Original articleEffective monitoring of isotretinoin safety in a pediatric dermatology population: A novel “patient symptom survey” approach
Section snippets
Methods
A retrospective chart review was conducted on a random sample of patients, who were prescribed isotretinoin at the pediatric dermatology clinic between February 2003 and August 2007. The study was approved by the institutional review board of Rady Children's Hospital/University of California, San Diego (protocol #070858).
The ISS (Fig 1) was designed to assess the presence or absence of 13 possible adverse effects: dry lips, dry/bloodshot eyes, dry skin, muscle aches/pains, nosebleeds, frequent
Results
The sample size was 102 individual patients, with 123 courses of isotretinoin. There were 760 patient-months of collected data. Of the 123 documented courses of isotretinoin, 73 (59.3%) patients were male and 50 (40.7%) were female. The age range was 11 to 21 years, with an average age of 15.26 years and SD of 1.62. There were 722 (95.0%) complete symptom surveys, 30 (3.95%) with incomplete data entry, and only 8 (1.05%) unsubmitted surveys (Table I).
The incidence of symptoms is demonstrated in
Discussion
We found that the ISS was used in 98.95% of isotretinoin visits and 95.0% of these surveys recorded a complete data set. We included both complete and incomplete surveys, because we believed that responses should not be invalidated simply because the patient failed to circle a response to one question on the survey. Calculations reflect only the reported data, without modification for answers omitted by the patient.
The ISS presents individualized patient-reported information, providing a
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Supported in part by a grant from the National Institutes of Health.
Conflicts of interest: None declared.