The clinical outcomes and healthcare resource utilization in IgG4-related disease: a claims-based analysis of commercially insured adults in the United States.

OBJECTIVES: IgG4-related disease (IgG4-RD) can affect nearly any organ and is often treated with glucocorticoids, which contribute to organ damage and toxicity. Comorbidities and healthcare utilization in IgG4-RD are poorly understood. METHODS: We conducted a cohort study using claims data from a United States managed care organization. Incident IgG4-RD cases were identified using a validated algorithm; general population comparators were matched by age, sex, race/ethnicity, and index date. The frequency of 21 expert-defined clinical outcomes associated with IgG4-RD or its treatment and healthcare-associated visits and costs were assessed 12 months before and 36 months after the index date (date of earliest IgG4-RD-related claim). RESULTS: There were 524 cases and 5,240 comparators. Most cases received glucocorticoids prior to (64.0%) and after (85.1%) the index date. Nearly all outcomes, many being common glucocorticoid toxicities, occurred more frequently in cases vs comparators. During follow-up, the largest differences between cases and comparators were seen for gastroesophageal reflux disease (prevalence difference: +31.2%, p< 0.001); infections (+17.3%, p< 0.001); hypertension (+15.5%, p< 0.01); and diabetes mellitus (+15.0%, p< 0.001). The difference in malignancy increased during follow-up from +8.8% to + 12.5% (p< 0.001). 17.4% of cases used pancreatic enzyme replacement therapy during follow-up. Over follow-up, cases were more often hospitalized (57.3% vs 17.2%, p< 0.01) and/or had an ER visit (72.0% vs 36.7%, p< 0.01); all costs were greater in cases than comparators. CONCLUSIONS: Patients with IgG4-RD are disproportionately affected by adverse outcomes, some of which may be preventable or modifiable with vigilant clinician monitoring. Glucocorticoid-sparing treatments may improve these outcomes.

Incidence, prevalence and mortality of IgG4-related disease in the USA: a claims-based analysis of commercially insured adults.

BACKGROUND: IgG4-related disease (IgG4-RD) is an immune-mediated condition that can affect nearly any organ or anatomic site. We sought to describe the epidemiology of IgG4-RD in the USA. METHODS: We used Optum's deidentified Clinformatics Data Mart Database from 1 January 2009 to 31 December 2021 to identify IgG4-RD cases using a validated algorithm. We estimated the incidence rate and prevalence between 2015 and 2019 (when rates stabilised), standardised to the US population by age and sex. We compared mortality rates among patients with IgG4-RD to the non-IgG4-RD population matched in a 1:10 ratio on age, sex, race/ethnicity and encounter date. We used Cox proportional hazards models to estimate HRs and 95% CIs. RESULTS: We identified 524 IgG4-RD cases. The mean age was 56.5 years with 57.6% female and 66% White. The incidence of IgG4-RD increased during the study period from 0.78 to 1.39 per 100 000 person-years in 2015 and 2019, respectively. The point prevalence on 1 Janury 2019 was 5.3/100 000 persons. During follow-up, there were 39 and 164 deaths among 515 IgG4-RD cases and 5160 comparators, resulting in a mortality rate of 3.42 and 1.46/100 person-years, respectively, and adjusted HR of 2.51 (95% CI 1.76 to 3.56). CONCLUSIONS: The incidence of IgG4-RD is similar to that of systemic rheumatic diseases such as ANCA-associated vasculitis and systemic sclerosis but may be increasing as familiarity with this diagnosis grows. Clinicians should be aware of this condition, especially given the excess risk of death. Identification of effective therapies is an important research agenda.

An observational analysis of disease burden in patients with cold agglutinin disease: Results from a large US electronic health record database.

BACKGROUND: Cold agglutinin disease (CAD) is a rare autoimmune hemolytic anemia (AIHA). Information regarding the impact of CAD from the patient and health care system perspective is limited. OBJECTIVE: To understand longitudinal trends in outcomes in patients with CAD, including anemia severity, hemolytic status, administration of CAD-related therapies, and health care resource utilization (HCRU). METHODS: This retrospective, observational cohort study used data from the US Optum Electronic Health Record database. Included patients were aged 18 years and older at the index date (first CAD mention in physician"s notes), had 1 or more medical encounters with an AIHA-related diagnosis code during the study period, and had 3 or more CAD mentions during the patient identification period (January 2008 to March 2019). The baseline period was the 12 months preceding the index date. Anemia severity (severe, hemoglobin < 8.0 g/dL; moderate, 8.0-10.0 g/dL; mild, 10.1-11.9 g/dL; no anemia, ≥ 12.0 g/dL) and hemolytic status (elevated lactate dehydrogenase [LDH; > 250 µ/L] and/or elevated bilirubin [> 1.2 mg/dL]) were assessed at baseline and 6-monthly followup intervals. Use of CAD-related therapies, blood transfusions, and all-cause HCRU were analyzed every 6 months; results were stratified by anemia severity. RESULTS: The analysis included 610 adults with CAD (median [interquartile range; IQR] age 72.0 [61.0-78.0] years; 65.4% female). Median (IQR) duration of follow-up was 42.8 (22.8-68.4) months. The proportion of patients with moderate/severe anemia was 51.0% at baseline, 57.7% over 12 months' follow-up, and 66.6% over full follow-up. During the full follow-up period, approximately 50% of patients had elevated bilirubin and LDH levels. Corticosteroids were the most frequently used medication (65.6% of patients) over full follow-up. Mean (SD) number of blood transfusions per patient was 3.26 (9.21) over 12 months and 5.47 (17.11) over the full follow-up. At full follow-up, 68.7% of patients with severe anemia received a transfusion vs 12.6% and 0.0% with moderate or mild anemia, respectively. At 12 months, 34.1%, 97.7%, and 29.3% of patients had 1 or more hospitalizations, outpatient services, or emergency department visits (full follow-up: 52.5%, 99.0%, and 53.9%), respectively. Across all time periods, HCRU was greater in patients with severe anemia vs mild or moderate anemia. CONCLUSIONS: CAD imposed a substantial long-term burden on patients and health care systems, and despite the use of several therapies, hemolysis and anemia still occurred. The use of CAD-related therapies and HCRU was generally greater with greater anemia severity. These results suggest a lack of effective treatment options available for patients with CAD at the time of this analysis. DISCLOSURES: This study was sponsored by Sanofi. Dr Wilson, Dr Joly, Mr Carita, and Ms Miles are employees and stockholders of Sanofi. Dr Adeyemi was an employee and may have held stocks at Sanofi at the time of the study. Ms Miles and Ms Kuang were employees of Aetion Inc at the time of this study; Aetion Inc is a software company that received funding from Sanofi for the current study. Dr Pham is a consultant for Sanofi and Argenx.

Leadership Disparities in State Governmental Public Health Workforce: Examining the Influence of Gender.

OBJECTIVE: To determine the extent to which gender disparities exist in either obtaining a leadership position or pay equity among those with leadership positions in state governmental public health agencies. DESIGN: Utilizing the 2014 Public Health Workforce Interests and Needs Survey, a nationally representative cross-sectional study of state governmental public health agency employees, the characteristics of the state governmental public health agency leadership were described. We estimated the odds of being a manager or an executive leader and the odds of leaders earning greater than $95 000 annually for women compared with men using polytomous multinomial regression and logistic regression models, respectively. SETTING AND PARTICIPANTS: The Public Health Workforce Interests and Needs Survey was conducted via electronic survey at 37 state health departments. This study utilized only those respondents who listed their current position as a supervisory position (n = 3237). MAIN OUTCOME MEASURES: Leadership position and high-earning leadership were the 2 main outcome measures explored. Leadership position was defined as a 3-level ordinal variable: supervisor, manager, or executive leader. High-earning leadership was defined as a member of leadership earning $95 000 or greater. RESULTS: Women accounted for 72.0% of the overall state governmental public health agency workforce and 67.1% of leadership positions. Women experienced lower odds (odds ratio = 0.55, 95% confidence interval: 0.39-0.78) of holding executive leadership positions than men and lower odds (odds ratio = 0.64, 95% confidence interval: 0.50-0.81) of earning an annual salary greater than $95 000. CONCLUSION: While women were represented in similar proportions in the general workforce as in leadership positions, gender disparities still existed within leadership positions. Increased effort is needed to ensure that opportunities exist for women in executive leadership positions and in pay equity. With public health's commitment to social justice and the benefits of diversity to an agency's policies and programs, it is important to ensure that women's voices are equally represented at all levels of leadership.

