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RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions
Open accessAbstract
Assessment of the risk of bias is an essential component of any systematic review. This is true for both nonrandomized studies and randomized trials, which are the main study designs of systematic reviews. The Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) was developed in 2013 and has gained wide usage as a risk-of-bias assessment tool for nonrandomized studies. Four risk-of-bias assessment experts revised it by reviewing existing assessment tools and user surveys. The main modifications included additional domains of selection and detection bias susceptible to nonrandomized studies of interventions, a more detailed consideration of the comparability of participants, and more reliable and valid outcome measurements. A psychometric assessment of the revised RoBANS (RoBANS 2) revealed acceptable inter-rater reliability (weighted kappa, 0.25 to 0.49) and construct validity in which intervention effects of studies with an unclear or high risk of bias were overestimated. The RoBANS 2 has acceptable feasibility, fair-to-moderate reliability, and construct validity. It provides a comprehensive framework for allowing authors to assess and understand the plausible risk of bias in nonrandomized studies of interventions.
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Written from the paper’s full text.
TL;DR
RoBANS 2 is a revised outcome-based risk-of-bias tool for nonrandomized studies of interventions, adding selection and detection bias domains and more detailed consideration of participant comparability and outcome measurement. In psychometric testing it showed acceptable feasibility, fair-to-moderate inter-rater reliability (weighted kappa 0.25–0.49), and construct validity, with unclear/high risk-of-bias studies overestimating intervention effects.
Key findings
- RoBANS 2 revised the original RoBANS by adding domains for selection and detection bias, separating participant selection into comparability of participants and target group selection, and revising outcome assessment to consider blinding of outcome assessors and reliable/valid outcome measurement methods.
- Feasibility: mean time to complete risk-of-bias assessment was 8.72±5.00 minutes per article, with a range from 20 seconds to 36.35 minutes.
- Inter-rater reliability: all eight RoBANS 2 domains had fair agreement or higher, with weighted kappa statistics ranging from 0.25 to 0.49.
- Construct validity: among 112 nonrandomized studies included for inter-rater reliability, 77 were included for construct validity; studies conducted inadequately for each risk-of-bias domain were likely to report low odds ratios in seven of eight domains, indicating that intervention effects with unclear or high risk of bias were overestimated.
Methods
- The revision reviewed existing risk-of-bias/critical appraisal checklists (SIGN, Newcastle-Ottawa Scale, AHRQ checklist, RTI Item Bank) and held consultative meetings with five systematic review methodologists; a sample of nonrandomized studies was compiled via the National Evidence-based Healthcare Collaborating Agency, Health Insurance Review and Assessment Service, PubMed, and the Cochrane Library.
- Inclusion criteria for psychometric evaluation were studies with no intervention or placebo control, dichotomous outcome data except before-and-after studies, and designs including cohort, case-control, cross-sectional, or before-and-after studies; 112 studies were selected: 45 cohort, 16 case-control, 25 cross-sectional, and 26 before-and-after. The minimum required by two raters was 85 studies, based on 80% power to detect a kappa of 0.70 against a null kappa of 0.40.
- Paired assessors with doctoral degrees and at least 10 years of systematic review experience independently rated studies after pilot testing; analyses used weighted kappa for reliability and compared effect sizes by risk-of-bias domain using Cohen’s d for continuous outcomes and Hasselblad and Hedges’s transformation for odds ratios, with SAS 9.4, Stata SE 16.0, and RevMan 5.4; tests were two-sided at α=0.05.
Limitations
- Stated in the paper: further refinement and extensive feedback from RoBANS 2 users are required; for controlled before-after studies, interrupted time series, and interrupted time series with comparisons, assessors need to determine domain judgments considering study design nature from epidemiological experts; the authors recommend Cochrane risk-of-bias tools for RCTs, non-RCTs, or quasi-experimental trials; further research is needed to compare inter-rater agreement and usability of RoBANS 2 and ROBINS-I for cohort-type designs.
- Evident from the text: reliability was only fair-to-moderate (weighted kappa 0.25–0.49), not substantial or almost perfect; construct validity analysis excluded 26 before-and-after studies without comparison and nine studies unable to extract data, leaving 77 of 112 studies; no direct comparison with ROBINS-I was performed in this study.
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Claims the paper makes
2 of 14 cited sources checked · 1 supported · 0 flagged · accuracy not yet measured
Every source the paper cites for this claim was checked and supports it.
