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Sjögren's disease (SjD), a highly female predominant systemic autoimmune disease, peaks in perimenopause. Prior studies lack details on timing or type of sex hormone exposure. We examined SjD risk using endogenous and exogenous hormone exposure and related comorbidities.We performed a retrospective case-control study of adult women, nested within a population cohort. Cases had SjD diagnosed by a rheumatology provider or two SjD diagnoses from a non-rheumatology provider with a positive anti-SSA antibody or salivary gland biopsy. Cases were age-matched to three SjD-free controls. We calculated modified composite estrogen scores (mCES) and collected demographics, comorbidities, and endogenous and exogenous hormone exposures. Risk ratios were adjusted for demographics.Of 546 SjD cases and 1637 age-matched controls, mCES was not significantly associated with SjD in adjusted models. The top individual hormone exposures associated with SjD included estrogen replacement therapy (ERT; RR 1.78 [95% CI 1.47-2.14]), polycystic ovarian syndrome (1.65 [1.28-2.12]), and hysterectomy without bilateral oophorectomy (1.51 [1.13-2.03]). We identified comorbidities preceding SjD including fibromyalgia, pulmonary disease, diabetes, lymphoma, osteoporosis, peripheral vascular disease, and renal disease. Taking comorbidities into account, we developed a predictive model for SjD that included fibromyalgia (2.50 [1.93-3.25]), osteoporosis (1.84 [1.27-2.66]), hormone replacement therapy (HRT) (1.61 [1.22-2.12]), diabetes (0.27 [0.13-0.50]), and body mass index (BMI) (0.97 [0.95-0.99]).We report a novel algorithm to improve identifying patients at risk for SjD and describe sex hormone association with SjD. Finally, we report new comorbidities associated with SjD decrease, BMI and diabetes, and increase, lymphoma and osteoporosis.. Key Points •Given female predominance and typical perimenopausal onset, sex hormones should be considered when studying comorbidities in Sjögren's disease. •The top exposures associated with developing Sjögren's disease included fibromyalgia, osteoporosis, and use of hormone replacement therapy. Possible protective factors included prior diabetes and higher body mass index. •We used our newly identified exposures to generate a predictive algorithm, which has potential to improve diagnosis and pathogenic insights into Sjögren's disease.

ObjectiveTo explore trends in blood pressure (BP) control before and during the COVID-19 pandemic.Patients and methodsHealth systems participating in the National Patient-Centered Clinical Research Network (PCORnet) Blood Pressure Control Laboratory Surveillance System responded to data queries, producing 9 BP control metrics. Averages of the BP control metrics (weighted by numbers of observations in each health system) were calculated and compared between two 1-year measurement periods (January 1, 2019, through December 31, 2019, and January 1, 2020, through December 31, 2020).ResultsAmong 1,770,547 hypertensive persons in 2019, BP control to

Introduction Pneumonia is caused by microbes that establish an infectious process in the lungs. The gold standard for pneumonia diagnosis is radiologist-documented pneumonia-related features in radiology notes that are captured in electronic health records in an unstructured format. Objective The study objective was to develop a methodological approach for assessing validity of a pneumonia diagnosis based on identifying presence or absence of key radiographic features in radiology reports with subsequent rendering of diagnostic decisions into a structured format. Methods A pneumonia-specific natural language processing (NLP) pipeline was strategically developed applying Clinical Text Analysis and Knowledge Extraction System (cTAKES) to validate pneumonia diagnoses following development of a pneumonia feature–specific lexicon. Radiographic reports of study-eligible subjects identified by International Classification of Diseases (ICD) codes were parsed through the NLP pipeline. Classification rules were developed to assign each pneumonia episode into one of three categories: “positive,” “negative,” or “not classified: requires manual review” based on tagged concepts that support or refute diagnostic codes. Results A total of 91,998 pneumonia episodes diagnosed in 65,904 patients were retrieved retrospectively. Approximately 89% (81,707/91,998) of the total pneumonia episodes were documented by 225,893 chest X-ray reports. NLP classified and validated 33% (26,800/81,707) of pneumonia episodes classified as “Pneumonia-positive,” 19% as (15401/81,707) as “Pneumonia-negative,” and 48% (39,209/81,707) as “episode classification pending further manual review.” NLP pipeline performance metrics included accuracy (76.3%), sensitivity (88%), and specificity (75%). Conclusion The pneumonia-specific NLP pipeline exhibited good performance comparable to other pneumonia-specific NLP systems developed to date.

