Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-030134 on 8 September 2019. Downloaded from Ulcerative colitis outcomes research in Japan: protocol for an observational prospective cohort study of YOURS (YOu and Ulcerative colitis: Registry and Social network) Hajime Yamazaki, 1 Katsuyoshi Matsuoka,2 Jovelle Fernandez,3 Toshifumi Hibi,4 Mamoru Watanabe,5,6 Tadakazu Hisamatsu,7 Shunichi Fukuhara1 To cite: Yamazaki H, ABSTRACT Strengths and limitations of this study Matsuoka K, Fernandez J, et al. Introduction Ulcerative colitis (UC) is a chronic Ulcerative colitis outcomes inflammatory disease that mainly affects the colon in research in Japan: protocol for ► The YOu and Ulcerative colitis: Registry and Social young patients. Typical symptoms of UC are bloody an observational prospective network (YOURS) study is a large-scale, long-term, cohort study of YOURS (YOu diarrhoea and faecal urgency, which disturb the quality prospective observational study to explore optimal and Ulcerative colitis: Registry of life (QOL) of patients, and intractable UC leads to ulcerative colitis management for improving rele- and Social network). BMJ Open hospitalisation and colectomy. To improve relevant vant outcomes. 2019;9:e030134. doi:10.1136/ outcomes such as symptoms, QOL and colectomy, many ► The YOURS study reflects the real clinical setting bmjopen-2019-030134 clinical questions need to be resolved regarding what because any concomitant drugs and therapies are ► Prepublication history for the ideal lifestyle, psychosocial burden and optimal allowed. this paper is available online. practice patterns are. In this YOu and Ulcerative colitis: ► The YOURS study can be expanded for subsequent To view these files, please visit Registry and Social network (YOURS) study, we will surveys because patients and healthcare profes- the journal online (http:// dx. doi. investigate the effect of lifestyle, psychosocial factors and sionals can ask research questions not otherwise org/ 10. 1136/ bmjopen- 2019- practice patterns on patient-reported outcomes (PRO), included in the survey. 030134). hospitalisation rate and colectomy rate in Japanese ► Patients will be able to access their own data and compare them with summarised data from all pa- Received 28 February 2019 patients with UC. http://bmjopen.bmj.com/ Revised 22 July 2019 Methods and analysis For this prospective cohort tients on the website beyond the YOURS study. Accepted 01 August 2019 study, we recruited 2006 patients from five hospitals ► All investigational sites are located within one region (Tokyo and Chiba; May 2018–January 2019). Patients will of Japan, which may affect the study results, espe- be able to access their own data and compare them with cially because of lifestyle and psychosocial factors. 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 INTRODUCTION work), psychosocial factors (stress, depression and social Ulcerative colitis (UC) is a chronic inflam- on September 28, 2021 by guest. Protected copyright. support) and PRO (symptoms and QOL). Information matory disease with no curative treatment. on practice patterns (eg, medications, endoscopy frequency) will be collected from electronic medical It mainly affects the colon and is associated with bloody diarrhoea and faecal urgency records. Gaps between patients’ needs and healthcare 1 professionals’ practice will be identified. Follow-up as typical symptoms. Aberrant immunity surveys will be conducted periodically for approximately in the gut is considered to be involved in 2 3 years. Research questions suggested by patients and the pathogenesis of UC; however, the aeti- healthcare professionals may be used in subsequent ology of UC is not fully understood. UC is © Author(s) (or their surveys. Results from the YOURS study will demonstrate increasing around the world, especially in employer(s)) 2019. Re-use optimal UC management strategies to improve relevant Asia, including Japan.3–5 The prevalence of permitted under CC BY-NC. No commercial re-use. See rights outcomes. UC has been reported to range from 5.3 to and permissions. Published by ETHICS AND DISSEMINatiON 63.6 per 100 000 people in Asia and from 37.5 BMJ. 1 The study was approved by the ethics committees of five to 238 per 100 000 people in North America, For numbered affiliations see investigational sites before starting the study. The results and differs between regions, with the preva- end of article. will be submitted to journals. lence in Japan reported as approximately 100 per 100 000 people in 2013.5 Correspondence to TRIAL REGistratiON NUMBER The onset of UC often has a major influ- Hajime Yamazaki; UMIN000031995. yamazaki- myz@ umin. ac. jp ence on patients’ quality