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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