Aim: BrainIT is a multi centre, European Project to collect high quality continuous data from severely head injured patients from 31 participating centres. A core data set has been previously defined¹, which includes minute-by-minute physiological data and simultaneous treatment and management information. It is crucial that the data is correctly collected and validated. We describe the methodology used for this.
Methods: Minute-by-minute physiological monitoring data is collected from the bedside monitors. Demographic and clinical information, intensive care management and secondary insult management data, are collected using a handheld computer. Data is transferred from the handheld device to a local computer where it is reviewed and anonymised before being sent electronically, with the physiological data, to the central database in Glasgow.
Results: Automated computer tools have been developed to validate the data when it has been received in Glasgow. These parse the input data, and highlight missing or potentially ambiguous data. The contributing centre is then requested to amend and resend the data. Of the required data elements 20% are randomly selected for validation against original documentation along with the actual number of specific episodic events during a known period. This will determine accuracy and the percentage of missing data for each record. To date, 19 patients from 9 centres have been enrolled and requests for missing data have amounted to an average of 2 requests per patient.
Conclusion: Advances in patient care require an improved evidence base. For accurate, consistent and repeatable data collection, robust mechanisms are required. The methodology developed from the BrainIT project has been shown to be capable of this. This should enhance the reliability of clinical trials, assessment of management protocols and equipment evaluations.
Reference: ¹. Piper I, Citerio G, Chambers I, Contant C, Enblad P, Fiddes H, Howells T, Kiening K, Nilsson P, and Yau YH for the BrainIT Group. The BrainIT group: concept and core dataset definition. Acta Neurochirurgica. 145: 615-629, 2003.
Barnes J, Chambers I, Piper I, Citerio G, Contant C, Enblad P, Fiddes H, Howells T, Kiening K, Nilsson P, Yau YH on behalf of the BrainIT Group. Accurate data collection for head injury monitoring studies: a data validation methodology. Oral presentation at the 12th International symposium on Intracranial Pressure and Brain Monitoring. Hong Kong 16-26th August 2004.
Dr. Iain R. Chambers, Cleveland Unit, Middlesbrough. Tel: +44 (0)1642-854-778.
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