Between February 2019 and February 2020 the study was being designed. This was an iterative process of reading; discussing with academic supervisors, the Patient and Public Involvement panel, and the Thesis Advisory Panel; adjusting; reading more; discussing more… and so on. The intention was always to design a pragmatic trial – one in which the treatments under investigation would be delivered just as they are in the real world, rather than under more laboratory-like conditions. And there was never any discussion about using any kind of placebo: for one thing, it doesn’t work in a pragmatic trial; and for another it’s not a good comparator for acupuncture* and clearly no placebo could be substituted for nutritional therapy. So from the outset, this was always going to be a pragmatic trial. In being pragmatic in nature, it follows in the footsteps of Professor Hugh MacPherson, the trialblazer (that was not a typo) whose trials of acupuncture and other complementary therapies carried out between 1990-2020 helped to create new credibility for complementary therapies.
In March 2020 the study was submitted for HRA Research Ethics Committee (REC) approval. It had first been given approval by the Health Sciences Research Governance Committee at the University of York, in what could be described as a “first pass” ethics application. This was designed to iron out major glitches, of which thankfully there were none – although the HSRGC did ask for some minor changes. Following this, the study was sent to the University’s Contracts & Sponsorship department for sponsor sign-off, and after that it was submitted via the NHS’s Integrated Research Application System (IRAS) to the first Health Research Authority (HRA) Research Ethics Committee with available time. This turned out to be the London (Surrey) REC; the committee gave the study very thorough scrutiny and asked many questions (see separate blog post here). After a few back-and-forth resubmissions, Ethics approval was given on 3rd November 2020.
Although the study gained Ethics approval and could have started in November 2020, unfortunately by that time Christmas was imminent. It wouldn’t have been a good idea to start the trial then, because the festive season would have imposed a break in treatments – so it was decided to wait until January. But then in early January, the UK went into a third lockdown. This was dismaying for all concerned with Santé-AF, but nothing was to be done. It was decided to make some small changes to the study to take account of COVID-19. These small changes included the collection of a small amount of extra data from participants regarding their feelings about taking part in a trial during a pandemic; and also a change in the eligibility criteria so that participants who were clinically vulnerable, or living/bubbled with anyone who was vulnerable, would not be able to take part. There were also some changes made to trial processes, including moving online for all nutritional therapy appointments, and all study assessments. Some of these amendments were classed by the HRA as “substantial”, and so the study was resubmitted to the London (Surrey) REC in April 2021. Some questions were raised, and answered, and the substantial amendment was given approval on 7 May 2021. This means the study is now effectively “COVID-proofed” – i.e., equipped to make some findings whether or not COVID is still rampant during the trial phase.
The study finally opened for recruitment in October 2021. Four GPs in the Vale of York area expressed an interest in taking part; they did a database search of their records for patients with AF who meet basic eligibility criteria (aged 45-70; diagnosed with AF between six and 60 months previously; and having been offered appropriate stroke prevention measures). Patients who met those criteria had their records screened by their GP and (if there were no other reasons why the patient shouldn’t take part) the practice sent a “Permission to Approach” pack to the patient, giving basic information and asking whether the patient is interested in participating. Patients who replied to say they were interested received a full Participant Information Sheet and a consent form; those who signed and returned the consent form were contacted for a final screening and a baseline assessment. In the baseline assessment, which was carried out online to minimise the risk from COVID-19, participants completed a questionnaire and take some measurements, then took away a 7-day symptom diary to complete. Participants who told us they were willing to be interviewed had their interview at the baseline assessment too, and the 33% of participants who were randomly allocated to wear the CardioSTAT® heart monitor were guided to fit this at the assessment. After the baseline assessment, participants were enrolled in the study and randomly allocated to a group (A: acupuncture + usual care, B: nutritional therapy + usual care or C: usual care alone).
In the intervention phase, which should ran between November 2021 and July 2022, all participants received their treatments (or simply their usual care, if they were in Group C). Participants in the acupuncture group received up to eight acupuncture treatments once a week; participants in the nutritional therapy group received up to three nutrition consultations at about monthly intervals; and participants in the usual care group simply continued with their usual care without receiving any extra treatment. After the baseline assessment at the start of the study, we carried out an end-of-treatment follow-up assessment, similar to the baseline assessment, including the interview and the fitting of the CardioSTAT® monitor as applicable. Participants who stayed in the study received a £10 retail voucher as a thank-you.
The trial closed in July 2022 – the date by which all participants had received their final treatment. In practice, that was later than planned, mainly because one participant (in the usual care group) repeatedly couldn’t be available for their follow-up appointment; we kept offering, and the participant was willing, but unpredictable demands on their time meant they couldn’t be available when it came down to it. So we finally decided to call it a day in July 2022. Data analysis began almost straight away after the trial closed (although some kinds of analysis, including transcription of the qualitative data, had begun before trial close).
Data analysis happened between August 2022 and August 2023, and involved various analytical methods of qualitative and quantitative data, then synthesising these using mixed methods. Using both quantitative and qualitative data in the study allowed us to find out not just whether a given aspect of the trial is feasible, but also to understand why it is feasible (or not). This gives us a good way of understanding whether or not a future trial as a whole is feasible, and if not, what recommendations can be made for changes to the future trial to make it more feasible. For more information on the data analysis phase of the trial, see the blog post.
Publication of the trial’s results started in the autumn of 2023 and onwards. Following data analysis the results were written up, initially in the form of the researcher’s doctoral thesis, and then as publications in academic journals and practitioner membership magazines, and presented at conferences. You can get a summary of the results (written for the public) from the Results blog post.
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* while so-called “sham” acupuncture can be given in theory, in practice all forms of sham acupuncture have been shown to have some therapeutic effect, meaning they are not a good comparator for real, or “verum” acupuncture. If you would like to know more about this, there is a brief, clear discussion in this 1995 paper by Charles Vincent and George Lewith.