News & Updates
The National Evaluation System for Health Technology Coordinating Center (NESTcc) Announces the First Round of Real-World Evidence Test-Cases
Recent press release about the NESTcc:
ARLINGTON, Va.–(from BUSINESS WIRE)–The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces the first round of NESTcc test-cases that address topics of high-priority from the medical device industry using Real-World Data (RWD) and Real-World Evidence (RWE).
@NESTccMedTech announces Round 1 Test-Cases, bringing together Network Collaborators and industry partners on #RealWorldEvidence projects to answer key questions for the #medicaldevice ecosystem. Read more: https://bit.ly/2RzHlKM
“It’s exciting to reveal this milestone for NEST with the launch of these first test-cases that will explore the feasibility of generating Real-World Evidence with health systems and coordinated registry networks through the NESTcc Network Collaborators,” said Rachael Fleurence, PhD, executive director of NESTcc. “These test-cases will show proof-of-concept for the use of Real-World Evidence for medical devices in preparation for regulatory submissions, such as label expansions, and to meet post-market surveillance requirements.”
The initial concepts were submitted in January 2018 through a public call open to medical device manufacturers. These test-cases will address two primary objectives. First, they will explore the feasibility for the medical device industry to work with RWD sources and NESTcc’s initial set of Network Collaborators. Second, the test-cases will help identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies).
The first round of test-cases will be executed through collaborations with Abbott, Adhesys Medical, Johnson & Johnson Medical Devices Companies, and W.L. Gore & Associates, Inc. as industry partners. In addition to the industry groups working through independent collaborations, the American Academy of Orthopaedic Surgeons (AAOS) is serving as a neutral convener, bringing together DJO Global, DePuy Synthes, Smith & Nephew, Stryker, and Zimmer Biomet for a test-case that will bring together NESTcc Network Collaborators with the American Joint Replacement Registry (AJRR) which is housed at AAOS.
The industry partners and the Network Collaborators are working together on eight projects within the first round of test-cases that include projects along the 510(k) and premarket approval regulatory pathways and throughout the medical device total product lifecycle.
“This is an important step to show the potential for NEST to efficiently generate evidence for both medical device evaluation and post-market safety information,” said Jeff Shuren, M.D., Director of the FDA’s Center for Devices and Radiological Health who is a board member of MDIC. “Our goal with NEST is to improve access to, value, use, and efficiency of real-world evidence to meet the needs of the medical device ecosystem stakeholders. With more robust, informative, and timely evidence, health care providers and patients can make better informed healthcare decisions, and be assured they have access to the safest medical devices.”
The test-cases will address the following disease areas and corresponding products:
TOTAL-PRODUCT LIFE CYCLE (TPLC) ALIGNMENT
TECHNOLOGY OF INTEREST
|Pre-market Submission||Comparative Effectiveness of Alternative Approaches for Wound Closure||510(k)||Wound Closure||Dermatology|
|Label Expansion||Testing the Use of Real-World Data from Three Unique Sources to Expand Indications||PMA||Endovascular Therapies||Vascular|
|Label Expansion||The Feasibility of Using Real- World Data in the Evaluation of Cardiac Ablation Catheters||PMA||Ablation Catheters||Cardiology|
|Label Expansion||Real-World Clinical Outcomes in Patients with Mechanical Heart Valve Replacement and Anticoagulation Variability||PMA||Mechanical Aortic Heart Valves||Cardiology|
|Label from General to Specific Indication||Feasibility of Using Real-World Data to Evaluate Thermal Ablation of Liver Tumors||510(k)||Ablation Device||Surgery|
|Postmarket Surveillance||Testing the Feasibility of Registry and Claims Data Linkages||510(k)||Total Joint Arthroplasty (TJA), Primary Total Knee Arthroplasty||Orthopedics|
|Postmarket Surveillance||Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data||510(k)||Craniomaxillofacial Distractors||Orthopedics|
|Postmarket Surveillance||Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data||510(k)||Intervertebral Body Fusion Devices||Orthopedics|
For a description of each test-case, please visit: https://nestcc.org/test-cases/
About the National Evaluation System for health Technology Coordinating Center
In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The Coordinating Center seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using Real-World Data (RWD) that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making. For more information, visit http://nestcc.org.
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.
Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (1 U01 FD 006292-01). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
Medical Device Innovation Consortium
Leah McConnell, +1 202-900-9099
Obesity Cohort Study Paper Published in the Annals of Internal Medicine
Congratulations to all the PCORnet PIs working with the Obesity cohort and their recent publication in the Annals of Internal Medicine.
Via the press release:
Adults with severe obesity had greater initial and sustained weight loss with gastric bypass surgery than either sleeve gastrectomy or adjustable gastric banding, according to a new study published today in the Annals of Internal Medicine.
