218 results on '"Spatz, Erica S"'
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2. Race, Ethnicity, and Gender Differences in Patient Reported Well-Being and Cognitive Functioning Within 3 Months of Symptomatic Illness During COVID-19 Pandemic.
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Hill MJ, Huebinger RM, Ebna Mannan I, Yu H, Wisk LE, O'Laughlin KN, Gentile NL, Stephens KA, Gottlieb M, Weinstein RA, Koo K, Santangelo M, Saydah S, Spatz ES, Lin Z, Schaeffer K, Kean E, Montoy JCC, Rodriguez RM, Idris AH, McDonald S, Elmore JG, and Venkatesh A
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Background: Differences in acute COVID-19 associated morbidity based on race, ethnicity, and gender have been well described; however, less is known about differences in subsequent longer term health-related quality of life and well-being., Methods: This prospective cohort study included symptomatic adults tested for SARS-CoV-2 who completed baseline and 3-month follow-up surveys. Using the PROMIS-29 tool, a validated measure of health and well-being, we compared outcomes at 3 months and change in outcomes from baseline to 3 months among groups with different races, ethnicities, and/or sexes., Results: Among 6044 participants, 4113 (3202 COVID +) were included. Among COVID + participants, compared to non-Hispanic White participants, Black participants had better PROMIS T-scores for cognitive function (3.6 [1.1, 6.2]) and fatigue (- 4.3 [- 6.6, - 2.0]) at 3 months and experienced more improvement in fatigue over 3 months (- 2.7 [- 4.7, - 0.8]). At 3 months, compared with males, females had worse PROMIS T-scores for cognitive function (- 4.1 [- 5.6, - 2.6]), physical function (- 2.1 [- 3.1, - 1.0]), social participation (- 2.8 [- 4.2, - 1.5]), anxiety (2.8 [1.5, 4.1]), fatigue (5.1 [3.7, 6.4]), and pain interference (2.0 [0.9, 3.2]). Females experienced less improvement in fatigue over 3 months (3.1 [2.0, 4.3]). Transgender/non-binary/other gender participants had worse 3-month scores in all domains except for sleep disturbance and pain interference., Conclusions: Three months after the initial COVID-19 infection, Black participants reported better cognitive function and fatigue, while females and other gender minoritized groups experienced lower well-being. Future studies are necessary to better understand how and why social constructs, specifically race, ethnicity, and gender, influence differences in COVID-19-related health outcomes. Trials Registration ClinicalTrials.gov Identifier: NCT04610515., (© 2024. The Author(s).)
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- 2024
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3. The association between prolonged SARS-CoV-2 symptoms and work outcomes.
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Venkatesh AK, Yu H, Malicki C, Gottlieb M, Elmore JG, Hill MJ, Idris AH, Montoy JCC, O'Laughlin KN, Rising KL, Stephens KA, Spatz ES, and Weinstein RA
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- Humans, Female, Male, Adult, Middle Aged, Prospective Studies, Return to Work statistics & numerical data, United States epidemiology, Employment, Self Report, Pandemics, Absenteeism, Young Adult, COVID-19 epidemiology, SARS-CoV-2 isolation & purification
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While the early effects of the COVID-19 pandemic on the United States labor market are well-established, less is known about the long-term impact of SARS-CoV-2 infection and Long COVID on employment. To address this gap, we analyzed self-reported data from a prospective, national cohort study to estimate the effects of SARS-CoV-2 symptoms at three months post-infection on missed workdays and return to work. The analysis included 2,939 adults in the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) study who tested positive for their initial SARS-CoV-2 infection at the time of enrollment, were employed before the pandemic, and completed a baseline and three-month electronic survey. At three months post-infection, 40.8% of participants reported at least one SARS-CoV-2 symptom and 9.6% of participants reported five or more SARS-CoV-2 symptoms. When asked about missed work due to their SARS-CoV-2 infection at three months, 7.2% of participants reported missing ≥10 workdays and 13.9% of participants reported not returning to work since their infection. At three months, participants with ≥5 symptoms had a higher adjusted odds ratio of missing ≥10 workdays (2.96, 95% CI 1.81-4.83) and not returning to work (2.44, 95% CI 1.58-3.76) compared to those with no symptoms. Prolonged SARS-CoV-2 symptoms were common, affecting 4-in-10 participants at three-months post-infection, and were associated with increased odds of work loss, most pronounced among adults with ≥5 symptoms at three months. Despite the end of the federal Public Health Emergency for COVID-19 and efforts to "return to normal", policymakers must consider the clinical and economic implications of the COVID-19 pandemic on people's employment status and work absenteeism, particularly as data characterizing the numerous health and well-being impacts of Long COVID continue to emerge. Improved understanding of risk factors for lost work time may guide efforts to support people in returning to work., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AHI receives research grant funding from the University of Texas Southwestern Medical Center outside of the submitted work. AKV receives grants from the Agency for Healthcare Research and Quality and the SAEM Foundation outside the submitted work. ESS receives grant funding from the National Heart, Lung, and Blood Institute (R01HL151240), and the Patient Centered Outcomes Research Institute (HM-2022C2-28354). JCCM receives research grant funding from SAMHSA (1H79TI084428-01 and 1H79TI085981-01, PI LeSaint), FDA (75F40122C00116, PI Anderson), NIH-NINDS (U24NS129501, PI Rodriguez) outside the submitted work. JE is Editor-in-chief of the Adult Primary Care topics at UpToDate. KLR receives research grant funding from Abbott Diagnostics, DermTech, MeMed, Prenosis, Siemens Healthcare Diagnostics, PROCOVAXED funded by NIAID 1R01AI166967, and PREVENT funded by CDC U01CK00048 outside the submitted work. KNO receives research grant funding for PROCOVAXED funded by NIAID R01 AI166967, PI: Rodriguez outside the submitted work. MG receives grant funding from the Biomedical Advanced Research and Development Authority Research Grant, the Bill and Melinda Gates Foundation, and the Society of Directors of Research in Medical Education Grant outside the submitted work. MJH receives research grant funding from an Investigator Award from Merck, MISP 100099, PI: Hill outside the submitted work. The following authors have declared that no competing interests exist: HY, KAS, RAW. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Venkatesh et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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4. Transforming Hypertension Diagnosis and Management in The Era of Artificial Intelligence: A 2023 National Heart, Lung, and Blood Institute (NHLBI) Workshop Report.
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Shimbo D, Shah RU, Abdalla M, Agarwal R, Ahmad FS, Anaya G, Attia ZI, Bull S, Chang AR, Commodore-Mensah Y, Ferdinand K, Kawamoto K, Khera R, Leopold J, Luo J, Makhni S, Mortazavi BJ, Oh YS, Savage LC, Spatz ES, Stergiou G, Turakhia MP, Whelton PK, Yancy CW, and Iturriaga E
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Hypertension is among the most important risk factors for cardiovascular disease, chronic kidney disease, and dementia. The artificial intelligence (AI) field is advancing quickly, and there has been little discussion on how AI could be leveraged for improving the diagnosis and management of hypertension. AI technologies, including machine learning tools, could alter the way we diagnose and manage hypertension, with potential impacts for improving individual and population health. The development of successful AI tools in public health and health care systems requires diverse types of expertise with collaborative relationships between clinicians, engineers, and data scientists. Unbiased data sources, management, and analyses remain a foundational challenge. From a diagnostic standpoint, machine learning tools may improve the measurement of blood pressure and be useful in the prediction of incident hypertension. To advance the management of hypertension, machine learning tools may be useful to find personalized treatments for patients using analytics to predict response to antihypertension medications and the risk for hypertension-related complications. However, there are real-world implementation challenges to using AI tools in hypertension. Herein, we summarize key findings from a diverse group of stakeholders who participated in a workshop held by the National Heart, Lung, and Blood Institute in March 2023. Workshop participants presented information on communication gaps between clinical medicine, data science, and engineering in health care; novel approaches to estimating BP, hypertension risk, and BP control; and real-world implementation challenges and issues.
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- 2024
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5. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome After SARS-CoV-2 Infection.
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Unger ER, Lin JS, Wisk LE, Yu H, L'Hommedieu M, Lavretsky H, Montoy JCC, Gottlieb MA, Rising KL, Gentile NL, Santangelo M, Venkatesh AK, Rodriguez RM, Hill MJ, Geyer RE, Kean ER, Saydah S, McDonald SA, Huebinger R, Idris AH, Dorney J, Hota B, Spatz ES, Stephens KA, Weinstein RA, and Elmore JG
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- Humans, Female, Adult, Male, Prospective Studies, Middle Aged, Longitudinal Studies, Prevalence, Young Adult, United States epidemiology, Adolescent, Fatigue Syndrome, Chronic epidemiology, COVID-19 epidemiology, COVID-19 complications, SARS-CoV-2
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Importance: Chronic symptoms reported following an infection with SARS-CoV-2, such as cognitive problems, overlap with symptoms included in the definition of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)., Objective: To evaluate the prevalence of ME/CFS-like illness subsequent to acute SARS-CoV-2 infection, changes in ME/CFS symptoms through 12 months of follow-up, and the association of ME/CFS symptoms with SARS-CoV-2 test results at the acute infection-like index illness., Design, Setting, and Participants: This prospective, multisite, longitudinal cohort study (Innovative Support for Patients with SARS-CoV-2 Infections Registry [INSPIRE]) enrolled participants from December 11, 2020, to August 29, 2022. Participants were adults aged 18 to 64 years with acute symptoms suggestive of SARS-CoV-2 infection who received a US Food and Drug Administration-approved SARS-CoV-2 test at the time of illness and did not die or withdraw from the study by 3 months. Follow-up surveys were collected through February 28, 2023., Exposure: COVID-19 status (positive vs negative) at enrollment., Main Outcome and Measures: The main outcome was the weighted proportion of participants with ME/CFS-like illness based on the 2015 Institute of Medicine clinical case definition using self-reported symptoms., Results: A total of 4378 participants were included in the study. Most were female (3226 [68.1%]). Mean (SD) age was 37.8 (11.8) years. The survey completion rates ranged from 38.7% (3613 of 4738 participants) to 76.3% (1835 of 4738) and decreased over time. The weighted proportion of participants identified with ME/CFS-like illness did not change significantly at 3 through 12 months of follow-up and was similar in the COVID-19-positive (range, 2.8%-3.7%) and COVID-19-negative (range, 3.1%-4.5%) groups. Adjusted analyses revealed no significant difference in the odds of ME/CFS-like illness at any time point between COVID-19-positive and COVID-19-negative individuals (marginal odds ratio range, 0.84 [95% CI, 0.42-1.67] to 1.18 [95% CI, 0.55-2.51])., Conclusions and Relevance: In this prospective cohort study, there was no evidence that the proportion of participants with ME/CFS-like illness differed between those infected with SARS-CoV-2 vs those without SARS-CoV-2 infection up to 12 months after infection. A 3% to 4% prevalence of ME/CFS-like illness after an acute infection-like index illness would impose a high societal burden given the millions of persons infected with SARS-CoV-2.
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- 2024
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6. Comparing Methods for Identifying Post-Market Patient Preferences at the Point of Decision-Making: Insights from Patients with Chronic Pain Considering a Spinal Cord Stimulator Device.
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Golembiewski EH, Leon-Garcia M, Gravholt DL, Brito JP, Spatz ES, Bendel MA, Montori VM, Maraboto AP, Hartasanchez SA, and Hargraves IG
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Purpose: To compare three methods for identifying patient preferences (MIPPs) at the point of decision-making: analysis of video-recorded patient-clinician encounters, post-encounter interviews, and post-encounter surveys., Patients and Methods: For the decision of whether to use a spinal cord stimulator device (SCS), a video coding scheme, interview guide, and patient survey were iteratively developed with 30 SCS decision-making encounters in a tertiary academic medical center pain clinic. Burke's grammar of motives was used to classify the attributed source or justification for a potential preference for each preference block. To compare the MIPPs, 13 patients' encounters with their clinician were video recorded and subsequently analyzed by 4 coders using the final video coding scheme. Six of these patients were interviewed, and 7 surveyed, immediately following their encounters., Results: For videos, an average of 66 (range 33-106) sets of utterances potentially indicating a patient preference (a preference block), surveys 33 (range 32-34), and interviews 25 (range 18-30) were identified. Thirty-eight unique themes (75 subthemes), each a preference topic, were identified from videos, surveys 19 themes (12 subthemes), and interviews 39 themes (54 subthemes). The proportion of preference blocks that were judged as expressing a preference that was clearly important to the patient or affected their decision was highest for interviews (72.8%), surveys (68.0%), and videos (27.0%). Videos mostly attributed preferences to the patient's situation (scene) (65%); interviews, the act of receiving or living with SCS (43%); surveys, the purpose of SCS (40%)., Conclusion: MIPPs vary in the type of preferences identified and the clarity of expressed preferences in their data sets. The choice of which MIPP to use depends on projects' goals and resources, recognizing that the choice of MIPP may affect which preferences are found., Competing Interests: Victor Montori works at Mayo Clinic’s Knowledge and Encounter Research Unit where we design, test, implement and disseminate shared decision-making interventions. We release free to use and derive no income from their use. The authors report no other conflicts of interest in this work., (© 2024 Golembiewski et al.)
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- 2024
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7. Evaluating Ischemic Heart Disease in Women: Focus on Angina With Nonobstructive Coronary Arteries (ANOCA).
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Maayah M, Latif N, Vijay A, Gallegos CM, Cigarroa N, Posada Martinez EL, Mazure CM, Miller EJ, Spatz ES, and Shah SM
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Ischemic heart disease (IHD) is common in women, and cardiovascular disease is a leading cause of morbidity and mortality. While obstructive coronary artery disease is the most common form of IHD, millions of women suffer from angina with nonobstructive coronary arteries (ANOCA), an umbrella term encompassing multiple nonatherosclerotic disorders of the coronary tree. The underlying pathology leading to ischemia in these syndromes may be challenging to diagnose, leaving many women without a diagnosis despite persistent symptoms that impact quality of life and adversely affect long-term cardiovascular prognosis. In the last decade, there have been significant advances in the recognition and diagnostic evaluation of ANOCA. Despite these advances, the standard approach to evaluating suspected IHD in women continues to focus predominantly on the assessment of atherosclerotic coronary artery disease, leading to missed opportunities to accurately diagnose and treat underlying coronary vasomotor disorders. The goal of this review is to describe advances in diagnostic testing that can be used to evaluate angina in women and present a pragmatic diagnostic algorithm to guide evaluation of ANOCA in symptomatic patients. The proposed approach for the assessment of ANOCA is consistent with prior expert consensus documents and guidelines but is predicated on the medical interview and pretest probability of disease to inform a personalized diagnostic strategy.
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- 2024
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8. Development and Iterative Design of Peer-based Discussions about Heart Health for Women.
