Institutions In Japan Research Articles

Impact of party balloon inflation manoeuvre during saline contrast transthoracic echocardiography to detect a patent foramen ovale: multicenter registry study

Abstract Background Paradoxical embolism due to patent foramen ovale (PFO) can cause cryptogenic stroke. Agitated saline contrast transthoracic echocardiography (ASC-TTE) is an essential diagnostic tool for PFOs, and provocation using the Valsalva manoeuvre (VM) is necessary during the examination. Although VM is the standard method, assessing whether sufficient provocation has been achieved can pose challenges for the patients and examining staff. Conversely, a party balloon inflation manoeuvre (PBIM), which we previously reported (1, 2), offered a clear visual confirmation of provocation than conventional VM and showed effectiveness in cases of inadequate provocation. However, collective evaluation of PBIM by group remains unknown. Purpose This study aimed to demonstrate the superiority of PBIM over standard provocative methods, such as conventional or inferior vena cava compression VM, during ASC-TTE. Methods This multicentre registry study was conducted across eight high-volume institutions in Japan. A total of 117 consecutive patients (62.3% men, mean age; 56.2 ± 13.8 years, as of December 31, 2023) in whom paradoxical embolism was suspected and PFO was detected by transesophageal echocardiography, underwent PBIM and standard provocative methods during ASC-TTE. We compared them using a five-point microbubble grade (none or 1–4) using the right-to-left cardiac shunt as the primary endpoint (Figure 1). Results PBIM produced microbubble upgrading in 51 (43.6%, yellow panels in Figure 2), no change in 54 (46.1%), and down-grading in 12 (10.3%, blue panels in Figure 2) patients, compared to standard provocative methods. Wilcoxon paired analysis revealed that PBIM had a significantly larger microbubble grade than the standard provocative methods (median 3.0 interquartile range (IQR) [3.0–4.0] vs 3.0 IQR [1.7–4.0], p<0.001). If significant right-to-left shunt was grade ≥2, which was considered as the indication of catheter PFO closure, the pairwise McNemar’s test showed diagnostic performance of significant right-to-left cardiac shunt using PBIM improved from 75.2% to 91.5% (improvement rate; 16.3%, 95% CI; 8.4–24.0, p<0.001). Logistic regression analysis showed insufficient balloon inflation due to inexperience and risk of paradoxical embolism score independently associated with downgrading in PBIM after adjustments for age, sex, clinically relevant variables, and other echocardiographic parameters (odds ratio (OR); 24.0, 95% interquartile range (CI); 3.3–172.1, p<0.01 and OR; 0.60, 95% CI; 0.39–0.91, p<0.05, respectively). Conclusions PBIM significantly increased the microbubble grade compared to standard provocative methods. PIBM, using a simple tool, may provide an appropriate treatment strategy for patients with potential cryptogenic stroke attributed to PFO, especially those who are falsely diagnosed as negative for significant right-to-left cardiac shunts.Primary endpointsAgreement of 5-point microbubble grade

Comorbidities in Japanese testicular cancer survivors: A multi-institutional, cross-sectional study.

To evaluate comorbidities in Japanese testicular cancer (TC) survivors in a multi-institutional, cross-sectional study. This study enrolled TC survivors who visited any of the eight high-volume institutions in Japan from 2018 to 2019. After obtaining informed consent, participants answered questionnaires about their comorbidities. We analyzed the impact of treatment on comorbidities rate in TC survivors. A total of 509 TC survivors responded to the comorbidity questionnaires. Median age at the time of response was 43 years (IQR 35-51 years) and median follow-up period after treatment was 5.1 years (IQR 2.1-9.2 years). TC survivors were divided according to the number of cycles of chemotherapy into the following groups: None (n = 153); 1-2 cycles (n = 34); 3-4 cycles (n = 234); or ≥5 cycles (n = 88). The prevalence of kidney disease increased significantly with increasing number of cycles of chemotherapy (p < 0.05). The relative risk of cardiovascular disease in the groups with three or more cycles was 2.6 compared to the group without chemotherapy. The present study showed that the prevalence of kidney disease in TC survivors was increased with increasing number of cycles of chemotherapy.

