Patient expectations in placebo-controlled randomized clinical trials
Patient expectations in placebo-controlled randomized clinical trials
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DOI：
10.1111/j.1365-2753.2004.00512.x
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发表时间：
2005-02-01
影响因子：
2.4
通讯作者：
Kaptchuk, TJ
中科院分区：
文献类型：
--
作者：
Stone, DA;Kerr, CE;Kaptchuk, TJ
目的探讨安慰剂对照随机临床试验（RCT）中受试者的经验与其期望值的关系。研究背景：研究者们已经对随机对照试验的各个方面进行了研究，如知情同意、获益感知和对随机化的理解。相比之下，很少有人知道有关患者的期望形成之前和期间的试验。方法采用定性研究方法，对来自4个不同RCT的9例患者进行半结构化访谈。数据分析是使用一个密码本格式安排参与者的反应下广泛的分析标题。面试官使用半结构化的面试指南，在正在进行的对话的背景下，将对话从一个广泛的主题引导到下一个主题。主题清单鼓励参与者描述他们在RCT中的经验。比较关于预期、设盲和安慰剂的叙述，以确定共同主题。结果患者的预期过程在试验前和试验中均受到多种输入的影响和修正。这些因素包括过去的随机对照试验经验、无效治疗的经验、不定期服药的压力、害怕成为“安慰剂反应者”、非研究医生或其他卫生专业人员的投入、其他参与者的经验、试验期间对健康参数的测量以及是否存在副作用，所有这些因素都会影响患者的期望。结论：随机对照试验的预期不是固定的，而是可以被视为由多个输入（包括试验前和试验期间收到的经验和信息）持续塑造的。在既往研究中观察到的安慰剂反应的变异性可能与预期的不稳定性有关。在随机对照试验中试图控制和平衡期望可能比以前假设的要困难得多。
Objective To explore participants' experience in placebo-controlled randomized clinical trials (RCTs) specifically in relationship to their expectations. Background Aspects of being in RCTs, such as informed consent, perception of benefit and understanding of randomization, have been examined. In contrast, little is known concerning the formation of patient expectations before and during trials. Methods Qualitative methods using in-depth interviews with a semi-structured interview guide of nine patients from four different RCTs. Data analysis was conducted using a codebook format arranging participant responses under broad analytical headings. The interviewer used a semi-structured interview guide to direct the conversation from one broad topic to the next within the context of the ongoing conversation. A checklist of topics encouraged participants to describe their experiences in RCTs. Narratives concerning expectation, blinding and placebo were compared to identify common themes. Results Patient anticipatory processes were influenced and modified both before and during the trial from multiple inputs. Such factors as past experiences in RCTs, past experiences of ineffective treatment, stress of being off regular medications, fear of being a 'placebo responder', input of non-study doctors or other health professionals, the experience of other participants, measurements of health parameters made during the trial and the presence or absence of side-effects all affected patient expectation. Conclusion Expectations in RCTs are not fixed and instead may be viewed as continuously shaped by multiple inputs that include experience and information received both before and during the trial. Variability in placebo response observed in previous studies may be related to the fluid nature of expectations. Trying to control and equalize expectations in RCTs may be more difficult than previously assumed.