Search

Introduction: Considering Japan's aging society, the number of older individuals who die at home is expected to increase. In Japan, there are challenges in utilizing and promoting home‐visit nursing services at the end of life for community‐dwelling older adults. We examined the use of home‐visit nursing services at the end of patients' lives and the recommended use patterns of this service (utilization, timing of initiation, and continuity) that contribute to reducing the medical care and long‐term care costs (total costs) in the last 3 months of life. Design: This was a retrospective cohort study. Methods: We examined 33 municipalities in Japan, including depopulated areas. The analysis included 22,927 people aged 75 or older who died between September 2016 and September 2018. We used monthly medical care and long‐term care insurance claims data. Participants were classified into five groups based on their history of home‐visit nursing service use: (1) early initiation/continuous use, (2) early initiation/discontinued or fragment use, (3) not‐early initiation/continuous use, (4) not‐early initiation/fragment use, and (5) no use. Univariate and multivariate linear regression analyses were performed to examine the association between total costs in the last 3 months of life and patterns of home‐visit nursing service use. Results: Overall, the median age was 85, and 12,217 participants were men (53.3%). In the last half year before death, 5424 (23.7%) older adults used home‐visit nursing services. Multivariable linear regression analysis of the log10‐transformed value of total costs revealed that compared with the no use group, the early initiation/continuous use group was estimated to have 0.88 times (95% confidence interval: 0.84, 0.93) the total costs in the last 3 months of life (p < 0.001). Conclusion: Early initiation use of home‐visit nursing services may contribute to reducing total costs in the last 3 months of life for Japanese people aged 75 years or older living at home as they approach the end of life. Clinical relevance: When approaching the end of life, many older adults require daily life care and palliative care. Policymakers are strengthening end‐of‐life care for community‐dwelling older adults in Japan. Although the current results do not demonstrate the effectiveness of home‐visit nursing services, they provide a perspective from which to assess the use of home‐visit nursing services and its impact on older adults. The findings can be helpful in considering how to provide nursing care in home‐care settings for older adults who prefer to spend their final days at home. [ABSTRACT FROM AUTHOR]

Aim: To determine the predictors of physical function (PF) decline among nursing home residents using items from the Long‐term care Information system For Evidence (LIFE), a system launched in 2021 to ensure the quality of long‐term care. Methods: The LIFE data of 1648 residents from 45 nursing homes in Japan were retrospectively collected in July 2021 (T0) and January 2022 (T1), including demographics, PF assessed by the Barthel index (BI), nutrition and oral health, and cognitive function. The Dementia Behavior Disturbance scale was used to assess the frequency of certain behaviors, such as "waking at midnight." The predictors of PF decline, defined as a decrease ≥5 in the BI score at T1 compared with that at T0, were determined using mixed‐effects logistic regression analyses. PF at T0 was classified into high (>60 BI) and low (≤60 BI) groups. Results: The participants' mean age was 87.2 ± 7.1 years, and 45.3% experienced PF decline. The significant predictors of PF decline were age ≥ 90 years, body mass index <18.5 kg/m2, dementia diagnosis, moderate and severe cognitive impairments, not vocalizing reciprocal exchanges at will, always "waking at midnight," and high PF at T0. Conclusions: The LIFE items predicted PF decline among nursing home residents, suggesting that LIFE data can be used to ensure the quality of long‐term care. Geriatr Gerontol Int 2024; 24: 123–132. [ABSTRACT FROM AUTHOR]

