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The objective of this study was to evaluate indicators of diabetes quality of care for US nonelderly, adult Medicaid enrollees with type 2 diabetes and compare federally qualified health centers (FQHCs) versus non-FQHCs.We analyzed diabetes process measures and acute health services utilization with 2012 US fee-for-service and managed care Medicaid claims in all 50 states and DC. We compared FQHC (N=121,977) to non-FQHC patients (N=700,401) using propensity scores to balance covariates and generalized estimating equation models.Overall, laboratory-based process measures occurred more frequently (range, 65.7%-76.6%) than measures requiring specialty referrals (retinal examinations, 33.3%; diabetes education, 3.4%). Compared with non-FQHC patients, FQHC patients had about 3 percentage point lower rates of each process measure, except for higher rates of diabetes education [relative risk=1.09, 95% confidence interval (CI): 1.03-1.16]. FQHC patients had fewer overall [incident rate ratio (IRR)=0.87, 95% CI: 0.86-0.88] and diabetes-related hospitalizations (IRR=0.79, 95% CI: 0.77-0.81), but more overall (IRR=1.06, 95% CI: 1.05-1.07) and diabetes-related emergency department visits (IRR=1.10, 95% CI: 1.08-1.13).This national analysis identified opportunities to improve diabetes management among Medicaid enrollees with type 2 diabetes, especially for retinal examinations or diabetes education. Overall, we found slightly lower rates of most diabetes care process measures for FQHC patients versus non-FQHC patients. Despite having higher rates of emergency department visits, FQHC patients were significantly less likely to be hospitalized than non-FQHC patients. These findings emphasize the need to identify innovative, effective approaches to improve diabetes care for Medicaid enrollees, especially in FQHC settings.

A population health approach to depression screening using patient portals may be a promising strategy to proactively engage and identify patients with depression.To determine whether a population health approach to depression screening is more effective than screening during clinic appointments alone for identifying patients with depression.A pragmatic clinical trial at an adult outpatient internal medicine clinic at an urban, academic, tertiary care center.Eligible patients (n = 2713) were adults due for depression screening with active portal accounts. Patients with documented depression or bipolar disorder and those who had been screened in the year prior to the study were excluded.Patients were randomly assigned to usual (n = 1372) or population healthcare (n = 1341). For usual care, patients were screened by medical assistants during clinic appointments. Population healthcare patients were sent letters through the portal inviting them to fill out an online screener regardless of whether they had a scheduled appointment. The same screening tool, the Computerized Adaptive Test for Mental Health (CAT-MH™), was used for clinic- and portal-based screening.The primary outcome was the depression screening rate.The depression screening rate in the population healthcare arm was higher than that in the usual care arm (43% (n = 578) vs. 33% (n = 459), p0.0001). The rate of positive screens was also higher in the population healthcare arm compared to that in the usual care (10% (n = 58) vs. 4% (n = 17), p0.001).Findings suggest depression screening via a portal as part of a population health approach can increase screening and case identification, compared to usual care.ClinicalTrials.gov Identifier: NCT03832283.

Major ethnic disparities in diabetes care, especially for intermediate outcomes and diabetes complications, were evident prior to the coronavirus disease 2019 (COVID-19) pandemic. Diabetes is a risk factor for severe COVID-19, and the combination of these ethnic disparities in diabetes care and outcomes may have contributed to the inequity in COVID-19 outcomes for people with diabetes. Overall, ethnic minority populations have suffered disproportionate rates of COVID-19 hospitalization and mortality. Results from the limited number of studies of COVID-19 in ethnic minority populations with diabetes are mixed, but there is some suggestion that rates of hospitalization and mortality are higher than those of White populations. Reasons for the higher incidence and severity of COVID-19–related outcomes in minority ethnic groups are complex and have been shown to be due to differences in comorbid conditions (e.g., diabetes), exposure risk (e.g., overcrowded living conditions or essential worker jobs), and access to treatment (e.g., health insurance status and access to tertiary care medical centers), which all relate to long-standing structural inequities that vary by ethnicity. While guidelines and approaches for diabetes self-management and outpatient and inpatient care during the pandemic have been published, few have recommended addressing wider structural issues. As we now plan for the recovery and improved surveillance and risk factor management, it is imperative that primary and specialist care services urgently address the disproportionate impact the pandemic has had on ethnic minority groups. This should include a focus on the larger structural barriers in society that put ethnic minorities with diabetes at potentially greater risk for poor COVID-19 outcomes.

Many patients do not receive guideline-recommended preventive, chronic disease, and acute care. One potential explanation is insufficient time for primary care providers (PCPs) to provide care.To quantify the time needed to provide 2020 preventive care, chronic disease care, and acute care for a nationally representative adult patient panel by a PCP alone, and by a PCP as part of a team-based care model.Simulation study applying preventive and chronic disease care guidelines to hypothetical patient panels.Hypothetical panels of 2500 patients, representative of the adult US population based on the 2017-2018 National Health and Nutrition Examination Survey.The mean time required for a PCP to provide guideline-recommended preventive, chronic disease and acute care to the hypothetical patient panels. Estimates were also calculated for visit documentation time and electronic inbox management time. Times were re-estimated in the setting of team-based care.PCPs were estimated to require 26.7 h/day, comprising of 14.1 h/day for preventive care, 7.2 h/day for chronic disease care, 2.2 h/day for acute care, and 3.2 h/day for documentation and inbox management. With team-based care, PCPs were estimated to require 9.3 h per day (2.0 h/day for preventive care and 3.6 h/day for chronic disease care, 1.1 h/day for acute care, and 2.6 h/day for documentation and inbox management).PCPs do not have enough time to provide the guideline-recommended primary care. With team-based care the time requirements would decrease by over half, but still be excessive.

