8515 Background: During NCI-sponsored clinical trials, clinicians elicit and report patient toxicity symptoms using the Common Terminology Criteria for Adverse Events (CTCAE). Alternatively, patients may be able to report this information directly, but it remains unclear how these patient reported outcomes (PROs) compare to clinician reports.
METHODS
Language from the CTCAE version 3 was adapted for patient self-reporting and pilot tested to assure comprehension. Then, a paper questionnaire containing 12 common CTCAE symptoms was administered to consecutive outpatients and their clinicians (physicians and nurses) in clinics specializing in lung or genitourinary malignancies at a specialty cancer center.
RESULTS
Between March and May 2005, 435 patients and their clinicians were approached in order to obtain 400 completed paired surveys. For most symptoms agreement was high and this was especially true for more observable symptoms (vomiting, diarrhea) compared to more subjective areas (fatigue, dyspnea) (Table). Most discrepancies were within one point. Only rarely would differences have altered treatment decisions (grade <2 vs. ≥3). Patients more commonly assigned greater severity than clinicians. There was no significant difference when patients reported before versus after caregivers. Kappa values did not accurately measure agreement due to asymmetry in the marginal distribution of scores.
CONCLUSION
Patients and clinicians generally agree on CTCAE symptom severity. Future research should examine the impact of symptom PROs on clinical outcomes and the use of real-time reporting for early detection of SAEs. [Table: see text] No significant financial relationships to disclose.