Table 3.
Cochrane's Risk of Bias (RoB)
Unique ID | S1 | Study ID | Mazzaglia et al. (2015) | Assessor | Author |
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Ref or Label | Mazzaglia et al. (2015) | Aim | assignment to intervention (the ‘intention-to-treat’ effect) | ||
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Experimental | A | Comparator | B | Source | |
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Outcome | Outcome 1 | Results | Weight | 1 | |
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Domain | Signalling question | Response | Comments | ||
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Bias arising from the randomization process | 1a. 1 Was the allocation sequence random? | Y | |||
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1a.2 Was the allocation sequence concealed until clusters were enrolled and assigned to interventions? | PN | ||||
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1a.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | N | ||||
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Risk of bias judgement | Low | ||||
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Bias arising from the timing of identification or recruitment of participants | 1b.1 Were all the individual participants identified and recruited (if appropriate) before randomization of clusters? | Y | |||
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1b.2 If N/PN/NI to 1b.1 : Is it likely that selection of individual participants was affected by knowledge of the intervention assigned to the cluster? | NA | ||||
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1b.3 Were there baseline imbalances that suggest differential identification or recruitment of individual participants between intervention groups? | N | ||||
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Risk of bias judgement | Low | ||||
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Bias due to deviations from intended interventions | 2.1a Were participants aware that they were in a trial? | Y | |||
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2.1b If Y/PY/NI to 2.1a: Were participants aware of their assigned intervention during the trial? | Y | ||||
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2.2 Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | Y | ||||
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2.3 If Y/PY/NI to 2.1b or 2.2: Were there deviations from the intended intervention that arose because of the trial context? | N | ||||
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2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome? | NA | ||||
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2.5 If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups? | NA | ||||
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2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention? | PY | ||||
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2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized? | NA | ||||
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Risk of bias judgement | Low | ||||
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Bias due to missing outcome data | 3.1a Were data for this outcome available for all clusters that recruited participants? | Y | |||
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3.1b Were data for this outcome available for all, or nearly all, participants within clusters? | PN | ||||
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3.2 If N/PN/NI to 3.1a or 3.1b: Is there evidence that the result was not biased by missing data? | N | ||||
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3.3 If N/PN to 3.2 Could missingness in the outcome depend on its true value? | PN | ||||
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3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | NA | ||||
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Risk of bias judgement | Low | ||||
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Bias in measurement of the outcome | 4.1 Was the method of measuring the outcome inappropriate? | N | |||
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4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | PY | ||||
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4.3a If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware that a trial was taking place? | NA | ||||
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4.3b If Y/PY/NI to 4.3a: Were outcome assessors aware of the intervention received by study participants? | NA | ||||
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4.4 If Y/PY/NI to 4.3b: Could assessment of the outcome have been influenced by knowledge of intervention received? | NA | ||||
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4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | NA | ||||
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Risk of bias judgement | Low | ||||
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Bias in selection of the reported result | 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | Y | |||
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5.2 … multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain? | Y | ||||
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5.3 … multiple eligible analyses of the data? | PN | ||||
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Risk of bias judgement | Some concerns | ||||
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Overall bias | Risk of bias judgement | Low |
Unique ID | S1 | Study ID | Mazzaglia et al. (2018) | Assessor | Author |
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Ref or Label | Karlsson et al. (2018) | Aim | assignment to intervention (the ‘intention-to-treat’ effect) | ||
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Experimental | A | Comparator | B | Source | |
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Outcome | Outcome 2 | Results | Weight | ||
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Domain | Signalling question | Response | Comments | ||
|
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Bias arising from the randomization process | 1a.1 Was the allocation sequence random? | Y | |||
|
|||||
1a.2 Was the allocation sequence concealed until clusters were enrolled and assigned to interventions? | Y | ||||
|
|||||
1a.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | N | ||||
|
|||||
Risk of bias judgement | Low | ||||
| |||||
Bias arising from the timing of identification or recruitment of participants | 1b.1 Were all the individual participants identified and recruited (if appropriate) before randomization of clusters? | Y | |||
|
|||||
1b.2 If N/PN/NI to 1b.1 : Is it likely that selection of individual participants was affected by knowledge of the intervention assigned to the cluster? | |||||
|
|||||
1b.3 Were there baseline imbalances that suggest differential identification or recruitment of individual participants between intervention groups? | N | ||||
|
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Risk of bias judgement | Low | Low | |||
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Bias due to deviations from | 2.1a Were participants aware that they were in a trial? | PY | |||
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Intended interventions | 2.1b If Y/PY/NI to 2.1a: Were participants aware of their assigned intervention during the trial? | PY | |||
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2.2 Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | NA | ||||
|
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2.3 If Y/PY/NI to 2.1b or 2.2: Were there deviations from the intended intervention that arose because of the trial context? | PY | ||||
|
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2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome? | PN | ||||
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2.5 If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups? | NA | ||||
|
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2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention? | Y | ||||
|
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2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized? | NA | ||||
|
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Risk of bias judgement | Low | ||||
| |||||
Bias due to missing outcome data | 3.1a Were data for this outcome available for all clusters that recruited participants? | Y | |||
|
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3.1b Were data for this outcome available for all, or nearly all, participants within clusters? | PN | ||||
|
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3.2 If N/PN/NI to 3.1a or 3.1b: Is there evidence that the result was not biased by missing data? | PN | ||||
|
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3.3 If N/PN to 3.2 Could missingness in the outcome depend on its true value? | N | ||||
|
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3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | NA | ||||
|
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Risk of bias judgement | Low | ||||
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Bias in measurement of the outcome | 4.1 Was the method of measuring the outcome inappropriate? | N | |||
|
|||||
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | PN | ||||
|
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4.3a If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware that a trial was taking place? | Y | ||||
|
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4.3b If Y/PY/NI to 4.3a: Were outcome assessors aware of the intervention received by study participants? | Y | ||||
|
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4.4 If Y/PY/NI to 4.3b: Could assessment of the outcome have been influenced by knowledge of intervention received? | PN | ||||
|
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4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | NA | ||||
|
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Risk of bias judgement | Low | ||||
| |||||
Bias in selection of the reported result | 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | Y | |||
|
|||||
5.2 … multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain? | PY | ||||
|
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5.3 … multiple eligible analyses of the data? | N | ||||
|
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Risk of bias judgement | |||||
| |||||
Overall bias | Risk of bias judgement | Low |