Clinical Outcomes of Early Diagnosis of Infections of Sterile Body Fluids: A Living Systematic Review and Meta Analysis
Author(s)
Priscilla Anyimiah, MSc1, Sophie Welk, MSc.2, Maarten Jacobus Postma, PhD1, Cornelis Boersma, PhD2, Simon Van der Pol, PharmD, PhD1.
1Health-Ecore, Groningen, Netherlands, 2Health-Ecore, Zeist, Netherlands.
1Health-Ecore, Groningen, Netherlands, 2Health-Ecore, Zeist, Netherlands.
OBJECTIVES: This review aims to critically evaluate existing evidence on the impact of early diagnosis of infections in normally sterile body fluids on clinical outcomes. By adopting a living systematic review (LSR) and meta-analysis approach, this review seeks to provide continuously updated evidence to support clinical and policy decision-making in the context of evolving diagnostic technologies.
METHODS: The review was conducted in accordance with PRISMA and Cochrane LSR guidelines and was prospectively registered with PROSPERO (CRD42024574733). Studies were selected using predefined eligibility criteria. A comprehensive literature search was performed in PubMed, Embase, Web of Science and Cochrane Central (Trials), covering literature from January 2000. Monthly automated database updates are scheduled to maintain currency. Primary outcomes include length of hospital stay, total treatment days, time to appropriate antimicrobial therapy, and mortality. Risk of bias was assessed using Cochrane’s Risk of Bias 2 (RoB-2) tool for randomized controlled trials and ROBINS-I for non-randomized studies.
RESULTS: A total of 65 studies met the set inclusion criteria. Studies employed a range of rapid diagnostic methods, including MALDI-TOF mass spectrometry, multiplex PCR and phenotypic susceptibility platforms. While gram-negative bacteria were the most frequently reported pathogens, infections involving Staphylococcus aureus were also commonly studied. There were consistent findings across studies indicating the association of rapid diagnostic interventions with improved clinical outcomes, particularly in enabling earlier initiation of effective antimicrobial therapy and reducing infection-related hospital and ICU stays.
CONCLUSIONS: This living systematic review and meta-analysis offers a robust and continuously updated synthesis of the clinical benefits of early diagnosis of infections in normally sterile body fluids. These findings will directly inform the economic evaluation of an emerging AI-guided whole genome sequencing (WGS) diagnostic tool by providing key model parameters estimating its cost-effectiveness compared to standard diagnostics.
METHODS: The review was conducted in accordance with PRISMA and Cochrane LSR guidelines and was prospectively registered with PROSPERO (CRD42024574733). Studies were selected using predefined eligibility criteria. A comprehensive literature search was performed in PubMed, Embase, Web of Science and Cochrane Central (Trials), covering literature from January 2000. Monthly automated database updates are scheduled to maintain currency. Primary outcomes include length of hospital stay, total treatment days, time to appropriate antimicrobial therapy, and mortality. Risk of bias was assessed using Cochrane’s Risk of Bias 2 (RoB-2) tool for randomized controlled trials and ROBINS-I for non-randomized studies.
RESULTS: A total of 65 studies met the set inclusion criteria. Studies employed a range of rapid diagnostic methods, including MALDI-TOF mass spectrometry, multiplex PCR and phenotypic susceptibility platforms. While gram-negative bacteria were the most frequently reported pathogens, infections involving Staphylococcus aureus were also commonly studied. There were consistent findings across studies indicating the association of rapid diagnostic interventions with improved clinical outcomes, particularly in enabling earlier initiation of effective antimicrobial therapy and reducing infection-related hospital and ICU stays.
CONCLUSIONS: This living systematic review and meta-analysis offers a robust and continuously updated synthesis of the clinical benefits of early diagnosis of infections in normally sterile body fluids. These findings will directly inform the economic evaluation of an emerging AI-guided whole genome sequencing (WGS) diagnostic tool by providing key model parameters estimating its cost-effectiveness compared to standard diagnostics.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
MT9
Topic
Health Technology Assessment, Medical Technologies, Study Approaches
Disease
Infectious Disease (non-vaccine)