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.

A broad assessment of covid-19 vaccine safety using tree-based data-mining in the vaccine safety datalink.

BACKGROUND: Except for spontaneous reporting systems, vaccine safety monitoring generally involves pre-specifying health outcomes and post-vaccination risk windows of concern. Instead, we used tree-based data-mining to look more broadly for possible adverse events after Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccination. METHODS: Vaccine Safety Datalink enrollees receiving ≥1 dose of COVID-19 vaccine in 2020-2021 were followed for 70 days after Pfizer-BioNTech or Moderna and 56 days after Janssen vaccination. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within both the hierarchical ICD-10-CM code structure and the post-vaccination follow-up period. We used the self-controlled tree-temporal scan statistic and TreeScan software. Monte Carlo simulation was used to estimate p-values; p = 0.01 was the pre-specified cut-off for statistical significance of a cluster. RESULTS: There were 4.1, 2.6, and 0.4 million Pfizer-BioNTech, Moderna, and Janssen vaccinees, respectively. Clusters after Pfizer-BioNTech vaccination included: (1) unspecified adverse effects, (2) common vaccine reactions, such as fever, myalgia, and headache, (3) myocarditis/pericarditis, and (4) less specific cardiac or respiratory symptoms, all with the strongest clusters generally after Dose 2; and (5) COVID-19/viral pneumonia/sepsis/respiratory failure in the first 3 weeks after Dose 1. Moderna results were similar but without a significant myocarditis/pericarditis cluster. Further investigation suggested the fifth signal group was a manifestation of mRNA vaccine effectiveness after the first 3 weeks. Janssen vaccinees had clusters of unspecified or common vaccine reactions, gait/mobility abnormalities, and muscle weakness. The latter two were deemed to have arisen from confounding related to practices at one site. CONCLUSIONS: We detected post-vaccination clusters of unspecified adverse effects, common vaccine reactions, and, for the mRNA vaccines, chest pain and palpitations, as well as myocarditis/pericarditis after Pfizer-BioNTech Dose 2. Unique advantages of this data mining are its untargeted nature and its inherent adjustment for the multiplicity of diagnoses and risk intervals scanned.

Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink.

BACKGROUND: The Centers for Disease Control and Prevention's Vaccine Safety Datalink (VSD) has been performing safety surveillance for COVID-19 vaccines since their earliest authorization in the United States. Complementing its real-time surveillance for pre-specified health outcomes using pre-specified risk intervals, the VSD conducts tree-based data-mining to look for clustering of a broad range of health outcomes after COVID-19 vaccination. This study's objective was to use this untargeted, hypothesis-generating approach to assess the safety of first booster doses of Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Ad26.COV2.S) COVID-19 vaccines. METHODS: VSD enrollees receiving a first booster of COVID-19 vaccine through April 2, 2022 were followed for 56 days. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within both the hierarchical ICD-10-CM code structure and the follow-up period. The self-controlled tree-temporal scan statistic was used, conditioning on the total number of cases for each diagnosis. P-values were estimated by Monte Carlo simulation; p = 0.01 was pre-specified as the cut-off for statistical significance of clusters. RESULTS: More than 2.4 and 1.8 million subjects received Pfizer-BioNTech and Moderna boosters after an mRNA primary series, respectively. Clusters of urticaria/allergy/rash were found during Days 10-15 after the Moderna booster (p = 0.0001). Other outcomes that clustered after mRNA boosters, mostly with p = 0.0001, included unspecified adverse effects, common vaccine-associated reactions like fever and myalgia, and COVID-19. COVID-19 clusters were in Days 1-10 after booster receipt, before boosters would have become effective. There were no noteworthy clusters after boosters following primary Janssen vaccination. CONCLUSIONS: In this untargeted data-mining study of COVID-19 booster vaccination, a cluster of delayed-onset urticaria/allergy/rash was detected after the Moderna booster, as has been reported after Moderna vaccination previously. Other clusters after mRNA boosters were of unspecified or common adverse effects and COVID-19, the latter evidently reflecting immunity to COVID-19 after 10 days.