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Spatz ES, Park T, and Breslin M
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Objective: To support women in their health journeys around cardiovascular risk reduction, providing: access to information; space to discuss complex and personal issues that may factor into decision making; and skills to support conversations with healthcare providers., Methods: We used a participatory design approach to develop peer sessions led by a non-clinical facilitator and a cardiologist, for women to learn, think, and discuss information and decision-making around cardiovascular risk. These sessions took place in-person and over video. A host invited her friends, family or network to the events. Sessions were designed to bring information to women at all stages of cardiovascular risk, including women with no prior experiences with heart health and women with established cardiovascular disease. The sessions provided information about cardiovascular risk and facilitated discussion around risk factors and treatment. Sessions were recorded, transcribed and analyzed using a grounded theory approach to identify emerging themes., Results: We conducted 12 groups, with an average of 6 women per group. Women were of all ages and spectrums of cardiovascular risk. The three major themes that emerged were: Starting Place (attitudes, beliefs, and behaviors toward cardiovascular care are informed by a blend of one's family history, personal interactions with their health and the health system, and approach to managing uncertainty); Lack of Sense-Making (seemingly simple recommendations to support heart health were much more complicated when related to their own risk and experience), and Self-Judgement and Judgement by Others (without support or validation, women may feel judged by others for not doing enough)., Conclusion: Peer sessions can illuminate the complicated issues women face when approaching decisions regarding cardiovascular health. These sessions may offer an alternative to the healthcare setting, for women to wrestle with complex issues that relate to their risk, and better prepare for visits with their healthcare providers.
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- 2024
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9. Secondary Prevention in Patients With Stroke Versus Myocardial Infarction: Analysis of 2 National Cohorts.
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Rivier CA, Acosta JN, Leasure AC, Forman R, Sharma R, de Havenon A, Spatz ES, Inzucchi SE, Kernan WN, Falcone GJ, and Sheth KN
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- Humans, Male, Female, Middle Aged, Cross-Sectional Studies, Aged, United States epidemiology, United Kingdom epidemiology, Blood Pressure drug effects, Risk Assessment methods, Antihypertensive Agents therapeutic use, Risk Factors, Practice Guidelines as Topic, Secondary Prevention methods, Myocardial Infarction prevention & control, Myocardial Infarction epidemiology, Stroke prevention & control, Stroke epidemiology, Platelet Aggregation Inhibitors therapeutic use, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use
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Background: The implementation of preventive therapies among patients with stroke remains inadequately explored, especially when compared with patients with myocardial infarction (MI), despite sharing similar vascular risk profiles. We tested the hypothesis that participants with a history of stroke have a worse cardiovascular prevention profile in comparison to participants with MI., Methods and Results: In cross-sectional analyses within the UK Biobank and All of Us Research Program, involving 14 760 (9193 strokes, 5567 MIs) and 7315 (2948 strokes, 4367 MIs) participants, respectively, we evaluated cardiovascular prevention profiles assessing low-density lipoprotein (<100 mg/dL), blood pressure (systolic, <140 mm Hg; and diastolic, <90 mm Hg), statin and antiplatelet use, and a cardiovascular prevention score that required meeting at least 3 of these criteria. The results revealed that, within the UK Biobank, patients with stroke had significantly lower odds of meeting all the preventive criteria compared with patients with MI: low-density lipoprotein control (odds ratio [OR], 0.73 [95% CI, 0.68-0.78]; P <0.001), blood pressure control (OR, 0.63 [95% CI, 0.59-0.68]; P <0.001), statin use (OR, 0.45 [95% CI, 0.42-0.48]; P <0.001), antiplatelet therapy use (OR, 0.30 [95% CI, 0.27-0.32]; P <0.001), and cardiovascular prevention score (OR, 0.42 [95% CI, 0.39-0.45]; P <0.001). Similar patterns were observed in the All of Us Research Program, with significant differences across all comparisons ( P <0.05), and further analysis suggested that the odds of having a good cardiovascular prevention score were influenced by race and ethnicity as well as neighborhood deprivation levels (interaction P <0.05 in both cases)., Conclusions: In 2 independent national cohorts, patients with stroke showed poorer cardiovascular prevention profiles and lower adherence to guideline-directed therapies compared with patients with MI. These findings underscore the need to explore the reasons behind the underuse of secondary prevention in vulnerable stroke survivors.
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- 2024
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10. Utilization of Fixed-Dose Combination Treatment for Hypertension in Medicare and Medicaid From 2016 to 2020.
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Essa M, Ross JS, Dhruva SS, Desai NR, Spatz ES, and Faridi KF
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- Humans, United States, Blood Pressure drug effects, Time Factors, Treatment Outcome, Drug Costs, Hypertension drug therapy, Hypertension diagnosis, Hypertension physiopathology, Antihypertensive Agents therapeutic use, Antihypertensive Agents administration & dosage, Antihypertensive Agents economics, Antihypertensive Agents adverse effects, Medicaid, Medicare economics, Drug Combinations, Practice Patterns, Physicians'
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Competing Interests: Disclosures Dr Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), and from Arnold Ventures; formerly received research support from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology and from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH; R01HS025164 and R01HL144644); and in addition, Dr Ross was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022. Dr Dhruva receives funding from Arnold Ventures and the Department of Veterans Affairs. Dr Dhruva serves on the Medicare Evidence Development & Coverage Advisory Committee and the Institute for Clinical and Economic Review California Technology Assessment Forum. Dr Desai reports working under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures used for public reporting and pay for performance programs. He reports research grants and/or consulting for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, MyoKardia, Novartis, scPharmaceuticals, and Vifor Pharma.” Dr Spatz receives funding from the Centers for Disease Control and Prevention (20042801-Sub01), the US Food and Drug Administration to support projects within the Yale-Mayo Clinic CERSI (U01FD005938), the NHLBI (R01HL151240), and the Patient Centered Outcomes Research Institute (HM-2022C2-28354). Dr Faridi receives research funding from the NIH/NHLBI (K23HL161424), outside the scope of the current work. The other author reports no conflicts.
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- 2024
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11. Development and multinational validation of an algorithmic strategy for high Lp(a) screening.
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Aminorroaya A, Dhingra LS, Oikonomou EK, Saadatagah S, Thangaraj P, Vasisht Shankar S, Spatz ES, and Khera R
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- Humans, Female, Male, Reproducibility of Results, Middle Aged, Predictive Value of Tests, Aged, Risk Assessment methods, Decision Support Techniques, Cardiovascular Diseases diagnosis, Cardiovascular Diseases epidemiology, Cardiovascular Diseases blood, Adult, United States epidemiology, Mass Screening methods, Lipoprotein(a) blood, Machine Learning, Biomarkers blood, Biomarkers analysis, Algorithms
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Elevated lipoprotein (a) (Lp(a)) is associated with premature atherosclerotic cardiovascular disease. However, fewer than 0.5% of individuals undergo Lp(a) testing, limiting the evaluation and use of novel targeted therapeutics currently under development. Here we describe the development of a machine learning model for targeted screening for elevated Lp(a) (≥150 nmol l
-1 ) in the UK Biobank (N = 456,815), the largest cohort with protocolized Lp(a) testing. We externally validated the model in 3 large cohort studies, ARIC (N = 14,484), CARDIA (N = 4,124) and MESA (N = 4,672). The model, Algorithmic Risk Inspection for Screening Elevated Lp(a) (ARISE), reduced the number needed to test to find one individual with elevated Lp(a) by up to 67.3%, based on the probability threshold, with consistent performance across external validation cohorts. ARISE could be used to optimize screening for elevated Lp(a) using commonly available clinical features, with the potential for its deployment in electronic health records to enhance the yield of Lp(a) testing in real-world settings., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)- Published
- 2024
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12. Predictors of Health-Related Quality of Life Among Women Participating in an Appointment-Based Cardiac Rehabilitation Program.
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Wright CX, Fournier S, Deng Y, Meng C, Tucker K, Spatz ES, Lichtman JH, Zhu C, Dreyer RP, and Oen-Hsiao JM
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Background: An alternative patient-centered appointment-based cardiac rehabilitation (CR) program has led to significant improvements in health outcomes for patients with cardiovascular disease. However, less is known about the effects of this approach on health-related quality of life (HRQoL), particularly for women., Objective: We examined the effects of a patient-centered appointment-based CR program on HRQoL by sex and examined predictors of HRQoL improvements specifically for women., Methods: Data were used from an urban single-center CR program at Yale New Haven Health (2012-2017). We collected information on patient demographics, socioeconomic status, and clinical characteristics. The Outcome Short-Form General Health Survey (SF-36) was used to measure HRQoL. We evaluated sex differences in SF-36 scores using t tests and used a multivariate linear regression model to examine predictors of improvements in HRQoL (total SF-36 score) for women., Results: A total of 1530 patients with cardiovascular disease (23.7% women, 4.8% Black; mean age, 64 ± 10.8 years) were enrolled in the CR program. Women were more likely to be older, Black, and separated, divorced, or widowed. Although women had lower total SF-36 scores on CR entry, there was no statistically significant difference in CR adherence or total SF-36 score improvements between sexes. Women who were employed and those with chronic obstructive pulmonary disease were more likely to have improvements in total SF-36 scores., Conclusion: Both men and women participating in an appointment-based CR program achieved significant improvements in HRQoL. This approach could be a viable alternative to conventional CR to optimize secondary outcomes for patients., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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13. Bundled Payments for Care Improvement and Quality of Care and Outcomes in Heart Failure.
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Oddleifson DA, Holmes DN, Alhanti B, Xu X, Heidenreich PA, Wadhera RK, Allen LA, Greene SJ, Fonarow GC, Spatz ES, and Desai NR
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- Humans, Male, Female, Aged, United States, Cross-Sectional Studies, Hospitals, Quality of Health Care, Medicare, Heart Failure
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Importance: The Centers for Medicare & Medicaid Services (CMS) Bundled Payments for Care Improvement (BPCI) program was launched in 2013 with a goal to improve care quality while lowering costs to Medicare., Objective: To compare changes in the quality and outcomes of care for patients hospitalized with heart failure according to hospital participation in the BPCI program., Design, Setting, and Participants: This cross-sectional study used a difference-in-difference approach to evaluate the BPCI program in 18 BPCI hospitals vs 211 same-state non-BPCI hospitals for various process-of-care measures and outcomes using American Heart Association Get With The Guidelines-Heart Failure registry and CMS Medicare claims data from November 1, 2008, to August 31, 2018. Data were analyzed from May 2022 to May 2023., Exposures: Hospital participation in CMS BPCI Model 2 Heart Failure, which paid hospitals in a fee-for-service process and then shared savings or required reimbursement depending on how the total cost of an episode of care compared with a target price., Main Outcomes and Measures: Primary end points included 7 quality-of-care measures. Secondary end points included 9 outcome measures, including in-hospital mortality and hospital-level risk-adjusted 30-day and 90-day all-cause readmission rate and mortality rate., Results: During the study period, 8721 patients were hospitalized in the 23 BPCI hospitals and 94 530 patients were hospitalized in the 224 same-state non-BPCI hospitals. Less than a third of patients (30 723 patients, 29.8%) were 75 years or younger; 54 629 (52.9%) were female, and 48 622 (47.1%) were male. Hospital participation in BPCI Model 2 was not associated with significant differential changes in the odds of various process-of-care measures, except for a decreased odds of evidence-based β-blocker at discharge (adjusted odds ratio [aOR], 0.63; 95% CI, 0.41-0.98; P = .04). Participation in the BPCI was not associated with a significant differential change in the odds of receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors at discharge, receiving an aldosterone antagonist at discharge, having a cardiac resynchronization therapy (CRT)-defibrillator or CRT pacemaker placed or prescribed at discharge, having implantable cardioverter-defibrillator (ICD) counseling or an ICD placed or prescribed at discharge, heart failure education being provided among eligible patients, or having a follow-up visit within 7 days or less. Participation in the BPCI was associated with a significant decrease in odds of in-hospital mortality (aOR, 0.67; 95% CI, 0.51-0.86; P = .002). Participation was not associated with a significant differential change in hospital-level risk-adjusted 30-day or 90-day all-cause readmission rate and 30-day or 90-day all-cause mortality rate., Conclusion and Relevance: In this study, hospital participation in the BPCI Model 2 Heart Failure program was not associated with improvement in process-of-care quality measures or 30-day or 90-day risk-adjusted all-cause mortality and readmission rates.
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- 2024
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14. Psychological Health and Ischemic Heart Disease in Women: A Review of Current Evidence and Clinical Considerations across the Healthspan.
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Gaffey AE and Spatz ES
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- Male, Humans, Female, Prospective Studies, Risk Factors, Anxiety, Anger, Myocardial Ischemia epidemiology
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Purpose of Review: Psychological health encompasses a constellation of negative and positive factors-i.e., psychosocial stress, depression, anxiety, trauma, loneliness and social isolation, anger and hostility, optimism, and a sense of purpose. This narrative review presents current evidence at the intersection of psychological health, risk of ischemic heart disease (IHD), and IHD-related outcomes, with an emphasis on associations in women., Recent Findings: For women, relations between psychological health and IHD reflect important sex and gender differences in biological and psychosocial factors. Although efforts devoted to understanding psychological health and IHD risk have varied by psychological factor-scientific evidence is strongest for psychosocial stress and depression, while anxiety, trauma, and positive psychological factors warrant more investigation-less optimal psychological health is consistently associated with an earlier and greater risk of IHD morbidity and mortality in women. Still, many past prospective studies of psychological factors and IHD risk had a limited representation of women, did not include analyses by sex, or failed to account for other influential, sex-specific factors. Thus, there are multiple pathways for further, rigorous investigation into psychological health-IHD associations, mechanisms, and empirically supported psychological interventions to mitigate IHD risk among women. Given the robust evidence linking psychological health with women's risk for IHD, implementing routine, brief, psychological screening is recommended. Significant life events, developmental milestones specific to women, and IHD diagnoses or events could cue further psychological assessment and referral, efforts which will mutually strengthen the evidence for integrated psychological and IHD care and delivery of such care to this vulnerable group., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
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- 2024
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15. Digital Health Interventions for Hypertension Management in US Populations Experiencing Health Disparities: A Systematic Review and Meta-Analysis.
