Real-world evidence on the survival benefit of immune checkpoint inhibitors in combination with cytotoxic chemotherapy for patients with extensive-disease small-cell lung cancer: the Tokushukai Real World Data Project (TREAD) 06.

Background: Small-cell lung cancer (SCLC) is an aggressive malignancy with a poor prognosis. Despite the initial chemosensitivity, survival for extensive-disease (ED) SCLC remains limited. Immune checkpoint inhibitors (ICIs) in combination with chemotherapy have recently been redefined as the standard of care.

Peripubertal lung growth pattern in Japanese school children.

The peripubertal growth pattern of lung function remains underexplored in relation to height growth. This study aimed to first clarify the relationship between the age at peak growth velocity in lung function variables and the age at peak height velocity (APHV) and second identify sex differences in lung function growth patterns. Lung function and height were measured annually in children aged 9-15 years (elementary schools, N = 1307; junior high schools, N = 792) from 2011 to 2018.

Cystathionine as a Potential Urinary Marker for Diagnosing and Assessing Pretreatment Risk in Neuroblastoma.

Urinary homovanillic acid (HVA) and vanillylmandelic acid (VMA) are widely used diagnostic markers for neuroblastoma, but urinary markers for risk assessment prior to invasive biopsy are lacking. We hypothesized that cystathionine (CTN) may be a new neuroblastoma biomarker and evaluated its utility for diagnosis and pretreatment risk assessment. 80 participants provided 202 urine samples: 32 from 32 control participants, 29 from 29 patients with primary neuroblastoma, and 141 from 30 patients with residual tumors, 11 of whom had primary neuroblastoma.

Analgesic efficacy and serum ropivacaine concentration of postoperative programmed intermittent bolus infusion with serratus anterior plane block in patients undergoing minimally invasive cardiac surgery: A randomized, double-blind, controlled trial.

Purpose: Minimally invasive cardiac surgery (MICS) involves fewer complications than median sternotomy. However, difficulties in post-MICS analgesia can undermine these advantages. The serratus anterior plane block (SAPB), an effective analgesic for thoracic surgery, could benefit post-MICS analgesia using programmed intermittent bolus infusion (PIBI).

Cardiovascular adverse events in patients with lung cancer treated with immune checkpoint inhibitors: a nationwide database study.

Background: Large, diverse cohort studies are essential for determining the incidence and risk factors of major adverse cardiovascular events (MACEs) associated with immune checkpoint inhibitors (ICIs). This study aimed to (1) compare the incidence of MACEs in primary lung cancer patients receiving ICIs versus those receiving non-ICI chemotherapy, and (2) identify risk factors for MACEs in ICI-treated patients.

Materials And Methods: We performed a retrospective analysis of primary lung cancer patients using a nationwide Japanese database.

Assessing the Reliability and Validity of Principles for Health-Related Information on Social Media (PRHISM) for Evaluating Breast Cancer Treatment Videos on YouTube: Instrument Validation Study.

Background: There is breast cancer-related medical information on social media, but there is no established method for objectively evaluating the quality of this information. Principles for Health-Related Information on Social Media (PRHISM) is a newly developed tool for objectively assessing the quality of health-related information on social media; however, there have been no reports evaluating its reliability and validity.

Objective: The purpose of this study was to statistically examine the reliability and validity of PRHISM using videos about breast cancer treatment on YouTube (Google).

False Discovery Rate Control for Confounder Selection Using Mirror Statistics.

While data-driven confounder selection requires careful consideration, it is frequently employed in observational studies. Widely recognized criteria for confounder selection include the minimal-set approach, which involves selecting variables relevant to both treatment and outcome, and the union-set approach, which involves selecting variables associated with either treatment or outcome. These approaches are often implemented using heuristics and off-the-shelf statistical methods, where the degree of uncertainty may not be clear.

Japan-multimodal intervention trial for the prevention of dementia in older people with lifestyle-related diseases: A community-based, 18-month, randomized controlled trial.

BackgroundThe prevalence of Alzheimer's disease is increasing in Japan, highlighting the need to establish evidence-based strategies for its prevention.ObjectiveWe aimed to evaluate the effectiveness of a multimodal community-based intervention for Japanese older people with lifestyle-related diseases and to identify challenges in implementing such interventions to prevent dementia in local communities.MethodsAn 18-month randomized controlled trial was conducted among individuals aged 65-85 years with lifestyle-related diseases (hypertension, hyperlipidemia, diabetes, overweight/underweight, smoking), residing in a single apartment complex.

Usefulness of Spleen Index and Alkaline Phosphatase Level for Predicting Post-Liver Biopsy Bleeding.

Aims: The significance of liver biopsy is increasing with an increase in chronic liver disease and gene panel testing. Although non-invasive methods such as elastography and biomarkers assess liver fibrosis, biopsy remains the definitive diagnostic gold standard. We evaluated the predictors of bleeding complications in liver biopsies.

Comparative effectiveness of romosozumab versus teriparatide for fracture prevention: A new-user, active comparator design.

Background: Comparative evidence on the effectiveness of romosozumab and teriparatide in preventing osteoporotic fractures remains limited. This study evaluated their effectiveness in fracture prevention.

Methods: This observational new-user cohort study used the DeSC Healthcare database, a nationwide claims database in Japan.

Transcatheter Aortic Valve Replacement for Structural Valve Deterioration After Aortic Valve Neocuspidization.

Background: Evidence on structural valve deterioration (SVD) after aortic valve neocuspidization (AVNeo) remains limited. While transcatheter aortic valve replacement (TAVR) offers a less invasive option, its feasibility is unclear. This study aimed to characterize SVD patients post-AVNeo and to assess TAVR feasibility.

A multicenter, prospective, observational study of nivolumab readministration for advanced gastric cancer (NIVO RETURNS).

Combination treatment with an anti-programmed cell death-1 (PD-1) antibody, an immune checkpoint inhibitor (ICI), and chemotherapy is the standard treatment for patients with HER2-negative advanced gastric/esophagogastric cancer (AGC). ICI re-administration has been reported to have a clinical benefit for patients with lung cancer or melanoma. However, data on patients with AGC have not yet been collected.

Partial areas under the curve of the cumulative distribution function as a new composite estimand for randomized clinical trials.

Clinical trials often face the challenge of post-randomization events, such as the initiation of rescue therapy or the premature discontinuation of randomized treatment. Such events, called "intercurrent events" (ICEs) in ICH E9(R1), may influence the estimation and interpretation of treatment effects. According to ICH E9(R1), there are five strategies for handling ICEs.

Patient and hospital factors for outcomes of completely resected, node-negative nonsmall cell lung cancer.

Objectives: To evaluate outcomes of early-stage nonsmall cell lung cancer (NSCLC) patients in relation to patient and hospital factors.

Summary Background Data: Results of randomized controlled trials (RCTs) may not be applicable to daily practice.

Methods: Outcomes of patients who had undergone curative surgery for node-negative NSCLC were retrospectively evaluated.

All-Cause and Cause-Specific Mortality Associated with Long-Term Exposure to Fine Particulate Matter in Japan: The Ibaraki Prefectural Health Study.

Aims: Long-term exposure to fine particulate matter (PM) is causally associated with mortality and cardiovascular disease. However, in terms of cardiovascular cause-specific outcomes, there are fewer studies about stroke than about coronary heart disease, particularly in Asia. Furthermore, there remains uncertainty regarding the PM-respiratory disease association.

Comparative cardiovascular safety of romosozumab versus bisphosphonates in Japanese patients with osteoporosis: a new-user, active comparator design with instrumental variable analyses.

This study analyzed the association of romosozumab, a human monoclonal antibody with bone-forming and bone resorption-inhibiting effects, and bisphosphonates with the development of cardiovascular disease among patients with osteoporosis. A new-user design was employed to address selection bias, and instrumental variable analysis was used to address confounding by indication. Japanese patients aged ≥40 years, diagnosed with osteoporosis or experienced a fragility fracture, were admitted to medical facilities covered by a commercial administrative claims database, and newly prescribed romosozumab or bisphosphonates after the commercialization of romosozumab in Japan (March 4, 2019) were included based on verification of a 180-day washout period.

Leucine-rich alpha-2 glycoprotein in combination with C-reactive protein for predicting endoscopic activity in Crohn's disease: a single-centre, cross-sectional study.

Background And Objective: Leucine-rich alpha-2 glycoprotein (LRG) is a novel biomarker for Crohn's disease (CD). The utility of combination use of LRG and C-reactive protein (CRP) has not been reported. This study aimed to investigate the diagnostic performance of LRG in combination with CRP to predict endoscopic activity.

Two-year scale-up dissemination study of a multi-strategic community-wide intervention promoting physical activity: a single-arm pre-post hybrid effectiveness-implementation trial.

Background: Intervention trials that have demonstrated significant effects may not always replicate those effects when scaled up. This study aimed to test whether scaling-up a successful cluster randomized trial (the COMMUNICATE study, 9 intervention communities), which promoted population-level physical activity (PA), could promote PA in a broader citywide setting (29 communities) after two years, as a mid-term evaluation of the six-year scaled-up trial.

Methods: This is a single-arm, pre-post comparison of a multi-strategic community-wide intervention covering the entire Unnan City, Japan.

Allopurinol, Febuxostat, and Nonuse of Xanthine Oxidoreductase Inhibitor Treatment in Patients Receiving Hemodialysis: A Longitudinal Analysis.

Rationale & Objective: Allopurinol and febuxostat, which are xanthine oxidoreductase inhibitors, have been widely used as uric acid-lowering medications. However, evidence regarding their cardiovascular effects in hemodialysis is insufficient. This study compared the effects of allopurinol and febuxostat on mortality and cardiovascular outcomes in patients receiving hemodialysis.