Ministry Of Labour Research Articles

Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.

New drug applications (NDAs) in Japan are reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA). Those that pass the review are subsequently subject to deliberation by the Ministry of Health, Labour and Welfare Pharmaceutical Affairs and Food Sanitation Councils (MHLW-PAFSC), and the MHLW legislatively grants approval based on its positive opinions. However, little is known regarding the relationship between the PMDA review and the MHLW decision. We retrospectively assessed the MHLW decision of NDAs that passed the PMDA review at the initial MHLW-PAFSC deliberation from 2002 to 2022. The reasoning behind a non-supportive opinion from the MHLW-PAFSC and the sponsor's actions to overcome unresolved issues were also documented. A total of 2,117 of 2,153 (98.3%) NDAs that passed the PMDA review were approved at the initial MHLW-PAFSC deliberation with a positive opinion. The remaining 36 applications were not approved at the initial deliberation and subjected to continued deliberation because of a non-supportive opinion from the councils, although 29 were finally approved through revision of the application document (24 applications), re-analysis of the data (1 application), or additional clinical trials (4 applications). Seven applications have not been approved, of which one was refused, four were withdrawn, and two were unknown. The MHLW approves NDAs that passed the PMDA review at the initial deliberation at a high rate, suggesting that NDAs only suitable for approval passed the review and reached the MHLW-PAFSC deliberation. Only a few NDAs were not approved at the initial deliberation; however, most of them were finally approved.

Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan.

Recent progress in materials chemistry has resulted in the development of several ceramic materials that are now being used in dental implants. The advantages of ceramic materials over conventional metallic materials are that they do not induce allergic reactions in individuals with metal allergies, they do not interfere with magnetic resonance imaging, and they provide improved esthetics. In addition, some ceramic materials are tougher than metallic materials and less brittle. However, despite these advantages, few ceramic dental implant materials are currently approved for use in Japan. In FY2022, the Ministry of Health, Labour and Welfare of Japan commissioned a project called the "Project for the Development of a Guideline for the Evaluation of Ceramic Dental Implants," the goal of which was to consider how best to facilitate swift clinical development and approval of emerging ceramic dental implant materials. At a meeting of experts from professional societies, related industry organizations, and government agencies, the issues related to evaluation of the efficacy and safety of ceramic implant were discussed. Here, we summarize the outcomes of that meeting as a set of principles for the premarketing evaluation of ceramic dental implant materials in Japan.

Effects of frequently prescribed antiseizure medications on motor vehicle driving performance: Narrative review based on a tiered approach for the assessment of clinically meaningful driving impairment in the Ministry of Health, Labour, and Welfare guideline.

Patients with epilepsy often require long-term treatment with antiseizure medications, and their impact on daily activities, particularly driving, is of significant concern. The recently published "Guideline for Evaluating Effects of Psychotropic Drugs on the Performance to Drive a Motor Vehicle" in Japan provides a framework that can be referred to for not only the evaluation of new drugs but also the reevaluation of approved drugs. This study conducted a literature review regarding the effects of carbamazepine, valproate, lamotrigine, lacosamide, and levetiracetam, which are frequently prescribed for epilepsy, on driving performance following the guideline's tiered evaluation approach. Analyses of pharmacological, pharmacodynamic, and adverse events suggested that these drugs primarily affect arousal function. Driving studies showed that acute administration of carbamazepine, but not chronic monotherapy with carbamazepine, valproate, lamotrigine, and levetiracetam, significantly impairs driving performance. Epidemiological studies have not identified a definitive association between these drugs and traffic accidents. Initial administration of these five antiseizure medications may affect driving performance, warranting special attention, but the influence appears to diminish with continued use. Nevertheless, while long-term administration of these five drugs may not have a clinically meaningful effect on driving performance, safe driving is not guaranteed for each individual patient, and appropriate individualized guidance is important in clinical practice.

