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To date, there has been a notable lack of peer-reviewed or publicly available data documenting rates of hospital quality outcomes and patient safety events during the coronavirus disease 2019 pandemic era. The dearth of evidence is perhaps related to the US health care system triaging resources toward patient care and away from reporting and research and also reflects that data used in publicly reported hospital quality rankings and ratings typically lag 2-5 years. At our institution, a learning health system assessment is underway to evaluate how patient safety was affected by the pandemic. Here we share and discuss early findings, noting the limitations of self-reported safety event reporting, and suggest the need for further widespread investigations at other US hospitals. During the 2-year study period from January 1, 2020, through December 31, 2021 across 3 large US academic medical centers at our institution, we documented an overall rate of 25.8 safety events per 1000 inpatient days. The rate of events meeting "harm" criteria was 12.4 per 1000 inpatient days, the rate of nonharm events was 11.1 per 1000 inpatient days, and the fall rate was 2.3 per 1000 inpatient days. This descriptive exploratory analysis suggests that patient safety event rates at our institution did not increase over the course of the pandemic. However, increasing health care worker absences were nonlinearly and strongly associated with patient safety event rates, which raises questions regarding the mechanisms by which patient safety event rates may be affected by staff absences during pandemic peaks., (© 2022 The Authors.)

Objective: We examined readmissions and resource use during the first postoperative year in patients who underwent thoracic endovascular aortic repair or open surgical repair of Stanford type B aortic dissection., Methods: The Nationwide Readmissions Database (2016-2018) was queried for patients with type B aortic dissection who underwent thoracic endovascular aortic repair or open surgical repair. The primary outcome was readmission during the first postoperative year. Secondary outcomes included 30-day and 90-day readmission rates, in-hospital mortality, length of stay, and cost. A Cox proportional hazards model was used to determine risk factors for readmission., Results: During the study period, type B aortic dissection repair was performed in 6456 patients, of whom 3517 (54.5%) underwent thoracic endovascular aortic repair and 2939 (45.5%) underwent open surgical repair. Patients undergoing thoracic endovascular aortic repair were older (63 vs 59 years; P  < .001) with fewer comorbidities (Elixhauser score of 11 vs 17; P  < .001) than patients undergoing open surgical repair. Thoracic endovascular aortic repair was performed electively more often than open surgical repair (29% vs 20%; P  < .001). In-hospital mortality was 9% overall and lower in the thoracic endovascular aortic repair cohort than in the open surgical repair cohort (5% vs 13%; P  < .001). However, the 90-day readmission rate was comparable between the thoracic endovascular aortic repair and open surgical repair cohorts (28% vs 27%; P  = .7). Freedom from readmission for up to 1 year was also similar between cohorts ( P  = .6). Independent predictors of 1-year readmission included length of stay more than 10 days ( P  = .005) and Elixhauser comorbidity risk index greater than 4 ( P  = .033)., Conclusions: Approximately one-third of all patients with type B aortic dissection were readmitted within 90 days after aortic intervention. Surprisingly, readmission during the first postoperative year was similar in the open surgical repair and thoracic endovascular aortic repair cohorts, despite marked differences in preoperative patient characteristics and interventions., (© 2022 The Author(s).)

