Smart Triage: Triage and Management of Sepsis in Children Using the Point-of-care Paediatric Rapid Sepsis Trigger (PRST) Tool
Phase: NA
Conditions: Sepsis, Infection
Sponsor: University of British Columbia

        
       
 
 
   
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RESEARCH STUDY PROTOCOL 
 
 
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 5.0  
October 19, 2020 
 
Confidentiality statement  
 
This document is confidential and is to be distributed for review only to investigators, 
potential investigators, consultants, study staff, applicable regulatory authorities, and 
applicable independent ethics committees or institutional review boards. The contents of 
this document shall not be disclosed to others without written authorization, unless it is 
necessary to obtain informed consent from potential study participants.  

        
       
 
 
   
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Table of Contents 
ADMINISTRATIVE INFORMATION ..................................................................................................................... 4 
1. 
TITLE ................................................................................................................................................................. 4 
2. 
TRIAL REGISTRATION ................................................................ ERROR! BOOKMARK NOT DEFINED. 
A. 
TRIAL IDENTIFIER AND REGISTRY NAME .................................................. ERROR! BOOKMARK NOT DEFINED. 
B. 
ALL ITEMS FROM THE WORLD HEALTH ORGANIZATION TRIAL REGISTRATION DATA SET ...................ERROR! 
BOOKMARK NOT DEFINED. 
3. 
PROTOCOL VERSION .................................................................................................................................... 4 
4. 
FUNDING ........................................................................................................................................................... 4 
5. 
ROLES AND RESPONSIBILITIES ................................................................................................................ 4 
A. 
NAMES, AFFILIATIONS, AND ROLES OF PROTOCOL CONTRIBUTORS ................................................................... 4 
B. 
NAME AND CONTACT INFORMATION FOR THE TRIAL SPONSOR ......................................................................... 5 
C. 
ROLE OF STUDY SPONSOR AND FUNDERS .......................................................................................................... 5 
INTRODUCTION ....................................................................................................................................................... 6 
6. 
BACKGROUND AND RATIONALE .............................................................................................................. 6 
7. 
OBJECTIVES .................................................................................................................................................... 7 
8. 
TRIAL DESIGN ................................................................................................................................................. 8 
METHODS: PARTICIPANTS, INTERVENTIONS, AND OUTCOMES ........................................................... 12 
9. 
STUDY SETTING ........................................................................................................................................... 12 
10. 
ELIGIBILITY CRITERIA ........................................................................................................................ 12 
11. 
INTERVENTION ........................................................................................................................................ 13 
12. 
OUTCOMES................................................................................................................................................ 13 
13. 
PARTICIPANT INVOLVEMENT ............................................................................................................ 14 
14. 
SAMPLE SIZE ............................................................................................................................................ 15 
15. 
SAMPLING AND RECRUITMENT STRATEGIES .............................................................................. 15 
METHODS: DATA COLLECTION, MANAGEMENT, AND ANALYSIS ........................................................ 16 
16. 
DATA COLLECTION................................................................................................................................ 16 
17. 
DATA MANAGEMENT ............................................................................................................................ 17 
18. 
STATISTICAL ANALYSIS ....................................................................................................................... 18 
METHODS: MONITORING ................................................................................................................................... 20 
19. 
DATA MONITORING ............................................................................................................................... 20 
20. 
HARMS ........................................................................................................................................................ 21 
ETHICS AND DISSEMINATION ........................................................................................................................... 21 
21. 
RESEARCH ETHICS APPROVAL/PROTOCOL AMENDMENTS .................................................... 21 
22. 
INFORMED CONSENT AND ASSENT .................................................................................................. 22 
23. 
CONFIDENTIALITY ................................................................................................................................. 23 
24. 
DECLARATION OF INTERESTS ........................................................................................................... 24 

        
       
 
 
   
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25. 
ACCESS TO DATA .................................................................................................................................... 24 
26. 
PRESENTATION AND DISSEMINATION OF RESULTS................................................................... 25 
27. 
REFERENCES ............................................................................................................................................ 25 
APPENDIX A ............................................................................................................................................................. 28 
APPENDIX B ............................................................................................................................................................. 45 
APPENDIX C ............................................................................................................................................................. 47 
APPENDIX D ............................................................................................................................................................. 50 
APPENDIX E ............................................................................................................................................................. 54 
APPENDIX F ............................................................................................................................................................. 59 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

        
       
 
 
   
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Administrative Information 
 
1. Title  
 
Title: Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
Lay Title: Development and testing of a digital tool for recognizing sick children 
 
2. Protocol Version  
 
Version 5.0, October 19, 2020 
 
3. Funding  
 
This study is funded by the Wellcome Trust Innovator Award.  
 
4. Roles and Responsibilities  
 
a. Names, affiliations, and roles of protocol contributors  
 
Mark Ansermino  
Principle Investigator  
Department of Anesthesiology, 
Pharmacology & Therapeutics, 
University of British Columbia, 217-
2176 Health Sciences Mall, Vancouver, 
BC V6T 1Z3, email 
anserminos@yahoo.ca
Alishah Mawji 
Project Coordinator  
Department of Anesthesiology, 
Pharmacology & Therapeutics, 
University of British Columbia, 217-
2176 Health Sciences Mall, Vancouver, 
BC V6T 1Z3, email 
alishah.mawji@bcchr.ca
Matthew O. Wiens 
Principle Investigator 
(Uganda) 
Center for International Child Health, 
BC Children’s Hospital Research 
Institute, 948 W 28th Ave, Vancouver, 
BC, V5Z 4H4, email 
mowiens@outlook.com 
Niranjan Kissoon 
Clinical Adviser  
 Department of Pediatrics, University of 
British Columbia, Rm B2W, 4480 Oak 

        
       
 
 
   
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Street, Vancouver, BC, V6H 3V4, email 
nkissoon@cw.bc.ca
Edmond Li 
Graduate Student  
School of Population and Public Health, 
University of British Columbia, 2206 
East Mall, Vancouver, BC, V6T 1Z3, 
email Edmond.li@alumni.ubc.ca
Guy Dumont 
Technical Lead  
University of British Columbia, 
Vancouver, Canada, , email 
guyd@ece.ubc.ca
Samuel Akech 
Principle Investigator 
(Kenya) 
Kenya Medical Research 
Institute/Wellcome Trust Research 
Programme, P.O. Box 43640-00100, 
Nairobi, Kenya, email sakech@kemri-
wellcome.org
David Kimutai 
Clinical Lead (Kenya) 
Consultant Paediatrician, Mbagathi 
County Hospital, Nairobi, Kenya, email 
dkimutaidr@yahoo.com
Nathan Kenya 
Mugisha 
Clinical Adviser 
Walimu,  
Plot 5-7, Coral Crescent, Kololo 
P.O. Box 9924, Kampala, Uganda, 
email kenya@walimu.org
Abner Tagoola 
Clinical Lead (Jinja, 
Uganda) 
Senior Consultant at Jinja Hospital, 
Jinja, Uganda, email 
avtagoola@yahoo.com
Paska Apiyo 
Clinical Lead (Gulu, 
Uganda) 
Physician at Gulu Regional Regerral 
Hospital, Gulu, Uganda, email 
apiyopaska2004@yahoo.co.uk 
 
 
b. Name and contact information for the trial sponsor 
 
Sponsor:  
Wellcome Trust
Address:  
215 Euston Rd, Bloomsbury, London NW1 
2BE, United Kingdom
Phone Number:  
+44 20 7611 8888
 
 
c. Role of study sponsor and funders  
 
The study sponsor and funders do not have a role in in study design; collection, management, 
analysis, and interpretation of data; writing of the report; and the decision to submit the report for 
publication. They will not have ultimate authority over any of these activities.  
 

        
       
 
 
   
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d. Collaborating organizations  
 
1. The University of British Columbia  
 
2. Centre for International Child Health 
 
3. Kenya Medical Research Institute (KEMRI)  
 
4. Walimu 
 
5. Jinja Regional Hospital 
 
6. Mbagathi County Hospital  
 
7. Kiambu County Referral Hospital 
 
 
Introduction 
5. Background and Rationale 
 
The global burden of pediatric mortality in low- and middle-income countries (LMICs) remains 
high, with 4.9 million deaths in children under 5 in 2016  [1]. Most of these deaths are due to 
sepsis, which is defined as the body’s response to an infection (such as pneumonia, diarrhea, or 
malaria) leading to organ damage and ultimately morbidity and mortality [2]. Sepsis is common 
worldwide, but countries in Africa report substantially higher case fatality rates (adjusted odds 
ratios: Africa, 7.89 [95% confidence interval (CI), 6.02-10.32]) as compared to the United States 
[3]. Recognizing the enormity of the global burden of sepsis (death, disability, social, and 
economic) led to a 2017 World Health Assembly resolution highlighting the need to prioritize 
prevention, recognition, and early treatment of sepsis [4]. 
Sepsis disproportionately affects socioeconomically disadvantaged populations in LMICs. 
Encouragingly, most deaths from sepsis are preventable by early detection and treatment. The 
majority of deaths occurring in health facilities happen occur as a result of delayed, inadequate, or 
inappropriate treatment. Every hour of delay in therapy is associated with an escalating risk of 
morbidity and mortality [5]. Simple, highly effective interventions to treat sepsis, including 
antimicrobials and intravenous (IV) fluids, are available at care facilities in LMICs. Yet 
availability and readiness to provide treatment is not always enough [6]—timely treatment may 
not occur because the sickest children are not prioritized. 
The World Health Organization (WHO) advocates the use of Emergency Triage Assessment and 
Treatment (ETAT) guidelines to triage children in resource limited settings [7]. Although the 
ETAT system is widely adopted in LMICs, successful implementation of the guidelines into 
clinical practice is not always the case [8]. In LMICs, patients are frequently admitted and 
treated on a first-come, first-serve basis, leading to delayed care for children who are in need of 

        
       
 
 
   
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urgent treatment. These priority children can receive faster treatment if every child is rapidly 
triaged upon arrival to identify danger and priority signs of sepsis [9]. However, sepsis is a 
syndrome that mimics many conditions and few health workers can confidently triage and 
diagnose sepsis. Evidence-based trigger tools and protocols may be useful in skilled hands, but 
require complex decision-making based on physiological, clinical, social, and laboratory 
parameters. 
The purpose of this study is to develop a digital triage tool that can be used rapidly and reliably, 
without the need for extensive memorization or training, by frontline health workers (including 
nurses and non-physician clinicians) to identify critically ill children (including those with 
sepsis). The digital platform consists of a mobile application integrating a pulse oximetry sensor 
attached to this device, with embedded smart algorithms that predict a critically ill state, or level 
of risk (below) in a child presenting at the hospital. The platform also includes an interactive 
dashboard located in strategic locations (e.g., laboratory, consultation rooms), which connects to 
the mobile application through a secure local network and displays the triage data to provide 
real-time monitoring for the physicians who manage the patients. 
Over the past 10 years, we have developed, implemented, and evaluated the core technology of 
the Digital Triaging Platform including vital sign measurement devices (PhoneOx [10]  and 
RRate [11]) and the mobile application and dashboard [12][13][14]. We have already identified 
candidate predictor variables using a modified Delphi process [15], and developed a risk 
prediction model based on the need for admission using predictors collected in over 1000 
children at a Kenyan hospital [16].  
 
6. Objectives  
 
Objective A: To develop and clinically validate a digital trigger tool and clinical dashboard for 
improving the hospital wait time to treatment administration in children with severe 
infections/suspected sepsis.  
 
Breakdown 
1. To collect a pre-selected list of clinical variables from participants and use the data to 
develop a prediction model based on the need for hospital admission.  
2. To develop a digital triage tool by implementing the derived prediction model and triage 
guidelines used in the study hospitals into the Digital Triaging Platform.  
3. To evaluate the usability/feasibility of the digital trigger tool prior to implementation in 
the study hospitals.  
4. To clinically evaluate effectiveness of the triage tool by comparing hospital wait times to 
treatment for children before and after implementation of the digital triage tool.  
 
Additional objectives due to the impact of COVID-19 at the study sites:  
1. Develop data driven prediction models for identifying vulnerable children with suspected 
sepsis that are robust during future COVID-19 surges and novel pandemics.  

        
       
 
 
   
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2. Identify the variables that contribute to vulnerability in children with suspected sepsis, 
during pandemic and non-pandemic times.  
3. Collect additional COVID-19 related prediction variables to inform understanding of the 
severity, risk factors, and clinical features of this disease at our three study sites (rural, 
urban and peri-urban).  
 
 
Objective B: To validate the use of an automated Radio-Frequency Identification (RFID) 
method to track timeliness of interventions.  
 
RFID tags will be small paper or plastic objects that can be attached to clothing or worn as a 
bracelet, anklet, or necklace (as preferred by child’s caregiver) that use Bluetooth frequency 
band. The tag sends signals which allows tracking exactly where a patient is at a given time for 
analysis. For example, if a patient wearing an RFID tag enters a room, a reader in the room will 
detect the signal and add a timestamp for when patient was in the room. The Bluetooth frequency 
is no different to that used by mobile phones and is not expected to interfere with other processes 
in the hospital.   
 
Objective C: To conduct an economic evaluation to contextualize our results for informing 
budgetary decisions of scaling-up Smart Triage. 
 
7. Trial Design  
 
This is a pre-post intervention study involving pediatric patients presenting to the study hospitals 
in seek of medical care for an acute illness. The study involves three phases: (I) Baseline Period, 
(II) Interphase Period, (III) Intervention Period.  
 
Changes due to the impact of COVID-19:  
Due to the impact of COVID-19 at our study sites, there will be an addition of a pandemic phase 
during Phase I. This will allow us to explore any differences that exist in a pandemic period 
compared to a non-pandemic period and develop data driven prediction models for identifying 
vulnerable children with suspected sepsis that are robust during future COVID-19 surges and 
novel pandemics.  
 
 
 
Phase I (3 
months) 
Baseline 
Period: 
Pandemic 
Cohort 
Phase I (3 
months) 
Baseline 
Period: Post-
Pandemic 
Cohort 
Phase II (1-3 
months) 
Interphase 
Period 
Phase III (5-6 
months)  
Intervention 
Period 
Analysis Period 
Site 1: 
Mbagathi 
 
 
 
Routine use of 
digital triage tool 
 

        
       
 
 
   
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County 
Hospital, 
Nairobi  
 
Data collection 
on predictors 
and outcomes 
by study nurses. 
 
Data 
collection on 
predictors and 
outcomes by 
study nurses. 
 
Technology 
development 
and usability 
testing 
by hospital 
nurses.  
 
Data collection 
continues as 
done in Phase I 
by study nurses. 
  
 
Determine 
effectiveness of 
intervention, 
results 
presentation and 
dissemination. 
Site 2: Jinja 
Regional 
Referral 
Hospital, 
Jinja 
Control 
Site: Kiambu 
County 
Hospital, 
Nairobi
Ongoing baseline data collection (12 months) 
 
Figure 1. Study Schema.  
 
Updated Timeline due to COVID-19:  
Phase:  
Baseline 
Training 
Intervention 
Analysis 
Duration: 
6 months 
1 month 
6 months 
11 months 
Site 1: Kenya 
Delayed 
Delayed 
Delayed 
Baseline data 
collection 
 
Site 2: Jinja  
 
Baseline 
data 
collection 
Model 
development, 
usability testing, 
and training 
Routine use of 
PRST and 
continued data 
collection
Statistical 
analysis and 
reporting of 
Results   
Control: Kenya 
Delayed  
Baseline data 
collection
Additional 
Site: Gulu 
Uganda 
 
Baseline data collection 
Routine use 
of PRST  
 
 
 
Phase I (6 months) will be a prospective observational cohort at Mbagathi County Hospital in 
Nairobi, Kenya, and Jinja Regional Referral Hospital in Jinja, Uganda. During this period, there 
will be no changes to healthcare delivery procedures in the study hospitals. Triage will continue 
to be performed by hospital staff using ETAT+ guidelines, the system that is currently in effect 
at the study hospitals [7]. Data collection will be undertaken in the triage waiting area. While 
participants are waiting for their turn to be seen by the hospital triage nurses, our trained study 
nurses will collect data on a pre-selected list of predictor variables (see Appendix A). These data 
will be used to develop a clinical prediction model based on the need for hospital admission.  
 

        
       
 
 
   
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Changes due to the impact of COVID-19:  
 
We anticipate that the weekly number of admissions will return to baseline over the next 2-3 
months. Therefore, Phase I will be split into baseline data collation during a pandemic period 
(first 3 months), and non-pandemic period (latter 3 months)  
 
 
Control Site (Phase I, 12 months): Kiambu County Referral Hospital in Nairobi, Kenya will 
serve as the control site and no intervention will be implemented. At this site, Phase I will 
commence for a period of 12 months. There will be no Phase II or Phase III.  
 
 
Phase II (1-3 months) will involve technology development, usability testing, and training.   
 
