Comparison of thrombotic adverse events in patients treated with factor VIII products and emicizumab using the 2018-2022 US Food and Drug Administration Adverse Event Reporting System data.

BACKGROUND: Relatively little is known about thrombotic adverse events (AEs) of emicizumab in postmarketing real-world settings, particularly in comparison with factor VIII (FVIII) products. A recent European study reported a potentially greater thrombotic risk of emicizumab compared with FVIII products. OBJECTIVES: This drug safety study aims to investigate whether thrombotic AEs are more frequently reported for emicizumab than for FVIII products and if so, whether it is independent of bypassing agents as coreporting drugs using the United States Food and Drug Administration Adverse Event Reporting System data. METHODS: Disproportionality analyses for thrombotic AEs of emicizumab vs FVIII products were conducted. Three signal detection indicators were used: proportional reporting ratio (PRR), reporting odds ratio (ROR), and informational component (IC). RESULTS: During 2018-2022, the proportions of thrombotic AEs among all AEs were 4.07% (97 out of 2383) and 1.44% (134 out of 9324) for emicizumab and FVIII products, respectively: PRR = 2.83 (2.19-3.66), ROR = 2.91 (2.23-3.79), and IC = 1.04 (0.70-1.28). Bypassing agents as coreporting drugs were identified in 36% and 15% of the total thrombotic AE reports associated with emicizumab and FVIII products, respectively. Even after thrombotic AE reports with bypassing agents were excluded, the reporting proportion of thrombotic AEs was still greater for emicizumab than for FVIII products: PRR = 2.19 (1.60-2.99). CONCLUSION: Thrombotic AEs in the United States Food and Drug Administration Adverse Event Reporting System data were about 3 times more frequently reported for emicizumab than for FVIII products. More research and efforts in the future are warranted for monitoring, elucidating, and preventing the potential risk of thrombotic AEs in hemophilia therapy, including emicizumab.

Developing a short standard questionnaire for assessing work organization hazards: the Healthy Work Survey (HWS).

Background: At present, no short standard questionnaire exists for assessing and comparing major work organization hazards in the workplaces of the United States. Methods: We conducted a series of psychometric tests (content validity, factor analysis, differential-item functioning analysis, reliability, and concurrent validity) to validate and identify core items and scales for major work organization hazards using the data from the 2002-2014 General Social Surveys (GSSs), including the Quality of Worklife (QWL) questionnaire. In addition, an extensive literature review was undertaken to find other major work organization hazards which were not addressed in the GSS. Results: Although the overall validity of the GSS-QWL questionnaire was satisfactory in the psychometric tests, some GSS-QWL items of work-family conflict, psychological job demands, job insecurity, use of skills on the job, and safety climate scales appeared to be weak. In the end, 33 questions (31 GSS-QWL and 2 GSS) were chosen as the least, but best validated core questions and included in a new short standard questionnaire (called the Healthy Work Survey [HWS]). And their national norms were established for comparisons. Furthermore, based on the literature review, fifteen more questions for assessing other significant work organization hazards (e.g., lack of scheduling control, emotional demands, electronic surveillance, wage theft) were included in the new questionnaire. Thus, the HWS includes 48 questions in total for assessing traditional and emerging work organization hazards, which covers seven theoretical domains: work schedule/arrangement, control, support, reward, demands, safety, and justice. Conclusions: The HWS is a short standard questionnaire for assessing work organization hazards which can be used as a first step toward the risk management of major work organization hazards in the workplaces of the US.

Low Job Control and Racial Disparities in Breastfeeding.

BACKGROUND: Low job control may predict shorter breastfeeding (BF) among working mothers and may contribute to racial disparities in BF. METHODS: We used demographic, employment, and health data for n = 631 observations from the Panel Study of Income Dynamics. Job control scores came from a job-exposure matrix.Using path analysis, we assessed whether job control predicted BF and mediated Black-White BF differences. We controlled for education, working hours, marital status, and low birthweight. RESULTS: Lower job control predicted decreased odds of BF for at least 6 months (odds ratio, 0.61; 95% confidence interval, 0.31-0.90; reference, no BF). Low job control explained 31% of the Black-White difference for both shorter-term and longer-term BF. CONCLUSIONS: Low job contributes to shorter BF and to BF disparities by race. Intervening to enhance job control could improve BF.

Comparison of Social Inequality in Human Papillomavirus (HPV) Vaccination among Teenagers with Parental Reports and Healthcare Providers' Records in the 2019 National Immunization Survey-Teen.

