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Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms

Por: Abe · H. · Sako · T. · Yamamoto · Y. · Ikeda · A. · Kawara · F. · Ose · T. · Takao · T. · Kitamura · Y. · Ariyoshi · R. · Morita · Y. · Ishida · T. · Ikegawa · T. · Ishida · R. · Yoshizaki · T. · Sakaguchi · H. · Toyonaga · T. · Kodama · Y.
Introduction

EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified.

Methods and analysis

The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%.

Ethics and dissemination

This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers.

Trial registration number

jRCT1052220166.

Cost-effectiveness of behavioural counselling intervention compared with non-intervention for adult patients with metabolic syndrome to prevent cardiovascular diseases and type 2 diabetes in Japan: a microsimulation modelling study

Por: Akune · Y. · Anezaki · H. · Nakao · Y. M. · Goto · R.
Objectives

Nationwide lifestyle intervention—specific health guidance (SHG) in Japan—employs counselling and education to change unhealthy behaviours that contribute to metabolic syndrome, especially obesity or abdominal obesity. We aimed to perform a model-based economic evaluation of SHG in a low participation rate setting.

Design

A hypothetical population, comprised 50 000 Japanese aged 40 years who met the criteria of the SHG, used a microsimulation using the Markov model to evaluate SHG’s cost-effectiveness compared with non-SHG. This hypothetical population was simulated over a 35-year time horizon.

Setting

SHG is conducted annually by all Japanese insurers.

Outcome measures

Model parameters, such as costs and health outcomes (including quality-adjusted life-years, QALYs), were based on existing literature. Incremental cost-effectiveness ratios were estimated from the healthcare payer’s perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to evaluate the uncertainty around the model input parameters.

Results

The simulation revealed that the total costs per person in the SHG group decreased by JPY53 014 (US$480) compared with that in the non-SHG group, and the QALYs increased by 0.044, wherein SHG was considered the dominant strategy despite the low participation rates. PSA indicated that the credibility intervals (2.5th–97.5th percentile) of the incremental costs and the incremental QALYs with the SHG group compared with the non-SHG group were –JPY687 376 to JPY85 197 (–US$6226 to US$772) and –0.009 to 0.350 QALYs, respectively. Each scenario analysis indicated that programmes for improving both blood pressure and blood glucose levels among other risk factors for metabolic syndrome are essential for improving cost-effectiveness.

Conclusions

This study suggests that even small effects of counselling and education on behavioural modification may lead to the prevention of acute life-threatening events and chronic diseases, in addition to the reduction of medication resulting from metabolic syndrome, which results in cost savings.

Rat hair-follicle-associated pluripotent (HAP) stem cells can differentiate into atrial or ventricular cardiomyocytes in culture controlled by specific supplementation

by Nanako Takaoka, Michiko Yamane, Ayami Hasegawa, Koya Obara, Kyoumi Shirai, Ryoichi Aki, Hiroyasu Hatakeyama, Yuko Hamada, Nobuko Arakawa, Manabu Tanaka, Robert M. Hoffman, Yasuyuki Amoh

There has been only limited success to differentiate adult stem cells into cardiomyocyte subtypes. In the present study, we have successfully induced beating atrial and ventricular cardiomyocytes from rat hair-follicle-associated pluripotent (HAP) stem cells, which are adult stem cells located in the bulge area. HAP stem cells differentiated into atrial cardiomyocytes in culture with the combination of isoproterenol, activin A, bone morphogenetic protein 4 (BMP4), basic fibroblast growth factor (bFGF), and cyclosporine A (CSA). HAP stem cells differentiated into ventricular cardiomyocytes in culture with the combination of activin A, BMP4, bFGF, inhibitor of Wnt production-4 (IWP4), and vascular endothelial growth factor (VEGF). Differentiated atrial cardiomyocytes were specifically stained for anti-myosin light chain 2a (MLC2a) antibody. Ventricular cardiomyocytes were specially stained for anti-myosin light chain 2v (MLC2v) antibody. Quantitative Polymerase Chain Reaction (qPCR) showed significant expression of MLC2a in atrial cardiomyocytes and MLC2v in ventricular cardiomyocytes. Both differentiated atrial and ventricular cardiomyocytes showed characteristic waveforms in Ca2+ imaging. Differentiated atrial and ventricular cardiomyocytes formed long myocardial fibers and beat as a functional syncytium, having a structure similar to adult cardiomyocytes. The present results demonstrated that it is possible to induce cardiomyocyte subtypes, atrial and ventricular cardiomyocytes, from HAP stem cells.