Phase IIa: Technology Development. A risk prediction model will be derived using the data 
collected in Phase I and implemented in a Digital Triaging Platform, along with a digitized 
version of the ETAT+ guidelines. The Digital Triaging Platform, including vital sign 
measurement devices (PhoneOx [10]  and RRate [11]) and the mobile application and clinical 
dashboard [12][13][14] has already been developed and evaluated. Once the digital triage tool 
has been developed, it will be evaluated in potential users using simulated patient scenarios and a 
‘Think Aloud’ method.  
 
Phase IIb: Usability Testing and Training.  
 
Usability Testing Initiative 
The digital triage tool will be evaluated for ease of interface navigation, functionality and basic 
workflow. A sample of 15 potential users in the study hospitals to represent the primary user 
groups will be selected for participation in the 60-minute-long usability testing initiatives. 
Participants will be recruited through word of mouth as there is a very small cadre of potential 
participants. The objective of the training is to (1) ensure healthcare workers understand how to 
correctly collect and interpret patient information, and (2) to obtain feedback on the digitization 
of the tool. Training will use a framework that meets key international norms for testing digital 
tools, including, the think-aloud method and a questionnaire.  
 
Each training session will be conducted by a moderator and observer. During the evaluation, the 
observer will be seated next to the participant and will record user interaction with each 
interface, comments, errors, and duration of each task. Participants will be given 3-5 patient 
scenarios which will list hypothetical information to be entered into the app (see Appendix B). 
This information will be designed to represent routine data collected during triage examination at 
the study hospitals. The moderator will provide the fictional charts to participants and instruct 
them throughout the tasks. During the simulated patient scenarios, participants will be asked to 
think aloud, in order to assess their thought process as they used the app. Participants will be 
specifically instructed to comment on the layout of the app screen, the dialogue on each 
interface, the order of tasks, and any additional observations or opinions. After learning the 
basics of the digital platform, the participants will be read the think aloud instructions and asked 

        
       
 
 
   
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to perform the list of tasks and answer questions (see Appendix C). The observer will complete a 
checklist to ensure that all tasks were completed, questions will be asked to evaluate task 
comprehension, and notes will be taken about whether help was needed in completing each task.  
At the end of the training session, participants will complete a triage tool training questionnaire 
(Appendix D) to provide an understanding of the practical benefits and drawbacks of 
incorporating the digital triage tool into a clinical context. The questionnaire will utilize open 
ended questions and comment responses. from this evaluation. Responses from the survey will 
be anonymous. The data generated from the training phase is fictitious and will not be linked to 
any individual subject. In light of ongoing physical restrictions due to COVID-19, the sessions 
will be recorded digitally with multiple audio and video feeds of each usability session. The 
session will record (1) the participant’s screen from within the software using screen capture 
technology (video only); (2) the participant physically using the digital tool (video only); (3) the 
participant’s reactions and comments towards the digital tool (audio and video). 
 
Interviews  
 
After the digital triage tool has undergone usability testing and updates, and has been implemented 
in the study hospitals, a one-week pilot period will take place. At the end of this period, healthcare 
workers and hospital staff will be invited to participate in an interview to allow evaluation of the 
acceptability, usability, and feasibility of the digital triage tool in the context of the hospital. A 
total of 30 staff, including clinicians, doctors, nurses, and administrators, will be selected to 
participate in focus group discussions and one-on-one interviews. Interviews will take place after 
the pilot phase, and periodically throughout the interventional phase (Phase III) to capture 
experiences and feedback from hospital staff throughout the course of the study. Interviews may 
be conducted either in person in a private room on site at the hospital, or, in consideration of 
personal safety and ongoing physical distancing restrictions due to COVID-19, through a secure 
digital conferencing software. Interviews will be facilitated by one interviewer and recorded 
digitally with an audio recorder. Interviews will last approximately 60 minutes, during which the 
interviewer will ask the interviewees series of questions from a semi-structured interview guide 
(Appendix E).  
 
 
Transcriptions, Think Aloud observations, and interview recordings will be analyzed using the 
Framework Method [17] to assess attitudes of health workers. Responses will be transcribed and 
coded using NVivo [18], for the identification, examination and interpretation of emerging 
themes and patterns. Results from the analysis, feedback from the questionnaires, and comments 
on the observer checklists will be used to generate a report with suggested improvements to be 
shared with the quality improvement implementation team prior to Phase III.  
 
Phase III (3-6 months) will be an interventional period involving routine use of the digital 
triage tool by the hospital triage nurses at Mbagathi County Hospital in Nairobi, Kenya, and Jinja 
Regional Referral Hospital in Jinja, Uganda. The digital triage tool will not replace triage 
policies already in place at the study hospitals, but rather it will supplement and strengthen 
existing triage systems. As done in Phase I, study nurses will collect data on the pre-selected list 
of predictor variables in the triage waiting area while participants are waiting to be seen by the 

        
       
 
 
   
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hospital triage nurses (who will be using the digital triage tool). Continued collection of 
predictor variables will allow comparison of participant characteristics in the pre-intervention 
cohort and the post-intervention cohort.   
Methods: Participants, Interventions, and Outcomes  
 
8. Study Setting  
 
Involved in Phase I, Phase II, and Phase III:  
  
1. Experimental Site #1: Jinja Regional Referral Hospital in Jinja, Uganda  
 
Jinja, a city of approximately 90,000 people, is located in the Eastern region of Uganda. The 
Jinja Regional Referral Hospital pediatrics ward admits approximately 5000 patients per year 
and the outpatient department sees approximately 100 patients per day. 
 
2. Experimental Site #2: Mbagathi County Hospital in Nairobi, Kenya  
 
Involved in Phase I only:  
 
3. Control Site: Kiambu County Referral Hospital in Nairobi, Kenya  
 
A typical outpatient department (OPD) in the Kenyan study hospitals serves approximately 
20,000 children per year and is staffed by one or two nurses who conduct triage and administer 
treatment, two or three clinicians who review patients and issue prescriptions, and one additional 
nurse who administers treatment and provides counselling to caregivers of children. The 
hospitals admit approximately 2,000 pediatric patients per year.  
 
Changes due to COVID-19  
The global COVID-19 has introduced many challenges to the successful completion of this project. 
We have been unable to initiate Phase I of the project in Nairobi, Kenya due to restrictions 
implemented to reduce the risk of spread of COVID-19. We have made good progress in 
recruitment in Jinja, Uganda. I consultation with our investigators, implementation partners and 
funders we have decided to add an additional site at Gulu Regional Hospital in Uganda. Gulu 
Regional Referral Hospital will serve as a control site while the intervention phase (Phase III) takes 
place at Jinja Regional Referral Hospital. Once the intervention period has been completed in Jinja, 
the intervention will be introduced at Gulu Regional Referral Hospital.  
 
 
9. Eligibility Criteria  
 

        
       
 
 
   
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Inclusion Criteria:  
1. All paediatric outpatients presenting to the study hospitals for medical treatment. The 
lower age limit will include children aged from 0 days, and the upper age limit will be in 
accordance to respective hospitals’ practice for paediatric admissions (this may be 12, 15 
or 19 years).  
2. Informed parental/guardian consent provided.  
3. Assent from children older than 13 years in addition to parental/guardian consent 
provided.  
 
Exclusion Criteria:  
1. Patients presenting to the outpatient department for elective cases (e.g. elective surgery or 
change of dressing) or for clinical review appointment.  
 
10. Intervention  
 
This is a pre-post intervention study to develop and evaluate the effectiveness of a digital triage 
tool. Prior to the intervention period, hospital nurses will be trained and prepared for routine use 
of the digital triage tool. Patients who enroll in the study during the intervention period will be 
triaged by the hospital nurses who will be using the digital triage tool. The digital platform will 
consist of a mobile application hosted on an Android tablet integrating a pulse oximetry sensor 
attached to the tablet, with embedded smart algorithms that predict a critically ill state, or level of 
risk in a child presenting to the hospital. The platform will also include an interactive dashboard 
which will display the triage data to provide real-time monitoring for the clinicians who manage 
the patients. The dashboard will be implemented as a password protected website accessible by 
registered medical staff on any computer or tablet on the local network, allowing for easy and 
non-disruptive integration into health systems with existing electronic health records. ETAT+ 
criteria for triage will be incorporated as part of the digital platform (in addition to model 
identified from Phase I).  
 
11. Outcomes  
 
Primary Outcomes 
 
1. Model Development: Hospital admission (within 5 days of assessment) status 
determined from hospital records and information system, and a follow up call 7 days 
post discharge (to ascertain outcome). This will inform development of a clinical 
prediction model based on need for hospital admission.  
 
 
 
2. Effectiveness Evaluation of Digital Triage Tool: Time to administration of an 
appropriate sepsis bundle of care, which includes at least one of antibiotics, intravenous 

        
       
 
 
   
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fluids, or oxygen as appropriate for age and clinical syndrome (treatment determined and 
administered by hospital staff). This will allow us to quantify the change from baseline 
in the proportion of children in each triage category (emergency, priority, queue) 
receiving treatment within 60 minutes of arrival at hospital.  
 
Secondary Outcomes  
1. Length of hospitalization determined from hospital records, and a follow up call 7 days 
post-discharge.  
2. Final diagnosis determined from hospital records.  
3. 7-day post-discharge mortality status determined from a follow up call 7 days post-
discharge.  
4. 7-day readmission status determined from a follow up call 7 days post-discharge.  
a. Facility of readmission.  
b. Treatment received during readmission. 
12. Participant Involvement  
 
Total study participation time is estimated to be a maximum of 60 minutes per participant in both 
the baseline (Phase I) and intervention (Phase III) periods. 
 
Participant Involvement in Phase I and Phase III 
Potential participants will be recruited by study nurses while they are waiting in line to be seen 
by the hospital triage nurses. Participants can anticipate study procedures (including consent, 
clinical examination, and interview) to take between 35 to 50 minutes. The study nurses will 
conduct study procedures in the triage waiting area, while the participant is waiting in line to be 
seen by the hospital triage nurses. If it is the participant’s turn to be seen by the hospital triage 
nurses, study procedures will stop and there will be no interference or delays in accessing 
standard care. Participants will also engage in a short (10 minutes) follow up call 7-days post-
discharge.  
 
Additional Procedures in Phase III 
In the intervention period, the hospital triage nurses will be conducting triage using the digital 
triage tool (which will include a digitized version of the triage guidelines in place at the study 
hospitals). Since our mobile health intervention will be integrated into standard care (NOT 
replacing standard care, but supplementing and strengthening existing triage systems), this will 
not require any additional time costs.  
 
To reiterate, the study nurses will conduct the same study procedures (consent, clinical 
examination, and interview) in both the baseline (Phase I) and intervention (Phase III) periods. 
These procedures are conducted while the participants are waiting in line to be seen by the 
hospital triage nurses. The difference in Phase III is that the hospital triage nurses (that the 
participants are waiting in line to see) will be using the digital triage tool to triage participants.  
 

        
       
 
 
   
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13. Sample Size  
 
Model Development Considerations 
The sample size for model development is based on a sampling strategy that takes into account 
the number of predictor variables (either binary or continuous) to be used in a model which has 
been used in a similar study [13]. This accounts for a minimum standard of 10 events per 
effective variable and can be expressed mathematically as: N = [n x 10]/I, which demonstrates 
the relationship between the number of predictor variables (n), the event rate (I), and the required 
sample size (N). Our previous experience that allowed for a minimum of 10 events per selected 
variable (admission rate of 12% and 10 predictors) would estimate a sample of at least 833 
children. The sample size needed to detect a 20% increase in the proportion of children who 
receive the bundle of care within one hour was calculated using the stats package in R.  
 
Power to Detect Difference Considerations 
We have estimated the proportion of children who currently receive a bundle of care within one 
hour in the pre-intervention group to be 27%, based on findings from previous studies [19] and 
confirmed in our feasibility trial of the application and dashboard in Uganda. We will need at 
least 750 children for each of the pre-intervention and post-intervention conditions, using an 
alpha of .05, at power of 80%, to detect a 20% decrease in the proportion of children who receive 
the bundle of care within one hour.  
 
Selected Sample size 
Based on the uncertainty commonly present in these smaller sample sizes [20], the desire to 
include the possibly of modelling non-linearities in our models (using machine learning 
methods) and the clinical feasibility (large case load) we plan to target a larger sample of 4000 at 
each site, with a minimum sample size of 1000 participants enrolled in Phase I. Based on the 
activity at our selected sites this would require no more than a 60% recruitment rate during a six-
month period.  
 
Changes due to the impact of COVID-19:  
We hypothesize that the case mix of the “pandemic period” cohort is likely to be different to the 
case mix seen during “non-pandemic” times. This includes a potential increase in the average 
severity of disease in those children presenting at the facility. We are requesting support for the 
addition of a pandemic phase in Phase 1 – the baseline observational component of PRST. This 
will include a 25% increase in sample size at each experimental site (250 additional participants 
per experimental site). This increase in sample size is critical to developing a risk stratification 
model that is robust during pandemic and non-pandemic times.  
 
 
 
14. Sampling and Recruitment Strategies   
 
A systematic method for enrollment based on order of arrival at pre-selected time cut-offs will be 
adopted to avoid bias in participant selection by the study nurses. Patient arriving at the 

        
       
 
 
   
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outpatient are given a number upon registration (unless they are emergency cases that require 
resuscitation) and this number will be used to systematically sample patients during periods of 
busy workload.  
 
A timekeeper will the record arrival time and sampling number for each patient in a notebook. 
When it is time to select a participant, the study nurse will report to the timekeeper, who will 
provide the sampling number of the first participant to arrive after the pre-selected time cut off. 
The study nurse will then approach and screen this patient. If the patient does not consent, the 
study nurse will move on to the second participant to arrive after the pre-selected time cut off, 
and so on.  
 
The interval between time cut-offs will correspond to the estimated time taken for a study nurse 
to consent and collect data from a participant (35-50 minutes) to maximize productivity. When 
there is more than one study nurse on a given shift, the time intervals will be staggered.  
 
 
Methods: Data Collection, Management, and Analysis  
15. Data Collection  
 
Predictors, Hospital Outcomes, 7-day Follow-up Calls  
All study nurses will be trained and well versed on the standard operating procedures to facilitate 
standardization of all measurements. Study nurses will collect data using a custom-built Android 
application on a Samsung Galaxy Tablet A8. The list of predictors to be collected include 
clinical signs and symptoms, demographic/sociodemographic data, and pregnancy/birth 
information (see Appendix A). Similarly, designated study nurses will obtain hospital outcomes 
(see Appendix A) from patient records and enter them into the application on the Samsung 
Galaxy Tablet. Study nurses will conduct 7-day follow up calls in accordance with the standard 
operating procedures and enter the data into the application on the Samsung Galaxy Tablet.  
 
Time Outcomes  
Timing tracking will be automated using customised RFID. RFID uses radio-frequency 
electromagnetic fields to identify the location of patients carrying special tags, with the help of 
readers located in key locations around the hospital, including the registration area, triage 
examination rooms, and treatment rooms. We intend to use Low Energy Bluetooth (BLE) tags 
that have a diameter of approximately 3cm and weigh <20g (see Figure 1). These tags will be 
inserted into a custom, washable arm, wrist or leg band. The tag could also be retained by the 
caregiver if the child was not willing to have the tag attached to them.  When in close vicinity to 
a reader (for example, in the same room), the tag (location beacon) sends a message to a 
strategically located receiver to track the time at which the patient was in that precise location. 
Initially, manual tracking will also be conducted by designated study staff who will be situated in 
the same key locations as the RFID readers in order to validate the RFID system and ensure 
optimal performance.  
 

        
       
 
 
   
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Figure 1: Picture of RFID patient tracking tag  
 
Usability Testing Data  
Think Aloud transcriptions and observer checklists will be entered into a computer and uploaded 
to REDCap. The Triage Tool Training Questionnaire (Appendix D) will be captured on paper 
and stored in a locked cabinet, in a locked room in our research spaces nearby the study sites.  
 
Hospital Staff Interviews 
Throughout Phase III of the study, healthcare workers and hospital staff will be invited to 
participate in an interview to allow for evaluation of the acceptability, usability, and feasibility of 
the digital triage tool in the context of the hospital. (Appendix E). This will be used to generate a 
report that provides insight on the overall perception of health worker’s experiences with the 
digital triage tool and make updates as necessary.  
 
16. Data Management  
 
Data Collection Infrastructure  
Study Nurses will collect data using a custom-built Android application, created using 
LambdaNative (lambdanative.org), the open-source cross-platform toolkit developed internally 
at BC Children’s Hospital Research institute. All data entered into the mobile application is 
stored in an encrypted database using the encryption cipher Rabbit. Access to the tablet and 
application is secured by passwords; without using the application, the encrypted files are not 
readable. The Masimo iSpO2® Pulse Oximeter with Micro USB Connector will be used to 
collect pulse oximetry and heart rate (including 30 seconds of raw plethysmographic data) and 
the Masimo Caregiver™ non-contact thermometer will be used to measure core temperature. The 
data collection application also contains complex error checking specific to the survey questions 
such as date inconsistency checks and ensures only relevant data items are collected, by 
dynamically hiding redundant questions. 
 