Background: Living alone without someone to cook meals for them can happen more frequently in aging due to bereavement, divorce, or other family changes. Health risks to older adults due to poor cooking skills may be more pronounced among those living alone. We aimed to examine whether cooking skills are associated with mortality according to cohabitation status in older Japanese people. Methods: Participants in the Japan Gerontological Evaluation Study, a population-based cohort of independent older adults, were followed for three years (n = 10,647). Cooking skill was assessed using a scale with good validity and modified for Japanese people in the baseline survey. After stratification by living alone or together, participants with high and low cooking skills were matched on demographic, socioeconomic, health-related factors, and availability of food stores using propensity score matching. All-cause mortality risks were compared between high and low cooking skills using Cox regression models. Results: During the follow-up, 520 of the 10,647 participants died. One hundred and seventy-one pairs of high and low cooking skills were matched among those living alone, and 2,161 pairs among those living with others were matched as well. The hazard ratio of the low level of cooking skills (vs. high) was 2.50 (95% confidence interval [CI]: 1.10–5.68) among those living alone, while 1.05 (95% CI: 0.82–1.33) among those living with others. Conclusion: Lower cooking skills were associated with a higher risk of mortality only among those living alone. Cooking skills may be important for older adults who live alone to reduce mortality risk. [ABSTRACT FROM AUTHOR]

Background: Little is known regarding the association between adverse events (AEs) and psychiatric medications administered to pregnant women in clinical trials during the pre-marketing period. This study analyzes reports of AE association with psychiatric medication administrated during pregnancy using post-marketing spontaneous reports of AE from the Japanese Adverse Drug Event Report (JADER) database and Food and Drug Administration Adverse Event Reporting System in the United States (FAERS-US). Methods: We summarized AE reports of psychiatric medication administrated during pregnancy by comparing data obtained from JADER and FAERS-US databases with medication patterns determined as classes via latent class analysis. The odds ratios (ORs) of AE reports categorized into system organ classes in which each class was compared with those without psychiatric medications. Results: The proportions of AE reports under psychiatric medication in pregnancy among all AE reports were 22.0% and 16.6% in JADER and FAERS-US, respectively. The 10,389 reports of psychiatric medication during pregnancy were classified into 11 classes. The proportion of patients receiving four or more psychiatric drugs in JADER was larger than that in FAERS-US. The maximum number of reports in combinations of AE and medication pattern in JADER was 169, for 'general disorders and administration site conditions' from the class of four or more medications (OR = 9.1), while that in FAERS-US was 1,654, for 'injury, poisoning, and procedural complications' from the class of single psychiatric medication (OR = 2.8). Conclusions: The main AE reports and associated AE differed depending on medication patterns in pregnant women taking psychiatric medication. This study may provide a prediction of AEs that are likely to be reported with each medication pattern. Our findings of the association between AE reports and medication patterns could help improve the administration of psychiatric medications during pregnancy, though further research on additional datasets is needed to clarify these results. [ABSTRACT FROM AUTHOR]

Introduction: The superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD.Methods: A protocol is developed for the VESUTO® study that investigates the efficacy of tiotropium/olodaterol fixed-dose combination (FDC) compared with tiotropium alone on inspiratory capacity (IC, volume from functional residual capacity to total lung capacity), exercise capacity, and daily physical activity in Japanese patients with COPD.Results: A total of 180 Japanese patients with COPD, aged ≥40 years will be enrolled into the double-blind, multicenter, active-controlled, crossover study (NCT02629965) and will be randomized to receive either tiotropium/olodaterol FDC or tiotropium for 6 weeks each [two puffs via RESPIMAT® (Boehringer Ingelheim, Ingelheim, Germany) inhaler in the morning]. The primary endpoint is IC at rest measured at 60 min post-dose after 6 weeks treatment. The secondary endpoints include the 6-min walk distance (6MWD) at 90 min post-dose and physical activity measured by the activity monitor in the last 2 weeks of the 6-week treatment periods. Lung function tests will also be assessed after 6 weeks treatment. A mixed-effects model repeated measures approach will be used for the primary and secondary endpoints.Conclusion: The VESUTO® study is the first randomized interventional study to investigate exercise capacity (6MWD) and physical activity measured by a 3-axis accelerometer in Japanese patients with COPD. The study could provide additional evidence of long-acting muscarinic antagonist (LAMA) + long-acting β2-agonist (LABA) combination therapy on patients' physical activities as well as lung function.Trial Registration: ClinicalTrials.gov: NCT02629965 (registered on December 1, 2015).Funding: The VESUTO study was funded by Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan. [ABSTRACT FROM AUTHOR]

