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Development and Validation of a Preoperative Frailty Index Using Health Administrative Data

Creation, Evaluation and Validation of a Preoperative Frailty Index Using Health Administrative Data: a Population-based Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03354546
Enrollment
511285
Registered
2017-11-28
Start date
2002-04-01
Completion date
2016-03-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail Elderly Syndrome, Surgery, Outcomes, Predictive Value of Tests

Brief summary

The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.

Detailed description

The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices. Once derived the index will be tested to measure its association with outcomes, as well as its discrimination. Various representations of the frailty index will be tested (primary-as a continuous measure; secondary as a binary, categorical and fractional polynomial variable). Performance in subgroups will also be evaluated,

Interventions

DIAGNOSTIC_TESTFrailty 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.

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Having elective or emergency noncardiac surgery

Exclusion criteria

* no provincial health insurance number

Design outcomes

Primary

MeasureTime frameDescription
Survival for One Year After SurgeryDate of surgery to 365 days after surgeryStill being alive (no death date) in the registered persons database Outcome is binary, exposure is per 0.1 unit increase

Secondary

MeasureTime frameDescription
Institutional DischargeDate of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)Discharge to long term care or continuing care facility at the time of hospital discharge

Participant flow

Participants by arm

ArmCount
Elective Surgery
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.
415,704
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.
95,581
Total511,285

Baseline characteristics

CharacteristicElective SurgeryEmergency SurgeryTotal
Age, Continuous
Frail
76 years
STANDARD_DEVIATION 6
76 years
STANDARD_DEVIATION 6
76 years
STANDARD_DEVIATION 6
Age, Continuous
Not Frail
73 years
STANDARD_DEVIATION 6
73 years
STANDARD_DEVIATION 6
73 years
STANDARD_DEVIATION 6
Sex: Female, Male
Frail
Female
58953 Participants21420 Participants80373 Participants
Sex: Female, Male
Frail
Male
60871 Participants18618 Participants79489 Participants
Sex: Female, Male
Not Frail
Female
165693 Participants30493 Participants196186 Participants
Sex: Female, Male
Not Frail
Male
130187 Participants25050 Participants155237 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
19,540 / 415,7040 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Survival for One Year After Surgery

Still being alive (no death date) in the registered persons database Outcome is binary, exposure is per 0.1 unit increase

Time frame: Date of surgery to 365 days after surgery

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 was not collected from Emergency Surgery patients.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Elective SurgerySurvival for One Year After Surgery396164 Participants
Emergency SurgerySurvival for One Year After Surgery0 Participants
Secondary

Institutional Discharge

Discharge to long term care or continuing care facility at the time of hospital discharge

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Elective SurgeryInstitutional Discharge57666 Participants
Emergency SurgeryInstitutional Discharge0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026