Last data update: Oct 07, 2024. (Total: 47845 publications since 2009)
Records 1-30 (of 32 Records) |
Query Trace: Koyama A[original query] |
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Homelessness and risk of end-stage kidney disease and death in veterans with chronic kidney disease
Koyama AK , Nee R , Yu W , Choudhury D , Heng F , Cheung AK , Cho ME , Norris KC , Yan G . JAMA Netw Open 2024 7 (9) e2431973 IMPORTANCE: Adults experiencing homelessness in the US face numerous challenges, including the management of chronic kidney disease (CKD). The extent of a potentially greater risk of adverse health outcomes in the population with CKD experiencing homelessness has not been adequately explored. OBJECTIVE: To evaluate the association between a history of homelessness and the risk of end-stage kidney disease (ESKD) and death among veterans with incident CKD. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted between January 1, 2005, and December 31, 2017. Participants included veterans aged 18 years and older with incident stage 3 to 5 CKD utilizing the Veterans Health Administration health care network in the US. Patients were followed-up through December 31, 2018, for the occurrence of ESKD and death. Analyses were performed from September 2022 to October 2023. EXPOSURE: History of homelessness, based on utilization of homeless services in the Veterans Health Administration or International Classification of Diseases, Ninth Revision or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes. Homelessness was measured during the 2-year baseline period prior to the index date of incident CKD. MAIN OUTCOMES AND MEASURES: The primary outcomes were ESKD, based on initiation of kidney replacement therapy, and all-cause death. Adjusted hazard ratios (HRs) were calculated to compare veterans with a history of homelessness with those without a history of homelessness. RESULTS: Among 836 361 veterans, the largest proportion were aged 65 to 74 years (274 371 veterans [32.8%]) or 75 to 84 years (270 890 veterans [32.4%]), and 809 584 (96.8%) were male. A total of 26 037 veterans (3.1%) developed ESKD, and 359 991 (43.0%) died. Compared with veterans who had not experienced homelessness, those with a history of homelessness showed a significantly greater risk of ESKD (adjusted HR, 1.15; 95% CI, 1.10-1.20). A greater risk of all-cause death was also observed (HR, 1.48; 95% CI, 1.46-1.50). After further adjustment for body mass index, comorbidities, and medication use, results were attenuated for all-cause death (HR, 1.09; 95% CI, 1.07-1.11) and were no longer significant for ESKD (HR, 1.04; 95% CI, 0.99-1.09). CONCLUSIONS AND RELEVANCE: In this cohort study of veterans with incident stage 3 to 5 CKD, a history of homelessness was significantly associated with a greater risk of ESKD and death, underscoring the role of housing as a social determinant of health. |
Urban-rural differences in acute kidney injury mortality in the United States
Xu F , Miyamoto Y , Zaganjor I , Onufrak S , Saelee R , Koyama AK , Pavkov ME . Am J Prev Med 2024 INTRODUCTION: Acute kidney injury (AKI) is associated with increased mortality. AKI-related mortality trends by US urban and rural counties were assessed. METHODS: In the cross-sectional study, based on the Centers for Disease Control and Prevention WONDER (Wide-ranging ONline Data for Epidemiologic Research) Multiple Cause of Death data, age-standardized mortality with AKI as the multiple cause was obtained among adults aged ≥25 years from 2001-2020, by age, sex, race and ethnicity, stratified by urban-rural counties. Joinpoint regressions were used to assess trends from 2001-2019 in AKI-related mortality rate. Pairwise comparison was used to compare mean differences in mortality between urban and rural counties from 2001-2019. RESULTS: From 2001-2020, age-standardized AKI-related mortality was consistently higher in rural than urban counties. AKI-related mortality (per 100,000 population) increased from 18.95 in 2001 to 29.46 in 2020 in urban counties and from 20.10 in 2001 to 38.24 in 2020 in rural counties. In urban counties, AKI-related mortality increased annually by 4.6% during 2001-2009 and decreased annually by 1.8% until 2019 (p<0.001). In rural counties, AKI-related mortality increased annually by 5.0% during 2001-2011 and decreased by 1.2% until 2019 (p<0.01). The overall urban-rural difference in AKI-related mortality was greater after 2009-2011. AKI-related mortality was significantly higher among older adults, men, and non-Hispanic Black adults than their counterparts in both urban and rural counties. Higher mortality was concentrated in rural counties in the Southern United States. CONCLUSIONS: Multidisciplinary efforts are needed to increase AKI awareness and implement strategies to reduce AKI-related mortality in rural and high-risk populations. |
Impact of race-free glomerular filtration rate estimations on CKD prevalence in the US military health system: A retrospective cohort study
Oliver JD , Nee R , Marneweck H , Banaag A , Koyama AK , Pavkov ME , Koehlmoos TP . Kidney Med 2024 6 (8) Rationale & Objective: The 2021 CKD-EPI removes Black race as a factor in calculating the estimated glomerular filtration rate (eGFR). We assessed its effect on CKD prevalence in the demographically-diverse US Military Health System. Study Design: A retrospective calculation of the eGFR from serum creatinine measured over 2016-2019 using both the 2009 and 2021 CKD-EPI equations. Setting & Population: Multicenter health care network with data from 1,502,607 adults in the complete case analysis and from 1,970,433 adults in an imputed race analysis. Predictors: Serum creatinine, age, sex, and race. Outcome: CKD stages 3-5, defined as the last eGFR persistently < 60 mL/min/1.73m2 for ≥90 days. Analytical Approach: The t test and Kruskal-Wallis test were used for continuous variables and Χ2 for categorical data. Results: The population in the complete case analysis had a median age of 40 years and was 18.8% Black race and 35.4% female. With the 2021 equation, the number of Black adults with CKD stages 3-5 increased by 58.1% from 4,147 to 6,556, a change in the crude prevalence from 1.47% to 2.32%. The number of non-Black adults with CKD stages 3-5 decreased by 30.4% from 27,596 to 19,213, a crude prevalence change from 2.26% to 1.58%. Similar results were seen with race imputation. Cumulatively, among adults with CKD stages 3-5 by at least one equation, 45.8% of Black adults were reclassified to more advanced stages of CKD and 44.0% of non-Black adults were reclassified to less severe stages across eGFR thresholds that could change clinical management. Limitations: Potential underestimation of CKD in individuals with only 1 measurement. Conclusions: Adoption of the 2021 CKD-EPI equation in the Military Health System reclassifies many Black adults into new CKD stages 3-5 or into more advanced CKD stages, with the opposite effect on non-Black adults. This may have an effect on CKD treatment and outcomes in ways that are yet unknown. Plain-Language Summary: Until recently, kidney function level was calculated from equations that adjusted the result if the individual was of Black race. Because this may contribute to racial disparities in kidney disease care, a new equation was developed in 2021 that excludes race as a factor. We assessed the possible effects of this equation using data from adults in the US Military Health System from 2016 to 2019. With the new equation, the number of Black adults classified with kidney disease increased while that of non-Black adults decreased. There were similar trends seen in the more severe levels of kidney disease, which could affect decisions in clinical care. These results emphasize the potential positive and negative outcomes to be monitored with the new equation. © 2024 The Authors |
Preventive service usage and new chronic disease diagnoses: Using PCORnet data to identify emerging trends, United States, 2018-2022
