All posts by Kinshasa Letts

PCORnet Blog

PCSK9 Inhibitor Study Demonstrates PCORnet’s Capacity for Rapid-Cycle Research

Sometimes, you need reliable research results fast. That was the case for one health plan that came to PCORnet for help understanding the prescribing patterns for PCSK9 inhibitors. These are effective but costly medications used to lower LDL cholesterol (also known as “bad” cholesterol).

“As the first PCORnet rapid-cycle research project, the PCSK9 inhibitor study was an exciting opportunity to test the power of PCORnet’s infrastructure,” said Rhonda Cooper-DeHoff, the study’s principal investigator. “The ability to offer the research community fast, reliable results is a central part of the PCORnet vision, and this was a chance to put that promise into practice.”

The results of the study confirmed what stakeholders suspected: that early utilization of PCSK9 inhibitors, which cost approximately $14,000 per year at the time, was low. It was predominately being prescribed by cardiologists, and use was greatest in patients with coronary artery disease or coronary heart disease.

Rapid Results

The PCSK9 inhibitor study is one of five rapid-cycle research projects being conducted with PCORnet supported by approximately $7 million in funding from the Patient-Centered Outcomes Research Institute (PCORI). The idea behind rapid-cycle research is to use PCORnet’s infrastructure to deliver fast responses to stakeholder-prioritized research questions.

The PCSK9 inhibitor study team was able to deliver results within eight months of the start of the analysis.

“Eight months is an aggressive timeline for any study, but we stayed on track, even in the face of three major holidays and two hurricanes that threatened to stall our progress,” said Cooper-DeHoff. “I’m impressed with the team and pleased that PCORnet empowered us to deliver excellent results for our customer in record time.”

The team used real-world data from electronic health records to characterize the early use of PCSK9 inhibitors, as well as other lipid lowering therapies, according to the patients’ cardiovascular risk status. The team obtained data from more than 17.5 million adults across seven geographically diverse PCORnet partner networks. Patients were all over 18 years old and interacted with their health system between July 2015, when PCSK9 inhibitors first became available, and March 2017.

The study results are important, but the most exciting part of the PCSK9 inhibitor study was the process, according to Cooper-DeHoff.

“PCORnet’s capacity for rapid-cycle research is changing the way we think about patient-reported outcomes and their potential to deliver real, meaningful insights to improve decision-making,” she said. “PCSK9 inhibitor usage was the first of these rapid-cycle projects, but it won’t be the last. It is an exciting concept that holds a lot of promise, not only for a third-party payer, but also for the research community and patients seeking faster insights than traditional clinical research can deliver.”

Learn more about PCORnet’s portfolio of rapid cycle research  projects.

PCORnet Blog

Want to Use Medicare Claims Data to Support Your Study? PCORnet’s CMS Linkage Team Shares How It Can Be Done

The Centers for Medicare and Medicaid Services (CMS) collect over two billion data points per year through the payment of Medicare health claims, and until now, this wealth of information has been largely inaccessible to researchers. Always seeking out new pathways to better insights, PCORnet, the National Patient-Centered Clinical Research Network, launched its CMS Linkage Pilot Project to answer this challenge.

The pilot team developed a process for using Medicare claims data to supplement PCORnet data in pragmatic clinical trials, such as the ADAPTABLE study comparing the effectiveness of different daily aspirin dosing for heart attack and stroke prevention. In a newly released white paper, the project team describes the processes and data flows used successfully in the pilot, as well as lessons learned and recommendations.

“As researchers, we have always been excited about the potential of Medicare data to fill in critical information gaps found in electronic medical records, but technological challenges have hindered our past efforts,” said Brad Hammill, Associate Professor of Population Health Sciences at DCRI.

“By pulling this data into PCORnet’s innovative architecture, we were able to rapidly extract important insights. For example, we found evidence of heart attacks that occurred when patients were traveling out-of-state in the Medicare data. These types of events are not usually captured in a patient’s primary electronic health record and are useful in giving us a more complete picture of the patient experience.”

