Paterson Charlotte, Zheng Zhen, Xue Charlie, Wang Yanyi
Institute of Health Service Research, Peninsula Medical School, Universities of Exeter & Plymouth, St. Luke's Campus, Exeter, United Kingdom.
J Altern Complement Med. 2008 Mar;14(2):199-208. doi: 10.1089/acm.2007.0682.
Qualitative research has an important part to play in investigating how complex interventions are implemented within randomized controlled trials (RCTs) and what impact the RCT context has on participants, their behavior, and their outcomes. We explored these issues within a randomized sham-acupuncture controlled trial of traditional Chinese acupuncture for people with migraine.
All trial participants who consented to take part in this qualitative study were interviewed twice by a researcher who was blind to all trial data. The acupuncture practitioner was interviewed once. Nineteen (19) semistructured interviews, 30-60 minutes long, were transcribed, coded, and analyzed both across and within cases.
The 10 participants, 6 female, age 23-70 years had severe migraine and conventional treatment had been of limited benefit. They were satisfied with the organization of the trial and no acupuncture was perceived as obviously "sham." Most participants, and the practitioner, actively "played their part" in the trial, taking on research roles that differed from their usual roles of "patient" and "doctor." The resulting changes to their normal expectations and behavior influenced how the intervention was delivered and experienced. There was a reduction in talking, explanations, and participation, and treatment was focused on the migraine and usually excluded other conditions, even if the participants considered them to be a cause or a trigger of the migraine.
We conclude that treatment in the trial differed from that described in studies of "real life" traditional acupuncture. These differences affected the needling-the characteristic or specific intervention-as well as contextual factors. This trial design limitation appears to be inevitable when a sham-controlled design is used to research an intervention that is based on a holistic and participative treatment strategy. These findings should be taken into account in the design and interpretation of RCTs of complex interventions such as acupuncture.
定性研究在调查随机对照试验（RCT）中复杂干预措施的实施方式以及RCT背景对参与者、其行为和结果的影响方面具有重要作用。我们在一项针对偏头痛患者的传统中医针灸随机假针灸对照试验中探讨了这些问题。
所有同意参与这项定性研究的试验参与者均由一位对所有试验数据不知情的研究人员进行了两次访谈。针灸从业者接受了一次访谈。对19次时长为30 - 60分钟的半结构化访谈进行了转录、编码，并进行了跨案例和案例内分析。
10名参与者（6名女性，年龄23 - 70岁）患有严重偏头痛，常规治疗效果有限。他们对试验的组织安排感到满意，且未察觉到任何针灸明显为“假的”。大多数参与者以及从业者在试验中积极“扮演自己的角色”，承担了与其通常的“患者”和“医生”角色不同的研究角色。他们正常期望和行为的变化影响了干预措施的实施和体验方式。交谈、解释和参与减少，治疗集中于偏头痛，通常排除其他病症，即使参与者认为这些病症是偏头痛的病因或触发因素。
我们得出结论，试验中的治疗与“现实生活”中传统针灸研究描述的不同。这些差异影响了针刺——这一特征性或特定的干预措施——以及背景因素。当采用假对照设计来研究基于整体和参与性治疗策略的干预措施时，这种试验设计局限性似乎是不可避免的。在设计和解释诸如针灸等复杂干预措施的RCT时，应考虑这些发现。
