Having patients, doctors, health plan managers, hospital executives, and other stakeholders participate in the design of comparative effectiveness studies can ensure that this vital research focuses on the evidence gaps most relevant to health care decision makers. Through a qualitative assessment of case studies, we identify five key principles for the effective engagement of a broad coalition of participants in research intended to improve health care and control costs. Those principles are to ensure balance among the participating stakeholders; get participants to "buy in" to the process and understand their roles; provide neutral and expert facilitators for research discussions; establish connections among the participants; and keep the participants engaged throughout the research process.

Patients, clinicians, payers, and policymakers face an environment of significant evidentiary uncertainty as they attempt to achieve maximum value, or the greatest level of benefit possible at a given level of cost in their respective health care decisions. This is particularly true in the area of oncology, for which published evidence from clinical trials is often incongruent with real-world patient care, and a substantial portion of clinical use is for off-label indications that have not been systematically evaluated. It is this uncertainty in the knowledge of the clinical harms and benefits associated with oncology treatments that prevents postregulatory decision makers from making accurate assessments of the value of these treatments. Because of the incentives inherent in the clinical research enterprise, randomized control trials (RCTs) are designed for the specific purpose of regulatory approval and maximizing market penetration. The pursuit of these goals results in RCT study designs that achieve maximal internal validity at the expense of generalizability to diverse real-world patient populations that may have significant comorbidities and other clinically mitigating factors. As such, systematic reviews for the purposes of coverage and treatment decisions often find relevant and high-quality evidence to be limited or nonexistent. For a number of reasons, including frequent off-label use of medications and the expedited approval process for cancer drugs by the U.S. Food and Drug Administration, this situation is exacerbated in the area of oncology. This paper investigates the convergence of incentives and circumstances that lead to widespread uncertainty in oncology and proposes new paradigms for clinical research, including pragmatic clinical trials, methodological guidance, and coverage with evidence development. Each of these initiatives would support the design of clinical research that is more informative for postregulatory decision makers, and would therefore reduce uncertainty and provide greater confidence in conclusions about the value of these treatments. The Oncologist 2010;15(suppl 1):58 -64

Population health is one of the pillars of the Triple Aim to improve US health care. The authors developed a framework for population health measurement and a proposed set of measures for further exploration to guide the population health efforts in Maryland. The authors searched peer-reviewed, expert-authored literature and current public health measures. Using a semi-structured analysis, a framework was proposed, which consisted of a conceptual model of several domains and identified population health measures addressing them. Stakeholders were convened to review the framework and identified the most feasible population health measures considering the underlying health information technology (IT) infrastructure in Maryland. The framework was organized based on health system factors, determinants of health, and population-based and clinical outcomes. Measurement specifications were developed that addressed different aspects of selected measures and assessed various national and local data sources for selected measures. Data sources were identified based on their key characteristics, challenges, opportunities, and potential applicability to the proposed measures, as well as the issue of interoperability of data sources among different organizations. The proposed framework and measures can act as a platform to quantify the determinants of health and the state overall population health goals. Key considerations for developing a population health measures framework include health IT infrastructure, data denominators, feasibility, health system environment, and policy factors. Measurement development and progression using the framework will largely depend on the users' focus areas and availability of data. The authors believe that the proposed framework and road map can serve as a model for communities elsewhere.

Innovation is needed to improve care of the seriously ill, and there are important opportunities as we transition from a volume-to value-based payment system. Not all seriously ill are dying; some recover, while others are persistently functionally impaired. While we innovate in service delivery and payment models for the seriously ill, it is important that we concurrently develop accountability that ensures a focus on high-quality care rather than narrowly focusing on cost containment. The Gordon and Betty Moore Foundation convened a meeting of 45 experts to arrive at guiding principles for measurement, create a starter measurement set, specify a proposed definition of the denominator and its refinement, and identify research priorities for future implementation of the accountability system. A series of articles written by experts provided the basis for debate and guidance in formulating a path forward to develop an accountability system for community-based programs for the seriously ill, outlined in this article. As we innovate in existing population-based payment programs such as Medicare Advantage and develop new alternative payment models, it is important and urgent that we develop the foundation for accountability along with actionable measures so that the healthcare system ensures high-quality person-and family-centered care for persons who are seriously ill.

The US Food and Drug Administration provides guidance to the pharmaceutical industry and others designing randomized clinical trials for regulatory approval. However, a gap exists for postregulatory decision makers, including patients, prescribers, and payers, because regulatory trials do not answer the questions most relevant to them. Therefore, guidance is needed for trials performed in the postapproval environment for these postapproval decision makers.