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Background: Less than 50% of non-Hispanic Asian adults taking antihypertensive medication have controlled blood pressure. Methods: We compared non-persistence and low adherence to antihypertensive medication between non-Hispanic Asian and other race/ethnicity groups among US adults ≥66 years who initiated antihypertensive medication between 2011 and 2018 using a 5% random sample of Medicare beneficiaries (non-Hispanic Asian, n = 2,260; non-Hispanic White, n = 56,000; non-Hispanic Black, n = 5,792; Hispanic, n = 4,212; and Other, n = 1,423). Non-persistence was defined as not having antihypertensive medication available to take in the last 90 of 365 days following treatment initiation. Low adherence was defined as having antihypertensive medication available to take on <80% of the 365 days following initiation. Results: In 2011–2012, 2013–2014, 2015–2016 and 2017–2018, the proportion of non-Hispanic Asian Medicare beneficiaries with non-persistence was 29.1%, 25.6%, 25.4% and 26.7% (p-trend = 0.381), respectively, and the proportion with low adherence was 58.1%, 54.2%, 53.4% and 51.6%, respectively (p-trend = 0.020). In 2017–2018, compared with non-Hispanic Asian beneficiaries, non-persistence was less common among non-Hispanic White beneficiaries (risk ratio 0.74 [95%CI, 0.64–0.85]), non-Hispanic Black beneficiaries (0.80 [95%CI 0.68–0.94]) and those reporting Other race/ethnicity (0.68 [95%CI, 0.54–0.85]) but not among Hispanic beneficiaries (1.04 [95%CI, 0.88–1.23]). Compared to non-Hispanic Asian beneficiaries, non-Hispanic White beneficiaries and beneficiaries reporting Other race/ethnicity were less likely to have low adherence to antihypertensive medication (relative risk 0.78 [95%CI 0.72–0.84] and 0.84 [95%CI 0.74–0.95], respectively); there was no association for non-Hispanic Black or Hispanic beneficiaries. Conclusions: Non-persistence and low adherence to antihypertensive medication were more common among older non-Hispanic Asian than non-Hispanic White adults. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine the association between diabetes stigma, socioeconomic status, psychosocial variables, and substance use in adolescents and young adults (AYAs) with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: This is a cross-sectional analysis of AYAs from the SEARCH for Diabetes in Youth study who completed a survey on diabetes-related stigma, generating a total diabetes stigma score. Using multivariable modeling, stratified by diabetes type, we examined the relationship of diabetes stigma with variables of interest. RESULTS: Of the 1,608 AYAs who completed the diabetes-related stigma survey, 78% had type 1 diabetes, and the mean age was 21.7 years. Higher diabetes stigma scores were associated with food insecurity (P = 0.001), disordered eating (P < 0.0001), depressive symptoms (P < 0.0001), and decreased health-related (P < 0.0001) and diabetes-specific quality of life (P < 0.0001). CONCLUSIONS: Diabetes stigma is associated with food insecurity, disordered eating, and lower psychosocial well-being. [ABSTRACT FROM AUTHOR]

Objective This study aimed to examine whether severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection during pregnancy is associated with increased odds of perinatal complications and viral transmission to the infant. Study Design A retrospective cohort study of women who delivered at Kaiser Permanente Southern California hospitals (April 6, 2020–February 28, 2021) was performed using data extracted from electronic health records (EHRs). During this time polymerize chain reaction (PCR)-based tests for SARS-CoV-2 was universally offered to all pregnant women at labor and delivery admission, as well as earlier in the pregnancy, if they were displaying symptoms consistent with SARS-CoV-2 infection or a possible exposure to the virus. Adjusted odds ratio (aOR) was used to estimate the strength of associations between positive test results and adverse perinatal outcomes. Results Of 35,123 women with a singleton pregnancy, 2,203 (6%) tested positive for SARS-CoV-2 infection with 596 (27%) testing positive during the first or second trimester and 1,607 (73%) during the third trimester. Women testing positive were younger than those who tested negative (29.7 [5.4] vs. 31.1 [5.3] years; mean [standard deviation (SD)]; p <.001). The SARS-CoV-2 infection tended to increase the odds of an abnormal fetal heart rate pattern (aOR: 1.10; 95% confidence interval [CI]: 1.00, 1.21; p = 0.058), spontaneous preterm birth (aOR: 1.28; 95% CI: 1.03, 1.58; p = 0.024), congenital anomalies (aOR: 1.69; 95% CI: 1.15, 2.50; p = 0.008), and maternal intensive care unit admission at delivery (aOR: 7.44; 95% CI: 4.06, 13.62; p < 0.001) but not preeclampsia/eclampsia (aOR: 1.14; 95% CI: 0.98, 1.33; p = 0.080). Eighteen (0.8%) neonates of mothers who tested positive also had a positive SARS-CoV-2 test after 24 hours of birth, but all were asymptomatic during the neonatal period. Conclusion These findings suggest that prenatal SARS-CoV-2 infection increases the odds of some adverse perinatal outcomes. The likelihood of vertical transmission from the mother to the fetus was low (0.3%), suggesting that pregnancy complications resulting from SARS-CoV-2 infection pose more risk to the baby than transplacental viral transmission. Key Points SARS-CoV-2 infection is associated with increased odds of adverse perinatal outcomes. The odds of specific adverse outcomes were greater when a mother was infected earlier in pregnancy. The proportion of vertical transmission from mother to fetus was 0.3% [ABSTRACT FROM AUTHOR]

Purpose: This study validated incident and recurrent ischemic stroke identified by International Classification of Diseases, Tenth Revision, Clinical Modification (ICD‐10) hospital discharge diagnosis codes. Methods: Using electronic health records (EHR) of adults (≥18 years) receiving care from Kaiser Permanente Southern California with ICD‐10 hospital discharge diagnosis codes of ischemic stroke (I63.x, G46.3, and G46.4) between October 2015 and September 2020, we identified 75 patients with both incident and recurrent stroke events (total 150 cases). Two neurologists independently evaluated validity of ICD‐10 codes through chart reviews. Results: The positive predictive value (PPV, 95% CI) for incident stroke was 93% (95% CI: 88%, 99%) and the PPV for recurrent stroke was 72% (95% CI: 62%, 82%). The PPV for recurrent stroke improved after applying a gap of 20 days (PPV of 75%; 95% CI: 63%, 87%) or removing hospital admissions related to stroke‐related procedures (PPV of 78%; 95% CI: 68%, 88%). Conclusion: The ICD‐10 hospital discharge diagnosis codes for ischemic stroke showed a high PPV for incident cases, while the PPV for recurrent cases were less optimal. Algorithms to improve the accuracy of ICD‐10 codes for recurrent ischemic stroke may be necessary. [ABSTRACT FROM AUTHOR]

Successful transition from a pediatric to adult diabetes care provider is associated with reduced ambulatory diabetes care visits and increased acute complications. This study aimed to determine whether the degree of independence in diabetes care and the rate of acute complications after transition to adult diabetes care were associated with individuals' student or employment status. Nonstudents were found to be less likely than students to be independent with diabetes care, and employed nonstudents were at lower risk of diabetic ketoacidosis than unemployed nonstudents. Additional support may be needed for young adults who are not students or are unemployed to improve independence and reduce the risk for acute complications. [ABSTRACT FROM AUTHOR]

Background Accurate blood pressure (BP) measurement is essential to identify and manage hypertension. Prior studies have reported a difference between BP measured in routine patient care and in research studies. We aimed to investigate the agreement between BP measured in routine care and research-grade BP in Kaiser Permanente Southern California, a large, integrated healthcare system with initiatives to standardize BP measurements during routine patient care visits. Methods We included adults ≥65 years old with hypertension, taking antihypertensive medication, and participating in the Ambulatory Blood Pressure in Older Adults (AMBROSIA) study in 2019–2021. Clinic BP from routine care visits was extracted from the electronic health record. Research-grade BP was obtained by trained AMBROSIA study staff via an automatic oscillometric device. The mean difference between routine care and research-grade BP, limits of agreement, and correlation were assessed. Results We included 309 participants (mean age 75 years; 54% female; 49% non-Hispanic white). Compared with measurements from routine care, mean research-grade systolic BP (SBP) was 0.1 mm Hg higher (95% CI: −1.5 to 1.8) and diastolic BP (DBP) was 0.4 mm Hg lower (95% CI: −1.6 to 0.7). Limits of agreement were −29 to 30 mm Hg for SBP and −21 to 20 mm Hg for DBP. The intraclass correlation coefficient was 0.42 (95% CI: 0.33 to 0.51) for SBP and 0.43 (95% CI: 0.34 to 0.52) for DBP. Conclusions High within-person variation and moderate correlation were present between BP measured in routine care and following a research protocol suggesting the importance of standardized measurements. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine the prevalence, progression, and modifiable risk factors associated with the development of diabetic retinopathy (DR) in a population-based cohort of youth-onset diabetes. RESEARCH DESIGN AND METHODS: We conducted a multicenter, population-based prospective cohort study (2002–2019) of youth and young adults with youth-onset type 1 diabetes (n = 2,519) and type 2 diabetes (n = 447). Modifiable factors included baseline and change from baseline to follow-up in BMI z score, waist/height ratio, systolic and diastolic blood pressure z score, and A1C. DR included evidence of mild or moderate nonproliferative DR or proliferative retinopathy. Prevalence estimates were standardized to estimate the burden of DR, and inverse probability weighting for censoring was applied for estimating risk factors for DR at two points of follow-up. RESULTS: DR in youth-onset type 1 and type 2 diabetes is highly prevalent, with 52% of those with type 1 diabetes and 56% of those with type 2 diabetes demonstrating retinal changes at follow-up (mean [SD] 12.5 [2.2] years from diagnosis). Higher baseline A1C, increase in A1C across follow-up, and increase in diastolic and systolic blood pressure were associated with the observation of DR at follow-up for both diabetes types. Increase in A1C across follow-up was associated with retinopathy progression. BMI z score and waist/height ratio were inconsistently associated, with both positive and inverse associations noted. CONCLUSIONS: Extrapolated to all youth-onset diabetes in the U.S., we estimate 110,051 cases of DR developing within ∼12 years postdiagnosis. Tight glucose and blood pressure management may offer the opportunity to mitigate development and progression of DR in youth-onset diabetes. [ABSTRACT FROM AUTHOR]

Background: Venous thromboembolism (VTE) treatment requires complex management, and patients with limited health literacy (HL) may perceive higher burden and lower benefits associated with their treatment. Objective: To examine the association of HL with treatment satisfaction among patients with VTE. Design: Retrospective cohort study Participants: Kaiser Permanente Southern and Northern California members who were taking oral anticoagulants (OAC) for incident VTE between 2015 and 2018 were surveyed. Main Measures HL was assessed using a 3-item HL assessment and dichotomized as having adequate or limited HL. High treatment burden and low treatment benefit were defined as Anti-Clot Treatment Scale (ACTS) scores below the 25th percentile of the distributions for ACTS Burdens and Benefits survey components, respectively. Using Poisson regression, multivariable adjusted risk ratios (RR) and 95% confidence intervals (CI) were calculated for the association of HL with high treatment burden and low treatment benefits. Results: Among 2154 respondents, 397 (18.4%) had limited HL. Patients with limited vs adequate HL were older (47.9% vs 27.5% aged ≥ 75 years, p<0.001), more likely to use a non-English language when discussing their health (10.8% vs 1.7%, p<0.001), to have less than high school education (10.1% vs 1.7%, p<0.001), and to self-rate their health as fair or poor (47.6% vs 25.5%, p<0.001). After multivariable adjustment, patients with limited HL were more likely to have higher perceived treatment burden (RR 1.24, 95% CI 1.07, 1.45) and lower perceived treatment benefits (RR 1.21, 95% CI 1.08, 1.37). Conclusions: Limited HL was associated with lower OAC treatment satisfaction, though absolute differences in satisfaction scores were small. Further examination of the intersection of HL with VTE treatment satisfaction and compliance among older and non-English speaking patients is warranted. [ABSTRACT FROM AUTHOR]

