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 new section of the Living Textbook’s Dissemination and Implementation chapter describes how the Trauma Survivors Outcomes & Support (TSOS) pragmatic trial research team developed a rapid approach to implementation process assessments: the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE). Implementation assessments are typically time consuming and expensive, and the new approach embeds these procedures ...

Members of the NIH Collaboratory Electronic Health Records Core have authored 2 new sections of the Living Textbook chapter Using Electronic Health Record Data in Pragmatic Clinical Trials: Interoperability This section describes efforts to support interoperability and the sharing of patient data across care teams and organizations, including the creation the United States Core Data for Interoperability ...

An analysis of data collected as part of EMBED, an NIH Collaboratory Trial, found significant decreases in emergency department visits in 5 large healthcare systems in the early months of the COVID-19 pandemic in the United States. The study was published online today in JAMA Internal Medicine. In 24 emergency departments in Colorado, Connecticut, Massachusetts, New York, ...

A new report from an NIH Collaboratory roundtable discussion held in 2017 discusses considerations for the capture of patient-reported health (PRH) data in clinical trials. The report is part of an effort by the ADAPTABLE Supplement project team “to address best practices for capturing PRH data in pragmatic studies and optimal analytic approaches for integrating ...

A co–principal investigator of the Fibromyalgia TENS in Physical Therapy Study (FM TIPS), an NIH Collaboratory Trial supported by the NIH HEAL Initiative, will be featured in the next session of NIH Collaboratory Grand Rounds on July 24. The project is the first of the NIH Collaboratory Trials funded through the Pragmatic and Implementation Studies ...

The prevalence of diagnosed Alzheimer disease and related dementias (ADRD) is lower in Medicare Advantage health insurance plans than in traditional fee-for-service Medicare, according to a new analysis of data from the NIH Collaboratory Distributed Research Network (DRN). The study was published this month in Alzheimer’s & Dementia. Much of the current understanding about the characteristics and ...

Judith Carrithers and Jeremy Sugarman, co-chairs of the NIH Collaboratory’s Ethics and Regulatory Core, recently published an article in the journal Learning Health Systems that examines the NIH’s Certificate of Confidentiality (CoC) policy for NIH-funded human subjects research. Since October 1, 2017, the CoC is issued automatically and applies to all biomedical, behavioral, clinical, and ...

Join us Friday, July 17, for “Choosing What to Measure and Making It Happen: Your Keys to Pragmatic Trial Success,” the final session in our special 5-part Grand Rounds series focused on the Living Textbook of Pragmatic Clinical Trials. NIH Collaboratory investigators Drs. Rachel Richesson and Devon Check will discuss endpoints and outcome measures in ...

Watch the recent Grand Rounds webinar presented by Dr. Ken Gersing of the National Center for Advancing Translational Sciences and Dr. Robert Star of the National Institute of Diabetes and Digestive and Kidney Diseases to learn more about the COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C). The N3C initiative aims to build ...

In 2012, the NIH Common Fund established the NIH Health Care Systems Research Collaboratory. The goal of the program is to improve the way clinical trials are conducted by creating an infrastructure for collaborative research with healthcare systems. The NIH Collaboratory launched with a Coordinating Center, Core Working Groups, and NIH Collaboratory Trials to conduct ...

The NIH Collaboratory this week published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, “Electronic Health Records-Based Phenotyping,” provides an overview of considerations for identifying, defining, and evaluating computable phenotypes for use with electronic health records (EHRs). EHR-based phenotyping is an important strategy in large-scale pragmatic clinical trials, because these studies ...

The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. This conversation, led by Dr. Wendy Weber of the National Center for Complementary and Integrative Health, reflects on the NIH Collaboratory’s special EHR workshop Grand Rounds series, “Advances at the Intersection of Digital Health, Electronic Health Records, and ...

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. Ken Gersing of the National Center for Advancing Translational Sciences and Dr. Robert Star of the National ...

Congratulations to Drs. Vincent Mor, Susan Mitchell, and Angelo Volandes and their team for the publication of their article in JAMA Internal Medicine reporting the primary results of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial. PROVEN was the first large-scale embedded pragmatic clinical trial conducted in nursing homes. The ...

The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. Part of a special Grand Rounds series on electronic health records (EHRs), “Real World Evidence: Contemporary Experience and Future Directions” follows an in-depth conversation between NIH Collaboratory PI Dr. Lesley Curtis and Dr. Joshua C. Denny, chief executive ...

Members of the National Institute on Aging (NIA) IMPACT Collaboratory (Imbedded Pragmatic Alzheimer’s Disease Clinical Trials) recently contributed 10 articles to a special issue of the Journal of the American Geriatrics Society. The articles support the IMPACT Collaboratory’s mission to “build the nation’s capacity to conduct ePCTs within healthcare systems for ...

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 ...