SUBSCRIBE TO OUR DAILY RSS FEED!
Facebook
Date posted: February 11, 2012

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 Castaneda, Charles R Elder, Mary S Koithan, Elizabeth G Sutherland, Marja J Verhoef, Sara L Warber andStephen J Coons

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, 106 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.

Source : http://www.biomedcentral.com/1472-6882/11/135/abstract

Comments

1. Comments will be moderated. Please use a genuine email ID and provide your name, to   avoid rejection.
2. Comments that are abusive, personal, incendiary or irrelevant cannot be published.
3. Please write complete sentences. Do not type comments in all capital letters, or in all   lower case letters, or using abbreviated text. (example: u cannot substitute for you, d is not   'the', n is not 'and')


*

Comment moderation is enabled. Your comment may take some time to appear.