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

NCT ID: NCT07194369

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2025-12-30

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.

Conditions

Quality of Recovery (QoR-15); Quality of Recovery From Anaesthesia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sefako Makgatho Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Unathi Mzinyathi

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charle Dr Steyl

Role: STUDY_DIRECTOR

Sefako Makgatho Health Sciences University

Locations

Dr George Mukhari Academic Hospital

Pretoria, Gauteng, South Africa

Countries

South Africa

Central Contacts

Unathi Dr Mzinyathi

Role: CONTACT

201308763@swave.smu.ac.za

0711436058

Facility Contacts

Kenneth Dr Matea

Role: primary

Kenneth.Matea@gauteng.gov.za

0125293876/7 ext. 0125293876

Keitumetse Mongale

Role: backup

keitumetse.mongale@gauteng.gov.za

0125293877 ext. 0125293877

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

SMUREC/M/276/2025:PG

Identifier Type: -

Identifier Source: org_study_id