How to Use ROBIS (Risk Of Bias In Systematic Reviews)
ROBIS (Risk Of Bias In Systematic Reviews) is a structured tool designed to assess the risk of bias in systematic reviews (SRs) across various domains. Unlike AMSTAR-2 (which evaluates methodological quality), ROBIS specifically focuses on identifying biases that could distort the review’s conclusions.
ROBIS: Step-by-Step Guide
1. Understand the 3 Phases of ROBIS
ROBIS is applied in three phases:
Phase | Purpose |
---|---|
Phase 1 | Assess relevance (optional) – Is the review relevant to your research question? |
Phase 2 | Identify concerns about bias in 4 key domains |
Phase 3 | Judge overall risk of bias in the review |
2. Phase 2: Assess Bias in 4 Key Domains
Each domain is rated as “Low,” “High,” or “Unclear” risk of bias.
Domain 1: Study Eligibility Criteria
- Did the review use appropriate inclusion/exclusion criteria?
- Were the criteria pre-specified (e.g., in a protocol)?
- Bias risk: High if criteria were modified after seeing results.
Domain 2: Identification and Selection of Studies
- Was the search strategy comprehensive (databases, grey literature, no language restrictions)?
- Were multiple reviewers involved in study selection?
- Bias risk: High if key studies were missed due to poor search methods.
Domain 3: Data Collection and Study Appraisal
- Were data extracted independently by multiple reviewers?
- Was risk of bias assessed in included studies (e.g., using Cochrane RoB tool)?
- Bias risk: High if subjective decisions influenced results.
Domain 4: Synthesis and Findings
- Were appropriate methods used for meta-analysis (if applicable)?
- Was heterogeneity explored?
- Were conflicts of interest reported?
- Bias risk: High if synthesis methods were flawed (e.g., selective reporting).
3. Phase 3: Final Judgment of Overall Risk of Bias
After assessing all domains, determine the overall risk of bias:
- Low risk = No major concerns in any domain.
- High risk = Serious concerns in ≥1 domain.
- Unclear risk = Insufficient information.
When to Use ROBIS?
✔ Critical appraisal of SRs for clinical guidelines.
✔ Peer review of manuscripts.
✔ Comparing multiple SRs on the same topic.
Example ROBIS Assessment
Review Topic: “Effectiveness of probiotics for antibiotic-associated diarrhea.”
Domain | Judgment | Reason |
---|---|---|
Eligibility Criteria | Low risk | Clearly defined PICO criteria. |
Study Selection | High risk | Only English-language studies included. |
Data Collection | Low risk | Dual extraction & RoB assessment done. |
Synthesis | Unclear risk | Heterogeneity not fully explored. |
Overall Risk of Bias | High | Language bias could skew results. |
Strengths of ROBIS
✔ Focuses specifically on bias (unlike AMSTAR-2, which covers general quality).
✔ Applicable to all SRs (including non-intervention studies).
✔ Clear structured approach with signaling questions.
Limitations
✖ Subjective judgments required (experience helps).
✖ Time-consuming compared to simpler tools like CASP.
ROBIS vs. AMSTAR-2
Feature | ROBIS | AMSTAR-2 |
---|---|---|
Focus | Bias assessment | Methodological quality |
Scoring | Low/High/Unclear risk | High/Moderate/Low/Critically Low confidence |
Best for | Detecting flawed conclusions | Overall quality check |
Conclusion
ROBIS is a powerful tool for detecting bias in systematic reviews, helping clinicians and researchers decide whether to trust a review’s findings.