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Displaying 701 - 710 of 7611 in ACP Online
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Displaying 701 - 710 of 6848 in Annals of Internal Medicine
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Social, Behavioral, and Metabolic Risk Factors and Racial Disparities in Cardiovascular Disease Mortality in U.S. Adults: An Observational Study: Annals of Internal Medicine: Vol 176, No 9
Background: Cardiovascular disease (CVD) mortality is persistently higher in the Black population than in other racial and ethnic groups in the United States. Objective: To examine the degree to which social, behavioral, and metabolic risk factors are associated with CVD mortality and the extent to which racial differences in CVD mortality persist after these factors are accounted for. Design: Prospective cohort study. Setting: NHANES (National Health and Nutrition Examination Survey) 1999 to 2018. Participants: A nationally representative sample of 50 808 persons aged 20 years or older. Measurements: Data on social, behavioral, and metabolic factors were collected in each NHANES survey using standard methods. Deaths from CVD were ascertained from linkage to the National Death Index with follow-up through 2019. Results: Over an average of 9.4 years of follow-up, 2589 CVD deaths were confirmed. The age- and sex-standardized rates of CVD mortality were 484.7 deaths per 100 000 person-years in Black participants, 384.5 deaths per 100 000 person-years in White participants, 292.4 deaths per 100 000 person-years in Hispanic participants, and 255.1 deaths per 100 000 person-years in other race groups. In a multiple Cox regression analysis adjusted for all measured risk factors simultaneously, several social (unemployment, low family income, food insecurity, lack of home ownership, and unpartnered status), behavioral (current smoking, lack of leisure-time physical activity, and sleep <6 or >8 h/d), and metabolic (obesity, hypertension, and diabetes) risk factors were associated with a significantly higher risk for CVD death. After adjustment for these metabolic, behavioral, and social risk factors separately, hazard ratios of CVD mortality for Black compared with White participants were attenuated from 1.54 (95% CI, 1.34 to 1.77) to 1.34 (CI, 1.16 to 1.55), 1.31 (CI, 1.15 to 1.50), and 1.04 (CI, 0.90 to 1.21), respectively. Limitation: Causal contributions of social, behavioral, and metabolic risk factors to racial and ethnic disparities in CVD mortality could not be established. Conclusion: The Black–White difference in CVD mortality diminished after adjustment for behavioral and metabolic risk factors and completely dissipated with adjustment for social determinants of health in the U.S. population. Primary Funding Source: National Institutes of Health.
The New European Medical Device Regulation: Balancing Innovation and Patient Safety
The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New “expert panels” have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous “notified bodies” (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.
Achievement of Guideline-Recommended Targets in Diabetes Care in China: A Nationwide Cross-Sectional Study: Annals of Internal Medicine: Vol 176, No 8
Background: Nationwide achievement of guideline-recommended diabetes care targets has not been comprehensively assessed in China. Objective: To estimate the proportions of adults with diabetes achieving major clinical risk factor control, body mass index (BMI), lifestyle, and dietary targets specified in the Chinese diabetes guidelines. Design: Nationwide cross-sectional survey. Setting: China, 2015 to 2017. Participants: A national sample of 8401 adults with self-reported diabetes and a subset of 3531 with dietary data. Measurements: The assessed targets included 1) ABC targets (individualized hemoglobin A1c [HbA1c] target; blood pressure [BP] <130/80 mm Hg; and low-density lipoprotein cholesterol [LDL-C] level <2.6 or <1.8 mmol/L [<100 or <70 mg/dL], depending on the presence of atherosclerotic cardiovascular disease), 2) BMI below 24 kg/m2, 3) lifestyle targets (not currently smoking or drinking, guideline-recommended leisure time activity level, and sleep duration of 7 to 8 hours), and 4) dietary targets (50% to 65% of energy from carbohydrate, 15% to 20% from protein, 20% to 30% from fat, ≥14 g of fiber per 1000 kcal, and <2000 mg of sodium per day). Results: The proportion of adults with self-reported diabetes achieving each ABC target was 64.1% (95% CI, 61.4% to 66.8%) for HbA1c, 22.2% (CI, 20.2% to 24.1%) for BP, and 23.9% (CI, 21.9% to 25.9%) for LDL-C. The proportion achieving a BMI below 24 kg/m2 was 32.2% (CI, 30.3% to 34.2%). The proportion achieving each lifestyle target was 75.8% (CI, 73.9% to 77.7%) for smoking, 66.7% (CI, 64.4% to 69.1%) for drinking, 17.9% (CI, 15.8% to 20.1%) for leisure time activity, and 52.0% (CI, 49.6% to 54.3%) for sleep duration. The proportion achieving each dietary target was 39.1% (CI, 36.0% to 42.2%) for carbohydrate, 20.1% (CI, 16.9% to 23.3%) for protein, 20.5% (CI, 17.6% to 23.4%) for fat, 9.0% (CI, 7.0% to 10.9%) for sodium, and 2.5% (CI, 1.3% to 3.6%) for fiber. Only 4.4% (CI, 3.5% to 5.2%) of participants achieved all 3 ABC targets, 5.1% (CI, 4.3% to 6.0%) achieved all 4 lifestyle targets, and 4 participants achieved all 5 dietary targets. Limitations: Self-reported data and age of the data. Conclusion: Achievement of guideline-recommended diabetes care targets in Chinese adults with self-reported diabetes was exceedingly low. The findings highlight the need for immediate national health actions to improve diabetes care. Primary Funding Source: Shanghai Municipal Education Commission, National Key R&D Program of the People's Republic of China, and the National Health Commission of the People's Republic of China.
Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection: A Prospective Cohort Study: Annals of Internal Medicine: Vol 176, No 7
Background: The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARS-CoV-2 is not well established. Objective: To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants. Design: This prospective cohort study enrolled participants between October 2021 and January 2022. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days. Setting: Participants were enrolled digitally throughout the mainland United States. They self-collected anterior nasal swabs for Ag-RDTs and RT-PCR testing. Nasal swabs for RT-PCR were shipped to a central laboratory, whereas Ag-RDTs were done at home. Participants: Of 7361 participants in the study, 5353 who were asymptomatic and negative for SARS-CoV-2 on study day 1 were eligible. In total, 154 participants had at least 1 positive RT-PCR result. Measurements: The sensitivity of Ag-RDTs was measured on the basis of testing once (same-day), twice (after 48 hours), and thrice (after a total of 96 hours). The analysis was repeated for different days past index PCR positivity (DPIPPs) to approximate real-world scenarios where testing initiation may not always coincide with DPIPP 0. Results were stratified by symptom status. Results: Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDTs twice 48 hours apart resulted in an aggregated sensitivity of 93.4% (95% CI, 90.4% to 95.9%) among symptomatic participants on DPIPPs 0 to 6. When singleton positive results were excluded, the aggregated sensitivity on DPIPPs 0 to 6 for 2-time serial testing among asymptomatic participants was lower at 62.7% (CI, 57.0% to 70.5%), but it improved to 79.0% (CI, 70.1% to 87.4%) with testing 3 times at 48-hour intervals. Limitation: Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours. Conclusion: The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours. Primary Funding Source: National Institutes of Health RADx Tech program.