Differences in the Association Between Oral Glucocorticoids and Risk of Preterm Birth by Data Source: Reconciling the Results.

OBJECTIVE: To investigate causes of discrepancies in the association between early pregnancy oral glucocorticoid (OGC) use and preterm birth risk among women with rheumatoid arthritis (RA) in health care utilization data from California Medicaid (Medi-Cal) and the prospective cohort MotherToBaby Pregnancy Studies. METHODS: Separately, we estimated risk ratios (RRs) between OGC exposure before gestational day 140 and preterm birth risk in data from Medi-Cal (2007-2013; n = 844) and MotherToBaby (2003-2014; n = 528). We explored differences in socioeconomic status, OGC dose distribution, exposure misclassification, and confounding by RA severity across the data sources. RESULTS: Preterm birth risk in women without OGC was 17.3% in Medi-Cal and was 9.7% in MotherToBaby. There was no association between OGC and preterm birth in Medi-Cal (adjusted RR 1.00 [95% confidence interval (95% CI) 0.71, 1.42]), and a 1.85-fold (95% CI 1.20, 2.84) increased preterm birth risk in MotherToBaby. When restricting each sample to women with a high-school diploma or less, preterm birth risk following no OGC exposure was 15.9% in Medi-Cal and 16.7% in MotherToBaby; adjusted RRs were 1.16 (95% CI 0.74, 1.80) in Medi-Cal and 0.81 (95% CI 0.25, 2.64) in MotherToBaby. Cumulative OGC dose was higher in MotherToBaby (median 684 mg) than in Medi-Cal (median 300 mg). An OGC dose of ≤300 mg was not associated with increased preterm birth risk. Exposure misclassification and confounding by RA severity were unlikely explanations of differences. CONCLUSION: Higher baseline preterm birth risk and lower OGC dose distribution in Medi-Cal may explain the discrepancies. Studies are needed to understand the effects of autoimmune disease severity and undertreatment on preterm birth risk in low-income populations.

Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial.

Importance: Appendicitis is the most common pediatric surgical emergency. Efforts to improve efficiency and quality of care have increased reliance on computed tomography (CT) and ultrasonography (US) in children with suspected appendicitis. Objective: To evaluate the effectiveness of an electronic health record-linked clinical decision support intervention, AppyCDS, on diagnostic imaging, health care costs, and safety outcomes for patients with suspected appendicitis. Design, Setting, and Participants: In this parallel, cluster randomized trial, 17 community-based general emergency departments (EDs) in California, Minnesota, and Wisconsin were randomized to the AppyCDS intervention group or usual care (UC) group. Patients were aged 5 to 20 years, presenting for an ED visit with right-sided or diffuse abdominal pain lasting 5 days or less. We excluded pregnant patients, those with a prior appendectomy, those with selected comorbidities, and those with traumatic injuries. The trial was conducted from October 2016 to July 2019. Interventions: AppyCDS prompted data entry at the point of care to estimate appendicitis risk using the pediatric appendicitis risk calculator (pARC). Based on pARC estimates, AppyCDS recommended next steps in care. Main Outcomes and Measures: Primary outcomes were CT, US, or any imaging (CT or US) during the index ED visit. Safety outcomes were perforations, negative appendectomies, and missed appendicitis. Costs were a secondary outcome. Ratio of ratios (RORs) for primary and safety outcomes and differences by group in cost were used to evaluate effectiveness of the clinical decision support tool. Results: We enrolled 3161 patients at intervention EDs and 2779 patients at UC EDs. The mean age of patients was 11.9 (4.6) years and 2614 (44.0%) were boys or young men. RORs for CT (0.94; 95% CI, 0.75-1.19), US (0.98; 95% CI, 0.84-1.14), and any imaging (0.96; 95% CI, 0.86-1.07) did not differ by study group. In an exploratory analysis conducted in 1 health system, AppyCDS was associated with a reduction in any imaging (ROR, 0.82; 95% CI, 0.73- 0.93) for patients with pARC score of 15% or less and a reduction in CT (ROR, 0.58; 95% CI, 0.45-0.74) for patients with a pARC score of 16% to 50%. Perforations, negative appendectomies, and cases of missed appendicitis by study phase did not differ significantly by study group. Costs did not differ overall by study group. Conclusions and Relevance: In this study, AppyCDS was not associated with overall reductions in diagnostic imaging; exploratory analysis revealed more appropriate use of imaging in patients with a low pARC score. Trial Registration: ClinicalTrials.gov Identifier: NCT02633735.

