provided the motivation and the rationale for the development of “outcomes research.”

The goal of outcomes research was to determine what was known and what was not known about common interventions, thereby setting research agendas for common conditions. Existing evidence was systematically reviewed by using techniques for combining data from different studies previously described in the social sciences. Claims data linked to Social Security Administration mortality and other administrative data were used to glean outcomes information to fill the gaps in knowledge that existed at the time. Patient surveys were conducted to capture patients’ subjective responses to treatments and outcomes. Variations in these responses highlighted the importance of patients’ preferences as a source of warranted variation in clinical decisions. Decision models (a model is a representation of reality) were constructed to test the relative sensitivities of decisions to key probabilities of good or bad outcomes and to patient preferences. Decision support tools were developed; and trials were designed to help patients and doctors choose among treatment options, including randomization in a trial when a well-informed patient was at equipoise, that is, finding each treatment equally acceptable.

Other investigators used consensus methods to develop appropriateness criteria that were then applied to the medical records of patients who had undergone procedures with high rates of variation by geographic region. It was common for procedures for 30 percent or more of patients’ indications to be deemed inappropriate. The proportions of procedures deemed inappropriate was essentially the same in high- and low-volume settings, so the low-volume providers were not simply doing a better job of selecting only appropriate cases.

This work was extended with a focus on guideline development. Professional organizations such as the American College of Physicians instituted rigorous guideline development processes, increasing recognition of the severe limitations of the evidence base for the treatment of common conditions.

The limited evidence base for surgery and other procedures for the common conditions targeted by outcomes research contrasted sharply with the richer body of evidence for medical therapies. This difference can best be understood in the context of the regulation of medications that began in 1906 with the Pure Food and Drug Act, which made misrepresentation of ingredients illegal and which recognized the standardized drug formulae registered in a national formulary or pharmacopoeia. The 1906 act was silent on drug safety and efficacy.

Front Matter (R1-R22)

Executive Summary (1-12)

1 Introduction (13-33)

2 Prevalence, Cost, and Patterns of CAM Use (34-73)

3 Contemporary Approaches to Evidence of Treatment Effectiveness: A Context for CAM Research (74-107)

4 Need for Innovative Designs in Research on CAM and Conventional Medicine (108-128)

5 State of Emerging Evidence on CAM (129-167)

6 An Ethical Framework for CAM Research, Practice, and Policy (168-195)

7 Integration of CAM and Conventional Medicine (196-225)

8 Educational Programs in CAM (226-252)

9 Dietary Supplements (253-277)

10 Conclusion (278-282)

Appendix A: CAM Therapies, Practices, and Systems (283-292)

Appendix B: Consortium of Academic Health Centers for Integrative Medicine (293-294)

Appendix C: Table 1-1 List of Abbreviations (295-295)

Appendix D: Liaison Panel Organizations (296-297)

Appendix E: Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice (298-306)

Appendix F: National Center for Complementary and Alternative Medicine Research Centers (307-309)

Appendix G: Public Meetings (310-318)

Appendix H: Committee Biosketches (319-326)

Index (327-338)