Effectiveness of mRNA Booster Vaccine Against Coronavirus Disease 2019 Infection and Severe Outcomes Among Persons With and Without Immune Dysfunction: A Retrospective Cohort Study of National Electronic Medical Record Data in the United States.

Background: Real-world evidence of coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) booster effectiveness among patients with immune dysfunction are limited. Methods: We included data from patients in the United States National COVID Cohort Collaborative (N3C) who completed ≥2 doses of mRNA vaccination between 10 December 2020 and 27 May 2022. Immune dysfunction conditions included human immunodeficiency virus infection, solid organ or bone marrow transplant, autoimmune diseases, and cancer. We defined incident COVID-19 BTI as positive results from laboratory tests or diagnostic codes 14 days after at least 2 doses of mRNA vaccination; and severe COVID-19 BTI as hospitalization, invasive cardiopulmonary support, and/or death. We used propensity scores to match boosted versus nonboosted patients and evaluated hazards of incident and severe COVID-19 BTI using Cox regression after matching. Results: Among patients without immune dysfunction, the relative effectiveness of booster (3 doses) after 6 months from the primary (2 doses) vaccination against BTI ranged from 69% to 81% during the Delta-predominant period and from 33% to 39% during the Omicron-predominant period. Relative effectiveness against BTI was lower among patients with immune dysfunction but remained statistically significant in both periods. Boosted patients had lower risk of COVID-19-related hospitalization (hazard ratios [HR] ranged from 0.5 [95% confidence interval {CI}, .48-.53] to 0.63 [95% CI, .56-.70]), invasive cardiopulmonary support, or death (HRs ranged from 0.46 [95% CI, .41-.52] to 0.63 [95% CI, .50-.79]) during both periods. Conclusions: Booster vaccines remain effective against severe COVID-19 BTI throughout the Delta- and Omicron-predominant periods, regardless of patients' immune status.

Association of Neighborhood Disadvantage with Short- and Long-Term Outcomes After Pancreatectomy for Pancreatic Ductal Adenocarcinoma.

BACKGROUND: While lower socioeconomic status has been shown to correlate with worse outcomes in cancer care, data correlating neighborhood-level metrics with outcomes are scarce. We aim to explore the association between neighborhood disadvantage and both short- and long-term postoperative outcomes in patients undergoing pancreatectomy for pancreatic ductal adenocarcinoma (PDAC). PATIENTS AND METHODS: We retrospectively analyzed 243 patients who underwent resection for PDAC at a single institution between 1 January 2010 and 15 September 2021. To measure neighborhood disadvantage, the cohort was divided into tertiles by Area Deprivation Index (ADI). Short-term outcomes of interest were minor complications, major complications, unplanned readmission within 30 days, prolonged hospitalization, and delayed gastric emptying (DGE). The long-term outcome of interest was overall survival. Logistic regression was used to test short-term outcomes; Cox proportional hazards models and Kaplan-Meier method were used for long-term outcomes. RESULTS: The median ADI of the cohort was 49 (IQR 32-64.5). On adjusted analysis, the high-ADI group demonstrated greater odds of suffering a major complication (odds ratio [OR], 2.78; 95% confidence interval [CI], 1.26-6.40; p = 0.01) and of an unplanned readmission (OR, 3.09; 95% CI, 1.16-9.28; p = 0.03) compared with the low-ADI group. There were no significant differences between groups in the odds of minor complications, prolonged hospitalization, or DGE (all p > 0.05). High ADI did not confer an increased hazard of death (p = 0.63). CONCLUSIONS: We found that worse neighborhood disadvantage is associated with a higher risk of major complication and unplanned readmission after pancreatectomy for PDAC.

Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin.

BACKGROUND: There is mixed evidence about the relations of current versus past cancer with severe COVID-19 outcomes and how they vary by patient and cancer characteristics. METHODS: Electronic health record data of 104,590 adult hospitalized patients with COVID-19 were obtained from 21 United States health systems from February 2020 through September 2021. In-hospital mortality and ICU admission were predicted from current and past cancer diagnoses. Moderation by patient characteristics, vaccination status, cancer type, and year of the pandemic was examined. RESULTS: 6.8% of the patients had current (n = 7,141) and 6.5% had past (n = 6,749) cancer diagnoses. Current cancer predicted both severe outcomes but past cancer did not; adjusted odds ratios (aOR) for mortality were 1.58 [95% confidence interval (CI), 1.46-1.70] and 1.04 (95% CI, 0.96-1.13), respectively. Mortality rates decreased over the pandemic but the incremental risk of current cancer persisted, with the increment being larger among younger vs. older patients. Prior COVID-19 vaccination reduced mortality generally and among those with current cancer (aOR, 0.69; 95% CI, 0.53-0.90). CONCLUSIONS: Current cancer, especially among younger patients, posed a substantially increased risk for death and ICU admission among patients with COVID-19; prior COVID-19 vaccination mitigated the risk associated with current cancer. Past history of cancer was not associated with higher risks for severe COVID-19 outcomes for most cancer types. IMPACT: This study clarifies the characteristics that modify the risk associated with cancer on severe COVID-19 outcomes across the first 20 months of the COVID-19 pandemic. See related commentary by Egan et al., p. 3.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Treatment of Facial Fractures at a Level 1 Trauma Center: Do Medicaid and Non-Medicaid Enrollees Receive the Same Care?