Changes in Clinical Competence of Novice Physical Therapists During Their First Year of Employment: A Single Center Retrospective Observational Study in Japan

Background and Objectives: This study aimed to examine the development of clinical competence of novice physical therapists (PTs) during their first year of employment, following the implementation of an original in-house educational program. The educational program was designed to offer diverse training opportunities at an early stage, during the first year of employment. Methods: Thirty-eight novice PTs (21 males and 17 females, mean age 23.4 ± 3.2 years) participated in this study. All participants underwent educational programs and a self-assessment using the Clinical Competence Evaluation Scale in Physical Therapy (CEPT) on the first day of employment (entry-level) and after 1, 3, 6, and 12 months of employment. The total score and CEPT component-wise scores—“knowledge,” “clinical reasoning,” “skill,” “communication,” “attitude,” “self-education,” and “self-management”—at the 4 assessment points (1, 3, 6, and 12 months) were compared with values on the first day. Results: The total scores at 3, 6, and 12 months of employment were significantly higher than those on the first day of employment (P &lt; .05). Among the total scores on the 7 components, those for “knowledge,” “clinical reasoning,” “skill,” and “communication” at 3, 6, and 12 months after employment were also significantly higher than those on the first day of employment (P &lt; .05). The scores for “attitude” and “self-education” 12 months after employment were significantly higher than those on the first day of employment. However, the “self-management” scores at 1, 3, 6, and 12 months after employment did not significantly change compared with those on the first day of employment. Conclusions: The total score was significantly higher after 3 months. The participant’s clinical competence may have improved because they participated in an educational program related to “knowledge,” “clinical reasoning,” “skills,” and “communication” at an earlier stage in the first year. However, their progress was comparatively slower in other areas, suggesting that the content might not have been sufficient. This study revealed the effectiveness of the educational program on novice PTs’ clinical competence at a single institution in Japan. Positive outcomes were obtained for several parameters. Furthermore, the results reveal the need for content modifications within the educational program to improve PTs’ performance across all evaluated items.

Prognostic Impact of Pulmonary Diseases in 952 Patients with Thoracic and/or Abdominal Aortic Aneurysm

Background/Objectives: Pulmonary diseases are common in patients with thoracic aortic aneurysm (TAA) and abdominal aortic aneurysm (AAA). Although high prevalences of chronic obstructive pulmonary disease and lung cancer (LC) are known, the prevalence of these and other pulmonary diseases regarding their relation to the outcome of TAA and/or AAA are not determined. Methods: Pulmonary diseases present at aortic aneurysm (AA) diagnosis and follow-up periods and cause of death of 952 patients with TAA, AAA, or TAA + AAA (including thoracoabdominal AA) treated at our institution in Japan were retrospectively analyzed. Cox regression analysis was used to investigate potential risk factors of mortality. Results: The mean patient age was 72.4 years, and the median follow-up was 4.92 years. At diagnosis, 528 (55.5%) patients had pulmonary diseases, including emphysema without interstitial lung disease (ILD) or LC, LC, idiopathic pulmonary fibrosis (IPF) without LC, non-IPF ILD without LC, and interstitial lung abnormalities (ILAs) without LC in 250, 85, 65, 15, and 58 patients, respectively. During follow-up, LC and acute exacerbation (AE) of IPF developed in 50 and 12 patients, respectively. In 213 patients who died, there were 45 (21.1%) aortic disease-related deaths. Other causes of death included LC (27.7%), cardiovascular events (9.4%), pneumonia (5.6%), and interstitial lung disease (4.7%). In a multivariate Cox regression hazard model, age; larger maximum aneurysm diameter; and coexisting LC, IPF, or concomitant cancer were associated with poor prognosis. Conclusions: In patients with AA, not only age and aneurysm diameter but also coexisting LC and IPF were prognostic factors for mortality.

Urgent contrast-enhanced computed tomography before early colonoscopy in the management of colonic diverticular bleeding: A multicenter randomized controlled trial.

Contrast-enhanced computed tomography (CE-CT) has been gaining attention as an initial investigation in the management of colonic diverticular bleeding (CDB), yet the role of CE-CT other than its diagnostic yield, has not been adequately clarified. We aimed to determine whether the use of urgent CE-CT improves identification of stigmata of recent hemorrhage (SRH) in subsequently performed early colonoscopy (≤24 hours of arrival) or other clinical outcomes of CDB. We conducted a randomized, open-label, controlled trial at 23 institutions in Japan. Outpatients with suspected CDB were randomly assigned to undergo either urgent CE-CT followed by early colonoscopy (urgent-CE-CT + early-colonoscopy group) or early colonoscopy alone (early-colonoscopy group). The primary outcome was SRH identification. Secondary outcomes included successful endoscopic hemostasis, early (&lt;30 days) and late (&lt;1 year) rebleeding, length of hospital stay and transfusion requirements. In total, 240 patients, mostly in a hemodynamically stable condition, were randomized. A contrast extravasation on CE-CT was observed in 20 of 115 patients (17.4%) in the urgent-CE-CT + early-colonoscopy group. SRH was identified in 23 of 115 patients (20.0%) in the urgent-CE-CT + early-colonoscopy group and 21 of 118 patients (17.8%) in the early-colonoscopy group (difference, 2.2; 95% confidence interval [CI], -7.9 to 12.3; P=0.739). Successful endoscopic hemostasis was achieved in 21 patients in each group (18.3% and 17.8%, respectively) (difference, 0.5; 95% CI, -9.4 to 10.4; P=1.000). There were also no significant differences between groups in early and late rebleeding, length of hospital stay and transfusion requirements. The use of urgent CE-CT before early colonoscopy did not improve SRH identification or other clinical outcomes in patients with suspected CDB in a hemodynamically stable condition. The routine use of urgent CE-CT as an initial investigation is not recommended in this population, also considering the low rate of extravasation-positive cases (UMIN Registry number, UMIN000026865).

Alteration of treatment choices and the visual prognosis for diabetic macular edema in the era of anti-VEGF drugs: Analysis of the STREAT-DME 2 study.

To assess the real-world outcome of best-corrected visual acuity (BCVA) following 2-year intervention for treatment-naïve diabetic macular edema (DME) since the approval of anti-vascular endothelial growth factor (VEGF) therapy. A total of 1,780 treatment-naïve eyes with DME for which intervention was initiated between 2015 and 2019, and which were followed for 2 years, were extracted from the longitudinal medical records of 37 retinal disease institutions in Japan. Interventions included anti-VEGF therapy, topical corticosteroid therapy, macular photocoagulation, and vitrectomy. The baseline and final BCVA, and the number and timing of interventions were recorded. Eyes were classified according to the year in which intervention was initiated. Over a 2-year period, BCVA improved annually, finally reaching 7 letters. The proportion of eyes in which good vision was maintained (BCVA >20/40) increased to 73.3% in the latest period. The administration of anti-VEGF therapy remained stable, accounting for approximately 90% of eyes. Notably, the proportion of eyes receiving anti-VEGF drugs as first-line treatment increased dramatically to approximately 80%. Anti-VEGF therapy has become the first-line treatment since the approval of anti-VEGF drugs for DME. These findings reflect the evolution of DME treatment and highlight the superiority of anti-VEGF therapy and its increased uptake over time.

Compare the teaching effectiveness and student satisfaction between native Japanese language teachers and non-native Japanese language teachers

This study examines the comparative teaching effectiveness and student satisfaction between native Japanese language teachers (NJLTs) and non-native Japanese language teachers (NNJLTs). Utilizing a sample of 740 students from various educational institutions in Japan, the research employs a quantitative design, including structured questionnaires adapted from established scales. Advanced statistical methods, including factor analysis and multiple regression, were used to analyze the data. The findings reveal no significant differences in student satisfaction and language proficiency between students taught by NJLTs and NNJLTs. Additionally, regression analysis showed that cultural relatability and empathy were not significant predictors of teaching effectiveness, suggesting that factors beyond nativeness influence student outcomes. These results challenge the native-speakerism ideology, highlighting the importance of pedagogical skills, teacher-student rapport, and effective teaching strategies. The study underscores the need for inclusive hiring practices, comprehensive teacher training programs, and collaborative teaching models that leverage the strengths of both NJLTs and NNJLTs. Implications for educational policy, curriculum design, and teacher professional development are discussed, advocating for a balanced approach that values the contributions of both native and non-native teachers. Limitations include the reliance on self-reported data and the specific cultural context of Japan. Future research should explore additional variables, employ longitudinal designs, and utilize mixed-methods approaches to provide a more nuanced understanding of language teaching effectiveness.

Effect of Vericiguat on Left Ventricular Reverse Remodeling in Patients Who Have Heart Failure With Reduced Ejection Fraction - Special Focus on Patients Without Quadruple Medical Therapy.

A novel cardioprotective drug, vericiguat, reduces the risk of cardiovascular mortality for patients already on guideline-directed medical therapy. However, the effect of vericiguat on left ventricular (LV) reverse remodeling in patients with reduced LV ejection fraction (LVEF) with or without guideline-directed medical therapy, known as quadruple medical therapy, remains undetermined. This study comprised 73 heart failure (HF) patients with reduced LVEF (<45%) from 5 institutions in Japan. Echocardiography was performed before and 6.1±3.9 months after administration of vericiguat. LV reverse remodeling was observed in all patients (LV end-diastolic volume 156.1±52.6 vs. 139.3±60.0 mL; P<0.001; LV end-systolic volume 108.1±41.2 vs. 91.8±51.2 mL; P<0.001; LVEF 31.8±7.4 vs. 37.6±12.3 %; P<0.001). LV reverse remodeling was also observed in 54 patients who could not undergo quadruple medical therapy for several reasons. Moreover, the incidence of cardiovascular events was also similar for patients who received or did not receive quadruple medical therapy (log-rank P=0.555). Significant LV reverse remodeling was observed in HF patients with reduced LVEF following administration of vericiguat. LV reverse remodeling was also observed in patients who could not receive quadruple medical therapy, thus making administration of vericiguat a potential new approach for treatment of these patients.

Health Care Worker Usage of Large-Scale Health Information Exchanges in Japan: User-Level Audit Log Analysis Study.

Over 200 health information exchanges (HIEs) are currently operational in Japan. The most common feature of HIEs is remote on-demand viewing or searching of aggregated patient health data from multiple institutions. However, the usage of this feature by individual users and institutions remains unknown. This study aims to understand usage of the on-demand patient data viewing feature of large-scale HIEs by individual health care workers and institutions in Japan. We conducted audit log analyses of large-scale HIEs. The research subjects were HIEs connected to over 100 institutions and with over 10,000 patients. Each health care worker's profile and audit log data for HIEs were collected. We conducted four types of analyses on the extracted audit log. First, we calculated the ratio of the number of days of active HIE use for each hospital-affiliated doctor account. Second, we calculated cumulative monthly usage days of HIEs by each institution in financial year (FY) 2021/22. Third, we calculated each facility type's monthly active institution ratio in FY2021/22. Fourth, we compared the monthly active institution ratio by medical institution for each HIE and the proportion of cumulative usage days by user type for each HIE. We identified 24 HIEs as candidates for data collection and we analyzed data from 7 HIEs. Among hospital doctors, 93.5% (7326/7833) had never used HIEs during the available period in FY2021/22, while 19 doctors used them at least 30% of days. The median (IQR) monthly active institution ratios were 0.482 (0.470-0.487) for hospitals, 0.243 (0.230-0.247) for medical clinics, and 0.030 (0.024-0.048) for dental clinics. In 51.9% (1781/3434) of hospitals, the cumulative monthly usage days of HIEs was 0, while in 26.8% (921/3434) of hospitals, it was between 1 and 10, and in 3% (103/3434) of hospitals, it was 100 or more. The median (IQR) monthly active institution ratio in medical institutions was 0.511 (0.487-0.529) for the most used HIE and 0.109 (0.0927-0.117) for the least used. The proportion of cumulative usage days of HIE by user type was complex for each HIE, and no consistent trends could be discerned. In the large-scale HIEs surveyed in this study, the overall usage of the on-demand patient data viewing feature was low, consistent with past official reports. User-level analyses of audit logs revealed large disparities in the number of days of HIE use among health care workers and institutions. There were also large disparities in HIE use by facility type or HIE; the percentage of cumulative HIE usage days by user type also differed by HIE. This study indicates the need for further research into why there are large disparities in demand for HIEs in Japan as well as the need to design comprehensive audit logs that can be matched with other official datasets.

