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Pragmatic trials are increasingly used to study the implementation of weight loss interventions in real-world settings. This study compared researcher-measured body weights versus electronic medical record (EMR)-derived body weights from a pragmatic trial conducted in an underserved patient population.The PROPEL trial randomly allocated 18 clinics to usual care (UC) or to an intensive lifestyle intervention (ILI) designed to promote weight loss. Weight was measured by trained technicians at baseline and at 6, 12, 18, and 24 months. A total of 11 clinics (6 UC/5 ILI) with 577 enrolled patients also provided EMR data (n = 561), which included available body weights over the period of the trial.The total number of assessments were 2638 and 2048 for the researcher-measured and EMR-derived body weight values, respectively. The correlation between researcher-measured and EMR-derived body weights was 0.988 (n = 1 939; p 0.0001). The mean difference between the EMR and researcher weights (EMR-researcher) was 0.63 (2.65 SD) kg, and a Bland-Altman graph showed good agreement between the two data collection methods; the upper and lower boundaries of the 95% limits of agreement are -4.65 kg and +5.91 kg, and 71 (3.7%) of the values were outside the limits of agreement. However, at 6 months, percent weight loss in the ILI compared to the UC group was 7.3% using researcher-measured data versus 5.5% using EMR-derived data. At 24 months, the weight loss maintenance was 4.6% using the technician-measured data versus 3.5% using EMR-derived data.At the group level, body weight data derived from researcher assessments and an EMR showed good agreement; however, the weight loss difference between ILI and UC was blunted when using EMR data. This suggests that weight loss studies that rely on EMR data may require larger sample sizes to detect significant effects.ClinicalTrials.gov number NCT02561221.

Pneumococcal antibody deficiency has been the subject of limited study in chronic rhinosinusitis (CRS) and has not been studied in recurrent acute rhinosinusitis (RARS). The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is considered for patients with nonprotective Streptococcus pneumoniae titers. We hypothesized that both RARS and CRS patients with deficient S pneumoniae titers and subsequent PPSV23 vaccination would have reduced health-care encounters for sinusitis and fewer prescriptions for antibiotics or steroids.A retrospective cohort study was performed of patient encounters between January 2011 and December 2019. All patients included were ≥18 and ≤65 years old with a diagnosis of CRS or RARS and pneumococcal titer data. Patients with immunodeficiency and comorbid conditions requiring PPSV23 vaccination before 65 years of age were excluded.A total of 938 patients were included in the study. Nonprotective antibody titers were present in 75.8% of CRS and 74.8% of RARS patients. A total of 306 patients with deficient antibody titers received the PPSV23 vaccine. Eighty-nine percent of CRS and 90.1% of RARS patients had protective responses. Among the 217 patients with continuous data from 2 years before through 2 years after PPSV23 vaccination, a decrease in the number of encounter diagnoses of CRS (p 0.0001) and RARS (p = 0.0006) was observed. Decreases in the frequency of antibiotic (p = 0.002) and corticosteroid (p = 0.04) prescriptions were also appreciated.Most patients with CRS and RARS have nonprotective antibody titers. PPSV23 administration significantly decreases health-care utilization.

INTRODUCTION: Breast cancer is a heterogeneous disease, consisting of multiple molecular subtypes. Obesity has been associated with an increased risk for postmenopausal breast cancer, but few studies have examined breast cancer subtypes separately. Obesity is often complicated by type 2 diabetes, but the possible association of diabetes with specific breast cancer subtypes remains poorly understood. METHODS: In this retrospective case-control study, Louisiana Tumor Registry records of primary invasive breast cancer diagnosed in 2010–2015 were linked to electronic health records in the Louisiana Public Health Institute’s Research Action for Health Network. Controls were selected from Research Action for Health Network and matched to cases by age and race. Conditional logistic regression was used to identify metabolic risk factors. Data analysis was conducted in 2020–2021. RESULTS: There was a significant association between diabetes and breast cancer for Luminal A, Triple-Negative Breast Cancer, and human epidermal growth factor 2–positive subtypes. In multiple logistic regression, including both obesity status and diabetes as independent risk factors, Luminal A breast cancer was also associated with overweight status. Diabetes was associated with increased risk for Luminal A and Triple-Negative Breast Cancer in subgroup analyses, including women aged ≥50 years, Black women, and White women. CONCLUSIONS: Although research has identified obesity and diabetes as risk factors for breast cancer, these results underscore that comorbid risk is complex and may differ by molecular subtype. There was a significant association between diabetes and the incidence of Luminal A, Triple-Negative Breast Cancer, and human epidermal growth factor 2–positive breast cancer in Louisiana.

BACKGROUND: Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking. METHODS: We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months. RESULTS: All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, −4.99%; 95% confidence interval [CI], −6.02 to −3.96) than in the usual-care group (−0.48%; 95% CI, −1.57 to 0.61), with a mean between-group difference of −4.51 percentage points (95% CI, −5.93 to −3.10) (P

Background Clinicians who work in primary care are potentially the most influential healthcare professionals to address the problem of antibiotic resistance because this is where most antibiotics are prescribed. Despite a number of evidence based interventions targeting the management of community infections, the inappropriate antibiotic prescribing rates remain high. Discussion The question is how can appropriate prescribing of antibiotics through the use of Antimicrobial Stewardship (AMS) programs be successfully implemented in primary care. We discuss that a top-down approach utilising a combination of strategies to ensure the sustainable implementation and uptake of AMS interventions in the community is necessary to support clinicians and ensure a robust implementation of AMS in primary care. Specifically, we recommend a national accreditation standard linked to the framework of Core Elements of Outpatient Antibiotic Stewardship, supported by resources to fund the implementation of AMS interventions that are connected to quality improvement initiatives. This article debates how this can be achieved. Summary The paper highlights that in order to support the sustainable uptake of AMS programs in primary care, an approach similar to the hospital and post-acute care settings needs to be adopted, utilising a combination of behavioural and regulatory processes supported by sustainable funding. Without these strategies the problem of inappropriate antibiotic prescribing will not be adequately addressed in the community and the successful implementation and uptake of AMS programs will remain a dream.

