Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease—an International, Cross-disciplinary Consensus

Kim, Andrew; Roberts, Charlotte; Feagan, Brian G.; Banerjee, Rupa; Bemelman, Willem A.; Bodger, Keith; Derieppe, Marc; Dignaß, Axel; Driscoll, Richard; Fitzpatrick, Ray; Gaarentstroom-Lunt, Janette; Higgins, Peter; Kotze, Paulo Gustavo; Meissner, Jillian; O’Connor, Marian; Ran, Zhihua; Siegel, Corey A.; Terry, Helen; Deen, Welmoed K. van; Woude, C. Janneke van der; Weaver, Alandra; Yang, Suk‐Kyun; Sands, Bruce E.; Vermeire, Séverine; Travis, Simon

doi:10.1093/ecco-jcc/jjx161

Cited by 116 publications

(104 citation statements)

References 62 publications

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“…Instead patients with FC concentrations included in the intermediate grey area, which does not accurately predict the histologic state of disease should undergo colonoscopy with biopsies to resolve any doubts. The homogenisation of patient management with a standard of care is therefore increasingly necessary to guarantee the best results for patients . Recently it has been proposed to dose intramucosal FC (iMC) levels in order to overcome the variability related to FC measurement.…”

Section: Discussionmentioning

confidence: 99%

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Review article: faecal calprotectin and histologic remission in ulcerative colitis

D’Amico

Bonovas

Danese

et al. 2020

Aliment Pharmacol Ther

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Summary Background Histologic healing is emerging as a new therapeutic goal in both routine practice and clinical trials in ulcerative colitis (UC). However, it requires repeated endoscopies and biopsies. Faecal calprotectin is a non‐invasive marker of mucosal healing (endoscopic and histologic healing). Aim To conduct a systematic review to clarify the correlation between faecal calprotectin levels and histologic activity in UC patients. Methods We searched PubMed/MEDLINE, EMBASE and Web of Science through September 2019 to identify studies in patients with confirmed diagnosis of UC, reporting the correlation between faecal calprotectin levels and histologic analysis. Results Twelve studies enrolling 1168 patients were included in the final review. Histologic remission was defined according to nonvalidated scores in five articles and using partially validated scores in seven articles. Faecal calprotectin values were measured in 6 of 12 studies (50%) with the same kit, while the remaining six studies adopted individually different kits. A clear correlation between faecal calprotectin levels and histology was showed in all included studies. Eleven different faecal calprotectin cut‐off points were identified to distinguish histological remission from histological activity, ranging from 40.5 to 250 μg/g. Conclusions Faecal calprotectin can be used to predict histologic remission in patients with UC, but the cut‐off level varies across studies, according to the test used to measure this biomarker and according to the definition of histologic remission. Larger prospective studies using validated histologic indexes are needed to identify a globally accepted faecal calprotectin cut‐off level to discriminate between histologic remission and histologically active disease.

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Section: Discussionmentioning

confidence: 99%

“…However, as shown in Table 3 The homogenisation of patient management with a standard of care is therefore increasingly necessary to guarantee the best results for patients. 47 Recently it has been proposed to dose intramucosal FC (iMC) levels in order to overcome the variability related to FC measurement.…”

Section: Discussionmentioning

confidence: 99%

Review article: faecal calprotectin and histologic remission in ulcerative colitis

D’Amico

Bonovas

Danese

et al. 2020

Aliment Pharmacol Ther

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“…A modified Delphi approach that has been developed by ICHOM and was previously applied by ICHOM to develop standards for a number of other conditions was used. The process involved reaching consensus in 4 major decision areas: determination of which inflammatory arthritis conditions and treatments to include in the Standard Set, a minimally sufficient set of outcomes relevant for each of the conditions, standardized definitions and time points for assessing these outcomes, and standardized definitions for risk‐adjustment variables to ensure fair comparisons between health care providers who wish to implement the set.…”

Section: Methodsmentioning

confidence: 99%

International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group

Voshaar

Gupta²,

Bijlsma

et al. 2019

Arthritis Care & Research

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Objective The implementation of value‐based health care in inflammatory arthritis requires a standardized set of modifiable outcomes and risk‐adjustment variables that is feasible to implement worldwide. Methods The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary working group that consisted of 24 experts from 6 continents, including 6 patient representatives, to develop a standard set of outcomes for inflammatory arthritis. The process followed a structured approach, using a modified Delphi process to reach consensus on the following decision areas: conditions covered by the set, outcome domains, outcome measures, and risk‐adjustment variables. Consensus in areas 2 to 4 were supported by systematic literature reviews and consultation of experts. Results The ICHOM Inflammatory Arthritis Standard Set covers patients with rheumatoid arthritis (RA), axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis (JIA). We recommend that outcomes regarding pain, fatigue, activity limitations, overall physical and mental health impact, work/school/housework ability and productivity, disease activity, and serious adverse events be collected at least annually. Validated measures for patient‐reported outcomes were endorsed and linked to common reporting metrics. Age, sex at birth, education level, smoking status, comorbidities, time since diagnosis, and rheumatoid factor and anti‐citrullinated protein antibody lab testing for RA and JIA should be collected as risk‐adjustment variables. Conclusion We present the ICHOM inflammatory arthritis Standard Set of outcomes, which enables health care providers to implement the value‐based health care framework and compare outcomes that are important to patients with inflammatory arthritis.

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“…There is growing international interest in quality improvement and benchmarking of IBD care within individual health care systems and between countries . The UK IBD Audit has served as a model for a recent national programme in Australia .…”

Section: Introductionmentioning

confidence: 99%

Nationwide improvement in outcomes of emergency admission for ulcerative colitis in England, 2005‐2013

Shawihdi

Kallis

Dixon

et al. 2019

Aliment Pharmacol Ther

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Summary Background The UK IBD Audit Programme reported improved inpatient care processes for ulcerative colitis (UC) between 2005 and 2013. There are no independent data describing national or institutional trends in patient outcomes over this period. Aim To assess the association between the outcome of emergency admission for UC and year of treatment. Methods Retrospective analysis of hospital administrative data, focused on all emergency admissions to English public hospitals with a discharge diagnosis of UC. We extracted case mix factors (age, sex, co‐morbidity, emergency bed days in last year, deprivation status), outcomes of index admission (death and first surgery), 30‐day emergency readmissions (all‐cause, and selected causes) and outcome of readmission. Results There were 765 deaths and 3837 unplanned first operations in 44 882 emergency admissions, with 5311 emergency readmissions (with a further 171 deaths and 517 first operations). Case mix adjusted odds of death for any given year were 9% lower (OR 0.91, 95% CI: 0.89‐0.94), and that for emergency surgery 3% lower (OR 0.97, 95% CI: 0.95‐0.98) than the preceding year. Results were robust to sensitivity analysis (admissions lasting ≥4 days). There was no reduction in odds for all‐cause readmission, but rates for venous thromboembolism declined significantly. Analysis of institutional‐level metrics across 136 providers showed a stepwise reduction in outliers for mortality and unplanned surgery. Conclusions Risk of death and unplanned surgery for UC patients admitted as emergencies declined consistently, as did unexplained variation between hospitals. Risk of readmission was unchanged (over 1 in 10). Multiple factors are likely to explain these nationwide trends.

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Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease—an International, Cross-disciplinary Consensus

Abstract: A Standard Set of outcome measures for IBD has been developed based on evidence, patient input and specialist consensus. It provides an international template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.

Cited by 116 publications

References 62 publications

Review article: faecal calprotectin and histologic remission in ulcerative colitis

Review article: faecal calprotectin and histologic remission in ulcerative colitis

International Consortium for Health Outcome Measurement Set of Outcomes That Matter to People Living With Inflammatory Arthritis: Consensus From an International Working Group

Nationwide improvement in outcomes of emergency admission for ulcerative colitis in England, 2005‐2013

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