Suchergebnisse

INTRODUCTION: The US health care system faces pressure to improve quality while managing complexity, curbing costs, and reducing inefficiency. These shortcomings have sparked interest in the Learning Health Care System (LHCS) as an alternate approach to organizing research and clinical care. Although diverse stakeholders have expressed support for moving toward an LHCS model, limited guidance exists for institutions considering such a transition. METHODS: Interviews were conducted with institutional leaders from 25 health care systems considered to be at the forefront of LHCS. Interviews focused on the process of transitioning toward an LHCS, including motivations for change, key components, challenges encountered, and strategies for success, and on ethics and regulatory issues encountered. Qualitative analysis identified key themes across institutions. RESULTS: Respondents described 5 themes related to the origin of their LHCS transformation: (1) visionary leadership or influence of a key individual, (2) adaptation to a changing health care landscape, (3) external funding, (4) regulatory or legislative influence, and (5) mergers or expansions. They described 6 challenges: (1) organizational culture, (2) data systems and data sharing, (3) funding learning activities, (4) limited supply of skilled individuals, (5) managing competing priorities, and (6) regulatory challenges. Finally, they suggested 8 strategies to support transformation: (1) strong leadership, (2) setting a limited number of organizational priorities, (3) building on existing strengths, (4) training programs, (5) "purposeful" design of data systems, (6) internal transparency of quality metrics, (7) payer/provider integration, and, within academic medical centers, (8) academic/clinical integration. CONCLUSIONS: Even institutions at the forefront of LHCS described the transition as difficult. Their experiences provide insight into other institutions considering similar transitions, including elements essential for success and likely challenges.

ABSTRACTPragmatic clinical trials (PCTs) may improve the efficiency, relevance, and representativeness of research. While prior research has indicated that willingness to join a PCT is high, it is not universal among those asked in surveys exploring attitudes toward hypothetical PCTs. The objective of this study was to examine what factors predict willingness to join a hypothetical low‐risk PCT comparing two blood pressure medicines. In our study, 2,618 respondents, recruited from three populations (adult patients from an academic health system, adult patients from an integrated delivery system, and adults from an online nationally representative panel), completed an online survey. Most respondents (90%) expressed willingness to participate in the hypothetical PCT. The two key predictors of expressed willingness to join low‐risk PCTs were respondents' understanding of key features of PCTs, including how they differ from traditional research, and the degree of importance respondents perceived comparative research to have. Increasing awareness of the rationale for PCTs and understanding of these trials, including how they differ from explanatory trials, may increase prospective participants' willingness to contribute to this effort.

ABSTRACTA leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant‐level characteristics; investigator and research team characteristics; institution‐level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection‐ and efficiency‐based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.