Some case-control studies have been conducted to study the relationship between a drug and adverse events in Japan. However, most such studies adopted hospital controls and rarely adopted community controls. Here, we describe the methodological issues of performing a case-control study using Japanese community controls to illustrate the association between upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs.
To ensure efficient and accurate case identification, all candidate patients admitted to the participating hospitals with target conditions (upper gastrointestinal bleeding etc.) were listed by doctors/research coordinators. Summary tables with the candidates information on eligibility and whether or not the patient gave informed consent were reported back to the study office weekly. Using the summary tables, the fraction eligible and the participation rate for cases were estimated as 24% and 76%, respectively.
To select controls, residents matched with each case according to age, gender and district of residence were randomly sampled from the population registries in the municipal office. To achieve a satisfactory participation rate for residents (47%), we used envelopes with prestigious university letterhead and made phone calls in a timely manner rather than waiting for their replies, both of which yielded favorable results.
By telephone interview, a large amount of information was obtained in approximately 30 minutes. To help subjects' recall, a brochure displaying pictures of analgesics and a calendar for recent 4 weeks were sent in advance, and in the interview, questions using 6 kinds of “prompts” that might enhance recall were employed.

The curriculum evaluation by students was introduced into the two-weeks clinical curriculum of fifth years students at Saga Medical School, Department of Anesthesiology. The evaluation form is consisted of forty questions with the eleven figures from -5 to +5. These questionaries were divided into seven parts and covered instructors' evaluation and the minute course evaluation. This evaluation was done anonymously at the end of the two-weeks clinical course in Anesthesiology.
The analysis was done as follows: 1) divided up into the positive group, the neutral group and the negative group; 2) difined the positive rate, the negative rate and the effective rate; 3) presented these rates visually.
The result runs as follows: 1) the effective rate is proportional to the interaction between instructors and students; 2) a quick feedback can be done on instructors.
Finally, the important thing for medical education is not only curriculum but the interaction between instructors and students. In this sense, this trial in Saga Medical School is significant for medical education.

Objective : To find methods to minimize ‘lost to follow-up’ in the long-term follow-up in a pilot study of Prescription-Event Monitoring in Japan (J-PEM) where hypertensive subjects who took losartan or a control drug and gave informed consent to the study were directly followed by researcher for years.
Design : Cohort Study
Methods : We conducted the follow-up survey twice, in which questionnaires were sent to hypertensive patients who had consented to being involved in the survey and returned it by mail. In the questionnaire, we asked about the use of the monitoring drug, change of medical institutions for the treatment of hypertension, significant health-related events. In the second survey, we reminded the non-responders by a letter of reminder and by telephone. When no information was obtained from the subject, we sent a letter, together with a copy of the informed consent given by the subject, to the municipal office where the subject's home was registered to inquire about the subject's current address and related information including the vital status. We calculated Standardized Mortality Ratio (SMR) using the information on death obtained from the mailed questionnaires, telephone and information in the municipal office.
Results : In a pilot study of J-PEM on losartan, 4344 and 3517 questionnaires were sent to pharmacists and doctors, respectively. The doctors handed the informed consent form to the patients and 422 patients agreed to participate the study and sent back the signed form to the study office. In the first and second surveys, a questionnaire was mailed to the subject approximately 1 and 5 years after the first prescription of losartan or a control drug, respectively. The response rate was 73 and 60% in the 1 st and 2 nd survey, respectively. In the manuscript, the results of the 2 nd survey were mainly presented. The reminders by mail and telephone increased the response rate from 60 to 81% and provided the information on the vital status for 86% of the subjects. The response rate was further increased to 84% and the vital status was known for 99% when the information in the municipal office was used. SMR was estimated to be 0.59 (95% CI : 0.34-1.01) before reminding subjects, 0.78 (0.52-1.17) after reminding subjects by a letter and telephone and 0.92 (0.65-1.31) after further addition of the information from the municipal office. During the 5 years of the observation, 21% of 343 subjects who sent back a filled questionnaire did and 70% did not change the clinic/hospital where they received the care for hypertension, while 9% did not answer the relevant question.
Conclusion : The method of the systematic survey may be useful in minimizing the ‘lost to follow-up’ subjects in the long-term pharmacoepidemiology studies in Japan where a patient can change the clinic/hospital for his/her own health care without any letter of reference. In the systematic survey, the researchers may try to follow the subjects by using several methods including reminders like a letter or telephone as well as the use of the information in the municipal office. To facilitate better follow-up, a careful design of the study including the proper design of the informed consent form is essential to maximize the amount and quality of the available information, particularly when the subject has a serious event or dies in a hospital or institution apart from that where the patient has been registered.

