Ebetsu Active Future Study (EAFS) conducts comprehensive annual surveys of individuals who are independent in activities of daily living (ADLs) to track age-related physical and mental changes. These surveys include a variety of assessments such as cognitive function tests, physical function tests, blood tests, self-administered questionnaires about lifestyle and health, and interviews regarding medical and family history. In addition, serum, plasma and DNA samples from these assessments are stored at –80°C to facilitate future analyses and accommodate the potential addition of new measurement items. The purposes of this study are: (1) to identify potential blood-based biomarkers applicable to the detection of various types of mild cognitive impairment (MCI), (2) to explore diet-based strategies for preventing MCI and the progression of dementia, (3) to examine the relationship between urban characteristics, individual attributes and healthy life expectancy in Ebetsu City and (4) to return the research findings to the city.
From August to October 2023, EAFS invited Ebetsu residents to participate in the study. As a result, 1340 individuals applied and 1189 residents aged between 55 and 75 years who were independent in ADLs participated in the baseline survey for the first year.
EAFS initiated a follow-up of 1189 participants (38.9% male; 64.5±5.6 years) in the baseline year of 2023 and maintained a high follow-up rate of 98.5% by wave 3 (2025). The Montreal Cognitive Assessment-Japanese demonstrated that 53.6% of the participants had operational MCI. The proportion of participants with operational MCI increased with ageing. Regarding the APOE4 gene, which is associated with an increased risk of Alzheimer’s disease, 1.2% of the total population were homozygous carriers and 22.1% were heterozygous carriers.
EAFS will conduct annual follow-up surveys until 2032. In addition to analysing data for each objective, we also plan to perform further analysis of the stored specimens.
Methadone exerts analgesic effects through μ-opioid receptor affinity and N-methyl-D-aspartate receptor antagonism, which may benefit refractory cancer pain with neuropathic components. Methadone can be introduced by the ‘stop-and-go’ (SAG) method or the ‘add-on’ (AO) method, in which low-dose methadone is added to existing opioids. Observational studies suggest AO may improve pain control but no double-blind randomised controlled trial (RCT) has evaluated this approach. Therefore, the primary aim of this study is to assess the feasibility of conducting a double-blind RCT comparing methadone AO therapy with opioid dose escalation according to standard practice for refractory cancer pain while also exploring safety and preliminary efficacy signals.
A two-centre, randomised, double-blind, two-arm feasibility trial will enrol 22 patients with advanced or recurrent cancer and inadequately controlled pain (oral morphine equivalent daily dose 60–300 mg). Participants will be allocated 1:1 to the methadone AO or opioid-escalation group using a web-based randomisation system with the minimisation method. The primary endpoint is the completion rate of the 2-week study treatment. Secondary outcomes include pain intensity (Brief Pain Inventory), time to adequate pain control, achievement of a personalised pain goal, adverse events (Common Terminology Criteria for Adverse Events (CTCAE)/Patient-Reported Outcomes version of the CTCAE) and quality of life (European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Core 15-PAL). Feasibility will be determined based on achieving a treatment completion rate of 70% or higher.
The protocol was approved by the Certified Review Board of the National Cancer Centre Hospital (CRB3180008). Written informed consent will be obtained from all participants. The trial is registered in the Japan Registry of Clinical Trials. Results will be published in peer-reviewed journals and presented at international conferences.
jRCTs031240220.
To describe preconception care health literacy among medical students and examine knowledge–behaviour gaps across academic years and by future parenthood intention.
Cross-sectional online survey.
Kawasaki Medical School, Japan.
Medical students in years 1–6. A total of 613 students were included in the analysis.
Preconception care health literacy was assessed using a validated Japanese preconception care-specific scale comprising a knowledge domain (13 true/false/do not know items; total score 0–13) and a behaviour/skills domain (25 4-point Likert items; total score 25–100). Domain scores were compared across academic years and future parenthood intention groups. Multivariable linear regression analyses were performed adjusting for age.
The mean age of participants was 22.53 years (SD 2.19). The mean knowledge score was 9.99 (SD 2.60) and the mean behaviour/skills score was 73.66 (SD 12.25). Knowledge scores increased with academic progression (year 1, 8.47 (SD 3.00); year 6, 11.14 (SD 1.34); p
Integrating skills-based training and reflective life-planning components into medical curricula may help strengthen preconception-related behaviours in medical students and may have indirect implications for their future readiness to support preconception care.
The global prevalence of heart failure continues to increase, particularly in ageing populations. Many older patients receiving home-based medical care have limited access to standard diagnostic tools, such as chest radiography and echocardiography, which can delay the detection of disease progression. AMI-SSS01, an artificial intelligence (AI)-based portable phonocardiography device, enables rapid and reproducible analysis of heart sounds, potentially allowing earlier identification of heart failure exacerbations in home-based medical settings. This trial aims to evaluate the feasibility and safety of implementing the AMI-SSS01 phonocardiography system in patients receiving home-based medical care.
