Papers - Sato, Yasunori

【現代の臨床研究のための統計学2022-洗練された研究デザインと統計解析を理解してみよう】方法論の近年の発展　アダプティブデザインの基礎　実例とともに

長島 健悟, 佐藤 泰憲

医学のあゆみ (医歯薬出版(株))  280 ( 5 ) 442 - 450 2022.01

ISSN  0039-2359

　View Summary

アダプティブデザインとは、「試験中で蓄積しているデータを用いて、妥当性と完全性を損なうことなく、実施中の試験のひとつ以上の特性を修正する機会を事前に計画に盛り込んだ臨床試験デザイン」と定義されている。アダプティブデザインによって、従来の固定デザインよりも安全で有効な治療をより早く提供できるようになることが期待されており、近年注目が集まっている。また、2020年6月にはランダム化比較試験の報告のためのガイドラインであるCONSORTのアダプティブデザイン拡張版が出版されており、アダプティブデザイン用のチェックリストが提供されている。本稿では、アダプティブデザインの基礎について実例を交えて解説する。(著者抄録)

Topiroxostat versus allopurinol in patients with chronic heart failure complicated by hyperuricemia: A prospective, randomized, open-label, blinded-end-point clinical trial.

Sakuma M, Toyoda S, Arikawa T, Koyabu Y, Kato T, Adachi T, Suwa H, Narita JI, Anraku K, Ishimura K, Yamauchi F, Sato Y, Inoue T

PloS one 17 ( 1 ) e0261445 2022

• Access to Document (DOI)

Efficacy of Early Closed Toe Amputation for Toe Ulcers with Suspected Osteomyelitis after Revascularization for Chronic Limb-Threatening Ischemia

Shintani Tsunehiro, Suzuki Sachi, Kikuchi Naoya, Ariya Takumi, Natsume Kayoko, Ookura Kazuhiro, Okui Jun, Sato Yasunori, Obara Hideaki

Annals of Vascular Diseases (The Editorial Committee of Annals of Vascular Diseases)  advpub ( 0 )  2022

ISSN  1881641X

• Access to Document (DOI)
• CiNii Research

SARS-CoV-2 RT-qPCR testing of pooled saliva samples: A case study of 824 asymptomatic individuals and a questionnaire survey in Japan.

Oba J, Taniguchi H, Sato M, Takanashi M, Yokemura M, Sato Y, Nishihara H

PloS one 17 ( 5 ) e0263700 2022

• Access to Document (DOI)

Systematic Analysis of Clinical Trial Data for Personalized Therapy: Effects of Exercise Training in Chronic Heart Failure Patients Depend on Medications and Conditions

SOEJIMA Yukako, YOSHIOKA Hideki, SATO Hiromi, GURO Sayuri, HATAKEYAMA Hiroto, SATO Yasunori, FUJIMOTO Yoshihide, ANZAI Naohiko, HISAKA Akihiro

Annual Meeting of the Japanese Society of Toxicology (The Japanese Society of Toxicology)  49.1 ( 0 ) S13-4 2022

　View Summary

<p>Although results of clinical trials are thoroughly analyzed to define benefits of the treatment, but are not fully analyzed to extract interindividual differences to achieve precise medicine. We are analyzing individual patient data from previous clinical studies for this purpose utilizing clinical trial disclosure systems. Exercise therapy is generally recommended as an adjunctive treatment in chronic heart failure. However, interindividual differences in benefit of exercise mostly have not been analyzed. In this study, we obtained patient data on the HF-ACTION study (2331 subjects) from the National Heart, Lung, and Blood Institute. With regard to clinical endpoints such as all-caused mortality (AD), significant interactions with the exercise effect were analyzed including patient backgrounds and medications (renin-angiotensin system inhibitors [RASIs] and beta-blockers [BBs]) with multivariate Cox regression models, and the selected covariates were validated by bootstrapping. Based on the results, SEEM score was constructed to judge exercise suitability. </p><p>It was revealed that exercise reduced AD in patients taking both BB and RASI with a hazard ratio (HR) of 0.86, but increased in patients not taking BB with a HR of 4.58. The exercise effect on AD was also influenced by pulse pressure, hemoglobin, ECG status, BMI, and history of stroke, thus SEEM score was constructed including these factors. AD was expected to be reduced with HR 0.54 when exercise therapy was selected according SEEM, compared to the opposite selection (95% CI, 0.44-0.68). Although this study is a post-hoc and should be interpreted with caution, exercise therapy in heart failure patients should be carefully selected, taking into account the patient background. The analysis of data from clinical trial disclosure system was of great significance to improve precise medicine.</p>

• Access to Document (DOI)
• CiNii Research

MOG抗体関連疾患の疫学と臨床像

中村 正史, 小川 諒, 藤盛 寿一, 鵜沢 顕之, 佐藤 泰憲, 長島 健悟, 栗山 長門, 中島 一郎

Neurological Therapeutics (Japanese Society of Neurological Therapeutics)  39 ( 6 ) S196 - S196 2022

ISSN  09168443

• Access to Document (DOI)
• CiNii Research

Effect of Personality Traits on Sustained Remission Among Patients with Major Depression: A 12-Month Prospective Study.