• A dynamic change in suicides and human mobility were observed in the COVID-19 pandemic in Japan. • The number of suicides did not increase when human mobility decreased. • Suicide was statistically higher in the months with increased mobility compared with stable. • The burden from restricting mobility, might not lead to an increase in suicide immediately. • Intervention in burden may be important when pandemic restrictions are relaxed. During the COVID-19 pandemic in Japan, various measures have been implemented to prevent the spread of infection, including restrictions on human mobility. A dynamic fluctuation in the number of suicides has been observed during this period. The question is whether the increase/decrease in suicides during the pandemic is related to changes in human mobility. To answer the same, we estimated incidence rate ratios (IRR) of suicide for changes in human mobility using the relative number of suicides by month from March 2020 to September 2021, based on the same months in 2019 as reference. The IRR of suicide during the pandemic were significantly lower in the months when mobility decreased—in both the previous and current month—than in the months when mobility was stable; the IRR of suicide were statistically higher in the months with increased mobility compared with the stable months. The burden from a decrease in one's mobility, which might lead to an increase in suicide, may not occur immediately, as seen in the delayed effects of unemployment. It may be important to investigate people's mental health and stress levels after pandemic restrictions were relaxed. The findings may help practitioners and families consider the timing of intervention. [ABSTRACT FROM AUTHOR]

• The number of LTCF residents transferred to hospitals is increasing worldwide. • An AD for not hospitalizing decreased hospital transfers. • Discussions and documentation are necessary to provide care in line with resident's preferences. With the rapidly aging population, the number of residents transferred to hospitals from long-term care facilities (LTCFs) is increasing globally. The objective of this study was to investigate the association between family involvement and an advance directive (AD) for not hospitalizing and hospital transfers among LTCF residents with dementia. Using the InterRAI assessment database from September 2014 to June 2019, we included 874 residents from 16 LTCFs in Japan. Of the 874 participants, 19.0% had an AD for not hospitalizing, and 20.5% were transferred to hospitals. An AD for not hospitalizing decreased the likelihood of hospital transfers (p = 0.005). Multilevel logistic regression analysis showed that family involvement was not associated with hospital transfers (odds ratio [OR]: 1.18; 95% confidence interval [CI]: 0.77–1.80), while an AD for not hospitalizing was significantly associated with decreased hospital transfers (OR: 0.50; 95% CI: 0.28–0.89) among the LTCF residents. Although ADs are not legally defined in Japan, we found that an AD for not hospitalizing decreased hospital transfers. Given that many older people tend to hesitate to express their wishes in clinical decision-making situations in Japan, regular discussions are necessary to help them express their care preferences while also documenting the discussions to ensure the residents receive high-quality care. [ABSTRACT FROM AUTHOR]

In 2021, the Japanese government began operating a long-term care (LTC) database called the Long-Term Care Information System for Evidence (LIFE). However, its utility has not been verified. Regarding unplanned hospital visits of nursing home residents, one of the challenges in LTC is that poor oral health with undernutrition could indicate high-risk residents. Therefore, this study examined the association between poor oral health with undernutrition assessed using the LIFE data and unplanned hospital visits of nursing home residents. Retrospective cohort study. The participants were 237 residents aged ≥65 years in 4 nursing homes in Japan. The analyses included 1041 LIFE data entries repeatedly measured for the participants every month and unplanned hospital visit data during the observation period. The participants' LIFE and unplanned hospital visit data were obtained from the nursing home providers. Poor oral health was defined using oral items included in the LIFE data and body mass index. Using the LIFE data, the association between poor oral health and unplanned hospital visits within 1 month after LIFE assessment entries was analyzed. The odds ratios (ORs) and 95% CIs were calculated using a generalized linear mixed model. In total, 59 of 1041 LIFE data (5.7%) entries were unplanned hospital visits within 1 month after LIFE assessment. Among patient characteristics, significant differences were noted in dementia diagnosis [OR (95% CI): 2.66 (1.26-5.63)], although no significant differences were observed in other characteristics. Multivariate analysis using participant identification as a random effect confirmed that poor oral health was associated with unplanned hospital visits within 1 month [adjusted OR (95% CI): 2.63 (1.05-6.61)]. Poor oral health assessed using the LIFE data could be used as an indicator to identify nursing home residents at high risk for unplanned hospital visits. [ABSTRACT FROM AUTHOR]

