P151 Assessing comprehensive remission for Ulcerative Colitis in clinical practice: International consensus recommendations

Abstract

Background Real-world treatment of ulcerative colitis (UC) requires a patient-centric, holistic definition of ‘comprehensive remission' that goes beyond standard regulatory definitions. In an international initiative, we reviewed aspects of UC that affect patients and attempted to achieve consensus on which aspects should be considered in a definition of ‘comprehensive remission’, using a modified Delphi process. This initiative summarized expert consensus recommendations on aspects of UC that are important to patients and that affect their lives, how to measure and score these aspects, and objective markers of mucosal inflammation that are relevant to evaluate in remission, such as endoscopic and histological activity and inflammatory biomarkers. Methods The Delphi consensus panel comprised 10 physicians with expertise in UC and one patient advocate, and two additional physicians chaired the process. To inform the Delphi statements, we asked 18 patients about their experiences of living with UC in remission, asked panel members about their experience of treating patients and systematically reviewed associations between outcome measures in UC. Panel members voted on a 6-point Likert scale in three rounds of anonymous voting, the final round of which was preceded by a live discussion. Consensus was met if ≥ 67% of the panel agreed with the statement (4–6 on the 6-point Likert scale). Statements not meeting consensus in voting rounds 1 and 2 were revised and any not meeting consensus by the end of voting round 3 were discarded (Figure 1). Results The panel agreed that a definition of comprehensive remission should include aspects of UC that are currently measured in clinical trials (blood in stools, stool frequency, disease-related quality of life [QoL], endoscopic remission, histological inflammatory activity, inflammatory biomarkers and discontinuation of corticosteroids), but also additional patient-reported symptoms should be added. These were bowel urgency, abdominal pain, extra-intestinal manifestations, fatigue and sleep disturbance (Table 1). Suggestions for how the severity could be measured and thresholds for remission were agreed for each aspect, with the exception of extra-intestinal manifestations. Disease activity evaluated using ultrasound was voted as important to consider but was not recommended to be included in a measure of comprehensive remission at this stage. Conclusion We used a robust methodology to reach agreement and provide recommendations on the aspects of UC that can be used to define comprehensive remission and assessed in clinical practice. We plan to develop this as a combined measure which may also have applicability in clinical trials.

Proportion of inflammatory bowel diseases patients with suboptimal disease control in daily clinical practice—Real‐world evidence from the inflammatory bowel diseases‐podcast study

“…EIMs, fistulizing disease in CD), it is equally important to consider the disease impact on a patient's overall well‐being and improving the QoL should also be a primary goal. This is reinforced in the STRIDE‐II recommendations but also through other more recent consensus recommendations defining the term ‘comprehensive DC’ for daily clinical practice 25 . Comprehensive DC captures the patient‐centric aspects of UC not typically captured in clinical trials but encompasses multiple aspects of disease remission.…”

Editorial: Time to address quality of life in our IBD treatment—IBD nurse intervention as a key part of multimodal IBD management

“…This has led to the request for inclusion of patient-reported outcomes including QoL related outcomes by regulatory agencies and policymakers. 4,5 As caretakers of IBD patients, we simply must deal with QoL aspects of IBD to meet the treatment requirements of today.…”

“…Consequently, nursing-based methods to target QoL items have been developed. 3,5 However, the evidence for the effectiveness of advanced IBD nurse intervention has been relatively low as described in the most recent N-ECCO Consensus Statement in 2018. 3 Fortunately, this paper in APT by Bernd Bokemeyer and colleagues is a vast leap forward in evidence for advanced IBD nurse intervention; in this randomised, controlled open label multicentre trial, the effect of IBD nurse intervention on the disease-specific QoL sIBDQ is investigated.…”

“…As caretakers of IBD patients, we simply must deal with QoL aspects of IBD to meet the treatment requirements of today. Consequently, nursing‐based methods to target QoL items have been developed 3,5 . However, the evidence for the effectiveness of advanced IBD nurse intervention has been relatively low as described in the most recent N‐ECCO Consensus Statement in 2018 3 .…”

“…Many of these serious impairments of QoL persist even when patients are in remission and have been poorly addressed by study designs used by the industry in IBD drug development. This has led to the request for inclusion of patient‐reported outcomes including QoL related outcomes by regulatory agencies and policymakers 4,5 …”