Promoting Diversity in Health-Related Research

摘要自PANITAL PROJECT（图像引导编程：儿科语音， 语文和识字） 虽然最近的文献表明，接受人工耳蜗植入的儿童往往有 与前几代儿童相比，言语和语言能力显著提高 在听力损失的情况下，许多小儿人工耳蜗植入（CI）患者表现出持续的言语， 早期植入后的语言障碍和相关的言语/语言干预 [see（1，2）]。有一个显着的缺乏和持续需要的研究，系统地检查 手术植入参数、听力学特征和随后的 儿童CI的言语、语言和识字结果[见（3）]。拟建项目 提供了一个独特的机会，以检查是否个性化，图像引导的CI 程序（IGCIP）显著改善了儿童CI患者的结局。拟议 研究是听力学家（吉福德）和语言病理学家之间的合作 （Camarata）和生物统计学家（Dietrich）。拟议的研究活动将审查 个性化IGCIP对儿童基础听功能的影响 （频谱和时间分辨率），语音识别，语音产生，语言，和 使用随机等待列表控制的识字前和阅读理解的测量 处理设计共有60名6至12岁的CI儿童将参加 该项目和一半（n = 30）将被随机分配至立即IGCIP条件，一半被随机分配至 12个月的等待名单控制条件。候补受试者（n = 30）将接受IGCIP 经过12个月的监测并在术后再随访12个月 已提供了编程（研究总时间：24个月）。那些立即 IGCIP提供的患者也将入组，共24个月。所有参与者将接受 除了全面的听力和语言评估， 基线以及定期进行听力学评估：2、6、12、14、18和24 个月我们将使用预测分析来确定即时和递延的影响， IGCIP对随后的听觉，言语，语言和识字结果。

ABSTRACT FROM PARENT PROJECT (Image Guided Programming: Pediatric Speech, Language and Literacy) Although the recent literature has indicated that children receiving cochlear implants often have dramatically improved speech and language ability relative to previous generations of children with hearing loss, many pediatric cochlear implant (CI) patients display persistent speech and language disorders despite early implantation and associated speech/language intervention [see (1,2)]. There is a striking paucity and ongoing need for studies that systematically examine the relationship between surgical implantation parameters, audiological profile, and subsequent speech, language, and literacy outcomes in pediatric CI [see (3)]. The proposed project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric CI patients. The proposed research is a collaboration between an audiologist (Gifford) and a speech language pathologist (Camarata) and a biostatistician (Dietrich). The proposed research activities will examine the impact of personalized IGCIP in pediatric patients on measures of basic auditory function (spectral and temporal resolution), speech recognition, speech production, language, and measures of preliteracy and reading comprehension using a randomized wait-list control treatment design. A total of 60 children with CIs aged six to twelve years old will be enrolled in the project and one-half (n = 30) will be randomized to an immediate IGCIP condition and half to a 12 month waitlist control condition. The waitlisted participants (n = 30) will undergo IGCIP after 12 months of monitoring and followed up for an additional 12 months after the programming has been provided (total time in the study: 24 months). Those immediately provided with IGCIP will also be enrolled for a total of 24 months. All participants will undergo extensive audiological and speech and language assessments in addition to comprehensive audiological assessment at baseline as well as at regular intervals: 2, 6, 12, 14, 18, and 24 months. We will use predictor analyses to determine the impact of immediate and deferred IGCIP on subsequent auditory, speech, language, and literacy outcomes.