Background and Aims: Ascites and hyponatremia are important milestones of worsening portal hypertension in those with cirrhosis. The objective of our study was to evaluate the differences in clinical characteristics, resource utilization, and disposition of hospitalized cirrhotic patients with ascites with and without hyponatremia., Methods: The National Inpatient Sample (NIS) database was used to identify all adult hospitalized patients with a diagnosis of cirrhosis and ascites with or without hyponatremia from 2016 to 2017 using ICD-10 codes., Results: During the study period, 10,187 (7.6%) hospitalized patients with cirrhosis had ascites and hyponatremia and 34,555 (24.3%) had ascites but no hyponatremia. Elixhauser comorbidity score, excluding liver disease, was higher in hyponatremic patients (median 21 vs. 12, P  < 0.001). Acute kidney injury (50.3% vs. 32.8%, P < 0.001) and sepsis (16.8% vs. 11.8%, P  < 0.001) were more common in hyponatremic patients compared to those without hyponatremia. Similarly, acute respiratory failure, coagulopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, acute (on chronic) liver failure, and liver cancer were more common in hyponatremic patients. Hyponatremia patients had a higher number of inpatient procedures, longer (6 days vs. 4 days, P  < 0.001) hospital stay, and had higher hospital charges ($97,327 vs. $72,278, P  < 0.01) than those without hyponatremia. Inpatient mortality was 38% higher in hyponatremic patients (9.8% vs. 7.1%, P  < 0.001) compared to those without hyponatremia. Additionally, hyponatremic patients were less likely to have routine home discharges with self-care., Conclusion: In conclusion, using a large and diverse national cohort of unselected patients, we were able to show that hyponatremia in patients with cirrhosis and ascites is associated with poor clinical outcomes and increased resource utilization., (© 2021 Indian National Association for Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Background: : We sought to assess the prevalence and impact of left ventricular thrombus (LVT) in patients with peripartum cardiomyopathy (PPCM)., Methods: : We performed a retrospective cohort study of all admissions with PPCM as the primary diagnosis from the Nationwide Inpatient Sample database over a 11-year period. Univariate analysis of all risk factors and outcomes and multivariable logistic regression analysis of certain variables were performed and represented as odds ratio (OR) with 95% confidence interval (CI). A p value of < 0.05 was considered statistically significant. Statistical analysis was performed using epiDisplay in 'R' studio., Results: : In the time frame spanning 2005 -2014, 43,986 admissions with PPCM were found which included 43,534 without LVT and 452 patients with LVT. Black race was associated with a higher incidence of LV thrombus, ( p value <0.001). Comorbidities more prevalent in the LVT group were smoking, drug abuse, pregnancy induced hypertension, diabetes with complications, valvular heart disease, connective tissue disorders, coagulopathy, anemia and depression. Adverse outcomes such as congestive heart failure, arrhythmias and stroke were higher in LVT group. Conversely, Caucasian race, obesity, preeclampsia ( p <0.005) were higher in those without LVT. Mean length of stay (9 vs 5 days, p <0.001), in hospital mortality (3.32% vs 1.41%, p  = 0.001) and mean hospitalization charges ($85,390 vs $48,033) were higher in those with LVT. However, on multivariate logistic regression, although stroke was higher in the LVT group (adjusted OR 5.51, 95% CI, 2.2, 13.81, 5.05, p 0.002), in-hospital mortality was not significantly different between the two groups (adjusted OR 1.17, 95% CI,0.32, 4.23, p  = 0.817)., Conclusion: : Our study showed that PPCM patients with LV thrombus had worse outcomes with respect to stroke, length of stay and in hospital mortality. Higher prevalence in patients with black race, complicated diabetes, peripheral vascular disease, valvular disease, coagulopathy, smoking, drug abuse, depression and psychoses calls for special attention to such high-risk groups for aggressive risk factor modification., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 Published by Elsevier B.V.)

Background/objectives: Patients with cirrhosis have liver-related immune dysfunction that potentially predisposes the patients to increased influenza infection risk. Our study evaluates this cross-sectional relationship using a national registry of hospital patients., Methods: This study included the 2011-2017 National Inpatient Sample database. From this, respiratory influenza cases were isolated and stratified using the presence of cirrhosis into a cirrhosis-present study cohort and cirrhosis-absent controls; propensity score matching method was used to match the controls to the study cohort (cirrhosis-present) using a 1:1 matching ratio. The endpoints included mortality, length of stay, hospitalization costs, and influenza-related complications., Results: Following the match, there were 2,040 with cirrhosis and matched 2,040 without cirrhosis admitted with respiratory influenza infection. Compared to the controls, cirrhosis patients had higher in-hospital mortality (7.79 vs 3.43% p < 0.001, OR 2.38 95% CI 1.78-3.17), longer length of stay (7.25 vs 6.52 d p < 0.001), higher hospitalization costs ($70,009 vs $65,035 p < 0.001), and were more likely be discharged to a skilled nursing facility and home healthcare (vs routine home discharges). In terms of influenza-related complications, the cirrhosis cohort had higher rates of sepsis (29.8 vs 22% p < 0.001, OR 1.51 95% CI 1.31-1.74). In the multivariate regression analysis, cirrhosis was associated with higher mortality (p < 0.001, aOR 2.31 95% CI 1.59-3.35) and length of stay (p = 0.018, aOR 1.03 95% CI 1.01-1.06). In subgroup analysis of patients with decompensated (n = 597) versus compensated cirrhosis (n = 1443), those with decompensated cirrhosis had higher rates of in-hospital mortality (12.7 vs 5.75% p < 0.001, OR 2.39 95% CI 1.72-3.32), length of stay (8.85 vs 6.59 d p < 0.001), and hospitalization costs ($92,858 vs $60,556 p < 0.001). In the multivariate analysis, decompensated cirrhosis was associated with increased mortality (p < 0.001, aOR 2.86 95% CI 1.90-4.32)., Conclusion: This study shows the presence of cirrhosis to result in higher hospital mortality and postinfluenza complications in patients with influenza infection., (© 2021 Indian National Association for Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Background: Fingolimod is the first approved oral disease-modifying agent (DMA) in 2010 to treat Multiple Sclerosis (MS). There is limited real-world evidence regarding the determinants associated with fingolimod use in the early years., Objective: The objective of this study was to examine the factors associated with fingolimod prescribing in the initial years after the market approval., Methods: A retrospective, longitudinal study was conducted involving adults (≥18 years) with MS from the 2010-2012 IBM MarketScan. Individuals with MS were selected based on ICD-9-CM: 340 and a newly initiated DMA prescription. Based on the index/first DMA prescription, patients were classified as fingolimod or injectable users. All covariates were measured during the six months baseline period prior to the index date. Multivariable logistic regression was performed to determine the predisposing, enabling, and need factors, conceptualized as per the Andersen Behavioral Model (ABM), associated with prescribing of fingolimod versus injectable DMA for MS., Results: The study cohort consisted of 3118 MS patients receiving DMA treatment. Of which, 14.4% of patients with MS initiated treatment with fingolimod within two years after the market entry, while the remaining 85.6% initiated with injectable DMAs. Multivariable regression revealed that the likelihood of prescribing oral DMA increased by 2-3 fold during 2011 and 2012 compared to 2010. Patients with ophthalmic (adjusted odds ratio [aOR]-2.60), heart (aOR-2.21) and urinary diseases (aOR-1.37) were more likely to receive fingolimod. Patients with other neurological disorders (aOR-0.50) were less likely to receive fingolimod than those without neurological disorders. Use of symptomatic medication (for impaired walking (aOR-2.60), bladder dysfunction (aOR-1.54), antispasmodics (aOR-1.48), and neurologist consultation (aOR-1.81) were associated with higher odds of receiving fingolimod. However, patients with non-MS associated emergency visits (aOR-0.64) had lower odds of receiving fingolimod than those without emergency visits., Conclusions: During the initial years after market approval, patients with highly active MS were more likely to receive oral fingolimod than injectable DMAs. More research is needed to understand the determinants of newer oral DMAs., Competing Interests: None., (© 2021 The Author(s).)