The purpose of this report is to clarify urologic problems in rural districts. The number of patients who visited our clinic for these 10 years were 7, 313 as new outpatient and 1802 as inpatient. Three main diseases of rural area were acute inflammation of lower urinary tract, benign prostatic hypertrophy and lithiasis of upper urinary tract. Infection of lower urinary tract and aggravation of malignant tumors might be influenced by rural works and bad circumstances. Monthly distribution of patients was also under the influence of rural works.

During past 7 years, 43 patients less than 2 years of age underwent closure of the ventricular septal defect. Durations of postoperative use of a respirator were 3 days or less in 30 patients (short-period group) and over 3 days in remaining 13 patients (long-period group). There was no operative death. Pre-, intra- and postoperative factors affecting prolonged respiratory care were analyzed between two groups. Results were as follows: There were statistically significant differences between short- and long-period groups on age (9.7 versus 6.5 months), body weight (6.3 versus 5.2kg) at surgery, necessity of preoperative respiratory care on respirator (0/30 versus 4/13), duration of cardiopulmonary bypass (108 versus 132min.), aortic clamp time (56 versus 70min.) and respiratory index at the first postoperative day (1.1 versus 1.7). These results revealed the necessity of far earlier surgical intervention in symptomatic patients before respiratory distress develops. Furthermore, shorter cardiopulmonary bypass and aortic clamp times should always be in mind for attaining smooth postoperative course.

Background :There have been only a few comparative observational studies on the safety and effectiveness of drugs in Japan. Comparative observational studies would provide important information to address these issues and thus we need to establish a means to facilitate such studies. In comparative studies, it is important to prevent the distortion of results due to selection bias. Though we do not yet have a claims database for use in pharmacoepidemiological studies, recently many hospitals and pharmacies have computerized prescription data which may be used to minimize selection bias. Good standardized procedures for the identification of patients prescribed one of two or more drugs to compare in a study using computerized prescription data would serve as a basis for a variety of pharmacoepidemiological studies in Japan.
Methods :We carried out a questionnaire survey in 2753 hospitals and 909 community pharmacies to estimate the fraction of hospitals where computerized data can be used to identify all eligible patients who used a specific drug.
Results :Questionnaires were returned by 1942 (71%) of 2753 hospitals and 632 (70%) of 909 pharmacies. From among those which responded, patients were identified, the patient list was printed, and the electronic file of the patient list was generated in 75%, 64% and 36% of the 1942 hospitals and in 100%, 93% and 49% of the 632 pharmacies respectively.
Conclusion :With procedures using computerized prescription data, the cohort for observational comparative studies may be identified with a minimal selection bias in a majority of hospitals and pharmacies.

The gastrocnemius muscles are composed predominantly of type II B and II A fibers while the soleus muscle is composed of type I fibers. However, the relationships between the calcaneal bone stiffness and the triceps surae muscles consisting of the different types of skeletal muscle fibers are unknown. The purpose of this study was to investigate the relationships between the calcaneal bone stiffness and the gastrocnemius or soleus muscle thickness in 73 postmenopausal women. We measured the speed of sound (SOS) and the broad band ultrasound attenuation (BUA), using a ultrasonic measurement of the calcaneal and the gastrocnemius or soleus muscle thickness used to measure the B-mode ultrasound anatomy. There was a significant differences in age between the high-and low-SOS groups. In the high-BUA group, the body mass index, the lower leg girth and the triceps surae muscle thickness were significantly higher than those in the low-BUA group. This data indicated that SOS is related to ageing and BUA is related to the body mass or the muscle thickness. The other side, stiffness and SOS were significantly correlated with the gastrocnemius muscle thickness, but not with the soleus muscle mass. Therefore, this study suggests that the calcaneal bone stiffness is closely related to the muscle thickness, which may be related especialy to the fast twitch muscle.

