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OBJECTIVES: 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. DESIGN: 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. SUBJECTS: A total of 884 study participants who received CAM therapies completed post-treatment interviews. Of these, 327 provided qualitative data used in the analyses. RESULTS: 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. CONCLUSIONS: 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.
Hsu et al. (Mon,) studied this question.