Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
Volume
20
Publisher
Publisher URL
DOI
10.1186/s13063-019-3597-8
Journal
TRIALS
Issue
Metadata
Show full item recordAbstract
Background: Qualitative research has been used to explore patients’ and healthcare professionals’ experiences of
surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation
and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials
can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask
questions and reach a decision may be hindered by the impact of their injury. Little research, however, has
explored patients’ and healthcare professionals’ experiences of surgical RCTs in a trauma setting. This study aimed
to understand patients’ and staff’s experiences of an orthopaedic trauma trial.
Methods: We carried out semi-structured interviews with 11 patients and 24 staff (10 surgeons and 14 research
associates) participating in a UK multi-centre feasibility trial comparing intramedullary nails versus distal locking
plates for fractures of the distal femur (TrAFFix). Interviews explored patients’ experience of TrAFFix and their reason
for participating and staffs' experience of recruiting to TrAFFix and trauma trials more generally. Interviews were
audio recorded and transcribed verbatim. Transcripts were analysed using thematic analysis.
Results: Three themes were identified. These were i) navigating research with patients after orthopaedic trauma, ii)
knowing that it is the right decision and iii) making it work. These themes reflect: i) how research associates
supported and guided patients through the consent process enabling them to participate, ii) the difficulty in
engaging surgeons in a trial when individual equipoise and experience of the interventions are low despite the
presence of community equipoise and iii) the way in which research teams worked together and encouraged the
development of a research culture within the clinical teams in order to facilitate recruitment.
Conclusions: Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs
supported patients to enable them to make a decision about participation and assisted in developing a research
culture within the team by promoting studies and communicating research to clinical staff. Our findings also
reinforce surgeons’ difficulty with equipoise and suggest that accepting community equipoise could facilitate
recruitment.