'5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation
Conditions: Surgery, Failure to Rescue
Sponsor: University of Cape Town

 
 
                                            16 July 2024                                          Page 1 of 29 
 
‘5 Rs to Rescue’ 
A cluster trial with an embedded process evaluation 
 
Protocol version 1.0 
Date: 16 July 2024 
 
 
Chief Investigators 
Bruce Biccard 
Department of Anaesthesia and Perioperative Medicine 
University of Cape Town  
South Africa 
Email: bruce.biccard@uct.ac.za 
Telephone: +27 (0) 76 160 6387 
 
Rupert Pearse 
Professor & Consultant in Intensive Care Medicine 
Queen Mary University of London and Barts Health NHS Trust 
Royal London Hospital 
London 
United Kingdom 
Email: r.pearse@qmul.ac.uk  
Tel: +44 (0)20 3594 0351 
 
Steering Committee 
Pierre Barker:   
Institute for Health Improvement 
Fitsum Belachew: 
Debre Berhan University, Ethiopia 
Rowan Duys:  
 
University of Cape Town 
Charles Fadipe:  
Queen Mary’s University, London 
Adam Hewitt-Smith: 
Busitema University, Mbale, Uganda 
Busisiwe Mrara:  
Walter Sisulu University 
Tim Stephens:   
Queen Mary’s University, London 

 
 
                                            16 July 2024                                          Page 2 of 29 
 
Sponsor:  
Department of Anaesthesia and Perioperative Medicine, University of Cape Town, 
Anzio Road, Cape Town 7925 
 
Funder:  
National Institute for Healthcare and Care Research (NIHR) through the Global Health 
Group on Perioperative and Critical Care: “APPRISE” 
 
 
 

 
 
                                            16 July 2024                                          Page 3 of 29 
Contents 
LIST OF ABBREVIATIONS ......................................................................................................................... 4 
SUMMARY ............................................................................................................................................... 5 
INTRODUCTION ....................................................................................................................................... 6 
CLUSTER TRIAL ........................................................................................................................................ 8 
Objectives ........................................................................................................................................... 8 
Outcome measures ............................................................................................................................. 8 
Trial setting ..................................................................................................................................... 8 
Eligibility criteria.............................................................................................................................. 9 
Recruitment and screening ............................................................................................................. 9 
Ethical considerations, informed consent and study participation .................................................... 9 
Trial intervention .............................................................................................................................. 10 
Statistical analysis ............................................................................................................................. 11 
Sample size calculation ................................................................................................................. 11 
PROCESS EVALUATION .......................................................................................................................... 13 
Mixed methods process evaluation .................................................................................................. 13 
Objectives ......................................................................................................................................... 13 
Methods ............................................................................................................................................ 13 
SECTIONS PERTAINING TO BOTH COMPONENTS OF THE STUDY ......................................................... 15 
Data Handling and Management ...................................................................................................... 15 
Safety considerations ........................................................................................................................ 16 
Monitoring and Auditing ................................................................................................................... 16 
REFERENCES .......................................................................................................................................... 17 
APPENDICES .......................................................................................................................................... 18 
Appendix 1: Definitions ..................................................................................................................... 18 
Appendix 2: Broadcasting document ................................................................................................ 19 
Appendix 3: Patient information sheet ............................................................................................. 20 
Appendix 4: ASOS Surgical Risk Calculator Score .............................................................................. 21 
Appendix 5: Standard operating procedures manuals ..................................................................... 22 
Appendix 6: Case record form (CRF) ................................................................................................. 24 
Appendix 7: Participant Information Sheet for the process evaluation ........................................... 25 
Appendix 8: Interview topic guide .................................................................................................... 28 
 
 
 

 
 
                                            16 July 2024                                          Page 4 of 29 
LIST OF ABBREVIATIONS 
 
ASOS 
African Surgical Outcomes Study 
CEI  
community engagement and involvement  
CFIR 
Consolidated Framework for Implementation Research 
EuSOS European Surgical Outcomes Study 
EWS 
Early warning scores 
ICC 
intra-cluster correlation 
IHI 
Institute for Health Improvement 
QI 
quality improvement 
SSSA 
Safe Surgery South Africa 
 
 

 
 
