1.Physicians' Awareness Regarding Evidence-based Medicine, Practice Guidelines and Clinical Information Resources in Japan
Toshihiko Satoh ; Takeo Nakayama ; Yasuto Sato ; Keika Hoshi ; Koichi Miyaki ; Noriko Kojimahara ; Narumi Eguchi ; Takahiro Okamoto ; Yoko Hayashi ; Naohito Yamaguchi
General Medicine 2004;5(1):13-20
BACKGROUND: physicians' awareness regarding evidence-based medicine (EBM), clinical practice guidelines, and clinical information resources were rarely examined in Japan. We need to know them prior to the initiation of the Medical Information Network Distribution Service (Minds) by the Japan Council for Quality Health Care (JCQHC) .
METHODS: A total of 10, 000 directors/owners of private clinics (CDs: clinic physicians) affiliated with the Japan Medical Association (JMA) and 8682 physicians working for hospitals certified by the JCQHC (HDs: hospital physicians) were randomly selected and surveyed by a mailed questionnaire.
RESULTS: The response rate to the questionnaire was 18.7% (n=1865) among CDs and 67.8% (n=5885) among HDs. The percentage of respondents who uses internet was 39.9% among CDs and 69.3% among HDs. The information resource most commonly used by all respondents was medical journals, followed by textbooks. The percentage of respondents who used medical literature database was 10.8% among CDs and 49.7% among HDs, respectively. Approximately 80% of all respondents approved implementing EBM in daily practice. Fifty percent of all respondents indicated to have used clinical practice guidelines, and 90% of all the guideline users replied that clinical practice guidelines are useful tools for clinical decision-making. Over half of HDs required to access to the abstracts of the literature cited in the guidelines.
CONCLUSIONS: Many physicians who responded to the survey acknowledged that EBM will contribute to improving the quality of medical services. They are positive in using clinical practice guidelines that include a series of recommendations proposed by specialists in the relevant field (s) in accordance to the reviewed evidence.
2.Preferred Information Media for Providing Clinical Practice Guidelines to Physicians in Japan : A Needs Assessment Study by the Medical Information Network Distribution Service (Minds)
Yasuto Sato ; Takeo Nakayama ; Toshihiko Satoh ; Keika Hoshi ; Noriko Kojimahara ; Koichi Miyaki ; Narumi Eguchi ; Takahiro Okamoto ; Yoko Hayashi ; Naohito Yamaguchi
General Medicine 2006;7(2):45-52
BACKGROUND: The purpose of our study was to compare the characteristics of medical practitioners who prefer using the Internet as their information resource and those who prefer using printed materials.
METHODS: From December 2002 to January 2003, a non-anonymous questionnaire was sent out by post to members of the Japanese Medical Association (JMA) and physicians working in hospitals. Contributing factors were examined by using logistic regression analysis.
RESULTS: The response rates for the questionnaires were 18.7% (n=1868) for JMA physicians and 68.0% (n=5901) for hospital physicians. Factors associated with the preference for using the Internet were: ‘younger age’; ‘use of the Internet to solve clinical problems and uncertainties’; ‘use of personal computers at work’; and, ‘use of personal computers at home’.
CONCLUSION: The results of this study show that, although some younger physicians prefer printed materials, providing medical information via the Internet is better suited for younger physicians who are making full use of computers. In contrast, older physicians prefer printed materials because they tend to be less familiar with using computers and may have limited accessibility to the Internet. Therefore, using both the Internet and printed materials to provide medical information is necessary to meet the needs of the larger physician population.
