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A randomized large scale trial was conducted among 1653 patients with recent history of hospitalization for heart failure to undergo either telemonitoring or usual care to determine possible effect of telemonitoring for improvement of heart-failure outcomes. Telemonitoring which failed to show any outcome improvements among patients recently hospitalized for heart failure indicated the significance of a thorough, independent evaluation of disease-management strategies before their adoption.

Purpose Care transitions between hospitals and skilled nursing facilities (SNFs) are often associated with breakdowns in communication that may place patients at risk for adverse events. Less is known about how to address these issues in the context of busy patient care settings. We used process mapping to examine hospital discharge and SNF admission processes to identify opportunities for improvement. Methods: A quality improvement (QI) team worked with frontline staff to create a process map illustrating the sequence of events involved with hospital discharge and SNF admission. The project was completed at an academic medical centre and two local SNFs in the north‐eastern United States. Participants represented the care management, medicine, nursing, admissions, and physical therapy services. The data informed hospital QI interventions seeking to improve the quality and safety of hospital‐SNF transfers and reduce unplanned hospital readmissions. Results: The final process map highlighted numerous activities that need to be coordinated between care teams, including the time‐sensitive exchange of clinical and administrative information. Participants shared insights about how care teams reach critical decisions about patient disposition and post‐acute care utilization. Conclusions: Process mapping highlighted specific opportunities for improving communication between care teams. Participants advocated for earlier assessments of patients' functional status and support systems, including reliable at‐home services. They also reasoned that improved communication would help patients and providers reach decisions together, coordinate work efforts, and better prepare for hospital discharge and SNF admission. This information can be used to improve patient care transitions between hospitals and SNFs. [ABSTRACT FROM AUTHOR]

Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway., Methods and Results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions., Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.