                                            16 July 2024                                          Page 5 of 29 
SUMMARY 
Title 
‘5 Rs to Rescue’: A cluster trial with an embedded process evaluation 
Project Office 
Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital, 
University of Cape Town, South Africa. 
Trial Size 
20 centres in 4 countries – Ethiopia, South Africa, Tanzania, and Uganda.   
Trial Design 
Multi-centre, cluster trial with a baseline assessment to evaluate the efficacy of the ‘5 
Rs to Rescue’ quality improvement intervention.  
The trial will incorporate a mixed-methods process evaluation of the trial intervention. 
Primary 
Objectives 
To evaluate whether implementation of the ‘5 Rs to Rescue’ quality improvement 
intervention increases surveillance for patients at risk of ‘failure to rescue’ after surgery 
in hospitals in Africa. 
Secondary 
Objectives 
1. 30 day in-hospital mortality 
2. Duration of hospital stay 
Inclusion Criteria 
Hospitals: Sufficient volume of high-risk patients (ASOS score >10) having surgery, 
defined as ≥7 high risk patients having surgery per week. 
Patients: Patients aged 18 years and older undergoing any surgery, who receive 
postoperative care on a participating ward. 
Exclusion Criteria 
Hospitals: 1. Insufficient volume of high-risk patients having surgery. 2. No confirmed 
engagement with surgical and nursing teams. 3. (Ward level only) Participation in 
similar improvement programmes within previous 12 months   
Patients: 1. Patients that opt out of the trial will be excluded. Patients receiving end of 
life care. 
Recruitment 
Twenty facilities in Ethiopia, South Africa, Tanzania and Uganda 
Trial intervention 
 
 
 
Three-month ‘Set-up Phase’ which will serve as the control period providing baseline 
data and preparation for change associated with quality improvement.  
Six -month ‘Adaptation Phase’ will provide local clinical teams with education and 
training to implement the ‘5 Rs to Rescue’ quality improvement intervention.  
Three-month ‘Sustainability Phase’ to build a learning system for adoption and 
sustainability of the ‘5 Rs to Rescue’ quality improvement intervention. This Phase will 
provide efficacy outcomes data. 
The ‘5 Rs to Rescue’ includes: 1. Risk assessment using the ASOS risk score for all 
surgical patients, 2. Recognition of patient deterioration by regular, protocolised vital 
signs monitoring plus use of an Early Warning Score (EWS) system, 3. Response to 
deterioration by protocolised escalation based upon EWS plus protocolised care 
pathways for common complications (hypoxia, hypovolaemia, sepsis), 4. Reassessment 
following deterioration by protocolised re-assessment based upon EWS, and 5. 
Reflection on care provided following a patient’s deterioration or death using a 
structured review tool at regular reflection meetings 
Trial duration 
Twelve months 
 

 
 
                                            16 July 2024                                          Page 6 of 29 
INTRODUCTION 
‘Failure to rescue’ describes the preventable death of a patient following a complication after surgery. 
Patients who develop complications after surgery, such as haemorrhage or infection, begin to 
deteriorate physiologically and become acutely unwell. This is usually identified by careful monitoring 
of the patient’s basic ‘vital signs’ which include pulse rate, respiratory rate, oxygen saturation, blood 
pressure and consciousness level. However, if physiological deterioration is not identified and treated 
in a timely manner, it will progress and lead to organ dysfunction and then organ failure. This will 
ultimately lead to cardio-respiratory arrest and the death of the patient. 
 
‘Failure to rescue’ can be used as a key concept in delivering safe and effective perioperative care as 
well as a healthcare quality metric in general. The first African Surgical Outcomes Study (ASOS-1) 
showed that ‘failure to rescue’ is the mode of death in 19 out of 20 deaths following surgery across 
Africa.1 Hospitals in high-income countries use early warning systems to monitor patients after surgery 
and trigger the escalation of care for patients who are critically ill to ensure prompt treatment. 
However, these systems do not exist in many resource-poor African hospitals where nurse: patient 
ratios can be as high as 1:35 and limit capacity-to-rescue within the system. Furthermore, in many 
African hospitals they do not use early warning systems to monitor patients following surgery. These 
factors contribute to the higher mortality post-surgery in Africa compared to high-income countries. 
 
As patient outcomes tend to improve when enhanced monitoring increases the identification and 
treatment of critically ill patients,2-4 we have co-produced a complex intervention with healthcare 
staff, community engagement and involvement (CEI) partners, and the Institute for Health 
Improvement (IHI) across four African countries (Ethiopia, South Africa, Tanzania and Uganda) to 
improve the capacity-to-rescue. This complex quality improvement intervention focuses on improving 
five main areas of patient management following surgery: 1) Risk assessment, 2) Recognition of 
patient deterioration, 3) Response to patient deterioration, 4) Reassessment following intervention 
to manage deterioration, and 5) Reflection on care provided following a patient’s death. The complex 
quality improvement (QI) intervention is known as ‘5 Rs to Rescue’. Ultimately, we intend to conduct 
a large international cluster randomised trial of the ‘5 Rs to Rescue’ intervention comparing patient 
important outcomes for patients undergoing major surgery between intervention and usual care 
hospitals. We hope to demonstrate that the ‘5 Rs to Rescue’ intervention can decrease ‘failure to 
rescue’ in Africa, and improve postoperative survival. 
 

 
 
                                            16 July 2024                                          Page 7 of 29 
However, to inform the large international cluster randomised trial, we need to i) determine the 
efficacy of the intervention in demonstrating positive change to clinical management and ii) 
understand the factors which are either positively or negative impacting on the processes involved in 
the delivery of the quality improvement intervention. We will therefore undertake a pilot cluster trial 
to assess intervention efficacy with an embedded process evaluation.  
 