Objective The Greater Plains Collaborative (GPC) and other PCORnet Clinical Data Research Networks capture healthcare utilization within their health systems. Here, we describe a reusable environment (GPC Reusable Observable Unified Study Environment [GROUSE]) that integrates hospital and electronic health records (EHRs) data with state-wide Medicare and Medicaid claims and assess how claims and clinical data complement each other to identify obesity and related comorbidities in a patient sample. Materials and Methods EHR, billing, and tumor registry data from 7 healthcare systems were integrated with Center for Medicare (2011–2016) and Medicaid (2011–2012) services insurance claims to create deidentified databases in Informatics for Integrating Biology & the Bedside and PCORnet Common Data Model formats. We describe technical details of how this federally compliant, cloud-based data environment was built. As a use case, trends in obesity rates for different age groups are reported, along with the relative contribution of claims and EHR data-to-data completeness and detecting common comorbidities. Results GROUSE contained 73 billion observations from 24 million unique patients (12.9 million Medicare; 13.9 million Medicaid; 6.6 million GPC patients) with 1 674 134 patients crosswalked and 983 450 patients with body mass index (BMI) linked to claims. Diagnosis codes from EHR and claims sources underreport obesity by 2.56 times compared with body mass index measures. However, common comorbidities such as diabetes and sleep apnea diagnoses were more often available from claims diagnoses codes (1.6 and 1.4 times, respectively). Conclusion GROUSE provides a unified EHR-claims environment to address health system and federal privacy concerns, which enables investigators to generalize analyses across health systems integrated with multistate insurance claims.

Objective The aim of this study was to report the results of five weight-loss interventions in primary care settings in underserved patients and to compare the level of pragmatism across the interventions using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) tool. Methods Data from 54 primary care clinics (2,210 patients) were pooled from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) and Rural Engagement in Primary Care for Optimizing Weight Reduction (REPOWER) cluster-randomized trials. Clinics were randomized to one of five comparators: PROPEL usual care, PROPEL combination of in-clinic and telephone visits, REPOWER in-clinic individual visits, REPOWER in-clinic group visits, or REPOWER telephone group visits. Results At 24 months, weight loss (kilograms) was -0.50 (95% CI: -1.77 to 0.76), -3.05 (-4.10 to -2.01), -4.30 (-5.35 to -3.26), -4.79 (-5.83 to -3.75), and -4.80 (-5.96 to -3.64) in the PROPEL usual care, REPOWER in-clinic individual visits, REPOWER telephone group visits, REPOWER in-clinic group visits, and PROPEL in-clinic and telephone visits arms, respectively. At 24 months, percentage of weight loss was -0.360 (-1.60 to 0.88), -3.00 (-4.02 to -1.98), -4.23 (-5.25 to -3.20), -4.67 (-5.69 to -3.65), and -4.69 (-5.82 to -3.56), respectively, in the five arms. The REPOWER in-clinic individual visits intervention was the most pragmatic and reflects the current Centers for Medicare and Medicaid Services funding model, although this intervention produced the least weight loss. Conclusions Clinically significant weight loss over 6 months in primary care settings is achievable using a variety of lifestyle-based treatment approaches. Longer-term weight-loss maintenance is more difficult to achieve.

Ursodeoxycholic acid (UDCA) remains the first-line therapy for primary biliary cholangitis (PBC); however, inadequate treatment response (ITR) is common. The UK-PBC Consortium developed the modified UDCA Response Score (m-URS) to predict ITR (using alkaline phosphatase [ALP] > 1.67 times the upper limit of normal [*ULN]) at 12 months post-UDCA initiation). Using data from the US-based Fibrotic Liver Disease Consortium, we assessed the m-URS in our multi-racial cohort. We then used a dynamic modeling approach to improve prediction accuracy. Using data collected at the time of UDCA initiation, we assessed the m-URS using the original formula; then, by calibrating coefficients to our data, we also assessed whether it remained accurate when using Paris II criteria for ITR. Next, we developed and validated a dynamic risk prediction model that included post-UDCA initiation laboratory data. Among 1578 patients (13% men; 8% African American, 9% Asian American/American Indian/Pacific Islander; 25% Hispanic), the rate of ITR was 27% using ALP > 1.67*ULN and 45% using Paris II criteria. M-URS accuracy was “very good” (AUROC = 0.87, sensitivity = 0.62, and specificity = 0.82) for ALP > 1.67*ULN and “moderate” (AUROC = 0.74, sensitivity = 0.57, and specificity = 0.70) for Paris II. Our dynamic model significantly improved accuracy for both definitions of ITR (ALP > 1.67*ULN: AUROC = 0.91; Paris II: AUROC = 0.81); specificity approached 100%. Roughly 9% of patients in our cohort were at the highest risk of ITR. Early identification of patients who will not respond to UDCA treatment using a dynamic prediction model based on longitudinal, repeated risk factor measurements may facilitate earlier introduction of adjuvant treatment.