Jackson SL , Lekiachvili A , Block JP , Richards TB , Nagavedu K , Draper CC , Koyama AK , Womack LS , Carton TW , Mayer KH , Rasmussen SA , Trick WE , Chrischilles EA , Weiner MG , Podila PSB , Boehmer TK , Wiltz JL . Prev Chronic Dis 2024 21 E49 BACKGROUND: Data modernization efforts to strengthen surveillance capacity could help assess trends in use of preventive services and diagnoses of new chronic disease during the COVID-19 pandemic, which broadly disrupted health care access. METHODS: This cross-sectional study examined electronic health record data from US adults aged 21 to 79 years in a large national research network (PCORnet), to describe use of 8 preventive health services (N = 30,783,825 patients) and new diagnoses of 9 chronic diseases (N = 31,588,222 patients) during 2018 through 2022. Joinpoint regression assessed significant trends, and health debt was calculated comparing 2020 through 2022 volume to prepandemic (2018 and 2019) levels. RESULTS: From 2018 to 2022, use of some preventive services increased (hemoglobin A(1c) and lung computed tomography, both P < .05), others remained consistent (lipid testing, wellness visits, mammograms, Papanicolaou tests or human papillomavirus tests, stool-based screening), and colonoscopies or sigmoidoscopies declined (P < .01). Annual new chronic disease diagnoses were mostly stable (6% hypertension; 4% to 5% cholesterol; 4% diabetes; 1% colonic adenoma; 0.1% colorectal cancer; among women, 0.5% breast cancer), although some declined (lung cancer, cervical intraepithelial neoplasia or carcinoma in situ, cervical cancer, all P < .05). The pandemic resulted in health debt, because use of most preventive services and new diagnoses of chronic disease were less than expected during 2020; these partially rebounded in subsequent years. Colorectal screening and colonic adenoma detection by age group aligned with screening recommendation age changes during this period. CONCLUSION: Among over 30 million patients receiving care during 2018 through 2022, use of preventive services and new diagnoses of chronic disease declined in 2020 and then rebounded, with some remaining health debt. These data highlight opportunities to augment traditional surveillance with EHR-based data. |
Physical activity according to diabetes and metropolitan status: United States 2020 and 2022
Onufrak S , Saelee R , Zaganjor I , Miyamoto Y , Koyama AK , Xu F , Pavkov ME . Am J Prev Med 2024 INTRODUCTION: Physical activity (PA) can reduce morbidity and mortality among adults with diabetes. While rural disparities in PA exist among the general population, it is not known how these disparities manifest among adults with diabetes. METHODS: Data from the 2020 and 2022 National Health Interview Survey were analyzed in 2023 to assess prevalence of meeting aerobic and muscle-strengthening recommendations according to the 2018 Physical Activity Guidelines for Americans during leisure time. PA prevalence was computed by diabetes status, type of PA, and urban/rural residence (large central metro, large fringe metro, medium/small metro, and non-metro). Logistic regression models were used to estimate prevalence and prevalence ratios of meeting PA recommendations by urban/rural residence across diabetes status. RESULTS: Among adults with diabetes in non-metro counties, only 23.8% met aerobic, 10.9% met muscle-strengthening, and 6.2% met both PA recommendations. By contrast, among adults with diabetes in large fringe metro counties, 32.1% met aerobic, 19.7% met strengthening, and 12.0% met both guidelines. Multivariable adjusted prevalence of meeting muscle-strengthening recommendations was higher among participants with diabetes in large fringe metro compared to large central metro counties (PR=1.27; 95% CI 1.03-1.56). Among those without diabetes, adjusted prevalence of meeting each recommendation or both was lower in non-metro and small/medium metro compared to large central metro counties. CONCLUSIONS: Adults with diabetes are less likely to meet the PA recommendations than those without, and differences exist according to urban/rural status. Improving PA among rural residents with diabetes may mitigate disparities in diabetes-related mortality. |
Prevalence of cardiometabolic diseases among racial and ethnic subgroups in adults - Behavioral Risk Factor Surveillance System, United States, 2013-2021
Koyama AK , McKeever Bullard K , Xu F , Onufrak S , Jackson SL , Saelee R , Miyamoto Y , Pavkov ME . MMWR Morb Mortal Wkly Rep 2024 73 (3) 51-56 Although diabetes and cardiovascular disease account for substantial disease prevalence among adults in the United States, their prevalence among racial and ethnic subgroups is inadequately characterized. To fill this gap, CDC described the prevalence of diagnosed cardiometabolic diseases among U.S. adults, by disaggregated racial and ethnic subgroups, among 3,970,904 respondents to the Behavioral Risk Factor Surveillance System during 2013-2021. Prevalence of each disease (diabetes, myocardial infarction, angina or coronary heart disease, and stroke), stratified by race and ethnicity, was based on self-reported diagnosis by a health care professional, adjusting for age, sex, and survey year. Overall, mean respondent age was 47.5 years, and 51.4% of respondents were women. Prevalence of cardiometabolic diseases among disaggregated race and ethnicity subgroups varied considerably. For example, diabetes prevalence within the aggregated non-Hispanic Asian category (11.5%) ranged from 6.3% in the Vietnamese subgroup to 15.2% in the Filipino subgroup. Prevalence of angina or coronary heart disease for the aggregated Hispanic or Latino category (3.8%) ranged from 3.1% in the Cuban subgroup to 6.3% in the Puerto Rican subgroup. Disaggregation of cardiometabolic disease prevalence data by race and ethnicity identified health disparities among subgroups that can be used to better help guide prevention programs and develop culturally relevant interventions. |
Prevalence of testing for diabetes among US adults with overweight or obesity, 2016-2019
Chen Y , Lundeen EA , Koyama AK , Kompaniyets L , Andes LJ , Benoit SR , Imperatore G , Rolka DB . Prev Chronic Dis 2023 20 E116 INTRODUCTION: Screening for prediabetes and type 2 diabetes may allow earlier detection, diagnosis, and treatment. The US Preventive Services Task Force recommends screening every 3 years for abnormal blood glucose among adults aged 40 to 70 years with overweight or obesity. Using IQVIA Ambulatory Electronic Medical Records, we estimated the proportion of adults aged 40 to 70 years with overweight or obesity who received blood glucose testing within 3 years from baseline in 2016. METHODS: We identified 1,338,509 adults aged 40 to 70 years with overweight or obesity in 2016 and without pre-existing diabetes. We included adults whose records were present in the data set for at least 2 years before their index body mass index (BMI) in 2016 and 3 years after the index BMI (2017-2019), during which we examined the occurrence of blood glucose testing. We calculated the unadjusted and adjusted prevalence of receiving blood glucose testing. RESULTS: The unadjusted prevalence of receiving blood glucose testing was 33.4% when it was defined as having a hemoglobin A(1c) or fasting plasma glucose measure. The unadjusted prevalence was 74.3% when we expanded the definition of testing to include random plasma glucose and unspecified glucose measures. Adults with obesity were more likely to receive the test than those with overweight. Men (vs women) and adults aged 50 to 59 years (vs other age groups) had higher testing rates. CONCLUSION: Our findings could inform clinical and public health promotion efforts to improve screening for blood glucose levels among adults with overweight or obesity. |
Risk factors amenable to primary prevention of type 2 diabetes among disaggregated racial and ethnic subgroups in the U.S.