Due to the complex nature of a large multi-center study, data will be uploaded directly from the 
Android tablets to REDCap (Research Electronic Data Capture, https://projectredcap.org/). 
REDCap is a secure web-based application designed to support data capture for research studies 
and it has been used for over 300,000 projects, in over 100 countries, including prior studies in 
Uganda [17]. Encrypted data will be stored for less than 14 days after completion of data 
collection on the tablets. In Kenya, the data will be directly uploaded weekly (depending on 
internet availability) over a secured internet connection to KTWRP servers, where it will be 
stored. A deidentified copy will be sent to the central study server at the BC Children’s Hospital 
Research institute where data will be checked for completeness and consistency with data 
definitions. In Uganda, the data will be sent to the central study server at the BC Children’s 

        
       
 
 
   
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Hospital Research Institute. After this upload, the data on the tablets will be deleted. Each 
subject will be given a unique number and all data will be connected to this unique number. 
Using REDCap limits the amount of paper-based data, further ensuring data integrity and safety. 
The uploaded data will be accessible to only study team members with secure access to the 
server.  
 
Data collected during follow-up interviews conducted by phone or in person will also be 
collected electronically and shared in the same secured manner. Personal identifiers are required 
for the collection of admission data and follow-up data. The data collection application contains 
several forms. All identifiers are collected on a single form, separate from the other forms 
containing non-identifying information, and stored in a separate and restricted REDCap form. 
Access to identifiers will be limited to those requiring this data for follow-up (i.e. only study 
personnel involved in follow-up or data verification). No analysts, co-investigators or principal 
investigators not directly involved in the follow-up or data verification will have access to this 
data. Access to REDCap will require 2-way authentication: in addition to the normal password 
process, a secure code (sent via SMS to the user) will be required for access to this data.  
 
Paper based data collection items include consent forms and research assistant field notes (which 
do not contain identifiers).  These will be stored in a locked cabinet, in a locked at our research 
spaces next to each study site.  
 
Health Intervention Infrastructure  
The bundle of care during the intervention will include triage in the OPD using an additional 
custom Android web-app, running locally on the device with no required Internet connection. As 
with the data collection app, this application will be password protected and data will be stored 
encrypted on the device. Following each triage, the triage data will be sent to a local low-cost 
Unix server Soekris box based in a secure room at each site. Data will be sent through encrypted 
HTTPS requests to server-side PHP scripts, which insert it within MySQL tables. 
 
The clinician dashboard that will be used to clinically manage all children in the OPD who have 
been triaged will be implemented as a password protected website accessible by registered 
medical staff on any computer or tablet on the local network. As with the triage app, this website 
runs completely locally, independent of an outside Internet connection and is not accessible from 
off-site. The dashboard is implemented using the Laravel (https://laravel.com), a PHP web 
framework, which queries the MySQL server tables securely. Personal identifiers will be 
collected in the triage app and sent to the server for display on the dashboard as is necessary for 
correct identification of patients, but such information will never leave the hospital site. As the 
study hospitals already have computers in their OPDs, use of the clinical dashboard will not be 
extra work for the hospital staff or interfere with other tasks.   
 
 
17. Statistical Analysis  
 
Model Development 

        
       
 
 
   
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We will develop a logistic model that will predict severe infection and sepsis in children. 
Akaike’s Information Criterion (AIC) will be used as a summary measure to select predictors for 
inclusion in the model. The final selection of a model will be judged on model parsimony, 
availability of the predictors (with respect to resources and cost), discrimination and calibration. 
Bootstrapping (with replacement) will be used for internal validation. Net Reclassification Index 
for external (Kenya) and geographical/high malaria prevalence (Jinja) will be used for validation 
of the prediction model. These cohorts will allow us to optimize and re-calibrate (if required) the 
prediction model. Appropriate triage risk threshold selected based on data, simulation and expert 
opinion. The final model will be integrated into an application for use on a mobile device and 
electronic dashboard. 
 
Outcomes Analysis  
We will compare the proportion of children at the two intervention sites receiving a completed 
bundle within 60 minutes to the historical and the contemporaneous control group (Marascuillo 
procedure). The median time to an appropriate bundle of care will be compared using a Mann–
Whitney U test. The triage prioritization between the phases and the proportion of children who 
received and appropriate bundle of care within each triage categorization will be compared with 
Fisher’s exact tests. Segmented regression analysis of the interrupted time series of the pre- and 
post- intervention periods will be used to assess immediate effects and effects over time, 
controlling for prior trends that may continue without our intervention. Quantile regression will 
be used to estimate the median differences. We will compare the estimated times at end of the 
intervention period with the expected counterfactual value, had the pre-intervention trend 
continued as if the intervention never occurred. We will compare the time to event (treatment 
bundle) using the Kaplan-Meier estimator with censure at 180 minutes. Secondary outcomes will 
be compared using generalized estimating equations. 
 
Additional Analyses due to the impact of COVID-19:  
Develop data driven prediction models for identifying vulnerable children with suspected sepsis 
that are robust during future COVID-19 surges and novel pandemics.  
We will specifically look at the predictive performance of the model during this initial pandemic period 
(2-3 months) in comparison to following non-pandemic period. We will use traditional statistical 
modeling techniques (e.g. logistic regression) and data-driven algorithms (e.g. elastic net and random 
forest) to identify new predictors and calibrate existing predictors, exploring possible interactions 
between periods. We will validate the model using test sets that include both post-and during-pandemic 
data in order to ensure that any newly derived model performs consistently during both periods. 
Performance of prediction models will rely on area under receiver operating characteristics, and 
specificity corresponding to 80% sensitivity. Our goal is to develop a model for identifying those most at 
risk for sepsis that performs well despite changes in case mix of our cohort, even if this slightly degrades 
overall prediction performance. This will ensure that the final model will be more robust to future 
changes in case mix during future health crises.  
Identify the variables that contribute to vulnerability in children with suspected sepsis, during 
pandemic and non-pandemic times.  

        
       
 
 
   
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We will use descriptive statistics and standard statistical tests to compare the clinical, demographic and 
social factors of the pre-pandemic and pandemic cohorts. These include important identity factors such as 
gender, age, economic indicators, and geography. Multivariate models such as clustering algorithms and 
Principal Component Analysis will be used to further understand if and how the pre-and during-pandemic 
cohorts separate and differ.  
Economic Evaluation  
We will conduct a cost-effectiveness analysis of Smart Triage by calculating the cost per averted 
year of life lost (YLL) using decision analysis. Previous models (21) and expert opinion has been 
consulted for potential pathways of healthcare utilization.  We will model uncertainty using 
probabilistic sensitivity analysis and will take a societal perspective as our base case.   
Probabilities of healthcare utilization will be calculated via primary data from the Smart Triage 
case report form.  The primary outcome of “time to bundle of care” will be linked to mortality via 
existing evidence (22) as required in order to calculate YLL, as Smart Triage was not originally 
powered to detect mortality. We will use the World Health Organization’s life expectancy data in 
Uganda (23) to calculate projected YLL before and after program implementation.  Costs of 
healthcare utilization is available through existing literature (21, 24), and indirect costs due to lost 
wages will be gathered as primary data in Smart Triage.  Costs of program setup and maintenance 
will be tracked from study expenses and incorporated into the analysis.   
 
To contextualize our results for informing budgetary decisions of scaling-up Smart Triage, we will 
estimate a projected budget impact of scale up given the disease burden of pediatric sepsis in 
Uganda (25), as recommended for newly proposed healthcare programs (26). The results of this 
preliminary budget impact analysis can be refined in further multicenter trials and can be compared 
to that of other programs to facilitate healthcare resource allocation in Uganda. 
 
 
 
 
 
 
 
Methods: Monitoring  
18. Data Monitoring  
 

        
       
 
 
   
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Internal monitoring of study processes will be done regularly by the Study Coordinators at each 
hospital site. During monitoring, data and consent forms for 10% of enrolled participants will be 
reviewed for compliance. Retraining of study staff will be done to correct for any inconsistencies 
noted during monitoring and follow-up will be subsequently done by the Study Coordinator to 
ensure compliance.  
 
Data completeness will be continuously monitored using daily, weekly and monthly reports. 
Accuracy of data will be verified using an audit of 5% of cases by a Data Manager who will not 
be involved in enrolling subjects. Preliminary data quality checks and analysis will be performed 
throughout the data collection stage to ensure that data collected is valid and secure. These data 
quality checks will include checking the quality of pulse oximetry waveform data via 
implementing a Signal Quality Index (SQI) algorithm and checking for completeness and 
validity of input data. Further data quality checks will inspect the number of patients enrolled, 
the number of patients admitted, and the timed outcome data. Upon completion of data 
collection, a summary of the data collected will be compiled and will be discussed by the 
investigators and the study nurses to ensure that data is clean, correct and useful. 
 
19. Harms 
  
We do not anticipate any adverse events directly attributable to the study. The most significant 
risk in this study is a small delay in treatment administration due to incorrect triage by the digital 
triage tool. However, this delay would not be significantly different from the hospital standard of 
care. The risk of an adverse event is unlikely because our digital health intervention will only be 
used to triage participants, and all subjects will be assessed by a healthcare provider regardless of 
triage status.  
 
All children enrolled into this study will receive standard care according to local, regional and 
national guidelines. No study procedures will take place which in any way interfere with the 
prescribed care. Study procedures will be delayed, when necessary, to ensure that these 
procedures will not impact recommended care. 
 
Ethics and Dissemination  
 
20. Research Ethics Approval/Protocol Amendments  
 
Ethical approval will be sought from Makerere University School of Public Health (MUSPH) 
Higher Degrees, Research and Ethics Committee. Ethical approval will also be obtained from 
from the Kenya Medical Research Institute (KEMRI) Scientific & Ethics Review Unit (SERU), 
and from The University of British Columbia/ Children’s and Women’s Health Centre of British 
Columbia Research Ethics Board (UBC C&W REB). A copy of the protocol proposed informed 
consent forms, other written participation information, and any proposed advertising material 
will be submitted for written approval. The investigators will submit and, where necessary, 

        
       
 
 
   
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obtain approval from the IRB/IEC for any major protocol amendments and changes to the 
informed consent document. The study team are responsible for assuring that this protocol and 
the associated informed consent documents and study-related documents are approved prior to 
implementation of the protocol. Any major amendments to the protocol, informed consents, or 
other study- related documents must be approved by the IRB/IEC prior to implementation.  
 
21. Informed Consent and Assent  
 
The study nurses will be responsible for screening and consenting participants. This would be the 
norm in Kenya and Uganda. The Study Nurses will be certified and trained to ensure that the 
caregiver has a complete understanding of the consent processes, the consent form, and that the 
caregiver is of legal age and competent to provide consent.  
 
In obtaining and documenting informed consent, the site investigators and their designees will 
comply with applicable local and domestic regulatory requirements. This clinical study will have 
a paper-based informed consent form (ICF) for enrollment developed for local use that are in 
accordance with applicable guidelines. The consent form will include the purpose of the study, a 
description of the procedures to be followed and the risks and benefits of participation. The 
informed consent process will give individuals all of the relevant information they need to decide 
whether to participate, or to continue participation, in this study. Potential research participants’ 
caregivers will be encouraged to ask questions and to exchange information freely with the study 
team. Participants will be informed on who to contact (Principal Investigator) should they have 
any questions during, or after the study period. If the caregiver providing consent is illiterate, an 
independent witness will be present to verify to the caregiver that all the information read aloud 
is contained in the ICF. In this instance, both the caregiver and witness will sign the ICF. The 
caregiver will voluntarily sign, thumbprint and date (thumbprint acceptable if illiterate who will 
also require a witness) the consent form if they wish to participate in the study and will be 
provided with a copy of the consent form. A signed and dated copy of the consent form will be 
kept in the documentation file at all times. 
 
In emergency cases, consent will be deferred until the child is stable and study procedures will 
only begin after initiation of emergency treatment. Study procedures will not delay or interfere 
with access to standard care. If consent is not granted, the data will be deleted. This deferred 
consent procedure is to avoid introduction of bias by neglecting to obtain data from the most 
severely ill children while avoiding delays in providing care to the child. This procedure has 
been used in previous studies involving children with severe illness, including use by the Fluid 
Expansion As Supportive Therapy (FEAST) study [27].  
 
There will be separate consent forms for Phase I (Appendix F) and Phase III (Appendix G). 
Assent will be sought for children aged 13 and older (Appendix H). Consent will also be sought 
for participation in usability testing initiatives (Appendix I), the Triage Tool Training 
Questionnaire (Appendix J), and the Hospital staff Interviews (Appendix K). In addition, there 
will be separate consent forms for Kenya and Uganda as site specific guidelines differ (see 

        
       
 
 
   
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Appendices F to K). All consent materials will be approved by the appropriate Institutional 
Review Boards prior to use. 
 
22. Confidentiality  
 
Data will be stored and distributed using password protected locations and secure data transfer. 
All data entered into the digital triage tool is stored in an encrypted database using the encryption 
cipher Rabbit. Access to the digital tool is secured by passwords and without using the application, 
the encrypted files are not readable. Encrypted data will be stored for a maximum of two weeks 
on the tablets before being directly uploaded and stored stored in a secure research server at 
MUSPH (Uganda), or KEMRI (Kenya), and UBC. After this upload, the data on the devices will 
be deleted. Data will be entered into the digital triage tool using a REDCap electronic data 
collection form. REDCap is a secure, web-based application designed to support data capture for 
research studies. Each subject will be given a unique number and data will be connected to this 
unique number. Using REDCap limits the amount of paper-based data; further ensuring data 
integrity and safety. The uploaded data will be accessible to any team member with secure access 
to the server, including investigators from MUSPH, KEMRI, and UBC. Standard operating 
procedures will be implemented for the security of data, physical devices and networks. All 
research staff will be well trained and understand that privacy and confidentiality are imperative. 
All paper forms used for consent will not contain the study number. These forms will be stored in 
our research spaces near the study sites under lock and key, for the duration of the study and for 
any additional time required by the local and/or national guidelines at the time.  
 
23. Risks  
 
Altered medical management 
The most significant risk in this study is a small delay in administration of treatment due to 
inappropriate triage. This delay should not be significantly different from the baseline standard 
of care. The study process will be optimised to minimise the delay in the delivery of care and 
will be deferred in participants who require emergency treatment.  
 
 
 
RFID Tagging 
The RFID tag is a new and unfamiliar piece of technology that needs to be worn or attached to 
participants who may not feel comfortable with it. We will ensure that participants/caregivers are 
fully aware of the purpose of wearing the RFID tag and how the system works. Further, the tag is 
a tiny piece of plastic that can be easily concealed and will not cause any discomfort to 
participants. This has been discussed with our local PI’s and local ethics committees in Kenya 
and Uganda. This has been approved by both the local and national ethics committees. 
 
Blood Sampling 

        
       
 
 
   
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Blood sampling will only be conducted when clinically indicated are already routine hospital 
procedures. We will be ensuring the supplies are available to do this testing if indicated. These 
will not be done for research purposes. These will be communicated by the consultant during the 
consultation that follows the triage process. These are all point of care tests so results will be 
immediately available.  
 
Coercion 
Caregivers may feel coerced to enroll in the study in order to receive care for their child within a 
research setting, which may be perceived as of a higher quality than the standard of care. This 
will be minimized by ensuring that study nurses emphasize that the child will receive medical 
care whether enrolled in the study or not.  
 
 
24. Declaration of Interests  
 
There are no competing interests for any investigators involved in this study.  
 
25. Access to Data  
 
After the study period, a de-identified copy of the data will be prepared for deposition in a 
repository with open access with proper governance mechanisms. We will make every effort to 
prevent re-identification of subjects by coding data that has the potential of being identifiable. 
For example, we will convert all dates into meaningful decimal numbers (date of birth into days 
since birth and date of recruitment will be reduced to month of recruitment) and all locations will 
coded into data that is useful but not specific (such as address converted to distance and direction 
from facility). We will ensure that data elements with small numbers of subjects (less than 10) 
will be coded or lumped to avoid identification. The de-identified study data will be made 
publicly available using the Harvard Dataverse (https://dataverse.harvard.edu/), which is the data 
repository for KWTRP, and a URL will be made accessible. To enhance visibility, sharing and 
collating datasets with other collaborating sites for increased usability/re-use, de-identified will 
also be shared availed to reputable data hosting service such as the INDEPTH Data Repository 
(http://www.indepth-ishare.org/index.php/home), or through the newly established Pediatric 
Sepsis CoLab (sponsored by the World Federation of Pediatric Critical and Intensive care 
Societies). Sharing and access will be managed and subject to institutional agreements (KEMRI 
and UBC) that will set terms for how requests and access will be managed. We will ensure that a 
rigorous data governance structure is used by the data hosting service. The distribution will only 
occur with agreement from Principal Investigators and the investigators at all of the study sites. 
Data will also be shared through peer reviewed publications and through the Wellcome Trust 
open data initiatives. Data will be made available within 12 months following completion of the 
study. 
 
