PEDSnet

How Are Data Tools Improving Pediatric Care? PCORnet® Is Part Of The Answer

Posted on by Jodi Snare

Chris Forrest, PCORnet® Steering Committee member and principal investigator for PEDSnet, a PCORnet Network Partner, recently participated in a webinar hosted by U.S. News and World Report entitled “Improving Pediatric Care: How New Data Tools Are Moving the Needle.” The webinar was an exploration of the opportunities for children’s hospitals to use (and share) data to do a faster and more accurate job of diagnosing and treating patients while also improving safety and efficiency. Forrest cited PCORnet®, the National Patient-Centered Clinical Research Network, as an important tool for addressing pediatric challenges and identifying trends over time.

“PCORnet can offer researchers insights from the health records of more than 70 million Americans,” said Forrest on the webinar. He cited as an example that if a researcher wanted to enroll 20,000 kids who have been infected with COVID-19 in a study to explore their phenotypes over the long term, PCORnet can help. The Network offers a breadth of data not available at a single institution, making it a valuable resource for researchers.

Forrest also noted the importance of engaging patients and caregivers to better deploy data tools and move the needle for pediatric research. Patient engagement is a central component of all PCORnet-enabled research.

“We have established regulatory agreements and institutional trust for a national learning collaborative, but we also need to have conversations with families to earn the public’s trust around the bold new ways we can use their data,” he said. “To bring the larger vision of data and technology to life, that bedrock of trust with communities is essential.”

Forrest shared the webinar panel with several other experts:

  • Anthony Chang, Chief Intelligence and Innovation Officer, Children’s Hospital of Orange County
  • Kathy J. Jenkins, Executive Director, Center for Applied Pediatric Quality Analytics, Boston Children’s Hospital
  • Anthony Oliva, Vice President and Chief Medical Officer, Healthcare Division, Nuance

Watch the webinar in full at U.S. News and World Report’s events page.

MedWeight Study Uses PCORnet® to Assess Medication-Induced Weight Gain

Posted on by Jodi Snare

Medication-induced weight gain is a common challenge and often triggers concerns among patients who want to know if and how much weight they might gain if they take certain drugs. MedWeight, a PCORnet® Study, was launched to provide evidence that will help determine which medications contribute to weight gain and how much. Providing this evidence will help patients make better-informed choices that could lead to improved health outcomes. The study team is collaborating with three Network Partners of PCORnet®, the National Patient-Centered Clinical Research Network, to conduct the study, which will be the most comprehensive assessment to date of the risks of weight gain associated with taking certain drugs.

“Patients consistently flag concerns about weight gain from commonly prescribed medications as a reason for non-adherence, and yet there are still significant knowledge gaps around which medications contribute the most to weight gain and what role, if any, specific patient characteristics play in weight fluctuations,” said Jason Block, principal investigator of study. “Our goal with MedWeight is to fill in these gaps, offering patients and their clinicians data-driven insights into what they can expect from their medications so they can choose carefully and adhere with confidence.”

The study will include both children and adults and involve separate evaluations of the the five medication classes, comparing effects between subclasses and commonly prescribed individual medications. The MedWeight team will examine the medical records of the children and adults within each class up to 10.5 years after initiating treatment to evaluate how different drugs affected the weight of different types of people.

Deep patient involvement

PCORnet Network Partners PedsNet, OneFlorida, and STAR are the collaborating Clinical Research Networks (CRNs) on the MedWeight Study. From each CRN, a designated patient representative serves in a leadership role on the MedWeight team, advising on all project components from protocol design to dissemination.

“MedWeight is a study inspired by patient feedback, and their input is critical in the development and execution of the work,” said Block. “Once the study is complete, we hope to disseminate our results in a way that is helpful to patients and clinicians. We intend to develop an educational document for patients and providers to help guide choices. The patient perspective on how we disseminate results will be a critical component of this work.”

Patient partners have been with MedWeight from day one. In fact, many of them previously worked on other PCORnet observational studies on obesity and will carry forward lessons learned from those projects to MedWeight.

“Patient partners from our past work in obesity were huge proponents for MedWeight, and our work on the prior observational studies set the stage for us to carry out this new study on medications and weight,” said Block. “The extensive data curation and exploration of available data those studies required are assets that will allow us to hit the ground running with the MedWeight study.”

MedWeight is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The MedWeight team expects to have initial data characterization established in autumn 2020, with an estimated completion date of spring 2023.

PCORnet®-Enabled HERO Registry Launched, Unites Frontline Healthcare Workers to Fight COVID-19

Posted on by Jodi Snare

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry launched today, marking the first major milestone in a rapid-response effort to answer important questions about protecting healthcare workers from COVID-19. The HERO program is funded by the Patient-Centered Outcomes Research Institute (PCORI) coordinated by the Duke Clinical Research Institute (DCRI) and enabled by PCORnet®, the National Patient-Centered Clinical Research Network.

“The HERO Registry will leverage PCORnet® resources and capacity to help us develop fast knowledge to keep healthcare workers safe and healthy, which ultimately will help protect us all,” said Adrian Hernandez, MD, MHS, principal investigator for the PCORnet Coordinating Center and the HERO program.

With the launch of the registry, the HERO program is seeking participation from hundreds of thousands of healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental services workers, interpreters, and transporters—anyone who works in a setting where people receive health care. Participants will receive surveys and could be selected to participate in clinical trials. Healthcare workers can sign up via the registry and participate as much or as little as they like. The registry will follow a protocol developed by the DCRI and data guidelines to keep healthcare worker information secure.

“We’re calling on all healthcare workers to share their perspectives so that we can understand and provide answers to the problems they face in real time—and over time,” said Emily O’Brien, PhD, principal investigator of the HERO Registry and assistant professor in Duke University’s Department of Population Health Sciences.

The first rapid-cycle clinical trial using the registry, HERO-HCQ, is slated to start enrolling healthcare workers at the end of April, when sites within the PCORnet network will use the registry to identify about 15,000 interested healthcare workers to participate. The trial will randomize eligible participants to either one month of hydroxychloroquine or one month of placebo and will examine whether the drug is effective in preventing COVID-19 infection. Study results will be shared widely with the healthcare community.

Using PCORnet to conduct the study offers several major advantages over traditional trials. The network has a wealth of information to draw on in setting up the registry. It also has a well-established community of healthcare systems with experience collaborating on large clinical studies engaging patients and clinicians alike. This community will facilitate the oversight essential to ensure the study is carried out ethically and allow any interested healthcare or emergency worker to easily join the registry.

“Hospitals, health systems, and health plans that participate in PCORnet have worked in partnership for years and are well poised to deliver fast, reliable research infrastructure to study COVID-19,” said Chris Forrest, MD, PhD, co-chair of the HERO Registry and principal investigator of PEDSnet, one of multiple PCORnet Partner Networks participating in HERO-HCQ. “Infrastructure issues that might cause lag time for other studies are hurdles PCORnet has already crossed. PCORnet was developed for exactly this type of research challenge, and the network is ready to meet the moment.”