A 58-year-old male patient presented with acute alcohol-induced severe necrotizing pancreatitis. He reported a symptomatic acute necrotic collection in the pancreatic head. No improvements were observed despite one week of antimicrobial therapy. Endoscopic ultrasound-guided drainage via the superior duodenal angle was conducted and a lumen-apposing metal stent (LAMS) was placed. He had an obstructive jaundice progression 3 days postintervention. Endoscopic retrograde cholangiography showed that the cystic side flange of the LAMS caused the distal bile duct smooth stricture. The jaundice improved immediately after the placement of plastic stent in the bile duct, and the LAMS could be removed on the 15th day after placement. The plastic stent was removed after 4 months, and the biliary stricture improved, with no recurrence of jaundice. Here, we report a case of successful conservative treatment of a benign biliary stricture caused by the distal flange of the LAMS.

A 58-year-old male patient presented with acute alcohol-induced severe necrotizing pancreatitis. He reported a symptomatic acute necrotic collection in the pancreatic head. No improvements were observed despite one week of antimicrobial therapy. Endoscopic ultrasound-guided drainage via the superior duodenal angle was conducted and a lumen-apposing metal stent (LAMS) was placed. He had an obstructive jaundice progression 3 days postintervention. Endoscopic retrograde cholangiography showed that the cystic side flange of the LAMS caused the distal bile duct smooth stricture. The jaundice improved immediately after the placement of plastic stent in the bile duct, and the LAMS could be removed on the 15th day after placement. The plastic stent was removed after 4 months, and the biliary stricture improved, with no recurrence of jaundice. Here, we report a case of successful conservative treatment of a benign biliary stricture caused by the distal flange of the LAMS.

A 58-year-old male patient presented with acute alcohol-induced severe necrotizing pancreatitis. He reported a symptomatic acute necrotic collection in the pancreatic head. No improvements were observed despite one week of antimicrobial therapy. Endoscopic ultrasound-guided drainage via the superior duodenal angle was conducted and a lumen-apposing metal stent (LAMS) was placed. He had an obstructive jaundice progression 3 days postintervention. Endoscopic retrograde cholangiography showed that the cystic side flange of the LAMS caused the distal bile duct smooth stricture. The jaundice improved immediately after the placement of plastic stent in the bile duct, and the LAMS could be removed on the 15th day after placement. The plastic stent was removed after 4 months, and the biliary stricture improved, with no recurrence of jaundice. Here, we report a case of successful conservative treatment of a benign biliary stricture caused by the distal flange of the LAMS.

Early detection of third-generation cephalosporin-resistant bacteria in blood culture tests influences the choice of antimicrobial agents. We report on our hospital’s system for early reporting of third-generation cephalosporin-resistant bacteria and its utility. The hospital operates a 24-h simple cefpodoxime (CPDX) testing system, where the content of a sample container with a positive blood culture result is smeared on a CA Sheep Blood Agar/VCM Chocolate EX II fractionation medium, and an antibiotic susceptibility test (AST) disk (Sensi-Disk CPDX) is placed at the center of the medium and incubated. The presence or absence of third-generation cephalosporin-resistant bacteria is estimated from the diameter of the growth inhibition zone. The physician in charge of AST makes comments on the chart based on the simple CPDX test results. The sensitivity of the simple CPDX test for detecting third-generation cephalosporin-resistant bacteria, based on AST results, was 95.5%. Among patients with failed antimicrobial therapy, the rate of switching antimicrobials before the AST results were known was 57.9% in cases where there were comments made by the physicians in charge of AST, compared with 42.9% in cases without comments. These results suggest that the simple CPDX test enables early and accurate detection of third-generation cephalosporin-resistant bacteria, facilitating early switching of antimicrobial agents through collaboration with physicians in charge of AST.

