Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa: a Cross-Sectional Observational Study
Conditions: Quality of Recovery (QoR-15), Quality of Recovery From Anaesthesia
Sponsor: Sefako Makgatho Health Sciences University

 
 
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Protocol 
Validation of the Setswana-Translated Quality of 
Recovery Questionnaire in Orthopaedic Patients at a 
Tertiary Hospital in South Africa:  
a Cross-Sectional Observational Study 
 
ClinicalTrials.gov:  
 
 
MMed Anaesthesiology: 
Dr. Unathi Mzinyathi, Registrar, Department of Anaesthesiology 
Student number: 201308763 
 
Supervisor: 
Dr. Charle Steyl, Lecturer, Department of Anaesthesiology 
 
School of Medicine 
 
Issue Date:   
 
 
 
May 2024 
Protocol Version Number: 
 
3 
Authors: 
 
 
 
 
U.M. 

 
 
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Table of Contents 
1 
ADMINISTRATIVE INFORMATION ..........................................................................................................................3 
1.1 
TRIAL REGISTRATION ........................................................................................................................................................ 3 
1.2 
REVISION CHRONOLOGY ................................................................................................................................................... 3 
2 
INTRODUCTION ....................................................................................................................................................4 
2.1 
STUDY BACKGROUND AND LITERATURE REVIEW .................................................................................................................... 4 
2.2 
PURPOSE OF STUDY ....................................................................................................................................................... 11 
2.3 
RESEARCH QUESTION ..................................................................................................................................................... 11 
3 
METHODS .......................................................................................................................................................... 12 
3.1 
STUDY DESIGN .............................................................................................................................................................. 12 
3.2 
SETTING....................................................................................................................................................................... 12 
3.3 
STUDY POPULATION OR PARTICIPANTS .............................................................................................................................. 12 
3.4 
DATA COLLECTION ......................................................................................................................................................... 15 
3.5 
DATA ANALYSIS ............................................................................................................................................................. 19 
3.6 
MONITORING ............................................................................................................................................................... 15 
3.7 
RELIABILITY, VALIDITY AND TRUSTWORTHINESS ................................................................................................................... 20 
3.8 
BIAS ............................................................................................................................................................................ 20 
4 
ETHICAL CONSIDERATIONS ................................................................................................................................. 22 
5 
TIMELINES.......................................................................................................................................................... 24 
6 
BUDGET ............................................................................................................................................................. 25 
7 
REFERENCES ....................................................................................................................................................... 26 
8 
APPENDICES ....................................................................................................................................................... 23 
8.1 
DATA COLLECTION FORM................................................................................................................................................ 23 
8.2 
PATIENT INFORMATION LEAFLET ....................................................................................................................................... 32 
8.3 
CONSENT FORM ............................................................................................................................................................ 25 
8.4 
ORIGINAL ENGLISH QUALITY OF RECOVERY QUESTIONNAIRE ................................................................................................. 26 
8.5 
SETSWANA TRANSLATION OF QUALITY OF RECOVERY QUESTIONNAIRE .................................................................................... 27 

 
 
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8.6 
VARIABLE TABLE ............................................................................................................................................................ 28 
8.7 
HOSPITAL PERMISSION ................................................................................................................................................... 31 
8.8 
STROBE CHECKLIST ....................................................................................................................................................... 40 
 
 
 

 
 
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1 Administrative Information 
1.1 Trial Registration 
Registered in ClinicalTrials.gov with reference number: 
1.2 Revision Chronology 
Date 
Protocol 
Amendment 
Number 
Description 
23 Aug 2024 
1 
Original version of protocol 
11 Oct 2024 
2 
Revision after feedback from School Research Committee 
16 April 2025 
3 
Provisional approval pending minor revisions after meeting with 
School Research Committee 
 
 
 
 
 

 
 
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2 Introduction 
2.1 Study Background  
In perioperative medicine, quality of recovery is a patient reported outcome that evaluates physical and 
psychological well-being after a surgical procedure.(1) Effective assessment of postoperative recovery is crucial 
for patient-centered care and clinical decision-making.(2,3) Accurate assessment of postoperative recovery can 
help to evaluate surgical outcomes and can guide rehabilitation. This is especially relevant in orthopaedic surgery, 
which accounts for a large proportion of surgical case load in South Africa (4) and involves procedures that 
significantly impact mobility, function, and quality of life. In this context, patient-reported outcomes are essential 
for capturing the patient’s perspective on pain, functional improvement, and return to daily activities, factors that 
are not always fully reflected in clinician-reported outcomes or radiological assessments. (3,5) Evaluating quality 
of recovery in the short term after orthopaedic surgery enables clinicians to identify patients at risk of poor 
postoperative outcomes, and may facilitate targeted interventions to improve patient care.(6) 
Quality of recovery can be measured with a validated multidimensional questionnaire called the 15-Item Quality of 
Recovery questionnaire (QoR-15).(7) The original questionnaire was developed in English, but cultural and 
language barriers may impact the use of the tool among non-English speaking populations.(8) Multiple translations 
of the QoR-15 have been developed and validated internationally over the past few years with only one South 
African translation into isiZulu being done to date.(9) South Africa is a multicultural, multilingual country where 
language discordance may pose significant challenges in our healthcare system.(10) In the perioperative setting, 
language barriers may make it difficult for patients to communicate with their healthcare providers about how they 
are recovering after a procedure. Effective communication of health status requires assessment tools that are both 
culturally relevant and in the patient’s preferred language.(11) 
In South Africa, where Setswana is widely spoken, there is a need for validated Setswana versions of PROMs to 
ensure accurate and meaningful patient feedback.  Setswana is part of the Sotho-Tswana language group, which 
includes closely related languages such as Sesotho and Sepedi. Given the linguistic similarities within this group, 
this tool may also prove useful among Sesotho and Sepedi speaking populations.(9,12) A recent randomised 
control trial evaluating quality of recovery after volatile anaesthesia for ophthalmological surgery translated the 
English Quality of Recovery questionnaire into Setswana, but the translation could not be validated in that study 
as only two patients in the study used the translation.(13)  
This study is designed to validate the Setswana translation of the 15-Item Quality of Recovery questionnaire in a 
predominantly Setswana-speaking population, undergoing orthopaedic surgery. 

 
 
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2.2 Literature Review 
2.2.1 
Quality of Recovery as a Patient Reported Outcome in Perioperative Medicine 
The patient’s perspective of their health care is recognized as an important factor in assessing and ensuring good 
quality healthcare services. Much research is being done on the use of patient reported outcomes (PROs) and 
patient reported outcomes measures (PROMs).(14–17) PROMs are self-reported questionnaires that gather 
information and report on specific outcomes directly from the people who encounter them. Broadly speaking, 
PROMs may be condition specific, for example to assess outcomes after hip arthroplasty; or it may be more 
universal and used across different conditions by assessing constructs like health-related quality of life. (18) 
Several patient-centered and patient reported outcomes exist in the perioperative sphere.(17,19) Quality of 
Recovery (QoR) is one such a patient reported outcome, and it is a multi-faceted concept that evaluates patient 
comfort in the short term after surgery, within 24-48 hours postoperatively. It encompasses recovery from a 
physical, emotional and economic point of view.(16,20) There are a number of anaesthetic, surgical and patient 
factors that may have an impact on quality of recovery, for example: type and severity of surgery (21–24), duration 
of anaesthesia (9,16,21,22,24,25), time spent in the recovery room (23,24) and sex (21,23,24,26). More severe 
surgery and longer procedures are associated with worse quality of recovery. Likewise, longer time spent in the 
recovery room has also been associated with worse quality of recovery. Some studies indicate that female patients 
and older patients have overall worse quality of recovery scores, but this is not a universal finding. 
In orthopaedic patients specifically, quality of recovery is influenced by patient sex, surgical site, use of regional 
anaesthesia, postoperative pain, and postoperative nausea and vomiting.(6,27–29) Patients with low preoperative 
QoR-15 scores are also at risk for worse postoperative quality of recovery.(6) Evaluating quality of recovery in the 
short term after orthopaedic surgery enables clinicians to identify patients at risk of poor postoperative outcomes, 
and may facilitate targeted interventions to improve patient care.(6,15) This may hold benefit for a large surgical 
population, as orthopaedic patients account for a large proportion of the South African surgical population.(4) For 
example, providing timely pain relief or treatment for nausea and vomiting may improve early mobilization which 
may lead to faster discharge from hospital. Being able to educate patients on what to expect after a procedure 
based on feedback from other patients speaks to patient-centered care. 
There are many different tools that have been developed over the years to measure quality of recovery. In 1999, 
the 9-item quality of recovery (QoR-9) score was constructed from an initial 61 item questionnaire.(23) It was 
developed by taking the 9 most highly rated items on the questionnaire. It was evaluated in a group of 136 diverse 
participants and there was a positive correlation with a visual analogue scale for the patient’s perception of their 

