Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

jRCTs031240007.

Burnout and reduced well-being are highly prevalent among Japanese medical students during clinical training. Scalable, evidence-based interventions are urgently needed. This protocol outlines a nationwide randomised controlled trial (RCT) to evaluate a self-guided, on-demand Acceptance and Commitment Training (ACT) programme for reducing burnout and improving well-being during clinical clerkships.

This two-arm, open-label, parallel-group RCT will recruit 128 Japanese medical students in clinical clerkships, randomised to on-demand ACT or no-intervention control. The ACT intervention comprises three self-guided online modules at weeks 0, 2 and 4, plus a 30 min online booster (weeks 8–10). Self-reported outcomes are measured at baseline, mid-intervention, postintervention and at 14-week primary endpoint (week 14). The primary outcome is medical student burnout (Oldenburg Burnout Inventory for Medical Students). Secondary outcomes include well-being (Mental Health Continuum-Short Form), professional burnout (Maslach Burnout Inventory–Human Service Survey), psychological flexibility (Work-related Acceptance and Action Questionnaire, Valuing Questionnaire), depressive symptoms (Patient Health Questionnaire-9), mental illness stigma (Mental Illness: Clinicians’ Attitudes Scale version 4), ACT process knowledge (ACT Check, applied section); adverse events and serious adverse events and adherence (platform completion and engagement metrics), all assessed at prespecified time points. Data will be analysed using mixed-effects models for repeated measures on an intention-to-treat basis.

This protocol was approved by the Nagoya City University Clinical Research Review Board (No. 70-22-0022) and registered with the Japan Registry of Clinical Trials (jRCT1042250024). Results will be disseminated via publications and conference presentations.

jRCT1042250024.

To evaluate the impact of Japan’s COVID-19 state of emergency declarations on percutaneous coronary intervention (PCI) volumes using Seasonal AutoRegressive Integrated Moving Average with eXogenous variables (SARIMAX) modelling. This model offers methodological advantages by: (1) accounting for trends, seasonal variations and autocorrelation; (2) allowing the introduction of policy intervention periods as binary exogenous variables; and (3) enabling an accurate assessment of healthcare impacts during intermittent declaration phases while accounting for periods of subsidence.

Retrospective observational study using a SARIMAX model.

1377 acute care hospitals participated in Japan’s Diagnosis Procedure Combination (DPC) system between April 2018 and December 2021.

All patients who underwent emergency PCI (n=176 878) or elective PCI (n=272 811) during the study period, identified from a nationwide administrative database.

This study analysed the impact of Japan’s COVID-19 state of emergency declarations as policy intervention periods, which were implemented during four waves (April to May 2020, January to March 2021, May to June 2021 and July to September 2021). Months where more than half of the days fell within a state of emergency declaration were defined as intervention periods.

Primary outcome measures were nationwide changes in both emergency and elective PCI volumes during state of emergency periods compared with non-emergency periods, analysed through SARIMAX modelling. Secondary outcomes included regional analyses of changes in both types of PCI volumes across eight geographical regions of Japan and the distribution analysis of medical resources (DPC hospitals, hospital beds, physicians and board-certified cardiologists per million population) in each region.

Nationwide, emergency PCI volumes totalled 176 878 and elective PCI volumes 272 811 over the 45-month study period. SARIMAX modelling indicated that the state of emergency declarations were associated with significant reductions in both emergency PCI volumes (–211.4 cases/month, 95% CI –326.9 to –95.9; –5.4%) and elective PCI volumes (–632.4 cases/month, 95% CI –1045.9 to –219.0; –10.4%). Regional analyses showed varied effects, with some areas (eg, Hokkaido, Shikoku, Kyushu) experiencing non-significant volume decreases, potentially reflecting differences in medical resource distribution and capacity.

The COVID-19 state of emergency declarations in Japan were associated with decreased PCI volumes. Applying SARIMAX models to real-world data could allow us to examine the effects of various events on healthcare considering trends, seasonal variation and autocorrelation by incorporating events as exogenous variables.