August 11, 2021: EHR Core Facing Familiar Challenges, Intensified by Pandemic

Leaders of the NIH Collaboratory’s Electronic Health Records (EHR) Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on pragmatic trials. They also talked about upcoming projects and a recent survey of the NIH Collaboratory Trials.

 

“The pandemic amplified themes that we’ve heard all along, which is how to get resources, how to get support for the data that we need for these trials or to configure EHRs as we need for these trials,” said Dr. Rachel Richesson, a professor of learning health sciences at the University of Michigan and a cochair of the EHR Core. “The pandemic just shifted priorities tremendously and made it quite challenging. As a result, we’ve had discussions about…really making the value case for pragmatic research and embedded research,” Richesson said.

View the full video.

Dr. Keith Marsolo, also a cochair of the Core, added, “The pandemic obviously was a big challenge for health systems in general as they transitioned to telehealth, dealt with shutdowns, things of that nature.” Marsolo is an associate professor in population health sciences at Duke University.

“Things are starting to move forward a little bit more. In one [NIH Collaboratory Trial], they were able to leverage some infrastructure that was purchased to help provide telehealth services for their region. So they’ve been able to bootstrap their trial off of that infrastructure,” Marsolo said.

Richesson also described an upcoming paper reporting the results of a recent survey of the NIH Collaboratory Trials. The survey focused on the challenges of using EHR data in pragmatic trials embedded in healthcare systems.

“No surprise on the challenges we encountered: It’s still challenging to get data from organizations for research, the data are still heterogeneous,…and there are challenges on the research team to ensure that that information is equivalent and how these data can be pulled together to support the research question,” Richesson said. “There’s a particular emphasis with the newer studies on patient-reported outcomes and how to get those collected as part of routine care,” she said.

View the full video.

 

Screen shot of video interview with Dr. Rachel Richesson and Dr. Keith Marsolo
Dr. Rachel Richesson and Dr. Keith Marsolo

July 27, 2020: ADAPTABLE Roundtable Produces Consensus Statement on Capturing Patient-Reported Health Data in Clinical Trials

A new report from an NIH Collaboratory roundtable discussion held in 2017 discusses considerations for the capture of patient-reported health (PRH) data in clinical trials. The report is part of an effort by the ADAPTABLE Supplement project team “to address best practices for capturing PRH data in pragmatic studies and optimal analytic approaches for integrating PRH with other data sources.”

The statement was published online ahead of print this month in Healthcare.

The new consensus statement is the second report from the ADAPTABLE roundtable. A statement published in February offered guidance for the analysis and integration of PRH data in clinical trials.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and PRH data.

This work was supported by a supplemental grant award to the NIH Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.

Podcast July 8, 2020: Reflection on Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials (Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD; Patrick Heagerty, PhD; Keith Marsolo, PhD)

This episode of the NIH Collaboratory Grand Rounds Podcast, led by Wendy Weber, ND, PhD, MPH, reflects on the Grand Rounds EHR workshop series, “Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.” The podcast features panelists Lesley Curtis, PhD, Keith Marsolo, PhD and Patrick Heagerty, PhD, who all moderated webinars included in this Grand Rounds series.

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Read the transcript.

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