 
 

 
 
                                            16 July 2024                                          Page 8 of 29 
CLUSTER TRIAL 
 
Trial design 
Multi-centre, cluster trial with a baseline assessment to evaluate the efficacy of the ‘5 Rs to Rescue’ 
quality improvement intervention. The trial will incorporate a mixed-methods process evaluation of 
the trial intervention.  
 
Objectives  
Primary objective 
To evaluate whether implementation of the ‘5 Rs to Rescue’ quality improvement intervention 
increases surveillance for patients at risk of ‘failure to rescue’ after surgery in hospitals in Africa. 
Secondary objectives 
To evaluate the effect of the trial intervention on: 
1. 30 day in-hospital mortality. 
2. Duration of hospital stay. 
 
Outcome measures 
Co-primary outcome measures 
1. The number of ASOS Surgical Risk Calculator Scores documented.  
2. The number of completed Early Warning Scores (EWS) within the first 72 hours after surgery. 
3. The number of physician patient encounters within the first 72 hours after surgery. 
 
Secondary outcome measures  
1. All-cause in-hospital mortality within 30 days of surgery. 
2. Duration of hospital stay (number of days from day of surgery until hospital discharge). 
 
A list of definitions is available in the ‘Definitions document’ in Appendix 1. 
 
Trial setting 
Surgical wards of participating hospitals in four African countries (Ethiopia, South Africa, Tanzania, 
Uganda). It is anticipated that in some hospitals not every surgical ward will participate.  
 

 
 
                                            16 July 2024                                          Page 9 of 29 
Eligibility criteria 
Hospital inclusion criteria 
• 
Sufficient volume of high-risk patients (ASOS Surgical Risk Calculator Score >10) having surgery, 
defined as ≥7 high risk patients having surgery per week 
• 
Confirmed engagement with the surgical and nursing teams on target surgical wards 
 
Hospital exclusion criteria 
• 
Insufficient volume of high-risk patients having surgery. 
• 
No confirmed engagement with surgical and nursing teams.  
• 
Participation in similar improvement programmes within previous 12 months (Ward level only 
exclusion criteria). 
 
Patient inclusion criteria 
Patients aged 18 years and older undergoing any surgery, who receive postoperative care on a 
participating ward. 
 
Patient exclusion criteria 
• 
Patients who opt out of trial participation. 
• 
Patients receiving end of life care. 
 
Recruitment and screening 
We expect all consecutive adult patients aged 18 years and older admitted to participating hospital 
wards undergoing elective and non-elective surgery to be included in the trial. ‘Broadcasting’ through 
appropriate hospital notices and signage will inform the patients and the public that the hospital is 
participating in the complex quality improvement intervention study. 
 
Ethical considerations, informed consent and study participation 
The study will be carried out in accordance with the ethical principles in the International Conference 
on Harmonisation and Good Clinical Practice. Ethical approval will be obtained from the University of 
Cape Town with additional approvals in each country as required by national ethical committees, and 
from each institution as required by local regulatory requirements. The Country Coordinators will be 
responsible for clarifying the need for ethical and regulatory approvals and for ensuring these are in 
place prior to data collection. Participating hospitals will not be permitted to record data without 
providing confirmation that the necessary ethical and regulatory approvals are in place.   

 
 
                                            16 July 2024                                          Page 10 of 29 
 
The requirement for patient consent may vary according to national regulations. We anticipate that 
patient consent will not be required by most, or even all, nations on the basis that the study is, in 
effect, a large-scale quality improvement project, the dataset will only include variables documented 
as part of routine clinical care, and identifiable patient data will not leave the treating hospital. 
Therefore, we will apply to all ethics committees for a waiver of consent for participating sites for the 
following reasons. Firstly, more than 50% of surgery in Africa is urgent or emergent, and urgent or 
emergent surgery is a strong independent predictor of postoperative mortality in Africa.1 Attempts to 
obtain traditional consent in the preoperative period in predominantly urgent and emergent surgery, 
which may include patients with a decreased level of consciousness may lead to non-consecutive 
patient enrolment in the study. It is likely that this would lead to a biased sample, with artificially low 
estimates of adverse outcomes in African surgical patients, and data following the study which are not 
generalisable to the majority of African surgical patients. Secondly, for these reasons, a waiver of 
consent is increasingly common around the world in both interventional and observational research 
involving time-sensitive procedures, such as surgery, and has been accepted previously in a similar 
trial by our group across Africa.2 Thirdly, generating biased and poorly generalizable data would not 
address the research question, and thus would dishonour the contributions of the other included 
patients, and would be wasteful research, in a resource-limited environment. Fourthly, we believe 
that the trial intervention is low risk, as it is a complex quality improvement intervention. Finally, we 
will use ‘broadcasting’ signage informing patients and families that the site is a participating surgical 
trial site, through appropriate signage (Appendix 2) and a patient information sheet (Appendix 3).  A 
precedent for this approach was set internationally with the EuSOS and ASOS studies. In EuSOS, 
consent was waived in 27 of the 28 European countries participating,5 and in ASOS-11 and the ASOS-
22 trial consent was waived in the majority of hospitals participating across the African continent. 
 
