The expanding roles of hospital pharmacists in data science are reviewed through examples of real-world research using healthcare big data. Career paths for pharmacy graduates in Japan have diversified, with more students interested in clinical practice. From a hospital management perspective, reimbursements for pharmacist services are insufficient. However, the number of hospital pharmacist positions continues to grow, reflecting the increased expectations for pharmacists to ensure the safety of progressively more complex pharmacotherapies. In addition to their on-site responsibilities, pharmacists are increasingly involved in generating clinical evidence. Although case reports and retrospective chart reviews are common research methods, more pharmacists currently engage in large-scale analyses using real-world big data. The analysis of big data is challenging due to the structural complexity, but appropriate handling results in clinically relevant insights grounded in routine practice. Herein, the fundamental concepts of data structure and research design are introduced, and the future potential and significance of pharmacist-led big data research are reviewed using selected case studies.

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Recent advances in information technology support the rapid development and integration of large-scale healthcare databases, including medical records, claims data, and adverse event reports. Community pharmacists, who have traditionally had limited access to clinical information, now have opportunities to engage in data-driven research and practice. Publicly available databases, such as the NDB Open Data and JADER, are inexpensive, technically accessible, and well-suited for researching clinical questions arising from daily pharmacy practice. In addition, real-world data collected through the initiatives of pharmacist organizations, including nationwide surveys and drug event monitoring projects, are valuable resources for generating new evidence. This review outlines the characteristics, strengths, and limitations of various healthcare big data sources accessible to community pharmacists, highlighting the relevance and potential utility using representative examples.

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Pregnant women are a special patient population, as drug exposure during pregnancy requires the evaluation of drug effects on both the mother and fetus. Evidence from interventional studies is often limited due to the frequent exclusion of pregnant women from clinical trials; thus, utilization of medical big data is anticipated. Spontaneous reporting databases, which are primarily utilized for the early detection of drug safety signals, harbor limitations, such as the lack of denominator information, underreporting, and reporting bias. These databases are increasingly applied for the study of medication use during pregnancy, facilitated by recently developed algorithms for identifying pregnancy-related reports. Real-world data are used to understand drug utilization patterns before, during, and after pregnancy and to investigate associations between drug exposure and pregnancy/infant outcomes. A recent example is the contribution of real-world evidence derived from such data to the revision of the package insert for domperidone. Medical big data is a valuable resource for informing clinical decision-making in perinatal pharmacotherapy, and its effective utilization requires the generation of appropriate evidence tailored to the specific data characteristics.

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Japan is a super-aged society, with individuals aged 65 and above accounting for approximately 30％ of the population. As physical function and physiological reserve decline with age, the risk of multiple diseases and polypharmacy rises. Government statistics indicate that 27.4％ of individuals aged 65-74 and 39.7％ of those aged 75 and above take five or more medications, with a similar trend in hospitals. Polypharmacy heightens the risk of adverse drug reactions, cognitive decline, falls, and delirium. Therefore, interdisciplinary collaboration is vital to simplify regimens, optimize drug therapy, and prevent adverse events. The Role of Comprehensive Geriatric Assessment （CGA） and DASC-21. CGA is a multidisciplinary approach to evaluating cognitive function, activities of daily living, psychological state, nutrition, and medication use to identify problems across various domains. DASC-21, a key CGA tool, evaluates cognitive and functional abilities. It provides a foundation for developing care plans that support patients while also addressing the needs of caregivers and families, thereby improving overall care. DASC-21 can help identify cognitive and functional decline, indicating the need for dose reduction. Studies have shown that as DASC-21 scores worsen, the number of medications tends to decrease. This suggests that DASC-21 is a useful tool for guiding medication adjustments, reducing unnecessary medications, and potentially improving medication safety. Implementing CGA with tools like DASC-21 promotes personalized, patient-centered care by facilitating comprehensive polypharmacy management, thereby reducing unnecessary medications, minimizing adverse event risks, and enhancing quality of life. Ongoing efforts can shift the focus of medical care from merely prolonging life to enhancing overall well-being.

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Pharmacoeconomic evaluation is an analytical method used to assess the cost-effectiveness of pharmaceutical products. Cost-utility analysis is commonly used in healthcare policy. This method estimates the expected cost and effect of a product and its comparator and calculates the incremental cost-effectiveness ratio based on the differences in the cost and effect between groups. Among health-related big data, claims data is often used to estimate these expected costs and effects. With the growing interest in pharmacoeconomic evaluation, there is also increasing attention on applicability of claims data. As claims data directly reflect medical resource consumption, they are mainly used for cost estimation. Additionally, the application of findings from epidemiological studies using claims data has gained attention, as such studies have been actively conducted in recent years. However, because the effect component typically has a significant impact on the overall results of pharmacoeconomic analysis, its estimation methods and applications must be carefully considered. This article reviews the fundamental concepts of pharmacoeconomic evaluation, presents an example of its use in academic research, and highlights key considerations. This article also explains how pharmacoeconomic evaluation using health-related big data can inform healthcare policy based on the cost-effectiveness evaluation system in Japan. Finally, this article summarizes the role of health-related big data in pharmacoeconomic evaluation and outlines its expected contributions to the field.

