News

News

  • September 14, 2018: Tips for Submitting a Pragmatic Trial Application to 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 ...
  • September 10: NIH Collaboratory Launches New ePCT Training Resources 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 ...
  • September 7, 2018: Spotlight on a New Demonstration Project: HiLo 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 ...
  • September 6, 2018: Spotlight on a New Demonstration Project: ACP PEACE 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 ...
  • September 5, 2018: Spotlight on a New Demonstration Project: GGC4H 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 ...
  • September 4, 2018: Spotlight on a New Demonstration Project: PRIM-ER 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 ...
  • August 28, 2018: Spotlight on a New Demonstration Project: Nudge 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 ...
  • August 28, 2018: ADAPTABLE Patient-Reported Health Data Codes Now Available 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 ...
  • August 23, 2018: PROVEN Team Uses PRECIS-2 to Evaluate Ongoing Trial Implementation 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 ...
  • August 20, 2018: Spotlight on a New Demonstration Project: EMBED 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 ...
  • August 14, 2018: Interview With NIH Collaboratory Leadership Highlights New Demonstration Projects 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 Demonstration Projects. The projects include new areas of expertise, such as pediatrics, new digital technologies, and the Collaboratory’s first A vs B trial. “The new demonstration projects coming into the Collaboratory ...
  • August 13, 2018: JAMA Commentary Highlights the Value of Data Enclaves and Distributed Data Networks 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 ...
  • August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, 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 ...
  • August 9, 2018: New Interview with Dr. David Shurtleff about the NIH Collaboratory 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 ...
  • August 7, 2018: New Podcast: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Underdiagnosed Atrial Fibrillation in a Large Health Plan Population 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 ...
  • August 3: NIH Collaboratory Announces a Sixth New UG3 Demonstration Project Recently the Collaboratory added a sixth Demonstration Project to the UG3 portfolio: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo). Read more about HiLo.
  • July 30, 2018: Learn More About the New NIH Collaboratory Demonstration Projects Check out the new program materials from the Collaboratory: Study information for the 6 new UG3 Demonstration Projects: 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: Pragmatic Trial of Parent-Focused ...
  • July 30, 2018: Registration Open for 3rd Seattle Symposium on Health Care Data Analytics 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 ...
  • July 25, 2018: NIH Collaboratory Launches 5 New Demonstration Projects  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 Demonstration Projects. 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 estimated ...
  • July 23, 2018: New Report Summarizes Patient-Reported Health Data and Metadata Standards in the ADAPTABLE Trial 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 ...
  • July 17, 2018: New Podcast: Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing 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 ...
  • July 16, 2018: JAMA Editorial Highlights mSToPS Trial, Discusses Strengths and Challenges of Pragmatic Clinical Trials 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 ...
  • July 3, 2018: New Podcast: Rethinking University Research with State Data 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. ...
  • June 28, 2018: RFA for a New HCS Research Collaboratory 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 ...
  • June 22, 2018: New Podcast: Research at Scale – Exploring What is Possible with High-Quality Real-World Data. Examples from Flatiron Health. 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 ...
  • June 14, 2018: NIH Collaboratory Members to Host Session on Embedded PCTs at AcademyHealth Annual Research Meeting 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 ...
  • June 7, 2018: NIH Releases First Strategic Plan for Data Science 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 ...
  • June 4, 2018: New Article Explores Misleading Use of the Label “Pragmatic” for Some Randomized Clinical Trials 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 ...
  • May 23, 2018: New Podcast: Dr. Rachael Fleurence on Launching the NESTcc Data Network to Improve the Use of Real-World Evidence in the Medical Device Ecosystem 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 ...
  • May 5, 2018: New Article Explores Opportunities for Funding the Training of Future Health Services Researchers 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 ...
  • May 1, 2018: Proposal for 6-month Delay for Implementation of Revised Common Rule 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 ...
  • April 27, 2018: Collaboratory Investigators Pen Editorial Calling for Pragmatic Trials of Nonpharmacologic Dementia Interventions 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 ...
  • April 24, 2018: NIH Collaboratory ePCT Training Workshop Resources Now Available 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 ...
