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Davies L.1, Toye F.2, Cook J.1, Price A.1, Beard D.1
1University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 2Oxford University Hospitals Foundation Trust, Oxford, United Kingdom
Background: Strong treatment preferences of both clinicians and patients have been shown to impact on recruitment, adherence to treatment allocation and ultimately the success of a randomised controlled trial (RCT). This is particularly evident when the interventions being evaluated are markedly different, such as the comparison of surgery with a non-operative approach such as physiotherapy.
Purpose: The aim of this study was to explore clinicians' views at the pre-trial stage of NIHR HTA funded RCT of anterior cruciate ligament (ACL) deficiency management comparing surgery and rehabilitation (ACL SNNAP Surgical Necessity in Non-Acute Patients) and to identify issues that may influence trial feasibility.
Methods: Semi-structured qualitative interviews were undertaken with a purposive sample of surgeons (n=6) and physiotherapists (n=6) from 6 NHS hospitals. All clinicians were experienced in the management of ACL injuries and had expressed an interest in participating in the ACL SNNAP trial. Interviews were analysed using an Interpretative Phenomenological Analysis (IPA) approach.
Results: Several issues were identified which may impact on the feasibility of this trial. Despite indicating a willingness to randomise, clinicians expressed varying levels of uncertainty and preferences which may impact on their ability to deliver balanced descriptions of the treatment options. This was especially evident in relation to certain patient subgroups: young and highly active patients with the potential to affect which patients clinicians approach to participate. Clinicians indicated that patients often have strong preferences for treatment of this injury, particularly towards surgery, and considered this as a potential barrier to trial recruitment. Various sources were thought to influence patients views towards treatment, such as how information on the injury and its management are currently portrayed through the internet and media.
Conclusion(s): Exploring clinicians views at the pre-trial stage enabled potential trial specific issues to be identified. As a result of these findings, appropriate training and support for recruiting teams prior to the start of recruitment is being developed.
Implications: Trialists may wish to consider the use of pre-trial qualitative studies, particularly in trials where the interventions being evaluated are markedly different, to enable issues specific to a particular trial to be identified and addressed.
Funding acknowledgements: Supported through funding from Health Education Thames Valley
Topic: Research methodology & knowledge translation
Ethics approval: This work was approved by the Wales Research Ethics Committee 7 (14/WA/1108)
All authors, affiliations and abstracts have been published as submitted.
