Patient-centred outcomes research: brave new world meets old institutional policies

Abstract

Background: Engaging patients across the research trajectory supports research that is generalizable, high quality, timely and actionable. However, this approach comes with challenges and opportunities as investigators and engaged patient stakeholders encounter institutional policies around patient engagement, privacy and research participant protection.

Objective: To describe the resolution and impact of quandaries arising when patient stakeholders' values and preferences conflicted with institutional policies.

Methods: Case study from a Patient-Centered Outcomes Research Institute-funded trial.

Results: The first example focuses on the tension between the health care organization's requirements for background checks for all patient advisors and the funders' requirement to engage hard-to-reach populations. To create an environment of mutual trust and respect with patient stakeholders, the research team decided against imposing background checks. All 53 patient and parent advisors have served continuously for 2 years and meeting attendance exceeds 95%. The second example describes parent stakeholders' role in revising a letter informing patients about a privacy violation. Among 49 families affected by and informed about this violation, 35 (71%) agreed to participate. The third example focuses on how patient stakeholder preferences about study reminders conflict with the 1996 Health Insurance Portability and Accountability Act rules. While patient stakeholders strongly endorsed text message reminders, regulations and technology do not permit reminders with enough detail to ensure clarity. Although retention rates exceeded 90%, attendance at study appointments was below 75% and below 60% for minority and low socio-economic status families.

Conclusion: Patient engagement positively impacts research. Resolving conflicts between patient-engaged research and existing institutional policies and regulations would allow this impact to become fully realized.

Keywords: Background checks; HIPAA; PCOR; patient engagement; privacy.