The following is a summary of “Baseline Data and Measurement Instruments Reported in Observational Studies in Inflammatory Bowel Disease: Results from a Systematic Review,” published in the January 2024 issue of Gastroenterology by Wong et al.
Researchers conducted a retrospective study to address the lack of a standardized Minimum Data Set (MDS) for baseline characteristics in inflammatory bowel disease (IBD) research, aiming to overcome barriers to data pooling and analysis caused by heterogeneity in demographics, outcomes, and corresponding measurement instruments (MIs).
They conducted a systematic review spanning three databases [2000–2021]. Two reviewers screened titles and abstracts, reviewed full-text articles, and extracted data. Ten domains categorize baseline data, encompassing demographics, clinical features, disease behavior, biomarkers, endoscopy, histology, radiology, healthcare utilization, and patient-reported data. The report outlines baseline data and MI frequencies.
The results showed 315 studies with 600,552 subjects. The majority were from Europe [196; 62%] and North America [59; 19%], with publication years falling between 2011 and 2021 [251; 80%]. Dominant domains comprised demographics [311; 98.7%] and clinical aspects [289; 91.7%]. Notably, 224 studies [71.1%] addressed the triad of sex [306; 97.1%], age [289; 91.7%], and disease phenotype [231; 73.3%]. Radiology [19; 6%], healthcare utilization [19; 6%], and histology [17; 5.4%] were less frequently covered in baseline data. Reporting was sparse for ethnicity [19; 6%], race [17; 5.4%], and alcohol/drug consumption [6; 1.9%]. Out of 25 MIs for clinical disease activity, the Harvey–Bradshaw Index [n = 53] and Mayo score [n = 37] were most commonly used.
Investigators concluded an IBD study review with wide variation in baseline data, informing future efforts for a standardized set to boost data harmony and real-world evidence strength.