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Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 613797, 9 pages
http://dx.doi.org/10.1155/2013/613797
Research Article

Addressing the “It Is Just Placebo” Pitfall in CAM: Methodology of a Project to Develop Patient-Reported Measures of Nonspecific Factors in Healing

1Department of Psychiatry, University of Pittsburgh School of Medicine, UPMC Center for Integrative Medicine, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA 15232, USA
2Department of Psychiatry and Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Medical Director, UPMC Center for Integrative Medicine, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA 15232, USA
3Department of Medicine, Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh School of Medicine, 230 McKee Place, Suite 600, Pittsburgh, PA 15213, USA
4Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Sciences, 6035 Forbes Tower, University of Pittsburgh, Pittsburgh, PA 15241, USA

Received 10 August 2013; Accepted 30 September 2013

Academic Editor: Cheryl Hawk

Copyright © 2013 Carol M. Greco et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

CAM therapies are often dismissed as “no better than placebo;” however, this belief may be overcome through careful analysis of nonspecific factors in healing. To improve trial methodology, we propose that CAM (and conventional) RCTs should evaluate and adjust for the effects of intrapersonal, interpersonal, and environmental factors on outcomes. However, measurement of these is challenging, and there are no brief, precise instruments that are suitable for widespread use in trials and clinical settings. This paper describes the methodology of a project to develop a set of patient-reported instruments that will quantify the nonspecific or “placebo” effects that are in fact specific and active ingredients in healing. The project uses the rigorous instrument-development methodology of the NIH-PROMIS initiative. The methods include (1) integration of patients’ and clinicians’ opinions with existing literature; (2) development of relevant items; (3) calibration of items on large samples; (4) classical test theory and modern psychometric methods to select the most useful items; (5) development of computerized adaptive tests (CATs) that maximize information while minimizing patient burden; and (6) initial validation studies. The instruments will have the potential to revolutionize clinical trials in both CAM and conventional medicine through quantifying contextual factors that contribute to healing.