Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial.
Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-016-1236-1
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发表时间：
2016-03-01
期刊：
影响因子：
2.5
通讯作者：
Francis N
中科院分区：
文献类型：
--
作者：
Waldron CA;Thomas-Jones E;Cannings-John R;Hood K;Powell C;Roberts A;Tomkinson A;Fitzsimmons D;Gal M;Harris D;Shepherd V;Butler CC;Francis N
分泌性中耳炎（OME）是中耳积液，约80%的4岁儿童会受其影响。虽然OME通常可自行痊愈，但它会影响言语、行为和发育。对于伴有OME且听力持续受损的儿童，通常会提供助听器或通过鼓膜插入通气管。口服类固醇可能是一种安全有效的OME治疗方法，可在初级医疗中使用。口服类固醇治疗有可能使大量儿童受益，并减轻他们以及医疗服务的负担。然而，以往的试验要么规模太小、随访期太短，要么质量太差，无法给出明确答案。
儿童分泌性中耳炎口服类固醇治疗（OSTRICH）试验的目的是确定短期口服类固醇疗程在短期和长期内是否能改善OME儿童的听力。
从威尔士和英格兰的医院耳鼻喉科共招募了380名参与者（2至8岁的儿童）。一名训练有素的临床医生从有至少3个月可归因于OME的症状且在研究入组时经证实双侧听力受损的儿童的家长那里获取知情同意。参与者被随机分配接受为期1周的口服类固醇疗程或匹配的安慰剂疗程。结果包括听力测定、鼓室图和耳镜检查评估；症状；不良反应；功能健康状况；生活质量；资源使用；以及成本效益。参与者在随机分组后的第5周、第6个月和第12个月接受随访。主要结果是在第5周时经听力测定证实听力令人满意。
关于OME的短期口服类固醇治疗的临床效果和成本效益，存在重要的证据空白。确定一种用于儿童OME的有效、安全、非手术干预措施以供初级医疗使用，将对儿童、他们的家庭以及英国国家医疗服务体系（NHS）大有裨益。
ISRCTN注册号：ISRCTN49798431（2012年12月7日注册）
Otitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services. However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer. The aim of the Oral Steroids for the Resolution of Otitis Media with Effusion in Children (OSTRICH) trial is to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term. A total of 380 participants (children of 2 to 8 years of age) are recruited from Hospital Ear, Nose and Throat departments in Wales and England. A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation. The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks. An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS. ISRCTN: ISRCTN49798431 (Registered 7 December 2012)