The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011).
The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011).
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DOI：
10.1186/1745-6215-13-228
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发表时间：
2012-11-29
期刊：
影响因子：
2.5
通讯作者：
SPARE Trial Management Group
中科院分区：
文献类型：
--
作者：
Moynihan C;Lewis R;Hall E;Jones E;Birtle A;Huddart R;SPARE Trial Management Group
有证据表明，临床试验招募不佳取决于患者的“缺陷”模型-无法理解试验过程。沟通不畅也被认为是征聘的一个可能障碍。在肌层浸润性膀胱癌III期非劣效性随机对照试验（RCT）（SPARE，CRUK/07/011）的可行性阶段纳入了一项定性患者访谈研究。目的是阐明随机化背景下的问题。定性研究采用了“框架分析”，其中包括“不断比较”，半结构化的采访转录，分析，比较和对比之间和内成绩单。三名研究人员对数据进行编码和解释。24例患者同意进入访谈研究; 10例拒绝随机化，14例接受随机化，其中2例随后拒绝接受分配的治疗。适用于大多数样本的主题是混乱和模糊。几乎没有迹象表明混淆直接影响进入SPARE试验的决定。然而，混乱似乎影响到围绕“知情同意”的伦理考虑，以及造成病人和卫生人员之间的疏离感。在许多伪装下的次优沟通，以及涉及在多个地理位置提供治疗方案的试验的后勤要素，都是造成混乱的原因。这些数据凸显了在英国卫生系统内提供平衡和明确的试验信息的困难，尽管有最好的意图。多名专业人员的参与可能会影响与考虑参与RCT的患者的沟通过程。我们的研究结果使我们质疑患者行为的“赤字”模型。建议卫生专业人员可以考虑促进患者感觉完全纳入试验企业的背景，并可能考虑在测试复杂干预措施的情况下随机化的替代方案。ISRCTN61126465
Evidence suggests that poor recruitment into clinical trials rests on a patient ‘deficit’ model – an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization. The qualitative study used a ‘Framework Analysis’ that included ‘constant comparison’ in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data. Twenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment. The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding ‘informed consent’, as well as cause a sense of alienation between patients and health personnel. Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations. These data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the ‘deficit’ model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients feel fully included in the trial enterprise and potentially consider alternatives to randomization where complex interventions are being tested. ISRCTN61126465
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