Given the paucity of safety data on fluoroquinolone antibiotics in pregnancy, a prospective observational cohort study was conducted in pregnant women who sought help and advice on drug use at two teratology information institutes in Japan. The primary endpoint of the study was the incidence of major congenital anomalies. The study population included pregnant women exposed to (i) fluoroquinolones (fluoroquinolone group), (ii) β-lactams (infectious control group), or (iii) other agents considered to be nonteratogenic in humans (nonteratogenic control group) during the first trimester. The frequency of major congenital anomalies was compared across groups using a logistic regression model that adjusted for maternal age, smoking status, drinking status, facility consulted, and time of consultation. The fluoroquinolone group consisted of 411 women who had 383 children born alive. The infectious control and nonteratogenic control groups consisted of 1416 and 1482 women who had 1322 and 1401 children born alive, respectively. The incidence of major congenital anomalies was 1.5%, 2.0%, and 1.6% in the fluoroquinolone group, infectious control, and nonteratogenic control groups, respectively. Logistic regression showed that fluoroquinolone exposure is not a significant risk factor for major congenital anomalies. In conclusion, first-trimester exposure to fluoroquinolone antibiotics was not associated with increased maternal or fetal risks., (© 2024 The Author(s). Congenital Anomalies published by John Wiley & Sons Australia, Ltd on behalf of Japanese Teratology Society.)

Short stature in children is a marker of low nutritional status and has been suggested to be associated with dental caries. However, longitudinal studies on this topic are scarce. Data from a longitudinal study of elementary school children in Adachi City, Tokyo, Japan, were analyzed. In 2015, caregivers of children at grade 1 answered questionnaires, and information on dental caries and height measured at school health checkups was merged and followed to grade 6 (N = 3576; follow up rate = 83.3%). The association between short stature at grade 1 (-2.01 standard deviation (SD)--3.00 SD, or <-3.00 SD in height-for-age according to the World Health Organization criteria) and the number of decayed, missing, or filled permanent teeth (DMFT) at grade 6 was examined using multivariable Poisson regression with robust standard error. After adjusting for confounders, children with a short stature at grade 1 had a higher DMFT number at grade 6: the mean ratios (95% confidence interval) were 1.17 (0.89-1.54) and 2.18 (1.03-4.64) for children with a height-for-age -2.01 SD--3.00 SD, and those with a height-for-age < -3.00, respectively. Short stature at grade 1 could be a marker of future dental caries in the permanent teeth at grade 6., Competing Interests: The authors declare no conflicts of interest.

