Table 3

Detailed results from the testing process

Monitor function checkOutcome
Monitors passed initial screening test20/20 (100%)
Sensitivity and positive predictive value by factors potentially affecting accuracy
Sensitivity*Positive predictive value*
Regimen
 Low-use actuations878/880 (99.8) (99.2)878/881 (99.7) (99.0)
 High-use actuations1918/1920 (99.9) (99.6)1918/1918 (100) (99.8)
Period, days
 0 (screening)80/80 (100) (95.5)80/83 (96.4) (89.8)
 1–281918/1920 (99.9) (99.6)1918/1918 (100) (99.8)
 29–56399/400 (99.8) (98.6)399/399 (100) (99.1)
 57–84399/400 (99.8) (98.6)399/399 (100) (99.1)
Upload pattern
 Same day upload2397/2400 (99.9) (99.6)2397/2400 (99.9) (99.6)
 Delayed upload (days 56–84)399/400 (99.8) (98.6)399/399 (100) (99.1)
Turbuhaler attached to monitor prior to testing
 No1917/1920 (99.8) (99.5)1917/1917 (100) (99.8)
 Yes (days 0, 28 and 56)879/880 (99.9) (99.4)879/882 (99.7) (99.0)
Accuracy by monitor**
 Number of monitors with at least one missed actuation recording3/20 (15)
 Number of monitors with at least one spurious actuation recording2/20 (10)
Monitor battery check**
 Pass on day 8420/20 (100)
  • 1. Data from day 0 uploaded to V.7.7 Smartinhaler Connection Centre programme. Subsequently, all data were uploaded to V.7.8 Smartinhaler Connection Centre programme.

  • 2. Investigators were unable to access the Adherium website to upload data on day 14, so data were uploaded on day 15 when access was gained.

  • 3. All data from day 14 (320/320 actuations) were 1 h discrepant (to within 3 min), in keeping with the time prior to the cessation of the New Zealand daylight savings period on day 8. This discrepancy applied to data on day 14 only.

  • *Sensitivity is the proportion of diary actuations recorded by the monitor expressed as N/N (%) (lower 97.5% confidence bound). Positive predictive value is the proportion of monitor recorded actuations that were recorded in the diary expressed as N/N (%) (lower 97.5% confidence bound).

  • **N/N (%) (95% CI).