Navigating the challenges of NT-proBNP result disclosure in clinical research.

Abstract

Background: The Office of Human Research Protections and the National Academy of Sciences, Engineering, and Medicine (NASEM) recommend the return of individual research results (IRRs) to study participants as a strategy to build public trust in science. However, the feasibility of sharing IRRs is unclear. Within a National Institutes of Health (NIH) funded parent study about Long COVID, we embedded the My ILLInet RECOVER Return of Results study to explore clinician-level considerations (e.g., validity, actionability, recommendations for follow-up) about returning a clinically used biomarker for heart failure (N-terminal pro-B-type natriuretic peptide, (NT-proBNP) collected as part of the NIH RECOVER study protocol.

Approach: Clinicians participated in a three-phase modified Delphi process that sought their input to guide appropriate follow up recommendations the research team should provide to research participants with an abnormal NT-proBNP.

Results: Clinicians agreed that NT-proBNP results could be returned to study participants. However, consensus was not reached on specific NT-proBNP thresholds that warrant immediate medical attention versus general follow-up.

Discussion: Lack of clinical context presents a challenge in returning IRRs. Clinicians expressed concerns about the potential harm caused by misinformation or misinterpretation of these findings. While the NASEM report offers guidance on communicating IRRs, careful consideration is essential to ensure that clinical uncertainty is conveyed clearly, minimizing the risk of misinterpretation.

Conclusion: The feasibility of returning IRRs to study participants depends, in part, on sufficient clinical context for the information to be actionable.