Validating Select Physical Performance Outcome (PerfO) Assessments to Support Labelling Claims in the US: Methods and Lessons Learned

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As a type of Clinical Outcome Assessment (COA), Performance Outcome assessments (PerfOs) specifically refer to task(s) performed by a patient according to instructions administered by a health care professional. They thus require patient cooperation and motivation (FDA, COA Glossary of terms). While PerfO assessments such as walk and stair climbing tests are widely used to assess the effectiveness of interventions, and there is some evidence on the measurement properties of the tests, there is no regulatory guidance in terms of assessment development and validation specific to PerfOs. While the Patient Reported Outcome guidance (FDA/SEALD Guidance for Industry 2009) provides a useful framework, PerfOs do present specific challenges.

This webinar draws on experience in validating a select group of PerfO assessments in orthopaedics, an area with a strong history of performance measurement, with the intention of supporting future labelling claims. The PerfO assessments were Timed Up and Go, Stair Climbs and Repeated Chair Stands which were administered in hip fracture and elective hip and elective knee replacement patients in a multi-site study.

The webinar will present conceptual and logistical challenges of both qualitative and quantitative studies to assess the content validity and measurement properties of these PerfO assessments in these patient groups, and the results from these studies. We will also reflect on the value of FDA Guidance on the use of PRO measures (FDA/SEALD Guidance for Industry 2009) for PerfOs, and review the FDA Clinical Outcome Assessment Compendium and other sources for indication of the extent and nature of use of PerfOs to support labelling claims in conditions more widely.

The objectives of this webinar are to:

Briefly describe PerfOs and related terminology
Describe how PerfO assessments compare with other COAs and the breadth of PerfOs
Provide an in-depth orthopedic case study
Highlight practical and logistical issues of assessing select physical PerfO assessments
Demonstrate the approach taken to validating selected PerfO assessments
Share validation study results
Provide clear take-away messages to help inform approach to selecting and validating PerfO assessments for physical mobility-type conditions
Provide an indication as to the extent and nature of PerfOs used to support labelling claims more widely

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