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Monday, August 15, 2011

Routine NHS data can be used for Clinical Trials development and other biomedical research

The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial

This article was first published in April 2010 – “Old news”, you might think; representations from the Swansea University Health Information Research Unit’s Secure Anonymised Information Linkage (SAIL) team at a National Cancer Research Institute joint conference earlier this year, however, highlighted the ongoing need to establish the value which routinely collected patient data may have in clinical trials development and other forms of biomedical research.

Indeed the National Institute for Health Research are working on an initiative looking to make similar services available to researchers in the UK (see the Research Capability Programme). This service has already begun to deliver linked data to researchers at King’s College London facilitating a study investigating how mental disorder in patients impacts upon the diagnosis and treatment of cancer, the aim being to understand if there is any delay in cancer diagnosis and the effect this might have on a patient’s survival.

The HITE article demonstrates the use of a SAIL database of routinely collected primary care data to identify patients (through creation of SQL queries based on an algorithm assigning eligibility) suitable for participation in a clinical trial; and goes on to describe the validation of the computer-generated results by independent clinicians. The researchers’ algorithm identified 867 patients from a population of 37,263 drawn from five general practices and the measurement of the sensitivity and specificity of the selection demonstrated a high degree of accuracy for the algorithm such that the authors were able to conclude that “This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial.”

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