For those looking to learn from the CMS Linkage Pilot’s success, the team has a few tips:

  • Allow ample time for preparing and processing the CMS Data Use Agreement. Processing times of six months are not uncommon with complex Data Use Agreements involving multiple institutions. In the case of the pilot team, those institutions were two PCORnet Clinical Data Research Networks, Mid-South and the Greater Plains Collaborative, plus PCORnet’s Coordinating Center at the Duke Clinical Research Institute (DCRI).
  • Social security numbers are most reliable for identifying patients within Medicare data. If those aren’t available, try using the Medicare beneficiary identification number.
  • Use the CMS Data Linkage project team’s tools to transform Medicare data to the PCORnet Common Data Model format. By doing so, you can easily analyze both the Medicare data and PCORnet data using the same analytic programs. 

Much more about the CMS Linkage Pilot Project is detailed in the newly published white paper which is available on the PCORnet Commons. If you have questions on the pilot, you can send those to [email protected]

PCORnet Blog

AMIA 2018 Recap


The American Medical Informatics Association (AMIA) held its 2018 Annual Symposium in San Francisco, where PCORnet, the National Patient-Centered Clinical Research Network, shared how it is using data and technology to fuel a healthier, more engaged patient community. The symposium brings together diverse stakeholders, including clinicians, researchers, policy makers, and academics, making it a rich forum to spark new ideas on how to deploy data for better health.

“Informatics is all about transforming data into useful knowledge, which dovetails nicely with PCORnet’s overall mission to not just make research faster and less costly, but also more meaningful,” said Keith Marsolo of PCORnet’s Coordinating Center. “AMIA is a useful event for us to share some of the novel ways PCORnet is bringing health informatics to life, both within our internal teams and across our partner networks.”

Marsolo participated in a panel that dove into the nuts and bolts of PCORnet, offering answers to one of stakeholders’ most frequently asked questions: How does it work? With perspectives from both Coordinating Center staff and study investigators, the panelists explained how PCORnet uses its distributed research network to turn research questions into preparatory or observational research queries. Lesley Curtis, co-lead of the PCORnet Distributed Research Network Operations Center, moderated the event, which also included panelists’ real-world experiences working in the Network.

Colleagues at partner network Accessible Research Commons for Health (ARCH), formerly SCILHS, gave a system demonstration that showed how ARCH uses PCORnet’s Common Data Model to perform live, distributed queries across diverse environments with disparate data. ARCH also introduced AMIA attendees to its innovative patient portal that supports patient-level data analytics.

In another interesting PCORnet technology collaboration, Shyam Visweswaran of the University of Pittsburgh shared a poster that touted software that his team developed to extract patient-reported outcome (PRO) data from research electronic data capture (REDCap) surveys. The software then loads the PRO data into PCORnet’s Common Data Model, offering researchers a more complete healthcare narrative than is typically available. The software is configurable so that other PCORnet partner networks can readily deploy it.

For more AMIA highlights, check out #AMIA2018 or visit the full agenda.

PCORnet Blog

PCORnet Successes on Full Display at PCORI’s 2018 Annual Meeting

PCORI’s recent 2018 Annual Meeting showcased PCORnet-related research through more than 14 posters over the meeting’s three days. These posters highlighted PCORnet’s innovative tactics for patient recruitment and engagement, the power of PCORnet’s data and infrastructure, and patient-centered research in action. Here are some of the highlights:

Patient Recruitment & Engagement

The first step of patient-centered research is to figure out ways to bring patients into the fold—and keep them there. Several PCORnet posters at the Annual Meeting offered tactics for doing just that. For example, the OneFlorida Clinical Research Consortium, a PCORnet partner network, outlined the merit of collaborating with Citizen Scientists to create a learning curriculum on topics ranging from research ethics to cultural competency. The method was effective in bridging the gap between researchers and the community, as well as setting realistic expectations of the research process from both perspectives.

