Congenital cytomegalovirus (CMV) infections are associated with stillbirth, neonatal death, deafness, and cognitive and motor delay. Small observational studies have evaluated CMV hyperimmune globulin to prevent congenital infection in women with primary CMV infection during pregnancy; however, the results were either inconsistent or inconclusive. The goal of this study was to determine if CMV hyperimmune globulin can prevent congenital CMV in affected women early in pregnancy.This was a multicenter, double-blind trial conducted at 16 centers in the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and at 1 military medical center. Oral or written informed consent was obtained before enrolling in the study. Pregnant women with primary CMV infection diagnosed before 24 weeks' gestation were eligible for participation. Primary CMV infection was defined as either the presence of CMV IgM antibody of at least 1.00 index, IgG antibody of at least 6.0 AU per milliliter, and IgG avidity less than 50%; or a positive CMV IgG screening result after an initial negative screen earlier in pregnancy. Enrolled patients were randomly assigned to either receive a monthly infusion of CMV hyperimmune globulin or placebo until delivery. Each infusion was administered at a rate of 0.3 mL/kg per hour. If no adverse reactions were noted, the dose was increased in increments.The primary outcome for this study was a composite of confirmed fetal infection or congenital infection diagnosed by 3 weeks of age or fetal or neonatal death (including pregnancy termination) if CMV testing was not performed in the fetus or neonate. Secondary outcomes were hypertensive disorders of pregnancy, placental abruption, and adverse events. In all, 206,082 pregnant women were screened and 399 underwent randomization. Of the 399 enrolled patients, 206 were assigned to receive hyperimmune globulin and 193 were assigned to receive placebo. A total of 5 patients were lost to follow-up, so 203 were included in the final hyperimmune globulin group and 191 were included in the final placebo group.A primary outcome event occurred in 46 fetuses or neonates (22.7%) in the group that received hyperimmune globulin and in 37 fetuses or neonates in the placebo group (19.4%; relative risk, 1.17; 95% confidence interval [CI], 0.80-1.72; P = 0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66-5.41). Preterm birth occurred in 12.2% of the hyperimmune globulin group and 8.3% in the placebo group (relative risk, 1.47; 95% CI, 0.81-2.67). Birth weight was below the fifth percentile in 10.3% of the hyperimmune globulin group and 5.4% of the placebo group (relative risk, 1.92; 95% CI, 0.92-3.99). Participants who received hyperimmune
Introduction: Observational studies of SARS-CoV-2 vaccine effectiveness depend on accurate ascertainment of vaccination receipt, date, and product type. Self-reported vaccine data may be more readily available to and less expensive for researchers than assessing medical records. Methods: We surveyed adult participants in the COVID-19 Community Research Partnership who had an authenticated Electronic Health Record (EHR) (N = 41,484) concerning receipt of SARS-CoV-2 vaccination using a daily survey beginning in December 2020 and a supplemental survey in September–October 2021. We compared self-reported information to that available in the EHR for the following data points: vaccine brand, date of first dose, and number of doses using rates of agreement and Bland–Altman plots for visual assessment. Self-reported data was available immediately following vaccination (in the daily survey) and at a delayed interval (in a secondary supplemental survey). Results: For the date of first vaccine dose, self-reported “immediate” recall was within +/− 7 days of the date reported in the “delayed” survey for 87.9% of participants. Among the 19.6% of participants with evidence of vaccination in their EHR, 95% self-reported vaccination in one of the two surveys. Self-reported dates were within +/− 7 days of documented EHR vaccination for 97.6% of the “immediate” surveys and 92.0% of the “delayed” surveys. Self-reported vaccine product details matched those in the EHR for over 98% of participants for both “immediate” and “delayed” surveys. Conclusions: Self-reported dates and product details for COVID-19 vaccination can be a good surrogate when medical records are unavailable in large observational studies. A secondary confirmation of dates for a subset of participants with EHR data will provide internal validity.