Waka Nogami, Atsuo Nakagawa, Nariko Katayama, Yuka Kudo, Mizuki Amano, Sakae Ihara, Chika Kurata, Yuki Kobayashi, Yohei Sasaki, Natsumi Ishikawa, Yasunori Sato, Masaru Mimura

Neuropsychiatric disease and treatment (Informa UK Limited)  18   2771 - 2781 2022

ISSN  1176-6328

　View Summary

PURPOSE: Major depression is a heterogeneous disorder. Therefore, careful evaluation and comprehensive assessment are crucial elements for achieving remission. Personality traits influence prognosis and treatment outcomes, but there is not enough evidence on the association between personality traits and sustained remission (SR). Hence, the present study aimed to evaluate the relationship between personality traits and SR among patients with major depression. PATIENTS AND METHODS: The 12-month prospective study evaluated 77 patients diagnosed with major depressive disorder. All patients underwent a comprehensive assessment, including the Temperament and Personality Questionnaire (T&P) at baseline, and depression severity was measured at baseline as well as six and 12 months. SR was defined as remission (the GRID-Hamilton Depression Rating Scale [GRID-HAMD17] score ≦ 7) at both the 6- and 12-month follow-up. We compared eight T&P construct scores at baseline between the SR and non-SR groups. Multivariable logistic regression analyses were performed to determine the T&P personality traits related to SR. RESULTS: Patients who achieved SR had a lower T&P personal reserve and lower T&P rejection sensitivity. Further, lower scores on the T&P personal reserve trait were independently associated with higher rates of SR among patients with major depression. Patients who achieved SR had a shorter duration of the current depressive episode and milder severity of depression at baseline. CONCLUSION: A lower level of personal reserve predicted a higher probability of SR in the treatment of depression. Extended observations in naturalistic follow-up settings with larger sample sizes are required to better understand the personality traits affecting SR in patients with depression.

• Access to Document (DOI)

Imatinib mesylate in combination with pembrolizumab in patients with advanced KIT-mutant melanoma following progression on standard therapy: A phase I/II trial and study protocol.

Hirai I, Tanese K, Fukuda K, Fusumae T, Nakamura Y, Sato Y, Amagai M, Funakoshi T

Medicine 100 ( 49 ) e27832 2021.12

ISSN  0025-7974

• Access to Document (DOI)

Hyperferritinemia Is a Predictor of Onset of Diabetes in Japanese Males Independently of Decreased Renal Function and Fatty Liver: A Fifteen-Year Follow-Up Study.

Sakuma Y, Ogino J, Iwai R, Inoue T, Takahashi H, Suzuki Y, Kinoshita D, Takemura K, Takahashi H, Shimura H, Sato Y, Yoshida S, Hashimoto N

Journal of clinical medicine research 13 ( 12 ) 541 - 548 2021.12

ISSN  1918-3003

• Access to Document (DOI)

Comprehensive and long-term surveys of COVID-19 sequelae in Japan, an ambidirectional multicentre cohort study: study protocol.

Nakagawara K, Namkoong H, Terai H, Masaki K, Tanosaki T, Shimamoto K, Lee H, Tanaka H, Okamori S, Kabata H, Chubachi S, Ikemura S, Kamata H, Yasuda H, Kawada I, Ishii M, Ishibashi Y, Harada S, Fujita T, Ito D, Bun S, Tabuchi H, Kanzaki S, Shimizu E, Fukuda K, Yamagami J, Kobayashi K, Hirano T, Inoue T, Kagyo J, Shiomi T, Ohgino K, Sayama K, Otsuka K, Miyao N, Odani T, Oyamada Y, Masuzawa K, Nakayama S, Suzuki Y, Baba R, Nakachi I, Kuwahara N, Ishiguro T, Mashimo S, Minematsu N, Ueda S, Manabe T, Funatsu Y, Koh H, Yoshiyama T, Saito F, Ishioka K, Takahashi S, Nakamura M, Goto A, Harada N, Kusaka Y, Nakano Y, Nishio K, Tateno H, Edahiro R, Takeda Y, Kumanogoh A, Kodama N, Okamoto M, Umeda A, Hagimura K, Sato T, Miyazaki N, Takemura R, Sato Y, Takebayashi T, Nakahara J, Mimura M, Ogawa K, Shimmura S, Negishi K, Tsubota K, Amagai M, Goto R, Ibuka Y, Hasegawa N, Kitagawa Y, Kanai T, Fukunaga K

BMJ open respiratory research 8 ( 1 )  2021.11

• Access to Document (DOI)

ALSに対するロピニロール塩酸塩に関するランダム化臨床試験の結果(ROPALS)(Results Of A Randomized Clinical Trial of Ropinirole Hydrochloride For ALS(ROPALS))

高橋 愼一, 森本 悟, 伊東 大介, 伊達 悠岳, 岡田 健佑, Chai Muh Chyi, 西山 亜由美, 鈴木 直輝, 平井 美和, 加部 泰明, 末松 誠, 陣崎 雅弘, 青木 正志, 佐藤 泰憲, 中原 仁, 鈴木 則宏, 岡野 栄之

脳循環代謝 ((一社)日本脳循環代謝学会)  33 ( 1 ) 129 - 129 2021.11

ISSN  0915-9401

Effectiveness of mindfulness-based cognitive therapy follow-up programs for pharmacotherapy refractory anxiety disorders: a study protocol for a randomized controlled feasibility trial.

