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Background: Sparganosis is a rare zoonotic disease caused by plerocercoid larvae of the genera Spirometra or Sparganum (Cestoda: Diphyllobothriidae). The larvae of Spirometra generally do not undergo asexual reproduction, whereas those of Sparganum can induce proliferative lesions in infected tissues. This paper presents an unusual case of proliferative sparganosis due to infection with Spirometra mansoni in a cat, normally considered a definitive host of the species. Case presentation: A 9-year-old male domestic cat was presented with a mass on the right side of the face that underwent progressive enlargement for 1 month. The morphological and histopathological examinations revealed multiple asexual proliferative cestode larvae in the lesions, suggestive of proliferative sparganosis. Next-generation sequencing analysis of formalin-fixed and paraffin-embedded specimens of surgically excised tissue indicated that the worm was Spirometra mansoni. Conclusion: Although S. mansoni a common tapeworm species found in the small intestine of domestic cats and dogs in Japan, proliferative sparganosis is extremely rare. This is the first confirmed case of proliferative sparganosis due to infection with S. mansoni in cat. [ABSTRACT FROM AUTHOR]

Background: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. Objectives: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials. Methods: For this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees' gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees' burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews. Discussion: This pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data. Conclusions: This feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs. Trial registration: UMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570 [ABSTRACT FROM AUTHOR]

Background: Preoperative education can improve postoperative quality of life in patients undergoing stoma surgery. However, the prevalence and when, where, and how preoperative education is implemented are unclear. Therefore, this study aimed to assess the current status of outpatient preoperative education for patients undergoing stoma surgery for rectal cancer as perceived by nurses. Additionally, it sought to identify the information provided by Japanese healthcare providers as a part of preoperative education. Methods: This cross-sectional study included 1,716 wound, ostomy, and continence nurses (WOCNs) in charge of stoma clinics at Japanese hospitals. Unsigned self-administered survey forms were mailed to the participants, and paper- or web-based responses were obtained. The main questions included: overview of the participants and their facilities, provision of outpatient preoperative education, status of implementation, and preoperative education components. To examine the factors associated with preoperative education, the independent variable was the presence or absence of preoperative education in the clinic, and the explanatory variables were the years of experience as a nurse, years of experience as a WOCN, type of hospital, number of beds, and number of intestinal stoma surgeries per year. Regression analysis was performed. Results: We received 773 valid responses (valid response rate: 45%). Duration of experience as a nurse and as a WOCN were 24.6 and 10.9 years, respectively. Outpatient preoperative education was provided by 24% of the participants. Most preoperative education sessions were conducted for patients or caregivers. Preoperative education took 31–60 min per patient, and one to five patients received preoperative education each month. Booklets, ostomy appliances, and stoma models/dolls were used as supplementary materials for preoperative education. The most frequently mentioned components of preoperative education were stoma care, daily life, social security, stoma clinic, traveling and going out, quality of life after stoma surgery, and precautions for medical treatment. In addition, education on the use of restrooms on the go, disaster preparedness, defecation disorders after restorative proctectomy, and complications after stoma closure were considered necessary. Conclusions: The implementation rate of outpatient preoperative education was low (24%). Future challenges include the development of specific educational content and procedures suitable for the Japanese medical environment and the establishment of preoperative medical care teams for stoma surgery to promote the provision of outpatient preoperative education. [ABSTRACT FROM AUTHOR]

Background: Patients with Gaucher disease (GD), a rare lysosomal storage disorder, have reduced health-related quality of life (HRQOL). A patient-reported outcome measure (PROM) for HRQOL developed for type 1 GD (GD1) is not appropriate for patients with neuronopathic GD (nGD) types 2 (GD2) and 3 (GD3). In this study, we developed a new PROM for use in all GD types. We previously reported the qualitative analysis of interviews with Japanese patients with nGD, which was used to create nGD-specific PROM items. Here we evaluated the full PROM combining the type 1 questionnaire with the new nGD-specific items. Methods: Patients with confirmed GD were recruited (Association of Gaucher Disease Patients in Japan or leading doctors) for pre-testing (May 2021) or the main survey (October–December 2021). The PROM had three parts: Parts 1 and 2 were translated into Japanese from the pre-existing GD1 PROM, whereas Part 3 was newly developed. Patients (or their caregivers, where necessary) completed the PROM questionnaire on paper and returned it by mail. Mean scores were determined overall and by GD type. Inter-item correlations, content consistency (Cronbach's alpha), and test–retest reliability (Cohen's kappa; main survey only, taken 2 weeks apart) were calculated. Results: Sixteen patients (three with GD1; six with GD2; seven with GD3) and 33 patients (nine with GD1; 13 with GD2; 11 with GD3) participated in the pre-test and main survey, respectively. All GD2 patients and one-third (6/18) of GD3 patients required caregivers to complete the questionnaire. Mean scores indicated that the burden was highest in GD2 and lowest in GD1. In the main survey, internal consistency was high (Cronbach's alpha = 0.898 overall, 0.916 for Part 3), and test–retest reliability was high for Part 3 (kappa > 0.60 for 13/16 items) but low for Part 1 (kappa < 0.60 for 12/15 items). Conclusions: We have developed a flexible and reliable PROM that can be tailored for use in all types of GD and propose using Parts 1 and 2 for GD1, Parts 2 and 3 for GD2, and Parts 1, 2, and 3 for GD3. [ABSTRACT FROM AUTHOR]

