Electronic health records

June 24, 2020: EHR Workshop Grand Rounds Series Continues With Keys to Success in the Evolving EHRs Environment

Posted on by Damon Seils

The NIH Collaboratory is using its ePCT Grand Rounds platform for a special webinar series on electronic health records (EHRs). The series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, is highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials.

In this week’s EHR workshop session, a panel of investigators from the NIH Collaboratory Trials—including Drs. Teresa Zayas-Cabán, George (Holt) Oliver, Christopher Longhurst, and Rachel Richesson—will discuss “Keys to Success in the Evolving EHR Environment.” Dr. Keith Marsolo of Duke University will facilitate the discussion. The Grand Rounds session will be held on Friday, June 26, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the EHR workshop series include:

  • Recording June 30, Available July 7, 2020: Podcast: Summary Expert Panel Discussion (Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH; Moderator: Lesley H. Curtis, PhD)

May 27, 2020: EHR Workshop Grand Rounds Series Continues With Experiences From the Collaboratory PCTs

Posted on by Damon Seils

The NIH Collaboratory is using its ePCT Grand Rounds platform for a special webinar series on electronic health records (EHRs). The series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, is highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials.

In this week’s EHR workshop session, a panel of investigators from the NIH Collaboratory Trials—including Drs. Jerry Jarvik, Lynn DeBar, Doug Zatzick, and Vince Mor—will discuss “Experiences From the Collaboratory PCTs.” Dr. Wendy Weber of the National Center for Complementary and Integrative Health will facilitate the discussion. The Grand Rounds session will be held on Friday, May 8, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the EHR workshop series include:

  • June 26, 2020: Keys to Success in the Evolving EHRs Environment (Teresa Zayas-Cabán, PhD; George [Holt] Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH; Moderator: Keith Marsolo, PhD)
  • Recording June 30, Available July 7, 2020: Podcast: Summary Expert Panel Discussion (Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH; Moderator: Lesley H. Curtis, PhD)

May 15, 2020: Podcast for Dr. Robert Califf’s May 1 Grand Rounds Presentation Now Available

Posted on by Gina Uhlenbrauck
The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. “Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?” features a deep-dive discussion between NIH Collaboratory PI Dr. Lesley Curtis and Dr. Robert Califf, Head of Strategy and Policy at Verily Life Sciences and Google Health, on Dr. Califf’s May 1 Grand Rounds Presentation.
 
This discussion provides a deeper look into Dr. Califf’s keynote presentation, which kicked off the Grand Rounds Special Series: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.

In this episode, you will learn more about:

  • The state of the current healthcare delivery system
  • How the COVID-19 pandemic could influence change in the current system
  • Aspects of clinical research that have accelerated over the past several months
  • Access to digital technologies and adoption of electronic health records

Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

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Read the transcript.

May 6, 2020: EHR Workshop Grand Rounds Series Continues With Future Directions in Real-World Evidence

Posted on by Damon Seils

The NIH Collaboratory is using its ePCT Grand Rounds platform for a special webinar series on electronic health records (EHRs). The series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, is highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials.

In this week’s EHR workshop session, Dr. Jacqueline Corrigan-Curay of the US Food and Drug Administration and Dr. Joshua Denny of the National Institutes of Health will discuss “Real World Evidence: Contemporary Experience and Future Directions.” NIH Collaboratory investigator Dr. Patrick Heagerty of the University of Washington School of Public Health will facilitate the discussion. The Grand Rounds session will be held on Friday, May 8, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the EHR workshop series include:

  • May 29, 2020: Experiences From the Collaboratory PCTs (Jeffrey [Jerry] G. Jarvik, MD, MPH; Lynn DeBar, PhD; Doug Zatzick, MD; Vince Mor, PhD; Moderator: Wendy Weber, ND, PhD, MPH)
  • June 26, 2020: Keys to Success in the Evolving EHRs Environment (Teresa Zayas-Cabán, PhD; George [Holt] Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH; Moderator: Keith Marsolo, PhD)
  • Recording June 30, Available July 7, 2020: Podcast: Summary Expert Panel Discussion (Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH; Moderator: Lesley H. Curtis, PhD)

