Qualitative researchers within the SAFER trial research team are making a big difference to the design and conduct of the programme, contributing to important changes in both the feasibility study and the subsequent main trial.
SAFER is a major programme of research, led by the University of Cambridge’s Primary Care Unit and funded by the National Institute for Health and Care Research (NIHR).
The SAFER trial is investigating screening for the heart condition atrial fibrillation in older adults. The qualitative researchers in the SAFER team have influenced decisions on trial documentation, trial delivery, timing and content of measures and the information given to participating patients and practices.
The SAFER team have reported on how they are working together, how the trial has changed as a result and ‘11 top tips’ for other trial teams, published today in Trials journal.
Qualitative research is known to bring multiple benefits to trials in healthcare research, helping to answer key questions such as: what is it like for patients on the receiving end of the intervention? How informed is informed consent? What do health care staff think about delivering the intervention and what would make it better?
But very few trials have the benefit of an embedded qualitative research team to help with these questions. Usually such trials are run exclusively by quantitative researchers. A review of three trial registers from 1999 to 2016 found only 0.03 to 3.4% of trials reported using qualitative methods and only 2% of funded trial proposals in the UK from 2001 to 2010 described embedded qualitative research.
The SAFER team said that insights from the qualitative researchers led to changes in the programme, like asking practices to give screening results to all participants and not just to ‘screen positive’ participants, and greater recognition of the contribution of practice reception staff to trial delivery.
These changes were facilitated by a ‘one research team’ approach that underpinned all formal and informal working processes from the outset and maximised the value of both qualitative and trial coordination expertise. The team suggest 11 ways to embed qualitative research in a trial, drawing on their experience so far on the SAFER trials.
Qualitative research can contribute in lots of ways to trials and help to avoid costly mistakes and unwanted surprises. But this work cannot be done ‘off the side of the desk’. To get the full benefit of qualitative research within trials, a ‘one research team’ approach is needed. The qualitative researchers need to have equal status with the rest of the trial team, to be well resourced and to be embedded in the trial’s structures and relationships”.
– Dr Alison Powell, lead author, Primary Care Unit
Find out more
Reference: Alison Powell, Sarah Hoare, Rakesh Modi, Kate Williams, Andrew Dymond, Cheryl Chapman, Simon Griffin, Jonathan Mant and Jenni Burt. How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme. Trials. 12 May 2022
Lucy Lloyd, Communications, Primary Care Unit
Nick Saffell, University of Cambridge