SUNY Downstate Health Sciences University, Brooklyn, New York, USA.
School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-S55. doi: 10.1177/01945998211065662.
Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All these conditions are encompassed by the term (middle ear inflammation). This guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The guideline is intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals.
The purpose of this clinical practice guideline update is to reassess and update recommendations in the prior guideline from 2013 and to provide clinicians with trustworthy, evidence-based recommendations on patient selection and surgical indications for managing tympanostomy tubes in children. In planning the content of the updated guideline, the guideline update group (GUG) affirmed and included all the original key action statements (KASs), based on external review and GUG assessment of the original recommendations. The guideline update was supplemented with new research evidence and expanded profiles that addressed quality improvement and implementation issues. The group also discussed and prioritized the need for new recommendations based on gaps in the initial guideline or new evidence that would warrant and support KASs. The GUG further sought to bring greater coherence to the guideline recommendations by displaying relationships in a new flowchart to facilitate clinical decision making. Last, knowledge gaps were identified to guide future research.
In developing this update, the methods outlined in the American Academy of Otolaryngology-Head and Neck Surgery Foundation's "Clinical Practice Guideline Development Manual, Third Edition: A Quality-Driven Approach for Translating Evidence Into Action" were followed explicitly. The GUG was convened with representation from the disciplines of otolaryngology-head and neck surgery, otology, pediatrics, audiology, anesthesiology, family medicine, advanced practice nursing, speech-language pathology, and consumer advocacy.
The GUG made for the following KASs: (14) clinicians should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea; (16) the surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion AND should educate families regarding the need for routine, periodic follow-up to examine the ears until the tubes extrude.The GUG made for the following KASs: (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months' duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown); (2) clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties; (5) clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (6) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (7) clinicians should offer bilateral tympanostomy tube insertion in children with recurrent acute otitis media who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (8) clinicians should determine if a child with recurrent acute otitis media or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors; (10) the clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube; (12) in the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications; (13) clinicians should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement; (15) clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes.The GUG offered the following KASs as : (4) clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life; (9) clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer; (11) clinicians may perform adenoidectomy as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) OR in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.
鼓膜置管术是美国最常见的小儿门诊手术。鼓膜置管术最常因持续性中耳积液、频繁耳部感染或抗生素治疗后持续存在的耳部感染而进行。所有这些情况都包含在术语(中耳炎症)中。本指南更新提供了基于证据的推荐意见,用于管理儿童鼓膜置管术的患者选择和手术适应证。该指南适用于任何参与管理因任何类型中耳炎而接受鼓膜置管术或正在考虑因中耳炎而接受鼓膜置管术的 6 个月至 12 岁儿童的临床医生。目标受众包括专家、初级保健临床医生和联合健康专业人员。
本临床实践指南更新的目的是重新评估和更新 2013 年之前指南中的建议,并为临床医生提供关于管理儿童鼓膜置管术的患者选择和手术适应证的值得信赖的、基于证据的建议。在规划更新指南的内容时,指南更新小组(GUG)根据外部审查和 GUG 对原始建议的评估,确认并包含了所有原始的关键行动声明(KAS)。该指南更新还补充了新的研究证据和扩展了概况介绍,以解决质量改进和实施问题。该小组还讨论并确定了根据初始指南中的空白或需要支持和支持 KAS 的新证据提出新建议的必要性。GUG 还试图通过显示新流程图中的关系来使指南建议更加一致,以促进临床决策。最后,确定了知识空白,以指导未来的研究。
在制定本更新时,明确遵循了美国耳鼻喉科学-头颈外科学会基金会的“临床实践指南制定手册,第三版:将证据转化为行动的以质量为导向的方法”中概述的方法。GUG 由耳鼻喉科学、耳科学、儿科学、听力学、麻醉学、家庭医学、高级实践护理、言语语言病理学和消费者权益代表组成。
GUG 针对以下 KAS 做出了建议:(14)对于没有接受过口服抗生素治疗的急性鼓膜置管术后耳漏的儿童,临床医生应仅开具局部抗生素滴耳液,而不是口服抗生素;(16)手术医生或指定人员应在鼓膜置管术插入后 3 个月内检查儿童的耳朵,并教育家属需要定期进行常规、定期随访,以检查耳朵,直至管子脱出。GUG 针对以下 KAS 做出了建议:(1)对于单侧或双侧中耳炎性渗出液(OME)持续时间少于 3 个月的儿童,从发病日期(如果已知)或诊断日期(如果发病日期未知)开始,临床医生不应进行鼓膜置管术;(2)如果 OME 持续 3 个月或更长时间,或者儿童成为鼓膜置管术候选者时,应进行听力评估;(3)对于双侧 OME 持续 3 个月或更长时间且有听力障碍的儿童,临床医生应双侧放置鼓膜置管;(5)对于未接受鼓膜置管术且中耳积液持续存在、发现明显听力损失或怀疑鼓膜或中耳结构异常的慢性 OME 儿童,应每 3-6 个月进行重新评估;(6)对于在评估置管候选资格时双耳均无中耳积液的复发性急性中耳炎儿童,临床医生不应进行鼓膜置管术;(7)对于在评估置管候选资格时单侧或双侧中耳积液的复发性急性中耳炎儿童,临床医生应双侧放置鼓膜置管;(8)临床医生应确定是否有儿童因中耳炎而存在言语、语言或学习问题的风险增加,这些儿童有基线感觉、身体、认知或行为因素;(10)临床医生不应将长期管作为符合置管标准的儿童的初始手术,除非基于预期需要延长短期管的中耳通气而有特定原因;(12)在围手术期,临床医生应向接受鼓膜置管术的儿童的照顾者教育有关管子预期功能的信息、建议的随访时间表以及并发症的检测;(13)临床医生不应常规在鼓膜置管术后开具抗生素滴耳液;(15)临床医生不应鼓励有鼓膜置管术的儿童进行常规、预防性的水预防措施(使用耳塞或头带、避免游泳或水上运动)。GUG 还提供了以下 KAS 作为建议:(4)对于单侧或双侧 OME 持续 3 个月或更长时间(慢性 OME)且症状可能归因于 OME 的儿童,临床医生可以进行鼓膜置管术,这些症状包括但不限于平衡(前庭)问题、学业成绩不佳、行为问题、耳部不适或生活质量降低;(9)对于可能持续存在的单侧或双侧 OME 且表现为 B 型(平坦)鼓室图或记录的积液持续 3 个月或更长时间的有风险的儿童,临床医生可以进行鼓膜置管术;(11)对于有直接与腺样体相关的症状(腺样体感染或鼻腔阻塞)的儿童或年龄在 4 岁或以上的儿童,临床医生可以进行腺样体切除术,以潜在减少未来复发性中耳炎或需要重复置管的可能性。