Grand Rounds August 21: Adaptive Platform Trials: Scalable from Breast Cancer to COVID

Speaker:

Laura Esserman, MD, MBA
Director, UCSF Carol Franc Buck Breast Care Center
Alfred A. de Lorimier Endowed Chair in General Surgery
Professor of Surgery and Radiology, UCSF

Topic: Adaptive Platform Trials: Scalable from Breast Cancer to COVID
Date: Friday, August 21, 2020, 1:00-2:00 p.m. ET

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August 6, 2020: New Living Textbook Section Describes Rapid Approach for Implementation Assessments

A new section of the Living Textbook’s Dissemination and Implementation chapter describes how the Trauma Survivors Outcomes & Support (TSOS) pragmatic trial research team developed a rapid approach to implementation process assessments: the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE). Implementation assessments are typically time consuming and expensive, and the new approach embeds these procedures as part of the trial to increase efficiency and decrease cost.

Since its development within the NIH Health Care Systems Research Collaboratory, the RAPICE method has been used to address the Washington State COVID-19 outbreak to help rapidly identify primary and secondary COVID-19 prevention strategies that could be delivered using the TSOS care management platform.

For more information, see the April 19, 2019 Grand Rounds: Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims (Doug Zatzick, MD)

August 3, 2020: Study Using EMBED Data Finds Drop in Emergency Department Visits During COVID-19 Pandemic

An analysis of data collected as part of EMBED, an NIH Collaboratory Trial, found significant decreases in emergency department visits in 5 large healthcare systems in the early months of the COVID-19 pandemic in the United States.

The study was published online today in JAMA Internal Medicine.

In 24 emergency departments in Colorado, Connecticut, Massachusetts, New York, and North Carolina, the number of visits declined by 42% to 64%, doing so most rapidly as the public health emergency intensified in March. The study also found that hospital admissions from emergency departments began to increase as COVID-19 case rates increased at the local level.

Data from 4 of the 5 healthcare systems in the study were collected as part of EMBED, a pragmatic trial of prescribing practices for opioid use disorder in emergency departments. An amended study protocol enabled the researchers to collect the data as part of an effort to better understand the impact of the COVID-19 pandemic on trial enrollment.

Although the study could not identify the reasons for the trends, the researchers recommended that public health officials “emphasize the importance of continuing to visit the [emergency department] for serious symptoms, illnesses, and injuries that cannot be managed in other settings” and “provide guidance and resources to help patients determine the best place to receive care as the available health care capacity changes during the pandemic.”

EMBED is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and receives logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn more about the NIH Collaboratory Trials.

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

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

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)

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

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.

July 6, 2020: NIH Collaboratory EHR Workshop Podcast With Dr. Joshua Denny Now Available

The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. Part of a special Grand Rounds series on electronic health records (EHRs), “Real World Evidence: Contemporary Experience and Future Directions” follows an in-depth conversation between NIH Collaboratory PI Dr. Lesley Curtis and Dr. Joshua C. Denny, chief executive officer of the All of Us Research Program.

This discussion provides a deeper look into Denny’s May 8 Grand Rounds presentation with co-panelist Dr. Jacqueline Corrigan-Curay, JD, on advancing EHRs and the development of a health condition database by the NIH’s All of Us Program for multi-study use.

In this episode, you will learn more about:

  • Denny’s early experience with EHRs and the All of Us Research Program
  • The building of algorithms through an electronic medical records and genomics network
  • How the All of Us study is responding to the impact of the COVID-19 pandemic

June 8, 2020: NIA IMPACT Collaboratory to Host Special Grand Rounds on Pragmatic Responses to COVID-19 in Healthcare Systems

The NIA IMPACT Collaboratory will host a special edition of its Grand Rounds series to address pragmatic responses to the COVID-19 crisis among older adults in healthcare systems.

Dr. Lewis Lipsitz of Harvard Medical School and Drs. James Randolph and Elizabeth White of Brown University will present “COVID-19 Among Older Persons in Health Care Systems: Pragmatic Responses to the Crisis.” The NIA IMPACT Collaboratory is a national network of pragmatic clinical trials researchers advancing care for persons with dementia and their caregivers.

This free webinar will be held on Thursday, June 11, at 12:00 pm ET. Join the online meeting.

The NIA IMPACT Collaboratory is funded by a grant from the National Institute on Aging.

June 3, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Continues With the PCORnet COVID-19 Common Data Model

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. Thomas Carton of the Louisiana Health Institute, Dr. Keith Marsolo of Duke University, and Dr. Jason Block of Harvard Pilgrim Health Care Institute will present “PCORnet COVID-19 Common Data Model Design and Results.” The Grand Rounds session will be held on Friday, June 5, at 1:00 pm eastern. Join the online meeting.

Previous COVID-19 Grand Rounds:

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

Grand Rounds June 5: PCORnet COVID-19 Common Data Model Design and Results

Speakers:
Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

Keith Marsolo, PhD
Associate Professor
Department of Population Health Sciences
Duke Clinical Research Institute
Duke University School of Medicine

Jason Perry Block, MD, MPH
Associate Professor of Population Medicine
Department of Population Medicine
Harvard Pilgrim Health Care Institute
Harvard Medical School

Topic: PCORnet COVID-19 Common Data Model Design and Results
Date: Friday, June 5, 2020, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m7516d59dab184670d6fc892b1955b4eb

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 730 486 227
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 730 486 227

NOTE: For Toll-free users, the call-back (call me) services are also available.