A comparative effectiveness study of speech and surgical treatments using a Cleft Palate Registry/Research Outcomes Network.

项目摘要 在他们的一生中，腭裂+唇（CP + L）儿童经历了许多手术，正畸， 行为干预，旨在减少分裂的影响。真正的不确定性在于 专家医学界关于首选的手术方法腭裂修复。因此，治疗 决策是基于对来自先前培训、临床经验或提供者专业知识的偏见的处理。 拟议的项目旨在比较两种最常见的腭裂修复技术，直- 线闭合与软腭内成形术（IVVP）和Furlow Z成形术腭延长，以确定其效果 对言语结果和随后瘘管的发展产生影响，瘘管是以下常见的不良事件 上颚的外科修复。而不是有效性，在理想条件下对选定人群进行干预的研究 条件下，所提出的研究的目标是有效性，这些技术在现实世界中的比较 临床环境和临床护理中观察到的严重程度和合并症的完整连续性- 非常需要为CP + L的医疗决策提供信息。此外，我们还将收集以下详细信息： 手术后和后续护理以及语言治疗实践，以照亮整个视野， CP + L的早期护理实践。为了实现这一现实世界的数据捕获，我们将建立一个多机构， 护理点数据采集系统，协调来自领先的唇腭裂护理计划的实践数据， 北美 该拟议项目的完成将促进对CP + L手术方法的了解， 以及随后的住院和门诊治疗。真实而详细的护理信息， 不同的个人对手术干预的反应将有助于提供者在正确的时间提供正确的护理。 时间给正确的病人。更好地描述治疗干预措施将为护理的发展提供信息 有可能实现更知情、有效和公平的门诊CP + L护理途径 在乎最后，除了可以通过假设检验实现的对护理的直接影响之外， 在此，建立CP + L的即时数据采集临床研究注册中心具有潜力 成为该领域的持久贡献，并支持及时进行临床相关研究 在未来的岁月里。

PROJECT SUMMARY Over their lifetimes, children with cleft palate + lip (CP+L) undergo numerous surgical, orthodontic, and behavioral interventions designed to lessen the impact of clefting. There is genuine uncertainty within the expert medical community about the preferred surgical approaches to cleft palate repair. As a result, treatment decisions are based on treating biases from prior training, clinical experiences, or provider expertise. The proposed project intends to compare the two most common cleft palate repair techniques, straight- line closure with intra-velar veloplasty (IVVP) and Furlow Z-plasty palatal lengthening, to determine their effect on speech outcome and on the subsequent development of fistulas, a common adverse event following surgical repair of the palate. Instead of efficacy, the study of interventions in a select population under ideal conditions, the target of the proposed study is effectiveness, the comparison of these techniques in real-world clinical settings and across the full continuum of severity and comorbidity seen in clinical care – data that are sorely needed to inform medical decision making for CP+L. In addition, we will collect detailed information on post-operative and follow-up care as well as speech-language therapy practices to illuminate the full horizon of early care practices for CP+L. To achieve this real-world data capture, we will establish a multi-institutional, point-of-care data capture system that harmonizes the practice data from leading cleft care programs across North America. The completion of this proposed project will advance knowledge about surgical approaches to CP+L as well as subsequent inpatient and outpatient care. The authentic and detailed care information about how different individuals respond to surgical interventions would help providers deliver the right care at the right time to the right patient. Better characterization of therapy interventions would inform the development of care pathways for outpatient CP+L care that have the potential to realize more informed, effective and equitable care. Finally, in addition to the direct impact on care that can be realized by the hypothesis testing proposed herein, the establishment of a point-of-care data capture clinical research registry for CP+L holds the potential to be an enduring contribution to the field and to support conduction of timely and clinically relevant research for years to come.