Objective : To evaluate the necessity to complement the information obtained from pharmacists in the community pharmacy by that from the hospital pharmacy in Prescription-Event Monitoring in Japan (J-PEM) by using data in a J-PEM pilot study.
Methods : For each patient, two questionnaires were sent to the prescribing doctor and the pharmacist who registered the patient ID code in the pilot study. If the patient ID code was registered by the pharmacist in the community pharmacy and if a pharmacist inside the hospital where the prescription was issued was willing to co-operate, a third questionnaire for the same patient was sent to the pharmacist in the hospital pharmacy. The information given by pharmacists was analyzed for 150 pairs of questionnaires (on 150 patients) sent back from pharmacists in both community and hospital pharmacies. The questions in the questionnaire were categorized into [1] those on drugs used by patients (concurrent drugs, daily dose of the drug monitored, and compliance), [2] those on events which the patient had experienced after the prescription of the drug monitored, [3] those on patients (the first date of prescription, reason of prescribing the drug monitored, initial date when the disease developed, underlying diseases or complications and whether and when the patient was lost to follow-up). The questionnaires were examined to determine whether the answer was given to each question. When the answer was given, its quality and quantity were then assessed. The answer to each question given by the pharmacist in the community pharmacy (C) and that by the pharmacist in the hospital pharmacy (H) were compared by the McNemar test after the pairs of answers were classified into the following categories : [1] C is better than H, [2] H is better than C, [3] C and H are similar to each other, and [4] impossible to classify. The difference was considered to be significant where p<0.05.
Results and conclusion : For the initial date when the disease developed and 'underlying diseases or complications', H was significantly better than C. However, for concurrent drugs, compliance and events, C was significantly better than H. Otherwise, the difference was not statistically significant. Being compatible with the superiority of C over H in regard to concurrent drugs and events, the fraction of patients lost to follow-up during the observation period was small not only in H but also in C. This observation may be associated with the fact that almost all prescriptions were issued by a single hospital in more than 60% of community pharmacies in the pilot study, and most patients identified in the study were probably a regular visitor to one of such community pharmacies. The most important information to be provided by the pharmacists in J-PEM is that on events and drugs used by patients. It is thought to be not necessary to complement the information obtained from the community pharmacy by that from the hospital pharmacy.

Aim of the present study was to statistically evaluate the examination rule with use of a questionnaire obtained from physicians regarding treatment for chillness of the limbs, and to prove the clinical usefulness of the database. The database showed that tokishigyakukagoshuyushokyoto was the most frequently used to treat chillness of the limbs, and subsequently keishikajutsubuto, hachimijiogan, and tokishakuyakusan were ranked as drugs with wide use. When physicians determined a kampo formulation suitable for each patient, they used findings specific for the kampo formulation, but not uniform findings obtained from the four traditional examination methods (i.e., inspection, listening and smelling, interviewing, palpitation). There was a statistical difference in the selection mode of drugs among physicians. In a simulation obtained from a questionnaire, there was a positive association between time (time X) to the start of becoming physically warm in the limbs, and time (time Y) to remission (R² = 0.971, P = 0.014). The formula (Y = 4.379 X−0.519), which could predict time Y on the basis of information on time X, was able to accurately monitor the clinical courses of 7 responders to treatment for chillness of the limbs. Taken together, these results strongly suggest that the database constructed in the present study may be useful for evaluation of traditional Kampo medicine, and might allow us to perform more fittingly personalized Kampo medicine in the near future.

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.