The population of adults with congenital heart disease (ACHD) continues to expand, as patients live longer thanks to advances in surgical and medical care. “Adult congenital heart disease has not traditionally been a well-studied field,” says James Kirkpatrick, MD, chair of the University of Washington Medical Center Ethics Committee.
Previously, not many patients survived to adulthood with complex CHD. Those who did were spread among many centers. “Now that adults with congenital heart disease outnumber children with congenital heart disease, and with more research networks, the field can overcome many research limitations,” Kirkpatrick says.
There has been increasing interest in creating an ACHD national database for both quality and research purposes, according to Elisa A. Bradley, MD, FACC, associate professor of medicine at Penn State Heart and Vascular Institute. It can help clinicians understand long-term complications to hopefully improve survival. However, an ethical framework was lacking. “Various workgroups and societies have discussed pursuing the formation of an ACHD database, without fully considering how to be most inclusive,” Bradley explains. “Some societies were interested in supporting a database of patients at specific types of practices or institutions.”
The problem was this excluded several groups of patients without access to certain types of care. Bradley and colleagues developed recommendations on how to create a database ethically.1 They highlighted ethical considerations for creating a national ACHD database. “We covered several issues on the ethics of big data,” Bradley shares.
These ethical principles also apply to other large-scale data sets. “However, since database creation for the ACHD population has lagged behind other areas of cardiovascular medicine, we have a window in which we can make changes to strategically broaden and improve inclusivity,” Bradley explains.
Many patients are lost to follow-up medical care. “Inclusion strictly from specific care sites may inadvertently exclude those with the least medical access,” Bradley says.
Patients seen at sites without ACHD cardiologists might end up excluded from the database. The goal, says Bradley, was for “future efforts to aim for inclusivity and ethically sound data collection for all groups.”
Bradley and colleagues listed best practices for confidentiality and fairness that should be used in creating an ACHD database. These include proper informed consent for use of protected health information, de-identification of patient data (where appropriate), and proper procedures to protect against data loss and data leaks. Researchers should avoid excluding patient populations unless there is a rational reason to do so. Make sure patients are provided with opportunities to participate. Construct research protocols that overcome barriers to participation (e.g., transportation). Finally, ensure the burdens and risks of the research do not fall asymmetrically on certain populations, especially those who are not expected to experience benefits from the research.
“Diversity, equity, and inclusion are central concerns in national and regional databases — not just for reporting on disparities in outcomes and care processes, but also in ensuring access to clinical trials,” Kirkpatrick says.
REFERENCE
- Bradley EA, Khan A, McNeal DM, et al. Operational and ethical considerations for a national adult congenital heart disease database. J Am Heart Assoc 2022;11:e022338.
The population of adults with congenital heart disease (ACHD) continues to expand, as patients live longer thanks to advances in surgical and medical care. Thus, there has been increasing interest in creating an ACHD national database for both quality and research purposes.
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