Introduction: In the United States, there has been controversy over whether treatment of mild‐to‐moderate hypertension during pregnancy conveys more benefit than risk. Objective: The objective of the study was to compare risks and benefits of treatment of mild‐to‐moderate hypertension during pregnancy. Methods: This retrospective cohort study included 11,871 pregnant women with mild‐to‐moderate hypertension as defined by blood pressure (BP) values from three Kaiser Permanente regions between 2005 and 2014. Data were extracted from electronic health records. Dynamic marginal structural models with inverse probability weighting and informative censoring were used to compare risks of adverse outcomes when beginning antihypertensive medication treatment at four BP thresholds (≥155/105, ≥150/100, ≥145/95, ≥140/90 mm Hg) compared with the recommended threshold in the United States at that time, ≥160/110 mm Hg. Outcomes included preeclampsia, preterm birth, small‐for‐gestational‐age (SGA), Neonatal Intensive Care Unit (NICU) care, and stillbirth. Primary analyses allowed 2 weeks for medication initiation after an elevated BP. Several sensitivity and subgroup (i.e., race/ethnicity and pre‐pregnancy body mass index) analyses were also conducted. Results: In primary analyses, medication initiation at lower BP thresholds was associated with greater risk of most outcomes. Comparing the lowest (≥140/90 mm Hg) to the highest BP threshold (≥160/110 mm Hg), we found an excess risk of preeclampsia (adjusted Risk Difference (aRD) 38.6 per 100 births, 95% Confidence Interval (CI): 30.6, 46.6), SGA (aRD: 10.2 per 100 births, 95% CI: 2.6, 17.8), NICU admission (aRD: 20.2 per 100 births, 95% CI: 12.6, 27.9), and stillbirth (1.18 per 100 births, 95% CI: 0.27, 2.09). The findings did not reach statistical significance for preterm birth (aRD: 2.5 per 100 births, 95% CI: −0.4, 5.3). These relationships were attenuated and did not always reach statistically significance when comparing higher BP treatment thresholds to the highest threshold (i.e., ≥160/110 mm Hg). Sensitivity and subgroup analyses produced similar results. Conclusions: Initiation of antihypertensive medication at mild‐to‐moderate BP thresholds (140–155/90–105 mm Hg; with the largest risk consistently associated with treatment at 140/90 mm Hg) may be associated with adverse maternal and neonatal outcomes. Limitations include inability to measure medication adherence. [ABSTRACT FROM AUTHOR]

Background Coronavirus disease 2019 (COVID-19) social distancing policies resulted in reductions in community movement, however, fall rates during this time have not been described. Methods This prospective study included adults ≥65 years old participating in the Ambulatory Blood Pressure in Older Adults (AMBROSIA) cohort and who completed ≥1 monthly falls calendar (August 2019–March 2021; n = 250). Months were grouped to correspond to the fall 2020 phased reopening (August–October) and the shelter-in-place policy during the winter 2020 surge (November–January) in Los Angeles, California and compared to the same months, 1 year earlier (ie, before the pandemic). Results Participants had a mean (standard deviation [ SD ]) age of 75.2 (6.1) years, 49.6% were White, and 53.2% were women. We obtained 2 795 falls calendars during follow-up. Overall, 110 (44.0%) participants reported a total of 421 falls (rate 15.1 per 100 calendar months). The highest monthly fall rate during the pandemic was 22.9 (95% confidence interval [CI] 16.4–31.1) per 100 calendar-months in August 2020. The lowest fall rate during the pandemic was 8.6 (95% CI 3.5–17.8) per 100 calendar-months in February 2021. During the pandemic, fall rates in August, September, and October 2020 were higher than the previous year (rate ratio 1.8 [95% CI 1.1–2.9]), and fall rates in November and December 2020 and January 2021 were lower than the previous year (rate ratio 0.5 [95% CI 0.4–0.8]). Conclusion As the pandemic continues and older adults resume community mobility after a shelter-in-place period, providers should pay attention to the risk of falls. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine the association between diabetes stigma and HbA1c, treatment plan and acute and chronic complications in adolescents and young adults (AYAs) with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: The SEARCH for Diabetes in Youth study is a multicenter cohort study that collected questionnaire, laboratory, and physical examination data about AYAs with diabetes diagnosed in childhood. A five-question survey assessed frequency of perceived diabetes-related stigma, generating a total diabetes stigma score. We used multivariable linear modeling, stratified by diabetes type, to examine the association of diabetes stigma with clinical factors, adjusting for sociodemographic characteristics, clinic site, diabetes duration, health insurance, treatment plan, and HbA1c. RESULTS: Of 1,608 respondents, 78% had type 1 diabetes, 56% were female, and 48% were non-Hispanic White. The mean (SD) age at study visit was 21.7 (5.1) years (range, 10–24.9). The mean (SD) HbA1c was 9.2% (2.3%; 77 mmol/mol [2.0 mmol/mol]). Higher diabetes stigma scores were associated with female sex and higher HbA1c (P < 0.01) for all participants. No significant association between diabetes stigma score and technology use was observed. In participants with type 2 diabetes, higher diabetes stigma scores were associated with insulin use (P = 0.04). Independent of HbA1c, higher diabetes stigma scores were associated with some acute complications for AYAs with type 1 diabetes and some chronic complications for AYAs with type 1 or type 2 diabetes. CONCLUSIONS: Diabetes stigma in AYAs is associated with worse diabetes outcomes and is important to address when providing comprehensive diabetes care. [ABSTRACT FROM AUTHOR]

The Anticoagulation Length of Therapy and Risk of New Adverse Events In Venous Thromboembolism (ALTERNATIVE) study was designed to compare the benefits and harms of different treatment options for extended treatment of venous thromboembolism (VTE). In this paper, we describe the study cohort, survey data collection, and preliminary results. We identified 39,605 adult patients (age ≥ 18 years) from two large integrated health care delivery systems who were diagnosed with incident VTE and received initial anticoagulation therapy of 3 months or longer. A subset of the cohort (12,737) was invited to participate in a survey. Surveys were completed in English, Spanish or Mandarin via a mailed questionnaire, an online secure web link, or telephone. The survey domains included demographics, personal medical history, anticoagulant treatment history, anticoagulant treatment satisfaction, health-related quality of life and health literacy. A total of 5,017 patients participated in the survey for an overall response rate of 39.4%. The mean (SD) age of the survey respondents was 63.0 (14.5) years and self-reported race was 76.0% White/European, 11.1% Black/African American, and 3.8% Asian/Pacific Islander and 14.0% reported Hispanic ethnicity. Sixty percent of respondents completed the web survey, while 29.0% completed the mail-in paper survey, and 11.0% completed the survey via telephone. The ALTERNATIVE Study will address knowledge gaps by comparing several treatment alternatives for the extended management of VTE so that this information could be used by patients and clinicians to make more informed, patient-centered treatment choices. [ABSTRACT FROM AUTHOR]

