Objectives: Our understanding of blunt cerebrovascular injury (BCVI) has changed significantly in recent decades, resulting in a heterogeneous description of diagnosis, treatment, and outcomes in the literature which is not suitable for data pooling. Therefore, we endeavored to develop a core outcome set (COS) to help guide future BCVI research and overcome the challenge of heterogeneous outcomes reporting.
Methods: After a review of landmark BCVI publications, content experts were invited to participate in a modified Delphi study. For round 1, participants submitted a list of proposed core outcomes. In subsequent rounds, panelists used a 9-point Likert scale to score the proposed outcomes for importance. Core outcomes consensus was defined as >70% of scores receiving 7 to 9 and <15% of scores receiving 1 to 3. Feedback and aggregate data were shared between rounds, and four rounds of deliberation were performed to re-evaluate the variables not achieving predefined consensus criteria.
Results: From an initial panel of 15 experts, 12 (80%) completed all rounds. A total of 22 items were considered, with 9 items achieving consensus for inclusion as core outcomes: incidence of postadmission symptom onset, overall stroke incidence, stroke incidence stratified by type and by treatment category, stroke incidence prior to treatment initiation, time to stroke, overall mortality, bleeding complications, and injury progression on radiographic follow-up. The panel further identified four non-outcome items of high importance for reporting: time to BCVI diagnosis, use of standardized screening tool, duration of treatment, and type of therapy used.
Conclusion: Through a well-accepted iterative survey consensus process, content experts have defined a COS to guide future research on BCVI. This COS will be a valuable tool for researchers seeking to perform new BCVI research and will allow future projects to generate data suitable for pooled statistical analysis with enhanced statistical power.
•Markus Ziesmann, MD, MSc (University of Manitoba) - Principal Investigator
•Melissa Boltz, DO, MBA (Penn State Hershey Medical Center)
•Saskya Byerly, MD (University of Tennessee)
•Rondi Gelbard, MD (University of Alabama at Birmingham)
•Elliott Haut, MD, PhD (The Johns Hopkins Hospital)
•Jeffry Nahmias, MD, MHPE (University of California, Irvine)
•Jason Smith, MD, PhD, MBA (University of Louisville)
•Deborah Stein, MD, MPH (University of California, San Francisco)
•D. Dante Yeh, MD, MHPE (Ryder Trauma Center)
Disease Category: Orthopaedics & trauma
Disease Name: Blunt Cerebrovascular Injury
Age Range: 18 - 100
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Systematic review
Systematic reviews, Delphi Survey, and Consensus workshops with relevant stakeholders will be conducted to establish the core domains.