1. Did the feasibility study allow a sample size calculation for the main trial? |
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2. What factors influenced eligibility and what proportion of those approached were eligible? |
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3. Was recruitment successful? |
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4. Did eligible participants consent? |
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5. Were participants successfully randomized and did randomization yield equality in groups? |
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6. Were blinding procedures adequate? |
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7. Did participants adhere to the intervention? |
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8. Was the intervention acceptable to the participants? |
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9. Was it possible to calculate intervention costs and duration? |
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10. Were outcome assessments completed? |
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11. Were outcomes measured those that were the most appropriate outcomes? |
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12. Was retention to the study good? |
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13. Were the logistics of running a multicenter trial assessed? |
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14. Did all components of the protocol work together? |
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