 
 
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recovery and a negative correlation with the duration of hospital stay. However, the score had only moderate 
validity and was thought to be better suited for group assessments.(23,30) 
The following year, Myles et al developed the 40-item quality of recovery score (QoR-40). This was developed by 
recruiting 160 participants who were asked to complete a 100-mm visual analogue scale, the QoR-9 and a fifty-
item questionnaire. The questionnaires were repeated later the same day. From the results, a 40-item 
questionnaire was developed. It showed a positive correlation with the visual analogue scale and a negative 
correlation with the duration of hospital stay. There was good convergent validity, good test-retest reliability and 
internal consistency. It was concluded that the QoR-40 was a good objective measurement tool in quality of 
recovery following anaesthesia and surgery. The only drawback of the QoR-40 is that it takes around 10 minutes 
to complete.(30) 
In 2013, Stark et al developed the 15-item quality of recovery score (QoR-15) by using the best psychometrically 
performing items from each of the five domains of the 40-item score. This was then tested in 127 surgically 
heterogenous adult patients after general surgery and anaesthesia. Most patients completed the questionnaires 
independently, with patients who were discharged same-day being contacted for a telephonic interview. It showed 
good convergent validity between the QoR-15 and a global quality of recovery visual analog scale. Most patients 
could complete the questionnaire in under 3 minutes. It was concluded that this score provided a valid, reliable 
and efficient way of evaluating quality of recovery.(24)  
Kleif and Gögenur conducted a study with the aim of classifying the QoR-15 into poor, moderate, good and 
excellent classes of recovery. This was done on 276 participants who were undergoing laparoscopic 
appendicectomies under general anaesthesia. They concluded that the QoR-15 scores for excellent, good, 
moderate and poor recovery were 136 to 150, 122 to 135, 90 to 120 and 0 to 89 respectively.(31) 
Through its development, the QoR-15 and QoR-40 scores have been extensively validated in 
English.(16,24,26,30) A systematic review by Kleif et al used the COSMIN checklist to evaluate the measurement 
properties and interpretability of the QoR-15 questionnaire.(32) The QoR-15 was again found to have good validity 
and reliability, and using the COSMIN four-point checklist it was also shown that the questionnaire fulfils the 
requirements to be included in a “core outcome set”.(16) 
There has been limited work on quality of recovery in South Africa. A study in Johannesburg evaluated quality of 
recovery in orthopaedic patients at Helen Joseph hospital and found that low pre-operative baseline QoR-15 
scores predicted worse postoperative scores. It was suggested that being able to identify patients with low pre-
operative scores may help to focus limited resources on them in order to improve their post-operative course.(6) 

 
 
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A prospective clinical audit at New Somerset hospital in Cape Town in an undifferentiated surgical population, 
showed that most patients experienced “moderate” quality of recovery, with a QoR-15 score of 90-121, and the 
majority of patients achieved an acceptable symptom score of 118 or more. (33) A Study of quality or recovery 
after general anaesthesia for ophthalmological surgery at Dr George Mukhari Academic Hospital showed most 
patients had “excellent” quality of recovery, which may have been due to the minimally invasive nature of the 
surgery.(13) All of these studies used the English translation of the QoR-15 questionnaire. 
2.2.2 
Need for Translation of the 15-Item Quality of Recovery Questionnaire 
Effective communication of health status requires assessment tools that are both culturally relevant and in the 
patient's preferred language.(11) In South Africa, where Setswana is widely spoken, there is a need for validated 
Setswana versions of PROMs to ensure accurate and meaningful patient feedback.(9,12) Language concordance 
can improve patient satisfaction and optimize health outcomes.(34)  
Quality of recovery is not currently routinely captured as an outcome in daily practice in South Africa. Not having 
material available in a patient’s home language and low levels of literacy may present a barrier to widespread 
implementation of questionnaire-based assessments. In 2021, it was estimated that approximately 4 million adults 
were functionally illiterate. Black South Africans are more likely to be illiterate, with an illiteracy rate of 11.9% as 
opposed to 0.1% for white South Africans. (35) The Progress in International Reading Literacy Study in 2021 
revealed that 81% of Grade 4 learners in South Africa struggled to achieve the lowest benchmark of reading to 
find specific information. The lowest mean achievement scores were attained in Setswana speaking learners. (36) 
Utilizing the English version of patient-reported outcome measures (PROMs) with third-party assistance from an 
interpreter may seem practical. However, this approach presents several challenges, including the risk of 
misinterpretation, cultural and linguistic barriers, patient comfort and privacy, consistency and standardization, and 
regulatory compliance.(16,37) For instance, interpreters may inadvertently alter the meaning of questions or 
responses, leading to inaccuracies in data collection.(38) Regarding cultural and linguistic barriers, PROMs often 
contain culturally nuanced items.(39) Direct translation during interviews might not convey these subtleties 
effectively, leading to misunderstandings or incomplete data.(40) Discussing personal health information through 
an interpreter may make patients uncomfortable, potentially causing them to withhold sensitive details.(41) Self-
administration of PROMs in the patient's native language fosters a sense of privacy and encourages honest 
reporting.(37) Using interpreters can introduce variability in how questions are presented and answered, affecting 
the reliability of the data. On the other hand, validated translations ensure that all patients receive the same 
questions, maintaining consistency across responses.(42,43) 

 
 
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The QoR-15 has been translated into many different languages internationally, including French, Danish, Dutch, 
and recently Arabic.(44–46)  
De Vlieger et al aimed to validate the Dutch translation of the QoR-15 score across multiple surgical disciplines, 
where all patients received general anaesthesia. The questionnaires were completed independently by patients 
who received their questionnaires by mail. Convergent validity was displayed by a good correlation between the 
translated QoR-15 with the VAS for general recovery. The reliability indices of the score were also high with a 
Cronbach’s alpha and split half reliability of 0,87 and 0,8 respectively. The Dutch translation was found to have 
good validity and reliability and was easy to use with high responsiveness.(45) 
Demumieux et al translated the QoR-15 scale into French. In this validation study, a trained assessor read the 
questions to patients who then responded with their rating per item. The translated version was found to have 
good convergent and discriminatory validity, as well as good internal consistency and test-retest reliability. 
Responsiveness and acceptability were also found to be fair. Overall, these psychometric properties of the French 
version of the QoR-15 were comparable to the original English version.(44) 
South African work has also been done on translating the original English version of the QoR-15. A randomized 
quantitative observational study conducted by Sikhakhane et al translated the QoR-15 score into isiZulu and 
validated both the English and the translated versions in an isiZulu speaking population. The study was designed 
to compare the quality of recovery scores between the English and isiZulu translations, and against a general 
visual analog scale of overall sense of recovery. Patients were randomized into 2 groups: one receiving the English 
version of the questionnaire first, and 40 minutes later the isiZulu version, and the other receiving the isiZulu and 
later the English. The time between questionnaires was an arbitrary decision by the investigators. The finding from 
this study was that there was good correlation and agreement between the English original and the isiZulu 
translation, and both were suitable to be used in an isiZulu speaking population. The authors admit that the 
educational background of respondents was not assessed, instead self-professed literacy in English and isiZulu 
was used as inclusion criterion, which may impact the validity of the result. (9) 
In order to comply with ethics committee requirements, the QoR-15 questionnaire was translated from English into 
Afrikaans and Setswana during the recent Desflurane-Isoflurane Quality of Recovery (DIQoR) study performed at 
Dr. George Mukhari Academic Hospital. These translations could not be validated during the study as the English 
version was used in all but 2 patients who requested the Setswana translation. The purpose of the DIQoR study 
was not to validate the translations. Most patients in the DIQoR study needed help from a research assistant to 
complete their questionnaires. Visual disturbance after ophthalmological surgery as well as limited written literacy 
in the study population were barriers to the patients completing the questionnaires independently. The results of 

 
 
