Background/Aims: The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance. Methods: Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method. Results: All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months. Conclusions Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.

Background/Aims: The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance. Methods: Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method. Results: All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months. Conclusions Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.

Background/Aims: The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance. Methods: Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method. Results: All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months. Conclusions Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.

Objective: The incidence and mortality rates of endometrial cancer are increasing globally, including in Japan. Quality of cancer care is promoted through guideline adherence. This study aimed to establish quality indicators (QIs) for endometrial cancer and explore the factors contributing to treatment nonadherence. Methods: QIs and pattern-of-care indicators (PCIs) were developed using the Research and Development/University of California Los Angeles modified Delphi method. QIs reflect desirable healthcare patterns, whereas PCIs address treatment areas with lacking evidence.Data from the Hospital-Based Cancer Registry and Diagnosis Procedure Combination Survey were used. Patients diagnosed or treated between January 1 and December 31, 2020 were included. The reasons for nonadherence were collected. Logistic regression was used to analyze the factors influencing adherence, including age, body mass index, comorbidities, facilities, and recurrence risk. Results: Of the 35 proposed QI candidates, 8 QIs and 9 PCIs were selected, predominantly focusing on surgical aspects. Adherence rates varied, with peritoneal lavage cytology being the highest (93.1%), and postoperative hormone replacement therapy (HRT) for patients aged <45 years being the lowest (30.9%), when focusing on process indicators. Reasons for nonadherence included patient preference and medical comorbidities as significant factors. Multivariate analysis highlighted age, clinical stage, and Barthel index as significant contributors to nonadherence. Conclusion We developed QIs to comprehensively assess endometrial cancer treatment.Adherence rates are favorable; however, HRT has a low adherence rate. Factors leading to nonadherence include advanced age and incomplete activities of daily living, particularly in advanced stages.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.

Objective: This study aimed to clarify the details of inpatient cancer rehabilitation interventions provided by designated cancer hospitals in Japan. Methods: This questionnaire-based survey asked specialists regarding the outline of their facilities’ inpatient cancer rehabilitation, Dietz classification, disease, and intervention details. Results: Restorative interventions were the most common, and the most common cancer was lung cancer followed by colorectal cancer; hematologic malignancy; gastric cancer; and liver, gallbladder, and pancreatic cancer. Intervention proportions for colorectal and gastric cancer were significantly higher in general hospitals than in university hospitals and cancer centers; in contrast, those for hematological malignancy were significantly higher in university hospitals than in general hospitals. For bone and soft tissue sarcomas, intervention proportions in cancer centers were significantly higher than those in university and general hospitals; and for oral, pharyngeal, and laryngeal cancers, they were significantly higher in university hospitals and cancer centers than in general hospitals. The most common intervention was walking training, followed by resistance training, basic motor training, activities of daily living training, and respiratory rehabilitation. Respiratory rehabilitation was performed significantly more frequently in university and general hospitals than in cancer centers.Conclusion: The diseases had differed according to the characteristics of the facilities, and the interventions were considered accordingly. In future, it will be necessary to verify the effectiveness of inpatient cancer rehabilitation according to facility characteristics and to disseminate information on inpatient cancer rehabilitation.

Retrospective cohort study.

Retrospective cohort study.

Objective: In order to ensure the safety of nursing home residents, it is very important to implement appropriate assistance to ensure compliance with necessary medication. The purpose of this study is to identify issues and to plan solutions for medication assistance.Design: We conducted a workshop involving care workers (CWs), nurses and pharmacists together.Methods: Using the KJ method, participants extracted problems related to medication assistance and planned solutions in a mixed group of CWs, nurses and pharmacists. Questionnaire surveys were conducted for the participants before, immediately after, and 3 months after the workshop.Results: A number of important and urgent issues related to medication assistance were identified. There were differences in the recognition patterns of the importance and urgency of the issues among the three categories of participants. In addition, many possible solutions were proposed. Among these solutions, 25% had been implemented by at least two participants. More than 75 % of participants felt that their awareness of the value of cooperation in medication assistance had been improved by participating in the workshop.Conclusion: These results suggest that a workshop with a group of CWs, nurses and pharmacists in one place is a useful approach for extracting problems and planning effective solutions related to cooperation in medication assistance.