Trial intervention 
The trial will commence with a three-month ‘Set-up Phase’ which will serve as the control period 
providing baseline data and preparation for change associated with quality improvement. This will be 
followed by a six-month ‘Adaptation Phase’ where local clinical teams will receive education and 
training to implement the ‘5 Rs to Rescue’ quality improvement intervention. This will be supported 
by Improvement Advisors from the Institute for Health Improvement. We will collect data during this 
period, but this will not be used to describe intervention efficacy. The trial will conclude with a three-
month ‘Sustainability Phase’ to build a learning system for adoption and sustainability of the ‘5 Rs to 
Rescue’ quality improvement intervention. The ‘Sustainability Phase’ will provide efficacy outcomes 

 
 
                                            16 July 2024                                          Page 11 of 29 
data. Further adaptations to the complex intervention by the quality improvement teams are 
permissible during this phase. It is not essential for all clusters to commence the trial on the same 
date.  
 
The ‘5 Rs to Rescue’ clinical intervention is a complex intervention which comprises five key 
postoperative care processes designed to reduce ‘failure to rescue’: 
1. Risk assessment: use of the ASOS Surgical Risk Calculator Score (see Appendix 4) for all surgical 
patients. 
For those patients deemed high risk by the ASOS Surgical Risk Calculator Score (>10) or where the 
clinical team deems the patient high-risk: 
2. Recognition of patient deterioration: regular, protocolised vital signs monitoring plus use of 
an Early Warning Score (EWS) system (Appendix 5). 
3. Response to deterioration: protocolised escalation based upon EWS plus protocolised care 
pathways for common complications (e.g. hypoxia, hypovolaemia, sepsis).  
4. Reassessment following deterioration: protocolised re-assessment based upon the EWS. 
5. Reflection on care provided using structured review tools for daily ward ‘huddles’ and regular 
scheduled ‘reflection meetings’ to discuss patients who deteriorate and/ or died.  
Further adaptations to the complex intervention by the quality improvement teams are permissible 
during the trial. Any adaptions will be described as part of the embedded process evaluation. 
 
The case record form (CRF) is shown in Appendix 6.  
 
Statistical analysis 
 
Sample size calculation 
The sample size determination is based on four countries contributing approximately five hospitals 
each to the study. 
One-level clustering has been assumed, not accounting for clustering by countries separately. As no 
intra-cluster correlations (ICC) estimates are available, a high within cluster ICC is assumed (being 
conservative). 
All sample size calculations are for a one-sample proportion tests, testing against a fixed value and 
accounting for clustering. The fixed values are based on baseline estimates, however, choosing target 
values might be preferable. System optimisation step rates assumed not used in analyses. 

 
 
                                            16 July 2024                                          Page 12 of 29 
 
1. Documentation of the ASOS Surgical Risk Calculator Score postoperatively. 
Calculation based on i) a control rate from the pilot study of 25%, with ii) a post intervention (a 
‘Sustainability Phase’) compliance of 90%. 
 
 
2. The number of completed early warning scores (EWS) within the first 72 hours postoperatively 
(high-risk patients only). 
Calculation based on a post intervention (a ‘Sustainability Phase’) compliance of 80% of patients across 
all sites. 
 
3. The number of patients who have documented physician patient encounters within the first 
72 hours postoperatively (all postoperative patients). 
Calculation will be based on i) control rate of number of physician encounters per patient over 72 
hours (1 physician encounter per day), and ii) a post intervention (a ‘Sustainability Phase’) physician 
encounter increase of 30% from the baseline rate over 72 postoperative hours. 
 
 
 
 

 
 
                                            16 July 2024                                          Page 13 of 29 
PROCESS EVALUATION 
 
Mixed methods process evaluation  
Theory-informed process evaluations alongside trials of complex interventions are now standard. The 
process evaluation will provide an understanding of how the trial results were achieved and how the 
intervention mechanisms did, or did not, work in practice. 
 
Objectives 
To understand the influence of contextual and socio-dynamic factors on the effectiveness of the 
implementation of the ‘5 Rs to Rescue’ complex intervention, including:  how the quality improvement 
(QI) programme was delivered to hospital staff; how hospital staff perceived the QI programme, 
including its relative value and usability; the contextual enablers of and barriers to improvement, 
including structural and cultural influences and how individual staff in study sites responded to and 
enacted the guidance offered by the QI programme.   
 
Methods 
Mixed-methods study combining small group interviews, structured observations of care and an end 
of study on-line questionnaire for staff. 
 
