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写真a

シノダ サトル
篠田 覚
Satoru Shinoda
所属
附属病院 次世代臨床研究センター 講師
職名
講師
プロフィール

カテゴリカルデータ解析の中でも、特に分割表解析に対して、対称性や非対称性に関するモデルや尺度を研究している。また、医療データに対してモデルや尺度を適用し、これまでの方法では困難だった解釈を統計学的に示し、応用面での有用性についても着目している。

外部リンク

学位

  • 博士(理学)(東京理科大学) ( 2020年3月 )

研究キーワード

  • カテゴリカルデータ解析

  • 生物統計学

  • 臨床研究

研究分野

  • 情報通信 / 統計科学

  • 自然科学一般 / 応用数学、統計数学

学歴

  • 東京理科大学大学院   理工学研究科   情報科学専攻

    2017年4月 - 2020年3月

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    備考: 博士後期課程

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  • 東京理科大学大学院   理工学研究科   情報科学専攻

    2010年4月 - 2012年3月

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    備考: 修士課程

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  • 東京理科大学   理工学部   情報科学科

    2006年4月 - 2010年3月

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経歴

  • 横浜市立大学   医学部 臨床統計学教室,データサイエンス研究科 ヘルスデータサイエンス専攻,次世代臨床研究センター統計解析室   講師

    2025年4月 - 現在

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  • 横浜市立大学   医学部 臨床統計学教室,データサイエンス研究科 ヘルスデータサイエンス専攻,次世代臨床研究センター統計解析室   助教

    2021年4月 - 2025年3月

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  • 大正製薬株式会社   データサイエンス部

    2016年4月 - 2021年3月

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  • 大正製薬株式会社   医薬開発部

    2012年4月 - 2016年4月

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所属学協会

  • 日本数学会

    2019年4月 - 現在

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  • 応用統計学会

    2016年6月 - 現在

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  • 日本計量生物学会

    2011年6月 - 現在

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論文

  • Marginal Continuation odds Ratio Model and Decomposition of Marginal Homogeneity Model for Multi-way Contingency Tables 査読

    Satoru Shinoda, Kouji Tahata, Kouji Yamamoto, Sadao Tomizawa

    Sankhya B   83 ( S2 )   304 - 324   2020年6月

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    担当区分:筆頭著者   記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Springer Science and Business Media LLC  

    Abstract

    For square contingency tables with ordered categories, the marginal homogeneity model is represented by various expressions, and some extensions of the marginal homogeneity model were proposed. Herein we consider the marginal continuation-ratio to examine a new expression of the marginal homogeneity model. We also propose an extension of the marginal homogeneity model using the ratio of marginal continuation-ratios; namely, the marginal continuation odds ratio. The proposed model can be interpreted in various ways. Additionally, we propose a generalization of it, and decompose the marginal homogeneity model using the generalized model. Furthermore, we extend the models and decompositions into multi-way contingency tables.

    DOI: 10.1007/s13571-020-00228-9

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    その他リンク: https://link.springer.com/article/10.1007/s13571-020-00228-9/fulltext.html

  • A measure of asymmetry for ordinal square contingency tables with an application to modified LANZA score data 査読

    Satoru Shinoda, Kouji Yamamoto, Kouji Tahata, Sadao Tomizawa

    Journal of Applied Statistics   47 ( 7 )   1251 - 1260   2019年10月

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    担当区分:筆頭著者   記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Informa UK Limited  

    DOI: 10.1080/02664763.2019.1673325

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  • Association of Low Muscle Strength With Incident Pneumonia in Older Patients With Heart Failure 査読

    Kenta Yamaguchi, Masaaki Konishi, Nobuyuki Kagiyama, Takatoshi Kasai, Kentaro Kamiya, Hiroshi Saito, Kazuya Saito, Emi Maekawa, Takeshi Kitai, Kentaro Iwata, Kentaro Jujo, Hiroshi Wada, Satoru Shinoda, Eiichi Akiyama, Shin-Ichi Momomura, Kiyoshi Hibi, Yuya Matsue

    The Journals of Gerontology, Series A: Biological Sciences and Medical Sciences   80 ( 1 )   2024年11月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Oxford University Press (OUP)  

    Abstract

    Background

    Patients with heart failure (HF) are at an increased risk of developing pneumonia, leading to a high mortality. A decrease in muscle strength due to aging or concomitant disease may contribute to the development of pneumonia in older adults. We sought to investigate the relationship between low muscle strength and pneumonia incidence in older patients hospitalized for worsening HF.

    Methods

    We carried out a subanalysis of the FRAGILE-HF, a prospective multicenter observational study, including 1 266 consecutive older (≥65 years) patients hospitalized with HF (mean age 80.2 ± 7.8 years; 57.4% male; left ventricular ejection fraction 46% ± 17%) and information of incident pneumonia observed after discharge. Patients were followed up for 2 years post-discharge.

    Results

    A total of 88 patients (7.0%) developed pneumonia after discharge, with an incidence of 42.7 per 1 000 person-years. A total of 893 patients with low muscle strength, defined as handgrip strength <28 kg for men and <18 kg for women according to international criteria, were more likely to develop pneumonia than those with normal muscle strength (p < .001; log-rank test). Low muscle strength was a significant predictor of incident pneumonia (adjusted hazard ratio with 95% confidence interval: 2.65 [1.31–5.35], p = .007). Furthermore, the mortality rates were 43.2% in patients who developed pneumonia and 19.3% in those who did not, indicating a heightened risk of death following the onset of pneumonia (adjusted hazard ratio: 4.25 [2.91–6.19], p < .001).

    Conclusions

    In older patients hospitalized for HF, low muscle strength was associated with incident pneumonia after discharge.

    DOI: 10.1093/gerona/glae266

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    その他リンク: https://academic.oup.com/biomedgerontology/advance-article-pdf/doi/10.1093/gerona/glae266/61200234/glae266.pdf

  • Visualizing departures from marginal homogeneity for square contingency tables with ordered categories 査読

    Satoru Shinoda, Takuya Yoshimoto, Kouji Tahata

    Information Visualization   24 ( 2 )   165 - 178   2024年10月

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    担当区分:筆頭著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:SAGE Publications  

    Square contingency tables are a special case commonly used in various fields to analyze categorical data. Although several analysis methods have been developed to examine marginal homogeneity (MH) in these tables, existing measures are single-summary ones. To date, a visualization approach has yet to be proposed to intuitively depict the results of MH analysis. Current measures used to assess the degree of departure from MH are based on entropy such as the Kullback-Leibler divergence and do not satisfy distance postulates. Hence, the current measures are not conducive to visualization. Herein we present a measure utilizing the Matusita distance and introduce a visualization technique that employs sub-measures of categorical data. Through multiple examples, we demonstrate the meaningfulness of our analytical framework approach and validate its usefulness to provide insightful interpretations.