Koyama AK , Bullard KM , Onufrak S , Xu F , Saelee R , Miyamoto Y , Pavkov ME . Diabetes Care 2023 46 (12) 2112-2119 OBJECTIVE: Race and ethnicity data disaggregated into detailed subgroups may reveal pronounced heterogeneity in diabetes risk factors. We therefore used disaggregated data to examine the prevalence of type 2 diabetes risk factors related to lifestyle behaviors and barriers to preventive care among adults in the U.S. RESEARCH DESIGN AND METHODS: We conducted a pooled cross-sectional study of 3,437,640 adults aged ≥18 years in the U.S. without diagnosed diabetes from the Behavioral Risk Factor Surveillance System (2013-2021). For self-reported race and ethnicity, the following categories were included: Hispanic (Cuban, Mexican, Puerto Rican, Other Hispanic), non-Hispanic (NH) American Indian/Alaska Native, NH Asian (Chinese, Filipino, Indian, Japanese, Korean, Vietnamese, Other Asian), NH Black, NH Pacific Islander (Guamanian/Chamorro, Native Hawaiian, Samoan, Other Pacific Islander), NH White, NH Multiracial, NH Other. Risk factors included current smoking, hypertension, overweight or obesity, physical inactivity, being uninsured, not having a primary care doctor, health care cost concerns, and no physical exam in the past 12 months. RESULTS: Prevalence of hypertension, lifestyle factors, and barriers to preventive care showed substantial heterogeneity among both aggregated, self-identified racial and ethnic groups and disaggregated subgroups. For example, the prevalence of overweight or obesity ranged from 50.8% (95% CI 49.1-52.5) among Chinese adults to 79.8% (73.5-84.9) among Samoan adults. Prevalence of being uninsured among Hispanic subgroups ranged from 11.4% (10.9-11.9) among Puerto Rican adults to 33.0% (32.5-33.5) among Mexican adults. CONCLUSIONS: These findings underscore the importance of using disaggregated race and ethnicity data to accurately characterize disparities in type 2 diabetes risk factors and access to care. |
Change in testing for blood glucose during the COVID-19 pandemic, United States 2019–2021
Miyamoto Y , Saelee R , Koyama AK , Zaganjor I , Xu F , Onufrak S , Pavkov ME . Diabetes Res Clin Pract 2023 205 Aim: This study assessed changes in testing for blood glucose in the United States (US) from 2019 to 2021. Methods: We conducted a serial cross-sectional analysis of the 2019–2021 National Health Interview Survey by including adults aged ≥ 18 years without reported diagnosed diabetes. We estimated the prevalence of testing for blood glucose within 12 months and the difference in the testing prevalence between 2019 and 2021. Results: The study sample included 82,594 respondents without diabetes in 2019––2021, with a mean age between 46.4 and 46.8 years. Overall, the prevalence of testing for blood glucose decreased significantly from 64.2 % (95 % confidence interval [CI] 63.3 %, 65.1 %) in 2019 to 60.0 % (95 % CI 59.1 %, 60.9 %) in 2021. Among adults who met the United States Preventive Services Task Force's 2015 screening recommendation, the prevalence decreased from 73.4 % (95 % CI 72.2 %, 74.6 %) to 69.5 % (95 % CI 68.3 %, 70.6 %). Although decreases in testing were observed in most groups, the extent of the decline differed by subgroups. Conclusions: Testing for blood glucose decreased in the US during the COVID-19 pandemic. This may have delayed diagnosis and treatment of prediabetes and diabetes, underscoring the importance of continued access to diabetes screening during pandemics. © 2023 |
Assessing the association between food environment and dietary inflammation by community type: a cross-sectional REGARDS study
Algur Y , Rummo PE , McAlexander TP , De Silva SSA , Lovasi GS , Judd SE , Ryan V , Malla G , Koyama AK , Lee DC , Thorpe LE , McClure LA . Int J Health Geogr 2023 22 (1) 24 BACKGROUND: Communities in the United States (US) exist on a continuum of urbanicity, which may inform how individuals interact with their food environment, and thus modify the relationship between food access and dietary behaviors. OBJECTIVE: This cross-sectional study aims to examine the modifying effect of community type in the association between the relative availability of food outlets and dietary inflammation across the US. METHODS: Using baseline data from the REasons for Geographic and Racial Differences in Stroke study (2003-2007), we calculated participants' dietary inflammation score (DIS). Higher DIS indicates greater pro-inflammatory exposure. We defined our exposures as the relative availability of supermarkets and fast-food restaurants (percentage of food outlet type out of all food stores or restaurants, respectively) using street-network buffers around the population-weighted centroid of each participant's census tract. We used 1-, 2-, 6-, and 10-mile (~ 2-, 3-, 10-, and 16 km) buffer sizes for higher density urban, lower density urban, suburban/small town, and rural community types, respectively. Using generalized estimating equations, we estimated the association between relative food outlet availability and DIS, controlling for individual and neighborhood socio-demographics and total food outlets. The percentage of supermarkets and fast-food restaurants were modeled together. RESULTS: Participants (n = 20,322) were distributed across all community types: higher density urban (16.7%), lower density urban (39.8%), suburban/small town (19.3%), and rural (24.2%). Across all community types, mean DIS was - 0.004 (SD = 2.5; min = - 14.2, max = 9.9). DIS was associated with relative availability of fast-food restaurants, but not supermarkets. Association between fast-food restaurants and DIS varied by community type (P for interaction = 0.02). Increases in the relative availability of fast-food restaurants were associated with higher DIS in suburban/small towns and lower density urban areas (p-values < 0.01); no significant associations were present in higher density urban or rural areas. CONCLUSIONS: The relative availability of fast-food restaurants was associated with higher DIS among participants residing in suburban/small town and lower density urban community types, suggesting that these communities might benefit most from interventions and policies that either promote restaurant diversity or expand healthier food options. |
State-specific prevalence of depression among adults with and without diabetes - United States, 2011-2019
