NCT05684354

Patient Reported Outcome (PRO) in CARDiac Surgery.

Validation of the Quality of Recovery-15 Score in Cardiac Surgery: The PROCARDS Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The French version of the QoR-15 scale as validated by Demumieux et al was used in this study. Eligible patients were given oral and written information the day before or the morning before surgery. After patient agreed to participate, the first QoR-15 scale was distributed by one of the investigators. The patient filled in the questionnaire 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 and at the same time the patient was asked to rate his global recovery on a visual analog scale (VAS) graduated from 0 to 100 with 0 being the worst recovery and 100 the best recovery. Patient demographic characteristics were collected including age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status score, preoperative status of diabetes, hypertension, smoking status. Following perioperative data were recorded: type of surgery, duration of CPB, need for cardiac pacing or dobutamine support at the end of surgery, number of pleural and mediastinal chest tubes. Postoperative complications were also recorded: surgical revision, atrial fibrillation requiring antiarrhythmic medication or anticoagulation, pulmonary oedema requiring depletion, drained pleural effusion, drained pneumothorax, radiological atelectasis, radiologic pneumonia, stroke with radiological diagnosis, sepsis as defined by Third International Consensus Definitions for Sepsis and Septic Shock \[Sepsis-3\], Heparin-induced thrombocytopenia (HIT) documented by Serotonin release assay test. Total dose of morphine used in ICU, length of stay (LOS) in ICU and hospital, duration of surgical drains and mortality at day 28 were also assessed. Statistical analysis Sample size was The sample size was estimated at 150 patients and based on previous published studies(7,8) and guidelines recommending at least 10 subjects per item on the instrument scale(15). Data were reported as mean, median (inter-quartile range), or number (percentage) as appropriate. Correlations were calculated with Pearson correlation coefficient for Gaussian data or with Spearman correlation coefficient for non-Gaussian data. Factors associated with the QOR-15 score were searched by Analysis of Variance (ANOVA) for qualitative parameters and by linear regression for quantitative parameters. The null hypothesis was rejected if two-tailed P-value was inferior to 0.05

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
OTHER	Patient Reported Outcomes (PROs)	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

Timeline

• Start date: 2022-07-27
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2023-01-13
• Last updated: 2023-01-13

Locations

1 site across 1 country: France