Incidence of gastrointestinal perforation associated with bevacizumab in combination with neoadjuvant chemotherapy as first-line treatment of advanced ovarian, fallopian tube, or peritoneal cancer: analysis of a Japanese healthcare claims database / 부인종양

Objective@#To assess the incidence of bevacizumab-associated gastrointestinal (GI) perforation during first-line treatment of patients with ovarian, fallopian tube, or peritoneal cancer receiving neoadjuvant chemotherapy (NAC) in Japanese real-world clinical practice. @*Methods@#A retrospective study was conducted using a healthcare claims database owned by Medical Data Vision Co., Ltd. (study period, 2008–2020). Patients who initiated first-line treatment of ovarian, fallopian tube, or peritoneal cancer were identified and divided into NAC and primary debulking surgery (PDS) groups. The incidence of bevacizumab-associated GI perforation was compared within the NAC group and between the groups. @*Results@#Paclitaxel + carboplatin (TC) was most commonly used as first-line treatment (39.5% and 59.6% in the NAC and PDS groups, respectively). TC + bevacizumab was used in 9.3% and 11.6% of patients in the NAC and PDS groups, respectively. In the NAC group receiving TC, the proportion of patients with risk factors for GI perforation was lower among patients with versus without concomitant bevacizumab. The incidence of GI perforation in the NAC group was 0.38% (1/266 patients) in patients receiving TC + bevacizumab and 0.18% (2/1,131 patients) in patients receiving TC without bevacizumab (risk ratio=2.13; 95% confidence interval [CI]=0.19 to 23.36; risk difference=0.20; 95% CI=−0.58 to 0.97). None of the 319 patients in the PDS group receiving TC + bevacizumab had GI perforation. @*Conclusion@#No notable increase was observed in GI perforation associated with NAC containing bevacizumab. We conclude that bevacizumab is prescribed with sufficient care in Japan to avoid GI perforation.

Japanese Representation in High-impact International Primary Care Journals / 日本プライマリ・ケア連合学会誌

<p><b>Introduction: </b>There are no studies on how much primary care research from Japan has spread internationally. In this study, we aimed to investigate Japan's contribution to high-impact international primary care journals.</p><p><b>Methods: </b>We used the PubMed database and reviewed abstracts to examine the frequency of articles reporting clinical research or systematic reviews originating from Japan that were published in 5 high-impact international primary care journals from January 2011 to June 2016. We calculated the proportion of articles from Japan in the selected journals by year and journal.</p><p><b>Results: </b>Of the total articles (2,602), the proportion of Japanese articles in 5 high-impact international primary care journals was 0.15% (4 articles).</p><p><b>Conclusion: </b>Currently, Japan's contribution to high-impact international primary care journals is very small. In Japan, the development of research infrastructure, the education of researchers, and networks for research collaboration may be needed for international dissemination of primary care research.</p>

Gender differences in preferences for mentoring styles and topics in academic medicine in Japan / 医学教育

Objective: To evaluate gender differences in mentee’s preference for mentoring styles and topics in academic medicine in Japan.<br>Methods: We conducted a cross-sectional questionnaire survey of mentees at 6 graduate schools of medicine in Japan from December 2011 through January 2012. The study participants were 1700 Japanese-speaking graduate students and postdoctoral fellows. The primary outcome was the percentage of respondents who desired to be mentored with a particular style or topic.<br>Results: A total of 676 （227 women） mentees responded to the survey. Women were less likely than men to prefer a hierarchical mentoring relationship （men, 82%; women, 71%; p＝0.001） but were more likely to desire a mentor for career consultation （men, 51%; women, 64%; p＝0.001）. Women were more likely than men to want guidance in developing a research portfolio （men, 85%; women, 90%; p＝0.04）, in computer skills／statistical skills （men, 68%; women, 81%; p＝0.001）, and in long-term career planning （men, 38%; women, 50%; p＝0.003）.<br>Conclusion: Women mentees in Japan express different preferences for mentoring styles and topics from men. Mentors in Japan must take these differences into consideration.

A blended learning program providing core competency in clinical research / 医学教育

  In Japan, few health care professionals have a basic understanding（core competency）of the design of clinical research and statistical analysis. We developed a blended distance–learning program comprising face–to–face lectures with e–learning for busy health care professionals who work in the clinical settings to achieve core competency in clinical research. The purpose of this study was to examine the educational effects of this program.<br>1）Four months after the end of the program, 64％ of the participants had started to conduct clinical research.<br>2）This program may increase the number of research colleagues that can discuss clinical research.<br>3）This program could enhance the confidence（self–efficacy）of health care professionals in clinical research.

