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

基本信息

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
项目类别：
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

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

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项目摘要

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）：许多因素会影响先天性心脏手术中最佳结果的实现。其中，外科医生的技术表现可能是最重要的之一。需要在诊断和中心跨诊断和中心评估手术技术充足性的系统方法。技术性能得分（TPS）是一种基于广泛可用的临床和超声心动图特征来评估技术能力的新工具。来自单个中心的早期研究表明，TPS可用于预测早期和中期结局。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评估的技术绩效的影响，对普通先天性心脏运营的明确定义的早期和中期结果，用于在机构之间使用相对相似的手术技术。假设：TPS是结果的有效预测指标，包括术后不良事件的发生，资源利用率，晚期死亡率以及对先天性心脏缺陷手术后的解剖区域进行晚期重新干扰的需求。我们的主要结果是在手术后30天内活着的天数和出院。我们的次要结果是：1）E 1早期重大术后不良事件； 2）重症监护病房（ICU）住院时间，住院时间以及呼吸机上的初始时间和总时间； 3）在索引操作后，死亡率/移植； 4）从索引操作排出后，外观干预措施，以及5）程序特异性TPS对结果的每个组件的贡献，以随着时间的推移进一步完善仪器。如果患者是婴儿D12个月接受6个开放性心脏手术中的1个，则有资格进行这项研究。排除标准包括存在任何主要的先天性或获得的心外异常，这些异常可能会独立影响受试者符合主要终点的可能性。 TPS将根据超声心动图标准，旨在捕获特定操作的各个组件，以及计划的外科手术或基于导管的重新干扰，将其列为最佳（I类），足够（2类）或不足（3类）（3类）（3类）（3类）。通过RAND修改后的Delphi技术，由外科医生，超声心动图学家和心脏病专家的PHN专家小组最终确定每个操作的TPS元素。超声心动图将在核心实验室中进行解释。在住院期间，将在指数运行期间前瞻性收集数据，并在12个月的临时病史中再次收集数据，包括住院后发生的其他干预措施或死亡率。在每个程序类别中，至少有150至310名受试者将在2年内招募，我们将在入学后获得1年的随访。这项研究将是对先天性心脏手术社区的自我评估和质量改进工具的第一个多中心的前瞻性验证。