Modification of the Acute Otitis Media Severity of Symptoms Scale

急性中耳炎症状严重程度量表的修订

• 批准号: 9988638
• 负责人: Nader Shaikh
• 金额: $ 24.97万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9988638
• 关键词: Modification; Acute; Otitis; Media; Severity

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.

抽象的 急性中耳炎 (AOM) 是迄今为止幼儿（~10 尽管抗生素的使用主要是为了减轻 AOM 的症状，但直到 最近没有制定结果措施来跟踪试验中症状的改善或恶化 由于缺乏这种措施，评估抗生素的功效的数据很少。 可了解各种治疗对缓解症状的影响。 在不知道它是否优于其他可用治疗方案的情况下为患者选择抗生素 我们之前制定了一项家长报告的结果衡量标准，以减轻 AOM 症状的严重程度。 尽管我们已经成功地利用了这一结果，但仍追踪了 AOM 症状的严重程度。 测量——急性中耳炎症状严重程度量表（AOM-SOS）——在最近的一些试验中，我们的 该措施中制定的方法存在重大缺陷，其中最显着的是缺乏 进行广泛的定性研究，以确定要纳入衡量标准的概念和项目。 拟议研究的目标是 (a) 进行必要的定性工作，以便我们能够修改 AOM-SOS，以便全面捕获与父母相关的所有因素，以及 (b) 评估 为了实现这些目标，我们将（1）进行深入的、半的研究。 对 AOM 儿童的父母进行结构化访谈，(2) 使用最佳可用定性分析成绩单 研究方法，(3) 使用既定方法减少项目数量，(4) 开发试验版本 从这个减少的项目列表中得出结果测量，（5）使用多轮认知访谈来完善 测量，(6) 将测量翻译成西班牙语，并通过认知访谈确保可比性 西班牙语家长，以及 (7) 评估修改后的可靠性、构建有效性和响应性 此处概述的工作将使我们能够向 AOM-SOS 提交资格就绪版本。 在项目期结束时，如果没有这种性质的研究，研究人员将继续依赖 FDA。 在试验中具有可疑临床相关性的替代结果和拥护者将继续开处方 不知道是否能改善患者症状的治疗。

项目成果

Parents' experiences caring for children with acute otitis media: a qualitative analysis.

父母照顾急性中耳炎儿童的经验：定性分析。

• 发表时间: 2022-05-23
• 作者: Lee, Matthew C;Kavalieratos, Dio;Alberty, Anastasia;Groff, Destin;Haralam, Mary Ann;Shaikh, Nader
• 通讯作者: Shaikh, Nader