Assessment of cancer risk associated with 7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4] triazolo-[4,3-a]pyrazine-contaminated sitagliptin use: A retrospective cohort study.

AIMS/INTRODUCTION: A recent US Food and Drug Administration report highlighted concerns over nitrosamine (7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4] triazolo-[4,3-a]pyrazine [NTTP]) impurities in sitagliptin, prompting investigations into its safety profile. The present study aimed to determine if the use of NTTP-contaminated sitagliptin, in comparison with other dipeptidyl peptidase-4 (DPP-4) inhibitors, is associated with an increased cancer risk. MATERIALS AND METHODS: This retrospective cohort study secondarily used the National Database of Health Insurance Claims and Specific Health Checkups of Japan, encompassing data on >120 million individuals. The study involved patients who initiated DPP-4 inhibitor therapy (sitagliptin or other DPP-4 inhibitors) and continued its exclusive use for 3 years. Sitagliptin users were compared with other DPP-4 inhibitor users for assessing the occurrence of cancers, as defined by diagnosis codes. Further analyses focused on specific types of cancer, using either diagnosis codes or a combination of diagnosis and procedure codes. We also carried out various sensitivity analyses, including those with different exposure periods. RESULTS: Sitagliptin users (149,120 patients, 388,356 person-years) experienced 9,643 cancer incidences (2,483.0/100,000 person-years) versus 12,621 incidences (2,504.4/100,000 person-years) among other DPP-4 inhibitor users (199,860 patients, 503,952 person-years), yielding a minimal difference (incidence rate ratio 0.99, 95% confidence interval 0.97-1.02). A multiple Cox proportional hazards model showed no significant association between sitagliptin use and overall cancer incidence (hazard ratio 1.01, 95% confidence interval 0.98-1.04). Findings were also consistent across cancer types and sensitivity analyses. CONCLUSIONS: We observed no evidence to suggest an increased cancer risk among patients prescribed NTTP-contaminated sitagliptin, although continued investigation is needed.

Japanese fathers' work-related factors associated with involvement in childcare.

OBJECTIVES: Existing studies of fathers' involvement in childcare have focused on its impact on children's psychosocial development and the facilitation of family functions, like marital relationships. In this study, we investigated the factors that determine paternal childcare in Japan, particularly focusing on work-related hours and environment, separately, according to mothers' employment status. METHODS: We used data from the Longitudinal Survey of Newborns in the 21st Century (2010 cohort) conducted in Japan. We restricted the sample to 27 783 participants with working fathers and analyzed how paternal work-related factors affect fathers' childcare involvement by mothers' employment status using an ordered logistic regression model. RESULTS: In the model adjusting for all covariates, the odds ratio (OR) of spending less time with children on weekdays was higher: for fathers who worked 50 and more hours per week compared with those who worked 40-49 hours per week (OR = 1.95, 95% CI: 1.72-2.20 for 50-59 hours), for fathers whose commuting hours were longer than those commuting less than 0.5 hours per day (OR = 2.93, 95% CI: 2.34-3.69 for 1.5 or more hours), for larger workplace employee sizes than for 5-99 employee sizes (OR = 1.56, 95% CI: 1.38-1.77 for 500 or more employees). The associations between these paternal work-related variables and paternal hours spent with the children on weekdays were almost the same if the mothers were working or not working. CONCLUSIONS: Regardless of whether the mother is working, fathers' work environment factors, such as working hours, play a key role in their involvement in childcare.

Paternal involvement in childcare and housework and mothers' spanking behavior: The Japanese longitudinal survey of newborns in the 21st century.

BACKGROUND: No previous study reported an association between paternal involvement in childcare and housework and maternal physical punishment. METHODS: Using data from the Japanese Longitudinal Survey of Newborns in the 21st century (N = 38,554), we analyzed responses about fathers' involvement in childcare and housework at 6 months and mothers' spanking of children at 3.5 years. Fathers' involvement in childcare and housework was scored and categorized into quartiles. Spanking frequency was asked in the "often", "sometimes", or "not at all" categories. Multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for the mothers' often spanking children were computed for the fathers' involvement in childcare and housework. We also stratified the association by fathers' working hours (40-49, 50-59, or ≥ 60 hours/week). RESULTS: Among the 16,373 respondents, the proportion of mothers who often spanked their children was 4.8%. Compared with the lowest quartile, a higher frequency of paternal involvement in housework was associated with a lower risk of spanking children (p trend = 0.001). Adjustment for covariates attenuated the association, but significant association was observed in the 3rd quartile of paternal involvement in housework [OR (95% CI): 0.77 (0.62-0.96)]. When the fathers worked fewer than 50 hours a week, a significant negative association was observed between the fathers' frequency of childcare and the likeliness of the mothers' spanking their children (p trend = 0.02). CONCLUSIONS: The fathers' active involvement in childcare and housework could reduce the mothers' physical punishment for their children.

Quality of care measurement for patients with ovarian cancer in Japan.

AIM: Quality of care is important to reduce disease progression, and improve both survival and quality of life. The Japan Society of Gynecologic Oncology has published treatment guidelines to promote standardized high-quality care for ovarian cancer in Japan. We developed quality indicators based on the guideline recommendations and used them on large datasets of health service use to examine the quality of ovarian cancer care. METHODS: A panel of experts developed the indicators using a modified Delphi method. Adherence to each indicator was evaluated using data from a hospital-based cancer registry of patients diagnosed in 2018. All patients receiving first-line treatment at participating facilities were included. The adherence rates were returned to participating hospitals, and reasons for nonadherence were collected. A total of 580 hospitals participated, and the study examined the care received by 6611 patients with ovarian cancer and 1879 with borderline tumors using 11 measurable quality indicators. RESULTS: The adherence rate ranged from 22.6% for "Estrogen replacement within 6 months of operation" to 93.5% for "Bleomycin, etoposide, and cisplatin for germ cell tumor more than Stage II." Of 580 hospitals, 184 submitted the reasons for nonadherence. CONCLUSIONS: The quality of ovarian cancer care should be continuously assessed to encourage the use of best practices. These indicators may be a useful tool for this purpose.

Literature Review of Studies Using the National Database of the Health Insurance Claims of Japan (NDB): Limitations and Strategies in Using the NDB for Research.

The use of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) for research has increased over time. Researchers need to understand the characteristics of the data to generate quality-assured evidence from the NDB. In this review, we mapped and characterized the limitations and related strategies using the NDB for research based on the descriptions of published NDB studies. To find studies that used Japanese healthcare claims data, we searched MEDLINE, EMBASE, and Ichushi-Web up to June 2023. Additionally, we hand-searched the NDB data publication list from the Ministry of Health, Labour and Welfare (2017-2023). We abstracted data based on the NDB data type, research themes, age of the study sample or population, targeted disease, and the limitations and strategies in the NDB studies. Ultimately, 267 studies were included. Overall, the most common research theme was describing and estimating the prescriptions and treatment patterns (125 studies, 46.8%). There was a variation in the frequency of themes according to the type of NDB data. We identified the following categories of limitations: (1) lack of information on confounders/covariates, outcomes, and other clinical content, (2) limitations regarding patients not included in the NDB, (3) misclassification of data, (4) lack of unique identifiers and register of beneficiaries, and (5) others. Although the included studies noted several limitations of using the NDB for research, they also provided some strategies to address them. Organizing the limitations of NDB in research and the related strategies across research fields can help support high-quality NDB studies.