title: Head-to-head comparison of procalcitonin and presepsin for the diagnosis of sepsis in critically ill adult patients: a protocol for a systematic review and meta-analysis.
abstract: Early diagnosis and immediate therapeutic intervention, including appropriate antibiotic therapy and goal-directed resuscitation, are necessary to reduce mortality in patients with sepsis. However, a single clinical or biological marker indicative of sepsis has not been adopted unanimously. Although procalcitonin and presepsin are promising biomarkers that can effectively differentiate between sepsis/infection and systemic inflammatory response syndrome of non-infectious origin, little is known about which marker is superior.
  
  
  
  We will conduct a systematic review and meta-analysis of procalcitonin and presepsin for the diagnosis of sepsis/infection in critically ill adult patients. The primary objective is to evaluate the diagnostic accuracy of these 2 biomarkers to a reference standard of sepsis/infection and to compare the diagnostic accuracy with each other. We will search electronic bibliographic databases such as MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials for retrospective and prospective diagnostic test studies. We will assign 2 reviewers to review all collected titles and associated abstracts, review full articles, and extract study data. We will use the Quality of Diagnostic Accuracy Studies-II tool to report study characteristics and to evaluate methodological quality. If pooling is possible, we will use bivariate random effects and hierarchical summary receiver operating characteristic (ROC) models to calculate parameter estimates to output summary ROCs, pooled sensitivity and specificity data, and 95% CIs around the summary operating point. We will also assess heterogeneity via clinical and methodological subgroup and sensitivity analyses.
  
  
  
  This systematic review will provide guidance on the triage of these tests, help to determine whether existing tests should be revised or replaced, and may also identify knowledge gaps in sepsis diagnosis that could direct further research in the field. Research ethics is not required for this review. The findings will be reported at conferences and in peer-reviewed publications.
  
  
  
  CRD42016035784.
authors.affiliation: Departmen of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Hayashida
authors.affiliation: Department of Emergency Medicine, University of the Ryukyus, Okinawa, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kondo
authors.affiliation: Department of Anesthesiology and Critical Care Medicine, Fujita Health University School of Medicine, Aichi, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Hara
authors.affiliation: Department of Gastroenterology and Hematology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Morio
authors.initials: M
authors.lastname: Aihara
authors.affiliation: Division of Trauma and Surgical Critical Care, Osaka General Medical Center, Osaka, Japan.
authors.forename: Kazuma
authors.initials: K
authors.lastname: Yamakawa
mesh_terms: D015415:Biomarkers / Q000097:blood; D002116:Calcitonin / Q000097:blood*; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness; D006801:Humans; D018950:Lipopolysaccharide Receptors / Q000097:blood*; D010446:Peptide Fragments / Q000097:blood*; D015203:Reproducibility of Results; D012107:Research Design; D012196:Review Literature as Topic; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000097:blood / Q000175:diagnosis*; D000078202:Systematic Reviews as Topic; D015201:Meta-Analysis as Topic
chemical_list: D015415:Biomarkers; D018950:Lipopolysaccharide Receptors; D010446:Peptide Fragments; C000594167:presepsin protein, human; D002116:Calcitonin
keywords: Bacterial infection; Diagnostic test accuracy; Presepsin; Procalcitonin; Sensitivity and specificity; Sepsis