Background: The BrainIT group works collaboratively on developing standards for collection and analyses of data from brain-injured patients and to facilitate a more efficient infrastructure for assessing new health care technology with the primary objective of improving patient care. European Community (EC) funding supported meetings over a year to discuss and define a core dataset to be collected from patients with traumatic brain injury using IT-based methods. We now present the results of a subsequent EC-funded study with the aim of testing the feasibility of collecting this core dataset across a number of European sites and discuss the future direction of this research network.
Methods: Over a 3-year period, data collection client- and web-server-based tools were developed and core data (grouped into nine categories) were collected from 200 head-injured patients by local nursing staff in 22 European neuro-intensive care centres. Data were uploaded through the BrainIT website and random samples of received data were selected automatically by computer for validation by data validation staff against primary sources held in each local centre. Validated data were compared with originally transmitted data and percentage error rates calculated by data category. Feasibility was assessed in terms of the proportion of missing data, accuracy of data collected and limitations reported by users of the IT methods.
Findings: Thirteen percent of data files required cleaning. Thirty "one-off" demographic and clinical data elements had significant amounts of missing data (>15%). Validation staff conducted 19,461 comparisons between uploaded database data with local data sources and error rates were commonly less than or equal to 6%, the exception being the surgery data class where an unacceptably high error rate of 34% was found. Nearly 10,000 therapies were successfully recorded with start-times but approximately a third had inaccurate or missing "end-times" which limits the analysis of duration of therapy. Over 40,000 events and procedures were recorded but events with long durations (such as transfers) were more likely to have end-times missed.
Conclusions: The BrainIT core dataset is a rich dataset for hypothesis generation and post hoc analyses, provided that studies avoid known limitations in the dataset. Limitations in the current IT-based data collection tools have been identified and have been addressed. In order for multi-centre data collection projects to be viable, the resource intensive validation procedures will require a more automated process and this may include direct electronic access to hospital-based clinical data sources for both validation purposes and for minimising the duplication of data entry. This type of infrastructure may foster and facilitate the remote monitoring of patient management and protocol adherence in future trials of patient management and monitoring.