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Shekelle PG, Greeley AM, Tanner EP, et al. One-to-One Observation: A Systematic Review [Internet]. Washington (DC): Department of Veterans Affairs (US); 2019 Aug.

Cover of One-to-One Observation: A Systematic Review

One-to-One Observation: A Systematic Review [Internet].

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APPENDIX BRisk of Bias in Non-Randomised Studies – of interventions (ROBINS-I) Tool

Bias Domains Included in ROBINS-I12

Pre-interventionRisk of bias assessment is mainly distinct from assessments of randomised trials
Bias due to confounding

Baseline confounding occurs when one or more prognostic variables (factors that predict the outcome of interest) also predicts the intervention received at baseline

ROBINS-I can also address time-varying confounding, which occurs when individuals switch between the interventions being compared and when post-baseline prognostic factors affect the intervention received after baseline

Bias in selection of participants into the study

When exclusion of some eligible participants, or the initial follow-up time of some participants, or some outcome events is related to both intervention and outcome, there will be an association between interventions and outcome even if the effects of the interventions are identical

This form of selection bias is distinct from confounding—A specific example is bias due to the inclusion of prevalent users, rather than new users, of an intervention

At interventionRisk of bias assessment is mainly distinct from assessments of randomised trials
Bias in classification of interventions

Bias introduced by either differential or non-differential misclassification of intervention status

Non-differential misclassification is unrelated to the outcome and will usually bias the estimated effect of intervention towards the null

Differential misclassification occurs when misclassification of intervention status is related to the outcome or the risk of the outcome, and is likely to lead to bias

Post-interventionRisk of bias assessment has substantial overlap with assessments of randomised trials
Bias due to deviations from intended interventions

Bias that arises when there are systematic differences between experimental intervention and comparator groups in the care provided, which represent a deviation from the intended intervention(s)

Assessment of bias in this domain will depend on the type of effect of interest (either the effect of assignment to intervention or the effect of starting and adhering to intervention).

Bias due to missing dataBias that arises when later follow-up is missing for individuals initially included and followed (such as differential loss to follow-up that is affected by prognostic factors); bias due to exclusion of individuals with missing information about intervention status or other variables such as confounders
Bias in measurement of outcomesBias introduced by either differential or non-differential errors in measurement of outcome data. Such bias can arise when outcome assessors are aware of intervention status, if different methods are used to assess outcomes in different intervention groups, or if measurement errors are related to intervention status or effects
Bias in selection of the reported resultSelective reporting of results in a way that depends on the findings and prevents the estimate from being included in a meta-analysis (or other synthesis)
Copyright Notice

This publication is in the public domain and is therefore without copyright. All text from this work may be reprinted freely. Use of these materials should be acknowledged.

Bookshelf ID: NBK553695

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