Suchergebnisse

IMPORTANCE: Over the past decade, reducing 30-day readmission rates has been emphasized in the United States (including via the implementation of the Hospital Readmissions Reduction Program) but not Canada. OBJECTIVE: To examine changes that occurred from April 1, 2005, to December 31, 2015, in the United States and Canada for hospitalization length of stay and 30-day readmission rates of patients with heart failure. DESIGN, SETTING, AND PARTICIPANTS: This cohort study included patients admitted with a primary diagnosis of heart failure to Canadian and US hospitals between April 1, 2005, and December 31, 2015, using International Classification of Diseases, Ninth Revision code 428.xx and Tenth Revision code I50. The study examined secular trends in length of stay and readmissions in both countries and tested for changes after implementation of the Hospital Readmissions Reduction Program using segmented regression models and the association between length of stay and readmissions using patient-level and hospital-level multivariable logistic regression models. Data analysis was completed from February 2018 to August 2018. MAIN OUTCOMES AND MEASURES: Thirty-day readmissions. RESULTS: Between 2005 and 2015, mean length of stay declined marginally in Canadian hospitals (from a mean [SD] of 7.5 [5.7] to 7.3 [5.6] days; P < .001) but remained stable in US hospitals (mean [SD], 4.9 [3.7] days to 4.9 [3.5] days). Thirty-day readmission rates declined similarly in Canada (from 4088 of 20 758 patients [19.7%] to 3823 of 21 733 patients [17.6%] for all-cause readmissions; P < .001; and from 1743 of 20 758 patients [8.4%] to 1490 of 21 733 patients [6.9%] for heart failure–specific readmissions; P < .001) and the United States (from 21.2% to 18.5% for all-cause readmissions; from 7.6% to 5.7% for heart failure–specific readmissions; both P < .001). There were small but statistically significant positive correlations between length of stay and 30-day readmissions in both Canada (odds ratio, 1.01 [95% CI, ...

Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. Often, post-marketing research landscape is fragmented. When regulatory agencies require pharmaceutical and device manufacturers to conduct studies in the post-marketing period, these studies might remain incomplete many years after approval. Even when completed, many post-marketing studies lack meaningful active comparators, have observational designs, and might not collect patient-relevant outcomes. Regulators, in collaboration with the industry and patients, ought to ensure that the key questions unanswered at the time of drug and device approval are resolved in a timely fashion during the post-marketing phase. We propose a set of seven key guiding principles that we believe will provide the necessary incentives for pharmaceutical and device manufacturers to generate comparative data in the post-marketing period. First, regulators (for drugs and devices), notified bodies (for devices in Europe), health technology assessment organisations, and payers should develop customised evidence generation plans, ensuring that future post-approval studies address any limitations of the data available at the time of market entry impacting the benefit–risk profiles of drugs and devices. Second, post-marketing studies should be designed hierarchically: priority should be given to efforts aimed at evaluating a product's net clinical benefit in randomised trials compared with current known effective therapy, whenever possible, to address common decisional dilemmas. Third, post-marketing studies should incorporate active comparators as appropriate. Fourth, use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible. Fifth, efficiency of randomised trials should be improved by streamlining patient recruitment and data collection through innovative design elements. Sixth, governments should directly support and facilitate the production of comparative post-marketing data by investing in the development of collaborative research networks and data systems that reduce the complexity, cost, and waste of rigorous post-marketing research efforts. Last, financial incentives and penalties should be developed or more actively reinforced.

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper.