A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform
Conditions: Postoperative Complications
Sponsor: Sefako Makgatho Health Sciences University

 
 
 
 
 
The South African Collaborative Surgical Outcomes Study 
(SACSOS) 
 
A prospective observational cohort study of patient-reported outcomes 
after surgery using a digital health platform 
 
Study protocol  
 
May 2025 
 
 
 
 
 
 
 
 
 
 
 
 
Hyla-Louise Kluyts  
Principal investigator 
 
 

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ABSTRACT 
Background 
Improving quality of perioperative care depends on reliable measurement of clinically important and patient-
centred data, that will allow collaborative decision-making between patient and clinician. The use of digital 
health tools to share person-centric data with the aim of improving quality of care is encouraged by the World 
Health Organization Global Strategy on Digital Health. With virtual and online communication becoming a 
universal feature of modern life, there is a promising opportunity to engage patients and clinicians in 
perioperative data collection using digital health platforms. The Perioperative Shared Health Record (PSHR), 
developed by Safe Surgery South Africa, provides the opportunity to capture standardised patient-centric 
postoperative outcomes measures, like Quality of Recovery (QOR), Health Related Quality of Life (HRQOL), 
the WHO Disability Assessment Schedule (WHODAS). These are all standardised measures and 
questionnaires, which have been recommended by working groups focused on the patient’s experience after 
surgery. The PSHR enables sharing of data between the surgical patient and his/her clinical team (surgeons 
and anaesthetists). 
Method 
A prospective observational cohort study aiming to recruit patients 18 years and older presenting for any 
surgical procedure at South African hospitals from July 2021 to June 2026. Data will be collected by patients 
using a digital platform, the Perioperative Shared Health Record (PSHR). De-identified data will be extracted 
from the database at predetermined intervals and made available to the principal investigator for analysis. 
Logistic regression models will be constructed to identify factors independently associated with these 
outcomes and to adjust for differences in confounding factors. The PSHR will be updated to optimise health 
information exchange between the surgical patient and clinical team members during the study. 
Keywords (MeSH terms) 
Patient reported Outcome measures 
Perioperative care  
Patient-centered care 
Surgery 
Patients 

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TABLE OF CONTENTS 
Abstract ................................................................................................................................................................ 1 
Background ...................................................................................................................................................... 1 
Method ............................................................................................................................................................. 1 
Keywords (MeSH terms) ................................................................................................................................. 1 
Table of Contents ................................................................................................................................................ 2 
1 
Administrative Information ........................................................................................................................... 4 
1.1 
Roles & Responsibilities ...................................................................................................................... 4 
1.2 
Revision Chronology ............................................................................................................................ 5 
1.3 
Trial Registration .................................................................................................................................. 6 
2 
Introduction .................................................................................................................................................. 8 
2.1 
Background .......................................................................................................................................... 8 
2.2 
Research question ............................................................................................................................... 9 
2.3 
Aim and Objectives .............................................................................................................................. 9 
3 
Methods ..................................................................................................................................................... 10 
3.1 
Study Design ..................................................................................................................................... 10 
3.2 
Setting ................................................................................................................................................ 10 
3.3 
Participants ........................................................................................................................................ 10 
3.4 
Data collection and collation .............................................................................................................. 10 
3.5 
Dataset & Variables: .......................................................................................................................... 12 
3.6 
Data Security, Management and Ownership ..................................................................................... 15 
3.7 
Statistical Methods ............................................................................................................................. 16 
3.8 
Timeline & Milestones ........................................................................................................................ 18 
4 
Budget........................................................................................................................................................ 22 
5 
Ethics and Dissemination .......................................................................................................................... 23 
5.1 
Ethics approval .................................................................................................................................. 23 
5.2 
Dissemination .................................................................................................................................... 23 
6 
References ................................................................................................................................................ 24 
7 
Appendices ................................................................................................................................................ 25 
7.1 
Appendix A: Ethics Approval and Database & Registry Approval ..................................................... 25 

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7.2 
Appendix B: Patient Information Leaflet & SACSOS Consent Form ................................................. 29 
 

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1 ADMINISTRATIVE INFORMATION 
1.1 Roles & Responsibilities 
Principal Investigator (PI): 
Hyla-Louise Kluyts, DMed (Anaes), Department of Anaesthesiology and 
Critical Care, Sefako Makgatho Health Sciences University (SMU) 
Co-PI: 
Bruce M Biccard, PhD, Department of Anaesthesiology and Perioperative 
Medicine, University of Cape Town 
Co-investigator: 
Charlé Steyl, FCA (SA), MMed (Anaes), Department of Anaesthesiology, 
SMU 
Co-investigator: 
JGM (Thinus) Smit, FCS (SA), MMed (Surg), Department of General 
Surgery, SMU and Zuid-Afrikaans Hospital 
Co-investigator:  
Rouxanne Roos, FCS (SA), Zuid-Afrikaans Hospital 
Co-investigator:  
FN (Frederick) Mlimi, FCS (SA), Department of General Surgery, SMU and 
Dr George Mukhari Academic Hospital 
Kelly du Plessis, Rare Diseases South Africa, SACSOS patient representative 
Hanél Duvenage, Research & Development Manager (Safe Surgery SA) 
1.1.1 Co-principal investigator details: 
Professor Hyla-Louise Kluyts 
Department of Anaesthesiology  
Sefako Makgatho Health Sciences University, Pretoria, South Africa 
Email: hyla.kluyts@smu.ac.za 
Tel: +27 83 680 3839 
 
Executive director: Safe Surgery SA NPC 
Block A Willow Wood Office Park 
Corner 3rd street and Cedar Road 
Broadacres, 2021 
Professor Bruce M Biccard 
Department of Anaesthesia and Perioperative Medicine 
Groote Schuur Hospital and University of Cape Town 
Email: bruce.biccard@uct.ac.za 
Tel: +27 76 1606387 

