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. 2023 Feb 3;2023(2):CD013733. doi: 10.1002/14651858.CD013733.pub2

Risk of bias for analysis 2.4 Adverse effects ‐ anxiety and depression score.

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 2.4.1 GAD‐7 anxiety score 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.
Differences in baseline values were taken into account in the analysis Low risk of bias Less than 15% of data was missing for this outcome.
PHQ8; usual care 272/303, intervention 262/304
GAD‐7 ‐ usual care 273/303, intervention 263/304
 		 Low risk of bias AE and SAE reorded and reported. Results presented in full as supplementary material and also presented as expected AE (such as drop in FEV1) and other. GAD AND PHQ appropriate for measurement of anxiety and depression
Adverse effects were self reported
 		 Low risk of bias There was a pre‐specified analysis plan
  Low risk of bias There were some concerns about risk of bias due to the randomisation process leading to slight differences between groups at baseline but it is unlikely to have had an effect on this outcome and so we have graded the risk of bias as low overall.
Subgroup 2.4.2 PHQ‐8 depression score 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.
Differences in baseline values were taken into account in the analysis Low risk of bias Less than 15% of data was missing for this outcome.
PHQ8; usual care 272/303, intervention 262/304
GAD‐7 ‐ usual care 273/303, intervention 263/304
 		 Low risk of bias AE and SAE reorded and reported. Results presented in full as supplementary material and also presented as expected AE (such as drop in FEV1) and other. GAD AND PHQ appropriate for measurement of anxiety and depression
Adverse effects were self reported
 		 Low risk of bias There was a pre‐specified analysis plan
  Low risk of bias There were some concerns about risk of bias due to the randomisation process leading to slight differences between groups at baseline but it is unlikely to have had an effect on this outcome and so we have graded the risk of bias as low overall.