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Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions Comparative Effectiveness Review Number 139 Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An Update to the 2009 Report Comparative Effectiveness Review Number 139 Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An Update to the 2009 Report 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. 290-2012-00012 -I Prepared by: Brown Evidence-Based Practice Center Providence, RI Investigators: Issa J. Dahabreh, M.D., M.S. Lisa Susan Wieland, Ph.D. Gaelen P. Adam, M.L.I.S. Christopher Halladay, B.A., M.S. Joseph Lau, M.D. Thomas A. Trikalinos, M.D. AHRQ Publication No. 14-EHC040-EF September 2014 This report is based on research conducted by Brown Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00012-I). 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 of 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, among others—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. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. This report may periodically be assessed for the urgency to update. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at: www.effectivehealthcare.ahrq.gov. Search on the title of the report. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. Suggested citation: Dahabreh IJ, Wieland LS, Adam GP, Halladay C, Lau J, Trikalinos TA. Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An Update to the 2009 Report. Comparative Effectiveness Review No. 139. (Prepared by the Brown Evidence-based Practice Center under Contract 290-2012-00012-I.) AHRQ Publication No. 14-EHC040-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. 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 can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. 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. We welcome comments on this systematic review. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to [email protected]. Richard Kronick, Ph.D. Yen-Pin Chiang, Ph.D. Director Acting Deputy Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Elisabeth Kato, M.D., M.R.P. Director Task Order Officer Evidence-based Practice Program Center for Evidence and Practice Center for Evidence and Practice Improvement Improvement Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Technical Expert Panel In designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicting opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts. Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified. One Technical Expert was a patient and remains anonymous. The list of the remaining Technical Experts who participated in developing this report follows: Patricia Carney, Ph.D. Mark A. Helvie, M.D. Oregon Health and Science University University of Michigan Health System Portland, OR Ann Arbor, MI Joanne Elmore, M.D., M.P.H. Carol Lee, M.D. University of Washington Memorial Sloan Kettering Cancer Center School of Public Health New York City, NY Seattle, WA Barabara Monsees, M.D. Richard E. Fine, M.D. Evens Professor of Women's Health Department of Surgery Department of Radiology Department of Surgical Oncology Washington University School of Medicine University of Tennessee College of St. Louis, MO Medicine The West Clinic Comprehensive Breast Liane Philpotts, M.D. Center Yale University School of Medicine Memphis, TN New Haven, CT Melissa Pilewskie, M.D. Memorial Sloan-Kettering Cancer Center Evelyn H. Lauder Breast Center New York City, NY iv Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report does not necessarily represent the views of individual reviewers. Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential non-financial conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential non-financial conflicts of interest identified. The list of Peer Reviewers follows: Binita Ashar, M.D. Center for Devices and Radiological Health U.S. Food and Drug Administration Baltimore, MD Ira J. Bleiweiss, M.D. Icahn School of Medicine at Mount Sinai New York City, NY Edi Brogi, M.D. Memorial Sloan-Kettering Cancer Center New York City, NY Laurie L. Fajardo, M.D. University of Iowa Health Care Iowa City, IA Seema Khan, M.D. Feinberg School of Medicine Northwestern University Chicago, IL Tracy Lively, Ph.D. Cancer Diagnosis Program National Cancer Institute Bethesda, MD Robert A. Smith, Ph.D. American Cancer Society Atlanta, GA v Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An Update to the 2009 Report Structured Abstract Objective. Core needle biopsy and open surgical biopsy are the most frequently used procedures for diagnosis of suspicious breast lesions. An AHRQ evidence report on the comparative effectiveness and adverse events of breast biopsy methods was completed in 2009. The availability of additional studies and the uncertainties surrounding newer biopsy techniques prompted an update of that report. Study eligibility criteria. We searched nine electronic databases (last search on December 16, 2013) for English-language full-text reports of prospective or
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