April 29, 2020: Dr. Robert Califf Will Give Keynote Address to Launch EHR Workshop Grand Rounds Series

Posted on by Damon Seils

The NIH Collaboratory will use its ePCT Grand Rounds platform on Friday, May 1, to launch a special workshop series on electronic health records (EHRs). The webinar series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, will highlight advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials.

In this week’s series kickoff, Dr. Robert Califf will present a keynote address, “Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?” Dr. Califf is head of strategy and policy for Verily Life Sciences and Google Health. The Grand Rounds session will be held on Friday, May 1, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the EHR workshop series include:

April 23, 2020: New Workshop Summary on the Design and Analysis of Pragmatic Clinical Trials

Posted on by Karen Staman

In 2019, NIH Health Care Systems Research Collaboratory held a comprehensive workshop to explore and discuss statistical issues encountered with embedded pragmatic clinical trials (ePCTs). The new Workshop Summary describes panel discussions with the principal investigators and statisticians of NIH Collaboratory Trials and the challenges and solutions encountered during the design and analysis of their trials.

The 4 panel discussions covered the following topics:

  • Measurement and Data: Outcomes, Exposures, and Subgroups Based on EHR Data
  • To Cluster or Not to Cluster?
  • Choosing a Parallel Group or Stepped-Wedge Design
  • Unique Complications

This Workshop Summary also provides lessons learned and recommends tools to help others design and analyze future ePCTs. For more on the design and analysis of pragmatic clinical trials, see the tools provided by the Biostatistics and Study Design Core and Living Textbook chapters on Experimental Designs and Randomization Schemes and Analysis Plans.

January 16, 2020: NIH Collaboratory Investigators Describe Key Elements of Successful Distributed Research Networks

Posted on by Karen Staman

Members of the NIH Collaboratory Distributed Research Network (DRN) have helped build DRNs for the Sentinel System, the NIH Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet). In a new article published online in Contemporary Clinical Trials Communications, they describe the key elements of successful DRNs, as well as methods, challenges, and solutions encountered in using DRNs to support different phases of randomized, multisite clinical research.

“…[DRNs] are a vital component for trials that use real-world data to generate real-world evidence. Given their access to larger and more diverse populations, as well as health systems with a variety of care practices, DRN-based trials have the potential to produce more generalized results.” —Marsolo et al. 2020

DRNs enable the use of real-world data by repurposing electronic health record (EHR) and claims data for research. However, the use of these data to create evidence is “complicated by lack of uniformity in data collection, a fragmented healthcare system, and the imperative to protect research participants.”

The NIH Collaboratory DRN can support observational studies of comparative effectiveness and safety, prospective data collection, and randomized clinical trials. For more, see the list of publications and presentations.

May 31, 2019: Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems (Harriette Van Spall, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Harriette G.C. Van Spall, MD, MPH, FRCPC
Associate Professor of Medicine
Department of Medicine, Division of Cardiology
Department of Health Research Methods, Evidence, and Impact
McMaster University
Population Health Research Institute

Topic

Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems

Keywords

Learning health system; Pragmatic clinical trial; Patient-Centered Care Transitions in Heart Failure (PACT-HF); Heart failure; Stepped-wedge cluster trial

Key Points

  • Characteristics of a learning health system include:
    • Possessing a culture of knowledge and quality improvement
    • Encouraging research innovation by embedding research into clinical practice and generating knowledge at the point of care
    • Harnessing data from electronic health records and claims/administrative databases
    • Fostering trust between research and clinical teams
    • Engaging patients, clinicians, and key stakeholders
  • The Patient-Centered Care Transitions in Heart Failure (PACT-HF) trial evaluated the effectiveness of a group of transitional care services in patients hospitalized for HF within a publicly funded healthcare system.
  • Challenges of a learning health system include integrating care, intervention, and communications across silos; streamlining workflow; preventing “contamination” of usual care; and the limited interoperability of EHRs and slow updates to claims/administrative datasets.

