Delphi-derived development of a common core for measuring complementary and alternative medicine prevalence

Assessing complementary and alternative medicine (CAM) use remains difficult due to many problems, not the least of which is defining therapies and modalities that should be considered as CAM. Members of the International Society for Complementary Medicine Research (ISCMR) participated in a Delphi process to identify a core listing of common CAM therapies presently in use in Western countries. Lists of practitioner-based and self-administered CAM were constructed based on previous population-based surveys and ranked by ISCMR researchers by perceived level of importance. A total of 64 (49%) ISCMR members responded to the first round of the Delphi process, and 39 of these (61%) responded during the second round. There was agreement across all geographic regions (United States, United Kingdom, Canada, and Western Europe) for the inclusion of herbal medicine, acupuncture, homeopathy, Traditional Chinese Medicine (TCM), chiropractic, naturopathy, osteopathy, Ayurvedic medicine, and massage therapy in the core practitioner-based CAM list, and for homeopathy products, herbal supplements, TCM products, naturopathic products, and nutritional products in the self-administered list. This Delphi process, along with the existing literature, has demonstrated that (1) separate lists are required to measure practitioner-based and self-administered CAM; (2) timeframes should include both ever use and recent use; (3) researchers should measure and report prevalence estimates for each individual therapy so that direct comparisons can be made across studies, time, and populations; (4) the list of CAM therapies should include a core list and additionally those therapies appropriate to the geographic region, population, and the specific research questions addressed, and (5) intended populations and samples studied should be defined by the researcher so that the generalizability of findings can be assessed. Ultimately, it is important to find out what CAM modality people are using and if they are being helped by these interventions

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>From a database of patient interviews (n = 177) from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation.</p> <p>Results</p> <p>The resulting questionnaire contained 18 items, in visual analog scale format, in which each line was anchored by the positive and negative extremes relevant to the experiential domain. Because of frequent informant allusions to response set shifts from before to after CAM therapies, we chose a retrospective pretest format. Items cover physical, emotional, cognitive, social, spiritual, and whole person domains.</p> <p>Conclusions</p> <p>This paper reports the success of a novel approach to the development of outcome instruments, in which items are extracted from patients' words instead of being distilled from pre-existing theory. The resulting instrument, focused on measuring shifts in patients' perceptions of health and well-being along pre-specified axes, is undergoing continued testing, and is available for use by cooperating investigators.</p