The NIH Collaboratory is using its ePCT Grand Rounds platform for a special webinar series on electronic health records (EHRs). The series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, is highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic ...

The NIH Office of Disease Prevention will continue its Methods: Mind the Gap webinar series on July 14 with “Overview of Statistical Models for the Design and Analysis of Stepped Wedge Cluster Randomized Trials.” Dr. Fan Li of Yale University, a longtime participant in the NIH Collaboratory’s Biostatistics and Study Design Core Working Group, will ...

Join us Friday, June 19, for “Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials,” the fourth session in our special 5-part Grand Rounds series focused on the Living Textbook. NIH Collaboratory investigators Drs. Liz Turner, Patrick Heagerty, and David Murray will discuss statistical design considerations, choosing the right design, and implications for the analysis. Topics ...

A co–principal investigator of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), a recently completed NIH Collaboratory Trial, will report the main outcomes of the study during NIH Collaboratory Grand Rounds this week. The PROVEN team developed video-assisted decision support tools for advance care planning that showed efficacy in small randomized controlled trials. The ...

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 ...

A new chapter in the Living Textbook describes how patient-reported outcomes (PROs) are used in different settings and how to choose and integrate PRO measures into an embedded pragmatic clinical trial. The chapter also characterizes PRO use within the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) of the ...

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 ...

A new chapter in the Living Textbook describes special considerations and best practices for designing and evaluating clinical decision support (CDS) for use in embedded pragmatic clinical trials (ePCTs). CDS functionality can support recruitment, enable the delivery of a new intervention, or be the intervention under evaluation. The main topics of the chapter are: Introduction to Clinical ...

The annual update of the Living Textbook has brought new content and organization to the Experimental Designs and Analysis Plan chapters. We invite you to explore these chapters and the external resources linked from the resources sidebar in each section. The NIH Collaboratory Coordinating Center regularly refreshes content in the Living Textbook to improve the robust ...

The NIH Collaboratory is using its ePCT Grand Rounds platform for a special webinar series on electronic health records (EHRs). The series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, is highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic ...

On May 1, 2020, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) announced a final rule to implement provisions of the 21st Century Cures Act. The final rule is intended to advance interoperability and support the access, exchange, and use of electronic health ...

The NIH Collaboratory regularly refreshes content in the Living Textbook in order to offer a robust collection of resources to the wider research community about how to plan and implement a pragmatic clinical trial. We invite you to explore recent additions to the introductory chapter What Is a Pragmatic Clinical Trial? Highlights include information on the ...

Drs. Adrian Hernandez, Greg Simon, and Rich Platt of the NIH Collaboratory have authored two new sections of the Living Textbook as part of an ongoing commitment to sharing resources and data. Incentive Structure and Citations for Data Sets This section calls for a revision of the appointment, promotion, and tenure (APT) process to incorporate effective data ...

The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. “Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?” features a deep-dive discussion between NIH Collaboratory PI Dr. Lesley Curtis and Dr. Robert Califf, Head of Strategy and Policy at Verily Life Sciences and Google ...

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 ...

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 ...

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. Derek Angus of the University of Pittsburgh will present “Optimizing Learning While Doing: The REMAP-CAP Adaptive Platform ...

The NIH Collaboratory is using its ePCT Grand Rounds platform for a special webinar series on electronic health records (EHRs). The series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, is highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic ...

In case you missed the May 1 keynote address by Robert M. Califf, MD, MACC, you can now listen to the recorded webinar and Q&A. Dr. Califf, head of strategy and policy for Verily Life Sciences and Google Health, kicked off the Collaboratory’s Grand Rounds workshop series, Advances at the Intersection of Digital Health, Electronic ...

Clinicians and researchers at Seattle’s Harborview Medical Center documented their experiences in the early weeks of the COVID-19 outbreak in King County, Washington. Their report offers lessons from clinical and research personnel, patients, and peer interventionists during the evolving pandemic response in an early US COVID-19 epicenter. The article, published online in Psychiatry, presents a case ...

The NIH Collaboratory will use its ePCT Grand Rounds platform on Friday, May 1, to launch a special workshop series on electronic health records (EHRs). The webinar series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, will highlight advances in digital health, new approaches and evolving standards for EHRs, ...

