Evidence-Based Guideline on Prioritized Issues for the Management of Empyema Thoracis in Children.

justificationThe lack of clarity in the management of pediatric empyema thoracis necessitates evidence-based guidance.

objectiveTo develop an evidence-based guideline on high-priority issues in pediatric empyema management (laboratory investigations, antibiotic therapy, intrapleural fibrinolytic therapy, surgical intervention, and follow-up). PROCESS: The guideline was developed using contemporary methodology, viz. establishing a Steering Group; setting up an Evidence-Based Guideline Development Group (EBGDG); collating formal declarations of interest and managing conflicts; identifying and prioritizing questions; evidence synthesis; critical appraisal using GRADE methodology; translating evidence to recommendation statements; external peer review; and finalization of the guideline document. RECOMMENDATIONS: The dominant pathogen causing empyema in Indian children is Staphylococcus aureus, followed by Streptococcus pneumoniae. Therefore, the empirical antibiotics (pending culture reports) should preferably be the combination of Cloxacillin and Ceftriaxone (conditional recommendation, very low certainty of evidence). On the issue of intrapleural fibrinolytic therapy (IPFT) vs. no IPFT as the initial modality, pediatricians could use either option (in addition to oxygen, appropriate antibiotics, and effective pleural pus drainage) as the limited evidence did not show significant differences for critical outcomes (conditional recommendation, very low certainty of evidence). However, IPFT is recommended as the initial modality of therapy compared to Video-Assisted Thoracoscopic Surgery (VATS), on account of comparable efficacy, moderate savings, enhanced equity, stakeholder acceptability, and feasibility in diverse settings (conditional recommendation, very low certainty of evidence). The EBGDG does not recommend any particular intrapleural fibrinolytic agent over another due to a lack of comparative evidence (conditional recommendation, no evidence). The superiority of early initiation of IPFT (i.e. as the initial management, or at presentation), compared to late(r) instillation is not established in the absence of any evidence (conditional recommendation, no evidence). No recommendation can be made regarding the use of initial intrapleural fibrinolytic therapy (IPFT) (i.e., at or close to confirmation of empyema) versus IPFT after failure of intercostal chest drain (ICD) alone because of the absence of evidence (conditional recommendation, no evidence). Antibiotic therapy for ≤4 weeks is not suggested in preference to therapy for >4 weeks, despite the absence of direct evidence, owing to greater clinical experience with the latter, as well as its acceptability and feasibility (conditional recommendation, no evidence). Routine use of microbiologic molecular methods in preference to conventional culture techniques is not suggested, on account of greater specificity and lower cost of culture (conditional recommendation, very low certainty of evidence). Routine use of CT scan in preference to ultrasonography is not suggested for the management of children with empyema (conditional recommendation, very low evidence certainty). No clinical, radiological, microbiological, biomarker, or pleural fluid characteristics, either individually or in combination, were identified as predictors of failure of medical management (conditional recommendation, very low certainty of evidence). For each evidence-based recommendation, detailed justification, implementation considerations, and research priorities are outlined.

conclusionThis evidence-based guideline, developed using robust methodology, offers practical guidance for the management of empyema thoracis in children. This is expected to enhance the quality and standardization of care.