232 Background: Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are increasingly becoming an important aspect of cancer clinical trials and patient care, especially with regard to measuring drug efficacy, patient quality of life and drug safety. Subject compliance with completion of PRO/ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. It has been hypothesized that patient health status, length of time in a trial and country of origin, may affect compliance. Methods: To address this hypothesis, an operational analysis was conducted to assess oncology subject completion compliance of PRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of prostate cancer patients in completing three electronic questionnaires that were administered at clinic visits was evaluated. Subjects were asked to complete the Brief Pain Inventory – Short Form (BPI-SF) at every clinic visit. At some clinic visits, subjects were asked to additionally complete the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and the Euro Quality of Life 5 Dimensions (EQ-5D). Questionnaires were completed electronically on the tablet. Percent completion was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visits compiled for this review and the administration schedule for the questionnaires. Results: This review draws on the experience of over 1,000 subjects from 21 countries, and describes the individual and overall compliance with the expected questionnaire completion, the variance between subsequent visits, and compliance by country. Conclusions: The collection of ePRO using a clinic-based tablet yielded a highly complete data set in prostate cancer subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality of life assessments.
Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life