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The potential association between bivalent COVID-19 vaccination and ischemic stroke remains uncertain, despite several studies conducted thus far. This study aimed to evaluate the risk of ischemic stroke following bivalent COVID-19 vaccination during the 2022-2023 season. A self-controlled case series study was conducted among members aged 12 years and older who experienced ischemic stroke between September 1, 2022, and March 31, 2023, in a large health care system. Ischemic strokes were identified using International Classification of Diseases, Tenth Revision codes in emergency departments and inpatient settings. Exposures were Pfizer-BioNTech or Moderna bivalent COVID-19 vaccination. Risk intervals were prespecified as 1-21 days and 1-42 days after bivalent vaccination; all non-risk-interval person-time served as the control interval. The incidence of ischemic stroke was compared in the risk interval and control interval using conditional Poisson regression. We conducted overall and subgroup analyses by age, history of SARS-CoV-2 infection, and coadministration of influenza vaccine. When an elevated risk was detected, we performed a chart review of ischemic strokes and analyzed the risk of chart-confirmed ischemic stroke. With 4933 ischemic stroke events, we found no increased risk within the 21-day risk interval for the 2 vaccines and by subgroups. However, risk of ischemic stroke was elevated within the 42-day risk interval among individuals aged younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day; the relative incidence (RI) was 2.13 (95% CI 1.01-4.46). Among those who also had a history of SARS-CoV-2 infection, the RI was 3.94 (95% CI 1.10-14.16). After chart review, the RIs were 2.34 (95% CI 0.97-5.65) and 4.27 (95% CI 0.97-18.85), respectively. Among individuals aged younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the RI was 2.62 (95% CI 1.13-6.03) before chart review and 2.24 (95% CI 0.78-6.47) after chart review. Stratified analyses by sex did not show a significantly increased risk of ischemic stroke after bivalent vaccination. While the point estimate for the risk of chart-confirmed ischemic stroke was elevated in a risk interval of 1-42 days among individuals younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day and among individuals younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the risk was not statistically significant. The potential association between bivalent vaccination and ischemic stroke in the 1-42-day analysis warrants further investigation among individuals younger than 65 years with influenza vaccine coadministration and prior SARS-CoV-2 infection. Furthermore, the findings on ischemic stroke risk after bivalent COVID-19 vaccination underscore the need to evaluate monovalent COVID-19 vaccine safety during the 2023-2024 season.

COVID-19 vaccination is crucial in combating the COVID-19 pandemic. Messenger RNA COVID-19 vaccines were initially authorized as a 2-dose primary series and have been widely used in the United States; completing the 2-dose primary series offers protection against infection, severe illness, and death. Understanding the risk factors for not completing the 2-dose primary series is critical to evaluate COVID-19 vaccination programs and promote completion of the 2-dose primary series. This study examined potential risk factors for not completing a 2-dose primary series of mRNA COVID-19 vaccination. We conducted a retrospective cohort study among members aged ≥18 years from a large integrated health care system, Kaiser Permanente Southern California, from December 14, 2020, to June 30, 2022. Noncompletion of the 2-dose primary series was defined as not completing the second dose within 6 months after receipt of the first dose. Crude noncompletion rates were estimated overall and by demographic characteristics, health care use patterns, comorbidity, and community-level socioeconomic factors. A Poisson regression model was fit to examine associations of individual-level and community-level risk factors with noncompletion of the 2-dose primary series. Among 2.5 million recipients of ≥1 dose of mRNA COVID-19 vaccines, 3.3% (n=81,202) did not complete the second dose within 6 months. Members aged 25-44 years, 65-74 years, and ≥75 years were less likely to not complete the 2-dose primary series than those aged 18-24 years, while members aged 45-64 years were more likely to not complete the 2-dose primary series (adjusted risk ratio [aRR] 1.13, 95% CI 1.10-1.15). Male sex was associated with a higher risk of noncompletion (aRR 1.17, 95% CI 1.15-1.19). Hispanic and non-Hispanic Black race/ethnicity were associated with a lower risk of noncompletion (range aRR 0.78-0.91). Having Medicaid and prior influenza vaccination were associated with a higher risk of noncompletion. Having SARS-CoV-2 infection, experiencing an adverse event, or having an inpatient and emergency department visit during the minimum recommended dose intervals were associated with a higher risk of not completing the 2-dose primary series (aRR 1.98, 95% CI 1.85-2.12; 1.99, 95% CI 1.43-2.76; and 1.85, 95% CI 1.77-1.93, respectively). Those who received the first dose after June 30, 2021, were more likely to not complete the 2-dose primary series within 6 months of receipt of the first dose. Despite limitations such as being a single-site study and the inability to consider social factors such as employment and vaccine attitudes, our study identified several risk factors for not completing a 2-dose primary series of mRNA vaccination, including being male; having Medicaid coverage; and experiencing SARS-CoV-2 infection, adverse events, or inpatient and emergency department visits during the minimum recommended dose intervals. These findings can inform future efforts in developing effective strategies to enhance vaccination coverage and improve the completion rate of necessary doses.

