Ulcerative colitis outcomes research in Japan: protocol for an observational prospective cohort study of YOURS (YOu and Ulcerative colitis: Registry and Social network).
Hajime YamazakiKatsuyoshi MatsuokaJovelle FernandezToshifumi HibiMamoru WatanabeTadakazu HisamatsuShunichi FukuharaPublished in: BMJ open (2019)
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.
Keyphrases
- end stage renal disease
- newly diagnosed
- ejection fraction
- chronic kidney disease
- mental health
- healthcare
- depressive symptoms
- social support
- prognostic factors
- physical activity
- peritoneal dialysis
- public health
- cardiovascular disease
- ulcerative colitis
- adipose tissue
- type diabetes
- randomized controlled trial
- weight loss
- skeletal muscle
- patient reported outcomes
- machine learning
- sleep quality
- deep learning
- resistance training
- quality improvement
- phase ii
- double blind