Sado M, Ninomiya A, Nagaoka M, Koreki A, Goto N, Sasaki Y, Takamori C, Kosugi T, Yamada M, Park S, Sato Y, Fujisawa D, Nakagawa A, Mimura M

JMIR research protocols  2021.10

• Access to Document (DOI)

Japanese project for telepsychiatry evaluation during COVID-19: Treatment comparison trial (J-PROTECT): Rationale, design, and methodology.

Kishimoto T, Kinoshita S, Bun S, Sato Y, Kitazawa M, Kikuchi T, Sado M, Takamiya A, Mimura M, Nakamae T, Abe Y, Kanazawa T, Kawabata Y, Tomita H, Abe K, Hishimoto A, Asami T, Suda A, Watanabe Y, Amagai T, Sakuma K, Kida H, Funayama M, Kimura H, Sato A, Fujiwara S, Nagao K, Sugiyama N, Takamiya M, Kodama H, Azekawa T, J-PROTECT Collaborators.

Contemporary clinical trials    106596 2021.10

ISSN  1551-7144

• Access to Document (DOI)

SRS Results for Lung Cancer Patients: A Retrospective Comparison of 10-19 vs ≧20 Brain Metastases(和訳中)

山本 昌昭, 芹澤 徹, 佐藤 泰憲

肺癌 ((NPO)日本肺癌学会)  61 ( 6 ) 569 - 569 2021.10

ISSN  0386-9628

iPS細胞創薬に基づいた筋萎縮性側索硬化症(ALS)に対するロピニロール塩酸塩の医師主導治験(ROPALS試験)

森本 悟, 高橋 愼一, 伊東 大介, 伊達 悠岳, 岡田 健佑, Chai Muh Chyi, 西山 亜由美, 鈴木 直輝, 平井 美和, 加部 泰明, 末松 誠, 陣崎 雅弘, 青木 正志, 佐藤 泰憲, 中原 仁, 鈴木 則宏, 岡野 栄之

神経治療学 ((一社)日本神経治療学会)  38 ( 6 ) S261 - S261 2021.10

ISSN  0916-8443

Longitudinal Assessment of Prognostic Understanding in Advanced Lung Cancer Patients and Its Association with Their Psychological Distress.

Arai D, Sato T, Nakachi I, Fujisawa D, Takeuchi M, Sato Y, Kawada I, Yasuda H, Ikemura S, Terai H, Nukaga S, Inoue T, Nakamura M, Oyamada Y, Terashima T, Sayama K, Saito F, Sakamaki F, Naoki K, Fukunaga K, Soejima K

The oncologist  2021.09

ISSN  1083-7159

• Access to Document (DOI)

Best pre-ductal PaO₂ prior to extracorporeal membrane oxygenation as predictor of mortality in patients with congenital diaphragmatic hernia: a retrospective analysis of a Japanese database.

Terui K, Furukawa T, Nagata K, Hayakawa M, Okuyama H, Amari S, Yokoi A, Masumoto K, Yamoto M, Okazaki T, Inamura N, Toyoshima K, Uchida K, Okawada M, Sato Y, Usui N

Pediatric surgery international  2021.09

ISSN  0179-0358

• Access to Document (DOI)

Cost-effectiveness analyses of augmented cognitive behavioral therapy for pharmacotherapy-resistant depression at secondary mental health care settings.

Sado M, Koreki A, Ninomiya A, Kurata C, Mitsuda D, Sato Y, Kikuchi T, Fujisawa D, Ono Y, Mimura M, Nakagawa A

Psychiatry and clinical neurosciences  2021.08

ISSN  1323-1316

• Access to Document (DOI)

Transplantation of iPSC-derived corneal endothelial substitutes in a monkey corneal edema model.

Hatou S, Sayano T, Higa K, Inagaki E, Okano Y, Sato Y, Okano H, Tsubota K, Shimmura S

Stem cell research 55   102497 2021.08

ISSN  1873-5061

• Access to Document (DOI)

The Influence of Tofogliflozin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus.

Katakami N, Mita T, Yoshii H, Shiraiwa T, Yasuda T, Okada Y, Torimoto K, Umayahara Y, Kaneto H, Osonoi T, Yamamoto T, Kuribayashi N, Maeda K, Yokoyama H, Kosugi K, Ohtoshi K, Hayashi I, Sumitani S, Tsugawa M, Ryomoto K, Taki H, Nakamura T, Kawashima S, Sato Y, Watada H, Shimomura I, UTOPIA study investigators.

Diabetes therapy : research, treatment and education of diabetes and related disorders  2021.08

ISSN  1869-6953

• Access to Document (DOI)