Discussion Themes

Efficacy in explanatory randomized clinical trials (RCTs) does not equate to effectiveness in real-world settings.

Decisions about implementation of an intervention are not made “live”; you must wait until the study has ended, all the data are available for analysis, and analysis is complete before you can inform decision-maker partners about the risks and benefits of the intervention.

Read more about the PACT-HF study and results in JAMA Network (Van Spall et al. 2019)

Tags

#pctGR, @Collaboratory1

February 28, 2018: New Meeting Summary Examines How to Integrate Patient‐Reported Health Data for Pragmatic Research

Posted on by Karen Staman

A recently released summary from the ADAPTABLE Roundtable Meeting explores ways to better understand the sets of circumstances and considerations that could guide when and how to gather and integrate patient-reported health data with other data sources in pragmatic trials.

For outcomes that represent subjective experiences, such as pain, symptoms, and physical functioning, the patient is the unique and privileged source of information. Other patient-reported health data may not have a clear source of truth, such as co-morbidities and hospitalizations. In such cases, patient-reported health data may supplement, contradict, or agree with EHR and claims data. For example, medication data reported by patients might be a more accurate reflection of what patients are actually taking than medication data in the EHR, especially for over-the-counter medications.

Patient-reported health data come from various sources and can be feasibly collected in the conduct of a pragmatic clinical trial, but the optimal approaches for capturing and analyzing these data are unclear. Questions include how to integrate this information with other data collected as part of a study, including data from the EHR.

To better understand patient-reported health data and how to use them in pragmatic trials, 18 experts from 8 institutions convened at the roundtable meeting, coming from a wide variety of backgrounds including biostatistics, epidemiology, oncology, nursing, psychiatry, health policy, and regulation. Representatives from the NIH Collaboratory included Drs. Lesley Curtis and Rachel Richesson from the EHR Core and Dr. Kevin Weinfurt from the Patient-Reported Outcomes Core.

In addition to the meeting summary, two white papers are forthcoming. For more information about using patient-reported data in pragmatic trials, see the Living Textbook Chapter on Endpoints and Outcomes.

This effort was funded by Office of the Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services through a supplement provided to the NIH Collaboratory Coordinating Center.

October 11, 2017: New grant awarded to Dr. Jeffrey Jarvik and his team of investigators to promote pragmatic musculoskeletal clinical research

Posted on by Karen Staman

Congratulations to Dr. Jeffrey Jarvik and his colleagues at the University of Washington for their recent grant award to establish the Core Center for Clinical Research (CCCR). The initiative will promote pragmatic, multi-institutional clinical research on musculoskeletal conditions, such as the diagnosis and treatment of back pain. The new center—the UW Center for Clinical Learning, Effectiveness And Research (CLEAR)—will investigate the effectiveness of interventions such as imagining tests, physical therapy, opioids, spine injections, and spine surgery, as well as approaches for implementation.  The National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are funding the 5-year, $3.7 million initiative, which will include pragmatic and comparative effectiveness trials and Core groups, including:

  • The Methodology Core, led by Patrick J. Heagerty PhD, Chair of the Department of Biostatistics, and Sean Mooney PhD, Professor of Biomedical Informatics and Chief Research Information Officer
  • The Resource Core, led by Janna Friedly MD, Associate Professor of Rehabilitation Medicine, and Danielle Lavallee PharmD PhD, Research Associate Professor of Surgery

Dr. Jarvik is a Professor of Radiology at University of Washington and the Principal Investigator the Collaboratory NIH Collaboratory Trial, the Lumbar Imaging with Reporting of Epidemiology (LIRE) trial.