Task-based functional magnetic resonance imaging prediction of postsurgical cognitive outcomes in temporal lobe epilepsy: A systematic review, meta-analysis, and new data.

Task-based functional magnetic resonance imaging (tfMRI) has developed as a common alternative in epilepsy surgery to the intracarotid amobarbital procedure, also known as the Wada procedure. Prior studies have implicated tfMRI as a comparable predictor of postsurgical cognitive outcomes. However, the predictive validity of tfMRI has not been established. This preregistered systematic review and meta-analysis (CRD42020183563) synthesizes the literature predicting postsurgical cognitive outcomes in temporal lobe epilepsy (TLE) using tfMRI. The PubMed and PsycINFO literature databases were queried for English-language articles published between January 1, 2009 and December 31, 2020 associating tfMRI laterality indices or symmetry of task activation with outcomes in TLE. Their references were reviewed for additional relevant literature, and unpublished data from our center were incorporated. Nineteen studies were included in the meta-analysis. tfMRI studies predicted postsurgical cognitive outcomes in left TLE ( ρ ̂ = -.27, 95% confidence interval [CI] = -.32 to -.23) but not right TLE ( ρ ̂ = -.02, 95% CI = -.08 to .03). Among studies of left TLE, language tfMRI studies were more robustly predictive of postsurgical cognitive outcomes ( ρ ̂ = -.27, 95% CI = -.33 to -.20) than memory tfMRI studies ( ρ ̂ = -.27, 95% CI = -.43 to -.11). Further moderation by cognitive outcome domain indicated language tfMRI predicted confrontation naming ( ρ ̂ = -.32, 95% CI = -.41 to -.22) and verbal memory ( ρ ̂ = -.26, 95% CI = -.35 to -.17) outcomes, whereas memory tfMRI forecasted only verbal memory outcomes ( ρ ̂ = -.37, 95% CI = -.57 to -.18). Surgery type, birth sex, level of education, age at onset, disease duration, and hemispheric language dominance moderated study outcomes. Sensitivity analyses suggested the interval of postsurgical follow-up, and reporting and methodological practices influenced study outcomes as well. These findings intimate tfMRI is a modest predictor of outcomes in left TLE that should be considered in the context of a larger surgical workup.

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022.

On August 31, 2022, the Food and Drug Administration (FDA) authorized bivalent formulations of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines; these vaccines include mRNA encoding the spike protein from the original (ancestral) strain of SARS-CoV-2 (the virus that causes COVID-19) and from the B.1.1.529 (Omicron) variants BA.4 and BA.5 (BA.4/BA.5). These bivalent mRNA vaccines were authorized for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination; Pfizer-BioNTech bivalent booster was authorized for persons aged ≥12 years and Moderna for adults aged ≥18 years.*,† On September 1, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended that all persons aged ≥12 years receive an age-appropriate bivalent mRNA booster dose.§ To characterize the safety of bivalent mRNA booster doses, CDC reviewed adverse events and health impacts reported after receipt of bivalent Pfizer-BioNTech and Moderna booster doses during August 31-October 23, 2022, to v-safe,¶ a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and the Vaccine Adverse Event Reporting System (VAERS),** a U.S. passive vaccine safety surveillance system managed by CDC and FDA (1). During August 31-October 23, 2022, approximately 14.4 million persons aged ≥12 years received a bivalent Pfizer-BioNTech booster dose, and 8.2 million adults aged ≥18 years received a bivalent Moderna booster dose.†† Among the 211,959 registrants aged ≥12 years who reported receiving a bivalent booster dose to v-safe, injection site and systemic reactions were frequently reported in the week after vaccination (60.8% and 54.8%, respectively); fewer than 1% of v-safe registrants reported receiving medical care. VAERS received 5,542 reports of adverse events after bivalent booster vaccination among persons aged ≥12 years; 95.5% of reports were nonserious and 4.5% were serious events. Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses. Health impacts after COVID-19 vaccination are less frequent and less severe than those associated with COVID-19 illness (2).

