Targeting Surgeons Decision-Making for Lip Surgery

 描述(申请人提供)：唇腭裂(CL/P)是所有出生缺陷中最常见的。为了纠正患有CL/P的婴儿明显的面部残疾，外科医生在出生后不久就会对嘴唇和鼻子进行初步或初级修复。不幸的是，许多患者(和护理人员)对手术结果不满意：患者仍然留在面部 面部软组织运动中的毁容和损伤--特别是面部表情行为。在儿童和青春期进行多次翻修手术是常见的，以改善最初的结果。照顾这些儿童和他们的照顾者的心理社会和经济负担是巨大的。传统上，唇部整形手术的决定是基于对鼻唇形的主观评估，而较少的情况是周口部运动，但没有一种方法来量化手术前或手术后的面部运动/形态。为此，我们开发了一种干预措施，利用一套新的动态和静态量化措施和系统的主观评估来量化面部残疾，用于唇部手术的治疗计划和评估手术结果。量化措施包括(1)患者平均面部运动的3D动态和统计建模；(2)3D静态面部图像数据，分别与平均控制运动和静态图像数据进行比较。作为这项形成性研究中必要的第二步，我们将使用不同的接受唇部矫正和唇部修复手术的患者的预期队列，进行一项具有以下具体目标的“概念证明”第二阶段随机临床试验(RCT)。具体目的1.定性评估外科医生如何将干预的客观措施和视觉辅助手段与系统的主观评估相结合，为唇部矫正和修复的临床外科手术提供决策依据。具体目标2.定量评估干预在多大程度上改变了外科医生的唇部矫正和唇部修复的问题清单和治疗计划目标。具体目标3.获得对均值、方差和患者内部相关性的估计，并估计干预和护理标准或控制条件下外科医生对手术结果的交互作用效果。最终，虽然这项第二阶段RCT不是通常意义上的为患者提供治疗的治疗性试验，但它对于颅面康复来说将是独一无二的，因为FCUS将优化新评估的设计，改善可供外科医生用于手术规划的单个患者的诊断证据库，并评估手术后结果是否通过干预得到改善。

 DESCRIPTION (provided by applicant): Cleft lip/palate (CL/P) are among the most common of all birth defects. To correct the obvious facial disabilities of babies with CL/P, surgeons perform an initial or primary repair of the lip and nose soon after birth. Unfortunately, many patients (and caregivers) are dissatisfied with the surgical results: Patients remain with a facial disfigurement and impairment in facial soft tissue movements-particularly in facial expressive behaviors. Multiple revision surgeries during childhood and adolescence are common to improve the initial results. The psychosocial and economic burden of care on these children and their caregivers are great. Traditionally, the decision for lip revision surgery has been based on subjective assessments of nasolabial form, and less frequently, circumoral movement but without a method to quantify the facial movements/form before surgery or after surgery. To this end, we have developed an Intervention that utilizes a novel set of dynamic and static quantitative measures and a systematic subjective evaluation to quantify facial disability for the treatment planning of lip surgery and for assessing surgical outcomes. The quantitative measures include (1) 3D dynamic and statistical modeling of patients' mean facial movements and (2) 3D static facial image data, both compared with mean control movement and static image data, respectively. As a necessary second step in this formative research, using separate prospective cohorts of patients who have lip revision and lip repair surgery, we will conduct a 'proof of concept' Phase II randomized clinical trial (RCT) with the following Specific Aims. Specific Aim 1. To qualitatively assess how surgeons integrate the Intervention's objective measures and visual aids with the systematic subjective assessment in the decision-making process for the clinical surgical procedures of lip revision and lip repair. Specific Aim 2. To quantitatively assess the extent to which the Intervention changes surgeons' problem list and treatment planning goals for lip revision and lip repair. Specific Aim 3. To obtain estimates on means, variances, and intra-patient correlation, and to estimate surgeon-by-condition interaction effects for surgical outcomes under the Intervention and the standard of care or Control conditions. Ultimately, while this Phase II RCT is not a therapeutic trial in the usual sense of providing a patient with a therapy, it will be unique for craniofacial rehabilitation in that the fcus is to optimize the design of a novel assessment, improve an individual patient's diagnostic evidence base available to the surgeon for surgical planning, and evaluate whether post-surgical results are improved with the Intervention.