Relationship of Ethinylestradiol/Drospirenone Prescription on Work Productivity and Activity Impairment Among Women With Menstruation-Related Symptoms: A Multicenter Prospective Observational Study.

OBJECTIVE: The aim of the study is to examine changes in work productivity and daily activity impairment among women by starting ethinylestradiol (EE)/drospirenone (DRSP) for perimenstrual symptoms. METHODS: Participants were women who were newly prescribed EE/DRSP at 25 gynecological clinics in Japan. Eligible participants recorded daily intake of EE/DRSP and the Work Productivity Activity Impairment Questionnaire General Health every 2 weeks for 3 months by smartphone app. A linear mixed-effects model was used to see changes in work productivity impairment and activity impairment relative to baseline. RESULTS: A total of 222 participants were eligible. Work productivity impairment recovered by 20.0% (95% confidence interval, 14.1%-26.0%) at 1 m and maintained for 2 months. Activity impairment recovered by 20.1% (95% confidence interval, 15.5%-24.7%) at 1 m and thereafter. CONCLUSIONS: Improvements in work productivity and daily activities were observed at 1 m after EE/DRSP initiation, with a sustained effect thereafter.

Association between non-anemic iron deficiency in early pregnancy and perinatal mental health: A retrospective pilot study.

AIM: Postpartum anemia and iron deficiency are reportedly involved in postpartum depression, but the association between perinatal depression and iron deficiency with or without anemia is poorly documented. This pilot study retrospectively investigated the relationship between non-anemic iron deficiency (NAID) in early pregnancy and perinatal depressive symptoms. METHODS: This study included 31 non-anemic women among patients who received perinatal care with preserved residual serum from routine antenatal checkups in Kyoto University Hospital. All participants gave informed consent for research. The ferritin concentration in their preserved serum was measured. The hemoglobin (Hb) and ferritin in early pregnancy, as well as the Edinburgh Postpartum Depression Scale (EPDS) at mid-pregnancy and 1 month after childbirth were analyzed. Iron deficiency was defined as a serum ferritin concentration < 30 ng/mL. RESULTS: Based on the ferritin level in early pregnancy, 13 women (41.9%) had NAID, whereas 18 were normal. The mean Hb and ferritin were 12.7 ± 0.6 g/dL and 18.5 ± 5.8 ng/mL in the NAID group and 12.8 ± 0.9 g/dL and 74.7 ± 39.2 ng/mL in the normal group, respectively. The median EPDS scores at mid-pregnancy and 1 month postpartum, respectively, were 2.0 (2.0-3.3) and 5.0 (4.0-6.6) in the NAID group and 4.5 (2.3-7.3) and 4.5 (2.3-5.7) in the normal group. EPDS scores increased significantly from mid-pregnancy to 1 month postpartum in the NAID group only. CONCLUSION: NAID in early pregnancy was highly prevalent and was suggested to reduce resilience to depression during the perinatal period.

Predictive accuracy of the shock index for severe postpartum hemorrhage in high-income countries: A systematic review and meta-analysis.

AIM: The shock index has been suggested as a screening tool for predicting postpartum hemorrhage (PPH); however, there is little comprehensive evidence regarding its predictive accuracy. This systematic review and meta-analysis aim to investigate the predictive accuracy of the shock index for severe PPH in high-income countries. METHODS: A comprehensive search was conducted on MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science (from inception to June 2021). Studies assessing the predictive performance of the shock index for PPH in high-income countries were included. Two or more reviewers independently extracted the data and assessed the risk of bias and applicability concerns using the modified Quality Assessment of Diagnostic Accuracy Studies 2 tool. PPH requiring higher-level care, such as blood transfusions, were considered as primary analyses. We described the hierarchical summary receiver-operating characteristic curve for data synthesis. RESULTS: Nine studies were included after the eligibility assessment. All studies were considered to either have a high risk of bias or high applicability concerns. The sensitivity of the four studies that defined severe PPH as PPH requiring blood transfusion ranged from 0.51 to 0.80, whereas their specificity ranged from 0.33 to 0.92. CONCLUSIONS: This review shows that the predictive performance of the shock index for severe PPH is inconsistent. Therefore, the evidence for using the shock index alone as a screening tool for PPH in high-income countries is insufficient. STUDY REGISTRATION: This review was prospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000044230).

[Preparation, Confidence, and Attitude to Sell Emergency Contraceptive Pills at Pharmacies: A Web Survey of Japanese Community Pharmacists].

Emergency contraceptive (EC) pills are used to prevent pregnancy after unprotected sexual intercourse. Levonorgestrel is an EC pill, which has been only approved in Japan; it is more effective the sooner it is used after intercourse and safe without serious side effects. EC pills are already available at accessible community pharmacies in more than 90 countries around the world. In Japan, citizens have signed a petition calling for the sale of emergency contraceptives at community pharmacies. However, little is known about the thoughts of pharmacists who engage with patients and sell medicines at pharmacies. Therefore, we conducted a web-based cross-sectional survey to determine the level of preparation in community pharmacies and the awareness of pharmacists regarding the sale of EC pills. A total of 1338 pharmacists responded to the survey from November 7, 2020, to December 16, 2020. In terms of the level of preparation for selling EC pills at pharmacies, 1067 (83.9%) respondents cited "lack of preparation of medical questionnaires and explanatory materials", and 975 (76.7%) respondents cited "lack of knowledge of pharmacists" as the most common reasons that were "barriers to EC pill sales at pharmacies". In terms of confidence level, only 289 (22.7%) respondents were confident about conducting the necessary checks while administering medicine. On the other hand, 944 (74.3%) respondents agreed to be able to sell EC pills at their pharmacies. The survey revealed that most of the pharmacists who participated in the survey believe that it is possible to sell EC pills in pharmacies.

