Translation and Psychometric Validation of the Thai Version of the Pediatric Quality of Recovery Score (Thai-PedsQoR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
研究概览
简要总结
Postoperative recovery in children is a complex, multidimensional process that differs substantially from recovery in adults, encompassing physical comfort, emotional well-being, behavioral changes, and psychosocial functioning. While several validated Quality of Recovery (QoR) instruments are widely used in adult perioperative care, equivalent tools for pediatric populations remain limited, particularly in non-English-speaking settings. The Pediatric Quality of Recovery score (PedSQoR) was recently developed to address this gap by providing a comprehensive, patient- and proxy-reported outcome measure specifically designed for children. However, a culturally adapted and psychometrically validated Thai version of this instrument is currently unavailable.
The primary objective of this study is to translate and culturally adapt the PedSQoR into Thai in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for patient-reported outcome measures. The secondary objective is to evaluate the psychometric properties of the Thai-PedSQoR, including content validity, construct validity, reliability, and responsiveness, in Thai pediatric surgical patients.
This clinical applied research will be conducted at Siriraj Hospital and will include children aged 2-17 years undergoing elective surgery or procedures requiring anesthesia. The translation process will involve forward and backward translation, expert committee review, and cognitive debriefing with parents and children to ensure conceptual equivalence and cultural appropriateness. Psychometric validation will be performed in a cohort of 130 participants, stratified into proxy-report and self-report groups according to age. The Thai-PedSQoR will be administered on postoperative days 2, 6, and 21, alongside anchor measures including pain and global recovery visual analog scales.
The expected outcome of this study is a reliable and valid Thai version of the PedSQoR that can be used in clinical practice, quality improvement initiatives, and future pediatric perioperative research, supporting patient-centered and value-based pediatric surgical care in Thailand.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 2-17 years undergoing day surgery/intervention or surgery/intervention requiring postoperative hospital admission.
- •ASA Physical Status I-III.
排除标准
- •Patients or parents/guardians who are unable to communicate in Thai.
- •Urgent or emergent surgery.
- •Children with significant developmental delay or severe systemic disease that interferes with activities of daily living.
- •Parents, guardians, or patients who, in the opinion of the investigator, are unlikely to be available to complete follow-up.
研究组 & 干预措施
Pediatric patients undergoing surgery
Pediatric patients undergoing surgery who complete the Thai-PedsQoR questionnaire, either by self-report or proxy-report. No intervention or group comparison is performed.
结局指标
主要结局
Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
时间窗: With in 2 months after IRB approval
Completion of the translation and cultural adaptation process of the Pediatric Quality of Recovery Questionnaire (PedSQoR) into Thai, following the ISPOR guidelines. Successful adaptation is defined as finalized Thai-PedsQoR wording approved by forward translation, backward translation, expert review, and cognitive debriefing, with no unresolved major issues identified.
次要结局
- Internal Consistency of the Thai-PedsQoR(From initial questionnaire administration to repeat assessment within 21 days)
- Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)(From initial questionnaire administration to repeat assessment within 21 days)
- Item-Level Content Validity Index (I-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)(Within 3 months after IRB approval)
- Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)(Within 3 months after IRB approval)
- Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)(Within 3 months after IRB approval)