A. Bias arising from the randomisation process |
Inadequate generation of a random sequence |
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Inadequate allocation concealment |
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Imbalance in baseline characteristics |
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No adjustment for confounding in the analysis |
B. Bias due to deviations from intended interventions |
Non-blinded participants |
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Non-blinded clinician/treatment provider |
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Unbalanced delivery of additional interventions or co-interventions |
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Participants switching interventions within the trial and being analysed in a group different from the one to which they were randomized |
C. Bias due to missing/incomplete outcome |
Missing/incomplete outcome data (dropouts, losses to follow-up, or post-randomisation exclusions) |
D. Bias in measurement of outcomes |
Non-blinded outcome assessor |
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Non-blinded data analyst |
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Use of faulty measurement instruments (with low validity and reliability) |
E. Bias in selection of the reported result |
Selective reporting of a subset of outcome domains, or of a subset of outcome measures or analyses for a particular outcome domain. |