| Popis: |
Aim: In oncology clinical trials, Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are often used to collect data with regard to patient quality-of-life, symptoms, and drug safety and efficacy. 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 length of time in a trial and country of origin may affect compliance. To address this hypothesis, the compliance of multiple myeloma subjects in completing three questionnaires that were administered at clinic visits on an electronic tablet was evaluated. The goal of this research is ultimately to determine the suitability of the tablet. Methods: This review draws on the experience of over 400 subjects from 15 countries. Subjects completed the EORTC Quality of Life Questionnaire-Core 30, the EORTC Quality of Life Questionnaire-Multiple Myeloma 20, and the Euro Quality of Life-5 Dimensions on the tablet at clinic visits. The percent completion of the questionnaires was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visit. Results: Overall compliance (inclusive of all visits) for the three questionnaires was 95.9%. The overall percent completion was 96.2% (EORT QLQ-30), 97.7% (EORTC QLQ-MY20), and 93.8% (EQ-5D). Completion percentages remained stable for subsequent visits, even as the number of subjects remaining in the pool of participants decreased. The overall percent completion (inclusive of all visits) by country ranged from 88.7% to 100%. Thus, percentage completion was high and consistent in all countries. Conclusions: Percentage completion of questionnaires on the tablet by multiple myeloma subjects was very high, and there was no drop off in percent completion of questionnaires as a function of time. In addition, there was no pattern seen that would indicate that the country of the subject affected the subject's percent completion of the questionnaires. In conclusion, collection of ePRO using a clinic-based, touch-screen tabled yielded a highly complete data set in multiple myeloma subjects demonstrating that this is an effective and therefore suitable approach for recording symptom and quality of life assessments. Disclosure: All authors have declared no conflicts of interest. |
