The NIH Collaboratory recently convened a workshop to explore embedded pragmatic clinical trials comparing two or more therapeutic medical interventions. These “A vs B” trials are meant to test existing, viable treatment alternatives where there is uncertainty about which treatment is best in which populations. There are unique barriers that make these types of pragmatic ...

The National Institutes of Health (NIH) Office of Disease Prevention (ODP) needs your help to enhance the quality of research supported by the NIH. The ODP is building a directory of experts in research methods and study designs that can help NIH Scientific Review Officers identify the most appropriate reviewers for NIH research applications. Adding ...

In this episode of the NIH Collaboratory Grand Rounds podcast, Renee Mitchell, Terrie Reed, and Roseann White discuss the MDEpiNet RAPID and SPEED Projects. In their conversation with Dr. Adrian Hernandez, Renee, Terrie, and Roseann discuss the concept behind the projects, the collaborative nature, associated challenges, next phases, and the future. Listen to the episode here: Renee Mitchell, Terrie Reed, ...

In a new video, Drs. Wendy Weber and Dave Clark discuss the NIH-DoD-VA Pain Management Collaboratory, which is modeled after the NIH Health Care Systems Research Collaboratory. The Pain Management Collaboratory has a centralized Coordinating Center and is supporting a series of 11 pragmatic trials in military and veteran health care delivery organizations focusing on ...

In a new article in the Journal of General Internal Medicine, over 100 million person-years of curated claims data were evaluated to assess new rates and follow-up procedures for colorectal, breast, and cervical cancer. These observational data were collected from national and regional insurers participating in the NIH Collaboratory distributed research network. The proportion of ...

A panel funded by the Patient-Centered Outcomes Research Institute (PCORI) recently published recommendations for the oversight of patients who participate in research roles other than as “research subject.” Patients and caregivers participate in many roles, such as co-investigators, study personnel, and advisors in research studies, and this creates novel ethical and regulatory challenges. The panel ...

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Jeffrey Botkin and Dr. Consuelo Wilkins discuss returning individual research results to participants. In their conversation with Dr. Adrian Hernandez, Drs. Botkin and Wilkins emphasize the importance of returning results to participants, the present challenges, and hopes for the process in the next five years. For ...

In a new video, Dr. Greg Simon explains the intraclass correlation coefficient (ICC) with an analogy to a pie eating contest. The ICC is a descriptive statistic that measures the correlations among members of a group, and it is an important tool for cluster-randomized pragmatic trials because this calculation helps determine the sample size needed ...

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the new UG3 NIH Collaboratory Trials. These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH ...

In a new video, Dr. Wendy Weber, the Program Officer for the NIH Collaboratory Coordinating Center, provides some expert advice for investigators who are considering submitting an application for a pragmatic clinical trial to the NIH. “Don’t assume that the study panel is going to understand what pragmatic means. They may have their own completely different ...

The NIH Collaboratory is pleased to announce new training resources available on the Living Textbook. These resources are being shared with the research community to provide guidance about building partnerships with health systems and overcoming the challenges of conducting embedded pragmatic clinical trials (ePCTs). The materials reflect the knowledge, insight, and best practices acquired by ...

Kidney transplantation is the preferred treatment for patients with end-stage renal disease (ESRD), but an insufficient organ supply renders dialysis the only viable treatment option for most patients. Though clinical outcomes among patients receiving dialysis have improved modestly in recent years, annual rates of hospitalization and mortality remain unacceptably high, and quality of life is ...

Because many clinicians do not have the skill set to engage patients in conversations about advance care planning (ACP), many older Americans with advanced cancer receive aggressive interventions at the end of life that do not reflect their values, goals, and preferences. The ACP PEACE trial is investigating whether a comprehensive approach to ACP improves ...

Before the end of high school, more than half of all adolescents will use an illicit drug, about a quarter will meet the criteria for depression, and many others will engage in behaviors such as delinquency and violence. Guiding Good Choices is a universal evidence-based anticipatory guidance curriculum for parents of early adolescents that has ...

In the United States, half of persons 65 years and older have an emergency department visit in the last month of life, and three-quarters have an emergency department visit in the last 6 months of life. Admissions to intensive care units by emergency clinicians are on the rise, especially for older patients. Meanwhile, three-quarters of ...

More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management ...

The ADAPTABLE pragmatic trial relies on patients to report key information at baseline and throughout follow-up. To capture these data, ADAPTABLE investigators developed a LOINC (Logical Observation Identifiers Names and Codes) patient-reported item set, which is now publicly available. The development of the item set is part of the ADAPTABLE Supplement, an initiative funded by the ...

A tool used to rate how the design of a pragmatic clinical trial will influence the real-world applicability of its results can also be used in real time to assess the impact of changes in trial implementation, a recent study published in Trials found. When designing a pragmatic trial to test the effectiveness of an intervention under ...