 

        
       
 
 
   
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26. Presentation and Dissemination of Results  
 
Presenting the Results  
The results of this research will be primarily presented through at least one published manuscript 
with detailed description of the background, methods, results, and conclusion. The specific format 
and details of this manuscript will be in accordance with the requirements of the publishing journal. 
All usage of data for publications and other forms of data dissemination will occur jointly between 
collaborative institutions and include authors from both sites in all publications. 
 
Disseminating the Results  
Results will be disseminated to local hospital teams and key stakeholders such as at the annual 
conference held by the Kenya Pediatric Association (KPA). A robust knowledge translation 
approach is a key aspect of our transition and scale-up. An integrated equity-oriented cascade 
approach [28] will be used to guide knowledge translation across the duration of the project. We 
will engage the “6 Ps” stakeholder groups (public, patients/ caregivers, policymakers, 
practitioners, press, and private sector), all of which are critical to the successful outcome of our 
project. Our key knowledge translation activities will employ a rich range of communication 
channels and will be multifaceted: academic, governmental, policy-driven, and public-facing. 
Methods of dissemination will include social media, radio, websites, progress reports, workshops, 
community meetings, executive summaries, technical reports, verbal presentations to key 
stakeholders, peer-reviewed scientific publications and conference presentations. All relevant 
reports, publications and data will be freely available online.  
 
 
 
 
 
 
 
 
 
27. References  
 
 
[1] 
Global Burden of Disease Collaborative Network, “Cause-Specific Mortality 1980-2016,” 
Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2016. [Online]. 
Available: http://ghdx.healthdata.org/gbd-2016%0D%0A. [Accessed: 05-Oct-2019]. 
[2] 
M. Singer et al., “The third international consensus definitions for sepsis and septic shock 
(sepsis-3),” JAMA - Journal of the American Medical Association. 2016. 
[3] 
B. Tan et al., “Global Case-Fatality Rates in Pediatric Severe Sepsis and Septic Shock: A 

        
       
 
 
   
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Systematic Review and Meta-analysis,” JAMA Pediatrics. 2019. 
[4] 
Global Sepsis Alliance [Internet], “WHA Adopts Resolution on Sepsis,” Jena, Germany: 
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[5] 
A. Kumar et al., “Duration of hypotension before initiation of effective antimicrobial 
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[6] 
World Health Organization, Organisation for Economic Co-operation and Development, 
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[7] 
T. Duke, “New WHO guidelines on emergency triage assessment and treatment,” The 
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[8] 
G. W. Irimu et al., “Performance of health workers in the management of seriously sick 
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[9] 
I. V. R. Evans et al., “Association between the New York sepsis care mandate and in-
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J. Hudson et al., “Usability testing of a prototype phone Oximeter with healthcare 
providers in high- and low-medical resource environments,” Anaesthesia, 2012. 
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H. Gan et al., “ The Performance of a Mobile Phone Respiratory Rate Counter Compared 
to the WHO ARI Timer ,” J. Healthc. Eng., 2015. 
[12] 
B. A. Payne et al., “A Risk Prediction Model for the Assessment and Triage of Women 
with Hypertensive Disorders of Pregnancy in Low-Resourced Settings: The miniPIERS 
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[13] 
M. O. Wiens et al., “Postdischarge mortality in children with acute infectious diseases: 
Derivation of postdischarge mortality prediction models,” BMJ Open, 2015. 
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N. Lowlaavar et al., “Pediatric in-hospital death from infectious disease in Uganda: 
Derivation of clinical prediction models,” PLoS One, 2016. 
[15] 
J. S. T. Fung, S. Akech, N. Kissoon, M. O. Wiens, M. English, and J. Mark Ansermino, 

        
       
 
 
   
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“Determining predictors of sepsis at triage among children under 5 years of age in 
resource-limited settings: A modified Delphi process,” PLoS One, 2019. 
[16] 
A. Mawji et al., “Derivation and internal validation of a data-driven prediction model to 
guide frontline health workers in triaging children under-five in Nairobi, Kenya,” 
Wellcome Open Res., 2019. 
 [17] N. K. Gale, G. Heath, E. Cameron, S. Rashid, and S. Redwood, “Using the framework 
method for the analysis of qualitative data in multi-disciplinary health research,” BMC 
Med. Res. Methodol., 2013. 
[18] 
A. Edwards-Jones, “Qualitative data analysis with NVIVO,” J. Educ. Teach., 2014. 
Derivation of postdischarge mortality prediction models,” BMJ Open, 2015. 
 [19] H. C. Duber et al., “Appropriate and timely antibiotic administration for neonatal sepsis in 
Mesoamérica,” BMJ Glob. Heal., 2018. 
[20] M. van Smeden et al., “Sample size for binary logistic prediction models: Beyond events 
per variable criteria,” Statistical Methods in Medical Research, 2018. 
[21] Khowaja A, Wiens MO. Economic Evaluation of the Smart Discharges Program in 
Uganda. (Unpublished). 2020. 
[22] Evans IV, Phillips GS, Alpern ER, Angus DC, Friedrich ME, Kissoon N, et al. 
Association between the New York sepsis care mandate and in-hospital mortality for 
pediatric sepsis. Jama. 2018;320(4):358-67. 
[23]  World Health Organization. Global Health Observatory data repository: mortality and 
global health estimates. Global Health Observatory. 2019. 
[24]  de Broucker G, Ekirapa Kiracho E, Ssebagereka A, Constenla D, Aloysius M, Patenaude 
B. Cost of pneumonia in children under 5 in Uganda (2017-18). V2 ed: Harvard 
Dataverse; 2020. 
[25]  Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, 
regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global 
Burden of Disease Study. The Lancet. 2020;395(10219):200-11. 
[26]  Donaldson C, Currie G, Mitton C. Cost effectiveness analysis in health care: 
contraindications. Bmj. 2002;325(7369):891-4. 
[27]  E. C. George et al., “Predicting mortality in sick African children: The FEAST Pediatric 

        
       
 
 
   
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Emergency Triage (PET) Score,” BMC Med., 2015. 
[28]  P. Tugwell, V. Robinson, J. Grimshaw, and N. Santesso, “Systematic reviews and 
knowledge translation,” Bulletin of the World Health Organization. 2006. 
 
 
 
 
 
 
Appendix A  
 
Data Dictionary   
 
 
 
 
 
 

        
       
 
 
   
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Field Name in REDCap 
Variable Name  
Standardized Prompt  
Choices 
Initial Contact  
Patient Information 
study_id 
Study ID  
Study ID 
 
eligible 
Eligible 
Is the child eligible to participate 
in this study? 
0, No
1, Yes 
IF eligible = no 
not_eligible 
Reason for ineligibility 
Why is the participant NOT 
eligible?  
1, Non-infectious 
Cause  
2, Special Clinic  
3, Immunizations 
4, Scheduled 
Appointment 
5, Nutrition 
rehabilitation 
IF eligible = yes 
enrolled 
Enrolled   
Is the child enrolled in the 
study?  
0, No
1, Yes 
IF enrolled = no 
not_enrolled  
Reason for no 
Enrollment 
Why was the child not enrolled 
in the study?  
1, Declined consent 
2, Insufficient time  
3, Language barrier 
4, No explanation 
5, Already enrolled in 
the last 7 days  
6, Referred for blood 
transfusion 
7, Sent to do lab tests 
and never came back 
8, Sent to a non-
COIVD-19 facility 
99, Other
IF not_enrolled = other 
not_enrolled_other 
Other reason for no 
enrollment 
If reason for no enrollment is 
'other', please specify. 
sd 
SmartDischarges Study 
Did the child participate in the 
SmartDischarges study? 
0, No
1, Yes 
IF sd= yes 
sd_id 
SmartDischarges Study 
ID 
What is the child’s 
SmartDischarges study ID 
number? 
 
arrival_time 
Hospital Arrival Time  
Enter the child’s hospital arrival 
time. This can be found on a 
sticker, paper slip, or notebook 
which has been given to the 
caregiver.  
 
hosp_id 
Hospital ID 
Hospital ID 
 
first_name 
First Name  
First Name 
 
last_name 
Last Name  
Last Name 
 

        
       
 
 
   
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date_enrolled 
Date of Presentation 
Current Date 
 
exam_time 
Time of Initiation of 
Examination/interview 
(Current Time) 
Current Time 
 
sex 
sex 
Enter biological sex. 
1, Female
2, Male
dob_known 
Precise date of birth 
known? 
Ask: Do you know exactly what 
day the child was born? 
0, No 
1, Yes
IF dob_known = yes 
dob 
Date of birth 
Enter exact date of birth 
 
IF dob_known = no 
yob 
Estimated year of birth 
Enter estimated year of birth 
mob 
Estimated month of birth 
Enter estimated month of 
birth 
agecalc 
Calculated age at 
admission. 
Age (months)  
Vital Signs 
spo2 
Oxygen saturation 
Measure peripheral oxygen 
saturation using the mobile 
pulse oximeter (See SOP). 
 
sqi 
Signal Quality Index 
Enter the signal quality index 
achieved (See SOP).  
 
hr 
Heart Rate  
Record the patient's heart rate 
from previous pulse oximetry 
measurement (See SOP). 
 
rr 
Respiratory Rate  
Measure respiratory rate using 
the app provided (See SOP). 
 
temp 
Temperature 
Measure and record axillary 
temperature (See SOP). 
 
vitals_complete 
Time at completion of 
vitals (calculated) 
Time at completion of vital sign 
measurements.   
oxygen 
Supplemental oxygen  
Is the child receiving 
supplemental oxygen?  
0, No
1, Yes 
IF oxygen = yes 
o2_modality 
Modality of oxygen 
delivery 
What supplemental oxygen 
supply is the child receiving? 
0, Room air
1, Nasal cannula 2, 
Face mask 
3, Non rebreather 4, 
Ventilated 
 5, Other 
IF o2_modality = other 
o2_other 
Other modality of 
oxygen delivery 
What supplemental oxygen is 
the child receiving?  
IF o2_modality = nasal cannula, face mask, non-rebreather mask 
o2_flow 
Flow of oxygen 
delivered (L/min) 
What the oxygen flow in L/min?  
 
Anthropometrics 

        
       
 
 
   
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weight 
Weight (measured in 
kg) 
Measure and record the child's 
weight in kg (see SOP). 
 
height 
Height (measured in 
cm) 
Measure and record the child's 
height, or length if child is under 
2 years old in cm (see SOP). 
 
muac 
Middle upper arm 
circumference 
(measured in mm) 
Measure and record the child's 
mid-upper arm circumference in 
mm (See SOP). 
 
Danger Signs 
complaint  
Primary complaint 
(reported) 
Ask: What is the main reason 
for bringing the child here 
today? Read out options.  
1, Cough 
2, Difficulty breathing 
3, Nasal congestion 
4, Skin Rash  
5, Abscess  
6, Fever  
7, Eye pain/redness  
8, Ear pain/discharge 
9, Diarrhea 
10, Constipation 
11, Vomiting  
12, Nausea 
13, Abdominal Pain 
14, Pain on urination 
15, Jaundice 
16, Lethargy (less 
energy than normal, 
unable to eat or 
drink)  
17, Malaise 
(generalized aching)  
18, Convulsions 
19, Headache  
20, Swelling (of any 
body part)  
21, Anorexia  
22, Trauma  
23, Other 
IF complaint = other 
complaint_other 
Other primary complaint 
(reported)  
Ask: What is the main reason 
for bringing the child here 
today? Enter ONE complaint 
only.  
 
Airway and Breathing  
cyanosis 
Central cyanosis 
(observed) 
Are the child's lips or tongue a 
blue or dark blue color? 
0, No
1, Yes 
difficulty_breath_rep 
Difficulty breathing 
(reported) 
Ask: Compared to when the 
child was well, is the child 
having difficulty breathing? 
0, No
1, Yes 
difficulty_breath_obs 
Difficulty breathing 
(observed) 
Is the child having difficulty 
breathing compared to a well 
child? 
0, No
1, Yes 
Circulation 
cap_refill 
Capillary refill time > 3 
seconds (upper limb) 
Apply pressure to a thumb or 
finger for 3 seconds to blanch it. 
Does it take more than 3 
0, No
1, Yes 

        
       
 
 
   
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seconds to return to original 
pink color after you let go? (See 
SOP) 
IF cap_refill = yes 
cool_skin 
Cool peripheries 
(observed) 
Are the child's hands cold 
compared to the chest or trunk? 
0, No
1, Yes 
pulse_r 
Weak or absent radial 
pulse (observed) 
Does the child's radial pulse feel 
weak or absent? 
 
0, No
1, Yes 
IF pulse_r = yes 
pulse_c 
Weak or absent 
central pulse 
(observed) 
Does the child's central pulse 
feel weak or absent? 
0, No
1, Yes 
Coma/Convulsions 
alert  
Alert (observed) 
Is the child alert? (see SOP). 
0, No
1, Yes 
IF alert = no  
avpu 
AVPU (observed) 
Assess and select consciousness 
level using the AVPU scale (See 
SOP). 
0, Alert 
1, Responds to voice 
2, Responds to pain 
3, Unresponsive 
convulsions 
Convulsions (reported, 
history of)  
Ask: Has the child had 
convulsions before? (See SOP).  
0, No
1, Yes 
convulsions_now 
Convulsions during 
assessment, 
(observed)  
Was the child actively 
convulsing during this 
assessment?  
0, No
1, Yes 
Dehydration/GI/GU 
vomiting 
Vomiting (reported) 
Ask: Does the child throw up 
everything they eat or drink? 
0, No
1, Yes 
diarrhoea 
Diarrhoea (reported) 
Ask: Has the child had diarrhoea 
3 or times per day since getting 
sick? 
0, No
1, Yes 
IF diarrhoea = yes 
chronic_diarrhoea 
Persistent Diarrhoea 
(reported) 
Ask: Did the child have 
diarrhoea for more than two 
weeks? 
0, No
1, Yes 
dysentery 
Dysentery (reported) 
Ask: Has the child had blood in 
their stools? 
0, No
1, Yes 
IF HR > 120 for age < 5, or HR > 100 for age ≥ 5 or diarrhoea = yes 
skin_pinch 
Skin pinch (observed) 
Pinch the child's skin on the 
lower abdomen until it is 
tented, then release it. Does it 
take longer than 2 seconds to 
return to baseline? 
0, No
1, Yes 
sunken_eyes 
Sunken eyes 
(observed) 
Does the child's eyes appear to 
sink into their sockets? 
0, No
1, Yes 
IF sunken_eyes = yes 
sunken_eyes_rep 
Sunken Eyes 
(reported) 
Ask: Does the child's eyes 
appear to sink into their sockets 
0, No
1, Yes 

        
       
 
 
   
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compared to when the child is 
well?  
no_tears 
No tears when crying 
(reported) 
Ask: Has the child stopped 
making tears when crying? 
0, No
1, Yes 
dry_mouth 
Dry oral mucosa 
(observed) 
Does the child's oral mucosa 
(not lips) appear dry? 
0, No
1, Yes 
IF age < 18 months 
dep_fontanelles  
Depressed fontanelle 
(observed) 
Does the child's fontanelles 
appear depressed or sunken? 
0, No
1, Yes 
Priority Signs 
Trauma 
trauma 
Major trauma 
(observed) 
Has the child suffered trauma 
needing a designated trauma 
team or urgent surgery?   
OR Does he/she have a 
penetrating injury, pelvic or long 
bone fracture, or head or neck 
injury? 
0, No
1, Yes 
burn 
Burns (observed) 
Has the child suffered a burn 
resulting in skin breakdown? 
0, No
1, Yes 
poison 
Poisoning (reported) 
Ask: Has the child been 
poisoned from swallowing a 
chemical or drug? 
 
IF poison = yes 
poison_substance 
 
Potentially Poisonous 
Substance (reported) 
Ask: What did the child 
swallow?  
1, Drug (medicine)
2, Chemcial 
(organophosphate) 
3, Other
IF poison_substance = other 
poison_other 
Potentially Poisonous 
Substance (other) 
If poisonous substance is 
‘other’, please specify. 
 
IF poison_substance = drug or chemical 
poison_name 
Name of Potentially 
Poisonous Substance 
If known, enter the name of the 
drug or chemical that was 
consumed.  
 
sev_pain 
Severe Pain (observed) 
Does the child seem to be in 
severe pain? 
0, No
1, Yes 
Circulation 
pallor 
Palmar Pallor 
(observed) 
Is the child pale at their palms 
compared to their caretaker? 
0, No
1, Yes 
Neurological 
irritable 
Irritability/restlessness 
(observed) 
Has the child been crying 
uncontrollably throughout the 
interview, even before you 
approached them? 
0, No
1, Yes 
IF age < 12 months 
 
cant_drink 
Inability to 
drink/breastfeed/feed 
Ask: Has the child been too 
sleepy or tired to breastfeed, 
0, No
1, Yes 
98, Don’t know

        
       
 
 
   
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for longer than 6 
hours (reported)  
drink, or eat for more than 6 
hours? 
IF age ≥ 12 months 
cant_sit 
Inability to sit or stand 
for longer than 6 
hours (reported) 
Ask: Has the child been too sick 
to sit or stand for longer than 6 
hours? 
0, No
1, Yes 
98, Don’t know 
Respiratory 
IF:  difficulty_breathing_rep = yes OR  difficulty_breathing_obs = yes OR RR > 40 OR spo2 < 90% OR cant_drink 
= yes OR cant_sit = yes OR cyanosis = yes 
stridor  
Stridor (observed) 
Does the child have stridor? 
0, No
1, Yes
indrawing  
 
 
 
Chest in-drawing 
(observed) 
 
Does the child have chest 
indrawing?  
 
