著者

Ikuyo Tsutsumi Yusuke Tsutsumi Chikashi Yoshida Takuya Komeno Yuichi Imanaka

出版者

Japan Epidemiological Association

雑誌

Journal of Epidemiology (ISSN:09175040)

巻号頁・発行日

vol.32, no.1, pp.27-33, 2022-01-05 (Released:2022-01-05)

参考文献数

24

被引用文献数

5

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Background: The number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry.Methods: An interrupted time-series design was used in the analysis, which was conducted from April 2015 to March 2019. We collected data for studies registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network.Results: In total, 35,811 studies were registered; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new studies after CTA enforcement decreased significantly by 15.0 (95% confidence interval [CI], −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) studies from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical studies, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors.Conclusions: The number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

著者

Daisuke Takada Susumu Kunisawa Akira Kikuno Tomoko Iritani Yuichi Imanaka

出版者

Japan Epidemiological Association

雑誌

Journal of Epidemiology (ISSN:09175040)

巻号頁・発行日

vol.32, no.7, pp.323-329, 2022-07-05 (Released:2022-07-05)

参考文献数

21

被引用文献数

2

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Background: The transtheoretical model (TTM) is composed of the multiple stages according to patient’s consciousness and is believed to lead people to realize the importance of healthier behaviors. We examined the association of TTM stages with the decline of estimated glomerular filtration rate (eGFR).Methods: We used the annual health checkup data and health insurance claims data of the Japan Health Insurance Association in Kyoto Prefecture between April 2012 and March 2016. TTM stages of change obtained from questionnaires at the first health checkup and categorized into six groups. The primary outcome was defined as a more than 30% decline in eGFR from the first health checkup. We fitted multivariable Cox proportional-hazards model for time-to-event analyses adjusting for age, sex, eGFR, body mass index, blood pressure, blood sugar, dyslipidemia, uric acid, urinary protein, and existence of kidney diseases at first health checkup.Results: We analyzed 239,755 employees and the mean follow-up was 2.9 (standard deviation, 1.2) years. As compared with the stage 1 group, the risk of eGFR decline was significantly low in the stage 3 group (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.65–0.91); stage 4 group (HR 0.80; 95% CI, 0.65–0.98); and stage 5 group (HR 0.79; 95% CI, 0.66–0.95).Conclusion: Compared with the precontemplation stage (stage 1), the preparation, action and maintenance stages (stages 3, 4, and 5), were associated with a lower risk of eGFR decline.

著者

Hiroyuki Seto Naoto Ishimaru Jun Ohnishi Yohei Kanzawa Takahiro Nakajima Toshio Shimokawa Yuichi Imanaka Saori Kinami

出版者

The Japanese Society of Internal Medicine

雑誌

Internal Medicine (ISSN:09182918)

巻号頁・発行日

vol.61, no.16, pp.2417-2426, 2022-08-15 (Released:2022-08-15)

参考文献数

31

被引用文献数

7

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Objective This study evaluated the effectiveness of a multidisciplinary team deprescribing intervention to reduce polypharmacy and potentially inappropriate medications (PIMs) in elderly orthopedic inpatients. Methods In this single-center retrospective observational study, orthopedic inpatients ≥75 years old and prescribed ≥6 different medications were enrolled as participants. Interventions comprised multidisciplinary team-led polypharmacy screening and suggestions regarding deprescribing any unnecessary medications during hospital stays. The primary outcome was reduction in the mean number of regular medicines and PIMs. Secondary outcomes included falls, delirium, and other adverse events during hospitalization as well as emergency department visits or unplanned hospital admissions within six months after discharge. Results After propensity score matching, 184 patients (intervention group, n=92; control group, n=92) were included in the analysis. The mean patient age was 83 years old. The mean number of prescribed medications and PIMs at admission were similar in both groups. The mean change in the number of regular medicines was -1.4 [standard deviation (SD), 2.3] in the intervention group and +0.2 (SD, 1.8) in the control group (p<0.001). The mean change in the number of PIMs was -0.5 (SD, 0.9) in the intervention group and +0.1 (SD, 0.8) in the control group (p<0.001). In-hospital adverse events other than falls and delirium were significantly less common in the deprescribing intervention group than in the control group. Conclusion Deprescribing intervention by our multidisciplinary team seems to have been effective in reducing the number of prescribed medicines and PIMs in elderly orthopedic inpatients, with some accompanying reduction in certain adverse events.

著者

Osamu Hamada Takahiko Tsutsumi Ayako Miki Takafumi Fukui Toshio Shimokawa Yuichi Imanaka

出版者

The Japanese Society of Internal Medicine

雑誌

Internal Medicine (ISSN:09182918)

巻号頁・発行日

pp.2872-19, (Released:2019-08-06)

参考文献数

18

被引用文献数

17

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Objective The hospitalist system is considered successful with respect to the quality of care and cost effectiveness in the United States. Studies have consistently demonstrated an improved clinical efficiency with this system. In Japan, however, the efficacy of the hospitalist system has not yet been examined. As a "super-aged society", Japan has a high number of elderly patients with multiple comorbidities who may theoretically receive better care by the hospitalist system than by the conventional system. This study investigates the impact of the hospitalist system on the quality of care and healthcare economics in a Japanese population. Methods We analyzed 274 patients ≥65 years of age in whom the most resource-consuming diagnosis at admission was aspiration pneumonia over a 1-year period. We categorized patients as those managed by hospitalists and those managed by various departments (control group) and compared the groups. Propensity score matching was used to minimize selection bias. Results For matched pairs, the length of hospital stay in the hospitalist group was shorter than that in the control group. Care by the hospitalist system was associated with significantly lower hospital costs. The quality of care (rate of switching from intravenous to oral antibiotics, duration of antibiotics therapy, number of chest X-rays and blood tests during hospitalization) was also considered to be favorably impacted by the hospitalist system. There was no statistically significant difference in the mortality rate or readmission rate between the groups. Conclusion This study showed that the hospitalist system had a favorable impact on the quality of care and cost effectiveness, suggesting the potential utility of its implementation in the Japanese medical system.