Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

Traumatic brain injury (TBI) often causes permanent neurological dysfunction. Although no medication has been validated yet to prevent secondary injury of brain tissue, recent animal studies have reported that perampanel, a glutamine receptor antagonist, could improve the neurological functions of animals with TBI by mitigating the abnormal calcium influx and cell death around the site of primary injury. The present study aims to elucidate the efficacy of perampanel administration in improving the neurological function of patients with TBI.

The perampanel for alleviation of secondary injury in TBI trial is a multicentre, phase-II, open-label randomised controlled trial targeting patients with mild-to-moderate TBI. This trial will include adult TBI patients with a Glasgow Coma Scale score of 9–14 from five tertiary centres. Patients with epilepsy as a comorbidity, delayed presentation of symptoms (>24 hours after injury) or Injury Severity Score of ≥25 will be excluded. The study participants will be randomly assigned to either the perampanel group (2 mg/day) or the control group (fosphenytoin administered at a dose of 15–18 mg/kg/day, followed by 5–7.5 mg/kg/day of fosphenytoin). In both groups, the medication will be initiated within 12 hours of the TBI diagnosis and continued for 7 days. The antiepileptic drugs can be increased, changed or added as necessary if early post-traumatic seizures are observed. The primary outcome is favourable neurological outcome, defined as a Glasgow Outcome Scale Extended score of ≥5 at 90 days after the TBI diagnosis, which will then be compared between the groups through an intention-to-treat analysis.

The present study has been approved by the Certified Review Board of Keio at the principal institution (approval number: N20240004). Written informed consent will be obtained from all participants or their legal representatives. The results will be disseminated via publications and presentations.

Japan Registry of Clinical Trials (jRCTs031250067).

Presenteeism, defined as reduced work efficiency due to health issues despite attending work, accounts for a substantial proportion of labour productivity loss. Although pain significantly impacts presenteeism, the relationship between pain and presenteeism remains poorly understood due to the multifaceted nature of pain, encompassing psychosocial factors and daily functioning. This study aimed to identify which of these factors are significantly associated with presenteeism among employees.

Cross-sectional study using self-administered questionnaires and generalised additive model analysis.

Multiple workplaces (including a university and hospitals) in Japan.

Employed individuals (n=212, age range: 20–65 years; 59 males and 153 females) participated. They were recruited through workplace bulletin boards, email announcements and direct invitations. Participants with and without chronic pain were included.

Participants completed self-report measures, including the Health and Work Performance Questionnaire (HPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Pain Catastrophising Scale (PCS), Beck Depression Inventory-second edition (BDI-II), State-Trait Anxiety Inventory (STAI) and WHO Disability Assessment Schedule 2.0 (WHODAS 2.0).

The results indicated that absolute HPQ was significantly associated with BDI-II scores (F=4.51, p=0.035). On the other hand, relative HPQ was influenced by SF-MPQ (F=3.76, p=0.005), PCS (F=4.16, p=0.014), STAI (F=5.62, p=0.019) and limited daily activities (F=13.25, p=0.00035).

These findings suggest that presenteeism is multifactorial, with pain, psychosocial factors and daily functioning playing critical roles. Moreover, the impact of depression on presenteeism differs from that of pain and anxiety. Therefore, tailored intervention approaches may be required for each factor, ultimately improving workplace productivity.

This study was preregistered at UMIN-CTR (UMIN000054797).

We aimed to evaluate the effect of projection mapping (PM) on the quality and safety of central venous catheter (CVC) insertion under real-time ultrasound guidance.

Prospective, observational, simulation study.

This study was conducted at the Yokohama City University Medical Center (Yokohama, Japan). Volunteer residents were enrolled over 12 months from January to December 2023.

12 rotating residents (postgraduation year (PGY) 1 and 2) and eight anaesthesia residents (PGY 3–5) placed the CVC in the internal jugular vein in a simulator under the real-time ultrasound guidance using the short-axis out-of-plane approach. The ultrasound image was provided either just caudad to the puncture site using the PM method or on the monitor of the ultrasound machine (conventional method) placed next to the simulator’s right shoulder. Each resident performed four punctures alternating between the PM and conventional methods, and the first method for each resident was chosen randomly. Eye-tracking analysis was also used to evaluate differences in gaze behaviour.

The primary outcome was the procedure time defined as the time from the application of the ultrasound probe on the puncture field until successful puncture of the vein. The secondary outcomes were incidence of complications and eye-tracking analysis data.

The time to complete the line placement was significantly shorter for the PM than for the conventional method (median (IQR) 22.5 (15.5–30.6) s vs 30.0 (20.4–95.4) s; p=0.02, Wilcoxon’s signed-rank test). The incidence of posterior vessel wall puncture was significantly lower in the PM method (0% vs 25%; p=0.02, McNemar’s test). Eye-tracking analysis revealed that the percentage of time spent gazing at the ultrasound image was higher in the PM than in the conventional method (61.6% (55.0–69.2) vs 45.7% (34.1–54.5); p

The PM method facilitates ultrasound-guided CVC placement while preventing excessive needle advancement in the inexperienced operators. This was accompanied by enhanced fixation of the participants’ line-of-sight on the ultrasound image.

To examine how relationships between physicians, pharmacists and patients associate with generic drug (GE) utilisation in Japan’s healthcare system.

Observational study using longitudinal medical claims from April 2015 to March 2021.

Pharmacies across Japan serving beneficiaries of the National Health Insurance Association.

69 395 pharmacies, resulting in 322 097 pharmacy-year observations.

Quantity share of GEs dispensed by pharmacies.

Higher hospital prescription concentration was consistently associated with increased GE usage (1.1–2.3 percentage points higher for moderate to very high concentrations compared with low). The relationship between patient prescription concentration and GE usage varied, showing a positive association (0.3–0.6 percentage points higher) overall, but negative in settings with low hospital concentration. Smaller pharmacies exhibited a stronger positive association between hospital concentration and GE usage, while larger pharmacies and those in less urbanised areas showed a stronger positive association between patient concentration and GE usage.

This study reveals that pharmacy-stakeholder relationships significantly influence GE utilisation in Japan’s healthcare system. Our findings demonstrate that hospital-pharmacy relationships consistently drive generic usage, while patient-pharmacy relationships show contextual effectiveness. By measuring these relationships through concentration rates, we provide evidence that stakeholder interactions may affect medication dispensing decisions. These findings suggest that policies promoting GEs may benefit from considering the specific characteristics of pharmacies and their existing relationships with hospitals and patients. These insights can inform more effective policy design for GE promotion across different healthcare contexts.