From: Inter-rater reliability and concurrent validity of ROBINS-I: protocol for a cross-sectional study
Domains | Response options | Support for judgement | Review author’s decision | |
---|---|---|---|---|
1. | Bias due to confounding | |||
1.1 | Is there potential for confounding of the effect of intervention in this study? | |||
If N/PN to 1.1: the study can be considered to be at low risk of bias due to confounding and no further signaling questions need be considered. If Y/PY to 1.1: determine whether there is a need to assess time-varying confounding: | ||||
1.2 | Was the analysis based on splitting participants’ follow-up time according to intervention received? | |||
If N/PN, answer questions relating to baseline confounding (1.4 to 1.6) If Y/PY, go to question 1.3 | ||||
1.3 | Were intervention discontinuations or switches likely to be related to factors that are prognostic for the outcome? | |||
If N/PN, answer questions relating to baseline confounding (1.4 to 1.6) If Y/PY, answer questions relating to both baseline and time-varying confounding (1.7 and 1.8) | ||||
1.4 | Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | |||
1.5 | If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study? | |||
1.6 | Did the authors control for any post-intervention variables that could have been affected by the intervention? | |||
1.7 | Did the authors use an appropriate analysis method that controlled for all the important confounding domains and for time-varying confounding? | |||
1.8 | If Y/PY to 1.7: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to confounding? | ||||
2. | Bias in selection of participants into the study | |||
2.1 | Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention | |||
If N/PN to 2.1: go to 2.4 | ||||
2.2 | If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention? | |||
2.3 | If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome? | |||
2.4 | Do start of follow-up and start of intervention coincide for most participants? | |||
2.5 | If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to selection of participants into the study? | ||||
3. | Bias in classification of interventions | |||
3.1 | Were intervention groups clearly defined? | |||
3.2 | Was the information used to define intervention groups recorded at the start of the intervention? | |||
3.3 | Could classification of intervention status have been affected by knowledge of the outcome or risk of the outcome? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to classification of interventions? | ||||
4. | Bias due to deviations from intended interventions | |||
If your aim for this study is to assess the effect of assignment to intervention, answer questions 4.1 and 4.2 | ||||
4.1 | Were there deviations from the intended intervention beyond what would be expected in usual practice? | |||
4.2 | If Y/PY to 4.1: Were these deviations from intended intervention unbalanced between groups and likely to have affected the outcome? | |||
If your aim for this study is to assess the effect of starting and adhering to intervention, answer questions 4.3 to 4.6 | ||||
4.3 | Were important co-interventions balanced across intervention groups? | |||
4.4 | Was the intervention implemented successfully for most participants? | |||
4.5 | Did study participants adhere to the assigned intervention regimen? | |||
4.6 | If N/PN to 4.3, 4.4 or 4.5: Was an appropriate analysis used to estimate the effect of starting and adhering to the intervention? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to deviations from the intended interventions? | ||||
5. | Bias due to missing data | |||
5.1 | Were outcome data available for all, or nearly all, participants? | |||
5.2 | Were participants excluded due to missing data on intervention status? | |||
5.3 | Were participants excluded due to missing data on other variables needed for the analysis? | |||
5.4 | If PN/N to 5.1, or Y/PY to 5.2 or 5.3: Are the proportion of participants and reasons for missing data similar across interventions? | |||
5.5 | If PN/N to 5.1, or Y/PY to 5.2 or 5.3: Is there evidence that results were robust to the presence of missing data? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to missing data? | ||||
6. | Bias in measurement of outcomes | |||
6.1 | Could the outcome measure have been influenced by knowledge of the intervention received? | |||
6.2 | Were outcome assessors aware of the intervention received by study participants? | |||
6.3 | Were the methods of outcome assessment comparable across intervention groups? | |||
6.4 | Were any systematic errors in measurement of the outcome related to intervention received? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to measurement of outcomes? | ||||
7. | Bias in selection of the reported result | |||
Is the reported effect estimate likely to be selected, on the basis of the results, from… | ||||
7.1 | …multiple outcome measurements within the outcome domain? | |||
7.2 | …multiple analyses of the intervention-outcome relationship? | |||
7.3 | …different subgroups? | |||
Risk of bias judgement | ||||
Optional: What is the predicted direction of bias due to selection of the reported result? | ||||
Overall risk of bias | ||||
Risk of bias judgement | ||||
Optional: What is the overall predicted direction of bias for this outcome? |