Session (CTI)

PURPOSE: As task-based measures, PerfO assessments pose unique implementation challenges that impact study design, data collection, and data management compared to other clinical outcome assessments (COAs). Task force members will present their good practice recommendations for ensuring high-quality data generation along with the types of evidence needed to evaluate the appropriateness of a PerfO assessment in a specific context of use. DESCRIPTION: Ideally, PerfO assessments are used when the optimal means of capturing clinical benefit is through the completion of defined tasks involving physical, cognitive, and/or sensory function that reflect activities that are meaningful in daily life. The importance of standardization and the unique data collection considerations inherent in many PerfO assessments (eg, space requirements, specialized equipment) increase the complexity of implementation in clinical trials, impacting trial design. Participants will be invited to complete a small portion of both a cognitive and physical function PerfO assessment. Verbal fluency tasks, widely used in Alzheimer’s and dementia trials, are used to measure word finding difficulties and aspects of executive function; the TUG assessment is used to evaluate balance and ability to perform everyday movements. Via demonstration and completion of these exercises, the complexities related to task administration, standardization, administrator training, conduct, and scoring of assessments will be illustrated.Speakers will discuss and demonstrate through practical exercises, their recommendations on: 1) areas where PerfO assessments pose unique implementation challenges; 2) standardization and potential threats to a measure’s validity and interpretation; 3) the role of digital health technologies (DHTs) in PerfO assessments; and 4) the regulatory perspective and their expectations regarding clinical trial design and evidence that a PerfO assessment is fit-for-purpose. Audience Q&A will follow.