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the QoR-15 questionnaires were used to evaluate the patient’s perspective of their anaesthetic management, and 
the tool was found to be overall useful.(13) 
2.2.3 
Evaluating Patient Reported Outcomes Measures or Questionnaires  
Whenever a questionnaire is being developed or evaluated, it is important to ensure that the information gathered 
is valid and reliable. Validity considers what a specific tool measures (the so-called “construct”) and the precision 
with which it is measured, whereas reliability refers to repeatability, whether a tool will get the same answer when 
repeated over time.(47) Furthermore, responsiveness can be evaluated which refers to the ability of a 
questionnaire to detect a change. Feasibility and acceptability can also be assessed by evaluating patient 
recruitment rate, completion rate and time taken to complete a questionnaire. 
Different aspects of validity can be evaluated. Construct validity refers to how well a questionnaire measures the 
theoretical concept it is designed to assess. For QoR, this has been evaluated by looking for negative associations 
between QoR score and among others age, sex, severity and duration of surgery. Convergent validity is the degree 
to which two measures of the same construct are related. In QoR studies, convergent validity is determined by 
comparing QoR scores with a Visual Analog Scale (VAS) for general recovery. Discriminant validity confirms that 
the instrument measures what is intended without mistakenly capturing overlapping aspects. For QoR, 
discriminant validity is tested by evaluating QoR scores of patients with complications who are expected to have 
worse quality of recovery.  
Reliability can be tested with internal consistency using Cronbach’s alpha statistic, split-half reliability and test-
retest reliability. The Cronbach’s alpha statistic estimates how well a set of questions measures a unidimensional 
construct by looking for correlation between questions. For split-half reliability, the questions in a questionnaire are 
split into two equal halves, and the correlation between the scores for the two halves is calculated. Test-retest 
reliability is assessed by having patients repeat a questionnaire after a specified time period, and then evaluating 
responses with the Spearman’s rho correlation coefficient. 
Responsiveness is measured with the Cohen effect size, which is the average change of scores from pre-test to 
post-test. 
2.2.4 
Study Problem 
Patient-reported outcomes are seen as important in perioperative research, but they are not yet in widespread use 
in clinical practice 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 

 
 
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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 to tailor 
postoperative care to patient needs, which may lead to better patient-clinician communication, better surgical 
outcomes and better patient satisfaction.(48)  
c 
 A Setswana translation of the QoR-15 questionnaire exists from a previous study (13), 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 PROMs to be effective in non-English-speaking populations, rigorous linguistic 
and cultural adaptation is necessary.(49)  
2.2.5 
Study Rationale 
Patients coming for orthopaedic procedures make up a large percentage of the surgical patients at any facility.(4) 
Surgery ranges from minor to major procedures. Being able to evaluate quality of recovery on the first day after 
surgery in the orthopaedic surgery population will help improve patient care and levels of patient satisfaction.(6,48) 
By having standardized questionnaires covering different aspects of recovery, like pain, comfort and nausea, it is 
less likely that symptoms that patients are experiencing are overlooked in a postoperative consultation. Any patient 
whose quality of recovery deviates from the expected trajectory can be identified and can be given additional care 
to improve their condition.(6) Besides the benefit to patients or evaluating quality of recovery, orthopaedic patients 
also present an ideal patient population to do this validation study in, as male and female patients of all ages 
present for orthopaedic surgery, and procedures vary from minor to intermediate to major in terms of severity, so 
one can expect to find a wide range of quality of recovery in this patient population. 
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 languages spoken outside of 
the home most commonly are isiZulu, isiXhosa and the Sotho-Tswana languages.(50) Studies on the impact of 
language barriers in healthcare are very limited in South Africa, and mostly being done on isiXhosa in the Western 
Cape province.(51) 
In this study quality of recovery will be measured with the Setswana translation of the QoR-15 questionnaire, as 
well as with a visual analogue scale on which patients can rate their overall postoperative recovery from 0 (bad 
recovery) to 10 (good recovery). 

 
 
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By showing that the Setswana translation of the QoR-15 has good reliability, validity and ease of use in an 
orthopaedic population, we hope to add another tool to evaluate the patient reported outcome of quality of recovery 
in our local population. 
2.3 Purpose of Study 
2.3.1 
Aim 
The aim of this study is to determine if the Setswana translation of the 15-Item Quality of Recovery Questionnaire 
(QoR-15), is a valid, reliable and easy-to use outcome assessment tool in a Setswana speaking population 
undergoing orthopaedic surgery. 
2.3.2 
Objectives of the Study 
• 
To evaluate construct, convergent and discriminant validity of the Setswana translation of the 15-Item 
Quality of Recovery questionnaire in Setswana speaking patients undergoing orthopaedic surgery. 
• 
To evaluate reliability with internal consistency and test-retest reliability of the 15-Item Quality of Recovery 
questionnaire in Setswana speaking patients undergoing orthopaedic surgery. 
• 
To evaluate responsiveness with change from preoperative to postoperative scores of the 15-Item Quality 
of Recovery questionnaire in Setswana speaking patients undergoing orthopaedic surgery. 
• 
To evaluate acceptability and feasibility of the 15-Item Quality of Recovery questionnaire in Setswana 
speaking patients undergoing orthopaedic surgery. 
2.4 Research Question 
Is the Setswana translation of the 15-Item Quality of Recovery Questionnaire a valid, reliable and easy to use 
measure of quality of recovery in a Setswana speaking patient population undergoing orthopaedic surgery at a 
tertiary hospital in Gauteng Province, South Africa? 
 
 
 

 
 
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3 Methods 
3.1 Study Design 
This study will be a cross-sectional single-centre observational study.  
3.2 Setting 
The study will be conducted in the orthopaedic wards at Dr. George Mukhari Academic Hospital, a 1500 bed 
tertiary hospital in Gauteng province in South Africa. There are approximately 150 orthopaedic beds in the hospital, 
and an estimated 250 of orthopaedic procedures being performed at the hospital per month. 
3.3 Study Population or Participants 
The study population will consist of adult patients (aged 18 years and older) who are fluent in Setswana and are 
scheduled for elective orthopaedic surgery at the hospital. The population is expected to be diverse in terms of 
gender, age, and socioeconomic background, reflecting the typical demographic of Setswana-speaking patients. 
These patients are expected to be conscious and alert in the postoperative period, able to provide informed 
consent, and cognitively capable of understanding and responding to a questionnaire. Participants with known 
cognitive impairments, severe postoperative complications that impair communication, or those unwilling to 
participate will be excluded. A detailed inclusion and exclusion criteria has been outlined below: 
3.3.1 
Eligibility 
Inclusion Criteria: 
• 
Adult patients over 18 years 
• 
Scheduled elective orthopaedic surgery at Dr George Mukhari Hospital 
Exclusion Criteria: 
• 
Patients who are not fluent in Setswana 
• 
Patients booked for emergency procedures where a delay to surgery could be detrimental  
• 
Patients where the surgery is delayed beyond 10 days of the initial assessment and preoperative quality 
of recovery measurement. 
• 
Patients with a psychiatric disturbance that precludes complete cooperation 
• 
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 

 
 
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• 
Patients with a history of recent drug or alcohol abuse which may render responses unreliable 
• 
Incomplete quality of recovery questionnaires 
• 
Patients who do not have complete preoperative and postoperative questionnaires 
 
 

 
 
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3.3.2 
Participant timeline  
TIMEPOINT: 
Pre-op 
Day -1 
Surgery 
Day 0 
Postop 
Day 1 
RECRUITMENT: 
 
 
 
Eligibility Screen 
X 
 
 
Informed Consent 
X 
 
 
PREOPERATIVE ASSESSMENT: 
 
 
 
Preoperative Quality of Recovery score 
X 
 
 
SCHEDULED SURGERY 
 
X 
 
POSTOPERATIVE ASSESSMENT: 
 
 
 
Postoperative Quality of Recovery score 
 
 
X 
Visual Analog Scale 
 
 
X 
Table 1: Participant timeline 
3.3.3 
Sampling Procedure 
Non-probability convenience sampling will be used to recruit patients on consecutive weekdays. 
3.3.4 
Sample Size 
The recommended sample size to validate a questionnaire is 10 participants per item, which would be 150 
patients.(52,53). This fits well with the average number of patients recruited in recent validation studies., (9,22,44–
46). All 150 patients will complete all 15 questions on the preoperative and the postoperative questionnaires. Any 
incomplete forms will result in the patient being excluded from analysis. 
3.3.5 
Recruitment 
The Principal Investigator (PI) will screen the elective theatre lists on a daily basis and record detail of eligible 
patient on an electronic spreadsheet stored on a password protected device that only the PI and research assistant 
have access to. The PI or the research assistant will then visit eligible patients in the ward, and counsel them 
regarding voluntary participation in the research study, with the help of a patient information leaflet to ensure 
complete information sharing. The concept of quality of recovery will be explained to consenting patients, as well 
as the way that the questionnaires work, scoring a particular aspect from 0 to 10, with 0 being the worst score and 
10 being the best score. The visual analog scale will also be explained to them with 0 reflecting the worst recovery 
and 10 the best recovery. Consenting patients will be allocated a sequential study number which will be recorded 
on all study documents relating to a particular patient. 

