| |
2
|
Randomization is described and adequate (random numbers, computer generated, etc.)
|
|
Randomization
|
1
|
Randomization is described
|
| |
0
|
No or inappropriate randomization
|
|
Allocation
|
2
|
Allocation concealment is described and adequate (sequentially numbered opaque sealed envelopes, central randomization, etc.)
|
|
concealment
|
1
|
Allocation concealment is described
|
Adapted Jadad score
| |
0
|
No or inappropriate allocation concealment
|
|
Intervention
|
2
|
Blinding is described and adequate
|
|
blinding
|
1
|
Blinding is described
|
| |
0
|
No or inappropriate blinding
|
|
Withdrawal or
|
1
|
Withdrawals and dropouts are described
|
|
dropouts
|
0
|
Withdrawals or dropouts are not described
|
|
Intention-to-treat
|
1
|
ITT analysis is used
|
|
(ITT) analysis
|
0
|
ITT analysis is not used
|
|
Similar groups at baseline
|
1
|
Delirium-related factors (age, sex, pre-existing cognitive or sensory deficit, physical functional status, comorbid diseases, medications and alcohol consumption [12, 15, 16]) are similar between groups
|
| |
0
|
Delirium-related factors are not screened or different
|
Delirium specific score
|
Delirium assessor blinding
|
1
|
Delirium assessor is blinded to the interventions
|
| | |
Delirium assessor is not blinded to the interventions
|
| |
2
|
Frequency: ≥ 1/day since postoperative day (POD) 1 and duration: > 3 days since POD 1 [1, 14]
|
|
Delirium follow-up
|
1
|
Frequency: ≥ 1/day since POD 1 and duration: POD 1-3
|
| |
0
|
Frequency: < 1/day or duration < 3 days since POD 1
|