The ALDDeS study closed in June having exceeded its patient recruitment target by over 20 per cent, thanks to support from the Primary Care Research Network.
The study aims to find out whether it is possible to screen people, who may be drinking relatively moderate amounts of alcohol, for the early development of liver disease. It is significant because liver problems can begin to develop by drinking only slightly more than the government recommended levels of alcohol. These problems cause no symptoms until the disease is at a late stage, by which time it may be too late for treatment. If the problem can be detected early, then those at greatest risk will have the opportunity to modify their drinking behavior appropriately.
The study team set out recruit 5,000 patients; all aged 25-54 and registered at a general practice. Discussing alcohol intake with patients can be a sensitive issue and to achieve the 5,000 target they realised they would probably need to contact double that figure – setting a challenging target of inviting 10,000 patients to take part. The study also required a good social mix, which is where the Network came into its own, as Wendy O’Brien, Study Coordinator explains:
“The Network was key in finding practices in the right areas to provide the cross-section of patients we needed. Initially we expected inner city areas to provide a good proportion of the patients, but in reality, uptake there was poor due to cultural and other issues that we hadn’t anticipated. But the Network wasn’t phased, they simply did what they do best; used their local knowledge to find the right mix of patients in different areas and engage the relevant practices in the study.”
When the study closed in June it had recruited 6,368 patients, smashing the original target of 5,000. Since then Wendy has been working with the Network team on a second study called HEAT:
“Aspirin is a valuable drug, often prescribed at low doses to reduce the chance of heart attacks and strokes. However, it can sometimes cause internal bleeding from ulcers. HEAT is trying to find out whether this occurs more in patients who carry the bacteria Helicobacter (H.) pylori. This bacteria is present in the stomach of more than half the world’s population who usually do not know they have it because it seldom causes symptoms. We aim to find out whether getting rid of the bacteria with antibiotics reduces the chance of ulcer bleeding.”
HEAT is taking place in four locations in England, including Southampton and the south west. It aims to contact all suitable patients aged 60 or over who are prescribed aspirin on a regular basis. This equates to approximately 120,000 people across England making it the largest study of its kind in the UK currently. In Southampton this means sending out 30,000 invites with a view to engaging 10,000 patients in clinic to have a breath test to detect the bacteria – a mammoth challenge.
Again the Network is on the case and with the study set-up almost complete, HEAT is on the cusp of recruiting its first patient. Wendy reflects on the support HEAT has received so far:
“The Network has been fantastic in all aspects. They have helped us find adequate sites via their “expression of interest” process, again using their local knowledge and contacts to engage sites across a vast area. They have also been key in helping the sites to access NHS Service Support Costs for taking part in the study….. Because of their support we are ahead of the other centres and are optimistic that HEAT will be a success in the south west.”