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PCORnet’s Partner Networks Tackle Crohn’s, Colitis

Crohn’s and Colitis Awareness Week ends today, making this a great time to explore PCORnet’s efforts to tackle these two widespread forms of inflammatory bowel diseases (IBD), both of which are incurable and invisible. Two of PCORnet’s partner networks, the ImproveCareNow Patient Powered ResearchNetwork (PPRN) and the Crohn’s & Colitis Foundation of America (CCFA) PPRN, have progressive actions in place to combat these conditions.

ImproveCareNow is a research collaborative community of over 90 pediatric gastroenterology centers working together to improve the health and care of children and youth with Crohn’s disease and ulcerative colitis through quality improvement initiatives. To treat moderate to severe IBD, ostomy surgery can be an option for some individuals. However, there are fewer pediatric ostomy patients than adult patients, which unfortunately means there are also fewer pediatric mentors to help guide young people through the unique challenges of living with a temporary or permanent ostomy. Jennie David, ImproveCareNow’s former Patient Advisory Council co-chair, is an exception. A young patient with Crohn’s disease herself, Jennie is working with other patients to minimize the stigma of IBD and ostomies with approachable tools and communication tactics to engage other young IBD patients with ostomies.

For example, she led a primary-stakeholder research project to develop an ostomy tool kit, which is written at a fifth grade literacy level and includes colorful pictures with comic elements, informative literature, and suggestions for approaching ostomy conversations with friends and family. Jennie has also created a platform for pediatric patients with IBD to come together and learn about the illness and ImproveCareNow via her @FlatJennie Twitter handle. Flat Jennie is a four-inch paper girl representing Jennie herself who travels to see patients and has created an inspirational, light-hearted community to unite patients.

CCFA Partners is another PCORnet PPRN making great strides with these conditions. With over 15,000 participants (~1% of the U.S. adult IBD population), this network has successfully engaged participants in prioritizing a patient-centered research agenda and contributing health data for research.  In addition, CCFA Partners is leading a PCORnet demonstration study that will compare the effectiveness of the Specific Carbohydrate Diet (SCD) and a Mediterranean Diet in Crohn’s disease sufferers, promising new insights to this patient community.

CCFA Partners is also presenting the findings of two research studies this month at the 2016 Advances in Inflammatory Bowel Diseases Clinical and Research Conference (AIBD), taking place Dec 8-10.  One study is a description of CCFA Partners participants’ experience with “pouchitis,” or inflammation of the pouch that stores stool following a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) procedure. A key finding of this study is the fact that 82 percent of study participants reported at least one episode of pouchitis, a complication associated with worse quality of life and other patient reported outcomes.

The other study CCFA will report on at AIBD examines the utility of the newly developed Gastrointestinal Patient-Reported Outcomes Measurement Information System (GI-PROMIS) scale for measuring physical, mental, and social health in IBD patients. The results of this study suggest that the GI-PROMIS scales could be an important way to measure IBD symptoms in the future.

“We are making great strides toward Crohn’s and Colitis, but there is still more to be done,” said CCFA’s principal investigator, Michael Kappelman. “Crohn’s and Colitis Awareness Week is an excellent time to shed light on how far we have come with these prevalent conditions and inspire more good work to bring new tools and insights to patients in need.”


About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at


The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at


Research for the Rest of Us: Building Trustworthiness in PCORnet Public Webinar Sheds Light on Research Needs of Underserved Communities

People-centricity was front and center during the recent Building Trustworthiness in PCORnet public webinar, which took place on September 16, 2016. Similar to PCORnet’s Building Trustworthiness inaugural event in March 2016, the webinar was an opportunity to foster broad and rich discussions by listening deeply to community experts as they provide actionable insights on how we build a national clinical research network that communities can trust. In this webinar, moderated by Lesley Curtis, co-lead of the Distributed Research Network Operations Center for PCORnet, attendees heard perspectives from Sharon Terry, co-principal investigator, PCORnet Coordinating Center and principal investigator, Community-Engaged Network for All (CENA) Patient Powered Research Network (PPRN); Annesa Flentje, assistant professor at the University of California in San Francisco; Jennie David, former Patient Advisory Council co-chair for the ImproveCareNow PPRN; and Neely Williams, a patient advocate and administrator for the Community Partners Network and co-principal investigator for the PCORnet Bariatric Study.

Sharon set the framework for the session by challenging the audience to shift its approach to clinical research from the traditional sense of work that is done to the community to work that is done with the community. “We recognize that much of PCORnet’s research potential is gleaned from the knowledge and expertise of its stakeholders and partners,” she said. “Approaching clinical research with this posture of humility is just one feature that makes PCORnet so revolutionary.”



Annesa serves as the mental health lead for the PRIDEnet PPRN-affiliated Pride Study, which aims to help health professionals better understand the needs of the lesbian, gay, bisexual, transgender, and queer (LGBTQ) community. She kicked off her presentation with a focus on sexual and gender minorities, noting that in many cases, the key to building trust with this community is acknowledgement and respect.

“Many members of the LGBTQ community are not even asked about their gender identity and sexual orientation in research protocols,” said Annesa. “Failing to even ask about sexual orientation and gender identity makes this community invisible in our research. With simple efforts, like asking about gender identity prior to birth identity in our queries, we can show greater respect for this community and go a long way toward building trust and engagement.”

Jennie spoke next and leveraged the webinar to shed light on the pediatric chronic illness community. Using her own experience as a young patient with severe Crohn’s disease as an example, she explained how clinicians often diagnose pre-emptively without seeking to understand the rich spectrum of a patient’s lifestyle outside of his or her disease state.

