Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures

<p><strong>Aims:</strong> To explore staff’s experience of a multi-centre pilot randomised controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures.</p> <p><strong>Patients and Methods:</strong&g...

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Prif Awduron: Phelps, EE, Tutton, E, Costa, ML, Hing, CB, STIFF-F research collaborators
Fformat: Journal article
Iaith:English
Cyhoeddwyd: British Editorial Society of Bone and Joint Surgery 2021
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author Phelps, EE
Tutton, E
Costa, ML
Hing, CB
STIFF-F research collaborators
author_facet Phelps, EE
Tutton, E
Costa, ML
Hing, CB
STIFF-F research collaborators
author_sort Phelps, EE
collection OXFORD
description <p><strong>Aims:</strong> To explore staff’s experience of a multi-centre pilot randomised controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures.</p> <p><strong>Patients and Methods:</strong> A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone and were analysed using thematic analysis.</p> <p><strong>Results:</strong> The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes i) the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident, ii) an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills and iii) treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment.</p> Conclusion: Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice.
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spelling oxford-uuid:acea482d-c8c6-4f21-a6df-680e152bf5f62022-03-27T03:32:05ZUnattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fracturesJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:acea482d-c8c6-4f21-a6df-680e152bf5f6EnglishSymplectic ElementsBritish Editorial Society of Bone and Joint Surgery2021Phelps, EETutton, ECosta, MLHing, CBSTIFF-F research collaborators<p><strong>Aims:</strong> To explore staff’s experience of a multi-centre pilot randomised controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures.</p> <p><strong>Patients and Methods:</strong> A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone and were analysed using thematic analysis.</p> <p><strong>Results:</strong> The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes i) the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident, ii) an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills and iii) treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment.</p> Conclusion: Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice.
spellingShingle Phelps, EE
Tutton, E
Costa, ML
Hing, CB
STIFF-F research collaborators
Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures
title Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures
title_full Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures
title_fullStr Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures
title_full_unstemmed Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures
title_short Unattainable equipoise in randomised controlled trials: staff views of a feasibility study of surgical treatments for segmental tibial fractures
title_sort unattainable equipoise in randomised controlled trials staff views of a feasibility study of surgical treatments for segmental tibial fractures
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