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1.2 Revision Chronology 
Date 
Protocol Amendment 
Number 
Description 
May 2020 
1 
Original 
June 2020 
2 
Refining research question and objectives. 
Refining methodology. 
Refining dataset and variables. 
July 2020 
3 
Additions to Introduction and background. 
Detailed budget added. 
May 2021 
4 
Minor changes to Introduction. 
Changes to budget. 
June 2021 
5 
Minor changes to text. 
July 2021 
6 
Change to subtitle. 
Additions to Steering Committee. 
Change in Recruitment period. 
August 2021 
7 
Formatting updated. 
Headings according to STROBE. 
MRC-approved budget added. 
MRC-approved timeline & milestones added. 
September 2021 
8 
Adjusted list of secondary outcomes. 
January 2022 
9 
Remove validation of cost prediction model from protocol 
Add C Steyl as investigator 
Describe access to data for telephonic patient follow up 
Describe Well-Architected Review as contributing to data 
governance and data security. 
April 2023 
10 
Amend title and objectives to allow for recording of long-term 
patient-reported outcomes ‘post-COVID’. 
October 2023 
10 
Amendment submitted to SMUREC 
June 2024 
11 
Amended to allow for renewed recruitment based on extension 
of grant funding after enhancement of the data collection tool. 
Removal of COVID-19 measures from dataset and changes to 
patient information. 
Changes to primary and secondary objectives and outcomes. 
Removing ‘long-term’ from title. 
Add T Smit as investigator, removing the process of ‘clinical 
team’ recruitment from the methodology 

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October 2024 
11 
Amendment submitted to SMUREC 
February 2025 
12 
Final for SACSOS 
extension of study 
Site list and investigator list finalised to allow recruitment of 
patients at Dr George Mukhari Academic hospital 
Variable list and PSHR processes updated based on user 
experience study by SASUF (South African Swedish 
University Forum) collaborators 
Information, broadcasting and consent material reviewed 
Study registration updated 
 
1.3 Trial Registration 
1.3.1 Registry 
Registered in ClinicalTrials.gov with reference number: NCT05052021 
1.3.2 WHO Dataset 
Data category 
Information 
Primary registry and trial identifying number 
ClinicalTrials.gov: NCT05052021 
 
Date of registration in primary registry 
21 September 2021 
Secondary identifying numbers 
SMU Ethical approval: SMUREC/M/184/2020:IR 
UCT Ethical approval: HREC REF:533/2020 
Source(s) of monetary or material support 
SAMRC RCDI grant to SMU 
NRF-SASUF seed grant for enhancement of PSHR 
Primary sponsor 
SAMRC RCDI 
Secondary sponsor(s) 
NRF-SASUF 
Contact for public queries 
Prof. Hyla Kluyts: hyla.kluyts@smu.ac.za 
Contact for scientific queries 
Prof. Hyla Kluyts: hyla.kluyts@smu.ac.za 
Public title 
The South African Collaborative Surgical Outcomes Study 
Scientific title 
The South African Collaborative Surgical Outcomes Study 
(SACSOS): A prospective observational cohort study of 
patient-reported outcomes after surgery using a digital 
health platform. 
Countries of recruitment 
South Africa 
Health condition(s) or problem(s) studied 
Peri-operative outcomes 
Patient reported peri-operative outcomes 

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Data category 
Information 
Intervention(s) 
N/A 
Key inclusion and exclusion criteria 
• Patients 18 years and older presenting for any surgical 
procedure at South African hospitals accommodating 
the Deep Health information system, from June 2025 to 
June 2026.  
• Exclusion: Patients unable to provide consent to 
participation; Patients whose legal guardian is unable to 
provide consent to participation; Patients unable to 
nominate next-of-kin, guardian or a person of their 
choice, as their representative during follow up. 
Study type 
Observational Prospective Cohort Study 
Date of first enrolment after extension 
1 June 2025 
Target sample size 
N/A 
Recruitment status 
Preparing to recruit 
Primary outcome(s) 
Quality of life (EQ-5D-5L) score (preoperative and at 6 
months) 
Key secondary outcomes 
Quality of recovery (QoR) at 24-48 hours post-operatively 
Patient-reported Postoperative Morbidity Survey (POMS) 
 

