Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)

Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median sternotomy, cardiopulmonary bypass, and myocardial manipulation continues to impose significant challenges in patient's recovery experience, such as pain, sleep disorders. Paradoxically, this critical recovery phase remains underexplored, as traditional outcome metrics predominantly focus on mortality and major morbidity endpoints. However, no cardiac surgery-specific tools currently exist to adequately capture postoperative recovery experience, creating barriers to optimal care. Accordingly, the investigators aim to develop and validate a recovery scale after cardiac surgery and evaluate its clinical performance compared to the generic scale (QoR-15)

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; PROM; Postoperative Recovery

• Study Type: Observational
• Enrollment (Actual): 3043

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient aged 18 years or older, undergoing elective cardiac surgery.

Description

Inclusion Criteria:

• Elective cardiac surgery

Exclusion Criteria:

• Emergency surgery
• Age ≤ 18 years
• Refuse to participate in this study
• prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort 1: Item generation
Cohort 2: Item finalization and validation
Cohort 3: Clinical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death or unplanned readmission	3-month post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Occurrence of death during hospitalization	From surgery to discharge, up to 7 days
In-hospital stroke	Occurrence of stroke during hospitalization	From surgery to discharge, up to 7 days
In-hospital myocardial infarction	Occurrence of myocardial infarction during hospitalization	From surgery to discharge, up to 7 days
In-hospital acute renal failure	Occurrence of acute renal failure during hospitalization	From surgery to discharge, up to 7 days
In-hospital sternal wound infection	Occurrence of sternal wound infection during hospitalization	From surgery to discharge, up to 7 days
In-hospital reoperation	Occurrence of reoperation during hospitalization	From surgery to discharge, up to 7 days
Length of hospital stay	Length of hospital stay	Approximately 7 days

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022-1882

Drug and device information, study documents

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