Table 1.
Checklist of recommendations for future randomized clinical trials comparing plexus anesthesia with general anesthesia in patients with a symptomatic and significant (≥50%) stenosis undergoing carotid endarterectomy with patch angioplasty. In an attempt to bridge the information gap, a new trial should at least comprise as many patients as the hitherto largest and that preferably several new trials will be needed with at least as many patients as it takes to produce a boundary break through (boundary for benefit, harm or futility) in the Trial Sequential Analysis, or in the worst case scenario; to close the gap between the required and the presently accrued information size.
Item | Recommendation |
---|---|
To get the evaluation of serious adverse events (SAE) right | Count the number of patients with one or more SAE, and not just the total number of SAE. |
To prevent design error |
|
| |
| |
To avoid bias | Future trials should be in line with the CONSORT statements [49] |
To minimize risk of random error | The sample size should exceed e.g. 2000 participants in one or more future trials. |
Data sharing | Data sharing is important to increase sample sizes in future trials. |
Trial coordinators should be encouraged to participate in sharing anonymized data upon request review author. | |
Comparison | Outcome measures critical for decision making according to the GRADE (39). |