health outcomes

October 16, 2020: Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative (Danny Benjamin, MD, PhD; Kanecia Zimmerman, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Danny Benjamin, MD, PhD
Kiser-Arena Distinguished Professor of Pediatrics, Duke University
Chair, Pediatric Trials Network
Deputy Director, Duke Clinical Research Institute

Kanecia O. Zimmerman, MD, MPH
Associate Professor of Pediatrics
Co-chair, ABC Science Collaborative
Duke University School of Medicine

Topic

Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative

Keywords

COVID-19; ABC Science Collaborative; Public school administration; Health disparities; Infection mitigation; Risk-benefit ratio; Community engagement

Key Points

  • The ABC Science Collaborative is a program that pairs scientists and physicians with school and community leaders to help understand the most current and relevant information about COVID-19. The program uses a data-driven approach to help school leaders make informed decisions about returning to school, using data from their own communities, with the goal of keeping teachers, children, and their local communities healthy and safe.
  • School boards, superintendents, principals, staff, and families are essential stakeholders in the ABC Science Collaborative.
  • Science shows that bringing kids back to school can be a success—if done the right way, including adherence to mask-wearing, hand hygiene, and physical distancing. Leadership support and implementing a coordinated, detailed plan are crucial to a successful approach.

Discussion Themes

The real power of the ABC Science Collaborative is the partnership between the researchers and stakeholders and their commitment to study the outcomes—and learn—together.

With scarce school resources, it’s better to maximize what has been shown to work in an interior environment, such as boosting adherence to masking and hand hygiene.

It could be said that “an ounce of data on COVID-19 provides more than an ounce of prevention.”

For resources and information, visit the ABC Science Collaborative website.

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#pctGR, @Collaboratory1

October 2, 2020: Driving Toward Health Impact: Our Journey and Path Forward (Nakela Cook, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Nakela L. Cook, MD, MPH
Executive Director
Patient-Centered Outcomes Research Institute (PCORI)

Topic

Driving Toward Health Impact: Our Journey and Path Forward

Keywords

PCORI; Health outcomes; Health disparities; Patient-centered research; Comparative clinical effectiveness; COVID-19; Maternal health

Key Points

  • Despite improvements in health, disparities and variation in care remain—especially underscored by the unprecedented COVID-19 pandemic.
  • PCORI funds studies that can help patients and those who care for them make better informed healthcare choices.
  • PCORI has funded the HERO Registry to assess COVID-19 exposure responses and outcomes within the community of healthcare workers. Other research support is targeted toward vulnerable populations, healthcare delivery, and emerging health trends.
  • With PCORI 2.0, new funding will be available for large-scale, high-impact comparative effectiveness trials. Each study will include an initial phase to determine the feasibility and viability of the study and maximize the likelihood of success during the full-scale phase.

Discussion Themes

What are your observations regarding COVID-19’s impact on health, healthcare, and research that you think will be critical for PCORI's strategy? What will bring about the necessary innovations to the system?

Addressing maternal health disparities is a high priority in PCORI 2.0. The next phase will also expand PCORI’s role in collecting and generating relevant evidence and focusing on a deliberate and transparent process for implementation.

How will PCORI broaden its reach to reduce outcome disparities among people with disabilities?

Read more about PCORI.

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#pctGR, @Collaboratory1

September 25, 2020: Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program (Rick Bright, PhD; Rachael Fleurence, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Rick Bright, PhD
Senior Advisor to the NIH Director

Rachael Fleurence, PhD
Special Assistant to the NIH Director for COVID-19 Diagnostics

Topic

Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program

Keywords

National Institutes of Health; COVID-19; Rapid Acceleration of Diagnostics (RADx); COVID-19 testing protocols; Innovative technologies; Coronavirus testing

Key Points

  • The NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.
  • RADx is creating programs to rapidly scale-up testing across the country and enhance access to those most in need. Newer technologies offer user-friendly designs with lower cost and increased accessibility at home and at the point of care.
  • Deploying the right tests at the right time to the right people will be critical to managing the pandemic until a vaccine is available and beyond. Testing will still be necessary after the vaccine becomes available.

Discussion Themes

The supply chain continues to be a challenge in COVID-19 testing procedures, for example the availability of plastic tips and swabs. However, barriers are driving innovations such as saliva technologies and extraction-less approaches.

Are there efforts underway to link testing data from disparate sources such as EHR clinical data, administrative claims data, antibody testing, symptom trackers/COVID-19 registries?

A new goal will be implementing the real-time matching of COVID-19 hot spots with available testing.

Read more about the NIH’s RADx program and in a special report in New England Journal of Medicine.

