Food Insecurity Among Low-Income U.S. Adults During the COVID-19 Pandemic

Suicide Attempts After a Diagnosis of Polycystic Ovary Syndrome: A Cohort Study: Annals of Internal Medicine: Vol 177, No 3

Background: Limited evidence exists about suicide risk in persons with polycystic ovary syndrome (PCOS). Objective: To assess suicide risk in persons with PCOS, accounting for psychiatric comorbid conditions and age group. Design: Cohort study. Setting: Data from the Taiwanese nationwide database from 1997 to 2012. Patients: A cohort of 18 960 patients diagnosed with PCOS, each matched with control participants in a 1:10 ratio on the basis of age, psychiatric comorbid conditions, urbanization level, and income. Suicide attempts were evaluated using Cox regression models. Measurements: Suicide risk with hazard ratios (HRs). Results: Participants with PCOS had a notable 8.47-fold increase in risk for suicide attempt compared with the control group (HR, 8.47 [95% CI, 7.54 to 9.51]), after adjustment for demographic characteristics, psychiatric comorbid conditions, Charlson Comorbidity Index scores, and frequency of all-cause clinical visits. The elevated risk was evident across the adolescent (HR, 5.38 [CI, 3.93 to 7.37]), young adult (<40 years; HR, 9.15 [CI, 8.03 to 10.42]), and older adult (HR, 3.75 [CI, 2.23 to 6.28]) groups. Sensitivity analyses involving the exclusion of data from the first year or the first 3 years of observation yielded consistent results. Limitation: Potential underestimation of PCOS and mental disorder prevalence due to use of administrative claims data; lack of clinical data, such as body mass index and depressive symptoms; and no assessment of a confounding effect of valproic acid exposure. Conclusion: This study underscores the heightened risk for suicide attempt that persons with PCOS face, even after adjustment for demographics, psychiatric comorbid conditions, physical conditions, and all-cause clinical visits. This suggests the importance of routine monitoring of mental health and suicide risk in persons diagnosed with PCOS. Primary Funding Source: Taipei Veterans General Hospital, Yen Tjing Ling Medical Foundation, and Ministry of Science and Technology of Taiwan.

More Protection Against Respiratory Viral Infection: Respiratory Syncytial Virus Vaccines for Adults Aged 60 Years and Older

Reducing Care Overuse in Older Patients Using Professional Norms and Accountability: A Cluster Randomized Controlled Trial: Annals of Internal Medicine: Vol 177, No 3

Background: Effective strategies are needed to curtail overuse that may lead to harm. Objective: To evaluate the effects of clinician decision support redirecting attention to harms and engaging social and reputational concerns on overuse in older primary care patients. Design: 18-month, single-blind, pragmatic, cluster randomized trial, constrained randomization. (ClinicalTrials.gov: NCT04289753) Setting: 60 primary care internal medicine, family medicine and geriatrics practices within a health system from 1 September 2020 to 28 February 2022. Participants: 371 primary care clinicians and their older adult patients from participating practices. Intervention: Behavioral science–informed, point-of-care, clinical decision support tools plus brief case-based education addressing the 3 primary clinical outcomes (187 clinicians from 30 clinics) were compared with brief case-based education alone (187 clinicians from 30 clinics). Decision support was designed to increase salience of potential harms, convey social norms, and promote accountability. Measurements: Prostate-specific antigen (PSA) testing in men aged 76 years and older without previous prostate cancer, urine testing for nonspecific reasons in women aged 65 years and older, and overtreatment of diabetes with hypoglycemic agents in patients aged 75 years and older and hemoglobin A1c (HbA1c) less than 7%. Results: At randomization, mean clinic annual PSA testing, unspecified urine testing, and diabetes overtreatment rates were 24.9, 23.9, and 16.8 per 100 patients, respectively. After 18 months of intervention, the intervention group had lower adjusted difference-in-differences in annual rates of PSA testing (−8.7 [95% CI, −10.2 to −7.1]), unspecified urine testing (−5.5 [CI, −7.0 to −3.6]), and diabetes overtreatment (−1.4 [CI, −2.9 to −0.03]) compared with education only. Safety measures did not show increased emergency care related to urinary tract infections or hyperglycemia. An HbA1c greater than 9.0% was more common with the intervention among previously overtreated diabetes patients (adjusted difference-in-differences, 0.47 per 100 patients [95% CI, 0.04 to 1.20]). Limitation: A single health system limits generalizability; electronic health data limit ability to differentiate between overtesting and underdocumentation. Conclusion: Decision support designed to increase clinicians’ attention to possible harms, social norms, and reputational concerns reduced unspecified testing compared with offering traditional case-based education alone. Small decreases in diabetes overtreatment may also result in higher rates of uncontrolled diabetes. Primary Funding Source: National Institute on Aging.

