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Table 2 Primary and Secondary Outcomes

From: Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery

Domain Outcome Definition
Delirium Incident delirium
(Primary Outcome)
Any CAM (+) assessment
Delirium severity Maximum DRS-R-98 score
Number of days of delirium Number of CAM (+) days
Cognition Change in MMSE/TICS Change in score. Item response theory will be used to compare similar or exact items if TICS> 50% of responses.
Change in other individual test scores Verbal Fluency (all trials combined, sum of scores), TMT-A (time), TMB-B - TMT-A (time), DSF (longest span correct), DSB (longest span correct)
Function Any decline in IADL score Any decline in IADL score from baseline to 3- and 12-month follow-up
Disability Change in ODI score Change in ODI score (%) from baseline to 3- and 12-month follow-up
Health-Related Quality of Life Change in SF-12 PCS Change in PCS score from baseline to 3- and 12-month follow-up
Change in SF-12 MCS Change in MCS score from baseline to 3- and 12-month follow-up
Health Care Utilization Readmissions % Readmissions
Emergency department visits % Emergency department visits
Duration of hospitalization Number of days in hospital after surgery
Pain PACU pain Last pain score in PACU.
Total morphine equivalents
Time to first opoid
Hospital pain Last pre-discharge pain score.
Total morphine equivalents, pro-rated for 72 h in hospital
Post-discharge pain Average pain score at 3- and 12-month follow-up
  1. Abbreviations: CAM Confusion Assessment Method, DRS-R-98 Delirium Rating Scale-Revised 1998, MMSE Mini-Mental State Examination, TMT Trail Making Test, DSF Digit Span Forward, DSB Digit Span Backwards, IADL Instrumental Activities of Daily Living, ODI Oswestry Disability Index, SF-12 12-Item Short Form Health Survey, PCS physical component summary, MCS mental component summary, PACU postoperative anesthesia care unit