Validating a Necrotizing Enterocolitis (NEC) Risk Index for Neonates

背景：坏死性小肠结肠炎（NEC）是早产儿最常见的胃肠道急症。这是一种代价高昂的疾病，也是新生儿发病和死亡的主要原因。NEC患儿在新生儿重症监护室（NICU）接受手术治疗的平均住院时间超过90天，最有可能超过6个月，并可能在肠道、营养和认知能力方面遭受严重的长期损害。如果NEC症状很快被发现，可以停止喂养，以限制疾病进展，并方便转移到外科中心。风险指数可以提高NEC的早期识别，但没有可用的。本研究的目的是验证NEC风险指数GUTCHECK，以预测高危新生儿发生NEC的可能性，从而加强监测，在医学上进行管理的同时识别NEC，减少抢救失败。具体目的：本研究的具体目的是：(1)评估GUTCHECK指数的内容效度；(2)使用现有的国家围产期数据集测试该指数的个体内信度和预测效度。意义：早期识别有NEC危险的婴儿可以减少手术干预，降低发病率，降低死亡率，降低成本，更好地分配资源。方法：为了实现目标1，将使用E-Delphi来评估专家对GUTCHECK中的风险要素的一致程度。为了实现目标2，使用现有的国家数据集进行两阶段的验证过程将确定GUTCHECK的敏感性和特异性。个体内信度将使用由一个观察者在两个时间点打分的随机病例样本进行测试。预期结果：本研究的预期结果是一个个体内部可靠、有效、可预测的NEC风险指标。进一步研究的意义：未来的研究将评估GUTCHECK的评估者间信度。然后，它将被整合到临床决策支持系统中，整合从产前、产妇和出生记录中捕获的风险因素，实时提供风险评分。如果数值高于预设的截止点，则会生成警报。未来的研究将测量使用GUTCHECK对NEC早期识别和改进NEC风险交接沟通的影响。与NINR使命的相关性：GUTCHECK在自动化临床决策支持中的开发、验证和未来整合将使用技术将研究转化为护理点的实践。通过这种方式，GUTCHECK可以通过帮助临床医生识别NEC风险并早期干预来改善NEC的预后。

DESCRIPTION (provided by applicant): Background: Necrotizing Enterocolitis (NEC) is the most common gastrointestinal emergency for premature infants. It is a costly disease and a primary cause of neonatal morbidity and mortality. Infants with NEC who are managed surgically stay in the Neonatal Intensive Care Unit (NICU) over 90 days on average, are among the most likely to stay more than 6 months and may suffer significant long-term impairments to their bowel, nutrition and cognitive abilities. If NEC symptoms are identified soon enough, feedings can be stopped to limit disease progression and transport to a surgical center facilitated. A risk index may improve early recognition of NEC however none is available. The purpose of this research is to validate a NEC risk index, GUTCHECK, to predict the likelihood of NEC in at-risk neonates to enhance surveillance, recognize NEC while it can be managed medically and decrease failure to rescue. Specific Aims: The specific aims of this research are to: (1) assess the content validity of the GUTCHECK index and (2) test the intra-individual reliability and predictive validity of the index using an existing national perinatal dataset. Significance: Early identification of infants at risk for NEC can lead to fewer surgical interventions, lower morbidity, lower mortality, lower costs, and better resource allocation. Methodology: To achieve Aim 1, an E-Delphi will be used to assess the extent to which experts agree on risk elements in GUTCHECK. To achieve Aim 2, a two stage process of validation using an existing national dataset will determine GUTCHECK's sensitivity and specificity. Intra-individual reliability will be tested using a random sample of cases scored by one observer at two time points. Expected Results: The expected result of this research is an intra-individually reliable, valid and predictive risk index for NEC. Implications for Further Research: Future studies will evaluate the inte-rater reliability of GUTCHECK. Then it will be integrated into a clinical decision support system to integrate risk elements captured from prenatal, maternal, and birth records to provide a risk score in real time. An alert can then be generated if values rise above a preset cut-point. Future studies will measure the effect of using GUTCHECK on early recognition of NEC and improved handoff communication of NEC risk. Relevance to NINR Mission: The development, validation and future integration of GUTCHECK into automated clinical decision support will use technology to translate research into practice at the point of care. In this way, GUTCHECK may improve NEC outcomes by helping clinicians recognize NEC risk and intervene early. PUBLIC HEALTH RELEVANCE: Necrotizing enterocolitis (NEC) is the most common catastrophic gastrointestinal disease that affects newborns, accounting for 3000 deaths a year and nearly one-fifth of neonatal hospital costs in the US. The goal of this study is to validate a risk measure for NEC, GUTCHECK, to help clinicians recognize NEC in its early stages and facilitate appropriate and prompt medical management.