Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Rate of suspected spinal cord hematomas or infections |
Measured by the number of participants requiring spinal imaging |
1 year |
|
Other |
World Health Organization Disability Assessment Schedule 2.0 (WHODAS) |
Patient-reported disability scale that assesses limitations in six major life domains (cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score. People who die prior to follow up are assigned a score of 100% (completely disabled). |
30 days, 90 days, 1 year |
|
Other |
EuroQol Health-related quality of life (EQ-5D-5L) |
Well-validated instrument with Canadian valuation statistics and national implementation used to measure health-related quality of life at baseline, 30, 90, and 365 days after surgery and to inform incremental cost per quality-adjusted life year gained. Each item in the EQ-5D-5L has five levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). |
30 days, 90 days, 1 year |
|
Other |
Pain Score |
A numeric rating scale pain score (worst and average) will be collected at each prospective assessment point. Likert scale from 0-10 will be used where 0=No Pain At All and 10=Worst Possible Pain. |
up to 3 days, 30 days, 90 days, 1 year |
|
Other |
Satisfaction with anesthesic technique: 'Likelihood to recommend', reflecting on a 10-point scale their likelihood to recommend their anesthetic technique to a future patient having the same surgery |
At the first in-hospital follow up patients will complete the 'Likelihood to recommend' question, where they will report a score from 0=Not at all likely to recommend to 10=Very likely to recommend. |
up to 3 days |
|
Other |
Quality of Recovery Score: How well the patient feels they have recovered from their anesthetic and operation |
At the first in-hospital follow up patients will answer 15 questions regarding how they have been feeling in the last 24 hours and will score each question on a Likert scale. The scoring for the first 10 questions goes from 0 to 10, where 0=they experience the issue none of the time [poor] and 10=they experience the issue all of the time [excellent]. For the last 5 questions the score goes from 10 to 0, where 10=they experience this symptom none of the time [excellent] and 0=all of the time [poor]. Results are totalled to provide an overall score for the 15 questions |
up to 3 days |
|
Other |
Delirium |
Using the validated chart review tool, Chart-based Delirium Identification Instrument |
1 month |
|
Other |
Complications |
The validated and widely used Post-Operative Morbidity Survey (POMS) will be used to identify complications from the medical record; severity will be assessed using the Clavien-Dindo classification. At time of discharge, participants will also be administered a patient-reported version of the POMS tool. |
1 month |
|
Other |
Index hospitalization |
Length of stay post-surgery and discharge disposition post-surgery |
1 month |
|
Other |
Major adverse limb events |
Collected from medical records and by telephone follow up using Society of Vascular Surgery criteria |
30 days, 90 days, 1 year |
|
Other |
Days at home |
In the 30-days after surgery, is a validated patient-centered, outcome that can be ascertained from routinely collected data |
30 days |
|
Other |
Readmission |
Time to first, and count of any, acute hospitalization |
up to 1 year |
|
Other |
Emergency department visits |
Time to first, and count of any emergency department visits |
up to 1 year |
|
Other |
Survival |
All cause deaths and survival time after surgery will be captured from medical records and by telephone follow up. |
up to 1 year |
|
Other |
Healthy system costs |
A validated patient-level costing algorithm will be used to capture all health system costs accrued after surgery |
up to 1 year |
|
Other |
Rate of spinal hematomas or infections |
Measured by the number of participants requiring surgery to decompress or evacuate a spinal hematoma |
1 year |
|
Primary |
Monthly recruitment |
Monthly recruitment of >=2 participants per center means that the full trial should be feasible |
2 years |
|
Secondary |
Intervention adherence |
>=90% of participants were treated with allocated randomization arm to minimize the risk of contamination bias |
1 day |
|
Secondary |
Retention |
>=90% of participants at the patient-reported primary outcome point of 30-days after surgery should minimize attrition bias in the definitive trial's primary outcome data |
30 days |
|
Secondary |
Elicitation of patient, clinician and researcher-identified barriers and facilitators |
For study participants, at 30-day follow-up, a survey will be administered focusing on the acts of enrolling and being followed up in the trial. For research team members, a survey focused on the acts of participant recruitment and study support will be done once per site for all researchers, inclusive of clinician researchers and research staff, at approximately 3-4 months after study launch at their site. |
30 days, 120 days |
|