Petrol Pumps to Power Plugs: Is the Surge in Electric Two-Wheeler Adoption in Kathmandu Due to Unstable Petroleum Prices?

Since the dawn of the 21st century, the awareness towards environmental concern and sustainability slowly began to rise and the “Electric Wave” truly encompassed the world with electric automobiles. Nepal was no exception to this global electric wave. This research explores a key determinant behind this transition, the influence of fluctuating petroleum price. Using secondary data obtained from registrations of electric and petroleum two-wheelers at the Transport Management Office in Kathmandu, under the Ministry of Labor, Employment, and Transport as well as historical petrol prices over the past 4 years from 2019 to 2023, this research seeks to offer valuable insights into the connection between petrol prices and the adoption of electric vehicles in Kathmandu, Nepal. Using SPSS software, a linear regression analysis was conducted and it revealed that while petroleum prices played a role, they were not the sole determinant affecting adoption. This study contributes to the growing body of knowledge on sustainable transportation choices and their drivers. It provides valuable insights for policymakers, consumers, and industry stakeholders, as it underscores the influence of fuel prices on consumer choices and the potential for electric two-wheelers to become a viable alternative in the context of Kathmandu’s urban transport.

Prioritization of Evaluation Items for Industrial Accident Prevention Factors Using the Fuzzy TOPSIS Technique

With the rapid progress of industrialization, serious accidents have frequently occurred at industrial sites. Despite the existence of several laws and regulations for preventing industrial accidents, including the Occupational Safety and Health Act, social criticism has been raised regarding their inefficiency. To address this issue, the Serious Accident Punishment Act was implemented. The Ministry of Employment and Labor and the Korea Safety and Health Agency have prepared and implemented various industrial accident prevention measures and programs; however, the number of industrial accidents has not decreased. Therefore, new evaluation criteria must be introduced when establishing policies or systems to prevent industrial accidents. This study introduces evaluation items used in Europe and the United States as industrial accident prevention items for assessing industrial accident prevention projects and proposes a plan to select priorities for these items by applying the fuzzy TOPSIS technique. Prioritization was determined by calculating four evaluation criteria and ten industrial accident prevention items using a 7-point linguistic scale. Our results allow for the simultaneous consideration of several industrial accident prevention items. Thus, various aspects of industrial accident prevention activities can be comprehensively evaluated, enhancing the effectiveness and execution of safety and health management, thereby helping to reduce industrial accidents.

Digital rehabilitation care planning for people with chronic diseases (RehaPro-SERVE): study protocol for a German multicentre randomised controlled trial

BackgroundChronic diseases are a significant and growing problem of our time. They impair the ability to work and increase the risk of early retirement. To support the return to work, rehabilitation services can be applied for in Germany. Currently, the application system for rehabilitation allows only a limited degree of individualisation of the treatment and is associated with a lack of multidisciplinary communication. To facilitate rehabilitation care planning, we developed a complex intervention. A digital, platform-based case management approach (intervention) will ensure multidisciplinary communication and the tailored selection of medical treatments and/or non-medical support measures. The overall objective is to assess the effectiveness of the intervention compared to treatment as usual (control condition). The German Federal Ministry of Labour and Social Affairs (BMAS) funds the RehaPro-SERVE study (grant number: 661R0053K1).MethodsThis is the protocol for an investigator-initiated, pragmatic, multicentre, randomised and controlled two-arm parallel-group superiority trial with embedded qualitative process evaluation. The study will be conducted in Hesse state, Germany. N = 59 primary care physicians will be recruited and tasked with the recruitment of six eligible patients each. Eligibility criteria: age 40–60; minimum of 4-week work disability due to musculoskeletal, oncologic or psychological conditions or the post-COVID-19 syndrome within the last 6 months; at high risk for early retirement. In total, n = 352 patients will be randomised with a 1:1 allocation to intervention or control group and stratified by primary care practice using permuted blocks. The primary outcome is the number of days of sick leave during a 12-month period after the assumed completion of treatments (t1 to t2). Secondary outcomes include the number of days of sick leave (self-report), work ability, and health-related quality of life, as well as data from the qualitative process evaluation.DiscussionThe results of the study will inform the design of future care services and provide valuable information on multidisciplinary case management in the context of rehabilitation care planning. The results of the qualitative process evaluation will further contribute to the understanding of facilitating and hindering factors.Trial registrationDRKS-German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021.

