September 30, 2016: Dig If You Will the Picture of the NIH Collaboratory

September 30, 2016: Dig If You Will the Picture of the NIH Collaboratory


Dig If You Will the Picture of the NIH Collaboratory


Lesley Curtis, PhD, Professor in Medicine, and Director of the Center for Pragmatic Health Services at Duke Clinical Research Institute

Kevin P. Weinfurt, PhD, Co-Director of the Program for Empirical Bioethics, and Professor, Psychiatry and Behavioral Sciences at Duke University

Adrian Hernandez, MD, MHS, Associate Professor of Medicine, Cardiology, at Duke University School of Medicine


Pragmatic clinical trial; PCTs; NIH; Healthcare systems; Learning healthcare system; NIH Collaboratory; Demonstration projects; Dissemination; Implementation

Key Points

  • The NIH Health Care Systems Research Collaboratory’s mission is to “strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.” The Collaboratory advances this vision in continued collaborations with PCORI, CTSA, CTTI, PCORnet, the Precision Medicine Initiative, and MDEpiNet.
  • Year 4 of the NIH Collaboratory has seen progress in the Demonstration Projects: 3 multiple chronic condition PCTs began their implementation phase (TSOS, PROVEN, ICD-Pieces); 4 PCTs continue enrollment (STOP CRC, TiME, SPOT, PPACT); and 2 PCTs have completed enrollment (ABATE Infection, LIRE).
  • Year 4 updates also include publication of 71 manuscripts and 48 presentations/abstracts including a special issue on ethics and regulatory approaches for PCTs; an issue devoted to the ethics of research in usual care settings; an article on approaches for PCTs in the ICD-10 transition; several articles on biostatistical guidance for PCTs; and an article on the value of stakeholder engagement in the learning healthcare system.
  • Upcoming dissemination activities will involve a restructure of the Living Textbook and more tools and resources for data monitoring committees, patient-reported outcomes, and data sharing.

Discussion Themes

How do you design a pragmatic trial with dissemination and implementation in mind? What constitutes successful implementation of findings? How long for evidence to change clinical practice?

What are the challenges of doing PCTs in non-integrated health systems, especially around convincing leadership that PCTs should be integral to their mission?

How will the efforts of the NIH Collaboratory affect considerations for PCTs at other NIH Institutes and Centers?

What initiatives are taking place to create a methods framework for clinician engagement in PCTs?

For More Information

For the latest updates and publications, visit the websites of the NIH Collaboratory’s 9 Demonstration Projects and 7 Core Working Groups.

#PCORnet, #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork