From: Inter-rater reliability and concurrent validity of ROBINS-I: protocol for a cross-sectional study
NOS | ROBINS-I | Degree of overlap | ||
---|---|---|---|---|
Comparability | C: Comparability of cohorts on the basis of the design or analysis | Bias due to confounding | 1.1: Is there potential for confounding of the effect of intervention in this study? | Unique |
1a: Study controls for the most important factor | 1.2: Was the analysis based on splitting participants’ follow-up time according to intervention received? | Unique | ||
1b: Study controls for additional factor | 1.3. Were intervention discontinuations or switches likely to be related to factors that are prognostic for the outcome? | Unique | ||
Baseline confounding only | 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | Complete overlap | ||
1.5: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study? | Unique | |||
1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | Unique | |||
Time-varying confounding only | 1.7: Did the authors use an appropriate analysis method that controlled for all the important confounding domains and for time-varying confounding? | Unique | ||
1.8: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study? | Unique | |||
Selection | S1: Representativeness of exposed cohort | 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? | Unique |
1a: Truly representative | 2.2: Were the post-intervention variables that influenced selection likely to be associated with intervention? | Unique | ||
1b: Somewhat representative | 2.3: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome? | Unique | ||
1c: Selected group of users | 2.4. Do start of follow-up and start of intervention coincide for most participants? | Unique | ||
1d: No description of the derivation of the cohort | 2.5: Were adjustment techniques used that are likely to correct for the presence of selection biases? | Unique | ||
S2: Selection of non-exposed cohort | ||||
2a: Drawn from the same community as the exposed cohort | ||||
2b: Drawn from a different source | ||||
2c: No description of the derivation of the non-exposed cohort | ||||
Selection | S3: Ascertainment of exposure | Bias in classification of interventions | 3.1 Were intervention groups clearly defined? | Unique |
3a: Secure record | 3.2 Was the information used to define intervention groups recorded at the start of the intervention? | Unique | ||
3b: Structured interview | 3.3 Could classification of intervention status have been affected by knowledge of the outcome or risk of the outcome? | Partial overlap | ||
3c: Written self-report | ||||
3d: No description | ||||
S4: Demonstration of outcome of interest was not present at start of the study | ||||
4a: Yes | ||||
4b: No | ||||
Bias due to deviations from intended interventions | 4.1. Were there deviations from the intended intervention beyond what would be expected in usual practice? | Unique | ||
4.2: Were these deviations from intended intervention unbalanced between groups and likely to have affected the outcome? | Unique | |||
4.3: Were important co-interventions balanced across intervention groups | Unique | |||
4.4: Was the intervention implemented successfully for most participants? | Unique | |||
4.5: Did study participants adhere to the assigned intervention regimen? | Unique | |||
4.6: Was an appropriate analysis used to estimate the effect of starting and adhering to the intervention? | Unique | |||
Outcomes | O1: Was follow-up long enough for outcomes to occur (Yes/No) | Bias due to missing data | 5.1: Were outcome data available for all, or nearly all, participants? | Partial overlap |
O3: Adequacy of follow-up of cohorts | 5.2: Were participants excluded due to missing data on intervention status? | Unique | ||
3a: Complete follow-up -all subjects accounted for | 5.3: Were participants excluded due to missing data on other variables needed for the analysis? | Unique | ||
3b: Subjects lost to follow-up unlikely to introduce bias -small number lost | 5.4: Are the proportion of participants and reasons for missing data similar across interventions? | Partial overlap | ||
3c: Follow-up rate large (%) and no description of those lost | 5.5: Is there evidence that results were robust to the presence of missing data? | Unique | ||
3d: No statement | ||||
Outcomes | O2: Assessment of outcome | Bias in measurement of outcomes | 6.1 Could the outcome measure have been influenced by knowledge of the intervention received? | Partial overlap |
2a: Independent blind assessment | 6.2 Were outcome assessors aware of the intervention received by study participants? | Partial overlap | ||
2b: Record linkage | 6.3 Were the methods of outcome assessment comparable across intervention groups? | Partial overlap | ||
2c: Self report | 6.4 Were any systematic errors in measurement of the outcome related to intervention received? | Unique | ||
2d: No description | ||||
Bias in selection of the reported result | 7.1: Is the reported effect estimate likely to be selected, on the basis of the results, from multiple outcome measurements within the outcome domain? | Unique | ||
7.2: Is the reported effect estimate likely to be selected, on the basis of the results, from multiple analyses of the intervention-outcome relationship? | Unique | |||
7.3: Is the reported effect estimate likely to be selected, on the basis of the results, from different subgroups? | Unique |