Brief report: Assessment of children's gastrointestinal symptoms for clinical trials

Abstract

Objective: To conduct a pilot study evaluating a procedure for assessment of daily symptoms and functioning in pediatric patients. Method: Participants included 11 parent-child dyads referred to a tertiary care center for evaluation of constipation and abdominal pain. Each family was provided a hand-held computer and modem. For 7 consecutive days, parents and children (ages 6-10 years) responded as a team to questions regarding the level of children's gastrointestinal symptoms and the extent to which symptoms interfered with the day's activities. Parents responded to a telephone interview evaluating the procedure. Results: Parents reported that children understood most questions and that responses entered into the computer were accurate. Parents and children were enthusiastic about the data collection method. Some technical problems arose in use of the computers. Conclusions: Within the limitations of a small sample, this data collection procedure appears to have promise for evaluating pediatric symptom outcomes.