Koyama AK , Hora IA , Bullard KM , Benoit SR , Tang S , Cho P . Prev Chronic Dis 2023 20 E70 INTRODUCTION: In 2019 among US adults, 1 in 9 had diagnosed diabetes and 1 in 5 had diagnosed depression. Since these conditions frequently coexist, compounding their health and economic burden, we examined state-specific trends in depression prevalence among US adults with and without diagnosed diabetes. METHODS: We used data from the 2011 through 2019 Behavioral Risk Factor Surveillance System to evaluate self-reported diabetes and depression prevalence. Joinpoint regression estimated state-level trends in depression prevalence by diabetes status. RESULTS: In 2019, the overall prevalence of depression in US adults with and without diabetes was 29.2% (95% CI, 27.8%-30.6%) and 17.9% (95% CI, 17.6%-18.1%), respectively. From 2011 to 2019, the depression prevalence was relatively stable for adults with diabetes (28.6% versus 29.2%) but increased for those without diabetes from 15.5% to 17.9% (average annual percent change [APC] over the 9-year period = 1.6%, P = .015). The prevalence of depression was consistently more than 10 percentage points higher among adults with diabetes than those without diabetes. The APC showed a significant increase in some states (Illinois: 5.9%, Kansas: 3.5%) and a significant decrease in others (Arizona: -5.1%, Florida: -4.0%, Colorado: -3.4%, Washington: -0.9%). In 2019, although it varied by state, the depression prevalence among adults with diabetes was highest in states with a higher diabetes burden such as Kentucky (47.9%), West Virginia (47.0%), and Maine (41.5%). CONCLUSION: US adults with diabetes are more likely to report prevalent depression compared with adults without diabetes. These findings highlight the importance of screening and monitoring for depression as a potential complication among adults with diabetes. |
Role of anemia in dementia risk among veterans with incident CKD
Koyama AK , Nee R , Yu W , Choudhury D , Heng F , Cheung AK , Norris KC , Cho ME , Yan G . Am J Kidney Dis 2023 82 (6) 706-714 RATIONALE & OBJECTIVE: While some evidence exists of increased dementia risk from anemia, it is unclear if this association persists among adults with CKD. Anemia may be a key marker for dementia among adults with CKD. We therefore evaluated if anemia is associated with an increased risk of dementia among adults with CKD. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: The study included 620,095 veterans aged ≥45 years with incident stage 3 CKD (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m(2)) between January 2005 and December 2016 in the US Veterans Health Administration system and followed through December 31, 2018 for incident dementia, kidney failure or death. EXPOSURES: Anemia was assessed based on the average of hemoglobin levels (g/L) during the two years prior to the date of incident CKD and categorized as normal, mild and moderate/severe anemia (≥12.0, 11.0-11.9, <11.0 g/dL, respectively for women and ≥13.0, 11.0-12.9, <11.0 g/dL for men). OUTCOMES: Dementia and the composite outcome of kidney failure or death. ANALYTICAL APPROACH: Adjusted cause-specific hazard ratios were estimated for each outcome. RESULTS: At the time of incident CKD, mean age was 72 years, 97% were male, and mean eGFR was 51 mL/min per 1.73 m(2). Over a median 4.1 years of follow-up, 92,306 (15%) veterans developed dementia before kidney failure or death. Compared to veterans with CKD without anemia, multivariable-adjusted models showed a 16% (95% confidence interval [CI] 14% to 17%) significantly higher risk of dementia for those with mild anemia and a 27% (95% CI 23% to 31%) higher risk with moderate/severe anemia. Combined risk of kidney failure or death was higher at 39% (95% CI 37% to 40%) and 115% (95% CI 112% to 119%) for mild and moderate/severe anemia, respectively, compared to no anemia. LIMITATIONS: Residual confounding from the observational study design. Findings may not be generalizable to the broader U.S. CONCLUSIONS: Anemia was significantly associated with increased risk of dementia among veterans with incident CKD, underscoring the role of anemia as a predictor of dementia risk. |
Risk of cardiovascular disease after COVID-19 diagnosis among adults with and without diabetes
Koyama AK , Imperatore G , Rolka DB , Lundeen E , Rutkowski RE , Jackson SL , He S , Kuklina EV , Park S , Pavkov ME . J Am Heart Assoc 2023 12 (13) e029696 Background Growing evidence suggests incident cardiovascular disease (CVD) may be a long-term outcome of COVID-19 infection, and chronic diseases, such as diabetes, may influence CVD risk associated with COVID-19. We evaluated the postacute risk of CVD >30 days after a COVID-19 diagnosis by diabetes status. Methods and Results We included adults ≥20 years old with a COVID-19 diagnosis from March 1, 2020 through December 31, 2021 in a retrospective cohort study from the IQVIA PharMetrics Plus insurance claims database. A contemporaneous control group comprised adults without recorded diagnoses for COVID-19 or other acute respiratory infections. Two historical control groups comprised patients with or without an acute respiratory infection. Cardiovascular outcomes included cerebrovascular disorders, dysrhythmia, inflammatory heart disease, ischemic heart disease, thrombotic disorders, other cardiac disorders, major adverse cardiovascular events, and any CVD. The total sample comprised 23 824 095 adults (mean age, 48.4 years [SD, 15.7 years]; 51.9% women; mean follow-up, 8.5 months [SD, 5.8 months]). In multivariable Cox regression models, patients with a COVID-19 diagnosis had a significantly greater risk of all cardiovascular outcomes compared with patients without a diagnosis of COVID-19 (hazard ratio [HR], 1.66 [1.62-1.71], with diabetes; HR, 1.75 [1.73-1.78], without diabetes). Risk was attenuated but still significant for the majority of outcomes when comparing patients with COVID-19 to both historical control groups. Conclusions In patients with COVID-19 infection, postacute risk of incident cardiovascular outcomes is significantly higher than among controls without COVID-19, regardless of diabetes status. Therefore, monitoring for incident CVD may be essential beyond the first 30 days after a COVID-19 diagnosis. |
Prevalence of anemia and associated all-cause mortality among adults with diabetes: The role of chronic kidney disease
