From the Division of Trauma and Acute Care Surgery, Department of Surgery (R.B.G., J.B.H., J.K.), University of Alabama at Birmingham, Birmingham, Alabama; Division of Trauma, Burns and Surgical Critical Care (J.N.), University of California, Irvine, Orange, California; Department of Surgery (S.B.), University of Tennessee Health Science Campus, Memphis, Tennessee; Department of Surgery (M.Z.), University of Manitoba, Winnipeg, Manitoba, Canada; Department of Surgery (D.S.), R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine; Division of Acute Care Surgery, Department of Surgery (E.R.H.), Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Surgery (J.W.S.), University of Louisville School of Medicine, Louisville, Kentucky; Division of Trauma, Acute Care and Critical Care Surgery, Department of Surgery (M.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 Pathology and Molecular Medicine (J.C.), School of Medicine, Queen's University, Kingston, Ontario, Canada; Department of Surgery (B.A.C.), University of Texas Health McGovern Medical School, Houston, Texas; Department of Surgery (M.C.), University of Colorado Hospital, Aurora, Colorado; Department of Surgery (O.L.G.), Division of Acute Care Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery (L.Z.K.), Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California; Ernest E Moore Shock Trauma Center at Denver Health (E.E.M., D.D.Y.), University of Colorado Denver, Denver, Colorado; Department of Surgery (C.M.R.), Brooke Army Medical Center, San Antonio, Texas; Department of Surgery (M.S.), Oregon Health and Science University, Portland, Oregon; and Department of Surgery (J.L.S.), UPMC Presbyterian, Pittsburgh, Pennsylvania.
J Trauma Acute Care Surg. 2023 Jun 1;94(6):784-790. doi: 10.1097/TA.0000000000003884. Epub 2023 Jan 23.
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.
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.
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.
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.
Diagnostic Test or Criteria; Level V.
近几十年来，严重出血的管理发生了重大变化，导致文献中对诊断、治疗和结局的描述存在异质性，不适合数据汇总。因此，我们试图制定一个核心结局集（COS），以帮助指导未来的大量输血（MT）研究，并克服结局报告异质性的挑战。
大量输血内容专家应邀参加改良 Delphi 研究。在第 1 轮中，参与者提交了一份拟议核心结局的清单。在随后的几轮中，小组成员使用 9 分 Likert 量表对拟议的结局进行重要性评分。核心结局的共识定义为>85%的评分在 7 到 9 之间，<15%的评分在 1 到 3 之间。在各轮之间共享反馈和汇总数据。
从最初的 16 名专家小组中，有 12 名（75%）完成了三轮审议，重新评估了未达到预设共识标准的变量。共考虑了 64 项，其中有 4 项被认为是核心结局，包括：前 6 小时内接受的血液制品、6 小时死亡率、死亡时间和 24 小时死亡率。
通过迭代调查共识过程，内容专家已经确定了一个 COS，以指导未来的 MT 研究。这个 COS 将是研究人员进行新的 MT 研究的宝贵工具，并将允许未来的试验产生可以在汇总分析中使用的增强统计能力的数据。
诊断测试或标准；等级 V。
