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Is the raised volume rapid thoracic compression technique ready for use in clinical trials in infants with cystic

Stefan Matecki1, Lisa Kent2, Kris de Boeck3

  • 1Pediatric Functional Exploration Unit, University Hospital of Montpellier, UMR CNRS 9214-INSERM U1046, Université Montpellier, France.

Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society
|April 20, 2015
PubMed

Insights

The raised-volume rapid thoracic compression (RVRTC) technique shows promise for infants with cystic fibrosis (CF). However, standardization and more research are needed before it can be a primary outcome in clinical trials.

Area of Science:

  • Respiratory Medicine
  • Pediatric Pulmonology
  • Clinical Trial Methodology

Background:

  • The European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) is evaluating outcome measures for multicenter cystic fibrosis (CF) trials.
  • The raised-volume rapid thoracic compression (RVRTC) technique is a potential measure for infants with CF.

Purpose of the Study:

  • To review the clinimetric properties of the RVRTC technique in infants with CF.
  • To assess the feasibility of RVRTC for multicenter clinical trials.
  • To determine the potential of RVRTC as a surrogate endpoint in CF research.

Main Methods:

  • A literature search identified 20 papers on RVRTC use in infants with CF since 1985.
  • Data on repeatability, validity, correlation with other measures, responsiveness, and reference values were extracted.
  • A working group discussed findings and answered key questions on RVRTC's utility.

Main Results:

  • RVRTC, particularly forced expiratory volume in 0.5s, demonstrated good clinimetric properties with some individual variability.
  • Limited data exist on RVRTC's relationship with inflammation/infection and its responsiveness post-intervention.
  • Concerns were noted regarding multicenter feasibility and the availability of reference values.

Conclusions:

  • RVRTC requires universal standardization and inter-institutional networking before use as a primary outcome in infant CF trials.
  • Current recommendations advise RVRTC use in Phase I/II trials and as a secondary endpoint in Phase III studies.
  • Further research is needed on short-term variability, longitudinal natural history, and robust reference values for RVRTC devices.
Abstract

Keywords:
Clinical trialsClinimetric propertiesCystic fibrosisInfant pulmonary functionRaised volume rapid thoracic compressionSurrogate outcome

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