BACKGROUND
The utilization of resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma has grown exponentially in recent years. However, inconsistency in reporting of outcome metrics related to this intervention has inhibited the development of evidence-based guidelines for REBOA application. This study sought to attain consensus on a core outcome set (COS) for REBOA.
METHODS
A review of “landmark” REBOA articles was performed, and panelists (first and senior authors) were contacted for participation in a modified Delphi study. In round 1, panelists provided a list of potential core outcomes. In round 2, using a Likert scale (1 [not important] to 9 [very important]), panelists scored the importance of each potential outcome. Consensus for core outcomes was defined a priori as greater than 70% of scores receiving 7 to 9 and less than 15% of scores receiving 1 to 3. Feedback was provided after round 2, and a third round was performed to reevaluate variables not achieving consensus and allow a final “write-in” round by the experts.
RESULTS
From 17 identified panelists, 12 participated. All panelists (12 of 12, 100%) participated in each subsequent round. Panelists initially identified 34 unique outcomes, with two outcomes later added upon write-in request after round 2. From 36 total potential outcomes, 20 achieved consensus as core outcomes, and this was endorsed by 100% of the participants.
CONCLUSION
Panelists successfully achieved consensus on a COS for REBOA-related research. This REBOA-COS is recommended for all clinical trials related to REBOA and should help enable higher-quality study designs, valid aggregation of published data, and development of evidence-based practice management guidelines.
Nahmias, J. , Byerly, S. , Stein, D. , Haut, E. , Smith, J. , Gelbard, R. , Ziesmann, M. , Boltz, M. , Zarzaur, B. , Biffl, W. , Brenner, M. , DuBose, J. , Fox, C. , Galante, J. , Martin, M. , Moore, E. , Moore, L. , Morrison, J. , Norii, T. , Scalea, T. & Yeh, D.
Disease Category: Orthopaedics & trauma
Disease Name: N/A
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Procedure
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Systematic review
Systematic reviews, Delphi Survey, and Consensus workshops with relevant stakeholders will be conducted to establish the core domains.