Health Technology Assessment Tympanostomy Tubes in Children Final Evidence Report: Appendices 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 Provided by: Spectrum Research, Inc. Final Report APPENDICES October 16, 2015 WA – Health Technology Assessment October 16, 2015 Table of Contents Appendices Appendix A. Algorithm for Article Selection ................................................................................................. 1 Appendix B. Search Strategies ...................................................................................................................... 2 Appendix C. Excluded Articles ....................................................................................................................... 4 Appendix D. Class of Evidence, Strength of Evidence, and QHES Determination ........................................ 9 Appendix E. Study quality: CoE and QHES evaluation ................................................................................ 13 Appendix F. Study characteristics ............................................................................................................... 20 Appendix G. Results Tables for Key Question 1 (Efficacy and Effectiveness) ............................................. 39 Appendix H. Results Tables for Key Question 2 (Safety) ............................................................................. 97 Appendix I. Clinical Experts ..................................................................................................................... 117 References ................................................................................................................................................ 118 Tables Appendix Table G1. Hearing Levels by Child: TT vs. WW for OME ............................................................. 39 Appendix Table G2. Otorrhea: TT vs. WW for OME .................................................................................... 40 Appendix Table G3. AOM Episodes: TT vs. WW for OME ........................................................................... 40 Appendix Table G4. AOM Or OME Episodes: TT vs. WW for OME ............................................................. 41 Appendix Table G5. OME Episodes: TT vs. WW for OME ........................................................................... 41 Appendix Table G6. Attention And Behavioral Outcomes: TT vs. WW for OME ........................................ 42 Appendix Table G7. Academic Achievement: TT vs. WW for OME ............................................................ 44 Appendix Table G8. Auditory Processing: TT vs. WW for OME .................................................................. 45 Appendix Table G9. Reynell Or Schlichting Test (Speech And Language): TT vs. WW for OME ................. 47 Appendix Table G10. Other Speech And Language Outcome Measures: TT vs. WW for OME .................. 48 Appendix Table G11. Patient Quality Of Life: TT vs. WW for OME ............................................................. 49 Appendix Table G12. Patient And Parent Interaction: Quality Of Life: TT vs. WW for OME ...................... 50 Appendix Table G13. Pain: TT vs. WW for OME ......................................................................................... 53 Appendix Table G14. Surgery After Initial Treatment Protocol: TT vs. WW for OME ................................ 54 Appendix Table G15. Medication Usage: TT vs. WW for OME ................................................................... 55 Appendix Table G16. Hearing Levels by Ear: TT (One Ear) vs. No Treatment (Opposite Ear) for OME ...... 55 Appendix Table G17. OME Recurrence by Ear: TT (One Ear) vs. No Treatment (Opposite Ear) for OME .. 57 Appendix Table G18. Hearing Levels: TT vs. Myringotomy for OME .......................................................... 58 Appendix Table G19. Otorrhea: TT vs. Myringotomy for OME ................................................................... 59 Otorrhea (% (N/N)) ..................................................................................................................................... 59 Appendix Table G20. AOM Episodes: TT vs. Myringotomy for OME .......................................................... 59 Appendix Table G21. AOM Or OME Episodes: TT vs. Myringotomy for OME ............................................ 60 Tympanostomy Tubes in Children: Final Evidence Report - Appendices i WA – Health Technology Assessment October 16, 2015 Appendix Table G22. OME Episodes: TT vs. Myringotomy for OME .......................................................... 61 Appendix Table G23. Auditory Processing: TT vs. Myringotomy for OME ................................................. 62 Appendix Table G24. Pain: TT vs. Myringotomy for OME........................................................................... 63 Appendix Table G25. Surgery After Initial Treatment Protocol: TT vs. Myringotomy for OME ................. 64 Appendix Table G26. Medication Usage: TT vs. Myringotomy for OME .................................................... 65 Appendix Table G27. Office Visits: TT vs. Myringotomy for OME .............................................................. 65 Appendix Table G28. Hearing Levels: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME66 Appendix Table G29. Hearing Levels by Ear: TT (Unilateral) + Adenoidectomy vs. Myringotomy (Contralateral) + Adenoidectomy for OME ........................................................................................ 67 Appendix Table G30. Otorrhea: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME ........ 70 Appendix Table G31. Otorrhea by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME ............................................................................................................................................................ 70 Appendix Table G32. AOM: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .............. 71 Appendix Table G33. AOM by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME ... 71 Appendix Table G34. AOM Or OME: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME 72 Appendix Table G35. OME Episodes: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME 72 Appendix Table G36. OME Episodes by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................................................... 73 Appendix Table G37. Cholesteatoma by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................................................... 73 Appendix Table G38. Auditory Processing by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................... 74 Appendix Table G39. Patient Quality Of Life: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................................................... 74 Appendix Table G40. Pain by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME ..... 74 Appendix Table G41. Surgery After Initial Treatment Protocol: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................... 75 Appendix Table G42. Medication Usage: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................................................... 76 Appendix Table G43. Medication by Ear: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME .................................................................................................................................................... 76 Appendix Table G44. Office Visits: TT + Adenoidectomy vs. Myringotomy + Adenoidectomy for OME ... 77 Appendix Table G45. Hearing Levels by Ear: TT (Unilateral) + Adenoidectomy vs. Adenoidectomy for OME .................................................................................................................................................... 78 Appendix Table G46. OME Recurrence by Ear: TT (Unilateral) + Adenoidectomy vs. Adenoidectomy (RCT Data) for OME .................................................................................................................................... 80 Appendix Table G47. OME Episodes: TT + Adenoidectomy vs. Adenoidectomy (RCT Data) for OME ....... 80 Appendix Table G48. Cholesteatoma: TT + Adenoidectomy vs. Adenoidectomy (RCT Data) for OME ...... 81 Appendix Table G49. Hearing Levels by Patient: TT vs. Myringotomy + Adenoidectomy for OME ........... 81 Appendix Table G50. Otorrhea: TT vs. Myringotomy + Adenoidectomy for OME ..................................... 81 Appendix Table G51. AOM: TT vs. Myringotomy + Adenoidectomy for OME ............................................ 82 Tympanostomy Tubes in Children: Final Evidence Report - Appendices ii WA – Health Technology Assessment October 16, 2015 Appendix