Background: The National Patient-Centered Clinical Research Network (PCORnet) currently includes 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs). Even though PCORnet participants are open to collaboration, they must address issues surrounding patient privacy and confidentiality, data security, data control, and regulatory requirements. This often leads to time-consuming negotiations and paperwork, creating enormous barriers to conducting otherwise promising studies. Although these issues can be addressed in part by governance, the advent of several cutting-edge, privacy-preserving analytic and data-sharing methods offers a potential paradigm shift in patient-centered outcomes research (PCOR). These methods can increase stakeholders’ ability to collaborate efficiently through more streamlined security and privacy protection requirements without sacrificing the scientific rigor of the analysis. However, significant gaps remain because these methods are not understood by most PCOR stakeholders and have not been systematically assessed in PCOR.
- Aim 1: Assess stakeholders’ understanding of privacy-preserving methods, and the benefits and limitations of using them in multisite PCOR studies
- Aim 2: Develop a suite of analytic tools to perform rigorous PCOR analysis without sharing potentially identifiable data
- Aim 3: Create freely available analytic tools and educational materials for these methods
Methods: We will partner and meet regularly with two patient groups, a patient privacy expert, health system leaders, a multicenter research governance expert, regulatory, compliance, and confidentiality board members, and researchers (Aim 1); analyze simulations and real-world data (Aim 2); and partner with stakeholders (Aim 3).
Patient and Stakeholder Engagement: We will partner with stakeholders to:
- Inform them about how their data are shared and analyzed in multicenter research
- Assess their understanding and acceptance of these methods
- Explore their analytic needs, preferences, and priorities
- Engage them in setting methods priorities
- Implement and disseminate the methods
Anticipated Impact: This is the first study to systematically assess privacy-preserving analytic and data-sharing methods for PCOR. These methods can help reduce the barriers to conducting multicenter research.
Mazor KM, Richards A, Gallagher M, et al., Stakeholders' views on data sharing in multicenter studies. Journal of Comparative Effectiveness Research (August 2017).
VIDEO (below): Patients Fill Research Holes
Patients and other stakeholders help researchers ask important questions and find critical information they might otherwise miss.