The Complementary Nature of Patient-Reported Outcomes (PROs) and Adverse Event Reporting in Cooperative Group Oncology Clinical Trials: A Pooled Analysis (NCCTG N0591)
Journal of pain and symptom management, Jan 29, 2015
Clinical trials utilize clinician-graded adverse events (AEs) and patient-reported outcomes (PROs... more Clinical trials utilize clinician-graded adverse events (AEs) and patient-reported outcomes (PROs) to describe symptoms. To examine the agreement between PROs and AEs in the clinical trial setting. Patient-level data were pooled from seven North Central Cancer Treatment Group, two Southwest Oncology Group and three Radiation Therapy Oncology Group lung studies that included both PROs and AE data. Ten-point changes (on a 0-100 scale) in PRO scores were considered clinically significant differences (CSDs). PRO score changes were compared to AE grade (Gr) categories (2+ yes vs. no and 3+ yes vs. no) using Wilcoxon rank- sum or two-sample t-tests between Gr categories. Incidence rates and concordance of CSD in PRO scores and AE grade categories were compiled. Spearman correlations were computed between PRO scores and AE severity. PROs completed by patients (N=1013) were the Uniscale, Lung Cancer Symptom Scale (LCSS), Functional Assessment of Cancer Therapy-Lung (FACT-L), Symptom Distres...
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Papers by Carolyn Gotay