The reliability and validity of the Japanese version of the Daily Record of Severity of Problems (J-DRSP) and Development of a Short-Form version (J-DRSP (SF)) to assess symptoms of premenstrual syndrome among Japanese women.

PURPOSE: To assess the validity and reliability of the Japanese version of the Daily Record of Severity of Problems (J-DRSP, 24 items) for evaluating symptoms of premenstrual syndrome (PMS), and to develop a short form version of the J-DRSP. METHODS: Using the "DRSP-JAPAN" smartphone app, we collected daily J-DRSP records from cycle day - 6 (CD - 6) to CD 10, with CD 1 representing the menstruation onset date. Factorial validity (exploratory factor analysis: EFA, confirmatory factor analysis: CFA) and criterion validity were examined, and test-retest reliability (intraclass correlation: ICC) evaluated. The short-form version of the J-DRSP was developed using classical test theory. RESULTS: In total, 304 women participated and 243 recorded symptoms on at least 4 days spanning the week of the luteal phase (CD - 6 to CD 0) and 4 days spanning the week of the follicular phase (CD 4 to CD 10), with CD 0 set as the day before menstruation started. The EFA revealed a two-factor structure. Kaiser-Meyer-Olkin was 0.992, and Bartlett's test of sphericity chi-square was 3653.89 (P < 0.001). However, the model fitness of CFA was found to be suboptimal (comparative fit index (CFI): 0.83, root mean square error of approximation (RMSEA): 0.12). Total scores for J-DRSP and the sum scores for each subscale were higher on CD 0 than on CD 10 (p < 0.001), suggesting validity for some criteria. ICC values for the total J-DRSP score from CD 0 to CD - 1, and between CD 9 to CD 10, were 0.60 (95% CI: 0.48-0.72) and 0.76 (95% CI: 0.69-0.82), respectively. Having eliminated some original items after considering factor loading for each item, we developed an 8-item Short-Form J-DRSP (J-DRSP (SF)) comprising 2 factors (S-Psychological and S-Physical, 4 items for each). CFA showed a better model fit (CFI: 0.99, RMSEA: 0.048), and ICC values in the luteal and follicular phases were 0.61 (95%CI: 0.51-0.68) and 0.70 (95%CI: 0.62-0.77), respectively. CONCLUSION: The J-DRSP has moderate to good reliability and a certain level of validity. The 8-item J-DRSP (SF) has a two-factor structure and can be used effectively among Japanese women to assess their PMS symptoms.

Development of a Japanese Version of the Daily Record of Severity of Problems for Diagnosing Premenstrual Syndrome.

Background: Premenstrual syndrome (PMS) causes physical and mental symptoms in women during the luteal phase of the menstruation cycle. To confirm the relationship between symptoms and the menstruation cycle, daily symptom records are essential for diagnosing PMS. The daily record of severity of problems (DRSP) is currently the most validated tool for tracking symptoms to confirm and scale the severity of PMS, but there has been no validated Japanese version of this instrument. We developed a Japanese version of the DRSP and assessed its psychometric properties. Methods: A Japanese version of the DRSP was developed following the translation guidelines of the latest Patient-Reported Outcomes Consortium. We conducted a computational psychometric study among 119 women, all of whom completed the Japanese version of the DRSP, the Center for Epidemiologic Studies Depression Scale (CES-D), the Premenstrual Dysphoric Disorder (PMDD) scale, and a Numerical Rating Scale (NRS) for general health status. Each was filled out twice, 2 weeks apart, so that one set was completed in the luteal phase. Results: The Japanese version of the DRSP was developed with translation and cultural adaptation. The internal consistency coefficient for the total score was 0.93. The DRSP in the luteal phase correlated highly with the CES-D, PMDD scale, and NRS for general health status. Conclusions: Our Japanese version of the DRSP, developed as a PMS/PMDD diagnostic tool, was shown to provide substantial validity and reliability to rate premenstrual symptoms for Japanese women.

Isoechoic axillary lymph node metastases of mucinous carcinoma of the breast: a case report.

We report a case of isoechoic axillary lymph node metastasis of mucinous carcinoma (so-called pure mucinous carcinoma) of the breast. A 47-year-old premenopausal woman was referred to our hospital with a 2 years history of mass and distortion of her left breast and with recent worsening of her symptoms. Ultrasonography demonstrated a well-circumscribed mass, about 5 cm in diameter, which was isoechoic compared to the surrounding fat tissue. Distal enhancement was also recognized. A left axillary ultrasonographic scan demonstrated four nodules, which were indistinct because of their isoechogenicity compared to the surrounding tissue. Based on a preoperative diagnosis of mucinous carcinoma of the left breast with left axillary lymph nodes metastases, left mastectomy and left axillary nodal dissection were performed. Mucinous carcinoma with axillary lymph node metastases was diagnosed histologically. The lymph node metastases showed histological findings identical to those of the primary tumor, which was considered to be the reason for their isoechogenicity. Although lymph node metastasis of mucinous carcinoma of the breast is rare, ultrasonographers should perform careful scanning when the primary breast mass is suspicious for mucinous carcinoma, because lymph node metastases of mucinous carcinoma can be more indistinct and difficult to detect than those of other types of breast cancer.