Plinsinga Melanie Louise, Mellor Rebecca, Setchell Jenny, Ford Kelsie, Lynch Leonard, Melrose Joshua, Polansky Clare, Vicenzino Bill
School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Queensland, Australia.
School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Queensland, Australia
BMJ Open. 2021 Apr 21;11(4):e044934. doi: 10.1136/bmjopen-2020-044934.
To explore participants' perspectives on, and experiences of, being assigned to a wait-and-see arm of a gluteal tendinopathy trial.
Descriptive qualitative.
General community in Brisbane and Melbourne, Australia.
Fifteen participants who had been randomly allocated to the wait-and-see group in a recent parallel group superiority clinical trial. That trial compared the wait-and-see approach to a physiotherapist-led education plus exercise approach, and an ultrasound-guided corticosteroid injection. The wait-and-see approach involved one physiotherapy session in which participants received reassurance, general advice and encouragement to stay active for the management of gluteal tendinopathy.
Semistructured interviews were conducted by four interviewers in person or over the internet, audio recorded and transcribed verbatim. Transcripts were coded and data analysed using an inductive thematic approach.
Five themes were extracted from the interview transcripts: (1) Feeling disenfranchised by being assigned to a wait-and-see approach; (2) the importance of having a clinical and imaging diagnosis during screening for inclusion into the clinical trial; (3) feelings regarding the effectiveness of the approach; (4) the convenient and easy to follow nature of the wait-and-see approach and (5) the connotation of wait-and-see not always being perceived as an intervention.
Participants found the wait-and-see approach convenient and easy to follow, yet almost always felt disenfranchised that nothing was being done. Participants highlighted the importance of a definite clinical and imaging diagnosis.
ACTRN12612001126808; Post-results.
探讨参与者对于被分配至臀肌肌腱病试验的观察等待组的看法和体验。
描述性定性研究。
澳大利亚布里斯班和墨尔本的普通社区。
15名在近期一项平行组优势临床试验中被随机分配至观察等待组的参与者。该试验比较了观察等待方法与物理治疗师主导的教育加运动方法以及超声引导下皮质类固醇注射。观察等待方法包括一次物理治疗课程，参与者在课程中得到了安慰、一般性建议以及关于在臀肌肌腱病管理中保持活动的鼓励。
由四名访谈者亲自或通过互联网进行半结构化访谈，进行录音并逐字转录。使用归纳主题法对转录本进行编码和数据分析。
从访谈转录本中提取了五个主题：(1) 因被分配至观察等待方法而感到被剥夺权利；(2) 在筛选纳入临床试验期间进行临床和影像学诊断的重要性；(3) 对该方法有效性的感受；(4) 观察等待方法方便且易于遵循的性质；(5) 观察等待并不总是被视为一种干预的内涵。
参与者发现观察等待方法方便且易于遵循，但几乎总是觉得什么都没做而被剥夺了权利。参与者强调了明确的临床和影像学诊断的重要性。
ACTRN12612001126808；结果后。