Aims To assess associations of psychosocial factors with medication adherence in young adults with youth‐onset type 2 diabetes in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort. Methods Participants (mean age 26 years) completed validated psychosocial measures. Adherence to oral hypoglycemia agents (OHAs) was assessed with 3‐monthly unannounced phone pill counts; insulin adherence by self‐report. Logistic and linear regressions identified factors associated with “low‐adherence” (<80% of pills/insulin) controlling for confounders. Results Of 212 participants taking OHAs (67% female, 39% Hispanic, 36% non‐Hispanic Black), 69.8% were low‐adherent. After adjustment, beliefs that medicines are necessary was associated with lower odds of low‐adherence (p = 0.040, dichotomous). Less self‐management support (p = 0.008), no healthcare coverage (p = 0.001), ≥1 (p = 0.008)/≥2 (p = 0.045) need insecurities were associated with higher odds of low‐adherence. Factors associated with lower % adherence (continuous) were beliefs that medicines are harmful (p < 0.001)/overused (p = 0.007)/less necessary (p = 0.022), low self‐management support (p = 0.003), food insecurity (p = 0.036), no healthcare coverage (p < 0.001), ≥1 (p = 0.003)/≥2 (p = 0.018) need insecurities. Of 192 taking insulin (69% female, 36% Hispanic, 41% non‐Hispanic Black, 16% non‐Hispanic white), 37.0% were low‐adherent. Beliefs that medicines are overused (p = 0.009), that diabetes is not serious (p = 0.010), low diabetes self‐efficacy (p = 0.035), high distress (p = 0.027), low self‐management support (p = 0.001), food insecurity (p = 0.020), ≥1 (p = 0.011)/≥2 (p = 0.015) insecurities increased odds of insulin low‐adherence. Conclusions Poor medication adherence, common in young adults with youth‐onset type 2 diabetes, is associated with interfering beliefs, diabetes distress and social factors. We must address these factors to develop tailored interventions for this vulnerable group.
Aim: To identify psychosocial predictors of medication adherence in young adults with youth-onset type 2 diabetes in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort.Methods: Participants (mean age: 26 years) completed validated psychosocial measures. Unannounced telephone pill counts were completed at T1 (baseline) and T2 (follow-up, approximately 1 year later) to assess adherence to oral hypoglycaemia agents (OHAs). Adherence to insulin was assessed by self-report. Logistic and linear regressions identified factors that predicted 'low adherence' (<80% of pills/insulin) and per cent adherence, adjusted for potential confounders.Results: Of 171 participants with OHA adherence scores at T1 and T2 (65% women, 43% Hispanic and 35% non-Hispanic Black), 65.4% were low adherent.After adjustment (including T1 adherence), concerns about diabetes medicines (adverse effects, dependence) at T1 predicted higher odds of being low adherent (categorical) at T2 (p = 0.019). Housing insecurity (p = 0.045) and reporting ≥2 need insecurities (p = 0.027) at T1 predicted lower per cent adherence (continuous) at T2. Of 157 participants with insulin adherence scores at T1 and T2 (69% women, 38% Hispanic and 38% non-Hispanic Black), 36.3% were low adherent.After adjustment (including T1 adherence), beliefs that medicines are overused predicted higher odds of insulin low adherence at T2 (p = 0.013), and beliefs that medicines are harmful (p = 0.004) and overused (p = 0.010) predicted lower per cent insulin adherence at T2.
OBJECTIVE: To estimate whether maternal sense of control in labor is associated with breastfeeding at 4–8 weeks postpartum. METHODS: This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6–96 hours after delivery. The Labor Agentry Scale score, which is higher with more perceived control during childbirth, was analyzed both as a continuous and a categorical variable (quintiles). Self-reported breastfeeding at 4–8 weeks postpartum was categorized as exclusive breastfeeding, breastfeeding and formula feeding, or exclusive formula feeding. Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding. Multinomial logistic regression was used to adjust for confounders. RESULTS: Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860) were exclusively formula feeding 4–8 weeks after delivery. Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145–182). The median Labor Agentry Scale score was 169 (interquartile range 151–183) for women exclusively breastfeeding, 166 (interquartile range 142–182) for women who were breastfeeding and formula feeding, and 164 (interquartile range 142–181) for women who were only formula feeding (P<.001). In the unadjusted multinomial model, women with Labor Agentry Scale scores in the lowest two quintiles (ie, those with lower perceived control during childbirth) were less likely to be exclusively breastfeeding (as compared with those exclusively formula feeding) than women in the highest Labor Agentry Scale quintile. When controlling for confounders, however, this association was no longer significant. CONCLUSION: After adjustment for confounders, perceived control during childbirth was not associated with breastfeeding at 4–8 weeks postpartum among nulliparous women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
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