Piper I, Citerio G, Chambers I, Contant C, Enblad P, Fiddes H, Howells T, Kiening K, Nilsson P, Yau Y H
Department of Clinical Physics, Insatitute of Neurological Sciences, Southern General Hospital, 13455 Govan Road, Glasgow G51 4TF, Scotland, UK.
Acta Neurochir (Wien). 2003 Aug;145(8):615-28; discussion 628-9. doi: 10.1007/s00701-003-0066-6.
An open collaborative international network has been established which aims to improve inter-centre standards for collection of high-resolution, neurointensive care data on patients with traumatic brain injury. The group is also working towards the creation of an open access, detailed and validated database that will be useful for post-hoc hypothesis testing. In Part A, the underlying concept, the group coordination structure, membership guidelines and database access and publication criteria are described. Secondly, in part B, we describe a set of meetings funded by the EEC that allowed us to define a "Core Dataset" and we present the results of a feasibility exercise for collection of this core dataset.
Four group meetings funded by the EEC have enabled definition of a "Core Dataset" to be collected from all centres regardless of specific project aim. A paper based pilot collection of data was conducted to determine the feasibility for collection of the core dataset. Specially designed forms to collect the core dataset demographic and clinical information as well as sample the time-series data elements were distributed by both email and standard mail to 22 BrainIT centres. A deadline of two months was set to receive completed forms back from centres. A pilot data collection of minute by minute physiological monitoring data was also performed.
A core-dataset was defined and can be downloaded from the BrainIT web-site (go to "Core dataset" link at: www.brainit.org). Eighteen centres (82%) returned completed forms by the set deadline. Overall the feasibility for collection of the core data elements was high with only 10 of the 64 questions (16%) showing missing data. Of those 10 fields with missing data, the average number of centres not responding was 12% and the median 6%. An SQL database to hold the data has been designed and is being tested. Software tools for collection of the core dataset have been developed. Ethics approval has been granted for collection of multi-centre data as part of a pilot data collection study.
The BrainIT network provides a more standardised and higher resolution data collection mechanism for research groups, organisations and the device industry to conduct multi-centre trials of new health care technology in patients with traumatic brain injury.
已建立一个开放的国际合作网络，旨在提高各中心收集创伤性脑损伤患者高分辨率神经重症监护数据的标准。该小组还致力于创建一个开放获取、详细且经过验证的数据库，这将有助于事后假设检验。在A部分，描述了基本概念、小组协调结构、成员准则以及数据库访问和发布标准。其次，在B部分，我们描述了由欧洲经济共同体资助的一系列会议，这些会议使我们能够定义一个“核心数据集”，并展示收集该核心数据集的可行性研究结果。
由欧洲经济共同体资助的四次小组会议促成了从所有中心收集“核心数据集”的定义，而不考虑具体项目目标。进行了基于纸质的试点数据收集，以确定收集核心数据集的可行性。专门设计的用于收集核心数据集人口统计学和临床信息以及对时间序列数据元素进行采样的表格，通过电子邮件和标准邮件分发给了22个BrainIT中心。设定了两个月的期限以从各中心收回填好的表格。还进行了逐分钟生理监测数据的试点数据收集。
定义了一个核心数据集，可从BrainIT网站（访问：www.brainit.org上的“核心数据集”链接）下载。18个中心（82%）在规定期限前返回了填好的表格。总体而言，收集核心数据元素的可行性很高，64个问题中只有10个（16%）显示有缺失数据。在这10个有缺失数据的字段中，未回复的中心平均数量为12%，中位数为6%。已设计并正在测试一个用于存储数据的SQL数据库。已开发出用于收集核心数据集的软件工具。作为试点数据收集研究的一部分，已获得多中心数据收集的伦理批准。
BrainIT网络为研究小组、组织和设备行业提供了一种更标准化、分辨率更高的数据收集机制，用于对创伤性脑损伤患者进行新医疗技术的多中心试验。
