Antifungal drug price increases in the United States, 2000-2019.

BACKGROUND: Antifungal drugs treat a variety of conditions, ranging from localised dermatologic disease to life-threatening systemic infections. Some common antifungal drugs experienced large price increases in recent years, however, factors contributing to these price increases are poorly understood. We sought to examine trends in antifungal drug prices and determine underlying drivers of price changes. METHODS: Antifungal drug products in the United States were identified using the Food and Drug Administration (FDA) Label database. For each product, we determined the wholesale acquisition cost per unit over time between 2000 and 2019, adjusting for inflation, and examined variables that could impact price: route of administration, number of FDA indications, the quantity of professional guideline recommendations, use for prophylaxis, number of FDA-approved manufacturers, and whether it was compounded. Price trajectories were clustered into four groups: (1) stable, 2) moderate, (3) high, and (4) extreme price increases. RESULTS: Of 139 identified drug products, one outlier was removed due to exorbitant price increases. Cluster 1 (n = 31) demonstrated the most stable prices with a 25% mean price increase. Clusters 2 (n = 97), 3 (n = 7), and 4 (n = 3) demonstrated moderate, high, and extreme price increases with 52%, 318%, and 900% mean price increases, respectively. Atypical routes of administration and compounding were over-represented in clusters 3 and 4. There was no correlation between the number of manufacturers and price changes. CONCLUSIONS: Antifungal drugs exhibited large, inflation-adjusted price increases. Atypical routes of administration and compounding were over-represented within clusters exhibiting extraordinary price increases. Our data support policies aiming to curb large price increases for medically important drugs.

Association of COVID-19 vs Influenza With Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients.

Importance: The incidence of arterial thromboembolism and venous thromboembolism in persons with COVID-19 remains unclear. Objective: To measure the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability vs patients hospitalized with influenza. Design, Setting, and Participants: Retrospective cohort study of 41 443 patients hospitalized with COVID-19 before vaccine availability (April-November 2020), 44 194 patients hospitalized with COVID-19 during vaccine availability (December 2020-May 2021), and 8269 patients hospitalized with influenza (October 2018-April 2019) in the US Food and Drug Administration Sentinel System (data from 2 national health insurers and 4 regional integrated health systems). Exposures: COVID-19 or influenza (identified by hospital diagnosis or nucleic acid test). Main Outcomes and Measures: Hospital diagnosis of arterial thromboembolism (acute myocardial infarction or ischemic stroke) and venous thromboembolism (deep vein thrombosis or pulmonary embolism) within 90 days. Outcomes were ascertained through July 2019 for patients with influenza and through August 2021 for patients with COVID-19. Propensity scores with fine stratification were developed to account for differences between the influenza and COVID-19 cohorts. Weighted Cox regression was used to estimate the adjusted hazard ratios (HRs) for outcomes during each COVID-19 vaccine availability period vs the influenza period. Results: A total of 85 637 patients with COVID-19 (mean age, 72 [SD, 13.0] years; 50.5% were male) and 8269 with influenza (mean age, 72 [SD, 13.3] years; 45.0% were male) were included. The 90-day absolute risk of arterial thromboembolism was 14.4% (95% CI, 13.6%-15.2%) in patients with influenza vs 15.8% (95% CI, 15.5%-16.2%) in patients with COVID-19 before vaccine availability (risk difference, 1.4% [95% CI, 1.0%-2.3%]) and 16.3% (95% CI, 16.0%-16.6%) in patients with COVID-19 during vaccine availability (risk difference, 1.9% [95% CI, 1.1%-2.7%]). Compared with patients with influenza, the risk of arterial thromboembolism was not significantly higher among patients with COVID-19 before vaccine availability (adjusted HR, 1.04 [95% CI, 0.97-1.11]) or during vaccine availability (adjusted HR, 1.07 [95% CI, 1.00-1.14]). The 90-day absolute risk of venous thromboembolism was 5.3% (95% CI, 4.9%-5.8%) in patients with influenza vs 9.5% (95% CI, 9.2%-9.7%) in patients with COVID-19 before vaccine availability (risk difference, 4.1% [95% CI, 3.6%-4.7%]) and 10.9% (95% CI, 10.6%-11.1%) in patients with COVID-19 during vaccine availability (risk difference, 5.5% [95% CI, 5.0%-6.1%]). Compared with patients with influenza, the risk of venous thromboembolism was significantly higher among patients with COVID-19 before vaccine availability (adjusted HR, 1.60 [95% CI, 1.43-1.79]) and during vaccine availability (adjusted HR, 1.89 [95% CI, 1.68-2.12]). Conclusions and Relevance: Based on data from a US public health surveillance system, hospitalization with COVID-19 before and during vaccine availability, vs hospitalization with influenza in 2018-2019, was significantly associated with a higher risk of venous thromboembolism within 90 days, but there was no significant difference in the risk of arterial thromboembolism within 90 days.

Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.

Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US. Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.

Identification of cancer chemotherapy regimens and patient cohorts in administrative claims: challenges, opportunities, and a proposed algorithm.

BACKGROUND: Real-world evidence is a valuable source of information in healthcare. This study describes the challenges and successes during algorithm development to identify cancer cohorts and multi-agent chemotherapy regimens from claims data to perform a comparative effectiveness analysis of granulocyte colony stimulating factor (G-CSF) use. METHODS: Using the Biologics and Biosimilars Collective Intelligence Consortium's Distributed Research Network, we iteratively developed and tested a de novo algorithm to accurately identify patients by cancer diagnosis, then extract chemotherapy and G-CSF administrations for a retrospective study of prophylactic G-CSF. RESULTS: After identifying patients with cancer and subsequent chemotherapy exposures, we observed only 12% of patients with cancer received chemotherapy, which is fewer than expected based on prior analyses. Therefore, we reversed the initial inclusion criteria to identify chemotherapy receipt, then prior cancer diagnosis, which increased the number of patients from 2,814 to 3,645, or 68% of patients receiving chemotherapy had diagnoses of interest. Additionally, we excluded patients with cancer diagnoses that differed from those of interest in the 183 days before the index date of G-CSF receipt, including early-stage cancers without G-CSF or chemotherapy exposure. By removing this criterion, we retained 77 patients who were previously excluded. Finally, we incorporated a 5-day window to identify all chemotherapy drugs administered (excluding oral prednisone and methotrexate, as these medications may be used for other non-malignant conditions) as patients may fill oral prescriptions days to weeks prior to infusion. This increased the number of patients with chemotherapy exposures of interest to 6,010. The final cohort of included patients, based on G-CSF exposure, increased from 420 from the initial algorithm to 886 using the final algorithm. CONCLUSIONS: Medications used for multiple indications, sensitivity and specificity of administrative codes, and relative timing of medication exposure must all be evaluated to identify patient cohorts receiving chemotherapy from claims data.

Evaluation of Preferred Language and Timing of COVID-19 Vaccine Uptake and Disease Outcomes.

Importance: Beyond traditional race and ethnicity demographic characteristics, additional discrete data variables are needed for informed health interventions in the US. Objective: To examine whether COVID-19 vaccine uptake patterns and associated disease outcomes differ among language preference groups. Design, Setting, and Participants: A cohort study of 851 410 individuals aged 18 years or older in a large multispecialty health system in Minnesota and western Wisconsin was conducted between December 15, 2020, and March 31, 2022. Exposure: Self-identified language preference and limited English proficiency (LEP) as measured by interpreter need were used to create subgroups using US census categories and attention to capture languages known to represent refugee groups. Main Outcomes and Measures: The primary outcome was COVID-19 vaccination uptake rates and time to first vaccine. Secondary outcomes were rates of COVID-19-associated hospitalization and death. Results: Most of the 851 410 participants (women, 493 910 [58.0%]; median age, 29 [IQR, 35-64] years) were US-born English speakers; 7.5% were born in other countries, 4.0% had a language preference other than English (LPOE), and 3.0% indicated LEP as measured by interpreter need. Marked temporal clusters were observed for COVID-19 vaccination uptake, hospitalizations, and deaths associated with primary series vaccine eligibility, booster availability, and COVID-19 variants. Delayed first-dose vaccine was observed with LPOE (hazard ratio [HR], 0.83; 95% CI, 0.82-0.84) and interpreter need (HR, 0.81; 95% CI, 0.80-0.82) compared with those with English language preference and proficiency. Patients with LPOE were approximately twice as likely to be hospitalized (rate ratio [RR], 1.85; 95% CI, 1.63-2.08) or die (RR, 2.13; 95% CI, 1.65-2.69). Patients with LEP experienced even higher rates of hospitalization (RR, 1.98; 95% CI, 1.73-2.25) and COVID-19-associated death (RR, 2.32; 95% CI, 1.79-2.95). Outcomes varied for individual language preference groups. Conclusions and Relevance: In this study, delayed time to first-dose vaccine was associated with increased COVID-19 hospitalization and death rates for specific LPOE and LEP groups. The findings suggest that data collection of language preference and interpreter need provides actionable health intervention information. Standardized system-level data collection, including at a national level, may improve efficient identification of social groups with disproportionate health disparities and provide key information on improving health equity in the US.