BACKGROUND: Timing of surgical treatment of facial fractures may vary with the patient age, injury type, and presence of polytrauma. Previous studies using national data sets have suggested that trauma patients with government insurance experience fewer operations, longer length of hospital stay (LOS), and worse outcomes compared with privately insured patients. The objective of this study is to compare treatment of facial fractures in patients with and without Medicaid insurance (excluding Medicare). METHODS: All adults with mandibular, orbital, and midface fractures at a Level 1 Trauma Center between 2009 and 2018 were included. Statistical analyses were performed to assess the differences in the frequency of surgery, time to surgery (TTS), LOS, and mortality based on insurance type. RESULTS: The sample included 1541 patients with facial fractures (mandible, midface, orbital), of whom 78.8% were male, and 13.1% (208) were enrolled in Medicaid. Mechanism of injury was predominantly assault for Medicaid enrollees and falls or motor vehicle accidents for non-Medicaid enrollees (P < 0.001). Patients with mandible and midface fractures underwent similar rates of surgical repair. Medicaid enrollees with orbital fractures underwent less frequent surgery for facial fractures (24.8% versus 34.7%, P = 0.0443) and had higher rates of alcohol and drug intoxication compared with non-Medicaid enrollees (42.8% versus 31.6%, P = 0.008). TTS, LOS, and mortality were similar in both groups with facial fractures. CONCLUSIONS: Overall, the treatment of facial fractures was similar regardless of the insurance type, but Medicaid enrollees with orbital fractures experienced less frequent surgery for facial fractures. Further studies are needed to identify specific socioeconomic and geographic factors contributing to these disparities in care.

Treatment of Acute Cholecystitis: Do Medicaid and Non-Medicaid Enrolled Patients Receive the Same Care?

BACKGROUND: Nationally, Medicaid enrollees with emergency surgical conditions experience worse outcomes overall when compared with privately insured patients. The goal of this study is to investigate disparities in the treatment of cholecystitis based on insurance type and to identify contributing factors. METHODS: Adults with cholecystitis at a safety-net hospital in Central Massachusetts from 2017-2018 were included. Sociodemographic and clinical characteristics were compared based on Medicaid enrollment status (Medicare excluded). Univariate and multivariate analyses were used to compare the frequency of surgery, time to surgery (TTS), length of stay (LOS), and readmission rates between groups. RESULTS: The sample (n = 203) included 69 Medicaid enrollees (34%), with a mean age of 44.4 years. Medicaid enrollees were younger (p = 0.0006), had lower levels of formal education (high school diploma attainment, p < 0.0001), were more likely to be unmarried (p < 0.0001), Non-White (p = 0.0012), and require an interpreter (p < 0.0001). Patients in both groups experienced similar rates of laparoscopic cholecystectomy, TTS, and LOS; however, Medicaid enrollees experienced more readmissions within 30 days of discharge (30.4% vs 17.9%, p < 0.001). CONCLUSION: Despite anticipated population differences, the treatment of acute cholecystitis was similar between Medicaid and Non-Medicaid enrollees, with the exception of readmission. Further research is needed to identify patient, provider, and/or population factors driving this disparity.

Treatment of appendicitis: Do Medicaid and non-Medicaid-enrolled patients receive the same care?

BACKGROUND: Studies using national data sets have suggested that insurance type drives a disparity in the care of emergency surgery patients. Large databases lack the granularity that smaller, single-institution series may provide. The goal of this study is to identify factors that may account for differences in care between Medicaid and non-Medicaid enrollees with appendicitis in central Massachusetts. METHODS: All adult patients with acute appendicitis in an academic medical center between 2010 and 2018 were included. Sociodemographic and clinical characteristics were compared according to Medicaid enrollment status. Analyses were performed to assess differences in the frequency of operative treatment, time to surgery, length of stay, and rates of readmission. RESULTS: The sample included 1,257 patients, 10.7% of whom (n = 135) were enrolled in Medicaid. The proportions of patients presenting with perforated appendicitis (28.9% vs 31.2%, P = .857) and undergoing laparoscopic appendectomy (96.3% vs 90.7%, P = .081) were similar between the 2 groups, as were length of stay (20 hours 30 minutes versus 22 hours 38 minutes, P = .109) and readmission rates (17.8% vs 14.5%, P = .683). Medicaid enrollees did experience somewhat greater time to surgery (6 hours 47 minutes versus 4 hours 49 minutes, P < .001). CONCLUSION: Despite anticipated differences in population, the treatment of appendicitis was similar between Medicaid and non-Medicaid enrollees. Medicaid enrollees experienced greater time to surgery; however, further studies are needed to explain this disparity in care.

