Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population

This study is a observational study in China, which aims to explore the predictive effect of preoperative frailty defined by the modified frailty index in predicting postoperative survival and complications in elderly patients.

The objectives of the study include:

1. To demonstrate that the frailty scale can predict short- and long-term survival after surgery in elderly surgical patients; 2 Demonstrated that frailty as defined by this scale is associated with postoperative complications in older patients

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: Frailty Index

Detailed Description

Traditionally, frailty has been described as the form of chronological age. Evaluating the patient's risks based solely on age is difficult, several other factors contribute to physiologic aging and determine functional reserve and response to the risk of postoperative complications. To meet the clinical demand for simpler frailty measurement tools, a simplified 5-index modified frailty index (mFI-5) has been proposed and validated in many literatures. However, there is a lack of evidence on the link between preoperative weakness and poor prognosis in elderly patients undergoing non cardiac surgery.

Therefore, the purpose of this study is to verify the prognostic value of mFI-5 for short-term and long-term adverse outcomes such as postoperative delirium, anxiety, depression, acute pain, and mortality in elderly non-cardiac surgery patients. Our hypothesis is that frailty may be highly correlated with postoperative mortality and adverse outcomes in elderly patients undergoing non-cardiac surgery, and that mFI-5 may be an effective risk prediction tool for decision-making and surgical planning.

• Study Type: Observational
• Enrollment (Actual): 12000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The lack of sufficient study data, however, does not demonstrate a dose-response relationship, with higher frailty levels having a greater impact on mortality [9]. Accordingly, this article would focus on the relationship between patients with varying degrees of frailty and long-term postoperative adverse outcomes and how preoperative planning and interventions can alter surgical trajectories and associated outcomes. According to our hypothesis, preoperative frailty can provide prognostic information, in addition to frequently recognized risks and consequences.

Description

Inclusion Criteria:

(1) participants ≥ 65 years of age;

Exclusion Criteria:

1. lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);
2. ASA physical status Ⅴ;
3. Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;
4. Surgery time ≤ 60 min.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robust; Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.
Prefrail; Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.	Other: Frailty Index; The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database
frail; Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.	Other: Frailty Index; The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month all-cause mortality	12-month postoperative mortality in elderly patients over 65 years of age	postoperative 12-month
6-month all-cause mortality	6-month postoperative mortality in elderly patients over 65 years of age	postoperative 6-month
1-month all-cause mortality	1-month postoperative mortality in elderly patients over 65 years of age	postoperative 1-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rates	The rate of second admissions in elderly patients over 65 years old who underwent surgery within 30 days after surgery	postoperative 30-day
Admission to ICU	Elderly surgical patients over the age of 65 are admitted to the intensive care unit after surgery	From the moment of living operation room to the moment of discharge from hospital,up to 7 day
major complications	Postoperative complications include delirium, anxiety, depression, acute pain, stroke, major adverse cardiac events, acute kidney injury, infection, etc	From the moment of living operation room to the moment of discharge from hospital,up to 7 day

Collaborators and Investigators

• Sponsor: Weidong Mi
• Investigators: Study Director: Weidong Mi, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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