Table 2 Additional outcome data for each PERIT
| Â | Variable | Timing | Reason |
|---|---|---|---|
PEx therapy | Date and time of commencing IV therapy | Day 0 | As a time reference point for analyses |
PEx therapy | Location (hospital or HITH) | Daily | For description of the cohort. Location may constrain therapeutic options and plausibly confound or modify treatment effects |
Spirometry | FEV1 | Days 0 (at admission), 7, 14, 30, 60, and 180 | Treatment of PEx plausibly impacts on lung function, measured as ppFEV1; this is strongly associated with morbidity and mortality in CF |
Clinical assessment | Presence and quality of cough | Daily | Reduction in cough and/or improvement in cough quality are measures of successful treatment of PEx |
Presence of crepitations | Daily | Reduction in crepitations is a measure of successful treatment of PEx | |
Patient-reported outcomes | CRISS score (if > 12 years at admission) | Day 0: as close as practicable to the initiation of IV antibiotics, and not > 72 h afterwards, then days 7, 14, and 30 | CRISS is a validated measure of CF-related symptoms in the preceding 24 h. It is expected that successful treatment will result in an improved CRISS score. It will be used to assess clinical response to treatment for PEx |