PCORI

July 16, 2021: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials? (David Chambers, DPhil; Amanda Midboe, PhD; Anne Trontell, MD, MPH)

Posted on by terren.green@duke.edu

Speakers

Panel:
Amanda Midboe, PhD
Center for Innovation to Implementation
U.S. Department of Veterans Affairs
Chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory

Anne Trontell, MD, MPH
Associate Director
Clinical Effectiveness and Decision Science Program
Patient-Centered Outcomes Research Institute (PCORI)

Guest Moderator:
David Chambers, DPhil
Deputy Director for Implementation Science
Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Topic

Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?

Keywords

Dissemination research; Implementation research; Participant engagement; Participant diversity; Health equity; PCORI; Ci2i

Key Points

  • The study of methods to best implement and disseminate interventions in diverse groups is crucial to the ultimate goal of benefiting population health.

  • Patient-centered outcomes are important measures to determine the total effectiveness of any health intervention.

  • By engaging the community in which research takes place and treating patients as partners in the development of implementation strategies, we increase diverse participation and improve patient retention.

  • Targeted recruitment strategies that leverage administrative data increase diverse study participation.

  • Outreach materials and methods that are tailored and adapted to the local culture and colloquial language are effective in engaging diverse populations.

Discussion Themes

Are there any ethical issues raised when underserved populations receive monetary incentives to participate in research trials?

What are the challenges of identifying diverse potential participants from the medical record or administrative data?

Do efforts to increase diversity in the study team improve the engagement and retention of a diverse study population?

Read more about methods to increase diversity in implementation trials at the Patient-Centered Outcomes Research Institute (PCORI) and the Center for Innovation to Implementation (Ci2i).

Tags

#pctGR, @Collaboratory1

July 13, 2021: Diversity Workshop Continues With Lessons From Implementation Trials

Posted on by Damon Seils

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?”—Dr. David Chambers of the National Cancer Institute (NCI) will facilitate a discussion about lessons from implementation science for maximizing participant diversity in pragmatic clinical trials. Dr. Chambers is deputy director for implementation science in the Office of the Director in the NCI’s Division of Cancer Control and Population Sciences.

The panelists will include:

  • Dr. Amanda Midboe of the US Department of Veterans Affairs, chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory
  • Dr. Anne Trontell, associate director in the Clinical Effectiveness and Decision Science Program at the Patient-Centered Outcomes Research Institute (PCORI)

The Grand Rounds session will be held on Friday, July 16, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

Headshots of Drs. David Chambers, Amanda Midboe, and Anne Trontell
Left to right: Drs. David Chambers, Amanda Midboe, and Anne Trontell

July 8, 2021: New Living Textbook Section on Intervention Functions and Forms

Posted on by Gina Uhlenbrauck

Readers are invited to visit a recent addition to the chapter Monitoring Intervention Fidelity and Adaptations in the Living Textbook. The new content offers considerations for study teams who are preparing to track the fidelity of an embedded—and potentially complex—clinical intervention. Considerations include identifying which features of the intervention (i.e., functions) are so essential to its effectiveness that modifying them could negatively affect the study’s outcomes and impact. Equally important is knowing which elements (i.e., forms) can be adapted to accommodate contextual factors or local needs without affecting fidelity. The section provides an introduction and link to methodology standards for complex interventions recently developed by the Patient-Centered Outcomes Research Institute (PCORI).

“Functions of a complex intervention represent a purpose or goal, while forms are the tools or processes used to achieve a function. Identifying forms and functions allows adapted complex interventions to retain a level of standardization and integrity in design.” (Hill et al. 2020)

December 8, 2020: PCORI to Issue Funding Announcement for Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes

Posted on by Damon Seils

The Patient-Centered Outcomes Research Institute (PCORI) will issue a funding announcement in January for pragmatic clinical studies to evaluate patient-centered outcomes. A total of $90 million will be available in the funding cycle to support individual awards of up to $10 million in direct costs with a maximum project duration of 5 years.

More from the preannouncement:

PCORI seeks to fund clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare system-level approaches to managing care; or eliminating health or healthcare disparities. Randomized study designs are strongly encouraged but not required.

Proposed studies must address critical clinical choices faced by patients, their caregivers, clinicians, or delivery systems. They must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups.

The PCORI funding announcement will open on Tuesday, January 5, 2021, with more information about the funding opportunity.

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.

Tags

#pctGR, @Collaboratory1

September 30, 2020: PCORI’s Nakela Cook to Offer a Look Ahead in PCT Grand Rounds

Posted on by Damon Seils

Photograph of Dr. Nakela CookDr. Nakela Cook, executive director of the Patient-Centered Outcomes Research Institute (PCORI), will present “Driving Toward Health Impact: Our Journey and Path Forward” during the NIH Collaboratory’s PCT Grand Rounds.

The Grand Rounds session will be held on Friday, October 2, at 1:00 pm eastern. Join the online meeting.

Since 2010, PCORI has funded more than $2 billion in research to help patients, caregivers, and clinicians make informed healthcare decisions and to improve healthcare delivery and outcomes.

September 16-17: PCORI 2020 Virtual Annual Meeting – Accelerating Impact on Care and Patient-Centered Outcomes

Registration is now open for PCORI’s sixth Annual Meeting, Accelerating Impact on Care and Patient-Centered Outcomes, being held virtually September 16-17. Join this FREE event celebrating PCORI’s 10-year anniversary and discuss how to answer the research questions of the future.

The meeting will highlight results from several PCORI-funded studies and explore how we can shorten the time from research to improved health for patients. During the meeting, attendees will:

  • Learn about our efforts to disseminate research findings
  • Network with others
  • Examine PCORI’s emphasis on engagement
  • Explore participation in developing our research agenda
  • Listen to powerful, inspiring keynote speakers

REGISTER NOW for one session or the entire meeting.

For more information, visit the PCORI Virtual Annual Meeting website and follow #PCORI2020.

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 14, 2020: Healthcare Innovation Highlights Launch of NIH Collaboratory’s EHR Workshop Grand Rounds Series

Posted on by Gina Uhlenbrauck

An article on the Healthcare Innovation website last week highlighted the launch of the NIH Collaboratory’s special Grand Rounds series on electronic health records (EHRs). The article discusses a presentation by Dr. Robert Califf, head of strategy and policy for Verily Life Sciences and Google Health, who envisioned how the healthcare system can learn from innovations being implementing during the COVID-19 emergency. Dr. Califf gave the opening keynote address for the EHR workshop series.

The article mentions the new Healthcare Worker Exposure Response and Outcomes (HERO) registry, funded by the Patient-Centered Outcomes Research Institute (PCORI), and the RECOVERY Trial, a national platform trial in the United Kingdom. Both of these COVID-19 studies were recently featured on NIH Collaboratory Grand Rounds.

Read the full article and hear Dr. Califf’s keynote presentation.

The EHR Workshop Grand Rounds series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, will continue on May 29. Previous and upcoming presentations in the series include:

April 15, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Continues With Discussion of HERO Program for Healthcare Workers

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, leaders of the Patient-Centered Outcomes Research Institute (PCORI) and investigators from the Healthcare Worker Exposure Response and Outcomes (HERO) registry and the HERO-HCQ randomized clinical trial will present “The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence.” The Grand Rounds session will be held on Friday, April 17, at 1:00 pm eastern. Join the online meeting.

Previous COVID-19 Grand Rounds:

Recent news announcements:

We will continue to share new research, resources, and guidance as they become available.