Exploration of wound‐related complications post‐kidney transplantation

Abstract

An essential intervention for patients with end-stage renal disease is kidney transplantation. Nonetheless, patient outcomes are substantially affected by complications associated with postoperative wounds. The purpose of this research was to determine the prevalence, risk factors and repercussions of wound-related complications among kidney transplant recipients. A cross-sectional observational study was undertaken at Qilu Hospital of Shandong University Department of Organ Transplantation, China. Included in the study were 118 patients who had undergone kidney transplantation during the specified time period. Medical record evaluations, questionnaires and patient interviews were utilized to collect data, with an emphasis on demographics, transplant information, postoperative care and wound complications. Infection, dehiscence, lymphocoele, delayed wound healing, seroma formation and haematoma were classified as complications. The presence of comorbidities, age over 50 and living donor transplants were identified as significant risk factors for postoperative complications. The most prevalent complications observed were delayed wound healing (21.2%) and infections (16.9%) (p < 0.05). Antibiotics were found to be effective in managing infections, while prolonged conservative management was necessary for delayed wound healing. Prominent complications that recurred were infections and wound healing delays. No statistically significant correlation was observed between gender, BMI and prior transplants with the occurrence of complications (p > 0.05). The research highlighted the significance of taking into account patient-specific variables, including age and concurrent medical conditions, when conducting post-kidney transplantation treatment. The results supported the use of individualized strategies in postoperative care, particularly for populations at high risk, in order to reduce the incidence and severity of complications associated with wounds in pursuit to enhancing clinical practices and formulating focused intervention strategies to improve patient outcomes following transplantation.

Characteristics and trends of medical malpractice claims in Japan between 2006 and 2021

by Kaori Taniguchi, Takashi Watari, Kiwamu Nagoshi

Classification and analysis of existing data on medical malpractice lawsuits are useful in identifying the root causes of medical errors and considering measures to prevent recurrence. No study has shown the actual prevalence of all closed malpractice claims in Japan, including the number of cases and their trial results. In this study, we illustrated the recent trends of closed malpractice claims by medical specialty, the effects of the acceptance rates and the settlements and clarified the trends and characteristics. This was a descriptive study of all closed malpractice claims data from the Supreme Court in Japan from 2006–2021. Trends and the characteristics in closed malpractice claims by medical specialty and the outcomes of the claims, including settlements and judgments, were extracted. The total number of closed medical malpractice claims was 13,340 in 16 years, with a high percentage ending in settlement (7,062, 52.9%), and when concluding in judgment (4,734, 35.3%), the medical profession (3,589, 75.8%) was favored. When compared by medical specialty, plastic surgery and obstetrics/gynecology were more likely resolved by settlement. By contrast, psychiatry cases exhibited a lower likelihood of settlement, and the percentage of cases resulting in unfavorable outcomes for patients was notably high. Furthermore, there has been a decline in the number of closed medical malpractice claims in Japan in recent years compared to the figures observed in 2006. In particular, the number of closed medical malpractice claims in obstetrics/gynecology and the number of closed medical malpractice claims per 1,000 physicians decreased significantly compared to other specialties. In conclusion, half of the closed malpractice claims were settled, and a low percentage of patients won their cases. Closed medical malpractice claims in Japan have declined in most medical specialties since 2006. Additionally, obstetrics/gynecology revealed a significant decrease since introducing the Obstetrics/Gynecology Medical Compensation System in 2009.

The role of psychosocial factors and biological sex on rural Thai adolescents' drinking intention and behaviours: A structural equation model

Abstract

Aims

To examine the contributions of psychosocial factors (attitude towards drinking, perceived drinking norms [PDNs], perceived behavioural control [PBC]), and biological sex on drinking intention and behaviours among rural Thai adolescents.

Design

A cross-sectional study design.

Methods

In 2022, stratified by sex and grade, we randomly selected 474 rural Thai adolescents (M age = 14.5 years; SD = 0.92; 50.6% male) from eight public district schools in Chiang Mai Province, Thailand, to complete a self-administered questionnaire. Structural equation modelling with the weighted least square mean and variance adjusted was used for data analysis.

Results

All adolescents' psychosocial factors contributed significantly to the prediction of drinking intention, which subsequently influenced their drinking onset, current drinking and binge drinking pattern in the past 30 days. PDNs emerged as the strongest psychosocial predictor of drinking intention, followed by PBC. Rural adolescents' drinking intention significantly mediated the relationship between all psychosocial factors and drinking behaviours either fully or partially. The path coefficient between drinking attitude and drinking intention was significantly different between males and females.

Conclusion

Different from previous studies focus on adolescents' drinking attitude, rural Thai adolescents' PDNs play a significant role on their drinking intention and subsequently their drinking onset and patterns. This nuanced understanding supports a paradigm shift to target adolescents' perceived drinking norms as a means to delay their drinking onset and problematic drinking behaviours.

Impact

Higher levels of perceived drinking norms significantly led to the increase in drinking intention among adolescents. Minimizing adolescents' perceptions of favourable drinking norms and promoting their capacity to resist drinking, especially due to peer pressure, are recommended for nursing roles as essential components of health education campaigns and future efforts to prevent underage drinking.

Patient or Public Contribution

In this study, there was no public or patient involvement.

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