Pills & Patient Behavior Smarter Experience Tracking

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DESCRIPTION (provided by applicant): Medication noncompliance is highly problematic in pharmaceutical studies. Without direct observation of pilltaking patterns, investigators - much like clinicians-are often misled by reported adherence, resulting in false interpretation of a protocol's true effects. Pill counts fail to reveal timing of intake, lost or hoarded medications, and "white coat" compliance in which patients compensate for missed pills by dosing heavily before appointments. Applied researchers have relied on retrospectively captured data that suffer from autobiographical and recall biases; low frequency of measurement, which may result in poor reliability; and inability to capture fine-grained, process data that may shift and change over time. Gerontological studies are particularly vulnerable to reporting errors due to large quantities of drugs taken by elders, high dosing frequencies, interactions between pills, cognitive impairment that is associated with elder years-all of which result in further confusion in self reports. For Pharmaceuticals, improved data quality can lead to rapid time to market for a new therapy, and with it, cost savings and alleviation of suffering. More reliable data collection methods can reduce the period a drug needs to be under evaluation, its digitalization time, and number of specialized personnel before it can be commercialized. Various electronic tools have emerged that provide various parts of a solution. Personal digital assistants (PDAs) help investigators pose questions and collect data that can be transferred to the host environment, but none are attached to the behavior being measured. Electronic medminding devices serve to measure pilltaking in its temporal context but none for multiple medications simultaneously in an affordable, patient-friendly portable device. This application calls for an integrated infrastructure that will support a 4-bin computerized pillbox that exists in prototype form. Together, the system will provide passively monitored, real-time data capture of pill consumption in naturalistic settings, and collect responses to study questions posed daily. When built and tested, the integrated research system will be an affordable, flexible, and end-to-end data collection infrastructure to assist in human subjects trials. It will be tested here in a crossover study among 40 elderly patients, each taking four drugs and responding daily to device-generating questions.