Elborn 2000.
| Methods | Multicentred 3‐year trial, parallel design with two treatment arms. Allocation of treatment by the method of minimisation using age, severity based on chest radiographic score and treatment centre. | |
| Participants | 60 participants with CF, aged 8 years or over and with P. aeruginosa isolated on 3 or more occasions in the last year. Participants excluded if there was a positive past history of hypersensitivity reactions to anti‐pseudomonal agents, if they were on a regular treatment regimen of IV antibiotics, or if they had less than 2 or more than 4 exacerbations during the previous year requiring IV antibiotics. | |
| Interventions | Elective IV antibiotics every 3 months versus IV antibiotics only when symptoms indicated. | |
| Outcomes | On entry to trial and after 3 years, parameters measured were: FEV1 (% predicted); FVC (% predicted); Shwachman score; Chrispin‐Norman score; height and weight SD scores; weight/height (% predicted); and number of deaths. | |
| Notes | 5 dropouts recorded. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Allocation of treatment was by the method of minimisation using age, severity based on chest radiographic score, and treatment centre. |
| Allocation concealment (selection bias) | Unclear risk | Not discussed. |
| Blinding (performance bias and detection bias) All outcomes | High risk | Not possible given the intervention. |
CF: cystic fibrosis FEV1: forced expiratory volume at one second FVC: forced vital capacity IV: intravenous P. aeruginosa: Pseudomonas aeruginosa SD: standard deviation