While prior studies found no clear evidence of an association between COVID-19 vaccination and tinnitus, concerns about a potential link remain. This study assessed the risk of tinnitus following COVID-19 XBB.1.5 vaccination, administered alone or coadministered with influenza vaccine, using the event-dependent self-controlled case series (SCCS) design. We conducted an SCCS study among individuals aged ≥12 years enrolled at Kaiser Permanente Southern California, with tinnitus events occurring between September 1, 2023, and March 31, 2024. The exposures included Pfizer-BioNTech and Moderna COVID-19 XBB.1.5 vaccines, with or without influenza vaccine coadministration. The primary outcome was first-ever tinnitus (no documented history before September 1, 2023), and the secondary outcome was first-in-1-year tinnitus, identified using ICD-10 code H93.1* in inpatient, emergency department, and outpatient settings. Risk intervals were pre-specified as 1–14 days and 1–28 days after vaccination, with person-time outside the risk interval serving as the control interval. Relative incidences (RI) and 95% confidence intervals (CI) were estimated, adjusting for seasonality by including tinnitus events among non-recipients of COVID-19 XBB.1.5 vaccines and by including calendar month in the SCCS models. With 13,940 first-ever tinnitus events among recipients of COVID-19 XBB.1.5 vaccines, no increased risk was observed within 1–14 or 1–28 days following vaccination in overall analyses. The RI was 0.78 (95% CI: 0.67–0.90) for the 14-day risk interval and 0.87 (95% CI: 0.78–0.96) for the 28-day interval. Subgroup analyses by age and influenza vaccine coadministration status also showed no significant increase in RI. Similarly, no significantly elevated RI was found for first-in-1-year tinnitus in the overall analyses, age-specific analyses, or analyses by coadministration with influenza vaccine. Our findings suggest no increased tinnitus risk following COVID-19 XBB.1.5 vaccination, either administered alone or coadministered with influenza vaccine. These results provide reassuring evidence of the safety of COVID-19 vaccines with respect to tinnitus risk. •We assessed the risk of tinnitus following COVID-19 XBB.1.5 vaccination using a self-controlled case series study design.•Relative incidences of first-ever tinnitus for 1–14 and 1–28 day risk intervals were 0.78 and 0.87, respectively.•Subgroup analyses by age and coadministration with influenza vaccine also showed no significant increase in tinnitus risk.•Our findings provide reassuring evidence that COVID-19 XBB.1.5 vaccination, alone or with influenza vaccine, does not increase tinnitus risk.