AIM To compare the cardiovascular risks between users and non-users of sodium-glucose co-transporter-2 (SGLT2) inhibitors based on electronic medical record data from a large integrated healthcare system in South Louisiana. MATERIALS AND METHODS Demographic, anthropometric, laboratory and medication prescription information for patients with type 2 diabetes who were new users of SGLT2 inhibitors, either as initial treatments or as add-on treatments, were obtained from electronic health records. Mediation analysis was performed to evaluate the association of use of SGLT2 inhibitors and changes of metabolic risk factors with the risk of incident ischaemic heart disease. RESULTS A total of 5338 new users of SGLT2 inhibitors were matched with 13 821 non-users. During a mean follow-up of 3.26 years, 2302 incident cases of ischaemic heart disease were defined. After adjusting for multiple confounding factors, patients using SGLT2 inhibitors had a lower risk of incident ischaemic heart disease compared to patients not using SGLT2 inhibitors (hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.54-0.73). Patients using SGLT2 inhibitors also had a lower risk of incident ischaemic heart disease within 6 months (HR 0.36, 95% CI 0.25-0.44), 12 months (HR 0.40, 95% CI 0.32-0.49), 24 months (HR 0.53, 95% CI 0.43-0.60) and 36 months (HR 0.65, 95% CI 0.54-0.73), respectively. Reductions in systolic blood pressure partly mediated lowering risk of ischaemic heart disease among patients using SGLT2 inhibitors. CONCLUSIONS The real-world data in the present study show the contribution of SGLT2 inhibitors to reducing risk of ischaemic heart disease, and their benefits beyond glucose-lowering.

Objective To determine whether surge conditions were associated with increased mortality. Design Multicenter cohort study. Setting U.S. ICUs participating in STOP-COVID. Patients Consecutive adults with COVID-19 admitted to participating ICUs between March 4 and July 1, 2020. Interventions None Measurements and Main Results The main outcome was 28-day in-hospital mortality. To assess the association between admission to an ICU during a surge period and mortality, we used two different strategies: (1) an inverse probability weighted difference-in-differences model limited to appropriately matched surge and non-surge patients and (2) a meta-regression of 50 multivariable difference-in-differences models (each based on sets of randomly matched surge- and non-surge hospitals). In the first analysis, we considered a single surge period for the cohort (March 23 – May 6). In the second, each surge hospital had its own surge period (which was compared to the same time periods in matched non-surge hospitals). Our cohort consisted of 4342 ICU patients (average age 60.8 [sd 14.8], 63.5% men) in 53 U.S. hospitals. Of these, 13 hospitals encountered surge conditions. In analysis 1, the increase in mortality seen during surge was not statistically significant (odds ratio [95% CI]: 1.30 [0.47-3.58], p = .6). In analysis 2, surge was associated with an increased odds of death (odds ratio 1.39 [95% CI, 1.34-1.43], p Conclusions Admission to an ICU with COVID-19 in a hospital that is experiencing surge conditions may be associated with an increased odds of death. Given the high incidence of COVID-19, such increases would translate into substantial excess mortality.

Background Following the high morbidity and mortality due to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infections in New Orleans, Louisiana, we sought to assess progress toward herd immunity. Methods Ochsner Health employees and patients who volunteered for Abbott SARS-CoV-2 immunoglobulin G (IgG) antibody test between March 1 and May 1, 2020 were included. We estimated IgG prevalence and used logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI) for variables associated with IgG test status. Results Of the 13,343 participants with IgG test results, 78.6% were women, 70.6% were non-Hispanic White, 21.1% non-Hispanic Black, 2.9% Hispanic Americans and 5.4% belonged to other races. Overall, 7.99% (95% CI: 7.53-8.45%) of the participants tested IgG positive. In age-, sex- and body mass index (BMI)-adjusted analyses, non-Hispanic Blacks were 2.7-times more likely to test positive than non-Hispanic Whites (OR=2.72; 95% CI: 2.33-3.19). Corresponding ORs (95% CIs) were 1.29 (0.84-1.99) for Hispanic Americans and 1.22 (0.85-1.75) for Other race/ethnicities. Compared to participants in administrative occupations, physician assistants (OR=7.14; 95% CI: 1.72-29.6) and therapists (OR=4.74; 95% CI: 1.49-15.03) were significantly more likely to have IgG antibodies while the association among nurses was not significant (OR=2.35; 95% CI: 0.96-5.77). Relative to 1.40, the test threshold for positivity, our measurements indicate a strong immune response (5.38±1.69), especially among those with a higher BMI. Conclusions SARS-COV-2 IgG antibodies were prevalent only in 8% of the participants. IgG prevalence was highest among non-Hispanic Blacks and participants with higher BMI but was lower among older participants.

Patients with diabetes have a 10-fold higher risk of lower-extremity amputation (LEA) than people without diabetes (1). LEA is associated with the greatest reduction in quality of life and the greatest increase in mortality and medical costs in all diabetes complications. Previous studies suggested that the mean hemoglobin A1c (HbA1c) level was associated with an increased LEA risk among patients with type 2 diabetes (2). However, emerging evidence indicates that long-term glycemic variability evaluated by clinical visit-to-visit HbA1c variability may be a better predictor of diabetes complications (3). So far, the definitions of long-term HbA1c variability are inconsistent. In most studies, standard deviation of serial HbA1c measurements (HbA1c SD) and the intrapersonal coefficient of variation of HbA1c (HbA1c CV) are often used to represent HbA1c variability. In the current study, we added a new marker—HbA1c variability score (HVS) (4)—which is more easily applied to clinical practice. We collected data from electronic health records for patients with type 2 diabetes between 2013 and 2019 in the Louisiana Experiment Assessing Diabetes outcomes (LEAD) cohort study (5). We excluded patients who had LEA diagnosis before entry and within 2 years after the first date of diabetes diagnosis, those with incomplete baseline data, those who did not have at least four HbA1c tests within 2 …