“When I learned my large intestine needed to be removed, my surgeon assumed that for vanity reasons, a young woman like me would not want an external ostomy solution. But I had done research on my own and knew that the alternative procedure he suggested would lead to outcomes that were not a fit with my lifestyle and values,” said Jennie. “It is so important to remember that we are unique people with our own voices first and foremost—not patients, and definitely not research subjects. Our role as a patient is just one layer of identity in the broader spectrum of people’s lives.”

You can follow Jennie on Twitter at @Flat_Jennie and read more about her experience and recommendations for engaging children in research to advance meaningful outcomes.

Finally, Neely closed the webinar with her perspective as an African American woman who struggles with obesity. African Americans and people who are obese are often under-researched and under-represented in clinical studies. She explained the need to humanize data by using storytelling to transmit research results back to the community.

“When I speak to my community, I frequently hear that researchers came, they researched, and they were never heard from again,” said Neely. “If we want to build rich and beneficial relationships, it is essential that we bring communities into the fold by reporting outcomes and keeping the lines of communication open.”

Take a moment to read Neely’s opinion editorial recently published in The Tennessean.

Among these varied suggestions, one piece of advice from each presenter was consistent: we must keep the conversation going.

“We will never learn all that we can in a one-hour webinar or even a two-day workshop,” said Sharon. “This event was a great success, but there is still work to be done. Building a trustworthy, people-centered PCORnet necessitates frequent provocative discussions such as these, and I am already looking forward to the next opportunity to learn how we can make PCORnet a beacon for trustworthy clinical research.”

PCORI Spotlights PCORnet’s Obesity Focus for National Childhood Obesity Awareness Month

In observance of National Childhood Obesity Awareness Month, the Patient-Centered Outcomes Research Institute (PCORI) has authored a blog that highlights PEDSnet, a partner network of the National Patient-Centered Clinical Research Network, PCORnet, that has access to data from 5.1 million children. PEDSnet aims to find ways to provide the best medical care and best outcomes for children, and has obesity as a major focus.  The blog also highlights PCORI’s pediatric obesity focus, including two large observational research studies currently being conducted using PCORnet.

PCORnet Antibiotics & Childhood Obesity Study

One of these studies, based at Harvard Pilgrim Health Care in Boston, is examining the relationship between antibiotic use and weight gain during childhood, as well as engaging parents and physicians through focus groups and interviews to learn how results from this study might influence decisions about antibiotic use for young children. Previous research has found a link between the use of antibiotics, particularly broad-spectrum antibiotics, and an increased risk for obesity in later childhood, but research results are mixed. There also are many remaining questions about how timing and amount of antibiotics might be linked to childhood obesity and whether this relationship differs by race, ethnicity, and gender. In his recent PCORI guest blog, Lead Patient Principal Investigator Doug Lunsford brings the struggle of childhood obesity to life and discusses his efforts to make a difference. You can also hear him speak in the video below.

Ten of PCORnet’s Clinical Data Research Networks (CDRNs) and three of its Patient-Powered Research Networks (PPRNs) are participating in the study, with a possible cohort of 600,000 children overall to be included. All participating institutions have currently received IRB approval, and investigators are now finalizing the study’s first research query, which will examine de-identified individual data of children in participating institutions to assess 1) the association of antibiotic use before the age of two, 2) weight outcomes at age 5 and 10, and 3) growth trajectories until age 10. The study team has embraced stakeholder engagement as a core component of this study; its Executive Antibiotic Stakeholder Advisory Group (EASAG) has spent the first six months of the study developing an engagement plan, finalizing a focus group guide for parent focus groups, and initiating work on a study dissemination plan. In addition, the study was recently featured in the Knoxville Times and Stone Hearth News.

PCORnet Bariatric Study

The other PCORnet obesity study, based at Group Health Cooperative in Washington State, is comparing the health benefits and safety of the three main types of weight loss surgery. This bariatric surgery study is unusual in that it includes adolescents among its participants. The use of bariatric surgery to treat children and adolescents with severe obesity has increased in recent years; however, data on how well adolescents do after bariatric surgery are limited and include mostly studies of short duration. Leveraging the PCORnet Common Data Model (CDM) to organize data into a standard structure, the bariatric study will collect health data on several hundred adolescents who underwent bariatric surgery in the years 2005 through 2015. The study will follow these patients for up to five years after surgery to estimate the one-, three-, and five-year benefits and risks of the most common US procedures: roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy. Analyses will compare across the three procedures 1) changes in weight, 2) rates of diabetes remission and relapse, and 3) the incidence of adverse events. In her recently published opinion editorial in The Tennessean, Patient Co-Principal Investigator for the bariatric study Neely Williams explains what it was like to be part of an underrepresented patient community seeking bariatric surgery and why patients need a louder voice in clinical research. You can also watch Williams speak about the patient advocacy perspective in the video below.

The PCORnet bariatric study has currently completed an initial round of characterizing the data into a common language via the PCORnet CDM. The study team is targeting late-September to send out its first query to address changes in weight following weight loss surgery. In addition, the study has engaged with Smart Patients to build an interactive community where patients and caregivers can learn from one another and build knowledge about their condition. Representatives from Smart Patients attended the Obesity Action Coalition’s Your Weight Matters national convention to introduce Smart Patients to meeting attendees. The PCORnet bariatric study was also showcased recently at Advancing the Science of Community Engaged Research in Washington, DC.

ADAPTABLE Study protocol posted for stakeholder review

Review and provide comments on the ADAPTABLE study research protocol.  ADAPTABLE is  the first demonstration project to be conducted through PCORnet.  ADAPTABLE is based on a model of sharing knowledge and provides a unique opportunity to engage and collaborate with physicians, patients, patient representatives, investigators, research study team members, and support staff.