Table 1 Questions to ask during the design of surgical interventions in randomised controlled trials (RCTs)
From: Interventions in randomised controlled trials in surgery: issues to consider during trial design
| Â | Description |
|---|---|
1 | Does the RCT involve a surgical intervention? |
2 | What is/are the surgical intervention(s) under evaluation? |
3 | What is/are the concomitant intervention(s) accompanying surgery? |
4 | What will influence standardisation of the interventions? |
 a. What is the overall study design? | |
 b. What type of comparator is in the RCT? | |
 c. In what stage of development is/are the surgical intervention(s)? | |
5 | How will the intervention(s) be standardised in the RCT? |
6 | How will delivery of the intervention(s) be monitored in the RCT (fidelity)? |
7 | Who will deliver the intervention(s) (operator expertise)? |
8 | Where will the intervention(s) be delivered (context)? |