Neighborhood disadvantage across the transition from adolescence to adulthood and risk of metabolic syndrome.

This study investigates the association between neighborhood disadvantage from adolescence to young adulthood and metabolic syndrome using a life course epidemiology framework. Data from the United States-based National Longitudinal Study of Adolescent to Adult Health (n = 9500) and a structural equation modeling approach were used to test neighborhood disadvantage across adolescence, emerging adulthood, and young adulthood in relation to metabolic syndrome. Adolescent neighborhood disadvantage was directly associated with metabolic syndrome in young adulthood. Evidence supporting an indirect association between adolescent neighborhood disadvantage and adult metabolic syndrome was not supported. Efforts to improve cardiometabolic health may benefit from strategies earlier in life.

Neighborhood Disadvantage and Neighborhood Affluence: Associations with Breastfeeding Practices in Urban Areas.

Objective To estimate the associations between neighborhood disadvantage and neighborhood affluence with breastfeeding practices at the time of hospital discharge, by race-ethnicity. Methods We geocoded and linked birth certificate data for 111,596 live births in New Jersey in 2006 to census tracts. We constructed indices of neighborhood disadvantage and neighborhood affluence and examined their associations with exclusive (EBF) and any breastfeeding in multilevel models, controlling for individual-level confounders. Results The associations of neighborhood disadvantage and affluence with breastfeeding practices differed by race-ethnicity. The odds of EBF decreased as neighborhood disadvantage increased for all but White women [Asian: Adjusted odds ratio (AOR) 0.82 (95% confidence interval (CI) 0.69-0.97); Black: AOR 0.77 (95% CI 0.70-0.86); Hispanic: AOR 0.78 (95% CI 0.70-0.86); White: AOR 0.99 (95% CI 0.91-1.08)]. The odds of EBF increased as neighborhood affluence increased for Hispanic [AOR 1.19 (95% CI 1.08-1.31)] and White [AOR 1.12 (95% CI 1.06-1.18)] women only. The odds of any breastfeeding decreased with increasing neighborhood disadvantage only for Hispanic women [AOR 0.85 (95% CI 0.79-0.92)], and increased for White women [AOR 1.16 (95% CI 1.07-1.26)]. The odds of any breastfeeding increased as neighborhood affluence increased for all except Hispanic women [Asian: AOR 1.31 (95% CI 1.13-1.51); Black: AOR 1.19 (95% CI 1.07-1.32); Hispanic: AOR 1.08 (95% CI 0.99-1.18); White: AOR 1.30 (95% CI 1.24-1.38)]. Conclusions Race-ethnic differences in associations between neighborhood disadvantage and affluence and breastfeeding practices at the time of hospital discharge indicate the need for specialized support to improve access to services.

Maternal race and intergenerational preterm birth recurrence.