Introduction When and how to intensify treatment in patients with type 2 diabetes (T2D) not achieving glycated hemoglobin (HbA1c) targets with oral antidiabetic drugs (OADs) in clinical practice remains a matter of clinical preference. This pilot study was conducted using the retrospective observational data from such patients to evaluate the impact on HbA1c of three treatment sequences: simultaneous initiation of basal insulin (BI) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA; Cohort 1); BI followed by GLP-1 RA initiation within a 90-day timeframe (Cohort 2); or BI followed by GLP-1 RA initiation beyond 90 days (Cohort 3). Methods Data from the regional US electronic medical records database, Research Action for Health Network (REACHnet), were extracted for all patients with T2D aged ≥ 18 years who had encounter dates between January 2011 and August 2017 and ≥ 1 HbA1c laboratory value(s)

Background: In the early phases of the 2019 novel coronavirus (COVID-19) pandemic, health system leaders faced the urgent task of translating the unknown into forecasting models for hospital capacity. Our study objective was to demonstrate the application of a practical, locally informed model to estimate the hospital capacity needed even though the community COVID-19 caseload was unknown. Methods: We developed a susceptible-infected-recovered (SIR) model that was adopted from the University of Pennsylvania COVID-19 Hospital Impact Model for Epidemics and employed at 8 hospitals within Ochsner Health, the largest integrated delivery system in Louisiana, between March 16 and April 15, 2020. Intensive care unit (ICU) admissions of cases in the New Orleans area were used to estimate the community case load when testing was delayed. Results: Initially, the observed ICU census trended near R0=2.0, whereas the ventilator census trended between R0=2.0 and 3.0. After implementing social distancing, both the ICU and ventilator capacity trended toward R0=1.3, while non-ICU medical/surgical beds trended toward R0=1.5. The model accurately predicted peak ICU (n=250) and hospital bed (n=487) usage by April 6, 2020. In response to model trends, Ochsner added 130 ICU beds across its hospitals by opening a new ICU and converting operating rooms and parts of emergency departments to ICU beds. Conclusion: When disease testing is limited or results are delayed, ICU admissions data can inform SIR models of the rate of spread of COVID-19 in a community. Our model used various R0 plots to demonstrate an array of scenarios to guide planning for hospital and political leaders.

Background: Management of diabetes may be uniquely challenging for older individuals with multiple chronic conditions. Health systems and policymakers have attempted to reduce barriers to chronic care management (CCM) through incentives to provide non-face-to-face care. This qualitative study aimed to investigate and present views on non-face-to-face care management held by elderly patients with diabetes and other chronic conditions in order to contribute to improved programming for this population. Materials and methods: Semi-structured interviews were conducted with patients over the age of 64 who have been diagnosed with diabetes and at least one other chronic health condition. Interview recordings were transcribed and analyzed by experienced researchers using a thematic analytic approach, and an illustrative case study was developed. Results: Thirty individuals participated in this study. Participants were drawn from three health systems in south Louisiana, an area with high rates of morbidity and mortality related to chronic diseases. We identified themes related to lived experiences with diabetes and other medical conditions, perception of personal health status, perceived value of non-face-to-face programs, and support needs for future programming. Additionally, we present one case study describing in detail an individual patient's experience with non-face-to-face CCM. Conclusion: Health systems should consider intentionally recruiting participants who would benefit most from non-face-to-face care, including higher-need, less self-sufficient patients with resource constraints, while continuing to offer in-person services. Future research should examine whether tailoring non-face-to-face programming and support to address unique barriers can further enhance diabetes care at the population level.

Rationale & Objective Acute kidney injury treated with kidney replacement therapy (AKI-KRT) occurs frequently in critically ill patients with COVID-19. We examined the clinical factors that determine kidney recovery in this population. Study Design Multicenter cohort study. Setting & Participants 4221 adults with COVID-19 not receiving kidney replacement therapy who were admitted to intensive care units at 68 US hospitals with COVID-19 from March 1 to June 22, 2020 (the “ICU cohort”). Among these, 876 developed AKI-KRT after admission to the ICU (the “AKI-KRT subcohort”). Exposure(s) The ICU cohort was analyzed using AKI severity as the exposure. For the AKI-KRT subcohort, exposures included demographics, comorbidities, initial mode of KRT, and markers of illness severity at the time of dialysis initiation. Outcome(s) The outcome for the ICU cohort was estimated glomerular filtration rate (GFR) at hospital discharge. A three-level outcome including death, kidney nonrecovery, and kidney recovery at discharge, was analyzed for the AKI-KRT subcohort. Analytical approach The ICU cohort was characterized using descriptive analyses. The AKI-KRT subcohort was characterized with both descriptive analyses and multinomial logistic regression to assess factors associated with kidney nonrecovery while accounting for death. Results Among a total of 4221 patients in the ICU cohort, 2361 (56%) developed AKI, including 876 (21%) who received KRT. More severe AKI was associated with higher mortality. Among survivors, more severe AKI was associated with an increased rate of kidney nonrecovery and lower kidney function at discharge. Among the 876 patients with AKI-KRT, 588 (67%) died, 95 (11%) had kidney nonrecovery, and 193 (22%) had kidney recovery by the time of discharge. The odds of kidney nonrecovery was greater for lower estimated GFR with odds ratios (ORs) of 2.09 (95% CI, 1.09-4.04), 4.27 (95% CI, 1.99-9.17), and 8.69 (95% CI, 3.07-24.55) for CKD GFR categories 3, 4, and 5, respectively, compared to estimated GFR > 60 mL/min/1.73 m2. Oliguria at the time of KRT initiation was also associated with nonrecovery (OR 2.10 [95% CI, 1.14-3.88] and 4.02 [95% CI, 1.72-9.39] for patients with 50-499 and, Critically ill patients with COVID-19 often develop acute kidney injury (AKI). This study of 4221 patients demonstrated that more severe AKI was associated with greater in-hospital mortality and poorer kidney function at hospital discharge. Among the 876 patients who required dialysis for AKI, almost two-thirds died. Among those who survived to discharge, about two-thirds recovered kidney function and were discharged without the need for dialysis. Lower baseline kidney function and reduced urine output were associated with non-recovery of kidney function. Identification of such predictors is important in assessing prognosis among these critically ill patients and has implications for clinical care of individuals critically ill with COVID-19.