Does the presence or absence of preoperative lower extremity neurologic symptoms influence postoperative clinical outcome in patients with cervical intradural extramedullary tumors?: a single-center retrospective comparative study.

Retrospective comparative study OBJECTIVES: To investigate whether the presence or absence of preoperative lower extremities neurological symptoms (LENS) influences clinical outcomes following tumor resection in patients with cervical intradural extramedullary (IDEM) tumors. The single institution in Japan. Ninety-two patients with cervical IDEM tumors requiring surgical resection were included. Based on the degree of preoperative LENS assessed using the modified McCormick scale (MMCS), patients were categorized into LENS (-) and (+) groups. Demographic and surgical characteristics were compared between both groups. There were no significant differences observed in sex, tumor location, tumor size, surgical time, estimated blood loss, approach for tumorectomy, or tumor histopathology between the two groups. Additionally, the overall surgical outcomes were favorable for both groups. At the final follow-up, 91.1% of the patients in the LENS (+) group were able to walk without support. Improvement in LENS was observed after surgery in most patients with preoperative MMCS II-IV, but it persisted in approximately 40% of patients with preoperative MMCS V. In the LENS (+) group, there were no significant differences in demographic or surgical data between the patients with MMCS I and II-III at the final follow-up. Regardless of the presence or absence of preoperative LENS, clinical improvement was observed after tumor resection in most patients with cervical IDEM tumors. These findings suggest that neurological status is likely to improve sufficiently if tumor resection is performed before preoperative LENS deteriorates to an extremely severe stage as MMCS V.

Environmental enrichment for gerbils in the veterinary and domestic environment

Small exotics, commonly referred to as ‘small furries’, include hamsters, gerbils, rabbits and an array of other species. Gerbils are one of the easiest rodents to maintain and manage due to their typically non-aggressive nature. Usually found in deserts and semi-arid geographical regions of the world, the Mongolian gerbils available today originated from 20 pairs of captured animals. These were maintained in 1935 in a closed, random-bred colony at the Kitasato Institute in Japan.

Efficacy and Safety of Naldemedine for Opioid-Induced Constipation in Children.

Background: Naldemedine, a peripherally acting opioid μ receptor antagonist, is effective for prevention of opioid-induced constipation (OIC); however, evidence on its use in children is limited. Objective: To evaluate the efficacy and safety of naldemedine in pediatric patients with OIC. Design, Setting/Subjects: Retrospective analysis of 32 pediatric patients with OIC treated with naldemedine in a single institution in Japan from June 2017 to March 2021. Measurements: Efficacy was evaluated in 13 evaluable patients with bowel movement (BM) response, defined as those with at least three BMs in the first 7 days after naldemedine initiation and an increase of at least one BM from baseline. Safety was evaluated by examining adverse events (AEs) based on the Common Terminology Criteria for AEs (v5.0). Results: BM response was recorded in 11 of the 13 patients (85%), and the number BMs per day significantly increased from 0.43 before naldemedine to 1.00 after naldemedine (p = 0.025). The most common AE was diarrhea, observed in 16 of the 32 patients (50%), and all instances were grade 1 or 2. In three of the 16 patients, naldemedine was discontinued owing to worsening diarrhea. Conclusions: In pediatric patients, naldemedine resulted in a high rate of BM response and increased the BM frequency, indicating its efficacy. In some patients, grade 2 diarrhea required naldemedine discontinuation, suggesting that it should be used with caution in pediatric patients. Further studies are warranted to determine the optimal naldemedine dose in pediatric patients.

