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Published on: April 14, 2016
Methodological challenges to treatment trials for recurrent abdominal pain in children
1Department of Pediatrics and Steele Memorial Children's Research Center and Program in Integrative Medicine, University of Arizona Health Sciences Center, Tucson, AZ 85724-5073, USA. tball@u.arizona.edu
Insights
Parent and child pain reports align well in younger children but less so in adolescents. Functional gastrointestinal disorder subtypes may influence treatment outcomes in recurrent abdominal pain studies.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Methodology
- Child Psychology
Background:
- Standardizing study methods for recurrent abdominal pain (RAP) in children is challenging due to varied approaches.
- Expert panel recommendations for childhood RAP lack sufficient evidence and testing.
Purpose of the Study:
- To collect baseline data for a pilot study and randomized controlled trial on childhood RAP.
- To investigate agreement in pain reporting between children and parents.
- To identify factors influencing RAP in children.
Main Methods:
- Collected baseline data on pain frequency, intensity, missed activities, and psychological factors.
- Assessed child and parent reports of abdominal pain.
- Examined referral source (gastroenterologist vs. general pediatrician).
Main Results:
- Good agreement between child and parent pain reports for children under 13 (kappa=0.77).
- Marginal agreement for adolescents 13 and older (kappa=0.37).
- No significant differences in pain or psychological factors based on referral source.
- Parents reported less frequent pain and fewer missed activities for children with nonspecific functional abdominal pain compared to IBS or functional dyspepsia.
Conclusions:
- Subtype of functional gastrointestinal disorder is a crucial baseline characteristic for future RAP studies.
- Future interventional studies should prioritize child-reported outcomes for pain and missed activities.
- Proposed outcome measures for improvement and healing in childhood RAP studies.
Background:
Studies evaluating the efficacy of treatments for recurrent abdominal pain (RAP) in children have used a wide range of methods, causing difficulty in the comparison of results. An expert panel on functional gastrointestinal disorders recently made recommendations regarding the standardization of study methods for childhood RAP, but many of their recommendations remain untested or lack supportive evidence.
Methods:
During completion of a pilot study and randomized controlled trial for childhood RAP, baseline data were collected regarding the child and parent reports of abdominal pain frequency and intensity, type of abdominal pain, missed activities due to abdominal pain, psychological factors for the parent and child, parenting styles, and referral source (pediatric gastroenterologist vs general pediatrician).
Results:
Children and parent pain reports showed good agreement in children younger than 13 years (weighted kappa, 0.77; 95% confidence interval [CI], 0.71-0.84), but only marginal agreement in children 13 years or older (weighted kappa, 0.37; 95% CI, 0.30-0.45). We found no significant differences in pain characteristics or psychological factors between children referred by pediatric gastroenterologists in a tertiary care center and those referred by community-based primary care pediatricians. However, children with symptoms consistent with nonspecific functional abdominal pain were reported by their parents to have less frequent pain (P=.003) and fewer missed activities (P=.003) than children with symptoms of irritable bowel syndrome or functional dyspepsia.
Conclusions:
Subjects referred by gastroenterologists and general pediatricians were similar, but the subtype of functional gastrointestinal disorder might be an important baseline characteristic of subjects in future RAP studies. We suggest that future interventional studies of childhood RAP measure 2 outcomes with pain reports obtained directly from children. Any child with fewer days of pain and missed activities due to pain after therapy would be considered improved, and those with no missed activities and 4 or fewer days of pain per month at follow-up would be considered healed.