Understanding COVID-19 Health Disparities With Birth Country and Language Data.

INTRODUCTION: Understanding of COVID-19-related disparities in the U.S. is largely informed by traditional race/ethnicity categories that mask important social group differences. This analysis utilizes granular information on patients' country of birth and preferred language from a large health system to provide more nuanced insights into health disparities. METHODS: Data from patients seeking care from a large Midwestern health system between January 1, 2019 and July 31, 2021 and COVID-19-related events occurring from March 18, 2020 to July 31, 2021 were used to describe COVID-19 disparities. Statistics were performed between January 1, 2022 and March 15, 2023. Age-adjusted generalized linear models estimated RR across race/ethnicity, country of birth grouping, preferred language, and multiple stratified groups. RESULTS: The majority of the 1,114,895 patients were born in western advanced economies (58.6%). Those who were Hispanic/Latino, were born in Latin America and the Caribbean, and preferred Spanish language had highest RRs of infection and hospitalization. Black-identifying patients born in sub-Saharan African countries had a higher risk of infection than their western advanced economies counterparts. Subanalyses revealed elevated hospitalization and death risk for White-identifying patients from Eastern Europe and Central Asia and Asian-identifying patients from Southeast Asia and the Pacific. All non-English languages had a higher risk of all COVID-19 outcomes, most notably Hmong and languages from Burma/Myanmar. CONCLUSIONS: Stratifications by country of birth grouping and preferred language identified culturally distinct groups whose vulnerability to COVID-19 would have otherwise been masked by traditional racial/ethnic labels. Routine collection of these data is critical for identifying social groups at high risk and for informing linguistically and culturally relevant interventions.

Risk of admission to hospital with arterial or venous thromboembolism among patients diagnosed in the ambulatory setting with covid-19 compared with influenza: retrospective cohort study.

Objective: To measure the 90 day risk of arterial thromboembolism and venous thromboembolism among patients diagnosed with covid-19 in the ambulatory (ie, outpatient, emergency department, or institutional) setting during periods before and during covid-19 vaccine availability and compare results to patients with ambulatory diagnosed influenza. Design: Retrospective cohort study. Setting: Four integrated health systems and two national health insurers in the US Food and Drug Administration's Sentinel System. Participants: Patients with ambulatory diagnosed covid-19 when vaccines were unavailable in the US (period 1, 1 April-30 November 2020; n=272 065) and when vaccines were available in the US (period 2, 1 December 2020-31 May 2021; n=342 103), and patients with ambulatory diagnosed influenza (1 October 2018-30 April 2019; n=118 618). Main outcome measures: Arterial thromboembolism (hospital diagnosis of acute myocardial infarction or ischemic stroke) and venous thromboembolism (hospital diagnosis of acute deep venous thrombosis or pulmonary embolism) within 90 days after ambulatory covid-19 or influenza diagnosis. We developed propensity scores to account for differences between the cohorts and used weighted Cox regression to estimate adjusted hazard ratios of outcomes with 95% confidence intervals for covid-19 during periods 1 and 2 versus influenza. Results: 90 day absolute risk of arterial thromboembolism with covid-19 was 1.01% (95% confidence interval 0.97% to 1.05%) during period 1, 1.06% (1.03% to 1.10%) during period 2, and with influenza was 0.45% (0.41% to 0.49%). The risk of arterial thromboembolism was higher for patients with covid-19 during period 1 (adjusted hazard ratio 1.53 (95% confidence interval 1.38 to 1.69)) and period 2 (1.69 (1.53 to 1.86)) than for patients with influenza. 90 day absolute risk of venous thromboembolism with covid-19 was 0.73% (0.70% to 0.77%) during period 1, 0.88% (0.84 to 0.91%) during period 2, and with influenza was 0.18% (0.16% to 0.21%). Risk of venous thromboembolism was higher with covid-19 during period 1 (adjusted hazard ratio 2.86 (2.46 to 3.32)) and period 2 (3.56 (3.08 to 4.12)) than with influenza. Conclusions: Patients diagnosed with covid-19 in the ambulatory setting had a higher 90 day risk of admission to hospital with arterial thromboembolism and venous thromboembolism both before and after covid-19 vaccine availability compared with patients with influenza.

