建立钝性脑血管损伤的核心结局集：一项东部创伤外科学会改良德尔菲法共识研究
Establishing a core outcome set for blunt cerebrovascular injury: an EAST modified Delphi method consensus study.
作者信息
Ziesmann Markus, Byerly Saskya, Yeh Daniel Dante, Boltz Melissa, Gelbard Rondi, Haut Elliott R, Smith Jason W, Stein Deborah M, Zarzaur Ben L, Bensard Denis D, Biffl Walter L, Boyd April, Brommeland Tor, Cothren Burlew Clay, Fabian Timothy, Lauerman Margaret, Leichtle Stefan, Moore Ernest E, Timmons Shelly, Vogt Kelly, Nahmias Jeffry
机构信息
Surgery, University of Manitoba Max Rady College of Medicine, Winnipeg, Manitoba, Canada.
Surgery, UTHSC COM, Memphis, Tennessee, USA.
出版信息
Trauma Surg Acute Care Open. 2023 Jun 15;8(1):e001017. doi: 10.1136/tsaco-2022-001017. eCollection 2023.
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.
目的
近几十年来，我们对钝性脑血管损伤（BCVI）的认识发生了显著变化，这导致文献中对诊断、治疗和结果的描述存在异质性，不适合进行数据汇总。因此，我们努力制定一套核心结局集（COS），以帮助指导未来的BCVI研究，并克服结局报告异质性的挑战。
方法
在回顾了具有里程碑意义的BCVI出版物后，邀请内容专家参与一项改良的德尔菲研究。在第一轮中，参与者提交了一份拟议的核心结局清单。在随后的轮次中，小组成员使用9点李克特量表对拟议结局的重要性进行评分。核心结局共识定义为得分在7至9分的比例超过70%，得分在1至3分的比例低于15%。各轮之间共享反馈和汇总数据，并进行四轮审议，以重新评估未达到预定义共识标准的变量。
结果
最初的15名专家小组中，有12名（80%）完成了所有轮次。共考虑了22项内容，其中9项达成共识被纳入核心结局：入院后症状发作发生率、总体卒中发生率、按类型和治疗类别分层的卒中发生率、治疗开始前的卒中发生率、卒中发生时间、总体死亡率、出血并发症以及影像学随访中的损伤进展。该小组还确定了四项报告时非常重要的非结局项目：BCVI诊断时间、标准化筛查工具的使用、治疗持续时间以及所用治疗类型。
结论
通过一个广泛认可的迭代调查共识过程，内容专家定义了一套COS，以指导未来的BCVI研究。该COS将成为寻求开展新的BCVI研究的研究人员的宝贵工具，并将使未来的项目能够生成适合进行汇总统计分析且具有更强统计效力的数据。
证据水平
四级。
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