BACKGROUND: Relatively little is known about social inequality in human papillomavirus (HPV) vaccination among teenagers in the United States. This study aims to investigate whether there is a social disparity in HPV vaccination among teenagers and if so, whether it can differ according to the source of teen vaccination information (parental reports and provider records). METHODS: We used the data from the 2019 National Immunization Survey-Teen (NIS-Teen; 42,668 teenagers, aged 13-17) including parent-reported vaccination status. Among them, 18,877 teenagers had adequate provider-reported vaccination records. Two socioeconomic status (SES) measures were used: mother's education and annual family income. Multivariate logistic analyses were conducted. RESULTS: False negatives of parental reports against provider records were more than two times higher (p < 0.001) in low-SES teens than in high-SES teens. In both SES measures, the proportion of HPV-unvaccinated teenagers was lowest at the highest SES level in analyses with parental reports. However, it was the opposite in analyses with provider records. Interestingly, regardless of the vaccination information source, the HPV unvaccinated rate was highest in the middle-SES teens (>12 years, non-college graduates; above poverty level, but not >USD 75 K). CONCLUSIONS: Significant social inequality in HPV vaccination among teenagers exists in the United States. The pattern of social inequality in HPV vaccination can be distorted when only parent-reported vaccination information is used.

Developing a Job Exposure Matrix of Work Organization Hazards in the United States: A Review on Methodological Issues and Research Protocol.

BACKGROUND: Most job exposure matrices (JEMs) have been developed for chemical and physical hazards in the United States (US). In addition, the overall validity of most JEMs of work organization hazards using self-reported data in the literature remains to be further tested due to several methodological weaknesses. METHODS: This paper aims to review important methodological issues with regard to a JEM of work organization hazards using self-report data and to present a research protocol for developing a four-axis (job titles, hazards, sex, and time) JEM of major work organization hazards using the US General Social Survey-Quality of Work-Life (GSS-QWL) data (2002-2018; N = 7,100 workers). RESULTS: Five methodological weaknesses in existing JEMs of work organization hazards using self-report data were identified: having only two axes (hazard and occupation), using psychometrically weak items and scales, including scales having little interoccupational variability, unresolved optimal minimum numbers of subjects per occupation, and low accessibility. The methodological weaknesses were successfully addressed in the proposed research protocol. CONCLUSION: The work organization JEM to be developed will significantly facilitate and strengthen occupational epidemiological studies on work organization hazards and major health outcomes, improve national and occupational surveillance of work organization hazards, and promote interventions for a healthy work environment in the US.

Urinary bisphenol A, phthalate metabolites, and obesity: do gender and menopausal status matter?

Previous studies of urinary bisphenol A (BPA), phthalate metabolites, and obesity risk have shown inconsistent results. Menopausal status is one of the main factors that affect hormone secretion change in women. In this study, we examined whether urinary BPA and phthalate metabolite levels are associated with obesity and whether the associations differ by sex and menopausal status in a sample of Korean adult populations. We recruited participants at three branches (Yeouido, Gangnam, and Gwanghwamun) of the Korea Medical Institute, a nationwide health check-up center, from 2015 to 2016. Urinary BPA level was measured by high-performance liquid chromatography-tandem mass spectrometry (Agilent 6490 Triple Quad LC-MS/MS; Agilent Technologies, CA, USA). Urinary six phthalate metabolites were analyzed with ultra-high-performance liquid chromatography-tandem mass spectrometry (TSQ Quantum Access Mass; Thermo Fisher Scientific, MA, USA). Participants with body mass index ≥ 25 kg/m2 were defined as general obesity group. Men with waist circumference (WC) ≥ 90 cm and women with WC ≥ 85 cm were defined as abdominal obesity group. Age, sex, alcohol intake, smoking, and exercise were considered in multivariate logistic regression models. Among the total of 702 participants, 211 participants were classified into the general obesity group, and 131 participants were classified into the abdominal obesity group. Urinary phthalate metabolite levels were not associated with general and abdominal obesity in men and women. However, in women, urinary BPA concentration was positively associated with abdominal obesity (OR = 1.50, 95% CI 1.00-2.26). Also, the association was stronger in postmenopausal women (OR = 2.23, 1.01-4.92), while it was weak in premenopausal women (OR = 1.31, 0.78-2.20). In this study, urinary BPA concentration was associated with abdominal obesity in women, especially postmenopausal women. Future studies should consider sex and menopausal status when investigating associations between urinary BPA, phthalate metabolites levels, and obesity.

