Erin Gilroy, BS, was a Senior Research Coordinator in the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania’s Perelman School of Medicine and Study Project Manager for the PCORnet DINE-CD Demonstration Study which began in March 2016. Gilroy is now attending nursing school.
Most of us know the popular saying, “Don’t reinvent the wheel.” When you are an experienced researcher, you live by this statement. When it’s time to develop a new study, you pull from your previously-used tried and true techniques; you dig out those dusty patient instructions from your last trial and see how you can tweak them for your new trial. It’s all in the name of not reinventing the wheel. What do you do if you are new to research, or if you are doing a type of trial that is foreign to you? Where do you turn?
When it came time to develop our diet intervention trial called DINE-CD, (Comparative Effectiveness of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn’s Disease) a PCORI-funded PCORnet Demonstration Study, PCORnet infrastructure helped us navigate in exactly this type of situation.
A key pillar of PCORnet is to have patient stakeholders assist in each step of the project. This foundation of inclusion has also been helpful for us throughout our work. With PCORnet, my DINE-CD research team was exposed to other researchers who have done similar projects with whom we could collaborate. Our team developed a working relationship with the ImproveCareNow PPRN – an organization that is also doing diet trials with Crohn’s disease patients. We have helped each other through discussion of study techniques and protocol design and review of patient-directed instructional materials. We also share a Data and Safety Monitoring Board that oversees our trial.
Having never studied the Specific Carbohydrate Diet before, we learned tons of information about how to educate our research participants about the diet from the ImproveCareNow team. An example of this is through the use of informational handouts that are easy to read and aesthetically pleasing, with information laid out in a manner that quickly shows the participants foods that are permitted and not permitted on the diet.
Another collaboration that has helped us is with the PCORnet PPRN ArthritisPower (AR-PoWER), the Arthritis Partnership with Comparative Effectiveness Researchers. One of the common comorbidities for Crohn’s disease patients is arthritis. Through our collaboration with AR-PoWER and the Global Healthy Living Foundation, we obtained data collection tools for arthritis data that have proven successful in previous research studies. Had we not been engaged in this collaboration with AR-POWER, we may have missed this opportunity to study the joint symptoms of Crohn’s disease or would have been forced to inefficiently, and possibly ineffectively, develop our own tools to collect arthritis data.
Not only do we not have to reinvent the wheel when it comes to our patient instructions and data collection tools, we also don’t have to reinvent the wheel when it comes to our recruitment efforts. The Crohn’s and Colitis Foundation (CCFA Partners PPRN) is a network of thousands of potential participants from which we can recruit Crohn’s patients. Having this pool of Crohn’s patients ready and willing to participate in research is invaluable to this project.
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 www.pcori.org.
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 www.pcornet.org.