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Project Concept Review
Project Title: Outcomes, Cost-Effectiveness and the Decision Making Process to use CAM
Council Date: September 5, 2007
Program Officer:
Richard L. Nahin
Phone: 301-496-7801
Email: nahinr@mail.nih.gov
Background
The last ten years have seen an exponential increase in research investigating the efficacy and biological basis of many types of therapies commonly classified as CAM. However, little of this research has studied CAM as is actually used in a "real world" setting. In particular, NCCAM's most recent strategic plan has identified as high priority those studies examining the effectiveness and cost-effectiveness of CAM as practiced in community settings. In addition, a recent report from the Institute of Medicine (Complementary and Alternative Medicine in the United States), recognized gaps in knowledge regarding CAM use and recommended collecting a range of information regarding "CAM treatments in the manner in which they are practiced" including clinical outcomes, cost-effectiveness, patient-provider communication, and the decision-making process (patient and provider) in deciding to incorporate CAM into a patient's healthcare plan.
Purpose of Proposed Initiative
This initiative will stimulate the development of observational studies to evaluate the effectiveness and cost-effectiveness of CAM approaches as used in the community, and to elucidate the decision process employed by patients and providers in deciding to use CAM. Such studies will provide health care providers, patients and policy makers with additional information on which to base decisions concerning the incorporation of CAM into an integrated healthcare system.
Objectives
This FOA specifically encourages studies of how CAM therapies function in actual healthcare settings, where patients may have multiple problems and utilize multiple therapies, both CAM and conventional. This FOA emphasizes observational studies and secondary data analyses evaluating the use of CAM in "real-world" settings. Examples of the types of projects this initiative could support include case-control studies, retrospective observational studies, secondary analyses of existing data, and prospective observational studies. Clinical trials are NOT permitted under this FOA, and will be considered unresponsive and returned without review.
Proposed Funding Mechanisms
This initiative will solicit R01 applications only. Applicants wishing to submit pilot/developmental studies (R21's) are able to do so under existing FOA's: PAR-07-291 and PA-06-510.
