It’s taken a while to get to this stage. When we did the practitioner training back in July last year, we thought we’d be starting to treat patients in the trial within a couple of months. But there were more delays. Some of that was just the summer break – first of all, the Clinical Research Network (CRN) had to invite GPs in the Vale of York to take part, and the CRN wasn’t able to get that invitation out till August due to staff annual leave. Then when the invitation did go out, that was smack in the middle of the summer holidays and a lot of the GP practice staff were away too. So it was late September before the GP practices started to respond to the invitation.
Four GP practices from the Vale of York signed up to the trial, and their medical staff searched their patient lists to find everyone with atrial fibrillation (AF). Between them, they had 2,744 patients with AF on their records. Then the GPs applied the eligibility criteria (the rules that say whether a participant is actually eligible to take part). There were 25 eligibility criteria, including age (a person with AF had to be aged between 45 and 70), and awareness of AF (a person with AF had to be aware of when they were having an AF episode). Things that ruled patients out included having a pacemaker (because a pacemaker can regulate AF, which might give a false result), if they had a blood clotting disorder (meaning they wouldn’t be able to have acupuncture), and whether they had an eating disorder (meaning they wouldn’t be able to have nutritional therapy).
After the 25 eligibility criteria had been applied, the GPs had 220 possible participants remaining. All 220 were sent a Permission to Approach form by the GPs: this is basically a form that tells them a bit about the study and asks if they’d like to receive more information about it. (The GPs sent this form to their eligible patients to make sure their confidentiality was maintained, so we – the researchers – only get to know who the participants are if they reply to say YES, they’d like to receive more information about the study.) We received 74 YES forms, and we then sent out a full Participant Information Pack (PIP) to each one. The PIP was an invitation to take part in the study; it contained a covering letter introducing the study, a full Participant Information Sheet, a consent form for them to sign and return to us (if they wanted to take part), and a study-branded pen to help them reply.
Informed consent
A few days after sending out each pack, I called each person to see if they had any questions about the study. People were mostly happy with the information they’d received, but about 50% had questions like “I go on holiday in March, would that rule me out?” (no) or “I couldn’t come for acupuncture in person because I can’t leave the house, does that mean I can’t take part?” (yes). After that phone call, if people wanted to take part, they signed the consent form (this is a process called “informed consent” and it’s an important part of the ethics of a study). Then they returned the signed consent form to the study centre.
Thirty-seven people returned a signed consent form. After that, two people dropped out and two people were excluded (one was ineligible, and one didn’t respond to the screening invitation) so we had a total of 33 people.
All 33 went through a screening process, carried out by phone, to ask for eligibility information that wasn’t available on their medical records – for instance, if they had recently had acupuncture or nutritional therapy (which could have skewed the results), and whether they were trying to achieve a pregnancy (which would have ruled them out for the safety of the pregnancy). Two further people were excluded, and one dropped out due to getting COVID – so eventually we ended up with a list of 30 people. Thirty was the exact number we calculated we’d need – a happy coincidence, but it made me a bit uneasy because it was so close! It would have been reassuring to have some “extra” participants in case of dropout during the initial stages.
What did we find out about the eligibility criteria?
It’s already clear that before we run a future trial, we need to look at the eligibility criteria. In a pragmatic trial, you basically want to enrol as many people as possible with the condition you’re investigating. But we applied a lot of eligibility criteria and the effect was to exclude a lot of people. The thing that excluded most people was age: of the 2,744 patients with AF identified on the first database search, 2,031 (74%) were over 70. That was to be expected, because people are more at risk of developing AF as they get older – and we had anticipated that 70 would be a reasonable cut-off point, but it clearly isn’t! And that would be a problem in a future trial, because it means that a future trial’s sample of people with AF would be less representative of the general AF population than it should be. At feasibility testing stage, though, it’s not a big problem – in fact, this is why you do a feasibility study, to find these things out!
So there is a lot of feasibility data already coming in, even though we’ve only really just started…