DOWNLOADS: Benefit Classifications (WORD | PDF)
The ORBIT II classification system for missing or complete outcome reporting in harm outcomes |
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Classification |
Description |
Level of reporting |
Risk of bias* |
Explicit specific harm outcome: measured and compared across treatment groups |
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P1 |
States outcome analysed but reported only that p-value>0.05. |
Partial |
High Risk |
P2 |
States outcome analysed but reported only that p-value<0.05. |
Partial |
High Risk |
P3 |
Insufficient reporting for meta-analysis or full tabulation. |
Partial |
Low Risk |
Explicit specific harm outcome: measured but not compared across treatment groups |
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Q |
Clear that outcome was measured and clear outcome was not compared. |
NA |
No risk |
Explicit specific harm outcome: measured, not clear whether compared or not across treatment groups |
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R1 |
Clear that outcome was measured but no results reported. |
None |
High Risk |
R2 |
Result reported globally across all groups. |
None |
High Risk |
R3 |
Result reported from some groups only. |
None |
High Risk |
Specific harm outcome not explicitly mentioned: clinical judgment says likely measured and likely compared across treatment groups |
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S1 |
Only pooled adverse events reported (could include specific harm outcome). |
None |
High Risk |
S2 |
No harms mentioned or reported. |
None |
High Risk |
Specific harm outcome not explicitly mentioned: clinical judgment says likely measured but no events |
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T1 |
Specific harm not mentioned but all other specific harms fully reported. |
None |
Low Risk |
T2 |
No description of specific harms. |
None |
Low Risk |
Specific harm outcome not explicitly mentioned, clinical judgment says unlikely measured |
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U |
No harms mentioned or reported. |
None |
Low Risk |
Explicit the specific harm outcome was not measured |
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V |
Report clearly specifies that data on the specific harm of interest was not measured. |
NA |
No Risk |
*Bias would occur if specific harm had been measured, but data were presented or suppressed in a way that would mask the harm profile of particular interventions.