1.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
Akihiko UEDA ; Hidemichi WATARI ; Masaki MANDAI ; Shunichi FUKUHARA ; Yasuo SUGITANI ; Kiyoko OGINO ; Shuichi KAMIJIMA ; Takayuki ENOMOTO
Journal of Gynecologic Oncology 2022;33(6):e78-
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.
2.Report of Workshop "Don't Write Quick-and-dirty Clinical Research Portfolio -Clinical Research of Residents"
Yuki KATAOKA ; Motohiro KASHIWAZAKI ; Daisuke KATO ; Takeo KUSANO ; Shoko SOENO ; Risa NAKATA ; Akiko HANAMOTO-NAKANISHI ; Shunichi FUKUHARA
An Official Journal of the Japan Primary Care Association 2018;41(1):29-31
3.Japanese Representation in High-impact International Primary Care Journals
Takuya Aoki ; Shunichi Fukuhara
An Official Journal of the Japan Primary Care Association 2017;40(3):126-130
Introduction: 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.
Methods: 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.
Results: Of the total articles (2,602), the proportion of Japanese articles in 5 high-impact international primary care journals was 0.15% (4 articles).
Conclusion: 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.
4.Gender differences in preferences for mentoring styles and topics in academic medicine in Japan
Hiroki Mishina ; Ken Sakushima ; Kenei Sada ; Junji Koizumi ; Takashi Sugioka ; Naoto Kobayashi ; Masaharu Nishimura ; Junichiro Mori ; Hirofumi Makino ; Mitchell D Feldman ; Shunichi Fukuhara
Medical Education 2014;45(1):1-7
Objective: To evaluate gender differences in mentee’s preference for mentoring styles and topics in academic medicine in Japan.
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.
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).
Conclusion: Women mentees in Japan express different preferences for mentoring styles and topics from men. Mentors in Japan must take these differences into consideration.
5.A blended learning program providing core competency in clinical research
Naoki Kakudate ; Yukio Tsugihashi ; Yoko Yokoyama ; Yosuke Yamamoto ; Hiroki Mishina ; Fumiaki Nakamura ; Norio Fukumori ; Misa Takegami ; Shinya Ohno ; Keiko Sato ; Takafumi Wakita ; Kazuhiro Watanabe ; Takuhiro Yamaguchi ; Shunichi Fukuhara
Medical Education 2012;43(3):205-210
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.
1)Four months after the end of the program, 64% of the participants had started to conduct clinical research.
2)This program may increase the number of research colleagues that can discuss clinical research.
3)This program could enhance the confidence(self–efficacy)of health care professionals in clinical research.
6.Qualitative research for investigating the factors that facilitate or interfere
Hiroki Mishina ; Yoko Yokoyama ; Mitchell D Feldman ; Naoki Kakudate ; Shunichi Fukuhara
Medical Education 2011;42(2):75-80
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.
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.
2)We qualitatively analyzed transcripts of interviews to identify these factors.
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.
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.
5)Assessment of the mentoring process and education programs for mentors were expected to be necessary measures to promote mentoring programs.
7.Status of Provision of Drug Information to Hypertensive Patients at Community-based Pharmacies
Kazuhiro Watanabe ; Fumiaki Nakamura ; Shinji Matsumura ; Shunichi Fukuhara
General Medicine 2011;12(2):75-82
Objective: 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.
Design: A cross-sectional study was conducted by surveying patients using a self-administered questionnaire.
Methods: 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.
Results: 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.
Conclusions: 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.
8.Education and mentoring for physicians in the clinical research program at the University of California, San Francisco
Hiroki MISHINA ; John I TAKAYAMA ; Shunichi FUKUHARA
Medical Education 2010;41(1):55-57
1) I participated in the postgraduate clinical research training program at the University of California, San Francisco.
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.
3) To improve mentoring skills, trial programs were implemented, including specific education programs for faculty and performance evaluations.
9.Challenges in the conduct of clinical research
Yasuji ARIMURA ; Toshihiko NISHIDA ; Maya MINAMI ; Yoko YOKOYAMA ; Hiroki MISHINA ; Shin YAMAZAKI ; Tatsuro ISHIZAKI ; Koji KAWAKAMI ; Takeo NAKAYAMA ; Yuichi IMANAKA ; Takashi KAWAMURA ; Shunichi FUKUHARA
Medical Education 2010;41(4):259-265
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.
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.
2) Almost 40% of respondents (n=24) reported "no time" or "no research collaborators" for clinical research.
3) Twenty respondents (83%) have attempted to promote clinical research at their hospital or workplace, but only 1 has received institutional support.
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.
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.
10.A survey of clinicians' interest in performing clinical research and in education for clinical research
Hiroki MISHINA ; Yoko YOKOYAMA ; Koji KAWAKAMI ; Shunichi FUKUHARA
Medical Education 2009;40(2):105-112
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.


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