Limited data exist in large, representative populations about whether the risk of thromboembolic events varies after receiving four-factor human prothrombin complex concentrate (4F-PCC) versus treatment with human plasma for urgent reversal of oral vitamin K antagonist therapy. We conducted a multicenter observational study to compare the 45-day risk of thromboembolic events in adults with warfarin-associated major bleeding after treatment with 4F-PCC (Kcentra®) or plasma. Hospitalized patients in two large integrated healthcare delivery systems who received 4F-PCC or plasma for reversal of warfarin due to major bleeding from January 1, 2008 to March 31, 2020 were identified and were matched 1:1 on potential confounders and a high-dimensional propensity score. Arterial and venous thromboembolic events were identified up to 45 days after receiving 4F-PCC or plasma from electronic health records and adjudicated by physician review. Among 1119 patients receiving 4F-PCC and a matched historical cohort of 1119 patients receiving plasma without a recent history of thromboembolism, mean (SD) age was 76.7 (10.5) years, 45.6% were women, and 9.4% Black, 14.6% Asian/Pacific Islander, and 15.7% Hispanic. The 45-day risk of thromboembolic events was 3.4% in those receiving 4F-PCC and 4.1% in those receiving plasma (P = 0.26; adjusted hazard ratio 0.76; 95% confidence interval 0.49–1.16). The adjusted risk of all-cause death at 45 days post-treatment was lower in those receiving 4F-PCC compared with plasma. Among a large, ethnically diverse cohort of adults treated for reversal of warfarin-associated bleeding, receipt of 4F-PCC was not associated with an excess risk of thromboembolic events at 45 days compared with plasma therapy. [ABSTRACT FROM AUTHOR]

Background: Influenza infection can result in decompensation or exacerbation of heart failure (HF) symptoms, hospitalization, and death. Objective: To examine the association of influenza vaccination with mortality and hospitalization during influenza and non-influenza seasons between 2009 and 2018. Design, Setting, and Participants: In this prospective, observational cohort study, we included Kaiser Permanente Southern California members with a HF diagnosis prior to September 1 each year from 2009 to 2017. Exposure: The first influenza vaccination in each season (September 1 to May 31) was recorded. Vaccinated/unvaccinated patients were matched 1:1 on age, sex, and ejection fraction at the vaccination date (n-total = 74,870). Main Outcomes: Patients were followed through the end of each influenza season for all-cause mortality. Secondary outcomes included cardiovascular mortality and all-cause hospitalization. In a sensitivity analysis, we examined mortality in the non-influenza season. Results: Influenza vaccinated vs unvaccinated patients had more comorbidities and higher healthcare utilization. After multivariable adjustment for utilization, sociodemographics, comorbidities, and medications, influenza vaccinated vs unvaccinated patients had a lower risk of all-cause mortality and cardiovascular mortality during the influenza season (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.63, 0.70 and HR 0.68, 95% CI 0.63, 0.74, respectively) but a higher risk of all-cause hospitalization (HR 1.27, 95% CI 1.21, 1.31). There was no association between influenza vaccination and all-cause or cardiovascular mortality during the non-influenza season (HR 0.99, 95% CI 0.89, 1.09 and HR 1.00, 95% CI 0.84, 1.21, respectively). Conclusions: Influenza vaccination in HF patients was associated with a lower risk of mortality during the influenza season. Our findings provide support for recommendations of universal influenza vaccination in patients with HF. [ABSTRACT FROM AUTHOR]

Objective: To compare maternal and infant outcomes with different antihypertensive medications in pregnancy. Design: Retrospective cohort study. Setting: Kaiser Permanente, a large healthcare system in the United States. Population: Women aged 15–49 years with a singleton birth from 2005–2014 treated for hypertension. Methods: We identified medication exposure from automated pharmacy data based on the earliest dispensing after the first prenatal visit. Using logistic regression, we calculated weighted outcome prevalences, adjusted odds ratios (aORs) and 95% confidence intervals, with inverse probability of treatment weighting to address confounding. Main outcome measures: Small for gestational age, preterm delivery, neonatal and maternal intensive care unit (ICU) admission, preeclampsia, and stillbirth or termination at > 20 weeks. Results: Among 6346 deliveries, 87% with chronic hypertension, the risk of the infant being small for gestational age (birthweight < 10th percentile) was lower with methyldopa than labetalol (prevalence 13.6% vs. 16.6%; aOR 0.77, 95% CI 0.63 to 0.92). For birthweight < 3rd percentile the aOR was 0.57 (0.39 to 0.80). Compared with labetalol (26.0%), risk of preterm delivery was similar for methyldopa (26.5%; aOR 1.10 [0.95 to 1.27]) and slightly higher for nifedipine (28.5%; aOR 1.25 [1.06 to 1.46]) and other β-blockers (31.2%; aOR 1.58 [1.07 to 2.23]). Neonatal ICU admission was more common with nifedipine than labetalol (25.9% vs. 23.3%, aOR 1.21 [1.02 to 1.43]) but not elevated with methyldopa. Risks of other outcomes did not differ by medication. Conclusions: Risk of most outcomes was similar comparing labetalol, methyldopa and nifedipine. Risk of the infant being small for gestational age was substantially lower for methyldopa, suggesting this medication may warrant further consideration. [ABSTRACT FROM AUTHOR]