Background Overweight and obesity are common features of the rare disease Bardet–Biedl syndrome (BBS). Sleep and physical activity are behaviors that might impact overweight and obesity and thus may play a key role in the health and well-being of people with BBS. Objectively-measured sleep and physical activity patterns in people with BBS are not well known. We evaluated objectively-measured sleep and physical activity patterns in the largest cohort to date of people with BBS. Results Short sleep duration, assessed using wrist-worn accelerometers, was common in both children and adults with BBS. Only 7 (10%) of adults and 6 (8%) of children met age-specific sleep duration recommendations. Most adults 64 (90%) achieved recommended sleep efficiency. The majority of children 26 (67%) age 6–12 years achieved recommended sleep efficiency, but among children age 13–18, only 18 (47%). In both adults and children, sleep duration was significantly negatively correlated with duration of prolonged sedentary time. In children age 6–12 sleep duration was also significantly related to total activity score, children with lower sleep duration had lower total activity scores. Conclusions Insufficient sleep duration is very common in people with BBS. Prolonged sedentary time and short sleep duration are both potentially important health-related behaviors to target for intervention in people with BBS.

This study examines participation by residents of a rural community in programs implemented as part of The Heart of New Ulm (HONU) Project, a population-based cardiovascular disease (CVD) prevention initiative. The study compares participation rates for the various interventions to assess which were the most engaging in the priority community and identifies factors that differentiate participants vs. nonparticipants. Participation data were merged with electronic health record (EHR) data representing the larger community population to enable an analysis of participation in the context of the entire community. HONU individual-level interventions engaged 44% of adult residents in the community. Participation ranked as follows: (1) heart health screenings (37% of adult residents), (2) a year-long community weight loss intervention (12% of adult residents), (3) community health challenges (10% of adult residents), and (4) a phone coaching program for invited high CVD-risk residents (enrolled 6% of adult residents). Interventions that yielded the highest engagement were those that had significant staffing and recruited participants over several months, often with many opportunities to participate or register. Compared to nonparticipants, HONU participants were significantly older and a higher proportion were female, married, overweight or obese, and had high cholesterol. Participants also had a lower prevalence of smoking and diabetes than nonparticipants. Findings indicate community-based CVD prevention initiatives can be successful in engaging a high proportion of adult community members. Partnering with local health care systems can allow for use of EHR data to identify eligible participants and evaluate reach and engagement of the priority population.

Background The International Classification of Disease (ICD) coding for pneumonia classification is based on causal organism or use of general pneumonia codes, creating challenges for epidemiological evaluations where pneumonia is standardly subtyped by settings, exposures, and time of emergence. Pneumonia subtype classification requires data available in electronic health records (EHRs), frequently in nonstructured formats including radiological interpretation or clinical notes that complicate electronic classification. Objective The current study undertook development of a rule-based pneumonia subtyping algorithm for stratifying pneumonia by the setting in which it emerged using information documented in the EHR. Methods Pneumonia subtype classification was developed by interrogating patient information within the EHR of a large private Health System. ICD coding was mined in the EHR applying requirements for “rule of two” pneumonia-related codes or one ICD code and radiologically confirmed pneumonia validated by natural language processing and/or documented antibiotic prescriptions. A rule-based algorithm flow chart was created to support subclassification based on features including symptomatic patient point of entry into the health care system timing of pneumonia emergence and identification of clinical, laboratory, or medication orders that informed definition of the pneumonia subclassification algorithm. Results Data from 65,904 study-eligible patients with 91,998 episodes of pneumonia diagnoses documented by 380,509 encounters were analyzed, while 8,611 episodes were excluded following Natural Language Processing classification of pneumonia status as “negative” or “unknown.” Subtyping of 83,387 episodes identified: community-acquired (54.5%), hospital-acquired (20%), aspiration-related (10.7%), health care–acquired (5%), and ventilator-associated (0.4%) cases, and 9.4% cases were not classifiable by the algorithm. Conclusion Study outcome indicated capacity to achieve electronic pneumonia subtype classification based on interrogation of big data available in the EHR. Examination of portability of the algorithm to achieve rule-based pneumonia classification in other health systems remains to be explored.