Integrating behavioral health (BH) and primary care is an important strategy to improve health behaviors, mental health, and substance misuse, particularly at community health centers (CHCs) where disease burden is high and access to mental health services is low. Components of different integrated BH models are often combined in practice. It is unknown which components distinguish developing versus established integrated BH programs.A survey was mailed to 128 CHCs in 10 Midwestern states in 2016. Generalized estimating equation models were used to assess associations between program characteristics and stage of integration implementation (precontemplation, contemplation, preparation, action, or maintenance). Content analysis of open-ended responses identified integration barriers.Response rate was 60% (CHCs have implemented many foundational components of integrated BH. Future work should address barriers to integration and racial disparities in access to integrated BH. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

BACKGROUND Depression and anxiety are common among people living with HIV (PLWH) and contribute to adverse health outcomes. Conducting population-level depression and anxiety screening via the patient portal is a promising intervention and has not been studied in HIV care settings. OBJECTIVE To explore facilitators and barriers to implementing population-level portal-based depression and anxiety screening for PLWH. METHODS Semi-structured hour-long qualitative interviews were conducted with staff at an HIV clinic using the Consolidated Framework of Implementation Research. RESULTS Ten clinicians participated in interviews. Facilitators included (1) respect for patient privacy, (2) interest in evidence-based practices and lessons learned from prior implementation, (3) normalizing mental health screening, and (4) compatibility with clinic culture, workflows, and systems. Barriers included (1) limited availability of mental health services,(2) impersonal approach to sensitive topics, and (3) limited capacity to address mental health during HIV visits. CONCLUSIONS Strategies are needed for facilitating the implementation of population-level portal-based mental health screening for PLWH

Context Many patients with hypothyroidism receive suboptimal treatment that may affect hospital outcomes. Objective This work aimed to identify differences in hospital outcomes between patients with and without hypothyroidism. Methods A retrospective cohort study, using the propensity score-based fine stratification method to balance covariates, was conducted using a large, US-based, commercial claims database from January 1, 2008 to December 31, 2015. Participants included patients aged 64 years and younger who had a thyrotropin (TSH) level collected before a hospital admission. Covariates included age, sex, US region, type of admission, year of admission, and comorbidities. Exposure included clinical hypothyroidism, which was divided into 4 subgroups based on prehospitalization TSH level: low (TSH 10.00 mIU/L). Main outcome measures included length of stay (LOS), in-hospital mortality, and readmission outcomes. Results A total of 43 478 patients were included in the final study population, of whom 8873 had a diagnosis of hypothyroidism. Those with a high prehospitalization TSH level had an LOS that was 1.2 days longer (95% CI, 1.1-1.3; P = .003), a 49% higher risk of 30-day readmission (relative risk [RR] 1.49; 95% CI, 1.20-1.85; P Conclusion The results suggest suboptimal treatment of hypothyroidism is associated with worse hospital outcomes, including longer LOS and higher rate of readmission.

OBJECTIVE: Patient-centered studies have shown that several patients on thyroid hormone replacement therapy for hypothyroidism exhibit persistent symptoms, including “brain fog.” Here, we aimed to determine which of these specific symptoms are associated with brain fog, identify patient-reported factors that modify these symptoms, and identify patient concerns related to brain fog not included in thyroid-specific questionnaires. METHODS: A survey on brain fog symptoms adapted from thyroid-specific patient-reported outcome was distributed online. Textual data analysis was performed to identify common areas of concern from open-ended survey responses. RESULTS: A total of 5170 participants reporting brain fog while being treated for hypothyroidism were included in the analysis. Of these, 2409 (46.6%) participants reported symptom onset prior to the diagnosis of hypothyroidism, and 4096 (79.2%) participants experienced brain fog symptoms frequently. Of the symptoms listed, participants associated fatigue and forgetfulness most frequently with brain fog. More rest was the most common factor provided for improving symptoms. The textual data analysis identified areas of concern that are not often included in thyroid-specific quality of life questionnaires, including a focus on the diagnosis of hypothyroidism, the types and doses of medications, and the patient-doctor relationship. CONCLUSION: Brain fog in patients treated for hypothyroidism was associated most frequently with fatigue and cognitive symptoms. Several additional areas of patient concern were found to be associated with brain fog, which are not typically addressed in thyroid-specific questionnaires.

Depression is most often treated by primary care providers (PCPs), but low self-efficacy in caring for depression may impede adequate management. We aimed to identify which elements of integrated behavioral health (BH) were associated with greater confidence among PCPs in identifying and managing depression.Mailed cross-sectional surveys in 2016.BH leaders and PCPs caring for adult patients at community health centers (CHCs) in 10 midwestern states.Survey items asked about depression screening, systems to support care, availability and integration of BH, and PCP attitudes and experiences. PCPs rated their confidence in diagnosing, assessing severity, providing counseling, and prescribing medication for depression on a 5-point scale. An overall confidence score was calculated (range 4 (low) to 20 (high)). Multilevel linear mixed models were used to identify factors associated with confidence.Response rates were 60% (N=77/128) and 52% (N=538/1039) for BH leaders and PCPs, respectively. Mean overall confidence score was 15.25±2.36. Confidence was higher among PCPs who were satisfied with the accuracy of depression screening (0.38, p=0.01), worked at CHCs with depression tracking systems (0.48, p=0.045), had access to patients' BH treatment plans (1.59, p=0.002), and cared for more patients with depression (0.29, p=0.003). PCPs who reported their CHC had a sufficient number of psychiatrists were more confident diagnosing depression (0.20, p=0.02) and assessing severity (0.24, p=0.03). Confidence in prescribing was lower at CHCs with more patients living below poverty (-0.66, p0.001). Confidence in diagnosing was lower at CHCs with more Black/African American patients (-0.20, p=0.03).PCPs who had access to BH treatment plans, a system for tracking patients with depression, screening protocols, and a sufficient number of psychiatrists were more confident identifying and managing depression. Efforts are needed to address disparities and support PCPs caring for vulnerable patients with depression.

