The NIH Collaboratory recently welcomed 2 new embedded pragmatic clinical trials on pain management and reducing opioid prescribing. The projects are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program as part of the NIH’s Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠. The ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. David Boulware continue the discussion of the complexities of conducting virtual clinical trials during the COVID-19 pandemic. The full October 30 Grand Rounds webinar with Dr. Boulware is also available.

On November 9, 2020, the NIH Collaboratory held a virtual onboarding meeting to welcome two new UG3 NIH Collaboratory Trials to its Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program. More than 60 participants joined to welcome the new PRISM projects; provide introductions, an overview of the Collaboratory ...

The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the NIH Collaboratory’s Living Textbook. They include CDEs for adult acute pain, adult ...

NIH Collaboratory investigators Drs. Greg Simon, Rachel Richesson, and Adrian Hernandez published an opinion piece in Healthcare arguing that clinical trials investigators should align their dissemination processes with industry-sponsored trials to favor speed, and that years-long delays in dissemination reduce the relevance of clinical research. “Delays reduce the ability for researchers to apply trial findings to ...

In a qualitative analysis of the PRIM-ER pilot study, receiving the support of institutional leadership and leveraging existing institutional processes emerged as keys to successfully implementing the study intervention. The results of the analysis were published last week in the Journal of General Internal Medicine. PRIM-ER, an NIH Collaboratory Trial, is a stepped-wedge cluster randomized clinical trial ...

Ellen Tambor, MA, and colleagues have recently published in Learning Health Systems a PCORI-funded study of clinician perspectives on participating in pragmatic clinical trials (PCTs). In One size does not fit all: Insights for engaging front-line clinicians in pragmatic clinical trials, the authors wanted to better understand how clinicians view their role in research in ...

In this week’s COVID-19 Grand Rounds session, Dr. David Boulware of the University of Minnesota will present “Lessons From Virtual Trials in the Time of a Pandemic: Minnesota Hydroxychloroquine Experience.” The Grand Rounds session will be held on Friday, October 30, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is using ...

The NIA IMPACT Collaboratory, in collaboration with the Alzheimer’s Association, is seeking nominations for its Lived Experience Panel. Panel members will provide feedback to researchers and engage in discussions about methods and strategies for studying nonpharmacological interventions to improve the quality of life of people living with dementia and their family members and caregivers. Read more ...

A team of frontline healthcare workers in a level I trauma center recorded observations and summaries of conversations with other healthcare workers and patients about the impacts of a local surge in COVID-19 cases on care delivery. The ethnographic study at Seattle’s Harborview Medical Center identified impacts in 4 thematic areas, including impacts on procedures, providers, ...

The NIH Collaboratory’s PCT Grand Rounds will highlight an implementation framework for outpatient clinical decision support. In this week’s session, Drs. Patrick O’Connor and JoAnn Sperl-Hillen of HealthPartners Institute will present “Outpatient Clinical Decision Support – An Evidence-Based Implementation Framework.” The Grand Rounds session will be held on Friday, October 23, at 1:00 pm eastern. Join the ...

The All of Us Research Program has issued a new funding opportunity seeking partnerships with national, state, and local engagement partners to recruit and engage participants in the landmark NIH program. Through these partnerships, All of Us aims to create bidirectional and co-equal relationships that engage communities that have historically been underrepresented in biomedical research. All ...

In this week’s COVID-19 Grand Rounds session, Dr. Danny Benjamin of Duke University will present “Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative.” The Grand Rounds session will be held on Friday, October 16, at 1:00 pm eastern. Join the online meeting. The ABC Science Collaborative is a ...

The NIH Collaboratory is adding 2 new NIH Collaboratory Trials to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. The projects are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the Helping to End Addiction Long-Term Initiative℠, or NIH ...

The principal investigator of HiLo, an NIH Collaboratory Trial, will report on the study’s progress in the next session of PCT Grand Rounds on October 9. HiLo is a pragmatic clinical trial of higher vs lower serum phosphate targets in patients undergoing hemodialysis. The project entered the implementation phase last fall. Dr. Myles Wolfe of Duke ...

The NIH Collaboratory is pleased to announce that the four PRISM NIH Collaboratory Trials received approval to transition from the planning phase to the implementation phase of their studies. These embedded PCTs (ePCTs) are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments. Congratulations to the PIs and study ...

Dr. 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 ...