Sampling and Data collection  
We will purposefully sample eight study sites from across the four participating countries ensuring a 
mixture of hospital service level (primary, secondary, tertiary). 
Qualitative data collection will include site visits by research assistants (with structured fieldnotes 
taken) and up to 3 small group interviews with key actors (nurses, doctors and managers) per 
participating site (2-5 staff per interview). Data collection and analysis will occur concurrently, and 
sampling will cease when theoretical saturation is reached (or up to maximum number stated).  
One small group interview with the quality improvement project main delivery team (from the 
Institute of Healthcare Improvement) will also be conducted online. Questionnaire data collection will 
be online. Healthcare workers will provide informed consent to participate (Appendix 7). 
 
Healthcare staff inclusion criteria 
• 
Nurses and doctors who work on participating surgical wards and nurses and doctors in 
management roles within participating hospitals.  

 
 
                                            16 July 2024                                          Page 14 of 29 
Healthcare staff exclusion criteria 
• 
Refusal of written informed consent. 
 
Data collection 
A structured topic guide template will be used by the research assistants visiting the study sites 
(Appendix 8). The template will be completed following each visit to the site and will be emailed to 
the process evaluation team for analysis. The research assistants will be instructed in the methods for 
case study visits, field notes and interviews by a process evaluation expert who will oversee the 
qualitative analysis of the case study data. The small group interviews will be recorded on the research 
assistant’s cell phone and the audio files emailed to the process evaluation team for analysis directly 
from audio. The small group interview with the main quality improvement delivery team will be 
conducted and recorded using MS Teams. Interviews will not be transcribed. The post-trial 
questionnaire will be based in REDCap. Individual hospital lead investigators (one per hospital) will be 
invited in person to participate. Output will not identify any individual or hospital. 
 
Data analysis  
Deductive thematic analysis, mapped to the domains and constructs of Consolidated Framework for 
Implementation Research (CFIR)6 to answer the study objectives listed above. Analysis will be led by 
Tim Stephens, who will support other investigators in the theming process. Questionnaire responses 
will be reported using descriptive statistics.  
 
 
 

 
 
                                            16 July 2024                                          Page 15 of 29 
SECTIONS PERTAINING TO BOTH COMPONENTS OF THE STUDY 
 
Data Handling and Management  
The papers containing identifiable patient data for the follow-up of clinical outcomes will be stored 
within a locked office in each hospital or institution. Data will be pseudo-anonymised by generation 
of a unique numeric code and transcribed by local investigators onto an internet based electronic 
case-record file (e-CRF).  
 
Each patient will only be identified on the e-CRF by their numeric code; thus the central co-ordinating 
study team cannot trace data back to an individual patient. A participant list will be used in each 
hospital/site to match identifier codes in the database to individual patients in order to record clinical 
outcomes and supply any missing data points. This participant list will be stored on a password-
protected computer. Access to the data entry system will be based on the principle of least privilege 
and will be protected by username and password delivered during the registration process for 
individual local investigators.   
 
All electronic data transfer between participating hospitals and the co-ordinating institution will be 
encrypted using a secure protocol (HTTPS/SSL 3.0 or better). Data will be anonymised during the 
transcription process using the Research Electronic Data Capture (REDCap) tools hosted by Safe 
Surgery South Africa (SSSA) who will act as the data custodian. REDCap is a secure, web-based 
application designed to support databases and data capturing for research studies. Soft limits will be 
set for data entry, prompting investigators when data were entered outside these limits. In countries 
with poor internet access, paper case record forms may be forwarded to SSSA, for entry by SSSA. 
Pseudo-anonymised (coded) data may also be sent by encrypted e-mail to the coordinating institution 
if necessary. Each institution will maintain a secure trial file including a protocol, local investigator 
delegation log, ethics approval documentation, the participant list, etc. Copies of the relevant 
protocols, approvals and investigator lists will also be kept securely in an internal drive by SSSA. A final 
summary of included patients with aggregated data of patients, and outcomes will be produced for 
each hospital together with final data submission to double check for completeness and accuracy. 
 
Individual patient data provided by participating hospitals remain the property of the respective 
institution, once the study report has been published. Once each local co-ordinator has confirmed the 
data provided from their hospital are both complete and accurate, they will be provided with a 
spreadsheet of the raw (un-cleaned) data for their hospital. In the study report, only summary data 

 
 
                                            16 July 2024                                          Page 16 of 29 
will be presented publicly, and all national, institutional and patient level data will be strictly 
anonymised.  
 
Safety considerations 
There are no safety considerations relating to the study, as this is a quality improvement intervention. 
There is no risk of harm to either patients or investigators.  
 
Monitoring and Auditing 
Study documents may be selected by the Sponsor to ensure study activities are conducted according 
to the protocol, the Sponsor’s standard operating procedures, Good Clinical Practice and the 
applicable regulatory requirements. In participating hospitals, local study documents may also be 
selected for audit on a local basis. The trial team will not routinely monitor data collection in individual 
hospitals or conduct source data verification.  
 