Although the economic burden of multimorbidity is a growing global challenge, the contribution of multimorbidity in patients with high medical expenses remains unclear. We aimed to clarify multimorbidity patterns that have a large impact on medical costs in the Japanese population. We conducted a cross-sectional study using health insurance claims data provided by the Japan Health Insurance Association. Latent class analysis (LCA) was used to identify multimorbidity patterns in 1,698,902 patients who had the top 10% of total medical costs in 2015. The present parameters of the LCA model included 68 disease labels that were frequent among this population. Moreover, subgroup analysis was performed using a generalized linear model (GLM) to assess the factors influencing annual medical cost and 5-year mortality. As a result of obtaining 30 latent classes, the kidney disease class required the most expensive cost per capita, while the highest portion (28.6%) of the total medical cost was spent on metabolic syndrome (MetS) classes, which were characterized by hypertension, dyslipidemia, and type 2 diabetes. GLM applied to patients with MetS classes showed that cardiovascular diseases or complex conditions, including malignancies, were powerful determinants of medical cost and mortality. MetS was classified into 7 classes based on real-world data and accounts for a large portion of the total medical costs. MetS classes with cardiovascular diseases or complex conditions, including malignancies, have a significant impact on medical costs and mortality., Competing Interests: Fuminori Katsukawa received funding from the Japan Health Insurance Association. Yuki Nishida was paid from funding from the Japan Health Insurance Association for 1 year from April 2021 to March 2022. The other authors declare no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Nishida et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Three epidemiological small-scale studies on hypersensitivity pneumonitis (HP) have been performed in Japan to date. Herein, we aimed to clarify the clinical characteristics of various types of HP diseases using a large nationwide database in Japan., Methods: We used the Japanese Diagnostic Procedure Combination database that includes data from 1,031 participant hospitals. Patients with HP from 2011 to 2017 were identified using International Classification of Diseases 10th Revision codes. We analyzed patient characteristics, the yearly transition of the number of HP cases, rate per one million hospitalizations, geographical distribution, seasonality, and risk factors for in-hospital mortality., Results: In total, 3,634 patients with HP were identified, including summer-type HP (SHP) (n = 490), bird fancier's lung (BFL) (n = 199), ventilation pneumonitis (n = 106), farmer's lung (n = 48), and unspecified HP (n = 2761). The length of hospital stay was significantly longer in patients with BFL (19 days) than in patients with SHP (15 days). SHP was more prevalent in the southwestern region of Japan, and hospitalization occurred mainly in summer (37.8%) and fall (37.3%). Ventilation pneumonitis was predominant in winter (28.6%) and spring (38.7%). In-hospital mortality was significantly associated with old age (p < 0.001), low body mass index (p = 0.016), severe dyspnea (p < 0.001), and BFL diagnosis on admission (p = 0.031)., Conclusions: This study revealed the clinical characteristics of SHP and BFL, including the frequency of causative antigens, geographical distribution, seasonality, and risk factors for mortality, which may help in diagnosing HP and identifying causative antigens., Competing Interests: Conflict of Interest This study has received a Grant-in-Aid for Research on Policy Planning and Evaluation from the Ministry of Health, Labour and Welfare, Japan (20AA2005). Tsukasa Okamoto has received grants from Konica Minolta, Boehringer Ingelheim, Chugai, Kuramochi Clinic and Wako Filter Technology. Yasunari Miyazaki has received grants, consulting fees and payment for lectures and expert testimony from Thermo Fisher Scientific Inc. Shohei Yamashita, Tatsuo Kawahara, Tomoya Tateishi, Tatsuhiko Anzai, Kunihiko Takahashi and Kiyohide Fushimi have no conflict of interest to declare., (Copyright © 2023 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.)

Background: Japan has witnessed an unusual increase in the number of suicides among women during the coronavirus disease 2019 pandemic. An analysis is required to identify the influencing factors during the pandemic and develop new measures for preventing suicides., Methods: Data on the number of monthly suicides were collected from the National Police Agency of Japan. The expected number of suicides among women during the pandemic was estimated using a time-series model based on pre-pandemic data, considering year-to-year trends. The observed-to-expected (O/E) ratio of suicides was estimated from March 2020 to October 2021 using job status, suicide motive, and age., Results: The number of suicides among women in Japan increased beyond the expected number until October 2021. The O/E ratio based on job status, suicide motive, and age (except self-employed, unknown job status, and women aged ≥80 years) was significantly above 1.0 from March-December 2020, and the increase in suicides continued in almost all categories in 2021., Conclusion: Although several reasons were reported for increased suicides among women in Japan during the pandemic (eg, economic downturn, financial instability, and loneliness), suicides increased irrespective of job status, suicide motive, or age. Comprehensive measures to prevent suicide might have been important during the pandemic, instead of limiting interventions to the reported specific population.