The NIH Collaboratory is pleased to introduce the Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED). Led by co–principal investigators Dr. Ted Melnick and Dr. Gail D’Onofrio of Yale University, and supported by the National Institute on Drug Abuse, EMBED is a pragmatic, multicenter, group-randomized trial that will ...

In a recent video interview, NIH Collaboratory leaders Dr. Lesley Curtis, Dr. Adrian Hernandez, and Dr. Catherine Meyers share their enthusiasm for the Collaboratory’s 6 new NIH Collaboratory Trials. The projects include new areas of expertise, such as pediatrics, new digital technologies, and the Collaboratory’s first A vs B trial. “The new NIH Collaboratory Trials coming into ...

In a JAMA Viewpoint published online last week, NIH Collaboratory investigator Dr. Richard Platt and colleague Dr. Tracy Lieu discuss the value of “data enclaves” to facilitate information sharing in support of research, quality improvement, and public health reporting. Creating data enclaves allows health systems to share useful information from their clinical data without releasing the actual data. Data enclaves ...

The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Trial, were published online this week in JAMA Internal Medicine. The analysis found that colorectal cancer screening rates were higher in community clinics that implemented a mailed fecal immunochemical test (FIT) outreach program than ...

In a recent video interview, Dr. David Shurtleff, acting director of the National Center for Complementary and Integrative Health (NCCIH), discusses the unique work of the Collaboratory in bringing together multiple NIH Institutes and Centers to develop best practices, methods, guidance, and tools for conducting rigorous pragmatic research. “The Collaboratory has been transformative in how it’s ...

In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Steven Steinhubl discusses a digital and pragmatic clinical trial, mStops, that explores underdiagnosed Atrial Fibrillation in large health population. In his discussion with Dr. Lesley Curtis, Dr. Steinhubl discusses what lessons were learned through the study, what he found most surprising, and role patient engagement ...

Recently the Collaboratory added a sixth NIH Collaboratory Trial to the UG3 portfolio: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo). Read more about HiLo.

Check out the new program materials from the Collaboratory: Study information for the 6 new UG3 NIH Collaboratory Trials: ACP PEACE: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder GGC4H: Guiding Good Choices ...

Registration is open for the 3rd Seattle Symposium on Health Care Data Analytics. The symposium will bring together biostatisticians, health informaticists, epidemiologists, and other data scientists to discuss health research and methods that involve large health care databases. Experts involved in national research initiatives that use large health care databases will discuss methodological challenges encountered in this ...

 This post was updated on August 20, 2018. The NIH Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative NIH Collaboratory Trials. The new research awards, which are supported by 6 NIH institutes, centers, and offices, total $4.15 million for an initial 1-year planning phase and an ...

A new report in the Living Textbook describes results of a literature review of data standards and metadata standards for variables of interest to the ADAPTABLE trial. Based on the review, the authors recommend standards for ADAPTABLE, also known as the Aspirin Study, which is the first major randomized comparative effectiveness trial to be conducted ...

In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Michelle Mello discusses a study she and Dr. Steven Goodman recently conducted to determine how clinical trial participants think about having their participant-level data widely shared. In her discussion with Dr. Lesley Curtis, Dr. Mello discusses study results, what she found most surprising, and how ...

A recent editorial in JAMA highlights the mHealth Screening to Prevent Strokes (mSToPS) randomized clinical trial in a discussion of the strengths and challenges of pragmatic clinical trials. The mSToPS trial, which studied patients at increased risk of atrial fibrillation who used a self-applied electrocardiogram sensor patch, found that immediate monitoring, compared with delayed monitoring, led ...

In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Aaron McKethan discusses the idea of rethinking research with state-level data. Dr. McKethan serves as a faculty member in the Department of Population Health Sciences at Duke University and is the Chief Data and Analytics Officer for the NC Department of Health and Human Services. ...

NIA recently released an RFA for a new HCS Research Collaboratory focused on AD/ADRD, RFA-AG-19-009. “The purpose of this FOA is to solicit applications for the AD/ADRD Health Care Systems Research Collaboratory (“Collaboratory,” henceforth) to improve care for persons with dementia (PWD) and their caregivers through health systems. Health and long-term systems for this FOA are ...

In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Amy Abernethy discusses research at scale, with examples from Flatiron Health. In her discussion with moderator Adrian Hernandez, Dr. Abernethy focuses on the goals of Flatiron Health, approaches for building data-sets and underlying infrastructure, what’s next on the horizon for Flatiron Health, and more. Listen to ...

