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临床试验/NCT04169087
NCT04169087已完成不适用

Validation and Clinical Implications of the Korean Version of the "Quality of Recovery 15" After General Anesthesia: A Prospective Observational Cohort Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Convergent Validity of the QoR (Quality of Recovery)-15

研究概览

简要总结

The aim of this study is to test the Korean version of QoR-15 for its validity and clinical acceptability and feasibility.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Age under 18 or over
  • Do not understand our study
  • Medical or psychological disease that can affect the treatment response

结局指标

主要结局

Convergent Validity of the QoR (Quality of Recovery)-15

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hojin Lee, MD

Clinical assistant professor

Seoul National University Hospital

研究点 (1)

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