Monitor function check | Outcome | |
---|---|---|
Monitors passed initial screening test | 20/20 (100%) | |
Sensitivity and positive predictive value by factors potentially affecting accuracy | ||
Sensitivity* | Positive predictive value* | |
Regimen | ||
Low-use actuations | 878/880 (99.8) (99.2) | 878/881 (99.7) (99.0) |
High-use actuations | 1918/1920 (99.9) (99.6) | 1918/1918 (100) (99.8) |
Period, days | ||
0 (screening) | 80/80 (100) (95.5) | 80/83 (96.4) (89.8) |
1–28 | 1918/1920 (99.9) (99.6) | 1918/1918 (100) (99.8) |
29–56 | 399/400 (99.8) (98.6) | 399/399 (100) (99.1) |
57–84 | 399/400 (99.8) (98.6) | 399/399 (100) (99.1) |
Upload pattern | ||
Same day upload | 2397/2400 (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 | ||
No | 1917/1920 (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 recording | 3/20 (15) | |
Number of monitors with at least one spurious actuation recording | 2/20 (10) | |
Monitor battery check** | ||
Pass on day 84 | 20/20 (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).