Background: The Targeted Learning roadmap provides a systematic guide for generating and evaluating real-world evidence (RWE). From a regulatory perspective, RWE arises from diverse sources such as randomized controlled trials that make use of real-world data, observational studies, and other study designs. This paper illustrates a principled approach to assessing the validity and interpretability of RWE. Methods: We applied the roadmap to a published observational study of the dose–response association between ritodrine hydrochloride and pulmonary edema among women pregnant with twins in Japan. The goal was to identify barriers to causal effect estimation beyond unmeasured confounding reported by the study's authors, and to explore potential options for overcoming the barriers that robustify results. Results: Following the roadmap raised issues that led us to formulate alternative causal questions that produced more reliable, interpretable RWE. The process revealed a lack of information in the available data to identify a causal dose–response curve. However, under explicit assumptions the effect of treatment with any amount of ritodrine versus none, albeit a less ambitious parameter, can be estimated from data. Conclusions: Before RWE can be used in support of clinical and regulatory decision-making, its quality and reliability must be systematically evaluated. The TL roadmap prescribes how to carry out a thorough, transparent, and realistic assessment of RWE. We recommend this approach be a routine part of any decision-making process. [ABSTRACT FROM AUTHOR]

The public enquiry into the mass casualty incident at the Manchester Arena in the UK in which 23 people died and over 1000 were injured, identified the need for timely intramuscular administration of tranexamic acid to trauma patients. Since then, a number of studies and trials have been carried out and UK paramedics are now authorized to give intramuscular tranexamic acid in the pre-hospital setting. In Japan, pre-hospital administration by emergency life-saving technicians is not yet authorized, despite the fact that tranexamic acid was invented by Japanese scientists. In Japan, the need for the pre-hospital administration of tranexamic acid has been raised on several occasions, where a patient died from traumatic bleeding prior to hospital admission. This paper summarizes the evidence on the use of tranexamic acid in patients with traumatic bleeding, including new evidence on the intramuscular route. [ABSTRACT FROM AUTHOR]

Background: An automated web-based assessment and monitoring system ( www.psynary.com ) has been developed to assist non-specialist clinicians in managing common mood and anxiety disorders. Psynary promotes the use of standardised outcome measures to assess symptom severity and optimise treatments with the aim of improving outcomes and enabling faster recovery. This paper analyses the results from two parallel studies in New Zealand and Japan (OptiMA-1 NZ and Japan) to assess the validity of the R8 Depression scale, one of the system's core outcome measures.Methods: Clinical samples were recruited from a public secondary care and a private psychiatry clinic. Participants completed the outcome measures for the study via the online Psynary system. The R8 Depression scale is a 30-item questionnaire which includes all symptom domains covered in the ICD-10 classification of depression. The Patient Health Questionnaire (PHQ-9) was completed at the same time points as the R8 Depression, with a smaller sample also completing a paper-based Quick Inventory of Depressive Symptomatology (QIDS-SR16). Internal validity was quantified via Cronbach's alpha and Guttman lower bounds method. External validation against the PHQ-9 and QIDS used the Pearson's and Kendall's correlation coefficients. Severity categories were set using a multivariate regression model.Results: 270 patients participated in the study and completed a maximum of 1 baseline and 5 reviews within a 90-day period, giving a total of 1124 assessments with the PHQ-9 also being completed in 1053 of these assessments. R8 Depression normative data was also collected from 204 non-clinical volunteers with 187 of these also completing the PHQ9. Internal reliability scores were all higher than 0.9 (n = 1328). There was overall good external validity when comparing the R8 Depression to the PHQ-9, with a correlation of 0.91 for the combined normative and clinical samples (n = 1240).Conclusions: The R8 Depression has been developed as a patient-rated outcome measure for depression for administration on an online system called "Psynary". It has high internal and external validity against current widely used scales. Further work is underway to determine the sensitivity to change of the R8 Depression. [ABSTRACT FROM AUTHOR]

Background: The role of social ties, other-regarding preferences, and cultural traits in boosting community resilience and minimizing citizens' vulnerability to crises such as COVID-19 is increasingly being recognized. However, little is presently known about the possible routes through which such personal preferences and cultural norms pertinent to social behaviors are formulated. Thus, in this paper, factors that can be potentially associated with individuals to self-regulate strict hand hygiene practices before the pandemic, during the state of emergency, and after the state of emergency was lifted in Japan are investigated. Focus is given to the handwashing education in primary school, a cultural practice originating from the old Shinto tradition, and individuals' reciprocal inclinations. As people in Japan are known to be highly conscious of hygiene in all aspects of their daily life and are less likely to contract an infection, evidence obtained in this specific context could contribute to the better understanding of individuals' health-related behaviors in general, and during crises in particular.Methods: Using the data derived from a four-wave nationwide longitudinal online survey, we examined the extent to which elementary school education, childhood cultural experiences at shrines, and individual other-regarding preferences are associated with self-regulating hand hygiene practices prior to the pandemic and people's efforts to comply with the government-imposed measures aimed at preventing the spread of COVID-19 infection during the state of emergency. We also investigated the long-term trends in the relationships among these factors (i.e., after the abolishment of the state of emergency) using panel data.Results: Our findings reveal that childhood education and cultural experiences related to handwashing practices, as well as reciprocal inclinations, are significantly associated with Japanese attitudes toward personal hygiene (beyond handwashing practices) prior to, during, and after the state of emergency. In recognition of the possible effects of recall bias and measurement errors, several important attempts to mitigate these issues were made to strengthen the value of our findings.Conclusions: The importance of school education received during childhood, as well as culture and other-regarding preferences, in the individual attitudes toward hand hygiene in adulthood highlighted in this study contributes to the better understanding of the role that these factors play in the variations in voluntary compliance with strict hand hygiene practices before and during an uncertain and prolonged crisis. [ABSTRACT FROM AUTHOR]

