This webinar will be useful for researchers, regulators, academics, industry sponsors, and instrument developers in the clinical outcomes assessment (COA) field working on the development, evaluation, and implementation of performance outcome (PerfO) measures for use in capturing clinical benefits in treatment trials for medical label claims. Speakers will present work to date and invite audience feedback on several areas where there is a lack of consensus.
A 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).
While all COAs require careful consideration of concept(s) of interest, context(s) of use, and establishment of measurement properties, there are methodological considerations related to PerfO assessments that are unique. For instance, because PerfO assessments require completion of a defined task under observation, assessment of content validity must include linking that task to a real-world activity or behavior that is meaningful in a patient’s daily life. That can be a much more challenging undertaking than the direct report by the patient of the importance or meaningfulness of relief from a specific symptom.
The task force’s 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 report recommends draft good measurement practices for selection and development of PerfO assessments for use in capturing clinical benefit in treatment trials, an area where there is little specific guidance. These recommendations build upon earlier ISPOR Good Practices Task Force Reports based on the 2009 US Food & Drug Administration’s PRO Guidance for Industry.