Background: Aortic dissection (AD) research has focused on treatment for AD while patients’ voices have been absent and their priorities unexplored. To address this, the AD Collaborative identified seven areas of interest to patients and published methods and results in a dedicated issue of Seminars of Vascular Surgery (March 2022). The project team’s most recent survey of more than 800 patients with or at risk for AD indicated enthusiasm for research but limited willingness to participate.
Proposed Solution to the Problem: Building on the initial work of the AD Collaborative, this project will identify patient-centered outcomes important to patients for inclusion in future patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER). Further, because the AD community is small, a high level of participation will be necessary to support clinical trials; therefore, given the findings of limited willingness to participate, the project team will educate potential participants about trial participation and learn more about their barriers to participation. The project will also explore the feasibility of adding patient-centered outcomes and patient-reported outcomes in major national registries.
Objectives: This project will continue the work of readying the AD community for PCOR/CER by further exploring what is important to patients and expanding infrastructure for PCOR/CER. Specifically, the project will:
- Identify AD-specific patient-centered outcomes relevant to patients
- Ascertain CER methods acceptable to the AD patient community
- Collaborate with major national AD registries to evaluate the inclusion of patient-centered outcomes
Activities: The project team will work along three parallel aims:
- An AD Collaborative Outcomes Working Group, composed of researchers, clinicians and patients/care partners will review current outcomes measures in AD research and those currently in development. The final product of this group will be recommendations for patient-centered outcomes in future AD PCOR/CER.
- Within the AD Collaborative Virtual Research Network, the team will conduct four community co-learning sessions with the goals of 1) educating patients on what it means to participate in research and 2) learning more about patient barriers (i.e., questions, concerns and challenges) to participating in clinical trials.
- A multi-stakeholder AD Collaborative group will meet with representatives of national AD databases to understand current efforts toward adding patient-reported outcomes to their ongoing data collection. This group will provide patient-centered perspective and input to these AD databases to inform their ongoing work.
A final convening will share work to date and solicit additional community input to inform findings. Final deliverables will summarize work completed and input received, key findings, and next steps toward producing PCOR/CER results.
Projected Outcomes and Outputs: All outcomes support the AD Collaborative mission of improving lives of people with AD through patient-centeredness.
- Short-term outcomes during the project period include reports on community-informed findings:
- Recommendations for patient-centered outcomes for future PCOR/CER
- Barriers to research participation and recommendations for addressing them
- Operational plans for registry patient-reported outcomes incorporation
- Medium-term outcomes (zero to two years post project period) include adoption of patient-centered outcomes measures in research and increased willingness to participate in research.
- Long-term outcomes (three and more years post project period) include AD PCOR/CER that produces patient-centered research evidence helping patients and clinicians make healthcare decisions.
Patient and Stakeholder Engagement Plan: The AD Collaborative is led in part by an advisory board of 10 patients/family and a stakeholder group of nearly 100 people providing multiple perspectives. These groups are critical for outreach to the broader AD community, providing key bridges to their own networks.
Project Collaborators: Organizations partnering with the Collaborative include: John Ritter Foundation for Aortic Health, The Marfan Foundation, Genetic Aortic Disorders Association Canada, Loeys-Dietz Syndrome Foundation, Ehlers Danlos Society, The VEDS Movement, Aortic Dissection Awareness UK & Ireland, Think Aorta Foundation, International Registry of Acute Aortic Dissections, GenTAC Alliance, VEDS Collaborative, Vascular Surgery COVID-19 Collaborative, Montalcino Aortic Consortium, Vascular Low Frequency Disease Consortium.