  • April 17, 2018: New Podcast: Dr. George Hripcsak on OHDSI and Drawing Reproducible Conclusions From Observational Clinical Data 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 ...
  • April 16, 2018: Registration Now Open for Workshop on Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions 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 ...
  • April 13, 2018: PCORI Launches Tool for Exploring Literature on Engagement in Health Research 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. ...
  • April 11, 2018: New Podcast: Dr. Robert Califf on Data Science in the Era of Data Ubiquity 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 ...
  • April 9, 2018: PPACT Study Design Paper Published 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 Demonstration Projects, the trial is designed to test whether a primary care–based behavioral intervention the Pain Program for Active Coping and Training (PPACT)—will ...
  • March 22, 2018: New Podcast: Dr. Sean Tunis and Ellen Tambor on Clinicians’ Views on Participating in CER/PCOR 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 ...
  • March 21, 2018: Dr. Rob Califf to Speak on Data Science at March 23 Grand Rounds 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 ...
  • March 15, 2018: New Resource for Understanding Ethical and Regulatory Architecture of Patient-Centered Outcomes Research Data 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 ...
  • March 14, 2018: Public Input on Patient-Reported Outcome Measures Due April 1 The Agency for Healthcare Research and Quality (AHRQ) is requesting information to help inform a competition in the fall to develop and implement user-friendly technical tools for the collection of patient-reported outcome (PRO) data. The AHRQ is interested in learning about experiences with physical function PRO measures that are currently in use in ambulatory care ...
  • March 7, 2018: FDA Offers Workshop on Submitting Draft Guidance on Patient Experience Data The FDA is conducting a public workshop on Monday, March 19, to obtain input from stakeholders—including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons—to inform the drafting of a patient-focused drug development guidance as required by the 21st Century Cures Act. Workshop attendees will discuss considerations for development ...
  • February 28, 2018: New Meeting Summary Examines How to Integrate Patient‐Reported Health Data for Pragmatic Research A recently released summary from the ADAPTABLE Roundtable Meeting explores ways to better understand the sets of circumstances and considerations that could guide when and how to gather and integrate patient-reported health data with other data sources in pragmatic trials. For outcomes that represent subjective experiences, such as pain, symptoms, and physical functioning, the patient is ...
  • February 22, 2017: NIH Collaboratory Launches First Embedded Pragmatic Clinical Trial Training Workshop On February 20-21, 2018, a group of 27 clinical investigators met in Durham to learn from the NIH Collaboratory about the design and conduct of embedded pragmatic clinical trials (ePCTs). Through the experiences of the NIH Collaboratory, much has been learned about how to launch and implement successful ePCTs. The workshop’s goal was to help ...
  • February 20, 2018: National Academies Release Workshop Summary on Real-World Evidence in Medical Product Development The National Academies of Sciences, Engineering, and Medicine released a summary of the first workshop in a 3-part series on the development and use of real-world evidence in medical product development. The report, Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives, focuses on the role of incentives in supporting the collection ...
  • February 19, 2018: New Podcast: Dr. Andrew Faucett on Considerations for the Return of Genomic Results The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Andrew Faucett of Geisinger. In this episode, Dr. Faucett speaks with moderator Dr. Lesley Curtis about the scalability of returning genomic research to clinicians and patients, considering issues like technical validity and sample identity in genetic variants. He also ...
  • February 15, 2018: Timely Tips from Demonstration Project Principal Investigators The NIH Collaboratory will soon welcome a new group of Demonstration Projects and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)­—to share tips and advice for investigators who ...
  • February 14, 2018: Grand Rounds Podcasts Now Available on iTunes The NIH Collaboratory is pleased to announce that Grand Rounds podcasts are now available on iTunes. These podcasts aim to give listeners a deeper understanding of topics discussed during Grand Rounds presentations through interviews with the speakers. Topics covered in past episodes include the IMPACT-Afib trial and the role of Sentinel, data and safety monitoring ...
  • February 7, 2018: In New Video, Drs. Susan Huang and Gloria Coronado Give Advice to Pragmatic Trial Investigators In the spring of 2018, the NIH Collaboratory will be welcoming a new set of Demonstration Projects and will help shepherd the new pragmatic trials through the piloting and implementation phases of their studies. In a new video in the Living Textbook, two of our seasoned principal investigators—Drs. Susan Huang and Gloria Coronado—give advice to ...

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Citation:

News: News. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/news/. Updated September 14, 2018.