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

项目总结 在他们的一生中，患有唇腭裂的儿童(CP L)经历了无数次手术、正畸和 旨在减轻裂隙影响的行为干预。存在着真正的不确定性， 专家医学界对腭裂修复术的首选方法进行了探讨。因此，治疗 决策基于对先前培训、临床经验或提供者专业知识的偏见的处理。 这项拟议的项目旨在比较两种最常见的腭裂修复技术，直接式- 软组织瓣内成形术(IVVP)和Fllow Z成形术在腭裂手术中的应用 关于言语结果和随后发生的瘘管，这是一种常见的不良事件 腭部的外科修复手术。在理想情况下，对选定人群进行干预研究，而不是有效性 条件，建议研究的目标是有效性，这些技术在现实世界中的比较 临床设置和临床护理中看到的严重程度和共病的整个连续统-数据是 迫切需要为慢性阻塞性肺疾病的医疗决策提供信息。此外，我们还将收集有关 术后和后续护理以及言语语言治疗实践，以照亮全面的地平线 CP L的早期护理实践为了实现这种真实世界的数据捕获，我们将建立一个多机构、 护理点数据捕获系统，协调来自领先的唇裂护理计划的实践数据 北美。 这一拟议项目的完成将促进对CP L手术入路的了解 以及随后的住院和门诊护理。真实和详细的护理信息如何 不同的个体对手术干预的反应将帮助提供者在正确的地方提供正确的护理 是时候找对病人了。更好地描述治疗干预措施将为护理的发展提供信息 有潜力实现更知情、更有效、更公平的门诊CP L护理路径 关心。最后，除了可以通过假设检验实现的对护理的直接影响外，还提出了 在此，为CP L建立护理点数据捕获临床研究登记具有潜力 为该领域做出持久的贡献，并支持进行及时和临床相关的研究 在未来的几年里。

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.