Trial

Risk of 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

NCT00720941 Instrument: FACIT‐F Total trial population (combined risk groups)

Low risk of bias

Interactive voice response system was used for randomisation. There were no baseline imbalances that would suggest a problem with randomisation.

Low risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned interventions. Only 3 participants randomised to the experimental arm and 5 participants randomised to the control arm did not receive any treatment. The method of analysis was appropriate (ITT).

High risk of bias

Less than 1% did not receive the intended interventions and therefore did not have outcome data. 90.7% of those randomised did not have evaluable outcome data at the end of treatment. No analysis to correct for missing outcome data.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Low risk of bias

CSR and study protocol with SAP available. Scale and time point were prespecified in the protocol and SAP.

High risk of bias

Overall judged high risk of bias due to the high number of participants without outcome data and the outcome assessors’ awareness of assigned intervention.

NCT00098657/NCT00083889 Instrument:FKSI‐DRS Total trial population (combined risk groups)

Some concerns

Participants were randomised in a 1:1 ratio, but no information about allocation concealment. However, there were no baseline imbalances that would suggest a problem with randomisation.

Low risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned interventions. Only 15 participants randomised to the control arm did not receive any treatment. The method of analysis was appropriate (ITT).

Low risk of bias

2% did not receive the intended interventions and therefore did not have outcome data. 91.6% of those randomised did not have evaluable outcome data the end of treatment. Analysis to correct for missing outcome data were conducted.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Some concerns

No study protocol or SAP available.

High risk of bias.

Overall judged high risk of bias due to lack of information about the randomisation process and allocation concealment; the outcome assessors’ awareness of assigned intervention; missing study protocol and SAP.

NCT00098657/NCT00083889 Instrument: EQ‐5D (VAS) Total trial population (combined risk groups)

Some concerns

Participants were randomised in a 1:1 ratio, but no information about allocation concealment. However, there were no baseline imbalances that would suggest a problem with randomisation.

Low risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned interventions. Only 15 participants randomised to the control arm did not receive any treatment. The method of analysis was appropriate (ITT).

Low risk of bias

2% did not receive the intended interventions and therefore did not have outcome data. 91.4% of those randomised did not have evaluable outcome data the end of treatment. Analysis to correct for missing outcome data were conducted.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Some concerns

No study protocol or SAP available.

High risk of bias.

Overall judged high risk of bias due to lack of information about the randomisation process and allocation concealment; the outcome assessors’ awareness of assigned intervention; missing study protocol and SAP.

NCT00098657/NCT00083889 Instrument: FACT‐G Total trial population (combined risk groups)

Some concerns

Participants were randomised in a 1:1 ratio, but no information about allocation concealment. However, there were no baseline imbalances that would suggest a problem with randomisation.

Low risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned interventions. Only 15 participants randomised to the control arm did not receive any treatment. The method of analysis was appropriate (ITT).

Low risk of bias

2% did not receive the intended interventions and therefore did not have outcome data. 91.7% of those randomised did not have evaluable outcome data the end of treatment. Analysis to correct for missing outcome data were conducted.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Some concerns

No study protocol or SAP available.

High risk of bias.

Overall judged high risk of bias due to lack of information about the randomisation process and allocation concealment; the outcome assessors’ awareness of assigned intervention; missing study protocol and SAP.

NCT01108445 Instrument: FKSI‐ DRS Total trial population (combined risk groups)

Low risk of bias

Participants were randomised in a 1:1 ratio. Randomisation was done under allocation concealment. There were no baseline imbalances that would suggest a problem with randomisation.

High risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned intervention. Only 1 participant withdrew after consent, but before randomisation and before study drug was assigned. No precise information provided about the method of analysis.

High risk of bias

43.5% of those randomised did not have evaluable outcome data at the end of treatment. No analysis to correct for bias.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Some concerns

No study protocol or SAP available.

High risk of bias

Overall judged high risk of bias due to lack of information about method of analysis; high number of participants without outcome data; the outcome assessors’ awareness of assigned intervention; missing study protocol and SAP.

NCT00920816 Instrument: FKSI‐ DRS Total trial population (combined risk groups)

Low risk of bias

A centralised registration system was used for randomisation. There were no baseline imbalances that would suggest a problem with randomisation.

Low risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned interventions. Only 3 participants randomised to the experimental arm did not receive any treatment. The method of analysis was appropriate (ITT).

HIgh risk of bias

1% did not receive the intended interventions and therefore did not have outcome data. 60.4% of those randomised did not have evaluable outcome data. No analysis to correct for bias.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Some concerns

No study protocol or SAP available.

High risk of bias

Overall judged high risk of bias due to high number of participants without outcome data; the outcome assessors’ awareness of assigned intervention; missing study protocol and SAP.

NCT00920816 Instrument: EQ‐5D (VAS) Total trial population (combined risk groups)

Low risk of bias

A centralised registration system was used for randomisation. There were no baseline imbalances that would suggest a problem with randomisation.

Low risk of bias

The study was open‐label: both participants and those delivering the intervention were aware of assigned interventions. Only 3 participants randomised to the experimental arm did not receive any treatment. The method of analysis was appropriate (ITT).

High risk of bias

1% did not receive the intended interventions and therefore did not have outcome data. 60.8% of those randomised did not have evaluable outcome data. No analysis to correct for bias.

High risk of bias

QoL is a participant‐reported outcome, therefore outcome assessors were aware of the assigned intervention. Knowledge of intervention received could have affected outcome measurement.

Some concerns

No study protocol or SAP available.

Some concerns

Overall judged high risk of bias due to high number of participants without outcome data; the outcome assessors’ awareness of assigned intervention; missing study protocol and SAP.