 
 
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Should patients not be operated the following day, the PI will review the orthopaedic theatre registers on a daily 
basis to confirm when patients that were recruited come to theatre. The operative date will be recorded on the 
electronic spreadsheet, and the PI or the research assistant will follow-up with patients on day 1 after their surgery. 
3.4 Data Collection 
3.4.1 
Data Collection Procedures 
Patients will be assessed before their procedures, as well as on day 1 after their procedures. Where possible, 
patients will be assessed on the day before their scheduled surgery, but if cases are cancelled and rebooked, the 
interval before the procedure may be longer. Patients are usually rebooked within a week of their initial scheduled 
surgery, depending on availability of theatre time. Occasionally patients will be done on an after-hours list. Patients 
who are rebooked more than 10 days after their initial consultation and baseline QoR-15 assessment will be 
excluded from further participation. 
For the pre-operative visit, each patient will receive a hard copy of the Setswana translation of the QoR-15 
questionnaire on which they will record their response from 0 (worst response) to 10 (best response) on the paper 
form. The PI or research assistant will explain to the patient how to complete the form and may read the questions 
out to the patient as they are written without any interpretation but will offer no further assistance to limit bias. 
For the postoperative visit, each patient will receive a hard copy of the Setswana translation of the QoR-15 
questionnaire as well as the Visual Analog Scale. The PI or research assistant will explain to the patient how to 
complete the forms and may read the questions out to the patient as they are written without any interpretation but 
will offer no further assistance to limit bias. 
Once the forms are completed, the PI or research assistant will collect the forms which be identified with the 
patient’s sequential study number. The forms will be kept in a dedicated lever arch file in a secure location that the 
PI and research assistant have access to. 
The PI or research assistant will explain the scoring system to the patient, ensuring that they understand that in 
the QoR-15 questionnaire, 0 relates to the worst score per item and 10 to the best score per item. Different aspects 
of recovery are evaluated over the preceding 24-hour period. For the first 10 questions of the QoR-15 
questionnaire, 0 means the patient experienced a particular aspect (for example “Feeling rested”) none of the time 
and 10 means they experienced that aspect all of the time. For the last five questions the scoring is reversed, with 
zero still being the worst score, but now meaning that a patient experienced a negative aspect of recovery (for 
example nausea) all of the time.  

 
 
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Once the patients have completed the postoperative QoR-15 questionnaires, they will be asked to rate their quality 
of recovery on a 10-point visual analogue scale with 0 being the worst recovery and 10 being the best possible 
recovery. By comparing the QoR-15 total scores and the VAS scores it will be possible to assess convergent 
validity of responses to the Setswana translation. 
Every 6th patient that is recruited, will be asked to complete a second QoR-15 questionnaire 30-60minutes after 
completing their postoperative questionnaire. This data will be used to determine test-retest reliability. The same 
data collection procedures will be followed. In total 25 patients will be asked to complete a second QoR-15 
questionnaire. 
3.4.2 
Data Collection Tools 
The QoR-15 questionnaire consists of 15 statements relating to how the patient felt the previous 24 hours, and 
each question is rated from 0 to 10, with 0 being the worst score and 10 being the best score. Patients will receive 
paper questionnaires to complete their scores on, after having the questions read to them as detailed above. 
A translation of the English QoR-15 questionnaire into Setswana was done in a previous study at DGMAH.(13) 
Forward translation was done by an accredited medical translator, and back-translation was done by three first 
language speakers with the final translation being approved by all three reviewers. The Setswana version was 
reviewed again during the planning phases of the current study by three different first language Setswana 
speakers, who were all satisfied with the original translation. 
3.4.3 
Data management 
The data from paper forms will be captured electronically on the REDCap database by the research assistant. (54) 
REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture 
for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data 
manipulation and export procedures; 3) automated export procedures for seamless data downloads to common 
statistical packages; and 4) procedures for importing data from external sources. 
The patient’s study number assigned at recruitment will be used to identify all documents in REDCap relating to a 
particular patient. 
Study documents will be stored securely by the Principal Investigator. Hard copy documents will be kept in a 
dedicated lever-arch file and will be arranged sequentially according to study number. All study documents relating 
to a single patient will be stored together. The forms will be kept in a dedicated lever arch file in a secure location 
that the PI and research assistant have access to. The electronic database used for screening and recruitment 

 
 
Page 17 of 40 
will be stored on a password protected device that only the PI and research assistant have access to. Data in 
REDCap is also password protected. 
The principal investigator will monitor the completed study documents and the REDCap entries to ensure accurate 
capture of results. In case of incomplete data on the Data Collection Form, the principal investigator will review 
the source documents in the order listed to obtain the missing information. In case of incomplete quality of recovery 
questionnaires, patients will be asked to complete any blank questions. Cases with incomplete data collection 
forms will still be included in final analysis, but cases with incomplete quality of recovery questionnaires will not be 
included in final analysis. 
3.4.4 
Data sources 
The following documents will be used to source information: 
• 
Patient file: 
o 
Patient demographic data 
• 
Surgical consent form: 
o 
Procedure name, date, type of anaesthesia 
• 
Anaesthetic form: 
o 
Induction time, theatre out time, urgency of surgery, type of anaesthesia 
• 
Theatre record form: 
o 
Induction time, theatre out time, time of last vitals in recovery room, type of anaesthesia 
3.4.5 
Study documents 
The following documents will be used as study documents to record relevant information: 
• 
Case Report Form: Data collection 
• 
Case Report Form: VAS  
• 
Case Report Form: Quality of Recovery Questionnaires 
• 
Consent Form 
• 
Patient Information Leaflet 
3.4.6 
Variables 
Patient-related variables 
Patient age, sex and level of education will be recorded. Age will be recorded in years. Biological sex will be 
recorded as male or female.  
American Society of Anaesthesiologists classification of Physical State (ASA Score) will be recorded as follows: 
ASA 1: healthy normal patient, ASA 2: patient with mild systemic disease, ASA 3: patient with severe systemic 
disease, ASA 4: patient with severe systemic disease that is a constant threat to life, ASA 5: a moribund patient 
who is not expected to survive without surgery. 

 
 
Page 18 of 40 
Surgery-related Variables 
In this study, we will grade the magnitude or severity of orthopaedic procedures depending on the estimated length 
of time required to complete the procedure and the complexity of the procedure. 
• 
Minor orthopaedic surgery: Quick procedures, lasting 30 minutes or less. This may include incisions and 
drainages, realigning a dislocated joint and repairing a tendon. 
• 
Intermediate orthopaedic surgery: More complex procedures, typically taking between 30 – 90 minutes in 
the operating room. Common examples include rotator cuff repair, carpal tunnel release and open 
reduction and internal fixations. 
• 
Major orthopaedic surgery: This necessitates the skill and experience of highly qualified surgical teams, 
and often necessitates several hours of operating time. Major orthopaedic operations include joint 
replacement, spinal fusion and limb restoration. 
Anaesthesia-related Variables 
The following variables relating to anaesthetic management will be recorded: 
• 
Duration of anaesthesia: measured from theatre entry time until theatre exit time 
• 
Duration of stay in the post-anaesthesia recovery room: measured from theatre exit time until the time last 
vitals are recorded in the recovery room, as this is when patient is deemed ready to go to the postoperative 
surgical ward. 
• 
Type of anaesthesia: general anaesthesia, regional anaesthesia, sedation with monitored anaesthesia 
care, combination general anaesthesia and regional anaesthesia, combination sedation with regional 
anaesthesia. 
Quality of Recovery 
The QoR-15 is a 15-item post-operative questionnaire evaluating physical and mental well-being by assessing five 
aspects of patient recovery: emotional state, physical comfort, psychological support, physical independence and 
pain. The 15 questions are scored by the patient from 0 (worst score) to 10 (best score), giving a lowest possible 
score of 0, and a highest possible score of 150. This continuous composite score allows comparisons between 
intervention groups. The minimal clinically important difference (MCID) is 6 and patient acceptable symptom state 
score for the QoR-15 score has been found to be 118. The QoR-15 has good scaling properties, with scores 
showing a normal distribution during development and testing. Floor and ceiling effects have not been observed 
with the QoR-15. (55,56) 
The time it takes a patient to complete each version of the questionnaire will also be recorded. 