To investigate whether specific social determinants of health could be a "health barrier" toward achieving blood pressure (BP) control and to further evaluate any differences between Black patients and White patients.We conducted a retrospective cohort study of 3305 patients with elevated BP who were enrolled in a hypertension digital medicine program for at least 60 days and followed up for up to 1 year. Patients were managed virtually by a dedicated hypertension team who provided guideline-based medication management and lifestyle support to achieve goal BP.Compared with individuals without any health barriers, the addition of 1 barrier was associated with lower probability of control at 1 year from 0.73 to 0.60 and to 0.55 in those with 2 or more barriers. Health barriers were more prevalent in Black patients than in those who were White (44.6% [482 of 1081] vs 31.3% [674 of 2150]; P.001). There was no difference at all in BP control between Black individuals and those who were White if 2 or more barriers were present.Patient-related health barriers are associated with BP control. Black patients with poorly controlled hypertension have a higher prevalence of health barriers than their White counterparts. When 2 or more health barriers were present, there was no differences in BP control between White and Black individuals.

Introduction Increased utilization of electronic health records (EHR) has enriched databases for creating risk models. We used machine learning techniques to develop an EHR-based risk model locally fitted to patients with type 2 diabetes mellitus (T2DM) for predicting cardiovascular disease. Methods This retrospective observational study was conducted within Ochsner Health, Louisiana, USA, between 2013–2017. Data analysis included 6245 patients who had two outpatient diagnoses of T2DM recorded on separate days or a diagnosis recorded during an inpatient encounter. Baseline clinical data were limited to 180 days before the index diagnosis. Cardiovascular outcomes were coronary heart disease (CHD), heart failure and stroke. Machine learning approaches were used to select predictor variables into Cox proportional hazards models for each outcome. Locally fit equations were compared to “generalized” risk equations (RECODe, AS-CVD, QRISK3) using model discrimination and calibration. Results Among factors identified in the Ochsner (n = 11), RECODe (n = 14), AS-CVD (n = 15) and QRISK3 (n = 23), only age was common to all four risk equations. The Ochsner model had high internal discrimination for CHD (C-statistics 0.85) and better discrimination than RECODe (C-statistics 0.45), the QRISK3 (C-statistics 0.72) and AS-CVD (C-statistics 0.54). Conclusions The Ochsner model overestimated 5-year CHD risk, but had relatively higher calibration than the other models in CHD. Risk equations fitted for local populations improved cardiovascular risk stratification for patients with T2DM. Application of machine learning simplified the models compared to “generalized” risk equations. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01096-w.

Variation in hospital mortality has been described for coronavirus disease 2019 (COVID-19), but the factors that explain these differences remain unclear.Our objective was to utilize a large, nationally representative dataset of critically ill adults with COVID-19 to determine which factors explain mortality variability.In this multicenter cohort study, we examined adults hospitalized in intensive care units with COVID-19 at 70 United States hospitals between March and June 2020. The primary outcome was 28-day mortality. We examined patient-level and hospital-level variables. Mixed-effects logistic regression was used to identify factors associated with interhospital variation. The median odds ratio (OR) was calculated to compare outcomes in higher- vs. lower-mortality hospitals. A gradient boosted machine algorithm was developed for individual-level mortality models.A total of 4,019 patients were included, 1537 (38%) of whom died by 28 days. Mortality varied considerably across hospitals (0-82%). After adjustment for patient- and hospital-level domains, interhospital variation was attenuated (OR decline from 2.06 [95% CI, 1.73-2.37] to 1.22 [95% CI, 1.00-1.38]), with the greatest changes occurring with adjustment for acute physiology, socioeconomic status, and strain. For individual patients, the relative contribution of each domain to mortality risk was: acute physiology (49%), demographics and comorbidities (20%), socioeconomic status (12%), strain (9%), hospital quality (8%), and treatments (3%).There is considerable interhospital variation in mortality for critically ill patients with COVID-19, which is mostly explained by hospital-level socioeconomic status, strain, and acute physiologic differences. Individual mortality is driven mostly by patient-level factors. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Objective Centralized remote fetal monitoring (CRFM) has been proposed as a method to improve the performance of intrapartum fetal heart rate (FHR) monitoring and perinatal outcomes. The purpose of this study is to determine whether CRFM was associated with a reduction in unexpected term neonatal intensive care unit (NICU) admissions. Study Design A pre–post design was used to examine the effectiveness of CRFM which was implemented in stages across five hospitals. The exposure group was all women who underwent intrapartum monitoring via CRFM. The unexposed group was of women who delivered at the same hospitals prior to implementation of CRFM. Pregnancies with expected NICU admissions, gestational age Results There were 19,392 live births included in this analysis. In the univariable analysis, the odds of unexpected term NICU admission was lower among the CRFM exposed group compared with the unexposed group (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.75–0.99; p = 0.038). In multivariable analysis, this did not reach statistical significance (OR = 0.92, 95% CI: 0.79–1.06; p = 0.24). Cesarean and OVD were less likely in the exposed group (OR = 0.91, 95% CI: 0.85–0.97; p = 0.008) and (OR = 0.70, 95% CI: 0.59–0.83, p Conclusion In some practice settings, utilization of a CRFM system may decrease the risk of unexpected term NICU admission, cesarean, and OVD rate. Key Points

Summary: Many US states published crisis standards of care (CSC) guidelines for allocating scarce critical care resources during the COVID-19 pandemic. However, the performance of these guidelines in maximizing their population benefit has not been well tested. In 2,272 adults with COVID-19 requiring mechanical ventilation drawn from the Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19 (STOP-COVID) multicenter cohort, we test the following three approaches to CSC algorithms: Sequential Organ Failure Assessment (SOFA) scores grouped into ranges, SOFA score ranges plus comorbidities, and a hypothetical approach using raw SOFA scores not grouped into ranges. We find that area under receiver operating characteristic (AUROC) curves for all three algorithms demonstrate only modest discrimination for 28-day mortality. Adding comorbidity scoring modestly improves algorithm performance over SOFA scores alone. The algorithm incorporating comorbidities has modestly worse predictive performance for Black compared to white patients. CSC algorithms should be empirically examined to refine approaches to the allocation of scarce resources during pandemics and to avoid potential exacerbation of racial inequities.