Identifying the host genetic factors underlying severe COVID-19 is an emerging challenge 1-5 . Here we conducted a genome-wide association study (GWAS) involving 2,393 cases of COVID-19 in a cohort of Japanese individuals collected during the initial waves of the pandemic, with 3,289 unaffected controls. We identified a variant on chromosome 5 at 5q35 (rs60200309-A), close to the dedicator of cytokinesis 2 gene (DOCK2), which was associated with severe COVID-19 in patients less than 65 years of age. This risk allele was prevalent in East Asian individuals but rare in Europeans, highlighting the value of genome-wide association studies in non-European populations. RNA-sequencing analysis of 473 bulk peripheral blood samples identified decreased expression of DOCK2 associated with the risk allele in these younger patients. DOCK2 expression was suppressed in patients with severe cases of COVID-19. Single-cell RNA-sequencing analysis (n = 61 individuals) identified cell-type-specific downregulation of DOCK2 and a COVID-19-specific decreasing effect of the risk allele on DOCK2 expression in non-classical monocytes. Immunohistochemistry of lung specimens from patients with severe COVID-19 pneumonia showed suppressed DOCK2 expression. Moreover, inhibition of DOCK2 function with CPYPP increased the severity of pneumonia in a Syrian hamster model of SARS-CoV-2 infection, characterized by weight loss, lung oedema, enhanced viral loads, impaired macrophage recruitment and dysregulated type I interferon responses. We conclude that DOCK2 has an important role in the host immune response to SARS-CoV-2 infection and the development of severe COVID-19, and could be further explored as a potential biomarker and/or therapeutic target., (© 2022. The Author(s).)

Coronavirus disease 2019 (COVID-19) is a recently-emerged infectious disease that has caused millions of deaths, where comprehensive understanding of disease mechanisms is still unestablished. In particular, studies of gene expression dynamics and regulation landscape in COVID-19 infected individuals are limited. Here, we report on a thorough analysis of whole blood RNA-seq data from 465 genotyped samples from the Japan COVID-19 Task Force, including 359 severe and 106 non-severe COVID-19 cases. We discover 1169 putative causal expression quantitative trait loci (eQTLs) including 34 possible colocalizations with biobank fine-mapping results of hematopoietic traits in a Japanese population, 1549 putative causal splice QTLs (sQTLs; e.g. two independent sQTLs at TOR1AIP1), as well as biologically interpretable trans-eQTL examples (e.g., REST and STING1), all fine-mapped at single variant resolution. We perform differential gene expression analysis to elucidate 198 genes with increased expression in severe COVID-19 cases and enriched for innate immune-related functions. Finally, we evaluate the limited but non-zero effect of COVID-19 phenotype on eQTL discovery, and highlight the presence of COVID-19 severity-interaction eQTLs (ieQTLs; e.g., CLEC4C and MYBL2). Our study provides a comprehensive catalog of whole blood regulatory variants in Japanese, as well as a reference for transcriptional landscapes in response to COVID-19 infection., (© 2022. The Author(s).)

(1) Background: Near-miss incidents are the foundation of major injuries. They are warning signs that loss is imminent. Long working hours are a risk factor for near-misses along with sleep problems, job-related stress, and depressive symptoms. This study aimed to evaluate the indirect effects of long working hours via mediating variables on near-miss occurrences among Japanese healthcare professionals. (2) Methods: 1490 Japanese healthcare professionals' reports from a web-based survey of workers in October 2018 were analyzed to evaluate total, direct, and indirect effects of long working hours on near-misses. We applied a generalized structural equation model with three mediating variables: sleep problems, job-related stress, and depressive symptoms. (3) Results: The total effect and direct effect of the categories of working hours longer than 41 h per week (h/w) for occurrence of near-misses were not significantly higher than that of 35-40 h/w. However, for indirect effects on occurrence of near-misses that first passed through job-related stress, there were higher reports for each category compared to 35-40 h/w, with odds ratios (OR) and 95% confidence intervals (95% CI) of OR = 1.12, 95% CI (1.07, 1.21) for 41-50 h/w; 1.25, (1.14, 1.41) for 51-60 h/w; and 1.31, (1.18, 1.51) for ≥ 61 h/w. (4) Conclusion: The results suggest that reducing working hours might improve job-related stress, which could reduce near-misses and prevent injuries.