Cardiovascular Health of Middle-Aged U.S. Adults by Income Level, 1999 to March 2020: A Serial Cross-Sectional Study: Annals of Internal Medicine: Vol 176, No 12

Background: Although cardiovascular mortality has increased among middle-aged U.S. adults since 2011, how the burden of cardiovascular risk factors has changed for this population by income level over the past 2 decades is unknown. Objective: To evaluate trends in the prevalence, treatment, and control of cardiovascular risk factors among low-income and higher-income middle-aged adults and how social determinants contribute to recent associations between income and cardiovascular health. Design: Serial cross-sectional study. Setting: NHANES (National Health and Nutrition Examination Survey), 1999 to March 2020. Participants: Middle-aged adults (aged 40 to 64 years). Measurements: Age-standardized prevalence of hypertension, diabetes, hyperlipidemia, obesity, and cigarette use; treatment rates for hypertension, diabetes, and hyperlipidemia; and rates of blood pressure, glycemic, and cholesterol control. Results: The study population included 20 761 middle-aged adults. The prevalence of hypertension, diabetes, and cigarette use was consistently higher among low-income adults between 1999 and March 2020. Low-income adults had an increase in hypertension over the study period (37.2% [95% CI, 33.5% to 40.9%] to 44.7% [CI, 39.8% to 49.5%]) but no changes in diabetes or obesity. In contrast, higher-income adults did not have a change in hypertension but had increases in diabetes (7.8% [CI, 5.0% to 10.6%] to 14.9% [CI, 12.4% to 17.3%]) and obesity (33.0% [CI, 26.7% to 39.4%] to 44.0% [CI, 40.2% to 47.7%]). Cigarette use was high and stagnant among low-income adults (33.2% [CI, 28.4% to 38.0%] to 33.9% [CI, 29.6% to 38.3%]) but decreased among their higher-income counterparts (18.6% [CI, 13.5% to 23.7%] to 11.5% [CI, 8.7% to 14.3%]). Treatment and control rates for hypertension were unchanged in both groups (>80%), whereas diabetes treatment rates improved only among the higher-income group (58.4% [CI, 44.4% to 72.5%] to 77.4% [CI, 67.6% to 87.1%]). Income-based disparities in hypertension, diabetes, and cigarette use persisted in more recent years even after adjustment for insurance coverage, health care access, and food insecurity. Limitation: Sample size limitations could preclude detection of small changes in treatment and control rates. Conclusion: Over 2 decades in the United States, hypertension increased in low-income middle-aged adults, whereas diabetes and obesity increased in their higher-income counterparts. Income-based disparities in hypertension, diabetes, and smoking persisted even after adjustment for other social determinants of health. Primary Funding Source: National Institutes of Health.

Metformin Use in the First Trimester of Pregnancy and Risk for Nonlive Birth and Congenital Malformations: Emulating a Target Trial Using Real-World Data

Background: Metformin is a first-line pharmacotherapy for type 2 diabetes, but there is limited evidence about its safety in early pregnancy. Objective: To evaluate the teratogenicity of metformin use in the first trimester of pregnancy. Design: In an observational cohort of pregnant women with pregestational type 2 diabetes receiving metformin monotherapy before the last menstrual period (LMP), a target trial with 2 treatment strategies was emulated: insulin monotherapy (discontinue metformin treatment and initiate insulin within 90 days of LMP) or insulin plus metformin (continue metformin and initiate insulin within 90 days of LMP). Setting: U.S. Medicaid health care administration database (2000 to 2018). Participants: 12 489 pregnant women who met the eligibility criteria. Measurements: The risk and risk ratio of nonlive births, live births with congenital malformations, and congenital malformations among live births were estimated using standardization to adjust for covariates. Results: A total of 850 women were in the insulin monotherapy group and 1557 in the insulin plus metformin group. The estimated risk for nonlive birth was 32.7% under insulin monotherapy (reference) and 34.3% under insulin plus metformin (risk ratio, 1.02 [95% CI, 1.01 to 1.04]). The estimated risk for live birth with congenital malformations was 8.0% (CI, 5.7% to 10.2%) under insulin monotherapy and 5.7% (CI, 4.5% to 7.3%) under insulin plus metformin (risk ratio, 0.72 [CI, 0.51 to 1.09]). Limitation: Possible residual confounding by glycemic control and body mass index. Conclusion: Compared with switching to insulin monotherapy, continuing metformin and adding insulin in early pregnancy resulted in little to no increased risk for nonlive birth among women receiving metformin before pregnancy. Under conventional statistical criteria, anything between a 49% decrease and a 9% increase in risk for congenital malformations was highly compatible with our data. Primary Funding Source: National Institutes of Health.

