We, the delegates of the 2016 Japan-UK exchange, herein report our experiences and impressions of British primary care: "the difference between the career paths of general practitioners from Japan and UK", "medical interpreters and care in a multicultural society" and "framework for development of clinical research". We described our experiences in UK with a literature review. The authors wish for the article to support the advancement of Japanese primary care.

MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.

This paper proposes a method for evaluating and scoring the activities of rehabilitation service users in order to pinpoint the problems with the health service of this kind and set the adequate targets for each user. Sincs the Nursing Care Insurance System was introduced in Japan in 2000, it has been argued that home-visit rehabilitation services should be excluded from home-nursing care services. However, the methods of certifing that nursing care is required are not fully established yet for setting the rehabilitation targets for service users. As things stand, it is recommended that such a method as the Functional Independence Measure (FIM) or the Barthel Index (BI) should be utilized. However, these methods only evaluate “performing activities” (the activities that a user usually performs). In order to set the users' targets, we thought it necessary to establish a method for evaluating “possible activities” (the activities that a user is able to perform at his/her full capacity). We have established a method called Functional Scoring (FS) which evaluates and scores the both performing and possible activities based on the same evaluation items. We conducted experimental evaluations on the home-visit rehabilitation users for one year from October 2005 to September 2006. When the first evaluations in 2005 were compared with the second evaluations in 2006, the total score of the performing activities significantly increased from 44.1±13.7 to 47.8±14.2 (P<0.05). Although the total score of the possible activities did not significantly increase, it demonstrated an upward trend from 49.6±13.2 to 51.6±13.5. The result suggests that our method is useful for distinguishing between the performing and possible activities. The proposed method enables us to adequately recognize the problems each user has, and to set the rehabilitation target for each user, which can be shared between the user, care personnel, and care service provider.
Rehabilitation aspects ; Functional ; FS ; Care given by nurses ; Published Comment

BACKGROUND/AIMS: Although both radial- and convex-arrayed endoscopic ultrasonography (EUS) scopes are widely used for observational EUS examinations, there have been few comparative studies on their power of visualization. The aim of this study was to evaluate the capability of these EUS scopes for observation of the pancreatobiliary junction. METHODS: The rate of successful visualization of the pancreatobiliary junction was retrospectively compared between a radial-arrayed and a convex-arrayed echoendoscope, from a prospectively maintained database. Study periods were defined as January 2010 to December 2012 for the radial group, and February 2015 to October 2016 for the convex group because the respective scope was mainly used during those periods. RESULTS: During the study period, 1,660 cases with radial EUS and 1,984 cases with convex EUS were recruited. The success rates of observation of the pancreatobiliary junction were 80.0% and 89.5%, respectively (p < 0.0001). CONCLUSIONS: The capability of visualization of the pancreatobiliary junction in observational EUS was found to be better with a convex-arrayed than with a radial-arrayed echoendoscope.
Endosonography ; Prospective Studies ; Retrospective Studies

BACKGROUND/AIMS: It is often difficult to manage acute cholecystitis after metal stent (MS) placement in unresectable malignant biliary strictures. The aim of this study was to evaluate the feasibility of endoscopic ultrasonography-guided gallbladder drainage (EUS-GBD) for acute cholecystitis. METHODS: The clinical outcomes of 10 patients who underwent EUS-GBD for acute cholecystitis after MS placement between January 2011 and August 2018 were retrospectively evaluated. The procedural outcomes of percutaneous transhepatic gallbladder drainage (PTGBD) with tube placement (n=11 cases) and aspiration (PTGBA) (n=27 cases) during the study period were evaluated as a reference. RESULTS: The technical success and clinical effectiveness rates of EUS-GBD were 90% (9/10) and 89% (8/9), respectively. Severe bile leakage that required surgical treatment occurred in one case. Acute cholecystitis recurred after stent dislocation in 38% (3/8) of the cases. Both PTGBD and PTGBA were technically successful in all cases without severe adverse events and clinically effective in 91% and 63% of the cases, respectively. CONCLUSIONS: EUS-GBD after MS placement was a feasible option for treating acute cholecystitis. However, it was a rescue technique following the established percutaneous intervention in the current setting because of the immature technical methodology, including dedicated devices, which need further development.
Bile ; Cholecystitis, Acute ; Constriction, Pathologic ; Dislocations ; Drainage ; Gallbladder ; Humans ; Retrospective Studies ; Stents ; Treatment Outcome

Nijiiro Doctors offered a six-month LGBTQ healthcare training course for physicians in their third year of post-graduate studies or above, with the goal of implementing practice at their institutions. In addition to lectures, the course included dialogues with LGBTQ individuals, role-plays in which the LGBTQ individuals played the role of mock patients and reviews in small groups in each session.

