An inter-center comparison of speech outcomes: The Americleft project

描述(由申请人提供)：腭裂影响儿童的言语、语言和听力；外观；咬合和心理社会功能。尽管多年来的研究试图确定治疗唇裂儿童的最佳治疗方案，但对于哪种治疗方案效果最好，仍存在很大争议。为了提高治疗伴有或不伴有唇裂的儿童腭裂(CP+L)的现有证据的质量，许多消息来源表示，中心间研究提供了一种判断单个中心治疗方案的整体结果的方法。欧洲进行了许多非常成功的中心间研究(例如，EUROCLEFT；SCANCLEFT)，导致治疗方案发生重大变化。最近，一组正畸医生发表了一系列北美中心之间的比较：American Left研究。这项拟议的前瞻性研究的目的是比较美国三个不同的腭裂/颅面中心的语音结果，试图确定与更好的语音结果相关的治疗方案。180名患有CP+L的5岁和6岁儿童(每个地点60名)和60名健康的、发育正常的儿童参加了这项研究。所有在06年8月1日至10年6月31日期间出生并在这三个中心之一接受腭部手术的儿童都将被要求参加。将使用为此目的制定的标准方案，将这些儿童作为其年度小组访问的一部分进行评估。录制的视频样本将被发送到中央位置进行编辑，并发布在安全的网站上进行评级。盲法评分将由训练有素的言语语言病理学家(SLP)进行，包括可接受性、超鼻音和言语产出。评分者将被要求判断是否需要对腭咽闭合功能或语音干预进行额外评估。将在三个中心之间以及三组患有CP+L的儿童和没有CP+L的儿童之间进行比较。该项目还将提供成功率的基准，中心可以使用这些基准来判断他们的结果。这项研究的发现有可能减轻裂隙对腭裂儿童的生活质量、言语和心理社会功能的影响。

DESCRIPTION (provided by applicant): Palatal clefting impacts a child's speech, language, and hearing; appearance; occlusion, and psychosocial functioning. Despite years of research attempting to identify the best treatment protocols for children with clefts, there is still much debate about which treatments yield the best outcomes. In an attempt to improve the quality of evidence available for treatments for children with cleft palate with or without cleft lip (CP+L), number of sources have suggested that inter-center studies provide a way to judge the overall outcome of an individual center's treatment protocol. A number of very successful inter-center studies have been conducted in Europe (e.g., EUROCLEFT; SCANCLEFT), resulting in significant changes to treatment protocols. More recently, a group of orthodontists published a series of inter-center comparisons of North American centers: The Americleft Study. The aim of the proposed prospective study is to compare speech outcomes among three different Cleft Palate/Craniofacial Centers in the US in an attempt to identify treatment protocols that are associated with better speech outcomes. One-hundred eighty 5- and 6- year-old children with CP+L (60 per site) and 60 healthy, typically-developing children without CP+L will participate in the study. All children born between 8/1/06 and 6/31/10 who received palatal surgery at one of the three centers will be asked to participate. The children will be evaluated as part of their yearly team visits using a standard protocol developed for this purpose. The video recorded samples will be sent to a central location for editing and posting on a secure website for rating. Blinded ratings will be conducted by trained Speech-Language Pathologists (SLPs) acceptability, hypernasality, and speech production. The raters will be asked to judge whether additional evaluation of velopharyngeal function or speech intervention is needed. Comparisons will be made between the three centers and between each of the three groups of children with CP+L and children without CP+L. This project will also provide benchmarks for success rates that centers can use to judge their outcomes. The findings of this study have the potential to lessen the effects of clefting on quality of life, speech, and psychosocial functioning for childre with cleft palate.