INTRODUCTION: Depression is a prevalent condition for which screening rates remain low and disparities in screening exist. This study examines the impacts of a medical assistant screening protocol on the rates of depression screening, overall and by sociodemographic groups, in a primary care setting. METHODS: Between September 2016 and August 2018, a quasi-experimental study of adult primary care visits was conducted at an urban academic clinic to ascertain the change in the rates of completion of the Patient Health Questionnaire-2 after the implementation of a medical assistant protocol (intervention) versus that of physician-only screening (control arm). Analyses were conducted between April 2019 and April 2020 and used interrupted time-series models with generalized estimating equations. RESULTS: A total of 45,157 visits by 21,377 unique patients were included. Overall, screening increased from 18% (physician-only screening) to 57% (medical assistant protocol) (p

This report details ongoing efforts to improve integration in the 2 years following implementation of the Primary Care Behavioral Health model at a general internal medicine clinic of an urban academic medical center. Efforts were informed by a modified version of the validated Level of Integration Measure, sent to all faculty and staff annually. At baseline, results indicated that the domains of systems integration, training, and integrated clinical practices had the greatest need for improvement. Over the 2 years, the authors increased availability of behavioral medicine appointments, improved depression screening processes, offered behavioral health training for providers, disseminated clinical decision support tools, and provided updates about integration progress during clinic meetings. Follow-up survey results demonstrated that physicians and staff perceived improvements in integration overall and in targeted domains. However, the main ongoing barrier to integration was insufficient behavioral health staff to meet patient demand for behavioral health services.

BACKGROUND: Guidelines recommend sodium–glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) receptor agonists as second-line therapy for patients with type 2 diabetes. Expanding their use as first-line therapy has been proposed but the clinical benefits may not outweigh their costs. OBJECTIVE: To evaluate the lifetime cost-effectiveness of a strategy of first-line SGLT2 inhibitors or GLP1 receptor agonists. DESIGN: Individual-level Monte Carlo–based Markov model. DATA SOURCES: Randomized trials, Centers for Disease Control and Prevention databases, RED BOOK, and the National Health and Nutrition Examination Survey. TARGET POPULATION: Drug-naive U.S. patients with type 2 diabetes. TIME HORIZON: Lifetime. PERSPECTIVE: Health care sector. INTERVENTION: First-line SGLT2 inhibitors or GLP1 receptor agonists. OUTCOME MEASURES: Life expectancy, lifetime costs, incremental cost-effectiveness ratios (ICERs). RESULTS OF BASE-CASE ANALYSIS: First-line SGLT2 inhibitors and GLP1 receptor agonists had lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke compared with metformin. First-line SGLT2 inhibitors cost $43 000 more and added 1.8 quality-adjusted months versus first-line metformin ($478 000 per quality-adjusted life-year [QALY]). First-line injectable GLP1 receptor agonists cost more and reduced QALYs compared with metformin. RESULTS OF SENSITIVITY ANALYSIS: By removing injection disutility, first-line GLP1 receptor agonists were no longer dominated (ICER, $327 000 per QALY). Oral GLP1 receptor agonists were not cost-effective (ICER, $823 000 per QALY). To be cost-effective at under $150 000 per QALY, costs for SGLT2 inhibitors would need to be under $5 per day and under $6 per day for oral GLP1 receptor agonists. LIMITATION: U.S. population and costs not generalizable internationally. CONCLUSION: As first-line agents, SGLT2 inhibitors and GLP1 receptor agonists would improve type 2 diabetes outcomes, but their costs would need to fall by at least 70% to be cost-effective. PRIMARY FUNDING SOURCE: American Diabetes Association.

Time-based billing options for physicians have expanded, enabling many physicians to bill according to time spent instead of medical decision-making (MDM) level for fee-for-service outpatient visits. However, no study to date has estimated the revenue changes associated with time-based billing.To compare evaluation and management (E/M) reimbursement for physicians using time-based billing vs MDM-based billing for outpatient visits of varying lengths.This economic evaluation used 2019 billing data for outpatient E/M codes and 2021 reimbursement rates from the Centers for MedicareMedicaid Services. Modeling of generic clinic templates was performed to estimate expected yearly E/M revenues for a single full-time physician working in an outpatient clinic using fee-for-service billing.Yearly E/M revenues for different patient visit templates were modeled. The standardized length of return patient visits was 10 to 45 minutes, and new patient visits were twice as long in duration.Under MDM-based billing, increased visit length was associated with decreased E/M revenue ($564 188 for 30-minute new patient visit/15-minute return patient visit vs $423 137 for 40-minute new patient visit/20-minute return patient visit). Under time-based billing, yearly E/M revenue remained similar across increasing visit lengths ($400 432 for 30-minute new patient visit/15-minute return patient visit vs $458 718 for 40-minute new patient visit/20-minute return patient visit). Compared with time-based billing, MDM-based billing was associated with higher E/M revenue for 10- to 15-minute return patient visits ($400 432 vs $564 188). Time-based billing was associated with higher E/M revenue for return patient visits lasting 20 minutes or longer. The highest modeled E/M revenue of $846 273 occurred for 10-minute return patient visits under MDM-based billing.Results of this study showed that the relative economic benefits of MDM-based billing and time-based billing differed and were associated with the length of patient visits. Physicians with longer patient visits were more likely to experience revenue increases from using time-based billing than physicians with shorter patient visits.