Importance: The 2-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine; Heplisav-B) generated higher seroprotection in prelicensure trials than did a 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine; Engerix-B). However, in 1 trial, a higher number of acute myocardial infarction (MI) events were observed among those who received the HepB-CpG vaccine than among those who received the HepB-alum vaccine, an outcome requiring further study.Objective: To compare the rate of acute MI between recipients of HepB-CpG vaccine and HepB-alum vaccine.Design, Setting, and Participants: This prospective cohort noninferiority study was conducted at Kaiser Permanente Southern California (KPSC), an integrated health care system with 15 medical centers and approximately 4.7 million members. The study included 69 625 adults not undergoing dialysis who received at least 1 dose of a hepatitis B vaccine in either family medicine or internal medicine departments at KPSC from August 7, 2018, to October 31, 2019 (November 30, 2020, final follow-up).Exposures: Receipt of HepB-CpG vaccine vs HepB-alum vaccine. The first dose during the study period was the index dose.Main Outcomes and Measures: Individuals were followed up for 13 months after the index dose for occurrence of type 1 acute MI. Potential events were identified using diagnosis codes and adjudicated by cardiologists. The adjusted hazard ratio (HR) of acute MI was estimated comparing recipients of HepB-CpG vaccine with recipients of HepB-alum vaccine, with inverse probability of treatment weighting (IPTW) to adjust for demographic and clinical characteristics. The upper limit of the 1-sided 97.5% CI was compared with a noninferiority margin of 2.Results: Of the 31 183 recipients of HepB-CpG vaccine (median age, 49 years; IQR, 38-56 years), 51.2% (n = 15 965) were men, and 52.7% (n = 16 423) were Hispanic. Of the 38 442 recipients of HepB-alum (median age, 49 years; IQR, 39-56 years), 50.8% (19 533) were men, and 47.1% (n = 18 125) were Hispanic. Characteristics were well-balanced between vaccine groups after IPTW. Fifty-two type 1 acute MI events were confirmed among recipients of HepB-CpG vaccine for a rate of 1.67 per 1000-person-years, and 71 type 1 acute MI events were confirmed among recipients of HepB-alum vaccine for a rate of 1.86 per 1000 person-years (absolute rate difference, -0.19 [95% CI, -0.82 to 0.44]; adjusted HR, 0.92 [1-sided 97.5% CI, ∞ to 1.32], which was below the noninferiority margin; P < .001 for noninferiority).Conclusions and Relevance: In this cohort study, receipt of HepB-CpG vaccine compared with HepB-alum vaccine did not meet the statistical criterion for increased risk of acute myocardial infarction. [ABSTRACT FROM AUTHOR]

Background The mean systolic blood pressure (SBP) for US adults increases with age. Determining characteristics of US adults ≥65 years with normal blood pressure (BP) may inform approaches to prevent this increase. Methods We analyzed US National Health and Nutrition Examination Survey 2011–2018 data (n = 21,581). BP was measured up to 3 times and averaged. Normal BP was defined as SBP <120 mm Hg and diastolic BP (DBP) <80 mm Hg among participants not taking antihypertensive medication. Those with SBP ≥120 mm Hg, DBP ≥80 mm Hg, self-reporting having hypertension or taking antihypertensive medication were categorized as having elevated BP or hypertension. Results The prevalence of normal BP was 57.8%, 25.3%, 11.2%, and 5.0% among US adults who were 18–44, 45–64, 65–74, and ≥75 years, respectively. After multivariable adjustment, in US adults ≥65 years of age, normal BP vs. elevated BP/hypertension was more common among those with moderate and no vs. heavy alcohol consumption (prevalence ratio [PR] 3.03; 95% confidence interval [CI] 1.25–7.36 and 2.53; 95% CI 0.96–6.65, respectively), ≥150 vs. <150 minutes of physical activity per week (PR = 1.44; 95% CI 1.01–2.05), overweight and normal weight vs. obesity (PR = 1.88; 95% CI 1.22–2.90 and 2.94; 95% CI 1.89–4.59, respectively), and a high Dietary Approaches to Stop Hypertension score (PR = 1.43; 95% CI 1.00–2.05). US adults ≥65 years with normal BP vs. elevated BP/hypertension were less likely to have good or fair/poor vs. excellent/very good self-rated health, diabetes, albuminuria, atherosclerotic cardiovascular disease, and heart failure. Conclusions Among US adults ≥65 years, normal BP was associated with healthy lifestyle factors and a lower prevalence of adverse health conditions. [ABSTRACT FROM AUTHOR]

Background Not having a healthcare visit in the past year has been associated with a higher likelihood of uncontrolled blood pressure (BP) among individuals with hypertension. Methods We examined factors associated with not having a healthcare visit in the past year among US adults with hypertension using data from the US National Health and Nutrition Examination Survey 2013–2018 (n = 5,985). Hypertension was defined as systolic BP (SBP) ≥140 mm Hg, diastolic BP (DBP) ≥90 mm Hg, or antihypertensive medication use. Having a healthcare visit in the past year was self-reported. Results Overall, 7.0% of US adults with hypertension reported not having a healthcare visit in the past year. Those without vs. with a healthcare visit in the past year were less likely to be aware they had hypertension (45.0% vs. 83.9%), to be taking antihypertensive medication (36.7% vs. 91.4%, among those who were aware they had hypertension), and to have controlled BP (SBP/DBP <140/90 mm Hg; 9.1% vs. 51.7%). After multivariable adjustment, not having a healthcare visit in the past year was more common among US adults without health insurance (prevalence ratio [PR]: 2.22; 95% confidence interval [CI] 1.68–2.95), without a usual source of healthcare (PR: 5.65; 95% CI 4.16–7.67), who smoked cigarettes (PR: 1.34; 95% CI 1.02–1.77), and with heavy vs. no alcohol consumption (PR: 1.55; 95% CI 1.16–2.08). Also, not having a healthcare visit in the past year was more common among those without diabetes or a history of atherosclerotic cardiovascular disease, and those not taking a statin. Conclusions Interventions should be considered to ensure all adults with hypertension have annual healthcare visits. [ABSTRACT FROM AUTHOR]

Objective: There are few studies testing the amount of weight loss necessary to achieve initial remission of type 2 diabetes mellitus (T2DM) following bariatric surgery and no published studies with use of weight loss to predict initial T2DM remission in sleeve gastrectomy (SG) patients.Research Design and Methods: With Cox proportional hazards models we examined the relationship between initial T2DM remission and percent total weight loss (%TWL) after bariatric surgery. Categories of %TWL were included in the model as time-varying covariates.Results: Of patients (N = 5,928), 73% were female; mean age was 49.8 ± 10.3 years and BMI 43.8 ± 6.92 kg/m2, and 57% had Roux-en-Y gastric bypass (RYGB). Over an average follow-up of 5.9 years, 71% of patients experienced initial remission of T2DM (mean time to remission 1.0 year). With 0-5% TWL used as the reference group in Cox proportional hazards models, patients were more likely to remit with each 5% increase in TWL until 20% TWL (hazard ratio range 1.97-2.92). When categories >25% TWL were examined, all patients had a likelihood of initial remission similar to that of 20-25% TWL. Patients who achieved >20% TWL were more likely to achieve initial T2DM remission than patients with 0-5% TWL, even if they were using insulin at the time of surgery.Conclusions: Weight loss after bariatric surgery is strongly associated with initial T2DM remission; however, above a threshold of 20% TWL, rates of initial T2DM remission did not increase substantially. Achieving this threshold is also associated with initial remission even in patients who traditionally experience lower rates of remission, such as patients taking insulin. [ABSTRACT FROM AUTHOR]

