Who this Lunchtime Listen recommendation may benefit:
- any of you working in metrics for your clinic, as a clinician or as a program manager
- clinicians who want to understand more about patient-reported outcomes and patient-centered metrics
- if you are interested in health policy and how metrics and health policy collide
What this Lunchtime Listen is: the National Health Council's webinar series on the "FDA Roadmap" as it relates to growing and developing patient-centered metrics for your clinic or program. NHC is recommending clinical settings get ahead in creating these before federal mandates require this metrics to be in place. Depending on your program, your mission, your patient demographic and needs, and your resources, these metrics may take years to develop and implement.
Clinical Outcome Assessments Webinar Series with National Health Council (NHC)
National health policy is adopting more aspects of patient-centered paradigm. Part of this paradigm is using patient-reported outcome measures. In fact, the Food and Drug Administration (FDA) released guidance documents on clinical outcome assessment for 2019.
This webinar series by the NHC is intended to help clinicians and clinical programs and researchers better understand these ideas and this paradigm and discuss a little about what implementation looks like. The overall take-away I had from this was to start now because implementation of clinic-wide or system-wide metrics appropriately can take years, not weeks nor months...years.
"Nov. 7, 2018. In patient-centered research and care, we focus on the outcomes most important to patients. Often, patients tell us that what is most important to them is how they feel and how well they function in their everyday lives. These outcomes are referred to in research as patient-reported outcomes or PROs. So, what is the difference between a patient-centered outcome and a patient-reported outcome? Are they the same? The answer is: No, they are not the same! In this webinar, presented by Dr. Eleanor Perfetto, you will learn about the difference between patient-centered outcomes and patient-reported outcomes, and whey we need patient-centered PROs in research and care." Learn more at website listed above.
summary: "in patient-centered research and care we focus on the outcomes most import to patients. Often, patients tell us that what is most important to them is how they feel and how well they function in their everyday lives. To capture data on these outcomes in clinical trials, measures must first be developed. This webinar introduces participants to a document, the Roadmap, developed by the Clinical Outcome Assessment (COA) team at the Food and Drug Administration. The Roadmap helps researchers develop tools that measure outcomes that matter most to patients."
"Clinical Outcome Assessment Webinar Series: Untangling the Terms: Endpoints, Items, Outcomes, PROs, PROMS, PRO-PMs" with Ashley Slagle, MS, PhD
The presenter will be defining and providing examples of the following terms used in the past 2 webinars which are important to understand to be able to comprehend the FDA Roadmap about the new clinical outcome guidelines. Terms to include: endpoints, items, outcomes, PRO, PROM, and PRO-PM.
Why is this topic important?
"In 2019, the [FDA] will release two new draft guidance documents on COAs [clinical outcome measures]. COA-related terminology can be confusing. This webinar will provide a primer to help ...be prepared to participate in COA-related research and policy development."
video of the presentation: https://youtu.be/z56rm2n7PN8
February 20th, 2019
Successful Clinical Outcome Assessmements (COAs): It all starts with the "concept of interest" and "context of use" with T. Rosie Love, MPH, of the Maryland School of Pharmacy, Department of Pharmaceutical Health Services Research.
concept of interest = what you are trying to measure. examples: functional change; change in range of motion; change in inflammation markers; change in symptoms, etc.
context of use = (see presentation). examples: adults with chronic back pain age 35-60; adults with inflammatory bowel disease age 18 - 28; adults post-knee surgery 2-8 weeks post-surgery
content validity = are you measuring what matters? are you measuring what patients care about?
Video of the presentation (36 minutes): https://youtu.be/AWk558C04GQ
Next webinar in the Roadmap series is scheduled for March 20th, 2019 at 1300 Eastern/1000 Pacific. Title: What Do We Mean by Validation of a Measure? presenter will be Dr. Eleanor Perfetto, Executive Vice President, Strategic Initiatives at the National Health Council.
For this webinar, sign up at this National Health Council webpage