Oral Corticosteroids and Risk of Preterm Birth in the California Medicaid Program.

BACKGROUND: There is limited information regarding the impact of dose and gestational timing of oral corticosteroid (OCS) use on preterm birth (PTB), especially among women with asthma. OBJECTIVES: To evaluate OCS dose and timing on PTB for asthma and, as a comparison, systemic lupus erythematosus (SLE). METHODS: We used health care data from California Medicaid enrollees linked to birth certificates (2007-2013), identifying women with asthma (n = 22,084) and SLE (n = 1174). We estimated risk ratios (RR) for OCS cumulative dose trajectories and other disease-related medications before gestational day 140 and hazard ratios (HR) for time-varying exposures after day 139. RESULTS: For asthma, PTB risk was 14.0% for no OCS exposure and 14.3%, 16.8%, 20.5%, and 32.7% in low, medium, medium-high, and high cumulative dose trajectory groups, respectively, during the first 139 days. The high-dose group remained associated with PTB after adjustment (adjusted RR [aRR]: 1.46; 95% confidence interval [CI]: 1.00, 2.15). OCS dose after day 139 was not clearly associated with PTB, nor were controller medications. For SLE, PTB risk for no OCS exposure was 24.9%, and it was 39.1% in low- and 61.2% in high-dose trajectory groups. aRR were 1.80 (95% CI: 1.34, 2.40) for high and 1.24 (95% CI: 0.97, 1.58) for low groups. Only prednisone equivalent dose >20 mg/day after day 139 was associated with increased PTB (adjusted HR: 2.54; 95% CI: 1.60, 4.03). CONCLUSIONS: For asthma, higher OCS doses early in pregnancy, but not later, were associated with increased PTB. For SLE, higher doses early and later in pregnancy were associated with PTB.

The effects of financial incentives on diabetes prevention program attendance and weight loss among low-income patients: the We Can Prevent Diabetes cluster-randomized controlled trial.

BACKGROUND: Penetration and participation of real life implementation of lifestyle change programs to prevent type 2 diabetes has been challenging. This is particularly so among low income individuals in the United States. The purpose of this study is to examine the effectiveness of financial incentives on attendance and weight loss among Medicaid beneficiaries participating in the 12-month Diabetes Prevention Program (DPP). METHODS: This is a cluster-randomized controlled trial with two financial incentive study arms and an attention control study arm. Medicaid beneficiaries with prediabetes from 13 primary care clinics were randomly assigned to individually earned incentives (IND; 33 groups; n = 309), a hybrid of individual- and group-earned incentives (GRP; 30 groups; n = 259), and an attention control (AC; 30 groups; n = 279). Up to $520 in incentives could be earned for attaining attendance and weight loss goals over 12 months. Outcomes are percent weight loss from baseline, achieving 5% weight loss from baseline, and attending 75% of core and 75% of maintenance DPP sessions. Linear mixed models were used to examine weight change and attendance rates over the 16 weeks and 12 months. RESULTS: The percent weight change at 16 weeks for the IND, GRP, and AC participants were similar, at - 2.6, - 3.1%, and - 3.4%, respectively. However, participants achieving 5% weight loss in the IND, GRP, and AC groups was 21.5, 24.0% (GRP vs AC, P < 0.05), and 15.2%. Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants. Despite substantial attrition over time, attendance at 75% of the DPP maintenance sessions was also significantly higher among IND (23.0%, P < 0.001) and GRP (26.1%, P < 0.001) participants than among AC (11.0%) participants. CONCLUSIONS: Financial incentives can improve the proportion of Medicaid beneficiaries attending the 12-month DPP and achieving at least 5% weight loss. TRIAL REGISTRATION: ClinicalTrials.gov NCT02422420 ; retrospectively registered April 21, 2015.