Status of Provision of Drug Information to Hypertensive Patients at Community-based Pharmacies / General Medicine

<b>Objective:</b> The present study examined the status of the provision of drug information to hypertensive patients at community-based pharmacies by evaluating patients' satisfaction, understanding, and wishes.<br><b>Design:</b> A cross-sectional study was conducted by surveying patients using a self-administered questionnaire.<br><b>Methods:</b> Three items were evaluated: 1) the level of patient satisfaction with provision of drug information; 2) the level of patient understanding of information provided on antihypertensive drugs; and, 3) patient wishes regarding provision of drug information.<br><b>Results:</b> The level of satisfaction with provision of drug information was high (86.6%). Although patients were found to understand the precautions for use of antihypertensive drugs, their understanding of drug efficacy was insufficient. Also, patients wished to receive more explanation from pharmacists regarding the efficacy of drugs in addition to explanations of associated adverse reactions or precautions for use of the drugs.<br><b>Conclusions:</b> Hypertensive patients were highly satisfied with the provision of drug information at community-based pharmacies, but did not show sufficient understanding of the efficacy of antihypertensive drugs, an issue to be addressed in the future by pharmacists in their instructions to patients on the use of drugs.

Qualitative research for investigating the factors that facilitate or interfere / 医学教育

Mentorship in academic medicine in the United States and Europe has been recognized as an effective system for increasing a mentee's research productivity, career success, and ability to obtain research grants. Therefore, to promote mentoring programs in Japanese academic medicine, it is important to investigate factors that facilitate or interfere with mentoring.<br>1)We interviewed 12 physicians who have performed clinical research under existing mentoring programs in Japan and asked them about factors that, in their experience, had facilitated or interfered with mentoring.<br>2)We qualitatively analyzed transcripts of interviews to identify these factors.<br>3)Factors identified as facilitating mentoring were: appropriate evaluation of a mentee's research skill, knowledge of a mentee's career goals, mutual communication between mentor and mentee, and the presence of senior researchers close to a mentee.<br>4)Factors identified as interfering with mentoring were: the busyness of a mentor, a mentee's concerns about giving offense by consulting the mentor about trivial matters, and the hierarchically organized social relationship in which the mentor is superior and the mentee is inferior.<br>5)Assessment of the mentoring process and education programs for mentors were expected to be necessary measures to promote mentoring programs.

Challenges in the conduct of clinical research / 医学教育

The promotion of clinical research in Japan requires the establishment of a formal and systematic education and training program for clinicians to ensure they become effective clinician investigators. The first of its kind in Japan, a formal 1-year masters-degree-level training program (MCR course) was started at Kyoto University School of Medicine and Public Health. The first 28 students graduated in 2008, with most returning to their original clinical institutions. <br>1) As follow-up, we conducted a self-administered questionnaire survey of all 28 graduates (response rate, 86%) concerning the current status of clinical research and problems encountered at their institutions.<br>2) Almost 40% of respondents (n=24) reported &quot;no time&quot; or &quot;no research collaborators&quot; for clinical research.<br>3) Twenty respondents (83%) have attempted to promote clinical research at their hospital or workplace, but only 1 has received institutional support.<br>4) Over half of the respondents (54%) would like to be working in both clinical research and clinical practice at their hospital in the future (10-year timescale). Forty-two percent of respondents had a concrete image of the clinical researcher's career path. <br>5) Although open to improvement, the MCR program presents a concrete model for the education of clinical researchers. These findings suggest that promoting the conduct of clinical research requires the implementation of a support system and adjustment of personal and physical infrastructure.

Education and mentoring for physicians in the clinical research program at the University of California, San Francisco / 医学教育

1) I participated in the postgraduate clinical research training program at the University of California, San Francisco.<br>2) The program included course work for acquiring knowledge about conducting clinical research and an individual mentoring system that provided effective support for researchers to conduct their own research.<br>3) To improve mentoring skills, trial programs were implemented, including specific education programs for faculty and performance evaluations.

