Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
China International Neuroscience Institute (China-INI), Beijing, China.
BMJ Open. 2020 Nov 27;10(11):e040415. doi: 10.1136/bmjopen-2020-040415.
Acute basilar artery occlusion (BAO) can cause posterior circulation stroke. There are two predominant therapies for BAO: standard medical treatment (SMT) and SMT plus endovascular thrombectomy (EVT). However, a conclusive systematic comparison of the safety and efficacy of SMT and those of SMT plus EVT for the treatment of BAO is lacking. Thus, a systematic review and meta-analysis is needed to evaluate the safety and efficacy of SMT and SMT plus EVT for the treatment of BAO.
This protocol is drafted referring to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. We will search eligible studies from four main databases including MEDLINE, Web of Science, Cochrane Library and Embase. Randomised controlled trials (RCTs) and observational studies published before 1 October 2020 will be included. Two reviewers in our team will conduct the study selection and data extraction independently. Risk of bias will be assessed by Cochrane Collaboration criteria and the Newcastle-Ottawa scale for RCTs and observational studies, respectively. We will assess the good functional outcomes defining the modified Rankin scale score ≤2 at 90 days after treatment, short-term stroke severity as National Institutes of Health Stroke Scale score at 24 hours after intervention, and successful recanalisation as a modified Thrombolysis in Cerebral Infarction scale score of ≥2b after intervention. Also, safety outcomes will be assessed. The performance of this meta-analysis will depend on the quantity of included studies. The assessment of study heterogeneity will be performed by the I statistic. If there is mild heterogeneity (I<20%) of intervention outcomes in included studies, the fixed-effect model will be applied; otherwise, the random-effect model will be performed. Subgroup analyses and an assessment of publication bias will also be conducted with sufficient data.
No collection of primary data from patients is needed. Therefore, the ethical approval is unnecessary. The results may be presented in a peer-reviewed journal and related conferences.
CRD42020176764.
急性基底动脉闭塞（BAO）可引起后循环卒中。BAO 的两种主要治疗方法为标准药物治疗（SMT）加血管内血栓切除术（EVT）。然而，SMT 和 SMT 加 EVT 治疗 BAO 的安全性和疗效的系统比较结论仍缺乏。因此，需要进行系统评价和荟萃分析以评估 SMT 和 SMT 加 EVT 治疗 BAO 的安全性和疗效。
本方案参考系统评价和荟萃分析优先报告项目（PRISMA-P）指南制定。我们将从 MEDLINE、Web of Science、Cochrane 图书馆和 Embase 四个主要数据库中搜索合格的研究。纳入 2020 年 10 月 1 日前发表的随机对照试验（RCT）和观察性研究。我们团队的两名评审员将独立进行研究选择和数据提取。偏倚风险将分别根据 Cochrane 协作评价标准和纽卡斯尔-渥太华量表（RCT 和观察性研究）进行评估。我们将评估治疗后 90 天改良 Rankin 量表评分≤2 的良好功能结局、干预后 24 小时 NIHSS 评分的短期卒中严重程度以及干预后改良 Thrombolysis in Cerebral Infarction 评分≥2b 的成功再通。此外，还将评估安全性结局。荟萃分析的表现将取决于纳入研究的数量。通过 I ²统计量评估研究异质性。如果纳入研究的干预结局存在轻度异质性（I<20%），则应用固定效应模型；否则，应用随机效应模型。如果有足够的数据，将进行亚组分析和发表偏倚评估。
无需从患者处收集原始数据。因此，无需伦理批准。研究结果可能会发表在同行评议的期刊和相关会议上。
PRISMA 注册编号：CRD42020176764。