 
 
Page 19 of 40 
Visual Analogue Score (VAS) 
A 10-point visual analogue score will be given to patients to grade their overall postoperative recovery. This will 
give an objective measure of postoperative recovery against which to compare the quality of recovery scores 
measured with the QoR-15. Zero points will be the worst quality of recovery, and 10 points will be the best quality 
of recovery. 
3.5 Data Analysis 
3.5.1 
Outcomes 
The outcomes of the study are as follows: 
• 
To evaluate construct validity by looking for associations between QoR-15 scores and age, gender, 
duration of surgery, severity of surgery, and duration of stay in the recovery room. 
• 
To evaluate convergent validity by comparing it with a visual analogue scale of quality of recovery in 
general. 
• 
To evaluate discriminant validity by assessing QoR-15 scores in patients low VAS scores for general 
recovery. 
• 
To evaluate internal consistency with Cronbach’s alpha using the average correlation between the 
questions of the QoR-15. 
• 
To evaluate test-retest reliability in a subset of 25 patients who will be asked to have a repeat assessment 
60 minutes after their post-operative questionnaire. 
• 
To evaluate responsiveness by calculating the Cohen effect size of change from preoperative to 
postoperative scores. 
• 
To evaluate acceptability and feasibility by calculating patient recruitment rate, completion rate and time 
taken to complete the questionnaire. 
3.5.2 
Statistical Methods 
Data will be summarised with descriptive statistics and presented as mean ± standard deviation (SD), median 
(interquartile range (Q3-Q1)) or number (percentage) as appropriate to data type and distribution. Normal 
distribution will be assessed with the Shapiro–Wilk test. 
Psychometric evaluation of the scores will include construct validity, reliability and feasibility. Construct validity will 
be evaluated by looking for associations between total QoR-15 scores and severity of surgery, duration of surgery, 
duration of stay in the recovery room and sex using Spearman’s rank correlation. Very strong correlation will be 
defined as a Spearman’s rho of 0.90 – 1.0, strong correlation will be defined as 0.70 – 0.89, and moderate 

 
 
Page 20 of 40 
correlation will be defined as 0.40 – 0.69.(45). Convergent validity of the QoR-15ST will be assessed in a similar 
way by comparing total postoperative QoR15 scores with the patient VAS scores of quality of recovery. 
Discriminant validity will be by assessed by reporting QoR-15 scores of patients with low VAS scores for general 
recovery. Internal consistency as a measure of reliability will be calculated using Cronbach’s alpha statistic, with 
0.70-0.90 considered good.(45) Test-retest reliability will be evaluated by comparing the postoperative QoR15 
scores 60 minutes apart in a subset of patients who will be asked to have a repeat assessment. Responsiveness 
will be calculated with the Cohen effect size of change from preoperative to postoperative scores. 
Feasibility will be assessed by calculating recruitment rate, completion rate, time taken to complete the 
questionnaires, and by evaluating scores for floor and ceiling effects. Floor or ceiling effects will be deemed to be 
present if >15% of respondents give the lowest or highest scores, respectively.(45) The recruitment rate will be 
calculated as the percentage of eligible patients who were approached and who agreed to participate in the study. 
The completion rate will be calculated as the percentage of patients completed both pre- and postoperative 
questionnaires.  
3.6 Reliability and Validity 
Construct validity will be tested by evaluating if the quality of recovery scores in this study show negative correlation 
with duration of surgery, extent of surgery and female sex. To determine convergent validity of the QoR-15 scores, 
total scores will be compared with the visual analogue score using Spearman’s rank correlation. 
Reliability testing of the individual items from the questionnaires will be tested using internal consistency evaluated 
with Cronbach’s alpha.  
Feasibility will be assessed based on completion rate and on the time taken to complete the questionnaires. 
3.7 Bias 
Sampling bias will be avoided by submitting a well-designed research protocol clearly outlining data collection and 
analysis. Due to the nature of the project, convenience sampling will be used. 
Recall bias is possible with the use of a questionnaire. This will be minimized by offering the questionnaire on Day 
1 post operatively, prior to discharge to prevent poor memory recall. The use of a validated scoring tool that uses 
clear statements and easy to understand scoring should also minimize recall bias. 
Researcher bias will be avoided by using a validated and standardized questionnaire, and by having the PI and 
research assistant read questions to patients without interpretation. Independent analysis of the results will be 
done by a statistician who will not be in contact or directly involved in patient care. 

 
 
Page 21 of 40 
Publication bias will be avoided by pre-registration of the study in public databases and by ensuring that the title, 
the abstract and conclusion present a well-balanced and representative summary of the results. 

 
 
Page 22 of 40 
4 Ethical Considerations 
Prior to commencing data collection, permission to perform study at Dr George Mukhari Academic Hospital will be 
obtained from the hospital superintendent. Thereafter, the study will be submitted for approval to the School of 
Medicine Research Committee (SREC), whereafter it will be submitted for ethical approval to the Sefako Makgatho 
Health Sciences University Research Ethics Committee (SMUREC). 
The study will be registered as an observational trial on Clinicaltrials.gov. 
All participants will be asked to provide written informed consent of voluntary participation. All participants will 
receive and be required to understand all the information they need to decide whether they want to participate. 
Information on what the study is about; risks and benefits of taking part in the study; how long the study will take; 
contact details of the PI and institution’s approval number will be made available via a patient information leaflet 
that will be given to all participants to read. All participants will be free to choose to participate without any pressure 
or coercion. Refusal to participate will not affect their treatment plan in the hospital. Participants can also choose 
to opt out at any point of the study without explaining their reasons, and may have their study documents destroyed 
or returned to them. This can be done by contacting the PI, whose contact details will be provided to patients on 
the patient information leaflet. 
Regarding anonymity of patient information, the only documents to contain the patient’s name will be the consent 
form and a sequentially numbered list that will be completed at recruitment that the PI will store to keep track of 
patients in the study. All data will be de-identified, no personal information (for example name and file number) will 
be recorded on any of the other study documents. 
Confidentiality will be ensured by the PI storing all paper documents in lever-arch files in a secure location that 
only the PI and research assistant has access to. The sequentially numbered list will be stored electronically in a 
password controlled online folder that only the PI has access to. Personal information will not be shared without 
express patient permission. The only situation where it is foreseeable that patient information may be shared, 
would be if a quality of recovery score is very low and the PI needs to contact the treating physician to intervene. 
This is a non-interventional study that does not pose a risk of harm to patients. At most, there may be an 
inconvenience for a small subset of patient who will be asked to complete questionnaires 30-60 minutes apart. 
Patients will be adequately counselled regarding voluntary participation in the study. 
 
 
 

 
 
Page 23 of 40 
The PI will obtain a Good Clinical Practice Certificate before commencing data collection. 
The results of the study will be published in a peer-reviewed journal and will be presented at local and national 
research conferences. All supporting documents and de-identified data will be appended as supplements to the 
publication. 
. 
 
 

 
 
Page 24 of 40 
5 Timelines 
Gant Chart of Proposed Timeline 
Preparation 
2025 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
SREC corrections and response 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Submission to Supervisor 
 
 
 
 
 
 
 
 
 
 
 
 
Corrections 
 
 
 
 
 
 
 
 
 
 
 
 
SREC submission 
 
 
 
 
 
 
 
 
 
 
 
 
SREC Corrections and Response 
 
 
 
 
 
 
 
 
 
 
 
 
SMUREC submission 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment starts 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment ends 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
Report writing 
 
 
 
 
 
 
 
 
 
 
 
 
Year 2 
2026 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
Report writing 
 
 
 
 
 
 
 
 
 
 
 
 
Report submission to supervisor 
 
 
 
 
 
 
 
 
 
 
 
 
Corrections 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of final report, Preparation 
for publication 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Page 25 of 40 
6 Budget 
Expense 
Personal 
JPRF 
Research Assistant 
 
R 39 000 
Printing costs 
 
R   1 000 
Statistician 
 
R 10 000 
Total 
 
R 50 000 
 
Once ethical approval for the study has been obtained, the PI will apply for funding through the SASA Jan Pretorius 
Research Fund, to the value of R 50 000. No hospital or university resources will be used for the study. 
 