Opioid use disorder, job strain, and high physical job demands in US workers.

PURPOSE: Little is known about the work environmental risk factors for opioid use disorder (OUD) in working populations. The purpose of this study is to examine whether adverse physical and psychosocial working conditions are associated with OUD in a working population of the United States (US). METHODS: Among the participants of the National Survey of Midlife Development in the United States (MIDUS) II Study (2004-2006), 2134 workers (1059 men and 1075 women; mean age, 51 years) were chosen for this study. OUD was measured with self-administered questions in line with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSD-5). Physical demands (physical efforts, heavy lifting, and crouching/stooping/kneeling) and psychosocial work stressors (skill discretion, decision authority, job control, psychological job demands, supervisor and coworker support at work, job insecurity, and work hours) were measured with a standard questionnaire. RESULTS: The prevalence of OUD was 3.8%. In multivariate analyses, low skill discretion, high psychological job demands, job strain (a combination of low control and high demands), and high physical job demands were significantly associated with OUD. The multivariate prevalence ratios for OUD by job strain and frequent heavy lifting were 1.98 (1.27-3.10) and 2.23 (1.22-4.10), respectively. Job strain was more strongly associated with OUD in men, while high physical job demands were more strongly associated with OUD in women. CONCLUSION: This study implies that adverse physical and psychosocial working conditions may be important risk factors for OUD in US working populations. Future longitudinal and mechanistic studies are urgently warranted.

Workplace breastfeeding support and job satisfaction among working mothers in the United States.

BACKGROUND: Job satisfaction is associated with health and productivity. Workplace support for breastfeeding may affect working mothers' job satisfaction. METHODS: We analyzed responses from 488 women from the Infant Feeding Practices Study II (2005-2007). Using logistic regression, we assessed whether workplace breastfeeding problems at 3 months postpartum were related to low job satisfaction concurrently and, for a subsample (n = 265), at 9 and 12 months postpartum. RESULTS: Compared with women reporting no problems, women reporting three or more problems had higher odds (odds ratio [OR] = 4.76; 95% confidence interval [CI]: 2.03-11.18) of low job satisfaction at 3 months, and at 12 months (OR = 6.88, 95% CI: 1.33-35.58) after controlling for baseline job satisfaction. Models isolating problems with break time and space to pump/nurse showed more modest results. CONCLUSIONS: Work-related breastfeeding problems at 3 months postpartum were associated with low job satisfaction concurrently and at follow-up. Improving workplace breastfeeding accommodations could improve mothers' job satisfaction.

Concurrent use of benzodiazepines, antidepressants, and opioid analgesics with zolpidem and risk for suicide: a case-control and case-crossover study.

PURPOSE: To evaluate whether the concurrent use of benzodiazepines, antidepressants, and opioid analgesics with zolpidem increases the risk of suicide or triggers suicide compared with the use of zolpidem alone. METHODS: We conducted a case-control and case-crossover study using the Korean National Health Insurance Service-National Sample Cohort database. Cases were older than 20 years with a suicide record (International Codes of Disease 10th Revision codes: X-60-X84 and Y87.0 intentional self-harm) between January 1, 2004, and December 31, 2013. For case-control design, ten controls were matched to each case by age, sex, index year, region, income, and health insurance type. For case-crossover analysis, we set hazard period to 60 days and assigned five corresponding sets of control periods of equal length. Exposure was assessed during 60 days before suicide for combinations of benzodiazepines, antidepressants, opioid analgesics with zolpidem against zolpidem alone. We conducted a conditional logistic regression to estimate odds ratios (ORs) and their 95% confidence intervals (CIs). RESULTS: In the case-control study, the risk of suicide was 2.80-fold higher in cases taking benzodiazepines and antidepressants with zolpidem than in those taking zolpidem alone (adjusted OR [aOR], 2.80; 95% CI, 1.38-5.70). However, in the case-crossover study, suicide risk showed no significant difference (crude OR [cOR], 0.92; 95% CI, 0.55-1.52) and was underpowered. CONCLUSIONS: The results of the traditional case-control study confirmed that the concurrent use of benzodiazepines and antidepressants with zolpidem was associated with an increased risk of suicide compared with the use of zolpidem alone. However, there was no significant difference in the magnitude of risk in the within-person comparison design.

Zolpidem Use and Suicide Death in South Korea: A Population-Based Case-Control Study.

