Antithyroid drug-induced leukopenia and G-CSF administration: a long-term cohort study.

Although antithyroid drug (ATD)-induced agranulocytosis is a significant concern, its risks associated with long-term use and re-administration are not fully elucidated. Therefore, we performed this study to determine the incidence of ATD-induced leukopenia and G-CSF administration using administrative claims database. Retrospective cohort study. This study was performed using the DeSC Japanese administrative claims database. A total of 12,491 patients with newly diagnosed Graves' disease (GD) who received methimazole or propylthiouracil between April 2014, and February 2021 among 3.44 million patients in the database were included in the study. We measured the six-year incidence of leukopenia and granulocyte colony-stimulating factor (G-CSF) administration. The incidence of leukopenia and G-CSF administration was 1.34% (168 patients) and 0.30% (38 patients), respectively. Leukopenia had a dose-dependent and biphasic incidence. The incidence of leukopenia and G-CSF administration was 37.2 (0.7%) and 8.0 (0.2%) per 1000 person-years during the first 72 days of ATD initiation, whereas it was 3.1 and 0.7 per 1000 person-years during the subsequent 6 years, respectively. The incidence of both outcomes was comparable between first administration and re-administration of ATD. The incidence of ATD-induced leukopenia and G-CSF administration was high in the first 72 days, with a reduced risk for at least 6 years thereafter. The incidence was similar between first administration and re-administration. ATD, a standard therapy, is often administered for a long period; therefore, our findings can guide the treatment of GD.

Development of a self-efficacy questionnaire, 'Insulin Therapy Self-efficacy Scale (ITSS)', for insulin users in Japanese: The Self-Efficacy-Q study.

AIMS/INTRODUCTION: Although patient self-efficacy is known to affect adherence to therapy, no available tool measures self-efficacy of insulin therapy administration while addressing the entire therapeutic process and management. In light of this, we developed the 'Insulin Therapy Self-efficacy Scale (ITSS).' MATERIALS AND METHODS: Development of the ITSS involved three phases: (i) item generation and creation of a questionnaire draft; (ii) testing and correcting the items through interviews with patients; and (iii) a multicenter, single-arm study to validate the questionnaire. RESULTS: A factor analysis and Cronbach's α both confirmed good internal consistency in the patients' confidence regarding the following four factors: the insulin injection procedure, insulin titration, glycemic control and ability to cope with hypoglycemia. Reproducibility was confirmed using weighted κ statistics and intraclass correlations. Good concurrent validity was confirmed with two other questionnaires. The ITSS score was also found to correlate with several patient characteristics and clinical parameters, as well as with a better adherence to injected insulin therapy 6 months later, suggesting the predictive validity of this scale. CONCLUSIONS: The ITSS is a reliable and valid tool for assessing and quantifying patients' self-efficacy. The ITSS estimation of self-efficacy can predict a patient's glycemic control and future adherence to insulin therapy. These characteristics will ensure the usefulness of the ITSS in ensuring a successful therapeutic process for patients and physicians.

Correction to: Reproducibility and Validity of a Questionnaire Measuring Treatment Burden on Patients with Type 2 Diabetes: Diabetic Treatment Burden Questionnaire (DTBQ).

In the original publication, second author's name was incorrectly published as Hiroki Shin. The correct name should read as 'Koki Shin'.

Reproducibility and Validity of a Questionnaire Measuring Treatment Burden on Patients with Type 2 Diabetes: Diabetic Treatment Burden Questionnaire (DTBQ).

INTRODUCTION: To measure the burden of pharmacotherapy on patients with type 2 diabetes mellitus (T2DM), we developed the Diabetes Treatment Burden Questionnaire (DTBQ), a patient-administered questionnaire composed of 18 questions, and evaluated its reproducibility and validity. METHODS: We enrolled 240 patients with T2DM under pharmacotherapy over 20 years of age at seven institutes in Japan. Their physicians filled out report forms on patient backgrounds, and the patients answered both the DTBQ and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). For evaluation of reproducibility, 48 of the enrolled subjects completed a 2nd DTBQ at home after leaving the medical institutes. RESULTS: Statistical analyses were performed for two sets of subjects, the validity analysis set (N = 236) and the reproducibility analysis set (N = 47). Factor analysis found a simple structure in the DTBQ item scores using a three-factor model with varimax rotation; the three subscales were designated as "implementation burden", "flexibility burden", and "blood glucose control burden". All intraclass correlation coefficients for the subscale scores were 0.8 or higher, indicating high reproducibility. Negative correlations were observed between the DTSQ satisfaction score and the DTBQ subscale scores. Moreover, as the dosing frequency of diabetic medicines increased, the DTBQ total score (total burden score) also became higher. Likewise, expected associations were observed between patient backgrounds and DTSQ scores. CONCLUSION: The DTBQ has adequate reproducibility and validity as a measurement scale for treatment burden on T2DM patients. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN) 000026382. FUNDING: Eli Lilly Japan.

Anthropometric obesity indices and metabolic syndrome in Japanese working men.

BACKGROUND: Although the prevalence of obesity in the Japanese adult population is lower than that in the US adult population, there appears to be a trend towards increase in the prevalence of obesity in Japanese men. In this study, the usefulness of waist circumference (WC) and body mass index (BMI) determination as predictors of metabolic syndrome (MetS) was evaluated in Japanese working men. METHODS: A cross-sectional study was conducted in the spring of 2007. The sample included 3,486 working men aged 35 to 59 years. The standard criteria of the International Diabetes Federation were used to determine the prevalence of MetS. The results were adjusted for age, smoking, habitual drinking and serum uric acid. To calculate the OR, MetS was tentatively defined as the presence of two or more of the following criteria in the subjects: high blood pressure, glucose intolerance, and dyslipidemia. RESULTS: The prevalence of MetS was 17.0%, and it increased with age until the mid-50s. The percentages of subjects with high blood pressure, glucose intolerance, dyslipidemia and hyperuricemia were 57.3, 12.7, 29.4 and 21.3%, respectively. As compared to that in the subjects classified in the lowest WC quintile, the ORs (95% confidence interval (CI)) for MetS of a WC in the range of 76.0 to 81.4, 81.5 to 85.9, 86.0 to 90.9, and >or= 91 cm were 1.66 (1.13-2.45), 1.74 (1.13-2.67), 2.37 (1.50-3.74), and 2.84(1.73-4.64), respectively. In contrast, the OR (95% CI) for MetS of a BMI in the range of 24.5 to 26.5 and >or= 26.6 Kg/m2 were 2.43 (1.58-3.73) and 3.27 (2.04-5.27), which just about reached the significance level. CONCLUSIONS: The risk of MetS was correlated with the obesity indices. However, BMI values in the high normal range were not significantly associated with the risk of MetS.