Did you know the UNC Health Care system participates in research collaboratives that use clinical data to answer difficult questions and to advance quality improvement in practices? Read more here.
Do you know what clinical data is? Do you know how and why it is used for research? A couple of experts in the field as well as Janice Wells, an FMC Patient Advisory Council member, have some answers to frequently asked questions on this topic!
Q: What is clinical data?
A: Every time you go to the doctor, for an annual check-up, surgery, or hospitalization, data about the visit is recorded in your electronic medical record. This clinical data includes your blood pressure, heart rate, weight, whether you have had a flu shot, as well as other facts. When you leave the doctor’s office, this information is securely housed in an electronic data warehouse, along with data for all UNC Health Care patients. This way, progress and change in your health can be tracked by your provider. The clinical data can also be used for research and quality improvement efforts.
Q: Why is research being done with Electronic Medical Record data?
A: Researchers use health care data as one of many ways to improve health and the quality of health services. Accessing clinical data allows research to be done more quickly and with more patients than traditional clinical trials. It is especially useful for understanding health problems and treatment in the real world. The ultimate goal is to improve health through more timely and relevant research.
Q. How is clinical information from doctor’s visits used for research?
A: UNC Health Care is one of a number of other health institutions that can collaborate on projects together. These collaboratives are called Clinical Data Research Network – CDRNs are able to sponsor research that can benefit from using larger amounts of clinical data. In research, casting a larger net enables a greater degree of accuracy. For example, a recent project sponsored through Patient Centered Outcome Research Institute (PCORI) helped UNC bariatric surgeons answer the question, “Which kind of surgery is best for which patient population?” Researchers were able to use de-identified data from previous bariatric surgeries to better understand what works when. To read more, click here.
Clinical data can also be used to connect researchers with the appropriate patient population for a study.
It is important to note that the process of using health information is very tightly governed. Researchers must go through a number of steps and security measures to access and use clinical data. If they eventually use your data to invite you to a study, steps are taken to ensure patient confidentiality is protected.
Q. What are some ways that this information is used?
A: Though researchers and doctors have come so far in the last century, there are still many unanswered questions. In the 1950s, doctors recommended avoiding aspirin for those with heart disease– fifty years later, we may have discovered aspirin’s benefits, but we still do not know the proper dosage.
Researchers access data to ask questions like, “how many people seen at the Family Medicine Center have both diabetes and high blood pressure?” Or, “How many children who have asthma had a flu shots last year?”
In some cases, a question may prompt a more specific research study. The research team then must take many steps to protect patient health information before they are able to reach out and invite the patient into an approved study. At the end of the day, though, it is up to patients to decide if they are interested or not.
Q. Are there any examples of ongoing studies that use this kind of clinical data structure to invite potentially interested patients into studies?
A: Yes! One such study, the ADAPTABLE trial, will start recruiting soon, and some Family Medicine patients will be invited by the study team. The study promises to answer a key question: what is the right dose of Aspirin for people at risk for heart disease? It is a new kind of trial where patients can participate entirely from home, using their computers, phones or tablets. Because it uses technology in a creative way, the trial will not slow down clinic visits or burden providers.
Q. What do patients think of this?
A: We are still working to share with patients how these systems work. So far, patients seem to appreciate that their clinical data can contribute to a greater good— helping others stay healthy or find health solutions. That said, we are working to better understand how patients at UNC and in other health systems feel about clinical data being used secondarily for research.
We are also hoping that patients and community members can think of ways this kind of data could help their own efforts as well, so that research becomes a more engaging process.
Q. Do any patient groups keep an eye on research going on at the Family Medicine Center?
A: Fortunately, the FMC Patient Advisory Committee is often included in discussions about developing research ideas, so that patient voices are included in how the studies roll out. However, like so many things in a large university and healthcare system, it is very possible that the PAC does not know about every ongoing research project.
Janice Wells, part of the Family Medicine’s PAC as well as an Oversight Committee governing the use of Clinical data for research at UNC, is one such patient who has been engaged in the rise of Clinical Data Research Networks. She suggested that such data could be used to reduce Emergency Room use by Family Medicine patients, by analyzing data to understand what walk-in hours are most needed.
“Additionally, perhaps we could help diabetic patients by asking, ‘What language do you want us to use to explain the management of your diabetes?’”
Q. Do my family medicine providers know when I am invited to participate in a study?
A: Although sometimes providers may know about studies, they may not know you are in one unless you discuss it with them. If you are involved in a study that UNC supports, there is an indicator in your electronic medical record that may indicate you are in a study. However, if you really want your provider to know, it makes sense to just tell him or her.
Q. Where can I find out more?
A: Here is one quick video that a family medicine researcher put together to help people understand how clinical data can be used for research and merged with data systems from other health care systems to allow for even great numbers of participants.
Here is a quick video about the ADAPTABLE study, as well as the study’s website.
Here is an article in one of the recent UNC Vital Sign’s newsletters about another developing study where both a patient and a provider have commented about how they feel about using clinical data in this way.