Distinguishing factors in regional variations of TAVI in Japan: the unique role of administrative facility standards compared to other procedures in a high-cost medical care subsidy system

Abstract Background Transcatheter aortic valve implantation (TAVI) is less invasive than surgical aortic valve replacement and is becoming increasingly popular worldwide, particularly among patients with aortic valve stenosis (AS) due to aging. However, regional differences are expected to exist not only between countries but also within a single country. Reports from Western countries indicate the presence of regional differences in TAVI and the reasons for these differences, which include differences in medical infrastructure, economic resources, health insurance systems and policies, geographic factors, and availability of specialized medical personnel. TAVI is expensive, but in Japan, the economic aspect is relatively unimportant due to the high-cost medical assistance system. Furthermore, there is little socioeconomic disparity between regions. In such a society, we have reported that the number of specialists and resources for PCI can explain regional differences in ablation and endovascular treatment (EVT). However, unlike those other cardiovascular procedures, there are specific requirements for facilities to perform TAVI, such as the number of transesophageal echocardiographies, as well as cardiologists and cardiovascular surgeons, and the equipment itself, such as hybrid operating rooms. We examined how these facility requirements, which are thought to be controlled by the government, are related to regional differences in TAVI implementation. Methods and Results We used the Japanese Ministry of Health, Labour and Welfare national database to determine the rate of TAVI for patients with AS performed per 100,000 population aged ≥40 years in all 47 prefectures in 2022. A linear regression model was developed to assess factors contributing to the regional medical supply, including the rates of PCI per 100,000 population aged ≥40 years and the numbers of cardiologists, cardiovascular surgeons, cardiovascular intervention and therapy training facilities, cardiovascular surgery base facilities, and TAVI facilities. The numbers in the highest and lowest regions were 26.6 and 3.9 (a 6.8-fold difference) for TAVI number. The number of TAVI facilities contributed most significantly to the TAVI volumes (P = 0.0105), while the rates of PCI and other factors did not contribute significantly. The number of TAVI facilities was positively correlated with the number of transesophageal echocardiographies the most (r = 0.353). Conclusion This study revealed large regional variations in TAVI volumes in Japan, of which administrative facility standards were a major determinant.

Development and validation of a self-esteem improvement program for family caregivers with dementia ‐ Utilizing ICT

The sense of caregiving burden can be significant among family caring for people with dementia and can impact mental health. Research to find ways to alleviate this burden is extremely important. Dr Yoshihiro Saito, Faculty of Nursing, Reiwa Health Sciences University, Japan, is leading a team working to develop and validate a self-esteem improvement programme designed for family caregivers of those with dementia. The project was inspired by Saito experiencing firsthand the stresses placed on family carers of people with dementia. The goal of the programme is to reduce the self-blame of dementia family caregivers and is informed by Saito’s expertise in cognitive behavioural therapy. A key part of the programme is self-compassion in order to help caregivers realise their worth. Ultimately, the aim is that, through the programme, caregivers can be kinder to themselves and realise the value and significance of their efforts. Alongside heading up this project, Saito is a supervisor for the Cognitive Behavioural Therapy Training Programme of the Ministry of Health, Labour and Welfare in Japan, focusing on popularising cognitive behavioural therapy and training the next generation. In this role, he listens to and reviews recordings of cognitive behavioural therapy sessions, providing practical advice. In the context of Japan’s ageing population, there will be an increase in people with dementia and family caregivers. Therefore, Saitoâ–™s work will be hugely beneficial in assisting those with dementia, caregivers and society.

