Barzelloni et al,
2014
|
Bias arising from the randomization process
|
1.1. Was the allocation sequence random?
|
|
PY
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
Study: Abstract - Few information
|
NI
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
N
|
Domain-level judgement
|
Some concerns
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: 1 day of classroom training Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
Y
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
PY
|
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
|
Domain-level judgement
|
Low risk
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
NI
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
N
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
PN
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
PN
|
Domain-level judgement
|
Low risk
|
Barzelloni et al,
2014
|
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?
|
|
N
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
NA
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
NA
|
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
|
Domain-level judgement
|
Low risk
|
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?
|
Study: Abstract
- Few information
|
NI
|
5.2. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
Study:
Abstract Few information Evaluations were performed at T0 and quarterly (T1, T2, T3, T4) but only results comparing T0 and T4 were showed.
|
PY
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
PY
|
Domain-level judgement
|
High risk
|
Overall bias
|
High risk
|
Bragard et al,
2010
|
Bias arising from the randomization process
|
1.1. Was the allocation sequence random?
|
|
PY
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
Y
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
N
|
Domain-level judgement
|
Low risk
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: consolidation workshops Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
Y
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
Y
|
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
|
Domain-level judgement
|
Low risk
|
Bragard et al,
2010
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
PY
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
NA
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
NA
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
NA
|
Domain-level judgement
|
Low risk
|
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?
|
|
N
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
NI
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
N
|
4.5. If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
|
|
N
|
Domain-level judgement
|
Low risk
|
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?
|
|
NI
|
5.2. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
|
N
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
N
|
Domain-level judgement
|
Some concerns
|
Overall bias
|
Some concerns
|
Brown et al,
2014
|
Bias arising from the randomization process
|
1.1. Was the allocation sequence random?
|
Study: Abstract - Few information
|
PY
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
NI
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
PN
|
Domain-level judgement
|
Low risk
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: face-to-face workshop
Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
|
Y
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
NI
|
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?
|
|
PY
|
Domain-level judgement
|
High risk
|
Brown et al,
2014
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
NI
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
N
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
PN
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
PN
|
Domain-level judgement
|
Low risk
|
Bias in measurement of the outcome
|
4.1. Was the method of measuring the outcome inappropriate?
|
|
Y
|
4.2. Could measurement or ascertainment of the outcome have differed between intervention groups?
|
|
Y
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
NA
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
NA
|
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
|
Domain-level judgement
|
High risk
|
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?
|
|
NI
|
5.2. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
|
Y
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
Y
|
Domain-level judgement
|
High risk
|
Overall bias
|
High risk
|
Butow et al,
2008
|
Bias arising from the
randomization process
|
1.1. Was the allocation sequence random?
|
|
Y
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
|
PY
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
N
|
Domain-level judgement
|
Low risk
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: Communication skills training Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
Y
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
Y
|
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
|
Domain-level judgement
|
Low risk
|
Butow et al,
2008
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
Y
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
NA
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
NA
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
NA
|
Domain-level judgement
|
Low risk
|
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?
|
|
N
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
Y
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
N
|
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
|
Domain-level judgement
|
Low risk
|
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?
|
|
NI
|
5.2. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
|
N
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
N
|
Domain-level judgement
|
Some concerns
|
Overall bias
|
Some concerns
|
Mache et al,
2017
|
Bias arising from the
randomization process
|
1.1. Was the allocation sequence random?
|
|
Y
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
|
Y
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
N
|
Domain-level judgement
|
Low risk
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: problem-
and emotion- oriented coping Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
N
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
Y
|
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
|
Domain-level judgement
|
Low risk
|
Mache et al,
2017
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
Y
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
NA
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
NA
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
NA
|
Domain-level judgement
|
Low risk
|
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?
|
|
N
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
Y
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
N
|
4.5. If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
|
|
N
|
Domain-level judgement
|
Low risk
|
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?
|
|
NI
|
5.2. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
|
PN
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
PN
|
Domain-level judgement
|
Some concerns
|
Overall bias
|
Some concerns
|
Medisauskaite and Kamau, 2019
|
Bias arising from the
randomization process
|
1.1. Was the allocation sequence random?
|
|
Y
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
|
Y
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
N
|
Domain-level judgement
|
Low risk
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: learning
modules that presented doctors with information about stress Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
N
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
Y
|
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
|
Domain-level judgement
|
Low risk
|
Medisauskaite and Kamau, 2019
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
Y
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
NA
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
NA
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
NA
|
Domain-level judgement
|
Low risk
|
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?
|
|
N
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
N
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
NA
|
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
|
Domain-level judgement
|
Low risk
|
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. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
|
N
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
N
|
Domain-level judgement
|
Low risk
|
Overall bias
|
Low risk
|
Moody et al,
2013
|
Bias arising from the
randomization process
|
1.1. Was the allocation sequence random?
|
|
Y
|
1.2. Was the allocation sequence concealed until participants were recruited and assigned to interventions?
|
|
PY
|
1.3. Were there baseline imbalances that suggest a problem with the randomization process?
|
|
N
|
Domain-level judgement
|
Low risk
|
Bias due to deviations from intended interventions (effect of assignment to intervention)
|
2.1. Were participants aware of their assigned intervention during the trial?
|
Intervention: Mindfulnessbased course Control: No intervention
|
Y
|
2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?
|
Y
|
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?
|
|
N
|
2.4. If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
|
|
NA
|
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
|
|
NA
|
2.6. Was an appropriate analysis used to estimate the effect of assignment to intervention?
|
|
Y
|
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
|
Domain-level judgement
|
Low risk
|
Moody et al,
2013
|
Bias due to missing outcome data
|
3.1. Were data for this outcome available for all, or nearly all, participants randomized?
|
|
Y
|
3.2. If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?
|
|
NA
|
3.3. If N/PN to 3.2: Could missingness in the outcome depend on its true value?
|
|
NA
|
3.4. If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
|
|
NA
|
Domain-level judgement
|
Low risk
|
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?
|
|
N
|
4.3. If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
|
|
N
|
4.4. If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
|
|
N
|
4.5. If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
|
|
N
|
Domain-level judgement
|
Low risk
|
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?
|
|
NI
|
5.2. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
|
|
PN
|
5.3. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
|
|
PN
|
Domain-level judgement
|
Some concerns
|
Overall bias
|
Some concerns
|