| 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.
No deviation from intended intervention.
Analyses were adjusted to account for baseline differences. |
Low risk of bias |
Adherence data was only missing for 3.1% of participants (19/607). |
Low risk of bias |
Adherence was calculated as normative (effective) adherence using objective data from weeks 3 to 52 as the outcome and weeks 1 and 2 as the baseline. Objectively measured effective adherence was calculated daily as a composite of all inhaled medications then aggregated weekly for analysis.
Participants in both groups were given eTrack data‐logging controllers for their eFlow tech nebulsiers which sent time‐stamped and date‐stamped data to a 2net Hub for accurate recording of inhalation and adherance calculation. Same used for both groups.
Data for this outcome was captured electronically and so the fact that the outcome assessors were aware of allocation would not have made any difference. |
Low risk of bias |
All analyses were prespecificed and performed by intent‐to‐treat. Objectively measured adherence was analysed using a linear mixed‐effects model. |
Low risk of bias |
Participants were stratified based on centre and prior days of antibiotics. Baseline differences described suggest that the intervention group had slightly better lung health (FEV1), were slightly older, had slightly lower past years IV days and slghtly higher objectively measured adherance. However, results were also adjusted for this and reported as adjusted mean difference. |
