To evaluate training methods for basic clinical skills before bedside learning, we used questionnaires to ask students and instructors their opinions about the fixed-instructor system, in which one instructor teaches the entire course, and the rotation system, in which instructors share responsibilities for teaching according to their specialty. Students had positive impressions of training with both systems. Many students felt that communication with in structors was good inthe fixed-instructor system and that the specialized education provided by multiple instructors was good in the rotation system. However, students expressed dissatisfaction about differences in educational content between the systems. Instructors believed an advantage of the fixed-instructor system was that skills learned could be applied to all medical fields, whereas the rotation system made teaching easier because it was specialized. On the basis of this investigation, we conclude that training should establish good communication between instructors and students and should include the required educational contents. We also found that unifying educational contents is difficult, regardless of the training system. Few reports about educational methods used to teach basic clinical skills have been published in Japan, but studies focusing on this issue are becoming increasingly necessary.

BACKGROUND: In general practice, though patients often stop visiting ambulatory clinics of their own vo-lition despite the need for ongoing medical treatment, there is little reported research on the reasons for nonattendance in Japan. In this study, we investigated whether the patient/doctor relationship influences nonattendance rates in general practice. In addition, we investigated the reasons why patients stopped visiting the hospital.
METHODS: We collected data from 115 patients (58 males, 57 females; age range: 16 to 94 years old, median age: 52 years old) whose initial diagnoses were made in our department from June to July 2000. We classified the patients into five groups based on the level of their complaints concerning the initial consultation (‘A’ representing the highest degree of complaint, ‘E’ representing the lowest) and determined the relationship between the strength of complaints and the non-attendance rate. Furthermore, we investigated the reasons for non-attendance concerning 28 patients who stopped visiting the hospital from April 2000 to November 2001.
RESULTS: The non-attendance rates were 0% (014) for group A, 14.3% (2114) for group B, 5.6% (5189) for group C, 33.3% (216) for group D, and 50% (1/2) for group E. The rate tended to be higher in groups with fewer complaints. The reasons for non-attendance were the following: remission of symptoms (9 patients), request for another hospital or department (6 patients), relief due to consultation at the university hospital (6 patients), and lack of time to come to the particular hospital (5 patients) . In contrast, the most common reason for satisfaction at the time of consultation was ‘enough explanation and listening to complaints well’ in 7 of 11 patients who were satisfied with the consultation.
CONCLUSIONS: The level of patient's complaints at the time of consultation is related to the non-attendance rate. However, sufficient explanation about symptoms and careful listening to complaints are important for establishing a good patient/doctor relationship.

1) We investigated the patients'evaluations of the students, our management of the medical training, and the patients' recognition of our outpatient clinic education. We then requested the patients to give their opinions regarding such interviews.
2) The patients'evaluations of the outpatient clinic and the patients'recognition of our outpatient clinic education were relatively good, but some patients complained about the short duration of medical care and also expressed anxiety over the students'medical interview.
3) Many patients expressed the desire to positively participate in medical education because the patients had high expectations of the medical students.In addition, this interview training fulfilled the patients'desire to be listened to and have their concerns acknowledged.

A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.
1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2．How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3．How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4．How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5．Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6．Appendix: Checklist to help develop PVP activities in RMP
The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.