Patients participate more when the research matters to them. That’s why PCORnet’s Pulmonary Collaborative Research Group presented a poster on its work to assess which research questions are high priority to the pulmonary fibrosis community. Several posters presented at the meetings reflected lessons learned from patient-centered research conducted through PCORnet, such as the ADAPTABLE team’s lessons on improving retention in clinician and patient engagement, the PCORnet Coordinating Center’s lessons from PCORnet’s first chapter, and the MoodNetwork’s lessons learned on the challenges of stigma and mental health in study recruitment.

The Power of PCORnet Data & Infrastructure

PCORnet’s infrastructure is unique, and its data reach is wide. Several posters offered views of PCORnet’s power with real-world examples, such as Harvard Pilgrim’s showcasing how the standardized querying infrastructure and reusable tools PCORnet offers can give researchers answers in weeks versus months. A unique feature of PCORnet is its availability of lab result data, which enables research that can identify a cohort based on a lab value. The PCORnet Coordinating Center presented a poster on how they curated this data, readying it for study planning, reporting, and data quality monitoring.

PCORnet’s data power is increasing with the inclusion of Health Plan Research Networks as PCORnet partners, which now offers researchers the option of claims data to identify study participants. An ADAPTABLE team poster highlighted this strategy. Other PCORnet colleagues showcased work on the need to continually improve PCORnet’s data capacity to promote more equitable health research in the future.

Patient-Centered Research in Action

At the heart of PCORnet is the belief that patients should always have a seat at the table, working hand-in-hand with other stakeholders to generate insights that matter. A trailblazer for patient-centered research, PCORnet and its partner networks took the notion of patient-centerednessfrom concept to practice, launching studies that showed the research community it can be done. Posters showcasing the COPD network’s study of the patient burden of cough and phlegm and REACHnet’s study of older patients’ views on non-face-to-face diabetes chronic care management provided examples. In addition, a Health Systems Demonstration Project poster revealed how the team worked with patients to better understand the impact of clinical and social complexity on diabetes control.

This recap only offers a glimpse of the expertise our PCORnet teams had on display at the PCORI Annual meeting this year, but if you’d like more detail, you can visit the full list of displayed posters. Congratulations to all who exhibited their great work!

Nemours Researchers Tap PEDSnet to Glean New Insights on Link between Childhood Obesity and Asthma

In a recent Pediatrics paper, the nonprofit pediatric health system Nemours credited PEDSnet for increasing the speed and scope of a study of obesity and asthma in children. PEDSnet, a partner network of PCORnet, the National Patient-Centered Clinical Research Network, offered the Nemours research team access to deidentified data from the medical records of more than 500,000 children. The study’s results suggest obesity increases children’s risk of developing asthma, a finding that many researchers have long suspected, but lacked the hard data from a study of this size and scope to prove.


The study concluded that an estimated 23 percent to 27 percent of new asthma cases in children with obesity is directly attributable to obesity. In the absence of overweight and obesity, 10 percent of all cases of asthma would be avoided, the research team said.


“Access to detailed data in the PEDSnet system, which includes clinical and medical claims data collected longitudinally on a quarterly basis from eight large pediatric health systems in the United States, allowed the authors to conduct a stringent analysis of asthma diagnosis using different definitions routinely used in asthma research,” said pediatric pulmonologist Deepa Rastogi, MBBS, MS, who authored a supplemental commentary on the study results in Pediatrics.


Rastogi went on to note that the spread of PEDSnet’s partner health systems across the country allowed national representation of all races and ethnicities, offering a diversity of data in which PCORnet prides itself. With a network comprising more than 100 health institutions, PCORnet gives researchers access to real-world data from everyday health interactions that can counter the homogeneity of randomized clinical trials, which often miss big pockets of people due to strict eligibility criteria.