 
 
 

 
 
Page 26 of 40 
7 References 
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Boney O, Moonesinghe SR, Myles PS, Grocott MPW. Standardizing endpoints in perioperative research. 
Canadian Journal of Anesthesia. 2016;63(2):159–68.  
2. 
Bowyer A, Royse C. The importance of postoperative quality of recovery: influences, assessment, and 
clinical and prognostic implications. Canadian Journal of Anesthesia. 2016 Feb 1;63(2):176–83.  
3. 
Gagnier JJ. Patient reported outcomes in orthopaedics. Vol. 35, Journal of Orthopaedic Research. John 
Wiley and Sons Inc.; 2017. p. 2098–108.  
4. 
Biccard BM, Madiba TE. The South African Surgical Outcomes Study: A 7-day prospective observational 
cohort study. South African Medical Journal [Internet]. 2015 Nov 8 [cited 2024 Dec 17];105(6):465–75.  
5. 
Ayers DC, Bozic KJ. The Importance of Outcome Measurement in Orthopaedics. Clin Orthop Relat Res 
[Internet]. 2013 [cited 2025 Apr 17];471(11):3409.  
6. 
Wessels E, Perrie H, Scribante J, Jooma Z. Quality of Recovery Following Orthopedic Surgery in Patients 
at an Academic Hospital in South Africa. Anesth Analg. 2021;133(2):507–14.  
7. 
Myles PS, Grocott MPW, Boney O, Moonesinghe SR, COMPAC-StEP Group. Standardizing end points in 
perioperative trials: towards a core and extended outcome set. Br J Anaesth [Internet]. 2016 
May;116(5):586–9.  
8. 
Myles PS. Measuring Quality of Recovery. Southern African Journal of Anaesthesia and Analgesia 
[Internet]. 2018 Jun 5;24(3):3–4.  
9. 
Sikhakhane S, Kusel B, Rodseth R. Development and validation of the isiZulu quality of recovery score. 
South Afr J Anaesth Analg. 2018;24(3):65–9.  
10. 
van den Berg VL. Still lost in translation: Language barriers in South African health care remain. South 
African Family Practice. 2016;58(6):229–31.  
11. 
O’Toole JK, Alvarado-Little W, Ledford CJW. Communication with Diverse Patients: Addressing Culture 
and Language. Pediatr Clin North Am. 2019 Aug 1;66(4):791–804.  
12. 
Onagbiye SO, Moss SJ, Cameron M. Validity and reliability of the Setswana translation of the Short Form-
8 health-related quality of life health survey in adults. Health SA.2018;23.  

 
 
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13. 
Steyl C, Kluyts HL. A randomised controlled trial comparing quality of recovery between desflurane and 
isoflurane inhalation anaesthesia in patients undergoing ophthalmological surgery at a tertiary hospital in 
South Africa (DIQoR trial). BJA Open. 2024 Mar 1;9:1–9.  
14. 
Churruca K, Pomare C, Ellis LA, Long JC, Henderson SB, Murphy LED, et al. Patient-reported outcome 
measures (PROMs): A review of generic and condition-specific measures and a discussion of trends and 
issues. Vol. 24, Health Expectations. John Wiley and Sons Inc; 2021. p. 1015–24.  
15. 
Wang XS, Gottumukkala V. Patient-reported outcomes: Is this the missing link in patient-centered 
perioperative care? Best Pract Res Clin Anaesthesiol . 2020 Dec 1;35(4):565.  
16. 
Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported 
outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 
2018;120(1):28–36.  
17. 
Myles PS, Boney O, Botti M, Cyna AM, Gan TJ, Jensen MP, et al. Systematic review and consensus 
definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort. Br J 
Anaesth.2018 Apr 1;120(4):705–11.  
18. 
Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA 
Educ. 2017 Apr ;17(4):137–44.  
19. 
Moonesinghe SR, Jackson AIR, Boney O, Stevenson N, Chan MTV, Cook TM, et al. Systematic review 
and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-
centred outcomes. Br J Anaesth.019;123(5):664–70.  
20. 
Wessels E, Perrie H, Scribante J, Jooma Z. Quality of recovery in the perioperative setting: A narrative 
review. J Clin Anesth. 2022 Jun 1;78:110685.  
21. 
Chazapis M, Walker EMK, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 
after day case surgery. Br J Anaesth. 2016 Feb 1;116(2):241–8.  
22. 
Kleif J, Edwards HM, Sort R, Vilandt J, G€ Ogenur I. Translation and validation of the Danish version of the 
postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand.2015 ;59:912–20.  
23. 
Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, et al. Development and Psychometric 
Testing of a Quality of Recovery Score After General Anesthesia and Surgery in Adults. Anesth Analg 
.1999 Jan ;88(1):83–90.  

 
 
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24. 
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of 
recovery score: The QoR-15. Anesthesiology.2013 Jun 1;118(6):1332–40.  
25. 
Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative 
quality of recovery. Anaesthesia. 2014 Nov 1;69(11):1266–78.  
26. 
Buchanan FF, Myles PS, Cicuttini F. Effect of patient sex on general anaesthesia and recovery. BJA: British 
Journal of Anaesthesia .2011 Jun 1;106(6):832–9.  
27. 
Elkassabany N, Cai LF, Mehta S, Ahn J, Pieczynski L, Polomano RC, et al. Does Regional Anesthesia 
Improve the Quality of Postoperative Pain Management and the Quality of Recovery in Patients Undergoing 
Operative Repair of Tibia and Ankle Fractures? J Orthop Trauma.2015 Sep 22;29(9):404–9.  
28. 
Berg K, Idvall E, Nilsson U, Unosson M. Postoperative recovery after different orthopedic day surgical 
procedures. Int J Orthop Trauma Nurs. 2011 Nov 1;15(4):165–75.  
29. 
Moro ET, Silva MAN da, Couri MG, Issa D da S, Barbieri JM. [Quality of recovery from anesthesia in 
patients undergoing orthopedic surgery of the lower limbs]. Rev Bras Anestesiol.2016 Nov 1;66(6):642–50.  
30. 
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of 
recovery score: the QoR-40 †. Br J Anaesth.2000;84(1):11–5.  
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Kleif J, Gögenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg 
Res .2018 May 1;225:101–7 
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Gagnier JJ, Lai J, Mokkink LB, Terwee CB. COSMIN reporting guideline for studies on measurement 
properties of patient-reported outcome measures. Quality of Life Research.2021;30(8):2197–218.  
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Ally MA, Cloete E, Reed AR. A prospective clinical audit to evaluate postoperative quality of recovery in 
adults at New Somerset Hospital, Cape Town, South Africa. S Afr Med J .2020 Oct 1 ;110(10):1036–40.  
34. 
Molina RL, Kasper J. The power of language-concordant care: A call to action for medical schools. BMC 
Med Educ.2019 Nov 6 ;19(1):1–5.  
35. 
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training. 2021;(March).  
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37. 
Segal KR, Gomez JA, Schulz JF, Alvandi LM, Fornari ED. The Impact of Standardized Recovery Pathways 
on Language Barriers and Inpatient Pain Management. Hosp Pediatr.2023 Nov 1 [;13(11):1001–9.  
38. 
Krogsgaard MR, Brodersen J, Christensen KB, Siersma V, Jensen J, Hansen CF, et al. How to translate 
and locally adapt a PROM. Assessment of cross-cultural differential item functioning. Scand J Med Sci 
Sports.2021 May 1 ;31(5):999–1008.  
39. 
Halawi MJ, Jongbloed W, Baron S, Savoy L, Cote MP, Lieberman JR. Patient-Reported Outcome 
Measures are not a Valid Proxy for Patient Satisfaction in Total Joint Arthroplasty. J Arthroplasty .2020 Feb 
1;35(2):335–9.  
40. 
Eremenco S, Pease S, Mann S, Berry P. Patient-Reported Outcome (PRO) Consortium translation 
process: consensus development of updated best practices. J Patient Rep Outcomes . 2017;2(1).  
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Molefi M, Oladimeji O. Evaluating the validity and reliability of the Tswana adaptation of the MOS-HIV tool 
for health-related quality of life among HIV Sub-populations in Botswana: A study protocol. PLoS One .2024 
Oct 1;19(10):e0311904.  
42. 
Lee JH, Ki M, Choi S, Woo CJ, Kim D, Lim H, et al. Validity and reliability of the Korean version of the 
Quality of Recovery-15 questionnaire. Korean J Anesthesiol . 2020;74(2):142 
43. 
Kim D, Kim JK, Yeo J. Translation and Validation of the Korean Version of the Postoperative Quality of 
Recovery Score QoR-15. Biomed Res Int. 2020.  
44. 
Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, et al. Validation of the 
translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth . 2020 Jun 
1;124(6):761–7. 
45. 
de Vlieger JCN, Luiting WH, Lockyer J, Meyer P, Fleer J, Sanderman R, et al. Validation of the Dutch 
translation of the quality of recovery-15 scale. BMC Anesthesiol . 2022 Dec 1;22(1):1–10. 
46. 
Essafti M, Bahi M, Haji K, Lahouidek K, Myatt I, El Fassiki N, et al. Validation of the Arabic version of the 
postoperative Quality of Recovery-15 score. Br J Anaesth. 2023 Dec 1;131(6):e187–90.  
47. 
Mokkink LB, Prinsen CAC, Bouter LM, de Vet HCW, Terwee CB. The COnsensus-based standards for the 
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Strickland LH, Hamilton TW, Jenkinson CC, Murray DW, Pandit HG. Patient-Reported Outcome Measure 
for Early Postoperative Recovery Following Lower Limb Arthroplasty: A Systematic Review. Vol. 31, 
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49. 
Marsh SE, Truter I. Improving health-related quality of  life instrument translation into South African 
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50. 
Posel D, Hunter M, Rudwick S. Revisiting the prevalence of English: language use outside the home in 
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51. 
van den Berg VL. Still lost in translation: Language barriers in South African health care remain. South 
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52. 
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53. 
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55. 
Myles PS, Myles DB. An Updated Minimal Clinically Important Difference for the QoR-15 Scale. 
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56. 
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Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul 1;125(1):39–45.  
 
