title: Validation of a metered dose inhaler electronic monitoring device: implications for asthma clinical trial use.
abstract: BACKGROUND
  The SmartTouch Ventolin monitor (Adherium, Auckland, New Zealand) is an electronic monitor for use with a Ventolin metered dose inhaler, which records the date and time of inhaler actuations. This technology has the potential to allow in-depth analysis of patterns of inhaler use in clinical trial settings. The aim of this study was to determine the accuracy of the SmartTouch Ventolin monitor in recording Ventolin actuations.
  
  
  METHODS
  20 SmartTouch Ventolin monitors were attached to Ventolin metered dose inhalers. Bench testing was performed over a 10-week period, to reflect the potential time frame between visits in a clinical trial. Inhaler actuations were recorded in a paper diary, which was compared with data uploaded from the monitors.
  
  
  RESULTS
  2560 actuations were performed during the 10-week study period. Monitor sensitivity for diary-recorded actuations was 99.9% with a lower 97.5% confidence bound of 99.7%. The positive predictive value for diary-recorded actuations was 100% with a 97.5% lower confidence bound of 99.9%.
  
  
  CONCLUSIONS
  The SmartTouch Ventolin monitor is highly accurate in recording and retaining electronic data. It can be recommended for use in clinical trial settings in which training and quality control systems are incorporated into study protocols to ensure accurate data acquisition.
authors.affiliation: Capital and Coast District Health Board, Wellington, New Zealand; Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Janine
authors.initials: J
authors.lastname: Pilcher
authors.affiliation: Medical Research Institute of New Zealand , Wellington , New Zealand.
authors.forename: Mark
authors.initials: M
authors.lastname: Holliday
authors.affiliation: Medical Research Institute of New Zealand , Wellington , New Zealand.
authors.forename: Stefan
authors.initials: S
authors.lastname: Ebmeier
authors.affiliation: Medical Research Institute of New Zealand , Wellington , New Zealand.
authors.forename: Steve
authors.initials: S
authors.lastname: McKinstry
authors.affiliation: Medical Research Institute of New Zealand , Wellington , New Zealand.
authors.forename: Fatiha
authors.initials: F
authors.lastname: Messaoudi
authors.affiliation: Capital and Coast District Health Board, Wellington, New Zealand; Wellington School of Medicine & Health Sciences, University of Otago Wellington, Wellington, New Zealand.
authors.forename: Mark
authors.initials: M
authors.lastname: Weatherall
authors.affiliation: Capital and Coast District Health Board, Wellington, New Zealand; Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Richard
authors.initials: R
authors.lastname: Beasley
keywords: Asthma; Equipment Evaluations; Inhaler devices