“The gold standard in research is to conduct large, randomized clinical trials,” said Nemours President and CEO R. Lawrence Moss, MD, who discussed the study in a Becker’s Hospital Review blog post. “However, many questions can be answered in a shorter time and with less expense by analyzing large quantities of currently available data. Further, access to such large data sets, known as Big Data, will allow us to design more effective, efficient and focused randomized trials when we need them. PEDSnet is a wise investment. It allows our research dollars to have more impact on more children and bring more benefit to society.”


According to Rastogi, the study’s results are important because they suggest that over time, obesity-induced asthma will become a major type of childhood asthma. On the bright side, he said, obesity is a modifiable risk factor, which means there is an opportunity to intervene with preventive tactics.


Moss conveyed the study’s impact nicely:


“To put this new PEDSnet finding into perspective, consider the potential impact: If we prevent obesity in children, we could potentially prevent 800,000 kids in the U.S. from developing asthma. This is the largest-ever study of its kind that is a cross section of the U.S. and that estimates the attributable risk. But it wouldn’t be possible without collaboration and quality medical records data.”

People-Centered Research Foundation: Notice of intent to publish a request for proposals for privacy-preserving record linkage

PCRF is searching for software and technology vendors to provide services and/or solutions for a privacy-preserving record linkage method to be used in PCORnet. This standardized linkage method is intended to first assist PCRF in determining whether patients are present across multiple network partners, ultimately expanding PCORnet’s research capabilities.


A formal Request for Proposals (RFP) will be issued on December 31, 2018. If you would like to suggest a vendor or are interested in responding to this forthcoming RFP, please contact Lindsey Petro at [email protected]. For more information, please see the Notice of Intent  here.

PCORnet Obesity Studies to Present Findings at ObesityWeek 2018

The more we learn about obesity, the more we realize how complex and multifaceted the disease is. That’s why ObesityWeek 2018, taking place November 11-15 is an important meeting. Results of two PCORnet studies will be shared at this annual gathering of experts in obesity research.

David Arterburn, principal investigator for the PCORnet Bariatric Study and senior investigator at Kaiser Permanente Washington Health Research Institute, will present new insights from the Bariatric Study team that will guide patients to best-fit treatment options for their unique circumstances. In a talk titled, “The Kindest Cut — Is RYGB Still the Gold Standard?” Arterburn will discuss the results of this head-to-head comparison of three common surgeries for the treatment of obesity: Roux-en-Y bypass, which is currently the most popular, sleeve gastrectomy, and gastric banding.

The Bariatric Study team will also have posters highlighting other key aspects of the study. One will focus on diabetes outcomes and another on long-term safety.

The research team that conducted the PCORnet Antibiotics and Childhood Growth Study will present a poster entitled “Early Life Antibiotic Use and BMI-Z at 10 Years.” It will share key elements of their study, the largest to date to explore the possible link between antibiotic use in infancy and toddler years and weight gain in later childhood.

Want to learn more about the latest PCORnet contributions to obesity research? Check out these two recent blog posts on the PCORnet Bariatric Study and the Antibiotics and Childhood Growth Study. Can’t make it in person to ObesityWeek? Be sure to follow #OW2018 and join in the conversation!

PCORnet Blog

PCORnet Study Results Show Small Link between Childhood Obesity and Antibiotics

As researchers dig into the science behind obesity, particularly in young children, we are learning some interesting things. For example, a growing body of evidence shows that our microbiome, a word for the collective trillions of bacteria and other microbes that live in our gut, may be a factor in how our body handles fat. Our gut bacteria play a role in keeping us healthy. So, what happens to our children’s developing microbiome when they take antibiotics that kill some of these gut bacteria as well as those causing an infection? Could there be a link between antibiotics and childhood obesity?


PCORnet launched the Obesity Observational Study of the short- and long-term effects of antibiotics on childhood growth in 2015 to find answers. The journal Pediatrics published a manuscript that shares some of the study’s results.