Koyama AK , Lundeen E , McKeever Bullard K , Pavkov ME . Diabetes Res Clin Pract 2023 200 110695 AIMS: Among adults with diabetes in the United States, we evaluated anemia prevalence by CKD status as well as the role of CKD and anemia, as potential risk factors for all-cause mortality. METHODS: In a retrospective cohort study, we included 6,718 adult participants with prevalent diabetes from the 2003-March 2020 National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the non-institutionalized civilian population in the United States. Cox regression models evaluated the role of anemia and CKD, alone or combined, as predictors of all-cause mortality. RESULTS: Anemia prevalence among adults with diabetes and CKD was 20%. Having anemia or CKD alone, compared with having neither condition, was significantly associated with all-cause mortality (anemia: HR=2.10 [1.49-2.96], CKD: HR=2.24 [1.90-2.64]). Having both conditions conferred a greater potential risk (HR=3.41 [2.75-4.23]). CONCLUSIONS: Approximately one-quarter of the adult US population with diabetes and CKD also has anemia. The presence of anemia, with or without CKD, is associated with a two- to threefold increased risk of death by compared with adults who have neither condition, suggesting that anemia may be a strong predictor of death among adults with diabetes. |
Incidence of chronic kidney disease among adults with diabetes, 2015-2020
Tuttle KR , Jones CR , Daratha KB , Koyama AK , Nicholas SB , Alicic RZ , Duru OK , Neumiller JJ , Norris KC , Ríos Burrows N , Pavkov ME . N Engl J Med 2022 387 (15) 1430-1431 The prevalence of kidney failure warranting dialysis or transplantation more than doubled between 2000 and 2019 to nearly 800,000 persons in the United States, with diabetes as the leading cause in 47% of those affected.1,2 The incidence of chronic kidney disease (CKD) among patients with diabetes is unknown, yet such data are vital for identifying high-risk populations, determining the effectiveness of interventions, and assessing the effects on health care delivery and public health responses. |
Age-related association between multimorbidity and mortality in US veterans with incident chronic kidney disease
Burrows NR , Koyama AK , Choudhury D , Yu W , Pavkov ME , Nee R , Cheung AK , Norris KC , Yan G . Am J Nephrol 2022 53 1-11 INTRODUCTION: Mortality is an important long-term indicator of the public health impact of chronic kidney disease (CKD). We investigated the role of individual comorbidities and multimorbidity on age-specific mortality risk among US veterans with new-onset CKD. METHODS: The cohort included 892,005 veterans aged 18 years with incident CKD stage 3 between January 2004 and April 2018 in the US Veterans Health Administration (VHA) system and followed until death, December 2018, or up to 10 years. Incident CKD was defined as the first-time estimated glomerular filtration rate (eGFR) was <60 mL/min/1.73 m2 for >3 months. Comorbidities were ascertained using inpatient and outpatient clinical records in the VHA system and Medicare claims. We estimated death rates for any cardiovascular disease (CVD, a composite of 6 CVD conditions) and 15 non-CVD comorbidities, and adjusted risks of death (hazard ratio [HR], 95% confidence interval [CI]) overall and by age group at CKD incidence. RESULTS: At CKD incidence, the mean age was 72 years, and 97% were male; the mean eGFR was 52 mL/min/1.73 m2, and 95% had 2 comorbidities (median, 4) in addition to CKD. During a median follow-up of 4.5 years, among the 16 comorbidities, CVD was associated with the highest relative risk of death in younger veterans (HR 1.96 [95% CI: 1.61-2.37] in ages 18-44 years and HR 1.66 [1.63-1.70] in ages 45-64 years). Dementia was associated with the highest relative risk of death among older veterans (HR 1.71 [1.68-1.74] in ages 65-84 years and HR 1.69 [1.65-1.73] in ages 85-100 years). The additive effect of multimorbidity on risk of death was stronger in younger than older veterans. Compared to having 1 or no comorbidity at CKD onset, the risk of death with 5 comorbidities was >7-fold higher among veterans aged 18-44 years and >2-fold higher among veterans aged 85-100 years. CONCLUSION: The large burden of comorbidities in US veterans with newly identified CKD places them at the risk of premature death. Compared with older veterans, younger veterans with multiple comorbidities, particularly with CVD, at CKD onset are at an even higher relative risk of death. |
Prevalence of mental, behavioral, and developmental disorders among children and adolescents with diabetes, United States (2016-2019)
Barrett CE , Zhou X , Mendez I , Park J , Koyama AK , Claussen AH , Newsome K , McKeever Bullard K . J Pediatr 2022 253 25-32 OBJECTIVE: To assess the association of diabetes and mental, behavioral, and developmental disorders in youth, we examined the magnitude of overlap between these disorders in children and adolescents. STUDY DESIGN: In this cross-sectional study, we calculated prevalence estimates using the 2016-2019 National Survey of Children's Health. Parents reported whether their child was currently diagnosed with diabetes or with any of the following mental, behavioral, or developmental disorders: attention-deficit/hyperactivity disorder, autism spectrum disorder, learning disability, intellectual disability, developmental delay, anxiety, depression, behavioral problems, Tourette syndrome, or speech/language disorder. We present crude prevalence estimates weighted to be representative of the U.S. child population and prevalence ratios (aPR) adjusted for age, sex, and race/ethnicity. RESULTS: Among children and adolescents (aged 2-17 years; N=121,312), prevalence of mental, behavioral, and developmental disorders varied by diabetes status (diabetes: 39.9% [30.2-50.4]; no diabetes: 20.3% [19.8-20.8]). Compared with children and adolescents without diabetes, those with diabetes had a nearly two-fold higher prevalence of mental, behavioral, and developmental disorders (aPR: 1.72 [1.31-2.27]); mental, emotional, and behavioral disorders (aPR: 1.90 [1.38-2.61]); and developmental, learning, and language disorders (aPR: 1.89 [1.35-2.66]). CONCLUSIONS: These results suggest that approximately 2 in 5 children and adolescents with diabetes have a mental, behavioral, or developmental disorder. Understanding potential causal pathways may ultimately lead to future preventative strategies for mental, behavioral, and developmental disorders and diabetes in children and adolescents. |
Mental Health Conditions and Severe COVID-19 Outcomes after Hospitalization, United States.
