Objectives: The clinical role of sputum Gram stain for rapid etiologic pathogen diagnosis in patients with community-acquired pneumonia (CAP) remains an unresolved controversy. Variability in protocols and reporting of diagnostic performance in different studies has hampered assessments of clinical utility and interpretation. Since the last meta-analysis published in 1996, several reports and resources to accurately evaluate the diagnostic accuracy of sputum Gram stain have become available. Therefore, we will conduct a systematic review and meta-analysis of the clinical validity and utility of sputum Gram stain.
Methods: We will search PubMed, Ovid MEDLINE, Embase, and The Cochrane Controlled Register of Trials (CENTRAL) databases from inception through July 30, 2018, with no language restriction and perform a full-text evaluation of potentially relevant articles. We will include prospective and retrospective studies that assess sputum Gram stain in adults (aged ≥18 years) with CAP. Two reviewers will independently extract data and rate each study's validity with standard quality assessment tools. We will subsequently perform standard and latent-class random-effects model meta-analyses to quantitatively synthesize the diagnostic accuracy and yield. Finally, we will assess the totality of evidence by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach for diagnostic tests and strategies.
Results: Results of the analysis will be submitted for publication in a peer-reviewed journal.
Conclusions: This systematic review and meta-analysis will provide a 30-year synopsis of clinical evidence on sputum Gram stain in patients with CAP.
Keywords: Community-acquired pneumonia; Gram stain; Meta-analysis.