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2 INTRODUCTION 
2.1 Background 
Improving quality of perioperative care depends on reliable measurement of clinically important and patient-
centred data, that will allow collaborative decision-making between patient and clinician.1 Patient-reported 
outcomes measures after surgery are useful in adding to clinical outcomes measures such as the 
Postoperative Morbidity Survey (POMS)2 in assessing quality of care. Immediately postoperatively, surgical 
patients can report on Quality of Recovery (QOR).3,4 Patient reported outcome measures to assess longer 
term outcome after surgery include the EuroQol 5 Dimension scale to assess Health Related Quality of Life 
(HRQOL) at 6 or 12 months5 and the WHO Disability Assessment Schedule (WHODAS)6 12 item version to 
assess functional outcome after surgery at 6 or 12 months.7 
Virtual and online communication has become a global standard of living for people with access to the 
necessary technology. Patient engagement using an electronic patient-centric platform for perioperative data 
capture has the potential to contribute significantly to data on perioperative care in South Africa. There is also 
the opportunity to record outcomes that are currently accepted as the standard for understanding recovery 
after surgery, from a South African patient perspective. The use of digital health is an important step in 
exploring opportunities for innovative ways to accelerate progress in global health, as described by the World 
Health Organization.8 South Africa is implementing digital health to support universal health coverage through 
National Health Insurance.9,10 
Safe Surgery South Africa (SSSA) is a research-driven non-profit organisation aiming to enhance the role of 
perioperative clinicians in health information exchange to promote safe perioperative care. SSSA developed a 
digital health tool called the Perioperative Shared Health Record (PSHR). The PSHR allows patients to share 
their health information with their surgical team before a procedure. Patients can record their medical history, 
medications, allergies, functional status and other relevant information that can help inform their perioperative 
care. In addition to the preoperative data, the PSHR also allows for the capture of standardised patient-
reported postoperative outcomes measures, like quality of recovery and HRQOL. This should enable 
healthcare providers to assess patients' recovery progress and outcomes after surgery and to identify any 
potential complications or issues that may arise during the recovery period. It is expected that by providing 
patients with the ability to share their health information and participate in their perioperative care, the PSHR 
may help improve communication and coordination between patients and their healthcare providers, ultimately 
leading to better outcomes and improved patient satisfaction. 
The PSHR was used as the data collection tool in the South African Covid-19 Surgical Outcomes Study 
(SACSOS), a previous version of the current study. To date, patients have been recruited in the private health 
care sector in South Africa, pending efforts to optimise the data collection tool for use in the more diverse and 
challenging setting of the South African public health care sector. Patient recruitment for the study has been 
slower than expected, due to difficulties in integrating the PSHR in the workflow of surgical and anaesthetic 
practices, and use of the PSHR was impeded by usability issues associated with the platform from both the 
patient and the clinician perspective. End-users (both clinicians and patients / carers) were not included in the 

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initial design process of the PSHR, resulting in a lack of user-centeredness in its development. The omission 
of these key stakeholders in the design process may have led to an insufficient consideration of user needs 
and preferences, potentially hindering the adoption and effectiveness of the platform. The current iteration of 
the study protocol is the result of postponing recruitment to allow for enhancement of the PSHR after 
investigation by a South African Swedish University Forum (SASUF) collaborative, funded by an NRF-SASUF 
seed grant.  
2.2 Research question 
How can patient reported outcomes be used to inform decision-making in clinical practice in South Africa? 
2.3 Aim and Objectives 
2.3.1 Aim 
To describe questions constituting a preoperative health survey, validated patient reported outcomes and 
adapted patient-centered outcomes in a patient platform to enable digital sharing of information with 
healthcare providers. 
2.3.2 Primary objective 
To describe the relationship between preoperative and 6-month postoperative health-related quality of life in 
South African surgical patients.  
2.3.3 Secondary objectives 
To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient-
reported outcomes measures (quality of recovery, health-related quality of life). 
To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed 
provider POMS. 
To compare data quality (completeness) for patient-reported outcomes and provider POMS between public 
and private sector settings. 
 
 

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3 METHODS 
3.1 Study Design 
SACSOS is a prospective observational cohort study. 
3.2 Setting 
Dr George Mukhari Academic Hospital, Gauteng Department of Health and private sector hospitals in South 
Africa accommodating the use of the Bespoke Surgical Institute (BSI) Deep Health clinical data platform.9 
Recruitment will take place during the period June 2025 to June 2026. 
3.3 Participants 
Patients will be invited to participate in the study using email notifications and/or Whatsapp messages 
generated by health information systems (BSI Deep Health) used by clinicians. Patients will participate by 
capturing data on a web-based patient platform (the PSHR). A preoperative health status survey is included 
on the platform. Postoperative follow up using the PSHR is enabled at 24-48 hours, 7 days, 30 days, 6 
months and 12 months. 
3.3.1 Inclusion criteria 
• 
Patients 18 years and older presenting for any surgical procedure at South African hospitals 
accommodating the Deep Health information system, from June 2025 to June 2026.  
3.3.2 Exclusion criteria 
• 
Patients unable to provide consent to participation 
• 
Patients whose legal guardian is unable to provide consent to participation 
3.4 Data collection and collation 
Patients will be recruited during the period June 2025 to June 2026.  
The study will focus on patient participation with the web-based platform as the primary recruitment method. 
Patient participation and data capturing require internet access to the web-based platform. The proposed 
recruitment process is illustrated in the following flow diagram: 

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3.4.1 Patient data collection:  
Data will be collected by patients using the PSHR, a patient-centric platform developed by Safe Surgery South 
Africa NPC (CIPC registration number 2014/057792/08). Clinicians at the participating sites will invite patients 
to register on the PSHR via email and/or WhatsApp. When following the link sent by the system, patients will 
be able to register and provide consent to participate in the study. The patient will also consent to access of 
data for the surgical procedure by the clinicians in the team involved, e.g. the surgeon and anaesthetist. 
Postoperative data will be collected by the patient, using the PSHR, at 24-48 hours, 7 days, and 6 months 
postoperatively. Reminders will be sent to patients to complete the necessary forms, when they become 
available. Patients will also be able to register on the PSHR independently and choose their care team in 
order to facilitate patient recruitment.  
The PSHR is a patient platform that requires patients to register, consent to use, and enter complete 
demographics including patient identifiers. The platform is a secure web-based platform hosted on a server 
maintained by a company contracted with Safe Surgery South Africa (SSSA). For the platform to remain 
relevant to users, it requires intermittent updating based on user experience.  