Bivalent mRNA COVID-19 vaccines were developed to provide protection against the original SARS-CoV-2 strain and Omicron BA.4/BA.5 variants, but uptake in the United States has been low. Sociodemographic disparities in COVID-19 vaccine uptake have been documented, but it is unclear if similar disparities persist among individuals who previously completed a primary series of monovalent COVID-19 vaccine. We conducted a retrospective cohort study at Kaiser Permanente Southern California (KPSC) including youth aged 5–17 years and adults aged ≥18 years who were KPSC members and had completed a primary series of monovalent COVID-19 vaccine. Individuals were followed from index date (date of eligibility for bivalent vaccine) to 03/31/2023 to ascertain receipt of any dose of bivalent mRNA COVID-19 vaccine or until disenrollment from KPSC or death. Multivariable robust Poisson regression was conducted to assess the adjusted relative risk and 95 % confidence intervals of factors associated with receipt of bivalent vaccine. The final cohorts included 305,339 youth and 2,534,619 adults, of whom 19.5 % and 30.7 %, respectively, had received bivalent COVID-19 vaccine. Factors associated with being more likely to receive bivalent COVID-19 vaccine included older age, Asian race, more prior year outpatient and virtual visits, Charlson score ≥1, and immunocompromised status. Factors associated with being less likely to receive a bivalent COVID-19 vaccine included age 12–17 vs 5–11 years, Hispanic and non-Hispanic Black race/ethnicity, ≥1 prior year inpatient or emergency department visits, prior history of SARS-CoV-2 infection (adults only), Medicaid insurance, and higher neighborhood deprivation index. Even among youth and adults who had previously received a primary series of monovalent COVID-19 vaccine, sociodemographic and clinical disparities were observed in receipt of bivalent COVID-19 vaccine. These findings are critical to inform equitable strategies for the implementation of the updated monovalent COVID-19 vaccine targeting the Omicron XBB strain.

Vaccination with updated COVID-19 vaccines is important to maintain protection against circulating SARS-CoV-2 variants. We developed and validated a prediction model for non-receipt of updated COVID-19 vaccines at Kaiser Permanente Southern California. Of 3,287,287 adults, 20.2 % received 2023–2024 COVID-19 vaccine. We assessed the association of 15 variables available in electronic health records with non-receipt of 2023–2024 updated COVID-19 vaccine. The cohort was split into development and validation samples. Performance of the 15-variable model in the development sample was moderate, with a scaled Brier score of 35.6 %, R2 of 29.3 %, C-statistic of 0.882, discrimination slope of 0.354, and calibration slope of 1; performance was similar for the validation sample and simplified 6-variable and 2-variable models. The strongest predictors were prior non-receipt of bivalent COVID-19 vaccine or influenza vaccine. These results suggest that a simple model using variables available to healthcare providers can be optimized to guide intervention strategies for updated COVID-19 vaccines.

Differences in COVID-19 vaccination coverage across racial and ethnic groups have been widely documented in the U.S. We conducted Blinder-Oaxaca decomposition analyses to examine the contribution of 13 risk factors to COVID-19 XBB.1.5 vaccination differences across racial and ethnic groups within a large U.S. healthcare system. The retrospective cohort included adult members of Kaiser Permanente Southern California between September 12, 2023, and April 30, 2024. The outcome was COVID-19 XBB.1.5 vaccination. We used multivariable logistic regression to assess the association of demographic factors, socioeconomic status measured by neighborhood deprivation index (NDI), clinical factors, and healthcare utilization with vaccination. Decomposition analyses were performed to quantify the extent to which differences in these factors explained differences in vaccination rates between Hispanic, non-Hispanic Black, and non-Hispanic White individuals. Among 2,621,148 members eligible for decomposition analyses, COVID-19 XBB.1.5 vaccination rates were 25.5%, 15.5% and 19.7% for non-Hispanic White, Hispanic, and non-Hispanic Black individuals, respectively. Decomposition analyses showed that 78.9% of the vaccination difference between Hispanic and non-Hispanic White individuals and 86.2% of the difference between non-Hispanic Black and non-Hispanic White individuals were explained by observed risk factors. With non-Hispanic White individuals serving as the reference group, differences in age distribution explained 22.3% of the difference for Hispanic individuals and 11.5% for non-Hispanic Black individuals, and NDI explained 12.0% and 21.2%, respectively; differences in prior season influenza vaccination and prior bivalent COVID-19 vaccination accounted for 10.5% and 29.3% of the difference for Hispanic individuals, and 30.8% and 19.3% for non-Hispanic Black individuals, respectively. When prior vaccination history was excluded, the share of the difference explained by age and NDI increased substantially. Differences in COVID-19 XBB.1.5 vaccination across race/ethnicity were largely explained by differences in age, socioeconomic status, and healthcare utilization. The findings underscore the need for targeted interventions, particularly in younger populations and highly deprived neighborhoods, as well as leveraging outpatient visits to improve vaccine uptake. •We examined differences in COVID-19 XBB.1.5 vaccination across race/ethnicity using Blinder-Oaxaca decomposition approach.•Age, socioeconomic status, and healthcare utilization were factors associated with vaccination differences.•Prior season influenza vaccination and prior bivalent COVID-19 vaccination also accounted for vaccination differences.•The contribution of age and socioeconomic status increased substantially after excluding prior vaccinations.

