Table 2.
Study period |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Preallocation | Allocation | Postallocation |
Closeout | ||||||||
Time point* | Preoperative (−t1) | POD 0 (t0) | POD 0 (t1) | POD 1 (t2) | POD 2 (t3) | POD 3 (t4) | POD 30 (t5) | POD 60±30 (t6) | POD 180±45 (t7) | POD 365±60 (t8) | POD 365±60 (t9) |
Enrolment | |||||||||||
Eligibility | X | ||||||||||
Informed consent | X | ||||||||||
Allocation | X | ||||||||||
Intervention | X | ||||||||||
Assessments | |||||||||||
Medical history | X | ||||||||||
Locomotion ability | X | X | X | X | |||||||
Pain scales | X | X | X | X | X | X | X | ||||
Short Blessed Test (cognition) | X | X | X | X | X | ||||||
WHODAS V.2.0 (disability) | X | X | X | X | |||||||
Assessments | |||||||||||
3D-CAM (delirium) | X | X | X | X | |||||||
Bauer Scale (satisfaction)† | X | ||||||||||
Medical record review: intraoperative and postoperative events‡ | X | ||||||||||
Mortality (medical record review/telephone follow-up) | X | X | X | ||||||||
Mortality (National Death Index) | X | ||||||||||
Study closeout | X |
*REGAIN uses standard surgical conventions for counting postoperative days. Postoperative day 0 indicates the day of surgery, corresponding to the 24-hour period beginning on midnight of the day that includes the surgery end time. Postoperative day 1 indicates the 24-hour period beginning at the first midnight after the surgery end time.
†For patients discharged prior to postoperative day 3, the Bauer Scale is administered on the day of hospital discharge.
‡For patients who are discharged or who die prior to POD 30, medical record abstraction occurs at the time of discharge or death. Medical record abstraction encompasses only the index hospitalisation.
3D-CAM, 3 min assessment for CAM (Confusion Assessment Method)-defined delirium; POD, postoperative day; REGAIN, Regional versus General Anesthesia for Promoting Independence after Hip Fracture; WHODAS, WHO Disability Assessment Schedule.