OBJECTIVE: To investigate whether zolpidem use is associated with suicide death in adults. METHOD: We conducted a case-control study using the National Health Insurance Service-National Sample Cohort (NHIS-NSC) database. Cases were adults with a suicide record (ICD-10 codes; X-60-X84, Y87.0) between January 1, 2004 and December 31, 2013. 10 Controls were matched to each case by age, sex, index year, region, income level, and health insurance type. Zolpidem use during 2 years before suicide was quantified. Adjusted odd ratios (aORs) with 95% confidence intervals (CIs) were estimated using conditional logistic regression. RESULTS: The percentage of zolpidem users was significantly higher in cases (451 of 1,928 [23.4%]) than in controls (832 of 18,404 [4.5%]). After controlling for potential confounders, zolpidem use was significantly associated with suicide (aORs, 2.09; 95% CI, 1.74-2.52). Dose-response relationships were observed (for trend, p < .0001). Consistent findings were observed when analyses were restricted to suicide death (aORs, 2.08; 95% CI, 1.73-2.51) and nonmedication poisoning suicide death cases (aORs, 2.10; 95% CI, 1.74-2.53). CONCLUSIONS: We found a significant and positive association between zolpidem use and suicide. Zolpidem should be prescribed cautiously and with due caution of increased suicide risk.

Nonlinear Relationship Between Blood Pressure and Glaucoma in US Adults.

BACKGROUND: Previous studies have reported that vascular disease is associated with glaucoma. However, the relationship between blood pressure (BP) and glaucoma has been inconsistent. We investigated whether there is a nonlinear association between BP and glaucoma in an adult population of the United States. METHODS: From the 2005-2008 National Health and Nutrition Examination Survey data, 4,137 participants aged 40 years and older were chosen. BP was assessed based on a standard protocol. Glaucoma was determined using fundus photographs. Age, sex, race/ethnicity, education, poverty, antihypertensive medication, and history of cardiovascular disease were also considered in analyses. RESULTS: The prevalence of glaucoma was 1.2%. In the multivariate analysis, both high (≥161 mm Hg) and low (≤110 mm Hg) levels of systolic BP were found to be positively associated with glaucoma in those without antihypertensive medications: their prevalence ratios (95% confidence intervals) for glaucoma were 6.42 (1.01-40.81) and 5.46 (1.77-16.53), respectively, when compared to the reference levels of systolic BP (111-120 mm Hg). Also, both high (≥91 mm Hg) and low (≤60 mm Hg) levels of diastolic BP were positively associated with glaucoma in those without antihypertensive medications. The prevalence of glaucoma was lowest in those having systolic BP levels of 111-120 mm Hg and diastolic BP levels of 81-90 mm Hg. However, there were no such U-shaped relationships in those with antihypertensive medications. CONCLUSIONS: There was a nonlinear (U-shaped) relationship between BP and the glaucoma in those without antihypertensive medications. Future longitudinal studies are warranted to confirm our findings, including the optimal BP levels for the prevention of glaucoma.

Job strain, long work hours, and suicidal ideation in US workers: a longitudinal study.

PURPOSE: To investigate whether chronic psychosocial work stressors (low job control, high job demands, job strain, low supervisor and coworker support, job insecurity, and long work hours) are longitudinally associated with suicidal ideation in a working population. METHODS: Five-hundred seventy-eight workers (aged 34-69) were chosen for this analysis from those who participated in both project 1 (2004-2006 at baseline) and project 4 (2004-2009 at follow-up) of the Midlife Development in the United States II study. The median time interval between the two projects was 26 months (range 2-62 months). RESULTS: About 11% of the workers reported suicidal ideation at follow-up, while 3% of them reported moderate/severe suicidal ideation at follow-up. After controlling for age, marital status, race, family history of suicide, and suicidal ideation at baseline, low skill discretion and job strain (a combination of low job control and high job demands) were associated with total suicidal ideation. After excluding those with suicidal ideation at baseline from analysis and further controlling for other work stressors, job strain was strongly associated with moderate/severe suicidal ideation: ORs, 4.29 (1.30-14.15) for quartile-based job strain and 3.77 (1.21-11.70) for median-based job strain. Long work hours (> 40 h/week vs. ≤ 40 h/week) also increased the likelihood for moderate/severe suicidal ideation: OR 4.06 (1.08-15.19). CONCLUSIONS: Job strain and long work hours were longitudinally associated with moderate/severe suicidal ideation. Increasing job control and ensuring optimal level of work demands, including 40 h or less of work per week may be an important strategy for the prevention of suicide in working populations.