Unique Considerations for the Management of Gout in the Hmong Population: Examining Tertiary Encounters at a Large Regional Health Care System.

OBJECTIVE: To evaluate demographic characteristics, care encounters, comorbidities, and clinical differences in Hmong and non-Hmong patients with gout. METHODS: Using retrospective chart review, all inpatient encounters (Hmong versus non-Hmong) were reviewed from 2014 to 2017. Acute or chronic gout was the primary or secondary diagnosis for the encounter. RESULTS: Hmong gout patients were on average 11 years younger than non-Hmong patients, but after adjustment for age, sex, and type of encounter, they had similar rates of hypertension, diabetes mellitus, and heart disease. Hmong patients had significantly decreased renal function at the time of presentation; the odds ratio of chronic kidney disease for Hmong patients was 2.33 versus 1.48 for non-Hmong patients (P < 0.05), the mean creatinine level was 3.3 mg/dl versus 2.0 mg/dl (ß = 1.35, P < 0.001), and the glomerular filtration rate was 44.8 ml/minute versus 49.3 ml/minute (ß = -6.95, P < 0.001). Hmong gout patients were more likely to use emergency care versus elective or urgent care, they were less likely to be using medications for the treatment of gout prior to admission (32.3% versus 58.2%), and the length of hospital stay was increased (8.8 versus 5.2 days; P < 0.05). CONCLUSION: Hmong gout patients who had a tertiary care encounter were 11 years younger than non-Hmong patients with similar rates of comorbidities but had worse renal function despite the age differences. They were more likely to use emergency services, to be insured through Medicaid, and not to use preventive medications for gout prior to their encounter. Intensive efforts are needed in the Hmong population for culturally appropriate preventive care management of gout along with diabetes mellitus, hypertension, heart disease, and kidney disease.

Case series of 148 tongue-tied newborn babies evaluated with the assessment tool for lingual frenulum function.

OBJECTIVE: the Assessment Tool for Lingual Frenulum Function (ATLFF) is the only available tool designed to assess newborn babies for the severity of tongue-tie. The aim of this study was to describe the ATLFF scores obtained on a series of 148 tongue-tied newborn babies. DESIGN: prospective case series. SETTING: a 420-bed community hospital in St. Paul, Minnesota, USA. PARTICIPANTS: newborn babies admitted to the normal newborn nursery from October 1, 2000 to May 1 2002. MEASUREMENTS AND FINDINGS: all babies in the nursery were examined for tongue-tie. One-hundred and forty-eight tongue-tied babies were examined using the ATLFF by at least one of three examiners. The ATLFF could not be completed on five babies. Of the remaining babies, 40 (28%) received 'perfect' scores, five (3.5%) received 'acceptable' scores, and 19 (13.3%) received 'function impaired' scores. The remaining 79 (55.2%) babies received scores that did not fall into any of the three categories of scores. The inter-rater agreement on whether or not the baby had a score of 'function impaired' on the ATLFF was moderate (kappa=0.44). KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: few tongue-tied babies had a score of 'function impaired' on the ATLFF. It is a major limitation of the ATLFF that it does not classify most babies. The development and testing of a useful tool to determine which tongue-tied babies will have difficulty with breast feeding remains a research priority.

Provider management of menopause after the findings of the Women's Health Initiative.