Autoimmune Disorders Associated With Surgical Remission of Cushing’s Disease: A Cohort Study: Annals of Internal Medicine: Vol 177, No 3

Background: Glucocorticoids suppress inflammation. Autoimmune disease may occur after remission of Cushing’s disease (CD). However, the development of autoimmune disease in this context is not well described. Objective: To determine 1) the incidence of autoimmune disease in patients with CD after surgical remission compared with patients with nonfunctioning pituitary adenomas (NFPAs) and 2) the clinical presentation of and risk factors for development of autoimmune disease in CD after remission. Design: Retrospective matched cohort analysis. Setting: Academic medical center/pituitary center. Patients: Patients with CD with surgical remission and surgically treated NFPA. Measurements: Cumulative incidence of new-onset autoimmune disease at 3 years after surgery. Assessment for hypercortisolemia included late-night salivary cortisol levels, 24-hour urine free cortisol (UFC) ratio (UFC value divided by the upper limit of the normal range for the assay), and dexamethasone suppression tests. Results: Cumulative incidence of new-onset autoimmune disease at 3 years after surgery was higher in patients with CD (10.4% [95% CI, 5.7% to 15.1%]) than in those with NFPAs (1.6% [CI, 0% to 4.6%]) (hazard ratio, 7.80 [CI, 2.88 to 21.10]). Patients with CD showed higher prevalence of postoperative adrenal insufficiency (93.8% vs. 16.5%) and lower postoperative nadir serum cortisol levels (63.8 vs. 282.3 nmol/L) than patients with NFPAs. Compared with patients with CD without autoimmune disease, those who developed autoimmune disease had a lower preoperative 24-hour UFC ratio (2.7 vs. 6.3) and a higher prevalence of family history of autoimmune disease (41.2% vs. 20.9%). Limitation: The small sample of patients with autoimmune disease limited identification of independent risk factors. Conclusion: Patients achieving surgical remission of CD have higher incidence of autoimmune disease than age- and sex-matched patients with NFPAs. Family history of autoimmune disease is a potential risk factor. Adrenal insufficiency may be a trigger. Primary Funding Source: Recordati Rare Diseases Inc.

Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting

Background: A 2-dose series of recombinant zoster vaccine (RZV) was 97% effective against herpes zoster (HZ) in a pivotal clinical trial. Objective: To evaluate real-world effectiveness of RZV against HZ. Design: Prospective cohort study. Setting: Four health care systems in the Vaccine Safety Datalink. Participants: Persons aged 50 years or older. Measurements: The outcome was incident HZ defined by a diagnosis with an antiviral prescription. Cox regression was used to estimate the hazard of HZ in vaccinated persons compared with unvaccinated persons, with adjustment for covariates. Vaccine effectiveness (VE) was calculated as 1 minus the adjusted hazard ratio and was estimated by time since the last RZV dose and by corticosteroid use. Results: The study included nearly 2.0 million persons who contributed 7.6 million person-years of follow-up. After adjustment, VE of 1 dose was 64% and VE of 2 doses was 76%. After 1 dose only, VE was 70% during the first year, 45% during the second year, 48% during the third year, and 52% after the third year. After 2 doses, VE was 79% during the first year, 75% during the second year, and 73% during the third and fourth years. Vaccine effectiveness was 65% in persons who received corticosteroids before vaccination and 77% in those who did not. Limitation: Herpes zoster could not be identified as accurately in these observational data as in the previous clinical trials. Conclusion: Two doses of RZV were highly effective, although less effective than in the previous clinical trials. Two-dose effectiveness waned very little during the 4 years of follow-up. However, 1-dose effectiveness waned substantially after 1 year, underscoring the importance of the second dose. Primary Funding Source: Centers for Disease Control and Prevention.

Accurate Measurements of Gastric Emptying and Gastrointestinal Symptoms in the Evaluation of Glucagon-like Peptide-1 Receptor Agonists

Prevalence of Pharmacologic and Nonpharmacologic Pain Management Therapies Among Adults With Chronic Pain—United States, 2020