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

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

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.

Experience, Interviews, Qualitative, Recruitment, Trials
1745-6215
1-11
Phelps, Emma Elizabeth
8d903586-1891-4590-9fc1-d43f12d30c3f
Tutton, Elizabeth
0348edbd-fc1a-4955-b7e9-0740124c32b1
Griffin, Xavier
95c2a79c-af80-47c8-9475-338eb506aa7a
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824
Phelps, Emma Elizabeth
8d903586-1891-4590-9fc1-d43f12d30c3f
Tutton, Elizabeth
0348edbd-fc1a-4955-b7e9-0740124c32b1
Griffin, Xavier
95c2a79c-af80-47c8-9475-338eb506aa7a
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824

Phelps, Emma Elizabeth, Tutton, Elizabeth, Griffin, Xavier and Baird, Janis (2019) Facilitating trial recruitment: a qualitative study of patient and staff experiences of an orthopaedic trauma trial. Trials, 20 (1), 1-11, [492]. (doi:10.1186/s13063-019-3597-8).

Record type: Article

Abstract

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.

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Accepted/In Press date: 18 July 2019
Published date: 9 August 2019
Keywords: Experience, Interviews, Qualitative, Recruitment, Trials

Identifiers

Local EPrints ID: 433470
URI: http://eprints.soton.ac.uk/id/eprint/433470
ISSN: 1745-6215
PURE UUID: 27f78d3d-002c-426b-8e21-44f8dfcc068e
ORCID for Janis Baird: ORCID iD orcid.org/0000-0002-4039-4361

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Date deposited: 23 Aug 2019 16:30
Last modified: 07 Oct 2020 01:47

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Contributors

Author: Emma Elizabeth Phelps
Author: Elizabeth Tutton
Author: Xavier Griffin
Author: Janis Baird ORCID iD

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