health outcomes

July 24, 2020: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (Leslie J. Crofford, MD; Kathleen Sluka, PT, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Leslie J. Crofford, MD
Wilson Family Chair and Professor of Medicine
Vanderbilt University Medical Center

Kathleen Sluka, PT, PhD
Kate Daum Research Professor
Department of Physical Therapy and Rehabilitation Science
University of Iowa

Topic

TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial

Keywords

Fibromyalgia; Musculoskeletal pain; Neuropathic pain; Transcutaneous electrical nerve stimulation (TENS); Physical therapy; Nonpharmacologic pain treatment; PRISM; Patient-reported outcomes (PROs)

Key Points

  • Fibromyalgia (FM) is a condition of widespread pain that is worsened with physical activity. It involves chronic musculoskeletal and visceral pain and is often accompanied by fatigue, depression, or anxiety.
  • Transcutaneous electrical nerve stimulation (TENS) is a technique that uses a device to deliver an electric impulse through the skin. Treatment with TENS has been shown to improve resting and movement-evoked pain and fatigue.
  • While physical therapists generally are trained in the use of TENS, the technique remains underused in clinical practice.
  • The goal of the FM TIPS pragmatic trial is to determine, in a real-world clinical setting, whether physical therapy combined with TENS for patients with FM is more effective than physical therapy alone. The study is being piloted in 24 sites across 5 physical therapy health systems.

Discussion Themes

While COVID-19 has had an impact on piloting the FM TIPS study, some kind of physical therapy will be possible through telemedicine. Other challenges include that conducting embedded research in physical therapy clinics is new, and there are multiple different EHR systems in use across the partnering clinics.

The recently published results from Fibromyalgia Activity Study With TENS (FAST) showed that TENS can be safely used in addition to other treatments to improve pain and fatigue in women with fibromyalgia in the setting of a randomized controlled trial.

Read more about the Fibromyalgia TENS in Physical Therapy Study (FM TIPS) NIH Collaboratory Trial and watch a brief interview with the PIs of the study.

FM TIPS is one of the NIH HEAL Initiative’s PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) studies.

Tags

#pctGR, @Collaboratory1

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

July 15, 2020: Living Textbook Grand Rounds Series Continues With “Choosing What to Measure and Making It Happen”

Posted on by Damon Seils

Join us Friday, July 17, for “Choosing What to Measure and Making It Happen: Your Keys to Pragmatic Trial Success,” the final session in our special 5-part Grand Rounds series focused on the Living Textbook of Pragmatic Clinical Trials. NIH Collaboratory investigators Drs. Rachel Richesson and Devon Check will discuss endpoints and outcome measures in pragmatic clinical trials embedded in healthcare systems. Topics covered will include:

  • The ins and outs of using EHR data
  • Choosing and specifying your trial’s endpoints and outcomes

See below for the full schedule of Living Textbook sessions and a special message from Dr. Kevin Weinfurt.

 

Living Textbook Grand Rounds Series
Date Title Speakers
January 31, 2020 Pragmatic Clinical Trials: How Do I Start?
  • Greg Simon, MD, MPH, Kaiser Permanente Washington Health Research Institute
  • Lesley H. Curtis, PhD, Duke University
February 28, 2020 Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts
  • Jerry Jarvik, MD, MPH, University of Washington
  • Vince Mor, PhD, Brown University
  • Leah Tuzzio, MPH, Kaiser Permanente Washington Health Research Institute
March 27, 2020 Tips for Putting Together a Successful PCT Grant Application
  • Wendy Weber, ND, PhD, MPH, National Center for Complementary and Integrative Health
June 19, 2020 Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials
  • Liz Turner, PhD, Duke University
  • Patrick Heagerty, PhD, University of Washington
  • David M. Murray, PhD, National Institutes of Health
July 17, 2020 Choosing What to Measure and Making It Happen: Your Keys to Pragmatic Trial Success
  • Rachel Richesson, PhD, MPH, Duke University
  • Devon Check, PhD, Duke University

 

July 14, 2020: Grand Rounds Webinar Presents the New N3C Analytics Platform for COVID-19 Research

Posted on by Gina Uhlenbrauck

Watch the recent Grand Rounds webinar presented by Dr. Ken Gersing of the National Center for Advancing Translational Sciences and Dr. Robert Star of the National Institute of Diabetes and Digestive and Kidney Diseases to learn more about the COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C).