Thromboembolic events after Ad.26.COV2.S COVID-19 vaccine: Reports to the Vaccine Adverse Event Reporting System.

PURPOSE: The Food and Drug Administration (FDA) has identified a potential safety concern for thromboembolic events (TEEs) after Ad.26.COV2.S COVID-19 Vaccine. We sought to characterize the frequency, severity, type, and anatomic location of TEEs reported to the Vaccine Adverse Event Reporting System (VAERS) following Ad.26.COV2.S. METHODS: Reports of TEEs after Ad.26.COV2.S were identified in VAERS, and demographics, clinical characteristics, and relevant medical history were summarized. For a subset of reports, physicians reviewed available medical records and evaluated clinical presentation, diagnostic evaluation, risk factors, and treatment. The crude reporting rate of TEEs was estimated based on case counts in VAERS and vaccine administration data. RESULTS: Through February 28, 2022, FDA identified 3790 reports of TEEs after Ad.26.COV2.S. Median age was 56 years, and 1938 individuals (51.1%) were female. Most reports, 2892 (76.3%), were serious, including 421 deaths. Median time to onset was 12 days post-vaccination. Obesity and ischemia were among the most commonly documented risk factors. Thrombocytopenia (platelet count less than 150 000/µl) was documented in 63 records (11.5%) and anti-platelet 4 antibodies in 25 (4.6%). Medical review identified cases of severe clot burden (e.g., bilateral, saddle, or other massive pulmonary embolism with or without cor pulmonale; lower extremity thrombus involving the external iliac, common femoral, popliteal, posterior tibial, peroneal, and gastrocnemius veins). The crude reporting rate was ~20.7 cases of TEE per 100 000 doses of Ad.26.COV2.S administered. CONCLUSIONS: Life-threatening or fatal TEEs have been reported after Ad.26.COV2.S, including bilateral massive pulmonary embolism or other severe clot burden.

Perceived Barriers to Serving on National Institutes of Health Scientific Review Groups Experienced by Black and African American Scientists.

Importance: African American and Black scientists are awarded disproportionately fewer National Institutes of Health (NIH) grants than White scientists. Increasing Black representation on NIH scientific review groups (SRGs) likely will contribute to increased equity in funding rates because research topics of Black and African American scientists' submitted applications will be more highly valued; however, Black and African American scientists often perceive barriers that prevent them from serving on NIH SRGs. Objective: To examine perceived barriers that prevent Black and African American scientists from serving on NIH SRGs. Design, Setting, and Participants: This qualitative study used a mixed methods online approach with a convenience sample of Black and African American scientists to identify barriers to NIH grant review participation. Eligible participants were recruited online from professional organizations with primarily Black and African American membership. From February through April 2021, participants were asked to identify barriers to serving on NIH SRGs using concept mapping. Participants brainstormed statements describing barriers to serving on NIH SRGs, sorted statements into content themes, and rated statements on how true they were. Multidimensional scaling and a hierarchical cluster analysis identified content themes. Data analysis was conducted in May and June of 2021. Main Outcomes and Measures: Self-reported barriers to serving on an NIH SRG among Black and African American scientists. Results: A total of 52 scientists participated in both phases of the study (mean [SD] age, 42.3 [8.2] years; 46 women [88.5%]). Participants provided 68 unique statements that were organized into 9 thematic clusters describing barriers to serving on NIH SRGs. Themes included structural racism, diversity not valued, toxic environment, review workload demand, lack of reward, negative affect about the review process, competing demands at home institution, lack of opportunity, and perceptions of being unqualified. Conclusions and Relevance: Black and African American scientists reported many barriers to serving on NIH SRGs that are unique to Black and African American scientists, as well as barriers that transcend race but are exacerbated by structural racism. This study provides NIH with concrete opportunities to address realized barriers to increase inclusion of Black and African American scientists on NIH SRGs, fund more Black and African American scientists, and ultimately reduce health inequities in the US.

