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Why do common sense trials fail in the UK? Lessons learned from a trial which tested the effectiveness and
Joy Adamson1, Arabella Scantlebury2, Avril Drummond3
1York Trials Unit, ARRC Building, University of York, Heslington, York, YO10 5DD, UK. joy.adamson@york.ac.uk.
Background:
The Firefli study was funded from a commissioned call to conduct a individually randomised controlled trial to assess the effectiveness and cost-effectiveness of Home Fire Safety Visits (also known as Safe and Well Visits) in their ability to reduce falls and improve quality of life in older adults living in the community. These visits are routinely carried out by fire and rescue services in England and aim to reduce risk of fire, support independent living and improve quality of life. In this paper, we reflect on our experience of attempting to deliver a definitive trial within the fire service, with the aim of informing future commissioning and methodological practice for non-National Health Service hosted trials in the UK.
Lesson Learned:
It proved impossible to conduct the trial as planned in the current research landscape, randomising only 63 participants from a target of 1156. Whilst there were challenges associated with the COVID-19 pandemic, it was key issues pertaining to current regulatory requirements, the acquisition of data and lack of research culture and infrastructure with the fire service which were fundamental barriers to successful research delivery. Specifically, these barriers meant it was not feasible to implement the trial as designed to reflect actual service delivery. The adapted trial design had very low recruitment and resulted in differences between the target population and the trial population.
Conclusions:
Conducting trials outside of health is extremely challenging in the UK. We recommend an urgent review of research governance processes which are primarily designed for health-related research in the National Health Service and are not fit for purpose when conducting research within other sectors. Many of the challenges identified are not exclusive to delivering trials in the fire service and have wider implications as the scope for evidence-based practice expands outside of health.
Trial Registration:
ClinicalTrials.gov: NCT04717258.
