Objective: Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website.  The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.
Methods: The risks listed in RMPs on the PMDA website were assessed on February 10, 2014.  We investigated the documentation of these risks on the PL.
Results: Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs.  The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%).  Ninety-four percent of risks listed in RMPs were documented on the PL.  A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.
Conclusion: This study was clearly the relation between risks listed in RMPs and documents on the PL.  Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information.  It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.

This study examined the effectiveness of a communication program in undergraduate medical education in improving communication in physicians' clinical practice. The effectiveness of the program was assessed with a mail survey using self-rated questionnaires 9 years later. Ninety participants were follwed up in late 1994; 57.8% of them replied to the questionnaire. Of the respondents, 60% replied that programs concerned with active listening and role-playing had benefits on communicating with patients and families. In addition, 40% of respondents answered that case studies aimed at teaching comprehensive medicine with the team approach was effective in improving communication with co-medical staff. These results suggest that the communication program in undergraduate medical education is effective in improving clinical communication in clinical practice when students are highly motivated.

Objective：To clarify the effect of exclusion items on the KRW achievement index (KRW-AI) in the outcome evaluation of a convalescent rehabilitation ward.Methods：The subjects were 812 inpatients in a convalescent rehabilitation ward. The objective variable was the KRW-AI of 40 or less, and the explanatory variables were the items excluded from the KRW-AI and their combination for a total of eight categories, such as (1) low motor FIM, (2) high motor FIM, (3) low cognitive FIM, (4) elderly, (5) (1)＋(3), (6) (1)＋(4), (7) (3)＋(4), (8) (1)＋(3)＋(4). The adjusted variables were sex, rehabilitation calculation category, and time from onset to admission to the ward. Poisson regression analysis was performed. The Incidence Rate Ratio (IRR) and 95％ confidence interval (CI) were calculated.Results：Five of the eight exclusion categories were significantly associated with low-KRW-AI scores. The highest IRR was 2.29 (95％ CI：1.41-3.69, p＜0.001) for (2).Conclusion：High motor FIM are associated with a higher relative risk of falling below the KRW-AI of 40. Conversely, being older and the presence of cognitive disorder did not interfere with low-KRW-AI scores.

Objective：To clarify the effect of exclusion items on the KRW achievement index (KRW-AI) in the outcome evaluation of a convalescent rehabilitation ward.Methods：The subjects were 812 inpatients in a convalescent rehabilitation ward. The objective variable was the KRW-AI of 40 or less, and the explanatory variables were the items excluded from the KRW-AI and their combination for a total of eight categories, such as (1) low motor FIM, (2) high motor FIM, (3) low cognitive FIM, (4) elderly, (5) (1)＋(3), (6) (1)＋(4), (7) (3)＋(4), (8) (1)＋(3)＋(4). The adjusted variables were sex, rehabilitation calculation category, and time from onset to admission to the ward. Poisson regression analysis was performed. The Incidence Rate Ratio (IRR) and 95％ confidence interval (CI) were calculated.Results：Five of the eight exclusion categories were significantly associated with low-KRW-AI scores. The highest IRR was 2.29 (95％ CI：1.41-3.69, p＜0.001) for (2).Conclusion：High motor FIM are associated with a higher relative risk of falling below the KRW-AI of 40. Conversely, being older and the presence of cognitive disorder did not interfere with low-KRW-AI scores.

Introduction  The objective of this study was to identify measures Japan should take to achieve health (goal 3) and gender (goal 5) goals of the Sustainable Development Goals (SDGs) in synergy by comparing the status of health and gender in Japan and the United Kingdom based on gender analysis.Methods  In-depth interviews were conducted with 8 gender experts and 2 obstetrician/gynecologists in Japan and 9 informants in government, civil society and academia in the UK. The status of sexual and reproductive health and rights (SRHR) and measures against gender-based violence were elaborated. Qualitative content analysis was conducted on the transcripts of the interview audio-records.Results  We have compared contraception and abortion, control of sexually transmitted infections, sexuality education, measures against breast and cervical cancers and measures against gender-based violence in Japan and the UK. Significant differences were noted in contraception and abortion, sexuality education and measures against gender-based violence. There were four areas where the UK applied gender-transformative measures (measures that address not only the condition of women but also the gender relations between men and women and social status of women) whereas Japan has not yet applied such measures: 1) Ensuring selection of a wide range of contraceptive methods with low price, 2) Enabling abortion solely based on the decision by women, 3)Comprehensive sexuality education that includes gender and human relationship, and 4) Setting an integrated strategy against gender-based violence. Conclusion  Japan can strive for both health and gender goals of the SDGs by addressing above four aspects. Promotion of civil society participation in policy decision and increased proportion of female parliamentarians will help address these aspects.

Gastric adenocarcinoma of the fundic gland mucosa type (GA-FGM) was proposed as a new variant of gastric adenocarcinoma of the fundic gland type (GA-FG). However, at present, the influence of Helicobacter pylori and the speed of progression and degree of malignancy in GA-FGM remain unclear. Herein, we report the first case of intramucosal GA-FGM that was endoscopically observed before and after H. pylori eradication over 15 years. The lesion showed the same tumor size with no submucosal invasion and a low MIB-1 labeling index 15 years after its detection using endoscopy. The endoscopic morphology changed from 0-IIa before H. pylori eradication to 0-IIa+IIc and then 0-I after H. pylori eradication. These findings suggest that the unaltered tumor size reflects low-grade malignancy and slow growth, and that the endoscopic morphology is influenced by H. pylori eradication.

Purpose: General surgeons at regional hospitals should have the primary trauma care skills necessary to treat critically ill trauma patients to withstand transfer. This study was conducted to identify a consensus on primary trauma care skills for general surgeons. Methods: An initial list of acute care surgical skills was compiled, and revised by six trauma experts (acute care surgeons); 33 skills were nominated for inclusion in the Delphi consensus survey. Participants (councilors of the Japanese Society for Acute Care Surgery) were presented with the list of 33 trauma care skills and were asked (using web-based software) to rate how strongly they agreed or disagreed (using a 5-point Likert scale) with the necessity of each skill for a general surgeon. The reliability of consensus was predefined as Cronbach’s α ≥ 0.8, and trauma care skills were considered as primarily required when rated 4 (agree) or 5 (strongly agree) by ≥ 80% participants. Results: There were 117 trauma care specialists contacted to participate in the Delphi consensus survey panel. In the 1st round, 85 specialists participated (response rate: 72.6%). In the 2nd round, 66 specialists participated (response rate: 77.6%). Consensus was achieved after two rounds, reliability using Cronbach’s α was 0.94, and 34 items were identified as primary trauma care skills needed by general surgeons. Conclusion A consensus-based list of trauma care skills required by general surgeons was developed. This list can facilitate the development of a new trauma training course which has been optimized for general surgeons.

Objective: The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial. Methods: Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%. Results: Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met. Conclusion The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.

Introduction: Recently, community-based medical education has become widespread in Japanese medical schools, but the current status is not clear on a national level. A second survey of community-based medical education at all Japanese medical schools was conducted. The first survey was done in 2011. Methods: Members of the Council made and distributed a questionnaire to medical schools in order to assess the situation of community-based medical education as of April 2014. Results: A total of eighty schools responded. The number of schools which had community medicine programs was seventy-eight. In the first survey, the number was seventy-three. Seventy-seven schools gave community-based clinical clerkships. Discussion: The number of medical schools that had curriculum about community medicine was more than indicated in the first survey. Further research about the contents or implementation system of community-based clerkships is needed.