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Bronchial innervation is closely associated with multiple pulmonary diseases. However, modern morphological studies of human bronchial nerves limited. In this study, the relevance of nerves and surrounding tissues in the bronchi was determined using conventional transmission electron microscopy （TEM）. The segmental bronchi distant from the lesion in surgical lung specimens were excised for examination. There were 15 cases, 10 men and 5 women, ranging in age from 38 to 73 years old. None of them had diffuse lung disease or chronic obstructive pulmonary disease. The primary disease was lung cancer in 11 cases, metastatic lung tumor in 2 cases, and tuberculoma in 2 cases. Specimens were fixed with 2.5％ glutaraldehyde, sectioned into ultrathin slices, and double-stained with uranium acetate and lead citrate for TEM. Sensory and centrifugal nerve fibers were identified in the airway epithelium. Sensory nerves were optimally positioned for stimulation. Vascular networks in the lamina propria were interwoven with myelinated and unmyelinated nerves, which may connect the epithelium to the central nervous system. Neurotransmitters in the axon profiles near blood vessels may regulate the vascular network flow rate. Varicosities of various shapes with neurotransmitter were clearly observed around the airway smooth muscle. It is supposed that the bronchial glands are controlled by two types of systems, namely the vagus nerve for emergency responses and the endogenous nerves for baseline secretion. The dense distribution of sensory and efferent nerves is consistent with these two types of innervations. Parasympathetic-like nerves surrounded the bronchial arteries from the outside, indicating that blood flow to the arteries is controlled by vagal innervation. Sparse nerves were detected near macrophages and mast cells, indicating the absence of severe respiratory disease in these patients. The detailed ultrastructural features of bronchial wall nerves and surrounding tissues, align with contemporary physiological and pharmacological advances.

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The present study aimed to assess the impact of breath-hold position variations on dose distribution during deep inspiration breath-hold （DIBH） irradiation in patients with left breast cancer. DIBH irradiation has been widely used to minimize radiation exposure to the heart. However, a stable breath-hold position may vary among individuals. Breath-hold position instabilities can affect the dose distribution. Given that maintaining a stable chest wall position is crucial to ensure accuracy in radiation therapy, we investigated the chest wall position variations and their effects on dose distribution using the Abches system, a respiratory monitoring device. The patients’ chest wall position was recorded for 40 s by cine magnetic resonance imaging （MRI） with an MRI-compatible device. The chest wall displacement and gamma passing rate （γ pass rate） were measured at each Abches display value. Furthermore, the dose distribution changes were evaluated through a γ analysis with a three-dimensional semiconductor detector, ArcCHECK, at various chest wall positions. Our study findings indicated a maximum chest wall displacement of 3.5％ during the breath-hold position. The γ pass rate significantly decreased when the Abches display value was ＜4.7. Additionally, the pass rate was ＜80％ when the display value was ≤4.0, indicating that chest wall position instability can notably affect the irradiation accuracy. In conclusion, maintaining a stable breath-hold position is crucial for accurate dose management during left breast cancer treatment with DIBH irradiation. Our study provides guidelines for a safe and effective treatment with DIBH irradiation for these patients.

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This study aimed to investigate the relationship between the combination of obesity and central obesity status and hyperuricemia, with a particular focus on normal weight with central obesity. Among individuals aged 40–64 years who underwent a health checkup conducted by the All Japan Labor Welfare Foundation in fiscal year 2014 （baseline）, those who underwent the same health checkup in fiscal year 2019 were investigated. A body mass index （BMI） of ≥18.5kg/m² but＜25kg/m² indicated normal weight, whereas a BMI of ≥25 kg/m² defined obesity. Waist-to-height ratios of ＜0.5 and ≥0.5 indicated the absence and presence of central obesity, respectively. Subjects were grouped into four according to the combination of obesity and central obesity status: “normal weight without central obesity,” “normal weight with central obesity,” “obesity without central obesity,” and “obesity with central obesity.” A uric acid level of＞7.0mg/dl in men and ≥6.0 mg/dl in women or currently receiving treatment for hyperuricemia indicated hyperuricemia. The odds ratio （OR） and 95％ confidence interval （95％ CI） for hyperuricemia were calculated using logistic regression analysis. In total, 49,354 individuals （34,142 men; 15,212 women） were analyzed. Compared with the “normal weight without central obesity” group, the “normal weight with central obesity” group was more likely to develop hyperuricemia, obtaining an OR of 1.31 （95％ CI, 1.19-1.43） for men and 1.89 （1.63-2.20） for women. Similar results were obtained after adjusting for age, smoking status, alcohol consumption, physical activity, hypertension, dyslipidemia, and diabetes. Hyperuricemia incidence differed depending on central obesity status even among individuals with normal weight. Therefore, normal weight with central obesity may be considered in hyperuricemia prevention.

