health analytics

February 5, 2021: Generating High-Quality Evidence During a Pandemic: The Brazilian COALITION Experience (Renato Lopes, MD, MHS, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Renato D. Lopes, MD, MHS, PhD
Professor of Medicine
Division of Cardiology
Duke University Medical Center
Duke Clinical Research Institute
Brazilian Clinical Research Institute

Topic

Generating High-Quality Evidence During a Pandemic: The Brazilian COALITION Experience

Keywords

COVID-19; Patient outcomes; Cardiology; Randomized clinical trials; COALITION; Levels of evidence

Key Points

  • The SARS-CoV-2 infection affects the cardiovascular system and is associated with complications such as myocardial ischemia, myocarditis, arrhythmias, and thromboembolic events. These manifestations result mainly from the intense systemic inflammatory response and disorders of the coagulation system. 
  • The COALITION collaborative includes several major Brazilian hospitals and research networks with the aim of accelerating multicenter randomized controlled trials that generate high-quality evidence to guide the treatment of patients with COVID-19.
  • To move toward a world in which most clinical decisions are supported by high-quality evidence requires structural changes in the clinical trials ecosystem.

Discussion Themes

How did you overcome contractual and regulatory concerns to execute your trials?

Instead of “publish or perish,” it should be “collaborate or perish.” Collaboration is the key to surviving in modern academic medicine.

Read more about the need for high-quality evidence to treat COVID-19 patients in Anticoagulation in COVID-19: It Is Time for High-Quality Evidence (J Am Coll Cardiol, 2020)

Tags

#pctGR, @Collaboratory1

January 29, 2021: The COVID-19 Citizen Science Study (Gregory M. Marcus, MD, MAS)

Posted on by Gina Uhlenbrauck

Speaker

Gregory M. Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic

The COVID-19 Citizen Science Study

Keywords

Eureka digital research platform; COVID-19 infections; Mobile health; Risk factors; Citizen science; Geolocation; Participant engagement

Key Points

  • Eureka is an NIH-supported digital research platform built to use mobile health technology to combat the novel coronavirus, focusing on identifying risk factors for infection, transmission, and severity of disease that may inform best practices.
  • Eureka is also intended to serve as a platform for collaborating investigators to answer their own research questions.
  • As a citizen science project, any adult with a smartphone can participate and contribute information. Nearly 50,000 participants have enrolled to date.

Discussion Themes

The COVID-19 Citizen Science website provides data visualizations that show how people answered the survey questions. A study blog through the app is used to translate key information to participants.

Will this project be collaborating with other entities that are potentially overlapping in terms of their COVID-19 applications?

Best practices in mHealth include keeping it simple, avoiding over-explaining, listening to participants, and providing a feedback pathway.

Learn more about the Eureka platform. The smartphone app is available under the name “UCSF Eureka Research.”

Tags

#pctGR, @Collaboratory1  

September 11, 2020: Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (Gordon Bernard, MD; Sonia Thomas, DrPH)

Posted on by Gina Uhlenbrauck

Speakers

Gordon R. Bernard, MD
CONNECTS ACC Science Unit P
Professor of Medicine
Executive Vice President for Research
Senior Associate Dean for Clinical Science
Vanderbilt University Medical Center

Sonia Thomas, DrPH
CONNECTS ACC Principal Investigator
Senior Research Statistician
RTI International

Topic

Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies

Keywords

COVID-19; CONNECTS; NHLBI; Collaborative research; Data sharing; Adaptive trials; Data standardization; ACTIV; Therapeutic agent prioritization

Key Points

  • The Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) is a research partnership coordinated by the Research Triangle Institute, Vanderbilt University Medical Center, and the National Heart, Lung, and Blood Institute (NHLBI) of the NIH.
  • CONNECTS aims to build on existing clinical research networks to better understand the risk of severe illness from COVID-19 and to identify therapies that will slow or halt the disease progression and speed recovery. Studies will enroll participants with health conditions that are known to increase their risk for severe complications from COVID-19.
  • The immediate goal is to design and implement master protocol-driven adaptive clinical trials, including outpatient, inpatient, and recovering master protocols.
  • CONNECTS is part of a larger ecosystem in the Department of Health and Human Services that includes the FDA, CDC, BARDA, Operation Warp Speed, and NIH. More than 34 trial networks and 1,000 sites are participating in CONNECTS.

Discussion Themes

Are the CONNECTS resources, such as the common data elements manual, draft protocols, and case report forms, publicly available?

In your effort to reach underrepresented communities, have you considered collaborating with Historically Black Colleges and Universities (HBCUs), particularly those that conduct health research?