3.Adverse Event Signals of Interstitial Lung Disease in the FDA Adverse Event Reporting System (FAERS) Database and the Japanese Adverse Drug Event Report (JADER) Database
Toshinobu Matsui ; Ryogo Umetsu ; Yamato Kato ; Natsumi Ueda ; Junko Abe ; Yoko Nakayama ; Yuuki Hane ; Yasutomi Kinosada ; Mitsuhiro Nakamura
Japanese Journal of Drug Informatics 2015;17(3):145-154
The Japanese Ministry of Health, Labor, and Welfare lists interstitial lung disease as an serious adverse drug event. The Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases are available to detect adverse events signals. We analyzed reports of interstitial lung disease in FAERS and JADER and calculated the reporting fraction and reporting odds ratio (ROR) of drugs potentially associated with interstitial lung disease. We applied Weibull shape parameter to time-to-event data in JADER. We found FAERS to contain 3,522,995 reports from January 2004 to March 2013 and JADER to contain 292,720 reports from April 2004 to November 2013. In FAERS, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 7.4% (285/3,856 reports), 3.2% (86/2,663 reports), and 1.9% (357/18,366 reports), and RORs (95% confidence interval [CI]) were 29.26 (25.89-33.07), 11.99 (9.66-14.88), and 7.29 (6.55-8.11), respectively. In JADER, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 45.6% (1,070/2,348 reports), 22.1% (77/348 reports), and 27.9% (468/1,678 reports), and RORs (95% CI) were 18.46 (16.99-20.06), 5.83 (4.52-7.51), and 8.14 (7.31-9.07), respectively. Adverse event signals of interstitial lung disease were observed in most drugs, which are warned as a suspected drug in the literature. With the time-to-event analysis using Weibull shape parameter, time-dependency of adverse events in each drug was different. Therefore, these drugs should be used carefully in clinical practice.
4.Analysis of the Association between Neuraminidase Inhibitors and Neuropsychiatric Adverse Events Using Japanese Adverse Drug Event Report (JADER)
Natsumi Ueda ; Yamato Kato ; Junko Abe ; Yoko Nakayama ; Toshinobu Matsui ; Yuuki Hane ; Sayaka Sasaoka ; Yumi Motooka ; Haruna Hatahira ; Yasutomi Kinosada ; Zenichiro Kato ; Mitsuhiro Nakamura
Japanese Journal of Drug Informatics 2016;18(1):38-45
There have been concerns that neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) cause neuropsychiatric adverse events (NPAEs). We evaluated the number of relevant reports, reporting ratio, and reporting odds ratio (ROR) by using spontaneous reporting database, such as the Japanese Adverse Drug Event Report (JADER) (April 2004 to July 2014). The RORs of oseltamivir, zanamivir, laninamivir, and peramivir were 11.8 (95% confidence interval (CI), 10.8-13.0), 47.0 (95% CI, 40.0-55.3), 9.5 (95% CI, 6.8-13.2), and 3.3 (95% CI, 2.1-5.1), respectively. The lower limit of the ROR 95% CI of NPAEs of all neuraminidase inhibitors was ≥1. We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model. The adjusted ROR of NPAEs was 66.9 (95% CI, 50.3-88.9) in male patients treated with osletamivir aged 10-19 years. The adjusted RORs of NPAEs were increased in male and female patients under the age of 20 years. Neuraminidase inhibitors including oseltamivir treatment could be associated with NPAEs. Therefore, these drugs should be used carefully in clinical practice.
5.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.
6.The Effect of High-flow Nasal Cannula Oxygen for Dyspnea in Patients with Advanced Disease: Systematic Review
Sho GOYA ; Yasushi NAKANO ; Hiroaki TSUKUURA ; Yusuke TAKAGI ; Hiroaki WATANABE ; Yoshinobu MATSUDA ; Jun KAKO ; Yoko KASAHARA ; Hiroyuki KOHARA ; Masanori MORI ; Takeo NAKAYAMA ; Takashi YAMAGUCHI
Palliative Care Research 2023;18(4):261-269
Objective: To evaluate the efficacy of high-flow nasal cannula oxygen (HFNC) for dyspnea in patients with advanced disease. Methods: A literature search was conducted using MEDLINE, Cochrane Library, EMBASE, and Ichu-shi Web. Inclusion criteria were: 1) randomized controlled trials evaluating the effect of HFNC on dyspnea; 2) aged 18 years or older with advanced disease with hypoxemia; 3) control group was conventional oxygen therapy or noninvasive positive pressure ventilation. Exclusion criteria were: 1) patients in intensive care unit, 2) weaning from ventilator. Results: Six studies (4 from database searches, and 2 from hand searches) were included. In the 2 studies evaluating short-term intervention, one showed HFNC was more efficacious, and the other conventional oxygen was more efficacious. In the 2 studies evaluating long-term interventions: one showed HFNC was more efficacious, and the other showed no significant difference. In the 2 studies evaluating the intervention during exercise, one showed HFNC was more efficacious, and the other showed no significant difference. Conclusion: HFNC may be effective for dyspnea in patients with advanced disease associated with hypoxemia.