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.

Level of evidence

Level IV.

Objectives

Damage control laparotomy (DCL) remains an important tool in the trauma surgeon's armamentarium. Inconsistency in reporting standards have hindered careful scrutiny of DCL outcomes. We sought to develop a core outcome set (COS) for DCL clinical studies to facilitate future pooling of data via meta-analysis and Bayesian statistics while minimizing reporting bias.

Methods

A modified Delphi study was performed using DCL content experts identified through Eastern Association for the Surgery of Trauma (EAST) 'landmark' DCL papers and EAST ad hoc COS task force consensus.

Results

Of 28 content experts identified, 20 (71%) participated in round 1, 20/20 (100%) in round 2, and 19/20 (95%) in round 3. Round 1 identified 36 potential COS. Round 2 achieved consensus on 10 core outcomes: mortality, 30-day mortality, fascial closure, days to fascial closure, abdominal complications, major complications requiring reoperation or unplanned re-exploration following closure, gastrointestinal anastomotic leak, secondary intra-abdominal sepsis (including anastomotic leak), enterocutaneous fistula, and 12-month functional outcome. Despite feedback provided between rounds, round 3 achieved no further consensus.

Conclusions

Through an electronic survey-based consensus method, content experts agreed on a core outcome set for damage control laparotomy, which is recommended for future trials in DCL clinical research. Further work is necessary to delineate specific tools and methods for measuring specific outcomes.

Level of evidence

V, criteria.