Characteristics and Price Increases Among Sole-Source, Off-Patent Drugs in the United States, 2008 to 2018.

Importance: Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy. Objectives: To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases. Design, Setting, and Participants: In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank. Main Outcomes and Measures: The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured. Results: Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013. Conclusions and Relevance: Price increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.

Cost-Effectiveness of a Community-Based Diabetes Prevention Program with Participation Incentives for Medicaid Beneficiaries.

OBJECTIVE: To examine the cost-effectiveness of a community-based Diabetes Prevention Program (DPP) for Medicaid beneficiaries from the perspective of the health care sector. DATA SOURCES/STUDY SETTING: A total of 847 Medicaid enrollees at high risk for type 2 diabetes participating in a community-based DPP. STUDY DESIGN: Pre- and post clinical outcome and cost data were used as inputs into a validated diabetes simulation model. The model was used to evaluate quality-adjusted life years (QALYs) and health care costs over a 40-year time horizon from the perspective of the health care sector. DATA COLLECTION/EXTRACTION METHODS: Clinical outcome and cost data were derived from a study examining the effect of financial incentives on weight loss. PRINCIPAL FINDINGS: Study participants lost an average of 4.2 lb (p < .001) and increased high-density lipoprotein cholesterol by 1.75 mg/dl (p = .002). Intervention costs, which included financial incentives for participation and weight loss, were $915 per participant. The incremental cost-effectiveness ratio was estimated to be $14,011 per QALY but was sensitive to the time horizon studied. CONCLUSIONS: Widespread adoption of community-based DPP has the potential to reduce diabetes and cardiovascular-related morbidity and mortality for low-income persons at high risk for diabetes and may be a cost-effective investment for Medicaid programs.

Financial incentives for diabetes prevention in a Medicaid population: Study design and baseline characteristics.

BACKGROUND: Medicaid beneficiaries at high risk for diabetes can benefit from the Diabetes Prevention Program (DPP) lifestyle intervention. The We Can Prevent Diabetes (WCPD) trial examined whether financial incentives are more effective than no financial incentives in sustaining participation in the DPP and increasing weight loss. Here we describe the study design and baseline characteristics. METHODS: The WCPD was a 3-arm group-randomized controlled trial. Medicaid beneficiaries were aged 18 to 74years, had prediabetes or gestational diabetes, and were overweight or obese. Subjects enrolled from 13 primary care clinics into groups of 8 to 15 participants. Participants received the 12-month DPP delivered by the YMCA or trained clinic staff, free of costs. Participants from groups randomized into the intervention conditions were eligible to receive incentives up to $520 by attending sessions and meeting weight loss goals. RESULTS: The WCPD enrolled 1154 participants into 98 groups. Among the 847 attending at least one DPP session, 71.2% were women; the mean age was 48.3years; 79.3% were obese; and 87.6% entered the study with an elevated HbA1c or fasting plasma glucose. Participants' primary languages were Somali (21.0%), Hmong (3.1%), Spanish (2.2%), or English (72.4%). CONCLUSIONS: The WCPD trial demonstrated that a collaborative approach with primary care clinics and the YMCA can efficiently identify, enroll, and deliver the 12-month DPP to Medicaid beneficiaries. If the WCPD incentive arms increase attendance and weight loss, the use of financial incentives may be an avenue for engaging low-income, high-risk patients in lifestyle change.