A survey of hospital managers' interest in conducting clinical research and clinical research education / 医学教育

Background: In Japan, although clinicians have been extremely interested in conducting clinical research, the shortage of clinical researchers is a serious problem. Therefore, it is important to explore barriers to conducting clinical research.1) We mailed a cross-sectional survey to hospital managers asking about their interest in and barriers to conducting clinical research and training clinical researchers at their hospitals.2) Of 810 eligible hospital managers, 301 completed questionnaires (response rate: 37.2%).3) The managers of university hospitals and national medical centers were more interested in conducting clinical research than were managers of other hospitals.4) Furthermore, 60.6% of managers of university hospital and 18.8% of managers of other hospitals reported the need to employ physicians who specialized in clinical research. However, given public research grants, about 50% of hospital managers were willing to employ research residents.5) Our results suggest there are still barriers to conducting clinical research, such as a lack of time set aside for clinicians and specialists to teach clinical research. A substantial strategy is needed to address the shortage of clinical researchers in Japan.

A survey of clinicians' interest in performing clinical research and in education for clinical research / 医学教育

Background: Because of a severe shortage of clinical researchers in Japan, training clinical physicians to perform clinical research is an important issue in medical education. Although education has started to provide a foundation for clinical research, it is unclear whether clinicians, who should play a central role in a clinical research, are interested in performing clinical research and participating in a training program for clinical research.1) We performed a cross-sectional Internet survey to determine the interest of clinicians' interest in performing a clinical research and participating in a clinical-research training program.2) A total of 2176 clinicians were sent emails requesting their participation in this survey, and 310 responded (response rate, 14.6%). Eighty-five percent of the respondents were interested in conducting clinical research, and 78% were willing to participate in a clinical-research training program.3) Most respondents were willing to participate in a training program as part of an educational seminar or a training course after a few years of clinical practice. The respondents desired an educational system that would allow them to learn about clinical research while continuing their clinical practice.4) Although the rate of willingness to participate in a training program was highest (90%) among respondents who wanted to earn a doctorate, the rates were also high among those who did not want to earn a doctorate (76%) and those who had already earned a doctorate (74%).5) An educational system for clinical research should allow graduate schools to play leading role in training and should be flexible enough for clinicians who do not want to earn a doctorate.

Sociodemographic Characteristics for Use of Complementary and Alternative Medicine in Japan / General Medicine

BACKGROUND: Use of complementary and alternative medicine (CAM) has become popular in Japan.<BR>OBJECTIVE: To investigate associations of symptom-related CAM use with sociodemographic factors in Japan.<BR>DESIGN AND SETTING: A prospective cohort study of a nationally representative sample of households in Japan.<BR>PARTICIPANTS: Community-dwelling adults who developed at least one symptom during a 31-day period.<BR>MAIN OUTCOME MEASURES: Self-reported, symptom-related use of CAM, either physical CAM or oral CAM.<BR>RESULTS: Of 2, 453 adults, 2, 103 participants (86%) developed at least one symptom. Of these symptomatic adults, 156 (7.4% ; 95% CI: 6.3-8.5%) used physical CAM therapy. The likelihood of using physical CAM was not significantly influenced by annual household income, employment, or education. Participants living in large cities had an increased likelihood of using physical CAM with an odds ratio (OR) of 2.6 (95% CI: 1.2-5.8), compared to those living in rural areas. Oral CAM therapy was used by 480 participants (22.8%; 95% CI: 21.0-24.6%) among the symptomatic adults. An age of 60 years old and older (OR 2.0; 95% CI: 1.2-3.3) and female gender (OR 1.8; 95% CI: 1.3-2.6) were significantly associated with an increased use of oral CAM. The unemployed participants had a lower likelihood of using oral CAM, with an OR of 0.6 (95% CI: 0.4-0.9), compared to the employed.<BR>CONCLUSIONS: Oral CAM use is common among Japanese patients and is associated with older age, female gender, and employed status, while physical CAM use is less common and is associated with living in a large city.

Cultivating a New Community of Clinical Researchers in Japan / 医学教育

1) Japanese clinical research and population-based medicine have different origins and have lived separate lives. After 100 years of mutual isolation, their paths are about to cross.<BR>2) Clinical research is not confined to clinical trials and translational research, but covers a wider area that includes outcomes research, economic evaluation, and studies of the quality of care.<BR>3) Government policymakers very recently turned their attention to clinical research, and set up administrative schemes to provide large-scale funding.<BR>4) However, unlike the US, Japan cannot catch this wave because it does not have the necessary intellectual infrastructure of trained clinical investigators.<BR>5) Population-based medicine and clinical research have similar emphases and core values. Both are concerned with measuring frequencies, with socially relevant outcomes, and with the impact of research on clinical practice and health policy.

