Carter, Hayley
(2025)
Shared decision-making following anterior cruciate ligament rupture: a mixed methods feasibility study.
PhD thesis, University of Nottingham.
Abstract
BACKGROUND
Anterior cruciate ligament (ACL) ruptures are common, affecting over 20,000 people in the UK each year. Treatment may follow a surgical, non-surgical (rehabilitation) or combined pathway whereby patients engage with rehabilitation prior to surgical intervention. Most commonly, surgery is the treatment of choice. Not all patients receive rehabilitation prior to surgery, this may be due to a lack of evidence supporting its efficacy on improving post-operative treatment outcomes. Previous research has also identified that rehabilitation prior to surgery varies. However, all patients in the UK will routinely have rehabilitation after surgery.
Despite increasing rates of ACL surgical procedures over the past two decades (predominately ACL reconstruction, ACLR), only 28% of patients return to their preinjury physical activity levels (a typical goal for most patients) by 18-months. By comparison, 24% of those treated with rehabilitation alone (non-surgical treatment) have returned by the same timeframe. Understanding which patients are appropriate for which treatment pathway is challenging. The sequence of specific treatments also continues to be debated (i.e. when and whether to undergo rehabilitation prior to surgery). Patients’ lived experiences of the UK surgical pathway (both prior to and following surgery) are currently unknown.
Development of an evidence-based and theoretically-informed intervention to support decision-making about treatment following an ACL rupture may improve patient outcomes and satisfaction, ensuring the chosen care pathway meets their individual needs. Further, development of clinical recommendations to inform practice following an ACL rupture may address the uncertainty and inconsistency in practice.
AIMS
The primary aims of this research were to:
• Develop an intervention for use with patients post-injury to support decision-making around ACLR
• Understand the interventions acceptability and tolerability among patients and clinicians
• Explore indicators of the intervention’s effectiveness and implementation factors in clinical practice
OBJECTIVES
This research involved a three-phase approach to address the above aims.
Objective 1: To understand patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and planned surgical management (Phase 1).
Objective 2: To work with patients and stakeholders to develop a novel intervention (Phase 2) to address the patients’ unmet needs identified in Phase 1.
Objective 3: To understand feasibility, acceptability and tolerability of the intervention with respect to participants and clinicians in an NHS setting (Phase 3).
METHODS
This project utilised a mixed-methods approach involving three phases of research.
Phase 1: Individual semi-structured interviews with patients at three time-points on the ACLR pathway: (1) up to 3-months before surgery, (2) 3-months post-surgery and (3) 12-months post-surgery.
Phase 2: Nominal group technique consensus study (online) with patients and key stakeholders.
Phase 3: Non-randomised single site feasibility study with embedded qualitative interviews with patients and clinicians.
The design, implementation and refinement of the intervention was underpinned by the Extended Normalisation Process Theory.
RESULTS
Interviews with 18 participants (Phase 1) offered novel insight into the lived experiences of the NHS ACL surgical treatment pathway, both prior to and after surgery. Several gaps in patient support were identified by participants who faced key challenges when: communicating with clinicians, navigating NHS systems and seeking support for a diagnosis and injury management; making decisions about treatment; receiving personalised care; coping independently in the preoperative period and managing conflicting sources of healthcare advice.
These key issues were combined with the current literature to form an evidence summary provided to participants (n=8) in Phase 2. This supported co-production of a shared decision-making intervention to support treatment decision-making following an ACL rupture and evidence-based recommendations to inform key components of care in the post-injury and/or pre-surgical period. This was achieved through an online nominal group consensus study with patients and key stakeholders including NHS healthcare professionals (physiotherapists, an orthopaedic surgeon and occupational therapist) and an NHS therapy manager.
The shared decision-making intervention was explored in a non-randomised feasibility study with 20 participants at one large acute NHS hospital trust. Feasibility data were collected on recruitment rate, acceptability, fidelity and follow-up questionnaire completion. 94%-100% was achieved across all four outcomes. Embedded qualitative interviews with patients (n=5) and physiotherapists (n=5) supported further exploration of feasibility, acceptability and an understanding of effectiveness and implementation factors. The intervention was acceptable to both patients and clinicians and appeared effective in supporting shared decision-making processes following an ACL rupture. Several implementation factors were identified, mapped to constructs of the Extended Normalisation Process Theory, to consider barriers and enablers to future implementation and normalisation within practice.
CONCLUSION
This mixed-methods study co-developed a shared decision-making intervention and evidence-based consensus recommendations supporting care following an ACL rupture. The shared decision-making intervention was demonstrated to be acceptable, and indicators of effectiveness were identified. Refinements were made to both the intervention and its logic model ready for evaluation in future research. Implementation factors were identified to support planning for a future trial and translation of knowledge into clinical practice, considering barriers and enablers to normalisation.
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