Warning: the next paragraph is full of jargon! We’ll explain it afterwards.
Santé-AF is a three-arm parallel randomised controlled pragmatic open-label trial investigating the effect of acupuncture and nutritional therapy in addition to usual care for symptoms and health-related quality of life in people with atrial fibrillation. The initial feasibility study will follow the design of the future trial as closely as possible. Participants are recruited from NHS primary care settings and randomised to one of the three groups on a 2:2:1 ratio in favour of the intervention groups. Private practitioners of each therapy will deliver the interventions in routine clinical settings, following their usual scope of practice. Participants will be assessed at baseline and end of treatment. A range of quantitative and qualitative data on feasibility objectives will be analysed and synthesised using mixed methods to produce a full understanding of the effect of each therapy on symptoms and quality of life.
So let’s pick that apart!
Three arms – this means there are three groups in the trial. The first group will get eight weekly sessions of acupuncture alongside their usual care; the second group will get three monthly sessions of nutritional therapy alongside usual care; and a third group (the control group) will get only their usual care. For Santé-AF, usual care means the care provided by the NHS for atrial fibrillation, as set out in the clinical guideline NG196, comprising medications and procedures.
Parallel trial – this just means that all three groups will run at the same time, rather than being staggered or sequential.
Randomised – see the blog entry for more about the principles of randomisation and how we used it in Santé-AF.
Controlled – this just means we used a control group who received no therapy except their usual care for AF. At the end of the trial, we compare the control group’s results with each of the two therapy groups to find out what difference there is between usual care and each of the therapies. Hopefully there is a positive difference (i.e., people’s AF and quality of life has improved) between the therapies and the control group. If there is a negative difference, meaning that people’s AF and quality of life has deteriorated, we would logically conclude that the therapy in question had made symptoms and quality of life worse.
Pragmatic trial – this means that we’re aiming to keep the trial’s processes as close as possible to what happens “in real life”. For instance, it’s common in a trial for the therapy that’s being investigated to be standardised, so everyone in the trial gets the same thing. So if we were standardising the acupuncture we might agree on, say, a dozen specific acupoints that everyone would get, while in nutritional therapy we might agree on a dietary plan aimed at weight loss and blood sugar control. But that wouldn’t represent how the two therapies are practised in everyday life. In Santé-AF, our acupuncturists and nutritional therapists will work as they normally do, by formulating a unique, individualised treatment plan for every person they work with. So one person having acupuncture might get, say, some needles, a bit of massage, some cupping, and some lifestyle advice about exercise and relaxation; the next person might get some needles, and some lifestyle advice about their diet, but no massage or cupping – it depends on what the person needs. The same principle will apply for the nutritional therapists.
This individualised treatment plan is based on a detailed first consultation with the patient to understand what the practitioner needs to treat them as a person, rather than specifically to treat their atrial fibrillation. Given that AF is often seen in the presence of other health conditions – such as high blood pressure, obesity, diabetes and so on – we think that the approach of “treat the person, not the disease” might be helpful. It also means we’re not aiming to find out which specific bit of the therapy is most effective; we’re packaging it all up and aiming to find out the effects of the therapy as a whole. With this approach, the trial results are more likely to reflect what might happen in real life.
Open-label trial – this means that acupuncturists and nutritional therapists won’t be blinded to the treatment they are giving. Blinding is a research term, meaning that the doctor doesn’t know what drug they are giving – whether it’s the ‘active’ drug or a placebo. But it’s impossible for an acupuncturist or a nutritional therapist not to know what treatment they are giving. For the same reasons, participants won’t be blinded to the treatment they are receiving (because it’s also impossible to blind a participant to whether they are receiving acupuncture or nutritional therapy). This lack of blinding is a criticism of some types of randomised controlled trials because, for instance, we can’t rule out positive placebo effects arising from participants’ belief that they’re receiving some treatment that might help them. But in a pragmatic trial these so-called drawbacks are permitted partly because the whole point of a pragmatic trial is that we’re trialling therapies in circumstances as close as possible to “the real world”, where placebo is a very real part of any good healthcare treatment.
All that said, there will be some blinding in Santé-AF. Specifically, Icentia, the manufacturers of the CardioSTAT® heart monitor, will be blinded. At the end of each seven-day monitoring period, our participants will send the monitor directly back to Icentia for analysis, and the Icentia technicians will do the analysis without knowing what group the participants are in.
Participants are recruited from NHS primary care settings – we’ll be approaching GP practices in the Vale of York to request that they search their databases for possible participants who meet the study’s eligibility criteria. See the blog post on recruitment for more about this.
2:2:1 allocation ratio in favour of the intervention groups – this just means for every one participant we randomly allocate to the usual care group, another two will be randomly allocated to the acupuncture group and another two to the nutritional therapy group. It’s slightly unusual in a trial to use this “unequal” allocation ratio (the normal ratio is 1:1:1) and if you’d like to know more about why we chose this, please read the blog post on randomisation.
Private practitioners of each therapy will deliver the interventions in routine clinical settings, following their usual scope of practice – this is just us saying that the trial is pragmatic in the area of therapy delivery. If you’d like to know more about this, please read the section on Pragmatic trials, above, or read the blog post on Training the practitioners.
Participants will be assessed at baseline and end of treatment – everyone who joins the trial will be asked to complete an assessment before they receive any treatment, and again once their treatment is finished. For more about this, please read the blog post on data collection.
A range of quantitative and qualitative data will be analysed and synthesised using mixed methods – just basically means we’re aiming to collect data that’s both quantitative (numbers) and qualitative (words, basically) and analyse these, then bring them together to answer the question of whether it’s feasible to carry out a large-scale trial. If you’d like to know more about this part of the trial, please read the blog post on data analysis.
Feasibility objectives – basically the seven questions about feasibility that we looked to answer in this preliminary study. They were:
- How willing were participants to take part?
- How appropriate were the eligibility criteria? (these are the rules that say whether participants are eligible to take part or not; for more about eligibility criteria, see the blog post on recruitment)
- How many participants were retained at the end of the trial?
- How acceptable were the therapies to participants?
- How acceptable were the study assessments to participants?
- How useful was the CardioSTAT® heart monitor?
- What was participants’ overall experience of study participation?
Each of these objectives was broken down into several different parts. Some of these parts focused on feasibility relating to COVID-19 – for instance, in Objective 1, how did COVID affect participants’ willingness to take part? Other parts of each objective focused on feasibility relating to the practitioners of acupuncture and nutritional therapy. That’s because our therapists were private practitioners – they didn’t work in the NHS – and therefore the study couldn’t simply assume that they would want to take part or that they would follow the study’s procedures. So there was an element of feasibility that related to the practitioners as well.
If you’d like to skip to the end and read about the answers we found to all these objectives, you can read the blog post on the study results!
For more information about other aspects of Santé-AF, please use these links:
What are acupuncture and nutritional therapy?