Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format

Cheryl Ritenbaugh, Mimi Nichter, Mark A Nichter, Kimberly L Kelly, Colette M Sims, Iris R Bell, Heide M Castañeda, Charles R Elder, Mary S Koithan, Elizabeth G Sutherland, Marja J Verhoef, Sarah L Warber, Stephen J Coons

Patients receiving complementary and alternative medicine (CAM) therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately.