Technical Performance Score-Quality Assessment Tool in Congenital Cardiac Surgery

描述（申请人提供）：许多因素影响先天性心脏手术最佳结果的实现。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）是一种基于广泛可用的临床和超声心动图特征评估技术能力的新工具。来自一个中心的早期研究表明，TPS在预测早期和中期结果方面都很有用。利用NHLBI儿科心脏网络的基础设施，在博士的指导下。del Nido和Newburger，我将分析技术性能的影响，正如TPS评估的那样，对明确定义的常见先天性心脏手术的早期和中期结果的影响，这些手术在各机构中使用相对相似的手术技术。假设：TPS是先天性心脏缺陷手术后预后的有效预测指标，包括术后不良事件的发生、资源的利用、晚期死亡率以及对介入解剖区域后期再干预的需求。我们的主要指标是手术后30天内存活和出院的天数。我们的次要结局是：1)术后早期主要不良事件的发生；2)重症监护病房（ICU）住院天数、住院时间、初次使用呼吸机时间和总使用呼吸机时间；3)指数手术出院后死亡率/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个月大的婴儿，正在接受6次心脏直视手术中的1次，则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先天性或获得性心脏外异常。根据超声心动图标准，TPS将被评为最佳（I类）、适当（2类）或不充分（3类），超声心动图标准旨在捕捉特定手术的单个组成部分，以及出院前与手术过程相关的解剖区域的计划外手术或基于导管的再干预。由外科医生、超声心动图医师和心脏病专家组成的PHN专家小组将使用RAND改进的德尔菲技术确定每次手术的TPS要素。超声心动图将在核心实验室进行解释。前瞻性数据将在住院期间收集索引手术，并在12个月时再次收集中期病史，包括其他干预措施或出院后发生的死亡率。在2年的时间内，每个手术类别至少纳入150 - 310名受试者，入组后我们将进行1年的随访。这项研究将是首个针对先天性心脏外科社区的自我评估和质量改进工具的多中心前瞻性验证。

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.