 

 
 
Page 31 of 40 
8  
9 APPENDICES 
9.1  Data Collection Form 
 
Date: ___ / ___ / ___ 
Study #: _______________ 
 
Age: 
 
years 
 
Sex: 
Male 
Female 
 
Home Language: 
Setswana 
English 
IsiZulu 
IsiXhosa 
Tshivenda 
Xitsonga 
 
Sepedi 
Sesotho 
isiNdebele 
siSwati 
Afrikaans 
Other: 
 
ASA Status: 
I 
II 
III 
IV 
V 
 
Level of Education: 
After School Qualification Secondary School 
Completed 
Primary School 
Completed 
No Formal Education 
Completed 
Other: 
 
Literacy Setswana: 
Speak 
Read 
Write 
 
Literacy English: 
Speak 
Read 
Write 
 
Pre-op assessment date: 
 
 
 
Pre-op QoR-15 Score: 
 
 
Start Pre-Op QoR: 
 
Done Pre-Op QoR: 
 
 
Procedure: 
 
 
 
Procedure Date: 
 
Induction Time 
(a): 
 
Out  
Time (b): 
 
Time last vitals in 
Recovery (c): 
 
 
Duration of Anaesthesia 
(min): 
= b – a  
Duration of Stay Recovery Room 
(min): 
= c – b  
 
Severity of Surgery: 
Minor 
Intermediate 
Major 
 
Type of Anaesthesia: 
General 
Neuraxial alone 
Regional alone 
General & Neuraxial 
General & Regional 
Sedation 
Sedation & Neuraxial 
Sedation & Regional 
 
 
Post-op assessment 
date: 
 
 
 
Post-op QoR-15 Score: 
 
 
Start Post-Op QoR: 
 
Done Post-Op QoR: 
 

 
 
Page 32 of 40 
9.2 
 
 

 
 
Page 33 of 40 
9.3 
SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY ENGLISH CONSENT FORM 
 
We kindly invite you to participate in a Research Project, 
Title of Study: 
Validation of the Setswana translated Quality of Recovery questionnaire in orthopaedic patients at a Tertiary Hospital in South Africa:  a Cross-Sectional Observational Study 
 
 
I have read the information / heard the aims and objectives of the proposed study and was provided the opportunity to ask questions and given adequate time to rethink the issue. The 
aim and objectives of the study are sufficiently clear to me.  I have not been pressurized to participate in any way. 
I know that photographs / electronic images / sound recordings will be taken of me.  I am aware that this material may be used in scientific publications which will be electronically 
available throughout the world.  I consent to this provided that my personal information is not revealed.  Regarding images of the face, I understand that it may not always be possible to 
disguise my identity, and I consent to the use of these images. 
I understand that participation in this study is completely voluntary and that I may withdraw from it at any time and without supplying reasons.  This will have no influence on the regular 
treatment that holds for my condition neither will it influence the care that I receive from my regular doctor. 
I know that this study has been approved by the Sefako Makgatho University Research Ethics Committee (SMUREC), Sefako Makgatho Health Sciences University / Dr George Mukhari 
Academic Hospital. I am fully aware that the results of this study will be used for scientific purposes and may be published.  I agree to this, provided my privacy is guaranteed. 
I hereby give consent to participate in this study. 
 
 
Statement by the Researcher 
I provided verbal and/or written* information regarding this study 
I agree to answer any future questions concerning the study as best as I am able. 
I will adhere to the approved protocol. 
 
 
 
 
 
 
 
Name of Researcher 
Signature   
  Date 
Place 
Participant  
 
 
 
 
 
Name of participant/volunteer 
 
Signature of participant or guardian 
 
 
 
 
 
Place     
Date 
Signature of Witness  

 
 
Page 34 of 40 
9.4 ENGLISH QoR-15 
 
 

 
 
Page 35 of 40 
9.5 
 
 
 

 
 
Page 36 of 40 
9.6 VARIABLE TABLE 
9.6.1 
Variable Table 
Nr 
Variable 
Variable 
Name 
Definition or Calculation 
Data source and 
Recording of variable 
Data type 
1 
Age 
Age 
Age in years 
Recorded from file by 
research assistant or PI 
Numerical, 
continuous 
2 
Biological sex 
Sex 
1 = Male 
2 = Female 
Recorded from file by 
research assistant or PI 
Categorical, 
nominal 
3 
Home Language 
Language 
1 = Setswana 
2 = English 
3 = IsiZulu 
4 = IsiXhosa 
5 = Tshivenda 
6 = Sepedi 
7 = Sesotho 
8 = Xitsonga 
9 = isiNdebele 
10 = siSwati 
11 = Afrikaans 
12 = Other 
Recorded by research 
assistant 
Categorical, 
nominal 
4 
ASA physical 
status 
ASA 
1 = I 
2 = II 
3 = III 
4 = IV 
5 = V 
Recorded from anaesthetic 
chart by research assistant. 
If not recorded, PI will review 
anaesthetic chart and assign 
ASA score based on history. 
Categorical, 
ordinal 
5 
Level of 
Education 
Education 
1 = After School Qualification  
2= Secondary School Completed 
3 = Primary School Completed 
4 = No Formal Education Completed 
5 = Other 
Recorded by research 
assistant 
Categorical, 
nominal 
6 
Literacy level 
Setswana 
Lit_Setswana 
1 = Speak 
2 = Read 
3 = Write 
Recorded by research 
assistant 
Categorical, 
nominal 
7 
Literacy level 
English 
Lit_English 
1 = Speak 
2 = Read 
3 = Write 
Recorded by research 
assistant 
Categorical, 
nominal 
8 
Procedure 
Procedure 
Procedure as specified on the consent 
form 
Recorded by research 
assistant or PI from consent 
form  
Categorical, 
nominal 
9 
Procedure date 
Proc_Date 
DDMMYYY as specified on the consent 
form 
Recorded by research 
assistant or PI from consent 
form 
Numerical, 
continuous 
10 
Induction time 
Induct_Time 
HH:MM as specified on the anaesthetic 
record or the theatre record form in 
patient’s file 
Recorded by research 
assistant or PI 
Numerical, 
continuous 
11 
Out time 
Out_Time 
HH:MM as specified on the anaesthetic 
record or the theatre record form in 
patient’s file 
Recoded by research 
assistant 
Numerical, 
continuous 
12 
Time last vitals in 
recovery room 
Recovery_Time 
Time of last vitals in recovery room as per 
the theatre record form in the patient’s file. 
Recorded by research 
assistant or PI 
Numerical, 
continuous 
13 
Duration of 
Anaesthesia 
Duration_Anaesth 
Out_Time minus Induct_Time 
Calculated 
Numerical, 
continuous 
14 
Duration of Stay 
in Recovery 
Room 
Duration_Recov 
Recovery_Time minus Out_Time 
Calculated 
Numerical, 
continuous 
15 
Severity of 
Surgery 
Severity 
1 = Minor 
2 = Intermediate 
3 = Major 
Assigned by research 
assistant or PI based on 
type of procedure, according 
to ASOS trial definitions. 
Categorical, 
ordinal 
16 
Type of 
Anaesthesia 
Anaesth_Type 
1 = General 
2 = Neuraxial alone 
3 = Regional alone 
4 = General & Neuraxial 
5 = General & Regional 
6 = Sedation 
7 = Sedation & Neuraxial 
8 = Sedation & Regional 
Recorded from the 
anaesthetic chart by the 
research assistant. 
If any uncertainty, PI will 
review the anaesthetic chart 
and assign type of 
anaesthetic. 
Categorical, 
nominal 
18 
Pre-Op Date 
Pre_Op_Date 
DDMMYYY as specified on the data 
collection form 
Recorded by research 
assistant or PI from consent 
form 
Numerical, 
continuous 
19 
Time start Pre-op 
Start_Pre-op 
HH:MM recorded on data collection form 
Recorded by research 
assistant or PI 
Numerical, 
continuous 