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Katz ME, Mszar R, Grimshaw AA, Gunderson CG, Onuma OK, Lu Y, and Spatz ES
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- Female, Humans, Male, Middle Aged, Healthcare Disparities statistics & numerical data, United States, Digital Health, Hypertension therapy, Hypertension prevention & control, Telemedicine
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Importance: Hypertension remains a leading factor associated with cardiovascular disease, and demographic and socioeconomic disparities in blood pressure (BP) control persist. While advances in digital health technologies have increased individuals' access to care for hypertension, few studies have analyzed the use of digital health interventions in vulnerable populations., Objective: To assess the association between digital health interventions and changes in BP and to characterize tailored strategies for populations experiencing health disparities., Data Sources: In this systematic review and meta-analysis, a systematic search identified studies evaluating digital health interventions for BP management in the Cochrane Library, Ovid Embase, Google Scholar, Ovid MEDLINE, PubMed, Scopus, and Web of Science databases from inception until October 30, 2023., Study Selection: Included studies were randomized clinical trials or cohort studies that investigated digital health interventions for managing hypertension in adults; presented change in systolic BP (SBP) or baseline and follow-up SBP levels; and emphasized social determinants of health and/or health disparities, including a focus on marginalized populations that have historically been underserved or digital health interventions that were culturally or linguistically tailored to a population with health disparities. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline., Data Extraction and Synthesis: Two reviewers extracted and verified data. Mean differences in BP between treatment and control groups were analyzed using a random-effects model., Main Outcomes and Measures: Primary outcomes included mean differences (95% CIs) in SBP and diastolic BP (DBP) from baseline to 6 and 12 months of follow-up between digital health intervention and control groups. Shorter- and longer-term follow-up durations were also assessed, and sensitivity analyses accounted for baseline BP levels., Results: A total of 28 studies (representing 8257 participants) were included (overall mean participant age, 57.4 years [range, 46-71 years]; 4962 [60.1%], female). Most studies examined multicomponent digital health interventions incorporating remote BP monitoring (18 [64.3%]), community health workers or skilled nurses (13 [46.4%]), and/or cultural tailoring (21 [75.0%]). Sociodemographic characteristics were similar between intervention and control groups. Between the intervention and control groups, there were statistically significant mean differences in SBP at 6 months (-4.24 mm Hg; 95% CI, -7.33 to -1.14 mm Hg; P = .01) and SBP changes at 12 months (-4.30 mm Hg; 95% CI, -8.38 to -0.23 mm Hg; P = .04). Few studies (4 [14.3%]) reported BP changes and hypertension control beyond 1 year., Conclusions and Relevance: In this systematic review and meta-analysis of digital health interventions for hypertension management in populations experiencing health disparities, BP reductions were greater in the intervention groups compared with the standard care groups. The findings suggest that tailored initiatives that leverage digital health may have the potential to advance equity in hypertension outcomes.
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- 2024
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16. Prioritizing the Exposome to Reduce Cardiovascular Disease Burden.
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Spatz ES, Chen K, and Krumholz HM
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- Humans, Heart, Exposome, Cardiovascular Diseases prevention & control, Cardiovascular System
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- 2024
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17. Ethnic and racial differences in self-reported symptoms, health status, activity level, and missed work at 3 and 6 months following SARS-CoV-2 infection.
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O'Laughlin KN, Klabbers RE, Ebna Mannan I, Gentile NL, Geyer RE, Zheng Z, Yu H, Li SX, Chan KCG, Spatz ES, Wang RC, L'Hommedieu M, Weinstein RA, Plumb ID, Gottlieb M, Huebinger RM, Hagen M, Elmore JG, Hill MJ, Kelly M, McDonald S, Rising KL, Rodriguez RM, Venkatesh A, Idris AH, Santangelo M, Koo K, Saydah S, Nichol G, and Stephens KA
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- Adult, Humans, Self Report, Race Factors, COVID-19 Vaccines, Prospective Studies, SARS-CoV-2, Health Status, White, COVID-19 epidemiology
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Introduction: Data on ethnic and racial differences in symptoms and health-related impacts following SARS-CoV-2 infection are limited. We aimed to estimate the ethnic and racial differences in symptoms and health-related impacts 3 and 6 months after the first SARS-CoV-2 infection., Methods: Participants included adults with SARS-CoV-2 infection enrolled in a prospective multicenter US study between 12/11/2020 and 7/4/2022 as the primary cohort of interest, as well as a SARS-CoV-2-negative cohort to account for non-SARS-CoV-2-infection impacts, who completed enrollment and 3-month surveys ( N = 3,161; 2,402 SARS-CoV-2-positive, 759 SARS-CoV-2-negative). Marginal odds ratios were estimated using GEE logistic regression for individual symptoms, health status, activity level, and missed work 3 and 6 months after COVID-19 illness, comparing each ethnicity or race to the referent group (non-Hispanic or white), adjusting for demographic factors, social determinants of health, substance use, pre-existing health conditions, SARS-CoV-2 infection status, COVID-19 vaccination status, and survey time point, with interactions between ethnicity or race and time point, ethnicity or race and SARS-CoV-2 infection status, and SARS-CoV-2 infection status and time point., Results: Following SARS-CoV-2 infection, the majority of symptoms were similar over time between ethnic and racial groups. At 3 months, Hispanic participants were more likely than non-Hispanic participants to report fair/poor health (OR: 1.94; 95%CI: 1.36-2.78) and reduced activity (somewhat less, OR: 1.47; 95%CI: 1.06-2.02; much less, OR: 2.23; 95%CI: 1.38-3.61). At 6 months, differences by ethnicity were not present. At 3 months, Other/Multiple race participants were more likely than white participants to report fair/poor health (OR: 1.90; 95% CI: 1.25-2.88), reduced activity (somewhat less, OR: 1.72; 95%CI: 1.21-2.46; much less, OR: 2.08; 95%CI: 1.18-3.65). At 6 months, Asian participants were more likely than white participants to report fair/poor health (OR: 1.88; 95%CI: 1.13-3.12); Black participants reported more missed work (OR, 2.83; 95%CI: 1.60-5.00); and Other/Multiple race participants reported more fair/poor health (OR: 1.83; 95%CI: 1.10-3.05), reduced activity (somewhat less, OR: 1.60; 95%CI: 1.02-2.51; much less, OR: 2.49; 95%CI: 1.40-4.44), and more missed work (OR: 2.25; 95%CI: 1.27-3.98)., Discussion: Awareness of ethnic and racial differences in outcomes following SARS-CoV-2 infection may inform clinical and public health efforts to advance health equity in long-term outcomes., Competing Interests: JGE is Editor in Chief of Adult Primary Care topics for UpToDate. MG reports grant funding from the Rush Center for Emerging Infectious Diseases Research Grant, Biomedical Advanced Research and Development Authority Research Grant, Emergency Medicine Foundation/Council of Residency Directors in Emergency Medicine Education Research Grant, Emergency Medicine: Reviews and Perspectives Medical Education Research Grant, University of Ottawa Department of Medicine Education Grant; and Society of Directors of Research in Medical Education Grant. KLR reports research grant funding from Abbott Diagnostics, DermTech, MeMed, Prenosis, and Siemens Healthcare Diagnostics. RMR reports research funding for PROCOVAXED funded by NIAID R01AI166967-01 (PI: Rodriquez). KK reports HECAP funded by RWJF (contract number: 79308 PI: Ansell); Chicago Department of Public Health Order 2020–4 COVID-19 Data Sharing for Patient Safety and Capacity Management funded by CDC (contract number: 6NU50CK000556-01-04 PI: Saldanha). GN reports funding through National Institutes of Health. PROCOVAXED Trial, Site PI. Centers for Disease Control and Prevention. Clinical Core, INSPIRE Registry, PI. Patient-Centered Outcomes Research Institute, Washington, DC. University of Washington PCORNet Expansion Award, Joint PI. Abiomed Inc., Danvers, MA. Emergency Care Core for Trial of Impella in Patients with STEMI and Cardiogenic Shock (RECOVER IV), PI. ZOLL Medical Corp., Chelmsford, MA, Multidimensional Study of Oxygenation in Early Post-Resuscitation (MOSER), PI. Vapotherm Inc., Exeter, NH. Vapotherm Device for Rapid Cooling Study (VOS), Co-PI. ZOLL Circulation Inc., San Jose, CA. Better Resuscitation with Supersaturated Oxygen (BASSO) Study, Co-PI. Powerful Medical Inc., Bratislava, Slovakia, US Validation Study of AI-Enhanced Diagnosis of Occluding Myocardial Infarction, PI. CPR Therapeutics Inc., Putney, VT. Consultant. Heartbeam Inc., Santa Clara, CA. Consultant. Invero Health LLC, Montville, NJ. Consultant. Kestra Medical Technologies Inc., Kirkland, WA. Consultant. Orixha Inc., Saint Cyr Au Mont d’Or, France. Consultant. BrainCool AB, Lund, Sweden. Consultant Patent for measurement of blood flow during CPR; non-provisional patent pending for blood flow measurement during CPR using signal gating; non-provisional patent pending for reperfusion-injury modifying device; all assigned to University of Washington. KNO reports research grant funding for PROCOVOXED funded by NIAID R01 AI166967 (PI: Rodriguez). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 O’Laughlin, Klabbers, Ebna Mannan, Gentile, Geyer, Zheng, Yu, Li, Chan, Spatz, Wang, L’Hommedieu, Weinstein, Plumb, Gottlieb, Huebinger, Hagen, Elmore, Hill, Kelly, McDonald, Rising, Rodriguez, Venkatesh, Idris, Santangelo, Koo, Saydah, Nichol, Stephens and the INSPIRE Group.)
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- 2024
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18. Association of marital/partner status with hospital readmission among young adults with acute myocardial infarction.
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Zhu C, Dreyer RP, Li F, Spatz ES, Caraballo C, Mahajan S, Raparelli V, Leifheit EC, Lu Y, Krumholz HM, Spertus JA, D'Onofrio G, Pilote L, and Lichtman JH
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- Humans, Male, Female, Young Adult, Middle Aged, Risk Factors, Socioeconomic Factors, Heart, Patient Readmission, Myocardial Infarction epidemiology
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Introduction: Despite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We examined the association between marital/partner status and 1-year all-cause readmission and explored sex differences among young AMI survivors., Methods: Data were from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled young adults aged 18-55 years with AMI (2008-2012). The primary end point was all-cause readmission within 1 year of hospital discharge, obtained from medical records and patient interviews and adjudicated by a physician panel. We performed Cox proportional hazards models with sequential adjustment for demographic, socioeconomic, clinical, and psychosocial factors. Sex-marital/partner status interaction was also tested., Results: Of the 2,979 adults with AMI (2002 women [67.2%]; mean age 48 [interquartile range, 44-52] years), unpartnered individuals were more likely to experience all-cause readmissions compared with married/partnered individuals within the first year after hospital discharge (34.6% versus 27.2%, hazard ratio [HR] = 1.31; 95% confidence interval [CI], 1.15-1.49). The association attenuated but remained significant after adjustment for demographic and socioeconomic factors (adjusted HR, 1.16; 95% CI, 1.01-1.34), and it was not significant after further adjusting for clinical factors and psychosocial factors (adjusted HR, 1.10; 95%CI, 0.94-1.28). A sex-marital/partner status interaction was not significant (p = 0.69). Sensitivity analysis using data with multiple imputation and restricting outcomes to cardiac readmission yielded comparable results., Conclusions: In a cohort of young adults aged 18-55 years, unpartnered status was associated with 1.3-fold increased risk of all-cause readmission within 1 year of AMI discharge. Further adjustment for demographic, socioeconomic, clinical, and psychosocial factors attenuated the association, suggesting that these factors may explain disparities in readmission between married/partnered versus unpartnered young adults. Whereas young women experienced more readmission compared to similar-aged men, the association between marital/partner status and 1-year readmission did not vary by sex., Competing Interests: Dr. Spertus discloses providing consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare. He holds research grants from Bristol Meyers Squibb, Abbott Vascular and Janssen. He owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. No other authors report having any other disclosures to report. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Zhu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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19. Wearable Digital Health Technologies for Monitoring in Cardiovascular Medicine.
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Spatz ES, Ginsburg GS, Rumsfeld JS, and Turakhia MP
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- Humans, Digital Health, Wearable Electronic Devices, Monitoring, Ambulatory instrumentation, Monitoring, Ambulatory methods, Cardiovascular System
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- 2024
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20. National Trends in Racial and Ethnic Disparities in Use of Recommended Therapies in Adults with Atherosclerotic Cardiovascular Disease, 1999-2020.
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Lu Y, Liu Y, Dhingra LS, Caraballo C, Mahajan S, Massey D, Spatz ES, Sharma R, Rodriguez F, Watson KE, Masoudi FA, and Krumholz HM
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- Adult, Humans, Female, Aged, Nutrition Surveys, Cross-Sectional Studies, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Cardiovascular Diseases
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Importance: Despite efforts to improve the quality of care for patients with atherosclerotic cardiovascular disease (ASCVD), it is unclear whether the US has made progress in reducing racial and ethnic differences in utilization of guideline-recommended therapies for secondary prevention., Objective: To evaluate 21-year trends in racial and ethnic differences in utilization of guideline-recommended pharmacological medications and lifestyle modifications among US adults with ASCVD., Design, Setting, and Participants: This cross-sectional study includes data from the National Health and Nutrition Examination Survey between 1999 and 2020. Eligible participants were adults aged 18 years or older with a history of ASCVD. Data were analyzed between March 2022 and May 2023., Exposure: Self-reported race and ethnicity., Main Outcome and Measures: Rates and racial and ethnic differences in the use of guideline-recommended pharmacological medications and lifestyle modifications., Results: The study included 5218 adults with a history of ASCVD (mean [SD] age, 65.5 [13.2] years, 2148 women [weighted average, 44.2%]), among whom 1170 (11.6%) were Black, 930 (7.7%) were Hispanic or Latino, and 3118 (80.7%) were White in the weighted sample. Between 1999 and 2020, there was a significant increase in total cholesterol control and statin use in all racial and ethnic subgroups, and in angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) utilization in non-Hispanic White individuals and Hispanic and Latino individuals (Hispanic and Latino individuals: 17.12 percentage points; 95% CI, 0.37-37.88 percentage points; P = .046; non-Hispanic White individuals: 12.14 percentage points; 95% CI, 6.08-18.20 percentage points; P < .001), as well as smoking cessation within the Hispanic and Latino population (-27.13 percentage points; 95% CI, -43.14 to -11.12 percentage points; P = .002). During the same period, the difference in smoking cessation between Hispanic and Latino individuals and White individuals was reduced (-24.85 percentage points; 95% CI, -38.19 to -11.51 percentage points; P < .001), but racial and ethnic differences for other metrics did not change significantly. Notably, substantial gaps persisted between current care and optimal care throughout the 2 decades of data analyzed. In the period of 2017 to 2020, optimal regimens were observed in 47.4% (95% CI, 39.3%-55.4%), 48.7% (95% CI, 36.7%-60.6%), and 53.0% (95% CI, 45.6%-60.4%) of Black, Hispanic and Latino, and White individuals, respectively., Conclusions and Relevance: In this cross-sectional study of US adults with ASCVD, significant disparities persisted between current care and optimal care, surpassing any differences observed among demographic groups. These findings highlight the critical need for sustained efforts to bridge these gaps and achieve better outcomes for all patients, regardless of their racial and ethnic backgrounds.
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- 2023
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21. Healthcare Market-Level and Hospital-Level Disparities in Access to and Utilization of High-Quality Hip and Knee Replacement Hospitals Among Medicare Beneficiaries.