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De-identified data will be extracted from the database at predetermined intervals by the named SSSA 
administrator and made available to the principal investigator for analysis. 
3.5 Dataset & Variables: 
All data will be captured electronically. The variables to be collected for the purposes of this study, are 
displayed in Table 1. Additional variables have been added to the PSHR to support user (patient and clinician) 
experience of the tool and enhance the exchange of information between patient and clinician. 
Table 1: Study variables 
Variable set 
Variable 
Definitions / Questions 
Demographics 
Date of Birth 
YYYY/MM/DD 
Sex 
Male / Female 
Weight 
What is your weight? (in kg) 
Height 
What is your height? (in cm) 
BMI 
Calculation: weight in kilograms divided by height in meters squared. 
Preoperative 
Self-
Assessment 
Adapted ASA-PS category 
Physical status self-assessment as reported by the patient, based 
on the ASA-PS classification. 
Choose ONE of the following to describe your health in general: 
- 
You are healthy. 
- 
You have an on-going (chronic) condition/illness that 
affect your daily life only mildly; that is, you can continue 
with your daily life as previously, e.g. hypertension. 
- 
You have an on-going (chronic) condition/illness that 
affect your daily life severely, that is, the disease does 
not allow you to continue with your daily life as 
previously, e.g. a stroke with disability. 
- 
You have an on-going (chronic) condition/illness that is a 
constant threat to life, so severe that you must stay in 
bed to survive. 
Comorbid 
Disease 
 
Preoperatively 
 
Hypertension 
Do you have high blood pressure? 
If yes, since when? 
Do you take medication for high blood pressure regularly? 
Diabetes Mellitus 
Do you have diabetes (high blood sugar)?  
If yes, since when? 
Do you use insulin for the diabetes (high blood sugar)? 
If yes, for how long? 
Smoking history  
Have you been smoking cigarettes in the past year? 
Did you smoke before but stopped? 
If yes: how many years have you been smoking/did you smoke? 
If yes: how many cigarettes per day do you smoke/did you 
smoke? 
Stroke 
Have you had a stroke? 

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Transient Ischaemic Attack 
Have you suffered from short-lived weakness in your arms or legs, 
or short-lived blindness?  
Chronic Obstructive Lung 
Disease 
Are your lungs damaged due to smoking? 
Asthma 
Do you have asthma? 
Tuberculosis 
Have you ever been treated for tuberculosis? 
HIV infection 
Do you have HIV? 
If yes, since when? 
Cancer 
Have you ever been told you have cancer? 
If yes, have you ever had an operation for cancer? 
If yes, have you ever received medication or radiation for cancer? 
If yes, are you currently receiving medication or radiation for 
cancer? 
If yes, have you been told that the cancer is not under control, or 
has spread? 
Chronic Kidney Disease  
Have you ever had any kidney problems? 
Do you currently have kidney problems? 
Have you ever received dialysis? 
Are you currently receiving dialysis? 
Congestive heart failure  
Do you wake up at night because of difficulty breathing? 
Do you get short of breath when lying flat on your back? 
Do your ankles or legs swell? 
Do you get short of breath when climbing stairs? 
Do you wake up coughing at night? 
Ischaemic heart disease 
Have you ever been told that you have a problem with the blood 
supply to your heart? 
 If yes, when? 
Have you ever had a heart attack? 
If yes, when? 
Have you ever received a stent in the blood supply to your heart? 
If yes, when? 
Have you ever had a bypass or surgery of the blood supply to your 
heart? 
If yes, when? 
Vascular disease 
Do you have 'bad circulation' in your hands or feet? For example 
cold or blue hands or feet? 
Have you been diagnosed with disease of the large blood vessels 
such as the aorta? 
Have you had surgery to the large blood vessels? 
Have you had a blood clot in the deep veins or in your lung 
previously? 
Mental Health 
Have you been feeling sad or depressed much of the time? 
Do you take medication for depression? 
Chronic Pain 
Are you in constant pain for any reason? 
If yes, are you taking medication or receiving treatment for the 
chronic pain? 

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Procedural data 
 
Obtained from 
clinical records 
Time from admission to operation 
Date of admission to hospital 
Date of surgical procedure  
Surgical procedure codes 
E.g. Standardised codes used in Deep Health system 
ICD10 codes (surgical diagnosis) 
E.g. Standardised codes used in Deep Health system 
Health-Related 
Quality of Life 
(EQ-5D-5L)11 
 
Preoperatively, 
postoperatively 
6 months 
Mobility 
 
I have no problems in walking about 
I have slight problems in walking about 
I have moderate problems in walking about 
I have severe problems in walking about 
I am unable to walk about 
Self-care 
I have no problems with washing or dressing myself 
I have slight problems with washing or dressing myself 
I have moderate problems with washing or dressing myself 
I have severe problems with washing or dressing myself 
I am unable to wash or dress myself 
Usual activities (e.g. work, study, 
housework, family or leisure 
activities) 
I have no problems doing my usual activities 
I have slight problems doing my usual activities 
I have moderate problems doing my usual activities 
I have severe problems doing my usual activities 
I am unable to do my usual activities 
Pain / Discomfort 
I have no pain or discomfort 
I have slight pain or discomfort 
I have moderate pain or discomfort 
I have severe pain or discomfort 
I have extreme pain or discomfort 
Anxiety / Depression 
I am not anxious or depressed 
I am slightly anxious or depressed 
I am moderately anxious or depressed 
I am severely anxious or depressed 
I am extremely anxious or depressed 
EQ-5D-5L score 
Calculation based on answers to above 5 questions 
EQ-5D-5L Overall quality of life 
Please indicate how good or bad your health is TODAY. 
 
The scale below is numbered from 0 to 100. 
100 means the BEST health you can imagine. 
0 means the WORST health you can imagine. 
 
Move the slider to indicate how your health is TODAY. 
Quality of 
Recovery 
(QoR-15) 
 
Preoperatively 
and 24-48 hrs 
postoperatively 
 
Physical comfort 
How have you been feeling in the last 24 hours? 0 to 10, where 0 
= none of the time (poor) and 10 = all of the time (excellent): 
- 
Able to breathe easily 
- 
Feeling rested 
- 
Have had a good sleep 
- 
Been able to enjoy food 
Have you had any of the following in the last 24 hours? 10 to 0, 
where 10 = none of the time (excellent) and 0 = all of the time 
(poor): 

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- 
Nausea or vomiting 
Pain 
Have you had any of the following in the last 24 hours? 10 to 0, 
where 10 = none of the time (excellent) and 0 = all of the time 
(poor): 
- 
Moderate pain 
- 
Severe pain 
Physical independence 
How have you been feeling in the last 24 hours? 0 to 10, where 0 
= none of the time (poor) and 10 = all of the time (excellent): 
- 
Able to look after personal hygiene unaided 
- 
Able to return to work or usual home activities 
 
Psychological support 
How have you been feeling in the last 24 hours? 0 to 10, where 0 
= none of the time (poor) and 10 = all of the time (excellent): 
- 
Able to communicate with family or friends 
- 
Getting support from hospital doctors and nurses 
Emotional state 
How have you been feeling in the last 24 hours? 0 to 10, where 0 
= none of the time (poor) and 10 = all of the time (excellent): 
- 
Feeling comfortable and in control 
- 
Having a feeling of general well-being 
- 
Feeling worried or anxious 
- 
Feeling sad or depressed 
Postoperative 
Morbidity 
Adapted Postoperative Morbidity 
Survey (POMS) 
 
(After day 5) 
Were there any complications after the procedure? 
If yes to above:  
- 
Did you develop an infection of the wound? 
- 
Did you need a procedure to take care of wound 
complications? 
- 
Did you have to, for the first time, use oxygen or require 
support to breathe? 
- 
Did you have any new heart or circulation problems? 
- 
Did you receive antibiotics? 
- 
Did you have any problems with eating, or use of your 
gut? 
- 
Did your kidneys stop working well? 
- 
Did you have a blood clot anywhere in your body? 
- 
Did you have any new neurological problems? 
- 
Did you require any blood product transfusion? 
- 
Did you have any new/unexpected pain after recovering 
from your procedure? 
 
3.6 Data Security, Management and Ownership 
Safe Surgery South Africa NPC (SSSA) will act as custodian of data captured using the PSHR platform.  
The PSHR platform is secure, and the data server is provided by Microsoft Azure and maintained by Deep 
Health. Access to the database is through secure login by authorized personnel. The personnel with 

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authorized access are the PI, Prof Hyla Kluyts, and the Safe Surgery SA Research and Development 
Assistant, Ms Hanel Duvenage. Apart from data export for analysis, data will be accessed to obtain 
information to monitor recruitment and participation. This process will be managed by SSSA.  
Sites leads and clinicians will also have access to the data entered into the system by themselves/their sites. 
For Dr George Mukhari Academic Hospital, the site leads will be Dr Mlimi and Prof Kluyts. For the private 
hospitals, no site level access will be granted and clinicians will only have access to their own patient’s data. 
SSSA will have access to all study data for data quality management, recruitment monitoring and patient 
follow-up.  
SSSA’s research support for this project includes assisting researchers, clinicians and (when requested) 
patients with the data collection tool. User management will also include adding clinicians to the PSHR system 
to allow them to invite patients.  
3.7 Statistical Methods 
Categorical variables will be described as proportions and will be compared using chi-square tests. 
Continuous variables will be described as mean and standard deviation if normally distributed or median and 
inter-quartile range if not normally distributed. Comparisons of continuous variables between groups will be 
performed using t-tests, one-way ANOVA or equivalent nonparametric tests as appropriate. Univariate 
analysis will be performed to test factors associated with postoperative complications, morbidity and mortality 
at 30 days.  
Missing data patterns will be investigated, and multiple imputation will be considered if it is deemed 
appropriate to impute variables. 
Logistic regression models will be constructed to identify factors independently associated with these 
outcomes and to adjust for differences in confounding factors. Factors will be entered into the models based 
on their univariate relation to outcome, biological plausibility and low rate of missing data. We will also 
investigate predictors simultaneously using a combination of a LASSO and a Ridge penalty in order to do 
variable selection. 
Results of logistic regression will be reported as adjusted odds ratios (OR) with 95% confidence intervals. The 
models will be assessed through the use of sensitivity analyses to explore possible interacting factors and 
examine any effect on the results. 
Poisson models will be used to model the length of stay outcomes with relative risk ratios as measure of 
association. The cox proportional hazards model may be considered if outcomes are seen as time to event 
where Hazard ratios will be reported. 
Models will be adjusted for clustering if many sites are included in the data. 
Prediction models will be internally validated using bootstrapping, as well as cross-validation. Both leave-one-
out and K-fold cross validation will be considered. Bayesian models may be considered in order to have 
distributions of model parameters, rather than only point estimates with 95% confidence intervals. This may 

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provide a different way of understanding the uncertainty in the model parameters changes as more and more 
data is collected. 
3.7.1 Sample size 
There is no specific sample size. Statistical models will be adapted to the event rate found in the cohort and 
updated as the sample increases.  
3.7.2 Primary outcomes 
• 
Health Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months 
postoperatively 
3.7.3 Secondary outcomes 
• 
Quality of recovery (QoR) preoperatively and at 24-48 hours postoperatively 
• 
Amended Postoperative Morbidity Survey (POMS) postoperatively after 5 days 
• 
POMS recorded by surgeon at discharge from hospital after surgical procedure 
 
 
 

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3.8 Timeline & Milestones 
3.8.1 Milestone table for initial funding application 
Milestones not met, or only partially met, are indicated in red text in the Key Tasks column, without 
amendments included. 
Year 1 
Milestone 1: Clinical Team Recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Recruitment of 25 clinical teams from diverse 
surgical specialities 
July to September 2021 
Team 
registration 
on 
platform 
Agreements in place 
Study 
material 
in 
clinic/consultation rooms 
Milestone 2: Patient Recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Recruitment of 20 patients per clinical team 
October to December 2021 
Patient participation and 
data capturing in platform 
for surgical procedure 
Telephonic 
follow 
up 
during first postoperative 
month 
Milestone 3: Preliminary report on 6 month patient follow up 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Data analysis of first 500+ patients 
January to July 2022 
Report on primary and 
secondary outcomes 1 & 6 
months postop 
Milestone 4: Digital health (platform) development 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Source funding based on results of study 
Engage developers 
October 2021 to July 2022 
Develop platform to be 
used 
for 
patient 
engagement 
in 
low 
resource settings 
 

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Year 2 
Milestone 1: Clinical Team recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Increase number of clinical teams participating and 
increase diversity of teams (specialty, geographical 
location, health sector) 
July 2022 to July 2023 
Data for 500+ patients 
included in database 
Milestone 2: Patient Recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Recruit additional patients to the study and increase 
diversity 
of 
patients 
(social- 
and 
cultural 
backgrounds) 
 
July 2022 to July 2023 
Data for 500+ patients 
included in database 
Milestone 3: Increase reporting of results 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Data analysis 
July 2022 to July 2023 
Report on all outcomes 
including 
1 
year 
postoperative 
Validation and updating of 
clinical prediction model 
 
Year 3 
Milestone 1: Data Science 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Open Science approach to data management, 
analysis and reporting 
July 2023 to July 2024 
Impact 
analysis 
& 
implementation of clinical 
prediction 
models/risk 
stratification tools 
Machine 
Learning 

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Page 20 of 33 
algorhythms 
Milestone 2: Complete recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Last patients recruited to study to allow for 12 
month follow up. 
July 2023 to July 2024 
Final report 
 
3.8.2 Timetable for proposed funding extension 
Year 4 
Milestone 1: PSHR development and maintenance 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Finalise and deploy upgraded data collection tool 
August 2024 to May 2025 
PSHR ready for patient 
recruitment 
Monthly assessment of PSHR performance during 
recruitment 
June 2025 to June 2026 
Bug 
fixes 
and 
other 
maintenance as required 
Milestone 2: Patient Recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Recruitment of patients 
June 2025 to June 2026 
Patient participation and 
data capturing using PSHR 
Milestone 3: Monitoring & evaluation 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Monthly investigator meetings 
June 2025 to June 2026 
Review 
of 
recruitment 
status 
and 
revision 
of 
recruitment 
strategy 
as 
needed. 
 
Year 5 
Milestone 1: Patient Recruitment 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 

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Recruit patients from private and public healthcare 
sector to the study 
June 2025 to June 2026 
Data for patients included 
in database 
Milestone 2: Reporting of results 
Key Tasks 
Duration (Start-End Date) 
Deliverable(s)* 
Data analysis and publication 
July 2026 to December 2026 
Publication 
in 
peer-
reviewed journal 
Presentation 
at 
conferences 
Advocacy 
Ongoing 
Stakeholder (patients and 
policy makers) engagement 
on 
data-driven 
surgical 
decision-making 
 

SACSOS Protocol Final revision March 2025 
 
 
 
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4 BUDGET 
Item 
Year 1 
Year 2 
Year 3 
Total Amount 
requested from the 
MRC 
A. Running Cost 
 
 
 
 
Consumables 
 
 
 
 
1. Materials, and supplies 
 
 
 
 
PSHR maintenance costs 
60 000.00 
60 000.00 
- 
120 000.00 
PSHR hosting costs 
60 000.00 
60 000.00 
- 
120 000.00 
2. Laboratory including reagents, 
kits disposable labware /field 
costs 
 
 
 
 
3. Patient participation cost 
 
 
 
 
4. Office supplies, printing & 
photocopies, data, sim cards, 
telephone cost 
12 000.00 
12 000.00 
- 
24 000.00 
Sub Total 
132 000.00 
132 000.00 
- 
264 000.00 
B. Personnel cost 
 
 
 
 
1. Research Assistants 
132 000.00 
132 000.00 
- 
264 000.00 
2. Field workers  
 
 
 
 
3. Consultants (only allowed with 
motivation) 
 
 
 
 
Sub Total 
132 000.00 
132 000.00 
- 
264 000.00 
C. Publication cost (if not covered 
by university) 
 
 
 
 
D. Research travel 
 
 
 
 
1. Travel to sites 
 
 
 
 
2. Participant /patient transport 
 
 
 
 
3. Other, specify 
 
 
 
 
Sub Total 
 
 
 
 
E. Minor Equipment Cost 
 
 
 
 
F. Conferences and Workshops  
 
 
 
 
1. Local Conferences 
36 000.00 
 
 
36 000.00 
Travel 
 
 
 
 
Accommodation 
 
 
 
 
Living expenses 
 
 
 
 
2. International Conferences  
 
36 000.00 
- 
36 000.00 
Travel 
 
 
 
 
Accommodation 
 
 
 
 
Living expenses 
 
 
 
 
3. Workshops 
 
 
 
 
Travel 
 
 
 
 
Accommodation 
 
 
 
 
Living expenses 
 
 
 
 
Sub Total 
36 000.00 
36 000.00 
- 
72 000.00 
VAT 15%  (TO BE PAID BY SAMRC) 
 
 
 
 
TOTAL 300 000.00 
300 000.00 
 
600 000.00 

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5 ETHICS AND DISSEMINATION 
5.1 Ethics approval 
Primary ethics approval for the study has been obtained from the Sefako Makgatho Health Research Ethics 
Committee (SMUREC), Reference number: SMUREC/M/184/2020:IR. SMUREC also approved the 
Perioperative Shared Health Record (PSHR) database and registry and the BSI: Deep Health database 
(Appendix A). Amended protocols will be submitted for approval by SMUREC. 
The study has been registered on ClinicalTrials.gov, with the Identifier NCT05052021. The registration will be 
updated after approval of extension of the study. 
Patient consent to participation will be captured in the PSHR. Upon using the PSHR, the patient will also be 
asked to agree to the Safe Surgery South Africa database Terms and Conditions and consent to data capture 
in PSHR. 
The protocol, and ethics approval, will be circulated to the research oversight committees of hospital groups 
outside of the academic sector, as required by involvement, and agreement, of hospital managers. 
The prepared patient information and electronic consent to the study is attached as Appendix B. 
5.2 Dissemination 
The result of the study will be published in peer-reviewed journals and presented at conferences. Depending 
on availability of additional funding, the results will also be disseminated to the general public in appropriate 
format. 
 