The N3C initiative aims to build a centralized national data resource that researchers can use to study COVID-19 and identify potential treatments as the pandemic continues to evolve. N3C is a partnership among the Clinical and Translational Science Awards Program hubs and the National Center for Data to Health, with overall stewardship by the National Center for Advancing Translational Sciences (NCATS).

The goals of N3C are to:

  • Rapidly collect and aggregate clinical, lab, and imaging data from hospitals, health plans, and CMS at the peak of the COVID-19 pandemic and as it evolves
  • Provide a longitudinal dataset to understand acute hospital and recovery phases
  • Understand pathophysiology of disease
  • Support clinical trials by identifying patients who might wish to participate in trials

Watch the Grand Rounds webinar or download the slides. For more details, visit the NCATS N3C website.

July 10, 2020: COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C) (Ken Gersing, MD; Robert Star, MD)

Posted on by Gina Uhlenbrauck

Speakers

Ken Gersing, MD
Director of Informatics, NCATS
National Institutes of Health  

Robert A. Star, MD
Director, Division of Kidney, Urologic, and Hematologic Disorders, NIDDK
Chief, Renal Diagnostics and Therapeutics Unit, NIDDK
National Institutes of Health  

Topic

COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C)

Keywords

COVID-19; Coronavirus; Pandemic; Data exchange; Data use agreement; Phenotypes; Data harmonization; Common data model; Fast Healthcare Interoperability Resources (FHIR); Synthetic data

Key Points

  • The National COVID Cohort Collaborative (N3C) initiative aims to build a centralized national data resource that the research community can use to study COVID-19 and identify potential treatments as the pandemic continues to evolve.

  • N3C is a partnership among the Clinical and Translational Science Awards Program hubs and the National Center for Data to Health, with overall stewardship by the National Center for Advancing Translational Sciences (NCATS).

  • The goals of N3C are to:
    • Rapidly collect and aggregate clinical, lab, and imaging data from hospitals, health plans, and CMS at the peak of the COVID-19 pandemic and as it evolves
    • Provide a longitudinal dataset to understand acute hospital and recovery phases
    • Understand pathophysiology of disease
    • Support clinical trials by identifying patients who might wish to participate in trials

Discussion Themes

The N3C analytics platform is cloud-based and provides a secure data enclave. Data can be received via multiple data models and transformed into a common analytic model for research.

As a centralized data model, N3C complements existing federated data models like PCORnet and OMOP. The tool does not replace the need for randomized controlled trials.

NCATS, FDA, and NCI are working together on common data model (CDM) harmonization so that data will be publicly available and reusable in human and machine-readable formats.

Read more on the NCATS N3C website as well as view a short video demonstration.

Tags

#pctGR, @Collaboratory1, @ncats_nih_gov

May 19, 2020: New Updates to What is a Pragmatic Clinical Trial Chapter in the Living Textbook

Posted on by Gina Uhlenbrauck

The NIH Collaboratory regularly refreshes content in the Living Textbook in order to offer a robust collection of resources to the wider research community about how to plan and implement a pragmatic clinical trial. We invite you to explore recent additions to the introductory chapter What Is a Pragmatic Clinical Trial?

Highlights include information on the broader embedded PCT (ePCT) ecosystem, an updated table describing the 19 NIH Collaboratory Trials, a new illustration of the PRECIS-2 continuum, webinars on how to start a PCT, and more.

“The Living Textbook reflects a collection of expert consensus regarding special considerations, standard approaches, and best practices in the design, conduct, and reporting of PCTs.” – Dr. Kevin Weinfurt, Editor-in-Chief of the Living Textbook

Sections in What is a Pragmatic Clinical Trial include:

  1. Why Are We Talking About Pragmatic Trials?
  2. The Embedded Pragmatic Clinical Trial Ecosystem
  3. Differentiating Between RCTs, PCTs, and Quality Improvement Activities
  4. Pragmatic Elements: An Introduction to PRECIS-2
  5. Key Considerations for PCTs
  6. Additional Resources

May 14, 2020: Healthcare Workers Invited to Join the HERO Registry

Posted on by Gina Uhlenbrauck

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry invites both clinical and nonclinical healthcare workers to share their life experiences in order to understand the perspectives and problems faced by those on the COVID-19 pandemic frontlines. HERO Registry participants could have the opportunity to participate in future research studies to improve the understanding of COVID-19 and beyond, generating evidence to help healthcare workers stay safe and healthy.

The HERO Registry is open to all healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental service workers, interpreters, transporters — anyone who works in a setting where people receive health care.

Learn more about the HERO Registry and how to join.

Don’t miss the recent COVID-19 Grand Rounds introducing the HERO Program and get the latest information and resources on COVID-19 for clinical researchers.

May 8, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions (Patrick Heagerty, PhD, Jacqueline Corrigan-Curay, JD, MD, Joshua C. Denny, MD, MS)

Posted on by Gina Uhlenbrauck

Speakers

Guest Moderator:
Patrick J. Heagerty, PhD
Professor, Department of Biostatistics, University of Washington

Panel:
Jacqueline Corrigan-Curay, JD, MD
Director of CDER’s Office of Medical Policy (OMP)
U.S. Food and Drug Administration (FDA)

Joshua C. Denny, MD, MS, FACMI
Chief Executive Officer, All of Us Research Program, NIH

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions

Keywords

Electronic health records; Real-world evidence; RWE; Real-world data; RWD; FDA; All of Us; Phenotypes; Regulatory; Fit-for-use data; Digital heath

Key Points

  • To create quality clinical/research records, we must design for multiuse by integrating standards-based tools in the EHR to bring together health care and research. 
  • Quality real-world evidence cannot be built without quality real-world data. With greater efficiencies in data capture, randomization with real-world data provides a pathway for reliable—and persuasive—real-world evidence.

Discussion Themes

Patient-generated health data is part of FDA’s MyStudies Application, designed to facilitate the input of real-world data directly by patients, which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies, and registries.

In assessing data quality we can ask, How does a data element travel from clinical care to a research data set?

The NIH’s All of Us program is building a diverse database that can inform thousands of studies on a variety of health conditions.

The All of Us study is tracking COVID-19 in its patients. Sites have identified their COVID-19 participants and relevant labs. Consent is obtained for future sharing of data.

Tags

#pctGR, @Collaboratory1

May 5, 2020: Dr. Robert Califf Discusses Next Steps for Reforming the Evidence Generation Ecosystem After COVID-19

Posted on by Gina Uhlenbrauck

In case you missed the May 1 keynote address by Robert M. Califf, MD, MACC, you can now listen to the recorded webinar and Q&A. Dr. Califf, head of strategy and policy for Verily Life Sciences and Google Health, kicked off the Collaboratory’s Grand Rounds workshop series, Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.

His presentation outlined several opportunities to drive change and rebuild clinical research in the aftermath of COVID-19, including:

  • Evaluate what has and has not worked in the changes that have been made in response to the crisis
  • Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
  • Do everything possible to fix the “purposefulness issue”:
    • Create methods for deciding the most important questions
    • Reward behavior that gets important questions answered quickly
  • Develop inclusive networks driven by people with the health problems of interest; increase incentives for clinicians and investigators that lead to reliable and faster evidence generation (balance financial focus with purpose); and automate mapping of EHR data beyond individual systems

“The effective use of digital information such as electronic health records, telehealth, applications, and patient-reported outcomes should free up effort to fix the human components that are holding us back.” – Dr. Robert Califf

View the full presentation for more insights from Dr. Califf.

Stay tuned for these upcoming presentations in the series:

April 29, 2020: Materials from the Collaboratory Steering Committee’s Virtual Meeting Now Available

Posted on by Gina Uhlenbrauck

On April 22 and 23, 2020, more than 90 participants joined the online Steering Committee meeting to hear about the evolution of the embedded PCT (ePCT) ecosystem, discuss how to strengthen partnerships across the ecosystem, and identify approaches and lessons that will help inform and broaden the ecosystem. All presentations are available for downloading.