{"title":"正中神经电刺激用于恢复脑外伤患者的意识:系统综述和荟萃分析的研究方案。","authors":"Ying Yang, Yulan Luo, Mei Feng, Ping Luo, Jiarong Zeng, Xinmao Shi, Menglin Tang","doi":"10.1136/bmjopen-2024-091560","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Traumatic brain injury (TBI) is one of the prevalent critical illnesses encountered in clinical practice, often resulting in a spectrum of consciousness disorders among survivors. Prolonged states of impaired consciousness can significantly elevate the susceptibility to complications such as urinary tract infections and pulmonary issues, consequently leading to a compromised prognosis and substantially impacting the quality of life for affected individuals. Clinical studies have reported that median nerve electrical stimulation (MNES) may have a therapeutic effect in the treatment of disorders of consciousness (DOC). 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To ensure rigour and consistency, two independent reviewers will screen the studies for inclusion, extract relevant data and assess the risk of bias. Any discrepancies will be resolved through discussion or consultation with a third reviewer. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Data synthesis and meta-analysis will be conducted using STATA 15.1 software.</p><p><strong>Ethics and dissemination: </strong>This systematic review and meta-analysis do not involve the collection or use of any individual patient data, thereby obviating the necessity for ethical review. 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引用次数: 0
摘要
导言:创伤性脑损伤(TBI)是临床上常见的危重疾病之一,通常会导致幸存者出现一系列意识障碍。长时间的意识障碍会大大增加泌尿道感染和肺部问题等并发症的易感性,从而导致预后不良,严重影响患者的生活质量。临床研究表明,正中神经电刺激(MNES)对治疗意识障碍(DOC)有一定疗效。我们计划进行一项系统性综述和荟萃分析,以评估正中神经电刺激治疗创伤后意识障碍(DOC)的有效性和安全性:我们将在以下电子数据库中进行全面的文献检索:方法与分析:我们将在以下电子数据库中进行全面的文献检索:Web of Science、Embase、PubMed、Cochrane Library、China Biology Medicine、China National Knowledge Infrastructure、万方数据库和中文科技期刊数据库。检索将从数据库建立之初持续到 2024 年 9 月 30 日。此外,我们还将在国际临床试验注册平台、ClinicalTrials.gov 和中国临床试验注册中心搜索正在进行的相关试验。我们还将从 GreyNet International、Open Grey 和 Google Scholar 等著名来源获取灰色文献。我们将纳入符合条件的随机对照试验。我们关注的主要结果是意识障碍严重程度的评估。为确保严谨性和一致性,两名独立审稿人将筛选纳入研究、提取相关数据并评估偏倚风险。任何不一致之处都将通过与第三位审稿人讨论或协商来解决。证据质量将采用建议、评估、发展和评价分级法进行评估。将使用 STATA 15.1 软件进行数据综合和荟萃分析:本系统综述和荟萃分析不涉及收集或使用任何患者个人数据,因此无需进行伦理审查。研究结果将在同行评审的科学期刊上发表:CRD42024533359。
Median nerve electrical stimulation for restoring consciousness in patients with traumatic brain injury: study protocol for a systematic review and meta-analysis.
Introduction: Traumatic brain injury (TBI) is one of the prevalent critical illnesses encountered in clinical practice, often resulting in a spectrum of consciousness disorders among survivors. Prolonged states of impaired consciousness can significantly elevate the susceptibility to complications such as urinary tract infections and pulmonary issues, consequently leading to a compromised prognosis and substantially impacting the quality of life for affected individuals. Clinical studies have reported that median nerve electrical stimulation (MNES) may have a therapeutic effect in the treatment of disorders of consciousness (DOC). We plan to conduct a systematic review and meta-analysis to evaluate the efficacy and safety of MNES in the management of DOC subsequent to TBI.
Methods and analysis: We will conduct a comprehensive literature search in the following electronic databases: Web of Science, Embase, PubMed, Cochrane Library, China Biology Medicine, China National Knowledge Infrastructure, Wan Fang Database and Chinese Scientific Journal Database. The search will be performed from the inception of the databases until 30 September 2024. Furthermore, we will search for relevant ongoing trials in the International Clinical Trial Registry Platform, ClinicalTrials.gov and China Clinical Trial Registry. Grey literature will also be sourced from reputable sources like GreyNet International, Open Grey and Google Scholar. We will include eligible randomised controlled trials. The primary outcome of interest will be the assessment of consciousness disorder severity. To ensure rigour and consistency, two independent reviewers will screen the studies for inclusion, extract relevant data and assess the risk of bias. Any discrepancies will be resolved through discussion or consultation with a third reviewer. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Data synthesis and meta-analysis will be conducted using STATA 15.1 software.
Ethics and dissemination: This systematic review and meta-analysis do not involve the collection or use of any individual patient data, thereby obviating the necessity for ethical review. The research findings will be disseminated through publication in peer-reviewed scientific journals.
期刊介绍:
BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.