Targeting Surgeons Decision-Making for Lip Surgery

 描述（由申请人提供）：唇腭裂（CL/P）是所有出生缺陷中最常见的。为了纠正CL/P婴儿明显的面部残疾，外科医生在出生后不久对嘴唇和鼻子进行初步或初步修复。不幸的是，许多患者（和护理人员）对手术结果不满意： 面部软组织运动，特别是面部表情行为的缺陷和损伤。儿童和青少年时期多次翻修手术很常见，可以改善初步结果。照顾这些儿童及其照顾者的心理社会和经济负担很大。传统上，唇修复手术的决定是基于鼻唇形状的主观评估，较少的情况下，环口运动，但没有一种方法来量化手术前或手术后的面部运动/形状。为此，我们开发了一种干预措施，利用一套新的动态和静态定量措施和系统的主观评价来量化面部残疾，用于唇手术的治疗计划和评估手术结果。定量测量包括（1）患者平均面部运动的3D动态和统计建模，以及（2）3D静态面部图像数据，两者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的必要第二步，我们将使用单独的前瞻性患者队列进行唇部翻修和唇部修复手术，我们将进行一项具有以下特定目的的“概念验证”II期随机临床试验（RCT）。具体目标1。定性评估外科医生如何将干预措施的客观测量和视觉辅助与系统的主观评估结合起来，用于唇翻修和唇修复的临床手术决策过程。具体目标2。定量评估干预措施改变外科医生的问题列表和唇修复和唇修复治疗计划目标的程度。具体目标3。获得平均值、方差和患者内相关性的估计值，并估计干预和标准治疗或对照条件下外科医生与条件的相互作用对手术结局的影响。最终，虽然该II期RCT不是通常意义上的为患者提供治疗的治疗试验，但它对于颅面康复来说是独一无二的，因为其重点是优化新型评估的设计，改善外科医生可用于手术计划的个体患者诊断证据库，并评估干预是否改善了术后结果。

 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.