Division of General Pediatrics, British Columbia Children's Hospital, Vancouver, British Columbia, Canada
Department of Pediatrics, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.
BMJ Open. 2022 Oct 25;12(10):e063183. doi: 10.1136/bmjopen-2022-063183.
Brief Resolved Unexplained Events (BRUEs) are a common presentation among infants. While most of these events are benign and self-limited, guidelines published by the American Academy of Pediatrics inaccurately identify many patients as higher-risk of a serious underlying aetiology (positive predictive value 5%). Recently, new clinical prediction rules have been derived to more accurately stratify patients. This data were however geographically limited to the USA, with no large studies to date assessing the BRUE population in a different healthcare setting. The study's aim is to describe the clinical management and outcomes of infants presenting to Canadian hospitals with BRUEs and to externally validate the BRUE clinical prediction rules in identified cases.
This is a multicentre retrospective study, conducted within the Canadian Paediatric Inpatient Research Network (PIRN). Infants (<1 year) presenting with a BRUE at one of 11 Canadian paediatric centres between 1 January 2017 and 31 December 2021 will be included. Eligible patients will be identified using diagnostic codes.The primary outcome will be the presence of a serious underlying illness. Secondary outcomes will include BRUE recurrence and length of hospital stay. We will describe the rates of hospital admissions and whether hospitalisation was associated with an earlier diagnosis or treatment. Variation across Canadian hospitals will be assessed using intraclass correlation coefficient. To validate the newly developed clinical prediction rule, measures of goodness of fit will be evaluated. For this validation, a sample size of 1182 is required to provide a power of 80% to detect patients with a serious underlying illness with a significance level of 5%.
Ethics approval has been granted by the UBC Children's and Women's Research Board (H21-02357). The results of this study will be disseminated as peer-reviewed manuscripts and presentations at national and international conferences.
短暂性不明原因事件（BRUE）是婴儿常见的一种表现。虽然大多数 BRUE 是良性和自限性的，但美国儿科学会发布的指南不准确地将许多患者识别为具有更高严重潜在病因风险（阳性预测值 5%）。最近，新的临床预测规则已被推导出来，以更准确地对患者进行分层。然而，这些数据在地理上仅限于美国，迄今为止，没有大型研究评估不同医疗保健环境中的 BRUE 人群。本研究的目的是描述在加拿大医院就诊的 BRUE 婴儿的临床管理和结局，并在已确定的病例中对 BRUE 临床预测规则进行外部验证。
这是一项多中心回顾性研究，在加拿大儿科住院研究网络（PIRN）内进行。2017 年 1 月 1 日至 2021 年 12 月 31 日期间，11 家加拿大儿科中心的 BRUE 婴儿（<1 岁）将被纳入研究。将使用诊断代码识别符合条件的患者。主要结局是严重潜在疾病的存在。次要结局包括 BRUE 复发和住院时间。我们将描述住院率以及住院是否与更早的诊断或治疗相关。将使用组内相关系数评估加拿大各医院之间的差异。为了验证新开发的临床预测规则，将评估拟合优度的度量。对于此次验证，需要 1182 名患者的样本量，以提供 80%的效力来检测具有严重潜在疾病的患者，其显著性水平为 5%。
UBC 儿童和妇女研究委员会（H21-02357）已批准该研究的伦理。本研究的结果将以同行评议的论文和全国及国际会议上的演讲形式传播。
