The Chicago Area Clinical Research Data Network
The Patient-Centered Outcomes Research Institute (PCORI) supports comparative effectiveness research (CER) into clinical outcomes that matter to patients and their families. PCORI has funded a number of regional collaborations: the Clinical Data Research Networks (CDRN) and the Patient-Powered Research Networks (PPRN). In this region, the CDRN is known as CAPriCORN.
CAPriCORN, the Chicago Area Patient Centered Outcomes Research Network, is a remarkable alliance of Chicagoland institutions representing a diverse community—diverse both in the type of institutions involved and, importantly, in the populations they serve.
The initial goal of all CDRNs was to create an interoperable infrastructure each within their own network, and to prove it through a number of initial studies. A national network of networks, PCORnet, has been established with 13 CDRNs and 20 PPRNs as its nodes, again as a national infrastructure for CER.
Except where an IRB has given approval to approach patients for consent, all data for sharing within CAPriCORN—and in the wider community at a later stage—are in a HIPAA-compliant, de-identified format. The Informatics Working Group has devised a federated data architecture, a data model with appropriate standards and a designed data flow engineered to ensure that no protected health information (PHI) is released other than under strictly controlled conditions. At the same time, all efforts are made to ensure the research value of the data that is released. De-identified data is released only on a study-by-study basis. A pseudo-identity generated for each patient allows for patients’ records to be distributed across different providers in the network; they can be matched and integrated without data being moved outside protected home institution environments. Consent is always sought when access to PHI or directly to the patient for patient-reported outcomes is necessary.
In the first phase of the project, NorthShore investigators studied four conditions: anemia in inpatients; weight; asthma; and recurrent Clostridium Difficile infection. We conducted these studies using de-identified data except for small numbers of patients who consented to be interviewed about their outcomes. The investigators are currently analyzing the results.
In the current phase, we are participating in a number of national studies and looking forward to initiating some additional ones. The current studies are:
- ADAPTABLE: a study of aspirin dosing for patients with a history of cardiovascular disease
- Antibiotics and Pediatric Weight: do antibiotics in the first years of life affect the child’s weight as the youngster grows up?
- Bariatric Surgery: comparing the effects on the patient’s subsequent health and weight depending on the type of surgery the individual received
Futures studies may include a closer look at patients with high health care needs and costs; patients with chronic obstructive pulmonary disease (COPD); and other areas of inquiry.