Video capsule endoscopy as a tool for evaluation of obscure overt gastrointestinal bleeding in the intensive care unit.

BACKGROUND AND STUDY AIMS: Video capsule endoscopy (VCE) is a minimally invasive tool that helps visualize the gastrointestinal tract from the esophagus to the right colon without the need for sedation or preparation. VCE is safe with very few contraindications. However, its role and safety profile in the intensive care unit (ICU) population have not been reported. The aim of this study is to evaluate the safety, efficacy, and feasibility of VCE use in ICU patients. PATIENTS AND METHODS: We conducted a single-center retrospective observational study of patients who underwent VCE for evaluation of obscure overt gastrointestinal bleeding in the ICU between 2008 and 2016. RESULTS: This study included 48 patients who were admitted to the UMass Memorial Medical Center ICUs for gastrointestinal bleeding. VCE was successfully completed in 43/48 (90 %) patients. The entire length of small bowel could be evaluated in 75 % and the source of bleeding was identified in 44 % of the patients. The most commonly identified source of bleeding included small bowel angioectasias, duodenal erosions/ulcers, and small bowel polyps. No major complications could be attributed to the VCE. Only 1 capsule was retained after 2 wk; however, there was no incidence of bowel obstruction, perforation, or capsule aspiration. CONCLUSIONS: This observational retrospective study demonstrates that VCE may be a safe, feasible, and effective diagnostic tool in evaluation of gastrointestinal bleeding in the ICU population with few complications. VCE may be a safe diagnostic prelude and be a guide to the correct therapeutic procedure if needed, in the context of patients who are seriously ill.

OncDRS: An integrative clinical and genomic data platform for enabling translational research and precision medicine.

We live in the genomic era of medicine, where a patient's genomic/molecular data is becoming increasingly important for disease diagnosis, identification of targeted therapy, and risk assessment for adverse reactions. However, decoding the genomic test results and integrating it with clinical data for retrospective studies and cohort identification for prospective clinical trials is still a challenging task. In order to overcome these barriers, we developed an overarching enterprise informatics framework for translational research and personalized medicine called Synergistic Patient and Research Knowledge Systems (SPARKS) and a suite of tools called Oncology Data Retrieval Systems (OncDRS). OncDRS enables seamless data integration, secure and self-navigated query and extraction of clinical and genomic data from heterogeneous sources. Within a year of release, the system has facilitated more than 1500 research queries and has delivered data for more than 50 research studies.

Dexmedetomidine for awake carotid endarterectomy: efficacy, hemodynamic profile, and side effects.

: A randomized, double-masked, placebo-controlled study was designed to compare dexmedetomidine as a primary sedative agent with a commonly used drug combination in patients undergoing awake carotid endarterectomy (CEA). Sixty-six patients undergoing CEA (ASA II-IV) were randomly assigned to receive either dexmedetomidine (total dose of 97.5 +/- 54.7 mcg) or normal saline (control). Supplemental doses of midazolam, fentanyl, and/or propofol were administered as deemed necessary by the anesthesiologist. An observer blinded to the study drug assessed sedation level (Observer's Assessment of Alertness-Sedation [OAA/S] scale). The primary outcomes were defined as the number of patients with an OAA/S score of 4 intraoperatively and an OAA/S score of 5 postoperatively. The authors also compared cardiorespiratory parameters, intra- and postoperative side effects, and complications. Chi-square tests were used to analyze the primary endpoints. All secondary parameters were analyzed using the Wilcoxon rank sum test. Three patients in the dexmedetomidine group (10%) had an OAA/S score of 4 at all four time points assessed intraoperatively, while no patient in the control group had a score of 4 at all the time points considered. Thirteen patients in the dexmedetomidine group had a score of 4 at three or more time points (42%) compared with six patients (19%) in the control group. Four patients in the control group (13%) and one patient in the dexmedetomidine group (3%) did not achieve a score of 4 at any of the four critical intraoperative time points (chi for association = 9.9, P < 0.05; chi for a trend = 8.6, P < 0.004, with the trend favoring dexmedetomidine). More patients in the control group required treatment with metoprolol (26% vs. 6%, P = 0.04) and labetalol (48% vs/ 6%, P < 0.01). Plasma levels of norepinephrine were significantly lower in the dexmedetomidine group during and after surgery compared with the control group. Six patients (19%) in the dexmedetomidine group required intra-arterial shunts, while only two patients (6%) required shunts in the control group (P = 0.16). These data show that the use of dexmedetomidine in patients undergoing awake CEA resulted in fewer fluctuations from the desired sedation level. Patients receiving dexmedetomidine required less antihypertensive therapy compared with the midazolam/fentanyl/propofol combination. The effect of dexmedetomidine on cerebrovascular circulation in the study population needs further investigation.