Carter Hayley M, Beard David J, Dodsley Charlotte, Leighton Paul, McCallion Joshua, Moffatt Fiona, Smith Benjamin E, Webster Kate E, Logan Pip
Physiotherapy Outpatients, Florence Nightingale Community Hospital, Level 3, Derby, DE1 2QY, UK.
School of Medicine, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK.
Pilot Feasibility Stud. 2024 May 7;10(1):72. doi: 10.1186/s40814-024-01503-6.
Treatment for anterior cruciate ligament (ACL) rupture may follow a surgical or nonsurgical pathway. At present, there is uncertainty around treatment choice. Two shared decision-making tools have been codesigned to support patients to make a decision about treatment following an ACL rupture. The shared decision-making tools include a patient information leaflet and an option grid. We report the protocol for a mixed-methods feasibility study, with nested qualitative interviews, to understand feasibility, acceptability, indicators of effectiveness and implementation factors of these shared decision-making tools (combined to form one shared decision-making intervention).
A single-centre non-randomised feasibility study will be conducted with 20 patients. Patients diagnosed with an ACL rupture following magnetic resonance imaging will be identified from an orthopaedic clinic. The shared decision-making intervention will be delivered during a clinical consultation with a physiotherapist. The primary feasibility outcomes include the following: recruitment rate, fidelity, acceptability and follow-up questionnaire completion. The secondary outcome is the satisfaction with decision scale. The nested qualitative interview will explore experience of using the shared decision-making intervention to understand acceptability, implementation factors and areas for further refinement.
This study will determine the feasibility of using a newly developed shared decision-making intervention designed to support patients to make a decision about treatment of their ACL rupture. The acceptability and indicators of effectiveness will also be explored. In the long term, the shared decision-making intervention may improve service and patient outcomes and ensure cost-effectiveness for the NHS; ensuring those most likely to benefit from surgical treatment proceed along this pathway.
Pending registration on ISRCTN.
前交叉韧带（ACL）断裂的治疗可以采用手术或非手术方式。目前，治疗选择存在不确定性。已经共同设计了两种共享决策工具，以支持患者就ACL断裂后的治疗做出决策。共享决策工具包括一份患者信息手册和一个选项网格。我们报告一项混合方法可行性研究的方案，该研究包括嵌套的定性访谈，以了解这些共享决策工具（合并形成一种共享决策干预措施）的可行性、可接受性、有效性指标和实施因素。
将对20名患者进行单中心非随机可行性研究。将从骨科诊所中识别出经磁共振成像诊断为ACL断裂的患者。共享决策干预措施将在与物理治疗师的临床咨询期间提供。主要可行性结果包括：招募率、保真度、可接受性和随访问卷完成情况。次要结果是对决策量表的满意度。嵌套的定性访谈将探索使用共享决策干预措施的经验，以了解可接受性、实施因素和进一步完善的领域。
本研究将确定使用新开发的共享决策干预措施的可行性，该措施旨在支持患者就其ACL断裂的治疗做出决策。还将探索其可接受性和有效性指标。从长远来看，共享决策干预措施可能会改善服务和患者结局，并确保英国国家医疗服务体系（NHS）的成本效益；确保那些最有可能从手术治疗中受益的患者沿着这条途径进行治疗。
等待在国际标准随机对照试验编号（ISRCTN）上注册。
