July 17, 2020: Living Textbook Grand Rounds Series: Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success (Devon Check, PhD; Rachel Richesson, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Rachel Richesson, PhD, MPH
Associate Professor, Informatics
Duke University School of Nursing

Devon Check, PhD
Assistant Professor, Population Health Sciences
Department of Population Health

Topic

Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success

Keywords

Measuring outcomes; Phenotypes; Data quality; Data linkage; Endpoints; Patient-reported outcomes (PROs)

Key Points

  • Endpoints and outcomes for embedded pragmatic clinical trials (ePCTs) should be meaningful to providers and patients and be relatively easy to collect as part of routine care. Endpoints and outcomes also should be clearly defined and reproducible.
  • Patient-reported outcomes (PROs) are often the best way to measure quality of life, but come with challenges in that they are not routinely or consistently used in clinical care nor are regularly recorded in the EHR.
  • To fully capture all care—complete longitudinal data—it is often necessary to link research and insurance claims data.

Discussion Themes

Data in EHRs are an important component of ePCTs. While ePCTs strive for efficiency, there remain tradeoffs. Sometimes it will be necessary to collect data outside of the EHR to ensure important and compelling results.

It is also important that the endpoint that is conveniently available will also be accepted as influential for stakeholders when the trial results are disseminated.

In the future, it is essential that more meaningful data as well as more patient-reported outcomes are routinely collected and incentivized.

Developing a robust data quality assessment plan will improve the value of data and detect and address data issues. Read more about how to do this in Assessing Data Quality for Healthcare Systems Data Used in Clinical Research.

To learn more about measuring outcomes, visit these Living Textbook chapters:

Tags

#pctGR, @Collaboratory1