A link, but a slight one

Researchers have previously come to conflicting conclusions as to whether antibiotics at a young age have potential to affect weight. That’s why the PCORnet Obesity Observational Study, the largest study to date on this topic, is so significant. The study team examined data from 362,550 children between the ages of 4 and 5 across 35 PCORnet partner institutions. They looked at a wide scope of factors, including diagnosis of chronic conditions, number of antibiotic prescriptions given to children, and the specific types of antibiotics given.

Researchers found that antibiotic use in children less than 2 years of age was associated with only a slightly higher body weight at age 5. Specifically, the effect was less than a pound difference in weight for children of average height and weight who received four 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,” Jason Block, MD, MPH, principal investigator for the study and associate professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School, said in a news release about the findings.

A test of PCORnet’s capability

The Obesity Observational Study is one PCORnet’s first large studies. It demonstrates the network’s capacity for using large amounts of health data and patient partnerships to answer research questions. The study’s results are evidence of the PCORnet’s capability to deliver on its promise: research results that are faster, easier, less costly and, most importantly, relevant to patients’ needs.


Block said that the ability to conduct research with large, diverse populations in networks like PCORnet provides a critical opportunity to examine important research questions, no matter the outcome.


As the research community continues its efforts to unlock insights into childhood obesity, the PCORnet Obesity Observational Study results provide an important reference point and a stepping-stone to new discoveries.

PCORnet Blog

Weighing the Options: PCORnet Study Shows Gastric Bypass Surgery Yields Greater Weight Loss than Other Procedures

PCORnet, the National Patient-Centered Clinical Research Network, is delivering on its mission to answer important questions that help patients make better-informed health care decisions. The Annals of Internal Medicine this week published findings from the PCORnet Bariatric Study.


This study compared the health benefits of three common weight-loss operations: gastric bypass, sleeve gastrectomy, and adjustable gastric banding. Researchers found that adults with severe obesity had greater initial and sustained weight loss with gastric bypass surgery (71 pounds on average five years post-surgery) than with sleeve gastrectomy (52 pounds on average) or adjustable gastric banding (33 pounds on average).


Rates of major problems occurring within 30 days of surgery were small for all three procedures, though highest for bypass.


With data from more than 46,000 patients across 41 health systems accessed through PCORnet, the study is the largest long-term study of bariatric surgery to date.


Although the ultimate choice of weight loss surgery has many variables for patients and their doctors to consider, the study’s head-to-head comparison of 1-, 3-, and 5-year results from the three most commonly performed weight-loss operations sheds much needed light on an important aspect of what to expect from weight loss procedures.


“Bariatric surgery is widely considered the most effective way to treat severe obesity and induce long-term weight loss,” David Arterburn, MD, MPH, an internist and senior investigator at Kaiser Permanente Washington Health Research Institute, who served as a co-principal investigator of the study, said in a news release. “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.

The new results showcase the power of PCORnet to deliver on its goal to produce faster, less costly, and more meaningful research results than traditional clinical trials. By working with PCORnet’s partner networks, which collectively represent more than 100 million patients, researchers were able to securely assess de-identified health information collected during routine care to compare each weight loss procedure. As with all PCORnet studies, patients played a central role as partners in the research process.


“Our patients and providers were critical to the success of this study,” Karen J. Coleman, PhD, a research scientist at Kaiser Permanente in Southern California’s Department of Research and Evaluation in Pasadena and co-author of the study, noted in the news release. “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.”


Are you interested and want to learn more?

  • Arterburn and patient co-investigator Neely Williams discuss the implications of this study in this blog post.
  • Study co-principal investigator Kathleen McTigue, MD, MPH, Associate Professor of Medicine, Epidemiology, and Clinical/Translational Science at the University of Pittsburgh, will discuss the results at the 4th PCORI Annual Meeting taking place October 31-November 2 in Washington, DC. In-person attendance at sessions is free and the session will be available via live webcast 1:30 to 3 pm ET Thursday, November 1.
  • In addition, Arterburn will present details on the results at Obesity Week, taking place November 11-15 in Nashville, Tennessee. There is still time to register.