CFDB - Cystic Fibrosis DataBase

primary studies published RCT

"You're on mute!" Does pediatric CF home spirometry require physiologist supervision?

Study design (if review, criteria of inclusion for studies)

Randomized controlled trial

Participants

Sixty-one children with CF

Interventions

Children were randomly allocated to either supervised or unsupervised home spirometry following a detailed training session. Home spirometry was performed every 2 weeks for 12 weeks.

Outcome measures

Tests were assigned a quality factor (QF) using our laboratory grading system as per American Thoracic Society/European Respiratory Society standards, with tests marked from A to D, or Fail. In our laboratory, we aim for QF A in all spirometry tests, but report results of QF B or C with a cautionary note. QF A was, therefore, the primary outcome, and QF A-C, the secondary outcome.

Main results

Sixty-one patients were enrolled; 166 measurements were obtained in the supervised group, and 153 in the unsupervised group. Significantly more measurements achieved QF A in the supervised compared to unsupervised group (89% vs. 74%; p = <0.001), while proportions reaching Grade A-C were similar (99% vs. 95%; p = 0.1). All significant declines in spirometry results had a clinical rather than technical reason. Family/patient feedback for both arms was very positive.

Authors' conclusions

These results suggest that home spirometry in children should ideally be remotely supervised by a physiologist, but acceptable results can be obtained if resources do not allow this, provided that training is delivered and results monitored according to our protocol.

Keywords: Adolescent; Adult; Child; training; non pharmacological intervention - psyco-soc-edu-org;