Background Coronavirus disease 2019 (COVID-19) has high infectivity and causes extensive morbidity and mortality. Cardiovascular disease is a risk factor for adverse outcomes in COVID-19, but baseline left ventricular ejection fraction (LVEF) in particular has not been evaluated thoroughly in this context. Methods We analyzed patients in our state's largest health system who were diagnosed with COVID-19 between March 20 and May 15, 2020. Inclusion required an available echocardiogram within one year prior to diagnosis. The primary outcome was all-cause mortality. LVEF was analyzed both as a continuous variable and using a cutoff of 40%. Results Among 396 patients (67±16 years, 191 [48%] male, 235 [59%] Black, 59 [15%] LVEF ≤40%), 289 (73%) required hospital admission, and 116 (29%) died during 85±63 days of follow-up. Echocardiograms, performed a median of 57 (IQR 11-122) days prior to COVID-19 diagnosis, showed a similar distribution of LVEF between survivors and decedents (p=0.84). Receiver operator characteristic analysis revealed no predictive ability of LVEF for mortality, and there was no difference in survival among those with LVEF ≤40% vs. >40% (p=0.49). Multivariable analysis did not change these relationships. Similarly, there was no difference in LVEF based on whether the patient required hospital admission (56±13 vs. 55±13, p=0.38), and patients with a depressed LVEF did not require admission more frequently than their preserved-LVEF peers (p=0.87). A premorbid history of dyspnea consistent with symptomatic heart failure was not associated with mortality (p=0.74). Conclusions Among patients diagnosed with COVID-19, pre-COVID-19 LVEF was not a risk factor for death or hospitalization.

The 2 primary efforts of Medicare to advance value-based care are Medicare Advantage (MA) and the fee-for-service-based Medicare Shared Savings Program (MSSP). It is unknown how spending differs between the 2 programs after accounting for differences in patient clinical risk.To examine how spending and utilization differ between MA and MSSP beneficiaries after accounting for differences in clinical risk using data from administrative claims and electronic health records.This retrospective economic evaluation used data from 15 763 propensity score-matched beneficiaries who were continuously enrolled in MA or MSSP from January 1, 2014, to December 31, 2018, with diabetes, congestive heart failure (CHF), chronic kidney disease (CKD), or hypertension. Participants received care at a large nonprofit academic health system in the southern United States that bears risk for Medicare beneficiaries through both the MA and MSSP programs. Differences in beneficiary risk were mitigated by propensity score matching using validated clinical criteria based on data from administrative claims and electronic health records. Data were analyzed from January 2019 to May 2022.Enrollment in MA or attribution to an accountable care organization in the MSSP program.Per-beneficiary annual total spending and subcomponents, including inpatient hospital, outpatient hospital, skilled nursing facility, emergency department, primary care, and specialist spending.The sample of 15 763 participants included 12 720 (81%) MA and 3043 (19%) MSSP beneficiaries. MA beneficiaries, compared with MSSP beneficiaries, were more likely to be older (median [IQR] age, 75.0 [69.9-81.8] years vs 73.1 [68.3-79.8] years), male (5515 [43%] vs 1119 [37%]), and White (9644 [76%] vs 2046 [69%]) and less likely to live in low-income zip codes (2338 [19%] vs 750 [25%]). The mean unadjusted per-member per-year spending difference between MSSP and MA disease-specific subcohorts was $2159 in diabetes, $4074 in CHF, $2560 in CKD, and $2330 in hypertension. After matching on clinical risk and demographic factors, MSSP spending was higher for patients with diabetes (mean per-member per-year spending difference in 2015: $2454; 95% CI, $1431-$3574), CHF ($3699; 95% CI, $1235-$6523), CKD ($2478; 95% CI, $1172-$3920), and hypertension ($2258; 95% CI, $1616-2,939). Higher MSSP spending among matched beneficiaries was consistent over time. In the matched cohort in 2018, MSSP total spending ranged from 23% (CHF) to 30% (CKD) higher than MA. Adjusting for differential trends in coding intensity did not affect these results. Higher outpatient hospital spending among MSSP beneficiaries contributed most to spending differences between MSSP and MA, representing 49% to 62% of spending differences across disease cohorts.In this study, utilization and spending were consistently higher for MSSP than MA beneficiaries within the same health system even after adjusting for granular metrics of clinical risk. Nonclinical factors likely contribute to the large differences in MA vs MSSP spending, which may create challenges for health systems participating in MSSP relative to their participation in MA.

Background: Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. Methods: The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. Results: As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, −4.51% [95% CI, −5.93 to −3.10]; P P P =0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9–6.3]; P z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of −0.31 (95% CI, −0.47 to −0.14; P P =0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. Conclusions: A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02561221.