 
 

 
 
                                            16 July 2024                                          Page 17 of 29 
REFERENCES 
 
1. Biccard BM, Madiba TE, Kluyts HL, et al. Perioperative patient outcomes in the African Surgical 
Outcomes 
Study: 
a 
7-day 
prospective 
observational 
cohort 
study. 
Lancet 
2018;391(10130):1589-98. doi: 10.1016/S0140-6736(18)30001-1 [published Online First: 
2018/01/08] 
2. Biccard BM, du Toit L, Lesosky M, et al. Enhanced postoperative surveillance versus standard of care 
to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised 
controlled trial. The Lancet Global Health 2021;9(10):e1391-e401. doi: 10.1016/s2214-
109x(21)00291-6 
3. O'Cathain A, Croot L, Duncan E, et al. Guidance on how to develop complex interventions to improve 
health and healthcare. BMJ Open 2019;9(8):e029954. doi: 10.1136/bmjopen-2019-029954 
[published Online First: 20190815] 
4. Johnston M, Arora S, King D, et al. Escalation of care and failure to rescue: a multicenter, 
multiprofessional 
qualitative 
study. 
Surgery 
2014;155(6):989-94. 
doi: 
10.1016/j.surg.2014.01.016 [published Online First: 20140207] 
5. Pearse RM, Moreno RP, Bauer P, et al. Mortality after surgery in Europe: a 7 day cohort study. Lancet 
2012;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9 [published Online First: 
2012/09/25] 
6. Damschroder LJ, Reardon CM, Widerquist MAO, et al. The updated Consolidated Framework for 
Implementation Research based on user feedback. Implementation Science 2022;17(1):75. 
doi: 10.1186/s13012-022-01245-0 
7. RCP. National Early Warning Score (NEWS) 2: Standardising the assessment of acute-illness severity 
in the NHS. Updated report of a working party London: Royal Colleage of Physicians; 2017 [16 
May 2024]. Available from: https://www.rcp.ac.uk/improving-care/resources/national-early-
warning-score-news-2/ accessed 14 May 2024. 
8. Baker T, Schell CO, Lugazia E, et al. Vital Signs Directed Therapy: Improving Care in an Intensive Care 
Unit 
in 
a 
Low-Income 
Country. 
PLoS 
One 
2015;10(12):e0144801. 
doi: 
10.1371/journal.pone.0144801 [published Online First: 2015/12/24] 
 
 
 

 
 
                                            16 July 2024                                          Page 18 of 29 
APPENDICES 
 
Appendix 1: Definitions 
 
1. 72 hours after surgery: 72 hours from the patient’s arrival on the ward postoperatively   
 
2. Documented African Surgical Outcomes Study (ASOS) Score: ASOS score written in an 
appropriately visible location on the patients notes / ward charts 
 
3. Completed Early Warning Scores (EWS): This is dependent on the EWS chart chosen.  
Each score requires a set of measured and documented vital signs that includes all the 
following: 
• 
Conscious level (AVPU Scale) 
• 
Respiratory rate per minute  
• 
Oxygen saturation (%) 
• 
Heart rate per minute 
• 
Systolic blood pressure (mmHg) 
• 
Plus documentation of the aggregate score (e.g. for NEWS) or documentation of any out-
of-range vital signs (e.g. for the VSDT) 
 
4. Physician encounters: any documented reviews of a patient by a physician 
  
5. Hospital population: all adult patients aged 18 years or over who have been admitted for 
inpatient care in any department or ward in participating hospitals on the day of data 
collection 
 
6. In-hospital mortality: Death in-hospital within 30 days of surgery. Patients discharged alive are 
not followed-up at home.  
 
 
 
 

 
 
                                            16 July 2024                                          Page 19 of 29 
Appendix 2: Broadcasting document 
 
IMPORTANT PATIENT INFORMATION 
A research study is being conducted at …………………..Hospital. 
The research study is being done by Dr ………. from the Department of ……….. 
Why is this research study being done? 
We have attempted to change the way we care for our patients after an operation by 
using a new system called “5R’s to Rescue.” 
The “5R’s to Rescue” project aims to improve how we categorise patients into high 
and low risk patients groups, how we recognise who are developing complications 
earlier after surgery, how respond with earlier care, and how we learn from each 
case. 
Through this study we aim to understand whether this project will improve how our 
patients recover after surgery. 
Why are we telling you about this research study? 
All surgical patients in this hospital are part of the research study. It is a requirement 
that some details of your clinical care will entered into a research study folder. All 
information will be used anonymously to understand how surgical patients respond 
to the increased care given in the study.  
Will this research study affect my care while I am in hospital? 
Yes. We have set early warning systems to alert the doctors and nurses if you are 
very ill, and given advice on how to provide more care while you are in hospital. 
Will my name or any personal details be kept by this research study? 
No. Your name and personal details will not be kept as part of this research study. 
All information from the study will be kept strictly confidential.  
Are there any risks or benefits associated with this project? 
No.  There are no risks or direct benefits associated with this research study. 
Who should I contact if I have any questions or concerns? 
Please contact Dr ………….…. on telephone…………….…. 
If you have questions about your rights or welfare as a participant, please contact the 
UCT Faculty of Health Sciences Human Research Ethics Committee on +27 
(0)21 406 6338.   
 