Koyama AK , Koumans EH , Sircar K , Lavery AM , Ko JY , Hsu J , Anderson KN , Siegel DA . Emerg Infect Dis 2022 28 (7) 1533-1536 Among 664,956 hospitalized COVID-19 patients during March 2020-July 2021 in the United States, select mental health conditions (i.e., anxiety, depression, bipolar, schizophrenia) were associated with increased risk for same-hospital readmission and longer length of stay. Anxiety was also associated with increased risk for intensive care unit admission, invasive mechanical ventilation, and death. |
Trends in lifetime risk and years of potential life lost from diabetes in the United States, 1997-2018
Koyama AK , Cheng YJ , Brinks R , Xie H , Gregg EW , Hoyer A , Pavkov ME , Imperatore G . PLoS One 2022 17 (5) e0268805 BACKGROUND: Both incidence and mortality of diagnosed diabetes have decreased over the past decade. However, the impact of these changes on key metrics of diabetes burden-lifetime risk (LR), years of potential life lost (YPLL), and years spent with diabetes-is unknown. METHODS: We used data from 653,811 adults aged ≥18 years from the National Health Interview Survey, a cross-sectional sample of the civilian non-institutionalized population in the United States. LR, YPLL, and years spent with diabetes were estimated from age 18 to 84 by survey period (1997-1999, 2000-2004, 2005-2009, 2010-2014, 2015-2018). The age-specific incidence of diagnosed diabetes and mortality were estimated using Poisson regression. A multistate difference equation accounting for competing risks was used to model each metric. RESULTS: LR and years spent with diabetes initially increased then decreased over the most recent time periods. LR for adults at age 20 increased from 31.7% (95% CI: 31.2-32.1%) in 1997-1999 to 40.7% (40.2-41.1%) in 2005-2009, then decreased to 32.8% (32.4-33.2%) in 2015-2018. Both LR and years spent with diabetes were markedly higher among adults of non-Hispanic Black, Hispanic, and other races compared to non-Hispanic Whites. YPLL significantly decreased over the study period, with the estimated YPLL due to diabetes for an adult aged 20 decreasing from 8.9 (8.7-9.1) in 1997-1999 to 6.2 (6.1-6.4) in 2015-2018 (p = 0.02). CONCLUSION: In the United States, diabetes burden is declining, but disparities by race/ethnicity remain. LR remains high with approximately one-third of adults estimated to develop diabetes during their lifetime. |
Reported cases of end-stage kidney diseaseUnited States, 20002019
Ríos Burrows N , Koyama A , Pavkov ME . Am J Transplant 2022 22 (5) 1483-1486 This article describes trends in end-stage kidney disease in the US between 2000 and 2019, when a 42% increase in incident cases and a 119% increase in prevalent cases of end-stage kidney disease were observed. Hypertension and diabetes mellitus were the primary causes of both incident and prevalent cases of end-stage kidney disease. These trends suggest there will be an ongoing increase in the demand for organ transplantation, a potential negative impact on future organ supply, and underscore the need for increased access to kidney transplantation nationally. |
Progression to diabetes among older adults with hemoglobin a1c-defined prediabetes in the US
Koyama AK , Bullard KM , Pavkov ME , Park J , Mardon R , Zhang P . JAMA Netw Open 2022 5 (4) e228158 This cohort study estimates the progression to diabetes among older adults with hemoglobin A(1c)-defined prediabetes in clinical settings in the US. |
Reported cases of end-stage kidney disease - United States, 2000-2019
Burrows NR , Koyama A , Pavkov ME . MMWR Morb Mortal Wkly Rep 2022 71 (11) 412-415 End-stage kidney disease (ESKD) (kidney failure requiring dialysis or transplantation) is a costly and disabling condition that often results in premature death (1). During 2019, Medicare fee-for-service expenditures for ESKD were $37.3 billion, accounting for approximately 7% of Medicare paid claims costs (1). Diabetes and hypertension remain the leading causes of ESKD, accounting for 47% and 29%, respectively, of patients who began ESKD treatment in 2019 (1). Compared with White persons, Black, Hispanic, and American Indian or Alaska Native persons are more likely to develop ESKD (1,2) and to have diagnosed diabetes (3). After declining for more than a decade, the incidence rate of ESKD with diabetes reported as the primary cause (ESKD from diabetes) has leveled off since 2010 (1,4). Further, after increasing for many years, the prevalence of diagnosed diabetes has also leveled off (4). Although these flattening trends in rates are important from a population perspective, the trend in the number of ESKD cases is important from a health systems resources perspective. Using United States Renal Data System (USRDS) 2000-2019 data, CDC examined trends in the number of incident and prevalent ESKD cases by demographic characteristics and by primary cause of ESKD. During 2000-2019, the number of incident ESKD cases increased by 41.8%, and the number of prevalent ESKD cases increased by 118.7%. Higher percentage changes in both incident and prevalent ESKD cases were among Asian, Hispanic, and Native Hawaiian or other Pacific Islander persons and among cases with hypertension or diabetes as the primary cause. Interventions to improve care and better manage ESKD risk factors among persons with diabetes and hypertension, along with increased use of therapeutic agents such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), and sodium-glucose cotransporter 2 (SGLT2) inhibitors shown to have kidney-protective benefits (5,6) might slow the increase and eventually reverse the trend in incident ESKD cases. |
Is dietary intake of advanced glycation end products associated with mortality among adults with diabetes
Koyama AK , Pavkov ME , Wu Y , Siegel KR . Nutr Metab Cardiovasc Dis 2022 32 (6) 1402-1409 BACKGROUND AND AIMS: Prior studies suggest a positive association between dietary AGEs and adverse health outcomes but have not well-characterized AGEs intake and its association with mortality in a general adult population in the United States. METHODS AND RESULTS: We included 5474 adults with diabetes from the 2003 to 2018 National Health and Nutrition Examination Survey, a nationally representative sample of the non-institutionalized civilian population in the United States. Concordance to dietary guidelines (Healthy Eating Index 2015 [HEI-2015]) and intake of the AGE Nϵ-(carboxymethyl)lysine (CML) were estimated using an existing database and two 24-h food recalls. Multivariable Cox regression evaluated the association between AGEs intake and all-cause mortality. A secondary analysis measured CML, Nϵ-(1-carboxyethyl)lysine (CEL), and Nδ-(5-hydro-5-methyl-4-imidazolon-2-yl)-ornithine (MGH1) from an alternative database. Higher AGEs intake was associated with lower concordance to dietary guidelines (Means and standard errors of HEI-2015 score, by quartiles of AGEs intake: Q1 = 55.2 ± 0.6, Q2 = 54.1 ± 0.5, Q3 = 52.1 ± 0.5, Q4 = 49.0 ± 0.5; p < 0.001). There were 743 deaths among 3884 adults in the mortality analysis (mean follow-up = 3.8 years). AGEs intake was not significantly associated with all-cause mortality (Q2 vs. Q1: Hazard Ratio [HR] = 0.91 [0.69-1.21], Q3 vs. Q1: HR = 0.90 [0.63-1.27], Q4 vs. Q1: HR = 1.16 [0.84-1.60]). Results were similar in secondary analyses. CONCLUSION: While dietary AGEs intake was associated with concordance to dietary guidelines, it was not significantly associated with all-cause mortality among adults with diabetes. Further research may consider other health outcomes as well as the evaluating specific contribution of dietary AGEs to overall AGEs burden. |
Severe Outcomes, Readmission, and Length of Stay Among COVID-19 Patients with Intellectual and Developmental Disabilities.
