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INTRODUCTION: Heart failure (HF) is a frequent cause of readmissions. Despite caring for underresourced patients and dependence on government funding, safety net hospitals frequently incur penalties for failing to meet pay-for-performance readmission metrics. Limited research exists on the causes of HF readmissions in safety net hospitals. Therefore, we sought to investigate predictors of 30-day all-cause readmission in HF patients in the safety net setting. METHODS: We performed a retrospective chart review of patients admitted for HF from October 2018 to April 2019. We extracted data on demographics and medical comorbidities and performed patient-specific review of social determinants and mental health in 4 domains: race/ethnicity, housing status, substance use, and mental illness. Multivariable Poisson regression modeling was employed to evaluate associations with 30-day all-cause readmission. RESULTS: The study population included 290 patients, among whom the mean age was 59 years and 71% (n = 207) were male; 42% (120) were Black/African American (AA), 22% (64) were Hispanic/Latino, and 96% (278) had public insurance; 28% (79) were not housed, 19% (56) had a diagnosis of mental illness, and active substance use was common. The 30-day readmission rate was 25.5% (n = 88). Factors that were associated with increased risk of readmission included self-identifying as Black/AA (relative risk 2.28, 95% confidence interval 1.00-5.20) or Hispanic/Latino (2.53, 1.07-6.00), experiencing homelessness (2.07, 1.21-3.56), living in a shelter (3.20, 1.27-8.02), or intravenous drug use (IVDU) (2.00, 1.08-3.70). CONCLUSION: Race/ethnicity, housing status, and substance use were associated with increased risk of 30-day all-cause readmission in HF patients in a safety net hospital. In contrast to prior studies, medical comorbidities were not associated with increased risk of readmission.

To support informed decisions on drug registration and prescription, clinical trials need tools to assess the efficacy and safety signals related to a given therapeutic intervention. Standardized assessment facilitates reproducibility of results. Furthermore, it enables weighted comparison between different interventions, instrumental to facilitate shared decisions. When focused on adverse events in clinical trials, tools are needed to assess seriousness, causality and severity. As part of such a toolbox, the international Neonatal Consortium (INC) developed a first version of the neonatal adverse event severity scale (NAESS). This version underwent subsequent validation in retro-and prospective trials to assess its applicability and impact on the inter-observer variability. Regulators, sponsors and academic researchers also reported on the use of the NAESS in regulatory documents, trial protocols and study reports. In this paper, we aim to report on the trajectory, current status and impact of the NAESS score, on how stakeholders within INC assess its relevance, and on perspectives to further develop this tool.

Donna Punch,1 Jonathan S Davis,2 Rebecca Hahn,2 Rav Gill,3 Chia-Wen Hsiao,4 Richard Kara4 1Kensington Eye Institute (Retired), Toronto, Ontario, Canada; 2KJT Group, Inc, Rochester, NY, USA; 3Alcon Canada, Inc, Mississauga, Ontario, Canada; 4Alcon Vision LLC, Fort Worth, TX, USACorrespondence: Donna Punch, Tel +1 905-238-3228 ; +1 647-980-7716, Email mmdpunch@rogers.comPurpose: Surgical procedure packs are commonly used in ophthalmological surgeries, but quantitative evidence demonstrating the time efficiency and economic impact of their use is limited. Evaluating the time and cost of surgical pack use is particularly important for publicly funded healthcare systems with tight budgets and/or an emphasis on value-based care. This study sought to estimate the economic impact of comprehensive surgical pack use in cataract and vitreoretinal (retina) surgeries across operating room (OR), materials management, and accounting departments in Canada.Methods: A budget impact model developed for the United States (US) from a self-reported cross-sectional study was adapted for Canada. The US study obtained data via an online survey and timing exercises of surgical procedures. The model was adapted using relevant Canadian-specific labor and cost inputs. Use of generic commodity packs (no proprietary equipment-specific supplies) was compared to full utilization of Custom-Pak®, a comprehensive pack (disposables plus equipment-specific supplies) in cataract and retina surgeries at the facility and aggregate group (provincewide) levels.Results: Switching from generic to comprehensive pack use in all 2500 cataract procedures at a community hospital saves 287 labor hours per year, primarily in the materials management department. Surgery preparation (OR) hours saved allow for an additional 196 potential procedures annually. Most of the Canadian Dollar (CAD) $39,815 annual cost savings are realized for the OR. Aggregating across 50,000 cataract surgeries at the provincial le