Rationale & Objective Underlying kidney disease is an emerging risk factor for more severe COVID-19 illness. We examined the clinical courses of critically ill COVID-19 patients with and without pre-existing kidney disease and investigated the association between degree of underlying kidney disease and in-hospital outcomes. Study Design Retrospective cohort study Settings & Participants 4,264 critically ill COVID-19 patients (143 dialysis patients, 521 chronic kidney disease [CKD] patients, and 3,600 patients without CKD) admitted to ICUs at 68 hospitals in the United States. Predictor(s) Presence (versus absence) of pre-existing kidney disease Outcome(s) In-hospital mortality (primary); respiratory failure, shock, ventricular arrhythmia/ cardiac arrest, thromboembolic event, major bleed, and acute liver injury (secondary) Analytical Approach We used standardized differences to compare patient characteristics (values >0.10 indicate a meaningful difference between groups) and multivariable adjusted Fine and Gray survival models to examine outcome associations. Results Dialysis patients had a shorter time from symptom onset to ICU admission compared to other groups (median [quartile 1-quartile 3] days: 4 [2-9] for dialysis patients; 7 [3-10] for CKD patients; 7 [4-10] for patients without pre-existing kidney disease). More dialysis patients (25%) reported altered mental status than those with CKD (20%, standardized difference = 0.12) and no kidney disease (12%, standardized difference = 0.36). Half of dialysis and CKD patients died within 28-days of ICU admission versus 35% of patients without pre-existing kidney disease. Compared to patients without pre-existing kidney disease, dialysis patients had a higher risk of 28-day in-hospital death (adjusted HR 1.41; 95% CI 1.09, 1.81), while patients with CKD had an intermediate risk (adjusted HR 1.25; 95% CI 1.08, 1.44). Limitations Potential residual confounding Conclusions Findings highlight the high mortality of individuals with underlying kidney disease and severe COVID-19, underscoring the importance of identifying safe and effective COVID-19 therapies for this vulnerable population., Individuals with underlying kidney disease may be particularly vulnerable to severe COVID-19 illness, marked by multi-system organ failure, thrombosis, and a heightened inflammatory response. Among 4,264 critically ill adults with COVID-19 admitted to 68 intensive care units across the U.S., we found that both chronic kidney disease and dialysis patients had a ∼50% 28-day in-hospital mortality rate. Patients with underlying kidney disease had higher in-hospital mortality than patients without kidney disease, with patients on maintenance dialysis having the highest risk. As evidenced by differences in symptoms and clinical trajectories, patients with pre-existing kidney disease may have unique susceptibility to COVID-19-related complications which warrants additional study and special consideration in the pursuit and development of targeted therapies.

Hypercoagulability may be a key mechanism of death in patients with COVID-19. This cohort study evaluated the incidence of venous thromboembolism and major bleeding in critically ill patients with COVID-19 and examined the observational effect of early therapeutic anticoagulation on survival., Visual Abstract. Early Anticoagulation in COVID-19 Hypercoagulability may be a key mechanism of death in patients with COVID-19. This cohort study evaluated the incidence of venous thromboembolism and major bleeding in critically ill patients with COVID-19 and examined the observational effect of early therapeutic anticoagulation on survival. Visual Abstract. Early Anticoagulation in COVID-19 Hypercoagulability may be a key mechanism of death in patients with COVID-19. This cohort study evaluated the incidence of venous thromboembolism and major bleeding in critically ill patients with COVID-19 and examined the observational effect of early therapeutic anticoagulation on survival., Background: Hypercoagulability may be a key mechanism of death in patients with coronavirus disease 2019 (COVID-19). Objective: To evaluate the incidence of venous thromboembolism (VTE) and major bleeding in critically ill patients with COVID-19 and examine the observational effect of early therapeutic anticoagulation on survival. Design: In a multicenter cohort study of 3239 critically ill adults with COVID-19, the incidence of VTE and major bleeding within 14 days after intensive care unit (ICU) admission was evaluated. A target trial emulation in which patients were categorized according to receipt or no receipt of therapeutic anticoagulation in the first 2 days of ICU admission was done to examine the observational effect of early therapeutic anticoagulation on survival. A Cox model with inverse probability weighting to adjust for confounding was used. Setting: 67 hospitals in the United States. Participants: Adults with COVID-19 admitted to a participating ICU. Measurements: Time to death, censored at hospital discharge, or date of last follow-up. Results: Among the 3239 patients included, the median age was 61 years (interquartile range, 53 to 71 years), and 2088 (64.5%) were men. A total of 204 patients (6.3%) developed VTE, and 90 patients (2.8%) developed a major bleeding event. Independent predictors of VTE were male sex and higher D-dimer level on ICU admission. Among the 2809 patients included in the target trial emulation, 384 (11.9%) received early therapeutic anticoagulation. In the primary analysis, during a median follow-up of 27 days, patients who received early therapeutic anticoagulation had a similar risk for death as those who did not (hazard ratio, 1.12 [95% CI, 0.92 to 1.35]). Limitation: Observational design. Conclusion: Among critically ill adults with COVID-19, early therapeutic anticoagulation did not affect survival in the target trial emulation. Primary Funding Source: None.

IntroductionThe prevalence of diabetes self-management education and support (DSME/S) use among patients with newly diagnosed type 2 diabetes mellitus (T2DM) and patients with insulin prescription has not been evaluated. It is also unclear what demographic, behavioral, and clinical factors associated with use of DSME/S.Research design and methodsThis retrospective analysis was based on electronic health records from the Research Action for Health Network (2013–2019). Patients with newly diagnosed T2DM were identified as 35–94 year-olds diagnosed with T2DM≥1 year after the first recorded office visit. Patients with insulin were identified by the first insulin prescription records. DSME/S (Healthcare Common Procedure Coding System G0108 and G0109) codes that occurred from 2 months before the ‘new diagnosis date’ or first insulin prescription date through 1 year after were defined as use of DSME/S. Age-matched controls (non-users) were identified from the Electronic Health Records (EHR). The date of first DSME/S record was selected as the index date. Logistic regression was used to estimate the associations between patient factors and use of DSME/S.ResultsThe prevalence of DSME/S use was 6.5% (8909/137 629) among patients with newly diagnosed T2DM and 32.7% (13,152/40,212) among patients with diabetes taking insulin. Multivariable analysis found that among patients with newly diagnosed T2DM, black and male patients were less likely to use DSME/S, while in patients with insulin, they were more likely to use the service compared with white and female counterparts, respectively. Among patients taking insulin, those with private insurance or self-pay status were significantly less likely, while those with Medicaid were more likely to use the service compared with their Medicare counterparts. A strong positive association was found between HbA1c, obesity, and DSME/S use in both cohorts, while hypertension was negatively associated with DSME/S in both cohorts.ConclusionWe showed a low rate of DSME/S use in Louisiana, especially in patients with newly diagnosed T2DM. Our findings demonstrated heterogeneity in factors influencing DSME/S use between patients with newly diagnosed T2D and patients with insulin.