This two-arm, parallel-group, randomised controlled feasibility trial is being conducted at two primary care clinics affiliated with the Research Organisation for Education and Network in Primary Care-Based Research Network in Nagasaki, Japan. Participants aged ≥65 years with symptomatic heart failure receiving home-based medical care are eligible for study inclusion. Participants are randomised in a 1:1 ratio to either the intervention group, in which AI-assisted phonocardiography using the AMI-SSS01 device is performed during physician home visits, or the control group receiving conventional home-based medical care without phonocardiography. Feasibility outcomes include recruitment rate, overall data completeness and completion and protocol-concordant completion rates for phonocardiography examinations. Safety outcomes include adverse events related to device use. The registered primary clinical outcome, collected as an exploratory clinical outcome, is the time from randomisation to hospitalisation for heart failure or cardiovascular death during the 24-week follow-up period. The registered secondary clinical outcome is the number of heart failure exacerbation events.
Ethical approval was obtained from the Nagasaki University Hospital Clinical Research Ethics Committee (CRB24-028). The findings will be disseminated through peer-reviewed publications and scientific conferences.
Japan Registry of Clinical Trials (jRCT1072240118).
by Gen Tsujio, Masakazu Yashiro, Yuichiro Miki, Kohei Matsuoka, Koji Maruo, Mami Yoshii, Tatsuro Tamura, Katsunobu Sakurai, Takahiro Toyokawa, Naoshi Kubo, Shigeru Lee, Tomohisa Okuno, Kishu Kitayama, Go Masuda, Masaichi Ohira, Kiyoshi Maeda
BackgroundOur group revealed that the combination of intra-operative stamp cytology and peritoneal lavage cytology (CY) improved the identification of individuals with high risk of peritoneal metastasis. In this exploratory Phase II study, we aimed to evaluate the effect on relapse-free survival (RFS) of extensive intraoperative peritoneal lavage (EIPL) for gastric cancer with positive peritoneal cytology (CY1) and/or stamp cytology positive (stamp+).
Materials and methodsThis study was a single arm, multi-institutional, exploratory phase 2 trial to assess the effects of EIPL after open gastrectomy for gastric cancer with CY1 and/ or stamp+. The primary endpoint was RFS. Secondary endpoints were overall survival (OS), postoperative recurrence site and incidence of postoperative adverse events.
ResultsBetween 2017 and 2021, 13 patients from 2 institutions were enrolled in this study. Because of the recent decline in open abdominal surgery, the number of cases did not increase and the trial was closed due to lack of applicants at 13 cases. Median 3-year RFS was 14.5 months (95% CI 5.4-NA), median 3-year OS was not reached (95% CI 14.5-NA) and median3-year peritoneal RFS was 16.0 months (95% CI 5.4-NA). Median 3-year peritoneal RFS rate was 83% in CY0 and stamp+ cases (n=6), and 0% in CY1 and stamp+/- cases (n=7). (Log-rank p=0.015).
ConclusionBecause of the slow accrual pace and early stop of the trial, we were not able to evaluate the prespecified endpoints thoroughly. However, EIPL might be effective to prevent perineal recurrence, especially in CY0 and stamp+ case.
To clarify how public health nurses allocate their time across various tasks and compare time-use patterns between prefectural and municipal public health nurses in Japan, where distinct administrative mandates define their roles.
A self-reported, prospective time study.
Public health nurses from two municipalities and one prefecture recorded their daily practices and time allocations using Kintone. Time allocation differences by administrative level and job position were analysed using linear mixed-effects models.
Overall, 121 participants contributed 9502 person-days of data. Participants spent an average of 463.6 min/workday on work-related activities. Municipal public health nurses dedicated more time to application paperwork (64.0 min), health examinations (57.6 min), and individual coordination (48.3 min). Prefectural public health nurses allocated more time to business management and organisational operations (69.0 min) and traveliing, particularly in rural contexts. Managers spent less time on direct care and more on administrative tasks.
This study provides the first quantitative, self-reported evidence of task distribution among public health nurses across administrative levels and positions. The findings reflect structural differences in role expectations and underscore the need to reallocate workloads to better align with each level's mandate.
Task prioritisation, information and communication technology tool integration, and administrative support are essential in optimising public health nurses' contributions to community health. These strategies can reduce non-clinical workload and enable public health nurses to focus on high-impact, value-added public health services that promote health equity.
This study closes a longstanding gap by quantifying PHNs' time allocation, revealing the hidden burden of administrative work, and providing critical insights for workforce planning and sustainable public health service delivery.
This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology guideline.
No Patient or Public Involvement.
UMIN Clinical Trials Registry; UMIN000051509 (https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000058761; August 1, 2023)