0, No
1, Yes 
flaring  
Nasal flaring 
(observed) 
 
Does the child have nasal 
flaring?  
 
0, No
1, Yes 
grunting 
Grunting (observed) 
 
Does the child have a grunt?  
 
0, No
1, Yes 
tracheal_tug 
Tracheal tug 
(observed) 
 
Does the child have a tracheal 
tug?  
 
0, No
1, Yes 
accessory_use 
Accessory muscle use 
(observed) 
 
Does the child use accessory 
muscles when breathing? 
 
0, No
1, Yes 
wheezing 
Wheezing (observed) 
Does the child have wheezing? 
0, No
1, Yes 
cough 
Cough (observed) 
Have you observed coughing 
from the child? 
0, No
1, Yes 
Malnutrition 
oedema 
Visible oedema (feet, 
knees, face) 
(observed) 
Does the child have pitting 
oedema on their feet, knees, or 
face? 
0, No
1, Yes 
IF: muac < 125 mm OR age < 12 months 
 
sev_wasting 
Visible severe wasting 
(observed)  
Does the child seem wasted? 
0, No
1, Yes 
Infection 
fever  
History of fever 
(reported) 
Ask: Does the child have a 
history of fever?  
0, No
1, Yes 
IF age < 1 month 
neo_jaundice 
Neonatal jaundice 
(observed) 
Does the child have yellowed 
sclera, palms, or soles? 
0, No
1, Yes 
umbilicus_red 
Umbilicus - red 
(observed) 
Is the child's umbilicus or 
surrounding skin red? 
0, No
1, Yes 
IF umbilicus_red = yes 
umbilicus_drain 
Umbilicus- 
draining/pus 
(observed) 
Does the child's umbilicus or 
surrounding skin have pus 
draining from it or trapped in it? 
0, No
1, Yes 

        
       
 
 
   
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rash 
Rash (observed) 
Does the child have a rash? 
0, No
1, Yes 
IF rash = yes 
location_rash 
Rash body part 
(observed) 
Where is the rash located?  
1, Generalized
2, Face 
3, Neck 
4, Torso 
5, Arm 
6, Hand 
7, Leg 
8, Foot 
9, Genital 
10, Perianal 
lesion 
Infective lesion 
(observed) 
Does the child have an infective 
lesion on the skin, eye or ear?  
0, No
1, Yes 
IF age < 1 month 
oral_thrush 
Oral thrush (observed) 
Does the child have white 
patches on the roof of their 
mouth? 
0, No
1, Yes 
IF temp ≥ 37.5°C OR fever = yes  
neck_pain 
Neck pain/stiffness 
(observed) 
Does the child have pain on 
flexion of the neck?  
0, No
1, Yes 
bul_fontanelles 
Bulging fontanelles 
(observed) 
Does the child's fontanelles 
seem to bulge out above 
surrounding skin when lying 
supine and not crying? 
0, No
1, Yes 
muscle_tone 
Abnormal muscle tone 
(observed)  
Is the child’s muscle tone 
abnormal? (see SOP) 
0, No
1, Yes 
IF muscle_tone = yes 
abnormal_tone 
Type of abnormal 
muscle tone 
Is the child’s muscle tone 
increased or decreased? (see 
SOP) 
1, Increased
2, Decreased 
Laboratory Testing  
hiv 
HIV testing 
Enter HIV test result. 
 
malaria 
Malaria test 
Enter malaria test result. 
 
hb 
Hemoglobin (g/dL) 
Enter hemoglobin test result. 
 
hb_done 
Hemoglobin test 
done?  
Did the child receive a 
hemoglobin test today?  
0, No
1, Yes 
glucose 
Blood sugar (mmol/L) 
Enter blood glucose test result. 
 
glucose_done 
Blood sugar test 
done?  
Did the child receive a glucose 
test today?  
0, No
1, Yes 
lactate 
Lactate (mmol/L) 
Enter lactate test result. 
 
lactate_done 
Lactate test done?  
Did the child receive a lactate 
test today?  
0, No
1, Yes 
IF neo_jaundice = yes 
 
bilirubin 
Bilirubin measurement 
(micromol/L) 
Enter bilirubin test result.  
 
bilirubin_done 
Bilirubin test done?  
Did the child receive a bilirubin 
test today?  
0, No
1, Yes 

        
       
 
 
   
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Patient History 
Demographic Information 
KENYA RESIDENTIAL INFORMATION 
district  
District  
Select district of residence from 
dropdown menu.  
 
county 
County 
Select county of residence from 
dropdown menu. 
 
division 
Division 
Select division of residence from 
dropdown menu. 
 
location 
Location 
Select location of residence 
from dropdown menu. 
 
sub_location 
Sub location 
Select sub location of residence 
from dropdown menu. 
 
village 
Village or Estate  
Select village/estate of 
residence from dropdown 
menu. 
 
UGANDA RESIDENTIAL INFORMATION  
district 
District 
Select district of residence from 
dropdown menu. 
 
county 
County 
Select county of residence from 
dropdown menu. 
 
sub_county 
Sub-County 
Select sub-county of residence 
from dropdown menu. 
 
parish 
Parish 
Select parish of residence from 
dropdown menu. 
 
village 
Village 
Select village of residence from 
dropdown menu. 
 
chairman 
Chairman 
Select chairman of residence 
from dropdown menu. 
 
BOTH SITES  
telephone_1 
Telephone1 
Enter a contact phone number.  
 
contact_1 
Relationship to child  
Ask: What is the relationship of 
this contact to the child?  
 
telephone_2 
Telephone2 
Enter a second contact phone 
number. 
 
contact_2 
Relationship to child  
Ask: What is the relationship of 
this contact to the child? 
 
telephone_3 
Telephone2 
Enter a third contact phone 
number. 
 
contact_3 
Relationship to child 
Ask: What is the relationship of 
this contact to the child? 
 
lo_illness 
Length of Acute Illness 
(days, reported)  
Ask: How many days has your 
child been sick in this illness? 
 
prev_admissions 
Admission within 6 
months (reported) 
Ask: Has the child been 
admitted to a hospital or health 
center in the last 6 months? 
0, No
1, Yes 
IF prev_admissions = yes 

        
       
 
 
   
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time_since_last_hosp 
Time since last 
hospitalization (days, 
reported)  
Ask: How long ago was the child 
last admitted to a hospital or 
health center? 
1, <7 days
2, 7-14 days 
3, 14-30 days 
4, 1 month 
5, 2 months 
6, 3 months 
7, 4 months 
8, 5 months 
9, 6 months 
prev_hosps 
Number of times 
hospitalized within 6 
months (reported) 
Ask: How many times was the 
child admitted to a hospital or 
health center in the last 6 
months? 
urgent_referral 
Referred within last 24 
hours? 
Ask: Was the child referred to 
this hospital from another 
health facility in the last 24 
hours? 
0, No
1, Yes 
Sociodemographic Information 
primary_caregiver 
Primary caregiver 
Ask: Who is the primary 
caregiver of the child?  
0, Mother
1, Father 
2, Grandparent 
3, Other relative 
4, Non-relative 
5, Day-care 
IF primary_caregiver NOT = mother 
mother_alive 
Mother alive 
If mother not present, ask: Is 
the child's mother still alive? 
0, No
1, Yes 
98, Don’t know 
IF (primary_caregiver NOT = mother AND mother_alive = yes) OR  primary_caregiver = mother 
maternal_age 
Maternal age (years), 
if alive 
Ask: How old is the child's 
mother? 
IF age < 12 months 
breastfeeding 
Breastfeeding regimen 
(reported) 
Ask: Was the child exclusively, 
partially or never breastfed for 
the first six months of life? 
1, Exclusive
2, Partial 
3, Never 
98, Don't know 
maternal_hiv 
 
Maternal HIV status 
(reported) 
Record HIV status if records 
available.  Otherwise ask: Is the 
child's mother’s HIV status? 
0, Negative
1, Positive 
98, Don’t know 
IF maternal_hiv = positive 
maternal_hiv_tx 
Maternal HIV 
treatment (reported) 
Ask: What HIV medication is the 
mother taking?  
0, None
1, PMTCT 
2, ART 
98, Don’t know 
child_hiv 
Child HIV status 
(reported)  
Record HIV status if records 
available.  Otherwise ask: Has 
your child tested positive for 
HIV? 
0, No
1, Yes 
98, Don’t know 
maternal_edu 
Maternal education 
(reported) 
Ask: What is the highest level of 
school completed by the child's 
mother?  Read out options. 
0, No school
1, Primary 
2, Secondary 
3, Post-secondary 
98, Don’t know  
water_pure 
All drinking water 
purified (reported) 
Ask:   Do you boil, filter (good 
sand/ceramic) or disinfect (using 
0, No
1, Yes 

        
       
 
 
   
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bleach/waterguard) all drinking 
water?  
water_source 
Primary water source 
for drinking (reported) 
Ask: Where does your child get 
most of his/her drinking water 
from?  Read out options. 
1, Bottled
2, Tap/Municipal 
water 
3, Bore hole  
4, Protected spring 
5, Open source 
(unprotected, 
stagnant water dam) 
6, Slow running water 
7, Fast running water  
98, Don’t know 
99, Other 
IF water_source = other 
water_source_other 
Other primary water 
source for drinking 
Ask:  Where does your child get 
most of his/her drinking water 
from?   
Pregnancy and Birth Information (children <12 months)  
IF age < 12 months 
bw_known 
Exact birth weight 
known 
Check yes if record of birth 
weight is available.  Otherwise 
ask: Do you know the child's 
weight when they were born? 
0, No
1, Yes 
IF bw_known = yes 
birth_weight 
Exact birth weight 
(records, use reported 
if unavailable) 
Enter birth weight from records 
if available. Otherwise ask: 
What was the child's weight 
when they were born? 
IF bw_known = no 
low_bw_est 
Estimated low birth 
weight (reported) 
Ask: Was the child diagnosed to 
have low birth weight when 
they were born? 
0, No
1, Yes 
98, Don’t know 
IF age < 12 months 
gestage_known 
Exact gestational age 
known 
Check yes if record of 
gestational age is available. 
Otherwise ask: Do you know 
how many weeks the pregnancy 
was when the child was born?  
0, No
1, Yes 
 
IF gestage_known = yes 
gestage 
Gestational age at 
delivery (records, use 
reported if 
unavailable) 
Enter gestational age at delivery 
in weeks from records if 
available.  Otherwise ask: How 
many weeks was the child when 
they were born? 
IF gestage_known = no 
gestage_est 
Approximate 
gestational age in 
months (reported) 
Ask: How many months (weeks) 
was the mom pregnant when 
the child was born? 
0, < 7 (28)
1, 7-8 (28-32) 
2, > 8 (32) 
98, Don’t know 
IF age < 12 months 

        
       
 
 
   
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facility_birth 
Facility of birth 
(reported) 
Ask: Where was the child born? 
Read out options. 
1, Hospital
2, Health centre 
3, Clinic 
4, Home 
5, Other 
98, Don't know 
Other 
parent_concern 
Parental Concern 
Ask:  Do you think your child 
needs to be admitted to the 
hospital? 
0, No
1, Yes 
2, Healthcare workers 
should decide 
COVID-19 QUESTIONS 
IF fever = YES or difficulty_breath_rep = YES or difficulty_breathing_obs = YES or temp >= 37.5
covid_contact 
Contact with a 
confirmed or 
suspected COVID-19 
case 
Ask: In the 14 days before 
getting sick, has the child been 
in contact with someone who 
tested positive for COVID-19 or 
someone suspected to have 
COVID-19? 
 
0, No
1, Yes 
 
IF covid_contact = YES
covid_confirmed 
Contact with a 
confirmed case 
Ask: Was the contact with 
someone who tested positive 
for COVID-19?  
0, No
1, Yes 
 
contact_source 
Source of contact 
Ask: What is the relationship 
between the person of contact 
and the child?  
1, Parent
2, Sibling 
3, Grandparent 
4, Extended family 
5, Caregiver or nanny 
6, Friend 
99, Other 
 
IF contact_source = OTHER 
source_other 
Other source of 
contact 
Please specify the relationship 
between the person of contact 
and the child. 
contact_setting 
 
Setting in which the 
contact occurred 
Ask: In what setting did the 
contact occur? (read options) 
 
1, Child's home
2, Extended family's 
home 
3, School/Daycare 
4, Friend's house 
5, Parent's workplace 
99, Other 
 
IF contact_setting = OTHER
setting_other 
 
Other setting in which 
the contact occurred 
Please specify the setting in 
which the contact occurred.  
 
profession_risk 
 
Family with a high-risk 
profession 
Ask: Does the child have a 
parent or family member 
working in any of the following 
fields? (read out options)  
 
1, Healthcare
2, Laboratory 
3, Market 
4, Driver/Public 
Transport 5, School 
teacher 
 

        
       
 
 
   
Version 5 October 2020  
 
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facility_risk 
 
Facility Risk 
Ask: Has the child visited any 
healthcare facility in the 14 days 
prior to symptom onset?  
 
0, No
1, Yes 
 
covid_test 
 
COVID-19 test done?  
Has the child been tested for 
COVID-19? 
 
0, No
1, Yes 
 
IF covid_test = YES
covid_result 
COVID-19 test result 
Select COVID-19 test result.  
 
0, Negative 
1, Positive 
2, Inconclusive 
3, Results not yet 
available 
 
Outcomes 
Hospital Outcomes 
*admitted 
Hospital Admission 
Was the participant admitted to 
the hospital? 
0, No
1, Yes 
IF admitted = yes  
diagnosis 
Final Diagnosis 
Look at the child's record to find 
the clinician diagnosis. Select 
the best category.   
1, Malaria
2, Pneumonia 
3, Bronchiolitis 
4, URTI (cold, flu, etc) 
5, Reactive airway 
disease/asthma 
6, 
Gastroenteritis/Diarr
hoea  
7, HIV/AIDS or AIDS 
related illness 
8, 
Meningitis/encephalit
is or other CNS 
infection 
9, Malnutrition 
10, Tuberculosis 
11, Any skin or soft 
tissue infection 
12, Measles 
99, Other 
IF diagnosis = other  
diagnosis_other
Final Diagnosis Other 
If diagnosis is ‘other’, please 
specify. 
IF admitted = yes 
*admitted_date 
Date of Admission 
Enter date of admission from 
record. 
*discharge_date  
Date of Discharge 
Enter date of discharge from 
record. 
*los  
Length of Stay at 
Hospital 
Calculated length of 
hospitalization. 
IF admitted = no 
not_admitted_status 
Status of Non-
Admitted Children 
What is the status of the child?  
1, Prescribed oral 
medication and sent 
home 

        
       
 
 
   
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2, Went to do lab 
tests and never came 
back  
3, Sent to a non-
COVID-19 facility  
4, Sent to main Jinja 
hospital to see 
specialist 
5, Sent for blood 
transfusion at 
another facility  
99, Other 
not_admitted_status = sent to a non-covid-19 facility OR sent for blood transfusion at another facility  
not_admitted_status_loc 
Location for those 
non-admitted patients 
who were referred to 
another facility  
What is the name of the facility 
the child was sent to?  
mort_enrol  
Death on day of 
enrollment 
Did the child die on the day of 
enrollment?  
0, No
1, Yes 
IF mort_enrol = YES 
deathcause_enrol 
Cause of death on day 
of enrollment 
What was the cause of death?  
Follow-up Call 
*mortality  
7-day Mortality Status 
Find out whether the child is 
alive (See SOP).  
0, Alive 
1, Dead 
IF mortality = yes 
*mort_inhosp 
Died in hospital? 
Ask: Did the child die in 
hospital? 
0, No
1, Yes 
mort_location 
Location of death 
Where did the child die?  
1, During the FIRST 
visit to Jinja hospital 
2, During a 
READMISSION to any 
healthcare centre 
3, At a healthcare 
centre without being 
readmitted 
4, At home or in the 
community, not at a 
healthcare centre  
mort_date 
Date of death  
What date did the child die?  
deathcause  
Cause of death  
What was the cause of death? 
confirm_admitted 
Confirm Admission 
Ask: Was your child admitted to 
Jinja hospital when we first met 
you? 
0, No
1, Yes 
IF admitted = yes 
confirm_admission 
Confirm Date of 
Admission 
Ask: What date was your child 
admitted to the hospital? (See 
SOP). 
confirm_discharge 
Confirm Date of 
Discharge 
Ask: What date was your child 
discharged from the hospital? 
(See SOP).  