    DOI: 10.1177/14738716241286858

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    その他リンク: https://journals.sagepub.com/doi/full-xml/10.1177/14738716241286858

  • Temporal Changes in the Retinal Pigment Epithelium–Bruch's Membrane Complex Thickness After Autologous Retinal Transplantation in Myopic Eyes 査読

    Shohei Kitahata, Tatsuya Inoue, Shin Tanaka, Jacob Y. H. Chin, Satoru Shinoda, Maiko Maruyama-Inoue, Kazuaki Kadonosono

    Investigative Ophthalmology & Visual Science   65 ( 12 )   25 - 25   2024年10月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Association for Research in Vision and Ophthalmology (ARVO)  

    DOI: 10.1167/iovs.65.12.25

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  • Generalized Marginal Cumulative Homogeneity Model for Multi-way Contingency Tables 査読

    Satoru Shinoda, Ayumu Uehara, Ryuya Yahagi, Takuya Yoshimoto, Kouji Tahata

    Journal of Statistical Theory and Practice   18 ( 4 )   2024年9月

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    担当区分:筆頭著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Springer Science and Business Media LLC  

    DOI: 10.1007/s42519-024-00401-7

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    その他リンク: https://link.springer.com/article/10.1007/s42519-024-00401-7/fulltext.html

  • PNI is useful for predicting the prognosis of patients with soft tissue sarcoma: A retrospective study 査読

    Keiju Saito, Yusuke Kawabata, Ikuma Kato, Satoru Shinoda, Kenta Hayashida, Shintaro Fujita, Tomotaka Yoshida, Hyonmin Choe, Masanobu Takeyama, Yutaka Inaba

    Journal of Orthopaedic Science   2024年9月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Elsevier BV  

    DOI: 10.1016/j.jos.2024.08.005

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  • Outcomes of patients with initially unresectable pancreatic cancer who underwent conversion surgery after <scp>FOLFIRINOX</scp> or gemcitabine plus nab‐paclitaxel chemotherapy: A multicenter retrospective cohort study (<scp>PC</scp>‐<scp>CURE</scp>‐1) 査読

    Naohiro Okano, Manabu Kawai, Makoto Ueno, Xianjun Yu, Yosuke Inoue, Shinichiro Takahashi, Wenquan Wang, Hidenori Takahashi, Yukiyasu Okamura, Soichiro Morinaga, Ippei Matsumoto, Yasuhiro Shimizu, Kazuhiro Yoshida, Tomohisa Yamamoto, Masayuki Ohtsuka, Yoshikuni Inokawa, Satoshi Nara, Jun Tamura, Satoru Shinoda, Kouji Yamamoto, Hiroki Yamaue, Junji Furuse

    Journal of Hepato-Biliary-Pancreatic Sciences   2024年8月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Wiley  

    Abstract

    Background

    The efficacy and safety of conversion surgery (CS) after FOLFIRINOX or gemcitabine plus nab‐paclitaxel (GnP) chemotherapy in patients with initially unresectable pancreatic cancer (PC) remains unclear.

    Methods

    This multicenter retrospective cohort study enrolled patients, between 2014 and 2018, with initially locally advanced or metastatic PC who were considered candidates for CS following FOLFIRINOX or GnP chemotherapy. They were classified into surgery (207 patients [194 resection and 13 exploratory laparotomy only]) and continued chemotherapy (10 patients, control) groups. The primary endpoint was overall survival (OS) from the day of diagnosis of potentially curative resection on imaging studies, with an expected hazard ratio (HR) of 0.7.

    Results

    OS in the surgery group was longer than that in the control group (HR, 0.47; 95% confidence interval [CI]: 0.24–0.93). The median OS was 34.4 (95% CI: 27.9–43.4) and 19.8 (95% CI: 14.9–31.1) months in the surgery and control groups, respectively. The Clavien‐Dindo grade ≥ IIIa postoperative complication and in‐hospital mortality rates were 19.6% and 0.5%, respectively. Multivariate analysis revealed that preoperative chemotherapy duration was not associated with OS.

    Conclusions

    CS, following a favorable response to FOLFIRINOX or GnP chemotherapy, improved initially unresectable PC prognosis (specifically, OS), regardless of the chemotherapy duration.

    DOI: 10.1002/jhbp.12066

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  • Bayesian Predictive Probability Based on a Bivariate Index Vector for Single Arm Phase II Study With Binary Efficacy and Safety Endpoints 査読

    Takuya Yoshimoto, Satoru Shinoda, Kouji Yamamoto, Kouji Tahata

    Pharmaceutical Statistics   2024年8月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Wiley  

    ABSTRACT

    In oncology, Phase II studies are crucial for clinical development plans as such studies identify potent agents with sufficient activity to continue development in the subsequent Phase III trials. Traditionally, Phase II studies are single‐arm studies, with the primary endpoint being short‐term treatment efficacy. However, drug safety is also an important consideration. In the context of such multiple‐outcome designs, predictive probability‐based Bayesian monitoring strategies have been developed to assess whether a clinical trial will provide enough evidence to continue with a Phase III study at the scheduled end of the trial. Therefore, we propose a new simple index vector to summarize the results that cannot be captured by existing strategies. Specifically, we define the worst and most promising situations for the potential effect of a treatment, then use the proposed index vector to measure the deviation between the two situations. Finally, simulation studies are performed to evaluate the operating characteristics of the design. The obtained results demonstrate that the proposed method makes appropriate interim go/no‐go decisions.

    DOI: 10.1002/pst.2431

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  • Sarcopenia shortens overall survival of patients with platinum-resistant recurrent ovarian cancer: inverse probability of treatment-weighting analysis 査読

    Masahiro Aichi, Sho Hasegawa, Satoru Shinoda, Yukio Suzuki, Natsuko Kamiya, Yumi Ishidera, Yuichi Imai, Etsuko Miyagi, Taichi Mizushima

    International Journal of Gynecologic Cancer   ijgc - 2024   2024年8月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:BMJ  

    Objective

    The association between sarcopenia and prognosis in patients with platinum-resistant recurrent ovarian cancer remains unclear. This study investigated whether sarcopenia is a prognostic factor in patients with platinum-resistant recurrent ovarian cancer.

    Methods

    A total of 52 patients diagnosed with platinum-resistant recurrent ovarian cancer who had undergone non-platinum chemotherapy at our institution formed our study population. Body composition and clinicopathological data of these patients were collected retrospectively. Abdominal computed tomography (CT) scans obtained at the time of platinum-resistant recurrent ovarian cancer diagnosis were used to measure the cross-sectional area of skeletal muscles at L3 level. These values were corrected for height to calculate the skeletal muscle index, and accordingly sarcopenia was defined. Overall survival was defined as the primary outcome of the study. The impact of sarcopenia on overall survival was assessed using Cox proportional hazards regression models with inverse probability weighting of treatment based on propensity scores and log-rank tests.

    Results

    The median patient age was 63 years (IQR: 53–71). The most common International Federation of Gynecology and Obstetrics (FIGO) 2018 stage was stage III (50%) and the most common histology was serous or adenocarcinoma (67.3%). The optimal cut-off value of skeletal muscle index was 35.6 cm<sup>2</sup>/m<sup>2</sup>, which was calculated using the data of 21 patients with sarcopenia and 31 without sarcopenia. Sarcopenia was significantly associated with shorter overall survival (HR 1.93; 95% CI 1.06–3.49; p=0.03). Subgroup analysis based on patient attributes and prognostic factors suggested a consistent prognostic impact of sarcopenia. Sarcopenia was identified as a significant risk factor, particularly in patients who had higher CA125 levels (HR, 2.47; 95% CI, 1.07 to 5.69; p=0.034) and a higher neutrophil-to-lymphocyte ratio (HR, 2.92; 95% CI, 1.02 to 8.31; p=0.045).

