[Nottingham, UK / Medicine] - A major clinical trial to investigate whether eliminating a common stomach bug could help make taking aspirin safer is using a software tool to extract patient data from GP systems. It will save time and money and reduce the burden on patients taking part in the trial.
The Helicobacter Eradication Aspirin Trial (HEAT) will investigate whether wiping out the bacterium Helicobacter pylori in the gut of patients taking up to 325mg of aspirin a day could reduce their chances of developing a stomach ulcer and dangerous associated bleeding. Aspirin is so widely used that it has become the commonest cause of ulcer bleeding. In 2007, peptic ulcers killed almost 3,000 people in England and Wales, principally through bleeding, and in the same year, stomach ulcers saw almost 13,000 people admitted to hospital in England, at an estimated cost to the NHS of more than £10,000 per patient.
The trial, being led by The University of Nottingham in collaboration with the Universities of Durham, Southampton, Oxford and Birmingham, aims to recruit in the region of 10,000 aspirin patients found to be infected with H. pylori. It will cover a geographical area containing almost half the population of England and aims to identify about 120,000 people who fit the criteria to participate in the study. The research team expect to hear back from around 40,000 patients, around one-quarter of whom are likely to already be infected by the H. pylori bacterium, which will be diagnosed through a simple breath test.
The benefits of mining primary care records
Professor Chris Hawkey of the Nottingham Digestive Diseases Centre said, “Aspirin has many health benefits. Ulcer bleeding is one of its main drawbacks. If eradicating H. pylori reduces this, it will be a major step forward. We are also excited about the new way we are doing this trial. By using electronic record linkage to follow patients up we reduce the burden on the patient and the cost of the trial, so that we can ask big important questions that previously only the pharmaceutical industry could afford.”
Professor Hawkey told BJHC, “Primary care is an excellent setting to conduct large-scale studies such as this, as patients′ medical records are all in electronic format. Therefore it is much easier to collate data on patients, without the need to see them face-to-face. In this study, a tool called MIQUEST will be used to gather relevant information on patients who have been consented to the study.
“MIQUEST is a methodology and an approach to common data access which enables enquirers to execute queries and extract data from different types of general medical practice computer systems using a common query language. Therefore, we can find out information on what drugs patients are prescribed, and whether they′ve been into hospital, by running queries on the GP records, saving time and money. This makes the trial much more efficient, and less onerous for patients.”[hw][Photo: Staining of H. pylori from a gastric biopsy / Wikipedia]
The MIQUEST data extraction software web pages