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

Risk of bias for analysis 2.3 Quality of Life CFQ‐R score: other domains.

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 2.3.1 CFQ‐R: physical domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall. 
Subgroup 2.3.2 CFQ‐R: emotional domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall. 
Subgroup 2.3.3 CFQ‐R: social domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall. 
Subgroup 2.3.4 CFQ‐R: eating domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall. 
Subgroup 2.3.5 CFQ‐R: body image domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall. 
Subgroup 2.3.6 CFQ‐R: respiratory domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall. 
Subgroup 2.3.7 CFQ‐R: digestion domain 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% data missing for this outcome. Reported as CFQR score domains.
Usual care:  physical, emotional, social, eating, body image, treatment burden: 274/303
resp 271/303
digestion: 272/303
CFHealthHub: physical, emotional, social, eating, body image 264/304
treatment burden 265/304
resp and digestion 263/304
 		 High risk of bias Questionnaires were self assessed.
It is likely that knowledge of the intervention may have influenced QoL assessments.
  Low risk of bias There was a prespecified analysis plan which was adhered to. Low risk of bias There were some concerns with the randomisation process which may have lead to baseline difference between the two groups. However the authors account for this and adjust for this accordingly in their analysis. This was reported and discussed in detail therefore we feel the risk of bias is low overall.