The upcoming AcademyHealth Annual Research Meeting, June 24-26, 2018, will feature a special session on Embedding Pragmatic Clinical Trials in Health Care Systems: Trials and Tribulations, Monday, June 25, at 5:15 pm, hosted by members of the Health Care Systems Interactions Core Working Group: Chair: Cathy Meyers, MD, NIH/NICCH Discussant: Eric B. Larson, MD, MPH, Kaiser Permanente ...

On June 4, the National Institutes of Health (NIH) released its first Strategic Plan for Data Science. The plan outlines steps the agency will take to modernize research data infrastructure and resources and to maximize the value of data generated by NIH-supported research. Data science challenges for NIH have evolved and grown rapidly since the launch ...

A recent study published in BMC Medicine found that many randomized controlled trials (RCTs) self-labeled as “pragmatic” were actually explanatory in nature, in that they assessed investigational medicines compared with placebo to test efficacy before licensing. Of the RCTs studied, one-third were pre-licensing, single-center, or placebo-controlled trials and thus not appropriately described as pragmatic. Appropriately describing ...

In a new episode of the Grand Rounds podcast which is now available, Dr. Rachael Fleurence, Executive Director of the National Evaluation System for health Technology Coordinating Center (NESTcc) and the Medical Device Innovation Consortium (MDIC), discusses the mission, challenges, and long term goals of NESTcc with moderator Dr. Adrian Hernandez. Dr. Fleurence describes how NESTcc is ...

In a new article, Dr. Vincent Mor, an NIH Collaboratory investigator, and Dr. Paul Wallace describe the history, current status, and opportunities for funding training in health services research (HSR). While the number of organizations seeking to solve problems with health services research has been expanding, direct government support for HSR is declining. The authors ...

On April 20, 2018, the Department of Health and Human Services and 15 other federal departments and agencies proposed a rule to delay both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). The Interim Final Rule initially announced a ...

NIH Collaboratory investigators Dr. Susan Mitchell and Dr. Vincent Mor coauthored an editorial for an upcoming issue of JAMDA highlighting the need for pragmatic trials of nonpharmacologic interventions in Alzheimer disease and related dementias. The editorial summarizes conclusions from a recent workshop at the National Institute on Aging (NIA), where experts discussed the state of ...

Interested in learning more about the complexities of designing and conducting embedded pragmatic clinical trials (ePCTs)? Now you can view and download the slide sets and handouts from the first NIH Collaboratory ePCT Training Workshop. Held on February 20-21, 2018, at Duke University, this pilot workshop offered training in the conduct of ePCTs to 27 ...

A new episode of the Grand Rounds podcast is now available, featuring Dr. George Hripcsak, Chair of the Bioinformatics Department at Columbia University. In this episode, Dr. Hripcsak discusses the Observational Health Data Sciences and Informatics (OHDSI) Program with moderator Dr. Adrian Hernandez, and describes the program’s vision to create accessible and reliable clinical evidence by ...

Registration is now open for a one-day workshop sponsored by the NIH Common Fund and organized by NIH Collaboratory thought leaders. The workshop, to be held on May 16, will focus on expanding the understanding of a specific type of pragmatic trial, the A vs. B trial, which compares two or more distinct therapeutic medical ...

Seeking to advance the study and practice of engagement in health research, the Patient-Centered Outcomes Research Institute (PCORI) recently launched the Engagement in Health Research Literature Explorer. Locating relevant research articles about engagement can be challenging because of a lack of standard terminology. The new tool searches a curated database of peer-reviewed literature on engagement. ...

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Robert Califf, former FDA Commissioner and current Director of Duke Forge. In this episode, Dr. Califf discusses with moderator Dr. Adrian Hernandez how the vast amount of information now available to people through cell ...

Congratulations to Dr. Lynn DeBar and the investigators of the Collaborative Care for Chronic Pain in Primary Care pragmatic trial for recently publishing their study design paper. One of the NIH Collaboratory Trials, the trial is designed to test whether a primary care–based behavioral intervention the Pain Program for Active Coping and Training (PPACT)—will provide ...

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Sean Tunis and Ellen Tambor of the Center for Medical Technology Policy (CMTP). In this episode, the speakers discuss with moderator Dr. Kevin Weinfurt their findings on clinician attitudes towards research participation, and how and ...

Robert Califf, MD, former FDA Commissioner and current Vice Chancellor for Health Data Science at Duke University School of Medicine, will present at NIH Collaboratory Grand Rounds on Friday, March 23 at 1 pm ET. The webinar will be broadcast live and is open to the public. Following the presentation, Dr. Califf will answer questions from ...

Using patient-centered outcomes research (PCOR) data requires balancing the need for sufficient private health information to support meaningful research with the need to protect patient privacy and autonomy. In support of this dual goal, The Office of the National Coordinator for Health Information Technology (ONC) has just released a document that provides a collection of ...