PRO-CTCAE vs REQUITE: a comparison of two patient reported outcome (PRO) measurement tools in a lung cancer population

Abstract

Introduction: Symptom assessment and collection through the use of patient reported outcomes (PROs) has been shown to improve the accuracy of symptom collection, increase quality of life, delineate between clinical trial arms and improve overall survival. This will be the first study comparing concordance and patient preference for two PRO questionnaires; the REQUITE Lung Questionnaire and the PRO-CTCAE (Common Terminology Criteria for Adverse Events). The main aims of this study are to correlate the PRO tools to clinician reported outcomes and to assess correlation and patient preference between the PRO tools. Methods: In June 2018, lung cancer patients attending outpatient clinics at the Christie NHS foundation Trust were recruited to the study. Clinician reported outcomes were generated through patient assessment with the CTCAE. Participants completed the PROCTCAE, REQUITE and study evaluation questionnaires. REQUITE and CTCAE concordance was assessed by calculating Spearmans rank correlation coefficient. PRO-CTCAE concordance was demonstrated by assessing linear predictors from ordinal logistic regression analysis for Spearmans rank correlation coefficient and p-values were generated. Results: 63/65 (96.9%) of patients that provided written informed consent completed the study. Pearsons Rho correlation between the PRO tools was 0.8-0.83 (p<0.001). Correlation between the CTCAE and the PRO-CTCAE ranged between 0.66-0.82 (p<0.001). REQUITE and CTCAE correlation was higher for all symtom domains (except shortness of breath) ranging between 0.79-0.91 (p<0.001). Acceptable discrepancies within one grade were present in 96.8% to 100% of symptom domains for REQUITE and in 92.1-96.8%% for all domains in the PRO-CTCAE. 54% of the total participant cohort favored the REQUITE questionnaire due to reduced subjectivity in the questions and ease of use. Conclusion: The REQUITE questionnaire has shown superior correlation to clinician reported outcomes and higher patient preference than the PRO-CTCAE. Based on the results of this study we recommend the use of the REQUITE questionnaire in the lung cancer setting.