 
 
 
 
 

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6 REFERENCES  
1. 
Roberts GP, Levy N, Lobo DN. Patient-centric goal-oriented perioperative care. Br J Anaesth. 
2021;126(3):559-564. doi:10.1016/j.bja.2020.12.004 
2. 
Grocott MPW, Browne JP, Van der Meulen J, et al. The Postoperative Morbidity Survey was validated 
and used to describe morbidity after major surgery. J Clin Epidemiol. 2007;60(9):919-928. 
doi:10.1016/j.jclinepi.2006.12.003 
3. 
Stark P, Myles P, Burke J. Development and psychometric evaluation of a postoperative quality of 
recovery 
score. 
Anesthesiology. 
2013;118(6):1332-1340. 
Accessed 
January 
31, 
2019. 
www.anesthesiology.org 
4. 
Chazapis M, Walker EMK, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-
15 after day case surgery. Br J Anaesth. Published online 2016. doi:10.1093/bja/aev413 
5. 
Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version 
of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-1736. doi:10.1007/s11136-011-9903-x 
6. 
Andrews G, Kemp A, Sunderland M, von Korff M, Ustun TB. Normative data for the 12 item WHO 
disability assessment schedule 2.0. PLoS One. 2009;4(12):1-6. doi:10.1371/journal.pone.0008343 
7. 
Myles PS. More than just morbidity and mortality – quality of recovery and long-term functional 
recovery after surgery. Anaesthesia. 2020;75(S1):e143-e150. doi:10.1111/anae.14786 
8. 
The World Health Organization. Global strategy on digital health 2020 - 2025. Geneva: World Health 
Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO. 
9. 
Seebregts C, Dane P, Parsons AN, et al. Designing for scale: optimising the health information system 
architecture for mobile maternal health messaging in South Africa (MomConnect). BMJ Glob Heal. 
2018;3:e000563. doi:doi:10.1136/bmjgh-2017-000563 
10. 
Farao J. Digital health communication in South Africa during COVID-19. Glob Heal Innov. 2020;3(1):1-
3. doi:10.15641/ghi.v3i1.891 
11. 
EQ-5D-5L | EuroQol [Internet]. [cited 2024 Jun 16]. Available from: https://euroqol.org/information-and-
support/euroqol-instruments/eq-5d-5l/ 
 
 
 
 

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7 APPENDICES 
7.1 Appendix A: Ethics Approval and Database & Registry Approval 
 
 

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7.2 Appendix B: Patient Information Leaflet & SACSOS Consent Form 
Note: The information will be provided electronically, and electronic consent will be obtained. This information 
and consent is specific to SACSOS, and in addition to the usual information and consent for a patient using 
the perioperative shared health record (PSHR) developed by Safe Surgery South Africa. 
 
SACSOS INFORMATION TO PATIENT 
TITLE OF STUDY: 
 
South African Collaborative Outcomes Study (SASCOS)  
PRINCIPAL INVESTIGATORS: 
Hyla-Louise Kluyts, Sefako Makgatho Health Sciences University 
Bruce M Biccard, University of Cape Town 
 
Dear Patient, 
 
You are being invited to consider participating in a research project/study when you undergo the planned surgical 
procedure.  
The study is being co-directed by the principal investigators: Prof Hyla-Louise Kluyts, Safe Surgery South Africa, (email: 
hyla.kluyts@smu.ac.za) and Prof Bruce M Biccard, University of Cape Town (email: bruce.biccard@uct.ac.za).  
The study project office is Safe Surgery SA NPC, Block A, Willow Wood Office Park, corner 3rd Street & Cedar road, 
Broadacres, 2021, Cell: +27 67 429 2053, telephone: +27 11 065 9501, Email: admin@safesurgery.co.za 
www.safesurgery.co.za, CIPC Reg no 2014/057792/08.  
The clinical team participating in the study, at each site or hospital, will be the surgeon who will perform the surgical 
procedure, the anaesthetist for the surgical procedure and the hospital manager. 
Before you decide if you would like to participate, we want you to know why we are doing the study, including any risks 
(anything unexpected that might happen), and what you will be expected to do in the study.  
This form gives you information about the study. Any questions you have can be referred to the study directors/project 
office.  We encourage you to discuss this study with your family and anyone else you trust before making your decision. 
We will ask you to agree to take part, and that you understand the study (your consent). It is important that you know:   
• 
You do not have to join the research study. 
• 
You may change your mind and stop being in the study any time you want.   
• 
If we make any important change to the study, we will tell you about it and make sure you still want to be in the 
study.  
Why should I participate? 
 
 
With this study, we hope to better understand your experience of surgical care, using measures that are called patient-
reported outcomes or patient-centric measures.  
The research project will: 
• 
Compare measures of your health-related quality of life before and 6 months after surgery 
• 
Describe the relationship between your health status, the surgery you undergo, and your recovery after surgery 
 
Who can join the study? 
 
Any adult patient (age 18 years and older) that undergoes non-emergency surgery may be included in this study.  
 
