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

Abstract

BackgroundPatients 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.MethodsFrom 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.ResultsThe 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.ConclusionsThis 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.

Pathways to Healing: Person-centered Responses to Complementary Services

“…The SAC was developed under a National Center for Complementary and Alternative Medicine (NCCAM)–funded research project with Cheryl Ritenbaugh, PhD, MP, University of Arizona, Tucson, as the principal investigator and other team members from universities in Florida, Oregon, Michigan, and Canada. This team used extensive interviews and focus groups in the development of the SAC with input from people facing serious health challenges who had participated in a variety of CAM services 17 . Ritenbaugh et al developed the SAC instrument with the goal of assessing the patient's perception of effects beyond direct medical treatment goals.…”

“…What is often lacking is an understanding of the benefits of these practices and an evaluation of changes from the individual's perspective at the level of the whole person (quality of life, well-being, functionality, and meaningfulness) 12 – 16 . To address this issue, Ritenbaugh et al developed the Self Assessment of Change (SAC) measure, a survey instrument designed to identify the extent of perceived personal changes following participation in complementary interventions 17 . The intent of this instrument was to enable researchers to collect data on changes that are meaningful to patients 17 .…”

Complementary and Alternative Medicine (CAM) and the Public Health: an Innovative Healthcare Practice in Supporting and Sustaining Health and Well-Being

“…Allied to this is the importance of exploring what patient's value, and thus recognising the credibility and validity of 'selfreported perceptions'. Moreover, in order to appropriately measure the efects of a particular CAM, modiied or new (outcome) measurement tools may be a need to be developed [16,40] and potentially modalityspeciic tools.…”

“…Allied to this is the importance of exploring what patient's value, and thus recognising the credibility and validity of 'selfreported perceptions'. Moreover, in order to appropriately measure the efects of a particular CAM, modiied or new (outcome) measurement tools may be a need to be developed [16,40] and potentially modalityspeciic tools.he second issue, of model validity, is closely linked. As Verhoef et al [16] powerfully argue in the context of the relevance of randomised controlled trials to CAM,CAM modalities tend to comprise whole systems of health and healing, including inter alia approaches to provide individualised diagnosis and treatment.…”

Perspectives on the effects and mechanisms of craniosacral therapy: A qualitative study of users’ views

“…One newly developed patient-centered outcome measure for CAM therapies called the SelfAssessment of Change questionnaire (SAC) [37][38] can assess patient's perception of personal changes associated with a CAM intervention. This makes the SAC a possible contender for use when assessing CST outcomes but further investigation will need to be done to confirm that it does pick up the development of greater health awareness.…”