 
 
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16 
Time finish Pre-op 
Done_Pre-op 
HH:MM recorded on data collection form 
Recorded by research 
assistant or PI 
Numerical, 
continuous 
20 
Post-Op Date 
Post_Op_Date 
DDMMYYY as specified on the data 
collection form 
Recorded by research 
assistant or PI from consent 
form 
Numerical, 
continuous 
21 
Time to complete 
pre-op 
questionnaire 
Duration_Pre-op 
Done_Pre-op minus Start_Pre-op 
Calculated 
Numerical, 
continuous 
22 
Time start post-op 
Start_Post-op 
HH:MM recorded on data collection form 
Recorded by research 
assistant or PI 
Numerical, 
continuous 
23 
Time finish Post-
op 
Done_Post-op 
HH:MM recorded on data collection form 
Recorded by research 
assistant or PI 
Numerical, 
continuous 
17 
Time to complete 
post-op 
questionnaire 
Duration_Post-op 
Done_Post-op minus Start_post-op 
Calculated 
Numerical, 
continuous 
24 
Days since 
surgery till QoR 
score 
Timing_QoR 
Post_Op_Date minus Proc_Date 
Calculated 
Numerical, 
continuous 
27 
Visual Analogue 
Score 
VAS 
0-10 
Recorded by research 
assistant or PI from data 
collection form 
Categorical, 
ordinal 
28 
Total Pre-op QoR-
15 score 
Total_QoR_Pre-
op 
0 to 150, calculated in RedCAP from 
patient responses to questions 1 to 15 
Calculated from 
questionnaires 
Numerical, 
continuous 
29 
Total Post-op  
QoR-15 score 
Total_QoR_Post-
op 
0 to 150, calculated in RedCAP from 
patient responses to questions 1 to 15  
Calculated from 
questionnaires 
Numerical, 
continuous 
30 
Pre-op: Able to 
breathe easily 
Pre-op_Breathe 
Score from 0 to 10, as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
31 
Pre-op: Been able 
to enjoy food 
Pre-op_Food 
Score from 0 to 10, as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
32 
Pre-op: Feeling 
rested 
Pre-op_Rest 
Score from 0 to 10, as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
33 
Pre-op: Have had 
a good sleep 
Pre-op_Sleep 
Score from 0 to 10 as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
34 
Pre-op: Able to 
look after 
personal toilet and 
hygiene unaided 
Pre-op_toilet 
Score from 0 to 10 as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
35 
Pre-op: Able to 
communicate with 
family or friends 
Pre-op_Comm 
Score from 0 to 10 as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
36 
Pre-op: Getting 
support from 
hospital doctors 
and nurses 
Pre-op_Support 
Score from 0 to 10 as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
37 
Pre-op: Able to 
return to work or 
usual home 
activities 
Pre-op_Home 
Score from 0 to 10 as recorded by patient 
on data collection form. 
Recorded from 
questionnaires 
Numerical, 
continuous 
38 
Pre-op Feeling 
comfortable and 
in control 
Pre-op_Comfort 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
39 
Pre-op: Having a 
feeling of general 
well-being 
Pre-op_Well 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
40 
Pre-op: Moderate 
pain 
Pre-op_Mod_Pain 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
41 
Pre-op: Severe 
pain 
Pre-op_Sev_Pain 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
42 
Pre-op: Nausea or 
vomiting 
Pre-op_NV 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
43 
Pre-op: Feeling 
worried or anxious 
Pre-op_Worried 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
44 
Pre-op: Feeling 
sad or depressed 
Pre-op_Sad 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
45 
Post-op: Able to 
breathe easily 
Post_Breathe 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
46 
Post-op: Been 
able to enjoy food 
Post_Food 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 

 
 
Page 38 of 40 
47 
Post-op: Feeling 
rested 
Post_Rest 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
48 
Post-op: Have 
had a good sleep 
Post_Sleep 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
49 
Post-op: Able to 
look after 
personal toilet and 
hygiene unaided 
Post_toilet 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
50 
Post-op: Able to 
communicate with 
family or friends 
Post_Comm 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
51 
Post-op: Getting 
support from 
hospital doctors 
and nurses 
Post_Support 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
52 
Post-op: Able to 
return to work or 
usual home 
activities 
Post_Home 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
53 
Post-op: Feeling 
comfortable and 
in control 
Post_Comfort 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
54 
Post-op: Having a 
feeling of general 
well-being 
Post_Well 
Score from 0 to 10 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
55 
Post-op: 
Moderate pain 
Post_Mod_Pain 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
56 
Post-op: Severe 
pain 
Post_Sev_Pain 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
56 
Post-op: Nausea 
or vomiting 
Post_NV 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
57 
Post-op: Feeling 
worried or anxious 
Post_Worried 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
58 
Post-op: Feeling 
sad or depressed 
Post_Sad 
Score from 10 to 0 as recorded by patient 
on data collection form. 
 
Recorded from 
questionnaires 
Numerical, 
continuous 
 
 

 
 
Page 39 of 40 
9.7 
 

 
 
Page 40 of 40 
9.8 STROBE checklist 
STROBE Statement—Checklist of items that should be included in reports of cohort studies  
 
 
Item 
No 
Recommendation 
Page 
No 
Title and abstract 
1 
(a) Indicate the study’s design with a commonly used term in the title or the abstract 
 
(b) Provide in the abstract an informative and balanced summary of what was done and what was found 
1 
Introduction 
Background/rationale 
2 
Explain the scientific background and rationale for the investigation being reported 
4-11 
Objectives 
3 
State specific objectives, including any prespecified hypotheses 
11 
Methods 
Study design 
4 
Present key elements of study design early in the paper 
12 
Setting 
5 
Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and 
data collection 
12 
Participants 
6 
(a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of 
follow-up 
12 
(b) For matched studies, give matching criteria and number of exposed and unexposed 
 
Variables 
7 
Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give 
diagnostic criteria, if applicable 
17-19 
Data sources/ 
measurement 
8* 
 For each variable of interest, give sources of data and details of methods of assessment (measurement). 
Describe comparability of assessment methods if there is more than one group 
17-19 
Bias 
9 
Describe any efforts to address potential sources of bias 
20-21 
Study size 
10 
Explain how the study size was arrived at 
14 
Quantitative 
variables 
11 
Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were 
chosen and why 
 
Statistical methods 
12 
(a) Describe all statistical methods, including those used to control for confounding 
 
(b) Describe any methods used to examine subgroups and interactions 
 
(c) Explain how missing data were addressed 
 
(d) If applicable, explain how loss to follow-up was addressed 
 
(e) Describe any sensitivity analyses 
 
Results 
 
Participants 
13* 
(a) Report numbers of individuals at each stage of study—e.g. numbers potentially eligible, examined for 
eligibility, confirmed eligible, included in the study, completing follow-up, and analysed 
 
(b) Give reasons for non-participation at each stage 
 
(c) Consider use of a flow diagram 
 
Descriptive data 
14* 
(a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures 
and potential confounders 
 
(b) Indicate number of participants with missing data for each variable of interest 
 
(c) Summarise follow-up time (eg, average and total amount) 
 
Outcome data 
15* 
Report numbers of outcome events or summary measures over time 
 
Main results 
16 
(a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% 
confidence interval). Make clear which confounders were adjusted for and why they were included 
 
(b) Report category boundaries when continuous variables were categorized 
 
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period 
 
Other analyses 
17 
Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses 
 
Discussion 
Key results 
18 
Summarise key results with reference to study objectives 
 
Limitations 
19 
Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction 
and magnitude of any potential bias 
 
Interpretation 
20 
Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results 
from similar studies, and other relevant evidence 
 
Generalisability 
21 
Discuss the generalisability (external validity) of the study results 
 
Other information 
Funding 
22 
Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on 
which the present article is based 
 
 
*Give information separately for exposed and unexposed groups. 
 
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent 
reporting. The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at 
http://www.plosmedicine.org/, Annals of Internal Medicine at http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on 
the STROBE Initiative is available at http://www.strobe-statement.org.