This study aims to describe the characteristics of hospitalised COVID-19 patients in a tertiary care hospital close to an international airport in Japan and to compare these characteristics among different waves during the pandemic.

Retrospective observational study.

Tertiary care centre in Japan.

All patients diagnosed with COVID-19 who were hospitalised between January 2020 and April 2022 were included.

Clinical characteristics, characteristics of admission, treatments and outcomes were investigated and compared among six pandemic waves.

A total of 827 patients were included. The median age was 58.0 years. More than half of the patients (58.3%) had at least one comorbidity. The majority of patients (89.0%) were domestically infected patients admitted under the Infectious Diseases Law, while the remaining patients (11.0%) were those diagnosed during airport quarantine and admitted under the Quarantine Act. Hospital-acquired COVID-19 infection occurred in 7.0% of cases, and mainly during the sixth wave. Overall, some form of oxygen therapy, high-flow oxygen devices, invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation was provided in 46.3%, 10.4%, 4.5% and 1.5% of cases, respectively. Only 1.8% of patients were treated in the intensive care unit (ICU), and 59.5% of patients on IMV were managed in the non-ICU ward. The in-hospital mortality rate was 5.8%. Median age, percentages of some comorbidities, vaccination coverage, medications for COVID-19, types of supportive care and ICU admissions differed significantly among waves.

This study suggests that patient characteristics, vaccination coverage, standard of treatment and severity of illness changed across waves during the COVID-19 pandemic. Intensive care delivery in non-ICU wards was unavoidable due to limited ICU capacity, which may be a key consideration when preparing for future pandemics.

The global need for developing comprehensive mental healthcare systems for children and adolescents has been increasingly evident. The system-of-care (SOC) model in the USA is among the most studied cases for such a system, which demonstrates how integrated services, encompassing psychiatric care, can effectively support children and adolescents with severe emotional disturbance. Over the past decades, the SOC framework has been widely expanded, with nearly every state in the USA receiving federal funding to implement or expand the SOC initiatives. The number of studies investigating the efficacy of the SOC is increasing, but no systematic review of the instruments for the evaluation of the implementation of the SOC exists today. This protocol paper documents the plan of a systematic review, which aims to identify and synthesise the existing instruments, which are designed and used to evaluate the implementation of the SOC.

This systematic review will be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis Protocol guidelines. To identify relevant studies, we will perform a comprehensive search in five databases: PubMed, PsycINFO, ERIC, Social Work Abstracts and Web of Science. The title and abstracts of all searched articles will be screened independently by two reviewers according to the eligible criteria. Full-text screening of potentially relevant articles will be performed by at least two independent reviewers. A summary of included articles will describe the availability, progress and cultural adaptability of instruments.

The current systematic review will be solely based on previously reported data and will not involve new data collection. There are no concerns that require ethical vetting. Findings of the review will be disseminated through conference presentations and publication in a peer-reviewed journal.

1065693.

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.

The standard treatment for unresectable head and neck cancer typically involves radiotherapy (RT) alone or chemoradiotherapy (chemo-RT). Non-squamous cell carcinomas exhibit relatively low radiosensitivity, limiting the efficacy of conventional photon RT. Carbon-ion (C-ion) RT, characterised by high linear energy transfer (LET) and high relative biological effectiveness (RBE), has shown promising outcomes in treating radioresistant head and neck cancers. However, local recurrences still occur, and further improvements in treatment outcomes are needed. To enhance the local control rate, an increase in dose-averaged LET (LETd) to the tumour was considered.

Following a simulation study, a clinical trial was conducted to optimise LETd using only C-ion therapy, and its safety was confirmed. However, in this clinical trial, LETd could only be increased to approximately 70 keV/μm. To further escalate LETd, multi-ion therapy using ions heavier than carbon was developed. Simulation studies demonstrated that multi-ion therapy incorporating carbon, oxygen and neon ions could increase LETd up to 90 keV/μm, regardless of tumour size, while maintaining high-dose uniformity within the tumour. Based on these results, a clinical study was planned to evaluate the safety of escalating LETd from 70 keV/μm to 90 keV/μm using multi-ion therapy. The primary objective of this study is to evaluate the safety of escalating LETd to the tumour using multi-ion therapy for head and neck cancer, with the secondary goal of identifying the maximum tolerated LETd.

This is a non-randomised, open-label, phase 1 study focused on LETd escalation. A maximum of 18 patients with histologically confirmed inoperable head and neck malignancies will be enrolled. All patients will receive multi-ion therapy using helium, carbon, oxygen or neon ions, either alone or in combination, at an RBE-weighted dose ranging from 57.6 to 70.4 Gy, delivered in 16 fractions (4 fractions per week) over 4 weeks. The specific dose will be determined according to histology. LETd escalation will begin at 70 keV/μm and will increase by 10 keV/μm increments, reaching a maximum of 90 keV/μm. The safety of multi-ion therapy will be assessed based on the frequency and severity of dose-limiting toxicities, monitored up to 90 days after the initial irradiation. Patients will be followed up according to the protocol for 180 days after the initial multi-ion therapy irradiation.

The study protocol has been approved by the National Institutes for Quantum Science and Technology Certified Review Board (#L24-002). The results will be published in a peer-reviewed journal and presented at a scientific conference.

jRCTs032240451.

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.