Targeting Surgeons' Decision Making for Lip Revision Surgery

主要研究员：卡罗尔·安·特罗特曼，BDS，MA，MS NIDCR协议号：15-069-E/NIDCR授权编号：U01 DE024503 唇裂外科医生的针对性决策 协议摘要 这项研究包括：(1)一组外科医生评分员，他们将审查图像和定量信息 唇腭裂患者(CL/P)；和(2)两个前瞻性组/队列的患者 唇腭裂(CL/P)-一组建议进行二次唇部整形手术，另一组建议进行二次唇部整形手术 计划进行一次唇部修复手术。 这项研究将指派外科医生评分员来评估计划在另一家医院接受治疗的患者 参与研究的地点。每个外科医生-评价员将被指派对几名患者进行假设性评估 从两个手术队列中分离出来。外科医生评分员将使用一种新的手术前计划系统来进行这项工作 评估-面部外科(SAFS)干预的系统评估。在每个SAF之后， 外科医生评分员将参加深度访谈(IDI)，旨在阐明外科医生评分员的 决策过程。这项研究将确定SAFS干预如何影响外科医生的 外科手术的决策和治疗计划。目标： 这项研究的主要目标是： ·定性评估外科医生评分员如何将SAFS的客观措施和视觉辅助工具结合起来 SAFS在临床决策过程中的系统主观评价 唇部整形的外科手术。 ·定性评估外科医生评分员如何将SAFS的客观措施和视觉辅助工具结合起来 SAFS在临床决策过程中的系统主观评价 初级唇部修复术的外科操作。 这项研究的次要目标是： ·定量评估SAFS改变外科医生评分员问题清单的程度，以及 唇部矫正的治疗计划目标。 ·定量评估SAFS改变外科医生评分员问题清单的程度，以及 初次唇部修复的治疗计划目标。 ·定量评估SAFS改变外科医生评分员问题清单的程度，以及 唇部矫正的治疗计划目标作为外科专业知识的一项功能。

Principal Investigator: Carroll Ann Trotman, BDS, MA, MS NIDCR Protocol Number: 15-069-E/ NIDCR Grant Number: U01 DE024503 Targeting Surgeons’ Decision-Making for Cleft Lip Surgery PROTOCOL SUMMARY This study includes: (1) A group of surgeon-raters who will review images and quantitative information of patients with Cleft Lip and Palate (CL/P); and (2) Two prospective groups/cohorts of patients with cleft lip/palate (CL/P) – one cohort recommended to have secondary lip revision surgery and another slated to have primary lip repair surgery. The study will assign surgeon-raters to evaluate patients who are scheduled to be treated at another participating study site. Each surgeon-rater will be assigned to hypothetically assess several patients from both cohorts for surgery. Surgeon-raters will use a novel pre-surgical planning system for this evaluation – the Systematic Assessment for Facial Surgery (SAFS) Intervention. Subsequent to each SAFS, surgeon-raters will participate in an In-depth interview (IDI), designed to illuminate the surgeon-raters’ decision making process. This study will determine how the SAFS Intervention affects surgeons’ decision-making and treatment plans for surgery. Objectives: The Primary objectives of this study are: • To qualitatively assess how surgeon-raters integrate the SAFS’s objective measures and visual aids with the SAFS’s systematic subjective assessment in the decision-making process for the clinical surgical procedures of lip revision. • To qualitatively assess how surgeon-raters integrate the SAFS’s objective measures and visual aids with the SAFS’s systematic subjective assessment in the decision-making process for the clinical surgical procedures of primary lip repair. The secondary objectives of this study are: • To quantitatively assess the extent to which the SAFS changes surgeon-raters’ problem list and treatment planning goals for lip revision. • To quantitatively assess the extent to which the SAFS changes surgeon-raters’ problem list and treatment planning goals for primary lip repair. • To quantitatively assess the extent to which the SAFS changes surgeon-raters’ problem list and treatment planning goals for lip revision as a function of surgical expertise.