SAFER: The complete works

Dr Rakesh Modi is a GP and Wellcome PhD Fellow in the Primary Care Unit of the University of Camrbridge. He is performing research on the landmark NIHR-funded SAFER trial investigating screening to detect an undiagnosed heart condition responsible for one in ten strokes. Here he writes on how the SAFER programme has evolved and adapted to the COVID-19 pandemic with the support of various funders. The SAFER study was supported by the earlier SPCR's Screening for Atrial Fibrillation project.

Whilst coding transcripts of my interviews with practice staff who generously shared their experiences on our trial, I melted into Beethoven’s seventh symphony. Last year was marked by the pandemic, but an escapist will also find another landmark: it was Beethoven’s 250^th birthday. With the same realisation that hit me in the first year of my PhD that life’s questions will not be answered in three years, it dawned on me that the SAFER trial is less like a Beethovian symphony, and has more in common with his entire biography. Journeys are always longer than we thought, more obstructed than we thought, but with meaningful collaborations– more worthwhile than we thought.

Ludwig Van Beethoven by Joseph Karl Stieler (1820). Public domain, via Wikimedia Commons

Feasibility 1: Optimism

The SAFER trial (Screening for Atrial Fibrillation with ECG to Reduce stroke) is the largest ever randomised controlled trial of atrial fibrillation (AF) screening. It is a pragmatic trial to see if screening for atrial fibrillation with a hand-held device in people aged 70 and over is effective and cost-effective at reducing stroke (among other outcomes). Such a question, which seeks to inform the remaining evidence around whether or not there should be national screening programmes for AF, can only be answered by building a solution piece by piece, gradually creating a body of work that shows progression and direction. Our feasibility 1 study in 2019 showed that it was indeed possible to screen for AF and this would be both acceptable and adequate to diagnose new cases. This project utilised the full scope of primary care, using face-to-face appointments to train participants in how to use the device, collaborating with Clinical Research Networks to train practices, and engaging cardiologists to provide robust diagnoses; like Beethoven’s early piano concertos, it used familiar techniques but offered bright promise, and NIHR SPCR, like Beethoven’s patrons, recognised our potential and were generous in funding and fora to raise our profile. 

Feasibility 2: Obstacles

The reception of feasibility 1 gave us all the confidence we needed to try out the more ambitious symphony of a pilot study in 36 practices. Then the pandemic approached like a wall of sound. Like the tinnitus in Beethoven’s ear, the closing down of face-to-face appointments in general practice was an omen – fate knocking on our door. Patrons did not give up on us now: as NIHR continued our funding to find out new ways of delivering AF screening in this foreign landscape, 2020 saw us press our ears to the soundboard and diligently work around our obstacles, re-imagining each and every detail of our investigation with methodical caution and sheer determination. Wellcome Trust supplied my PhD funding with great understanding to the impact of Covid-19 on my clinical role, and supported me in comparing the different models of delivering the SAFER programme. The result was feasibility 2: a study in a handful of practices to see firstly, if we could explain the use of the hand-held devices via remote consultations, and secondly, if we could minimise the pressure on general practices by delivering these consultations through trial administrators as opposed to practice staff. It was a success and our Eroica: adversity had been met with passages of development where we sometimes felt lost, but we had emerged with a brawny new model, born of the struggle.  

Pilot and main trial: Overcoming

Beethoven’s hearing was so impaired in his late period that he was forced to explore the music inside him; he eventually came to realise that it was truly bright and original. We are now at the point where we realise that frustration was formative and we have a wonderfully modern intervention, with self-directed AF screening by participants, a central team on hand for support, and practices geared to manage diagnoses of AF, all with minimal face to face exposure. The darker tone of our plans early in the pandemic, seeking brute utility, have given over to nuanced and creative solutions: a roadmap to future endeavours. It’s too early to say whether this is our 9^th symphony – all-encompassing and utilitarian in scope – but what we have learnt from Beethoven is that the adversity of the pandemic is not the end. It is but an ode to journeys.