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INTRODUCTION AND BACKGROUND 19 1 Introduction and Background . . .with [humility] comes not only a reverence for truth, but also a proper estimation of the difficulties encountered in our search for it. William Osler, Aequanimitas In November 1989, Congress amended the Public Health Service Act to create the Agency for Health Care Policy and Research (AHCPR). Under the terms of Public Law 101-239 (Appendix A), this agency has been given broad responsibilities for supporting research, data development, and other activities that will "enhance the quality, appropriateness, and effectiveness of health care services. . . ." The needs and priorities of the Medicare program are an important but not exclusive focus of the agency. Many of AHCPR's responsibilities formerly belonged to the National Center for Health Services Research, which AHCPR has now replaced, but the emphasis on outcomes and effectiveness research is considerably stronger. Other functions of the agency are new, in particular, those involving a joint public-private enterprise to develop, disseminate, and evaluate guidelines for clinical practice under the sponsorship of the agency's Forum for Quality and Effectiveness in Health Care. (Appendix B provides some examples of guidelines already developed by public and private organizations.) This report was prompted by AHCPR's request to the Institute of Medicine (IOM) for advice about how the agency and the Forum might approach their new and challenging responsibilities for practice guidelines.