Trial Outcomes & Findings for Development and Validation of a Preoperative Frailty Index Using Health Administrative Data (NCT NCT03354546)
NCT ID: NCT03354546
Last Updated: 2024-09-23
Results Overview
Still being alive (no death date) in the registered persons database Outcome is binary, exposure is per 0.1 unit increase
Recruitment status
COMPLETED
Target enrollment
511285 participants
Primary outcome timeframe
Date of surgery to 365 days after surgery
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Elective
Individuals having major noncardiac surgery following an elective hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
Emergency
Individuals having general surgery following an urgent hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
|---|---|---|
|
Overall Study
STARTED
|
415704
|
95581
|
|
Overall Study
COMPLETED
|
415704
|
95581
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
Baseline characteristics by cohort
| Measure |
Elective Surgery
n=415704 Participants
Individuals having major noncardiac surgery following an elective hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
Emergency Surgery
n=95581 Participants
Individuals having general surgery following an urgent hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
Total
n=511285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Frail
|
76 years
STANDARD_DEVIATION 6 • n=119824 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
76 years
STANDARD_DEVIATION 6 • n=40038 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
76 years
STANDARD_DEVIATION 6 • n=159862 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
|
Age, Continuous
Not Frail
|
73 years
STANDARD_DEVIATION 6 • n=295880 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
73 years
STANDARD_DEVIATION 6 • n=55543 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
73 years
STANDARD_DEVIATION 6 • n=351423 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
|
Sex: Female, Male
Frail · Female
|
58953 Participants
n=119824 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
21420 Participants
n=40038 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
80373 Participants
n=159862 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
|
Sex: Female, Male
Frail · Male
|
60871 Participants
n=119824 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
18618 Participants
n=40038 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
79489 Participants
n=159862 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
|
Sex: Female, Male
Not Frail · Female
|
165693 Participants
n=295880 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
30493 Participants
n=55543 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
196186 Participants
n=351423 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
|
Sex: Female, Male
Not Frail · Male
|
130187 Participants
n=295880 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
25050 Participants
n=55543 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
155237 Participants
n=351423 Participants • Analysis for elective and emergency surgery groups were further separated into frail and not frail participants
|
PRIMARY outcome
Timeframe: Date of surgery to 365 days after surgeryPopulation: We measured the unadjusted and adjusted associations between the pFI and postoperative outcomes in our elective surgery cohort. The unadjusted analysis contained only the pFI. Data was not collected from Emergency Surgery patients.
Still being alive (no death date) in the registered persons database Outcome is binary, exposure is per 0.1 unit increase
Outcome measures
| Measure |
Elective Surgery
n=415704 Participants
Individuals having major noncardiac surgery following an elective hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
Emergency Surgery
Individuals having general surgery following an urgent hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
|---|---|---|
|
Survival for One Year After Surgery
|
396164 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)Population: We measured the unadjusted and adjusted associations between the pFI and postoperative outcomes in our elective surgery cohort. The unadjusted analysis contained only the pFI. Data not collected from Emergency Surgery patients.
Discharge to long term care or continuing care facility at the time of hospital discharge
Outcome measures
| Measure |
Elective Surgery
n=415704 Participants
Individuals having major noncardiac surgery following an elective hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
Emergency Surgery
Individuals having general surgery following an urgent hospital admission
Frailty index: A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
|
|---|---|---|
|
Institutional Discharge
|
57666 Participants
|
0 Participants
|
Adverse Events
Elective Noncardiac Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19540 deaths
Emergency General Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place