This paper discusses the challenges of disseminating COVID-19 information to migrant populations by sharing our trial-and-error approach. In 2018, the Migrants' Neighbor Network & Action (MINNA), a consortium of individuals and organizations that addressed the issues of accessing relevant information and services for migrants in Japan, was launched. Amidst the COVID-19 pandemic, the MINNA attempted to investigate and improve access to health information among Vietnamese, Nepali, and Burmese migrants in Japan. We had three assumptions in distribution of information to reach a large audience, such as building a multilingual website, requesting stakeholders to disseminate information, or posting on Facebook. None of our assumptions were sufficient to reach the target audience in the context of COVID-19, as total number of views that accessed our materials were less than 300 at most. We viewed these myths as the result of overlooking critical elements of effective communication strategies. Eventually, MINNA managed to establish communication with the manager of a Facebook page with the largest number of followers from the Vietnamese community in Japan. Compared with our previous attempts, the messages were delivered to a large audience on the Facebook page, such as the article on COVID-19 vaccines that was viewed more than 300,000 times. In public health emergencies, interactive process of information dissemination is necessary. It is a key component for risk communication and should be prioritized. Breakthroughs in communicating with a larger audience could be possible through partnerships with online communities. [ABSTRACT FROM AUTHOR]

Background: During the long-lasting economic stagnation, the popularity of medical school has dramatically increased among pre-medical students in Japan. This is primarily due to the belief that medicine is generally a recession-proof career. As a result, pre-medical students today who want to enter medical school have to pass a more rigorous entrance examination than that in the 1980s. This paper explores the association between the selectivity of medical school admissions and graduates' later career choices.Methods: A unique continuous measure of the selectivity of medical school admissions from 1980 to 2017, which is defined as the deviation value of medical schools, was merged with cross-sectional data of 122 990 physicians aged 35 to 55 years. The association between the deviation value of medical schools and various measures of physicians' career choices was explored by logistic and ordinary least square regression models. Graduates from medical schools in which the deviation value was less than 55 were compared with those from more competitive medical schools, after controlling for fixed effects for the medical school attended by binary variables.Results: From 1980 to 2017, the average deviation value increased from 58.3 to 66.3, indicating a large increase in admission selectivity. Empirical results suggest that increasing selectivity of a medical school is associated with graduates having a higher probability of choosing a career in an acute hospital as well as having a lower probability of opening their own clinic and choosing a career in primary health care. Graduating from a highly competitive medical school (i.e., deviation value of more than 65) significantly increases the probability of working at typical acute hospitals such as so-called 7:1 hospitals (OR 1.665 2, 95%CI 1.444 0-1.920 4) and decreases the probability of working at primary care facilities (OR 0.602 6, 95%CI 0.441 2-0.823 0). It is also associated with graduates having a higher probability of becoming medical board certified (OR 1.294 6, 95%CI 1.108 8-1.511 4).Conclusion: Overall, this paper concludes that increased selectivity of medical school admissions predicts a higher quality of physicians in their own specialty, but at the same time, it is associated with a lower supply of physicians who go into primary care. [ABSTRACT FROM AUTHOR]

Background: Japan has opened its labor market to care workers from Indonesia under the Japan-Indonesia Economic Partnership Agreement (EPA). However, few studies have examined the types of care skills transferred between countries. We therefore analyzed Indonesian care workers employed in Japan and Indonesia to identify discrepancies in their attentiveness toward oral care in older adults.Methods: A checklist comprising 42 items of universal oral care assessment was developed prior to the study and distributed via the Internet to 418 Indonesian EPA care workers in Japan and via a paper survey to 213 Indonesian care workers in Indonesia. The Mann-Whitney U test was used to compare the distribution of scores for each checklist item for each group.Results: The respondents were 110 Japan-based EPA care workers (response rate: 26.3%) and 213 Indonesia-based care workers (response rate: 99.1%). Japan-based care workers were significantly more likely to perform environmental observations of their older adult patients (p < 0.001) and to check items on the oral care checklist during feeding (p < 0.001) and post-meal (p = 0.001), while Indonesia-based care workers were more likely to check the overall condition of patients before meals (p = 0.021).Conclusions: Discrepancies in checking oral care between the two groups were attributed to the differences in laws and regulations governing the care environments. Indonesian care workers employed in Japan have the advantage of learning to employ a more systematic approach in caring for older adults, in accordance with Japan's Long-Term Care Act. This approach could contribute toward lowering the risk of aspiration pneumonia in Indonesia. A training program designed for returning migrant workers to transfer newly developed oral care skills will thus be essential for Indonesia to diminish the negative impacts of its aging population. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