3.O. Scientific session: Migrant labour exploitation and health: How can research foster protection of migrant workers?

Abstract Migrant workers sustain essential industries such as the food supply chain, construction, and domestic and care work. They tend to perform onerous and risk-laden tasks at low pay without employment or health protections, and often under exploitative terms (e.g., debt bonding, piecework). Current evidence on associations between migration, employment terms and conditions, and health indicates profound inequities in work-related health outcomes for migrant workers. Although the COVID-19 pandemic highlighted these disparities and their potential social and public health implications, migrant workers continue to be overlooked by public health scholars and policymakers. Supranational regulations (such as EU directives) and national policies rarely consider migrants in their role as workers, and little research is dedicated to questions at the intersection of migration, employment, and health. The invisibility of migrant workers is also a matter of disciplinary and sectoral silos, with different aspects of migrant labour regulated separately by Ministries of Immigration, Labour, Agriculture, Health, and others. These silos create incompatible, context-contingent definitions, terminologies, and administrative categorizations, leading to inconsistent data collection and data gaps which, in turn, translate into policy blind spots. Data that are comparable across contexts and that refer to migration, employment/work and health are generally scarce. For some sectors and contexts, virtually no data exist; e.g., for migrant workers in agriculture, construction, and domestic work, and for migrant workers in low- and middle-income countries. There is barely any evidence about interventions to improve the structures that dictate migrant workers’ employment conditions or obligations of employers. Given the limited participatory research with migrant workers, we have a very poor understanding of their views and viable intervention options, and migrant workers’ voices thus also remain absent from policymaking. This workshop aims to contribute to greater visibility of - and ultimately action on - migrant labour exploitation in research and policy. To this end, it will map current challenges and shortcomings in generating evidence on the links between migration, work/employment, and health; and it will suggest ways to improve research and interventions to address migrant workers’ health, based on the speakers’ experience in developing intervention-focused evidence in different contexts. The workshop will conclude with an open discussion to identify further relevant questions and elaborate steps towards better research and greater protections for mobile worker populations. Key messages • Harm from exploitative working conditions among migrant workers is substantial, yet data collection methods and intervention designs are limited. • For public health research to effectively help protect the health and rights of migrant workers, it is essential to share methods and insights across disciplines to drive research for action.

Human papillomavirus vaccine to prevent CIN3 or worse (CIN3+): A nationwide case-control study in Japan.

An increase in cervical cancer incidence has been reported in Japan. The Ministry of Health, Labor, and Welfare of Japan has resumed the active recommendation of regular HPV vaccines in 2022. In Japan, the preventive effect of CIN3+ in the real world has not yet been demonstrated in age-adjusted cohort or case-control studies. This study aimed to estimate the effect of the HPV vaccine against CIN3+ in Japanese women. This nationwide case-control study from April 2013 to March 2020 targeted women aged 20-26 years old at the time of cervical screening. We compared HPV vaccination exposure between those with abnormal and those with normal cytology. Abnormal cytology was classified into cervical intraepithelial neoplasia (CIN)1+, CIN2+, and CIN3+. We calculated the odds ratio (OR) and 95% confidence interval (CI) of the above endpoints and vaccination exposure using the conditional logistic regression model and estimated vaccine effectiveness using the formula (1 -OR) × 100. A total of 2790 cases and 13,990 controls (one-to-five matching) were eligible in 37 municipalities in Japan. In this study, 61 CIN3 (2.2%) and 10 squamous cell carcinomas (SCC) (0.4%) were found. The OR for CIN3+ versus controls was 0.14 (95% CI, 0.03-0.75), equating to a vaccine effectiveness of 86%. Of the 10 patients who had SCC none were vaccinated. This nationwide case-control study in Japan demonstrated a substantial risk reduction in CIN3+ among women who did versus those who did not receive HPV vaccination.

