Treatment Strategies for Patients with Peripheral Artery Disease
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Comp r tive Effectiveness Review Number 118 Tre tment Str tegies for P tients With Peripher l Artery Dise se Comparative Effectiveness Review Number 118 Treatment Strategies for Patients With Peripheral Artery Disease 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. 290-2007-10066-I Prepared by: Duke Evidence-based Practice Center Durham, NC Investigators: W. Schuyler Jones, M.D. Kristine M. Schmit, M.D., M.P.H. Sreekanth Vemulapalli, M.D. Sumeet Subherwal, M.D., M.B.A. Manesh R. Patel, M.D. Victor Hasselblad, Ph.D. Brooke L. Heidenfelder, Ph.D. Megan M. Chobot, M.S.L.S. Rachael Posey, M.S.L.S. Liz Wing, M.A. Gillian D. Sanders, Ph.D. Rowena J. Dolor, M.D., M.H.S. AHRQ Publication No. 13-EHC090-EF May 2013 This report is based on research conducted by the Duke Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10066-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 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: Jones WS, Schmit KM, Vemulapalli S, Subherwal S, Patel MR, Hasselblad V, Heidenfelder BL, Chobot MM, Posey R, Wing L, Sanders GD, Dolor RJ. Treatment Strategies for Patients With Peripheral Artery Disease. Comparative Effectiveness Review No. 118. (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-2007- 10066-I.) AHRQ Publication No. 13-EHC090-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2013. 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 email 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]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Elisabeth U. Kato, M.R.P. Director Task Order Officer Evidence-based Practice Program Center for Outcomes and Evidence Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments The authors thank Megan von Isenburg, M.S.L.S., for help with the literature search and retrieval. Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants. Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest. The list of Key Informants who participated in developing this report follows: Peter Alagona, M.D. Erin O’Connell Peiffer Penn State Hershey Heart and Vascular Spokesperson Institute WomenHeart Hershey, PA Baltimore, MD Mike S. Conte, M.D. Jeffrey Olin, M.D. Codirector, Heart and Vascular Center Professor of Medicine, Cardiology University of California San Francisco Mount Sinai School of Medicine Medical Center New York, NY San Francisco, CA Diane Reid, M.D. Mark Creager, M.D. Division of Heart and Vascular Diseases Director, Vascular Center National Heart, Lung, and Blood Institute Brigham and Women’s Hospital, Bethesda, MD Cardiovascular Division Boston, MA Diane Treat-Jacobsen, Ph.D., R.N. Associate Professor and Chair, Adult & Mary McDermott, M.D. Gerontological Health Cooperative Professor of Medicine and Preventive University of Minnesota School of Nursing Medicine Minneapolis, MN Northwestern University Feinberg School of Medicine Christopher White, M.D. Chicago, IL Director, John Ochsner Heart & Vascular Institute Sanjay Misra, M.D. Ochsner Medical Center Associate Professor of Radiology New Orleans, LA Mayo Clinic Rochester, MN iv 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 conflicted 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. The list of Technical Experts who participated in developing this report follows: Mike S. Conte, M.D. Jeffrey Olin, M.D. Codirector, Heart and Vascular Center Professor of Medicine, Cardiology University of California San Francisco Mount Sinai School of Medicine Medical Center New York, NY San Francisco, CA Diane Reid, M.D. Mark Creager, M.D. Division of Heart and Vascular Diseases Director, Vascular Center National Heart, Lung, and Blood Institute Brigham and Women's Hospital, Bethesda, MD Cardiovascular Division Boston, MA Diane Treat-Jacobsen, Ph.D., R.N. Associate Professor and Chair, Adult & Mary McDermott, M.D. Gerontological Health Cooperative Professor of Medicine and Preventive University of Minnesota School of Nursing Medicine Minneapolis, MN Northwestern University Feinberg School of Medicine David Vanness, Ph.D. Chicago, IL Associate Professor of Population Health Sciences David Moher Affiliate, Center for Demography and Senior Scientist, Clinical Epidemiology Ecology Ottawa Hospital Research Institute University of Wisconsin School of Medicine Ottawa, Ontario, Canada