Author(s): Lu, Mei; Bowlus, Christopher L; Lindor, Keith; Rodriguez-Watson, Carla V; Romanelli, Robert J; Haller, Irina V; Anderson, Heather; VanWormer, Jeffrey J; Boscarino, Joseph A; Schmidt, Mark A; Daida, Yihe G; Sahota, Amandeep; Vincent, Jennifer; Li, Jia; Trudeau, Sheri; Rupp, Loralee B; Gordon, Stuart C; FOLD Investigators | Abstract: BackgroundBiopsy remains the gold standard for determining fibrosis stage in patients with primary biliary cholangitis (PBC), but it is unavailable for most patients. We used data from the 11 US health systems in the FibrOtic Liver Disease Consortium to explore a combination of biochemical markers and electronic health record (EHR)-based diagnosis/procedure codes (DPCs) to identify the presence of cirrhosis in PBC patients.MethodsHistological fibrosis staging data were obtained from liver biopsies. Variables considered for the model included demographics (age, gender, race, ethnicity), total bilirubin, alkaline phosphatase, albumin, aspartate aminotransferase (AST) to platelet ratio index (APRI), Fibrosis 4 (FIB4) index, AST to alanine aminotransferase (ALT) ratio, and g100 DPCs associated with cirrhosis/decompensated cirrhosis, categorized into ten clusters. Using least absolute shrinkage and selection operator regression (LASSO), we derived and validated cutoffs for identifying cirrhosis.ResultsAmong 4328 PBC patients, 1350 (32%) had biopsy data; 121 (9%) were staged F4 (cirrhosis). DPC clusters (including codes related to cirrhosis and hepatocellular carcinoma diagnoses/procedures), Hispanic ethnicity, ALP, AST/ALT ratio, and total bilirubin were retained in the final model (AUROC=0.86 and 0.83 on learning and testing data, respectively); this model with two cutoffs divided patients into three categories (no cirrhosis, indeterminate, and cirrhosis) with specificities of 81.8% (for no cirrhosis) and 80.3% (for cirrhosis). A model excluding DPCs retained ALP, AST/ALT ratio, total bilirubin, Hispanic ethnicity, and gender (AUROC=0.81 and 0.78 on learning and testing data, respectively).ConclusionAn algorithm using laboratory results and DPCs can categorize a majority of PBC patients as cirrhotic or noncirrhotic with high accuracy (with a small remaining group of patients' cirrhosis status indeterminate). In the absence of biopsy data, this EHR-based model can be used to identify cirrhosis in cohorts of PBC patients for research and/or clinical follow-up.

Background: African ancestry is associated with a higher prevalence and greater severity of asthma than European ancestries, yet genetic studies of the most common locus associated with childhood-onset asthma, 17q12–21, in African Americans have been inconclusive. The aim of this study was to leverage both the phenotyping of the Children's Respiratory and Environmental Workgroup (CREW) birth cohort consortium, and the reduced linkage disequilibrium in African Americans, to fine map the 17q12–21 locus. Methods: We first did a genetic association study and meta-analysis using 17q12–21 tag single-nucleotide polymorphisms (SNPs) for childhood-onset asthma in 1613 European American and 870 African American children from the CREW consortium. Nine tag SNPs were selected based on linkage disequilibrium patterns at 17q12–21 and their association with asthma, considering the effect allele under an additive model (0, 1, or 2 effect alleles). Results were meta-analysed with publicly available summary data from the EVE consortium (on 4303 European American and 3034 African American individuals) for seven of the nine SNPs of interest. Subsequently, we tested for expression quantitative trait loci (eQTLs) among the SNPs associated with childhood-onset asthma and the expression of 17q12–21 genes in resting peripheral blood mononuclear cells (PBMCs) from 85 African American CREW children and in upper airway epithelial cells from 246 African American CREW children; and in lower airway epithelial cells from 44 European American and 72 African American adults from a case-control study of asthma genetic risk in Chicago (IL, USA). Findings: 17q12–21 SNPs were broadly associated with asthma in European Americans. Only two SNPs (rs2305480 in gasdermin-B [GSDMB] and rs8076131 in ORMDL sphingolipid biosynthesis regulator 3 [ORMDL3]) were associated with asthma in African Americans, at a Bonferroni-corrected threshold of p

Clinical guidelines recommend statins for patients with atherosclerotic cardiovascular disease (ASCVD), but many remain untreated. The goal of this study was to assess the impact of statin use on recurrent major adverse cardiovascular events (MACE). This study used medical records and insurance claims from 4 health care systems in the United States. Eligible adults who survived an ASCVD hospitalization from September 2013 to September 2014 were followed for 1 year. A multivariable extended Cox model examined the outcome of time-to-first MACE, then a multivariable joint marginal model investigated the association between post-index statin use and nonfatal and fatal MACE. There were 8,168 subjects in this study; 3,866 filled a statin prescription ≤90 days before the index ASCVD event (47.33%) and 4,152 filled a statin prescription after the index ASCVD event (50.83%). These post-index statin users were younger, with more co-morbidities. There were 763 events (315/763, 41.3% terminal) experienced by 686 (8.4%) patients. The adjusted overall MACE risk reduction was 18% (HR 0.82, 95% CI 0.70 to 0.95, p = 0.007) and was more substantial in the first 180 days (HR 0.72, 95% CI 0.60 to 0.86, p0.001). There was a nonsignificant 19% reduction in the number of nonfatal MACE (rate ratio 0.81, 95% CI 0.49 to 1.32, p = 0.394) and a 65% reduction in the risk of all-cause death (HR 0.35, 95% CI 0.22 to 0.56, p0.001). In conclusion, we found a modest increase in statin use after an ASCVD event, with nearly half of the patients untreated. The primary benefit of statin use was protection against early death. Statin use had the greatest impact in the first 6 months after an ASCVD event; therefore, it is crucial for patients to quickly adhere to this therapy.

In this secondary analysis of the Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER) randomized trial, the authors determined the effectiveness of weight-loss interventions in people with diabetes compared with those without diabetes living in rural areas.The RE-POWER study was a randomized trial designed to determine the effectiveness of nonpharmacological behavioral weight-loss interventions in rural participants with obesity, comparing the individual in-clinic visit model to in-person group sessions and phone group sessions over 24 months. In this secondary analysis, weight loss was compared in participants with and without diabetes. The effects of factors such as medications, insulin, and behavioral factors were compared.Participants with diabetes were less likely to lose weight during the study compared with those without diabetes up to 18 months (4.12% vs. 5.31%; net difference = 1.46%; 95% CI: 0.63%-2.28%). Participants with diabetes on insulin lost less weight than patients with diabetes not on insulin at 6 months (4.52% vs. 6.88%; net difference = 2.35%; 95% CI: 0.55%-4.16%). The group with diabetes had significantly lower changes in blood pressure and lipid parameters versus the group without diabetes.Patients with diabetes in rural areas were less likely to lose weight, and metabolic parameters were less responsive to weight loss, compared with patients without diabetes.

Lifestyle significantly influences development of cardiovascular disease (CVD), but limited data exists demonstrating lifestyle improvements in community-based interventions. This study aims to document how lifestyle risk factors changed at the population level in the context of Heart of New Ulm (HONU), a community-based CVD prevention initiative in Minnesota.HONU intervened across worksites, healthcare and the community/environment to reduce CVD risk factors. HONU collected behavioral measures including smoking, physical activity, fruit/vegetable consumption, alcohol use and stress at heart health screenings from 2009 to 2014. All screenings were documented in the electronic health record (EHR). Changes at the community level for the target population (age 40–79) were estimated using weights created from EHR data and modeled using generalized estimating equation models.Screening participants were similar to the larger patient population with regard to age, race, and marital status, but were slightly healthier in regards to BMI, LDL cholesterol, blood pressure, and less likely to smoke. Community-level improvements were significant for physical activity (62.8% to 70.5%, p

BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Cardiovascular disease (CVD) is a major public health concern in the United States. In response to the federally sponsored Million Hearts Risk Check Challenge, a team of programmers, software developers, health-information technologists, and clinicians in an integrated healthcare system in Wisconsin collaborated to develop Heart Health MobileTM (HHM), designed to improve awareness of cardiovascular disease risk and promote risk factor control among users. This paper outlines the development processes and highlights key lessons learned for mobile health applications. An agile project management methodology was used to dedicate adequate resources and employ adaptive planning and iterative development processes with a self-organized, cross-functional team. The initial HHM iOS app was developed and tested, and after additional modifications, gamified and HTML 5 versions of the app were released. The development of an iOS app is low in cost and sustainable by a healthcare system. Future app modifications to enhance data security and link self-reported cardiovascular risk assessment data to patient medical records may improve performance, patient relevance, and clinician acceptance of HHM in the primary-care setting. Legal and institutional barriers regarding the capture and analyses of protected health information must be mitigated to fully capture, analyze, and report patient health outcomes for future studies.

Background Cardiovascular disease (CVD) and its associated risk factors are the principal drivers of mortality and healthcare costs in the United States with rural residents experiencing higher CVD death rates than their urban counterparts. Methods The purpose of this study was to examine incidence of major CVD events over 9 years of implementation of the Heart of New Ulm (HONU) Project, a rural population-based CVD prevention initiative. HONU interventions were delivered at individual, organizational, and community levels addressing clinical risk factors, lifestyle behaviors and environmental changes. The sample included 4,056 residents of New Ulm matched with 4,056 residents from a different community served by the same health system. The primary outcome was a composite of major CVD events (myocardial infarction, ischemic stroke, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and CVD-related death). Secondary outcomes were the individual CVD events and procedures. Results The proportion of residents in New Ulm with a major CVD event (7.79%) was not significantly different than the comparison community (8.43%, p =0.290). However, the total number of events did differ by community with fewer events in New Ulm than the comparison community (447 vs 530, p = 0.005), with 48 fewer strokes (84 vs 132, p = 0.001) and 42 fewer PCI procedures (147 vs 189, p=0.019) in New Ulm. Incidence of ischemic stroke was lower in the New Ulm community (1.85 vs 2.61, p=0.020) than in the comparison community. Other specific CVD events did not have significantly different incidence or frequencies between the two communities. Conclusions In HONU, the proportion of residents experiencing a CVD event was not significantly lower than a match comparison community. However, there was a significant reduction in the total number of CVD events in New Ulm, driven primarily by lower stroke, PCI, and CABG events in the intervention community.

Aspirin has demonstrated a clear benefit in secondary prevention of coronary syndrome, while aspirin's effect in primary prevention is unclear. This report will explore the role of aspirin as primary prevention for various vascular events. It strives to provide a clear guide for clinicians on whether or not to prescribe aspirin for their patients for primary prevention. Current guidelines and recent trials failed to show clear benefit against primary prevention, with risks outweighing benefits in moderate to high risk patients. A thoughtful discussion between patients and their doctors should be conducted before beginning aspirin use. More studies are needed to gain a better understanding of aspirin use in primary prevention.

Summary Background Bardet‐Biedl syndrome (BBS) is a rare genetic disorder that severely inhibits primary cilia function. BBS is typified by obesity in adulthood, but pediatric weight patterns, and thus optimal periods of intervention, are poorly understood. Objectives To examine body mass differences by age, gender, and genotype in children and adolescents with BBS. Methods We utilized the largest international registry of BBS phenotypes. Anthropometric and genetic data were obtained from medical records or participant/family interviews. Participants were stratified by age and sex categories. Genotype and obesity phenotype were investigated in a subset of participants with available data. Results Height and weight measurements were available for 552 unique individuals with BBS. The majority of birth weights were in the normal range, but rates of overweight or obesity rapidly increased in early childhood, exceeding 90% after age 5. Weight z‐scores in groups >2 years were above 2.0, while height z‐scores approached 1.0, but were close to 0.0 in adolescents. Relative to those with the BBS10 genotype, the BBS1 cohort had a lower BMI z‐score in the 2‐5 and 6‐11 age groups, with similar BMI z‐scores thereafter. Children with biallelic loss of function (LOF) genetic variants had significantly higher BMI z‐scores compared to missense variants. Conclusion Despite normal birth weight, most individuals with BBS experience rapid weight gain in early childhood, with high rates of overweight/obesity sustained through adolescence. Children with LOF variants are disproportionally affected. Our findings support the need for earlier recognition and initiation of weight management therapies in BBS.

Prior studies of early antibiotic use and growth have shown mixed results, primarily on cross-sectional outcomes. This study examined the effect of oral antibiotics before age 24 months on growth trajectory at age 2-5 years.We captured oral antibiotic prescriptions and anthropometrics from electronic health records through PCORnet, for children with ≥1 height and weight at 0-12 months of age, ≥1 at 12-30 months, and ≥2 between 25 and 72 months. Prescriptions were grouped into episodes by time and by antimicrobial spectrum. Longitudinal rate regression was used to assess differences in growth rate from 25 to 72 months of age. Models were adjusted for sex, race/ethnicity, steroid use, diagnosed asthma, complex chronic conditions, and infections.430,376 children from 29 health U.S. systems were included, with 58% receiving antibiotics before 24 months. Exposure to any antibiotic was associated with an average 0.7% (95% CI 0.5, 0.9, p 0.0001) greater rate of weight gain, corresponding to 0.05 kg additional weight. The estimated effect was slightly greater for narrow-spectrum (0.8% [0.6, 1.1]) than broad-spectrum (0.6% [0.3, 0.8], p 0.0001) drugs. There was a small dose response relationship between the number of antibiotic episodes and weight gain.Oral antibiotic use prior to 24 months of age was associated with very small changes in average growth rate at ages 2-5 years. The small effect size is unlikely to affect individual prescribing decisions, though it may reflect a biologic effect that can combine with others.

