Comparative Effectiveness Review Number 149 Treatments for Ankyloglossia and Ankyloglossia With Concomitant Lip-Tie Comparative Effectiveness Review Number 149 Treatments for Ankyloglossia and Ankyloglossia With Concomitant Lip-Tie 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. 290-2012-00009-I Prepared by: Vanderbilt Evidence-based Practice Center Nashville, TN Investigators: David O. Francis, M.D., M.S. Sivakumar Chinnadurai, M.D., M.P.H. Anna Morad, M.D. Richard A. Epstein, Ph.D., M.P.H. Sahar Kohanim, M.D. Shanthi Krishnaswami, M.B.B.S., M.P.H. Nila A. Sathe, M.A., M.L.I.S. Melissa L. McPheeters, Ph.D., M.P.H. AHRQ Publication No. 15-EHC011-EF May 2015 This report is based on research conducted by the Vanderbilt Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00009-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. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may periodically be assessed for the currency of conclusions. 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: Francis DO, Chinnadurai S, Morad A, Epstein RA, Kohanim S, Krishnaswami S, Sathe NA, McPheeters ML. Treatments for Ankyloglossia and Ankyloglossia With Concomitant Lip-Tie. Comparative Effectiveness Review No. 149. (Prepared by the Vanderbilt Evidence-based Practice Center under Contract No. 290-2012-00009-I.) AHRQ Publication No. 15-EHC011-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2015. 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]. Richard G. Kronick, Ph.D. David Meyers, M.D. Director Acting 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. Kim M. Wittenberg, M.A. Director, EPC Program Task Order Officer 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 Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project. Annette Williams assisted with managing the report. Tanya Surawicz extracted data, created tables, and assisted with screening studies and quality assessment. Jessica Kimber and Sanura Latham provided invaluable assistance with retrieving studies, data entry, and table formatting. 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: Jeanne L. Ballard, M.D. Cincinnati College of Medicine Cincinnati, OH Lori Feldman-Winter, M.D., M.P.H. Cooper Medical School of Rowan University Camden, NJ Donna Geddes, Ph.D. University of Western Australia Crawley, Western Australia, Australia Timothy Hickman, M.D., M.Ed, M.P.H. University of Missouri-Kansas City School of Medicine Kansas City, MO Gregory L. Lof, Ph.D., CCC-SLP, FASHA MGH Institute of Health Professions Boston, MA Diana Mayer, M.D., IBCLC, FAAP CentraState Medical Center Freehold, NJ iv Greg Notestine, D.D.S. Beavercreek, OH Richard Rosenfeld, M.D., M.P.H. SUNY Downstate Medical Center Brooklyn, NY Catherine Watson Genna, IBCLC, RLC Private Practice Woodhaven, NY 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. The list of Technical Experts who participated in developing this report follows: Jeanne L. Ballard, M.D. Cincinnati College of Medicine Cincinnati, OH Lori Feldman-Winter, M.D., M.P.H. Cooper Medical School of Rowan University Camden, NJ Ann L. Kellams, M.D., IBCLC University of Virginia Health System Charlottesville, VA Diana Mayer, M.D., IBCLC, FAAP CentraState Medical Center Freehold, NJ Megan Overby, Ph.D., CCC-SLP Duquesne University Pittsburgh, PA v Gautham K. Suresh, M.D. Dartmouth-Hitchcock Medical Center Lebanon, NH Dale Amanda Tylor, M.D., M.P.H. Washington Township Medical Foundation Fremont, CA Catherine Watson Genna, IBCLC, RLC Private Practice Woodhaven, NY Lynn S. Wolf, M.O.T., O.T.R., IBCLC Seattle Children’s Hospital Seattle, WA 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