Methods: Male and female patients with computed tomography data were selected. Dimensions of the first thoracic (T1), fourth lumbar (L4), and fifth lumbar (L5) vertebrae were measured, and bone models consisting of the cancellous and cortical bones made from polyurethane foam were created. PS with diameters of 4.5 mm, 5.5 mm, and 6.5 mm were used. T1 PS were 25 mm long, and L4 and L5 PS were 40 mm long. The bone models were secured with cement, and the MIT was measured using a calibrated torque wrench. After MIT testing, the PS head was attached to the machine’s crosshead. POS was then calculated at a crosshead speed of 5 mm/min until failure. Results: The L4 and L5 were notably larger in female bone models, whereas the T1 vertebra was larger in male bone models. Consequently, the MIT and POS for L4 and L5 were higher in female bone models across all PS diameters than in male bone models. Conversely, the MIT for T1 was higher in male bone models across all PS; however, no significant differences were observed in the POS values for T1 between sexes. Conclusions The mechanical properties of the proposed bone models can vary based on the vertebral structure and size. For accurate 3D surgical and mechanical simulations in the creation of custom-made medical devices, bone models must be constructed from patientspecific medical images.

Methods: Male and female patients with computed tomography data were selected. Dimensions of the first thoracic (T1), fourth lumbar (L4), and fifth lumbar (L5) vertebrae were measured, and bone models consisting of the cancellous and cortical bones made from polyurethane foam were created. PS with diameters of 4.5 mm, 5.5 mm, and 6.5 mm were used. T1 PS were 25 mm long, and L4 and L5 PS were 40 mm long. The bone models were secured with cement, and the MIT was measured using a calibrated torque wrench. After MIT testing, the PS head was attached to the machine’s crosshead. POS was then calculated at a crosshead speed of 5 mm/min until failure. Results: The L4 and L5 were notably larger in female bone models, whereas the T1 vertebra was larger in male bone models. Consequently, the MIT and POS for L4 and L5 were higher in female bone models across all PS diameters than in male bone models. Conversely, the MIT for T1 was higher in male bone models across all PS; however, no significant differences were observed in the POS values for T1 between sexes. Conclusions The mechanical properties of the proposed bone models can vary based on the vertebral structure and size. For accurate 3D surgical and mechanical simulations in the creation of custom-made medical devices, bone models must be constructed from patientspecific medical images.

Methods: Male and female patients with computed tomography data were selected. Dimensions of the first thoracic (T1), fourth lumbar (L4), and fifth lumbar (L5) vertebrae were measured, and bone models consisting of the cancellous and cortical bones made from polyurethane foam were created. PS with diameters of 4.5 mm, 5.5 mm, and 6.5 mm were used. T1 PS were 25 mm long, and L4 and L5 PS were 40 mm long. The bone models were secured with cement, and the MIT was measured using a calibrated torque wrench. After MIT testing, the PS head was attached to the machine’s crosshead. POS was then calculated at a crosshead speed of 5 mm/min until failure. Results: The L4 and L5 were notably larger in female bone models, whereas the T1 vertebra was larger in male bone models. Consequently, the MIT and POS for L4 and L5 were higher in female bone models across all PS diameters than in male bone models. Conversely, the MIT for T1 was higher in male bone models across all PS; however, no significant differences were observed in the POS values for T1 between sexes. Conclusions The mechanical properties of the proposed bone models can vary based on the vertebral structure and size. For accurate 3D surgical and mechanical simulations in the creation of custom-made medical devices, bone models must be constructed from patientspecific medical images.

Methods: Male and female patients with computed tomography data were selected. Dimensions of the first thoracic (T1), fourth lumbar (L4), and fifth lumbar (L5) vertebrae were measured, and bone models consisting of the cancellous and cortical bones made from polyurethane foam were created. PS with diameters of 4.5 mm, 5.5 mm, and 6.5 mm were used. T1 PS were 25 mm long, and L4 and L5 PS were 40 mm long. The bone models were secured with cement, and the MIT was measured using a calibrated torque wrench. After MIT testing, the PS head was attached to the machine’s crosshead. POS was then calculated at a crosshead speed of 5 mm/min until failure. Results: The L4 and L5 were notably larger in female bone models, whereas the T1 vertebra was larger in male bone models. Consequently, the MIT and POS for L4 and L5 were higher in female bone models across all PS diameters than in male bone models. Conversely, the MIT for T1 was higher in male bone models across all PS; however, no significant differences were observed in the POS values for T1 between sexes. Conclusions The mechanical properties of the proposed bone models can vary based on the vertebral structure and size. For accurate 3D surgical and mechanical simulations in the creation of custom-made medical devices, bone models must be constructed from patientspecific medical images.