Evaluation of the Clinical Clerkship Program at the University of Tokyo (part 2): Course Evaluation and Faculty Evaluation by Students / 医学教育

The purpose of this study was to evaluate the clinical clerkship program at the University of Tokyo Hospital. We report results of course and faculty evaluations by students and of qualitative evaluations, such as students, free comments and group interviews. Methods: Each item of the course and faculty evaluations was related to the overall educational goals developed in advance. Students evaluated the course and faculty immediately after the course ended. Results: Students rated the clerkship program favorably overall, but the scores of thesecond month (3.38) were lower that those of the first month (3.63). Although learning basic clinical procedures is not the main educational goal of the clerkship, students varied widely in their opportunities to perform procedures. Scores of faculty evaluations ranged from 2.93 to 3.87 in the first month and were lower in the second month for all but two items. Interviews revealed that students had fewer learning experiences in the second month because new residents started their rotations at that time. Conclusion: The results suggest that the scheduling of clinical clerkships should be changed. The contents of clerkship need further consideration.

Evaluation of the Clinical Clerkship Program at the University of Tokyo (part 1): Student's Self-evaluation and Evaluation by Faculty / 医学教育

A clinical clerkship program was introduced at the University of Tokyo in 2002 to help students acquire clinical knowledge, skills, and attitudes by increasing their involvement in clinical activities. We assessed the learning effectiveness of clinical clerkships at the University of Tokyo Hospital by examining evaluations of student's clinical competence by themselves and by the faculty. Methods: We evaluated each clerkship with reference to overall educational goals developed in advance. We measured students' self-evaluations and evaluatio s by the faculty before and after the clerkship. Results: At the end of the 2-month clerkship, students' self-evaluation scores (3.18) were significantly higher than before the clerkship (2.71). In particular, scores for patient care were markedly higher. Evaluation scores by the faculty were also higher during (3.64) and after (3.57) clerkships than before (3.26) clerkships. Conclusion: We will use this data to make next year's clerkship programs more effective. We should also develop more-objective strategies for evaluation and establish relevant educational goals.

Contributions of Clinical Epidemiologists and Medical Librarians to Developing Evidence-Based Clinical Practice Guidelines in Japan: A Case of the Treatment of Rheumatoid Arthritis / General Medicine

In Japan, a government-funded project to develop evidence-based guidelines for the treatment of rheumatoid arthritis started in 1999. Methodologists, including epidemiologists and medical librarians, were asked to participate in this project. Working as a team, the rheumatologists, clinical epidemiologists, and medical librarians reviewed the published evidence systematically. The process and the results, particularly systematic search and review of literature, were assessed from the viewpoint of epidemiology and evidence-based medicine (EBM) . The librarians, supervised by the clinical epidemiologists, searched the literature according to 30 key questions defined by the rheumatologists and classified the articles according to the“level of evidence”. Finally, 379 articles were selected (drug therapy, 207; surgical treatment, 108; rehabilitation/devices, 64) . Meta-analyses and randomized controlled trials accounted for more than 80% of the drug treatment and rehabilitation/device reports, while nearly 70% of the articles retrieved regarding surgical treatment were case series without relevant control groups. The rheumatologists wrote structured abstracts for each article so that they could be used as reference for developing practice guidelines. The literature search, individual original articles, and the PubMed system were examined from the viewpoint of research methodology; the lessons learned were described.<BR>In conclusions, clinical epidemiologists and medical librarians have contributed to developing evidence-based practice guidelines. Clinical epidemiologists were able to work as a coordinator between clinicians and medical librarians. The popularity of EBM requires that expertise in this field be strengthened and made available to a broader audience.

