Interactive Inflammatory Bowel Disease Biologics Decision Aid Does Not Improve Patient Outcomes Over Static Education: Results From a Randomized Trial

Am J Gastroenterol. 2022 Sep 1;117(9):1508-1518.doi: 10.14309/ajg.0000000000001866. Epub 2022 Jun 10.


Christopher V Almario 1 2Welmoed K van Deen 3Michelle Chen 4Rebecca Gale 2Stéphanie Sidorkiewicz 5So Yung Choi 6Nirupama Bonthala 1 7Christina Ha 8Gaurav Syal 1 7Taylor Dupuy 2Xiaoyu Liu 2Gil Y Melmed 1 7Brennan M R Spiegel 1 2


Author information

1Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.

2Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California, USA.

3Erasmus School of Health Policy and Management, Division of Health Technology Assessment, Erasmus University Rotterdam, Rotterdam, the Netherlands.

4UC San Diego School of Medicine, La Jolla, California, USA.

5Department of General Practice, Université de Paris, Paris, France.

6Biostatistics and Bioinformatics Research Center, Cedars-Sinai Cancer, Los Angeles, California, USA.

7Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

8Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA.


Introduction: To support shared decision-making (SDM) between patients and providers surrounding biologic treatments, we created IBD&me ( ibdandme.org )-a freely available, unbranded, interactive decision aid. We performed a multicenter comparative effectiveness trial comparing the impact of IBD&me on SDM vs a biologics fact sheet developed by the Crohn's & Colitis Foundation.

Methods: We enrolled patients with inflammatory bowel disease (IBD) being seen at a clinic within IBD Qorus-a multicenter adult IBD learning health system-between March 5, 2019, and May 14, 2021. Eligible patients included those with recent IBD-related symptoms who reported that they wanted to discuss biologics with their provider during their upcoming visit. Patients were randomized 1:1 using stratified block randomization and received an e-mail 1 week before their visit inviting them to review either IBD&me or a fact sheet. The primary outcome was patient perception of SDM as measured by the 9-Item SDM Questionnaire (0-100 scale; higher = better); the Student t test was used to compare outcomes between arms.

Results: Overall, 152 patients were randomized (biologics fact sheet 75, IBD&me 77); most patients had Crohn's disease (66.4%) and were biologic-experienced (82.9%). No differences were seen between groups regarding SDM (fact sheet 72.6 ± 25.6, IBD&me 75.0 ± 20.8; P = .57). Most patients stated they would be likely to recommend the fact sheet (79.6%) or IBD&me (84.9%; P = .48) to another patient with IBD.

Discussion: No differences in outcomes were seen between IBD&me and the biologics fact sheet in this comparative effectiveness study; patients reported high satisfaction with both resources. Further study, particularly among biologic naïve patients, is needed to determine the utility of interactive components to IBD decision aids.


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