# RoB 2 (Risk of Bias 2) Assessment Template

<!--
Usage: Use this template to assess risk of bias in randomized controlled trials.
Reference: Sterne JAC, et al. BMJ 2019;366:l4898
Save to: RESEARCH/[topic]/rob_rct.md
-->

# Risk of Bias Assessment (RoB 2) - Randomized Trials

## Review: [Your Review Title]
## Date: [Date]

---

## Summary Table

| Study | D1 | D2 | D3 | D4 | D5 | Overall |
|-------|----|----|----|----|----|---------|
| [Study 1] | 🟢/🟡/🔴 | 🟢/🟡/🔴 | 🟢/🟡/🔴 | 🟢/🟡/🔴 | 🟢/🟡/🔴 | 🟢/🟡/🔴 |
| [Study 2] | | | | | | |
| [Study 3] | | | | | | |

**Legend:**
- 🟢 Low risk
- 🟡 Some concerns
- 🔴 High risk

**Domains:**
- D1: Randomization process
- D2: Deviations from intended interventions
- D3: Missing outcome data
- D4: Measurement of outcome
- D5: Selection of reported result

---

## Detailed Assessment

### Study: [Author, Year]

#### Domain 1: Risk of bias arising from the randomization process

| Signalling Question | Response | Notes |
|---------------------|----------|-------|
| 1.1 Was the allocation sequence random? | Y/PY/PN/N/NI | |
| 1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions? | Y/PY/PN/N/NI | |
| 1.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | Y/PY/PN/N/NI | |

**Risk of bias judgement:** Low / Some concerns / High

**Rationale:** [Explain judgement]

---

#### Domain 2: Risk of bias due to deviations from the intended interventions

*Effect of assignment to intervention (intention-to-treat)*

| Signalling Question | Response | Notes |
|---------------------|----------|-------|
| 2.1 Were participants aware of their assigned intervention during the trial? | Y/PY/PN/N/NI | |
| 2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial? | Y/PY/PN/N/NI | |
| 2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context? | Y/PY/PN/N/NA | |
| 2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome? | Y/PY/PN/N/NA | |
| 2.5 If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups? | Y/PY/PN/N/NA | |
| 2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention? | Y/PY/PN/N/NI | |
| 2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact on the result? | Y/PY/PN/N/NA | |

**Risk of bias judgement:** Low / Some concerns / High

**Rationale:** [Explain judgement]

---

#### Domain 3: Risk of bias due to missing outcome data

| Signalling Question | Response | Notes |
|---------------------|----------|-------|
| 3.1 Were data for this outcome available for all, or nearly all, participants randomized? | Y/PY/PN/N/NI | |
| 3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data? | Y/PY/PN/N/NA | |
| 3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value? | Y/PY/PN/N/NA | |
| 3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | Y/PY/PN/N/NA | |

**Risk of bias judgement:** Low / Some concerns / High

**Rationale:** [Explain judgement]

---

#### Domain 4: Risk of bias in measurement of the outcome

| Signalling Question | Response | Notes |
|---------------------|----------|-------|
| 4.1 Was the method of measuring the outcome inappropriate? | Y/PY/PN/N/NI | |
| 4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | Y/PY/PN/N/NI | |
| 4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants? | Y/PY/PN/N/NI | |
| 4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received? | Y/PY/PN/N/NA | |
| 4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | Y/PY/PN/N/NA | |

**Risk of bias judgement:** Low / Some concerns / High

**Rationale:** [Explain judgement]

---

#### Domain 5: Risk of bias in selection of the reported result

| Signalling Question | Response | Notes |
|---------------------|----------|-------|
| 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | Y/PY/PN/N/NI | |
| 5.2 Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements within the outcome domain? | Y/PY/PN/N/NI | |
| 5.3 Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data? | Y/PY/PN/N/NI | |

**Risk of bias judgement:** Low / Some concerns / High

**Rationale:** [Explain judgement]

---

#### Overall Risk of Bias

**Overall judgement:** Low / Some concerns / High

**Rationale:** [Summarize across all domains]

---

## Response Options Key

| Code | Meaning |
|------|---------|
| Y | Yes |
| PY | Probably Yes |
| PN | Probably No |
| N | No |
| NI | No Information |
| NA | Not Applicable |

---

## Traffic Light Visualization

```
Study           D1    D2    D3    D4    D5    Overall
────────────────────────────────────────────────────────
Study 1         🟢    🟡    🟢    🟢    🟢    🟡
Study 2         🟢    🟢    🟢    🟡    🟢    🟡
Study 3         🔴    🟡    🟡    🟢    🟢    🔴
```

---

*Assessment completed: [Date]*
*Assessor(s): [Name(s)]*

*Reference: Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898.*
