Background: Value-based healthcare aims to achieve the best possible health outcomes for the lowest cost. Key to its success involves measuring outcomes that matter most to patients. Currently for inflammatory bowel disease (IBD), registries and clinical trials lack a unifying set of well-defined outcomes, making comparisons between populations difficult. Our goal was to develop a minimum Standard Set of patient-centered outcomes for IBD to provide a common language for outcomes that can be tracked systematically in a variety of healthcare settings.
Methods: An international, multidisciplinary working group (n=25) from 12 countries within Europe, North America, Asia, Australia, and South America representing patients, gastroenterologists, surgeons, specialist nurses, IBD registries, patient-reported outcome measure (PROM) methodologists, and patient organisations participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures, the best validated tools for measurement and baseline risk-adjustment variables.
Results: A minimum Standard Set of outcomes (Figure 1), preferred tools and measurement frequency was defined by the Working Group for patients (aged ≥16) with IBD. Outcome domains included patient reported outcomes (including quality of life, symptom score, nutritional status and impact of fistulae); survival and disease control (survival, disease activity/remission, colorectal cancer, and anaemia); disutility of care (treatment-related complications); and healthcare utilisation (IBD-related admissions and emergency room visits), all measured at baseline and 6 or 12 month intervals. A single, accessible PROM (IBD-Control questionnaire) was recommended. A core set of patients' baseline characteristics including demographics, baseline clinical and condition factors, and treatment factors were further defined for collection at baseline and tracking annually to enable meaningful comparisons of outcomes between centres, regions, or countries.
Conclusions: An international, multidisciplinary IBD Working Group that included patients has defined a minimum set of patient-centred outcomes, tools and PROMs for collection in patients with IBD based on evidence, patient input, and specialist consensus. The Standard Set provides a template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.