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Journal of Pediatric Psychology, Vol. 27, No. 3, 2002, pp. 303-307
© 2002 Society of Pediatric Psychology

Brief Report: Assessment of Children's Gastrointestinal Symptoms for Clinical Trials

Lynn S. Walker, PhD1 and Susan C. Sorrells, PharmD2

1 Vanderbilt University School of Medicine, 2 GlaxoSmithKline, Inc.

All correspondence should be sent to Lynn S. Walker, Department of Pediatrics, Division of Adolescent Medicine and Behavioral Science, 436 Medical Center South, Vanderbilt University School of Medicine, Nashville, TN 37232. E-mail: Lynn.Walker{at}mcmail.vanderbilt.edu .

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.

Key words: clinical trials; irritable bowel syndrome; electronic diary; quality of life; children.


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