A multicenter study of clinical predictors of positive pyrophosphate scintigraphy findings in the diagnosis of transthyretin amyloidosis

BackgroundThe prevalence of wild-type transthyretin (ATTR) amyloidosis is increasing with advancements in diagnostic techniques and growing awareness of the disease worldwide. 99mTc-labeled pyrophosphate (99mTc-PYP) scintigraphy exhibits high performance in diagnosing ATTR cardiac amyloidosis. This study aimed to validate the characteristics of patients with positive 99mTc-PYP scintigraphy results in a multicenter setting to provide more accurate case selection criteria. Methods and resultsIn total, 180 patients with suspected ATTR amyloidosis underwent 99mTc-PYP scintigraphy in participating institutions in Japan between January 2018 and July 2022. Of 135 patients included in the analysis, 62 were 99mTc-PYP-positive. Logistic regression analysis was performed, and the following five factors were adopted to create a scoring system, with each weighted according to its odds ratio value; 1 point was scored for the absence of hypertension, existence of peripheral entrapment neuropathy (carpal tunnel syndrome or spinal canal stenosis), conduction disturbance (the presence of QRS complex ≥120 ms, first-degree atrioventricular block, higher degree of atrioventricular block, or presence of pacemaker implantation), and left ventricular hypertrophy and 2 points for troponin I/T ≥ 0.06 ng/mL. 99mTc-PYP scintigraphy positivity rate in the 0-point group was 0 %, whereas that in the 6-point group was 100 %. The area under the curve of the criteria was 0.820 (95 % confidence interval, 0.752–0.888; P < 0.001). ConclusionsThe combination of clinical information, which is easily available in local clinics, can provide accurate pretest prediction of positive 99mTc-PYP scintigraphy results. This will help clinicians to make an early diagnosis of ATTR amyloidosis.

Relationship between body mass index and clinical events in patients with atrial fibrillation undergoing percutaneous coronary intervention

Background It is still unclear whether body mass index (BMI) affects bleeding and cardiovascular events in patients requiring oral anticoagulants (OAC) for atrial fibrillation (AF) and antiplatelet agents after percutaneous coronary intervention (PCI) for coronary artery disease (CAD). The aim of this study was to evaluate the relationship between BMI and clinical events in patients who underwent PCI under OAC therapy for AF. Method This was a multicenter, observational cohort study conducted at 15 institutions in Japan. AF patients who underwent PCI with drug-eluting stents for CAD were retrospectively and prospectively included. Patients were divided into the Group 1 (BMI &lt;21.3 kg/m2) and the Group 2 (BMI ≥21.3 kg/m2) according to the first-quartile value of BMI. The primary endpoint was net adverse clinical events (NACE), a composite of major adverse cardiovascular events (MACE) and major bleeding events within one year after index PCI procedure. Results In the 720 patients, 180 patients (25.0%) had BMI value &lt;21.3 kg/m2. While the rates of NACE and MACE were significantly higher in the Group 1 than the counterpart (21.1% vs. 11.9%, p = 0.003 and 17.2% vs. 8.9%, p = 0.004), that of major bleeding did not differ significantly between the 2 groups (5.6% vs. 4.3%, p = 0.54). The cumulative rate of NACE and MACE was significantly higher in the Group 1 than the Group 2 (both log-rank p = 0.002), although that of major bleeding events was equivalent between the 2 groups (log-rank p = 0.41). In multivariable Cox regression analyses, while BMI value &lt;21.3 kg/m2 was not associated with major bleeding events, that cut-off value was an independent predictor for increased NACE and MACE. Conclusions Among the patients undergoing PCI for CAD and requiring OAC for AF, BMI value was a useful indicator to predict major adverse clinical events.

