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ドイハラ ヒロヨシ
Hiroyoshi Doihara
土井原 博義 所属 川崎医科大学 医学部 臨床医学 総合外科学 職種 特任教授 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study. |
| 掲載誌名 | 正式名：BMJ open 略 称：BMJ Open ISSNコード：20446055/20446055 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 11(2),pp.e042099 |
| 著者・共著者 | Saiga Miho, Hosoya Yuko, Utsunomiya Hiroki, Kuramoto Yukiko, Watanabe Satoko, Tomita Koichi, Aihara Yukiko, Muto Mayu, Hikosaka Makoto, Kawaguchi Takashi, Miyaji Tempei, Yamaguchi Takuhiro, Zenda Sadamoto, Goto Aya, Sakuraba Minoru, Kusano Taro, Miyabe Kenta, Kuroki Tomoaki, Yano Tomoyuki, Taminato Mifue, Sekido Mitsuru, Tsunoda Yui, Satake Toshihiko, Doihara Hiroyoshi, Kimata Yoshihiro |
| 発行年月 | 2021/02 |
| 概要 | INTRODUCTION:The aim of breast reconstruction (BR) is to improve patients' health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient's life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate breast reconstruction (IBR).METHODS AND ANALYSIS:This ongoing prospective, observational multicentre study will assess 406 patients who had unilateral breast cancer and underwent mastectomy and IBR, and were recruited from April 2018 to July 2019. All participants were recruited from seven hospitals: Okayama University Hospital, Iwate Medical University Hospital, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Showa University Hospital, University of Tsukuba Hospital, Osaka University Hospital and Yokohama City University Medical Center. The patients will be followed up for 36 months postoperatively. The primary endpoint of this study will be the time-dependent changes in BREAST-Q satisfaction with breast subscale scores for 12 months after reconstructive surgery, which will be collected via an electronic PRO system.ETHICS AND DISSEMINATION:This study will be performed in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare, the modified Act on the Protection of Personal Information and the Declaration of Helsinki. This study protocol was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, on 2 February 2018 (1801-039) and all other participating sites. The findings of this trial will be submitted to an international peer-reviewed journal.TRIAL |
| DOI | 10.1136/bmjopen-2020-042099 |
| PMID | 33589456 |