The Validity of the Quality of Recovery Score 15 Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Reliability (3.2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients undergoing cardiac surgery (outpatient or inpatient surgery)
排除标准
- •At baseline patient screening:
- •Patients who have severe cognitive impairment (score of 1 or 2) measured through the use of the three minute screening tool, Mini-Cog 26
- •Patient has limited ability to complete assessment at baseline
- •Unable to read/speak English
- •Significant hearing impairments
- •Critical state before surgery with high probability of death within 24 hours
- •After cardiac surgery, patients will be removed from further data collection if:
- •They require a tracheostomy or 5 days of ventilation
结局指标
主要结局
Reliability (3.2)
时间窗: Aug 4, 2022 to Feb 1, 2023
15-25 patients will be asked to repeat a second time 30-60min later and their QoR 15 score compared
Validity (2.2)
时间窗: Aug 4, 2022 to Feb 1, 2023
Correlation with NRS pain score (Pearson correlation coefficient)
Reliability (3.4)
时间窗: July 18. 2022 to Jan 1, 2023
Interdimensional and item total dimension correlation
Feasibility of the QoR 15 (1.2)
时间窗: Aug 4, 2022 to Jan 1, 2023
Proportion of questions completed independently without help/clarification by research assistant (Percentage)
Feasibility of the QoR 15 (1.4)
时间窗: Aug 4, 2022 to Feb 1, 2023
Time taken to complete the questionnaire (median +/- IQR)
Validity (2.3)
时间窗: Aug 4, 2022 to Feb 1, 2023
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
Reliability (3.3)
时间窗: Aug 4, 2022 to Feb 1, 2023
Inter-item correlation matrix
Feasibility of the QoR 15 (1.1)
时间窗: Aug 4, 2022 to Jan 1, 2023
Response rate (Percentage of questionnaires completed at each time point)
Feasibility of the QoR 15 (1.3)
时间窗: Aug 4, 2022 to Jan 1, 2023
Proportion of questions completed/answered (Percentage)
Validity (2.1)
时间窗: Aug 4, 2022 to Feb 1, 2023
Correlation between QoR 15 compared with VAS global rating of health using 100mm scale (Pearson correlation coefficient)
Reliability (3.1)
时间窗: Aug 4, 2022 to Feb 1, 2023
Internal consistency - averaged correlation between each item with QoR15
Responsiveness (4.1)
时间窗: July 18. 2022 to Jan 1, 2023
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)
次要结局
未报告次要终点
研究者
Terri Sun
Clinical Associate Professor
University of British Columbia