While COVID-19 is providing you with plenty to focus on, do you see the potential for sustainability of CONNECTS beyond this pandemic?

Read more about CONNECTS.

Tags

#pctGR, @Collaboratory1

August 11, 2020: Grand Rounds Webinar Discusses the Democratization of Medical Research

Posted on by Gina Uhlenbrauck

A recent Grand Rounds webinar presented by C. Michael Gibson, MS, MD, described how open access, patient empowerment, social media, and digital health are transforming clinical trials. Dr. Gibson is a professor of medicine at Harvard Medical School and president and CEO of Baim and PERFUSE Research Institutes.

Among the key points:

  • The COVID-19 pandemic has been a call to arms to physicians to combat not only the virus but the misinformation.
  • As the internet is replacing the printing press, “copyleft” is replacing copyright in this new open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information.
  • In this new world of clinical research, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.
  • Patient-empowered trials have the potential to provide more generalizable study results and to lead to patient-specific predictions through use of artificial intelligence.

Watch the complete webinar and download the slides.

Read more in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (Gibson, JAMA Cardiology, 2017) and learn about the Heartline Study as an example of a “giga trial.”

August 7, 2020: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research (C. Michael Gibson, MS, MD)

Posted on by Gina Uhlenbrauck

Speaker

C. Michael Gibson, MS, MD
Professor of Medicine
Harvard Medical School
President and CEO
Baim and PERFUSE Research Institutes

Topic

The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research

Keywords

Clinical research; Open access; Social media; Artificial intelligence; Heartline study; WikiDoc; WikiPatient

Key Points

  • As the internet is replacing the printing press, “copyleft” is replacing copyright in the open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information from huge volumes of data.
  • Social media and open access during the COVID-19 pandemic has meant that physicians are citizen journalists, innovators, activists, and educators.
  • In this new world, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.

Discussion Themes

The COVID-19 pandemic has been a call to arms to clinicians to combat not only the virus but the misinformation. As educators we must set the path and not allow uninformed people to take control.

Enabling patient-empowered trials has the potential for more generalizable study results and can lead to patient-specific predictions through use of artificial intelligence.

How do we validate the quality of open-access data and reports that are not peer-reviewed?

How can we diminish the hazards of skewed research outcomes arising from trial participant conversations on social media?

Read more from C. Michael Gibson in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (JAMA Cardiology 2017).

Tags

#pctGR, @Collaboratory1

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

July 8, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Continues With the National COVID Cohort Collaborative Data Enclave

Posted on by Damon Seils

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

In this week’s COVID-19 Grand Rounds session, 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 will present “COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C).” The Grand Rounds session will be held on Friday, July 10, at 1:00 pm eastern. Join the online meeting.

Drs. Gersing and Star will discuss the recent launch by the NIH of a centralized data repository and analytics platform, the N3C Data Enclave, to store and study large quantities of medical record data from people diagnosed with COVID-19 in the United States.

Previous COVID-19 Grand Rounds:

For more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

June 26, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment (Keith Marsolo, PhD; Teresa Zayas-Cabán, PhD; George (Holt) Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Guest Moderator:
Keith Marsolo, PhD
Associate Professor, Population Health Sciences
Duke University

Panel:
Teresa Zayas-Cabán, PhD
Chief Scientist
Office of the National Coordinator for Health Information Technology
Office of the Secretary, DHHS

George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovations

Christopher A. Longhurst, MD, MS
CIO and Associate CMO, Quality/Safety
Professor of Pediatrics and Medicine
UC San Diego Health

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

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment

Keywords

Embedded PCTs; Electronic health records; EHR; Digital health; Data interoperability; Clinical decision support; Information technology

Key Points

  • A defining feature of the 19 NIH Collaboratory embedded pragmatic clinical trials is their use of the EHR, whether for eligibility screening, intervention delivery, and/or outcome assessment.
  • As an example, the ICD-Pieces NIH Collaboratory Trial showed that a standard set of EHR data can be used to identify patients. The study involved a diverse set of health systems, and the study team overcame many IT challenges, including integrating data from 3 different EHR systems.
  • It is possible to implement a system-wide data warehouse, as the University of California has done across its 5 academic medical centers.

Discussion Themes

The vision is to ensure that healthcare systems are able to learn from every patient, at every visit, every time.

A common challenge for trials embedded in healthcare delivery is access to operational IT expertise and the relative priority in those environments. How can we more effectively partner with our IT colleagues in these trials?

The U.S. Department of Health and Human Services released a comprehensive strategy to reduce the regulatory and administrative burden related to the use of health IT, including EHRs. Visit HealthIt.gov for more information.

Tags

#pctGR, @Collaboratory1

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.