Center for Community Health and Evaluation, Group Health Research Institute, Seattle, WA, USA.
J Altern Complement Med. 2010 Feb;16(2):157-63. doi: 10.1089/acm.2009.0188.
The goal of this research was to provide insight into the full range of meaningful outcomes experienced by patients who participate in clinical trials of complementary and alternative medicine (CAM) therapies.
Data for this study were assembled from five randomized trials evaluating six different CAM treatments for back pain. A conventional qualitative content analysis was conducted on responses to open-ended questions asked at the end of telephone interviews assessing treatment outcomes.
A total of 884 study participants who received CAM therapies completed post-treatment interviews. Of these, 327 provided qualitative data used in the analyses.
Our analysis identified a range of positive outcomes that participants in CAM trials considered important but were not captured by standard quantitative outcome measures. Positive outcome themes included increased options and hope, increased ability to relax, positive changes in emotional states, increased body awareness, changes in thinking that increased the ability to cope with back pain, increased sense of well-being, improvement in physical conditions unrelated to back pain, increased energy, increased patient activation, and dramatic improvements in health or well-being. The first five of these themes were mentioned for all of the CAM treatments, while others tended to be more treatment specific. A small fraction of these effects were considered life transforming.
Our findings suggest that standard measures used to assess the outcomes of CAM treatments fail to capture the full range of outcomes that are important to patients. In order to capture the full impact of CAM therapies, future trials should include a broader range of outcomes measures.
本研究旨在深入了解参与补充和替代医学(CAM)疗法临床试验的患者所经历的各种有意义的结果。
本研究的数据来自于五项评估六种不同 CAM 治疗背痛的随机试验。对电话访谈结束时提出的评估治疗结果的开放式问题的回答进行了常规的定性内容分析。
共 884 名接受 CAM 治疗的研究参与者完成了治疗后访谈。其中,327 名参与者提供了用于分析的定性数据。
我们的分析确定了一系列参与者认为重要但标准定量结果测量无法捕捉到的积极结果。积极的结果主题包括增加了选择和希望,增强了放松的能力,情绪状态的积极变化,增强了身体意识,改变了思维,增强了应对背痛的能力,幸福感的提高,与背痛无关的身体状况的改善,能量的增加,患者的激活,以及健康或幸福感的显著改善。前五个主题适用于所有 CAM 治疗,而其他主题则更倾向于特定于治疗。这些影响中的一小部分被认为具有改变生活的作用。
我们的发现表明,用于评估 CAM 治疗结果的标准措施未能捕捉到对患者重要的全部结果范围。为了捕捉 CAM 疗法的全部影响,未来的试验应包括更广泛的结果测量。