Harder Thomas, Seidel Juliane, Eckmanns Tim, Weiss Bettina, Haller Sebastian
Robert Koch Institute, Berlin, Germany.
BMJ Open. 2017 Mar 29;7(3):e014986. doi: 10.1136/bmjopen-2016-014986.
Hospitals conduct extensive screening procedures to assess colonisation of the body surface of neonates by gram-negative bacteria to avoid complications like late-onset sepsis. However, the benefits of these procedures are controversially discussed. Until now, no systematic review has investigated the value of routine screening for colonisation by gram-negative bacteria in neonates for late-onset sepsis prediction.
We will conduct a systematic review, considering studies of any design that include infants up to an age of 12 months. We will search MEDLINE and EMBASE (inception to 2016), reference lists and grey literature. Screening of titles, abstracts and full texts will be conducted by two independent reviewers. We will extract data on study characteristics and study results. Risk of bias will be assessed using Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Quality in Prognosis Studies (QUIPS) tools. Subgroup analyses are planned according to characteristics of studies, participants, index tests and outcome. For quantitative data synthesis on prognostic accuracy, sensitivity and specificity of screening to detect late-onset sepsis will be calculated. If sufficient data are available, we will calculate summary estimates using hierarchical summary receiver operating characteristics and bivariate models. Applying a risk factor approach, pooled summary estimates will be calculated as relative risk or OR, using fixed-effects and random-effects models. I-squared will be used to assess heterogeneity. All calculations will be performed in Stata V14.1 (College Station, Texas, USA). The results will be used to calculate positive and negative predictive value and number needed to be screened to prevent one case of sepsis. Grading of Recommendations Assessment, Development and Evaluation (GRADE) will be used to assess certainty in the evidence. The protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guideline.
This study will not require ethical approval since it is not carried out in humans. The systematic review will be published in an open-access peer-reviewed journal.
CRD42016036664.
医院开展广泛的筛查程序，以评估新生儿体表革兰氏阴性菌的定植情况，避免诸如晚发性败血症等并发症。然而，这些程序的益处存在争议。到目前为止，尚无系统评价研究新生儿常规筛查革兰氏阴性菌定植对预测晚发性败血症的价值。
我们将进行一项系统评价，纳入任何设计的研究，研究对象为12个月龄以内的婴儿。我们将检索MEDLINE和EMBASE（从创刊至2016年）、参考文献列表和灰色文献。由两名独立评审员进行标题、摘要和全文的筛选。我们将提取有关研究特征和研究结果的数据。将使用诊断准确性研究质量评估（QUADAS-2）和预后研究质量（QUIPS）工具评估偏倚风险。计划根据研究、参与者、指标检测和结局的特征进行亚组分析。对于预后准确性的定量数据合成，将计算筛查检测晚发性败血症的敏感性和特异性。如果有足够的数据，我们将使用分层汇总接受者操作特征和双变量模型计算汇总估计值。应用风险因素方法，使用固定效应和随机效应模型将汇总汇总估计值计算为相对风险或比值比。I²将用于评估异质性。所有计算将在Stata V14.1（美国得克萨斯州大学站）中进行。结果将用于计算阳性和阴性预测值以及预防一例败血症所需筛查的人数。将使用推荐分级评估、制定和评价（GRADE）来评估证据的确定性。本方案遵循系统评价和Meta分析方案的首选报告项目（PRISMA-P）指南。
本研究无需伦理批准，因为它不是在人体上进行的。系统评价将发表在开放获取的同行评审期刊上。
CRD42016036664。