Assessing the development of a human-centered economy in Russia: A methodological approach

Aim. To build and sub stantiate the author’s methodology for assessing the development of human-centered economy. In view of the insufficiency of theoretical and empirical research in the field of formation and development of economy for human beings, the demand for this scientific research is actualized in order to better meet human needs.Objectives. To develop a methodology for assessing the development of human-centered economy; to test it on the example of the Russian Federation (RF), including Russian regions.Methodology. The methodological basis of the study was formed by the provisions of the theory of human-centered economy. The methods used include normalization, linear scaling, and “series of information criteria” methods. Visualization of the obtained results was carried out on the basis of spatial modeling software package GeoDA. The information base was the data of the Federal State Statistics Service (Rosstat), the Unified Interdepartmental Information and Statistical System, the Ministry of Labor and Social Protection of the Russian Federation, the Ministry of Culture of the Russian Federation, the Ministry of Science and Higher Education of the Russian Federation, the Ministry of Sports of the Russian Federation, Rospatent for 2018-2022.Results. The methodology for calculating the integral index of human-centered economy development has been developed. It was calculated by integrating 87 specific indices and eight subindices. The process of research revealed that this economic system is at the initial stages of development with isogressive-regressive trajectory, has insignificantly developed constituent components in the form of creative and cognitive spheres.Conclusions. The proposed methodology provides a basis for further scientific research in similar studies, as well as for the formation of targeted measures to support the challenging spheres of human activity and human-centered economy as a whole.

Clinical manifestations of interstitial cystitis and bladder pain syndrome: Analysis of a patient registry in Japan.

To describe clinical manifestations of patients with interstitial cystitis and bladder pain syndrome (IC/BPS) using a patient registry in Japan. This retrospective cohort study utilized a patient registry supported by the Japanese Ministry of Health, Labor, and Welfare. Patients were classified as IC or BPS based on cystoscopic findings. Data on demographics, comorbidities, symptom severity, pain intensity, and bladder function were collected and we evaluated the differences in clinical characteristics between IC and BPS, and used multivariate analysis to search for additional factors that might contribute to pain. A data set comprising 529 patients was obtained from 14 university hospitals. 66.5% of the cases were classified as IC and 33.5% as BPS. IC patients were significantly aged and female-dominant. Comorbidities such as autoimmune diseases were more prevalent in IC patients. All of the symptom severity, quality of life impairment, and bladder function were significantly worse in patients with IC. Urinary frequency and maximum voided volume on the Frequency-volume chart were 18.8 times and 15.0 times, and 160.9 and 214.1 mL, respectively. Bladder capacity under anesthesia was 293.8 and 472.6 mL, respectively. Maximum voided volume and the number of Hunner lesions were significant predictors of pain in IC patients. The analysis revealed clinical manifestations of IC/BPS using the largest cohort in Japan. The results indicated higher age, higher female proportion, and higher symptomatic and functional severity in IC patients compared to BPS.

Effect of oral health on functional disability and mortality in older adults in Japan: a cohort study.

