Background: Recruitment for clinical research in paediatric inflammatory bowel disease (IBD) could be difficult. Patients' willingness to participate in clinical research is affected by several factors including research-related, patient-related and disease-related factors. Understanding the nature of barriers to recruitment for clinical studies is important for better planning of future research. Data on barriers for recruiting children with IBD to clinical studies are limited. The aim of this study was to examine possible barriers for clinical research in children with IBD from patients' perspective
Methods: In a cross-sectional single center paediatric study, children with IBD or their care givers when appropriate were surveyed via a questionnaire that addressed patients'/parents' willingness to participate in clinical studies and factors that may influence patients' willingness to participate. Univariate logistic regression analysis was used to examine any possible effect of factors such as disease nature, type of biological samples, and parental education on willingness to participate in clinical research.
Results: Out of 96 children with IBD (mean age 13.9+ 2.78 years, 53 boys, 49 Crohn's disease (CD)) who were consecutively recruited in the Pediatric IBD clinic, Winnipeg Children's Hospital, Winnipeg, Manitoba, 84 (87.5%) were “definitely or probably” willing to participate in clinical research while 12 (12.5%) were neutral or unwilling to participate (p<0.01). Factors associated with increased willingness to participate included providing research blood (OR=2.1, 95% CI 1.2–4.1, p=0.03) and urine (OR=2.04, 95% CI 1.03–4.1, p=0.04) samples but not stool samples (OR=1.3, 95% CI 0.73–2.47, p=0.3) or endoscopy (OR=1.45, 95% CI 0.83–2.56, p=0.19). Patients with CD were more willing to participate (OR=3.27, 95% CI 1.11–9.66, p=0.03). Parents' education, income, age at diagnosis, money incentive, disease activity and medications such as immunosuppressive or biological medications at the time of the survey did not have any significant effect on willingness to participate.
Conclusions: The majority of children with IBD are willing to participate in clinical research especially in studies that include blood and urine sample collection but not stool samples or endoscopy. Children with Crohn's disease are more likely to participate in research studies.