Context Small adjustments in levothyroxine (LT4) dose do not appear to provide clinical benefit despite changes in thyrotropin (TSH) levels within the reference range. We hypothesize that the accompanying changes in serum total triiodothyronine (T3) levels do not reflect the magnitude of the changes in serum TSH. Objective This work aims to characterize the relationships of serum free thyroxine (FT4) vs T3, FT4 vs TSH, and FT4 vs the T3/FT4 ratio. Methods This cross-sectional, observational study comprised 9850 participants aged 18 years and older treated with LT4 from a large clinical database from January 1, 2009, to December 31, 2019. Patients had been treated with LT4, subdivided by serum FT4 level. Main outcome measures included model fitting of the relationships between serum FT4 vs TSH, FT4 vs T3, and FT4 vs T3/FT4. Mean and median values of TSH, T3, and T3/FT4 were calculated. Results The relationships T3 vs FT4 and TSH vs FT4 were both complex and best represented by distinct, segmented regression models. Increasing FT4 levels were linearly associated with T3 levels until an inflection point at an FT4 level of 0.7 ng/dL, after which a flattening of the slope was observed following a convex quadratic curve. In contrast, increasing FT4 levels were associated with steep declines in TSH following 2 negative sigmoid curves. The FT4 vs T3/FT4 relationship was fit to an asymptotic regression curve supporting less T4 to T3 activation at higher FT4 levels. Conclusion In LT4-treated patients, the relationships between serum FT4 vs TSH and FT4 vs T3 across a range of FT4 levels are disproportionate. As a result, dose changes in LT4 that robustly modify serum FT4 and TSH values may only minimally affect serum T3 levels and result in no significant clinical benefit.

Whether lowering the hemoglobin A1c to6.0% in patients with type 2 diabetes can reduce the risk of cardiovascular disease (CVD) remains under debate. The ACCORDION and the VADT studies both found reductions in the primary CVD composite associated with intensive glycemic control, though the difference is not statistically significant. However, the lack of significance is often overinterpreted as non-effective: a

Objective: In the US, Hispanic persons have a higher rate of Type 2 diabetes (T2D) than the national average, as well as experience more diabetes-related complications than non-Hispanic whites (NHWs) . This increased prevalence can be attributed to social and biological factors, like access to care and increased predisposition to pre-diabetic conditions. Currently, limited evidence exists for the effectiveness of randomized controlled trials (RCTs) at improving A1C levels in this population with T2D. Methods: A systematic search focused on T2D interventions published from 1985 to 20was conducted using PubMed, Scopus, PsycInfo, and CINAHL. Search terms were structured around five broad concepts: diabetes, study design, language, race/ethnicity, and disparities. We focused on non-pharmacologic interventions, and included RCTs with ≥18.5% Hispanic persons, utilizing the 2020 US Census as standard. A random effects meta-analysis was performed to calculate the pooled effect size to provide summary estimates. Results: Of the 111,289 articles reviewed, 28 trials met inclusion criteria. Participants were 90% Hispanic and 70% female with a mean age of 55.8 years. Most interventions used cultural tailoring, lifestyle and behavioral changes, or telehealth support and included bilingual nurses, Spanish educational materials, or community health workers. Compared to control, these interventions were associated with a 0.19% (95% confidence interval: -0.39% to 0.01%; p Conclusion: This meta-analysis examined non-pharmacologic interventions in Hispanic persons with T2D and found that they reduced A1c to a small degree. This finding is important for future T2D interventions tailoring to this population, as well as future health policy. Future analyses will examine which type of interventions (i.e. individual, community, societal, or multi-level) are most successful at reducing A1c among Hispanic persons. Disclosure S.Uranga: None. L.Bianco: None. A.Deckard: None. W.Wan: n/a. J.Alexander: None. E.M.Staab: None. A.W.Rodriguez: None. R.Shetty: None. N.Laiteerapong: None.

Background: The prevalence of Type 2 diabetes (T2D) is high among non-Hispanic Black persons. This population also has a high rate of poorly controlled T2D and a high burden of T2D related complications. To address this, various interventions have been studied to improve glycemic control. We performed a meta-analysis of published interventions on Black persons with T2D and their effects on HbA1c outcomes. Methods: An electronic search of literature in PubMed, Scopus, CINAHL, PsycINFO, and Medline was conducted from 1985 to 20for studies evaluating T2D interventions among predominantly minority populations. This analysis was limited to non-pharmacologic randomized controlled trials (RCTs) and studies that had an average ≥12.5% of total participants identifying as Black, utilizing the 2020 US Census as standard. Interventions were aimed at improving outcomes including blood pressure, weight, and lipids. For this analysis, we focused on the outcome HbA1c and its differences between experimental and control groups. A random effects meta-analysis was performed to calculate the pooled effect size of the various outcomes. Results: For this analysis, 35 RCTs were included (n=6467) . The participants were 61% Black and 65% female with a mean age of 56 years. Interventions included interdisciplinary T2D management, telehealth-based support, lifestyle focused programs, and peer support programs. There was a statistically significant reduction in HbA1c in the experimental group when compared to the control group (-0.17, 95% CI -0.28 to -0.06, p Conclusion: This meta-analysis found non-pharmacologic interventions were effective in reducing HbA1c among Black persons to a small degree. Future research is needed to estimate the effects of the level of intervention (i.e. individual, community, societal, or multi-level) in reducing HbA1c among this population to inform future public health programming and policy. Disclosure F.Osman: None. C.Jiang: None. A.Deckard: None. W.Wan: n/a. J.Alexander: None. E.M.Staab: None. A.W.Rodriguez: None. R.Shetty: None. N.Laiteerapong: None.

The cost-effectiveness of SGLT2i can be modulated by patients’ characteristics, such as cardiovascular risks. We performed an individualized cost-effectiveness assessment of SGLT2i when added to metformin in people with inadequately controlled T2D to quantify the modulating effect of patients’ characteristics on the cost-effectiveness of SGLT2i. We identified survey participants with T2D receiving metformin monotherapy who had an A1c level above 7.0% from the National Health and Nutrition Examination Survey (2013-2018) . We applied a simulation-based smoothing method to populate the survey sample to its represented national population. We used the BRAVO diabetes model to simulate the lifetime cost and QALYs associated with SGLT2i or sulfonylureas. Treatment escalations were governed by the A1c level at 7% and 8% consequentially. Both costs and QALYs were discounted at 3% annually, and the incremental cost-effectiveness ratio (ICER) threshold was set at $100,000/QALYs. The study sample included 2.89 million individuals. Compared with sulfonylureas, the use of SGLT2i was associated with an average of $9,400 higher medical cost and 0.10 additional QALY, leading to an ICER of $94,000/QALY in the overall population. SGLT2i was cost-effective in people with a history of heart failure (ICER: $67,000/QALY) and myocardial infarction (ICER: $94,000/QALY) , and marginally cost-effective in stroke patients (ICER: $100,000/QALY) . Among individuals without CVD, SGLT2i was cost-effective only in subgroups with HbA1c > 7.5%, age > 60, and diabetes duration > 10 years. Overall, SGLT2i was only cost-effective in individuals with a baseline 10-year CVD risk over 16%, constituting 51.6% of the overall population. Our results align closely with the ADA guideline on the recommended population for SGLT2i use. Out-of-pocket payment subsidy or cost-sharing reduction of SGLT2i should be prioritized in patient subgroups in which SGLT2i has high economic values. Disclosure D. Guan: None. S. Niu: None. V. Fonseca: Consultant; Abbott, Asahi Kasei Corporation, Bayer AG, Novo Nordisk, Sanofi, Research Support; Fractyl Health, Inc., Jaguar Gene Therapy, Stock/Shareholder; Abbott, Amgen Inc., BRAVO4Health, Mellitus Health. L. Shi: None. N. Laiteerapong: None. J. Guo: None. H. Shao: Board Member; BRAVO4HEALTH, LLC.

Purpose: The purpose of this study is to develop a diabetes outcomes model for the US (DOMUS) using a multi-ethnic, real-world-data cohort of newly diagnosed Type II diabetics that can predict outcomes for a U.S. multi-ethnic type 2 diabetes population. Methods: The Kaiser Permanente Northern California (KPNC) Diabetes Registry, which is a well-described epidemiologic cohort with up to 13 years of follow-up from EMR and claims, were used to identify over 150,000 newly diagnosed diabetes patients between 2005-2016 with up to 13-year follow-up. The DOMUS model integrates separate, but interdependent risk equations to predict events for each of the micro and macro-vascular events, hypoglycemia, dementia, depression, and death, and predictive models for eight biomarker levels. Model accounted for static demographic factors (e.g., race) , neighborhood deprivation, and dynamic factors, such as age, duration of diabetes, fifteen-possible glucose -lowering treatment combinations, biomarker levels, and history of diabetes-related events. Moreover, the models explicitly allow for a legacy effect (average A1c in the first year after diagnosis) for all outcomes. Results: Data were randomly split into 75,000, 18,750, and 18,750 patients to perform estimation, out-of-sample calibration, and validation respectively. Model predictions in the validation sample closely aligned with the observed longitudinal trajectory of biomarkers and outcomes. Moreover, we examine the model performance within by age, race/ethnicity, and sex and found excellent predictive performance within subgroups. Conclusion: The DOMUS Model is able to simulate event histories and biomarker trajectories that closely match observed outcomes in a real-world, multi-ethnic population of newly diagnosed diabetics. DOMUS has the potential to carry out many complex analyses that examine the effectiveness and cost-effectiveness of new medications, value of diabetes prevention, and serve as decision support tools in health care settings. Disclosure A.N.Winn: Consultant; Takeda Pharmaceutical Company Limited. E.Huang: Advisory Panel; Twin Health, Stock/Shareholder; AbbVie Inc. P.Clarke: None. A.J.Karter: Research Support; Dexcom, Inc. W.Wan: n/a. D.R.Miller: None. M.Franco: None. A.Deckard: None. N.Laiteerapong: None.

Objective: Asian persons have an increased risk of type 2 diabetes (T2D) compared to non-Hispanic white persons, with approximately two in five individuals being diagnosed. The prevalence of T2D among this population has grown in recent years as Asian persons are the fastest growing racial/ethnic group in the US. We conducted a meta-analysis of US randomized controlled trials (RCTs) to evaluate the effectiveness of T2D interventions at improving systolic blood pressure (SBP) , diastolic blood pressure (DBP) , and HbA1c among this population. Methods: An electronic search of literature in PubMed, Scopus, CINAHL, PsycINFO, and Medline was conducted from 1985 to 2019 for studies evaluating T2D interventions among predominantly minority populations. This analysis was limited to RCTs with an average >6% of total participants identifying as Asian, utilizing the 2020 US Census as standard. Interventions focusing on the efficacy of a drug, device, diet, surgery, or procedure were excluded. A random effects meta-analysis was performed to calculate the pooled effect size of the various outcomes. Results: Of the articles reviewed, 9 met inclusion criteria. All 9 included HbA1c and 5 included SBP/DBP. Participants were 62.8% Asian and 40.3% female with a mean age of 53.4 years. Interventions included diabetes education programs, utilization of community health workers, bilingual counseling, and cognitive therapy. There was a 0.36% decrease in HbA1c in the experimental group when compared to the control group (95% CI -0.48 to -0.25, p=0.80, I2=0%) . Compared to control, these interventions had minimal effects on SBP (-0.08, 95% CI -0.22 to 0.07, p=0.73, I2=0%) and DBP (0.01, 95% CI -0.22 to 0.25, p=0.23, I2=29%) . Conclusion: This meta-analysis found that RCTs for T2D in Asian persons modestly lowered HbA1c, with minimal impact on SBP/DBP. Future analysis should include observational studies to evaluate a larger sample and investigate their impact on other markers of health, as well as characterize these effects by level of intervention to inform health policy. Disclosure J. Xiao: None. J. Yu: None. A. Deckard: None. W. Wan: n/a. E. M. Staab: None. A. W. Rodriguez: None. R. Shetty: None. N. Laiteerapong: None.

Background: Uncontrolled blood pressure (BP) is a major cardiovascular disease (CVD) risk factor, and CVD is the leading cause of death among non-Hispanic Black persons with type 2 diabetes (T2D) . While many interventions have been designed to improve BP control in this population, disparities persist. A meta-analysis of randomized controlled trials was conducted to evaluate the effectiveness of T2D interventions at improving BP. Methods: An electronic search of Medline, PubMed, Scopus, CINAHL, and PsychINFO was conducted from 1985 to 2019. Keywords included those related to diabetes, study design and race/ethnicity. We included non-pharmacologic trials with ≥12.5% Black persons (using the 2020 US Census as a standard) . Interventions were aimed at improving outcomes including HbA1c, BP, weight and lipids. For this analysis, we focused on the outcomes mean systolic (SBP) and diastolic blood pressure (DBP) differences between control and experimental groups. A random effects meta-analysis was performed to calculate the pooled effect size to provide summary estimates. Results: Sixteen trials (n=2314) reported SBP and DBP outcomes; two additional trials (total n=2919) reported only SBP outcomes. The participants were 59% Black and 71% female with a mean age of 55.9 years. Average baseline BP was similar for the control and intervention groups (134/78 and 134/77, respectively) . Interventions included self-management education, telehealth support, lifestyle programs, and pharmacist-led support. Compared to control, these interventions demonstrated no difference in SBP (0.01, 95% CI -0.to 0.mmHg, p=0.55, I2=0%) or DBP (-0.05, 95% CI -0.15 to 0.mmHg, p=0.20, I2=22%) . Conclusion: In this meta-analysis of trials aimed to improve outcomes in Black patients with T2D, there was no improvement in BP control. Given the high risk of CVD in this population, more effective interventions are needed to improve BP control in Black persons with T2D. Disclosure C.Jiang: None. F.Osman: None. A.Deckard: None. W.Wan: n/a. J.Alexander: None. R.Shetty: None. E.M.Staab: None. N.Laiteerapong: None.

Objective: Communities of racial/ethnic minority groups experience a higher prevalence of type 2 diabetes (T2DM) with higher rates of diabetes-related complications compared to non-Hispanic Whites. Interventions that utilize community health workers (CHW) are often successful at improving glycemic control. This analysis aimed to examine the effectiveness of CHW interventions on glycemic control in people of racial/ethnic minority groups with T2DM. Methods: A search of electronic databases (PubMed, Scopus, CINAHL, PsycInfo) to identify articles published between 1985 and 20was conducted using broad search terms for diabetes, race/ethnicity, and disparities. To further refine articles to those focusing on CHW-based randomized controlled trials, abstracts were searched for “community workers” and “promotores.” A random effects model was used to calculate the effect of CHW interventions on hemoglobin A1c (HbA1c) with future plans to analyze effects on other cardiovascular risk factors such as body mass index, blood pressure, and cholesterol. Results: A total of 22 RCTs were identified, involving 4996 adults (26% Black, 50% Hispanic, 11% Asian, and 11% Pacific Islander) . CHW interventions among people of racial/ethnic minority groups was associated with a 0.44% (95% confidence interval: -0.56% to -0.31%; p Conclusion: CHW interventions are an effective means to lower HbA1c among people of racial/ethnic minority groups with T2DM. This finding is important for future healthcare policies, which should work to emphasize culturally sensitive interventions for patients with T2DM while maintaining cost effectiveness through CHWs. Future research should examine the effectiveness of CHWs for diabetes prevention. Disclosure R.Shetty: None. A.Deckard: None. W.Wan: n/a. A.Nathan: None. E.M.Staab: None. A.W.Rodriguez: None. A.Gandhi: None. A.A.Baig: None. N.Laiteerapong: None.

Aim To evaluate the U.S. population-level impact of two alternatives for initial type 2 diabetes screening [opportunistic random plasma glucose (RPG) > 6.7 mmol/l and a 1-h 50-g glucose challenge test (GCT) > 8.9 mmol/l] compared with American Diabetes Association (ADA)-recommended tests. Methods Using a sample (n = 1471) from the National Health and Nutrition Examination Survey (NHANES) 2013-2014 that represented 145 million U.S. adults at high risk for developing type 2 diabetes, we simulated a two-test screening process. We compared ADA-recommended screening tests [fasting plasma glucose (FPG), 2-h 75-g oral glucose tolerance test (OGTT), HbA1c ] vs. initial screening with opportunistic RPG or GCT (followed by FPG, OGTT or HbA1c ). After simulation, participants were entered into an individual-level Monte Carlo-based Markov lifetime outcomes model. Primary outcomes were representative number of U.S. adults correctly identified with type 2 diabetes, societal lifetime costs and quality-adjusted life years (QALYs). Results In NHANES 2013-2014, 100 individuals had undiagnosed diabetes [weighted estimate: 8.4 million, standard error (se): 1.1 million]. Among ADA-recommended screening tests, FPG followed by OGTT (FPG-OGTT) was most sensitive, identifying 35 individuals with undiagnosed diabetes (weighted estimate: 3.2 million, se: 0.9 million). Four alternative screening strategies performed superior to FPG-OGTT, with RPG followed by OGTT being the most sensitive overall, identifying 72 individuals with undiagnosed diabetes (weighted estimate: 6.1 million, se: 1.0 million). There was no increase in average lifetime costs and comparable QALYs. Conclusions Initial screening using opportunistic RPG or a GCT may identify more U.S. adults with type 2 diabetes without increasing societal costs.

