Technical Performance Score-Quality Assessment Tool in Congenital Cardiac Surgery

先天性心脏病手术技术绩效评分-质量评估工具

• 批准号: 9480873
• 负责人: Meena Nathan
• 金额: $ 14.8万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9480873
• 关键词: 1 year old; Address; Admission activity; Adverse event; Affect; Age; Anatomy; Area; Assessment tool; Attention; Cardiac; Cardiac Surgery procedures; Cardiopulmonary; Cardiovascular system; Caring; Categories; Catheters; Characteristics; Charge; Child; Childhood; Clinical; Communities; Competence; Congenital Heart Defects; Congenital atresia of pulmonary valve; Data; Debridement; Delphi Technique; Diagnosis; Dialysis procedure; Echocardiography; Elements; Enrollment; Environment; Environmental air flow; Exclusion Criteria; Future; Genetic; Goals; Grant; Heart; Heart Abnormalities; Heart Arrest; Hospital Charges; Hospital Costs; Hospitalization; Hospitals; Hour; Incidence; Individual; Infant; Institution; Intensive Care Units; Interruption; Intervention; Kidney Failure; Laboratories; Laparotomy; Length; Length of Stay; Measures; Mediastinitis; Medical History; Mentors; Mentorship; Methods; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Necrotizing Enterocolitis; Operative Surgical Procedures; Outcome; Patients; Performance; Perioperative; Pharmaceutical Preparations; Postoperative Period; Procedures; Repair Complex; Repeat Surgery; Reporting; Research Infrastructure; Resources; Respiratory Paralysis; Risk; Self Assessment; Severities; Sternum; Surgeon; Syndrome; Techniques; Tetralogy of Fallot; Time; Transplantation; Validation; Ventilator; Ventricular Septal Defects; Vocal Cord Paralysis; Work; adverse outcome; atrioventricular septal defect; base; cardiac repair; d-transposition of the great arteries; design; follow-up; indexing; instrument; meetings; mortality; novel; operation; outcome prediction; premature; primary endpoint; primary outcome; prospective; public health relevance; repaired; secondary outcome; study population; tool

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.

描述（由申请人提供）：许多因素影响先天性心脏手术最佳结局的实现。其中，外科医生的技术表现可能是最重要的因素之一。需要系统的方法来评估不同诊断和中心的手术技术充分性。技术性能评分（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。早期来自单中心的研究表明，TPS在预测早期和中期结果方面都很有用。使用NHLBI儿科心脏网络的基础设施，在del Nido和Newburger博士的指导下，我将分析TPS评估的技术性能对常见先天性心脏病手术的明确子集的早期和中期结果的影响。假设：TPS是一种有效的结局预测因子，包括先天性心脏缺陷手术后术后不良事件的发生、资源利用、晚期死亡率以及对介入解剖区域的晚期再介入需求。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率; 2）重症监护室（ICU）的住院天数、住院时间、使用呼吸机的初始时间和总时间; 3）首次手术出院后的死亡率/移植; 4）从首次手术出院后的计划外再干预，以及5）手术特定TPS的每个组成部分对结局的贡献，随着时间的推移进一步完善仪器。如果患者是接受6次心内直视手术之一的12个月婴儿，则有资格参加本研究。排除标准包括存在可能独立影响受试者达到主要终点的可能性的任何重大先天性或获得性心外异常。根据超声心动图标准，TPS将被分为最佳（I类）、充分（2类）或不充分（3类），超声心动图标准旨在捕获特定手术的各个组成部分，以及出院前在与外科手术相关的解剖区域进行的计划外手术或基于导管的再次干预。由外科医生、超声心动图技师和心脏病专家组成的PHN专家小组将使用兰德改良德尔菲技术最终确定每次手术的TPS要素。超声心动图将在核心实验室进行解读。将在首次手术住院期间前瞻性收集数据，并在12个月时再次收集中期病史数据，包括出院后发生的额外干预或死亡。每个手术类别中至少有150 - 310名受试者将在2年内入组，我们将在入组后获得1年的随访。这项研究将是第一个多中心前瞻性验证的工具，自我评估和质量改善特定的先天性心脏病外科社区。