Background: Heterogeneity exists in reported outcomes and outcome measurement instruments [OMI] from observational studies. A core outcome set [COS] for observational and real-world evidence [RWE] in inflammatory bowel disease [IBD] will facilitate pooling large datasets. This systematic review describes and classifies clinical and patient-reported outcomes, for COS development.
Methods: The systematic review of MEDLINE, EMBASE, and CINAHL databases identified observational studies published between 2000 and 2021 using the population exposure outcome [PEO] framework. Studies meeting eligibility criteria were included. After titles
and abstracts screening, full-text articles were extracted by two independent reviewers. Primary and secondary outcomes with corresponding OMI were extracted and categorised in accordance with OMERACT Filter 2.1 framework. The frequency of outcomes and OMIs
are described.
Results: From 5854 studies, 315 were included: 129 [41%] Crohn’s disease [CD], 60 [19%] ulcerative colitis [UC], and 126 [40%] inflammatory bowel disease [IBD] studies with 600 552 participants. Totals of 1632 outcomes and 1929 OMI were extracted mainly from medical therapy [181; 72%], surgical [34; 11%], and endoscopic [6; 2%] studies. Clinical and medical therapy-related safety were frequent outcome domains recorded in 194 and 100 studies. Medical therapy-related adverse events [n = 74] and need for surgery [n = 71] were the commonest outcomes. The most frequently reported OMI were patient or event numbers [n = 914], Harvey-Bradshaw Index [n = 45], and Montreal classification
[n = 42].
Conclusions: There is substantial variability in outcomes reporting and OMI types. Categorised outcomes and OMI from this review will inform a Delphi consensus on a COS for future RWE in IBD. Data collection standardisation may enhance the quality of RWE applied to decision-making.
The primary objective is to describe and list IBD-related outcomes and outcome measurement instruments [OMI].
ContributorsCharlotte Wong, Joep van Oostrom, Peter Bossuyt, Valerie Pittet, Jurij Hanzel, Mark Samaan, Monika Tripathi, Wladyslawa Czuber-Dochan, Johan Burisch, Salvatore Leone, Roberto Saldaña, Filip Baert, Uri Kopylov, Susanna Jaghult, Michel Adamina, Krisztina Gecse, Naila Arebi
Disease Category: Gastroenterology
Disease Name: Inflammatory bowel disease (IBD)
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Systematic review of outcomes measured in trials
- Systematic review
An electronic systematic search was carried out on the Ovid SP version of MEDLINE, EMBASE, and CINAHL for studies published from January 1, 2000, to January 31, 2021. Key
search terms were combined using Boolean operators.