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Oddleifson DA, Xu X, Wiznia D, Gibson D, Spatz ES, and Desai NR
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Introduction: This study aimed to determine whether healthcare markets with higher social vulnerability have lower access to high-quality hip and knee replacement hospitals and whether hospitals that serve a higher percentage of low-income patients are less likely to be designated as high-quality., Methods: This cross-sectional study used 2021 Centers for Medicare and Medicaid Services outcome measures and 2022 Joint Commission (JC) process-of-care measures to identify hospitals performing high-quality hip and knee replacement. A total of 2,682 hospitals and 304 healthcare markets were included. For the market-level analysis, we assessed the association of social vulnerability with the presence of a high-quality hip and knee replacement center. For the hospital-level analysis, we assessed the association of disproportionate share hospital (DSH) percentage with each high-quality designation. Healthcare markets were approximated by hospital referral regions. All associations were assessed with fractional regressions using generalized linear models with binomial family and logit links., Results: We found that healthcare markets in the most vulnerable quartile were less likely to have a hip and knee replacement hospital that did better than the national average (odds ratio [OR] 0.22, P = 0.02) but not more or less likely to have a hospital certified as advanced by JC (OR 0.41, P = 0.16). We found that hip and knee replacement hospitals in the highest DSH quartile were less likely to be designated by the Centers for Medicare and Medicaid Services as better than the national average (OR 0.18, P = 0.001) but not more or less likely to be certified as advanced by JC (OR 1.40, P = 0.28)., Discussion: Geographic distribution of high-quality hospitals may contribute to socioeconomic disparities in patients' access to and utilization of high-quality hip and knee replacement. Equal access to and utilization of hospitals with high-quality surgical processes does not necessarily indicate equitable access to and utilization of hospitals with high-quality outcomes., Level of Evidence: Level III., (Copyright © 2023 by the American Academy of Orthopaedic Surgeons.)
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- 2023
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22. 2022 ACC/AHA guideline for the diagnosis and management of aortic disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.
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Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A Jr, Fanola CL, Girardi LN, Hicks CW, Hui DS, Schuyler Jones W, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Ross EG, Schermerhorn ML, Singleton Times S, Tseng EE, Wang GJ, Woo YJ, Faxon DP, Upchurch GR Jr, Aday AW, Azizzadeh A, Boisen M, Hawkins B, Kramer CM, Luc JGY, MacGillivray TE, Malaisrie SC, Osteen K, Patel HJ, Patel PJ, Popescu WM, Rodriguez E, Sorber R, Tsao PS, Santos Volgman A, Beckman JA, Otto CM, O'Gara PT, Armbruster A, Birtcher KK, de Las Fuentes L, Deswal A, Dixon DL, Gorenek B, Haynes N, Hernandez AF, Joglar JA, Jones WS, Mark D, Mukherjee D, Palaniappan L, Piano MR, Rab T, Spatz ES, Tamis-Holland JE, and Woo YJ
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- Female, Pregnancy, United States, Humans, American Heart Association, Aorta, Aortic Diseases diagnosis, Aortic Diseases therapy, Bicuspid Aortic Valve Disease, Cardiology
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Aim: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes)., Methods: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate., Structure: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease., (Copyright © 2022 American College of Cardiology Foundation and the American Heart Association, Inc. Published by Elsevier. Published by Elsevier Inc. All rights reserved.)
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- 2023
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23. Development and Multinational Validation of a Novel Algorithmic Strategy for High Lp(a) Screening.
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Aminorroaya A, Dhingra LS, Oikonomou EK, Saadatagah S, Thangaraj P, Shankar SV, Spatz ES, and Khera R
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Importance: Elevated lipoprotein(a) [Lp(a)] is associated with atherosclerotic cardiovascular disease (ASCVD) and major adverse cardiovascular events (MACE). However, fewer than 0.5% of patients undergo Lp(a) testing, limiting the evaluation and use of novel targeted therapeutics currently under development., Objective: We developed and validated a machine learning model to enable targeted screening for elevated Lp(a)., Design: Cross-sectional., Setting: 4 multinational population-based cohorts., Participants: We included 456,815 participants from the UK Biobank (UKB), the largest cohort with protocolized Lp(a) testing for model development. The model's external validity was assessed in Atherosclerosis Risk in Communities (ARIC) (N=14,484), Coronary Artery Risk Development in Young Adults (CARDIA) (N=4,124), and Multi-Ethnic Study of Atherosclerosis (MESA) (N=4,672) cohorts., Exposures: Demographics, medications, diagnoses, procedures, vitals, and laboratory measurements from UKB and linked electronic health records (EHR) were candidate input features to predict high Lp(a). We used the pooled cohort equations (PCE), an ASCVD risk marker, as a comparator to identify elevated Lp(a)., Main Outcomes and Measures: The main outcome was elevated Lp(a) (≥150 nmol/L), and the number-needed-to-test (NNT) to find one case with elevated Lp(a). We explored the association of the model's prediction probabilities with all-cause and cardiovascular mortality, and MACE., Results: The Algorithmic Risk Inspection for Screening Elevated Lp(a) (ARISE) used low-density lipoprotein cholesterol, statin use, triglycerides, high-density lipoprotein cholesterol, history of ASCVD, and anti-hypertensive medication use as input features. ARISE outperformed cardiovascular risk stratification through PCE for predicting elevated Lp(a) with a significantly lower NNT (4.0 versus 8.0 [with or without PCE], P<0.001). ARISE performed comparably across external validation cohorts and subgroups, reducing the NNT by up to 67.3%, depending on the probability threshold. Over a median follow-up of 4.2 years, a high ARISE probability was also associated with a greater hazard of all-cause death and MACE (age/sex-adjusted hazard ratio [aHR], 1.35, and 1.38, respectively, P<0.001), with a greater increase in cardiovascular mortality (aHR, 2.17, P<0.001)., Conclusions and Relevance: ARISE optimizes screening for elevated Lp(a) using commonly available clinical features. ARISE can be deployed in EHR and other settings to encourage greater Lp(a) testing and to improve identifying cases eligible for novel targeted therapeutics in trials., Key Points: Question: How can we optimize the identification of individuals with elevated lipoprotein(a) [Lp(a)] who may be eligible for novel targeted therapeutics? Findings: Using 4 multinational population-based cohorts, we developed and validated a machine learning model, Algorithmic Risk Inspection for Screening Elevated Lp(a) (ARISE), to enable targeted screening for elevated Lp(a). In contrast to the pooled cohort equations that do not identify those with elevated Lp(a), ARISE reduces the "number-needed-to-test" to find one case with elevated Lp(a) by up to 67.3%. Meaning: ARISE can be deployed in electronic health records and other settings to enable greater yield of Lp(a) testing, thereby improving the identification of individuals with elevated Lp(a).
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- 2023
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24. Shared Decision-Making and Cardiovascular Health: A Scientific Statement From the American Heart Association.
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Dennison Himmelfarb CR, Beckie TM, Allen LA, Commodore-Mensah Y, Davidson PM, Lin G, Lutz B, and Spatz ES
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- Humans, Decision Making, Shared, Patient Participation methods, Communication, American Heart Association, Decision Making
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Shared decision-making is increasingly embraced in health care and recommended in cardiovascular guidelines. Patient involvement in health care decisions, patient-clinician communication, and models of patient-centered care are critical to improve health outcomes and to promote equity, but formal models and evaluation in cardiovascular care are nascent. Shared decision-making promotes equity by involving clinicians and patients, sharing the best available evidence, and recognizing the needs, values, and experiences of individuals and their families when faced with the task of making decisions. Broad endorsement of shared decision-making as a critical component of high-quality, value-based care has raised our awareness, although uptake in clinical practice remains suboptimal for a range of patient, clinician, and system issues. Strategies effective in promoting shared decision-making include educating clinicians on communication techniques, engaging multidisciplinary medical teams, incorporating trained decision coaches, and using tools (ie, patient decision aids) at appropriate literacy and numeracy levels to support patients in their cardiovascular decisions. This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes and the potential of shared decision-making as a driver of health equity so that everyone has just opportunities. Multilevel solutions must align to address challenges in policies and reimbursement, system-level leadership and infrastructure, clinician training, access to decision aids, and patient engagement to fully support patients and clinicians to engage in the shared decision-making process and to drive equity and improvement in cardiovascular outcomes.
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- 2023
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25. Impact of Marital Stress on 1-Year Health Outcomes Among Young Adults With Acute Myocardial Infarction.
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Zhu C, Dreyer RP, Li F, Spatz ES, Caraballo-Cordovez C, Mahajan S, Raparelli V, Leifheit EC, Lu Y, Krumholz HM, Spertus JA, D'Onofrio G, Pilote L, and Lichtman JH
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- Humans, Female, Male, Young Adult, Heart, Angina Pectoris, Drugs, Generic, Outcome Assessment, Health Care, Quality of Life, Myocardial Infarction epidemiology
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Background Stress experienced in a marriage or committed relationship may be associated with worse patient-reported outcomes after acute myocardial infarction (AMI), but little is known about this association in young adults (≤55 years) with AMI. Methods and Results We used data from VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), an observational cohort study that enrolled individuals aged 18 to 55 years with AMI (2008-2012). Marital stress was self-reported 1 month after AMI using the Stockholm Marital Stress Scale (categorized as absent/mild, moderate, and severe). Outcomes were physical/mental health (Short Form-12 ) , generic health status (EuroQol-5 Dimensions), cardiac-specific quality of life and angina (Seattle Angina Questionnaire), depressive symptoms (Patient Health Questionnaire-9), and all-cause readmission 1 year after AMI. Regression models were sequentially adjusted for baseline health, demographics (sex, age, race or ethnicity), and socioeconomic factors (education, income, employment, and insurance). Sex and marital stress interaction was also tested. Among 1593 married/partnered participants, 576 (36.2%) reported severe marital stress, which was more common in female than male participants (39.4% versus 30.4%, P =0.001). Severe marital stress was significantly associated with worse mental health (beta=-2.13, SE=0.75, P =0.004), generic health status (beta=-3.87, SE=1.46, P =0.008), cardiac-specific quality of life (beta=-6.41, SE=1.65, P <0.001), and greater odds of angina (odds ratio [OR], 1.49 [95% CI, 1.06-2.10], P =0.023) and all-cause readmissions (OR, 1.45 [95% CI, 1.04-2.00], P =0.006), after adjusting for baseline health, demographics, and socioeconomic factors. These associations were similar across sexes ( P -interaction all >0.05). Conclusions The association between marital stress and worse 1-year health outcomes was statistically significant in young patients with AMI, suggesting a need for routine screening and the creation of interventions to support patients with stress recovering from an AMI.
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- 2023
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26. Association of SGLT-2 Inhibitors With Treatment Satisfaction and Diabetes-Specific and General Health Status in Adults With Cardiovascular Disease and Type 2 Diabetes.
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Ding Q, Spatz ES, Bena JF, Morrison SL, Levay M, Lin H, Grey M, Edwards NE, Isaacs D, West L, Combs P, and Albert NM
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- Humans, Adult, Quality of Life, Propensity Score, Personal Satisfaction, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Cardiovascular Diseases epidemiology
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Background It is unknown if initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT-2i) is associated with changes in patient-reported health status outside of clinical trials. Methods and Results Using a prospective observational study design, adults with type 2 diabetes and cardiovascular disease were recruited from 14 US hospitals between November 2019 and December 2021 if they were new users of noninsulin antidiabetic medications. The primary outcome was change in 6-month diabetes treatment satisfaction. Secondary outcomes included diabetes-related symptom distress, diabetes-specific quality of life, and general health status for all patients and based on cardiovascular disease type. Inverse probability of treatment weight using propensity score was performed to compare outcome changes based on medication use. Of 887 patients (SGLT-2i: n=242) included in the inverse probability of treatment weight analyses, there was no difference in changes in treatment satisfaction in SGLT-2i users compared with other diabetes medication users (0.99 [95% CI, -0.14 to 2.13] versus 1.54 [1.08 to 2.00], P =0.38). Initiating an SGLT-2i versus other diabetes medications was associated with a greater reduction in ophthalmological symptoms (-3.09 [95% CI, -4.99 to -1.18] versus -0.38 [-1.54 to 0.77], P =0.018) but less improvement in hyperglycemia (1.08 [-2.63 to 4.79] versus -3.60 [-5.34 to -1.86], P =0.026). In subgroup analyses by cardiovascular disease type, SGLT-2i use was associated with a greater reduction in total diabetes symptom burden and neurological sensory symptoms in patients with heart failure. Conclusions Among patients with type 2 diabetes and cardiovascular disease, initiating an SGLT-2i was not associated with changes in diabetes treatment satisfaction, total diabetes symptoms, diabetes-specific quality of life, or general health status.
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- 2023
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27. Prevalence of Symptoms ≤12 Months After Acute Illness, by COVID-19 Testing Status Among Adults - United States, December 2020-March 2023.
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Montoy JCC, Ford J, Yu H, Gottlieb M, Morse D, Santangelo M, O'Laughlin KN, Schaeffer K, Logan P, Rising K, Hill MJ, Wisk LE, Salah W, Idris AH, Huebinger RM, Spatz ES, Rodriguez RM, Klabbers RE, Gatling K, Wang RC, Elmore JG, McDonald SA, Stephens KA, Weinstein RA, Venkatesh AK, and Saydah S
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- Adult, Humans, Acute Disease epidemiology, Cohort Studies, COVID-19 Testing, Post-Acute COVID-19 Syndrome epidemiology, Prevalence, Prospective Studies, SARS-CoV-2, United States epidemiology, COVID-19 epidemiology
- Abstract
To further the understanding of post-COVID conditions, and provide a more nuanced description of symptom progression, resolution, emergence, and reemergence after SARS-CoV-2 infection or COVID-like illness, analysts examined data from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), a prospective multicenter cohort study. This report includes analysis of data on self-reported symptoms collected from 1,296 adults with COVID-like illness who were tested for SARS-CoV-2 using a Food and Drug Administration-approved polymerase chain reaction or antigen test at the time of enrollment and reported symptoms at 3-month intervals for 12 months. Prevalence of any symptom decreased substantially between baseline and the 3-month follow-up, from 98.4% to 48.2% for persons who received a positive SARS-CoV-2 test results (COVID test-positive participants) and from 88.2% to 36.6% for persons who received negative SARS-CoV-2 test results (COVID test-negative participants). Persistent symptoms decreased through 12 months; no difference between the groups was observed at 12 months (prevalence among COVID test-positive and COVID test-negative participants = 18.3% and 16.1%, respectively; p>0.05). Both groups reported symptoms that emerged or reemerged at 6, 9, and 12 months. Thus, these symptoms are not unique to COVID-19 or to post-COVID conditions. Awareness that symptoms might persist for up to 12 months, and that many symptoms might emerge or reemerge in the year after COVID-like illness, can assist health care providers in understanding the clinical signs and symptoms associated with post-COVID-like conditions., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Joann G. Elmore reports serving as editor-in-chief and receiving royalties from UpToDate, Inc. Michael Gottlieb reports grant support from the Society for Academic Emergency Medicine, the Society of Directors of Research in Medical Education, Rush Center for Emerging Infectious Diseases, Emergency Medicine: Reviews and Perspective, and the Emergency Medicine Foundation. Ahamed H. Idris reports travel support from the University of Michigan for attendance at Wolf Creek 17 conference, unpaid membership on the Stryker clinical advisory board, and unpaid volunteer chairmanship of the American Heart Association ethics writing group. Kelli N. O’Laughlin reports support from PROCOVAXED, from the National Institute on Allergy and Infectious Diseases, National Institutes of Health (NIH). Kristin Rising reports research grants from Abbott, Siemens diagnostics, DermTech, Ortho Diagnostics, NIH, and the Philadelphia Department of Public Health. Arjun K. Venkatesh reports grant support from the Society for Academic Emergency Medicine Foundation to study COVID-19 effects on hospitals. Robert A. Weinstein reports payments from UpToDate, Inc. for reviewing topics. No other potential conflicts of interest were disclosed.