Primary Care Cluster RCT to Increase Diabetes Prevention Program Referrals.

INTRODUCTION: The Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic. STUDY DESIGN: A pragmatic, cluster randomized, mixed-methods study. SETTING/PARTICPANTS: Clusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians. INTERVENTION: Implementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes. MAIN OUTCOME MEASURES: The primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019. RESULTS: Study clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful. CONCLUSIONS: Intervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.

Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice.

PURPOSE: Lifestyle change programs are an effective but underutilized approach to prevent or delay type 2 diabetes in people with prediabetes. Understanding clinician prediabetes knowledge, attitudes, and practices can inform implementation efforts to increase lifestyle change program referrals. METHODS: We surveyed clinicians at an academic family medicine clinic about their prediabetes knowledge, attitudes, and practices. From the same clinic, we reviewed electronic health records to assess prediabetes screening, diagnosis, and treatment coverage in the cohort of adults seen from 2015 to 2017. RESULTS: Thirty-one clinicians (69.6%) completed the survey. Clinicians believed prediabetes was an important health issue (n = 29; 93.7%) and that prediabetes screening (n = 20, 64.5%) and diagnosis (n = 31, 100%) were important for prediabetes management. About half of the respondents (n = 14; 45.2%) reported familiarity with the National Diabetes Prevention Program (DPP). Electronic chart review included 15,520 adult patients. Most of the 5360 nondiabetic patients meeting US Preventive Services Task Force diabetes screening guidelines (n = 4068; 75.9%) received a hemoglobin A1c test. Of the 1437 patients with an A1c result diagnostic of prediabetes, 729 (50.7%) had the diagnosis in their chart. Prediabetes patients receiving point-of-care A1c testing instead of laboratory testing had 4.7 increased odds (95% CI, 3.5 to 6.4) of metformin prescription. No patients were referred to a DPP. CONCLUSIONS: Clinicians' positive attitudes toward prediabetes screening, moderate knowledge of prediabetes management, and low awareness of DPPs were reflected by high diabetes screening coverage, limited prediabetes diagnosis, and no DPP referrals. We will tailor our implementation strategy to overcome these prediabetes care barriers.

Patient and Clinician Perceptions of Prediabetes: A Mixed-Methods Primary Care Study.

PURPOSE: The purpose of the study was to assess patient and clinician perceptions of prediabetes in an academic family medicine practice. Data were collected in preparation for an implementation study to increase utilization of the National Diabetes Prevention Program (N-DPP). METHODS: In this mixed-methods study, discussions from 3 focus groups composed of patients with prediabetes were evaluated using thematic analysis for their understanding of and beliefs about prediabetes, care experiences, and attitudes toward N-DPP. Clinicians completed a Likert-scaled survey assessing attitudes and perceived barriers to providing prediabetes care. RESULTS: Among the 15 focus group participants, more than half were not aware of their diagnosis. Attitudes toward prediabetes were mixed: while many believed it was serious and elicited more fear than being "at risk," others thought there were varying degrees of risk within the same diagnosis, making the diagnosis less impactful. Patients repeatedly expressed the perception that clinicians were not forthcoming about necessary behavior changes. Patients agreed on barriers to N-DPP, including scheduling and transportation. Clinicians (N = 31) concurred that patients lack awareness of their prediabetes diagnosis. They reported that time is available to screen all patients and that a prediabetes diagnosis is effective for advising patients of the need for lifestyle modification. There was consensus from both patients and clinicians that prediabetes is curable. CONCLUSIONS: Increased patient awareness and patient-centered education is needed to overcome barriers to prediabetes care. To facilitate implementation of N-DPP referral processes, clinicians should clearly communicate risk, treatment information, and linkage to N-DPP as the suggested treatment plan.