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Ayer — Abril 19th 2024Tus fuentes RSS

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.

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Cohort profile: rationale and design of the Resource Center for Health Science (RECHS) project - a study of health hazards and medical cost burden among the Japanese population

Por: Morishita · T. · Takemura · M. · Hayashi · M. · Saito · K. · Yamamoto · Y. · Tsurumi · H. · Matsunami · H.
Purpose

The increased global burden of non-communicable diseases and mental disorders is an urgent health challenge for countries around the entire world, especially those experiencing super-ageing societies, where over 21% of the population is age 65 years or older. Japan is the world’s most rapidly ageing society, and as a result, medical costs are also rising dramatically. With the aims of establishing a foundational framework for future research efforts, primarily focusing on the development of a personal health record (PHR) system, and creating a long-term repository for bioresources integrated with PHRs, this study investigated potential health risks and future healthcare burdens based on a longitudinal analysis of health records.

Participants

The Resource Center for Health Science (RECHS) project is a long-term, prospective biobank project, population and health check-up-based cohort that primarily investigates the associations between lifestyle and environmental factors and some surrogate markers of non-communicable diseases, such as diabetes, hypertension, cardiovascular disease and cancer. Starting in 2010, we initiated an annual cohort study among voluntary participants recruited from health check-up programmes and collected data from the following sources: a self-administered baseline questionnaire that included items on dietary habits and stress, a Brief Self-Administered Diet History Questionnaire, the Centre for Epidemiologic Studies Depression Scale and the General Health Questionnaire-28.

Findings to date

For this prospective cohort study, we planned to enrol approximately 10 000 participants. We collected and stored serum samples from all participants for future analyses. The study participants who still were able to participate in these health check-ups and their outcomes were then obtained from the measurements and questionnaire responses.

Future plans

Insights emerging from the RECHS study can provide researchers and public health policy administrators with evidence to aid in the prevention of non-communicable diseases and clarify the most malleable status to implement preventive measures.

Evaluation of photoreceptor features in retinitis pigmentosa with cystoid macular edema by using an adaptive optics fundus camera

by Shohei Kitahata, Kiyoko Gocho, Naohiro Motozawa, Satoshi Yokota, Midori Yamamoto, Akiko Maeda, Yasuhiko Hirami, Yasuo Kurimoto, Kazuaki Kadonosono, Masayo Takahashi

Objective

Cystoid macular edema (CME) in retinitis pigmentosa (RP) is an important complication causing visual dysfunction. We investigated the effect of CME on photoreceptors in RP patients with previous or current CME, using an adaptive optics (AO) fundus camera.

Methods

We retrospectively observed the CME and ellipsoid zone (EZ) length (average of horizontal and vertical sections) by optical coherence tomography. The density and regularity of the arrangement of photoreceptor cells (Voronoi analysis) were examined at four points around 1.5° from superior to inferior and temporal to nasal. We also performed a multivariate analysis using CME duration, central macular thickness and transversal length of CME.

Results

We evaluated 18 patients with previous or current CME (18 eyes; age, 48.7 ± 15.6 years) and 24 patients without previous or current CME (24 eyes; age, 46.0 ± 14.5 years). There were no significant differences in age, logMAR visual acuity, or EZ length. In groups with and without CME, cell density was 11967 ± 3148 and 16239 ± 2935 cells/mm2, and sequence regularity was 85.5 ± 3.4% and 88.5 ± 2.8%, respectively; both parameters were significantly different. The correlation between photoreceptor density and age was more negative in group with CME. The CME group tended toward greater reductions in duration of CME.

Conclusion

Complications of CME in RP patients may lead to a decrease in photoreceptor density and regularity. Additionally, a longer duration of CME may result in a greater reduction in photoreceptor density.

Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan

Por: Shibagaki · Y. · Yamazaki · H. · Wakita · T. · Ware · J. E. · Wang · J. · Onishi · Y. · Yajima · T. · Sada · K.-E. · Yamamoto · Y. · Fukuhara · S.
Introduction

Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin–angiotensin–aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients’ quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient’s QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient’s QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient’s QOL, in patients with HK.

Methods and analysis

This is a prospective cohort study with 6 months of follow-up in 30–40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients’ characteristics. To assess the impact of treatment on a patient’s QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient’s QOL.

Ethics and dissemination

Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals.

Trial registration number

NCT05297409.

Elucidation of the needs for telecritical care services in Japan: a qualitative study

Por: Morimoto · M. · Nawa · N. · Okada · E. · Itsui · Y. · Kashimada · A. · Yamamoto · K. · Akaishi · Y. · Yamawaki · M.
Objective

To clarify the reasons for consultation, advice sought by frontline physicians and relationship between the patient’s pathology and the type of advice provided to guide the future development of telecritical care services.

Design

Secondary analysis of transcripts of telephone calls originally recorded for quality control purposes was conducted using a thematic content analysis. The calls were conducted between December 2019 and April 2021 (total cases: 70; total time: ~15 hour).

Settings

Intensivists provided consultation services to frontline physicians at secondary care institutions in the Kansai and Chubu regions.

Participants

Non-intensive care frontline physicians working in five secondary care institutions in the Kansai and Chubu regions and intensivists providing a consultation service (n=26).

Interventions

Not applicable.

Primary and secondary outcome measures

The main outcome was the themes emerging from the language used during telephone and video consultations, indicating the gap filled by the telecritical care service.

Findings

We analysed 70 cases and approximately 15 hours of anonymised audio data. We identified the following reasons for consultation: ‘lack of competence in treatment and diagnostic testing’ and ‘lack of access to consultation in their own hospital’. Frontline physicians most often sought advice related to ‘treatment’, followed by ‘patient triage and transfer’, ‘diagnosis’ and ‘diagnostic testing and evaluation’. Regarding the relationship between the patient’s pathology and type of advice provided, the most commonly sought advice by frontline physicians varied based on the patient’s pathology.

Conclusion

This study explored the characteristics of 70 telecritical sessions and identified the reasons for and nature of the consultations. These findings can be used to guide the future provision and scale up of telecritical services.

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