Editorial Comment to "One hundred cases of Rezum water vapor thermal therapy for benign prostatic hyperplasia: Real-world data at a single institution in Japan".

Editorial Comment to "One hundred cases of Rezum water vapor thermal therapy for benign prostatic hyperplasia: Real-world data at a single institution in Japan".

Multi-institutional questionnaire-based survey on online adaptive radiotherapy performed using commercial systems in Japan in 2023.

In this study, we aimed to conduct a survey on the current clinical practice of, staffing for, commissioning of, and staff training for online adaptive radiotherapy (oART) in the institutions that installed commercial oART systems in Japan, and to share the information with institutions that will implement oART systems in future. A web-based questionnaire, containing 107 questions, was distributed to nine institutions in Japan. Data were collected from November to December 2023. Three institutions each with the MRIdian (ViewRay, Oakwood Village, OH, USA), Unity (Elekta AB, Stockholm, Sweden), and Ethos (Varian Medical Systems, Palo Alto, CA, USA) systems completed the questionnaire. One institution (MRIdian) had not performed oART by the response deadline. Each institution had installed only one oART system. Hypofractionation, and moderate hypofractionation or conventional fractionation were employed in the MRIdian/Unity and Ethos systems, respectively. The elapsed time for the oART process was faster with the Ethos than with the other systems. All institutions added additional staff for oART. Commissioning periods differed among the oART systems owing to provision of beam data from the vendors. Chambers used during commissioning measurements differed among the institutions. Institutional training was provided by all nine institutions. To the best of our knowledge, this was the first survey about oART performed using commercial systems in Japan. We believe that this study will provide useful information to institutions that installed, are installing, or are planning to install oART systems.

One hundred cases of Rezum water vapor thermal therapy for benign prostatic hyperplasia: Real-world data at a single institution in Japan.

The objective of our study was to assess the efficacy of Rezum, a minimally invasive surgical treatment, for patients with lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) in real-world clinical practice at a single institution in Japan. We conducted a prospective study involving 100 patients who underwent the Rezum procedure between October 2022 and February 2024. We analyzed patient backgrounds that are compliant with Japanese regulations and assessed descriptive outcomes such as symptom scores, peak flow in uroflowmetry, post-void residual (PVR) volume, and prostate volume (PVol). These data were collected at 1 and/or 3 months postoperatively. On average, 4.7 water vapor injections were administered during the Rezum procedures, with a mean operative time of 6.3 min. Patients experienced significant relief in symptoms, with reductions of 55% in International Prostate Symptom Score, 53% in quality of life score, and 30% in Overactive Bladder Symptom Score. There was also a significant decrease in mean PVR volume (50% reduction) and PVol (27% reduction). Among the subgroup of 23 pre-interventional catheter-dependent patients, 91% achieved catheter independence. Our single-center analysis demonstrates that Rezum is an effective and safe minimally invasive therapeutic option for patients with BPH. This promising novel technique can be particularly beneficial for patients at an augmented risk of bleeding or those considered high risk for anesthesia.

Oxaliplatin Added to Fluoropyrimidine/Bevacizumab as Initial Therapy for Unresectable Metastatic Colorectal Cancer in Older Patients: A Multicenter, Randomized, Open-Label Phase III Trial (JCOG1018).