Inclusion of racial/ethnic minorities in cancer research can reduce disparities in health outcomes; however, data regarding barriers and motivators to participation are sparse. This study assessed African American (AA) and Latinx healthy volunteers' perspectives regarding willingness to participate in noninvasive and invasive research activities.Using a 38-item questionnaire adapted from the Tuskegee Legacy Project Questionnaire, we assessed willingness to participate in 12 research activities, offering 27 possible barriers and 14 motivators. The sample was segmented into four subgroups by AA/Latinx and rural/urban.Across five states and Puerto Rico, 533 participants completed questionnaires. Overall, participants were more willing to participate in noninvasive versus invasive procedures, although, all subgroups were willing to participate in research if asked. Rural AA were most willing to complete a survey or saliva sample, while rural Latinx were least willing. Urban AA were least willing to provide cheek swab, while rural counterparts were most willing. Self-benefit and benefit to others were among the top three motivators for all subgroups. Curiosity was a primary motivator for urban AA while obtaining health information motivated rural Latinx. Primary barriers included fears of side effects and being experimented on, lack of information, and lack of confidentiality.Latinx and AAs are willing to participate in the continuum of nontherapeutic research activities suggesting their lack of participation may be related to not being asked. Inclusive enrollment may be achieved by assessing needs of participants during the design phase of a study in order to reduce barriers to participation.

AIM: To investigate the association between visit-to-visit HbA1c variability and the risk of cardiovascular disease in patients with type 2 diabetes. MATERIALS AND METHODS: We performed a retrospective cohort study of 29 260 patients with at least four HbA1c measurements obtained within 2 years of their first diagnosis of type 2 diabetes. Different HbA1c variability markers were calculated, including the standard deviation (SD), coefficient of variation (CV) and adjusted SD. Cox proportional hazards regression models were used to estimate the association of these HbA1c variability markers with incident cardiovascular disease. RESULTS: During a mean follow-up of 4.18 years, a total of 3746 incident cardiovascular disease cases were diagnosed. Multivariate-adjusted hazard ratios for cardiovascular disease across the first, second, third and fourth quartiles of HbA1c SD values were 1.00, 1.30 (95% confidence interval [CI] 1.18–1.42), 1.40 (95% CI 1.26–1.55) and 1.59 (95% CI 1.41–1.77) (P for trend

Objective While many seroprevalence studies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been performed, few are demographically representative. This investigation focused on defining the nature and frequency of symptomatic and asymptomatic SARS-CoV-2 infection in a representative, cross-sectional sample of communities in Louisiana, USA. Methods A sample of 4,778 adults from New Orleans and Baton Rouge, Louisiana were given a survey of symptoms and comorbidities, nasopharyngeal swab to test for an active infection (PCR), and blood draw to test for a past infection (immunoglobulin G). Odds ratios, cluster analysis, quantification of virus and antibody, and linear modeling were used to understand whether certain symptoms were associated with a positive test, how symptoms grouped together, whether virus or antibody varied by symptom status, and whether being symptomatic was different across the age span. Results Reported anosmia/ageusia was strongly associated with a positive test; 40.6% (93/229) tested positive versus 4.8% (218/4,549) positivity in those who did not report anosmia/ageusia (Common OR: 13.6; CI 10.1, 18.3). Of the people who tested positive, 47.3% (147/311) were completely asymptomatic. Symptom presentation clustered into three groups; low/no symptoms (0.4±0.9 average ±SD), highly symptomatic (7.5±1.9) or moderately symptomatic (4.0±1.5). Quantity of virus was lower in the asymptomatic versus symptomatic group (cycle number 23.3±8.3 versus 17.3±9.0, average ±SD; p, Graphical abstract Image 1

Even though current prescribing trends reveal that high-dose opioid prescribing and opioid prescribing in general has decreased, sustained efforts are needed to help providers adopt and maintain safe prescribing behaviors. The purpose of this four-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized trial is to: (1) compare the clinical and cost effectiveness of electronic medical record-based clinical decision support [EMR-CDS] versus additional integrated, collaborative behavioral health [EMR-CDS + BHI-CCM] for opioid management of patients with co-morbid chronic non-cancer pain with depression or anxiety; and (2) examine facilitators and barriers to implementing these interventions within 35 primary care clinics in a integrated delivery health system. The EMR-CDS alerts providers to employ opioid risk mitigation and safe prescribing practices at the point of care. The BHI-CCM consists of primary care embedded community health workers for case management; licensed clinical social workers for cognitive behavioral therapy, and a clinical pharmacist for medication management who provide care management via telemedicine (virtual video or audio only visits) under the guidance of a consulting psychiatrist. The primary outcome is reduction in the percentage of patients with average daily opioid dose ≥50 mg morphine equivalent. Secondary outcomes include changes in service utilization, patient reported outcomes and processes of care. The investigators anticipate that study results will elucidate the role of technology versus care team optimization in changing opioid prescribing behaviors. The investigators further anticipate that integrated mental/behavioral health care will increase value-based care and the efficiency with which guideline concordant care is delivered.

Using paired molecular and antibody testing for SARS-CoV-2 infection, we determined point prevalence and seroprevalence in a municipality in Louisiana, USA during the second phase of reopening. Infections were highly variable by race, work environment, and ZIP code. Census-weighted seroprevalence and point prevalence were 3.6% and 3.0%, respectively.

Chronic diseases impact 117 million adults in the United States and account for $3.3 trillion in health care spending. This qualitative study investigated experiences with reimbursement structure for non-face-to-face (NFF) chronic care management (CCM) through diverse health system approaches in primary care settings in Southeastern Louisiana. In-depth interviews were conducted with 16 purposively selected key informants, and reflexive thematic analysis was utilized to explore findings. Variation in health system approaches for implementing and quality of NFF CCM programs were identified. Results included differences in health system motivation and methods for financial structuring and quality of third-party vendor and alternative models.

