Carter Hayley, Beard David, Dodsley Charlotte, Leighton Paul, McCallion Joshua, Moffatt Fiona, Smith Benjamin Edward, Webster Kate E, Logan Phillipa
Physiotherapy Outpatients, Florence Nightingale Community Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
University of Nottingham, School of Medicine, Nottingham, UK.
BMJ Open. 2025 Aug 27;15(8):e095189. doi: 10.1136/bmjopen-2024-095189.
To understand feasibility, acceptability and indicators of effectiveness of a shared decision-making (SDM) intervention with patients following an anterior cruciate ligament (ACL) rupture.
Non-randomised feasibility study with embedded qualitative interviews.
Orthopaedic and physiotherapy service at an acute National Health Service (NHS) Teaching Hospital in the Midlands, UK, between 29 January and 5 June 2024.
Patients diagnosed with an ACL rupture following MRI.
Delivery of a SDM intervention which comprised of two components: (1) patient information leaflet and (2) option grid.
The primary outcome was to determine feasibility for a definitive trial using four outcomes: (1) recruitment rate, (2) fidelity of intervention delivery, (3) acceptability and (4) follow-up questionnaire completion. The secondary outcome was to explore indicators of the intervention's effectiveness using quantitative data from patient reported outcome measures (acceptability questionnaire and satisfaction with decision scale) and qualitative data from patient and clinician interviews.
21 patients were approached to take part in the study, 20 were recruited with a mean age of 32.2 (SD 9.7), 40% were female. The recruitment rate was 95.2%, fidelity of intervention 100%, acceptability 94% and follow-up questionnaire completion 100%. The mean overall satisfaction with decision scale score was 24.85/30 (SD 3.82). There were no adverse events. Data from qualitative interviews with patients (n=5) and physiotherapists (n=5) suggested the SDM was acceptable and appeared effective in: (1) supporting decision-making about treatment, (2) conversations between patients and clinicians, (3) improving patient knowledge, (4) providing patients with access to health language and (5) supporting patients to ask questions deemed important to them.
The novel SDM intervention is acceptable to both patients and physiotherapists. Indicators of effectiveness explored through quantitative and qualitative data suggest the intervention to be beneficial to decision-making processes for patients and clinicians deciding on treatment following an ACL rupture. All four feasibility outcomes were achieved, indicating a full trial is feasible to run in the NHS.
ISRCTN17801081.
了解前交叉韧带（ACL）断裂患者参与共同决策（SDM）干预措施的可行性、可接受性及有效性指标。
嵌入定性访谈的非随机可行性研究。
2024年1月29日至6月5日期间，英国中部一家急性国民保健服务（NHS）教学医院的骨科和理疗科。
经磁共振成像（MRI）诊断为ACL断裂的患者。
提供一项包含两个部分的SDM干预措施：（1）患者信息手册；（2）选项网格。
主要结局是使用四项指标确定进行确定性试验的可行性：（1）招募率；（2）干预措施实施的保真度；（3）可接受性；（4）随访问卷完成情况。次要结局是利用患者报告结局指标（可接受性问卷和决策满意度量表）的定量数据以及患者和临床医生访谈的定性数据，探索干预措施有效性的指标。
21名患者被邀请参与研究，20名被招募，平均年龄为32.2岁（标准差9.7），40%为女性。招募率为95.2%，干预保真度为100%，可接受性为94%，随访问卷完成率为100%。决策满意度量表的总体平均得分为24.85/30（标准差3.82）。未发生不良事件。对患者（n = 5）和物理治疗师（n = 5）进行定性访谈的数据表明，SDM是可接受的，并且在以下方面似乎有效：（1）支持治疗决策；（2）患者与临床医生之间的沟通；（3）提高患者知识水平；（4）使患者能够理解医学术语；（5）支持患者提出对他们来说重要的问题。
这种新型的SDM干预措施对患者和物理治疗师而言都是可接受的。通过定量和定性数据探索的有效性指标表明，该干预措施有利于患者和临床医生在ACL断裂后决定治疗方案的决策过程。所有四项可行性指标均达成，表明在NHS进行全面试验是可行的。
ISRCTN17801081。
