A systematic methodological evaluation of sepsis guidelines : Protocol for quality assessment and consistency of recommendations

Abstract

Background: Sepsis is a leading cause of mortality worldwide, characterized by a dysregulated host response to infection. Despite the development of multiple clinical practice guidelines (CPGs) to standardize sepsis management, substantial variability exists in methodological quality and key clinical recommendations. This inconsistency complicates guideline implementation and potentially affects patient outcomes. The proposed systematic methodological review aims to evaluate the quality and consistency of sepsis guidelines to identify areas for improvement and provide actionable insights for guideline developers. Methods: This protocol outlines a systematic methodological review of sepsis CPGs published over the last two decades (2004–2025). A comprehensive search strategy will be conducted across PubMed, EMBASE, the Cochrane Library, and the official websites of professional societies to identify relevant guidelines. The inclusion criteria are CPGs targeting adult sepsis management published by recognized medical or governmental organizations with detailed methodological descriptions. We will use the Appraisal of Guidelines for Research and Evaluation II instrument to assess methodological quality across six domains: scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. Data extraction will focus on key clinical recommendations, including fluid resuscitation, antimicrobial therapy, vasopressor and inotrope use, corticosteroids, source control, blood glucose management, hemodynamic management, and mechanical ventilation management. The consistency of the recommendations will be analyzed, and trends in guideline quality over time will be evaluated. Artificial intelligence (AI) tools will be evaluated for data extraction processes in systematic reviews to determine their capacity for efficiency and accuracy in extracting data compared to human-driven methods. Conclusion: By systematically appraising the quality and consistency of sepsis guidelines, this review aims to address the existing gaps and discrepancies in guideline development and application. These findings will provide valuable insights into the evolution of sepsis guideline quality, highlight areas for improvement, and support the development of more robust evidence-based recommendations. These results will inform clinicians and guideline developers, ultimately enhancing the standardization and effectiveness of sepsis management worldwide. Integrating AI into the review process represents a novel methodological advancement that streamlines data extraction and analysis.