Background We used data from the Fibrotic Liver Disease Consortium to evaluate the impact of ursodeoxycholic acid (UDCA) treatment across race/ethnicity, gender, and clinical status among patients with primary biliary cholangitis. Methods Data were collected from "index date" (baseline) through December 31, 2016. Inverse Probability of Treatment Weighting was used to adjust for UDCA treatment selection bias. Cox regression, focusing on UDCA-by-risk factor interactions, was used to assess the association between treatment and mortality and liver transplant/death. Results Among 4,238 patients with primary biliary cholangitis (13% men; 8% African American, 7% Asian American/American Indian/Pacific Island [ASINPI]; 21% Hispanic), 78% had ever received UDCA. The final multivariable model for mortality retained age, household income, comorbidity score, total bilirubin, albumin, alkaline phosphatase, and interactions of UDCA with race, gender, and aspartate aminotransferase/alanine aminotransferase ≥1.1. Among untreated patients, African Americans and ASINPIs had higher mortality than whites (adjusted hazard ratio [aHR] = 1.34, 95% confidence interval [CI] 1.08-1.67 and aHR = 1.40, 95% CI 1.11-1.76, respectively). Among treated patients, this relationship was reversed (aHR = 0.67, 95% CI 0.51-0.86 and aHR = 0.88, 95% CI 0.67-1.16). Patterns were similar for liver transplant/death. UDCA reduced the risk of liver transplant/death in all patient groups and mortality across all groups except white women with aspartate aminotransferase/alanine aminotransferase ≥1.1. As compared to patients with low-normal bilirubin at baseline (≤0.4 mg/dL), those with high-normal (1.0 > 0.7) and mid-normal bilirubin (0.7 > 0.4) had significantly higher liver transplant/death and all-cause mortality. Discussion African American and ASINPI patients who did not receive UDCA had significantly higher mortality than white patients. Among African Americans, treatment was associated with significantly lower mortality. Regardless of UDCA treatment, higher baseline bilirubin, even within the normal range, was associated with increased mortality and liver transplant/death compared with low-normal levels.

Practices that actively encourage employees to stay home when ill are crucial to reduce transmission in workplaces., We assessed determinants of work attendance during the first 3 days after onset of acute respiratory illness (ARI) among workers 19–64 years of age who had medically attended ARI or influenza during the 2017–2018 influenza season. The total number of days worked included days worked at the usual workplace and days teleworked. Access to paid leave was associated with fewer days worked overall and at the usual workplace during illness. Participants who indicated that employees were discouraged from coming to work with influenza-like symptoms were less likely to attend their usual workplace. Compared with workers without a telework option, those with telework access worked more days during illness overall, but there was no difference in days worked at the usual workplace. Both paid leave benefits and business practices that actively encourage employees to stay home while sick are necessary to reduce the transmission of ARI and influenza in workplaces.

PURPOSE Low oral health literacy (OHL) is an emerging risk factor for several oral health outcomes, but there are very few studies of OHL overall and no studies of OHL in the rural United States. The purpose of this study was to examine the association between OHL and sociodemographic factors, as well as several oral health outcomes, in rural adults served by an integrated medical and dental care system in Wisconsin. METHODS A cross-sectional survey was administered to a stratified random sample of patients from 2 rural communities. Survey data were linked to local electronic health records. Multivariable regression was used to identify sociodemographic determinants of low OHL, as well as associations between OHL and: oral hygiene, oral health quality of life, dentist visits, and emergency/urgent care visits for nontraumatic dental conditions. FINDINGS Among the 164 respondents, OHL scores were generally high but were significantly lower among nonwhite participants (P < .001), as well as those without a college degree (P < .001) and those with an annual household income under $40,000 (P = .029). Lower OHL scores were significantly associated with lower quality of life scores (P = .005), fewer visits to the dentist (P = .007), and more emergency room visits for nontraumatic dental conditions (P = .021). CONCLUSION In rural Wisconsin, low OHL tracked closely with markers of socioeconomic status and appeared most influential in the context of appropriate dental care utilization. Future research should consider longitudinal explorations of how OHL influences preventive and emergency dental visits over time.

Few studies have assessed adolescent human papillomavirus (HPV) vaccine attitudes and whether they are associated with vaccination uptake. This study characterized HPV vaccine attitudes among male and female adolescents, identified factors associated with attitude changes, and examined associations between attitudes and vaccination receipt. Surveys were administered to adolescents aged 15–16 years who had not completed the HPV vaccine series. A modified version of the Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) was employed to assess barriers, harms, ineffectiveness, and uncertainties scores. Surveys were available from 108 participants; 63% were male and 33% had initiated the HPV vaccine series at baseline. CHIAS scores significantly decreased (i.e., became more favorable) between baseline and follow-up for barriers (p = 0.01) and uncertainties (p, Highlights • Adolescent HPV vaccine attitudes were generally favorable and improved over time. • Some sociodemographic or clinical factors were associated with changes in attitudes. • Greater baseline harms concerns were associated with lower odds of vaccine receipt. • Changes in HPV vaccine attitudes did not predict vaccine receipt.