Koyama AK , Koumans EH , Sircar K , Lavery A , Hsu J , Ryerson AB , Siegel DA . Int J Infect Dis 2022 116 328-330 OBJECTIVES: The aim of this study was to evaluate the association between intellectual and developmental disabilities (IDDs) and severe COVID-19 outcomes, 30-day readmission, and/or increased length of stay (LOS) using a large electronic administrative database. METHODS: Patients hospitalized with COVID-19 were identified between March 2020 and June 2021 from more than 900 hospitals in the United States. IDDs included intellectual disability, cerebral palsy, Down syndrome, autism spectrum disorder (ASD), and other intellectual disabilities. Outcomes included intensive care unit (ICU) admission, invasive mechanical ventilation (IMV), 30-day readmission, mortality, and LOS. RESULTS: Among 643,765 patients with COVID-19, multivariate models showed that patients with any IDD were at a significantly greater risk of at least 1 severe outcome, 30-day readmission, or longer LOS than patients without any IDD. Compared with those without any IDD, patients with Down syndrome had the greatest odds of ICU admission (odds ratio [OR] and 95% confidence interval [CI]: 1.96 [1.73-2.21]), IMV (OR: 2.37 [2.07-2.70]), and mortality (OR: 2.33 [2.00-2.73]). Patients with ASD and those with Down syndrome both had over a 40% longer mean LOS. Patients with intellectual disabilities had a 23% (12-35%) increased odds of 30-day readmission. CONCLUSIONS: Results suggest that patients hospitalized with COVID-19 with IDD have a significantly increased risk of severe outcomes, 30-day readmission, and longer LOS. |
Risk for Newly Diagnosed Diabetes >30 Days After SARS-CoV-2 Infection Among Persons Aged <18 Years - United States, March 1, 2020-June 28, 2021.
Barrett CE , Koyama AK , Alvarez P , Chow W , Lundeen EA , Perrine CG , Pavkov ME , Rolka DB , Wiltz JL , Bull-Otterson L , Gray S , Boehmer TK , Gundlapalli AV , Siegel DA , Kompaniyets L , Goodman AB , Mahon BE , Tauxe RV , Remley K , Saydah S . MMWR Morb Mortal Wkly Rep 2022 71 (2) 59-65 The COVID-19 pandemic has disproportionately affected people with diabetes, who are at increased risk of severe COVID-19.* Increases in the number of type 1 diabetes diagnoses (1,2) and increased frequency and severity of diabetic ketoacidosis (DKA) at the time of diabetes diagnosis (3) have been reported in European pediatric populations during the COVID-19 pandemic. In adults, diabetes might be a long-term consequence of SARS-CoV-2 infection (4-7). To evaluate the risk for any new diabetes diagnosis (type 1, type 2, or other diabetes) >30 days(†) after acute infection with SARS-CoV-2 (the virus that causes COVID-19), CDC estimated diabetes incidence among patients aged <18 years (patients) with diagnosed COVID-19 from retrospective cohorts constructed using IQVIA health care claims data from March 1, 2020, through February 26, 2021, and compared it with incidence among patients matched by age and sex 1) who did not receive a COVID-19 diagnosis during the pandemic, or 2) who received a prepandemic non-COVID-19 acute respiratory infection (ARI) diagnosis. Analyses were replicated using a second data source (HealthVerity; March 1, 2020-June 28, 2021) that included patients who had any health care encounter possibly related to COVID-19. Among these patients, diabetes incidence was significantly higher among those with COVID-19 than among those 1) without COVID-19 in both databases (IQVIA: hazard ratio [HR] = 2.66, 95% CI = 1.98-3.56; HealthVerity: HR = 1.31, 95% CI = 1.20-1.44) and 2) with non-COVID-19 ARI in the prepandemic period (IQVIA, HR = 2.16, 95% CI = 1.64-2.86). The observed increased risk for diabetes among persons aged <18 years who had COVID-19 highlights the importance of COVID-19 prevention strategies, including vaccination, for all eligible persons in this age group,(§) in addition to chronic disease prevention and management. The mechanism of how SARS-CoV-2 might lead to incident diabetes is likely complex and could differ by type 1 and type 2 diabetes. Monitoring for long-term consequences, including signs of new diabetes, following SARS-CoV-2 infection is important in this age group. |
Trends in chronic kidney disease care in the US by race and ethnicity, 2012-2019
Chu CD , Powe NR , McCulloch CE , Crews DC , Han Y , Bragg-Gresham JL , Saran R , Koyama A , Burrows NR , Tuot DS . JAMA Netw Open 2021 4 (9) e2127014 IMPORTANCE: Significant racial and ethnic disparities in chronic kidney disease (CKD) progression and outcomes are well documented, as is low use of guideline-recommended CKD care. OBJECTIVE: To examine guideline-recommended CKD care delivery by race and ethnicity in a large, diverse population. DESIGN, SETTING, AND PARTICIPANTS: In this serial cross-sectional study, adult patients with CKD that did not require dialysis, defined as a persistent estimated glomerular filtration rate less than 60 mL/min/1.73 m2 or a urine albumin-creatinine ratio of 30 mg/g or higher for at least 90 days, were identified in 2-year cross-sections from January 1, 2012, to December 31, 2019. Data from the OptumLabs Data Warehouse, a national data set of administrative and electronic health record data for commercially insured and Medicare Advantage patients, were used. EXPOSURES: The independent variables were race and ethnicity, as reported in linked electronic health records. MAIN OUTCOMES AND MEASURES: On the basis of guideline-recommended CKD care, the study examined care delivery process measures (angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker prescription for albuminuria, statin prescription, albuminuria testing, nephrology care for CKD stage 4 or higher, and avoidance of chronic nonsteroidal anti-inflammatory drug prescription) and care delivery outcome measures (blood pressure and diabetes control). RESULTS: A total of 452 238 patients met the inclusion criteria (mean [SD] age, 74.0 [10.2] years; 262 089 [58.0%] female; a total of 7573 [1.7%] Asian, 49 970 [11.0%] Black, 15 540 [3.4%] Hispanic, and 379 155 [83.8%] White). Performance on process measures was higher among Asian, Black, and Hispanic patients compared with White patients for angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker use (79.8% for Asian patients, 76.7% for Black patients, and 79.9% for Hispanic patients compared with 72.3% for White patients in 2018-2019), statin use (72.6% for Asian patients, 69.1% for Black patients, and 74.1% for Hispanic patients compared with 61.5% for White patients), nephrology care (64.8% for Asian patients, 72.9% for Black patients, and 69.4% for Hispanic patients compared with 58.3% for White patients), and albuminuria testing (53.9% for Asian patients, 41.0% for Black patients, and 52.6% for Hispanic patients compared with 30.7% for White patients). Achievement of blood pressure control to less than 140/90 mm Hg was similar or lower among Asian (71.8%), Black (63.3%), and Hispanic (69.8%) patients compared with White patients (72.9%). Achievement of diabetes control with hemoglobin A1c less than 7.0% was 50.1% in Asian patients, 49.3% in Black patients, and 46.0% in Hispanic patients compared with 50.3% for White patients. CONCLUSIONS AND RELEVANCE: Higher performance on CKD care process measures among Asian, Black, and Hispanic patients suggests that differences in medication prescription and diagnostic testing are unlikely to fully explain known disparities in CKD progression and kidney failure. Improving care delivery processes alone may be inadequate for reducing these disparities. |
Symptoms Reported With New Onset of Loss of Taste or Smell in Individuals With and Without SARS-CoV-2 Infection.
