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 ...

In a new video interview, Dr. Lesley Curtis, chair of the NIH Collaboratory Steering Committee, describes the importance of the four PRISM NIH Collaboratory Trials, which are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments. “We are particularly excited about the answers that will come out of ...

Evidence supporting the safety and effectiveness of treatments for chronic low back pain in older adults is lacking. Although acupuncture is known to be effective in younger adults, clinical trials of acupuncture have rarely included older adults, a population with greater comorbidity and different healthcare needs. The Pragmatic Trial of Acupuncture for Chronic Low Back Pain ...

Prescriptions for narcotic pain relief after surgery often lead to unintended prolonged opioid use. Nonpharmacologic approaches are effective and are recommended by clinical guidelines for postoperative pain but are rarely used as first-line or second-line therapy. The Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) pragmatic trial, a new NIH Collaboratory Demonstration Project, will ...

The recently completed Fibromyalgia Activity Study With TENS (FAST) established the efficacy of transcutaneous electrical nerve stimulation (TENS) for the treatment of musculoskeletal pain in patients with fibromyalgia. Physical therapists generally are trained in the use of TENS, but the technique is underused in clinical practice. The Fibromyalgia TENS in Physical Therapy Study (FM TIPS), a ...

In a new section of the Living Textbook on Building Partnerships to Ensure a Successful Trial, Kenneth Sands, the chief epidemiologist and chief patient safety officer at HCA, and Jonathan Perlin, the chief medical officer and president of clinical services at HCA, offer advice to investigators who wish to conduct pragmatic clinical trials. “Healthcare systems have ...

Chronic low back pain is among the most common conditions treated in primary care settings, yet treatment remains unsatisfactory for many patients. The American College of Physicians now recommends mindfulness-based stress reduction as initial treatment for patients with chronic low back pain. Yet, despite strong evidence of effectiveness, this therapy has not been integrated into ...

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the UG3 PRISM 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 ...

Want to know more about the goals and challenges of the NIH Collaboratory Trials? New downloadable handouts summarize the study aims, implementation lessons, and recent publications and presentations from these innovative pragmatic clinical trials. Study Snapshots are accessible from each NIH Collaboratory Trial page and the links below: ACP PEACE: Improving Advance Care Planning: Promoting Effective and ...

Recently, the Collaboratory Coordinating Center conducted video interviews describing the critical work being done in the NIH HEAL Initiative program to address the national opioid crisis. As part of this program, the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) NIH Collaboratory Trials present exciting new possibilities for answering ...

A roundtable discussion organized by the NIH Collaboratory in 2017 has produced consensus findings on the analysis and integration 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 ...

The NIH Collaboratory Distributed Research Network (DRN) is soliciting queries from investigators at academic institutions, federal agencies, and not-for-profit organizations. The DRN facilitates innovative, multi-institutional collaborations for large, longitudinal observational studies and can support randomized trials. A new handout from the NIH Collaboratory Coordinating Center summarizes the capabilities of the DRN and connects readers to more information, ...

The National Center for Complementary and Integrative Health (NCCIH) will hold an NIH Videocast on the recently reissued RFA-AT-20-004, “HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trials Optional).” The videocast, to be held on Monday, March 2, from 2:30 to 3:30 pm eastern, will ...

The Collaboratory has made available all the presentations from their recent PRISM Kickoff meeting held in Bethesda November 19-20, 2019. The PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program is a component of the NIH HEAL Initiative to address the opioid crisis. Highlights of Day 1 included welcoming the ...

The ADAPTABLE Supplement project team released user documentation and source code for an open-source tool that enables rapid assessment of concordance between electronic health record (EHR) data and information reported directly by patients. The tool is part of a larger effort supported by the NIH Collaboratory Coordinating Center to develop and test methods for integrating ...

Readers have a new way to navigate the NIH Collaboratory’s Living Textbook of Pragmatic Clinical Trials. A Table of Contents now offers a comprehensive overview of the Living Textbook’s evolving content on the design, conduct, and dissemination of pragmatic clinical trials embedded in healthcare systems. The Living Textbook is frequently updated with new content. Recent additions ...

Join us Friday, January 31st, for “Pragmatic Clinical Trials: How Do I Start?”—the first in our special 5-part Grand Rounds series focused on the Living Textbook. NIH Collaboratory investigators Dr. Greg Simon and Dr. Lesley Curtis will offer guidance on what researchers need to begin an embedded pragmatic clinical trial, including: Developing your research question Establishing close ...