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- 2023
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28. Physician responses to apple watch-detected irregular rhythm alerts.
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Demkowicz PC, Dhruva SS, Spatz ES, Beatty AL, Ross JS, and Khera R
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- Humans, Physicians, Atrial Fibrillation drug therapy, Cardiology
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Background: While the US Food and Drug Administration (FDA) has cleared smartwatch software for detecting atrial fibrillation (AF), there is lack of guidance on management by physicians. We sought to evaluate the approach to management of Apple Watch alerts for AF by physicians and assess whether respondent and case characteristics were associated with their approach., Methods: We conducted a case-based survey of physicians practicing primary care, emergency medicine, and cardiology at 2 large academic centers (Yale and University of California San Francisco) between September and December 2021. Cases described asymptomatic patients receiving Apple Watch AF alerts; cases varied in sex, race, medical history, and notification frequency. We evaluated physician responses among prespecified diagnostic testing, referral, and treatment options., Results: We emailed 636 physicians, of whom 95 (14.9%) completed the survey, including 39 primary care, 25 emergency medicine, and 31 cardiology physicians. Among a total of 192 cases (16 unique scenarios), physicians selected at least one diagnostic test in 191 (99.5%) cases and medications in 48 (25.0%). Physicians in primary care, emergency medicine, and cardiology reported varying preference for patient referral (14%, 30%, and 16%, respectively; P=.048), rhythm monitoring (84%, 46%, and 94%, respectively; P<.001), measurement of BNP (8%, 20%, and 2%; P=.003), and use of antiarrhythmics (16%, 4%, and 23%; P=.023). There were few physician differences in reported practices across patient demographics (sex and race), clinical complexity, and alert frequency of the clinical case., Conclusions: In hypothetical cases of patients presenting without clinical symptoms, physicians opted for further diagnostic testing and often to medical intervention based on Apple Watch irregular rhythm notifications. There was also considerable variation across physician specialties, suggesting a need for uniform clinical practice guidelines. Additional study is required before irregular rhythm notifications should be used in clinical settings., Competing Interests: Conflict of Interest The authors declare no competing nonfinancial interests., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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29. Illness Perception and the Impact of a Definitive Diagnosis on Women With Ischemia and No Obstructive Coronary Artery Disease: A Qualitative Study.
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Tseng LY, Göç N, Schwann AN, Cherlin EJ, Kunnirickal SJ, Odanovic N, Curry LA, Shah SM, and Spatz ES
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- Humans, Female, Middle Aged, Quality of Life psychology, Ischemia, Perception, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Myocardial Ischemia diagnosis
- Abstract
Background: Ischemia and no obstructive coronary artery disease (INOCA) disproportionately impacts women, yet the underlying pathologies are often not distinguished, contributing to adverse health care experiences and poor quality of life. Coronary function testing at the time of invasive coronary angiography allows for improved diagnostic accuracy. Despite increased recognition of INOCA and expanding access to testing, data lack on first-person perspectives and the impact of receiving a diagnosis in women with INOCA., Methods: From 2020 to 2021, we conducted structured telephone interviews with 2 groups of women with INOCA who underwent invasive coronary angiography (n=29) at Yale New Haven Hospital, New Haven, CT: 1 group underwent coronary function testing (n=20, of whom 18 received a mechanism-based diagnosis) and the other group who did not undergo coronary function testing (n=9). The interviews were analyzed using the constant comparison method by a multidisciplinary team., Results: The mean age was 59.7 years, and 79% and 3% were non-Hispanic White and non-Hispanic Black, respectively. Through iterative coding, 4 themes emerged and were further separated into subthemes that highlight disease experience aspects to be addressed in patient care: (1) distress from symptoms of uncertain cause: symptom constellation, struggle for sensemaking, emotional toll, threat to personal and professional identity; (2) a long journey to reach a definitive diagnosis: self-advocacy and fortitude, healthcare interactions brought about further uncertainty and trauma, therapeutic alliance, sources of information; (3) establishing a diagnosis enabled a path forward: relief and validation, empowerment; and (4) commitment to promoting awareness and supporting other women: recognition of sex and racial/ethnic disparities, support for other women., Conclusions: Insights about how women experience the symptoms of INOCA and their interactions with clinicians and the healthcare system hold powerful lessons for more patient-centered care. A coronary function testing-informed diagnosis greatly influences the healthcare experiences, quality of life, and emotional states of women with INOCA., Competing Interests: Disclosures Dr Spatz receives grant funding from the Centers for Disease Control and Prevention (20042801-Sub01), National Institute on Minority Health and Health Disparities (U54MD010711-01), and the US Food and Drug Administration to support projects within the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI; U01FD005938), including a project to develop a novel survey tool for women with ischemia and no obstructive coronary artery disease. She also receives funding from the National Institute of Biomedical Imaging and Bioengineering (R01 EB028106-01) and the National Heart, Lung, and Blood Institute (R01HL151240). S.M. Shah receives research support from Women’s Health Research at Yale, Abbott Vascular Inc and the US Food and Drug Administration to support projects within the Yale-Mayo CERSI (U01FD005938), including a project to develop a novel survey tool for women with ischemia and no obstructive coronary artery disease. The other authors report no conflicts.
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- 2023
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30. Exertional Syncope in College Varsity Athletes.
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Gier C, Shapero K, Lynch M, Spatz ES, Young L, Arlis-Mayor S, and Lampert R
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- Humans, Syncope diagnosis, Syncope epidemiology, Syncope etiology, Athletes, Sports
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- 2023
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31. Variation in Risk-Standardized Acute Admission Rates Among Patients With Heart Failure in Accountable Care Organizations: Implications for Quality Measurement.
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Chuzi S, Lindenauer PK, Faridi K, Priya A, Pekow PS, D'Aunno T, Mazor KM, Stefan MS, Spatz ES, Gilstrap L, Werner RM, and Lagu T
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- Aged, Aged, 80 and over, Female, Humans, Male, Costs and Cost Analysis, Medicare, United States epidemiology, Accountable Care Organizations methods, Heart Failure diagnosis, Heart Failure epidemiology, Heart Failure therapy, Hospitalization
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Background Accountable care organizations (ACOs) aim to improve health care quality and reduce costs, including among patients with heart failure (HF). However, variation across ACOs in admission rates for patients with HF and associated factors are not well described. Methods and Results We identified Medicare fee-for-service beneficiaries with HF who were assigned to a Medicare Shared Savings Program ACO in 2017 and survived ≥30 days into 2018. We calculated risk-standardized acute admission rates across ACOs, assigned ACOs to 1 of 3 performance categories, and examined associations between ACO characteristics and performance categories. Among 1 232 222 beneficiaries with HF, 283 795 (mean age, 81 years; 54% women; 86% White; 78% urban) were assigned to 1 of 467 Medicare Shared Savings Program ACOs. Across ACOs, the median risk-standardized acute admission rate was 87 admissions per 100 people, ranging from 61 (minimum) to 109 (maximum) admissions per 100 beneficiaries. Compared to the overall average, 13% of ACOs performed better on risk-standardized acute admission rates, 72% were no different, and 14% performed worse. Most ACOs with better performance had fewer Black beneficiaries and were not hospital affiliated. Most ACOs that performed worse than average were large, located in the Northeast, had a hospital affiliation, and had a lower proportion of primary care providers. Conclusions Admissions are common among beneficiaries with HF in ACOs, and there is variation in risk-standardized acute admission rates across ACOs. ACO performance was associated with certain ACO characteristics. Future studies should attempt to elucidate the relationship between ACO structure and characteristics and admission risk.
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- 2023
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32. Association of Population Well-Being With Cardiovascular Outcomes.
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Spatz ES, Roy B, Riley C, Witters D, and Herrin J
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- Adult, Female, Humans, Male, Cross-Sectional Studies, Middle Aged, Aged, Cardiovascular Diseases epidemiology, Heart Diseases, Heart Failure, Stroke epidemiology
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Importance: Mortality from cardiovascular disease (CVD) varies across communities and is associated with known structural and population health factors. Still, a population's well-being, including sense of purpose, social relationships, financial security, and relationship to community, may be an important target to improve cardiovascular health., Objective: To examine the association of population level measures of well-being with rates of CVD mortality in the US., Design, Setting, and Participants: This cross-sectional study linked data from the Gallup National Health and Well-Being Index (WBI) survey to county-level rates of CVD mortality from the Centers for Disease Control and Prevention Atlas of Heart Disease and Stroke. Participants were respondents of the WBI survey, which was conducted by Gallup with randomly selected adults aged 18 years or older from 2015 to 2017. Data were analyzed from August 2022 to May 2023., Main Outcomes and Measures: The primary outcome was the county-level rate of total CVD mortality; secondary outcomes were mortality rates for stroke, heart failure, coronary heart disease, acute myocardial infarction, and total heart disease. The association of population well-being (measured using a modified version of the WBI) with CVD mortality was assessed, and an analysis of whether the association was modified by county structural factors (Area Deprivation Index [ADI], income inequality, and urbanicity) and population health factors (percentages of the adult population who had hypertension, diabetes, or obesity; were currently smoking; and were physically inactive) was conducted. Population WBI and its ability to mediate the association of structural factors associated with CVD using structural equation models was also assessed., Results: Well-being surveys were completed by 514 971 individuals (mean [SD] age 54.0 [19.2] years; 251 691 [48.9%] women; 379 521 [76.0%] White respondents) living in 3228 counties. Mortality rates for CVD decreased from a mean of 499.7 (range, 174.2-974.7) deaths per 100 000 persons in counties with the lowest quintile of population well-being to 438.6 (range, 110.1-850.4) deaths per 100 000 persons in counties with the highest quintile of population well-being. Secondary outcomes showed similar patterns. In the unadjusted model, the effect size (SE) of WBI on CVD mortality was -15.5 (1.5; P < .001), or a decrease of 15 deaths per 100 000 persons for each 1-point increase of population well-being. After adjusting for structural factors and structural plus population health factors, the association was attenuated but still significant, with an effect size (SE) of -7.3 (1.6; P < .001); for each 1-point increase in well-being, the total cardiovascular death rate decreased by 7.3 deaths per 100 000 persons. Secondary outcomes showed similar patterns, with mortality due to coronary heart disease and heart failure being significant in fully adjusted models. In mediation analyses, associations of income inequality and ADI with CVD mortality were all partly mediated by the modified population WBI., Conclusions and Relevance: In this cross-sectional study assessing the association of well-being and cardiovascular outcomes, higher well-being, a measurable, modifiable, and meaningful outcome, was associated with lower CVD mortality, even after controlling for structural and cardiovascular-related population health factors, indicating that well-being may be a focus for advancing cardiovascular health.
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- 2023
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33. Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial.
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Talasaz AH, Sadeghipour P, Bakhshandeh H, Sharif-Kashani B, Rashidi F, Beigmohammadi MT, Moghadam KG, Rezaian S, Dabbagh A, Sezavar SH, Farrokhpour M, Abedini A, Aliannejad R, Riahi T, Yadollahzadeh M, Lookzadeh S, Rezaeifar P, Matin S, Tahamtan O, Mohammadi K, Zoghi E, Rahmani H, Hosseini SH, Mousavian SM, Abri H, Sadeghipour P, Baghizadeh E, Rafiee F, Jamalkhani S, Amin A, Mohebbi B, Parhizgar SE, Soleimanzadeh M, Aghakouchakzadeh M, Eslami V, Payandemehr P, Khalili H, Talakoob H, Tojari T, Shafaghi S, Tabrizi S, Kakavand H, Kashefizadeh A, Najafi A, Jimenez D, Gupta A, Madhavan MV, Sethi SS, Parikh SA, Monreal M, Hadavand N, Hajighasemi A, Ansarin K, Maleki M, Sadeghian S, Barco S, Siegerink B, Spatz ES, Piazza G, Kirtane AJ, Tassell BWV, Lip GYH, Klok FA, Goldhaber SZ, Stone GW, Krumholz HM, and Bikdeli B
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- Adult, Humans, Female, Middle Aged, Male, Atorvastatin therapeutic use, Treatment Outcome, Intensive Care Units, Double-Blind Method, COVID-19, Thrombosis drug therapy
- Abstract
Background: In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days., Methods: This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale., Results: In the primary analysis, 587 patients were included (age: 57 [Q1-Q3: 45-68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.60-1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR: 0.60, 95% CI: 0.42-0.86, p
interaction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal : 0.64, 95% CI: 0.41-1.01, p = 0.05)., Conclusion: Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset (NCT04486508)., Competing Interests: D. V. reports consultant and speaker for BMS/Pfizer, Daiichi-Sankyo, Rovi, and Sanofi. Dr. Gupta received payment from the Arnold & Porter Law Firm for work related to the Sanofi clopidogrel litigation and from the Ben C. Martin Law Firm for work related to the Cook inferior vena cava filter litigation. A. G. holds equity in a health care telecardiology startup, Heartbeat Health, Inc., and received consulting fees from Edwards LifeSciences. M. V. M. has received support from an institutional grant by the National Institutes of Health/National Heart, Lung, and Blood Institute to Columbia University Irving Medical Center (T32 HL007854). S. S. S. reports honoraria from Janssen and Chiesi and research grant support from the American Heart Association. G. P. has received research support from Bristol-Myers Squibb/Pfizer Alliance, Bayer, Janssen, Alexion, Amgen, and Boston Scientific Corporation, and consulting fees from Bristol-Myers Squibb/Pfizer Alliance, Boston Scientific Corporation, Janssen, Namsa, Prairie Education and Research Cooperative, Boston Clinical Research Institute, and Amgen. S. A. P. reports being on the Advisory Board for Abbott, Boston Scientific, Medtronic, CSI, Philips, Janssen; research grants: Abbott, Boston Scientific, Surmodics, TriReme Medical, Shockwave Medical; and receiving consulting fees from Terumo and Abiomed. M. M. received an unrestricted educational grant for research from Sanofi, Leo, and Rovi, and fees for participating in advisory meetings from Sanofi. A. J. K. reports institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: consulting from IMDS; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. S. B. reports unrestricted research grants from Bayer, Concept Medical, INARI, Boston Scientific, Bard, and Sanofi; honoraria from Bayer, Concept Medical, INARI, and Boston Scientific. B. W. V. T. has received research support from Novartis, Swedish Orphan Biovitrum, Olatec Therapeutics, Serpin Pharm, and R-Pharm. He has been a consultant of R-Pharm and Serpin Pharma. G. W. S. has received speaker or other honoraria from Cook, Terumo, and Orchestra Biomed; served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, and Cardiomech; and has received equity or options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. G. Y. H. L. reports consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are received personally. H. M. K. reports personal fees from UnitedHealth, personal fees from IBM Watson Health, personal fees from Element Science, personal fees from Aetna, personal fees from Facebook, personal fees from Siegfried & Jensen Law Firm, personal fees from Arnold & Porter Law Firm, personal fees from Ben C. Martin Law Firm, personal fees from National Center for Cardiovascular Diseases, Beijing, ownership of HugoHealth, ownership of Refactor Health, contracts from the Centers for Medicare & Medicaid Services, grants from Medtronic and the Food and Drug Administration, grants from Medtronic and Johnson and Johnson, grants from Shenzhen Center for Health Information, and is a Venture Partner at FPrime. Outside the submitted work. B. B. is supported by a research grant from The Mary Horrigan Connors Center for Women's Health and Gender Biology at Brigham and Women's Hospital. B. B. reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to two specific brand models of IVC filters. All other authors report no relevant disclosures., (Thieme. All rights reserved.)- Published
- 2023
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34. Association of Marital/Partner Status with Hospital Readmission Among Young Adults With Acute Myocardial Infarction.
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Zhu C, Dreyer RP, Li F, Spatz ES, Caraballo C, Mahajan S, Raparelli V, Leifheit EC, Lu Y, Krumholz HM, Spertus JA, D'Onofrio G, Pilote L, and Lichtman JH
- Abstract
Introduction: Despite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We aimed to examine the association between marital/partner status and 1-year all-cause readmission, and explore sex differences, among young AMI survivors., Methods: Data were from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled young adults aged 18-55 years with AMI (2008-2012). The primary end point was all-cause readmission within 1 year of hospital discharge, obtained from medical record, patient interviews, and adjudicated by a physician panel. We performed Cox proportional hazards models with sequential adjustment for demographic, socioeconomic, clinical and psychosocial factors. Sex-marital/partner status interaction was also tested., Results: Of the 2,979 adults with AMI (2002 women [67.2%]; mean age 48 [interquartile range, 44-52] years), unpartnered individuals were more likely to experience all-cause readmissions compared with married/partnered individuals within the first year after hospital discharge (34.6% versus 27.2%, hazard ratio [HR]=1.31; 95% confidence interval [CI], 1.15-1.49). The association attenuated but remained significant after adjustment for demographic and socioeconomic factors (adjusted HR, 1.16; 95%CI, 1.01-1.34), and was not significant after further adjusting for clinical factors and psychosocial factors (adjusted HR, 1.10; 95%CI, 0.94-1.28). Sex-marital/partner status interaction was not significant (p=0.69). Sensitivity analysis using data with multiple imputation, and restricting outcomes to cardiac readmission yielded comparable results., Conclusions: In a cohort of young adults aged 18-55 years, unpartnered status was associated with 1.3-fold increased risk of all-cause readmission within 1 year of AMI discharge. Further adjustment for demographic, socioeconomic, clinical and psychosocial factors attenuated the association, suggesting that these factors may explain disparities in readmission between married/partnered versus unpartnered young adults. Whereas young women experienced more readmission compared to similar-aged men, the association between marital/partner status and 1-year readmission did not vary by sex.
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- 2023
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35. Classification of blood pressure during sleep impacts designation of nocturnal nondipping.
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Mortazavi BJ, Martinez-Brockman JL, Tessier-Sherman B, Burg M, Miller M, Nowroozilarki Z, Adams OP, Maharaj R, Nazario CM, Nunez M, Nunez-Smith M, and Spatz ES
- Abstract
The identification of nocturnal nondipping blood pressure (< 10% drop in mean systolic blood pressure from awake to sleep periods), as captured by ambulatory blood pressure monitoring, is a valuable element of risk prediction for cardiovascular disease, independent of daytime or clinic blood pressure measurements. However, capturing measurements, including determination of wake/sleep periods, is challenging. Accordingly, we sought to evaluate the impact of different definitions and algorithms for defining sleep onset on the classification of nocturnal nondipping. Using approaches based upon participant self-reports, applied definition of a common sleep period (12 am -6 am), manual actigraphy, and automated actigraphy we identified changes to the classification of nocturnal nondipping, and conducted a secondary analysis on the potential impact of an ambulatory blood pressure monitor on sleep. Among 61 participants in the Eastern Caribbean Health Outcomes Research Network hypertension study with complete ambulatory blood pressure monitor and sleep data, the concordance for nocturnal nondipping across methods was 0.54 by Fleiss' Kappa (depending on the method, 36 to 51 participants classified as having nocturnal nondipping). Sleep quality for participants with dipping versus nondipping was significantly different for total sleep length when wearing the ambulatory blood pressure monitor (shorter sleep duration) versus not (longer sleep duration), although there were no differences in sleep efficiency or disturbances. These findings indicate that consideration of sleep time measurements is critical for interpreting ambulatory blood pressure. As technology advances to detect blood pressure and sleep patterns, further investigation is needed to determine which method should be used for diagnosis, treatment, and future cardiovascular risk., Competing Interests: The authors declare that no competing interests exist., (Copyright: © 2023 Mortazavi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2023
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36. Severe Fatigue and Persistent Symptoms at 3 Months Following Severe Acute Respiratory Syndrome Coronavirus 2 Infections During the Pre-Delta, Delta, and Omicron Time Periods: A Multicenter Prospective Cohort Study.
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Gottlieb M, Wang RC, Yu H, Spatz ES, Montoy JCC, Rodriguez RM, Chang AM, Elmore JG, Hannikainen PA, Hill M, Huebinger RM, Idris AH, Lin Z, Koo K, McDonald S, O'Laughlin KN, Plumb ID, Santangelo M, Saydah S, Willis M, Wisk LE, Venkatesh A, Stephens KA, and Weinstein RA
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- Adult, Humans, SARS-CoV-2, COVID-19 Testing, Prospective Studies, Fatigue epidemiology, Fatigue etiology, COVID-19 epidemiology
- Abstract
Background: Most research on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants focuses on initial symptomatology with limited longer-term data. We characterized prevalences of prolonged symptoms 3 months post-SARS-CoV-2 infection across 3 variant time-periods (pre-Delta, Delta, and Omicron)., Methods: This multicenter prospective cohort study of adults with acute illness tested for SARS-CoV-2 compared fatigue severity, fatigue symptoms, organ system-based symptoms, and ≥3 symptoms across variants among participants with a positive ("COVID-positive") or negative SARS-CoV-2 test ("COVID-negative") at 3 months after SARS-CoV-2 testing. Variant periods were defined by dates with ≥50% dominant strain. We performed multivariable logistic regression modeling to estimate independent effects of variants adjusting for sociodemographics, baseline health, and vaccine status., Results: The study included 2402 COVID-positive and 821 COVID-negative participants. Among COVID-positives, 463 (19.3%) were pre-Delta, 1198 (49.9%) Delta, and 741 (30.8%) Omicron. The pre-Delta COVID-positive cohort exhibited more prolonged severe fatigue (16.7% vs 11.5% vs 12.3%; P = .017) and presence of ≥3 prolonged symptoms (28.4% vs 21.7% vs 16.0%; P < .001) compared with the Delta and Omicron cohorts. No differences were seen in the COVID-negatives across time-periods. In multivariable models adjusted for vaccination, severe fatigue and odds of having ≥3 symptoms were no longer significant across variants., Conclusions: Prolonged symptoms following SARS-CoV-2 infection were more common among participants infected during pre-Delta than with Delta and Omicron; however, these differences were no longer significant after adjusting for vaccination status, suggesting a beneficial effect of vaccination on risk of long-term symptoms. Clinical Trials Registration. NCT04610515., Competing Interests: Potential conflicts of interest. M. G. reports the following institutional funding: Rush Center for Emerging Infectious Diseases Research Grant, Society for Academic Emergency Medicine Grant, Emergency Medicine Foundation/Council of Residency Directors in Emergency Medicine Education Research Grant, Emergency Medicine: Reviews and Perspectives Medical Education Research Grant, and University of Ottawa Department of Medicine Education Grant. E. S. S. receives grant funding from the National Institute on Minority Health and Health Disparities (U54MD010711-01), the US Food and Drug Administration (FDA) to support projects within the Yale–Mayo Clinic Center of Excellence in Regulatory Science and Innovation (U01FD005938), the National Institute of Biomedical Imaging and Bioengineering (R01 EB028106-01), and the National Heart, Lung, and Blood Institute (R01HL151240); and has received honorarium paid to author for a 1-day educational session from Regeneron. J. G. E. reports serving as Editor in Chief of Adult Primary Care topics for UpToDate. A. V. reports funding for coronavirus disease 2019 (COVID-19)–related studies from the Society of Academic Emergency Medicine Foundation Emerging Infectious Disease and Preparedness Grant, the Agency for Healthcare Research and Quality (R01 HS 28340-01), the FDA (ID: 75F40120C00174), and the Emergency Medicine Health Policy Institute/Emergency Medicine Foundation; grants or contracts from the American Board of Emergency Medicine National Academy of Medicine Fellowship, Centers for Medicare and Medicaid Services, National Institute on Drug Abuse, Moore Foundation, Genentech, and FORE Foundation; consulting fees from Liminal Sciences; payment for expert testimony from Salvi, Shostok & Pritchard; support for attending meetings and/or travel from the American College of Emergency Physician, and stock or stock options with Hyperfine Inc/Liminal Sciences. A. H. I. reports participation on a data and safety monitoring board (DSMB) or advisory board for Stryker, Inc. A. M. C. reports grants or contracts from the CDC, unrelated to this work. L. E. W. reports participation on a DSMB or advisory board for a diabetes project at University of Washington. R. R. reports a grant from the National Institute of Allergy and Infectious Diseases (R01 AI166967-01, all payments made to the University of California, San Francisco). R. A. W. reports consulting fees from UpToDate as a reviewer for infection control sections, and participation as unpaid member of a scientific advisory board for the European Clinical Research Alliance on Infectious Diseases Foundation. S. M. reports an NIH Institutional Training Grant (5KL2TR003981-02), not related to the submitted work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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37. Long COVID Clinical Phenotypes up to 6 Months After Infection Identified by Latent Class Analysis of Self-Reported Symptoms.
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Gottlieb M, Spatz ES, Yu H, Wisk LE, Elmore JG, Gentile NL, Hill M, Huebinger RM, Idris AH, Kean ER, Koo K, Li SX, McDonald S, Montoy JCC, Nichol G, O'Laughlin KN, Plumb ID, Rising KL, Santangelo M, Saydah S, Wang RC, Venkatesh A, Stephens KA, and Weinstein RA
- Abstract
Background: The prevalence, incidence, and interrelationships of persistent symptoms after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection vary. There are limited data on specific phenotypes of persistent symptoms. Using latent class analysis (LCA) modeling, we sought to identify whether specific phenotypes of COVID-19 were present 3 months and 6 months post-infection., Methods: This was a multicenter study of symptomatic adults tested for SARS-CoV-2 with prospectively collected data on general symptoms and fatigue-related symptoms up to 6 months postdiagnosis. Using LCA, we identified symptomatically homogenous groups among COVID-positive and COVID-negative participants at each time period for both general and fatigue-related symptoms., Results: Among 5963 baseline participants (4504 COVID-positive and 1459 COVID-negative), 4056 had 3-month and 2856 had 6-month data at the time of analysis. We identified 4 distinct phenotypes of post-COVID conditions (PCCs) at 3 and 6 months for both general and fatigue-related symptoms; minimal-symptom groups represented 70% of participants at 3 and 6 months. When compared with the COVID-negative cohort, COVID-positive participants had higher occurrence of loss of taste/smell and cognition problems. There was substantial class-switching over time; those in 1 symptom class at 3 months were equally likely to remain or enter a new phenotype at 6 months., Conclusions: We identified distinct classes of PCC phenotypes for general and fatigue-related symptoms. Most participants had minimal or no symptoms at 3 and 6 months of follow-up. Significant proportions of participants changed symptom groups over time, suggesting that symptoms present during the acute illness may differ from prolonged symptoms and that PCCs may have a more dynamic nature than previously recognized. Clinical Trials Registration. NCT04610515., Competing Interests: Potential conflicts of interest. M. G. reports funding from the Rush Center for Emerging Infectious Diseases Research Grant, Emergency Medicine Foundation/Council of Residency Directors in Emergency Medicine Education Research Grant, Emergency Medicine: Reviews and Perspectives Medical Education Research Grant, University of Ottawa Department of Medicine Education Grant, and Society of Directors of Research in Medical Education Grant. E. S. S. receives grant funding from the National Institute on Minority Health and Health Disparities (U54MD010711-01), the US Food and Drug Administration to support projects within the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI, U01FD005938), the National Institute of Biomedical Imaging and Bioengineering (R01EB028106-01), and the National Heart, Lung, and Blood Institute (R01HL151240). J. G. E. reports serving as Editor-in-Chief of Adult Primary Care topics for UpToDate. N. L. G. receives grant funding from the CDC (BAA75D301-20-75D30121C10207). A. V. reports funding for COVID-19–related studies from the Society of Academic Emergency Medicine Foundation Emerging Infectious Disease and Preparedness Grant, the Agency for Healthcare Research and Quality (R01 HS 28340-01), the Food and Drug Administration (ID: 75F40120C00174), and the Centers for Medicare and Medicaid Services. G. N. reports the following: funding for COVID-19–related studies from the National Institute of Allergy and Infectious Diseases (NIAID) (1R01AI66967), research funding from Abiomed, Vapotherm, and ZOLL Medical; consultant to CPR Therapeutics, Heartbeam Inc, Invero Health LLC, Kestra Medical Technologies, Orixha, and ZOLL Circulation; and reports a patent (Method for non-imaging ultrasound to measure blood flow during CPR) and nonprovisional patent (Method for modifying cell injury associated with reduced blood flow). K. N. O. reports funding for COVID-19–related studies from NIAID (1R01AI66967). K. L. R. reports funding for COVID-19–related studies from NIAID (1R01AI66967) and the Philadelphia Department of Public Health. All other authors report no potential conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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38. Association Between SARS-CoV-2 Variants and Frequency of Acute Symptoms: Analysis of a Multi-institutional Prospective Cohort Study-December 20, 2020-June 20, 2022.
