Validation and Clinical Implications of the Korean Version of the "Quality of Recovery 15" After General Anesthesia: A Prospective Observational Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Convergent Validity of the QoR (Quality of Recovery)-15
Study Overview
Brief Summary
The aim of this study is to test the Korean version of QoR-15 for its validity and clinical acceptability and feasibility.
Detailed Description
Quality of recovery (QoR) after anesthesia is an important measure of the early postoperative health status of patients. The QoR-40 is a widely-used questionnaire for postoperative patients and the short-form version of it (QoR-15) was developed in 2013. The validation of QoR-15 has been reported in the version of English, Portuguese, Danish, Chinese and Swedish. However, the study to validate the Korean version of QoR-15 has not been demonstrated.
Patients undergoing surgery and general anesthesia are asked by the investigators to complete the QoR-15 questionnaire and Korean 36-Item Short Form Health Survey (SF-36) a day before surgery. They are then asked to repeat the QoR-15 questionnaire 24 h postoperatively and also rate their overall postoperative pain score using 11-point numeric rating scale (NRS).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled to undergo elective general surgery, thoracic surgery and gynecological surgery under general anesthesia
- •Age between 18 and 80 years
- •Willingness and ability to sign an informed consent document
- •Ability to understand the contents of questionnaires
Exclusion Criteria
- •Age under 18 or over
- •Do not understand our study
- •Medical or psychological disease that can affect the treatment response
Outcomes
Primary Outcomes
Convergent Validity of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
The QoR-15 (0-150) is compared with the global QoR visual analog scale (VAS) (0-100), 36-Item Short Form Health Survey (SF-36) and interitem correlations are measured.
Discriminant Validity of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
To investigate if there is differences in the QoR-15 (0-150) and postoperative complications (Clavien Dindo grade II or high, %) between the high QoR score group and low QoR score group
Construct Validity of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
To investigate if there is an correlation between the QoR-15 (0-150) and age (yr), gender (male/female), American Society of Anesthesiologists (ASA) physical status (I-IV), type of surgery (minor/major), postoperative complication (Clavien Dindo grade II or high, %) and 11-point numeric rating scale (NRS) pain score.
Secondary Outcomes
- Response success rate of the QoR-15(A day before and 24 hours after the surgery)
- Correlation of postoperative outcomes with QoR-15(24 hours after the surgery)
- Reliability of the QoR (Quality of Recovery)-15(24 hours after the surgery)
Investigators
Hojin Lee, MD
Clinical assistant professor
Seoul National University Hospital