Performance Outcome Assessment Emerging Good Practices Task Force: Final Recommendations

Author(s)

Moderator: Stephen Joel Coons, PhD, Critical Path Institute, Tucson, AZ, USA
Speakers: Christopher James Edgar, MSc, PhD, Cogstate, New Haven, CT, USA; Elektra Papadopoulos, MD, MPH, AbbVie Inc., North Chicago, IL, USA; Michelle Campbell, PhD, CDER, US Food and Drug Administration, Silver Spring, MD, USA

A performance outcome (PerfO) assessment is a type of clinical outcome assessment (COA) based on measurement of standardized task(s) actively undertaken by a patient according to a set of instructions and administered by a trained individual or completed by the patient independently. PerfO assessments reflect physical (eg, mobility), cognitive (eg, working memory), sensory (eg, visual acuity), and other functional skills (eg, instrumental activities of daily living). Such assessments require special attention due to the nature of the concepts of interest for measurement, and in the execution and interpretation of those assessments. For instance, because PerfO assessments require completion of a defined task, confirmation of content validity must include linking that task to a real-world activity or behavior that is meaningful in a person’s daily life. This task force’s recommendations build upon earlier ISPOR task force reports covering other COA types. The goal is to improve the evaluation and documentation of content validity and other measurement properties, including reliability, construct validity, and ability to detect change for PerfO assessments.

The forum will cover the task force’s final report on emerging good measurement practice recommendations for evaluating and/or developing PerfO assessments for use in capturing clinical benefit in treatment trials. Task force members will discuss: 1. Identifying the concept of interest and determining when a PerfO assessment is the optimal approach to measuring it 2. Considerations when identifying, selecting, or modifying existing PerfO assessments or developing new ones 3. Unique challenges when evaluating content validity and other measurement properties of PerfO assessments 4. Importance of conducting a pilot evaluation of PerfO assessments in the target population Attendees will evaluate the final good practice recommendations. This feedback will form the basis of an interactive discussion with polling between the panel and the audience around the practical application of the task force’s recommendations.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA

Code

135

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