Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial

<p><strong>Background:</strong><br/> 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 eng...

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Main Authors: Phelps, E, Tutton, E, Griffin, X, Baird, J
Other Authors: TrAFFix Study Co-applicants
Format: Journal article
Published: BioMed Central 2019
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author Phelps, E
Tutton, E
Griffin, X
Baird, J
author2 TrAFFix Study Co-applicants
author_facet TrAFFix Study Co-applicants
Phelps, E
Tutton, E
Griffin, X
Baird, J
author_sort Phelps, E
collection OXFORD
description <p><strong>Background:</strong><br/> 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.</p><br/> <p><strong>Methods:</strong><br/> 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.</p><br/> <p><strong>Results:</strong><br/> 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.</p><br/> <p><strong>Conclusions:</strong><br/> 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.</p>
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spelling oxford-uuid:d82aae10-8ee4-4554-8479-b511c97add2b2022-11-18T15:10:24ZFacilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:d82aae10-8ee4-4554-8479-b511c97add2bSymplectic Elements at OxfordBioMed Central2019Phelps, ETutton, EGriffin, XBaird, JTrAFFix Study Co-applicants<p><strong>Background:</strong><br/> 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.</p><br/> <p><strong>Methods:</strong><br/> 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.</p><br/> <p><strong>Results:</strong><br/> 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.</p><br/> <p><strong>Conclusions:</strong><br/> 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.</p>
spellingShingle Phelps, E
Tutton, E
Griffin, X
Baird, J
Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
title Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
title_full Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
title_fullStr Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
title_full_unstemmed Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
title_short Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
title_sort facilitating trial recruitment a qualitative study of patient and staff experiences of an orthopaedic trauma trial
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