OBJECTIVE: A survey was conducted to determine current provider behaviors and concerns related to menopause management. DESIGN: All gynecology, internal medicine, and family medicine providers (both physicians and nurse practitioners) within a large Midwestern integrated health system were surveyed about current approaches to menopause management, frequency and reasons for hormone therapy (HT) use, approaches to HT discontinuation, treatments for symptom control, bone mineral density testing, and concerns related to menopause management. Descriptive statistics and chi-square tests were performed to examine frequencies and differences based on gender, specialty, and years in practice. RESULTS: Overall the response rate was 58% with providers from owned clinics, with female providers being the most likely to respond (P < 0.001). Changes in menopause management included using lower dose hormones (74%), encouraging use for shorter time periods (73%), and using different modes of delivery (21%). Most providers (89%) initiate HT use in symptomatic patients, and only 12% initiate use to prevent symptoms. Patients were most likely to discuss HT with gynecologists (78% gynecologists vs 64% family medicine providers and 48% internal medicine providers, P = 0.015). Nearly two thirds of providers (64%) claimed to order bone mineral density testing frequently. Providers' concerns related to information on symptom management, alternative and over-the-counter medications, the risk/benefits of medications, patients' sexual concerns, and maintaining bone health. CONCLUSIONS: We found that providers were responsive to current literature, shifting the agents and dosages they prescribe. Still they are faced with women reporting symptoms that interfere with their ability to function optimally and must continue to help women maintain healthy bones.

ACL Tears in School-Aged Children and Adolescents Over 20 Years.

BACKGROUND: Anterior cruciate ligament (ACL) tears are thought to occur with increasing frequency in young patients. No study has shown increased incidence over time. We hypothesized the incidence of ACL tears in young patients has increased over the past 20 years. METHODS: This descriptive epidemiology study is a retrospective review of insurance billing data of all patients aged 6 to 18 years with Current Procedural Terminology, Fourth Revision codes for ACL tear and reconstruction or International Classification of Diseases, Ninth Revision, Clinical Modification codes from 1994 to 2013. Injuries were normalized to persons per year enrolled in the insurance database based on age and sex. Analysis was performed based on sex and age (6-14, 15-16, and 17-18 years). RESULTS: The rate of ACL tears per 100 000 person-years averaged 121 ± 19 (range 92-151). All trends increased significantly except for the male 6- to 14-year-old and 17- to 18-year-old age groups. Overall there was an annual increase of 2.3%. Females had significantly higher incidence except in the 17- to 18-year-olds. Females peaked at age 16 years and males at age 17 years, with rates of 392 ACL tears and 422 ACL tears per 100 000 person-years, respectively. CONCLUSIONS: The incidence of ACL tears in pediatric patients increased over the last 20 years. Females were at higher risk except in the 17- to 18-year -old group. Peak incidence is noted during high school years. These data help target the most at-risk patients for ACL prevention programs.

Hormone use and patient concerns after the findings of the Women's Health Initiative.

OBJECTIVE: To assess behaviors and concerns related to hormone therapy after the findings of the Women's Health Initiative (WHI). DESIGN: A survey was mailed to a random sample of 1,200 women identified through the pharmacy database as taking one of two estrogen + progestogen therapies (EPT) during the 6-month period before the publication of WHI findings. Questions included hormone use history, changes in usage, an assessment of symptoms, symptom changes, health behavior changes, use of alternative therapies, and demographics. RESULTS: The response rate was 70%, with women in their 60s and those receiving hormone therapy for 5 or more years were more likely to respond (P < 0.05). The majority had started hormones for symptom relief (69%) and expected to continue use. Many reported discontinuation (63%) or modifying their medication (18%). Half of these women stopped then restarted, the other half changed products. Women in their 50s were more likely to remain on hormones than older women (P < 0.01), and those taking ethinyl estradiol and norethindrone acetate were more likely to remain on their medication than those on conjugated estrogens (43% vs 29%, P < 0.01). Little change was reported in exercise and 19% increased their calcium intake. Patient concerns fell into five major categories: long-term effects, symptom control, breast cancer risk, bone health, and cognitive function. CONCLUSIONS: Women seem to be heeding the warnings about hormones but remain concerned about the potential long-term sequelae and symptom control. More research is needed to identify safer approaches to symptom relief and to address the concerns expressed.

Cholesterol levels and statin use in patients with coronary heart disease treated in primary care settings.

