Division of Biological Sciences, University of Georgia, Athens, GA, USA.
BMC Complement Altern Med. 2011 Dec 29;11:136. doi: 10.1186/1472-6882-11-136.
Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which the content and format is refined through cognitive interviews.
We conducted cognitive interviews across five iterations of questionnaire refinement with a culturally diverse sample of 28 CAM users. In each iteration, participant critiques were used to revise the questionnaire, which was then re-tested in subsequent rounds of cognitive interviews. Following all five iterations, transcripts of cognitive interviews were systematically coded and analyzed to examine participants' understanding of the format and content of the final questionnaire. Based on this data, we established summary descriptions and selected exemplar quotations for each word pair on the final questionnaire.
The final version of the Self-Assessment of Change questionnaire (SAC) includes 16 word pairs, nine of which remained unchanged from the original draft. Participants consistently said that these stable word pairs represented opposite ends of the same domain of experience and the meanings of these terms were stable across the participant pool. Five pairs underwent revision and two word pairs were added. Four word pairs were eliminated for redundancy or because participants did not agree on the meaning of the terms. Cognitive interviews indicate that participants understood the format of the questionnaire and considered each word pair to represent opposite poles of a shared domain of experience.
We have placed lay language and direct experience at the center of questionnaire revision and refinement. In so doing, we provide an innovative model for the development of truly patient-centered outcome measures. Although this instrument was designed and tested in a CAM-specific population, it may be useful in assessing multi-dimensional shifts in well-being across a broader patient population.
现有的补充和替代医学（CAM）患者报告结局测量方法不能充分捕捉患者报告的治疗效果范围。自我评估变化问卷旨在衡量 CAM 用户的幸福感的多维变化。通过从患者叙述中得出的内容，通过对新的参与者群体进行访谈，对项目进行了后续的集中关注。在这里，我们展示了最终版本的开发，该版本通过认知访谈进一步完善了内容和格式。
我们在文化多样性的 28 名 CAM 用户样本中进行了五次问卷修订的认知访谈。在每一次迭代中，参与者的评价都用于修改问卷，然后在随后的认知访谈中进行重新测试。在完成所有五次迭代后，系统地对认知访谈的记录进行编码和分析，以检查参与者对最终问卷格式和内容的理解。根据这些数据，我们为最终问卷中的每一对词总结了描述并选择了示例引文。
自我评估变化问卷（SAC）的最终版本包括 16 对词，其中 9 对与原始草案相同。参与者一致表示，这些稳定的词对代表了同一体验领域的两端，这些术语的含义在整个参与者群体中是稳定的。五个词对进行了修订，增加了两个词对。四个词对因冗余或参与者对术语的含义不一致而被删除。认知访谈表明，参与者理解问卷的格式，并认为每一对词都代表了共同体验领域的两极。
我们将日常语言和直接经验置于问卷修订和完善的中心。通过这种方式，我们为开发真正以患者为中心的结局测量工具提供了一个创新的模型。虽然这个工具是在特定的 CAM 人群中设计和测试的，但它可能对评估更广泛的患者群体的幸福感的多维变化有用。