    Conclusion

    Sarcopenia significantly shortened the overall survival of patients with platinum-resistant recurrent ovarian cancer.

    DOI: 10.1136/ijgc-2024-005323

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  • Multicenter prospective study on anastomotic leakage after right‐sided colon cancer surgery with laparoscopic intracorporeal overlap anastomosis (<scp>KYCC</scp> 2101) 査読

    Keisuke Kazama, Masakatsu Numata, Hiroyuki Mushiake, Nobuhiro Sugano, Teni Godai, Akio Higuchi, Tetsushi Ishiguro, Yosuke Atsumi, Satoru Shinoda, Aya Saito

    Annals of Gastroenterological Surgery   8 ( 5 )   836 - 844   2024年6月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Wiley  

    Abstract

    Aim

    Intracorporeal anastomosis (IA) is becoming increasingly popular and replacing extracorporeal anastomosis (EA) for reconstruction in laparoscopic and robotic surgery for right‐sided colon cancer (LSRCC). Intracorporeal overlap anastomosis (IOA) is the most widely used IA technique. This study aimed to examine the safety of IOA by investigating its short‐term results during the implementation phase.

    Methods

    This multicenter prospective cohort study was conducted by the Kanagawa Yokohama Colorectal Cancer (KYCC) Study Group. Patients with stage 1–3 colon cancer who planned to undergo LSRCC with IOA reconstruction were eligible. The incidence of anastomotic leakage (AL) of Clavien–Dindo (C–D) grade ≥3 was evaluated as the primary endpoint, and other surgical outcomes and postoperative complications of C–D grades ≥2 were the secondary endpoints.

    Results

    A total of 127 patients were enrolled, of whom 120 were finally analyzed. The incidence of C–D grade ≥2 complications was 8.3%. The incidence of C–D grade ≥3 AL was 0.8%. This trend was lower than that reported in previous randomized controlled trials (RCTs) and acceptable. Additionally, 1.7% of the patients developed abdominal abscesses, and no cases of anastomotic stenosis were observed. The median operative time was 257 min, and the reconstruction procedure required 32 min. Stapler closure of the enterotomy and facility experience of more than 30 cases were associated with a shorter reconstruction time during IOA.

    Conclusion

    IOA is feasible and can be safely performed during the implementation phase in patients undergoing LSRCC.

    DOI: 10.1002/ags3.12831

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  • The epidemiology of postoperative dobutamine and phosphodiesterase inhibitors after adult elective cardiac surgery and its impact on the length of hospital stay: a post hoc analysis from the multicenter retrospective observational study.

    Takuo Yoshida, Atsushi Goto, Satoru Shinoda, Yuki Kotani, Takahiro Mihara

    Heart and vessels   2024年1月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    The optimal administration of inotrope after cardiac surgery is unknown. This study aimed to investigate the impact of postoperative inotrope on clinical outcomes in adult elective cardiac surgery patients. Data from the Blood Pressure and Relative Optimal Target after Heart Surgery in Epidemiologic Registry study were analyzed, employing propensity score considering the hospital of admission. The primary outcome was the length of hospital stay evaluated using quantile regression. Secondary outcomes were kidney injury progression, renal replacement therapy, atrial fibrillation, mortality, mechanical ventilation duration, and length of intensive care unit (ICU) stay. Among 870 patients from 14 ICUs in Japan, 535 received inotropes within 24 h of ICU admission, with usage rates ranging from 40 to 100% among facilities. After propensity score matching, 218 patients were included in each group. The inotrope group had a significantly longer hospital stay compared to the control group (16 days vs. 14 days; median difference 1.78 [95% confidence interval [CI] 0.31-3.24]; p = 0.018). However, no significant differences were observed in the secondary outcomes, except for mechanical ventilation duration. The results of the sensitivity analysis using a mixed-effects quantile regression analysis considering the hospital of admission for length of hospital stay in the original cohort were consistent with the results of the propensity analyses (median difference in days, 2.35 [95% CI, 0.35-4.36]; p = 0.022). The use of inotropes within 24 h of ICU admission in adult elective cardiac surgery patients was associated with an extended hospitalization period of approximately 2 days, without offering any prognostic benefit. Clinical trial registration: UMIN-CTR, https://www.umin.ac.jp/ctr/index-j.htm , UMIN000037074.

    DOI: 10.1007/s00380-023-02349-3

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  • Impact of interpregnancy weight changes and perinatal outcomes: A retrospective study in Japan. 国際誌

    Masafumi Yamamoto, Shigeru Aoki, Satoru Shinoda, Hiroshi Ishikawa, Etsuko Miyagi

    PloS one   19 ( 2 )   e0299794   2024年

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    Previous studies have shown that interpregnancy weight fluctuations impact perinatal outcomes. In order to examine this in Japanese women, we analyzed the data of 2,861 women in their first and second pregnancies who delivered singletons between 2000 and 2022. We compared the second pregnancy perinatal outcomes of women whose interpregnancy body mass index (BMI) change was -1 to 1 unit with those of women whose BMI change was < -1 or ≥ 1 unit. An interpregnancy BMI change ≥ 1 unit was associated with an increased risk of developing gestational diabetes mellitus (adjusted odds ratio [aOR], 1.51; 95% confidence interval [CI], 1.18-1.95) and delivering a large for gestational age neonate (aOR, 1.67; 95% CI, 1.15-2.42) but a decreased risk of preterm birth (aOR, 0.66; 95% CI, 0.46-0.95). An interpregnancy BMI change < -1 unit was associated with a decreased risk of developing gestational diabetes mellitus (aOR, 0.51; 95% CI, 0.31-0.85). In a subgroup analysis of three groups divided according to prepregnancy BMI, interpregnancy BMI changes ≥ 1 unit in women with a BMI of < 18.5 kg/m2 before their first pregnancy were associated with a remarkable risk reduction of developing preterm birth (aOR, 0.30; 95% CI, 0.11-0.81). Interpregnancy BMI changes < -1 unit in women with a BMI of ≥ 25 kg/m2 before their first pregnancy were associated with a remarkable risk reduction of developing gestational diabetes mellitus (aOR, 0.33; 95% CI, 0.12-0.88). Weight gain during interpregnancy period was related to an increased risk of gestational diabetes mellitus and delivery of a large-for-gestational-age neonate, whereas weight loss was related to a decreased risk of developing gestational diabetes mellitus. These results indicate the importance of interpregnancy weight control as part of preconception care; therefore, women considering additional pregnancies should be educated on the importance of maintaining a healthy weight.

    DOI: 10.1371/journal.pone.0299794

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  • Efficacy and safety of rifaximin in patients with chronic intestinal pseudo-obstruction: a randomized, double-blind, placebo-controlled, phase II-a exploratory trial.