Objective: In this study we sought to investigate the clinical factors that affect postprogression survival (PPS) in patients with recurrent or persistent clear cell carcinoma (CCC).We utilized the JGOG3017/Gynecological Cancer InterGroup data to compare paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P) in the treatment of stages I to IV CCC. Methods: We enrolled 166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC. Results: A total of 77 patients received TC, and 89 patients received CPT-P. The median PPS for patients with platinum-resistant disease was 10.9 months, compared with 18.8 months for patients with platinum-sensitive disease (hazard ratio [HR]=1.88; 95% confidence interval [CI]=1.30–2.72; log-rank p<0.001). In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC. Conclusions Our findings revealed that platinum sensitivity and primary stage are clinical factors that significantly affect PPS in patients with recurrent or persistent CCC as wellas other histologic subtypes of ovarian cancer. PPS in patients with recurrent CCC should establish the basis for future clinical trials in this population.

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.

Background: New methods are needed to assist medical students with active learning during histopathology classes. The built–in digital cameras of cell phones and smart phones have recently been used to capture histopathological images during histopathology classes. We examined how the use of the cameras affected students’ attitudes to classwork.
Method: The students were encouraged to capture histopathological images with the digital cameras of cell phones and smart phones. We observed and recorded changes in their learning attitude.
Result: The students captured many histopathological images with their digital cameras. They discussed the pathology of the diseases with their instructors while viewing captured images on the phones’ screens. Some students sorted the image files and used them for self–study after class.
Conclusion: Active learning is encouraged by allowing medical students to record histopathological images with the built–in digital cameras of cell phones and smart phones during histopathology classes.

The Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.

Purpose : To examine the characteristics of second-year residents intending to become primary care physicians.
Methods : Using a self-administered questionnaire, we surveyed 7344 second-year residents in March, 2006. Of the 4167 responders (response rate 56.7%), the 3838 who answered that they intended to make a career choice of being clinical practitioners were taken as subjects for analysis. The odds ratios (OR) for the intention of being a primary care physician was calculated, together with the 95% confidence interval (95% CI), using logistic regression models (primary care physicians intended=1 vs. specialist intended=0)
Results : In total, 56% of the residents affirmed an interest in becoming primary care physicians. Multiple stepwise logistic models showed that residents intending to become primary care physicians planned to open their own clinics in the future (OR 1.44, 95% CI : 1.20-1.73), did not wish to obtain doctor of medical science (DMSc) degrees (OR 1.29, 95% CI : 1.07-1.55), and were more likely to choose internal medicine (OR 1.44, 95% CI : 1.07-1.94).
Conclusion : This study demonstrated that second-year residents who aimed to be primary care physicians were associated with more interest in opening private clinics for their future practice, preferably in the field of internal medicine, and with less interest in earning DMSc degrees.

  We have managed information on adverse drug reaction using the clinical records to obtain data from within our hospital and using Medicine-Pocketbooks to obtain data outside our hospital.  Our system for management of side effect information does not require the development of a separate specialized system.  Our method of collecting side effect information was changed in April 2007.  Therefore, we evaluated our present method of collecting information on side effects by comparing the method used before the change with the new method.  The amount of side effect information collected has clearly increased since April 2007.  Although the amount of data collected directly from doctors has increased eight-fold, the amount collected from other data sources has hardly changed.  Side effect symptoms have hardly changed, with skin symptoms being the most frequent side effect.  Suspected drugs have also hardly changed, with antibiotics being the most frequently suspected drugs.  In addition, we conducted questionnaire surveys on the use of Medicine-Pocketbooks by patients who registered side effect information at our hospital to determine whether Medicine-Pocketbooks were being used effectively as a tool for the management of side effect information.  Among patients who registered their side effect information at our hospital, 76% also presented their Medicine-Pocketbooks to other medical institutions.  In addition, all patients received a change in prescription or were questioned about their side effect information when they presented their Medicine-Pocketbooks.  Our present method of collecting side effect information is considered appropriate since there was an increase in the amount of side effect information collected from doctors.  Medicine-Pocketbooks have also been effectively used as a tool for managing side effect information.