Oral health has previously shown associations with functional disability and mortality. We aimed to explore the associations of various aspects of oral health status with functional disability and mortality using survival analysis, as well as the relative magnitudes of the impact of these aspects on outcomes. We obtained data for individuals aged 75years and older in Shimane, Japan, who had at least one oral health check-up between April 1, 2016, and March 31, 2022under Japan's long-life medical care system insurance system. Those with missing data or with functional disability at baseline were excluded. 13aspects of oral health status were assessed by dentists or dental hygienists as part of the check-up (using protocols provided by the JapanDental Association and the Japanese Ministry of Health, Labour and Welfare): number of remaining teeth, subjective masticatory performance, objective masticatory performance, periodontal tissue status, functional dysphagia, tongue mobility, articulation, oral hygiene, number of decayed teeth, inadaptation of dentures of the upper jaw and lower jaw (considered separately), oral mucosal disease, and dry mouth. Multivariate Cox proportional hazards models were used to analyse the associations between each aspect of oral health and functional disability and mortality, with fully adjusted models adjusting for sex, age, BMI, medical history, or a propensity score derived from these covariates. Population-attributable fractions (PAFs) were calculated to assess the differential impacts of these oral health status aspects on outcome occurrence. Of the 24 619individuals who had an oral health check-up during the study period, 21 881individuals wereincluded in the analysis of functional disability (9175 [41·93%] men, 12 706 [58·07%] women, mean age 78·31years [SD 2·88], mean follow-up 41·43months [20·80]), and 22 747individuals in the analysis of mortality (9722 [42·74%] men, 13 025 [57·26%] women, mean age 78·34years [2·89], mean follow-up 42·63months [20·58]). All 13aspects of oral health status showed significant associations with the occurrence of mortality, while functional disabilitywas associated with 11aspects (excluding oral mucosal disease and dry mouth) in the fully adjusted model. Based on PAFs, of all oral health aspects assessed, objective masticatory performance hadthegreatestimpact on both functional disability (PAF 23·10% [95% CI 20·42-25·69] for the lowest and 10·62% [8·18-12·99] for the second-lowest quartile of performance) and mortality (16·47% [13·44-19·40] and 8·90% [5·87-11·82]). Various aspects of oral health are associated with mortality and functional disability. Maintaining good oral health in older adults might help to reduce these outcomes. None.

Effectiveness and Safety of Matrix-Associated Autologous Chondrocyte Implantation for the Treatment of Articular Cartilage Defects: A Real-World Data Analysis in Japan

Background: The effectiveness and safety of matrix-associated autologous chondrocyte implantation with an autologous periosteal flap (pMACI) remain unclear. The Japanese Ministry of Health, Labor, and Welfare requires postmarketing surveillance of all patients undergoing pMACI using the tissue-engineered product JACC. Purpose: To evaluate the effectiveness and safety of pMACI for large articular cartilage defects (≥4 cm2) in the knee joint using real-world data analysis. Study Design: Case series; Level of evidence, 4. Methods: Data were collected from patients who underwent pMACI between 2012 and 2019, with 2 years of follow-up. The primary outcomes were the Lysholm knee score and Knee injury and Osteoarthritis Outcome Score (KOOS) at 6, 12, and 24 months. Adverse events were assessed by physical examination, magnetic resonance imaging, and/or arthroscopy. Results: Overall, 232 knees in 225 patients who presented with trauma (198 knees) or osteochondritis dissecans (34 knees) in the medial (132 knees) and lateral (44 knees) femoral condyle, patella (25 knees), trochlea (86 knees), and tibial plateau (4 knees) were included. The mean age of the patients was 40.9 ± 15.0 years, with mean cartilage defects of 5.6 ± 2.4 cm2 in size. Concomitant surgeries, such as osteotomy (50 knees), ligament reconstruction (27 knees), meniscal procedures (28 knees), osteochondral autograft transplantation (24 knees), and microfracture (14 knees), were performed in 113 (48.7%) knees. The minimal clinically important difference in the Lysholm knee score and KOOS Symptoms subscale was achieved in 79.7% and 63.5% of patients, respectively, and the Patient Acceptable Symptom State was achieved in 90.1% and 73.7%, respectively. Substantial clinical benefit was achieved in the KOOS Sports/Recreation and Quality of Life subscales at 39.6% and 37.8%, respectively. Knees that underwent concomitant microfracture had significantly worse KOOS values than the remainder of the cohort. Complications, including effusion (16.8%), graft delamination (14.7%), knee contracture (9.1%), graft hypertrophy (8.2%), and ossification (3.4%), were observed in 86 (37.1%) knees. Osteochondritis dissecans was significantly associated with graft hypertrophy and ossification, whereas concomitant surgery was significantly associated with delamination and contracture. Treatment failure required additional cartilage procedures in 11 (4.7%) knees. Conclusion: Treatment of large cartilage defects (≥4 cm2) with pMACI resulted in improved outcome scores in approximately 75% of patients. However, complications occurred in one-third of patients, and 4.7% required reoperation.

