December 7, 2017: Dr. Greg Simon Explains Individual, Cluster, and Stepped-Wedge Randomization in a New Prop Video

In a new video in the Living Textbook, Dr. Greg Simon describes the differences between individual, cluster, and stepped-wedge randomization using props, including marbles, Play-Doh, and glassware.

“In the end, it’s all about randomly assigning who gets which treatment, or who gets which treatment when, so that we’re able to make some un-biased judgement about which treatment is really better.” —Greg Simon, MD

December 5, 2017: Dr. Greg Simon Answers the Question: What is a Pragmatic Trial?

In a new video for the Living Textbook, Dr. Greg Simon uses props—including Play-Doh and toys—to define pragmatic trials and their importance in clinical research.

“Pragmatic clinical trials are about helping doctors make better decisions to take care of their patients.” —Greg Simon, MD

November 17, 2017: New Video in Living Textbook Explores Data Sharing and Embedded Research

As part of an article published in Annals of Internal Medicine, Dr. Greg Simon created a short video in which he describes concerns related to data sharing and embedded research, as well as potential solutions for those concerns. We recently added this video to the Living Textbook chapter on Data Sharing and Embedded Research. In the chapter, the authors expand on the ideas presented in the Annals article and fame them using lessons learned from the Collaboratory’s Demonstration Projects. Data collected as part of research embedded in a health system comes from a fundamentally different context than stand-alone explanatory trials. When they are taken out of context or used for comparisons, they have the potential to do harm—something that can potentially discourage health systems from volunteering to participate in embedded research. The authors suggest that data sharing plans for embedded research be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.

“Ultimately, it’s a practical question: if we want healthcare providers and healthcare systems to participate in research, we shouldn’t expect them to bear extra risk. In an ideal world, all information about the quality of health care and healthcare outcomes across the country would be completely open to everyone, but we don’t live in that world now. So if we are asking healthcare providers and healthcare systems to open up and be more transparent by participating in research, we certainly would not want to punish those who volunteer.” — Simon et al. in video for Ann Intern Med

 

Simon G, Coronado G, DeBar L, et al. Data Sharing and Embedded Research: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://www.rethinkingclinicaltrials.org/data-share-top/data-sharing-and-embedded-research-introduction/. Updated November 13, 2017.

November 3, 2017: Dr. Miguel Vazquez Shares Lessons From the Improving Chronic Disease Management with Pieces (ICD-Pieces) Trial

In this interview, Dr. Miguel Vazquez gives an update on the first years of the Improving Chronic Disease Management with Pieces (ICD-Pieces) trial. Dr. Vazquez discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

“Try to really learn from others who have done this—even if you are the first one doing your specific trial with your specific questions. It was helpful for us to learn from the other Collaboratory projects; they had already faced some problems, and we were able to anticipate and develop solutions proactively.” – Dr. Miguel Vazquez

Read more from Dr. Vazquez in the full interview (PDF).

October 27, 2017: Dr. Doug Zatzick Shares Lessons From the Trauma Survivors Outcomes and Support (TSOS) Trial

In this interview, Dr. Doug Zatzick gives an update on the first years of the Trauma Survivors Outcomes and Support (TSOS) trial. Dr. Zatzick discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

Dr. Zatzick’s advice: “Embed implementation teams within embedded trials. The bottom line is, go to the sites, do training at the sites and with the team, and take field notes in real time. ”

Read more from Dr. Zatzick in the full interview.

October 23, 2017: NIH Collaboratory Coordinating Center Co-PIs Discuss the Next Phase of the Program in a Video Interview

In a new video interview, NIH Collaboratory Coordinating Center co-principal investigators, Kevin Weinfurt, PhD, Lesley Curtis, PhD, and Adrian Hernandez, MD, MHS, discuss the next phase of the NIH Collaboratory program, including what they are most excited about and what success would look like over the next 5 years.

We’ll be releasing more video interviews with NIH Collaboratory leadership in the weeks to come – stay tuned!

October 20, 2017: Dr. Vincent Mor Shares Lessons From the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) Trial

In this interview, Dr. Vincent Mor gives an update on the first years of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) project. Dr. Mor discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

Dr. Mor’s advice: “The health care system must agree that the outcome your intervention is seeking to achieve is consistent with their mission. Your outcome goal should be something they care about.”

Read more from Dr. Mor in the full interview.

October 18, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Biostatistics and Study Design Core

We recently asked Dr. Liz DeLong, Chair of the Biostatistics and Study Design Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. She says the biggest impact of the Core has been working with the individual Demonstration Projects to provide a sounding board to discuss statistical challenges. Further, Core members have contributed to new knowledge through manuscripts that address key methodological issues related to pragmatic clinical trials. She’s hoping the Core will continue to push the boundaries of statistical methods in the coming years.

“The statisticians on the individual trials have not only developed excellent statistical methods for their own studies, but also contributed substantively to the Core.” Dr. Liz DeLong

Download the interview (PDF).

October 16, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Stakeholder Engagement Core

At the NIH Collaboratory Steering Committee meeting in May 2017, we asked Ellen Tambor, a member of the Stakeholder Engagement Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. She says it’s key for stakeholder engagement to take place throughout the entire healthcare system, from leadership to the frontline providers and staff. And, because of the nature of pragmatic trials conducted in clinical settings, engagement is essential from the early stages through trial completion. Tambor also suggests asking two questions to ensure the right people are involved throughout pragmatic research: Who is going to use the evidence that results from the study? Who will help ensure that the study is implemented as seamlessly as possible?

“Pragmatic trials take stakeholder engagement to a new level of importance in terms of both the scope of engagement and the array of potential stakeholders.” Ellen Tambor

Download the interview (PDF).

October 11, 2017: New grant awarded to Dr. Jeffrey Jarvik and his team of investigators to promote pragmatic musculoskeletal clinical research

Congratulations to Dr. Jeffrey Jarvik and his colleagues at the University of Washington for their recent grant award to establish the Core Center for Clinical Research (CCCR). The initiative will promote pragmatic, multi-institutional clinical research on musculoskeletal conditions, such as the diagnosis and treatment of back pain. The new center—the UW Center for Clinical Learning, Effectiveness And Research (CLEAR)—will investigate the effectiveness of interventions such as imagining tests, physical therapy, opioids, spine injections, and spine surgery, as well as approaches for implementation.  The National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are funding the 5-year, $3.7 million initiative, which will include pragmatic and comparative effectiveness trials and Core groups, including:

  • The Methodology Core, led by Patrick J. Heagerty PhD, Chair of the Department of Biostatistics, and Sean Mooney PhD, Professor of Biomedical Informatics and Chief Research Information Officer
  • The Resource Core, led by Janna Friedly MD, Associate Professor of Rehabilitation Medicine, and Danielle Lavallee PharmD PhD, Research Associate Professor of Surgery

Dr. Jarvik is a Professor of Radiology at University of Washington and the Principal Investigator the Collaboratory Demonstration Project, the Lumbar Imaging with Reporting of Epidemiology (LIRE) trial.