Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa

Not yet recruiting

• Conditions: Quality of Recovery (QoR-15); Quality of Recovery From Anaesthesia

• Registration Number: NCT07194369
• Lead Sponsor: Sefako Makgatho Health Sciences University

Brief Summary

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).

Detailed Description

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.

By adding another validated translation in a local language, it is hoped that it will be easier to measure quality of recovery in Setswana speaking populations to address health disparities.

A Setswana translation of the QoR-15 questionnaire exists from a previous study which may be of use in Ga-Rankuwa, which is home to a Setswana speaking population. This translated questionnaire is yet to be validated in this population. For patient reported outcome measures (PROMs) to be effective in non-English speaking populations, rigorous linguistic and cultural adaptation is necessary.

In this study, quality of recovery will be measured with the Setswana translation of the QoR-15 questionnaire as well as with a visual analog scale on which patients can rate their overall postoperative recovery.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-01
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-15
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Convergent validity of the Setswana-translated QoR-15 score	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).

Secondary Outcome Measures

Name	Time	Method
Acceptability and feasibility of the Setswana-translated QoR-15 score	During recruitment and postoperative assessment	To evaluate acceptability and feasibility by calculating the recruitment rate, completion rate and time taken to complete the questionnaire
Construct validity of the Setswana-translated QoR-15 score	Pre-operative (baseline) and 24 hours postoperatively	To evaluate construct validity by assessing associations between the QoR-15 score and patient factors (age, gender, duration \& severity of surgery).; Unit of Measure: Regression coefficients/association statistics
Internal consistency of the Setswana translated QoR-15 score	Pre-operative (baseline) and 24 hours postoperatively	To evaluate internal consistency using Cronbach's alpha based on the average correlation between the QoR-15 items.
Test-retest variability of the Setswana-translated QoR-15 score	60 minutes after first postoperative questionnaire	To evaluate test-retest variability in a subset of 25 patients who will be asked to complete a repeat assessment 60 minutes after their first postoperative questionnaire.; Unit of measure: intraclass correlation coefficient
Responsiveness of the Setswana-translated QoR-15 score	Pre-operative (baseline) and 24 hours postoperatively.	To evaluate responsiveness by calculating Cohen's effect size of change in QoR-15 scores from pre-operative to postoperative assessment.

Trial Locations

Locations (1)

Dr George Mukhari Academic Hospital; 🇿🇦 Pretoria, Gauteng, South Africa