The Heart of New Ulm Project (HONU), is a population-based project designed to reduce modifiable cardiovascular disease (CVD) risk factors in the rural community of New Ulm, MN. HONU interventions address multiple levels of the social-ecological model. The community is served by one health system, enabling the use of electronic health record (EHR) data for surveillance. The purpose of this study was to assess if trends in CVD risk factors and healthcare utilization differed between a cohort of New Ulm residents age 40-79 and matched controls selected from a similar community, using EHR data from baseline (2008-2009) through three follow up time periods (2010-2011, 2012-2013, 2014-2015). Matching, using covariate balance sparse technique, yielded a sample of 4077 New Ulm residents and 4077 controls. We used mixed effects longitudinal models to examine trends over time between the two groups. Blood pressure, total cholesterol, low-density lipoprotein-cholesterol, and triglycerides showed better management in New Ulm over time compared to the controls. The proportion of residents in New Ulm with controlled blood pressure increased by 6.2 percentage points compared to an increase of 2 points in controls (p 0.0001). As the cohort aged, 10-year ASCVD risk scores increased less in New Ulm (5.1) than the comparison community (5.9). The intervention and control community did not differ with regard to inpatient stays, smoking, or glucose. Findings suggest efficacy for the HONU project interventions for some outcomes.

OBJECTIVES: The National Patient-Centered Clinical Research Network (PCORnet) supports observational and clinical research using healthcare data. The PCORnet Antibiotics and Childhood Growth Study is one of PCORnet’s inaugural observational studies. The objectives of this manuscript are to describe (1) the processes used to integrate and analyze data from children across 36 participating institutions and (2) the cohort characteristics and prevalence of antibiotic use. METHODS: We included children in the cohort if they had at least one same-day height and weight measured in each of three age periods: 1) before 12 months, 2) 12 to 30 months, and 3) after 24 months. We distributed statistical queries that each institution ran on its local version of the PCORnet Common Data Model, with aggregate data returned for analysis. We defined overweight or obesity as age-sex-specific body mass index ≥ 85(th), obesity ≥95(th) percentile, and severe obesity ≥120% of the 95(th) percentile. RESULTS: 681,739 children met the cohort inclusion criteria and were racially/ethnically diverse (24.9% black, 17.5% Hispanic). Before 24 months, 55.2% of children received at least one antibiotic prescription; 21.3% received a single antibiotic prescription, 14.3% received four or more, and 33.3% received a broad spectrum antibiotic. Overweight and obesity prevalence was 27.6% at 4 to

BACKGROUND Summer weight gain in children has been reported; however, this is usually based on two time points. Our objective was to investigate monthly variation in weight status. METHODS Cross-sectional, de-identified health records including height, weight and demographics, collected between 2007 and 2012 from South Central Wisconsin in 70 531 children age 5-16 years were analysed. The monthly averages in body mass index (BMI) z-score were analysed cross-sectionally followed by a paired analysis for a subset with one visit each during school and summer months. RESULTS BMI z-scores during the summer months (June-August) were lower than values during the school year (September-May). Of note, there was a rapid decrease in BMI z-scores from May to June, with June BMI z-score values being 0.065 units less (95% CI 0.046-0.085) than those in May, little change from June to August and a rapid increase between the August and September BMI z-scores. CONCLUSION The monthly pattern does not fully agree with previous two-point school-based studies. Results raise concern that the use of two time point measures of BMIs (early fall and late spring) is suboptimal for evaluation of circannual variation. We suggest that future evaluation of the effect of school-based or summer interventions utilizes additional measures in those periods so that a seasonal analysis can be performed.

Objective Excess body weight negatively impacts health, but there are few evaluations of low-intensity weight management challenge programs in defined populations. This study examined weight change in adults who participated in the LOSE IT to WIN IT (LIWI) health challenge in a US community. The community-level impact on body mass index was also explored. Methods Body weight was analysed over 1 year in the cohort of LIWI enrolees, stratified by participants who were healthy weight or overweight/obese at baseline. Secondarily, a multiple cross-sectional analysis compared the 2.5-year trends in body mass index between community adults who did vs. did not participate in LIWI. Results LOSE IT to WIN IT participants who were overweight/obese lost a mean (95% confidence interval) 1.6 (1.2, 2.0) kg (~2%) over 1 year (p