Objective Acute infection is the most common presentation of children to hospital. A minority of these infections are serious, but early recognition and adequate management are essential. We aimed to develop improved tools to assess children attending ambulatory hospital care, integrating clinical features with point-of-care C reactive protein (CRP).
Design Prospective observational diagnostic study.
Setting and patients 5517 acutely ill children (1 month–16 years) presenting to 106 paediatricians at six outpatient clinics and six emergency departments in Belgium.
Index test Point-of-care CRP alongside vital signs and objective symptoms measurements.
Main outcome Hospital admission for >24 hours with a serious infection <5 days after presentation.
Results An algorithm was developed consisting of clinical features and CRP. This achieved 97.1% (95% CI 94.3% to 98.7%) sensitivity and 99.6% (95% CI 99.2% to 99.8%) negative predictive value, excluding serious infections in 36.4% of children. It stratifies patients into three groups based on CRP level: high-risk group with CRP >75 mg/L (26.8% risk of infection), intermediate-risk group with CRP 20–75 mg/L and at least one of seven clinical features (8.1%), and lower risk group with CRP <20 mg/L with at least one of the 11 features (3.8%). Children in intermediate-risk or low-risk groups with normal clinical assessment have 0.6% and 0.4% risk of serious infections, respectively.
Conclusions Conducting a CRP test may first enable children to be stratified into three risk groups, guiding assessment of clinical features that could be performed by junior doctors or nurses. In one-third of acutely ill children, the algorithm could exclude serious infection. Prospective validation of the algorithm is needed.
Clinical trial registration NCT02024282 (post-results).
- general paediatrics
- infectious diseases
- data collection
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Contributors JYV, MBL, ADS, AVdB and FB conceived the study. JYV, MBL and TDB supervised data collection and performed data follow-up and data cleaning. JYV performed the analyses, which were discussed with MBL, ADS, BA, BS, DB, AVdB and FB. JYV drafted this report, and MBL, TDB, ADS, BA, BS, DB, AVdB and FB codrafted and commented on the final version. All authors had full access to all of the data (including statistical reports and tables) in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. JYV affirms that the manuscript is an honest, accurate and transparent account of the study being reported, and that no important aspects of the study have been omitted. All authors have read and approved the final manuscript.
Funding This study was funded by the National Institute for Health and Disability Insurance (RIZIV, Belgium) under reference CGV n° 2012/235 and the Research Foundation Flanders (FWO) under reference n° G067509N. AVdB was funded by the NIHR Diagnostic Evidence Co-operative Oxford and BS by the NIHR Diagnostic Evidence Co-operative Leeds. DB is a recipient of a senior clinical investigator fellowship from the Research Foundation Flanders (FWO).
Competing interests None declared.
Patient consent Obtained from the parents/guardian.
Ethics approval The protocol of this study was approved by the Ethical Review Board of the University Hospitals/KU Leuven under reference ML8601.
Provenance and peer review Not commissioned; externally peer reviewed.