Background We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. Methods GS-US-540–5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540–5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. Results After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34–3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22–.68, P = .001). Conclusions In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. Clinical Trials Registration NCT04292899 and EUPAS34303.

Using a novel recruitment method to reduce selection bias with paired molecular and antibody testing for SARS-CoV-2 infection, we determined point prevalence in a racially diverse municipality. Infections were highly variable by ZIP and differed by race. Overall census-weighted prevalence was 7.8% and the calculated infection fatality rate was 1.63%.

Aims: This study compares the cardiovascular benefits between SGLT2 inhibitors and other glucose-lowering drugs (oGLDs) based on electronic medical record data from a large integrated delivery health system in South Louisiana. Materials and Methods: Demographic, anthropometric, laboratory and medication prescription information for patients with type 2 diabetes who were new users of SGLT2 inhibitors either as initial treatments or as add-on treatments were obtained from electronic health records. Mediation analysis was performed in demonstrating the association of use of SGLT2 inhibitors and changes of metabolic risk factors with the risk of incident coronary heart disease. Results: A total of 5,338 new users of SGLT2 inhibitors were matched with 13,821 patients using oGLDs. During a mean follow up of 3.26 years, 2,303 incident cases of coronary heart disease were defined. After adjusting for multiple confounding factors, patients using SGLT2 inhibitors had a lower risk of incident coronary heart disease compared to patients using oGLDs (hazard ratio [HR] 0.63; 95% confidence interval [CI] 0.55-0.72). Patients using SGLT2 inhibitors also had a lower risk of incident coronary heart disease within 6 months (HR 0.32; 95% CI 0.23-0.43), 12 months (HR 0.38; 95% CI0.31-0.48), 24 months (HR 0.49; 95% CI 0.41-0.59) and 36 months (HR 0.59; 95% CI 0.51-0.69), respectively. Reductions in systolic blood pressure attributed the lower risk of coronary heart disease among patients using SGLT2 inhibitors. Conclusions: Evidence from real world data indicated the contribution of SGLT2 inhibitors to reducing risk of coronary heart disease, as well as the benefits beyond glucose-lowering. Disclosure Y. Shen: None. J. Zhou: None. L. Shi: None. E. Nauman: None. P.T. Katzmarzyk: None. E.G. Price-Haywood: None. S. Chu: None. S. Yang: None. A.N. Bazzano: None. S. Nigam: None. G. Hu: None.

Background and Purpose— Few studies have assessed the association of HDL (high-density lipoprotein) cholesterol with stroke risk among patients with type 2 diabetes mellitus. We aimed to investigate the association of HDL cholesterol with total and type-specific stroke risk in patients with type 2 diabetes mellitus. Methods— We performed a retrospective cohort study of 27 113 blacks and 40 431 whites with type 2 diabetes mellitus. Cox proportional hazards regression models were used to estimate the association of different levels of HDL cholesterol with stroke risk. Results— During a mean follow-up period of 3.0 years, 8496 patients developed stroke (8048 ischemic and 448 hemorrhagic). Multivariable-adjusted hazard ratios across levels of HDL at baseline (P trend P trend P trend =0.021) for hemorrhagic stroke, respectively. When we used an updated mean value of HDL cholesterol, the inverse association of HDL cholesterol with stroke risk did not change. This inverse association was consistent among patients of different ages, races, sexes, body mass index, hemoglobin A1c levels, never and past or current smokers, and patients with and without using glucose-lowering, cholesterol-lowering, or antihypertensive agents. Conclusions— The present study found consistent inverse associations between HDL cholesterol and the risk of total, ischemic and hemorrhagic stroke among patients with type 2 diabetes mellitus.

BACKGROUND Obesity affects nearly half of adults in the United States and is contributing substantially to a pandemic of obesity-associated chronic conditions such as type 2 diabetes, hypertension, and arthritis. The obesity-associated chronic condition pandemic is particularly severe in low-income, medically underserved, predominantly African-American areas in the southern United States. Little is known regarding the impact of geographic, income, and racial disparities in continuity of care on major health outcomes for patients with obesity-associated chronic conditions. OBJECTIVE The aim of this study is to assess, among patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes, (1) whether continuity of care is associated with lower overall and potentially preventable emergency department and hospital utilization, (2) the effect of geographic, income, and racial disparities on continuity of care and on health care utilization, (3) whether continuity of care particularly protects individuals at risk for disparities from adverse health outcomes, and (4) whether characteristics of health systems are associated with higher continuity of care and better outcomes. METHODS Using 2015-2018 data from 4 practice-based research networks participating in the Southern Obesity and Diabetes Coalition, we will conduct a retrospective cohort analysis and distributed meta-analysis. Patients with obesity-associated chronic conditions and with type 2 diabetes will be assessed within each health system, following a standardized study protocol. The primary study outcomes are overall and preventable emergency department visits and hospitalizations. Continuity of care will be calculated at the facility level using a modified version of the Bice-Boxerman continuity of care index. Race will be assessed using electronic medical record data. Residence in a low-income area or a health professional shortage area respectively will be assessed by linking patient residence ZIP codes to the Centers for Medicare & Medicaid Services database. RESULTS In 4 regional health systems across Tennessee, Mississippi, Louisiana, and Arkansas, a total of 53 adult hospitals were included in the study. A total of 147,889 patients with obesity-associated chronic conditions who met study criteria were identified in these health systems, of which 45,453 patients met the type 2 diabetes criteria for inclusion. Results are expected by the end of 2020. CONCLUSIONS This study should reveal whether health system efforts to increase continuity of care for patients with obesity and diabetes have potential to improve outcomes and reduce costs. Analyzing disparities in continuity of care and their effect on major health outcomes can help demonstrate how to improve care and use of health care resources for vulnerable patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes. Better understanding of the association between continuity and health care utilization for these vulnerable populations will contribute to the development of higher-value health systems in the southern United States. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20788