Variants in hereditary cancer risk genes are frequently identified following tumor-based DNA sequencing and represent an opportunity to diagnose hereditary cancer. We implemented an automated hereditary cancer screening program in a large HMO for all patients who underwent tumor-based DNA sequencing to identify patients with hereditary cancer and determine if this approach augmented existing genetic counseling approaches driven by personal/family history criteria. Regular automated searches of a centralized tumor DNA variant database were performed for ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PALB2, and/or PMS2 variants, and germline hereditary cancer gene panel testing was offered to patients with tumor variants who had never undergone germline testing. Patients completing germline testing due to their tumor DNA test results were considered part of the tumor DNA safety net. Patients previously completing germline testing via traditional genetic counseling and tumor DNA safety net were compared for demographics, tumor type, presence of germline pathogenic/likely pathogenic (P/LP) variant, and whether NCCN criteria were met for hereditary cancer genetic testing. Germline P/LP variants were common in both groups. Patients who received germline testing through traditional genetic counseling were more likely to have cardinal hereditary tumors than the tumor DNA safety net group. Patients identified with hereditary cancer through traditional genetic counseling were more likely to meet NCCN personal/family history criteria for germline testing than the tumor DNA safety net group (99% versus 34%). A universal tumor DNA safety net screen is an important diagnostic strategy which augments traditional genetic counseling approaches based on personal/family history.

BackgroundIn 2016, the Patient-Centered Outcomes Research Institute funded the National Patient Centered Clinical Research Network (PCORnet) Bariatric Study (PBS). Understanding the experience of postoperative patients was a key component of this study.MethodsNine focus groups were conducted in Southern California, Louisiana, Pennsylvania, and Ohio and in a national advocacy conference for patients with obesity. Participants were identified and recruited in both clinical and community settings. Focus group transcripts were analyzed using an iterative inductive-deductive approach to identify global overarching themes.ResultsThere were 76 focus group participants. Participants were mostly women (81.4%), had primarily undergone gastric sleeve (47.0%), were non-Hispanic white (51.4%), had some college education (44.3%), and made $100,000 annual income or less (65.7%). Qualitative findings included negative reactions patients received from friends, family, and co-workers once they disclosed that they had bariatric surgery to lose weight; and barriers to follow-up care included insurance coverage, emotional and situational challenges, and physical pain limiting mobility.ConclusionsThese findings confirm the other qualitative findings in this area. The approach to bariatric surgery should be expanded to provide long-term comprehensive care that includes in-depth postoperative lifetime monitoring of emotional and physical health.

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PhD-trained scientists are essential contributors to the workforce in diverse employment sectors that include academia, industry, government, and nonprofit organizations. Hence, best practices for training the future biomedical workforce are of national concern. Complementing coursework and laboratory research training, many institutions now offer professional training that enables career exploration and develops a broad set of skills critical to various career paths. The National Institutes of Health (NIH) funded academic institutions to design innovative programming to enable this professional development through a mechanism known as Broadening Experiences in Scientific Training (BEST). Programming at the NIH BEST awardee institutions included career panels, skill-building workshops, job search workshops, site visits, and internships. Because doctoral training is lengthy and requires focused attention on dissertation research, an initial concern was that students participating in additional complementary training activities might exhibit an increased time to degree or diminished research productivity. Metrics were analyzed from 10 NIH BEST awardee institutions to address this concern, using time to degree and publication records as measures of efficiency and productivity. Comparing doctoral students who participated to those who did not, results revealed that across these diverse academic institutions, there were no differences in time to degree or manuscript output. Our findings support the policy that doctoral students should participate in career and professional development opportunities that are intended to prepare them for a variety of diverse and important careers in the workforce.