BACKGROUND: Preterm birth is a complex disorder with a heritable genetic component. Studies of primarily White women born preterm show that they have an increased risk of subsequently delivering preterm. This risk of intergenerational preterm birth is poorly defined among Black women. OBJECTIVE: Our objective was to evaluate and compare intergenerational preterm birth risk among non-Hispanic Black and non-Hispanic White mothers. STUDY DESIGN: This was a population-based retrospective cohort study, using the Virginia Intergenerational Linked Birth File. All non-Hispanic Black and non-Hispanic White mothers born in Virginia 1960 through 1996 who delivered their first live-born, nonanomalous, singleton infant ≥20 weeks from 2005 through 2009 were included. We assessed the overall gestational age distribution between non-Hispanic Black and White mothers born term and preterm (<37 weeks) and their infants born term and preterm (<37 weeks) using Cox regression and Kaplan-Meier survivor functions. Mothers were grouped by maternal gestational age at delivery (term, ≥37 completed weeks; late preterm birth, 34-36 weeks; and early preterm birth, <34 weeks). The primary outcomes were: (1) preterm birth among all eligible births; and (2) suspected spontaneous preterm birth among births to women with medical complications (eg, diabetes, hypertension, preeclampsia and thus higher risk for a medically indicated preterm birth). Multivariable logistic regression was used to estimate odds of preterm birth and spontaneous preterm birth by maternal race and maternal gestational age after adjusting for confounders including maternal education, maternal age, smoking, drug/alcohol use, and infant gender. RESULTS: Of 173,822 deliveries captured in the intergenerational birth cohort, 71,676 (41.2%) women met inclusion criteria for this study. Of the entire cohort, 30.0% (n = 21,467) were non-Hispanic Black and 70.0% were non-Hispanic White mothers. Compared to non-Hispanic White mothers, non-Hispanic Black mothers were more likely to have been born late preterm (6.8% vs 3.7%) or early preterm (2.8 vs 1.0%), P < .001. Non-Hispanic White mothers who were born (early or late) preterm were not at an increased risk of early or late preterm delivery compared to non-Hispanic White mothers born term. The risk of early preterm birth was most pronounced for Black mothers who were born early preterm (adjusted odds ratio, 3.26; 95% confidence interval, 1.77-6.02) compared to non-Hispanic White mothers. CONCLUSION: We found an intergenerational effect of preterm birth among non-Hispanic Black mothers but not non-Hispanic White mothers. Black mothers born <34 weeks carry the highest risk of delivering their first child very preterm. Future studies should elucidate the underlying pathways leading to this racial disparity.

Trends in Food and Beverage Consumption Among Infants and Toddlers: 2005-2012.

BACKGROUND: Nutritional guidance for infants and toddlers is lacking, and the diets of American children in the first 2 years of life are not well characterized. METHODS: Cross-sectional data from the NHANES were used to describe the diets of 0- to 23-month-olds in the United States. Participants with complete dietary data were eligible for the analysis (N = 2359). Linear regression models were constructed to identify changes from 2005 to 2008 and from 2009 to 2012 in food and beverage consumption, both overall and within sociodemographic groups. RESULTS: We observed several trends toward meeting early-feeding recommendations, such as a decline in the prevalence of complementary feeding among 0- to 5-month-olds. However, the prevalence of vegetable consumption was consistently lower than desired (∼25% of 6- to 11-month-olds and 20% of 12- to 23-month-olds had no reported vegetable consumption on dietary recall days in the 2009-2012 set). Subgroup analyses revealed that some trends were limited to certain populations (eg, a decline in juice consumption was observed among 6- to 11-month-old non-Hispanic whites and non-Hispanic blacks but not among Mexican Americans), and additional trends emerged within groups (eg, the prevalence of breast milk consumption declined among 0- to 5-month-old Mexican Americans). CONCLUSIONS: Although there have been some improvements in the diets of 0- to 23-month-olds in recent years, there are areas in which this population continues to fall short of current recommendations. This underscores the need for additional policy guidance for providers and education for parents and caretakers on helping infants and toddlers achieve healthy diets.

Neighborhood context and birth outcomes: Going beyond neighborhood disadvantage, incorporating affluence.

•Neighborhood affluence protects against the risk of poor birth outcome. •The protective effect of affluence holds for Whites, Blacks, Hispanics and Asians. •Mediation of these pathways by prenatal smoking varies by racial group. •The discourse on neighborhoods and birth outcomes should include affluence.