of life (QOL), and Yamazaki H, et al. BMJ Open 2019;9:e030134. doi:10.1136/bmjopen-2019-030134 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-030134 on 8 September 2019. Downloaded from Figure 1 Factors and outcomes assessed in the YOURS study. All four factors can contribute to all four outcomes. HCP, healthcare professional; YOURS, YOu and Ulcerative colitis: Registry and Social network. intractable UC can lead to hospitalisation and colec- Optimal disease monitoring and treatment need to be tomy. Patients need to manage UC throughout their lives clarified. with both self-management and support from health- The last challenge is gaps between patients’ needs and care professionals (HCPs) to avoid unwanted clinical HCPs’ practice. A previous survey has identified important outcomes, including relapse/exacerbation, hospital- differences between patients and HCPs in their percep- isation, and colectomy, as well as to improve patient-re- tion of the impact of UC symptoms on patients’ lives, ported outcomes such as QOL. suggesting that HCPs may underestimate the effect of UC In this YOURS (YOu and Ulcerative colitis: Registry and symptoms on patients.12 However, the effect of percep- Social network) study, we identified four main factors/ tion gaps on patient outcomes is unknown. challenges to the improvement of patient outcomes: (1) The YOURS study is an observational prospective lifestyle, (2) psychosocial factors, (3) practice patterns cohort study in patients with UC in Japan that aims to and (4) gaps between patients’ needs and HCPs’ practice clarify how these four challenges affect relapse/exacer- (figure 1). bation, hospitalisation, colectomy and patient-reported First, there has been much discussion and debate about outcomes such as QOL. http://bmjopen.bmj.com/ the optimal lifestyle (diet, exercise, sleep and work) for UC management. In particular, diet is a critical issue for both patients and their HCPs. Although a large-scale METHODS AND ANALYSIS study has reported that the relationship between diet and Study design relapse is of major interest to patients with inflammatory The YOURS study is an observational prospective cohort 6 bowel disease (IBD) and their HCPs, only two explor- study with a 3-year follow-up being conducted at five 7 8 atory studies have examined the relationship. However, investigational sites in Japan. Patient registration started the results from these studies were not consistent. in May 2018 and ended in January 2019. As of 11 January on September 28, 2021 by guest. Protected copyright. Second, psychosocial factors including stress, depres- 2019, 2006 patients have been enrolled. sion and social support may affect clinical outcomes in The study is being conducted in compliance with the UC. Approximately half of patients with IBD have low Declaration of Helsinki, Ethical Guidelines for Medical 9 QOL and depression, and one-third of patients are Research on Humans, Ministry of Education, Culture, 10 reported to feel stigmatised. It remains unknown how Sports, Science and Technology of Japan and Ministry these psychosocial factors affect disease course. of Health, Labour and Welfare of Japan and all appli- The third challenge is practice patterns. The Selecting cable laws and guidelines. Written informed consent will Therapeutic Targets in Inflammatory Bowel Disease be obtained from all patients. The study is registered at programme, published in 2015 by IBD specialists, recom- the University hospital Medical Information Network mends setting concrete treatment goals as part of a (UMIN) Center. ‘Treat to Target’ strategy.11 The agreed treatment goals for UC were clinical remission (defined as resolution of Study population and sample size rectal bleeding and diarrhoea/altered bowel habit) and Patients diagnosed with UC, as defined by the ‘Evidence- endoscopic remission (based on endoscopic findings). based Clinical Practice Guidelines for Inflammatory However, achievement of these treatment goals may be Bowel Disease’,5 who are ≥16 years of age at informed accompanied by decreased QOL due to frequent colo- consent and are attending the investigational sites are noscopies or side effects caused by immune suppression. eligible for enrolment. 2 Yamazaki H, et al. BMJ Open 2019;9:e030134. doi:10.1136/bmjopen-2019-030134 Open access BMJ Open: first published as 10.1136/bmjopen-2019-030134 on 8 September 2019. Downloaded from The sample size was determined by considering the validated questionnaires for most measures of lifestyle, feasibility of enrolling patients. psychosocial factors and symptoms. At the initial survey, patients will complete written Outcome measures and survey items questionnaires with demographic,