INTRODUCTION: Therapy with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins, has proven to be effective in the treatment of lipid disorders. However, statin therapy continues to be underused, even though statins are a relatively safe and well-tolerated class of agents. In this study, we assessed trends in lipid control in patients with heart disease who receive most of their health care in primary care clinics. The objective was to determine whether systems of care implemented within a large medical group are associated with improved treatment and control of dyslipidemia in a high-risk group of coronary heart disease patients. METHODS: All adults with heart disease in a Minnesota medical group (N = 2947) were identified using diagnosis and procedure codes related to coronary heart disease (sensitivity = 0.85; positive predictive value = 0.89) in 1996. Study subjects were observed from 1995 to 1998. Subjects had a baseline and follow-up test for low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Changes between baseline and follow-up measurements and trends in the use of statins and other lipid-active agents among the study subjects were analyzed. RESULTS: Among 1388 subjects with two or more eligible lipid measurements, mean low-density lipoprotein cholesterol improved from 137.6 mg/dL to 111.0 mg/dL (P < .001), and mean high-density lipoprotein cholesterol improved from 42.3 mg/dL to 46.3 mg/dL (P < .001). The percentage of patients with low-density lipoprotein cholesterol < or = 100 mg/dL rose from 12.5% to 39.8% (P < .001), and the percentage with high-density lipoprotein cholesterol > or = 40 mg/dL rose from 52.5% to 67.6% (P < .001). In multivariate models, statin use was identified as the main factor that contributed to the improvement in low-density lipoprotein cholesterol (P < .001). Men had greater decreases in low-density lipoprotein cholesterol than women after adjusting for other variables (P < .001). Statin use rose from 24.3% at baseline to 69.6% at follow-up. The statin discontinuation rate was 8.3% for baseline statin users and 12.2% for subjects who used statins at any time during the study period. CONCLUSION: Investment in better heart disease care for patients in primary care clinics led to major improvement in lipid control over 30 months, primarily due to increased statin use. Improvements in low-density lipoprotein cholesterol and high-density lipoprotein cholesterol were sufficient to substantially reduce risk of subsequent major cardiovascular events.

Newborn length of stay, health care utilization, and the effect of Minnesota legislation.

OBJECTIVE: To describe newborn length of stay, postdischarge follow-up, and health care utilization in the context of Minnesota's early discharge legislation. DESIGN AND SETTING: Retrospective study using claims data from a large managed care organization. PARTICIPANTS: Term newborns born from January 1995 through February 1999 (N = 22 944). OUTCOME MEASURES: Newborn length of stay, home or clinic visits within 1 week of discharge (early follow-up), immunizations completed by age 3 months, readmissions within 1 month of discharge, and urgent care or emergency department visits within 2 months of discharge. RESULTS: After enactment of Minnesota's early discharge legislation in 1996, the percentage of newborns with short stays (0-1 days after vaginal birth or 2-3 days after cesarean birth) decreased from 52% to 16% for vaginally born infants and from 87% to 63% for cesarean-born infants (P =.001). Although the legislation mandated coverage for home visits after short stays, only 12.4% of short-stay newborns had early home visits. Overall, 50% of infants had early home or clinic follow-up; compared with those who did not receive early follow-up, these infants were more likely to have complete immunizations (adjusted odds ratio [OR], 1.09; 95% confidence interval [CI], 1.03-1.14), urgent care or emergency department visits (adjusted OR, 1.22; 95% CI, 1.07-1.39), and readmissions (adjusted OR, 2.49; 95% CI, 2.02-3.08). CONCLUSIONS: Although implementation of Minnesota's early discharge legislation corresponded with significantly increased lengths of stay, very few short-stay infants received the postdischarge care for which coverage was mandated. Our findings indicate, however, that infants at higher risk for adverse outcomes were appropriately identified to receive early follow-up.

Books and babies: clinical-based literacy programs.

INTRODUCTION: The purpose of this study was to assess parental response to a clinic-based literacy program at a health maintenance organization. It was hypothesized that participation would be associated with increased literacy orientation by children. METHOD: This randomized community trial took place at a Midwestern health maintenance organization. Six clinics were paired and randomly assigned to participate or not participate in Project Read. The main outcome variable was literacy orientation (book use). The target population was parents of children younger than 12 months (N = 165). After 6 months of participation, parents were surveyed by telephone. RESULTS: Seventy-five percent and 77% of the treatment and control groups, respectively, had positive literacy orientation; this difference was not significant. Persons receiving a videotape were more likely to have a positive literacy orientation (82.9% vs 69.2%; P <.05). The multivariate regression analyses also showed that receiving the free videotape was a significant intervention exposure. DISCUSSION: The members of the population in this study are reading to their children. Parents who receive a videotape on the importance of reading are likely to read more to their children.