ImportancePhysician parents, particularly women, are more likely to experience burnout, poor family-career balance, adverse maternal and fetal outcomes, and stigmatization compared with nonparent colleagues. Because many physicians delay child-rearing due to the rigorous demands of medical training, favorable parental leave policies for faculty physicians are crucial to prevent physician workforce attrition.ObjectiveTo evaluate paid and unpaid parental leave policies at medical schools ranked by US News & World Report in 2020 and identify factors associated with leave policies.Design, Setting, and ParticipantsThis cross-sectional national study was performed at US medical schools reviewed from December 1, 2019, through May 31, 2020, and February 1 through March 31, 2021, due to the COVID-19 pandemic. All medical schools ranked by US News & World Report in 2020 were included.Main Outcomes and MeasuresThe primary outcome was the number of weeks of paid and unpaid leave for birth, nonbirth, adoption, and foster care physician parents. Institutional policies for the number of weeks of leave and requirements to use vacation, sick, or disability leave were characterized. Institutional factors were evaluated for association with the duration of paid parental leave using χ2 tests.ResultsAmong the 90 ranked medical schools, 87 had available data. Sixty-three medical schools (72.4%) had some paid leave for birth mothers, but only 13 (14.9%) offered 12 weeks of fully paid leave. While 11 medical schools (12.6%) offered 12 weeks of full paid leave for nonbirth parents, 38 (43.7%) had no paid leave for nonbirth parents. Adoptive and foster parents had no paid leave in 35 (40.2%) and 65 (74.7%) medical schools, respectively. Median paid parental leave was 4 (IQR, 0-8) weeks for birth parents, 4 (IQR, 0-6) weeks for adoptive parents, 3 (IQR, 0-6) weeks for nonbirth parents, and 0 (IQR, 0-1) weeks for foster parents. About one-third of medical schools required birth mothers to use vacation (29 [33.3%]), sick leave (31 [35.6%]), or short-term disability (9 [10.3%]). Among institutional characteristics, higher ranking (top vs bottom quartile: 30.4% vs 4.0%; P = .03) and private designation (private vs public, 23.5% vs 9.4%; P Conclusions and RelevanceIn this cross-sectional national study of medical schools ranked by US News & World Report in 2020, many physician faculty receive no or very limited paid parental leave. The lack of paid parental leave was associated with higher rates of physician burnout and work-life integration dissatisfaction and may further perpetuate sex, racial and ethnic, and socioeconomic disparities in academic medicine.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) are a recent class of medication approved for the treatment of type 2 diabetes (T2D). Previous meta-analyses have quantified the benefits and harms of SGLT2Is; however, these analyses have been limited to specific outcomes and comparisons and included trials of short duration. We comprehensively reviewed the longer-term benefits and harms of SGLT2Is compared to placebo or other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov from inception to July 2019 for randomized controlled trials of minimum 52 weeks’ duration that enrolled adults with T2D, compared an SGLT2I to either placebo or other anti-hyperglycemic medications, and reported at least one outcome of interest including cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events. We conducted random effects meta-analyses to provide summary estimates using weighted mean differences (MD) and pooled relative risks (RR). The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Fifty articles describing 39 trials (vs. placebo, n = 28; vs. other anti-hyperglycemic medication, n = 12; vs. both, n = 1) and 112,128 patients were included in our analyses. Compared to placebo, SGLT2Is reduced cardiovascular risk factors (e.g., hemoglobin A1c, MD − 0.55%, 95% CI − 0.62, − 0.49), macrovascular outcomes (e.g., hospitalization for heart failure, RR 0.70, 95% CI 0.62, 0.78), and mortality (RR 0.87, 95% CI 0.80, 0.94). Compared to other anti-hyperglycemic medications, SGLT2Is reduced cardiovascular risk factors, but insufficient data existed for other outcomes. About a fourfold increased risk of genital yeast infections for both genders was observed for comparisons vs. placebo and other anti-hyperglycemic medications. DISCUSSION: We found that SGLT2Is led to durable reductions in cardiovascular risk factors compared to both placebo and other anti-hyperglycemic medications. Reductions in macrovascular complications and mortality were only observed in comparisons with placebo, although trials comparing SGLT2Is vs. other anti-hyperglycemic medications were not designed to assess longer-term outcomes. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07227-0.

Objectives Early antibiotic administration is a central component of sepsis guidelines, and delays may increase mortality. However, prior studies have examined the delay to first antibiotic administration as a single time period even though it contains two distinct processes: antibiotic ordering and antibiotic delivery, which can each be targeted for improvement through different interventions. The objective of this study was to characterize and compare patients who experienced order or delivery delays, investigate the association of each delay type with mortality, and identify novel patient subphenotypes with elevated risk of harm from delays. Design Retrospective analysis of multicenter inpatient data. Setting Two tertiary care medical centers (2008-2018, 2006-2017) and four community-based hospitals (2008-2017). Patients All patients admitted through the emergency department who met clinical criteria for infection. Interventions None. Measurements and main results Patient demographics, vitals, laboratory values, medication order and administration times, and in-hospital survival data were obtained from the electronic health record. Order and delivery delays were calculated for each admission. Adjusted logistic regression models were used to examine the relationship between each delay and in-hospital mortality. Causal forests, a machine learning method, was used to identify a high-risk subgroup. A total of 60,817 admissions were included, and delays occurred in 58% of patients. Each additional hour of order delay (odds ratio, 1.04; 95% CI, 1.03-1.05) and delivery delay (odds ratio, 1.05; 95% CI, 1.02-1.08) was associated with increased mortality. A patient subgroup identified by causal forests with higher comorbidity burden, greater organ dysfunction, and abnormal initial lactate measurements had a higher risk of death associated with delays (odds ratio, 1.07; 95% CI, 1.06-1.09 vs odds ratio, 1.02; 95% CI, 1.01-1.03). Conclusions Delays in antibiotic ordering and drug delivery are both associated with a similar increase in mortality. A distinct subgroup of high-risk patients exist who could be targeted for more timely therapy.

The urgency of the COVID-19 pandemic has increased attention on the need to include patients traditionally underrepresented in research, especially people with comorbid diseases, racial/ethnic minorities, pregnant/lactating women, and children.1–4 We characterized the inclusion and exclusion criteria of US COVID-19 treatment trials to understand their applicability to highly affected populations and groups traditionally underrepresented in research.