This is the largest long-term study of bariatric surgery to date. It included more than 46,000 patients at 41 participating health systems in 11 Clinical Data Research Networks nationwide, thanks to its use of a large new resource called PCORnet®, the National Patient-Centered Clinical Research Network.
Bariatric surgeons can use various operations to help people lose weight by making changes to their digestive system. This study did a head-to-head comparison of 1-, 3- and 5-year results from the three most commonly performed weight-loss operations: gastric bypass, sleeve gastrectomy and adjustable gastric banding.
The findings are important because severe obesity — a body mass index (or BMI) of at least 35 kg/m2 —affects more than 15 percent of U.S. adults, according to the National Health and Nutrition Examination Survey. National Institutes of Health guidelines consider people with a BMI of 40 kg/m2, or at least 35 kg/m2 for people with diabetes or other obesity-related diseases, eligible for bariatric surgery.
“Bariatric surgery is widely considered the most effective way to treat severe obesity and induce long-term weight loss,” said first author David Arterburn, MD, MPH, an internist and senior investigator at Kaiser Permanente Washington Health Research Institute. “We wondered about sleeve gastrectomy, which has quickly become the most commonly performed bariatric procedure in the United States. Because it’s the newest — introduced less than a decade ago — less evidence has been available to compare it against the longstanding gastric bypass and adjustable gastric band.”
The investigators found that:
- People who had gastric bypass surgery had lost 31 percent of their weight at the first year and maintained 26 percent of their loss at 5 years.
- People who had sleeve gastrectomy had lost 25 percent of their pre-surgery body weight at 1 year and maintained 19 percent weight loss at 5 years.
- That translates into a 19-pound difference in weight loss between gastric bypass and sleeve gastrectomy at 5 years for the average person in this study, who weighed 277 pounds before surgery.
- By contrast, adjustable gastric banding was much less effective for losing weight and keeping it off, with 14 percent and 12 percent of weight lost at 1 and 5 years, respectively. Gastric banding used to be the most commonly performed bariatric procedure, but it now represents just 10 percent of bariatric procedures.
“These findings give strong evidence that bypass and sleeve are effective for lasting weight loss for adults with severe obesity,” said Kathleen M. McTigue, MD, MPH, MS, another study leader and an associate professor of medicine and epidemiology at the University of Pittsburgh. “We hope this helps people to make more informed decisions about their care, as they talk with their health care providers about the respective benefits and risks of the most common weight-loss procedures.”
Members of the same PCORnet® Bariatric Study Collaborative team had found similar results in teenagers.
Because of the large sample size, the researchers could examine subgroups of people to assess whether certain characteristics improved or worsened their chance of weight loss success. They found that men, African-Americans, Hispanics, people age 65 and older, and people with diabetes or lower BMIs (less than 50) tended to lose less weight than did other people in the study. But these differences between patient groups were small — less than 3 percent differences in weight lost at 1, 3 and 5 years across groups — which was much less than the differences between the procedures. For instance, the difference between weight lost with gastric bypass and sleeve gastrectomy was 6 percent at 1 year and 7 percent at 5 years.
The 30-day risk of major adverse events, such as a prolonged hospitalization or another operation, were generally low across all three procedures. Sleeve gastrectomy had the lowest rate of major adverse events (2.6 percent), followed by gastric banding (2.9 percent), and then gastric bypass (5.0 percent).
The new results are among the first to be produced using the resources of PCORnet®, an innovative initiative funded by the Patient-Centered Outcomes Research Institute (or PCORI). PCORnet® is designed to produce clinical insights faster and less expensively than traditional clinical studies. It involves multiple individual networks that together represent more than 100 million patients.
The network securely collects health information during routine care — not including data that could help identify individuals — to produce real-world evidence with outcomes that matter to patients, who are full partners in this research.
“Our patients and providers were critical to the success of this study,” said Karen J. Coleman, PhD, MS, another study leader and a research scientist at Kaiser Permanente in Southern California’s Department of Research & Evaluation in Pasadena. “They helped us craft the question, pick the variables to study, interpret the findings and present the results. We could never have done such a comprehensive study without their partnership.”
“We helped the group think through the most important questions for patients, like risks and safety concerns,” said the Rev. Neely Williams, MDiv, a patient-principal investigator on the study and the CEO of the Community Partners’ Network in Nashville. “We also explored how best to share evidence with patients.”
The PCORnet® Bariatric Study Collaborative team is continuing to examine the outcomes of different types of weight-loss surgery for longer-term safety as well as outcomes in people with diabetes.
This PCORnet® study, registered at ClinicalTrials.gov (NCT02741674), was funded by PCORI through PCORI Award OBS-1505-30683.