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Noninvasive positive-pressure ventilation （NPPV） is a widely used treatment for acute and chronic respiratory failure, which requires appropriate heating and humidification to ensure patient comfort and therapeutic effectiveness. However, humidifiers cannot eliminate occurrences of dry mouth and condensation in circuits. This study investigates the optimal external environment of NPPV. Experiments were performed on two types of NPPV circuits at different room temperatures （20℃ and 25℃）. We recorded the tidal volume, leak volume, relative and absolute humidities at the mouth, chamber temperature, and time to reach the mouth temperature. Comparing the results, we investigated the effects of circuit shape and room temperature on these parameters. The heating and humidification performances did not significantly depend on the circuit shape. Circuit condensation was observed at 20℃ but was absent at 25℃. A room temperature of 25℃ was deemed suitable for heating and humidification during NPPV. Our verification method can evaluate the heating and humidification performances in various environments, thereby establishing appropriate heating and humidification conditions. The heating and humidification performance of NPPV is more strongly affected by room temperature than by circuit shape. Specifically, a room temperature of 25℃ may prevent condensation in the circuit and provide a comfortable heating and humidification environment for patients. The present results can contribute to the optimization of heating and humidification environments of NPPV in clinical settings.

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This study aimed to establish treatment guidelines for pediatric phimosis at our institution by analyzing surgical cases. We retrospectively reviewed pediatric phimosis cases treated from January 2000 to December 2023 and conducted a detailed analysis of cases that ultimately underwent surgery. During the study period, 209 phimosis cases were treated. Of these cases, 42 underwent surgery. The age at the time of surgery ranged from 1 to 14 years （median: 6 years）. Symptoms included balanoposthitis （18 cases）, preputial ballooning （8 cases）, micturition pain （6 cases）, and urinary tract infection （1 case）. At consultation, 16 cases were asymptomatic, mainly presenting due to nonretractable foreskin. All cases initially received conservative treatment with topical steroids. However, surgery was subsequently performed due to a lack of improvement. Procedures included superficial preputial incision （22 cases）, circumcision （14 cases）, dorsal slit （2 cases）, and preputial adhesion detachment alone （4 cases）. Two cases of superficial incision later required circumcision due to foreskin restenosis, and three cases were diagnosed with Lichen sclerosus et atrophicus upon pathological assessment of resected tissue. Outcomes in all cases demonstrated no morphological defects. The outcomes of phimosis surgery at our institution were favorable. Surgical intervention was frequently performed only due to nonretractable foreskin without symptomatic phimosis, thereby emphasizing the importance of standardized treatment protocols in managing pediatric phimosis.

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Immune-related adverse events （irAEs） arising from immune checkpoint inhibitor （ICI） therapy can be unpredictable in onset and severity. Because outpatient treatment is common, home monitoring of irAEs is challenging for healthcare providers. We therefore conducted a preliminary evaluation of a novel monitoring system in which patients use a personal health record （PHR） app to record their symptoms and share those data with healthcare providers. The system was designed based on the Japanese User’s Guide to Implementing Patient-Reported Outcomes （PRO） Assessment in Clinical Practice. The PHR application selected for the trial was Welby My Carte ONC, in which patients can record their daily symptoms using PRO-CTCAE. A healthcare team of physicians, pharmacists, and nurses was organized, and based on an established implementation framework, they simultaneously monitored the recorded symptoms. Provider responses to AEs, patient–provider communication methods, and patient support for app operations were assessed. During the preliminary evaluation, two patients receiving ICI therapy were monitored. Patient 1 successfully documented irAE-related symptoms. Patient 2 experienced an infusion reaction with a fever of 39.0℃, prompting a healthcare provider to advise acetaminophen use, leading to symptom resolution. The number of patients being monitored will be increased over time to evaluate the effectiveness and practicality of the system.

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Patients with mandibular fractures have a displaced jawbone and require intermaxillary fixation of the upper and lower jawbones. At the Showa University Dental Hospital, mandibular fractures are treated with intermaxillary fixation using surgical brackets. However, the placement of surgical bracket and fixation of wires require skillful techniques, and patients must keep their mouths open for extended periods while on the chair, which confers a heavy burden on them. Therefore, this study attempted to shorten the chair time by applying surgical brackets using an indirect bonding system. This study described the use of this approach in a 69-year-old woman with bilateral mandibular neck fractures. As the direct bonding method requires approximately 60-90 min of chair time, the chair time was markedly shortened compared with that following bracket placement and wire fixation. Once the digital workflow is established, the use of a 3D printer for model creation and an indirect bonding system, as described herein, is expected to further reduce the patient burden.

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Intracranial blood blister-like aneurysms account for 0.5％-2.0％ of all ruptured cerebral aneurysms and are associated with a high risk of early relapse and postoperative rehemorrhage. These lesions are typically small and difficult to treat using either surgical or endovascular approaches. As effective treatment strategies remain poorly defined, we report a case of a patient with a ruptured blood blister-like aneurysm who showed a favorable outcome following stent-assisted coil embolization.

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