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Wang RC, Gottlieb M, Montoy JCC, Rodriguez RM, Yu H, Spatz ES, Chandler CW, Elmore JG, Hannikainen PA, Chang AM, Hill M, Huebinger RM, Idris AH, Koo K, Li SX, McDonald S, Nichol G, O'Laughlin KN, Plumb ID, Santangelo M, Saydah S, Stephens KA, Venkatesh AK, and Weinstein RA
- Abstract
Background: While prior work examining severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern focused on hospitalization and death, less is known about differences in clinical presentation. We compared the prevalence of acute symptoms across pre-Delta, Delta, and Omicron., Methods: We conducted an analysis of the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), a cohort study enrolling symptomatic SARS-CoV-2-positive participants. We determined the association between the pre-Delta, Delta, and Omicron time periods and the prevalence of 21 coronavirus disease 2019 (COVID-19) acute symptoms., Results: We enrolled 4113 participants from December 2020 to June 2022. Pre-Delta vs Delta vs Omicron participants had increasing sore throat (40.9%, 54.6%, 70.6%; P < .001), cough (50.9%, 63.3%, 66.7%; P < .001), and runny noses (48.9%, 71.3%, 72.9%; P < .001). We observed reductions during Omicron in chest pain (31.1%, 24.2%, 20.9%; P < .001), shortness of breath (42.7%, 29.5%, 27.5%; P < .001), loss of taste (47.1%, 61.8%, 19.2%; P < .001), and loss of smell (47.5%, 55.6%, 20.0%; P < .001). After adjustment, those infected during Omicron had significantly higher odds of sore throat vs pre-Delta (odds ratio [OR], 2.76; 95% CI, 2.26-3.35) and Delta (OR, 1.96; 95% CI, 1.69-2.28)., Conclusions: Participants infected during Omicron were more likely to report symptoms of common respiratory viruses, such as sore throat, and less likely to report loss of smell and taste., Trial Registration: NCT04610515., Competing Interests: Potential conflicts of interest. Dr. Elmore reports serving as Editor in Chief of Adult Primary Care topics for UpToDate. Dr. Venkatesh reports funding for COVID-19-related studies from the Society of Academic Emergency Medicine Foundation Emerging Infectious Disease and Preparedness Grant, the Agency for Healthcare Research and Quality (R01 HS 28340-01) the Food and Drug Administration (ID: 75F40120C00174), and the Emergency Medicine Health Policy Institute/Emergency Medicine Foundation. Dr. Wang reports funding from CDC for research on N95 respirators. Dr. Gottlieb reports grant funding from the Rush Center for Emerging Infectious Diseases Research Grant, Emergency Medicine Foundation/Council of Residency Directors in Emergency Medicine Education Research Grant, Emergency Medicine: Reviews and Perspectives Medical Education Research Grant, University of Ottawa Department of Medicine Education Grant; and Society of Directors of Research in Medical Education Grant. Dr. Nichol reports the following: Vapotherm Inc, Exeter, NH- Research funding; ZOLL Medical, Chelmsford, MA- Research funding; Abiomed Inc., Danvers, MA- Consultant; CellPhire Inc., Rockville, MD- Consultant; CPR Therapeutics, Putney, VT- Consultant; ZOLL Circulation, San Jose, CA- Consultant; Patent- Method for non-imaging ultrasound to measure blood flow during CPR; Non-provisional patent- Method for modifying cell injury associated with reduced blood flow; Heartbeam Inc., Santa Clara, CA- Consultant; Invero Health, LLC., Montvale, NJ- Consultant; Orixha Inc., Saint Cyr Au Mont d’Or, France- Consultant; Kestra Medical Technologies, Kirkland, WA- Consultant; Medic One Foundation, Seattle, WA- Salary Support via Univ. Washington (UW). Dr. Elmore reports serving as Editor in Chief of Adult Primary Care topics for UpToDate. Dr. Venkatesh reports funding for COVID-19-related studies from the Society of Academic Emergency Medicine Foundation Emerging Infectious Disease and Preparedness Grant, the Agency for Healthcare Research and Quality (R01 HS 28340-01), the Food and Drug Administration (ID: 75F40120C00174), and the Emergency Medicine Health Policy Institute/Emergency Medicine Foundation. Dr. Wang reports funding from CDC for research on N95 respirators. All other authors report no potential conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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39. Three-Month Symptom Profiles Among Symptomatic Adults With Positive and Negative Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group.
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Spatz ES, Gottlieb M, Wisk LE, Anderson J, Chang AM, Gentile NL, Hill MJ, Huebinger RM, Idris AH, Kinsman J, Koo K, Li SX, McDonald S, Plumb ID, Rodriguez RM, Saydah S, Slovis B, Stephens KA, Unger ER, Wang RC, Yu H, Hota B, Elmore JG, Weinstein RA, and Venkatesh A
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- Adult, Female, Humans, Male, Post-Acute COVID-19 Syndrome, Prospective Studies, SARS-CoV-2, COVID-19 diagnosis, COVID-19 epidemiology, Text Messaging
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Background: Long-term symptoms following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are a major concern, yet their prevalence is poorly understood., Methods: We conducted a prospective cohort study comparing adults with SARS-CoV-2 infection (coronavirus disease-positive [COVID+]) with adults who tested negative (COVID-), enrolled within 28 days of a Food and Drug Administration (FDA)-approved SARS-CoV-2 test result for active symptoms. Sociodemographic characteristics, symptoms of SARS-CoV-2 infection (assessed with the Centers for Disease Control and Prevention [CDC] Person Under Investigation Symptom List), and symptoms of post-infectious syndromes (ie, fatigue, sleep quality, muscle/joint pains, unrefreshing sleep, and dizziness/fainting, assessed with CDC Short Symptom Screener for myalgic encephalomyelitis/chronic fatigue syndrome) were assessed at baseline and 3 months via electronic surveys sent via text or email., Results: Among the first 1000 participants, 722 were COVID+ and 278 were COVID-. Mean age was 41.5 (SD 15.2); 66.3% were female, 13.4% were Black, and 15.3% were Hispanic. At baseline, SARS-CoV-2 symptoms were more common in the COVID+ group than the COVID- group. At 3 months, SARS-CoV-2 symptoms declined in both groups, although were more prevalent in the COVID+ group: upper respiratory symptoms/head/eyes/ears/nose/throat (HEENT; 37.3% vs 20.9%), constitutional (28.8% vs 19.4%), musculoskeletal (19.5% vs 14.7%), pulmonary (17.6% vs 12.2%), cardiovascular (10.0% vs 7.2%), and gastrointestinal (8.7% vs 8.3%); only 50.2% and 73.3% reported no symptoms at all. Symptoms of post-infectious syndromes were similarly prevalent among the COVID+ and COVID- groups at 3 months., Conclusions: Approximately half of COVID+ participants, as compared with one-quarter of COVID- participants, had at least 1 SARS-CoV-2 symptom at 3 months, highlighting the need for future work to distinguish long COVID., Clinical Trials Registration: NCT04610515., Competing Interests: Potential conflicts of interest . All authors: No potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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40. Assessment of Market-Level Information on Quality Using Hospital Care Compare.
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Oddleifson DA, Xu X, Ross JS, Spatz ES, and Desai NR
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- Humans, United States, Economic Competition, Hospitals, Quality of Health Care
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- 2023
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41. Quantifying Blood Pressure Visit-to-Visit Variability in the Real-World Setting: A Retrospective Cohort Study.
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Lu Y, Linderman GC, Mahajan S, Liu Y, Huang C, Khera R, Mortazavi BJ, Spatz ES, and Krumholz HM
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- Adult, Humans, Female, Middle Aged, Adolescent, Male, Blood Pressure, Retrospective Studies, Risk Factors, Blood Pressure Determination, Hypertension diagnosis, Hypertension drug therapy
- Abstract
Background: Visit-to-visit variability (VVV) in blood pressure values has been reported in clinical studies. However, little is known about VVV in clinical practice and whether it is associated with patient characteristics in real-world setting., Methods: We conducted a retrospective cohort study to quantify VVV in systolic blood pressure (SBP) values in a real-world setting. We included adults (age ≥18 years) with at least 2 outpatient visits between January 1, 2014 and October 31, 2018 from Yale New Haven Health System. Patient-level measures of VVV included SD and coefficient of variation of a given patient's SBP across visits. We calculated patient-level VVV overall and by patient subgroups. We further developed a multilevel regression model to assess the extent to which VVV in SBP was explained by patient characteristics., Results: The study population included 537 218 adults, with a total of 7 721 864 SBP measurements. The mean age was 53.4 (SD 19.0) years, 60.4% were women, 69.4% were non-Hispanic White, and 18.1% were on antihypertensive medications. Patients had a mean body mass index of 28.4 (5.9) kg/m
2 and 22.6%, 8.0%, 9.7%, and 5.6% had a history of hypertension, diabetes, hyperlipidemia, and coronary artery disease, respectively. The mean number of visits per patient was 13.3, over an average period of 2.4 years. The mean (SD) intraindividual SD and coefficient of variation of SBP across visits were 10.6 (5.1) mm Hg and 0.08 (0.04). These measures of blood pressure variation were consistent across patient subgroups defined by demographic characteristics and medical history. In the multivariable linear regression model, only 4% of the variance in absolute standardized difference was attributable to patient characteristics., Conclusions: The VVV in real-world practice poses challenges for management of patients with hypertension based on blood pressure readings in outpatient settings and suggest the need to go beyond episodic clinic evaluation.- Published
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42. Association of vitamins, minerals, and lead with lipoprotein(a) in a cross-sectional cohort of US adults.
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Brandt EJ, Brandt DJ, Desai NR, Spatz ES, Nasir K, and Mani A
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- Humans, Adult, Lipoprotein(a), Nutrition Surveys, Cross-Sectional Studies, Vitamin A, Folic Acid, Vitamin K, Vitamin B 12, Vitamins, Selenium
- Abstract
Lipoprotein(a)(Lp[a]) is a low-density lipoprotein-cholesterol (LDL-C)-like particle with potent pro-atherothrombotic properties. The association of Lp(a) with several circulating factors, including vitamins, remains unresolved. We performed an observational analysis using the National Health and Nutrition Examination Survey III cohort, a cohort used to monitor the nutrition status of US-citizens. We used multivariable linear regression to test associations of Lp(a) and LDL-C with levels of serum vitamins and minerals and whole-blood lead. Analyses controlled for factors known to associate with Lp(a) (age, sex, race/ethnicity, statin use, hemoglobin A1c, body mass index, hypertension, diabetes, glomerular filtration rate, alcohol intake, and saturated fat intake). LDL-C was corrected for Lp(a) mass. Multiple sensitivity tests were performed, including considering factors as categorical variables (deficient, normal, elevated). Among 7,662 subjects, Lp(a) correlated (β-coefficient) positively (change per 1 conventional unit increase) with carotenoids (lycopene (0.17(0.06,0.28), p=0.005), lutein (0.19(0.07,0.30), p=0.002), β-cryptoxanthin (0.21(0.05,0.37), p=0.01), β-carotene (0.05(0.02,0.09), p=0.003), and α-carotene (0.15(0.01,0.30), p=0.04)) and lead (0.54(0.03,1.05), p=0.04) levels when tested as continuous variables. LDL-C had similar associations. Lp(a) did not associate with vitamins A, B12, C, or E retinyl esters, folate, RBC-folate, selenium, ferritin, transferrin saturation, or calcium. With factors as categorical variables, Lp(a) but not LDL-C negatively associated with elevated vitamin B12 (-5.41(-9.50, -1.53), p=0.01) and folate (-2.86(-5.09, -0.63), p=0.01). In conclusion, Lp(a) associated similarly to LDL-C when vitamins, minerals, and lead were tested as continuous variables, while only Lp(a) correlated with vitamin B12 and folate when tested as categorical variables. These observations are hypotheses generating and require further studies to determine causality.
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43. Lifetime healthcare expenses across demographic and cardiovascular risk groups: The application of a novel modeling strategy in a large multiethnic cohort study.
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Khera R, Kondamudi N, Liu M, Ayers C, Spatz ES, Rao S, Essien UR, Powell-Wiley TM, Nasir K, Das SR, Capers Q, and Pandey A
- Abstract
Objective: To understand the burden of healthcare expenses over the lifetime of individuals and evaluate differences among those with cardiovascular risk factors and among disadvantaged groups based on race/ethnicity and sex., Methods: We linked data from the longitudinal multiethnic Dallas Heart Study, which recruited participants between 2000 and 2002, with inpatient and outpatient claims from all hospitals in the Dallas-Fort Worth metroplex through December 2018, capturing encounter expenses. Race/ethnicity and sex, as well as five risk factors, hypertension, diabetes, hyperlipidemia, smoking, and overweight/obesity, were defined at cohort enrollment. For each individual, expenses were indexed to age and cumulated between 40 and 80 years of age. Lifetime expenses across exposures were evaluated as interactions in generalized additive models., Results: A total of 2184 individuals (mean age, 45±10 years; 61% women, 53% Black) were followed between 2000 and 2018. The mean modeled lifetime cumulative healthcare expenses were $442,629 (IQR, $423,850 to $461,408). In models that included 5 risk factors, Black individuals had $21,306 higher lifetime healthcare spending compared with non-Black individuals ( P < .001), and men had modestly higher expenses than women ($5987, P < .001). Across demographic groups, the presence of risk factors was associated with progressively higher lifetime expenses, with significant independent association of diabetes ($28,075, P < .001), overweight/obesity ($8816, P < .001), smoking ($3980, P = .009), and hypertension ($528, P = .02) with excess spending., Conclusion: Our study suggests Black individuals have higher lifetime healthcare expenses, exaggerated by the substantially higher prevalence of risk factors, with differences emerging in older age., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr Khera receives support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under award K23HL153775) and the Doris Duke Charitable Foundation (under award, 2022060). He also receives research support, through Yale, from Bristol-Myers Squibb and Novo Nordisk. He is a coinventor of U.S. Provisional Patent Applications 63/177,117, 63/428,569, and 63/346,610, unrelated to current work. He is also a founder of Evidence2Health, a precision health platform to improve evidence-based care. Dr. Pandey reports financial support was provided by GEMSSTAR Grant 1R03AG067960. Dr. Powell-Wiley reports financial support was provided by Division of Intramural Research of the National Heart, Lung, and Blood Institute and the Intramural Research Program of the National Institute on Minority Health, and Health Disparities of the NIH., (© 2023 The Author(s).)
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44. Adjustment for Social Risk Factors in a Measure of Clinician Quality Assessing Acute Admissions for Patients With Multiple Chronic Conditions.