 
 
 

 
 
                                            16 July 2024                                          Page 20 of 29 
Appendix 3: Patient information sheet 
 
Patient Information Sheet 
 
(To be read to all surgical patients) 
 
A research study is being conducted at …………………..Hospital.  
 
The research study is being done by Dr ………. from the Department of ………..  
 
We hope to improve the care of patients after an operation by using a new system called “5R’s to 
Rescue”. 
 
The “5R’s to Rescue” system aims to help us recognise patients early, who may be developing 
complications after surgery, and then how we respond to provide increased care where it is needed. 
 
We are studying all our surgical cases to understand whether the “5R’s to Rescue” system improves 
how our patients recover after surgery. 
 
Some of the details of your clinical care will be entered into a research study folder. Information 
from this folder will be used anonymously to understand how surgical patients respond to the 
increased care given in the study.  
 
Your name and personal details will not be kept as part of this research study. All information from 
the notes will be kept strictly confidential.  
 
There are no risks or direct benefits associated with this research study.  
 
 

 
 
                                            16 July 2024                                          Page 21 of 29 
Appendix 4: ASOS Surgical Risk Calculator Score 
 
The ASOS Surgical Risk Calculator for preoperative risk prediction of severe postoperative 
complications and mortality 
Age 
18- 29 
0 
30-69 
+1 
≥ 70 
+3 
ASA 
ASA 1 
0 
ASA 2 
+2 
ASA 3 
+5 
ASA 4 and more 
+8 
Surgery timing 
Elective surgery 
0 
Urgent surgery 
+3 
Emergent surgery 
+4 
Surgery severity 
Minor 
0 
Intermediate  
+2 
Major 
+4 
Indication for surgery 
Non-communicable disease 
0 
Caesarean section 
-2 
Trauma 
+1 
Infection 
+2 
Surgery type 
Gynaecology/ obstetrics 
-1 
Plastics and breast  
+1 
Urology 
+2 
Ear, nose and throat, gastro-intestinal, hepato-biliary, cardiothoracic, vascular 
+3 
Neurosurgery 
+4 
Other 
0 
ASA American Society of Anesthesiologists; A single point represents a standard increase in risk, defined as a 
0·25 increase in the logistic regression coefficient, equivalent to a 30% increase in the risk of the outcome being 
present. Total score possible: -3 to 25 
 
 

 
 
                                            16 July 2024                                          Page 22 of 29 
Appendix 5: Standard operating procedures manuals 
 
1. NEWS scoring system7 
 
 
 
 

 
 
                                            16 July 2024                                          Page 23 of 29 
2. Vital Signs Directed Therapy (VSDT) system8 
 
 
 
 
 

 
 
                                            16 July 2024                                          Page 24 of 29 
Appendix 6: Case record form (CRF) 
 

 
 
                                            16 July 2024                                          Page 25 of 29 
 
Appendix 7: Participant Information Sheet for the process evaluation 
 
A mixed-methods process evaluation of the ‘5 Rs to Rescue’ complex quality improvement intervention. 
 
Introduction 
This Participant Information Sheet explains the research study and what taking part will mean. Knowing 
what is involved will help you decide if you want to take part in the study. 
Please read this information carefully. Ask questions about anything that you don’t understand or want to 
know more about. Participation in this research is voluntary and it is your choice to agree to be a part of the 
study or not. If you do not wish to take part, you do not have to. If you decide you want to take part in the 
research project, you will be asked to sign the consent section. By signing it you are telling us that you: 
• 
Understand what you have read 
• 
Consent (agree) to take part in the research project 
• 
Consent to the research that is described 
You will be given a copy of this Participant Information and Consent Form to keep. 
 
Background and purpose of this study 
You are invited to take part in this research project because you work at a hospital participating in the ‘5 Rs 
to Rescue’ project. You are a critically important voice in understanding the current status of post-surgical 
care at the hospital, what is required for post-surgical service improvement and capacity building, and the 
potential implications of this for yourself, your colleagues, and patients based on your experiences 
participating in ‘5 Rs to Rescue’. 
 
Surgery is an important part of healthcare and worldwide; approximately 40% of illnesses, which can’t be 
spread from person to person, require surgery. Over the past 10 years, there has been an increase in 
research into how to make surgery safe, affordable, and effective. 
 

