We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Baseline Data and Measurement Instruments Reported in Observational Studies in Inflammatory Bowel Disease: Results from a Systematic Review.
- Authors
Wong, Charlotte; Oostrom, Joep van; Pittet, Valerie; Bossuyt, Peter; Hanzel, Jurij; Samaan, Mark; Tripathi, Monika; Czuber-Dochan, Wladyslawa; Burisch, Johan; Leone, Salvatore; Saldaña, Roberto; Baert, Filip; Kopylov, Uri; Jaghult, Susanna; Adamina, Michel; Gecse, Krisztina; Arebi, Naila
- Abstract
Background Heterogeneity in demographic and outcomes data with corresponding measurement instruments [MIs] creates barriers to data pooling and analysis. Several core outcome sets have been developed in inflammatory bowel disease [IBD] to homogenize outcomes data. A parallel Minimum Data Set [MDS] for baseline characteristics is lacking. We conducted a systematic review to develop the first MDS. Methods A systematic review was made of observational studies from three databases [2000–2021]. Titles and abstracts were screened, full-text articles were reviewed, and data were extracted by two reviewers. Baseline data were grouped into ten domains: demographics, clinical features, disease behaviour/complications, biomarkers, endoscopy, histology, radiology, healthcare utilization and patient-reported data. Frequency of baseline data and MIs within respective domains are reported. Results From 315 included studies [600 552 subjects], most originated from Europe [196; 62%] and North America [59; 19%], and were published between 2011 and 2021 [251; 80%]. The most frequent domains were demographics [311; 98.7%] and clinical [289; 91.7%]; 224 [71.1%] studies reported on the triad of sex [306; 97.1%], age [289; 91.7%], and disease phenotype [231; 73.3%]. Few included baseline data for radiology [19; 6%], healthcare utilization [19; 6%], and histology [17; 5.4%]. Ethnicity [19; 6%], race [17; 5.4%], and alcohol/drug consumption [6; 1.9%] were the least reported demographics. From 25 MIs for clinical disease activity, the Harvey–Bradshaw Index [ n = 53] and Mayo score [ n = 37] were most frequently used. Conclusions Substantial variability exists in baseline population data reporting. These findings will inform a future consensus for MDS in IBD to enhance data harmonization and credibility of real-world evidence.
- Publication
Journal of Crohn's & Colitis, 2024, Vol 18, Issue 6, p875
- ISSN
1873-9946
- Publication type
Article
- DOI
10.1093/ecco-jcc/jjae004