Table 3.
| Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) items related to randomization
| Statement | Item number | Checklist item |
|---|---|---|
| CONSORT | 8a | Method used to generate the random allocation sequence |
| 8b | Type of randomization; details of any restriction | |
| 9 | Mechanism used to implement the random allocation sequence, describing any steps to conceal the sequence until interventions were assigned | |
| 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | |
| SPIRIT | 16a | Method of generating the allocation sequence, and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction should be provided in a separate document that is unavailable to those who enroll participants or assign interventions |
| 16b | Mechanism of implementing the allocation sequence, describing any steps to conceal the sequence until interventions are assigned | |
| 16c | Who will generate the allocation sequence, who will enroll participants, and who will assign participants to interventions |