Members of the NIH Collaboratory Distributed Research Network (DRN) have helped build DRNs for the Sentinel System, the NIH Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet). In a new article published online in Contemporary Clinical Trials Communications, they describe the key elements of successful DRNs, as well as methods, challenges, and solutions encountered ...

The NIH Collaboratory Coordinating Center has published a new Data and Resource Sharing Page on the Living Textbook, which is designed to share the data and resources generated by the NIH Collaboratory Trials. “As part of the Collaboratory’s commitment to sharing, all NIH Collaboratory Trials are expected to share data and resources, such as protocols, consent ...

As the National Library of Medicine (NLM) celebrates 20 years of ClinicalTrials.gov, a new multi-year initiative is underway to modernize and enhance the user experience of this public resource. To that end, NLM is seeking actionable input through a Request for Information (RFI) and will hold an informational webinar for stakeholders as well as a ...

NIH Collaboratory leadership and NIH Collaboratory Trial principal investigators, along with their colleagues, responded this week to the recently released Draft NIH Policy for Data Management and Sharing and supplemental draft guidance. The draft policy proposes that applicants for research funding submit a plan describing how scientific data will be managed and shared. “We applaud the ...

Registration opened on January 1 for the 13th Annual University of Pennsylvania Conference on Statistical Issues in Clinical Trials. The theme of this year’s conference is “Cluster Randomized Clinical Trials: Challenges and Opportunities.” The conference will be held on April 29 at the Smilow Center for Translational Research on the campus of the University of Pennsylvania Perelman ...

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, will reissue a funding opportunity announcement to solicit applications for the HEAL Initiative’s Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program. The NCCIH published its notice of intent to reissue the PRISM announcement to allow ...

Coming in 2020, the NIH Collaboratory will host a 5-part Grand Rounds Series focused on the Living Textbook. The series will feature Collaboratory expert speakers guiding the audience through the life cycle of an ePCT by way of the textbook—from idea to funding to implementation. The series begins January 31 with “Pragmatic Clinical Trials: How Do ...

The National Institute on Aging (NIA) IMbedded Pragmatic Alzheimer’s disease (AD) and AD Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory has launched a new website highlighting the project. The IMPACT Collaboratory recently invited applications for pilot grant funding for projects that aim to generate preliminary data necessary to design and conduct full-scale embedded pragmatic clinical trials ...

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the NIH Collaboratory Trials. So far this year, the NIH ...

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, intends to reissue Funding Opportunity Announcement (FOA) HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain To Reduce Opioid Prescribing (PRISM) (UG3/UH3 Clinical Trial Optional). This RFA solicits applications for phased cooperative research applications to conduct efficient, large-scale ...

Presentations from a recent seminar offered by the NIH Collaboratory in partnership with the American Society of Nephrology are now available on the Living Textbook. The seminar, Embedded Pragmatic Clinical Trials: Accelerating Evidence Generation in Nephrology, was held at ASN Kidney Week 2019. The sessions provide an introduction to concepts in the design of embedded ...

Two new studies from the NIH Collaboratory’s Distributed Research Network (DRN) demonstrated the feasibility of using administrative data and claims to define populations, identify outcomes, and generate hypotheses in support of pragmatic clinical trials and other prospective studies. In an analysis of data for 53,000,000 patients from 3 health insurers, researchers evaluated the feasibility of using claims to ...

The NIH Collaboratory welcomed 4 new NIH Collaboratory Trial teams last week during a kickoff meeting in Bethesda, Maryland. These pragmatic clinical trials embedded in healthcare systems are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the NIH HEAL Initiative to address ...

The NIH recently released a Draft NIH Policy for Data Management and Sharing and supplemental draft guidance for public comment. In the draft, the NIH reiterates its commitment to making available the results and products of the research it funds, and acknowledges that data sets come from a variety of sources that may have unique data ...

The NIH Health Care Systems Research Collaboratory program is welcoming new embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing as part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). At the same time, many of the Collaboratory’s early NIH Collaboratory Trials are completed and now publishing results. ...

In a study supported by the NIH Collaboratory, researchers found that imbalance in individual-level baseline covariates influences bias in the observed treatment effect in cluster randomized trials. Using race as an example, the study highlights the importance of reducing covariate imbalance in the design stage of cluster randomized trials and of using statistical analysis techniques ...

Six NIH Collaboratory Trials—ACP PEACE, EMBED, GGC4H, HiLo, Nudge, and PRIM-ER—have recently transitioned from the planning to implementation phase of their embedded pragmatic clinical trial (ePCT). During the transition, study teams reviewed and updated their ethics and regulatory meeting minutes from discussions with the Ethics and Regulatory Core. The minutes describe ethics and regulatory issues ...