Technical Performance Score-Quality Assessment Tool in Congenital Cardiac Surgery

描述(申请人提供)：在先天性心脏手术中，影响最佳结果实现的因素很多。其中，外科医生的技术表现可能是最重要的之一。需要系统的方法来评估跨诊断和中心的手术技术充分性。技术表现评分(TPS)是一种基于广泛存在的临床和超声心动图特征来评估技术能力的新工具。来自单一中心的早期研究表明，TPS在预测早期和中期结果方面都是有用的。利用NHLBI儿科心脏网络的基础设施，在Del Nido博士和Newburger博士的指导下，我将分析TPS评估的技术性能对定义明确的常见先天性心脏手术子集的早、中期结果的影响，这些手术技术在各个机构都使用了相对相似的手术技术。假设：TPS是一个有效的预后预测因子，包括先天性心脏缺陷术后不良事件的发生、资源利用、晚期死亡率以及是否需要在介入的解剖区域进行晚期再干预。我们的主要结果是手术后30天内存活和出院的天数。我们的次要结果是：1)早期主要术后不良事件的发生；2)重症监护病房(ICU)住院天数、住院时间、初始和总呼吸机使用时间；3)指数手术后的死亡率/移植；4)指数手术出院后的计划外再干预；5)特定程序TPS的每个组成部分对结果的贡献，以随着时间的推移进一步完善该工具。如果患者是12个月内接受6例心脏直视手术中的1例的婴儿，他们将有资格参加这项研究。排除标准包括存在任何可能独立影响受试者达到主要终点的可能性的重大先天性或获得性心外畸形。TPS将被评为最佳(I级)、适当(2级)或不足(3级)，根据超声心动图标准，这些标准旨在捕捉特定手术的个别组成部分，以及在与外科手术相关的解剖区域出院前的计划外手术或基于导管的再干预。由外科医生、超声心动图医生和心脏病专家组成的PHN专家小组将使用兰德改进的Delphi技术最终确定每个手术的TPS要素。超声心动图将在核心实验室进行解释。将在住院期间为指数操作收集数据，并在12个月时再次收集临时病史的数据，包括出院后发生的额外干预或死亡率。每个程序类别的最少150到310个科目将在两年内登记，登记后我们将获得一年的跟踪调查。这项研究将是第一次对先天性心脏病手术社区特有的自我评估和质量改进工具进行多中心前瞻性验证。

DESCRIPTION (provided by applicant): Many factors affect the realization of optimal outcomes in congenital cardiac surgery. Among these, the technical performance of the surgeon may be one of the most important. Systematic methods for evaluating operative technical adequacy across diagnoses and centers are needed. The Technical Performance Score (TPS) is a novel tool for assessing technical competency based on widely available clinical and echocardiographic characteristics. Earlier studies from a single center have suggested that the TPS is useful in predicting both early- and mid-term outcomes. Using the infrastructure of the NHLBI's Pediatric Heart Network, under mentorship from Drs. del Nido and Newburger, I will analyze the impact of technical performance, as assessed by the TPS, on early and mid-term outcomes in a well-defined subset of common congenital cardiac operations for which relatively similar operative techniques are used across institutions. Hypothesis: TPS is an effective predictor of outcomes, including occurrence of postoperative adverse events, resource utilization, late mortality, and need for late re-interventions in anatomic areas intervened upon, after surgery for congenital cardiac defects. Our primary outcome is number of days alive and out of the hospital within 30 days of surgery. Our secondary outcomes are: 1) occurrence of e 1 early major postoperative adverse event; 2) days of intensive care unit (ICU) stay, hospital length of stay, and initial and total time on the ventilator; 3) mortality/transplant after dischare for index operation; 4) unplanned re- interventions after discharge from index operation, and 5) the contribution of each component of the procedure-specific TPS to outcomes, to further refine the instrument over time. Patients will be eligible for the study if they are infants d12 months undergoing 1 of 6 open heart procedures. Exclusion criteria include the presence of any major congenital or acquired extra-cardiac anomalies that could independently affect the likelihood of the subject meeting the primary endpoint. The TPS will be ranked as optimal (Class I), adequate (Class 2), or inadequate (Class 3), based upon echocardiographic criteria that are designed to capture the individual components of specific operations, as well as unplanned surgical or catheter-based re-interventions prior to discharge in the anatomic areas relevant to the surgical procedure. A PHN expert panel of surgeons, echocardiographers, and cardiologists will finalize the TPS elements for each operation using the RAND modified Delphi technique. Echocardiograms will be interpreted in a Core Laboratory. Data will be prospectively collected during hospitalization for the index operation and again at 12 months for interim medical history, including additional interventions or mortality that occurred after hospital discharge. A minimum of 150 to 310 subjects in each procedural category will be enrolled over 2 years, and we will obtain 1 year of follow-up after enrollment. This study will be the first multi-center prospective validation of a tool for self-assessment and quality improvement specific to the congenital heart surgery community.