        
       
 
 
   
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*readmitted 
7-day 
Readmission/admissio
n to another hospital 
after discharge 
Ask: Was the child admitted to 
any hospital after being 
discharged? (See SOP).  
0, No 
1, Yes 
IF readmitted = yes 
readmitted_reason 
Reason for 
readmission/admissio
n to hospital after 
discharge  
Ask: What was the reason the 
child was admitted?  
 
 
 
 
 
 
 
 
1, Malaria
2, Pneumonia 
3, Bronchiolitis 
4, URTI (cold, flu, etc) 
5, Reactive airway 
disease/asthma 
6, 
Gastroenteritis/Diarr
hoea  
7, HIV/AIDS or AIDS 
related illness 
8, 
Meningitis/encephalit
is or other CNS 
infection 
9, Malnutrition 
10, Tuberculosis 
11, Any skin or soft 
tissue infection 
12, Measles 
99, Other 
*readmitted_location 
Location of 
readmission/admissio
n to hospital after 
discharge 
Ask: Which hospital was the 
child admitted to?   
IF readmitted_reason = other  
reason_other 
Readmission Reason 
Other 
If reason for readmission is 
'other', please specify.  
readmitted_tx
Treatment Received 
During Readmission 
What treatment was the child 
given when readmitted? 
0, None
1, Antibiotics 
2, Intravenous Fluids 
3, Oxygen 
99, Other 
IF readmitted_tx = other 
readmitted_tx_other 
Treatment Received 
During Readmission 
Other 
If treatment is 'other', please 
specify. 
*readmitted_date_known 
Readmission dates 
known 
Do you know exactly what dates 
the child was admitted again 
and discharged again from the 
hospital? 
0, No 
1, Yes 
IF readmitted_date_known =  yes 
*readmitted_start 
Readmission date 
What date was the child 
admitted again from the 
hospital after being sent home? 
*readmitted_end 
Readmission discharge 
date 
What date was the child sent 
home again after being 
readmitted? 

        
       
 
 
   
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*readmitted_los_calc 
Length of stay on 
readmission 
(calculated) 
Calculated length of stay on 
readmission 
IF readmitted_date_known = no 
*readmitted_los_reported 
Length of stay on 
readmission 
(reported) 
When your child was admitted 
to the hospital again, how many 
days did your child stay in 
hospital? 
IF readmitted = yes 
*seek_help_before_readmit 
Seeking help at 
medical facility before 
readmission 
Ask: Other than the place where 
your child was readmitted, did 
you seek any other medical 
help? 
0, No
1, Yes 
IF readmitted = no
*seek_help 
Seeking help at 
medical facility 
(regardless of 
readmission) 
Ask: Did  you seek help from a 
medical facility after being 
discharged from hospital? 
0, No
1, Yes 
IF readmitted = yes OR seek_help = yes  
(invoke branching logic to find out what the care center of readmission/seeking help was) 
*center _district 
District of care center 
Ask: In what district was the 
care center where the child was 
readmitted/sought help? 
Text field populated 
by app.  13 choices 
*center_sub_district 
Health Sub District of 
care center 
Ask: In what sub-district was the 
care center where the child was 
readmitted/sought help? 
Text field populated 
by app, choices 
depends on answer 
to 
readmitted_district. 
*center_name 
Health Facility of care 
center 
Ask: What was the name of care 
center where the child was 
readmitted/sought help? 
Text field populated 
by app.  Choices 
depends on answer 
to 
readmitted_sub_distr
ict 
*center_tier 
Care center tier of 
health facility.   
 
Auto-populated by 
app depending on 
answer to 
center_name 
*center_own 
Ownership of health 
facility 
 
Auto-populated by 
app depending on 
answer to 
center_name 
 
Govt vs. PNFP vs. PFP 
(government, private 
not for profit, private 
for profit) 
IF ask_missed_wages = 1 OR readmitted = yes or seek_help = yes  
(note: will ask about missed wages if patient was readmitted, sought help after discharge, or 20% of the time for 
everyone else).  Included readmitted or seeking help to get a representative sample size in these grouops as N is 
smaller for these groups.  
*who_missed_wages 
Person who missed 
wages, to calculate 
indirect costs of illness 
Ask: During this illness, who 
missed daily wages as a result of 
the child being sick [read out 
1, Mother 
2, Father 
3, Other relative 

        
       
 
 
   
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options and check all that 
apply]? 
98, Other 
99, Don’t know 
IF who_missed_wages = Mother 
*days_missed_wages1 
# days missed wage 
mother 
Ask: During this illness, how 
many days of paid work did the 
mother miss? 
Number, min:0, 
max: 10 
IF who_missed_wages = Father 
*days_missed_wages2 
# days missed wage 
father 
Ask: During this illness, how 
many days of paid work did the 
father miss? 
Number, min:0, 
max: 10 
IF who_missed_wages = Relative 
*days_missed_wages3 
# days missed wage 
relative 
Ask: During this illness, how 
many days of paid work did the 
relative miss? 
Number, min:0, 
max: 10 
IF who_missed_wages = Other 
*days_missed_wages98 
# days missed wage 
other 
Ask: During this illness, how 
many days of paid work did this 
individual miss? 
Number, min:0, 
max: 10 
Clinical Timekeeper 
study_id 
Study ID  
Enter the study ID recorded in 
the participant’s notebook.  
study_id_2 
Study ID  
Again, enter the study ID 
recorded in the participant’s 
notebook. 
*abx_time 
Time at start of 
antibiotics 
administration.  
Time at start of antibiotics 
administration.  
*fluids_time 
Time at start of 
intravenous fluids 
administration.  
Time at start of intravenous 
fluids administration.  
*oxygen_time 
Time at start of 
oxygen 
administration. 
Time at start of oxygen 
administration. 
*antimalarial time 
Time at the start of 
antimalarial 
administration.  
Time at start of antimalarial 
administration. 
other_time 
Time at start of 
treatments that are 
NOT antibiotics, fluids 
or oxygen.  
Time at start of treatments that 
are NOT antibiotics, fluids or 
oxygen.  
IF tx = other  
tx_other 
Treatment Received 
Other 
If treatment is 'other', please 
specify. 
tx_delay 
Patient received all 
treatments on time.  
Patient received all treatments 
on time (choose No if a 
treatment was not received on 
time)  
0, No
1, Yes 
IF tx_delay = YES

        
       
 
 
   
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Appendix B 
 
Simulated Patient Cases  
 
Simulated Patient Case V1  
 
Field  
Value  
Username  
Test 
Password  
Test 
New ID  
0001 
First Name  
Jane 
Last Name  
Doe
Phone Number  
2565554321
Date of birth  
April 15th 2017
delay_reason 
Reason for receiving 
delayed treatment 
Why didn’t the patient receive 
treatment on time?  
1, Out of stock
2, All health workers 
were busy (no one 
available to treat)  

        
       
 
 
   
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Gender  
Female 
Weight  
7.3 kg
Mid-upper arm circumference  
Not Done
Pulse oximetry  
Measure Pulse Ox on yourself, plug it in and put 
on the pulse oximeter. 
Respiratory rate  
Measure RRate on yourself, tap each time you 
breathe. 
Temperature  
37.8 degrees Celsius 
Urgent referral?  
No 
HIV Status  
Negative 
Duration of illness/sign/symptom 
2 days 
Time since last hospitalization  
Never 
Symptoms  
The mother reports Jane is coughing and 
vomiting. Yes, there are tears when crying and 
yes, Jane is able to eat and drink. No other 
symptoms. 
Signs  
Jane is alert and there are no other signs. 
 
Simulated Patient Case V2 
 
Field  
Value  
Username  
Test 
Password  
Test 
New ID  
4321 
First Name  
John 
Last Name  
Doe  
Phone Number  
2655554321 
Age   
Approximately 1 month  
Gender  
Male  
Weight  
4.2 kg  
Mid-upper arm circumference  
134 mm 
Pulse oximetry  
Measure Pulse Ox on yourself, plug it in and put 
on the pulse oximeter. 
Respiratory rate  
Measure RRate on yourself, tap each time you 
breathe. 
Temperature  
Not done
Urgent referral?  
Yes 
HIV Status  
Positive, but no signs or symptoms from HIV
Duration of illness/sign/symptom 
1 day
Time since last hospitalization  
3 weeks 
Exclusive breastfeeding?  
Yes 
Symptoms  
The mother reports John is wheezing and has no 
tears when crying. He is not able to eat or drink 
anything. No other symptoms. 
Signs  
John is not alert but responds to voice. You also 
notice chest-indrawing but no other signs. 
 
Simulated Patient Case V3  

        
       
 
 
   
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Field  
Value  
Username  
Test 
Password  
Test 
New ID  
0003
First Name  
James 
Last Name  
Doe 
Phone Number  
2561234567
Date of Birth  
Approximately 2.5 years 
Gender  
Male 
Weight  
13.3 kg 
Mid-upper arm circumference  
120 mm
Pulse oximetry  
Measure Pulse Ox on yourself, plug it in and put 
on the pulse oximeter. 
Respiratory rate  
Measure RRate on yourself, tap each time you 
breathe. 
Temperature  
38.2 degrees Celsius 
Urgent referral?  
No
HIV Status  
Negative 
Duration of illness/sign/symptom 
5 days 
Time since last hospitalization  
7 months 
Symptoms  
The father reports James is coughing and irritable. 
He vomited his dinner last night and has a runny 
stool since last night. 
Signs  
James is alert and there are no other signs. 
 
 
 
 
Appendix C 
 
Think Aloud Script and Triage Tool Instructions  
 

        
       
 
 
   
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Appendix D 
 
Triage Tool Training Questionnaire  
 
Participant ID:
Date:
Time:
 
Impact  
Question #1: 
Do you think the triage tool would be a positive addition to the patient risk assessment 
process at triage?      
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #2: 
 
Do you think the triage tool would improve the patient risk assessment processes at 
your hospital? 
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #3: 
 
Do you think the triage tool would be an important part of meeting your information 
needs related to patient risk levels?        
 
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Perceived Usefulness  
Question #4: 
Do you think using the triage tool makes it easier for you to identify patients who may 
be at higher risk and need more attention?      
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #5: 
Do you think the triage tool enables you to identify higher risk patients more quickly?     
 

        
       
 
 
   
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Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #6: 
Do you think using the triage tool makes it more likely that you will identify patients 
who are higher risk at triage?        
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #7: 
Do you think that using the triage tool is useful for identifying high risk patients at 
triage?         
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #8: 
Do you think the triage tool presents a more equitable process for patient risk 
assessment at triage?  
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question #9: 
Are you satisfied with the triage tool for risk management of patients at triage?   
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#10:
  Do you think you will be able to manage patients risk assessment at triage in a timely 
manner because of the triage tool?   
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 

        
       
 
 
   
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Question 
#11:
Do you think using the triage tool increases your ability to assess patients’ risk levels 
at triage?   
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#12: 
 
Are you able to assess patient risk at triage whenever you use the triage tool?     
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
 
Perceived Ease of Use  
Question 
#13: 
Are you comfortable with your ability to use the new triage tool?  
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#14: 
 
Was learning to operate the triage tool easy for you?         
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#15: 
Was it easy for you to become skillful at using the triage tool?           
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
 
Do you find the triage tool easy to use?            

        
       
 
 
   
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Question 
#16: 
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#17: 
 
Can you always remember how to log on to and use the triage tool?              
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
 
User Control  
Question 
#18: 
Do you find the triage tool gives error messages that clearly tell you how to fix 
problems?
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#19: 
  
When you make a mistake using the triage tool, do you find you can recover easily and 
quickly? 
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#20: 
 
Do you think the information (such as on-screen messages and other documentation) 
provided with the triage tool is clear? 
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
 
Healthcare Worker Satisfaction  

        
       
 
 
   
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Question 
#21: 
Do you feel like you are well trained and prepped to use the triage tool and standard 
protocols when they are implemented in the hospital?       
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Question 
#22:
Overall, do you think the triage tool will be a positive addition to your hospital?          
 
Response:       
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
 
Additional Comments  
 
Do you have any other feedback for us about the digital triage system?  
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________ 
 
Your input and comments are an important part of evaluating the tools and training of this 
program. Thank you! 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix E 
 
Interview Guide  
 
 

        
       
 
 
   
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Administrative information – Filled out by participant 
ID number: 
Date of informed consent form signed: |D|D| - |M|M|M| - |Y|Y|Y|Y| 
First Name,  
    Sex: 
 Female   
 Male   
 Prefer not to say 
Last name, 
Age group: <20, 20-30, 30-40, 40-50, 50+ 
Program and year graduated 
 
Total months/years worked in current field 
|M|M| - |Y|Y| 
Total months/years worked at current hospital 
|M|M| - |Y|Y| 
Current department 
 
Current position 
 
Administrative information – Filled out by researcher 
Interview Group number (if applicable) 
Does the participant agree to be audio recorded? 
 Yes      
 No  
(If no, participant will be excluded from the study) 
Name of interviewer: 
Date of interview:  
|D|D| - |M|M|M| - |Y|Y|Y|Y| 
Location of interview: 
  Jinja Regional Referral Hospital 
  Other: ___________________________ 
Interview start time:
|H|H| : |M|M|  military time 
Interview end time:  
|H|H| : |M|M|  military time  
Instructions for qualitative research staff:
 
Use this document as a guide to conduct the interviews with the hospital staff (HS). 
 
Conduct the interview in the language with which the HS feels most comfortable. 
 
The interview should take place in a quiet place that allows privacy. 
 
Please introduce each question separately. The interview should flow as a conversation. If you notice that the HS is 
hesitant in answering, does not give an in-depth response, or the response is not satisfactory, please probe or ask 
follow-up questions, but do NOT prompt any specific answer. Several probes are suggested, and you may also ask 
follow-up questions that are not listed in this guide but are necessary for the complete expression of the HS’s views. 
 
Please record the interview using the designated audio recorder and state the HS ID number at the beginning and 
end of the recording.  
 
All comments from the HS should be recorded. 
 
All responses must be kept confidential. Do not discuss or share responses with anyone outside of the PRST study 
team. 
 
 

        
       
 
 
   
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SCRIPT FOR PROSPECTIVE INTERVIEW 
Ex. introduction:  
“Welcome, my name is <interviewer>. I would like to thank you for participating in this interview today. 
I’m here today to ask you questions and hear your thoughts, opinions, and feelings about the digital 
triage tool that has been <piloted/operational> at your facility for the past <1 week/6 months>. 
<Interviewer will provide a brief description of the tool and events to clarify the subject of the interview>. 
I’ll begin by asking you a few questions about yourself and your role at this hospital…” 
A. Demographic Information  
1. First, we will start with some questions about yourself; 
2. What is your first and last name?  
3. How many years of education and training have you completed?  
4. What is your highest level of education completed?  
 
B. Current role at this facility 
1. How long have you been employed at this healthcare facility?
2. What is your current job title or current role at this facility? 
3. How long have you been in this role at this facility and how long have you worked here in total? 
4. What are your responsibilities in this role? 
Probes: What does a typical day look like to you? 
5. Are you involved in patient care? If yes, explain your patient care responsibilities.  
(if no, skip question) 
Probes: Are you involved with identifying/treating emergency patients? How?  
6. Do you have experience with technology?  
Probes: At home? At work? At school? Elsewhere? 
 
C. Digital Triage Tool 
Usability
1. Are you familiar with the PRST Digital Triage Tool?  
 
2. In your own words, can you explain what the tool is and what it does?  
Probes: Can you tell me more about risk prediction/triage/patient tracking/etc.  
 
3. Are you expected to use the digital triage tool as part of your regular clinical care in the hospital? 
Probes: Have you ever used a system like this before? Tell me a bit about it. 
 
4. How do you feel about using a system like this at this facility?    
Probes: benefits/challenges? 
 
Training 
5. Tell me about the training you received to prepare you for using the digital triage tool. 
Probes: who provided the training [PHASE III]-did you attend a training session/ were trained by 

        
       
 
 
   
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other hospital staff, who? 
 
6. Do you feel you were properly trained to use this tool? Were others? 
Probes: Was training long enough? What do think the appropriate length of time and method of 
delivery of training? 
 
7. Which aspects of using this tool do you think were easy to learn? Which aspects were difficult? 
Probes: What barriers did you anticipate/experience during the test period (pilot)?  
 
8. [Newborn] How do you think using this tool will/has affect providing care to newborns at this 
facility? 
Probes: How would it be different using the tool with newborns compared with older children? 
 
9. What kinds of questions <do you think/have> caregivers or other hospital staff <would have/had> 
about this tool? 
Probes: basic functioning ‘what does it do?’/changes in care/risk prediction/patient tracking? 
 
10. Are there situations where you think this tool should not be used? If so, what are they? 
Probes: The baby is too sick? The hospital is too busy? Understaffed? 
 
11. Are there any changes you would make to this tool before it becomes part of standard clinical 
care here? If so, what are they? 
 
Acceptability 
12. What do you like (if anything) about this tool overall? What do you dislike (if anything)?  
Probe: <key issues that we want responses about. Does it take too long? … > 
 
13. How do you think other healthcare providers in your hospital <will feel/feel> about this tool?  
Probe: Do you think doctors will have a different opinion from nurses? 
 
Parent/Caregiver perspectives 
14. How do you think mothers and primary caregivers <will feel/feel> about this new tool? 
Probes: additional questions/technology/tracking/ 
 
15. Do you think fathers/mothers-in-law/other family members, <will feel/feel> the same way?  
Probes: Why/Why not? 
 
16. Do you think we should ask caregivers and their families directly?  
 
Facility 
17. How do you think healthcare administrators and decision-makers in your facility <would/have> 
react to this tool?  
Probes: Discuss at each level (local, district, national) sequentially. What stakeholders might 
influence the uptake of this technology? 
 

        
       
 
 
   
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18. What do you think about using Bluetooth technology to track patient movement?
Probe: Do you have specific concerns about Bluetooth technology? Have you heard others express 
concerns about Bluetooth technology? Do you use Bluetooth technology in your personal life? 
Description of the technology “Bluetooth is a wireless technology standard used for exchanging 
data between fixed and mobile devices over short distances using short-wavelength UHF radio 
waves”  
 
Trustworthiness 
19. Would you consider information collected and displayed by this tool trustworthy? Why or why 
not?  
 
20. What information does the tool currently provide that is of interest and of use to you? 
Probes: Missing Information-Is there information isn’t not giving you that you want? Usefulness-Is 
there information it currently gives that is not useful? 
 
Feasibility 
21. Do you think this tool is suitable for your facility?  
Probes: For example, staffing availability and skill to use the tool, training, complexity of the tool, 
availability of equipment and infrastructure needed for its use, durability and maintenance of tool 
and components, access to spare parts, protocols and guidelines for use, counselling caregivers 
and informational materials? What could be benefits/drawbacks? 
22. What would need to happen in order to integrate this tool successfully at this facility? Please 
explain.  
Probes: For example, ease of use during a patient visit, integration into current flow of hospital 
operations, acceptance by administrators, etc.? 
 
23. Do you think this tool is suitable for you and the work you do? Why/why not? 
 
24. Do you have any other comments about this tool that we did not talk about? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

        
       
 
 
   
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Appendix F 
 
 
Makerere University School of Public Health (MUSPH) Higher Degrees, Research and 
Ethics Committee  
 
Informed Consent Form  
(Phase I: Baseline Data Collection)  
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
Principal Investigators  
Dr. Mark Ansermino 
Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia 
    Dr. Abner Tagoola 
Senior consultant at Jinja Regional Referral Hospital, Jinja, Uganda 
Co-Investigators 
Samuel Akech  
Kenya Medical Research Institute/Wellcome 
Trust Research Programme
Alishah Mawji  
Department of Anesthesiology, Pharmacology 
& Therapeutics, University of British 
Columbia
 
Matthew O. Wiens 
Center for International Child Health, BC 
Children’s Hospital Research Institute 
Niranjan Kissoon 
Department of Pediatrics, University of British 
Columbia

        
       
 
 
   
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Edmond Li 
School of Population and Public Health, 
University of British Columbia
Nathan Kenya Mugisha 
Walimu 
 
 
 

        
       
 
 
   
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Introduction: 
Your child is invited to be part of this research study because he/she is a paediatric patient and 
has come to the hospital to get medical help. You can decide if your child joins or not. Your 
child will get all normal medical care no matter what you decide about this study.  You can talk 
to anyone you want to before deciding. If you want your child to join, we will ask you to sign 
this consent form. This form explains the study and how your child will help with the study. If 
you decide to have your child join, you are free to change your mind at any time. If you change 
your mind, you will not have to explain why. There will be no penalty if you change your mind. 
If you choose not to join, or to later quit the study, your child will still get all normal medical 
care. There will be more than 1000 children that join this study.  
 
 
Who is carrying out this study?  
This study is being done by Makerere University School of Public Health (in Jinja), and the 
University of British Columbia (in Canada). These organizations do medical research to find better 
ways of preventing and treating illness. This study is being funded by Wellcome Trust, which is a 
charity based in the United Kingdom but funds health research worldwide to improve lives. 
 
What is this study about?  
Many children become very sick from infections like malaria, pneumonia and diarrhea. It is very 
important for children with these infections who are very sick to be recognized as early as 
possible. In this study, we want to collect simple information about the health of children like 
your child to help us predict which children are very sick.  If we can do that, we can give the sick 
children treatment quicker. If you do not want to answer any questions, you do not have to. 
 
If you/your child fits the requirements of this research, we will: 
 
1. Take 30 minutes today while you are waiting.  If it is your turn to see the nurse or 
doctor, you will still see them right away and we can finish the study interview 
afterwards. 
2. Put a radio-frequency identification (RFID) tag on your child. This tag lets us keep track 
of where your child is in the hospital.  It will tell us how long your child had to wait to 
see the doctor and get treated. 
3. Ask you questions about your child’s sickness, general health and home life. 
4. Measure numbers used in normal medical care like oxygen levels, breathing speed, heart 
speed, temperature, height, weight, and arm thickness.  We will use devices that are used 
in normal medical care. 
5. Examine your child for signs related to your child’s sickness and general health. 
6. Ask you a few questions about the child’s mother and caregiver. 
7. Record whether your child was admitted and for how long.  Record how long your child 
had to wait before seeing the doctor and getting treated. 
8. We may call you within 7 days with a few short questions to check your child’s health. 
 
 

        
       
 
 
   
Version 5 October 2020  
 
Page 62 of 113 
 
We will use all this information to build a program that can tell us which children in the waiting 
room are the sickest.   
 
Are there any risks or disadvantages to me/my child of taking part? 
 Our priority for every participant is their well-being.   
 It is safe to join the study. Your child will get the same medical care he/she would get if they 
do not join the study.  
 Participation will take about 30 minutes of your time, and study procedures will not delay care 
for your child.  
 
Are there any advantages to me/my child of taking part? 
 This study offers no direct benefits to you or your child.  
 By joining in the study, you will help us learn to recognize children with bad infections 
sooner. This information could save some future children from dying of infections by getting 
them treatment sooner.    
 
Incentives/rewards for participating:  
We would like to provide you with a bar of soap to thank you for your participation.  
  
 
What happens if I refuse to participate? 
All participation in research is voluntary. You are free to decide if you want your child to take part. 
Your child will still receive the recommended standard of care if they do not take part.  If you do 
agree you can change your mind at any time and withdraw your child from the research. You do 
not need to give any reasons for your decision. This will not affect your child’s care now or in the 
future. 
 
Who will have access to information about me/my child in this research? 
All our research records are stored securely in locked cabinets and password protected computers. 
Your confidentiality will be respected. Research records identifying you may be inspected in the 
presence of the Investigator or his or her designate by representatives of the University of British 
Columbia for the purpose of monitoring the research. No information or records that disclose your 
identity will be published without your consent. No information or records that disclose your 
identity be removed or released without your consent unless required by law.  
This study is being done by researchers from Kenya, Uganda and from Canada. The electronic 
data that is collected will be stored safely on servers at MUSPH, and a copy will be shared with 
University of British Columbia in Canada. You will be given a unique study number. This 
number will not include any personal information that could identify you like your name or 
initials. Only this number will be used on any research-related information collected about you, 
so that your identity will be kept confidential. Information that contains your identity will remain 
only with the Principal Investigator and/or designate.  
Any and all information that could potentially identify you will be removed before publication of 
this data. You can decide that you do not want your data made publicly available. If you decide 

        
       
 
 
   
Version 5 October 2020  
 
Page 63 of 113 
 
you do not want your data to be available to the public (without identifying information), this is 
the same as withdrawing from the study.  
 
In future, information collected or generated during this study may be used to support new 
research by other researchers in Kenya, Uganda and Canada on preventable infections and 
sepsis. In all cases, we will only share information with other researchers in ways that do not 
reveal individual participants’ identities. For example, we will remove information that could 
identify people, like names and address, and replace this information with number codes. Any 
future research using information from this study must first be approved by the MUSPH Higher 
Degrees, Research and Ethics Committee, to make sure that the interests of participants and their 
communities are protected. 
Who has approved this research? 
All research at MUSPH must be approved before it begins by several national and international 
committees who look carefully at planned work. They must agree that the research is important, 
relevant to Uganda and follows nationally and internationally agreed research guidelines. This 
includes ensuring that all participants’ safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team 
using these contacts:  
 
Dr. Nathan Kenya-Mugisha 
Walimu Office 
Unit 4, Plot 5, Coral Crescent, Kololo, Kampala 
Tel: 0772-731-751 
Email: kenya@walimu.org 
 
Dr. John Ssempebwa 
Acting Chairperson  
HD Research and Ethics Committee  
Tel: +256-772-963-074 
 
If you have any concerns or complaints about your rights as a research participant and/or 
your experiences while participating in this study, contact the University of British 
Columbia Research Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 
 
 
 
 
 

        
       
 
 
   
Version 5 October 2020  
 
Page 64 of 113 
 
 
 
 
 
I, [being a parent/guardian of ________________________________ (name of child),] have had 
the research explained to me. I have understood all that has been read/explained and had my 
questions answered satisfactorily. And I agree to allow my child to take part in the research. 
 
I understand that I can change my mind at any stage, and it will not affect to my child in any 
way. 
 
Subject/Parent/guardian’s signature: ____________________________Date ___________ 
 
Subject/Parent/guardian’s name:  _____________________________ Time ____________ 
                                                                       (Please print name) 
---------------------------------------------------------------------------------------------------------------------
--------------------- 
 
Where parent/guardian cannot read, ensure a witness* observes consent process and signs 
below: 
 
I attest that the information concerning this research was accurately explained to and apparently 
understood by the subject/parent/guardian and that informed consent was freely given by the 
subject/parent/guardian. 
 
Witness’ signature:  _____________________________________ Date _____________ 
 
Witness’ name:       _____________________________________ Time ______________ 
 
*A witness is a person who is independent from the trial or a member of staff who was not 
involved in gaining the consent. 
 
Thumbprint of the parent as named above if they cannot write: _________________________ 
---------------------------------------------------------------------------------------------------------------------
--------------------- 
 
I have followed the study SOP to obtain consent from the [participant/guardian].  S/he apparently 
understood the nature and the purpose of the study and consents to the participation [of the child] 
in the study. S/he has been given opportunity to ask questions which have been answered 
satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _____________________________Time ____________ 
                                                                        (Please print name) 

        
       
 
 
   
Version 5 October 2020  
 
Page 65 of 113 
 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY 
TO KEEP

 
                                                                                                         
 
Version 3 April 2 
Page 66 of 113
 
KEMRI Wellcome Trust Research Programme: Patient Information and Consent Form 
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric 
Rapid Sepsis Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing 
sick children]. Phase I.  
 
Institution 
Investigators 
Kenya Medical Research Institute   
Samuel Akech  
Mike English  
Grace Irimu 
Ambrose Agweyu 
Morris Ogero 
Cynthia Khazenzi 
Jalemba Aluvaala 
Mbagathi Hospital 
David Kimutai 
Jinja Regional Hospital  
Abner Tagoola 
The University of British Columbia/BC Children’s 
Hospital Research Institute  
Mark J. Ansermino  
Niranjan Kissoon 
Matthew Wiens  
Guy Dumont  
Alishah Mawji 
 
Introduction: 
Your child is being invited to take part in this research study because he/she is under 19 years old and has 
come to the hospital to get medical treatment. Your participation is voluntary. You can decide whether or not 
your child joins. Before you decide, you can talk to anyone you feel comfortable with about your decision. If 
you want your child to participate, we will ask you to sign this consent form. This form explains the study and 
your child’s role in the study. If you decide to have your child join, you are free to change your mind at any 
time. If you change your mind, you will not have to explain your decision. There will be no penalty if you 
change your mind. If you choose not to participate, or to later quit the study, your child will still get all normal 
medical care. There will be more than 1000 children that join this study. 
 
Who is carrying out this study?  
This study is being carried out by the Kenya Medical Research Institute (in Nairobi), and the University of 
British Columbia (in Canada). These organizations conduct medical research to find better ways of preventing 
and treating illness in the future. This study is being funded by Wellcome Trust, which is a charity based in 
the United Kingdom but funds health research worldwide to improve lives. 
 
What is this study about?  
Many children become very sick from infections like malaria, pneumonia and diarrhea. It is very important 
for children with these infections who are very sick to be recognized as early as possible. In this study, we 
want to collect simple information about the health of children like your child to help us predict which 

 
                                                                                                         
 
Version 3 April 2 
Page 67 of 113
children are very sick.  If we can do that, we can give the sick children treatment quicker. If you do not want 
to answer any questions, you do not have to. 
 
If you/your child fits the requirements of this research, we will: 
 
1. Take 30 minutes today while you are waiting.  If it is your turn to see the nurse or doctor, you will 
still see them right away and we can finish the study interview afterwards. 
2. Put a radio-frequency identification (RFID) tag on your child. This tag lets us keep track of where 
your child is in the hospital.  It will tell us how long your child had to wait to see the doctor and get 
treated. 
3. Ask you questions about your child’s sickness, general health and home life. 
4. Measure numbers used in normal medical care like oxygen levels, breathing speed, heart speed, 
temperature, height, weight, and arm thickness.  We will use devices that are used in normal medical 
care. 
5. Examine your child for signs related to your child’s sickness and general health. 
6. Ask you a few questions about the child’s mother and caregiver. 
7. Record whether your child was admitted and for how long.  Record how long your child had to wait 
before seeing the doctor and getting treated. 
8. We may call you within 7 days with a few short questions to check your child’s health. 
 
We will use all this information to build a program that can tell us which children in the waiting room are the 
sickest.   
 
Are there any risks or disadvantages to me/my child of taking part? 
 Our priority for every participant is their well-being.   
 It is safe to join the study. Your child will get the same medical care he/she would get if they do not join 
the study.  
 Participation will take approximately 30 minutes of your time, and study procedures will not delay care 
for your child.  
 
Are there any advantages to me/my child of taking part? 
This study offers no direct benefits to you or your child. By participating in the study, you will help us learn 
how to better recognize children with bad infections. This information could protect some children in future 
with infections from dying by helping them get treated earlier.  
 
What happens if I refuse to participate? 
All participation in research is voluntary. You are free to decide if you want your child to take part. Your 
child will still receive the recommended standard of care if they do not take part.  If you do agree you can 
change your mind at any time and withdraw your child from the research. You do not need to give any 
reasons for your decision. This will not affect your child’s care now or in the future. 
 
Who will have access to information about me/my child in this research? 
All our research records are stored securely in locked cabinets and password protected computers. Your 
confidentiality will be respected. However, research records identifying you may be inspected in the presence 

 
                                                                                                         
 
Version 3 April 2 
Page 68 of 113
of the Investigator or his or her designate by representatives of the University of British Columbia for the 
purpose of monitoring the research. No information or records that disclose your identity will be published  
 
without your consent, nor will any information or records that disclose your identity be removed or released 
without your consent unless required by law.  
 
This study is being done by researchers from Kenya, Uganda and from Canada. The electronic data that is 
collected will be stored safely on servers at KEMRI Wellcome Trust Research Programme, and a copy will be 
shared with University of British Columbia in Canada. You will be assigned a unique study number as a 
participant in this study. This number will not include any personal information that could identify you (e.g., it 
will not include your identify number or your initials, etc.). Only this number will be used on any research-
related information collected about you during the course of this study, so that your identity will be kept 
confidential. Information that contains your identity will remain only with the Principal Investigator and/or 
designate.  
 
Any and all information that could potentially identify you will be removed before publication of this data. 
You can decide that you do not want your data made publicly available. If you decide you do not want your 
data to be available to the public, this is equivalent to withdrawing from the study.  
In future, information collected or generated during this study may be used to support new research by other 
researchers in Kenya, Uganda and Canada on preventable infections. In all cases, we will only share 
information with other researchers in ways that do not reveal individual participants’ identities. For example, 
we will remove information that could identify people, such as their names and where they live, and replace 
this information with number codes. Any future research using information from this study must first be 
approved by the Scientific Ethics and Review Unit in Kenya, to make sure that the interests of participants 
and their communities are protected. 
 
