A Core Outcome Set for inflammatory bowel diseases: development and recommendations for implementation in clinical practice through an international multi-stakeholder consensus process.

BACKGROUND AND AIMS: Standardising health outcome measurements supports delivery of care, enables data-driven learning systems, and secondary data use for research. As part of the Health Outcomes Observatory initiative and building on existing knowledge, a core outcome set (COS) for inflammatory bowel diseases (IBD) was defined through an international modified Delphi method. METHODS: Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set. RESULTS: In total, 136 stakeholders (45 IBD patients (advocates), 74 healthcare professionals/researchers, 13 industry representatives and 4 regulators), from 20 different countries participated. The final set includes 18 case-mix variables, 3 biomarkers (haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation) for completeness and 28 outcomes (including 16 patient-reported outcomes (PROs) and 1 patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form to collect generic PROs annually. CONCLUSIONS: A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.

Health-related quality of life, work productivity and costs related to patients with inflammatory bowel disease in Austria.

OBJECTIVE: Inflammatory-Bowel-Disease (IBD) is a lifelong illness with significant impact on health-related quality of life (HRQoL). The disease-burden causes work productivity impairment, such as sick-leave and restriction of leisure time activities. From a societal perspective, productivity loss often contributes significantly to the total costs. The aim of the study is to analyze the impact of disease-burden on work productivity, daily activities, and HRQoL. METHODS: We performed a survey among Austrian patients with IBD to assess general questions about demography and disease pattern, impaired work productivity and reduced daily activities using the Work Productivity and Activity Impairment questionnaire and HRQoL utilizing the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Associations were assessed employing linear regressions. The questionnaire was circulated by the Austrian Crohn's Disease/Ulcerative Colitis Association. RESULTS: In total, 510 patients with median age of 40 years completed the questionnaire. Patients had a median disease-duration of 9 years, 46% were treated with biologics and 64% were employed. The median SIBDQ score was 45 (16-69). Patients in self-assessed remission (n = 319) and relapse (n = 96) differed by 18 points on the SIBDQ score (p value < 0.0001). Mean work productivity reduction amounted to 7 h 17 min (95% CI 6:05-8:29) during the last 7 days. Work absenteeism accounted for 4 h 28 min (95% CI 3:25-5:31) and reduced productivity at the workplace (presenteeism) for 2 h 49 min (95% CI 2:31-3:07). During a relapse, 12 h 9 min were lost (p value < 0.0001). Productivity reduction correlated with HRQoL (r = 0.3964). In total, 143 €per patient per week (95% CI 119-167) were lost (7,411 €per year). On average, patients lost 4 h (95% CI 3:44-4:16) of unpaid daily activities; 3 h 17 min the employed subgroup and 5 h 19 min the not employed. CONCLUSION: IBD leads to a substantial burden of disease, which is associated with indirect costs for society related to work ability reduction. HRQoL significantly influences loss of work productivity. Improving HRQoL should be a key factor to reduce disease burden and societal costs.

Quality of Care Standards in Inflammatory Bowel Diseases: a European Crohn's and Colitis Organisation [ECCO] Position Paper.

The management of inflammatory bowel disease [IBD] is complex, and requires tight control of disease activity, close monitoring to avoid treatment side effects, health care professionals with expertise in IBD, and an interdisciplinary, holistic approach. Despite various efforts to standardise structures, processes, and outcomes,1-8 and due to the high variability at the local, national, and international levels, there are still no clear definitions or outcome measures available to establish quality of care standards for IBD patients which are applicable in all contexts and all countries. For this reason, the European Crohn's and Colitis Organisation [ECCO] supported the construction of a list of criteria summarising current standards of care in IBD. The list comprises 111 quality standard points grouped into three main domains [structure n = 31, process n = 42, outcomes n = 38] and is based on scientific evidence, interdisciplinary expert consensus, and patient-oriented perspectives. The list of proposed criteria is intended to represent the position of ECCO regarding the optimum quality of care that should be available to patients. Since health care systems and regulations vary considerably between countries, this list may require adaptation at local and national levels. It is recognised that not all these criteria that have been identified as optimal will be available in every unit. However, ECCO will continue its efforts to develop and coordinate projects and initiatives that will help to guarantee optimal quality of care for all IBD patients.