    Hidenori Ohkubo, Takaomi Kessoku, Kosuke Tanaka, Kota Takahashi, Tomohiro Takatsu, Tsutomu Yoshihara, Noboru Misawa, Keiichi Ashikari, Akiko Fuyuki, Shingo Kato, Takuma Higurashi, Kunihiro Hosono, Masato Yoneda, Toshihiro Misumi, Satoru Shinoda, Vincenzo Stanghellini, Atsushi Nakajima

    Bioscience of microbiota, food and health   43 ( 2 )   135 - 144   2024年

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    Chronic intestinal pseudo-obstruction (CIPO) is a rare intractable disease with limited treatment options. Small intestinal bacterial overgrowth (SIBO) often co-occurs with several diseases, including CIPO. While rifaximin (RFX) is effective in treating SIBO, its efficacy for CIPO remains unclear. Here, we aimed to investigate the efficacy and safety of RFX in adult patients with CIPO. Twelve patients were randomly assigned to receive RFX (400 mg three times daily, n=8) or a placebo (PBO, n=4) for 4 weeks. The global symptom score for abdominal bloating (GSS-bloating) and an original whole gastrointestinal symptoms score (O-WGSS) were collected, and a glucose hydrogen breath test (GHBT) and abdominal computed tomography (CT) were performed. No significant differences were observed in the primary endpoint. GSS-bloating improved by 75% and 25% in the PBO and RFX groups, respectively, and O-WGSS improved by 25% in both groups. No significant differences were observed in secondary and other endpoints, including the SIBO eradication rate in the GHBT and small intestinal volume on CT. In a post hoc analysis of SIBO-positive patients with CIPO (4/4 and 4/8 in the PBO and RFX groups), SIBO was eradicated in 25% and 75% of the patients (PBO and RFX groups, respectively) at the end of treatment, indicating a high eradication rate in the RFX group. Furthermore, the small intestinal gas volume decreased in the RFX group, and no severe adverse events occurred. Although no significant improvements were observed in subjective indicators, RFX may be beneficial in alleviating SIBO and reducing the small intestinal gas volume in SIBO-positive patients with CIPO.

    DOI: 10.12938/bmfh.2023-080

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  • Braided-type stent versus laser-cut-type stent for patients with unresectable distal malignant biliary obstruction: a randomized controlled trial. 国際誌

    Sho Hasegawa, Takamitsu Sato, Satoru Shinoda, Yusuke Kurita, Tomoki Ogata, Shinichi Nihei, Shin Yagi, Kunihiro Hosono, Itaru Endo, Noritoshi Kobayashi, Kensuke Kubota, Atsushi Nakajima

    Gastrointestinal endoscopy   2023年12月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    BACKGROUND AND AIMS: Fully covered self-expandable metallic stents (SEMS) are laser-cut (L) or braided (B); however, which is more effective for distal malignant biliary obstruction (DMBO) has been unclear. We compared the clinical outcomes of using L- type and B-type stents because we believe that recurrent biliary obstruction (RBO) is less likely to occur with L-type stents. METHODS: Patients diagnosed with unresectable DMBO were randomly assigned to groups L and B in a stratified block fashion, and outcomes were compared. The primary outcome was the rate of RBO within 1 year; secondary outcomes were adverse events, clinical success rate, time to RBO (TRBO), and overall survival. RESULTS: Of the 60 enrolled participants, 56 (group L: 27, group B: 29) were included. The rates of RBO within 1 year were 44.4% and 17.2% in groups L and B, respectively (odds ratio 2.57 [95% confidence interval {CI}: 1.045-6.353]). Early adverse events, which improved with conservative treatment, included pancreatitis (n=4) in group L and pancreatitis (n=3) and cholecystitis (n=1) in group B (p=0.913). The median TRBO (220 days [95% CI: 56-272] versus 418 days [95% CI: 232-454]) was significantly longer in group B than in group L (log-rank test, p=0.0118). The median overall survival (L: 158 days, B: 204 days) after stenting was not significantly different between the groups (p=0.8544). CONCLUSIONS: In the setting of DMBO, braided (B)-type stents are associated with less recurrent obstruction than laser-cut-type (L) stents, although there was no difference in safety.

    DOI: 10.1016/j.gie.2023.11.057

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  • Difficulty in Serologic Screening for Subclinical Rubella During Pregnancy.

    Kazuya Hiiragi, Ryosuke Shindo, Satoru Shinoda, Mika Okuda, Keiko Tanaka-Taya, Kentaro Kurasawa, Etsuko Miyagi, Shigeru Aoki

    Japanese journal of infectious diseases   2023年11月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    In Japan, rubella antibodies are measured in all pregnant women in order to detect subclinical infection. The study aimed to assess the validity of measuring rubella antibodies to detect subclinical rubella among pregnant women in Japan. This single-center, retrospective study measured rubella hemagglutination inhibition (HI) titers and rubella-specific IgM antibody index values (IgM-values). IgM-values were measured by enzyme immunoassay, and IgM-values > 1.2 were considered positive. Of 14965 pregnant women who were included, 186 (1.2%) were IgM-positive. Only one patient was clinically diagnosed with rubella (HI titer, 1:2048; IgM-value, 10) and developed a fever and skin rash. She decided to terminate her pregnancy without a repeat blood test. Of the IgM-positive patients, 136 (73.1%) had rubella HI titers of < 1:256. The correlation coefficient of rubella HI titers and IgM-values was weakly positive (0.2527; p < 0.0001). This study showed that the single combination of rubella HI and rubella-specific IgM measurements alone did not detect subclinical rubella. Creating awareness among pregnant women by informing them that almost all rubella-specific IgM-positive individuals without symptoms are not acutely infected could decrease their anxiety and prevent unnecessary termination of pregnancies.

    DOI: 10.7883/yoken.JJID.2023.222

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  • Inappropriate shock incidence in patients with subcutaneous implantable cardioverter-defibrillators with concomitant cardiac implantable electronic devices: A single-center cohort study. 国際誌

    Makiko Okazaki, Yuki Sahashi, Takahiko Nagase, Kanki Inoue, Yukio Sekiguchi, Junichi Nitta, Satoru Shinoda, Sayuri Shimizu, Makoto Kuroki, Mitsuaki Isobe, Takahiro Mihara

    Pacing and clinical electrophysiology : PACE   2023年11月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    BACKGROUND: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are occasionally used in combination with other cardiac implantable electronic devices (CIEDs). However, whether the incidence of inappropriate shock increases in patients with S-ICDs and concomitant CIEDs remains unclear. This study aimed to investigate the association between the concomitant use of CIEDs and the incidence of inappropriate shock in patients with current-generation S-ICDs. METHODS: A total of 127 consecutive patients received an S-ICD. Patients were assigned to two groups depending on concomitant use of CIEDs at the time of S-ICD implantation: patients without other CIEDs (non-combined group, 106 patients) and patients with other CIEDs (combined group, 21 patients). CIEDs included pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, and cardiac resynchronization therapy defibrillators. The primary outcome was inappropriate shock, defined as a shock other than ventricular arrhythmia. Hazard ratios and 95% confidence intervals were calculated using a time-varying Cox proportional hazards model which was adjusted for age because age differed between the groups and could be a confounder. RESULTS: During a median follow-up period of 2.2 years (interquartile range, 1.0-3.4 years), inappropriate shock events occurred in 17 (16%) and five (19%) patients of the non-combined and combined groups, respectively. While the age-adjusted hazard ratio for inappropriate shock was 24% higher in the combined than in the non-combined group (hazard ratio = 1.24, 95% confidence interval, 0.39-3.97), this difference was insignificant (p = .71). CONCLUSION: The incidence of inappropriate shock did not differ between patients with and without concomitant use of CIEDs, suggesting that S-ICDs could potentially be combined with other CIEDs without increasing the number of inappropriate shocks. Further studies are warranted to confirm the safety and feasibility of concomitant use of S-ICDs and CIEDs.

