Centre for Surgical Research, University of Bristol Medical School, Bristol, UK
Population Health Sciences, University of Bristol Medical School, Bristol, UK.
BMJ Open. 2020 Jan 13;10(1):e034372. doi: 10.1136/bmjopen-2019-034372.
There is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework.
Online archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials.
No ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences.
CRD42019141670.
麻醉在临床研究中的定义和报告方式存在显著差异。这种缺乏标准化的情况使得已发表证据的解读和未来临床试验的规划变得复杂。本系统评价将根据非药物治疗报告的统一标准(CONSORT-NPT)框架,评估随机对照试验(RCT)中麻醉作为干预措施的报告情况。
将对排名前六的麻醉影响因子期刊和排名前三的普通医学和普通外科期刊的在线档案进行系统手工搜索,以确定描述任何侵入性手术中使用麻醉干预的 RCT。将包括所有麻醉模式和技术。所有研究数据,包括所描述的麻醉干预类型,都将按照 CONSORT-NPT 清单进行提取。将使用描述性统计来总结一般研究细节,包括麻醉干预的类型/模式,以及试验的报告标准。
不需要伦理批准。研究结果将用于申请资金,以正式规范在临床研究中使用的全身麻醉、局部麻醉、区域麻醉和镇静。系统评价将通过同行评审的手稿和会议进行传播。
PROSPERO 注册号:CRD42019141670。