Purpose: Our objective was to calculate the positive predictive value (PPV) of the ICD‐9 diagnosis code for angioedema when physicians adjudicate the events by electronic health record review. Our secondary objective was to evaluate the inter‐rater reliability of physician adjudication. Methods: Patients from the Cardiovascular Research Network previously diagnosed with heart failure who were started on angiotensin‐converting enzyme inhibitors (ACEI) during the study period (July 1, 2006 through September 30, 2015) were included. A team of two physicians per participating site adjudicated possible events using electronic health records for all patients coded for angioedema for a total of five sites. The PPV was calculated as the number of physician‐adjudicated cases divided by all cases with the diagnosis code of angioedema (ICD‐9‐CM code 995.1) meeting the inclusion criteria. The inter‐rater reliability of physician teams, or kappa statistic, was also calculated. Results: There were 38 061 adults with heart failure initiating ACEI in the study (21 489 patient‐years). Of 114 coded events that were adjudicated by physicians, 98 angioedema events were confirmed for a PPV of 86% (95% CI: 80%, 92%). The kappa statistic based on physician inter‐rater reliability was 0.65 (95% CI: 0.47, 0.82). Conclusions: ICD‐9 diagnosis code of 995.1 (angioneurotic edema, not elsewhere classified) is highly predictive of angioedema in adults with heart failure exposed to ACEI. [ABSTRACT FROM AUTHOR]

Objective: To examine short-term mortality and cause of death among youth and young adults (YYAs) with youth-onset diabetes.Research Design and Methods: We included 19,717 YYAs newly diagnosed with diabetes before 20 years of age from 1 January 2002 to 31 December 2015 enrolled in the SEARCH for Diabetes in Youth Study. Of these, 14,721 had type 1; 4,141 type 2; and 551 secondary and 304 other/unknown diabetes type. Cases were linked with the National Death Index through 31 December 2017. We calculated standardized mortality ratios (SMRs) and 95% CIs based on age, sex, and race/ethnicity for state and county population areas and examined underlying causes of death.Results: During 170,148 person-years (PY) (median follow-up 8.5 years), 283 individuals died: 133 with type 1 (103.0/100,000 PY), 55 with type 2 (161.5/100,000 PY), 87 with secondary (1,952/100,000 PY), and 8 with other/unknown diabetes type (312.3/100,000 PY). SMRs (95% CI) for the first three groups were 1.5 (1.2-1.8), 2.3 (1.7-3.0), and 28.0 (22.4-34.6), respectively. Diabetes was the underlying cause of death for 42.1%, 9.1%, and 4.6% of deaths, respectively. The SMR was greater for type 2 than for type 1 diabetes (P < 0.001). SMRs were significantly higher for individuals with type 1 diabetes who were <20 years of age, non-Hispanic White and Hispanic, and female and for individuals with type 2 diabetes who were <25 years of age, from all race/ethnic minority groups, and from both sexes.Conclusions: Excess mortality was observed among YYAs for each type of diabetes with differences in risk associated with diabetes type, age, race/ethnicity, and sex. The root causes of excess mortality among YYAs with diabetes merit further study. [ABSTRACT FROM AUTHOR]

Treatment options for patients with venous thromboembolism (VTE) include warfarin and direct oral anticoagulants (DOACs). Although DOACs are easier to administer than warfarin and do not require routine laboratory monitoring, few studies have directly assessed whether patients are more satisfied with DOACs. We surveyed adults from two large integrated health systems taking DOACs or warfarin for incident VTE occurring between January 1, 2015 and June 30, 2018. Treatment satisfaction was assessed using the validated Anti-Clot Treatment Scale (ACTS), divided into the ACTS Burdens and ACTS Benefits scores; higher scores indicate greater satisfaction. Mean treatment satisfaction was compared using multivariable linear regression, adjusting for patient demographic and clinical characteristics. The effect size of the difference in means was calculated using a Cohen's d (0.20 is considered a small effect and ≥ 0.80 is considered large). We surveyed 2217 patients, 969 taking DOACs and 1248 taking warfarin at the time of survey. Thirty-one point five percent of the cohort was aged ≥ 75 years and 43.1% were women. DOAC users were on average more satisfied with anticoagulant treatment, with higher adjusted mean ACTS Burdens (50.18 v. 48.01, p < 0.0001) and ACTS Benefits scores (10.21 v. 9.84, p = 0.046) for DOACs vs. warfarin, respectively. The magnitude of the difference was small (Cohen's d of 0.29 for ACTS Burdens and 0.12 for ACTS Benefits). Patients taking DOACs for venous thromboembolism were on average more satisfied with anticoagulant treatment than were warfarin users, although the magnitude of the difference was small. [ABSTRACT FROM AUTHOR]

