verify vaccine coverage, vaccination tracking systems that are portable, interoperable, and secure must be identified. Lessons of past pandemics suggest that nations should invest in evidence-informed strategies to ensure that coronavirus disease 2019 (COVID-19) vaccines protect individuals, suppress transmission, and minimize disruption to health services and livelihoods.
Cancer research in Africa will have a pivotal role in cancer control planning in this continent. However, environments (such as those in academic or clinical settings) with limited research ...infrastructure (laboratories, biorespositories, databases) coupled with inadequate funding and other resources have hampered African scientists from carrying out rigorous research. In September 2012, over 100 scientists with expertise in cancer research in Africa met in London to discuss the challenges in performing high-quality research, and to formulate the next steps for building sustainable, comprehensive and multi-disciplinary programmes relevant to Africa. This was the first meeting among five major organizations: the African Organisation for Research and Training in Africa (AORTIC), the Africa Oxford Cancer Foundation (AfrOx), and the National Cancer Institutes (NCI) of Brazil, France and the USA. This article summarizes the discussions and recommendations of this meeting, including the next steps required to create sustainable and impactful research programmes that will enable evidenced-based cancer control approaches and planning at the local, regional and national levels.
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