Validation of a Novel Frailty Index in Surgical Cohorts

Testing and Validation of a Novel Frailty Index in a Surgical Cohort

This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older

Study Overview

• Status: Completed
• Conditions: Anesthesia Morbidity; Surgery--Complications; Perioperative Complication
• Intervention / Treatment: Other: Frailty risk groups

• Study Type: Observational
• Enrollment (Actual): 50000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals over 65 years of age undergoing surgery at a University Hospital Setting

Description

Inclusion Criteria:

• Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved

Exclusion Criteria:

• No American Society of Anesthesiology classification provided

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low frailty; Frailty risk score less than 5	Other: Frailty risk groups; Patients older than 65 will be separated into groups of varying frailty risk
Intermediate Frailty; Frailty risk score 5-15	Other: Frailty risk groups; Patients older than 65 will be separated into groups of varying frailty risk
High frailty; Frailty risk score 15 and above	Other: Frailty risk groups; Patients older than 65 will be separated into groups of varying frailty risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	Mortality within 30 days of surgery in each of the three frailty risk groups	30-days
Time to hospital readmission	For patients surviving index hospitalization, the proportional hazard ratio of readmission between the three frailty group	Up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term mortality	Long-term mortality of the three different frailty risk groups, compared with proportional hazard modeling	Up to 14 years
Prolonged hospital length-of stay	Incidence of patients staying more than 10-days after surgery in the three frailty risk cohorts	3 months

Collaborators and Investigators

• Sponsor: University of Iceland
• Investigators: Principal Investigator: Martin I Sigurdsson, MD, PhD, University of Iceland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: FrailtyAndSurgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Just summary data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No