Targeting Surgeons Decision-Making for Lip Surgery

针对唇部手术的外科医生决策

• 批准号: 8888275
• 负责人: CARROLL ANN TROTMAN
• 金额: $ 56.92万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 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/8888275
• 关键词: Adolescence; Affect; Age; Appearance; Appointment; Behavior; Bilateral; Birth; Caregivers; Caring; Characteristics; Child; Childhood; Cleaved cell; Cleft Lip; Clinical; Congenital Abnormality; Control Groups; Data; Databases; Decision Making; Diagnosis; Diagnostic; Economic Burden; Esthetics; Evaluation; Face; Feedback; Goals; Hospital Costs; Image; Impairment; Individual; Intervention; Interview; Learning; Lip structure; Measures; Methods; Movement; Nose; Operative Surgical Procedures; Outcome; Palate; Patients; Phase; Procedures; Process; 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; cleft lip and palate; cohort; craniofacial; design; disability; evidence base; experience; functional disability; improved; intervention effect; lip function; novel; orofacial cleft; peer; prospective; psychosocial; public health relevance; repaired; sex; soft tissue; standard of care; stressor; treatment planning

 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（由适用提供）：唇裂/pa/p/p）是所有先天缺陷中最常见的。为了纠正使用CL/P的婴儿的明显面部残疾，外科医生不久后不久就对嘴唇和鼻子进行初始或初级修复。不幸的是，许多患者（和看护人）对手术结果不满意：患者仍然有面部护理 面部软组织运动的毁容和损害，面部表达行为尤其是面部。在儿童期和青少年期间进行多次修订手术是改善初始结果的常见。对这些儿童及其护理人员的心理社会和经济伯恩伯恩很棒。传统上，唇部修订手术的决定是基于对鼻labial形式的主观评估，并且频率较低，但没有量化手术前或手术后面部运动/形式的方法。为此，我们开发了一种干预措施，该干预措施利用了一组新型的动态和静态定量测量以及系统的主观评估来量化面部残疾，以用于唇部手术的治疗计划并评估手术结果。定量测量包括（1）与平均控制运动和静态图像数据相比，（2）3D静态面部图像数据的3D动态和统计模型以及（2）3D静态面部图像数据。作为这种格式研究的必要第二步，使用具有唇部修订和唇部修复手术的患者的单独前瞻性人群，我们将进行以下特定目的的“概念验证”。具体目的1。要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设备与唇部修订和唇部修复的临床外科手术程序的决策过程中的系统评估相结合。具体目的2。定量评估干预措施改变外科医生的问题清单和治疗计划目标的程度。具体目的3。要在干预和护理或控制条件的标准下，对手术结果的均值，差异和患者内相关性进行估计，并逐步估算外科医生的关系互动效应。最终，虽然这II阶段RCT在通常的意义上是为患者提供治疗的治疗试验，但它对于颅面康复是独一无二的，因为FCU是为了优化新颖评估的设计，改善单个患者的诊断证据，可用于外科医生可用于外科手术计划，并评估该干预后是否可以改善该干预效果。