A core outcome set for resuscitative endovascular balloon occlusion of the aorta: A consensus based approach using a modified Delphi method

Jeffry Nahmias; Saskya Byerly; Deborah Stein; Elliott R Haut; Jason W Smith; Rondi Gelbard; Markus Ziesmann; Melissa Boltz; Ben Zarzaur; Walter L Biffl; Megan Brenner; Joseph DuBose; Charles Fox; Joseph Galante; Matthew Martin; Ernest E Moore; Laura Moore; Jonathan Morrison; Tatsuya Norii; Thomas Scalea; D Dante Yeh

doi:10.1097/TA.0000000000003405

A core outcome set for resuscitative endovascular balloon occlusion of the aorta: A consensus based approach using a modified Delphi method

J Trauma Acute Care Surg. 2022 Jan 1;92(1):144-151. doi: 10.1097/TA.0000000000003405.

Affiliation

¹ From the Department of Surgery (J.N.), University of California, Irvine, Orange, California; Department of Surgery (S.B.), University of Tennessee Health Science Campus, Memphis, Tennessee; Department of Surgery (D.S.), Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California; Division of Acute Care Surgery, Department of Surgery (E.R.H.), The Johns Hopkins University School of Medicine, Baltimore, Maryland; Hiram C. Polk Md Department of Surgery (J.W.S.), University of Louisville, Louisville, Kentucky; Division of Trauma and Acute Care Surgery, Department of Surgery (R.G.), University of Alabama at Birmingham, Boshell Building, Birmingham, Alabama; Department of Surgery (M.Z.), University of Manitoba, Winnipeg, Manitoba, Canada; Division of Trauma, Acute Care and Critical Care Surgery, Department of Surgery (Mel.B.), Penn State Hershey Medical Center, Hershey, Pennsylvania; Department of Surgery (B.Z.), University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin; Department of Surgery (W.L.B.), Scripps Clinic Medical Group, La Jolla, California; Department of Surgery (Meg.B.), University of California Riverside School of Medicine, Riverside CA; R Adams Cowley Shock Trauma Center (J.D., C.F., J.M., T.S.), University of Maryland School of Medicine, Baltimore, Maryland; Department of Surgery (J.G.), University of California, Davis, Sacramento; Department of Surgery (M.M.), Scripps Mercy Hospital, San Diego, California; Ernest E Moore Shock Trauma Center at Denver Health (E.E.M.), University of Colorado Denver, Denver Colorado; Department of Surgery (L.M.), The University of Texas Health McGovern Medical School, Houston, Houston, Texas; Department of Emergency Medicine (T.N.), University of New Mexico Health Sciences Center, Albuquerque, New Mexico; Department of Traumatology and Acute Critical Medicine (T.N.), Osaka University Graduate School of Medicine, Osaka, Japan; and Department of Surgery (D.D.Y.), University of Miami Miller School of Medicine, Miami, Florida.

PMID: 34554137
DOI: 10.1097/TA.0000000000003405

Abstract

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.

Level of evidence: Diagnostic test or criteria, level V.

Trial registration: Core Outcomes in Trauma Surgery: Development of a Core Outcome Set for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) http://www.comet-initiative.org/Studies/Details/1709.

MeSH terms

Aorta / surgery*
Balloon Occlusion* / adverse effects
Balloon Occlusion* / methods
Balloon Occlusion* / statistics & numerical data
Consensus
Delphi Technique
Endovascular Procedures / adverse effects
Endovascular Procedures / methods
Endovascular Procedures / statistics & numerical data
Humans
Outcome and Process Assessment, Health Care
Resuscitation / methods*
Wounds and Injuries* / complications
Wounds and Injuries* / therapy