Prateeti Khazanie

Purpose: There is a growing urgency to address health inequities in clinical trial design. Pragmatic trials hold promise in addressing inequities in research. We conducted a rapid qualitative analysis of barriers and facilitators to implementing health equity practices in pragmatic trials within the NIH Pragmatic Trials Collaboratory, informed by the DUSON-INFUSE checklist. Participants and Methods: A descriptive qualitative design was used to address barriers and facilitators to equitable pragmatic trials. Twelve semi-structured interviews with primary investigators and research associates were conducted. Included trials were selected to represent a variety of phases of funding and study progress to examine the full lifecycle of research. Interview transcripts were summarized using a standardized matrix. Rapid qualitative analysis was implemented to condense data into four emergent themes. Results: Trialists were in the enrollment (n=8), follow-up (n=1), and completion (n=3) phases of their research. Study themes described how (1) funding timelines dictate community relationship building, (2) concordant identities between research teams and study populations promote equity, (3) community alignment on priorities facilitates success, and (4) intervention flexibility is necessary to support participant engagement. Conclusion: To optimize the potential for pragmatic clinical trials to reduce health inequities, all phases of research must be designed with health equity in mind. This includes funding timelines and research budget planning that leave space for relationship building, as well as co-developed priorities between investigators and communities to ensure research fosters trust and engagement.

Kidney dysfunction after heart transplantation (HT) is associated with significant morbidity and mortality. Recipient and perioperative factors may all influence the risk of kidney injury. Furthermore, data suggest that the incidence of kidney dysfunction, both acute and chronic, is increasing after the implementation of the United States’ 2018 allocation system due to increasing use of temporary mechanical circulatory support and changing recipient characteristics. While data are robust regarding nephroprotective therapies such as renin-angiotensin-aldosterone system inhibition and SGLT2i (sodium-glucose cotransporter 2 inhibitors) to minimize the progression of chronic kidney disease in patients with heart failure, data in HT recipients are beginning to emerge. This state-of-the-art review will critically examine the existing literature regarding the epidemiology of kidney dysfunction after HT, mitigation strategies for acute kidney injury and chronic kidney disease, including pharmacotherapeutics, the need for kidney transplantation after HT, and practical next steps for the larger HT community.