Background: Demographic changes in the pattern of disease burden, escalating health expenditures and inequitable access to healthcare are global challenges. Irrespective of their level of development, all countries need to reform their health systems to prepare for the future emerging health needs, in order to meet their commitments of health systems strengthening, universal health coverage (UHC) and explicit targets in the Sustainable Development Goals (SDGs). We propose three core principles for the future health system as described herein. A health system is not simply a 'cure delivery machine' but part of a 'social security system' that engages all stakeholders through a shared vision and value of health and well-being, not merely an absence of diseases. The future health system shall provide people-centred, affordable care, tailored to the individual's needs, accessible at any time and any place, and reflect the notion of leaving no one behind through a life course approach - underpinned by the SDGs. Information and communications technology (ICT) offers the potential to facilitate the realisation of these principles by improving the information flow between different parts of the health system through electronic means. We introduce Japan's new data platform - Person-centred Open PLatform for wellbeing (PeOPLe) - planned to be introduced in 2020 as one example of an ICT-based intervention to realise the three proposed principles. PeOPLe integrates data collected throughout the life course to enable all people to receive affordable, personalised health and social care at any time and any place throughout their lifetime. Furthermore, we discuss the applicability of these principles and PeOPLe to the health systems context of Thailand and the Philippines, including elaborations on ICT transformation challenges.Conclusion: Current rising momentum and scale for ICTs in the UHC era offers a great opportunity to make a difference for countries. The PeOPLe concept is not only relevant to resource-rich countries; its applicability to other Asian countries could be feasible though it will need to be adapted to the various country contexts. We hope that this paper contributes to wider discussion around policy choices of ICT application for future health systems strengthening and UHC in order to achieve the SDGs. [ABSTRACT FROM AUTHOR]

Background: Henneguya Thélohan, 1892 (Myxobolidae) is one of the most species-rich genera of myxosporean parasites infecting fish. Although common in nature, there are few reports of these parasites causing important disease in aquaculture. In this paper, we describe a new species of Henneguya infecting Pagrus major (Temminck & Schlegel), a fish host introduced to the Mediterranean Sea from Japan in the late 1980s. Results: Large plasmodia of the parasite were found in the bulbus arteriosus and in the ventricle of the infected fish. Spores were found mainly in the kidney and heart and were accompanied by melanized macrophages or vascular intimal proliferation mixed with a mild non-suppurative response, respectively. Comparisons of morphometric data for spore and polar capsule length and width, suggest a unique combination of features in the newly described species. Molecular analysis, based on 18S rDNA sequence of the parasite, followed by phylogenetic analysis, indicated that the parasite described here is a novel species of Henneguya, clustered with the marine congeneric species. Conclusions: Henneguya aegea n. sp. infects in aquaculture P. major, a host introduced as eggs to the Mediterranean from Japan. Despite the high host specificity of the myxobolid parasites, H. aegea n. sp. seems to be able to use P. major as a host and propagate successfully, causing morbidity and mortality. This could result in spillback of the new species from high density cultured non-native P. major to native fish hosts. [ABSTRACT FROM AUTHOR]

Background Although dysgeusia is a common adverse event in chemotherapy patients; it has not been evaluated using objective methods, and its prevalence and frequency have not been quantified. Methods Salt-impregnated taste strips were used to objectively assess dysgeusia in patients receiving chemotherapy at Akita University (n = 38) and those off chemotherapy (n = 9). Participant characteristics, and ongoing and previous chemotherapies were evaluated, and their associations with dysgeusia analyzed. Results Dysgeusia developed in 38.8% (14/38) of chemotherapy patients, and was most prevalent in patients receiving 5-fluorouracil (5-FU) or its oral analogs (48.1%, 13/27). Particularly, dysgeusia developed in 55.6% (10/18) of patients receiving oral 5-FU analogs; however, prevalence in patients receiving and off chemotherapy was not significantly different. Patients aged ≥70 years also tended to experience dysgeusia (75.0%, 6/8). Conclusions Association with dysgeusia may be higher for some chemotherapeutic drugs. Dysgeusia should be routinely assessed in chemotherapy patients with objective methods such as paper strips; interventions for its prevention may be required. [ABSTRACT FROM AUTHOR]

Background: Complementary and alternative medicine (CAM), such as acupuncture and herbal medicine, is popular in many countries. Yet, treatment outcomes of CAM are found to vary significantly between medical trials in different social environments. This paper addresses how the social organization of medicine affects medical treatment outcomes. In particular, it examines the extent to which two popular complementary and alternative medicine (CAM) interventions (acupuncture and herbal medicine) are coordinated with biomedicine and how coordination characteristics are related to the treatment outcomes of the two CAM interventions. Methods: This paper conducts an archival analysis of the institutional settings of the CAM interventions in Japan and the U.S. It also conducts a systematic content analysis of the treatment outcomes in 246 acupuncture reports and 528 herbal medicine reports that are conducted in Japan or the U.S. and registered in the Cochrane Library's Central Register of Controlled Trials (CENTRAL), and 716 acupuncture reports and 3,485 herbal medicine reports that are from Japan or the U.S. and listed in MEDLINE. It examines the association between the treatment outcomes of the two interventions and the geographical location of the reports; it also explores how the institutional settings of the interventions are related to the treatment outcomes. Results: Japanese herbal medicine is integrated into the national medical system the most and American herbal medicine the least; American acupuncture and Japanese acupuncture fall in the middle. Treatment outcomes are the most favorable for Japanese herbal medicine and the least favorable for American herbal medicine. The outcomes of American acupuncture and Japanese acupuncture fall in the middle. Conclusions: The co-utilization of CAM with biomedicine can produce difficulties due to tensions between CAM and biomedicine. These difficulties and subsequent CAM treatment outcomes vary, depending on how CAM is institutionalized in relation to biomedicine in the national medical system. Coordinated CAM interventions are more likely to be effective and synergic with biomedicine, when compared to uncoordinated ones. [ABSTRACT FROM AUTHOR]

Background: With the goal of realizing genome-based personalized healthcare, we have developed a biobank that integrates personal health, genome, and omics data along with biospecimens donated by volunteers of 150,000. Such a large-scale of data integration involves obvious risks of privacy violation. The research use of personal genome and health information is a topic of global discussion with regard to the protection of privacy while promoting scientific advancement. The present paper reports on our plans, current attempts, and accomplishments in addressing security problems involved in data sharing to ensure donor privacy while promoting scientific advancement.Methods: Biospecimens and data have been collected in prospective cohort studies with the comprehensive agreement. The sample size of 150,000 participants was required for multiple researches including genome-wide screening of gene by environment interactions, haplotype phasing, and parametric linkage analysis.Results: We established the T ohoku M edical M egabank (TMM) data sharing policy: a privacy protection rule that requires physical, personnel, and technological safeguards against privacy violation regarding the use and sharing of data. The proposed policy refers to that of NCBI and that of the Sanger Institute. The proposed policy classifies shared data according to the strength of re-identification risks. Local committees organized by TMM evaluate re-identification risk and assign a security category to a dataset. Every dataset is stored in an assigned segment of a supercomputer in accordance with its security category. A security manager should be designated to handle all security problems at individual data use locations. The proposed policy requires closed networks and IP-VPN remote connections.Conclusion: The mission of the biobank is to distribute biological resources most productively. This mission motivated us to collect biospecimens and health data and simultaneously analyze genome/omics data in-house. The biobank also has the mission of improving the quality and quantity of the contents of the biobank. This motivated us to request users to share the results of their research as feedback to the biobank. The TMM data sharing policy has tackled every security problem originating with the missions. We believe our current implementation to be the best way to protect privacy in data sharing. [ABSTRACT FROM AUTHOR]

Background: A number of companies publish corporate social responsibility (CSR) reporting in booklets and other publicly available formats. The purpose of this paper is to clarify the nine-year (2004-2012) trend of occupational safety and health (OSH) activities as described in CSR reporting (by industry sector and company size).Methods: We investigated CSR reporting on the website in all Japanese companies listed on the first section of the Tokyo Stock Exchange. The data were extracted from CSR reporting of each company every year from 2004 to 2012. We counted the pages dedicated to information on OSH activities by industry sector and company size and calculated the rate of OSH divided by total CSR-related activities.Results: The number of companies publishing CSR reports increased in all industry sectors, although the rate of inclusion of OSH activity within CSR reports increased only among sectors such as construction, manufacturing, transportation, and commerce. Among all company size, CSR reporting increased constantly throughout all observed years. The proportion of companies that had described OSH in CSR reporting increased from 2004 to 2012, and 76.5% companies had described OSH activities in 2012. The average number of pages of CSR-related report was 34.2 in 2004, increasing to 43.1 in 2012. The proportion of described pages of OSH activities in total CSR reporting increased gradually, and 2.7% in 2012. The focus of CSR reporting gradually shifted from 'environment' to 'social activity including OSH'.Conclusions: Majority of companies are putting more emphasis on OSH in CSR reporting in Japan. [ABSTRACT FROM AUTHOR]

Background: Domestication is an important and contested concept. Insects are used as food worldwide, and while some have been described as domesticated and even 'semi-domesticated', the assumptions and implications of this designation are not clear. The purpose of this paper is to explore these aspects of insect domestication, and broader debates in domestication studies, through the case of edible wasps in central rural Japan. Methods: Both authors conducted ethnographic fieldwork with communities in central rural Japan. Fieldwork comprised participant observation, semi-structured interviews, quantitative surveys and a review of resources including the personal and public records of wasp collectors. Results: The practice of keeping wasps in hive boxes has historical roots and has changed significantly within living memory. Current attempts to further develop the practice involve collectors' great efforts to keep new queens during their hibernation. Collectors have also tried, still without success, to keep wasps living within a human-made enclosure for their entire life cycle. These and other practices are costly in both time and money for collectors, who emphasise enjoyment as their primary motivation. At the same time, they also engage in practices such as pesticide use that they recognise as damaging to wasp ecology. Conclusions: These practices can be understood to some extent in domesticatory terms, and in terms of care. We develop a framework for understanding domesticatory practices of insect care, discuss how this case contributes to ongoing debates within domestication studies, and recommend further research to be pursued. [ABSTRACT FROM AUTHOR]

Background: SUN(^_^)D, the Strategic Use of New generation antidepressants for Depression, is an assessor-blinded, parallel-group, multicenter pragmatic mega-trial to examine the optimum treatment strategy for the first- and second-line treatments for unipolar major depressive episodes. The trial has three steps and two randomizations. Step I randomization compares the minimum and the maximum dosing strategy for the first-line antidepressant. Step II randomization compares the continuation, augmentation or switching strategy for the second-line antidepressant treatment. Step III is a naturalistic continuation phase. The original protocol was published in 2011, and we hereby report its updated protocol including the statistical analysis plan.Results: We implemented two important changes to the original protocol. One is about the required sample size, reflecting the smaller number of dropouts than had been expected. Another is in the organization of the primary and secondary outcomes in order to make the report of the main trial results as pertinent and interpretable as possible for clinical practices. Due to the complexity of the trial, we plan to report the main results in two separate reports, and this updated protocol and the statistical analysis plan have laid out respective primary and secondary outcomes and their analyses. We will convene the blind interpretation committee before the randomization code is broken.Conclusion: This paper presents the updated protocol and the detailed statistical analysis plan for the SUN(^_^)D trial in order to avoid reporting bias and data-driven results.Trial Registration: ClinicalTrials.gov: NCT01109693 (registered on 21 April 2010). [ABSTRACT FROM AUTHOR]

