Viral pneumonia is a prevalent and high-burden respiratory infection in children, especially those under 5 years old, caused by viruses such as RSV, influenza virus and SARS-CoV-2. Severe cases may require hospitalization or ICU admission, leading to life-threatening complications like respiratory and heart failure, and imposing substantial burdens on children’s health, families and medical resources.
In clinical studies of pediatric viral pneumonia, inconsistent selection of outcome indicators has become a critical issue. Clinicians and researchers prioritize objective biomedical metrics (e.g., symptom resolution time, lung lesion absorption, hospital stay duration); parents focus on children’s subjective experience (e.g., discomfort, feeding difficulties, post-discharge recovery); public health personnel care about population-level indicators (e.g., disease burden, cost-effectiveness of prevention). This inconsistency hinders direct comparison and synthesis of study results, reduces the efficiency of translating research findings into clinical practice and guidelines, and ultimately impedes evidence-based medical decision-making. Thus, developing a multi-stakeholder-involved, internationally recognized COS for pediatric viral pneumonia is urgently needed and clinically valuable.
We have identified similar COS initiatives, but notable differences exist between our research and these counterparts:
1. Compared with *Development of core outcome sets for trials evaluating the management of pneumonia (COS Pneumonia) - A European Respiratory Society (ERS) Task Force*, the latter targets adults and covers multiple pneumonia types (CAP, HAP) with indicators based on adult characteristics. Our study focuses on pediatric viral pneumonia, accounting for children’s distinct pathogenesis (e.g., immune response intensity), clinical manifestations (e.g., higher wheezing susceptibility) and outcome trajectories (e.g., long-term pulmonary impacts), as well as the high prevalence and unique treatment logic of viral pneumonia in children.
2. In contrast to *The Construction of a Core Set for Clinical Research on Traditional Chinese Medicine Treatment of Community-Acquired Pneumonia in Children*, which builds a TCM-focused COS with TCM syndrome and efficacy indicators, our study excludes TCM and proprietary Chinese medicine systems. This avoids confusion caused by differing indicator definitions and evaluation logic between TCM and Western medicine, making our COS more suitable for Western medicine-based pediatric pneumonia clinical research.
3. As for *Position paper: recommended design features of future clinical trials of antibacterial agents for community-acquired pneumonia*, the document centers on designing antibacterial drug trials for adult CAP (e.g., dosage, control group design). Our research focuses on developing a COS for pediatric viral pneumonia: viral pneumonia does not require antibacterial treatment, placing our work in a different context; additionally, we prioritize outcome indicators tailored to pediatric viral infections rather than trial design.
4. When compared with *Evaluation of outcomes in community-acquired pneumonia: a guide for patients, physicians, and policy-makers*, a CAP outcome evaluation guideline targeting the general population (predominantly adults) to serve multi-stakeholder needs, our research delivers a pediatric viral pneumonia-specific COS. Restricted to the pediatric population and viral subtype, our indicators are more targeted and focused, directly supporting indicator selection and data reporting in relevant clinical research.
Our study’s core strength lies in its precise focus on pediatric viral pneumonia and exclusion of the TCM system, developing an exclusive COS that fills the research gap in this niche area and enhances indicator consistency and result comparability across clinical studies.
Following the COMET collaboration’s methodological framework, our study will identify existing indicators via systematic literature review, collect insights from global stakeholders (clinicians, researchers, parents, methodologists, policymakers) through multiple rounds of Delphi surveys, and reach consensus via a dedicated meeting. The final standardized COS will improve future study comparability, optimize evidence synthesis, guide clinical trial design, provide a unified evaluation benchmark for clinical guidelines and health policy formulation, fill the gap on the COMET platform, and promote coordinated development of global pediatric pneumonia research.
Ying Yang, Children's Hospital of Chongqing Medical University
Disease Category: Child health, Lungs & airways
Disease Name: Pneumonia
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Governmental agencies
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
Following the methodological framework of the COMET (Core Outcome Measures in Effectiveness Trials) collaboration, The purpose of this study was to identify existing indicators through systematic literature review, collect the views and preferences of clinicians, researchers, family members, caregivers, methodologists and relevant policy makers around the world through multiple rounds of structured Delphi Survey, and finally reach a consensus through a consensus meeting. To establish a set of standardized core outcome indicators for clinical research of viral pneumonia in children.