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Open Access Research article

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

Cheryl Ritenbaugh12*, Mimi Nichter2, Mark A Nichter2, Kimberly L Kelly12, Colette M Sims1, Iris R Bell1, Heide M Castañeda3, Charles R Elder4, Mary S Koithan5, Elizabeth G Sutherland6, Marja J Verhoef7, Sarah L Warber8 and Stephen J Coons9

Author Affiliations

1 Department of Family & Community Medicine, The University of Arizona, Tucson AZ, USA

2 School of Anthropology, The University of Arizona, Tucson AZ, USA

3 Department of Anthropology, University of South Florida, Tampa FL, USA

4 Kaiser Permanente Center for Health Research, Portland OR, USA

5 College of Nursing, The University of Arizona, Tucson AZ, USA

6 National College of Natural Medicine, Portland OR, USA

7 Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada

8 Department of Family Medicine, University of Michigan, Ann Arbor MI, USA

9 Patient-Reported Outcome Consortium, Critical Path Institute, Tucson AZ, USA

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BMC Complementary and Alternative Medicine 2011, 11:135  doi:10.1186/1472-6882-11-135

Published: 29 December 2011

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Keywords:
Complementary and alternative medicine (CAM); patient-reported outcomes (PROs); patient-centered care; non-specific outcomes; questionnaire development; retrospective pre-test; well-being