    DOI: 10.1111/pace.14887

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  • Effects of hybrid closed‐loop system on glycemic control and psychological aspects in persons with type 1 diabetes treated with sensor‐augmented pump: A prospective single‐center observational study

    Tomoaki Akiyama, Tadashi Yamakawa, Kazuki Orime, Masahiro Ichikawa, Marina Harada, Takumi Netsu, Ryoichi Akamatsu, Keita Nakamura, Satoru Shinoda, Yasuo Terauchi

    Journal of Diabetes Investigation   15 ( 2 )   219 - 226   2023年11月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Wiley  

    Abstract

    Aims/Introduction

    This study evaluated the effects of the Medtronic MiniMed 770G hybrid closed‐loop system on glycemic control and psychological aspects in persons with type 1 diabetes mellitus.

    Materials and Methods

    This 3‐month prospective observational study included 22 participants with type 1 diabetes mellitus who used the Medtronic MiniMed 640G predictive low‐glucose suspend system and were switched to the 770G system. Time in the range of 70–180 mg/dL and glycated hemoglobin levels were evaluated; satisfaction, emotional distress and quality of life were assessed using self‐reported questionnaires, including the Diabetes Treatment Satisfaction Questionnaire Status, Problem Area in Diabetes and Diabetes Therapy‐Related Quality of Life.

    Results

    Time in the range of 70–180 mg/dL increased (63.5 ± 13.4 to 73.0 ± 10.9% [mean ± standard deviation], P = 0.0010), and time above the range of 181–250 mg/dL decreased (26.9 ± 8.9 to 19.6 ± 7.1%, P &lt; 0.0005). Glycated hemoglobin levels decreased (7.7 ± 1.0 to 7.2 ± 0.8%, P = 0.0021). The percentage of participants with time below the range of 54–69 mg/dL &lt;4% of readings increased from 91% to 100% (P &lt; 0.0005). No significant changes were detected in the satisfaction, emotional distress and quality of life levels, but increased sensor calibration might be related to worsened emotional distress and quality of life.

    Conclusions

    The hybrid closed‐loop system decreased hyperglycemia and minimized hypoglycemia, but did not improve psychological aspects compared with the predictive low‐glucose suspend system, probably because sensor calibration was increased.

    DOI: 10.1111/jdi.14103

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  • Association of Reversal of Renin Suppression With Long-Term Renal Outcome in Medically Treated Primary Aldosteronism. 国際誌

    Sho Katsuragawa, Atsushi Goto, Satoru Shinoda, Kosuke Inoue, Kazuki Nakai, Jun Saito, Tetsuo Nishikawa, Yuya Tsurutani

    Hypertension (Dallas, Tex. : 1979)   2023年7月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    BACKGROUND: Renin suppression in primary aldosteronism indicates mineralocorticoid receptor activation via excessive aldosterone secretion, inducing renal damage. We investigated whether the reversal of renin suppression after the initiation of mineralocorticoid receptor antagonist therapy was associated with long-term renal outcomes in medically treated patients with primary aldosteronism. METHODS: This retrospective cohort study included 318 patients with primary aldosteronism treated with mineralocorticoid receptor antagonist between 2008 and 2020 at the Yokohama Rosai Hospital in Japan. The posttreatment renin status was defined as unsuppressed (ie, reversal of renin suppression) when individual plasma renin activity after the initiation of mineralocorticoid receptor antagonist (post-plasma renin activity) was ≥1.0 ng/(mL h); otherwise, it was defined as suppressed. We analyzed the association of posttreatment renin status with subsequent longitudinal estimated glomerular filtration rate changes using linear mixed-effects models for repeated measurements, adjusting for potential confounders. RESULTS: The posttreatment renin status of 119 patients was unsuppressed (median post-plasma renin activity, 1.7 ng/[mL h]) and that of 199 patients was suppressed (median post-PRA, 0.5 ng/[mL h]). Through the median follow-up period of 3.1 years, the decline in estimated glomerular filtration rate was milder among patients with the unsuppressed posttreatment renin (-0.46 [95% CI, -0.63 to -0.28] mL/min per 1.73 m2 per year) than those with suppressed posttreatment renin (-1.41 [95% CI, -1.56 to -1.27] mL/min per 1.73 m2 per year; difference, 0.96 [95% CI, 0.72-1.20] mL/min per 1.73 m2 per year). CONCLUSIONS: Our findings may highlight the importance of reversing renin suppression with optimal mineralocorticoid receptor antagonist titration in medically treated primary aldosteronism, which could mitigate adverse renal outcomes.

    DOI: 10.1161/HYPERTENSIONAHA.123.21096

    PubMed

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  • 初回治療前のサルコペニアは子宮頸癌III期の患者の独立した予後因子である

    愛知 正裕, 長谷川 翔, 栗田 裕介, 篠田 覚, 加藤 真吾, 水島 大一, ルイズ横田 奈朋, 宮城 悦子

    日本婦人科腫瘍学会学術講演会プログラム・抄録集   65回   260 - 260   2023年7月

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    記述言語:日本語   出版者・発行元:(公社)日本婦人科腫瘍学会  

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  • Low skeletal muscle mass predicts poor prognosis for patients with stage III cervical cancer on concurrent chemoradiotherapy 査読

    Masahiro Aichi, Sho Hasegawa, Yusuke Kurita, Satoru Shinoda, Shingo Kato, Taichi Mizushima, Naho Ruiz Yokota, Etsuko Miyagi

    Nutrition   109   111966 - 111966   2023年5月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Elsevier BV  

    DOI: 10.1016/j.nut.2022.111966

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  • Usual source and better quality of primary care are associated with lower loneliness scores: a cross-sectional study 査読

    Makoto Kaneko, Satoru Shinoda, Izumi Nakayama, Juan Xu, Susumu Yagome, Atsushi Goto

    Family Practice   2023年4月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Oxford University Press (OUP)  

    Abstract

    Background

    Loneliness is a global issue, and primary care physicians play an important role in assessing and intervening with loneliness. This study aimed to examine the association between having a usual source of care (USC) or a good quality of primary care, and loneliness.

    Methods

    This cross-sectional study was conducted in Japan in 2022. A total of 6,000 residents were randomly sampled from the general population, aged 20–74 years. The outcome was the total score of the University of California, Los Angeles (UCLA) 3-item loneliness scale. The exposure included USC and the Person-Centered Primary Care Measure (PCPCM), which assesses the quality of primary care. We conducted a linear regression analysis to adjust for age, sex, educational status, annual household income, self-rated health, living status (whether alone or not), and the existence of physical health problems.

    Results

    Of the 6,000 residents, 1,277 responded to the survey. The median score of the UCLA 3-item loneliness scale was 6.0 and the mean total score of the PCPCM was 2.62. Of the 1,277 individuals, 713 (55.8%) had USC. Having USC was significantly associated with lower scores on the UCLA 3-item loneliness scale; the coefficient was −0.34 (95% confidence interval (CI): −0.57 to −0.12). Also, the total PCPCM score was significantly associated with lower loneliness scores; the coefficient was −0.56 (P &amp;lt; 0.001, 95% CI: −0.78 to −0.35).

    Conclusions

    Having USC and a better quality primary care were associated with a lower loneliness score. The quality of primary care could be a factor to mitigate patient loneliness.

    DOI: 10.1093/fampra/cmad049

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  • Regional differences in epidermal growth factor receptor-tyrosine kinase inhibitor therapy in lung cancer treatment using a national database in Japan 査読

    Hiromi Matsumoto, Nobuaki Kobayashi, Satoru Shinoda, Atsushi Goto, Ayami Kaneko, Nobuhiko Fukuda, Chisato Kamimaki, Sousuke Kubo, Keisuke Watanabe, Nobuyuki Horita, Yu Hara, Yoshihiro Ishikawa, Takeshi Kaneko

    Scientific Reports   13 ( 1 )   2023年3月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Springer Science and Business Media LLC  

    Abstract

    Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are extensively used in the treatment of non-small cell lung cancer (NSCLC); hence, equal access to them is important. Therefore, this study aimed to identify regional differences in the prescription of EGFR-TKIs and the factors contributing to these differences. In this ecological study, we collected data using the National Database Open Data and the National Cancer Registry. The standardized claim ratio (SCR) was used as an indicator of the number of EGFR-TKI prescriptions. Additionally, we examined the association between SCR and various factors to identify the factors associated with this difference. The average SCR for the top three provinces was 153.4, while the average for the bottom three provinces was 61.6. Multivariate analysis used for evaluating the association of SCR with variables revealed that the number of designated cancer hospitals and radiation therapies were independent factors associated with the SCR of EGFR-TKIs. There were significant regional differences in the prescriptions of EGFR-TKIs in Japan based on the number of coordinated designated cancer hospitals and the number of patients receiving radiotherapy alone. These findings emphasize the need to implement policies to increase the number of hospitals to reduce regional differences.

    DOI: 10.1038/s41598-023-31856-6

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    その他リンク: https://www.nature.com/articles/s41598-023-31856-6

  • Blunted humoral immune response to the fourth dose of BNT162b2 COVID-19 vaccine in patients undergoing hemodialysis 査読

    Daisuke Kanai, Hiromichi Wakui, Masaaki Hanaoka, Tatsuya Haze, Kengo Azushima, Satoru Shinoda, Shunichiro Tsukamoto, Shinya Taguchi, Sho Kinguchi, Tomohiko Kanaoka, Yoshiyuki Toya, Nobuhito Hirawa, Hideaki Kato, Fumimasa Watanabe, Kanako Hanaoka, Hiroshi Mitsuhashi, Satoshi Yamaguchi, Toshimasa Ohnishi, Kouichi Tamura

    Clinical and Experimental Nephrology   2023年3月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Springer Science and Business Media LLC  

    DOI: 10.1007/s10157-023-02342-0

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    その他リンク: https://link.springer.com/article/10.1007/s10157-023-02342-0/fulltext.html

  • Decomposition of measure from symmetry for analyzing collapsed ordinal square contingency tables

    Satoru Shinoda, Kouji Yamamoto, Sadao Tomizawa

    Communications in Statistics - Theory and Methods   2023年

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    担当区分:筆頭著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    In some situations, square contingency tables with ordered categories are analyzed by considering collapsed tables where adjacent categories are combined. This study proposes measures to represent the degree of departure from symmetry using collapsed tables. The proposed measures are defined as the arithmetic mean of submeasures of each collapsed 3 × 3 table. Additionally, a theorem affirms that the value of the measure for symmetry is equal to the sum of the value of the proposed measures. Finally, examples are given.

    DOI: 10.1080/03610926.2023.2233152

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  • The indicators for early blood transfusion in patients with placental abruption with intrauterine fetal death: a retrospective review 査読

    Yasuko Sano, Michi Kasai, Satoru Shinoda, Etsuko Miyagi, Shigeru Aoki

    BMC Pregnancy and Childbirth   22 ( 1 )   2022年11月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Springer Science and Business Media LLC  

    Abstract

    Background

    Placental abruption (PA) with intrauterine fetal death (IUFD) is associated with a high risk of postpartum hemorrhage (PPH) resulting from severe disseminated intravascular coagulation (DIC). Therefore, blood products that are sufficient for coagulation factor replacement must be prepared, and delivery should occur at referral medical institutions that are equipped with sufficient blood products and emergency transfusion protocols. We retrospectively reviewed the records of patients with PA and IUFD (PA-IUFD) to identify possible factors that may indicate the need for early blood transfusion and investigated whether the Japanese scoring system for PPH can be applied in such cases.

    Methods

    We used a database of 16,058 pregnant patients who delivered at Yokohama City University Medical Center between January 2000 and February 2016. Thirty-three patients were diagnosed with PA-IUFD before delivery and categorized into two groups–blood transfusion and non-transfusion–to compare the maternal characteristics and pregnancy outcomes.

    Results

    In patients with PA-IUFD, the transfusion group exhibited significantly more blood loss; lower fibrinogen levels and platelet counts; higher levels of fibrin degradation products (FDP), D-dimer, and prothrombin time; and a tendency for tachycardia on admission, compared to the non-transfusion group. Many patients in the transfusion group had normal fibrinogen levels on admission but later displayed markedly decreased fibrinogen levels. The Japan Society of Obstetrics and Gynecology (JSOG) DIC score was significantly higher in the transfusion than in the non-transfusion group.

    Conclusions

    In PA-IUFD, the fibrinogen level, platelet count, D-dimer, FDP, heart rate, and JSOG DIC score on admission may indicate the need for blood transfusion. However, even with normal fibrinogen levels on admission, continuous monitoring is indispensable for identifying progressive fibrinogen reductions in patients with PA-IUFD.

    DOI: 10.1186/s12884-022-05187-9

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    その他リンク: https://link.springer.com/article/10.1186/s12884-022-05187-9/fulltext.html

  • A 3-step approach to predict advanced fibrosis in nonalcoholic fatty liver disease: impact on diagnosis, patient burden, and medical costs 査読

    Takashi Kobayashi, Yuji Ogawa, Satoru Shinoda, Michihiro Iwaki, Asako Nogami, Yasushi Honda, Takaomi Kessoku, Kento Imajo, Masato Yoneda, Satoru Saito, Kouji Yamamoto, Satoshi Oeda, Hirokazu Takahashi, Yoshio Sumida, Atsushi Nakajima

    Scientific Reports   12 ( 1 )   2022年10月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:Springer Science and Business Media LLC  

    Abstract

    A 2-step approach, Fibrosis-4 index (FIB-4) followed by vibration-controlled transient elastography (VCTE), has been proposed to predict advanced fibrosis in patients with nonalcoholic fatty liver disease (NAFLD). We aimed to develop a novel 3-step approach for predicting advanced fibrosis. We enrolled 284 biopsy-confirmed NAFLD patients from two tertiary care centers and developed subgroups (n = 190), including 3.7% of patients with advanced fibrosis, assuming a primary care setting. In the 3-step approach, patients with intermediate-to-high FIB-4 in the first step underwent an enhanced liver fibrosis test or measurement of type IV collagen 7S domain as the second step, and VCTE was performed if the second step value was higher than the cutoff. In 284 cases, a tertiary care cohort with 36.3% advanced fibrosis, the 3-step approach showed significantly higher specificity and positive predictive value than the 2-step approach. In the subgroup with 3.7% advanced fibrosis, the 3-step approach significantly reduced the referral rate to specialists, the number of high-risk patients (i.e., liver biopsy candidates), and healthcare costs by 12.5% to 15.8%. The 3-step approach may improve the diagnostic performance to predict advanced fibrosis in NAFLD, which could lower rates of referrals to specialists, liver biopsies, and medical costs.

    DOI: 10.1038/s41598-022-22767-z

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    その他リンク: https://www.nature.com/articles/s41598-022-22767-z

  • Fragmentation of ambulatory care among older adults: an exhaustive database study in an ageing city in Japan 査読

    Makoto Kaneko, Satoru Shinoda, Sayuri Shimizu, Makoto Kuroki, Sachiko Nakagami, Taiga Chiba, Atsushi Goto

    BMJ Open   12 ( 8 )   e061921 - e061921   2022年8月

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    掲載種別:研究論文(学術雑誌)   出版者・発行元:BMJ  

    Objectives

    Continuity of care is a core dimension of primary care, and better continuity is associated with better patient outcomes. Therefore, care fragmentation can be an indicator to assess the quality of primary care, especially in countries without formal gatekeeping system, such as Japan. Thus, this study aimed to describe care fragmentation among older adults in an ageing city in Japan.

    Design

    Cross-sectional study.

    Setting

    The most populated basic municipality in Japan.

    Participants

    Older adults aged 75 years and older.

    Interventions

    This study used a health claims database, including older adults who visited medical facilities at least four times a year in an urban city in Japan. The Fragmentation of Care Index (FCI) was used as an indicator of fragmentation. The FCI was developed from the Continuity of Care Index and is based on the total number of visits, different institutions visited and proportion of visits to each institution. We employed Tobit regression analysis to examine the association between the FCI and age, sex, type of insurance and most frequently visited facility.

    Results

    The total number of participants was 413 600. The median age of the study population was 81 years, and 41.6% were men. The study population visited an average of 3.42 clinics/hospitals, and the maximum number of visited institutions was 20. The proportion of patients with FCI &gt;0 was 85.0%, with a mean of 0.583. Multivariable analysis showed that patients receiving public assistance had a lower FCI compared with patients not receiving public assistance, with a coefficient of 0.137.

    Conclusions

    To our knowledge, this is the first study to demonstrate care fragmentation in Japan. Over 80% of the participants visited two or more medical facilities, and their mean FCI was 0.583. The FCI could be a basic indicator for assessing the quality of primary care.

    DOI: 10.1136/bmjopen-2022-061921

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  • Association of Serum and Fecal Bile Acid Patterns With Liver Fibrosis in Biopsy-Proven Nonalcoholic Fatty Liver Disease: An Observational Study 査読

    Yuki Kasai, Takaomi Kessoku, Kosuke Tanaka, Atsushi Yamamoto, Kota Takahashi, Takashi Kobayashi, Michihiro Iwaki, Anna Ozaki, Asako Nogami, Yasushi Honda, Yuji Ogawa, Shingo Kato, Kento Imajo, Takuma Higurashi, Kunihiro Hosono, Masato Yoneda, Haruki Usuda, Koichiro Wada, Miwa Kawanaka, Takumi Kawaguchi, Takuji Torimura, Masayoshi Kage, Hideyuki Hyogo, Hirokazu Takahashi, Yuichiro Eguchi, Shinichi Aishima, Noritoshi Kobayashi, Yoshio Sumida, Akira Honda, Shunsuke Oyamada, Satoru Shinoda, Satoru Saito, Atsushi Nakajima

    Clinical and Translational Gastroenterology   13 ( 7 )   e00503 - e00503   2022年5月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Ovid Technologies (Wolters Kluwer Health)  

    DOI: 10.14309/ctg.0000000000000503

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  • Using the drug repositioning approach to develop a novel therapy, tipepidine hibenzate sustained-release tablet (TS-141), for children and adolescents with Attention-Deficit/Hyperactivity Disorder 査読 国際誌

    Takuya Saito, Yushiro Yamashita, Akemi Tomoda, Takashi Okada, Hideo Umeuchi, Saki Iwamori, Satoru Shinoda, Akiko Mizuno-Yasuhira, Hidetoshi Urano, Izumi Nishino, Kazuhiko Saito

    BMC Psychiatry   20 ( 1 )   530 - 530   2020年11月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    BACKGROUND: Asverin® (tipepidine hibenzate) has been used as an antitussive for > 50 years in Japan. Studies revealed that tipepidine modulates monoamine levels, by inhibiting G-protein-activated inwardly rectifying potassium (GIRK) channels, expecting the potential therapeutic effects of tipepidine for attention-deficit/hyperactivity disorder (ADHD) in recent years. In this study, TS-141, a sustained-release tablet of tipepidine, was developed for the treatment of ADHD through a drug repositioning approach. METHODS: The sustained-release profile of TS-141 in healthy adults was investigated, and tipepidine exposure in the plasma after the TS-141 administration was compared to that of Asverin in the phase I study. Phase II study was conducted to examine the effects of TS-141 30 (once a day), 60 (once a day), 120 mg (60 mg twice a day), or placebo, that is within the exposure in the maximum dosage of Asverin, in children and adolescents with ADHD, and was designed as an 8-week treatment, randomized, parallel group, double-blind, placebo-controlled trial recruiting 6-17-year-old children and adolescents diagnosed with ADHD. A total of 216 patients were randomized according to the CYP2D6 phenotype. The primary end-point was ADHD Rating Scale IV-J changes. Furthermore, effects of CYP2D6 phenotype on the efficacy in the subgroup analysis were investigated. RESULTS: TS-141 had the sustained-release profile, and the CYP2D6 phenotype had effects on the plasma exposure of tipepidine. ADHD RS-IV-J scores in all TS-141 dosages decreased from their baseline scores; however, no significant difference was observed in ADHD RS-IV-J score changes between the placebo and TS-141-administered groups. In patients with intermediate metabolizer CYP2D6, ADHD RS-IV-J score changes in the 120 mg group tended to be larger than that in the placebo group. CONCLUSIONS: ADHD RS-IV-J changes on TS-141 may depend on the interaction between the TS-141 dose and CYP2D6 phenotype, suggesting that further clinical trials should be conducted with careful consideration of polymorphism. Drug repositioning approach of TS-141 was attempted at the same dose as that of antitussive; however, dose setting according to the indication was necessary. TRIAL REGISTRATION: Phase I study: JapicCTI-205235 (Registered 25 March 2020), Phase II study: JapicCTI-163244 (Registered 9 May 2016), https://www.clinicaltrials.jp/cti-user/trial/Show.jsp.

    DOI: 10.1186/s12888-020-02932-2

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  • Extended marginal homogeneity models based on complementary log-log transform for multi-way contingency tables 査読

    Satoru Shinoda, Kouji Tahata, Kiyotaka Iki, Sadao Tomizawa

    SUT Journal of Mathematics   55 ( 1 )   2019年6月

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    担当区分:筆頭著者   記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:SUT Journal of Mathematics - Tokyo University of Science  

    DOI: 10.55937/sut/1570041313

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  • Decompositions for Ordinal Quasi-Symmetry Model in Square Contingency Tables with Ordered Categories 査読

    Kouji Yamamoto, Satoru Shinoda, Sadao Tomizawa

    Journal of Mathematics and Statistics   7 ( 4 )   314 - 318   2011年10月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Science Publications  

    DOI: 10.3844/jmssp.2011.314.318

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▼全件表示

講演・口頭発表等

  • がん第Ⅱ相臨床試験におけるBayesian Sargent's Design

    小巻萌夏, 篠田覚, 山本紘司

    応用統計学会年会  2024年5月 

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    会議種別:ポスター発表  

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  • 単群第II相試験における二次元尺度を用いたベイズ流予測確率に基づく接近法

    吉本拓矢, 篠田覚, 山本紘司, 田畑耕治

    日本統計学会春季集会  2025年3月 

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    会議種別:ポスター発表  

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  • Bayesian screening design for phase II oncology trials

    Komaki M., Shinoda S., Zheng H., Yamamoto K.

    International Biometric Conference  2024年12月 

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    会議種別:ポスター発表  

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  • 正方分割表におけるcontinuation oddを用いた周辺非同等性の尺度:対応のある離散時間データへの適用を目指して

    田村惇, 篠田覚

    かごしまデータ科学シンポジウム  2024年8月 

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    会議種別:口頭発表(一般)  

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  • Estimands in EQ-5D-5L: How to Deal with the "Worse Than Death" and the Intercurrent Events of "Death"

    Kikumori K., Shinoda S., Ohwada S., Yamamoto K.

    ISPOR  2024年5月 

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    応用統計学会年会  2022年 

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    APSARD Annual Meeting  2021年 

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  • 順序カテゴリ正方分割表におけるContinuation-ratio に基づいた周辺同等性のモデル

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  • 多元分割表におけるContinuation-ratioに基づくモデルと周辺同等モデルの分解

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    統計関連学会連合大会  2021年 

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  • AROが支援した研究における終了時の振り返りと得られた知見の活用

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    臨床試験学会学術総会  2021年 

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  • 順序カテゴリ正方分割表における指数型の非対称モデルと分解について

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    科研費シンポジウム「非正則統計的推測とその応用 想定内と想定外」  2011年 

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  • Hybrid measure of asymmetry using collapsed square tables: application to clinical data

    Satoru Shinoda, Koji Yamamoto, Koji Tahata, Sadao Tomizawa

    International Society for Clinical Biostatistics  2018年 

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  • 順序カテゴリ正方分割表における非対称性に関する尺度の提案と臨床スコアへの適用

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    応用統計学会年会  2018年 

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  • 多元分割表における補対数対数変換に基づく周辺非同等性について

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    日本数学会  2019年 

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  • 順序カテゴリ正方分割表におけるスコアを用いた非対称モデルと分解

    篠田覚, 山本紘司, 富澤貞男

    統計関連連合大会  2011年 

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  • 多元分割表における補対数対数変換を用いた周辺対称モデルの拡張

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    応用統計学会年会  2022年 

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  • 初回治療前のサルコペニアは子宮頸癌III期の患者の独立した予後因子である

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    日本婦人科腫瘍学会学術講演会  2023年12月 

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  • ベイズ流アプローチによるランダム化選択デザイン

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    Biostatistics Network  2023年8月 

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  • A simultaneous evaluation of superiority and non-inferiority for comparing screening tests

    Kobayashi M, Shinoda S, Saigusa Y, Yamamoto K

    Conference of the International Society for Clinical Biostatistics  2023年8月 

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  • がん臨床試験におけるベイズ流ランダム化選択デザイン

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    統計関連学会連合大会  2023年9月 

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  • ベイズ法を用いた柔軟な選択デザインとその応用

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    日本計算機統計学会シンポジウム  2023年11月 

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  • 順序付けられたカテゴリからなる臨床評価スコアに対する定量的な治療評価のための統計手法:治療前後のカテゴリ移行を示すシフトテーブルへの適用

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    かごしまデータ科学シンポジウム  2023年7月 

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  • 医師により正常又は軽症と判定された潰瘍性大腸炎患者に対するアダリムマブの有効性を検討する治験データを二次利用した事後解析研究

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  • スクリーニング検査の性能評価における優越性および非劣性検定を組み合わせた新たな解析手法

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    応用統計学会年会  2023年4月 

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  • 新たなスクリーニング検査の追加に対する診断性能評価

    小林実結, 篠田覚, 三枝祐輔, 山本紘司

    日本計算機統計学会シンポジウム  2022年 

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  • Simultaneous evaluation of superiority and non-inferiority for sensitivity and specificity

    Miyui Hara, Yusuke Saigusa, Satoru Shinoda, Koji Yamamoto

    Annual Conference of the International Society for Clinical Biostatistics  2022年 

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  • アップフロント・アビラテロン治療

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    日本泌尿器科学会東部総会  2022年 

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  • 都市部の高齢者のケアは分断されている:データベースを用いた横断研究

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    日本プライマリ・ケア連合学会学術大会  2022年6月 

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▼全件表示

受賞

  • 優秀研究業績賞

    2020年3月   東京理科大学  

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共同研究・競争的資金等の研究課題

  • 臨床試験で用いられるカテゴリカル変数に対する統計手法

    研究課題/領域番号:21K20331  2021年8月 - 2023年3月

    日本学術振興会  科学研究費助成事業 研究活動スタート支援  研究活動スタート支援

    篠田 覚

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    配分額:2210000円 ( 直接経費:1700000円 、 間接経費:510000円 )

    質的変数に対して検出感度が高く,かつ,αインフレーションが起きない集計解析手法の開発について,数理的に導いた指標及び信頼区間を用いて数値シミュレーションを実施したところ,小標本における課題が見つかった.この課題に対して,経験ベイズ法による課題の解決を試み,改めて数値シミュレーションを実施して従来計画していた手法と修正案とを比較した.この数値シミュレーションによって一定の成果が得られたため,査読付き国際学術雑誌へのacceptを目標として論文を執筆中である.また,次年度の学会や研究集会等で研究成果を発表する予定である.
    質的変数に対して応用時における実施や結果解釈が有用である集計解析手法の開発について,既存の集計解析手法を調査して数理的な解決方法の考え方を整理している.また,この課題に関連して,応用時においては解釈を容易にするために質的変数のカテゴリを併合する場合があることに着目して新たな課題に取り組んだ.この課題において,新たな指標及び信頼区間に加えて,新たに提案する指標を用いた既存指標の分解定理を数理的に導くことができた.これらを用いて実データへの適用を行ったところ,従来の解析では得られなかったより詳細な解析を行うことが可能となり,新たな知見を得ることができた.更に,これらの成果を纏め,論文を執筆して査読付き国際学術雑誌へ投稿中である.また,応用統計学会2022年度年会で口頭発表を行う予定である.

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