Objective: The aim of this study was to establish the proper definitions of venous thromboembolism (VTE) and bleeding events for a healthcare database in Japan.
Study Design: Validation study.
Methods: The study comprised patients with VTE or who had undergone orthopedic surgery of the lower extremities and whose outpatient or inpatient medical information from April 1, 2008 to September 30, 2013 was available.  The source population of the database was derived from 100 acute-care hospitals.  The endpoints were VTE events (deep venous thrombosis [DVT], pulmonary thromboembolism [PE]) and bleeding events (bleeding requiring blood transfusion, intracranial hemorrhage, intraocular hemorrhage, upper gastrointestinal [GI] bleeding, and lower GI bleeding).  The frequent events with laboratory data were randomly extracted and evaluated, while all the infrequent events with laboratory data were extracted and evaluated.  Positive predictive value (PPV) was defined as the proportion of events judged to be clinical by medical experts of all the extracted events.  First, we conducted a test with a small number of cases and then revised the definitions of events.  Second, we extracted and evaluated data in 50 patients for VTE and bleeding events patients, based on which we defined the target PPV level between 60 and 70%.
Results: Of the 5,044,743 patients in the database, 36,947 patients underwent orthopedic surgeries of the lower extremities and 3,578 patients experienced a VTE event.  The PPV at the first evaluation was 80.0% (8/10) for DVT, 57.1% (4/7) for PE, and 27.3% (6/22) for bleeding events.  At the second evaluation using the revised definitions, the PPV were 75.0% (42/56) for VTE and 73.3% (33/45) for bleeding events.  Overall, the PPVs for VTE and bleeding events were over 70%.  The PPV of the VTE events were 76.9% (30/39) for DVT and 70.6% (12/17) for PE.  The PPVs of each type of bleeding event were over 70% except for intracranial hemorrhage (44.4%, 4/9).
Conclusion: The PPV was high for VTE events (75.0%) and bleeding events (73.3%).  The definitions used in this study are rational for the identification of VTE, DVT, PE, and bleeding events in the healthcare database in Japan.  The definition for each type of bleeding event should be investigated in further studies.

A 14-year-old women who had a history of aortic root replacement at 7 years old admitted our hospital due to dilatation of aortic arch aneurysm. Loeys-Dietz syndrome was diagnosed when she was 10 years old. Computed tomography showed 70 mm proximal arch aneurysm. Operative findings revealed brachiocephalic artery and left common carotid artery branched from aneurysm. Partial arch replacement was performed and distal anastomosis was made between left common carotid artery and left subclavian artery. Close observation by CT regularly is necessary and undergo aortic repair not to miss the timing of surgery.

We performed a survey on actual circumstances of work style of under-40 cardiovascular surgeons and obtained responses from 51 surgeons. We report the results and discussion about the questionnaire.

A Valsalva aneurysm filled with thrombi can be difficult to diagnose, because it mimics a cardiac tumor. Both cardiac magnetic resonance imaging (MRI) and transesophageal echocardiogram (TEE) were performed on a patient who showed a low-echoic mass located between the atrial septum and the non-coronary sinus. Based on MRI findings allowing tissue characterization and the accurate location of the mass and the TEE findings of an irregular surface of the mass and a partial defect in the edge of the non-coronary sinus, we diagnosed the mass as a thrombosed Valsalva aneurysm that had perforated the inter-atrial septum. The operative findings coincided with the preoperative diagnosis. Both MRI and TEE are useful for diagnosing this condition.
Aneurysm ; Atrial Septum ; Echocardiography ; Heart Neoplasms ; Humans ; Magnetic Resonance Imaging ; Sinus of Valsalva

Fentanyl buccal tablets place the tablet at the buccal site (above a rear molar, between the upper cheek and gum) and wait until it dissolves, but some patients may not be able to retain it due to defects of the maxillary molars. The aim of this study was to evaluate the effectiveness and safety of fentanyl buccal tablets when they were used outside the buccal site. Seven patients were treated with fentanyl buccal tablets outside the buccal site. For each of 5 episodes in which effective dose was identified, were investigated to average pain intensity assessed on a 0 to 10 numerical rating scale at 30 min postadministration and reduction in pain intensity of more than 33%. Pain intensity significantly decreased at 30 min postadministration in 5 patients with effective doses identified (p<0.001). In 92.0% of episodes treated, there was a reduction in pain intensity of more than 33%. Adverse events were somnolence and nausea with mild. However, these effects did not result in discontinuation of medication. Our findings suggested that fentanyl buccal tablets can be used effectively and safely even when patients used outside the buccal site.