Modification of the Acute Otitis Media Severity of Symptoms Scale

摘要 急性中耳炎（AOM）是迄今为止幼儿抗生素处方最常见的适应症（约10 每年百万张处方）。尽管抗生素主要用于减轻AOM的症状，但 最近没有结果的措施已经制定跟踪改善或恶化的症状在试验中 评估抗生素的功效。由于没有这种衡量标准， 提供各种治疗对症状缓解的影响。因此，临床医生目前 为患者选择抗生素，而不知道它是否上级其他可用的治疗方案， 减轻AOM症状的严重程度。我们以前开发了一个家长报告的结果测量， 追踪言语前儿童AOM症状的严重程度。尽管我们成功地利用了这一成果 急性中耳炎症状严重程度量表（AOM-SOS）-在最近的一些试验中，我们 在制定措施的方法有重要的缺点，其中最显着的是缺乏 进行广泛的定性研究，以确定纳入计量的概念和项目。因此 拟议研究的目标是（a）进行必要的定性工作，使我们能够修改 AOM-SOS，以便全面掌握与父母相关的所有因素，以及（B）评估 修改后的量表的心理测量学特性。为了实现这些目标，我们将（1）进行深入，半- 与AOM儿童的父母进行结构化访谈，（2）使用最佳可用定性分析方法分析成绩单 研究方法，（3）减少项目的数量使用既定的方法，（4）开发一个试点版本， 从这个减少的项目列表中测量结果，（5）使用认知访谈来完善 （6）将该措施翻译成西班牙语，并通过与下列人员的认知访谈确保可比性： 西班牙语的父母，和（7）评估的信度，结构效度，和反应的修改 measure.这里概述的工作将使我们能够提交AOM-SOS的资格就绪版本， 在项目期结束前向林业发展局提供资金。如果没有这种性质的研究，研究人员将继续依赖于 临床试验中临床相关性可疑的替代结局，临床医生将继续处方 治疗，而不知道他们是否改善患者的症状。

ABSTRACT Acute otitis media (AOM) is by far the most frequent indication for antibiotic prescription in young children (~10 million prescriptions per year). Even though antibiotics are given largely to reduce symptoms of AOM, until recently no outcome measures had been developed to track improvement or deterioration of symptoms in trials assessing the efficacy of antibiotics. As a direct result of the unavailability of such a measure, little data are available on the impact of various treatments on resolution of symptoms. Accordingly, clinicians currently have to choose an antibiotic for a patient without knowing if it is superior to other available treatment options at reducing the severity of symptoms of AOM. We previously developed a parent-reported outcome measure to track the severity of symptoms of AOM in preverbal children. Although we have successfully used this outcome measure–the Acute Otitis Media Severity of Symptoms Scale (AOM-SOS)–in a number of recent trials, our approach in developing the measure had important shortcomings, of which the most notable was the lack of extensive qualitative research to establish concepts and items to include in the measure. Accordingly, the objectives of the proposed research are (a) to perform the necessary qualitative work to allow us to modify the AOM-SOS so that it comprehensively captures all factors relevant to parents, and (b) to assess the psychometric properties of the modified scale. To achieve these objectives we will (1) conduct in-depth, semi- structured interviews with parents of children with AOM, (2) analyze transcripts using best available qualitative research methods, (3) reduce the number of items using established methods, (4) develop a pilot version of the outcome measure from this reduced list of items, (5) use rounds of cognitive interviews to refine the measure, (6) translate the measure into Spanish and ensure comparability through cognitive interviews with Spanish-speaking parents, and (7) assess the reliability, construct validity, and responsiveness of the modified measure. The work outlined here will allow us to submit a qualification-ready version of the AOM-SOS to the FDA by the end of the project period. Absent a study of this nature, investigators will continue to rely on surrogate outcomes with questionable clinical relevance in their trials and clinicians will continue to prescribe treatments without knowing if they improve the symptoms of their patients.