I’m delighted to announce that Santé-AF today received its ethical approval from the HRA London (Surrey) Research Ethics Committee.
It’s been a long journey (the initial submission was made just before the first lockdown in March), as the Committee went through all the documents thoroughly. There have been a few iterations; the REC needed, of course, to make sure that the study was scientifically robust as well as safe for its participants. We have established, amongst other things, that nutritional therapists are aware of the need to prescribe diets that do not conflict with anticoagulant medications, and that there is a very thorough protocol that acupuncturists use to safely treat anticoagulated patients.
One very useful and worthwhile thing to emerge from ethics review was an early question regarding what, exactly, the study was measuring:
it is not clear from the study documentation whether this, and any larger follow up study, is looking at reducing stroke, treating symptoms, reducing perception of symptoms and this needs to be clear.
I was taken aback by this, because of course I thought it was clear. But on re-reading the study protocol I realised the REC was absolutely right: the study’s aim wasn’t clear at all. Different documents used different words to describe the aim, and it’s important to be consistent.
So all the study documents were revised to show that the study, and a future large-scale trial, aim to measure two “primary” outcomes: quality of life and AF symptom levels. Revisions took some time, as there are currently more than 90 documents relating to the study (although not all of them refer to what the study is measuring, of course; but all of them had to be read to make sure that any reference to aim or outcomes was amended). But now, eight months later, ethics approval is final.
So in theory, the trial can start now!
But unfortunately Christmas is on the horizon. It would be unwise to start a trial now because the festive break will mean a break in treatment schedules, which wouldn’t give us a clear picture of how AF responds to consistent treatment over a three-month period. So the decision is to wait till January.
But I’m just wondering whether Christmas will lead us to a third lockdown in January. After the year we’ve all had, it’s impossible that families won’t want to be together at Christmas. That might lead to some infringement of social distancing, and I expect the R-rate and number of cases will go up in January, if not before…
So I guess we will just have to wait and see…