Doublet chemotherapy with fluoropyrimidine (FP) and oxaliplatin (OX) plus bevacizumab (BEV) is a standard regimen for unresectable metastatic colorectal cancer (MCRC). However, the efficacy of adding OX to FP plus BEV (FP + BEV) remains unclear for older patients, a population for whom FP + BEV is standard. We aimed to confirm the superiority of adding OX to FP + BEV for this population. This open-label, randomized, phase III trial was conducted at 42 institutions in Japan. Patients with unresectable MCRC age 70-74 years with Eastern Cooperative Oncology Group performance status (ECOG-PS) 2 and those 75 years and older with ECOG-PS 0-2 were randomly assigned (1:1) to an FP + BEV arm or an OX addition (FP + BEV + OX) arm. Fluorouracil plus levofolinate calcium or capecitabine was declared before enrollment. The primary end point was progression-free survival (PFS). The study was registered in the Japan Registry of Clinical Trials (identifier: jRCTs031180145). Between September 2012 and March 2019, 251 patients were randomly assigned to the FP + BEV arm (n = 125) and the FP + BEV + OX arm (n = 126). The median age was 80 and 79 years in the respective arm. The median PFS was 9.4 months (95% CI, 8.3 to 10.3) in the FP + BEV arm and 10.0 months (9.0 to 11.2) in the FP + BEV + OX arm (hazard ratio [HR], 0.84 [90.5% CI, 0.67 to 1.04]; one-sided P = .086). The median overall survival was 21.3 months (18.7 to 24.3) in the FP + BEV arm and 19.7 months (15.5 to 25.5) in the FP + BEV + OX arm (HR, 1.05 [0.81 to 1.37]). The proportion of any grade ≥3 adverse events was higher in the FP + BEV + OX arm (52% v 69%). There was one treatment-related death in the FP + BEV arm and three in the FP + BEV + OX arm. No benefit of adding OX to FP + BEV as first-line treatment was demonstrated in older patients with MCRC. FP + BEV is recommended for this population.

Symptoms, Course, and Factors Related to Long-Term Morbidity, Including Differences between Infection Strains, in Patients with Long COVID in a Primary Care Clinic in Japan: An Observational Study.

Objectives: The objectives were to investigate the clinical characteristics and course of long COVID, defined as the persistence of symptoms at least one month after the onset of COVID-19, in outpatients and to clarify differences in symptoms between SARS CoV-2 mutant strains. Methods: Our observational study in a primary care institution in Japan included 1053 patients with long COVID who visited our outpatient clinic between April 2021 and March 2023. Symptom distribution, performance status, and patient background at the time of the first outpatient visit were compared between infectious strains (Delta and before group and Omicron group). Background factors and symptoms related to time to remission were also analyzed. Results: The severity of COVID-19 in the acute phase was mild, moderate, and severe in 82.2%, 14.9%, and 2.9% in the Delta and before group; and in 97.6%, 1.7%, and 0.4% in the Omicron group, respectively. Vaccination coverage was significantly different between the Delta and before (37.1%) and Omicron groups (73.1%) (p < 0.001), probably due to the period of vaccine unavailability in the former group. Symptoms of fatigue and headache occurred most frequently, irrespective of infectious strain. The mean number of symptoms per patient was significantly higher in the Delta and before group than the Omicron group (3.4 vs. 2.7, p < 0.0001). The median time overall to remission of long COVID was 169 days. Cox hazard model analysis identified female sex, high body mass index, and dyspnea (but not infectious strain) as significant factors prolonging the time to remission (p < 0.05). Conclusions: Differences in the number of symptoms between infectious strains may be related to differences in viral virulence and/or vaccination coverage. However, the clinical course was found to be minimally influenced by the infectious strain. The present results should improve the understanding of prognosis in patients with long COVID from both the clinical and social perspectives.

A Comparative Study of Access Analysis Service Utilization on Japanese Medical Institutions' Websites with GDPR-Compliant Cases.

The browsing history of a medical institution's website can potentially reveal or identify information about the health condition of the website visitor through browser cookies and fingerprints. In Japan, although the Personal Information Protection Law was revised in April 2022, the use of access analysis services to collect browsing history on medical institution websites has not been investigated. Therefore, this study investigates the actual usage of access analysis services on Japanese medical institution websites and compares it with the current situation in France, which follows the General Data Protection Regulation. The results revealed that the larger the size of the hospital, the higher the percentage of adoption of access analytics services in Japan. However, the implementation of a system for obtaining consent for the use of access analysis in Japan was found to be poor compared to that of French medical institutions. While access analysis tools are used in the websites of several medical institutions in Japan, the implementation of the process of obtaining consent to acquire browsing history is poor.