Establishing a core outcomes set for massive transfusion: An Eastern Association for the Surgery of Trauma modified Delphi method consensus study

Abstract

BACKGROUND The management of severe hemorrhage has changed significantly over recent decades, resulting in a heterogeneous description of diagnosis, treatment, and outcomes in the literature, which is not suitable for data pooling. Therefore, we sought to develop a core outcome set (COS) to help guide future massive transfusion (MT) research and overcome the challenge of heterogeneous outcomes reporting. METHODS Massive transfusion 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 proposed outcomes for importance. Core outcomes consensus was defined as >85% of scores receiving 7 to 9 and <15% of scores receiving 1 to 3. Feedback and aggregate data were shared between rounds. RESULTS From an initial panel of 16 experts, 12 (75%) completed three rounds of deliberation to reevaluate variables not achieving predefined consensus criteria. A total of 64 items were considered, with 4 items achieving consensus for inclusion as core outcomes: blood products received in the first 6 hours, 6-hour mortality, time to mortality, and 24-hour mortality. CONCLUSION Through an iterative survey consensus process, content experts have defined a COS to guide future MT research. This COS will be a valuable tool for researchers seeking to perform new MT research and will allow future trials to generate data that can be used in pooled analyses with enhanced statistical power. LEVEL OF EVIDENCE Diagnostic Test or Criteria; Level V.