The NIA IMPACT Collaboratory has announced 2 new funding opportunities to support embedded pragmatic clinical trials (ePCTs) of nonpharmacological interventions within healthcare systems to improve the care of people living with Alzheimer disease and related dementias and their care partners. Applications that address dementia care for people of all backgrounds and that promote health equity ...

On April 22 and 23, 2020, more than 90 participants joined the online Steering Committee meeting to hear about the evolution of the embedded PCT (ePCT) ecosystem, discuss how to strengthen partnerships across the ecosystem, and identify approaches and lessons that will help inform and broaden the ecosystem. All presentations are available for downloading.

The NIA IMPACT Collaboratory will host a special edition of its Grand Rounds series to address the COVID-19 crisis in nursing homes. Drs. David Grabowski and Susan Mitchell of Harvard Medical School and Dr. Vince Mor of Brown University will present “COVID-19 in Nursing Homes: Pragmatic Research Responses to the Crisis.” Drs. Mitchell and Mor are ...

The NIH Office of Behavioral and Social Sciences Research, with other NIH Institutes, Centers, and Offices, has issued a notice of special interest calling for research on stigma in the context of chronic pain management and opioid use or opioid use disorder. The NIH will support administrative supplements to current awards and cooperative agreements under ...

In 2019, NIH Health Care Systems Research Collaboratory held a comprehensive workshop to explore and discuss statistical issues encountered with embedded pragmatic clinical trials (ePCTs). The new Workshop Summary describes panel discussions with the principal investigators and statisticians of NIH Collaboratory Trials and the challenges and solutions encountered during the design and analysis of their ...

A new article in JAMA Cardiology discusses the design of ADAPTABLE, a pragmatic clinical trial (PCT) which strives to answer a three-decade-old question with great potential significance for public health. ADAPTABLE is the first PCT to use many of the data-driven and patient-centric capabilities of the National Patient-Centered Clinical Research Network (PCORnet). Researchers in ADAPTABLE pursued ...

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, Prof. Martin Landray of the University of Oxford will present “The RECOVERY Trial: A UK National Platform Trial ...

NIH Collaboratory Grand Rounds will launch a special workshop series next month to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials. The series will highlight advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. The webinar series, Advances at the Intersection ...

In an article published today in the New England Journal of Medicine, NIH Collaboratory investigators Drs. Greg Simon, Rich Platt, and Adrian Hernandez describe why it has been so challenging to meet the National Academy of Medicine’s 2020 goal for the development of a learning health system. If the goal had been met, 90% of clinical ...

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 ...

A new chapter in the Living Textbook provides expert advice for investigators considering using mobile technologies in pragmatic clinical trials. The chapter outlines many of the possibilities, advantages, and challenges associated with mobile health (mHealth) interventions, with a particular focus on design and evaluation of these programs in pragmatic clinical trials. “We will illustrate many design ...

The NIH Collaboratory’s Biostatistics and Study Design Core Working Group supports the Demonstration Projects by offering guidance on their statistical plans and study designs during the planning phase and documenting new statistical and methodological issues that arise during planning and implementation. At the NIH Collaboratory PRISM kickoff meeting in November, we spoke with the leaders of ...

The Collaboratory is pleased to share a new resource with the clinical research community. The Quick Start Guide for Investigators is designed to help users navigate the steps of planning and launching an embedded pragmatic clinical trial (ePCT) in a real-world healthcare delivery setting. For each step, the guide highlights practical information found in the ...

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. Sean Collins will present “Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized ...

In a recent video interview, Dr. Eric Larson, chair of the Collaboratory’s Health Care Systems Interactions Core, and Leah Tuzzio, research associate, describe ways the Core is supporting the PRISM Demonstration Projects. A priority for conducting embedded PCTs (ePCTs) is establishing strong, sustainable relationships between the study team and health system leadership, clinicians, and staff. For ...

The Collaboratory recently interviewed Kevin Weinfurt, PhD, co-chair of the Patient-Centered Outcomes Core working group, to hear about the Core’s plans for supporting the PRISM Demonstration Projects. In this video, Dr. Weinfurt says one challenge for embedded trials of pain is in obtaining high-quality, complete patient-reported outcome data on pain intensity and functioning. Along with ...