Background: Major depression is one of the most debilitating diseases in terms of quality of life. Less than half of patients suffering from depression can achieve remission after adequate antidepressant treatment. Another promising treatment option is cognitive-behavior therapy (CBT). However, the need for experienced therapists and substantive dedicated time prevent CBT from being widely disseminated. In the present study, we aim to examine the effectiveness of switching antidepressants and starting a smartphone-based CBT program at the same time, in comparison to switching antidepressants only, among patients still suffering from depression after adequate antidepressant treatment.Methods/design: A multi-center randomized trial is currently being conducted since September 2014. The smartphone-based CBT program, named the "Kokoro-App," for major depression has been developed and its feasibility has been confirmed in a previous open study. The program consists of an introduction, 6 sessions and an epilogue, and is expected to be completed within 9 weeks by patients. In the present trial, 164 patients with DSM-5 major depressive disorder and still suffering from depressive symptoms after adequate antidepressant treatment for more than 4 weeks will be allocated to the Kokoro-App plus switching antidepressant group or the switching antidepressant alone group. The participants allocated to the latter group will receive full components of the Kokoro-App after 9 weeks. The primary outcome is the change in the total score on the Patient Health Questionnaire through the 9 weeks of the program, as assessed at week 0, 1, 5 and 9 via telephone by blinded raters. The secondary outcomes include the change in the total score of the Beck Depression Inventory-II, change in side effects as assessed by the Frequency, Intensity and Burden of Side Effects Rating, and treatment satisfaction.Discussion: An effective and reachable intervention may not only lead to healthier mental status among depressed patients, but also to reduced social burden from this illness. This paper outlines the background and methods of a trial that evaluates the possible additive value of a smartphone-based CBT program for treatment-resistant depression.Trial Registration: UMIN-CTR: UMIN000013693 (registered on 1 June 2014). [ABSTRACT FROM AUTHOR]

Background: It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determining an effective prevention strategy for these symptoms in nurses. After reviewing previous literature, we chose a strategy of treatment with omega-3 fatty acids and a mindfulness-based stress management program for this purpose. We aim to explore the effectiveness of these intervention options for junior nurses working in hospital wards in Japan. Methods/Design: A factorial-design multi-center randomized trial is currently being conducted. A total of 120 nurses without a managerial position, who work for general hospitals and gave informed consent, have been randomly allocated to a stress management program or psychoeducation using a leaflet, and to omega-3 fatty acids or identical placebo pills. The stress management program has been developed according to mindfulness cognitive therapy and consists of four 30-minute individual sessions conducted using a detailed manual. These sessions are conducted by nurses with a managerial position. Participants allocated to the omega-3 fatty acid groups are provided with 1,200 mg/day of eicosapentaenoic acid and 600 mg/day of docosahexaenoic acid for 90 days. The primary outcome is the change in the total score of the Hospital Anxiety and Depression Scale (HADS), determined by a blinded rater via the telephone at week 26. Secondary outcomes include the change in HADS score at 13 and 52 weeks; presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores and adverse events at 13, 26 and 52 weeks. Discussion: An effective preventive intervention may not only lead to the maintenance of a healthy mental state in nurses, but also to better quality of care for inpatients. This paper outlines the background and methods of a randomized trial that evaluates the possible additive value of omega-3 fatty acids and a mindfulness-based stress management program for reducing depression in nurses. [ABSTRACT FROM AUTHOR]

Background: Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods: For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG⩾7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results: Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics between the study arms. Conclusion: We have launched J-DOIT1, a nation-wide trial to prevent the development of T2DM in high-risk individuals using telephone-delivered intervention. This trial is expected to contribute to evidence-based real-world preventive practices. [ABSTRACT FROM AUTHOR]

Information about several papers discussed at second International Symposium on Genotoxic and Carcinogenic Threshold held November 23, 2011 in Tokyo in Japan on genotoxic carcinogens is presented. Topics include regulation of chemical carcinogen, carcinogenic ability of DNA reactive and non-reactive chemicals and impact of exposure to ethylating agents. The symposium features several notable researchers including Takehiko Nohmi, George S. Bailey and Samuel M. Cohen.

Background: Frequent and long-term commuting is a requirement for dialysis patients. Accessibility thus affects their quality of lives. In this paper, a new model for accessibility measurement is proposed in which both geographic distance and facility capacity are taken into account. Simulation of closure of rural facilities and that of capacity transfer between urban and rural facilities are conducted to evaluate the impacts of these phenomena on equity of accessibility among dialysis patients. Methods: Post code information as of August 2011 of all the 7,374 patients certified by municipalities of Hiroshima prefecture as having first or third grade renal disability were collected. Information on post code and the maximum number of outpatients (capacity) of all the 98 dialysis facilities were also collected. Using geographic information systems, patient commuting times were calculated in two models: one that takes into account road distance (distance model), and the other that takes into account both the road distance and facility capacity (capacity--distance model). Simulations of closures of rural and urban facilities were then conducted. Results: The median commuting time among rural patients was more than twice as long as that among urban patients (15 versus 7 minutes, p<0.001). In the capacity-distance model 36.1% of patients commuted to the facilities which were different from the facilities in the distance model, creating a substantial gap of commuting time between the two models. In the simulation, when five rural public facilities were closed, Gini coefficient of commuting times among the patients increased by 16%, indicating a substantial worsening of equity, and the number of patients with commuting times longer than 90 minutes increased by 72 times. In contrast, closure of four urban public facilities with similar capacities did not affect these values. Conclusions: Closures of dialysis facilities in rural areas have a substantially larger impact on equity of commuting times among dialysis patients than closures of urban facilities. The accessibility simulations using the capacity-distance model will provide an analytic framework upon which rational resource distribution policies might be planned. [ABSTRACT FROM AUTHOR]

