Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle WA 98101, USA.
BMC Complement Altern Med. 2014 Jan 25;14:39. doi: 10.1186/1472-6882-14-39.
No consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire.
We reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions - verbs, nouns, response options, terms and phrases describing back pain - were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators.
The questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. "Back pain" was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as "complete relief". The use of words to describe midpoints was found to be confusing. The word "expect" held different and shifting meanings for participants. Thus paired items comparing "hope" and "realistically expect" were chosen to evaluate 5 different aspects of treatment expectations (back pain; back dysfunction and global effects; impact of back pain on specific areas of life; sleep, mood, and energy; coping). "Impact of back pain" on various areas of life was found to be a consistently meaningful concept, and more global than "interference".
Cognitive interviews identified wordings with considerable agreement among both participants and investigators. Some items widely used in clinical studies had different meanings to participants than investigators, or were confusing to participants. The final 18-item questionnaire is undergoing psychometric evaluation with goals of streamlining as well as identifying best items for use when questionnaire length is constrained.
在临床试验中，各种补充和替代医学（CAM）疗法的治疗前预期与治疗效果之间没有一致的关系。然而，在这些研究中使用了许多不同的预期措施，没有一个经过验证的问卷专门针对 CAM 和疼痛。我们进行了认知访谈，作为开发和验证此类问卷的过程的一部分。
我们回顾了关于针灸、脊椎按摩、按摩或瑜伽对疼痛的预期益处的问题。确定了问题的组成部分 - 动词、名词、回答选项、描述背部疼痛的术语和短语。使用七种不同的认知访谈脚本，我们对 39 名患有慢性下背痛的参与者进行了访谈，以评估他们在尚未接受的治疗的预期问题背景下，如何理解这些单个成分。选择的项目是参与者之间最一致和最不容易混淆的项目，并且最接近调查人员的意图。
为心理测量评估起草的问卷有 18 个项目，涵盖了预期的各个领域。“背部疼痛”是最一致的描述符。最容易理解的回答选项是 0-10 刻度，这是整个问卷中使用的结构，0 始终表示没有变化，10 用绝对描述符锚定，如“完全缓解”。使用描述中点的单词被发现令人困惑。对于参与者来说，“期望”一词具有不同和不断变化的含义。因此，选择了配对项目来比较“希望”和“现实地期望”，以评估治疗预期的 5 个不同方面（背部疼痛；背部功能障碍和整体影响；背部疼痛对生活特定领域的影响；睡眠、情绪和能量；应对）。发现“背部疼痛”对生活的各个领域的影响是一个有意义的概念，比“干扰”更全面。
认知访谈确定了参与者和调查人员之间具有相当一致性的措辞。一些在临床研究中广泛使用的项目对参与者的含义与调查人员不同，或者对参与者来说令人困惑。最终的 18 项问卷正在进行心理测量评估，目标是简化并确定在问卷长度有限时使用的最佳项目。