The NIH Collaboratory’s Electronic Health Records (EHR) Core Working Group supports the Demonstration Projects by facilitating multisite research collaborations between investigators and data stewards and by developing tools and approaches for the secondary use of EHR data for clinical research. We spoke with the leaders of the EHR Core, Dr. Rachel Richesson and Dr. Keith Marsolo, ...

Using its popular Grand Rounds platform, the NIH Collaboratory Coordinating Center has launched a new effort to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency. Last week on Grand Rounds, we kicked off a vital new COVID-19–focused webinar series with “Clinical Trials in the Time of ...

Update (April 27, 2020): As a result of the COVID-19 public health emergency, AcademyHealth has canceled the in-person Annual Research Meeting, previously scheduled for June 13-16 in Boston, and all adjunct events. Read the announcement. The NIH Collaboratory is partnering with AcademyHealth to offer a full-day pre-conference workshop at the 2020 Annual Research Meeting in Boston. ...

A new document from the Ethics and Regulatory Core is available that provides considerations around determining which individuals or groups are engaged in research in pragmatic clinical trials (PCTs). Developed for investigators designing and conducting PCTs as well as institutional review boards overseeing them, the document introduces these questions in relation to research subjects, study ...

The new Monitoring Intervention Fidelity and Adaptations chapter of the Living Textbook was developed to introduce how to evaluate changes that may be encountered while conducting an embedded pragmatic clinical trial (ePCT). For example, a health system might experience competing clinical initiatives; turnover in leadership, clinicians, or staff; changes in technologies; new clinical practice guidelines; ...

The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. “Creating a Learning Health System Through Randomization” features a discussion between the NIH Collaboratory’s Dr. Adrian Hernandez and Grand Rounds presenter Dr. Leora Horwitz of NYU Langone Health. This discussion provides a deeper look into Horwitz’s March 6th Grand ...

The HiLo study team has activated its first wave of study sites and started enrollment. The first 5 participants were enrolled by DaVita Southpoint Dialysis in Durham, North Carolina, in the first week after site activation. HiLo, an NIH Collaboratory Demonstration Project, is a cluster randomized trial comparing the effects of pursuing high vs low serum ...

In a recent PCT Grand Rounds, Drs. Naggie, Hernandez, and Perakslis of Duke University discussed the impacts of the COVID-19 outbreak on the conduct of clinical trials. The panel described the status of COVID-19, its impact on trials currently begin conducted, some key questions to consider, and potential solutions and approaches. A brief Q&A followed ...

The NIH Collaboratory Biostatistics and Study Design Core has created an Intraclass Correlation Coefficient (ICC) Cheat Sheet to provide an introductory description of the ICC, which is important for the design and analysis of cluster-randomized trials. “The intraclass correlation coefficient (ICC) is a descriptive statistic that describes the extent to which outcomes 1) within each cluster ...

The NIH today announced new guidance describing the flexibility available to recipients who are conducting NIH-funded clinical trials or human subject studies affected by the COVID-19 public health emergency. The new guidance addresses the safety of research participants and research staff, delays in research progress, and unanticipated costs. Last week, the NIH created a new public ...

Recently, the NIH Collaboratory Coordinating Center conducted a video interview with Drs. Wendy Weber, Cathy Meyers, and Lesley Curtis to discuss the NIH Collaboratory Data Sharing Policy, including special requirements for the NIH Helping to End Addiction Long-term (HEAL) Initiative projects, and tips for sharing data and resources. “For all the Demonstration Projects, primary data sets ...

A new public web page offers guidance and resources for NIH applicants and recipients in response to the COVID-19 public health emergency declared by the Secretary of Health and Human Services. Information for NIH Applicants and Recipients includes information about application deadlines, proposal submission and award management, and flexibility available to applicants and recipients. The page ...

In a recent video interview, Dr. Helene Langevin, director of the National Center for Complementary and Integrative Health at the NIH, discusses the important work of the NIH Collaboratory in sharing knowledge and lessons learned as well as in harnessing expertise across the 19 Demonstration Projects it supports. “It is very important that we understand ...