Strong compliance with electronic observer-reported outcome reporting in a multinational Alzheimer's disease clinical trial

Abstract

Electronic Patient and Observer Reported Outcomes (ePRO, eObsRO) are increasingly becoming an important aspect of Alzheimer's disease (AD) clinical trials and patient care, used to measure drug efficacy, patient quality-of-life and drug safety. Subject compliance with completion of ePRO/eObsRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. The inherent cognitive impairment incurred by AD patients often necessitates the collection of ObsROs, especially as the disease progresses. It has been hypothesized that patient health status, caregiver burden, length of time in a trial and country of origin may affect compliance. To address this hypothesis, an operational analysis was conducted to assess AD patient caregiver's completion compliance of ObsRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of AD caregivers in completing four electronic questionnaires that were administered at clinic visits was evaluated. Caregivers were asked to complete the Disability Assessment for Dementia, Zarit Burden Interview, Cohen-Mansfield Agitation Inventory and Activity and Affect Indicators QoL electronically on a 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. This review draws on the experience of over 570 subjects from 10 countries in Europe, Eastern Europe and North America; and describes the individual and overall compliance with the expected questionnaire completion and the variance between subsequent visits. There was no impact on compliance. Overall compliance for all questionnaires was 97.7%. Percentage compliance did not significantly vary from the first to last visit and ranged between 96.9% - 98.4%. The collection of eObsRO using a clinic-based tablet yielded a highly complete data set in Alzheimer's subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality-of-life assessments. Collecting data electronically may also reduce site burden. If sites had used traditional paper questionnaires it is estimated that they would have had to handle more than 10,000 pages and review over 150,000 data entries.