In the paper
“Differential or non-differential misclassification of the outcome data could introduce detection bias in NSRI [15].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 1. The Key Changes of the Revised RoBANS 2
What the sources say
- Supportedcites [15] source
The Results (Monte Carlo Simulations) report that differential and nondifferential outcome misclassification biased risk-difference estimates when mortality was captured only through hospitalization claims. The Methods describe how differing healthcare contact could make mortality detection vary between treatment groups. The claim’s “could” is consistent with these findings; the paper does not say every effect estimate is biased. (LLM, conf=0.90)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“All domains of eight RoBANS 2 had fair agreement or higher, ranging from 0.25 to 0.49 κ statistics.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 2. Psychometric Characteristics of RoBANS 2
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“All domains of eight RoBANS 2 had fair agreement or higher, ranging from 0.25 to 0.49 κ statistics.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 2. Psychometric Characteristics of RoBANS 2
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Our findings revealed that studies conducted inadequately for each domain of the risk of bias were likely to report low ORs in seven of eight domains (Table 3).”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 2. Psychometric Characteristics of RoBANS 2
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“However, the tools overlap substantially in terms of the risk of bias domains (Appendix 3).”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DISCUSSION
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIn the paper
“The minimum number of studies required by the two raters was 85, based on a dichotomous variable with 80% power, to detect a kappa of 0.70, at a proportion of positive ratings of 0.70.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2)
What the sources say
- Not checked — no full text of the sourcecites [12] source
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In other words, intervention effect studies with an unclear or high risk of bias were overestimated.”
- Also stated in: § Abstract · plain
“intervention effects of studies with an unclear or high risk of bias were overestimated”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 2. Psychometric Characteristics of RoBANS 2
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Also stated in: § Abstract · plain
In the paper
“Consequently, confounding by indication or severity introduces systematic bias, leading to either over- or underestimation of treatment effects depending on the treatment decision mechanism [14].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 1. The Key Changes of the Revised RoBANS 2
What the sources say
- Not checked — no full text of the sourcecites [14] source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
- It may state two separate claims as one. 9
- Probably not a substantial claim. 9
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“However, a crucial limitation of observational studies on intervention effects and adverse reactions is that the intervention of interest is not randomly assigned, blinding is lacking, and there is often no comparison.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > INTRODUCTION
What the sources say
- Not checked yetcites [5] source
Checked before — its earlier verdict is held back until a new check runs.
- Partly supportedcites [6] sourceExperimental — accuracy not yet measured
The 'Inclusion of non-randomised studies in systematic reviews' section says non-randomised intervention studies face biases that can make their effect estimates inaccurate, supporting the concern about non-random assignment. It does not say that observational studies generally lack blinding or often have no comparison group. (LLM, conf=0.86)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Not checked yet
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The time spent assessing each study ranged from 20 seconds to 36.35 minutes, with a mean of 8.72±5.00 minutes per article.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 2. Psychometric Characteristics of RoBANS 2
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The main modifications included additional domains of selection and detection bias susceptible to nonrandomized studies of interventions, a more detailed consideration of the comparability of participants, and more reliable and valid outcome measurements.”
- Also stated in: § DISCUSSION · plain
“The main modifications included additional domains of selection and detection bias susceptible to the NRSI, a more detailed consideration of the comparability of participants, and more reliable and valid outcome measurements.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > Abstract
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Also stated in: § DISCUSSION · plain
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Similar to the original RoBANS, the assessments in RoBANS 2 were related to the risk of bias in the estimates of the intervention effect for a single outcome or endpoint rather than at the study level.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DISCUSSION
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Similar to the original version, RoBANS 2 is an outcome-based checklist.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 1. The Key Changes of the Revised RoBANS 2
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Additionally, the domains of blinding of outcome assessors, outcome assessment, and incomplete outcome data can be treated as result-based evaluations because they are classified as patient-reported outcomes or objective outcome measures.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 1. The Key Changes of the Revised RoBANS 2
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Therefore, the RoBANS 2 has construct validity and can detect significant differences in effect size estimates according to the risk of bias.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 2. Psychometric Characteristics of RoBANS 2
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Paired assessors of the review team independently evaluated the risk of bias of the included studies using RoBANS 2 after pilot testing a sample of included studies.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2)
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
In the paper
“The Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) was developed in 2013 and has gained wide usage as a risk-of-bias assessment tool for nonrandomized studies.”