In this paper we report two incidents of ciguatera fish poisoning (CFP) that occurred in 2008 on Kakeroma Island in Kagoshima Prefecture, Japan. A family consisting of father (42 y.o.), mother (39 y.o.), daughter (11 y.o.) and son (6 y.o.), as well as a friend of the family (male, 78 y.o.) consumed sliced flesh (sashimi) and developed typical symptoms of CPF 4-5 h later: diarrhea, vomiting, and paresthesia of the extremities. Additionally, the two male adults (42 and 78 y.o.) developed mild hypotention (84/48 and 94/40 mmHg, respectively) and bradycardia (36 and 50 bpm, respectively) and were rushed to the ER of the nearest hospital, located on an adjacent island. The implicated fish were caught together off the west coast of the island and were identified as Variola louti and Lutjanus monostigma based on analysis of 16S rRNA gene coded on mtDNA. Remnants of the implicated fish and other fish caught on the same occasion were examined by the official mouse bioassay method (MBA), which defines the minimum amount of CFP toxin needed to kill a male mouse of ddY strain of 20 g body weight within 24 h as one mouse unit (MU). A significantly high toxicity was detected in the V. louti (0.2 MU/g) eaten by the family and the L. monostigma (0.8 MU/g) eaten by the elderly man. Other specimens of Lethrinus nebulosus, Variola albimarginata, Lutjanus gibbus (2 specimens), Aphareus rutilans, and Sphyraena forsteri (2 specimens) were found to be nontoxic (< 0.025 MU/g). The medical records regarding island inhabitants (ca. 1,500) kept at Kakeroma Tokushukai Clinic, the only medical facility on the Island, and also at Setouchi Tokushukai Hospital, a nearest hospital on an adjacent island (Amami) revealed 6 CFP outbreaks involving 13 cases between 2005 and 2008. The estimated frequency of CFP was 10.0 incidents/10,000 persons/year and the morbidity rate was 21.7 cases/10,000 persons/year. The symptoms and signs observed in the patients and the implicated fish species, L. monostigma and V. louti, were typical of CFP in this region. [ABSTRACT FROM AUTHOR]

Background: A quantitative measurement of inequality in geographic accessibility to pediatric care as well as that of mean distance or travel time is very important for priority setting to ensure fair access to pediatric facilities. However, conventional techniques for measuring inequality is inappropriate in geographic settings. Since inequality measures of access distance or travel time is strongly influenced by the background geographic distribution patterns, they cannot be directly used for regional comparisons of geographic accessibility. The objective of this study is to resolve this issue by using a standardization approach. Methods: Travel times to the nearest pediatric care were calculated for all children in Oita Prefecture, Japan. Relative mean differences were considered as the inequality measure for secondary medical service areas, and were standardized with an expected value estimated from a Monte Carlo simulation based on complete spatial randomness. Results: The observed mean travel times in the area considered averaged 4.50 minutes, ranging from 1.83 to 7.02 minutes. The mean of the observed inequality measure was 1.1, ranging from 0.9 to 1.3. The expected values of the inequality measure varied according to the background geographic distribution pattern of children, which ranged from 0.3 to 0.7. After standardizing the observed inequality measure with the expected one, we found that the ranks of the inequality measure were reversed for the observed areas. Conclusions: Using the indicator proposed in this paper, it is possible to compare the inequality in geographic accessibility among regions. Such a comparison may facilitate priority setting in health policy and planning. [ABSTRACT FROM AUTHOR]

In the present paper, the semelid Theora lubrica is recorded for the first time in the Atlantic Ocean, based on numerous specimens collected in the Nervión Estuary and Pasajes Port (Basque coast, south-eastern Bay of Biscay). This species is native to Japan and the Pacific coast of Asia, and has previously been introduced to other areas outside its natural range. Its presence in ports or adjacent areas, suggests that the shipping activity is the most likely pathway of introduction of this alien species in the new settlements. On the Basque coast, the possible impact of T. lubrica on native communities is still uncertain. Future surveys will help us to evaluate its introduction. [ABSTRACT FROM AUTHOR]

Background: A previous suicide attempt is a potent risk factor for suicide later on. Crisis intervention, psychiatric and psychosocial evaluation at emergency medical facilities, and follow-up care for suicide attempters are considered important components for suicide prevention. The Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP) includes a randomized, controlled, multicenter trial of post-suicide attempt case management for the prevention of further attempts (ACTION-J) to address the continuing increase in suicides in Japan. The primary aim of ACTION-J is to examine the effectiveness of an extensive intervention for suicide attempters in prevention of recurrent suicidal behavior, as compared with standard intervention. This paper describes the rationale and protocol of the ACTION-J trial. Methods/Design: In this clinical trial, case management intervention will be provided at 19 emergency medical facilities in Japan. After crisis intervention including psychiatric evaluation, psychosocial assessment, and psychological education, subjects will be randomly assigned to either a group receiving continuous case management or a control group receiving standard care. Suicidal ideation, depressive symptoms, and general health condition will be evaluated as secondary measures. The intervention was initiated in July 2006. By December, 2009, 842 subjects will be randomized. Subject follow-up will continue for 1.5 to 5 years. Discussion: Suicide is a complex phenomenon that encompasses multiple factors. Case management by multi-sector collaboration is needed. ACTION-J may provide valuable information on suicide attempters and may develop effective case management to reduce future risk for suicide attempters. Trial registration: UMIN Clinical Trials Registry number, UMIN000000444. ClinicalTrials.gov number, NCT00736918. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

