Targeting Surgeons Decision-Making for Lip Surgery

针对唇部手术的外科医生决策

基本信息

批准号：
9334829
负责人：
CARROLL ANN TROTMAN
金额：
$ 56.17万
依托单位：
TUFTS UNIVERSITY BOSTON
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-03 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9334829
关键词：
Adolescence Affect Age Appearance Appointment Behavior Bilateral Birth Caregivers Caring Characteristics Child Childhood Cleft Lip Clinical Congenital Abnormality Control Groups Data Decision Making Diagnosis Diagnostic Economic Burden Esthetics Evaluation Face Feedback Goals Hospital Costs Image Impairment Intervention Interview Learning Lip structure Measures Methods Movement Nose Operative Surgical Procedures Outcome Palate Patients Phase Procedures Process Prospective cohort Quality of life Randomized Clinical Trials Rehabilitation therapy Research Residual state Statistical Models Surgeon Therapeutic Trials Time Tissues United States United States National Institutes of Health Visual Aid base care burden cleft lip and palate craniofacial design disability evidence base experience functional disability improved individual patient intervention effect lip function novel orofacial cleft peer psychosocial public health relevance repaired sex soft tissue standard of care stressor treatment planning

项目摘要

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.

描述（由申请人提供）：唇裂/腭裂（CL/P）是所有出生缺陷中最常见的一种，为了纠正患有 CL/P 的婴儿明显的面部残疾，外科医生对唇部和腭裂进行初步或初步修复。不幸的是，许多患者（和护理人员）在出生后不久就对手术结果不满意：患者仍然保留面部护理。面部软组织运动的毁容和损伤，特别是在儿童期和青春期进行多次修复手术，以改善最初的结果，这对这些儿童及其照顾者来说是巨大的心理和经济负担。唇部修复手术的评估基于鼻唇沟形状的主观评估，以及不太常见的环口运动，但没有量化手术前后面部运动/形状的方法。为此，我们开发了一种利用新颖的干预措施。一套动态和静态定量测量和系统的主观评估，用于量化唇部手术治疗计划和评估手术结果的面部残疾。定量测量包括 (1) 患者平均面部运动的 3D 动态和统计模型和 (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必要的第二步，我们将使用接受唇部修正和唇部修复手术的患者的单独前瞻性队列进行“。概念验证’II期随机临床试验(RCT) 具有以下具体目标具体目标 1. 定性评估外科医生如何将干预的客观测量和视觉辅助与唇部修正和唇部修复的临床手术决策过程中的系统主观评估相结合。 2. 定量评估干预措施改变外科医生的唇部修正和唇部修复的问题清单和治疗计划目标的程度。具体目标 3. 获得平均值、方差和患者内部相关性的估计值，并进行估计。最终，虽然该 II 期随机对照试验不是通常意义上的为患者提供治疗的治疗试验，但它将是独一无二的。对于颅面康复来说，重点是优化新颖评估的设计，改善个体患者的诊断证据基础，可供外科医生进行手术规划，并评估干预是否改善术后结果。