For the PCORnet® Bariatric Study Collaborative, the other coauthors are Robert Wellman, MS, R. Yates Coley, PhD, Andrea J. Cook, PhD, Jane Anau, and Roy Pardee, JD, MA, of Kaiser Permanente Washington Health Research Institute; Sameer Murali, MD, of Kaiser Permanente in Southern California’s Department of Research and Evaluation in Pasadena; Sengwee Toh, ScD, Jessica Sturtevant, MS, and Casie Horgan, MPH, of Harvard Medical School’s Department of Population Medicine and Harvard Pilgrim Health Care Institute in Boston; Ana Emiliano, M.D., of Rockefeller University in New York; Steven R. Smith, MD, of Florida Hospital’s The Translational Research Institute for Metabolism and Diabetes in Orlando; Andrew O. Odegaard, PhD, MPH, of the University of California, Irvine School of Medicine’s Department of Epidemiology; Cheri Janning RN, BSN, MS, of Duke Clinical & Translational Science Institute in Durham, NC; Anita Courcoulas, MD, MPH, of the University of Pittsburgh’s Department of Surgery.
Early Antibiotic Exposure and Weight Outcomes in Young Children
Congratulations to all PIs working on the Antibiotic and Weight study on the publication of “Early Life Antibiotic Use and Weight Outcomes in Children Ages 48 to <72 Months of Age” in Pediatrics.
Via the press release:
A pioneering study conducted within a nationwide network, the National Patient Centered Clinical Research Network (PCORnet), finds that antibiotic use at <24 months of age was associated with slightly higher body weight at 5 years of age. The study, “Early Life Antibiotic Use and Weight Outcomes in Children Ages 48 to <72 Months of Age,” appears in the journal Pediatrics published online today.
Antibiotic overuse has been a major population health concern, primarily due to the dangers of increasing antibiotic resistance but, recently, interest in antibiotics’ effect on weight has emerged. Antibiotics disrupt the natural balance of intestinal bacteria or gut microbiome. Because the microbiome has important effects on the body’s metabolism and how food is digested, researchers have hypothesized that changes in weight might occur with microbiome disruptions. This issue is important for parents and their doctors, who often must decide whether children should receive antibiotics.
PCORnet is an innovative research network that facilitates research across healthcare institutions through use of a process whereby each institution organizes their data from electronic health records into a common form. The network also uses a variety of important innovations to protect patient privacy. Studies conducted in PCORnet also incorporate patient views in the design and conduct of the study.
Previous studies have had conflicting results regarding the potential effect of antibiotics on weight. This new study is the largest to tackle the issue, involving a sample of over 360,000 children from 35 institutions across the country. Researchers examined the relationship between antibiotic use among children less than two years old and their weight at around five years old, analyzing such factors as: diagnosis of chronic conditions, number of antibiotic prescriptions given to children, and the specific types of antibiotics given.
Results demonstrate that the effect of antibiotic use in early childhood and weight around age 5 was small — less than a pound difference in weight for children of average height and weight receiving 4 or more courses of antibiotics, compared to children who received none. “While this small difference in weight might not be important for individual decisions regarding antibiotic prescribing by doctors and parents, these data may serve, in a small way, to further encourage efforts to decrease antibiotic use. The ability to conduct research on large, diverse populations in networks like PCORnet provides critical opportunities to examine important research questions, no matter the outcome.” says Jason Block, lead author and Associate Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.
New Paper Published as a Result of the Weight Cohort Study
Congratulations to Dr. William Heerman and the PIs and staff that worked on the Weight Cohort Study. On March 1 BMC Obesity published their paper, “Willingness to Participate in Weight-Related Research as Reported by Patients in PCORnet Clinical Data Research Networks.” The article in its entirety can be found here.
Face to Face Meeting Hosted by Duke
On October 4, Duke hosted a face to face meeting for the Mid South Clinical Data Research Network. Topics discussed included Marketing and Outreach, Stakeholder Engagement, Informatics, Sustainability, and the forthcoming PCRF. All the attendees enjoyed hearing remarks and presentations from Drs. Iain Sanderson, Russell Rothman, Jacquie Halladay, Rob Califf, Crystal Cene, Arlene Chung, and Tim Carey, as well as Kellie Walters, Keri Wolfe, and Melissa Basford.
Dr. Iain Sanderson of Duke University welcoming the attendees.
Dr. Rob Califf of Duke University reporting on the significance of the work our CDRN is doing.
Dr. Russell Rothman of Vanderbilt University Medical Center presenting on Mid-South CDRN clinical reach.
Kellie Walters and Jacquie Halladay of UNC Chapel Hill giving a CDRN Marketing and Outreach update.