The NIA IMPACT Collaboratory this week announced 2 new resources to support the design and conduct of embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners. The IMPACT Knowledge Repository is a searchable collection of NIA IMPACT Collaboratory resources, including all publications, podcasts, grand rounds, videos, and training modules developed by ...

In this week’s COVID-19 Grand Rounds session, Dr. Rick Bright and Dr. Rachael Fleurence of the National Institutes of Health will present “Accelerating the Nation’s COVID-19 Testing Capacity: An Update From the NIH’s RADx Program.” The Grand Rounds session will be held on Friday, September 25, at 1:00 pm eastern. Join the online meeting. The NIH ...

A recent article in Ethics & Human Research describes the experience and management of regulatory noncompliance during the conduct of a large, multisite embedded pragmatic clinical trial (ePCT). The Trauma Survivors Outcomes and Support (TSOS), an NIH Collaboratory Trial, was a stepped-wedge, cluster-randomized clinical trial of a collaborative care intervention for injured patients with symptoms ...

The principal investigator of the Trauma Survivors Outcomes and Support (TSOS) pragmatic clinical trial, an NIH Collaboratory Trial, will announce the study’s primary results in the next session of PCT Grand Rounds on September 18. Dr. Doug Zatzick of the University of Washington will present “The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Clinical Trial: Effectiveness ...

We are pleased to announce a new collection of short educational videos that highlight essential content in the NIH Collaboratory’s Living Textbook of Pragmatic Clinical Trials. The videos are drawn from our 2020 Living Textbook Grand Rounds series. The series featured expert speakers guiding the audience through the life cycle of an embedded pragmatic clinical ...

In this week’s COVID-19 Grand Rounds session, Dr. Gordon Bernard of Vanderbilt University and Dr. Sonia Thomas of RTI International will present “Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies.” The Grand Rounds session will be held on Friday, September 9, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory ...

Inserting benchmark prevalence information about common imaging findings into spine image reports did not reduce spine-related healthcare utilization but did slightly reduce subsequent opioid prescriptions. These were the main findings of the Lumbar Imaging With Reporting of Epidemiology (LIRE) trial, an NIH Collaboratory Trial. The report was published this month in JAMA Network Open. Spine imaging often ...

The NIH Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, “Assessing Fitness-for-Use of Real World Data Sources,” describes several approaches for determining whether real-world data are fit for their intended purpose in pragmatic clinical trials. “Real-world data” are collected for clinical care, insurance claims, administrative purposes, registries, or are ...

A recent article in Learning Health Systems from members of the NIH Collaboratory’s Ethics and Regulatory Core and colleagues describes key themes from stakeholder interviews about collateral findings in pragmatic clinical trials (PCTs). A collateral finding is information that emerges in a PCT that is unrelated to the primary research question but which may have ...

In a study supported by the NIH Collaboratory, researchers developed and validated a new sample size formula for detecting heterogeneity of treatment effect in cluster randomized trials. The work was published this month in Statistics in Medicine. Cluster randomization is frequently used in pragmatic clinical trials embedded in healthcare systems. Although cluster randomized trials are typically ...

The NIH Collaboratory this week published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, “Acquiring Real-World Data,” outlines strategies for obtaining real-world data for use in research. “Real-world data” include data relating to the health status of a patient or the delivery of healthcare services. Common sources include electronic health records ...

Members of the NIH Collaboratory’s Ethics and Regulatory Core, and colleagues, recently published an article in the Journal of General Internal Medicine highlighting potential challenges in managing collateral findings in pragmatic clinical trials (PCTs). A collateral finding is information that emerges in a PCT that is unrelated to the primary research question but which may ...

In this week’s COVID-19 Grand Rounds session, Dr. Laura Esserman of the University of California, San Francisco will present “Adaptive Platform Trials: Scalable From Breast Cancer to COVID.” The Grand Rounds session will be held on Friday, August 21, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is using its popular ...

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 ...

The NIA IMPACT Collaboratory is soliciting letters of intent for several 1-year pilot grant awards of up to $175,000. The awards will support pilot projects that aim to generate preliminary data for the design and conduct of full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and ...

The co–principal investigators of the Nonpharmacologic Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM) trial, an NIH Collaboratory Trial, will be featured in the next session of NIH Collaboratory Grand Rounds on August 14. The project is 1 of 4 NIH Collaboratory Trials funded through the NIH HEAL Initiative’s Pragmatic and Implementation Studies for ...

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 ...