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Title: Ulcerative colitis outcomes research in Japan: protocol for an observational prospective cohort study of YOURS (YOu and Ulcerative colitis: Registry and Social network)
Authors: Yamazaki, Hajime  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0002-9034-4370 (unconfirmed)
Matsuoka, Katsuyoshi
Fernandez, Jovelle
Hibi, Toshifumi
Watanabe, Mamoru
Hisamatsu, Tadakazu
Fukuhara, Shunichi
Author's alias: 山崎, 大
福原, 俊一
Issue Date: Sep-2019
Publisher: BMJ
Journal title: BMJ open
Volume: 9
Issue: 9
Thesis number: e030134
Abstract: Introduction: Ulcerative colitis (UC) is a chronic inflammatory disease that mainly affects the colon in young patients. Typical symptoms of UC are bloody diarrhoea and faecal urgency, which disturb the quality of life (QOL) of patients, and intractable UC leads to hospitalisation and colectomy. To improve relevant outcomes such as symptoms, QOL and colectomy, many clinical questions need to be resolved regarding what the ideal lifestyle, psychosocial burden and optimal practice patterns are. In this YOu and Ulcerative colitis: Registry and Social network (YOURS) study, we will investigate the effect of lifestyle, psychosocial factors and practice patterns on patient-reported outcomes (PRO), hospitalisation rate and colectomy rate in Japanese patients with UC. Methods and analysis: For this prospective cohort study, we recruited 2006 patients from five hospitals (Tokyo and Chiba; May 2018–January 2019). Patients will be able to access their own data and compare them with summarised data from all patients on the website beyond the YOURS study. At baseline, patients will answer a questionnaire regarding lifestyle (diet, exercise, sleep and work), psychosocial factors (stress, depression and social support) and PRO (symptoms and QOL). Information on practice patterns (eg, medications, endoscopy frequency) will be collected from electronic medical records. Gaps between patients’ needs and healthcare professionals’ practice will be identified. Follow-up surveys will be conducted periodically for approximately 3 years. Research questions suggested by patients and healthcare professionals may be used in subsequent surveys. Results from the YOURS study will demonstrate optimal UC management strategies to improve relevant outcomes. The study was approved by the ethics committees of five investigational sites before starting the study. The results will be submitted to journals. UMIN000031995.
Rights: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
URI: http://hdl.handle.net/2433/245697
DOI(Published Version): 10.1136/bmjopen-2019-030134
PubMed ID: 31501121
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