Current situation and trends of radiation therapy in Japan based on the National Database Open Data.

This study aimed to visualize the current situation and trends in radiation therapy in Japan using open data from the Japanese National Database of Health Insurance Claims and Specific Health Checkups (NDB). We downloaded the NDB open data from the website of Japan's Ministry of Health, Labor and Welfare and used Python libraries to analyze the receipt data related to radiation therapy from fiscal year 2014 to 2022. The number of radiation therapy plans peaked in 2019, temporarily declined and subsequently showed a gradual increase. Conversely, the total points associated with radiation therapy have consistently increased without any decline. The use of high-precision radiation therapies such as intensity-modulated radiation therapy (IMRT) has increased over time. Significant regional differences exist, with the Chubu and Kyushu regions showing higher total points and receipts per certified radiation oncologist. A correlation was observed between the number of IMRT plans per population and the number of certified radiation oncologists. Males exhibited a sharp peak in their early 70s, while females demonstrated a mild peak from their 40s to 80s. In recent years, the points for males in their early 70s have rapidly increased. We used the NDB open data to illustrate the current situation and trends in radiation therapy in Japan, highlighting reduced costs and workloads. This study underscored the regional differences in radiation therapy and emphasized the need to discuss strategies for meeting future demand.

Self-transcendence: Design Criticism in the 1928 Shanghai Exhibition of National Products

Abstract After establishing the Shanghai port in 1843, Western machine-made products inundated the Chinese consumer market, disrupting the local Chinese economic system. To foster the advancement of national industries, the Nanking nationalist government held the Ministry of Industry, Commerce, and Labour’s Exhibition of National Products in 1928, providing a platform for public discourse on the design of national products. This article analyses the progression of three representative types of early design criticism that emerged from the Exhibition of National Products. These criticisms examined the design’s economic benefits, responsiveness to cultural needs, and influence on shaping social consensus. Their progressive development can be characterized as a form of self-transcendence, indicating a move by critics beyond past limited understandings of the value, sphere of influence, and design’s role in society. Their focus transitioned from the economic interests of minorities to the diverse needs of broader social groups. In the process of self-transcendence, these design criticisms expanded the horizons of designers’ work. They facilitated collaborations between design and various industries, including production, consumption, and education, influencing broader socioeconomic and ideological fronts.

7055 Metabolic Disorders In Thalidomide Embryopathy

Abstract Disclosure: A. Tanabe: None. Thalidomide embryopathy (TE) is a congenital limb defect that occurs in neonates born to pregnant women who have taken thalidomide. Typical abnormalities of the TE are upper limb hypoplasia and and/or auditory dysfunction. In Japan, thalidomide was marketed as an agent for sleep-induce and digestive ulcers from 1958 to 1962. Up to now, approximately 290 cases have been certified and are supported by the government as drug-induced disease. Currently, many of the victims are in their late 50s, and in addition to congenital disabilities, various health issues such as lifestyle-related diseases can be developed. We investigated their metabolic condition using data of medical health checkup between 2017 and 2018. Fifty-one Japanese cases of TE (28 men and 23 women) were included in this study. The mean age was 56.4±1.6 years in men and 55.9±1.2 years in women. The prevalence of upper limb deformities was 64% in men and 74% in women; the remaining patients had only hearing impairment. The mean body mass index (BMI) was 22.7±2.1 in men and 22.5±4.0 in women. Eleven percent of men and 17% of women had a BMI between 25-30, while 9% of women and no men had a BMI of 30 or greater. Liver dysfunction was seen in 32% of men and 9% of women. The mean high-density lipoprotein cholesterol level was 60±17 mg/dL in men and 68±18 mg/dL in women. The mean low-density lipoprotein (LDL) cholesterol level was 120±28 mg/dL in men and 136±35 mg/dL in women, with 25% of men and 48% of women had LDL level of 140 mg/dL or greater. The mean triglyceride (TG) level was 144±85 mg/dL in men and 116±61 mg/dL in women, with 43% of men and 17% of women had a level of 150 mg/dL or greater. The mean HbA1c level was 6.0±1.0% in men and 5.9±0.4% in women. The prevalence of impaired glucose tolerance was 25% in men and 13% in women. Fatty liver (FL) evaluated by ultrasonography or CT scan was 61% in men and 39% in women. The patients with FL showed significantly high body fat percentage and TG level in men, high alanine aminotransferase, γ-glutamyl transpeptidase and TG levels in women, respectively, compared to the patients without FL. The prevalence of hypertriglyceridemia was significantly higher in men with FL compared with men without FL. There was no significant difference in with or without the upper limb abnormalities in both groups. Although without obvious overweight, more than 40 % of the patients had dyslipidemia and 50% of the patients had FL. The limb abnormalities can result in movement limitations however other factors may be involved in the development of metabolic disorders in TE. The results of this study provide valuable information for future health management in thalidomide embryopathy. (This study was conducted by a research grant from the National Center for Global Health and Medicine, Japan: 21A1015 and a Grant-in-Aid from the Ministry of Health, Labour, and Welfare, Japan: 20KC2005, 23KC2017). Presentation: 6/2/2024

Economic impact of screening on postdiagnosis work productivity in Japanese women with breast cancer: a life-table modeling approach.

In Japan, biennial mammography screening has been recommended for the early detection of breast cancer (BC) in women aged 40years or above since 2004 by the Ministry of Health, Labor and Welfare. The purpose of this study is to estimate the economic impact of BC screening on work productivity, using a new measure called the productivity-adjusted life-year (PALY). We used a dynamic life table modeling approach to estimate the work productivity of female patients aged 40-64years diagnosed with BC in 2019 over the year of diagnosis and the subsequent 5years. Changes in life-years, PALYs, and gross domestic product (GDP) were assessed by changing the screening detection rate from the current (34.2%) to an ideal (100%) percentage. Each input for modeling was obtained from the most recent public database available. BC patients were estimated to lose 1903 in life-years, 3596 in PALYs, and US$281 million in GDP at the current screening detection rate compared with the ideal detection rate. On the other hand, the following gains are expected when the current screening detection rate was increased to 40-80%; life-years gain; 168-1325, PALYs gain; 317-2503, GDP gain: US$25-196 million. This study has used modeling to show that detecting BC without screening is associated with a lower work productivity and an economic and life-years loss. Encouraging BC screening may be beneficial to maintaining work productivity after diagnosis.

Survey on sound exposure for musician using a noise dosemeter

Recently, the Ministry of Health, Labour and Welfare (MHLW) in Japan has revised guidelines for the prevention of noise-induced hearing loss among workers in the workplace. The target group is workers who are engaged in noisy work in factories and construction sites. It is thought that it is not only those engaged in noisy work who are exposed to loud noises. We considered that musicians playing musical instruments are also exposed to loud noises on a daily basis. Therefore, we have considered protecting musicians from hearing loss by determining the extent to which they are exposed to loud sounds on a daily basis. As a basic study, we explored the daily sound exposure of professional musicians using a RION dosemeter, which was developed in accordance with the Guidelines for the Prevention of Noise Disturbance.

Guidelines for the diagnosis and treatment of idiopathic portal hypertension, extrahepatic portal obstruction, and Budd-Chiari syndrome in Japan.

This is the English version of the guidelines for the diagnosis and treatment of idiopathic portal hypertension, extrahepatic portal obstruction, and Budd-Chiari syndrome, which were established and revised in 2018 by the Aberrant Portal Hemodynamics Study Group under the jurisdiction of the Ministry of Health, Labor, and Welfare in Japan. These guidelines are excerpts, and the full version consists of 86 clinical questions and explanations, totaling 183 pages in Japanese.