Japanese Attitudes toward Advance Care Planning for End-of-Life Decisions / General Medicine

<B>OBJECTIVE</B>: Advance directives that assume respect for individual autonomy in end-of-life decisions may not be accepted in all cultures. We studied Japanese preferences concerning care planning and written advance directives.<BR><B>DESIGN</B>: A nationally representative Japanese sample answered questions about their preferred mechanism of care planning and preferences for end-of-life care. Factors associated with wishing to participate in care planning were evaluated by logistic regression.<BR><B>RESULTS</B>: Seventy-eight percent of the respondents wanted to be directly involved in care planning. The preferred option for that planning was discussion within the family. The family also emerged as a potential source of knowledge of the patient's values that could inform a physician's decision. Only 23% of respondents desired any type of written advance directive. Greater desire for care planning was related to greater autonomy preference, greater information seeking, greater desire for personal and family decision making, and less willingness to tolerate adverse health states. Women, married subjects, better-educated subjects, and those living alone were more likely to want to participate in care planning.<BR><B>CONCLUSIONS</B>: Most Japanese people want to participate in care planning, but the types of written advance directives most commonly used in the U.S. are not suitable. Japanese physicians should provide adequate information about prognosis and should encourage early conversations about preferences for life-sustaining interventions between patients and their family members.

Health-Related Quality of Life : An Overview / 薬剤疫学

Under the prevailing ”disease-oriented” paradigm of health, Quality of Life (QOL) has been treated with profound skepticism. Two facts, however, militate for taking QOL seriously into account : first, both social and clinical decision making today require evidence presented in the form of patient outcomes; second, of patient outcomes, one of the most important from the patient's standpoint is QOL. Giving several examples, the author discusses why traditional endpoints are insufficient and why patient-based outcomes are relevant in modern social and clinical decision making.<BR>And yet not all outcomes are relevant : for the purposes of assessment of health and medical care, QOL should be confined to its health-related elements, and instruments to measure health-related quality of life (HRQOL) should be rigorously tested with psychometric methods. Even more important, however, is the instrument's content validity : i. e., whether it measures what one wants to measure. This paper lists criteria for selection of appropriate instruments and describes the recent debate and moves to formulate guidelines on the use of HRQOL evidence in pharmaceutical product approvals and manufacturers' product efficacy claims. Finally, the author discusses the future of HRQOL research and uses of HRQOL in clinical practice.

Introducing Evidence-Based Medicine Into Undergraduate Medical Curricula: Results of a Nationwide Survey in Japan / 医学教育

We conducted a nationwide survey in 2000 regarding undergraduate medical education in Evidence-based Medicine (EBM) in Japan. We asked faculty members responsible for medical education at each medical school 1) whether there are any barriers to teaching EBM, 2) what these barriers are, and 3) what educational resources are needed to overcome them. Responses were received from 64 schools (80%). More than half of the respondents reported barriers to teaching EBM. We identified two kinds of barriers: before EBM is introduced, skepticism toward the concept of EBM and the value of teaching EBM is encountered; later, problems of organizing a curriculum and shortages of staff and materials are encountered. To overcome these barriers, we need: 1) to establish organizations for coordinating educational programs among medical schools, 2) to hold seminars for faculty development, 3) to develop EBM curricula and teaching materials, and 4) to provide computer facilities and appropriate networks.

National Survey of Programs to Teach Evidence-based Medicine to Undergraduates in Japan / 医学教育

We conducted a national survey to examine the status of programs to teach evidence-based medicine (EBM) to undergraduates in Japan. Our survey specifically focused on four areas: 1) recognition of a need to teach EBM, 2) the present status of programs to teach EBM to undergraduates, 3) details of the timing of existing EBM teaching programs and of departments responsible for it. Sixty-four schools (80%) responded. Nearly all respondents agreed that EBM should be taught, and most agreed that it should be taught both before and after graduation. Most respondents stated that departments must collaborate when preparing to teach EBM. At the time of the survey, 22 medical schools (34%) had already started programs to teach EBM and 28 (42%) were planning to do so. Existing programs mainly targeted 4th-year students, but the department responsible for the programs varied among schools. Further evaluation of the effectiveness of existing programs is now needed.

A Proposal on the Curriculum of Clinical Epidemiology / 医学教育

Clinical Epidemiology has been increasingly recognized as a basic science of clinical medicine as well as a prerequisite discipline necessary in practicing evidence-based medicine. However, no formal curriculum has been formulated for teaching clinical epidemiology to undergraduate medical students in Japan.<BR>We, as the Education on Clinical Epidemiology Working Group of Japan Society for Medical Education, here propose a curriculum of clinical epidemiology consisting of 15 sessions of 90 minute lectures, small group discussions, and practice. Learning such basic concepts as study design, bias, chance, and confounding factors is to be followed by case-based discussions and practicing on-line reference retrieval using MEDLINE. Our proposal awaits further refinement after its implementation at ambitious medical schools.