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Retinal Prostheses in the Medicare Population Technology Assessment Retinal Prostheses in the Medicare Population Technology Assessment Program September 30, 2016 Prepared for: Agency for Healthcare Research and Quality 5600 Fishers Lane Rockville, Maryland 20857 Retinal Prostheses in the Medicare Population Technology Assessment Report Project ID: RPST0515 September 30, 2016 ECRI Institute – Penn Medicine Evidence-based Practice Center Joann Fontanarosa, Ph.D. Jonathan R. Treadwell, Ph.D. David J. Samson, M.S. Brian L. VanderBeek, M.D., M.P.H., M.S.C.E. Karen Schoelles, M.D., S.M. 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. The Centers for Medicare & Medicaid Services requested this report from the Evidence-based Practice Center (EPC) Program at the Agency for Healthcare Research and Quality (AHRQ). AHRQ assigned this report to the following EPC: (ECRI Institute-Penn Medicine) Evidence-based Practice Center (Contract Number: HHSA-290-2015-00005-I). The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new health care technologies and strategies. They also identify research gaps in the selected scientific area, identify methodological and scientific weaknesses, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of the available literature. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review and public comment prior to their release as a final report. AHRQ expects that the EPC evidence reports and technology assessments, when appropriate, will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. If you have comments on this evidence report, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected] Andrew Bindman, M.D. Arlene Bierman, M.D., M.S. Director 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. Elise Berliner, Ph.D. Director Task Order Officer Evidence-based Practice Center Program Director, Technology Assessment Program Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality iii This report is based on research conducted by the (ECRI Institute-Penn Medicine EPC) under contract to AHRQ, Rockville, MD (Contract No. HHSA-290-2015-00005-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. None of the investigators has any affiliations or financial involvement related to the material presented in this report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected] Suggested citation: Fontanarosa J, Treadwell J, Samson DJ, VanderBeek BL, Schoelles, K. Retinal Prostheses in the Medicare Population. AHRQ Publication No. XXX. Rockville, MD: Agency for Healthcare Research and Quality; 2016. iv Acknowledgments The authors acknowledge Dr. Craig A. Umscheid, M.D., M.S.C.E., Senior Associate Director of ECRI–Penn Medicine AHRQ Evidence-based Practice Center for recruiting clinical investigator Brian L. VanderBeek, M.D., M.P.H., M.S.C.E. We also gratefully acknowledge the skilled facilitation of our Key Informant calls by Meg Tucker, M.S.P.H., Senior Research Associate at Insight Policy Research, Inc. We would like to thank the following individuals at ECRI Institute for their contributions to this project: Janice Kaczmarek, M.S., Eloise DeHaan, E.L.S., Lydia Dharia, Helen Dunn, Gina Giradi, M.S., and Kristina McShea, M.S.L.I.S. We also thank our AHRQ Task Order Officer Elise Berliner, Ph.D. Key Informants In designing the study questions, the Evidence-based Practice Center (EPC) consulted a panel of Key Informants who represent subject experts and end-users of research. Key Informant input can inform key issues related to the topic of the technical brief. 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 Task Order Officer and the EPC work to balance, manage, or mitigate any conflicts of interest. The list of Key Informants who provided input to this report follows: Key Informants Ava K. Bittner, O.D., Ph.D., FAAO (Dipl.)* Associate Professor Nova Southeastern University College of Optometry Ft. Lauderdale, FL Denice Brown, M.Ed. President, Greater Philadelphia Chapter National Federation of the Blind National Trustee Foundation Fighting Blindness Philadelphia, PA Duane R. Geruschat, Ph.D.* Research Associate, Department of Ophthalmology Specialist in low vision and blindness rehabilitation research Wilmer Eye Institute Johns Hopkins University Baltimore, MD v Robert J. Greenberg, M.D., Ph.D. Chairman Second Sight Medical Products, Inc. Sylmar, CA Denise Hampton, Ph.D.* Chief, Contact Lenses and Retinal Devices Branch Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD Anil Lewis, M.P.A. Executive Director Jernigan Institute National Federation of the Blind Baltimore, MD Aleksandra Rachitskaya, M.D.* Assistant Professor of Ophthalmology Lerner College of Medicine of Case Western Reserve University Cole Eye Institute, Cleveland Clinic Cleveland, OH Sherie Smalley, M.D.* Senior Medical Director, Medical Policy UPMC Health Plan Pittsburgh, PA *This Key Informant (KI) also provided comments on the draft report. Peer Reviewers Before 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 do 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 nonfinancial conflicts may be retained. The Task Order Officer and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest identified. vi The list of Peer Reviewers appears below: Cagri G. Besirli, M.D., Ph.D. Assistant Professor, Ophthalmology and Visual Sciences Kellogg Eye Center University of Michigan Ann Arbor, MI Emily Y. Chew, M.D. Deputy Director, Division of Epidemiology and Clinical Applications Deputy Clinical Director National Eye Institute Bethesda, MD Ninel Z. Gregori, M.D. Associate Professor of Clinical Ophthalmology Bascom Palmer Eye Institute Chief, Ophthalmology Section Miami Veterans Affairs Medical Center Miami, FL Flora Lum, M.D. Vice President, Quality and Data Science American Academy of Ophthalmology San Francisco, CA vii Retinal Prostheses in the Medicare Population Structured Abstract Objectives. To determine the safety, efficacy, and evidence for halting disease progression for retinal prosthesis systems (RPSs) and the outcomes that are and could be assessed in future studies of these devices. Data sources. We searched Medline, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Library, PubMed (unprocessed records only), and gray literature sources, including conference proceedings from specialty societies, for studies of RPS devices published from January 1, 2000, through April 25, 2016. Review methods. We performed redundant title and abstract screening with one reviewer’s selection required for full-text article retrieval. Dual independent review was performed on all full-text articles, with disagreements resolved by consensus. Data extraction was performed by a single reviewer and was fully verified by a second reviewer. Extracted data included study design, psychometric
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