Background: During the early phases of the COVID-19 pandemic pandemic, stay-at-home orders and fear of acquiring COVID-19 may have led to an avoidance of care for medical emergencies, including acute myocardial infarction (AMI). We evaluated whether a decline in rates of AMI occurred during the COVID-19 stay-at-home order. Methods: Rates of AMI per 100,000 member-weeks were calculated for Kaiser Permanente Southern California patients from January 1 to March 3, 2020 (prepandemic period) and from March 20 to July 31, 2020 (pandemic period), and during the same periods in 2019. Rate ratios (RRs) were calculated comparing the time periods using Poisson regression. Case fatality rates (CFRs) were also compared. Results: Rates of AMI were lower during the pandemic period of 2020 compared to the same period of 2019 [3.20 vs 3.76/100,000 member-weeks; RR, 0.85; 95% confidence interval (CI) 0.80-0.90]. There was no evidence that rates of AMI differed during the 2020 prepandemic period compared to the same period in 2019 (4.45 vs 4.24/100,000 member-weeks; RR, 0.95; 95% CI, 0.88-1.03). AMI rates were lower during the early pandemic period (March 20-May 7: RR, 0.70; 95% CI, 0.66-0.77), but not during the later pandemic period (May 8-July 31: RR, 0.95; 95% CI, 0.88-1.02) compared to 2019. In-hospital and 30-day case fatality rates were higher during the pandemic period of 2020 compared to 2019 (8.8% vs 6.1% and 6.5% vs 5.0%, respectively). Conclusion: AMI rates were lower during the COVID-19 pandemic compared to the same period in 2019. During stay-athome orders, public health campaigns that encourage people to seek care for medical emergencies are warranted. [ABSTRACT FROM AUTHOR]

Background: Limited existing data suggest that the novel COVID-19 may increase risk of VTE, but information from large, ethnically diverse populations with appropriate control participants is lacking.Research Question: Does the rate of VTE among adults hospitalized with COVID-19 differ from matched hospitalized control participants without COVID-19?Study Design and Methods: We conducted a retrospective study among hospitalized adults with laboratory-confirmed COVID-19 and hospitalized adults without evidence of COVID-19 matched for age, sex, race or ethnicity, acute illness severity, and month of hospitalization between February 2020 and August 2020 from two integrated health-care delivery systems with 36 hospitals. Outcomes included VTE (DVT or pulmonary embolism ascertained using diagnosis codes combined with validated natural language processing algorithms applied to electronic health records) and death resulting from any cause at 30 days. Fine and Gray hazards regression was performed to evaluate the association of COVID-19 with VTE after accounting for competing risk of death and residual differences between groups, as well as to identify predictors of VTE in patients with COVID-19.Results: We identified 6,319 adults with COVID-19 and 6,319 matched adults without COVID-19, with mean ± SD age of 60.0 ± 17.2 years, 46% women, 53.1% Hispanic, 14.6% Asian/Pacific Islander, and 10.3% Black. During 30-day follow-up, 313 validated cases of VTE (160 COVID-19, 153 control participants) and 1,172 deaths (817 in patients with COVID-19, 355 in control participants) occurred. Adults with COVID-19 showed a more than threefold adjusted risk of VTE (adjusted hazard ratio, 3.48; 95% CI, 2.03-5.98) compared with matched control participants. Predictors of VTE in patients with COVID-19 included age ≥ 55 years, Black race, prior VTE, diagnosed sepsis, prior moderate or severe liver disease, BMI ≥ 40 kg/m2, and platelet count > 217 k/μL.Interpretation: Among ethnically diverse hospitalized adults, COVID-19 infection increased the risk of VTE, and selected patient characteristics were associated with higher thromboembolic risk in the setting of COVID-19. [ABSTRACT FROM AUTHOR]

Purpose A pre‐licensure clinical trial of a two‐dose cytosine phosphoguanine adjuvanted hepatitis B vaccine (HEPLISAV‐B® [Dynavax, USA]; HepB‐CpG vaccine) found an unanticipated numerical imbalance in acute myocardial infarction (AMI) compared to recipients of a three‐dose aluminum adjuvanted hepatitis B vaccine (ENGERIX‐B® [GlaxoSmithKline, Belgium]; HepB‐alum vaccine). A post‐licensure study was required to compare AMI rates among recipients of HepB‐CpG vaccine and HepB‐alum vaccine. Individuals with diabetes mellitus (DM), who are at higher risk of AMI, comprise more than half of the post‐licensure study cohort. To inform the ongoing post‐licensure study, we examined the association between AMI and receipt of HepB‐alum vaccine in individuals with DM. Methods: We conducted a case–control study nested in a cohort of individuals with DM ages ≥40 years at Kaiser Permanente Southern California using electronic health records. AMI cases from 2012 to 2017 were identified by principal discharge diagnosis and matched 1:1 with randomly selected controls. The adjusted odds ratio (aOR) for receipt of ≥1 HepB‐alum vaccine dose was compared for AMI cases and controls using conditional logistic regression. We subsequently performed the same matched case–control analysis stratified by year. Results: Of 8138 matched case–control pairs, 17.4% of cases and 15.0% of controls received HepB‐alum vaccine. The aOR of HepB‐alum vaccination comparing cases and controls was 0.97 (95% confidence interval 0.87–1.08). Similarly, there was no significant association between HepB‐alum vaccine and AMI in any of the study years. Conclusions: HepB‐alum vaccination was not associated with AMI in individuals with DM. This finding will provide contextual insight for the ongoing post‐licensure study of HepB‐CpG vaccine. [ABSTRACT FROM AUTHOR]

Background: In recent years, decreases in mortality rates attributable to cardiovascular diseases have slowed but mortality attributable to heart failure (HF) has increased.Methods: Between 2001-2017, trends in age-adjusted mortality with HF as an underlying cause for Kaiser Permanente Southern California (KPSC) members were derived through linkage with state death files and compared with trends among California residents and the US. Average annual percent change (AAPC) and 95% confidence intervals (CI) were calculated using Joinpoint regression. Analyses were repeated examining HF as a contributing cause of death.Results: In KPSC, the age-adjusted HF mortality rates were comparable to California but lower than the US, increasing from 23.9 per 100,000 person-years (PY) in 2001 to 44.7 per 100,000 PY in 2017, representing an AAPC of 1.3% (95% CI 0.0%, 2.6%). HF mortality also increased in California from 33.9 to 46.5 per 100,000 PY (AAPC 1.5%, 95% CI 0.3%, 2.7%), while remaining unchanged in the US at 57.9 per 100,000 PY in 2001 and 2017 (AAPC 0.0%, 95% CI - 0.5%, 0.5%). Trends among KPSC members ≥ 65 years old were similar to the overall population, while trends among members 45-64 years old were flat between 2001-2017. Small changes in mortality with HF as a contributing cause were observed in KPSC members between 2001 and 2017, which differed from California and the US.Conclusion: Lower rates of HF mortality were observed in KPSC compared to the US. Given the aging of the US population and increasing prevalence of HF, it will be important to examine individual and care-related factors driving susceptibility to HF mortality. [ABSTRACT FROM AUTHOR]

Previous research suggests that stressors may trigger the onset of acute cardiovascular disease (CVD) events within hours to days, but there has been limited research around sociopolitical events such as presidential elections. Among adults ≥18 y of age in Kaiser Permanente Southern California, hospitalization rates for acute CVD were compared in the time period immediately prior to and following the 2016 presidential election date. Hospitalization for CVD was defined as an inpatient or emergency department discharge diagnosis of acute myocardial infarction (AMI) or stroke using International Classification of Diseases, 10th revision codes. Rate ratios (RR) and 95% confidence intervals (CIs) were calculated comparing CVD rates in the 2 d following the 2016 election to rates in the same 2 d of the prior week. In a secondary analysis, AMI and stroke were analyzed separately. The rate of CVD events in the 2 d after the 2016 presidential election (573.14 per 100,000 person-years [PY]) compared to the rate in the window prior to the 2016 election (353.75 per 100,000 PY) was 1.62 times higher (95% CI 1.17, 2.25). Results were similar across sex, age, and race/ethnicity groups. The RRs were similar for AMI (RR 1.67, 95% CI 1.00, 2.76) and stroke (RR 1.59, 95% CI 1.03, 2.44) separately. Transiently heightened cardiovascular risk around the 2016 election may be attributable to sociopolitical stress. Further research is needed to understand the intersection between major sociopolitical events, perceived stress, and acute CVD events. [ABSTRACT FROM AUTHOR]

Background: To examine the individual and combined associations of noncardiac-related conditions and mobility limitation with morbidity and mortality in adults with heart failure (HF).Methods: We conducted a retrospective cohort study in a large, diverse group of adults with HF from five U.S. integrated healthcare delivery systems. We characterized patients with respect to the presence of noncardiac conditions (<3 vs ≥3) and/or mobility impairment (defined by the use/nonuse of a wheelchair, cane, or walker), categorizing them into four subgroups. Outcomes included all-cause death and hospitalizations for HF or any cause.Results: Among 114,553 adults diagnosed with HF (mean age: 73 years old, 46% women), compared with <3 noncardiac conditions/no mobility limitation, adjusted hazard ratios (HR) for all-cause death among those with <3 noncardiac conditions/mobility limitation, ≥3 noncardiac conditions/no mobility limitation, ≥3 noncardiac conditions/mobility limitation (vs) were 1.40 (95% CI, 1.31-1.51), 1.72 (95% CI, 1.69-1.75), and 1.93 (95% CI, 1.85-2.01), respectively. We did not observe an increased risk of any-cause or HF-related hospitalization related to the presence of mobility limitation among those with a greater burden of noncardiac multimorbidity. Consistent findings regarding mortality were observed within groups defined according to age, gender, and HF type (preserved, reduced, mid-range ejection fraction), with the most prominent impact of mobility limitation in those <65 years of age.Conclusions: There is an additive association of mobility limitation, beyond the burden of noncardiac multimorbidity, on mortality for patients with HF, and especially prominent in younger patients. [ABSTRACT FROM AUTHOR]

Background: Coronary heart disease (CHD) is a leading cause of morbidity and mortality for breast cancer survivors, yet the joint effect of adverse cardiovascular health (CVH) and cardiotoxic cancer treatments on post-treatment CHD and death has not been quantified.Methods: We conducted statistical and machine learning approaches to evaluate 10-year risk of these outcomes among 1934 women diagnosed with breast cancer during 2006 and 2007. Overall CVH scores were classified as poor, intermediate, or ideal for 5 factors, smoking, body mass index, blood pressure, glucose/hemoglobin A1c, and cholesterol from clinical data within 5 years prior to the breast cancer diagnosis. The receipt of potentially cardiotoxic breast cancer treatments was indicated if the patient received anthracyclines or hormone therapies. We modeled the outcomes of post-cancer diagnosis CHD and death, respectively.Results: Results of these approaches indicated that the joint effect of poor CVH and receipt of cardiotoxic treatments on CHD (75.9%) and death (39.5%) was significantly higher than their independent effects [poor CVH (55.9%) and cardiotoxic treatments (43.6%) for CHD, and poor CVH (29.4%) and cardiotoxic treatments (35.8%) for death].Conclusions: Better CVH appears to be protective against the development of CHD even among women who had received potentially cardiotoxic treatments. This study determined the extent to which attainment of ideal CVH is important not only for CHD and mortality outcomes among women diagnosed with breast cancer. [ABSTRACT FROM AUTHOR]

Background: Older adults with chronic kidney disease (CKD)-discordant conditions (comorbid conditions with treatment recommendations that potentially complicate CKD management) have higher risk of hospitalization and death. Our goal is to develop a CKD-Discordance Index using electronic health records to improve recognition of discordance.Methods: This retrospective cohort study included Kaiser Permanente Southern California patients aged ≥65 years and older with incident CKD (N = 30,932). To guide inclusion of conditions in the Index and weight each condition, we first developed a prediction model for 1-year hospitalization risk using Cox regression. Points were assigned proportional to regression coefficients derived from the model. Next, the CKD-Discordance Index was calculated as an individual's total points divided by the maximum possible discordance points. The association between CKD-Discordance Index and hospitalizations, emergency department visits, and mortality was accessed using multivariable-adjusted Cox regression model.Results: Overall, mean (SD) age was 77.9 (7.6) years, 55% of participants were female, 59.3% were white, and 32% (n = 9,869) had ≥1 hospitalization during 1 year of follow-up. The CKD-Discordance Index included the following variables: heart failure, gastroesophageal reflux disease/peptic ulcer disease, osteoarthritis, dementia, depression, cancer, chronic obstructive pulmonary disease/asthma, and having four or more prescribers. Compared to those with a CKD-Discordance Index of 0, adjusted hazard ratios (95% confidence interval) for hospitalization were 1.39 (1.27-1.51) and 1.81 (1.64-2.01) for those with a CKD-Discordance Index of 0.001-0.24 and ≥0.25, respectively (ptrend < .001). A graded pattern of risk was seen for emergency department visits and all-cause mortality.Conclusion: A data-driven approach identified CKD-discordant indicators for a CKD-Discordance Index. Higher CKD-Discordance Index was associated with health care utilization and mortality. [ABSTRACT FROM AUTHOR]