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#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 21, 2020: Adaptive Platform Trials: Scalable from Breast Cancer to COVID (Laura Esserman, MD, MBA)

Posted on by Gina Uhlenbrauck

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

Keywords

COVID-19; Adaptive platform trial; Study design; Learning healthcare system; Collaborative research

Key Points

  • Adaptive trial design is an innovative, collaborative approach with the potential to maximize learning about treatments so as to prioritize therapeutic agents and drive better patient outcomes.
  • Adaptive platform trials are designed to identify early endpoints that can be captured in the course of care. Multiple agents are evaluated simultaneously, and those with a potential for big impact are advanced quickly.
  • As a “learning engine,” adaptive platform trials could be used to accelerate high-impact treatments for COVID-19 and future pandemics.

Discussion Themes

Essential to an adaptive platform trial are checklists of data and nimble EHR tools that evolve as the disease evolves.

What is the process to monitor for and make the decision to modify the standard of care backbone?

Read more about adaptive platform trials at the I-SPY Trials website and a recent Grand Rounds presentation, Optimized Learning While Doing: The REMAP-CAP Adaptive Platform Trial.

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#pctGR, @Collaboratory1

August 14, 2020: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (Jon Tilburt, MD; Andrea Cheville, MD)

Posted on by Gina Uhlenbrauck

Speakers

Jon Tilburt, MD
Professor of Medicine and Biomedical Ethics
Mayo Clinic

Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic

Topic

Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial

Keywords

PRISM; NIH Heal Initiative; NOHARM; Postoperative care; Nonpharmacologic pain care (NPPC); Stepped wedge; Cluster-randomized trial; Electronic health records (EHRs); Patient engagement; Clinical decision support

Key Points

  • The Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) NIH Collaboratory Trial is completing its pilot phase. This embedded, stepped-wedge PCT will test a sustainable strategy in perioperative, nonpharmacologic pain management that preserves patient function, honors patient values, and maintains the availability of opioids as a last resort.
  • NOHARM is a pragmatic, EHR-integrated intervention that bundles a portal-based conversation guide that captures patient preferences for postsurgical pain care and a clinician-directed decision support tool.
  • Nonpharmacologic pain care management options include walking, yoga, tai chi, acupressure, massage, meditation, and relaxation.

Discussion Themes

Opioids are insufficient in postsurgical care. Guidelines recommend nonpharmacologic pain care (NPPC), but there have not been studies showing how to make NPPC more viable.

The COVID-19 pandemic caused disruption in scheduled surgeries and also air travel, which precluded on-the-ground support at two study sites. However, the team was able to adjust recruitment methods during the pilot phase.

What was the team’s proactive process in working with the IRB in order to obtain a waiver of consent?

The NOHARM intervention has sustained high-level institutional support despite the impact of COVID-19.

Read more about the NOHARM NIH Collaboratory Trial.

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#pctGR, @Collaboratory1

August 18, 2020: Grand Rounds Podcast With C. Michael Gibson on the Democratization of Medicine Is Available

Posted on by Gina Uhlenbrauck

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. C. Michael Gibson continue the discussion of how medicine and medical research are being transformed through patient empowerment and information sharing. Their conversation provides a deeper look into the power of social media and the role of physicians as citizen journalists, innovators, activists, and educators. The full August 7 Grand Rounds webinar with Dr. Gibson is also available.

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 31, 2020: Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative (Sudha Raman, PhD, MA; John Sheehan, PhD, MBA, RPh)

Posted on by Gina Uhlenbrauck

Speakers

Sudha Raman, PhD, MA
Assistant Professor
Department of Population Health Sciences
Duke University

John Sheehan, PhD, MBA, RPh
Senior Director, Value and Evidence (HEOR) Neuroscience
Janssen Scientific Affairs, LLC

Topic

Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative

Keywords

Clinical Trials Transformation Initiative (CTTI); Real-world data (RWD); Recruitment planning; EHR; Eligibility criteria; Fit-for-purpose data

Key Points

  • Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected by a variety of sources.
  • CTTI provides recent recommendations, resources, and case studies that highlight actionable tools and best practices for evaluating and using real-world data (RWD) in clinical trial recruitment activities:
    • General principles for using RWD
    • Using RWD to plan eligibility criteria
    • Using RWD to support recruitment
    • Enhancing RWD capabilities for the research enterprise
  • Using RWD from data sources such as electronic health records and claims data brings challenges for completeness, accuracy, and generalizability of the data.
  • RWD holds the potential to increase patient eligibility and enrollment as well as reduce recruitment timelines.

Discussion Themes

Insights from RWD should be sought early in the product lifecycle and include context from patients and sites.

One challenge of RWD data sources is finding appropriate databases for the disease area of interest, especially for trials of rare diseases.

Are there lessons learned about when using RWD becomes prohibitive or too expensive?

Read and download CTTI’s recommendations for using RWD. Learn more about FDA’s guidance for real-world data and real-world evidence. A publication is available about the health plan recruitment method used in the ADAPTABLE aspirin study.

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#pctGR, @Collaboratory1