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Tympanostomy Tubes in Children Final Evidence Report

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Tympanostomy Tubes in Children Final Evidence Report Health Technology Assessment Tympanostomy Tubes in Children Final Evidence Report October 16, 2015 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 www.hca.wa.gov/hta/ [email protected] Tympanostomy Tubes in Children Provided by: Spectrum Research, Inc. October 16, 2015 Prepared by: Robin Hashimoto, PhD Joseph R. Dettori, PhD, MPH Erika Brodt, BS Krystle Pagarigan, BS With assistance from: Katie Moran, BS Eric Schnell, BS Erin Anthony-Fick WA – Health Technology Assessment October 16, 2015 This technology assessment report is based on research conducted by a contracted technology assessment center, with updates as contracted by the Washington State Health Care Authority. This report is an independent assessment of the technology question(s) described based on accepted methodological principles. The findings and conclusions contained herein are those of the investigators and authors who are responsible for the content. These findings and conclusions may not necessarily represent the views of the HCA/Agency and thus, no statement in this report shall be construed as an official position or policy of the HCA/Agency. The information in this assessment is intended to assist health care decision makers, clinicians, patients and policy makers in making sound evidence-based decisions that may improve the quality and cost- effectiveness of health care services. Information in this report is not a substitute for sound clinical judgment. Those making decisions regarding the provision of health care services should consider this report in a manner similar to any other medical reference, integrating the information with all other pertinent information to make decisions within the context of individual patient circumstances and resource availability. Tympanostomy Tubes in Children: Final Evidence Report i WA – Health Technology Assessment October 16, 2015 Table of Contents Abbreviations .................................................................................................................................. VI Executive Summary ............................................................................................................................1 1. Appraisal ..................................................................................................................................... 24 1.1. Rationale ........................................................................................................................................ 24 1.2. Key Questions ................................................................................................................................ 25 1.3. Outcomes Assessed ....................................................................................................................... 27 1.4. Washington State Utilization And Cost Data ................................................................................. 34 2. Background ................................................................................................................................. 39 2.1. Epidemiology And Burden Of Disease ........................................................................................... 39 2.1.1. Otitis media with effusion (OME) .................................................................................................... 39 2.1.2. Acute otitis media (AOM) ................................................................................................................ 40 2.2. Technology: Tympanostomy Tubes ............................................................................................... 40 2.2.1. Procedure ........................................................................................................................................ 41 2.2.2. Anticipated outcomes ..................................................................................................................... 41 2.2.3. Consequences and adverse events .................................................................................................. 42 2.2.4. Costs ................................................................................................................................................ 43 2.3. Comparator Treatments ................................................................................................................ 43 2.3.1. Watchful waiting or delayed tube insertion .................................................................................... 43 2.3.2. Myringotomy................................................................................................................................... 44 2.3.3. Adenoidectomy ............................................................................................................................... 44 2.3.4. Antibiotics ....................................................................................................................................... 44 2.3.5. Other medications ........................................................................................................................... 44 2.3.6. Autoinflation of the Eustachian tube .............................................................................................. 45 2.3.7. Complementary and alternative medicine treatments ................................................................... 45 2.4. Clinical Guidelines .......................................................................................................................... 45 2.5. Previous Systematic Reviews/Technology Assessments ............................................................... 64 2.6. Medicare and Representative Private Insurer Coverage Policies .................................................. 82 3. The Evidence ............................................................................................................................... 86 3.1. Methods of the Systematic Literature Review .............................................................................. 86 3.1.1. Objectives ........................................................................................................................................ 86 3.1.2. Inclusion/exclusion .......................................................................................................................... 86 3.1.3. Critical and primary outcomes ........................................................................................................ 90 3.1.4. Data sources and search strategy ................................................................................................... 90 3.1.5. Data extraction ............................................................................................................................... 92 3.1.6. Quality assessment: Overall Strength of evidence (SoE), Class of evidence (CoE) and QHES evaluation ...................................................................................................................................................... 92 3.1.7. Analysis ........................................................................................................................................... 93 4. Results ......................................................................................................................................... 94 4.1. Key Question 1: Efficacy and effectiveness, indications ................................................................ 94 4.1.1. Number of studies retained ............................................................................................................. 94 4.1.2. OME: Tubes versus watchful waiting (WW) or no surgery (by-child analysis) ................................ 94 Tympanostomy Tubes in Children: Final Evidence Report ii WA – Health Technology Assessment October 16, 2015 4.1.3. OME: Tube (one ear) versus No surgery (opposite ear) (by-ear analysis) ..................................... 109 4.1.4. OME: Tubes versus Myringotomy ................................................................................................. 118 4.1.5. OME: Tubes + Adenoidectomy vs. Myringotomy + Adenoidectomy ............................................. 130 4.1.6. OME: Tubes + Adenoidectomy vs. Adenoidectomy ....................................................................... 144 4.1.7. OME: Tubes versus Myringotomy + Adenoidectomy .................................................................... 152 4.1.8. OME: Tubes versus Adenoidectomy .............................................................................................. 157 4.1.9. OME: Tubes versus Antibiotics ...................................................................................................... 162 4.1.10. Recurrent AOM: Tubes versus Antibiotics ..................................................................................... 165 4.1.11. Recurrent AOM: Tubes versus Placebo or No Treatment .............................................................. 171 4.1.12. OME or Recurrent AOM: Tubes (unilateral) versus Myringotomy or No Procedure (contralateral ear) 176 4.2. Key Question 2: Harms ................................................................................................................ 181 4.2.1. Number of studies retained ........................................................................................................... 181 4.2.2. OME: Tubes versus watchful waiting
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