Preliminary Content Validation Steps for the Pediatric Oncology Patient Self-Report CTCAE
The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4) is the standard lexicon for grading adverse events (AEs) experienced by pediatric cancer patients in oncology trials. The current standard in clinical trials is that all AEs are graded and reported by clinicians. However, in recent years, an increasing interest has emerged from parents, clinicians, researchers and federal organizations to seek, when possible, the child's perspective on treatment experiences including adverse events. Pediatric oncology patients experience multiple adverse events in treatment. Inviting the ill child's reports on treatment-related AEs could help clinicians to better anticipate and manage these events and positively influence the quality of life of these patients. Inviting the child's reports would contribute to an improved clinician understanding of the impact of treatment on these young patients and contribute to more reasoned judgments about the relative benefits and burdens of the study treatments. We seek to complete a two-part content validation study with pediatric clinicians and researchers directly involved with pediatric oncology patients regarding items on the CTCAE for which the child or their family caregiver proxy could reasonably be expected to provide descriptive responses. Information gained from this two-part content validity study will serve as formative research to design a pediatric version of the CTCAE for children and their family caregiver proxies that would accurately and sensitively capture the child's experiences with specific symptomatic AEs.
1/4/2012 Project Update
With the support of the Alex’s Lemonade Stand Foundation, we have initiated a two-part content validation study with pediatric clinicians and researchers directly involved with pediatric oncology patients regarding items on the CTCAE for which the child or their family caregiver proxy could reasonably be expected to provide descriptive responses. Information gained from this two-part content validity study is now serving as formative research to design a pediatric version of the CTCAE for children and their family caregiver proxies that would accurately and sensitively capture the child’s experiences with specific symptomatic AEs in NCI-sponsored clinical trials.
