The Quality of Recovery-15 Survey After Cardiac Surgery

The Validity of the Quality of Recovery Score 15 Following Cardiac Surgery

Patient reported outcomes are becoming increasingly recognized as an important metric to determine efficacy of interventions following recovery after cardiac surgery. Quality of Recovery 15 survey is a tool that attempts to measure patients' recovery across several different domains (i.e physical, emotional and social). This tool has been validated extensively in the post operative patient population, but these studies contained only small numbers of cardiac surgery patients. This population faces unique challenges to recovery such as a longer duration of mechanical ventilation, ICU and hospital LOS, delirium, significant pain in the first 24-48 hours and post operative arrhythmias. This study aims to validate the QoR 15 in this population exclusively to determine if it is feasible, valid, reliable and responsive in this unique population.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Cardiac Event; Cardiac Disease; Cardiac Complication; Cardiac Valve Disease; Surgery-Complications
• Intervention / Treatment: Other: Quality of Recovery 15 survey

Detailed Description

The QoR-15 will be administered at three time points, verbally to the patient by a standardized script. The time points are at baseline QoR-15 (t=0) at time of enrollment in the PAC, surgical daycare or surgical ward, post extubation day 1 (t=2), and post extubation day 2 (t=3) and 12 weeks following surgery. Concurrently, patients will also be asked to rate their overall postoperative recovery using an 100-mm visual analogue scale (VAS), from "poor recovery" to "excellent recovery". A subset of patients will also be asked to repeat the QoR 15 questionnaire 30-60 min later to measure repeatability. Duration to complete each QoR-15 will be recorded.

Baseline demographic information (sex, age, ethnicity, comorbidities such as smoking status, lung disease, history of MI, hypertension, heart failure, renal failure, NYHA class) will be collected at time of enrollment. Intraoperative data (type of surgical procedure, duration of procedure, duration of cardiopulmonary bypass and aortic cross clamp time), Cardiac Surgery Intensive Care Unit (CSICU) LoS, duration of mechanical ventilation, and hospital LoS will be collected following patient discharge from hospital.

Post operative complications will be assessed using the Clavien-Dindo Classification, which is a 5 scale classification system, ranking complications on severity, depending on therapy required. Days alive and at home to Day 30 (DAH 30) (10) is a quantifiable and patient centred outcome that may be used as a proxy for a patient's recovery after surgery. This will be collected from chart review at 30 days following surgery and will be used as a metric to assess construct validity.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Terri Sun; Phone Number: 6047797817; Email: terri.sun@gmail.com
• Study Contact Backup: Name: Nicola Edwards; Phone Number: 62115 604-682-2344; Email: nedwards@providencehealth.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital
      • Contact: Nicola Edwards, MHA; Phone Number: 604-861-9024; Email: nedwards@providencehealth.bc.ca
      • Principal Investigator: Terri Sun, MD
      • Sub-Investigator: Alana M Flexman, MD
      • Sub-Investigator: Nicola Y Edwards, MHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing inpatient or outpatient cardiac surgery at St. Paul's Hospital

Description

Inclusion Criteria:

• all patients undergoing cardiac surgery (outpatient or inpatient surgery)

Exclusion Criteria:

• At baseline patient screening:

  1. Patients who have severe cognitive impairment (score of 1 or 2) measured through the use of the three minute screening tool, Mini-Cog 26
  2. Patient has limited ability to complete assessment at baseline
  3. Unable to read/speak English
  4. Significant hearing impairments
  5. Critical state before surgery with high probability of death within 24 hours

• After cardiac surgery, patients will be removed from further data collection if:

  1. They require a tracheostomy or 5 days of ventilation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the QoR 15 (1.1)	Response rate (Percentage of questionnaires completed at each time point)	Aug 4, 2022 to Jan 1, 2023
Feasibility of the QoR 15 (1.2)	Proportion of questions completed independently without help/clarification by research assistant (Percentage)	Aug 4, 2022 to Jan 1, 2023
Feasibility of the QoR 15 (1.3)	Proportion of questions completed/answered (Percentage)	Aug 4, 2022 to Jan 1, 2023
Feasibility of the QoR 15 (1.4)	Time taken to complete the questionnaire (median +/- IQR)	Aug 4, 2022 to Feb 1, 2023
Validity (2.1)	Correlation between QoR 15 compared with VAS global rating of health using 100mm scale (Pearson correlation coefficient)	Aug 4, 2022 to Feb 1, 2023
Validity (2.2)	Correlation with NRS pain score (Pearson correlation coefficient)	Aug 4, 2022 to Feb 1, 2023
Validity (2.3)	Association between QoR 15 with age, gender, duration of surgery, duration of ICU stay, duration of hospital stay, opioid consumption, surgical complications and DAH 30 will be assessed using multivariable linear regression	Aug 4, 2022 to Feb 1, 2023
Reliability (3.1)	Internal consistency - averaged correlation between each item with QoR15	Aug 4, 2022 to Feb 1, 2023
Reliability (3.2)	15-25 patients will be asked to repeat a second time 30-60min later and their QoR 15 score compared	Aug 4, 2022 to Feb 1, 2023
Reliability (3.3)	Inter-item correlation matrix	Aug 4, 2022 to Feb 1, 2023
Reliability (3.4)	Interdimensional and item total dimension correlation	July 18. 2022 to Jan 1, 2023
Responsiveness (4.1)	Cohen effect size (avg change scores from pretest to post tes, divided by SD at baseline Standardised response mean (change scores divided by SD of change scores)	July 18. 2022 to Jan 1, 2023

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Study Director: Alana Flexman, University of British Columbia

Publications and helpful links

General Publications

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
• Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
• Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158.
• Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: H22-01459

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