COVID-19

March 23, 2021: EMBED Team Reports Widespread Worsening of the Opioid Epidemic in 2020

Posted on by Damon Seils

In an analysis of data collected as part of EMBED, an NIH Collaboratory Demonstration Project, the rate of opioid overdose visits per 100 all-cause visits to emergency departments rose nearly 30% in 2020. The absolute number of opioid overdose visits increased by more than 10%, even while visits for other life-threatening conditions declined. The findings provide insight into the widespread worsening of the opioid epidemic during the COVID-19 pandemic in the United States.

The paper was published ahead of print this month in the Annals of Emergency Medicine.

The study accessed data from 25 emergency departments in Alabama, Colorado, Connecticut, Massachusetts, North Carolina, and Rhode Island. Five of the 6 healthcare systems in the study are participating in 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.

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 Demonstration Projects.

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

March 19, 2021: HERO-Learning Together about Vaccines for SARS-CoV-2 (Emily O’Brien, PhD; Robert Califf, MD)

Posted on by Gina Uhlenbrauck

Speakers

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
 
Robert M. Califf, MD, MACC
Head of Clinical Policy and Strategy
Verily Life Sciences and Google Health

Topic

HERO-Learning Together about Vaccines for SARS-CoV-2

Keywords

COVID-19; Vaccine confidence; Side effects; Postmarketing surveillance; Long-term vaccine safety; Virus variants; PCORI; HERO Registry

Key Points

  • In the United States to date, more than 100 million doses of COVID-19 vaccine have been administered. Yet there remains concern about the increase in variants of the coronavirus.
  • Postmarket evidence generation around COVID-19 vaccines is critically important to understanding the long-term safety of vaccines and building confidence around their use.
  • A “pod” is the group of people you live with or relate to as family and have regular household contact with at least once per week for the past 3 months.

Discussion Themes

What does it mean to be a “safe vaccine”?

We’re still learning about how families are navigating the psychosocial aspects of this pandemic.

Over time, manual processes will be replaced by algorithms and automated systems. But we need to develop digital technologies that support human interactions in health.

What will be the key issues around COVID-19 in 2022?

HERO-TOGETHER is a paid observational research study for people aged 18 and older working in healthcare who have received a COVID-19 vaccine. Eligible participants include anyone who works in a setting where people receive healthcare. Read more about the HERO Program and how to join the registry.

Tags

#pctGR, #HEROTOGETHER, @Collaboratory1, @heroesresearch

March 16, 2021: Drs. Emily O’Brien and Robert Califf Will Discuss HERO Collaboration in Special COVID-19 Grand Rounds

Posted on by Damon Seils

In this week’s COVID-19 Grand Rounds session, Dr. Emily O’Brien of Duke University and Dr. Robert Califf of Verily Life Sciences and Google Health will present “HERO—Learning Together About Vaccines for SARS-CoV-2.” The Duke Clinical Research Institute and Verily are using the Healthcare Worker Exposure Response & Outcomes (HERO) Registry and its community of participants and researchers to gain long-term insights about the COVID-19 vaccine developed by Pfizer and BioNTech, including real-world safety data.

The Grand Rounds session will be held on Friday, March 19 at 1:00 pm eastern. Join the online meeting.

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.

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

March 12, 2021: Lessons Learned from the Gates MRI Virtual COVID-19 Trial (Mohamed Bassyouni, PharmD; Jintanat Ananworanich, MD, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Mohamed Bassyouni, PharmD
Product Development Program Leader
Bill and Melinda Gates Medical Research Institute
Cambridge, MA
 
Jintanat Ananworanich, MD, PhD
Clinical Development Leader
Bill and Melinda Gates Medical Research Institute
Cambridge, MA

Topic

Lessons Learned from the Gates MRI Virtual COVID-19 Trial

Keywords

COVID-19; Virtual trial; Gates Medical Research Institute (MRI); Underserved populations; Health outcomes; Treatment safety and efficacy; Decentralized trial

Key Points

  • The goal of this study was to conduct a randomized controlled, adaptive platform trial to evaluate safety and efficacy of interventions for high-risk people with mild COVID-19 disease.
  • A key feature of the virtual trial was the development of a “COVID trial in a box.” This innovative method involved a single shipment of the study materials—including the study drug, lab sample kits, pulse oximeter, and PPE—directly to study participants’ homes.
  • The study evaluated multiple strategies for participant identification and outreach. Challenges included finding a better approach to engage minority communities; having better access for potential participants to be screened for COVID-19; increasing participation in the elderly population.

Discussion Themes

100% remote trials are possible and are especially crucial during a pandemic.

How did the study use social medial for virtual screening?

Did you do exit interviews with participants to get feedback on outreach and study design? 

Were alternatives to eConsent offered to patients who may have had technical difficulty with electronic apps or platforms?

Read more at the Gates Medical Research Institute website.

Tags

#pctGR, @Collaboratory1

March 9, 2021: COVID-19 Grand Rounds Continues With the Gates MRI Virtual COVID-19 Trial

Posted on by Damon Seils

Drs. Mohamed Bassyouni and Jintanat AnanworanichIn this week’s COVID-19 Grand Rounds session, Drs. Mohamed Bassyouni and Jintanat Ananworanich of the Bill and Melinda Gates Medical Research Institute will present “Lessons Learned From the Gates MRI Virtual COVID-19 Trial.” The Grand Rounds session will be held on Friday, March 12, at 1:00 pm eastern. Join the online meeting.

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.

 

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

Podcast March 1, 2021: Beyond Politics: Promoting COVID Vaccination in the United States (Kevin Schulman, MD)

Posted on by Gina Uhlenbrauck

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez speaks with Dr. Kevin Schulman of Stanford about strategies for promoting widespread COVID-19 vaccination in the United States.

Click on the recording below to listen to the podcast.

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

For alerts about new episodes, subscribe free on Apple Podcasts or SoundCloud.

Read the transcript.

Grand Rounds March 19: HERO–Learning Together about Vaccines for SARS-CoV-2

Speakers:

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine

Robert M. Califf, MD, MACC
Head of Clinical Policy and Strategy
Verily Life Sciences and Google Health

Topic: HERO–Learning Together about Vaccines for SARS-CoV-2
Date: Friday, March 19, 2021, 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=m60b64f1826bed9d8f0b16c759c4fdcb0

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: 120 398 9257
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 398 9257

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

March 2, 2021: Grand Rounds Continues With Challenges of DSMBs in COVID-19 Vaccine Trials

Posted on by Damon Seils

Prof. Susan EllenbergIn this week’s COVID-19 Grand Rounds session, Dr. Susan Ellenberg of the University of Pennsylvania, will present “Data and Safety Monitoring Boards for Trials of COVID-19 Vaccines: The Challenges.” The Grand Rounds session will be held on Friday, March 5, at 1:00 pm eastern. Join the online meeting.

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.

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

February 16, 2021: NIH Collaboratory COVID-19 Grand Rounds Looks Beyond Politics in Promoting Vaccination

Posted on by Damon Seils

Photograph of Dr. Kevin SchulmanIn this week’s COVID-19 Grand Rounds session, Dr. Kevin Schulman of Stanford University will present “Beyond Politics: Promoting COVID Vaccination in the US.” The Grand Rounds session will be held on Friday, February 19, at 1:00 pm eastern. Join the online meeting.

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.

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