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临床试验/NCT07194369
NCT07194369尚未招募不适用

Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa: a Cross-Sectional Observational Study

Sefako Makgatho Health Sciences University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
Convergent validity of the Setswana-translated QoR-15 score

研究概览

简要总结

This observational study aims to evaluate the validity, reliability and feasibility of the Setswana-translated version of the 15-item Quality of Recovery (QoR-15) questionnaire. The question it aims to answer is:

Does the Setswana translation of the QoR-15 serve as a valid, reliable and user friendly tool for assessing postoperative recovery in Setswana speaking patients undergoing orthopaedic surgery at a tertiary hospital in Gauteng, South Africa?

The participants will be asked to complete the Setswana-translated QoR-15 questionnaire both preoperatively and postoperatively.

In addition, they will be asked to rate their overall postoperative recovery using a visual analog scale (VAS).

详细描述

Patient reported outcome measures are increasingly recognised as important in preoperative research, yet their routine use in clinical practice remains limited in South Africa.

While quality of recovery measures have been widely applied in general and ambulatory surgery settings, there is a relative paucity of data specifically addressing orthopaedic populations.

Orthopaedic surgical procedures are associated with significant postoperative pain, functional limitations and extended rehabilitation periods, all of which can substantially impact the patient's overall recovery experience. Evaluating a short-term postoperative outcome like quality of recovery in this surgical cohort may help tailor postoperative care to patient needs, which may lead to better patient-clinician communication, better surgical outcomes and better patient satisfaction.

A lack of standardised and validated outcome measures in local languages and high rates of illiteracy may be impediments to implementing widespread use of patient reported outcome questionnaires in practice. Patients who are functionally literate may still not understand medical terms if not presented in their home language and proficiency in English varies widely across South Africa. South Africa has a diverse language heritage with 11 official languages and high rates of functional illiteracy. While many South Africans are able to communicate in English, only a small minority reports English as the primary language used most often outside the household. For black South Africans, the most common languages spoken outside of the home most commonly are IsiZulu, IsiXhosa and the Sotho-Tswana languages.

At present, validated translations of the QoR-15 questionnaire are only available in English and IsiZulu for South African use.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Adult patients over 18 years of age
  • Scheduled elective orthopaedic surgery at Dr George Mukhari Academic Hospital

排除标准

  • Patients who are not fluent in Setswana
  • Patients booked for emergency surgery where a delay to surgery could be detrimental.
  • Patients where the surgery is delayed beyond 10 days of the initial assessment and pre-operative QoR-15 measurement.
  • Patients with a psychiatric disturbance that precludes complete co-operation.
  • Patients with a severe debilitating medical or surgical condition that may limit objective assessment after surgery.
  • Patients with any life threatening postoperative complication.
  • Postoperative confusion or delirium.
  • Patients with a history of recent drug or alcohol abuse which may render responses unreliable.
  • Incomplete QoR-15 questionnaires.

结局指标

主要结局

Convergent validity of the Setswana-translated QoR-15 score

时间窗: Pre-operative baseline and 24 hours postoperatively.

To evaluate convergent validity by assessing the Spearman correlation between the Setswana-translated QoR-15 score and a general visual analog scale (VAS). Unit of measure: Correlation co-efficient (r).

次要结局

  • Acceptability and feasibility of the Setswana-translated QoR-15 score(During recruitment and postoperative assessment)
  • Construct validity of the Setswana-translated QoR-15 score(Pre-operative (baseline) and 24 hours postoperatively)
  • Internal consistency of the Setswana translated QoR-15 score(Pre-operative (baseline) and 24 hours postoperatively)
  • Test-retest variability of the Setswana-translated QoR-15 score(60 minutes after first postoperative questionnaire)
  • Responsiveness of the Setswana-translated QoR-15 score(Pre-operative (baseline) and 24 hours postoperatively.)

研究者

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

Unathi Mzinyathi

DR

Sefako Makgatho Health Sciences University

研究点 (1)

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