Risk of bias for analysis 2.6 FEV1 % predicted.
| Study | Bias | |||||||||||
| Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | |||||||
| Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | |
| Subgroup 2.6.1 At 12 months | ||||||||||||
| CFHealthHub 2017 | Some concerns | Participants were allocated 1:1 to the intervention or usual care using a computer‐generated pseudorandom list with random‐permuted blocks of randomly varying sizes, via a central, web‐based randomisation system. The allocation sequence was hosted by the Sheffield Clinical Trials Research Unit, with the sequence created by a statistician (not otherwise involved with the trial) and held on a secure server. After recruiting each participant, the interventionist logged into the server and entered basic demographic information, then the allocation was revealed to the participants. The trial statistician remained blind to treatment allocation until database freeze. Baseline differences are described in an appendix and it is possible that the 2 levels of stratification (centre and prior days on IV antibiotics) affected baseline data. The intervention group had slightly better lung health, were older at baseline and slightly better objectively measured adherence. The play of chance is affected by the block size. | Low risk of bias | Both groups received eTrack data‐logging controllers for their eFlow technology nebulisers but only intervention participants had access to CFHealthHub. The trial was open label. There was a pre‐scpecified analysis plan. Analyses were adjusted to account for baseline differences. |
Low risk of bias | Less than 15% missing data for this outcome Usual care: 282/303 participants Internvetion; 274/304 participants | Low risk of bias | Measurement of FEV1 was captured electronically and was measured in the same way for both groups. | Low risk of bias | There was a pre‐specified analysis plan and results were reported according to this. | Some concerns | The concerns were due to the randomisation process leading to slight baseline differences, including lung function. Lung function was slightly better in the intervention group at baseline. |