Koyama AK , Siegel DA , Oyegun E , Hampton W , Maddox N , Koumans EH . JAMA Otolaryngol Head Neck Surg 2021 147 (10) 911-914 This cross-sectional study uses data from the Centers for Disease Control and Prevention's Coronavirus Self-checker to assess which symptoms are reported with new loss of taste or smell among individuals with and without SARS-CoV-2. |
Lung bioactivity of vapor grown carbon nanofibers
Porter DW , Orandle M , Mercer RR , Wu N , Zheng P , Chen BT , Holian A , Andrew M , Leonard S , Wolfarth M , Friend S , Battelli L , Hamilton RF Jr , Hagiwara Y , Koyama T , Castranova V . NanoImpact 2017 6 1-10 Vapor grown carbon nanofibers (VGCF-H) is an example of a two dimensional carbon based nanoparticle. In the present study, male C57Bl/6J mice were exposed to VGCF-H (10–80 μg) by pharyngeal aspiration; dispersion medium (DM) was used as the vehicle. At 1, 7 and 28 days post-exposure, lung lavage and histopathology studies were conducted. VGCF-H cytotoxicity was assessed by measuring acellular lavage fluid lactate dehydrogenase (LDH) activity, and determined that VGCF-H exposure produced dose-dependent increases in LDH activity which decreased over time. Using polymorphonuclear leukocytes as a marker, VGCF-H-exposure produced dose-dependent lung inflammation which decreased over time. Histologically, the incidence and severity of pulmonary inflammation was confirmed to be dose-dependent, and inflammatory infiltrates were characterized by increased numbers of alveolar macrophages with small numbers of neutrophils. VGCF-H caused dose- and time-dependent increases in cathepsin activity and cytokines in the acellular lavage fluid, indicating activation of the NLRP3 inflammasome by VGCFH may contribute to lung inflammation. VGCF-H exposure caused minimal to mild interstitial alveolar fibrosis, characterized by increased amounts of collagen fibers in the interstitium, and the incidence and severity of fibrosis tended to increase with the VGCF-H dose. Accumulation of VGCF-H fibers in the tracheobronchial lymph nodes was observed by 28 days after exposure at 40 and 80 μg doses. |
HDL cholesterol performance using an ultracentrifugation reference measurement procedure and the designated comparison method
Nakamura M , Yokoyama S , Kayamori Y , Iso H , Kitamura A , Okamura T , Kiyama M , Noda H , Nishimura K , Nakai M , Koyama I , Dasti M , Vesper HW , Teramoto T , Miyamoto Y . Clin Chim Acta 2015 439 185-90 BACKGROUND: Accurate high-density lipoprotein cholesterol (HDL-C) measurements are important for management of cardiovascular diseases. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform ultracentrifugation (UC) reference measurement procedure (RMP) to value assign HDL-C. Japanese CRMLN laboratory (Osaka) concurrently runs UC procedure and the designated comparison method (DCM). Osaka performance of UC and DCM was examined and compared with CDC RMP. METHODS: CDC RMP involved UC, heparin-MnCl₂ precipitation, and cholesterol analysis. CRMLN DCM for samples containing <200 mg/dl triglycerides involved 50-kDa dextran sulfate-MgCl2 precipitation and cholesterol determination. RESULTS: HDL-C regression equations obtained with CDC (x) and Osaka (y) were y=0.992x+0.542 (R(2)=0.996) for Osaka UC and y=1.004x-0.181 (R(2)=0.998) for DCM. Pass rates within ±1 mg/dl of the CDC target value were 91.9 and 92.1% for Osaka UC and DCM, respectively. Biases at 40 mg/dl HDL-C were +0.22 and -0.02 mg/dl for Osaka UC and DCM, respectively. CONCLUSIONS: Osaka UC and DCM were highly accurate, precise, and stable for many years, assisting manufacturers to calibrate products for clinical laboratories to accurately measure HDL-C for patients, calculate non-HDL-C, and estimate low-density lipoprotein cholesterol with the Friedewald equation. |
Total cholesterol performance of Abell-Levy-Brodie-Kendall reference measurement procedure: certification of Japanese in-vitro diagnostic assay manufacturers through CDC's Cholesterol Reference Method Laboratory Network
Nakamura M , Iso H , Kitamura A , Imano H , Kiyama M , Yokoyama S , Kayamori Y , Koyama I , Nishimura K , Nakai M , Dasti M , Vesper HW , Miyamoto Y . Clin Chim Acta 2015 445 127-32 BACKGROUND: Accurate measurement of total cholesterol (TC) is important for cardiovascular disease risk management. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform Abell-Levy-Brodie-Kendall (AK) reference measurement procedure (RMP) for TC as a secondary reference method, and implement Certification Protocol for Manufacturers. Japanese CRMLN laboratory at Osaka performed the AK RMP for 22 years, and conducted TC certification for reagent/calibrator/instrument systems of six Japanese manufacturers every 2 years for 16 years. Osaka TC performance was examined and compared to CDC's reference values. METHODS: AK RMP involved sample hydrolysis, cholesterol extraction, and determination of cholesterol levels by spectrophotometry. The Certification Protocol for Manufacturers includes comparison with AK RMP using at least 40 fresh specimens. Demonstration of average bias ≤3% and total coefficient of variation ≤3% qualified an analytical system for certification. RESULTS: In the AK RMP used in the Osaka CRMLN laboratory, the regression equation for measuring TC was y (Osaka)=1.000x (CDC)+0.032 (n=619, R2=1.000). Six Japanese manufacturers had allowable performance for certification. CONCLUSIONS: The AK RMP for TC measurement was accurate, precise, and stable for 22 years. Six Japanese manufacturers were certified for 16years. |
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