Baseline Data and Measurement Instruments Reported In Observational Studies In Inflammatory Bowel Disease: Results From A Systematic Review

Charlotte Wong; Joep van Oostrom; Valerie Pittet; Peter Bossuyt; 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

doi:10.1093/ecco-jcc/jjae004

Baseline Data and Measurement Instruments Reported In Observational Studies In Inflammatory Bowel Disease: Results From A Systematic Review

J Crohns Colitis. 2024 Jan 12:jjae004. doi: 10.1093/ecco-jcc/jjae004. Online ahead of print.

Authors

Charlotte Wong^{1

2}, Joep van Oostrom³, Valerie Pittet⁴, Peter Bossuyt⁵, Jurij Hanzel⁶, Mark Samaan⁷, Monika Tripathi⁸, Wladyslawa Czuber-Dochan⁹, Johan Burisch^{10

11}, Salvatore Leone¹², Roberto Saldaña^{12

13}, Filip Baert¹⁴, Uri Kopylov¹⁵, Susanna Jaghult¹⁶, Michel Adamina^{17

18}, Krisztina Gecse³, Naila Arebi^{1

2}

Affiliations

¹ Department of Inflammatory Bowel Disease, St Mark's National Bowel Hospital, London, UK.
² Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.
³ Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
⁴ Center for Primary Care and Public Health-University of Lausanne, Department of Epidemiology and Health Systems, Lausanne, Switzerland.
⁵ Department of Gastroenterology, Imelda General Hospital and Imelda Clinical Research Centre, Bonheiden, Belgium.
⁶ Faculty of Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia.
⁷ Inflammatory Bowel Diseases Unit, Guy's and St Thomas' Hospital, London, UK.
⁸ Department of Histopathology, Cambridge Biomedical Campus, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁹ Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
¹⁰ Department of Gastroenterology, Medical Division, Hvidovre Hospital, University of Copenhagen, Denmark.
¹¹ Copenhagen Centre for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen, Denmark.
¹² European Federation of Crohn's and Colitis Associations (EFCCA), Brussels, Belgium.
¹³ Confederation of Patients with Crohn's Disease and Ulcerative Colitis, Madrid, Spain.
¹⁴ Department of Gastroenterology, AZ Delta, Roeselare, Belgium.
¹⁵ Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel, Israel.
¹⁶ Department of Clinical Sciences, Karolinska Institutet, Stockholm, Sweden.
¹⁷ Department of Surgery, Cantonal Hospital Winterthur, Zurich, Switzerland.
¹⁸ Faculty of Medicine, University of Basel, Basel, Switzerland.

PMID: 38214470
DOI: 10.1093/ecco-jcc/jjae004

Abstract

Background: Heterogeneity in demographic and outcomes data with corresponding measurement instruments (MI) creates barriers for data pooling and analysis. Several core outcome sets developed in inflammatory bowel disease (IBD) homogenise 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 of observational studies from 3 databases (2000 to 2021). Titles and abstracts were screened; full-text articles reviewed, and data extracted by two reviewers. Baseline data were grouped into 10 domains: demographics, clinical features, disease behaviour/complications, biomarkers, endoscopy, histology, radiology, healthcare utilisation and patient-reported data. Frequency of baseline data and MI 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 utilisation (19; 6%) and histology (17; 5.4%). Ethnicity (19; 6%), race (17; 5.4%) and alcohol/drug consumption (6; 1.9%) were least reported demographics. From 25 MI for clinical disease activity, 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 harmonisation and credibility of real-world evidence.

Keywords: Core Outcome Set; Inflammatory bowel disease; Measurement Instruments; Minimum Dataset; Real-World Evidence.