Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand
Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.
BMJ Open. 2023 Apr 24;13(4):e067745. doi: 10.1136/bmjopen-2022-067745.
This study reports a process evaluation of the Otago MASTER (MAnagement of Subacromial disorders of The shouldER) feasibility trial. This mixed-methods, process evaluation study was conducted parallel to the Otago MASTER feasibility trial. Our aims were to investigate: (1) supervised treatment fidelity of the interventions and (2) clinicians' perceptions of the trial interventions through a focus group.
Nested process evaluation study using a mixed-methods approach.
Outpatient clinic.
Five clinicians (two men, three women) aged 47-67 years, with clinical experience of 18-43 years and a minimum of postgraduate certificate training, were involved with the delivery of interventions within the feasibility trial. We assessed treatment fidelity for supervised exercises through audit of clinicians' records and compared those with the planned protocol. Clinicians took part in a focus group that lasted for approximately 1 hour. The focus group was transcribed verbatim and focus group discussion was analysed thematically using an iterative approach.
The fidelity score for the tailored exercise and manual therapy intervention was 80.3% (SD: 7.7%) and for the standardised exercise intervention, 82.9% (SD: 5.9%). Clinicians' perspectives about the trial and planned intervention were summarised by one main theme 'conflict experienced between individual clinical practice and the intervention protocol', which was supported by three subthemes: (1) programme strengths and weaknesses; (2) design-related and administrative barriers; and (3) training-related barriers.
This mixed-methods study assessed supervised treatment fidelity of interventions and clinicians' perceptions on planned interventions tested in the Otago MASTER feasibility trial. Overall, treatment fidelity was acceptable for both intervention arms; however, we observed low fidelity for certain domains within the tailored exercise and manual therapy intervention. Our focus group identified several barriers clinicians faced while delivering the planned interventions. Those findings are of relevance for planning the definite trial and for researchers conducting feasibility trials.
ANZCTR: 12617001405303.
本研究报告了奥塔哥大师(肩部疾病管理)可行性试验的过程评估。这项混合方法的过程评估研究与奥塔哥大师可行性试验同时进行。我们的目的是调查:(1)干预措施的监督治疗一致性,(2)通过焦点小组了解临床医生对试验干预措施的看法。
采用混合方法的嵌套过程评估研究。
门诊诊所。
五名临床医生(两名男性,三名女性)年龄 47-67 岁,临床经验 18-43 年,至少有研究生证书培训,参与了可行性试验中的干预措施的实施。我们通过审核临床医生的记录来评估监督锻炼的治疗一致性,并将其与计划方案进行比较。临床医生参加了大约 1 小时的焦点小组。焦点小组的文字记录被逐字转录,并使用迭代方法对焦点小组讨论进行主题分析。
定制运动和手动治疗干预的一致性得分为 80.3%(标准差:7.7%),标准化运动干预的一致性得分为 82.9%(标准差:5.9%)。临床医生对试验和计划干预的看法可以概括为一个主要主题,即“个人临床实践与干预方案之间存在冲突”,这一主题得到了三个子主题的支持:(1)方案的优缺点;(2)设计相关和行政障碍;(3)培训相关障碍。
这项混合方法研究评估了奥塔哥大师可行性试验中干预措施的监督治疗一致性和临床医生对计划干预措施的看法。总体而言,两种干预措施的治疗一致性都可以接受;然而,我们观察到定制运动和手动治疗干预的某些领域存在低一致性。我们的焦点小组确定了临床医生在实施计划干预措施时面临的几个障碍。这些发现对于规划确定性试验和进行可行性试验的研究人员具有重要意义。
ANZCTR:12617001405303。