Recent nuclear accidents have prompted renewed interest in the fitness consequences of low-dose radiation. Hiyama et al. provided information on such effects in the Japanese pale grass blue butterfly in a paper that has been viewed more than 300,000 times, prompting a barrage of criticism. These exchanges highlight the role of scrutiny in studies with potential effects on humans, but also raise questions about minimum requirements for demonstrating biological effects. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

The triple goals of Universal Health Coverage (UHC) are to cover the whole population, to reduce patients' costs, and to expand coverage to all effective services, equitably available to all. This paper analyses the experience of Japan in achieving these goals, focusing on the central role played by the payment system. The payment system, or fee schedule, sets the price of services and pharmaceuticals, as well as the conditions that providers must comply with in order to receive payment. The fee schedule was first introduced following the enactment of social health insurance (SHI) in 1922. Initially, the SHI program covered only manual workers, who comprised a mere 3% of the population. However, the fee schedule of the largest SHI plan was subsequently adopted by all other SHI plans. From 1958, there has been only one fee schedule. Population coverage was achieved in 1961 by mandating all residing in Japan to enroll in SHI, thereby making everyone entitled to all the services and pharmaceuticals listed in the fee schedule. Next, co-insurance was capped to an affordable level by the introduction of catastrophic coverage in 1973. Lastly, extra billing and balance billing were explicitly restricted in 1984. The key to achieving and sustaining UHC goals in Japan lies in being able to contain costs and reallocate resources by revising the fee schedule. [ABSTRACT FROM AUTHOR]

Background: As research in family medicine covers varied topics, multiple methodologies such as qualitative research (QR) and mixed methods research (MMR) are crucial. However, we do not know about the difference in the proportion of QR or MMR between Japan, the UK and the US. This knowledge is needed to shape future research within countries with developing primary care such as Japan and other Asian countries. This study aims to describe the use of QR and MMR in Japanese primary care and compare this to the UK and US; then to make informed recommendations for primary care research. Methods: A repeated cross-sectional study (2012–2016) based on the abstracts submitted to the annual conferences of the Japanese Primary Care Association in Japan, the Royal College of General Practitioners in the UK, and the North American Primary Care Research Group in the US and other North American countries. The proportions of QR/MMR among all the posters and paper presentations for each of these three conferences were assessed. Also examined were trends and types of qualitative techniques for all three countries and participants/settings for Japan. Results: There were 1080 abstracts for Japan, 575 for UK and 3614 for US conferences. QR/MMR proportions were 7.5%, 15.1% and 28.1%, respectively. Japan's proportion was lower than that of UK and US (p < 0.001). The proportion was increasing over time for the UK (p = 0.02). Steps for coding and analyses was most popular for Japan, thematic analysis for the UK and grounded theory for the US. Primary care doctors and hospitals were the commonest contexts for Japan. Conclusions: QR and MMR were not as popular in primary care in Japan compared to the UK and the US, whereas their use was increasing in the UK. Approaches, participants and settings may differ among these countries. Education and promotion of QR/MMR and multi-disciplinary collaborations need to be recommended in Japan with developing primary care. [ABSTRACT FROM AUTHOR]

Background: Constant evaluation is important for maintaining and improving the quality of end-of-life care. We therefore conduct the fourth Japan Hospice and Palliative Evaluation Study (J-HOPE4) as a continuous evaluation study. In this present paper, we describe the design of J-HOPE4. The main purposes of J-HOPE4 are as follows:1) to evaluate the processes, structures, and outcomes of palliative care acute hospitals, palliative care units, and home hospice services; 2) to examine bereaved family members' self-reported psychosocial conditions, such as grief and depression as bereavement outcomes;3) to provide data to ensure and improve the quality of care provided by participating institutions via feedback based on the results from each institution; and 4) provide clinical and academic information concerning the implications of various issues in palliative care by conducting additional studies. Methods: We will conduct a cross-sectional, anonymous, self-reported questionnaire survey. In total, 190 institutions will participate in this study, meaning that 12,000 bereaved family members will be sent a questionnaire. Discussion: This is one of the largest cross-sectional surveys involving hospice and palliative care, both in Japan and worldwide. Because this study will have a large sample size, the findings are expected to be generalizable to other settings. [ABSTRACT FROM AUTHOR]

The specimens of Paralepas maculata on a sea urchin, Prionocidaris sp. were collected in Okinawa, southern Japan. This species has not been reported since its original description. This represents the first observation of this species from Okinawa and the first instance found on this sea urchin species. In this paper, the morphology of the new P. maculata specimens is reported, and compared with the type series of this species. Small individuals were found on the holotype. The probable androdioecious sexual system of the species, which includes dwarf-male like individuals and hermaphrodites, is discussed. This study was facilitated by the collaboration of scientists and aquarium staff, suggesting the potential of such collaborations in biodiversity studies. [ABSTRACT FROM PUBLISHER]

Little is known about the egg extrusion site and behaviour of the coconut crab Birgus latro. We first succeeded to observe a single instance of egg extrusion of this species in their habitat on Hatoma Island, south-west of Okinawa, Japan, on the night of 5 June 2008. In this paper, we present details of the egg extrusion site and behaviour of the coconut crab. [ABSTRACT FROM PUBLISHER]