Background: Health research participants want to receive the results from research studies in which they have participated, and health research funding agencies encourage the returning of results to research participants. However, researchers rarely return results to research participants. This study protocol aims to fill the significant gap in knowledge that exists regarding experiences, perceptions, and challenges health researchers have with returning results to research participants., Design: The study will use a mixed-methods concurrent triangulation design that will collect qualitative and quantitative data in one simultaneous phase to allow researchers to utilize each type of data to corroborate the findings from the other. The research team developed a mixed-methods survey to assess the experiences, perceptions, and challenges health researchers have with returning results to research participants., Method: The survey includes both quantitative and qualitative (open-ended) questions and will be implemented online and will take approximately 10-15 min for respondents to complete. The survey is divided into four topics areas, which include respondents': 1) general opinion of returning results to participants in health research studies, 2) experiences with a specific study in which they did not return results to participants, 3) perceptions of specific challenges they face in returning results to participants, and 4) demographic characteristics and professional background information., Summary: The study to be conducted will address knowledge gaps related to researchers' experiences, perceptions, and challenges with returning research results. The study is an important step toward pragmatic solutions that can improve researchers' ability to return results to participants.

Objective: The U.S. Agency for Healthcare Research and Quality's Prevention Quality Indicators comprise acute and chronic conditions for which hospitalization can be potentially prevented by high-quality ambulatory care. The Healthy Alaska 2020 initiative (HA2020) targeted reducing potentially preventable hospitalizations (PPH) for acute and chronic conditions among its health indicators. We estimated the PPH rate for adults aged ≥ 18 years in Alaska during 2010-2012., Methods: We conducted a cross-sectional analysis of state-wide hospital discharge data obtained from the Healthcare Cost and Utilization Project and the Indian Health Service. We calculated average annual PPH rates/1000 persons for acute/chronic conditions. Age-adjusted rate ratios (aRRs) were used for evaluating PPH rate disparities between Alaska Native (AN) and non-AN adults., Results: Among 127,371 total hospitalizations, 4911 and 6721 were for acute and chronic PPH conditions, respectively. The overall crude PPH rate was 7.3 (3.1 for acute and 4.2 for chronic conditions). AN adults had a higher rate than non-AN adults for acute (aRR: 4.7; p  < 0.001) and chronic (aRR: 2.6; p  < 0.001) PPH conditions. Adults aged ≥ 85 years had the highest PPH rate for acute (43.5) and chronic (31.6) conditions. Acute conditions with the highest PPH rate were bacterial pneumonia (1.8) and urinary tract infections (0.8). Chronic conditions with the highest PPH rate were chronic obstructive pulmonary disease (COPD; 1.6) and congestive heart failure (CHF; 1.3)., Conclusion: Efforts to reduce PPHs caused by COPD, CHF, and bacterial pneumonia, especially among AN people and older adults, should yield the greatest benefit in achieving the HA2020 goal.