Patient Reported Outcome (PRO) in CARDiac Surgery.

NCT05684354 | Completed

• 1 other identifier: 35RC22_3088 PROCARDS
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The use of Patient Reported Outcomes (PROs) in anaesthesia provides a measure of the patient's quality of postoperative recovery based on his/her own experience. The Quality-Of-Recovery-15 (QoR-15) is a widely used questionnaire which has never been validated in cardiac surgery patients. This study aimed at validating the French version of the QoR-15 scale in a cohort of cardiac surgical patients. The QoR-15 scale would have similar psychometric properties and interpretability in assessing postoperative recovery in this population than in general surgery patients.

Conditions

Cardiac Surgery

Keywords

cardiac; surgery; postoperative care

Outcome Measures

Primary Outcomes (1)

• Assess the validity of QoR-15 in the post-operative period of cardiac surgery

  Validity (the accuracy of a scale - does the QoR-15 measure what is intended: the quality of postoperative recovery). Convergent validity was tested by the hypothesis that there would be a positive correlation between the postoperative QoR-15 score and the global recovery assessment by the patient, or between the QoR-15 (postoperative-preoperative QoR-15 scores) and the global recovery assessment. Construct validity was tested by the hypothesis that there would be a negative association between the QoR-15 score and various known determinants of postoperative recovery

  Day 5

Secondary Outcomes (3)

• Assess the Reliability of QoR-15 in the post-operative period of cardiac surgery

  Day 5

• Assess the Responsiveness of QoR-15 in the post-operative period of cardiac surgery

  Day 5

• Assess the Feasibility of QoR-15 in the post-operative period of cardiac surgery

  Day 5

Interventions

Patient Reported Outcomes (PROs) OTHER

The day before or the morning before surgery, the patient filled the first QoR-15 scale alone or could be helped by one of the investigators in case of questions or difficulties. The second QoR-15 scale was distributed the day before or the day of discharge from the hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients scheduled for cardiac surgery under CPB including valve surgery, coronary artery bypass, ascending aorta surgery, combined procedure, and had given oral informed consent. Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, patients unable to complete the questionnaire independently (cognitive deficit or poor French comprehension) and pregnant or breastfeeding women were not included

You may qualify if:

• Patients over 18 years old
• Hospitalized for planned cardiac surgery among: coronary artery bypass grafting, valve plasty, valve replacement or ascending aortic surgery
• Patient not opposing his participation in the research
• Adults subject to legal protection (safeguard of justice, curatorship, guardianship)
• Persons deprived of liberty
• Patient unable to complete the questionnaire independently (cognitive deficit or patient who does not speak French)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Interventions

Patient Reported Outcome Measures

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Grégoire LE GAC

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: July 27, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

FR (1)