Mid-South CDRN Stakeholder Engagement Team representatives attending the annual Mid-South CDRN Face-to-Face meeting in Durham, North Carolina. Pictured from back row left: Kellie Walters, Bob Stevens (Patient Investigator), Tene Hamilton-Franklin (Stakeholder), Jacquie Halladay and Janice Wells (Stakeholder); front row from left: Jacquelyn Favours and Rowena Dolor.
ADAPTABLE and the Patient Experience
Recently, Linda Brown from Columbia, TN shared her story with the ADAPTABLE Team. Here’s what she had to say:
“Fortunately for me, my heart disease has been relatively minor. A single event and new medication has made my life relatively unchanged. However, my family history has a different story. All male members on the paternal side of my family have had early cardiac problems with many early deaths. My father had his first heart attack at age 39 and passed away at age 65 after bypass surgery, several more heart attacks, and two major strokes. For as long as I can remember, watching my father take a deep breath or lay his hand on his chest would stop me in my tracks. I was always worried it could be his last day. And, soon my worry was about my brothers, uncles, and cousins who, one- by- one became victims of heart disease.
When I was asked to become part of the ADAPTABLE study it was like a call home. I thought maybe I could help other cardiac patients. Every month of work with my fellow Adaptors, I have become more comfortable in a world of research that is very far from anything I have done. Dipping my toe in this pond has been rewarding in many ways that have ended up improving my life. In a way this has become a hobby for me. Right up there with sewing and reading, decorating and gardening, ADAPTABLE is a joy in my life.
Recently I have become a PCORI Ambassador. That has piqued my interest in what a difference this Southern California Valley Girl can make and adds another layer in learning about this new world.
In the last five years I have focused on being the best I can be. For me I must concentrate every day on healthy diet and exercise to keep my mind in a healthy place. I have lost nearly 70 pounds. I make a daily effort to reach 10,000 steps, and I try eating a healthy diet.”
For more about the ADAPTABLE study and to view a video of Linda, please see the ADAPTABLE study website.
Mid-South CDRN a part of 11 Announced Collaborative Research Groups by PCORnet
Mid-South CDRN Co-PI Tim Carey speaks on the importance of Collaborative Research Groups for patients and clinicians.
The Mid-South CDRN will co-lead 3 of the 11 announced PCORnet Collaborative Research Groups (CRGs). The CRGs bring together experts from multiple networks to generate high-priority research questions that will focus on providing patient-centered outcomes. The CRGs will be dedicated to engaging advocates, partner networks, and funders to answer these questions using the PCORnet infrastructure. To focus on specific research topics, some the CRGs have developed Research Interest Groups (RIGs) to investigate sub-categories of their research area. The CRGs will develop data elements that are relevant to the group’s focus area, as well as advance the PCORnet mission of advancing the science of patient-centered outcomes and pragmatic research through innovative methods. Mid-South will lead the Diabetes and Obesity, Kidney Health, and Hospital Medicine CRGs. For more on the PCORnet CRG launch click here.
Mid-South participates in the ADAPTABLE Kick-off Meeting
The Mid-South CDRN participated in the ADAPTABLE study kick-off meeting in Washington, DC on October 28th. The meeting was attended by patients, clinicians, and research staff, which allowed for a very interactive and collaborative kick-off meeting. The meeting included a panel discussion with the patient partners, as well as a panel discussion with the Principal Investigators and Co-Principal Investigators. Recruitment for the study has seen an increase over the last several weeks, with efforts largely being led by Mid-South. ADAPTABLE has 446 participants enrolled to date.
Mid-South CDRN PI, Dr. Russell Rothman, presents at ADAPTABLE study kick-off meeting.
ADAPTABLE patients, clinicians, and research team pose for a group photo
Neely Williams, Patient Investigator, Pens Op-Ed for The Tennessean
The Rev. Neely Williams wrote an op-ed, published by The Tennessean, calling for a louder patient voice in clinical research.
“The harsh reality is this: If we are from a community or population that is consistently underrepresented in the clinical research process, we are expected to simply make do, to accept the knowledge gaps around our unique situation and hope for the best outcomes.”
In the article, she urges communities to build bridges of trust with the medical community and accept PCORnet’s invitation to make clinical research a two-way street.
Click HERE to read the article.
Mid-South CDRN Stakeholder Engagement Team Member, Neely Williams Featured as Patient Advocate in PCORnet Video
Neely Williams, a member of our Stakeholder Engagement Team, shares why she was a natural fit for the PCORnet Bariatric Surgery Study. As a patient and a health advocate, she recognizes that clinical research outcomes are for all stakeholders. From clinicians, to the patients they serve. “Everybody wins, if we are able to develop a better process,” she shared as her hope for this project.