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Tympanostomy Tubes Tympanostomy Tubes Draft Evidence Report: Peer Review & Response 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] WA – Health Technology Assessment October 16, 2015 Responses To Public Comments Spectrum Research is an independent vendor contracted to produce evidence assessment reports for the Washington HTA program. For transparency, all comments received during the public comment periods are included in this response document. Comments related to program decisions, process, or other matters not pertaining to the evidence report are acknowledged through inclusion only. This document responds to clinical and peer reviews from the following parties: 1. Carol MacArthur, MD (peer reviewer) 2. Jack Paradise, MD (peer reviewer) No other comments (including public comments) were received. Specific responses pertaining to each comment are included in Table 1. Tympanostomy Tubes: Draft Evidence Report – Peer Review & Response Page 1 of 17 WA – Health Technology Assessment October 16, 2015 Page Comment Response (Section) Carol MacArthur, MD (peer reviewer) Introduction Overview of topic is adequate? Yes Thank you for your feedback. (general Topic of assessment is important to address? comments) Very much so. Public policy and clinical relevance are well defined? Yes. Page 1 You state: “Approximately 1 mm in diameter, Thank you for your comment; the (sixth paragraph) functioning tubes equalize middle ear pressure suggested change has been made. with atmospheric pressure and allow fluid drainage, alleviating symptoms of otitis media”. The internal diameter of the tympanostomy tube lumen is about 1 mm, but the outer diameter is around 2 mm. Not sure if this fine point matters or not. Maybe just say 1 mm in internal diameter. Page 5 Should there be a horizontal line in this table to tell Thank you for your comment; we have (TT (Unilateral the reader where the TT (unilat vs no treatment verified that the horizontal is correctly versus No contralateral) for OME studies start in the table? placed. treatment (contralateral) for OME)) Background Content of literature review/background is Thank you for your feedback. (general sufficient? Yes comments) Page 40 I recommend the following changes in wording: Thank you for your comment; the (section 2.1.1, “OME is diagnosed via ear examination and suggested changes have been made. second paragraph) sometimes pneumatic otoscopy, 105 which tests the movement of the ear drum; ears with middle ear effusion are often stiff stretched taut and have limited or lack of movement when air is blown into the ear during otoscopy.” Page 40 Regarding section 2.1.1 third paragraph – you use Thank you for your comment, this has (section 2.1.1, 20 dB as “normal hearing” but normal hearing been corrected. third paragraph) ranges from 0-20 dB, so all changes reported really should be reported in a range to include normal hearing down to 0 dB, not just 20dB. Children who benefit from the improved hearing from tubes can receive benefit when they hear at 0 dB while previously hearing at around 20-25 dB even. Page 43 This statement is incorrect. “Adverse events related Thank you for your comment, this has (section 2.2.3) to tympanostomy tubes can be either transient been corrected. (e.g., otorrhea) or cosmetic (e.g., cholesteatoma).” Cholesteatomas are NOT cosmetic; myringosclerosis can be considered “cosmetic”, but not cholesteatomas. Cholesteatomas if left Tympanostomy Tubes: Draft Evidence Report – Peer Review & Response Page 2 of 17 WA – Health Technology Assessment October 16, 2015 Page Comment Response (Section) untreated can wreak havoc with the middle ear, mastoid, ossicles and can in the long run, invade the cranial cavity if left untreated. I would change the word “cosmetic” to “chronic”. Page 43 Change the following statement as indicated: Thank you for your comment; the (cholesteatoma “Cholesteatomas are abnormal skin growths in the suggested changes have been made. paragraph) middle ear that can grow in size, causing hearing loss, dizziness, mastoiditis or even intracranial infections muscle weakness.2 Surgical treatment is the only effective management. Managed early, cholesteatomas are treatable with middle ear surgical excision antibiotics, ear drops, and cleaning of the ear; otherwise, tympanomastoid surgery is needed for larger cholesteatomas. Cholesteatoma incidence in tube-extruded ears occurs in approximately 0.7% of children with OM.71” Page 43 Change this sentence as follows: Blockage can Thank you for your comment; the (blockage of tube sometimes be treated by inserting otopical drops suggested changes have been made. lumen paragraph) for about a week, however, often the tube will remain non functional and need to be replaced..137 Page 43 Change this sentence as follows: Granulation Thank you for your comment; the (granulation tissue tissue, or granulomas, are accumulated squamous suggested changes have been made. paragraph) debris is new connective tissue and capillaries that form around the tube and are estimated to develop in 8% of children”.137 Page 45 Adenoidectomy IS guideline-driven: (Otolaryngol Thank you for your comment. The cited (section 2.3.3) Head Neck Surg. 2004 May;130(5 Suppl):S95-118. guideline states (see section 9 (surgery)): Clinical practice guideline: Otitis media with “When a child becomes a surgical effusion.Rosenfeld RM1, Culpepper L, Doyle KJ, candidate, tympanostomy tube insertion Grundfast KM, Hoberman A, Kenna MA, Lieberthal is the preferred initial procedure; AS, Mahoney M, Wahl RA, Woods CR Jr, Yawn B; adenoidectomy should not be performed American Academy of Pediatrics Subcommittee on unless a distinct indication exists (nasal Otitis Media with Effusion; American Academy of obstruction, chronic adenoiditis).” Family Physicians; American Academy of Otolaryngology--Head and Neck Surgery.): The text in section 2.3.3 has been Although Adenoidectomy is not guideline- expanded as such and now states: recommended for children presenting with OME “Further, adenoidectomy is not guideline- age 4 and older or for children presenting for their recommended as a first procedure in second set of tubes without adenoid disease,15 children presenting with OME unless studies have found that it adenoidectomy is additional conditions such as nasal effective for treating OM in this population.49,113 obstruction or chronic adenoiditis exist.” Page 45 Only in the instance of a patent PE tube or Thank you for your comment; corrections (antibiotics, end of perforated eardrum. Otherwise, typical AOM is have been made to the text. second sentence) treated by observation or oral antibiotics. When treating with topical antibiotics, you are really Tympanostomy Tubes: Draft Evidence Report – Peer Review & Response Page 3 of 17 WA – Health Technology Assessment October 16, 2015 Page Comment Response (Section) talking about tympanostomy tube otorrhea which is preferentially treated by topical antibiotics. Page 45 amoxicillin-clavulanate or or Ciprofloxicin- Thank you for your comment; the (antibiotics, last dexamethasone optic solution are NOT topical suggested change has been made. sentence) antibiotics drops. Please delete. Page 45 and are not recommended in OME guidelines. Thank you for your comment; this has (other HYPERLINK been clarified in the text. medications, re: "http://www.ncbi.nlm.nih.gov/pubmed/15138413" mucolytics and \o "Otolaryngology--head and neck surgery : official antihistamines journal of American Academy of Otolaryngology- with oral Head and Neck Surgery." Otolaryngol Head Neck decongestants) Surg. 2004 May;130(5 Suppl):S95-118. Page 47 (American along with hearing loss by audiogram Thank you for your comment; the Acadamy of guideline referenced was double-checked Otolaryngology… and does not specify hearing loss as an 2013) indication for tubes in children with recurrent AOM. Page 65 TULA definition? Maybe it is present in the report Thank you for your comment; no (CADTH report) earlier, but I have missed it. Be sure to define. definition was provided in the corresponding publication nor were we able to find one, thus “TULA” has been changed to “Tula”. Page 87 and rarely, anaphylaxis or Stevens-Johnson Thank you for your comment; this has (footnote for table syndrome been added to the footnote. 6) Report objectives Aims/objectives clearly address relevant policy Thank you for your feedback. and key questions and clinical issue? Yes (general Key questions clearly defined and adequate for comments) achieving aims? Yes Methods Method for identifying relevant studies is Thank you for your feedback. (general adequate? Yes comments) Criteria for the inclusion and exclusion of studies is appropriate? Yes Method for Level of Evidence (LoE) rating is appropriate and clearly explained? Yes Data abstraction and analysis/review are adequate? Yes Results Amount of detail presented in the results section Thank you for your feedback. (general appropriate? Yes Tympanostomy Tubes: Draft Evidence Report – Peer Review & Response Page 4 of 17 WA – Health Technology Assessment October 16, 2015 Page Comment Response (Section) comments) Key questions are answered? Yes Figures, tables and appendices clear and easy to read? Yes Implications of the major findings clearly stated? Yes Jack Paradise, MD (peer reviewer) Page 1 I still think that the introduction does not make Thank you for your comments. (Executive sufficiently clear the distinction
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