2026-04-17T08:19:50Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/121272025-10-24T10:18:23Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Fierens, Liselotte
author
Carney, Nicholas
author
Novacek, Gottfried
author
van der Woude, C Janneke
author
Siegmund, Britta
author
Casellas, Francesc
author
BORRUEL, NATALIA
2025-10-24T10:18:23Z
2025-10-24T10:18:23Z
2024-10-25T09:20:53Z2024-10-25T09:20:53Z2024-10
http://hdl.handle.net/11351/12127
Quality of life; Socioeconomical and psychological end pointsQualitat de vida; Aspectes socioeconòmics i psicològicsCalidad de vida; Aspectos socioeconómicos y psicológicosBackground and Aims
Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] 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 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three 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 one 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.This work was supported by the Innovative Medicines Initiative [IMI] 2 Joint Undertaking [945345-2]. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme, the European Federation of Pharmaceutical Industries and Associations [EFPIA], Trial Nation and the Juvenile Diabetes Research Foundation [JDRF]. The public grant funding is matched with in-kind contributions of EFPIA partners. About IMI: the Innovative Medicines Initiative is a partnership between the European Union and the European pharmaceutical industry, represented by EFPIA. It is working to improve health by speeding up the next generation of medicines, particularly in areas with unmet medical or social needs. It works by facilitating collaboration between the key players involved in health research, including universities, research centres, pharmaceutical and other industries, small and medium-sized enterprises [SMEs], patient organisations, and medicines regulators. IMI is the world’s most extensive public-private partnership [PPP] in the life sciences. This manuscript reflects only the authors’ views. The European Union and IMI are not responsible for any use that may be made of the information it contains.
Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
Intestins - Inflamació - Tractament
Gastroenteritis - Tractament
Avaluació de resultats (Assistència sanitària)
Decisió de grup
PSYCHIATRY AND PSYCHOLOGY::Behavior and Behavior Mechanisms::Psychology, Social::Group Processes::Consensus
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases
Other subheadings::Other subheadings::/therapy
HEALTH CARE::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires::Health Care Surveys::Patient Reported Outcome Measures
PSIQUIATRÍA Y PSICOLOGÍA::conducta y mecanismos de la conducta::psicología social::procesos de grupo::consenso
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal
Otros calificadores::Otros calificadores::/terapia
ATENCIÓN DE SALUD::administración de los servicios de salud::calidad de la atención sanitaria::evaluación de resultados y procesos (atención a la salud)::evaluación del desenlace (asistencia sanitaria)
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios::encuestas sobre atención a la salud::medidas de resultados percibidos por los pacientes
A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical Practice Through an International Multi-stakeholder Consensus Process
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion