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操作技术充分性。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颖工具。单一中心的早期研究表明，TPS 对于预测早期和中期结果都很有用。在 Drs. 的指导下，使用 NHLBI 儿科心脏网络的基础设施。 del Nido 和 Newburger，我将分析 TPS 评估的技术性能对常见先天性心脏手术的明确定义子集的早期和中期结果的影响，这些手术在不同机构中使用相对相似的手术技术。假设：TPS 是结果的有效预测因子，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、晚期死亡率以及对所干预的解剖区域进行后期重新干预的需要。我们的主要结果是手术后 30 天内的存活天数和出院天数。我们的次要结局是： 1) 发生 e 1 术后早期主要不良事件； 2) 重症监护病房 (ICU) 住院天数、住院时间以及使用呼吸机的初始时间和总时间； 3) 出院后进行指数手术的死亡率/移植率； 4) 从指数操作中退出后的计划外再干预，以及 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 个月大且接受 6 次心脏直视手术中的 1 次的患者，则有资格参加该研究。排除标准包括存在任何重大先天性或后天性心脏外异常，这些异常可能独立影响受​​试者达到主要终点的可能性。根据超声心动图标准，TPS 将被评为最佳（I 类）、足够（2 类）或不足（3 类），超声心动图标准旨在捕获特定手术的各个组成部分，以及计划外手术或基于导管的手术。出院前对与外科手术相关的解剖区域进行重新干预。由外科医生、超声心动图医师和心脏病专家组成的 PHN 专家小组将使用兰德公司改进的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。将在住院期间前瞻性地收集索引手术的数据，并在 12 个月时再次收集中期病史的数据，包括出院后发生的额外干预措施或死亡率。每个程序类别至少有 150 至 310 名受试者将在 2 年内入组，入组后我们将获得 1 年的随访。这项研究将是针对先天性心脏外科社区的自我评估和质量改进工具的首次多中心前瞻性验证。

项目成果

Technical performance scores in congenital cardiac operations: a quality assessment initiative.

先天性心脏手术的技术表现评分：质量评估举措。

• 发表时间: 2012-10
• 作者: Karamichalis, John M;Colan, Steven D;Nathan, Meena;Pigula, Frank A;Baird, Christopher;Marx, Gerald;Emani, Sitaram M;Geva, Tal;Fynn;Liu, Hua;Mayer Jr, John E;del Nido, Pedro J
• 通讯作者: del Nido, Pedro J

Surgical technical performance scores are predictors of late mortality and unplanned reinterventions in infants after cardiac surgery.

手术技术表现评分是心脏手术后婴儿晚期死亡率和计划外再干预的预测因素。

• 发表时间: 2012-11
• 作者: Nathan, Meena;Karamichalis, John M;Liu, Hua;Emani, Sitaram;Baird, Christopher;Pigula, Frank;Colan, Steven;Thiagarajan, Ravi R;Bacha, Emile A;Del Nido, Pedro
• 通讯作者: Del Nido, Pedro