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: 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

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

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.

BACKGROUND/AIMS: This study aimed to identify the predictive factors for inaccurate endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) diagnosis of swollen lymph nodes without rapid on-site cytopathological evaluation. METHODS: Eighty-three consecutive patients who underwent EUS-FNA for abdominal or mediastinal lymph nodes from January 2008 to June 2017 were included from a prospectively maintained EUS-FNA database and retrospectively reviewed. The sensitivity, specificity, and accuracy of EUS-FNA for the detection of neoplastic diseases were calculated. Candidate factors for inaccurate diagnosis (lymph node size and location, needle type, puncture route, number of passes, and causative disease) were evaluated by comparison between accurately diagnosed cases and others. RESULTS: The final diagnosis of the punctured lymph node was classified as neoplastic (65 cases: a metastatic lymph node, malignant lymphoma, or Crow-Fukase syndrome) or non-neoplastic (18 cases: a reactive node or amyloidosis). The sensitivity, specificity, and accuracy were 83%, 94%, and 86%, respectively. On multivariate analyses, small size of the lymph node was the sole predictive factor for inaccurate EUS-FNA diagnosis with a significant difference (odds ratios, 19.8; 95% confidence intervals, 3.15–124; p=0.0015). CONCLUSIONS: The lymph node size of <16 mm was the only independent factor associated with inaccurate EUS-FNA diagnosis of swollen lymph nodes.
Diagnosis ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Endosonography ; Humans ; Lymph Nodes ; Lymphatic Diseases ; Lymphoma ; Multivariate Analysis ; Needles ; Prospective Studies ; Punctures ; Retrospective Studies ; Risk Factors ; Sensitivity and Specificity

BACKGROUND/AIMS: In this study, we aimed to evaluate the predictive value of localized stenosis of the main pancreatic duct (MPD) for early detection of pancreatic cancer.METHODS: Among 689 patients who underwent endoscopic retrograde pancreatography from January 2008 to September 2018, 19 patients with MPD findings were enrolled. These patients showed findings for indicating suspicious pancreatic cancer at an early stage (FiCE); FiCE was defined as a single, localized stenosis in the MPD without a detectable mass (using any other imaging methods) and without other pancreatic diseases, such as definite chronic pancreatitis, intraductal papillary mucinous neoplasm, and autoimmune pancreatitis. Final diagnoses were established by examining resected specimens or through follow-up examinations after an interval of >5 years.RESULTS: Among 19 patients with FiCE, 11 underwent surgical resection and 8 were evaluated after a >5-year observation period. The final diagnosis of the MPD stenosis was judged to be pancreatic cancer in 9 patients (47%), including 3 with intraepithelial cancer, and to be a non-neoplastic change in 10. The sensitivity, specificity, and accuracy of preoperative pancreatic juice cytology were 75%, 100%, and 88%, respectively.CONCLUSIONS: The predictive value of FiCE for pancreatic cancer prevalence was 47%. Histological confirmation with pancreatic juice cytology is necessary before surgical resection.
Cholangiopancreatography, Endoscopic Retrograde ; Constriction, Pathologic ; Diagnosis ; Follow-Up Studies ; Humans ; Mucins ; Pancreatic Diseases ; Pancreatic Ducts ; Pancreatic Juice ; Pancreatic Neoplasms ; Pancreatitis ; Pancreatitis, Chronic ; Prevalence ; Sensitivity and Specificity

Background/Aims: The precise incidence of symptomatic uncomplicated diverticular disease (SUDD) and its effects on the quality of life (QOL) remain unclear, particularly in Asian patients with right-sided SUDD. We assess the prevalence of SUDD and its impact on QOL in a real-world population. Methods: Five institutional cohorts of patients who received outpatient treatment for unexplained abdominal symptoms from January 15, 2020 to March 31, 2022, were included. All patients underwent colonoscopy. SUDD was defined as the presence of recurrent abdominal symptoms, particularly pain in the lower right or left quadrant lasting > 24 hours in patients with diverticulosis at the site of pain. The 36-item short-form health survey was used to assess QOL. Results: Diverticula were identified in 108 of 361 patients. Among these 108 patients, 31% had SUDD, which was right-sided in 39% of cases.Of the 50 patients with right-sided diverticula, 36% had SUDD, as did 15 of 35 patients with left-sided diverticula (43%). Among the 33 patients with SUDD, diverticula were right-sided, left-sided, and bilateral in 39%, 45%, and 15% of patients, respectively. Diarrhea was more frequent in the SUDD group than in the non-SUDD group. Patients with SUDD had significantly lower physical, mental, and role/social component scores than those without SUDD. Conclusions It is important to recognize that patients with SUDD account for as high as 31% of outpatients with unexplained abdominal symptoms; these patients have diarrhea and a low QOL. The presence of right-sided SUDD was characteristic of Asian patients.

Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%).Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions The present study demonstrated that ca-4F12-E6 was well-tolerated in nonOMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.