How can I join the research study? 
 
You will capture most of the information yourself on an electronic platform: You will be invited to join the study by a doctor 
involved in your care. You will register before your surgery on the Perioperative Shared Health Record (PSHR). This is a 

SACSOS Protocol Final revision March 2025 
 
 
 
Page 30 of 33 
patient-centered personalised care platform developed by Safe Surgery South Africa NPC. Upon registration, you will be 
asked to agree to adding data related to your surgical procedure to a database, for the following reasons:  
• 
For the better management of the patient's health care 
• 
For research purposes, where researchers can use registry information for research projects in which the patient 
will never be identified if such research is published 
• 
For analytical purposes, e.g. create reports for doctors to evaluate themselves, in which patients will not be 
identified at all 
If you agree to the use of your data for research purposes, you will ALSO be asked specifically to participate in this study.  
Once you have registered with the PSHR, you will be asked questions about the state of your health before the operation, 
and your experience after the surgery, and/or outcomes after surgery. 
After your surgery, data will be collected by you using the PSHR, at 24 to 48 hours after surgery and at 7 days, 30 days, 6 
months and 12 months. You will receive reminders about the data request after surgery. If you are unfit as a result of the 
surgery at the time of the follow up, follow up will be with your nominee. The data obtained from your nominee will be 
captured separately (not in the PSHR) during telephonic follow up. 
Please note that the PSHR is a web-based platform, and you will need internet connection to complete the different sets of 
questions. The questions that you will be asked after the operation, will have to be answered by you on a device (mobile 
phone, tablet, or computer) that requires an internet connection. We are unfortunately not able to compensate you for the 
use of data bundles required to complete these sets of questions. 
 
What questions will I be asked? 
 
You will be asked: 
• 
Basic personal information (age, height, weight etc.) 
• 
About your general health and any other conditions (co-morbidities)  
• 
Symptoms you may have when you arrive at the hospital for your surgery 
• 
How long you have had any health condition (co-morbidity) and how it affects you. 
• 
Specific information about your procedure. 
• 
How well you recover after your surgery. 
• 
Patients enrolled via the PSHR will also be asked questions about quality of life. 
 
How safe is it for me to participate? 
 
This study is observational, so no new drug or technique is being studied. The study itself will not affect you physically, so 
there are no risks. Your personal information will be captured electronically, and there is a risk that the information may be 
obtained by people not involved in the study (cyber criminals). We will be implementing all possible measures to decrease 
this risk. 
All data will be collected electronically, i.e. by the patient and doctors entering information into a database. The database 
has been approved by an ethics committee whose job it is to check that measures are in place to protect your privacy. 
De-identified data will be extracted from the database at pre-planned intervals by the Safe Surgery South Africa (SSSA) 
administrator and overseer of the data, and be made available to the principal investigator for analysis. Neither you, the 
patient, nor your doctors will be identified in the data extracts (de-identified to prevent identification of individual patients 
and doctors). Only summary data will be presented publicly, and scientific reports issued at intervals throughout the 
project, including for publication in relevant medical publications as appropriate. 
Safe Surgery South Africa, the custodian of the data, will be insured against cyber privacy- or security breach. 
Taking part in this research is by your choice and you or your nominee may leave the research study at any point, without 
any negative outcomes. 
In terms of the Protection of Personal Information Act, the following forms are available here: 
• 
Objection to the processing of personal information (form 1) 
• 
Request for correction / deletion of personal information or destroying or deletion of record of personal 
information (form 2) 
There will be no costs to you as the patient to take part in the study and there are no incentives or repayments for joining 
the study. 
 

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Ethics Approval  
 
This study has been ethically reviewed and approved by the Sefako Makgatho Health Sciences University Research 
Ethics Committee (approval number SMUREC/M/184/2020:IR). 
In the event of any problems or concerns/questions you may contact the researchers using mobile number +27 67 429 
2053 or the SMU Research Ethics Committee, contact details as follows:  
Molotlegi Street, Ga-Rankuwa 
Pretoria, Gauteng 
PO Box 163, Medunsa, 0204 
www.smu.ac.za 
Telephone: +27 12 521 5617 / 3698 
Facsimile: +27 12 521 3749 
Email: lorato.phiri@smu.ac.za 
 
SACSOS ELECTRONIC CONSENT WORDING 
 
The South African Collaborative Surgical Outcomes Study 
 
I have read the information on 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: to 
compare measures of your health-related quality of life before and 6 months after surgery.  I have not been 
pressurized to participate in any way. 
 
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. When I withdraw, the data that 
I have contributed up to this point will not be used in the analysis for the study. 
 
If I have any more questions/concerns or doubts about the study, I understand that I may contact the 
researchers through the study project office. 
 
I know that this Study has been approved by the Sefako Makgatho University Research Ethics Committee 
(SMUREC), Sefako Makgatho Health Sciences University. I am fully aware that the results of this results of 
this Study will be used for scientific purposes and may be published.  I agree to this, provided my privacy is 
guaranteed. 
 
Subsequent to providing consent, the following information will be requested during registration on 
the PSHR, and will be linked to this consent process: 
 
• 
SA ID number of patient or Passport number 
• 
First Name  
• 
Initials  
• 
Last name 
• 
Email 
• 
Mobile number 
• 
Surgeon  
• 
Patient date of birth 
• 
Emergency contact name 
• 
Emergency contact mobile number  
• 
Emergency contact email address 
 

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eConsent 
 
I hereby give consent to participate in this Study. 
 
*In the event that I (the patient) am not able to participate due to the impact of surgery (or I am incapacitated 
or disabled in any way), I appoint ___”emergency contact name”_________________________________ as 
my nominee to provide information in my place after the surgical procedure. 
 
Yes/No 
 
Date of consent: