Thursday, December 13, 2018

Lunchtime Listen: FDA Roadmap on Patient Reported Outcome Measures

key terms:  for program managers, developing research study designs, designing patient-centered metrics for your clinical practice

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

Recommended Lunchtime Listen this week:  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.

National Health Council Webinar Series Patient-reported Outcome Measures
November 2018 – January 2019


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.

November 2018 webinar:  Patient-Reported Outcomes and Patient-Centered Outcomes 
"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.

Video of the presentation:

December 2018 webinar
"FDA's Roadmap to Patient-Focused Outcome Measurement in Clinical Trials"
Dec. 7th, 2018 webinar
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."

Video of the presentation:

The next webinar in the series will be January 17th at 1300 Eastern
"Clinical Outcome Assessment Webinar Series:  Untangling the Terms..." 
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
For this webinar, sign up at this National Health Council webpage

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