Lipid abnormalities in foreign-born and US-born patients in a medical group.

BACKGROUND: With an increasing foreign-born population in the United States, cardiovascular risk reduction through effective lipid treatment strategy is precluded by limited lipid profile information. OBJECTIVE: This study compares the patterns of lipid abnormalities of foreign-born and US-born patients treated by a single medical group. METHODS: We conducted a medical record review of 53,361 US-born and 6430 foreign-born patients in 2010. RESULTS: Compared with US-born, a higher proportion of foreign-born patients are younger than 40 years (26% vs 14%), receive Medicaid (24% vs 8%), and are less likely to be obese (26% vs 43%). More foreign-born patients have diabetes (25% vs 22%), are poor (4.7% vs 3.6%), and not on lipid-lowering drugs (63% vs 56%). Place of birth is not associated with total cholesterol levels. Adjusted for social and demographic characteristics, however, foreign-born are more likely than US-born to have elevated low-density lipoprotein cholesterol (adjusted difference, 2.1; 95% CI, 0.6-3.7), depressed high-density lipoprotein cholesterol (adjusted difference, 6.1; 95% CI, 4.4-7.8), and elevated triglycerides (adjusted difference, 2.4; 95% CI, 0.8-4.1). Foreign-born patients, on lipid-lowering medications, are more likely to still have elevated levels of low-density lipoprotein cholesterol (adjusted difference, 3.5; 95% CI, 1.4-5.6). CONCLUSION: Despite having a similar distribution of total cholesterol as their US-born counterparts, the other lipid fractions among foreign-born patients are more likely to be pathologic. Therefore, dyslipidemia screening tests need to include the lipid subfractions. The higher prevalence of dyslipidemias, both among foreign-born patients with and without lipid-lowering medications, challenges medical groups to intensify effective lipid treatment strategies.

Validity of diabetes self-reports in the Women's Health Initiative.

OBJECTIVE: This study aims to determine the positive and negative predictive values of self-reported diabetes during the Women's Health Initiative (WHI) clinical trials. METHODS: All WHI trial participants from four field centers who self-reported diabetes at baseline or during follow-up, as well as a random sample of women who did not self-report diabetes, were identified. Women were surveyed regarding diagnosis and treatment. Medical records were obtained and reviewed for documented treatment with antidiabetes medications or for physician diagnosis of diabetes supported by laboratory measurements of glucose. RESULTS: We identified 1,275 eligible participants; 732 consented and provided survey data. Medical records were obtained for 715 women (prevalent diabetes, 207; incident diabetes, 325; no diabetes, 183). Records confirmed 91.8% (95% CI, 87.0-95.0) of self-reported prevalent diabetes cases and 82.2% (95% CI, 77.5-86.1) of incident diabetes cases. Among those who never self-reported diabetes, there was no medical record or laboratory evidence for diabetes in 94.5% (95% CI, 89.9-97.2). Women with higher body mass index were more likely to accurately self-report incident diabetes. In a subgroup of participants enrolled in fee-for-service Medicare, a claims algorithm correctly classified nearly all diabetes cases and noncases. CONCLUSIONS: Among WHI clinical trial participants, there are high positive predictive values of self-reported prevalent diabetes (91.8%) and incident diabetes (82.2%) and a high negative predictive value (94.5%) when diabetes is not reported. For participants enrolled in fee-for-service Medicare, a claims algorithm has high positive and negative predictive values.

Effect of country of origin, age, and body mass index on prevalence of vitamin D deficiency in a US immigrant and refugee population.