 
 
                                            16 July 2024                                          Page 26 of 29 
Research is a very important part of surgery and the healthcare system, and it includes a varied group of 
people. These people include patients, policymakers (all people involved in making decisions on how 
healthcare is provided to patients), allied services (such as laboratories, pharmacy, biotechnology), and 
healthcare workers and administrators like you.  
 
The ultimate goal of our research is to improve post-surgical services for the communities living in the 
African region. The ‘5 Rs to Rescue’ study seeks to hear your perspective to inform how to adjust the 
initiative as we prepare to scale it to additional hospitals across Africa.  Through talking about your 
experiences and exploring aspects of surgical capacity building at your hospital, we hope to understand 
some of the facilitators and barriers to improving surgical care and make the intervention more successful 
and easier to adopt. 
 
This research is designed to directly benefit the patients of your hospital and wider community, but also to 
potentially provide a model for other African hospitals to improve their post-surgical services. In addition, 
taking part in this study could be important in helping the community to be more involved in healthcare and 
surgical delivery, for the benefit of the community in the future. 
 
What would taking part involve? 
One of the researchers will explain the study process to you and if you agree, to sign a consent form. You will 
then be asked a set of questions which will be audio-recorded and transcribed (copied word-by-word). The 
interview will either be done in person at your workplace, or if preferred, by video call (such as ZOOM), or 
over the telephone. You will be asked a set of questions in a conversation with a member of the research 
team.  
 
You will first be asked questions about your demographics, role and length of service. Further questions will 
be focused on your opinion of the current post-surgical service delivered at your hospital, and your 
perspective and recommendation of what might be required to improve, extend, and sustain these services. 
You will be asked to consider both positive and negative implications and to give us reasons for your 
answers. The interview will be conducted in English. 
 

 
 
                                            16 July 2024                                          Page 27 of 29 
Time commitment 
The time commitment will be 30-45 minutes. We will also ask you if you are interested in the research 
process, and if we can contact you in the future. This is entirely voluntary.  
 
Information to be collected, and stored confidentially 
The audio recordings and their transcripts will be stored securely. Any responses will be completely 
confidential; you will not be able to be identified from any research outputs.  
 
Who is organizing and funding the research? 
This research study has been conceived by the University of Cape Town’s Department of Anaesthesia and 
Perioperative Medicine. The research is funded by the National Institute of Health Research (NIHR).   
 
Will I get paid to take part in this study? 
There is no reimbursement for this study. 
 
Consent 
It is up to you whether you decide to join the study. If you agree to take part, we will ask you to sign a 
consent form. You are free to leave the study at any time, without giving a reason. Whether or not you take 
part in the study, if you wish to complain, or have any concerns about any aspect of the way you have been 
treated during this study, you should ask to speak to your local lead researchers who will do their best to 
answer your questions (contact details are at the bottom of this form). 
 
The UCT’s Faculty of Health Sciences Human Research Ethics Committee can be contacted on 021 406 6338 
in case you have any ethical concerns or questions about your rights or welfare as a participant in this 
research study. 
Contact details 
For any further information you may require, please contact Prof Bruce Biccard (021 404 5001). 
 
 

 
 
                                            16 July 2024                                          Page 28 of 29 
Appendix 8: Interview topic guide 
 
Topic guide – Healthcare staff interviews for “5Rs to Rescue” 
 
Summary of topics 
1. 
Short summaries of site experience   
2. 
Specifics about the “5Rs to Rescue” components 
3. 
Specifics about the quality improvement (QI) programme 
4. 
Specifics about key actors  
5. 
Reflections on what you might do differently (and anything you would definitely do the 
same) 
 
Topics guide 
1. Obtain a short overall summary 
“How did the “5Rs to Rescue” initiative unfold from your perspective?”  
 
(aiming for a bit of a narrative description of the story of the initiative at this site) - 5 
mins (if short of time, can ask each person for 1 or 2 words to describe the overall 
experience with a brief description of why they chose those words) 
 
2. The components of 5Rs – 15 mins 
“For each R component, we are going to discuss what worked and what didn’t” 
• 
ASOS Surgical Risk Score – what worked / what was difficult? 
• 
Early warning score (EWS) – what worked / what was difficult? 
• 
Response protocols - what worked / what was difficult? 
• 
Reassess - what worked / what was difficult? 
• 
Reflect - what worked / what was difficult? 
 
3. Discuss about the quality improvement (QI) support (including learning sessions, 
calls, visits)  
“Can you tell us about the quality improvement support of the project” 
• 
What worked well? 
• 
What was difficult? 
 
4. Discuss the improvement process  
“Can you describe or tell us” 
• 
Who or what in your sites was / were the biggest facilitators of change?  
• 
What would you do differently if you could do this again?  
 

 
 
                                            16 July 2024                                          Page 29 of 29 
5. Reflections on what you might do differently (and anything you would definitely do the 
same) 
“Can you tell us what you might do differently, or is there anything you would 
definitely do the same?”