Validation of the supplementary quality of life questionnaire for mouth/throat and hand/foot soreness.

Abstract

9574 Background: PISCES is a randomized crossover trial evaluating patient preference of pazopanib versus sunitinib in advanced/ metastatic renal cell carcinoma. The Supplementary Quality of Life Questionnaire (SQLQ) was developed for this trial to assess hand/foot soreness and mouth/throat soreness (MTS). The objective of this project is to validate the SQLQ. Methods: SQLQ was administered at baseline and every two weeks thereafter. EQ-5D was administered at baseline, during the washout period, and end of second treatment period. Treatment arms were collapsed for validation. SQLQ assesses severity of MTS (1 item), limitations due to MTS (5 items), severity of hand soreness (1 item), severity of foot soreness (1 item), limitations due to foot soreness (5 items) and ability to work (1 item). Cronbach’s coefficient alpha was used to evaluate the internal consistency reliability of the multi-item subscales.T-tests compared scores between groups defined by performance status (0 versus 1) and number of metastatic sites (0/1 versus 2+) at baseline. Effect sizes (ES = mean difference / pooled standard deviation) were calculated. Results: Of 169 patients randomized, data was available on 168. Over 80% of on-study patients completed the SQLQ at each assessment. Cronbach’s coefficient alpha was ≥ 0.80 for both limitations subscales at all assessments except baseline (limitations due to MTS). Both scores differentiated between performance status groups at baseline with ES > 0.40 (p<0.05). Scores significantly differed by severity of soreness with large ES of 0.9-2.1. Moderate correlations with EQ-5D were observed for limitations scores; correlations were smaller for soreness ratings. MTS and limitations due to MTS worsened after baseline with moderate – large ES; moderate ES was observed for changes in other scores. Limitation change scores were minimal in groups with no change in soreness rating; patients with worsened soreness reported similarly worsened limitations due to soreness with moderate – large ES. Conclusions: SQLQ is a valid and responsive measure of MTS, hand/foot soreness, and limitations due to soreness. Use of the SQLQ in future clinical trials will provide further external validation.