OBJECTIVE: To determine the prevalence of vitamin D deficiency (VDD) (25-hydroxyvitamin D level <20 ng/mL) and severe VDD (25[OH]D level <10 ng/mL) in a Minnesota immigrant and refugee population. PATIENTS AND METHODS: This retrospective study evaluated a cohort of adult immigrants and refugees seen at Health Partners Center for International Health in St Paul, Minnesota. Study participants were all patients seen from August 1, 2008, through July 31, 2009, with a first vitamin D screen (N=1378). Outcomes included overall prevalence of VDD and severe VDD. Covariates included country of origin, sex, age, month of test, and body mass index (BMI). RESULTS: Vitamin D deficiency was significantly more prevalent in our Minnesota clinic immigrant and refugee population than among US-born patients (827 of 1378 [60.0%] vs 53 of 151 [35.1%]; P<.001). Severe VDD was also significantly more prevalent (208 of 1378 [15.1%] vs 12 of 151 [7.9%]; P=.02). Prevalence of VDD varied significantly according to country of origin (42 of 128 Russian patients [32.8%] vs 126 of 155 Ethiopian patients [81.3%]; P<.001). The BMI correlated [corrected] with VDD (488 of 781 [62.5%] when BMI was ≥ 25 vs 292 of 520 [56.2%] when BMI was <25; P=.02). Vitamin D deficiency was present in 154 of 220 individuals (70.0%) 16 to 29 years old vs 123 of 290 (42.4%) in those older than 66 years (P<.001). CONCLUSION: Immigrants and refugees in a Minnesota clinic have a substantially higher rate and severity of VDD when compared with a US-born population. Country of origin, age, and BMI are specific risk factors for VDD and should influence individualized screening practices.

Delays in filling clopidogrel prescription after hospital discharge and adverse outcomes after drug-eluting stent implantation: implications for transitions of care.

BACKGROUND: Adjuvant clopidogrel therapy is essential after drug-eluting stent (DES) implantation. The frequency with which patients delay filling a clopidogrel prescription after DES implantation and the association of this delay with adverse outcomes is unknown. METHODS AND RESULTS: This was a retrospective cohort study of patients discharged after DES implantation from 3 large integrated health care systems. Filling a clopidogrel prescription was based on pharmacy dispensing data. The primary end point was all-cause mortality or myocardial infarction (MI). Of 7402 patients discharged after DES implantation, 16% (n=1210) did not fill a clopidogrel prescription on day of discharge and the median time delay was 3 days (interquartile range, 1 to 23 days). Compared with patients filling clopidogrel on day of discharge, patients with any delay in filling clopidogrel had higher death/MI rates during follow-up (14.2% versus 7.9%; P<0.001). In multivariable analysis, patients with any delay had increased risk of death/MI (hazard ratio, 1.53; 95% confidence interval, 1.25 to 1.87). Patients with any delay remained at increased risk of adverse outcomes when the delay cutoff was changed to >1, >3, or >5 days after discharge. Factors associated with delay included older age, prior MI, diabetes, renal failure, prior revascularization, cardiogenic shock, in-hospital bleeding, and clopidogrel use within 24 hours of admission. CONCLUSIONS: One in 6 patients delay filling their index clopidogrel prescription after hospital discharge after DES implantation. This delay was associated with increased risk of adverse outcomes and highlights the importance of the transition period from hospital discharge to outpatient setting as a potential opportunity to improve care delivery and patient outcomes.

Cardiovascular disease risks in Hmong refugees from Wat Tham Krabok, Thailand.

No epidemiological studies on cardiovascular disease (CVD) were conducted on Hmong refugees arriving to the U.S. from 1970s to 1990s. This study measured prevalence of CVD and CVD risk factors in Hmong refugees newly arriving from Wat Tham Krabok, Thailand 2004-2006. Cross-sectional study of 1,462 Hmong refugees who received refugee screening exams at seven primary care clinics in St. Paul MN, June 2004-March 2006. In younger age group (N = 988, 0-20 years old), overweight equaled 13.7%, hypertension = 8.2%, pre-hypertension = 9.6% and in a subset, hyperglycemia equaled 20.7% and hyperlipidemia = 13.5%. In older age group (N = 448, >20 years old), overweight equaled 33.4%, obese = 14.8%, hypertension = 16.5%, and pre-hypertension = 36.2%. In a subset, diabetes mellitus = 2.8%, hyperglycemia = 31.7%, hyperlipidemia = 25.8%, renal insufficiency = 9%, and hyperuricemia = 11.7%. Hmong refugees had significant CVD risk factors on arrival. Healthcare providers and public health officers must identify CVD in addition to infectious diseases when refugees arrive in the U.S. and must address long-term care in order to forestall the development of CVD.