Improving Performance: Selection and Development of PerfO Assessments to Capture Clinical Benefit: Performance Outcome Assessment Emerging Good Practices Task Force
Thursday, January 20, 2022
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.
For more information on the Performance Outcomes Assessment Task Force, please visit their website: https://www.ispor.org/member-groups/task-forces/performance-outcome-perfo-assessments
Moderator:
Elizabeth (Nicki) Bush, MA, Global Head, Patient-Focused Outcomes Center of Expertise, Eli Lilly and Company, Indianapolis, IN, USA
January 20, 2022
Open to all ISPOR Members and Non-members
Thursday, January 20, 2022
10:00AM EST | 3:00PM GMT | 4:00PM CET
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Description
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.
For more information on the Performance Outcomes Assessment Task Force, please visit their website: https://www.ispor.org/member-groups/task-forces/performance-outcome-perfo-assessments
Learning Objectives
Attendees will learn about:
- Identifying the concept of interest and determining when a PerfO assessment is the optimal approach to measurement
- Identifying, selecting, or modifying existing PerfO assessments or developing new ones
- Challenges when evaluating content validity of PerfO assessments
Moderator:
Elizabeth (Nicki) Bush, MA, Global Head, Patient-Focused Outcomes Center of Expertise, Eli Lilly and Company, Indianapolis, IN, USA
Presenters:
Christopher Edgar, MSc, PhD, Senior VP Clinical Science, Cogstate, New Haven, CT, USA
Rachel Ballinger, PhD, BSc, Principal, ICON, Oxford, England, UK
Michelle Campbell, PhD, Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, MD, USA
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later
date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.
Reservations are on a first-come, first-served basis.
Reservations are on a first-come, first-served basis.