Mee H, Korhonen T K, Castaño-Leon A M, Adeleye A, Allanson J, Anwar F, Bhagavatula I D, Bond K, Clement C, Rubiano A M, Grieve K, Hawryluk G, Helmy A, Honeybul S, Iaccarino C, Lagares A, Marcus H, Marklund N, Muehlschlegel S, Owen N, Paul M, Pomeroy V, Shukla D, Servadei F, Viaroli E, Warburton E, Wells A, Timofeev I, Turner C, Whiting G, Hutchinson P, Kolias A
Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.
Division of Rehabilitation Medicine, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.
Brain Spine. 2025 Jun 1;5:104288. doi: 10.1016/j.bas.2025.104288. eCollection 2025.
There is substantial heterogeneity in the reporting of outcomes in the global cranioplasty literature. This study aimed to establish a core outcome set (COS) for cranioplasty after decompressive craniectomy for stroke or traumatic brain injury.
The scope was defined according to the criteria recommended by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Phase 1 focused on outcome gathering through a systematic review and a qualitative study. Phase 2 focused on consolidation and consensus of outcomes through a two-round Delphi survey and consensus meeting. Participants from the four stakeholder groups (1. patients and/or relatives; 2. Surgeons, 3. physicians (non-surgeons), 4. Nurses, allied health professionals, and researchers) individually scored all outcomes on a 9-point Likert scale. Variables that did not reach the predefined consensus threshold for COS inclusion or exclusion were voted upon at the final consensus meeting.
In total, 208 verbatim outcomes were consolidated into 56 domains. A total of 153 participants completed round 1, with 45 additional outcomes suggested for inclusion. Following rationalisation, four were included in round 2. A total of 109/153 participants (71 %) from 16 countries completed Round 2 and re-scored all 60 outcomes (56 original + 4 additional). Nine outcomes were voted in, and 12 were excluded from the Delphi. The remaining 39 were discussed at a consensus meeting with 11 voted in. The final COS included 20 outcomes (12 + 8) across four domains: life impact, pathophysiological manifestations, resource use/economic impact, and mortality.
COAST COS covers key cranioplasty outcomes, as assessed by international stakeholders, including surgical, medical, rehabilitation, and nursing professionals, as well as patients and their relatives. Future implementation will aid in the standardisation of outcomes and facilitate the development of cranioplasty-specific outcome measures, aiding between-study comparisons and improving the relevance of trial findings to healthcare professionals and patients.
全球颅骨修补术文献中结局报告存在显著异质性。本研究旨在为中风或创伤性脑损伤减压性颅骨切除术后的颅骨修补术建立一个核心结局集（COS）。
范围根据有效性试验核心结局测量（COMET）倡议推荐的标准确定。第1阶段侧重于通过系统评价和定性研究收集结局。第2阶段侧重于通过两轮德尔菲调查和共识会议对结局进行整合和达成共识。来自四个利益相关者群体（1.患者和/或亲属；2.外科医生；3.内科医生（非外科医生）；4.护士、专职医疗人员和研究人员）的参与者分别以9点李克特量表对所有结局进行评分。未达到COS纳入或排除预定义共识阈值的变量在最终共识会议上进行投票表决。
总共208条逐字记录的结局被整合为56个领域。共有153名参与者完成了第1轮，另外提出了45条结局建议纳入。经过合理化后，4条在第2轮中被纳入。来自16个国家的109/153名参与者（71%）完成了第2轮，并对所有60条结局（56条原始结局+4条新增结局）重新评分。9条结局被投票纳入，12条被排除在德尔菲调查之外。其余39条在共识会议上进行了讨论，11条被投票纳入。最终的COS包括四个领域的20条结局（12条+8条）：生活影响、病理生理表现、资源使用/经济影响和死亡率。
COAST COS涵盖了国际利益相关者评估的颅骨修补术关键结局，这些利益相关者包括外科、内科、康复和护理专业人员以及患者及其亲属。未来的实施将有助于结局标准化，并促进颅骨修补术特定结局测量的发展，有助于研究间的比较，并提高试验结果对医疗专业人员和患者的相关性。
Zotero 插件