- Also stated in: § INTRODUCTION · plain
“The Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS), published in 2013 [7], is a widely used bias tool.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > Abstract
What the sources say
- Not checked — no full text of the sourcecites [7] source
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
- Also stated in: § INTRODUCTION · plain
None of the sources cited for this claim have been checked yet.
In the paper
“In nonrandomized studies, selection bias occurs when participants chosen for the intervention of interest have different characteristics from those allocated to the alternative intervention (or not treated) because the choice of a given intervention might be affected by the discretion of the treating clinician or patient preference, patient characteristics, and clinical history [13].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 1. The Key Changes of the Revised RoBANS 2
What the sources say
- Not checked yetcites [13] source
Checked before — its earlier verdict is held back until a new check runs.
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
- Not checked yet
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Each study was randomly assigned to paired assessors using computer-based random number generation.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2)
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In conclusion, RoBANS 2 had acceptable feasibility, fair to moderate reliability, and construct validity.”
- Also stated in: § Abstract · plain
“The RoBANS 2 has acceptable feasibility, fair-to-moderate reliability, and construct validity.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > CONCLUSION
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Also stated in: § Abstract · plain
None of the sources cited for this claim have been checked yet.
In the paper
“Real-world evidence has become increasingly critical for identifying the effects and safety of healthcare interventions.”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > INTRODUCTION
What the sources say
- Not checked yetcites [4] source
Checked before — its earlier verdict is held back until a new check runs.
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
- Not checked yet
None of the sources cited for this claim have been checked yet.
In the paper
“The findings of nonrandomized studies of interventions (NRSI) can be generalized to the population and provide clinical evidence regarding the benefits or risks of healthcare interventions [1].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > INTRODUCTION
What the sources say
- Not checked yetcites [1] source
Checked before — its earlier verdict is held back until a new check runs.
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Not checked yet
None of the sources cited for this claim have been checked yet.
In the paper
“Moreover, these reviews may allow for the evaluation of adverse events and long-term effects after exposure to healthcare interventions [3].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > INTRODUCTION
What the sources say
- Not checked yetcites [3] source
Checked before — its earlier verdict is held back until a new check runs.
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Not checked yet
None of the sources cited for this claim have been checked yet.
In the paper
“Thus, the study findings are susceptible to confounding and selection biases, which could result in biased estimates of intervention effects compared with smaller RCTs [5,6].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > INTRODUCTION
What the sources say
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
In the paper
“Researchers have increasingly included NRSI in systematic reviews to examine various interventions such as medications, hospital procedures, community health interventions, and health systems [2].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > INTRODUCTION
What the sources say
- Not matchedcites [2]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
In the paper
“Bias can occur when outcome assessors are aware of the intervention status, if different methods are used to assess outcomes in different intervention groups, or if measurement errors are related to the intervention status or effects [16].”
§ RoBANS 2: A Revised Risk of Bias Assessment Tool for Nonrandomized Studies of Interventions > DEVELOPMENT OF THE REVISED ROBANS (ROBANS 2) > 1. The Key Changes of the Revised RoBANS 2
What the sources say
- Not checked yetcites [16] source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
Citations
Cites
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“24) The RoBANS 2 is a comprehensive checklist instrument for assessing the risk of bias in cohort studies, case-control studies, cross-sectional studies, and before and after studies of interventions with user guidance to support educational purposes and improve inter-rater agreement of the…”
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Metadata
- Authors
- Seo, H.-J., Kim, S. Y., Lee, Y. J., & Park, J.-E.
- Affiliations
- Chungnam National University (KR)
- Hallym University (KR)
- Jaseng Medical Foundation (KR)
- Corresponding author
- Kim, Soo Young
- Venue
- Korean Journal of Family Medicine
- Published
- 2023-09-20
- Volume
- 44
- Issue
- 5
- Pages
- 249-260
- ISSN
- 2005-6443 (ISSN-L)
- 2092-6715
- PMC
- PMC10522469
- OpenAlex
- W4383550757
- Cited by
- 128
- References
- 23
- Citations by year
- 2026: 55 · 2025: 52 · 2024: 21
- FWCI
- 13.06
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Korean Journal of Family Medicine (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Health Insurance Review and Assessment Service
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- risk of bias assessment, non-randomized studies, selection bias, detection bias, outcome measure validity, inter-rater reliability, construct validity, psychometric properties, systematic review methodology
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-11-10, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-11-10 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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