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Lipska KJ, Altaf FK, Barthel AGB, Spatz ES, Lin Z, Herrin J, Bernheim SM, and Drye EE
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- Humans, Male, Aged, United States, Female, Medicaid, Cohort Studies, Reimbursement, Incentive, Retrospective Studies, Hospitalization, Risk Factors, Medicare, Multiple Chronic Conditions
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Importance: Adjusting quality measures used in pay-for-performance programs for social risk factors remains controversial., Objective: To illustrate a structured, transparent approach to decision-making about adjustment for social risk factors for a measure of clinician quality that assesses acute admissions for patients with multiple chronic conditions (MCCs)., Design, Setting, and Participants: This retrospective cohort study used 2017 and 2018 Medicare administrative claims and enrollment data, 2013 to 2017 American Community Survey data, and 2018 and 2019 Area Health Resource Files. Patients were Medicare fee-for-service beneficiaries 65 years or older with at least 2 of 9 chronic conditions (acute myocardial infarction, Alzheimer disease/dementia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease or asthma, depression, diabetes, heart failure, and stroke/transient ischemic attack). Patients were attributed to clinicians in the Merit-Based Incentive Payment System (MIPS; primary health care professionals or specialists) using a visit-based attribution algorithm. Analyses were conducted between September 30, 2017, and August 30, 2020., Exposures: Social risk factors included low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility., Main Outcomes and Measures: Number of acute unplanned hospital admissions per 100 person-years at risk for admission. Measure scores were calculated for MIPS clinicians with at least 18 patients with MCCs assigned to them., Results: There were 4 659 922 patients with MCCs (mean [SD] age, 79.0 [8.0] years; 42.5% male) assigned to 58 435 MIPS clinicians. The median (IQR) risk-standardized measure score was 38.9 (34.9-43.6) per 100 person-years. Social risk factors of low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility were significantly associated with the risk of hospitalization in the univariate models (relative risk [RR], 1.14 [95% CI, 1.13-1.14], RR, 1.05 [95% CI, 1.04-1.06], and RR, 1.44 [95% CI, 1.43-1.45], respectively), but the association was attenuated in adjusted models (RR, 1.11 [95% CI 1.11-1.12] for dual eligibility). Across MIPS clinicians caring for variable proportions of dual-eligible patients with MCCs (quartile 1, 0%-3.1%; quartile 2, >3.1%-9.5%; quartile 3, >9.5%-24.5%, and quartile 4, >24.5%-100%), median measure scores per quartile were 37.4, 38.6, 40.0, and 39.8 per 100 person-years, respectively. Balancing conceptual considerations, empirical findings, programmatic structure, and stakeholder input, the Centers for Medicare & Medicaid Services decided to adjust the final model for the 2 area-level social risk factors but not dual Medicare-Medicaid eligibility., Conclusions and Relevance: This cohort study demonstrated that adjustment for social risk factors in outcome measures requires weighing high-stake, competing concerns. A structured approach that includes evaluation of conceptual and contextual factors, as well as empirical findings, with active engagement of stakeholders can be used to make decisions about social risk factor adjustment.
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- 2023
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45. Developing an Actionable Taxonomy of Persistent Hypertension Using Electronic Health Records.
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Lu Y, Xinxin Du C, Khidir H, Caraballo C, Mahajan S, Spatz ES, Curry LA, and Krumholz HM
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- Aged, Female, Humans, Male, Antihypertensive Agents therapeutic use, Blood Pressure, Middle Aged, Electronic Health Records, Hypertension diagnosis, Hypertension drug therapy, Hypertension epidemiology
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Background: The digital transformation of medical data presents opportunities for novel approaches to manage patients with persistent hypertension. We sought to develop an actionable taxonomy of patients with persistent hypertension (defined as 5 or more consecutive measurements of blood pressure ≥160/100 mmHg over time) based on data from the electronic health records., Methods: This qualitative study was a content analysis of clinician notes in the electronic health records of patients in the Yale New Haven Health System. Eligible patients were 18 to 85 years and had blood pressure ≥160/100 mmHg at 5 or more consecutive outpatient visits between January 1, 2013 and October 31, 2018. A total of 1664 patients met criteria, of which 200 records were randomly selected for chart review. Through a systematic, inductive approach, we developed a rubric to abstract data from the electronic health records and then analyzed the abstracted data qualitatively using conventional content analysis until saturation was reached., Results: We reached saturation with 115 patients, who had a mean age of 66.0 (SD, 11.6) years; 54.8% were female; 52.2%, 30.4%, and 13.9% were White, Black, and Hispanic patients. We identified 3 content domains related to persistence of hypertension: (1) non-intensification of pharmacological treatment, defined as absence of antihypertensive treatment intensification in response to persistent severely elevated blood pressure; (2) non-implementation of prescribed treatment, defined as a documentation of provider recommending a specified treatment plan to address hypertension but treatment plan not being implemented; and (3) non-response to prescribed treatment, defined as clinician-acknowledged persistent hypertension despite documented effort to escalate existing pharmacologic agents and addition of additional pharmacologic agents with presumption of adherence., Conclusions: This study presents a novel actionable taxonomy for classifying patients with persistent hypertension by their contributing causes based on electronic health record data. These categories can be automated and linked to specific types of actions to address them.
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46. Association of marital/partner status and patient-reported outcomes following myocardial infarction: a systematic review and meta-analysis.
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Zhu C, Tran PM, Leifheit EC, Spatz ES, Dreyer RP, Nyhan K, Wang SY, and Lichtman JH
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Aims: Little is known about the relationship between marital/partner status and patient-reported outcome measures (PROMs) following myocardial infarction (MI). We conducted a systematic review/meta-analysis and explored potential sex differences., Methods and Results: We searched five databases (Medline, Web of Science, Scopus, EMBASE, and PsycINFO) from inception to 27 July 2022. Peer-reviewed studies of MI patients that evaluated marital/partner status as an independent variable and reported its associations with defined PROMs were eligible for inclusion. Results for eligible studies were classified into four pre-specified outcome domains [health-related quality of life (HRQoL), functional status, symptoms, and personal recovery (i.e. self-efficacy, adherence, and purpose/hope)]. Study quality was appraised using Newcastle-Ottawa Scale, and data were synthesized by outcome domains. We conducted subgroup analysis by sex. We included 34 studies ( n = 16 712), of which 11 were included in meta-analyses. Being married/partnered was significantly associated with higher HRQoL {six studies [ n = 2734]; pooled standardized mean difference, 0.37 [95% confidence interval (CI), 0.12-0.63], I
2 = 51%} but not depression [three studies ( n = 2005); pooled odds ratio, 0.72 (95% CI, 0.32-1.64); I2 = 65%] or self-efficacy [two studies ( n = 356); pooled β , 0.03 (95% CI, -0.09 to 0.14); I2 = 0%]. The associations of marital/partner status with functional status, personal recovery outcomes, and symptoms of anxiety and fatigue were mixed. Sex differences were not evident due to mixed results from the available studies., Conclusions: Married/partnered MI patients had higher HRQoL than unpartnered patients, but the associations with functional, symptom, and personal recovery outcomes and sex differences were less clear. Our findings inform better methodological approaches and standardized reporting to facilitate future research on these relationships., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)- Published
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47. Routine saliva testing for SARS-CoV-2 in children: Methods for partnering with community childcare centers.
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Rayack EJ, Askari HM, Zirinsky E, Lapidus S, Sheikha H, Peno C, Kazemi Y, Yolda-Carr D, Liu C, Grubaugh ND, Ko AI, Wyllie AL, Spatz ES, Oliveira CR, and Bei AK
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- Humans, Child, COVID-19 Testing, Saliva, Pandemics prevention & control, Child Care, SARS-CoV-2, COVID-19 diagnosis
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While considerable attention was placed on SARS-CoV-2 testing and surveillance programs in the K-12 setting, younger age groups in childcare centers were largely overlooked. Childcare facilities are vital to communities, allowing parents/guardians to remain at work and providing safe environments for both children and staff. Therefore, early in the COVID-19 pandemic (October 2020), we established a PCR-based COVID-19 surveillance program in childcare facilities, testing children and staff with the goal of collecting actionable public health data and aiding communities in the progressive resumption of standard operations and ways of life. In this study we describe the development of a weekly saliva testing program and provide early results from our experience implementing this in childcare centers. We enrolled children (aged 6 months to 7 years) and staff at seven childcare facilities and trained participants in saliva collection using video chat technology. Weekly surveys were sent out to assess exposures, symptoms, and vaccination status changes. Participants submitted weekly saliva samples at school. Samples were transported to a partnering clinical laboratory or RT-PCR testing using SalivaDirect and results were uploaded to each participant's online patient portal within 24 h. SARS-CoV-2 screening and routine testing programs have focused less on the childcare population, resulting in knowledge gaps in this critical age group, especially as many are still ineligible for vaccination. SalivaDirect testing for SARS-CoV-2 provides a feasible method of asymptomatic screening and symptomatic testing for children and childcare center staff. Given the relative aversion to nasal swabs in younger age groups, an at-home saliva collection method provides an attractive alternative, especially as a routine surveillance tool. Results can be shared rapidly electronically through participants' private medical chart portals, and video chat technology allows for discussion and instruction between investigators and participants. This study fosters a cooperative partnership with participating childcare centers, parents/guardians, and staff with the goal of mitigating COVID-19 transmission in childcare centers. Age-related challenges in saliva collection can be overcome by working with parents/guardians to conceptualize new collection strategies and by offering parents/guardians continued virtual guidance and support., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Rayack, Askari, Zirinsky, Lapidus, Sheikha, Peno, Kazemi, Yolda-Carr, Liu, Grubaugh, Ko, Wyllie, Spatz, Oliveira and Bei.)
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- 2023
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48. Screening for atrial fibrillation to prevent stroke: increasing enthusiasm but outcomes still lag.
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Spatz ES and Herrin J
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- Humans, Cost-Benefit Analysis, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Stroke etiology, Stroke prevention & control, Stroke diagnosis
- Abstract
Competing Interests: Conflict of interest: E.S.S. receives grant funding from the U.S. Centers for Disease Control and Prevention (20042801-Sub01), the National Institute on Minority Health and Health Disparities (U54MD010711-01), the U.S. Food and Drug Administration to support projects within the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI, U01FD005938), the National Institute of Biomedical Imaging and Bioengineering (R01 EB028106-01), and from the National Heart, Lung, and Blood Institute (R01HL151240). J.H. receives grant funding from the Centers for Medicare and Medicaid Services, the National Institutes of Health, the Patient Centered Outcomes Research Institute, Johnson & Johnson, Delta Airlines, and the Department of Defense.
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- 2023
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49. Primary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study.
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Zhou T, Wang Y, Zhang H, Wu C, Tian N, Cui J, Bai X, Yang Y, Zhang X, Lu Y, Spatz ES, Ross JS, Krumholz HM, Lu J, Li X, and Hu S
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- Humans, Cross-Sectional Studies, Antihypertensive Agents therapeutic use, China epidemiology, Primary Health Care, Hypertension diagnosis, Hypertension epidemiology, Hypertension therapy
- Abstract
Background: Since 2010, China has made vast financial investments and policy changes to the primary care system. We aimed to assess how hypertension awareness, treatment, and control might be used to assess quality of primary care systems, which reflect the outcomes of public health services and medical care., Methods: We used The China Patient-centred Evaluative Assessment of Cardiac Events Million Persons Project, a government-funded public health project that focuses on cardiovascular disease risk in China. We linked primary care institution characteristics that were captured in the survey between 2016 and 2017 to the participant-level data gathered in baseline visits between 2014 and 2021. Participants were included if they had hypertension and lived in the towns or streets that took part in the primary care survey. Participants were excluded if they had missing data for blood pressure measurement, history of hypertension, sex, or age. Primary care institutions were excluded if the catchment area had fewer than 100 participants with hypertension. Hypertension awareness was defined as the proportion of participants with hypertension who self-reported a hypertension diagnosis. Hypertension treatment was defined as the proportion of participants who currently use antihypertensive medications among those who were aware. Hypertension control was defined as the proportion of participants with an average systolic blood pressure less than 140 mm Hg and an average diastolic blood pressure less than 90 mm Hg over two readings among those who were treated during the study. All patients were included in the analysis. This trial was registered at ClinicalTrials.gov, NCT02536456., Findings: Between Sept 15, 2014, and March 16, 2021, we assessed 503 township-level primary care institutions for eligibility. 70 institutions were excluded as they could not be linked with individual data or because their catchment area had fewer than 100 participants with hypertension. We analysed 433 township-level primary care institutions across all 31 provinces of mainland China, including 660 565 individuals with hypertension in their catchment areas. Across townships, age-sex standardised hypertension awareness varied from 8·2% to 81·0%, treatment varied from 2·6% to 96·5%, and control proportions varied from 0% to 62·4%. Hypertension awareness, treatment, and control were significantly associated with the following institutional characteristics: government funding through balance allocation (ie, institutions have their human resources funded by local government, but need to be self-supporting in other aspects; awareness odds ratio 0·88, 95% CI 0·78-0·99; p=0·027), having financial problems that interrupted routine service delivery (awareness 0·81, 0·72-0·92; p=0·0007, control 0·84; 0·75-0·94, p=0·0034), setting performance-based bonus (treatment 1·39, 1·07-1·80; p=0·013), basic salary defined by number of patient visits (control 0·85, 0·76-0·95; p=0·0053), using electronic referrals (treatment 1·41, 1·14-1·73; p=0·0012, control 1·17; 1·03-1·33, p=0·014), implementing family physician contract services (awareness 1·13, 1·00-1·28; p=0·045, control 1·30; 1·15-1·46, p<0·0001), and proportion of physicians who are formally licensed (awareness per 10% increase 1·04, 1·01-1·08; p=0·019, treatment 1·08; 1·02-1·14, p=0·0077; control per 10% increase 1·07, 1·03-1·10; p=0·0006)., Interpretation: The role of primary care role in hypertension management might benefit from new strategies that promote best practices in institutional financing, performance appraisal, service delivery, and information technology., Funding: Chinese Academy of Medical Sciences Innovation Fund for Medical Science, and the National High Level Hospital Clinical Research Funding., Translation: For the Chinese translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests HMK received expenses or personal fees from UnitedHealth, Element Science, Aetna, Reality Labs, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin/Baughman Law Firm, and F-Prime. HMK is a co-founder of Refactor Health and HugoHealth, and is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from Johnson & Johnson. JSR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation programme (U01FD005938), the Agency for Healthcare Research and Quality (R01HS022882), the National Heart, Lung and Blood Institute of the National Institutes of Health (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, JSR is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. YL is supported by the National Heart, Lung and Blood Institute (K12HL138037) and the Yale Center for Implementation Science., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
50. Revisiting ACCORD: Should Blood Pressure Targets in People With and Without Type 2 Diabetes Be Different?
- Author
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Du CX, Huang C, Lu Y, Spatz ES, Lipska KJ, and Krumholz HM
- Subjects
- Humans, Blood Pressure, Vital Signs, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy
- Published
- 2023
- Full Text
- View/download PDF
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