Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities
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Comparative Effectiveness Review Number 2 Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities This report is based on research conducted by the ECRI Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0019). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers, patients and clinicians, health system leaders, and policymakers make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. Neither AHRQ’s nor the U.S. Department of Health and Human Services’ endorsement of such derivative products may be stated or implied. Comparative Effectiveness Review Number 2 Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-02-0019 Prepared by: ECRI Evidence-based Practice Center Plymouth Meeting, Pennsylvania Investigators Wendy Bruening, PhD Jason Launders, MSc Nathan Pinkney, BS, RDMS Harvey Kostinsky, MS Karen Schoelles, MD, SM Charles Turkelson, PhD AHRQ Publication No. 06-EHC005-EF February 2006 This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted, for which further reproduction is prohibited without the specific permission of copyright holders. Suggested citation: Bruening W, Launders J, Pinkney N, Kostinsky H, Schoelles K, Turkelson C. Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities. Comparative Effectiveness Review No. 2. (Prepared by ECRI Evidence-based Practice Center under Contract No. 290-02-0019.) Rockville, MD: Agency for Healthcare Research and Quality. February 2006. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care Program as part of its mission to organize knowledge and make it available to inform decisions about health care. As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Congress directed AHRQ to conduct and support research on the comparative outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services to meet the needs of Medicare, Medicaid, and the State Children’s Health Insurance Program (SCHIP). AHRQ has an already-established network of Evidence-based Practice Centers (EPCs) that produce Evidence Reports/Technology Assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care. The EPCs now lend their expertise to the Effective Health Care Program by conducting Comparative Effectiveness Reviews of medications, devices, and other relevant interventions, including strategies for how these items and services can best be organized, managed, and delivered. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews are useful because they define the strengths and limits of the evidence, clarifying whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about systematic reviews, see www.effectivehealthcare.ahrq.gov/purpose. AHRQ expects that Comparative Effectiveness Reviews will be helpful not only to government programs but also to individual health plans, providers, and purchasers, and to the health care system as a whole. In addition, AHRQ is committed to presenting information in different formats so that the greatest range of decisionmakers possible (and that includes consumers who make decisions about their own and their family’s health) can benefit from the evidence. Work under this program is transparent and user driven. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an e- mail list to learn about new program products and opportunities for input. iii Acknowledgments We would like to acknowledge with appreciation the following members of the Technical Expert Panel for their advice and consultation to the Evidence-based Practice Center during preparation of this report. Technical Expert Panel Robyn L. Birdwell, MD Robert D. Rosenberg, MD Director, Breast Imaging Section Professor of Radiology Brigham and Women’s Hospital Chief, Diagnostic Imaging Department of Radiology University of New Mexico/ Boston, MA Albuquerque, NM M. Carolina Hinestrosa, MA, MPH Executive Vice President for Programs and Planning National Breast Cancer Coalition Washington, DC EPC Program Director We would also like to acknowledge with appreciation the EPC Program Director during the conduct of this project. Kenneth S. Fink, MD, MGA, MPH Director Evidence-based Practice Center Program Center for Outcomes and Evidence Agency for Healthcare Research and Quality Rockville, MD AHRQ Contacts Beth A. Collins Sharp, PhD, RN William Lawrence, MD, MS Acting Director Task Order Officer Evidence-based Practice Center Program Evidence-based Practice Center Program Center for Outcomes and Evidence Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Rockville, MD Rockville, MD iv Contents Executive Summary...............................................................................................................1 Introduction............................................................................................................................5 Background.......................................................................................................................5 Methods.............................................................................................................................7 Scope and Key Questions ............................................................................................7 Outcomes .....................................................................................................................7 Evidence Base........................................................................................................................11 Literature Searches............................................................................................................11 Inclusion/Exclusion Criteria for Questions 1 and 2..........................................................11 Data Abstraction ...............................................................................................................13 Analysis ..............................................................................................................................15 Strength and Stability of Evidence Assessment................................................................15 Data Synthesis...................................................................................................................17 Peer Review ......................................................................................................................19 Results ..............................................................................................................................21 Overview of Evidence Base for Questions 1 and 2 ..........................................................21 Summary of Results..........................................................................................................22 Positron Emission Tomography Scanning...................................................................22 Scintimammography....................................................................................................35 Magnetic Resonance Imaging......................................................................................67 Ultrasound....................................................................................................................84 Overall Summary...................................................................................................................97 References ..............................................................................................................................99 Appendix A. Literature Search Strategies .............................................................................A-1 Appendix B. Study Quality and Strength of Evidence