Background Current reproducibility standards for spirometry were derived using a small adult dataset and may not be optimal for interpretation of repeated measurements of lung function in children.
Objective To define reproducibility limits for forced expiratory volume in 1 s (FEV1) change that represent the normal within-subject between-visit variability in healthy children and evaluate these limits as a tool to monitor children with cystic fibrosis (CF).
Methods Repeated FEV1 measurements (3 months to 5 years apart) from healthy children from the Global Lung Function Initiative data repository were used to derive a conditional change score. Spirometry and clinical data from a CF clinical database was used to verify utility in clinical practice.
Results A reproducibility change score was derived from 47 938 FEV1 measures from 7885 healthy children 6–18 years of age. The simple algorithm, which is conditional on the initial measurement, also accounts for age and time interval between measurements. The change score limits of reproducibility were much narrower than currently used cut-offs. Specifically, changes, considered as improvements using either a 12% or 10% relative change from baseline, are too wide for children. In CF, there was overall agreement between different approaches, with the distinct advantage that the change score was not biased by regression to the mean.
Conclusions Compared with current approaches to interpretation of repeated lung function measurements, the proposed change score was less biased and provides a simple alternative to reduce misinterpretation.
- cystic fibrosis
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Contributors SS: conceptualisation ideas, methodology, formal analysis, writing original draft, supervision, funding acquisition. NF: formal analysis, interpretation, writing original draft. FR: conceptualisation ideas, writing revise and edit, funding acquisition.
Funding This study was funded by a Cystic Fibrosis Research Innovation Award from Vertex Pharmaceuticals.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Research Ethics Board approval was obtained to reanalyse the existing data sources (Hospital for Sick Children REB #1000057344).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available in a public, open access repository. Data are available on reasonable request. Healthy data are open access and available from the GLI Network data repository (www.lungfunction.org). Data from the Toronto CF database are available on reasonable request from the Hospital for Sick Children Research Ethics Board (firstname.lastname@example.org).
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