Biochemistry, McMaster University Faculty of Science, Hamilton, Canada.
Department of Health Research Methods Evidence and Impact, McMaster University Faculty of Health Sciences, Hamilton, Canada.
BMJ Open. 2021 Sep 8;11(9):e050754. doi: 10.1136/bmjopen-2021-050754.
Sepsis is a dysregulated host response to infection characterised by activation of proinflammatory and procoagulant mechanisms. Protein C (PC)'s activity as an anticoagulant and antiinflammatory molecule makes it an appealing target for sepsis biomarker studies. To date, there has been no systematic review of PC as a sepsis biomarker.
To evaluate the diagnostic accuracy and prognostic strength of PC as a biomarker for adult sepsis.
Medline, Embase, Cochrane Library, PubMed and Cumulative Index to Nursing and Allied Health Literature (CINAHL) will be searched from inception through 20 January 2021 for prospective observational studies that evaluate the use of PC as a diagnostic or prognostic biomarker for adult sepsis. Title and abstract screening, full-text screening and data extraction will be conducted in duplicate. Risk of bias will be assessed using the Quality Assessment of Diagnostic Accuracy Studies and Quality in Prognostic Studies tools. If sufficient data are available, a meta-analysis will be conducted. The standardised mean difference and 95% CI will be calculated for prognostic and diagnostic studies. If possible, a hierarchical summary receiver operator characteristic curve will be generated to assess overall prognostic and diagnostic biomarker accuracy. I statistics will be used to assess heterogeneity. Sensitivity analysis will be performed by removing studies with a high risk of bias and re-examining the meta-analysis results.
Given this is a systematic review and meta-analysis, there is no requirement for ethics approval. Findings will be disseminated through a peer-reviewed publication and social media.
CRD42021229786.
败血症是一种宿主对感染的失调反应，其特征为促炎和促凝机制的激活。蛋白 C（PC）作为抗凝和抗炎分子的活性使其成为败血症生物标志物研究的一个有吸引力的靶点。迄今为止，尚未有关于 PC 作为败血症生物标志物的系统评价。
评估 PC 作为成人败血症生物标志物的诊断准确性和预后强度。
将从建库起至 2021 年 1 月 20 日，通过 Medline、Embase、Cochrane 图书馆、PubMed 和 Cumulative Index to Nursing and Allied Health Literature（CINAHL）对评估 PC 作为成人败血症诊断或预后生物标志物的前瞻性观察性研究进行检索。将进行标题和摘要筛选、全文筛选和数据提取。使用诊断准确性研究的质量评估工具和预后研究的质量工具评估偏倚风险。如果有足够的数据，将进行荟萃分析。将计算预后和诊断研究的标准化均数差和 95%置信区间。如果可能，将生成分层综合受试者工作特征曲线以评估总体预后和诊断生物标志物准确性。将使用 I 统计量评估异质性。通过去除偏倚风险高的研究并重新检查荟萃分析结果，进行敏感性分析。
鉴于这是一项系统评价和荟萃分析，因此不需要伦理批准。研究结果将通过同行评审的出版物和社交媒体进行传播。
PROSPERO 注册号：CRD42021229786。