Introduction Many patients in the US with hypothyroidism receive suboptimal treatment with thyroid hormone. Sustained off-target TSH levels have been shown to cause serious harm to patients, including increased risk of cardiovascular disease and excess mortality over time. Suboptimal treatment may also impact hospital outcomes. The primary objective of the study was to identify differences in hospital outcomes between patients with and without hypothyroidism. Methods This is a retrospective cohort study that utilized the propensity score-based fine stratification method to balance covariates. Patient data was extracted from a large, US-based, IBM MarketScan® Commercial Claims and Encounters Database from January 1, 2008 to December 31, 2015. Participants included patients 64 years and younger who had commercial insurance and a thyrotropin (TSH) level collected prior to a medical or surgical hospital admission. Covariates included age, sex, US region, type of admission (medical vs surgical), year of admission, and co-morbidities. The primary exposure was defined as clinical hypothyroidism, which was divided into 4 subgroups based on pre-hospitalization TSH level: low (TSH 10.00 mIU/L). Non-hypothyroidism was the non-exposure (control). The primary outcomes were length of stay (LOS), in-hospital mortality, and readmission outcomes following medical and surgical admission. Results A total of 46,235 patients were included in the final study population, of whom 9,394 had a diagnosis of hypothyroidism. Those with a high pre-hospitalization TSH level had a LOS that was 1.2 days longer (95% CI [1.1–1.3]; p = 0.001), a 41% higher risk of 30-day readmission (RR 1.41, 95% CI [1.13–1.75]; p = 0.002), and 33% higher rate of 90-day readmission (RR 1.33, 95% CI [1.13–1.56]; p Conclusions Suboptimal treatment of hypothyroidism appears to be associated with worse hospital outcomes, including longer LOS and higher rate of readmission. Public health strategies designed to deliver appropriate, consistent outpatient treatment of hypothyroidism are needed to improve hospital outcomes in those patients with off-target TSH levels. Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m., Sunday, June 12, 2022 12:30 p.m. - 12:35 p.m.

BACKGROUND: Previous meta-analyses of the benefits and harms of glucagon-like peptide-1 receptor agonists (GLP1RAs) have been limited to specific outcomes and comparisons and often included short-term results. We aimed to estimate the longer-term effects of GLP1RAs on cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events in patients with type 2 diabetes, compared to placebo and other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov (inception–July 2019) for randomized controlled trials ≥ 52 weeks’ duration that compared a GLP1RA to placebo or other anti-hyperglycemic medication and included at least one outcome of interest. Outcomes included cardiovascular risk factors, microvascular and macrovascular complications, all-cause mortality, and treatment-related adverse events. We performed random effects meta-analyses to give summary estimates using weighted mean differences (MD) and pooled relative risks (RR). Risk of bias was assessed using the Cochrane Collaboration risk of bias in randomized trials tool. Quality of evidence was summarized using the Grading of Recommendations, Assessment, Development, and Evaluation approach. The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Forty-five trials with a mean duration of 1.7 years comprising 71,517 patients were included. Compared to placebo, GLP1RAs reduced cardiovascular risk factors, microvascular complications (including renal events, RR 0.85, 0.80–0.90), macrovascular complications (including stroke, RR 0.86, 0.78–0.95), and mortality (RR 0.89, 0.84–0.94). Compared to other anti-hyperglycemic medications, GLP1RAs only reduced cardiovascular risk factors. Increased gastrointestinal events causing treatment discontinuation were observed in both comparisons. DISCUSSION: GLP1RAs reduced cardiovascular risk factors and increased gastrointestinal events compared to placebo and other anti-hyperglycemic medications. GLP1RAs also reduced MACE, stroke, renal events, and mortality in comparisons with placebo; however, analyses were inconclusive for comparisons with other anti-hyperglycemic medications. Given the high costs of GLP1RAs, the lack of long-term evidence comparing GLP1RAs to other anti-hyperglycemic medications has significant policy and clinical practice implications. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07105-9.

In this narrative review, we summarise the evidence for and against the glycaemic legacy effect from the long-term follow-up of major diabetes trials and observational cohort studies. We provide a summary of the pathophysiological basis for the legacy effect and discuss some translational research. Results from trials of early diabetes and observational cohort studies suggest that a long-term effect of early glycaemic control exists; however, long-term follow-up from trials in participants with established diabetes is not supportive. Additionally, findings for the legacy effect are more conclusive for microvascular complications than macrovascular events. Overall, these results suggest that the glycaemic legacy effect is a long-term benefit (or risk) conferred to individuals in the early stages of diabetes and which is muted over time as individuals' vasculature changes and they develop complications from diabetes.

Importance: Medication non-adherence is highly costly and leads to worse disease control and outcomes. However, knowledge about medication adherence is often disconnected from prescribing decisions, and this disconnect may lead to inappropriate increases in medications and higher risks of adverse events. Objectives: To evaluate the association between medication non-adherence and the likelihood of increases in the intensity of medication regimens for two chronic conditions, hypertension and type 2 diabetes. Design: Cohort Study. Setting and Participants: This study used US national pharmacy claims data for Medicare Part D (ages ≥ 65) and commercial (ages 50–64) plans to evaluate medication adherence and its association with the likelihood of receiving an increase in medication intensity for patients with hypertension and/or oral diabetes medication fills. Patients had an index fill for hypertension (N = 2,536,638) and/or oral diabetes (N = 701,376) medications in January 2015. Medication fills in the follow-up period from August 2015 to December 2016 were assessed for increases in medication regimen intensity. Main Outcome(s) and Measure(s): The proportion of days covered (PDC) over 181 days was used as a measure for patient’s medication adherence before a medication addition, medication increase, or dosage increase. Differences in the likelihood of experiencing an escalation in medication intensity was considered between patients with a PDC &lt, 80% vs. PDC ≥ 80%. Results: Among Medicare Part D and commercial plan patients filling hypertension and/or oral diabetes medications, non-adherent patients were significantly more likely to experience an intensification of their medication regimens (p &lt, 0.001). Conclusions and Relevance: This study found a significant association between non-adherence to medications and a higher likelihood of patients experiencing potentially inappropriate increases in treatment intensity. Sharing of objective patient refill data between retail pharmacies and prescribers can enable prescribers to have more targeted discussions with patients about their adherence and overall treatment plan. Additionally, it can increase safe medication prescribing and plausibly reduce adverse drug events and healthcare costs while improving patient health outcomes.