Background: Suicide amidst the coronavirus disease (COVID-19) pandemic is an important issue. In Japan, the number of suicides in April 2020 decreased by nearly 20% from that in 2019. To assess the impact of an infectious disease pandemic, excess mortality is often discussed. Our main purpose was evaluating excess mortality from suicide in Japan during the early pandemic period., Methods: We used data on suicides collected by the National Police Agency of Japan until June 2020. We estimated excess mortality during the early pandemic period (March-June 2020) using a time-series model of the number of suicides before the pandemic. A quasi-Poisson model was employed for the estimation. We evaluated excess mortalities by the categories of age and sex, and by prefecture., Results: No significant excess mortality was observed throughout the early pandemic; instead, a downward trend in the number of suicides for both sexes was noted. For males, negative values of excess mortalities below the lower bound of the 95% prediction interval were observed in April and May. All numbers of females during the period were included in the interval, and the excess mortalities in June were positive and higher than those in April and May. In Tokyo, the number of suicides was below the lower bound throughout the period., Conclusion: Our results suggest that various changes, such as communication, and social conditions amid the early COVID-19 pandemic induced a decrease in suicides in Japan. However, continuous monitoring is needed to evaluate the long-term effects of the pandemic on suicides.

Aim: This study evaluates reports on neuroleptic malignant syndrome (NMS) as an adverse event associated with the use of atypical antipsychotic agents (AAA) in Japan. We examined NMS occurrence following monotherapy and combination therapy with AAA in real clinical practice using the Japanese Adverse Drug Event Report database., Methods: Adverse drug reaction reports associated with the use of one or more AAA or haloperidol were analyzed. The odds ratios of NMS occurrence after monotherapy and combination therapy with AAA without typical antipsychotic agents (TAA) relative to those after haloperidol monotherapy were estimated using multiple logistic regression., Results: Associated with the use of one or more AAA without TAA were 721 events of NMS in 11 071 cases. NMS occurrence after monotherapy with most AAA and their combinations had lower odds ratios than that after haloperidol use. However, the odds ratios after blonanserin monotherapy and combination therapies with quetiapine and zotepine, and risperidone and zotepine were estimated higher than 1., Conclusion: Monotherapy or combination therapy with most AAA without TAA was not likely to cause NMS as an adverse reaction compared to haloperidol monotherapy. However, blonanserin monotherapy and combination therapies with quetiapine and zotepine, and risperidone and zotepine, possibly increase the report of NMS. Our results may provide useful information for medications such as AAA that are clinically used to treat mental disorders, though further research with more data are needed to clarify this., (© 2018 The Authors. Psychiatry and Clinical Neurosciences © 2018 Japanese Society of Psychiatry and Neurology.)

Background: The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER) database and the US Food and Drug Administration Adverse Event Reporting System (FAERS), and how they affect signal detection., Methods: Two AE data sources from 2010 were examined, ie, JADER cases (JP) and Japanese cases extracted from the FAERS (FAERS-JP). Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS), were used on drug-event combinations for three substances frequently recorded in both systems., Results: The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37) in the JP and 3.3±3.5 (maximum 62) in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and paroxetine. Signals identified by GPS for the JP and FAERS-JP, as referenced by Japanese labeling, showed higher positive sensitivity than was expected., Conclusion: The FAERS-JP was different from the JADER. Signals derived from both datasets identified different results, but shared certain signals. Discrepancies in type of AEs, drugs reported, and average number of AEs per case were potential contributing factors. This study will help those concerned with pharmacovigilance better understand the use and pitfalls of using spontaneous AE data.