Two well-attended focus groups run by the HTC this autumn will help to fill gaps in knowledge around patient participation in medical device trials.
The groups were organised and run by Miss Candice Downey, NIHR Doctoral Research Fellow in General Surgery, working with Will Kitchen, a University of Cambridge third-year medical student who joined the HTC for a summer internship.
Miss Downey recently led a pilot study of the SensiumVitals® system, a device that enables remote continuous monitoring of patients’ vital signs. The study involved patients admitted to surgical wards at St James’s University Hospital in Leeds, and it was from this cohort that Miss Downey recruited the focus groups.
“We sent out the invitation to 120 people and received forty replies, which is a fantastic response rate and far more than the dozen or so we were hoping for,” she said.
The unprecedented response allowed Miss Downey and Will to organise four groups, held on September 14. Two discussed general issues around patient participation in medical device trials, while the others helped to provide a patient perspective on a new HTC-supported trial on nerve stimulation to aid bowel recovery post surgery.
General areas discussed included what patients most valued about taking part in studies, what aspects could be improved, how the consent process worked and the level of contact and interaction they wanted during the trial.
“As researchers, we tend to try and minimise the burden on patients taking part in our trials, but sometimes the balance can tip too far,” said Miss Downey. “Patients said they preferred to have more involvement and understanding of what was happening in the trial and, in particular, really appreciated getting information about the outcomes.”
Although the focus groups were a one-off, many of those who attended expressed interest in getting involved in trial committees and PPI groups in the future.
The full discussions are still being transcribed, but Miss Downey plans to publish the findings once this is completed.
“There were some really useful insights that came out of the discussion and we’d like to ensure those are made available to other clinicians and academics,” she said. “Although there is a lot published on the patient perspective in drug treatment trials, there is very little for medical devices and we hope to go some way towards remedying that.”