Impact of routine spirometry on clinical decisions and quality of life in children: an open-label randomised controlled trial

Abstract

Background: There is limited evidence on the efficacy of using spirometry routinely in paediatric practice for improving outcomes. We aimed to determine whether the routine use of spirometry alters clinical decisions for children being managed by respiratory paediatricians. Our secondary aims were to: (1) determine whether spirometry impacts diagnostic certainty and patient-related outcome measures and (2) quantify the benefits of routine spirometry.

Methods: In this RCT, children (aged 4-18 years) able to perform spirometry were randomised to either routine use of spirometry (intervention) or delayed spirometry access (control) for one respiratory clinic visit. The primary outcome was the proportion of children with any change in clinical decisions and ‘change score’ in diagnosis and/or management. Secondary outcomes were change of patient-related outcome measures [State-Trait Anxiety Inventory (STAI), paediatric cough quality-of-life (PC-QoL)].

Findings: Of 106 children, the intervention (n=54/54, 100%) had significantly higher proportion of children with any change in clinical decisions compared to controls (n=34/52, 65.4%), p<0·001, and higher clinical decision ‘change score’ [median=2 (IQR 1-4) vs 1 (0-2) respectively, p<0·001]. Also, improvement was significantly better in the intervention group for overall STAI score [median=-5 (IQR -10, -2) vs -2·5 (-8·5, 0), p=0·021], and PC-QoL social domain [median=3 (IQR 0, 5) vs 0 (-1, 1), p=0·017].

Interpretation: In children evaluated for respiratory issues in outpatients, the routine use of spirometry is beneficial for optimising clinical management and improving parent psychosocial wellbeing.