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Table 1 (abstract A1). Attitude of RCTs: Domains of PRECIS2

From: The ethics of ‘Trials within Cohorts’ (TwiCs): 2nd international symposium

1. Eligibility: How similar are trial participants to those in intended usual care?

2. Recruitment: Is trial recruitment process similar to that of entry into usual care?

3. Setting: How similar is the trial setting to the intended usual care setting?

4. Organisation: Are resources added for care in the trial beyond those in usual care?

5. Flexibility-delivery: Are clinicians constrained differently from usual care?

6. Flexibility-adherence: Are participants selected, burdened beyond usual care?

7. Follow up: Are participants followed up more closely that in usual care?

8. Primary outcome: How similar are trial outcomes to usual care criteria for success?

9. Primary analysis: Are all participants included in the main analysis?