Speakers
Theresa Coles, PhD
Assistant Professor
Department of Population Health Sciences
Duke University School of Medicine
Kevin Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine
Topic
Enabling Patient-Reported Outcome Measures (PROMs) in Clinical Trials, Exemplified by Cardiovascular Trials
Keywords
Patient-reported outcomes; PROM; Validity Theory; Patient engagement
Key Points
- Patient-reported outcome scores have value and bring different measures of outcome, such as quality of life and burden of treatment into focus in a study.
- PROMs, or Patient Reported Outcome Measures, are not routinely collected in clinical care so they are not readily available in the electronic health record.
- Challenges of integrating PROMs into clinical trials include the culture of the health care system, budget, time, missing information, and unclear or uncertain interpretation of scores.
- Modern Validity Theory refers to the validity of the interpretation of test scores for the proposed use of the test, not the validity of the score itself.
- A repository for validity arguments may help avoid redundant research and provide examples of successful validity arguments.
Discussion Themes
How do we educate regulators and researchers about interpreting validity arguments?
Validating PROMs to ensure they are appropriate for use across different cultures and population groups requires historical evidence across many different validity arguments.
PROMs offered in different formats receive better response rates.
Read more about Dr. Coles and Dr. Weinfurt’s work with PROMs in their recent publication, “Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials.”
Tags
#pctGR, @Collaboratory1