Patient-reported outcome measures for paediatric acute lower respiratory infection studies

Background Patient-reported outcome measures (PROMs) are recommended for capturing meaningful outcomes in clinical trials. The use of PROMs for children with acute lower respiratory infections (ALRIs) has not been systematically reported. We aimed to identify and characterise patient-reported outcomes and PROMs used in paediatric ALRI studies and summarise their measurement properties.Methods Medline, Embase and Cochrane were searched (until April 2022). Studies that reported on patient-reported outcome (or measure) use or development and included subjects aged <18 years with ALRIs were included. Study, population and patient-reported outcome (or measure) characteristics were extracted.Results Of 2793 articles identified, 18 met inclusion criteria, including 12 PROMs. Two disease-specific PROMs were used in settings in which they had been validated. The Canadian Acute Respiratory Illness and Flu Scale was the most frequently used disease-specific PROM (five studies). The EuroQol-Five Dimensions-Youth system was the most frequently used generic PROM (two studies). There was considerable heterogeneity in validation methods. The outcome measures identified in this review lack validation for young children and none involve sufficient content validity for use with First Nations children.Conclusions There is an urgent need for PROM development that considers the populations in which the burden of ALRI predominates.

Automated summary

This study aimed to identify and characterize patient-reported outcomes and PROMs used in pediatric ALRI studies and summarize their measurement properties. A total of 18 articles met the inclusion criteria, including 12 PROMs. The findings showed that these PROMs lack validation for children and have insufficient content validity for use with First Nations children.