Who has approved this research? 
All research at KEMRI has to be approved before it begins by several national [and international] committees 
who look carefully at planned work. They must agree that the research is important, relevant to Kenya and 
follows nationally and internationally agreed research guidelines. This includes ensuring that all participants’ 
safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team using these 
contacts:  
Dr. Samuel Akech, KEMRI Wellcome Trust Research Programme, P.O, Box 43640-00100 Nairobi, Kenya. 
Telephone: +254 721490166 or +254 20 270163 
 
If you want to ask someone independent about this research please contact: 
Community Liaison Manager, KEMRI Wellcome Trust Research Programme, P.O. Box 230, Kilifi.  
Telephone: 041 7522 063, Mobile 0723 342 780 or 0705 154 386 
And 
The Head, KEMRI Scientific and Ethics Review Unit, P. O. Box 54840-00200, Nairobi; Telephone numbers: 
0717 719477; 0776 399979 Email address: seru@kemri.org 
 
 

 
                                                                                                         
 
Version 3 April 2 
Page 69 of 113
 
If you have any concerns or complaints about your rights as a research participant and/or your 
experiences while participating in this study, contact the University of British Columbia Research 
Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 

 
 
    
 
 
Version 3 April 2020 
 
Page 70 of 113
KEMRI Wellcome Trust Research Programme consent form for Saving young lives: Triage and 
management of sepsis in children using the point-of care Paediatric Rapid Sepsis Trigger (PRST) tool 
[Lay Title: Development and testing of a digital tool for recognizing sick children]. Phase I.  
 
I, [being a parent/guardian of ________________________________ (name of child),] have had the research 
explained to me. I have understood all that has been read/explained and had my questions answered 
satisfactorily. And I agree to allow my child to take part in the research. 
 
I understand that I can change my mind at any stage, and it will not affect to my child in any way. 
 
Subject/Parent/guardian’s signature: ____________________________Date ___________ 
 
Subject/Parent/guardian’s name:  _____________________________ Time ____________ 
                                                                       (Please print name) 
------------------------------------------------------------------------------------------------------------------------------------
------ 
 
Where parent/guardian cannot read, ensure a witness* observes consent process and signs below: 
 
I attest that the information concerning this research was accurately explained to and apparently understood 
by the subject/parent/guardian and that informed consent was freely given by the subject/parent/guardian. 
 
Witness’ signature:  _____________________________________ Date _____________ 
 
Witness’ name:       _____________________________________ Time ______________ 
 
*A witness is a person who is independent from the trial or a member of staff who was not involved in gaining 
the consent. 
 
Thumbprint of the parent as named above if they cannot write: _________________________ 
------------------------------------------------------------------------------------------------------------------------------------
------ 
 
I have followed the study SOP to obtain consent from the [participant/guardian].  S/he apparently understood 
the nature and the purpose of the study and consents to the participation [of the child] in the study. S/he has 
been given opportunity to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _____________________________Time ____________ 
                                                                        (Please print name) 
 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 

 
 
    
 
 
Version 3 April 2020 
 
Page 71 of 113
Appendix G 
 
Makerere University School of Public Health (MUSPH) Higher Degrees, Research and Ethics 
Committee  
 
Informed Consent Form  
(Phase III: Intervention)  
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric 
Rapid Sepsis Trigger (PRST) tool 
 
Principal Investigators  
Dr. Mark Ansermino 
Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia 
     Dr. Abner Tagoola 
Senior Consultant at Jinja Regional Referral Hospital, Jinja, Uganda 
Co-Investigators 
Samuel Akech  
Kenya Medical Research Institute/Wellcome 
Trust Research Programme
Alishah Mawji  
Department of Anesthesiology, Pharmacology 
& Therapeutics, University of British Columbia
 
Matthew O. Wiens 
Center for International Child Health, BC 
Children’s Hospital Research Institute 
Niranjan Kissoon 
Department of Pediatrics, University of British 
Columbia
Edmond Li 
School of Population and Public Health, 
University of British Columbia
Nathan Kenya Mugisha 
Walimu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
    
 
 
Version 3 April 2020 
 
Page 72 of 113
 
Introduction: 
Your child is invited to be part of this research study because he/she is a paediatric patient and has come to the 
hospital to get medical help. You can choose to participate or not. You can decide if your child joins or not. 
Your child will get all normal medical care no matter what you decide about this study.  You can talk to anyone 
you want to before deciding. If you want your child to join, we will ask you to sign this consent form. This form 
explains the study and how your child will help with the study. If you decide to have your child join, you are 
free to change your mind at any time. If you change your mind, you will not have to explain why. There will be 
no penalty if you change your mind. If you choose not to join, or to later quit the study, your child will still get 
all normal medical care. There will be around 4000 children that join this study. 
 
Who is carrying out this study?  
This study is being done by Makerere University School of Public Health (in Jinja), and the University of British 
Columbia (in Canada). These organizations do medical research to find better ways of preventing and treating 
illness. This study is being funded by Wellcome Trust, which is a charity based in the United Kingdom but 
funds health research worldwide to improve lives. 
 
What is this study about?  
Many children become very sick from infections like malaria, pneumonia and diarrhea. It is very important 
for children with these infections who are very sick to be recognized as early as possible. In this study, we are 
testing a computer program that can help health workers find very sick children so they can get treatment 
earlier. We want to collect simple information about the health of children coming to the hospital. This 
information will let us test if we can predict which children are very sick and give them treatment earlier. This 
information will also help us make that computer program better.   
 
If you/your child fits the requirements of this research, we will: 
1. Take 30 minutes today while you are waiting.  If it is your turn to see the nurse or doctor, you will 
still see them right away and we can finish the study interview afterwards. 
2. Put a radio-frequency identification (RFID) tag on your child. This tag lets us keep track of where 
your child is in the hospital.  It will tell us how long your child had to wait to see the doctor and get 
treated. 
3. Ask you questions about your child’s sickness, general health and home life. 
4. Measure numbers used in normal medical care like oxygen levels, breathing speed, heart speed, 
temperature, height, weight, and arm thickness.  We will use devices that are used in normal medical 
care. 
5. Examine your child for signs related to your child’s sickness and general health. 
6. Ask you a few questions about the child’s mother and caregiver. 
7. Record whether your child was admitted and for how long.  Record how long your child had to wait 
before seeing the doctor and getting treated. 
8. We may call you within 7 days with a few short questions to check your child’s health. 
 
 
 
 
Are there any risks or disadvantages to me/my child of taking part? 

 
 
    
 
 
Version 3 April 2020 
 
Page 73 of 113
 Our priority for every participant is their well-being.   
 It is safe to join the study. Your child will get the same medical care he/she would get if they do not join the 
study.  
 Participation will take about 30 minutes of your time, and study procedures will not delay care for your 
child.  
 
Are there any advantages to me/my child of taking part? 
 This study offers no direct benefits to you or your child.  
 By joining in the study, you will help us learn to recognize children with bad infections sooner. This 
information could save some future children from dying of infections by getting them treatment sooner.   
 
What happens if I refuse to participate? 
All participation in research is voluntary. You are free to decide if you want your child to take part. Your child 
will still receive the recommended standard of care if they do not take part.  If you do agree you can change 
your mind at any time and withdraw your child from the research. You do not need to give any reasons for your 
decision. This will not affect your child’s care now or in the future. 
 
Who will have access to information about me/my child in this research? 
All our research records are stored securely in locked cabinets and password protected computers. Your 
confidentiality will be respected. Research records identifying you may be inspected in the presence of the 
Investigator or his or her designate by representatives of the University of British Columbia for the purpose of 
monitoring the research. No information or records that disclose your identity will be published without your 
consent. No information or records that disclose your identity be removed or released without your consent 
unless required by law.  
This study is being done by researchers from Kenya, Uganda and from Canada. The electronic data that is 
collected will be stored safely on servers at MUSPH, and a copy will be shared with University of British 
Columbia in Canada. You will be given a unique study number. This number will not include any personal 
information that could identify you like your name or initials. Only this number will be used on any research-
related information collected about you, so that your identity will be kept confidential. Information that contains 
your identity will remain only with the Principal Investigator and/or designate.  
Any and all information that could potentially identify you will be removed before publication of this data. You 
can decide that you do not want your data made publicly available. If you decide you do not want your data to 
be available to the public (without identifying information), this is the same as withdrawing from the study.  
In future, information collected or generated during this study may be used to support new research by other 
researchers in Kenya, Uganda and Canada on preventable infections. In all cases, we will only share 
information with other researchers in ways that do not reveal individual participants’ identities. For example, 
we will remove information that could identify people, like names and address, and replace this information 
with number codes. Any future research using information from this study must first be approved by the 
MUSPH Higher Degrees, Research and Ethics Committee, to make sure that the interests of participants and 
their communities are protected. 
 
Who has approved this research? 

 
 
    
 
 
Version 3 April 2020 
 
Page 74 of 113
All research at MUSPH has to be approved before it begins by several national [and international] committees who look 
carefully at planned work. They must agree that the research is important, relevant to Uganda and follows nationally and 
internationally agreed research guidelines. This includes ensuring that all participants’ safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team using these 
contacts:  
 
Dr. Nathan Kenya-Mugisha 
Walimu Office 
Unit 4, Plot 5, Coral Crescent, Kololo, Kampala 
Tel: 0772-731-751 
Email: kenya@walimu.org 
 
Dr. John Ssempebwa 
Acting Chairperson  
HD Research and Ethics Committee  
Tel: +256-772-963-074 
 
If you have any concerns or complaints about your rights as a research participant and/or your 
experiences while participating in this study, contact the University of British Columbia Research 
Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I, [being a parent/guardian of ________________________________ (name of child),] have had the research 
explained to me. I have understood all that has been read/explained and had my questions answered 
satisfactorily. And I agree to allow my child to take part in the research. 

 
 
    
 
 
Version 3 April 2020 
 
Page 75 of 113
 
I understand that I can change my mind at any stage, and it will not affect to my child in any way. 
 
Subject/Parent/guardian’s signature: ____________________________Date ___________ 
 
Subject/Parent/guardian’s name:  _____________________________ Time ____________ 
                                                                       (Please print name) 
------------------------------------------------------------------------------------------------------------------------------------
------ 
 
Where parent/guardian cannot read, ensure a witness* observes consent process and signs below: 
 
I attest that the information concerning this research was accurately explained to and apparently understood 
by the subject/parent/guardian and that informed consent was freely given by the subject/parent/guardian. 
 
Witness’ signature:  _____________________________________ Date _____________ 
 
Witness’ name:       _____________________________________ Time ______________ 
 
*A witness is a person who is independent from the trial or a member of staff who was not involved in gaining 
the consent. 
 
Thumbprint of the parent as named above if they cannot write: _________________________ 
------------------------------------------------------------------------------------------------------------------------------------
------ 
 
I have followed the study SOP to obtain consent from the [participant/guardian].  S/he apparently understood 
the nature and the purpose of the study and consents to the participation [of the child] in the study. S/he has 
been given opportunity to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _____________________________Time ____________ 
                                                                        (Please print name) 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 
 
 
 
 
 
 
 
KEMRI Wellcome Trust Research Programme: Patient Information and Consent Form  

 
 
    
 
 
Version 3 April 2020 
 
Page 76 of 113
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric Rapid Sepsis 
Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing sick children]. Phase III.  
 
Institution
Investigators
Kenya Medical Research Institute  
Samuel Akech 
Mike English  
Grace Irimu 
Ambrose Agweyu 
Morris Ogero 
Cynthia Khazenzi 
Jalemba Aluvaala 
 
Mbagathi Hospital
David Kimutai
Jinja Regional Hospital 
Abner Tagoola
The University of British Columbia/BC Children’s Hospital 
Research Institute  
Mark J. Ansermino 
Niranjan Kissoon 
Matthew Wiens  
Guy Dumont  
Alishah Mawji  
 
 
Introduction: 
Your child is being invited to take part in this research study because he/she is under 19 years old and has come to the 
hospital to get medical treatment. Your participation is voluntary. You can decide whether or not your child joins. Before 
you decide, you can talk to anyone you feel comfortable with about your decision. If you want your child to participate, 
we will ask you to sign this consent form. This form explains the study and your child’s role in the study. If you decide to 
have your child join, you are free to change your mind at any time. If you change your mind, you will not have to explain 
your decision. There will be no penalty if you change your mind. If you choose not to participate, or to later quit the 
study, your child will still get all normal medical care.  
 
Who is carrying out this study?  
This study is being carried out by the Kenya Medical Research Institute (in Nairobi), and the University of British Columbia 
(in Canada). These organizations conduct medical research to find better ways of preventing and treating illness in the 
future. This study is being funded by Wellcome Trust, which is a charity based in the United Kingdom but funds health 
research worldwide to improve lives. 
 
What is this study about?  
Many children become very sick from infections like malaria, pneumonia and diarrhea. It is very important for children 
with these infections who are very sick to be recognized as early as possible. In this study, we are testing a computer 
program that can help health workers find very sick children so they can get treatment earlier. We want to collect simple 
information about the health of children coming to the hospital. This information will let us test if we can predict which 
children are very sick and give them treatment earlier. This information will also help us make that computer program 
better.   

 
 
    
 
 
Version 3 April 2020 
 
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If you/your child fits the requirements of this research, we will: 
1. Take 30 minutes today while you are waiting.  If it is your turn to see the nurse or doctor, you will still see 
them right away and we can finish the study interview afterwards. 
2. Put a radio-frequency identification (RFID) tag on your child. This tag lets us keep track of where your child is 
in the hospital.  It will tell us how long your child had to wait to see the doctor and get treated. 
3. Ask you questions about your child’s sickness, general health and home life. 
4. Measure numbers used in normal medical care like oxygen levels, breathing speed, heart speed, temperature, 
height, weight, and arm thickness.  We will use devices that are used in normal medical care. 
5. Examine your child for signs related to your child’s sickness and general health. 
6. Ask you a few questions about the child’s mother and caregiver. 
7. Record whether your child was admitted and for how long.  Record how long your child had to wait before 
seeing the doctor and getting treated. 
8. We may call you within 7 days with a few short questions to check your child’s health. 
 
 
Are there any risks or disadvantages to me/my child of taking part? 
 
Our priority for every participant is their well-being.   
 
It is safe to join the study. Your child will get the same medical care he/she would get if they do not join the study.  
 
Participation will take approximately 30 minutes of your time, and study procedures will not delay care for your 
child.  
 
Are there any advantages to me/my child of taking part? 
This study offers no direct benefits to you or your child. By participating in the study, you will help us learn how to 
better recognize children with bad infections. This information could protect some children with infections from dying 
by helping them get treated earlier.  
 
What happens if I refuse to participate? 
All participation in research is voluntary. You are free to decide if you want your child to take part. Your child will still 
receive the recommended standard of care if they do not take part.  If you do agree you can change your mind at any 
time and withdraw your child from the research. You do not need to give any reasons for your decision. This will not 
affect your child’s care now or in the future. 
 
Who will have access to information about me/my child in this research? 
All our research records are stored securely in locked cabinets and password protected computers. Your confidentiality 
will be respected. However, research records identifying you may be inspected in the presence of the Investigator or his 
or her designate by representatives of the University of British Columbia for the purpose of monitoring the research. No 
information or records that disclose your identity will be published without your consent, nor will any information or 
records that disclose your identity be removed or released without your consent unless required by law.  
This study is being done by researchers from Kenya, Uganda and from Canada. The electronic data that is collected will 
be stored safely on servers at KEMRI Wellcome Trust Research Programme, and a copy will be shared with University 
of British Columbia in Canada. You will be assigned a unique study number as a participant in this study. This number 
will not include any personal information that could identify you (e.g., it will not include your identify number or your 
initials, etc.). Only this number will be used on any research-related information collected about you during the course 

 
 
    
 
 
Version 3 April 2020 
 
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of this study, so that your identity will be kept confidential. Information that contains your identity will remain only 
with the Principal Investigator and/or designate.  
Any and all information that could potentially identify you will be removed before publication of this data. You can 
decide that you do not want your data made publicly available. If you decide you do not want your data to be available 
to the public, this is equivalent to withdrawing from the study.  
In future, information collected or generated during this study may be used to support new research by other 
researchers in Kenya, Uganda and Canada on preventable infections. In all cases, we will only share information with 
other researchers in ways that do not reveal individual participants’ identities. For example, we will remove 
information that could identify people, such as their names and where they live, and replace this information with 
number codes. Any future research using information from this study must first be approved by a local or national 
expert committee to make sure that the interests of participants and their communities are protected. 
Who has approved this research? 
All research at KEMRI has to be approved before it begins by several national [and international] committees who look 
carefully at planned work. They must agree that the research is important, relevant to Kenya and follows nationally and 
internationally agreed research guidelines. This includes ensuring that all participants’ safety and rights are respected.  
 
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team using these contacts:  
Dr. Samuel Akech, KEMRI Wellcome Trust Research Programme, P.O, Box 43640-00100 Nairobi, Kenya. Telephone: 
+254 721490166 or +254 20 270163 
 
If you want to ask someone independent about this research please contact: 
Community Liaison Manager, KEMRI Wellcome Trust Research Programme, P.O. Box 230, Kilifi.  Telephone: 041 7522 
063, Mobile 0723 342 780 or 0705 154 386 
And 
The Head, KEMRI Scientific and Ethics Review Unit, P. O. Box 54840-00200, Nairobi; Telephone numbers: 0717 719477; 
0776 399979 Email address: seru@kemri.org 
 
If you have any concerns or complaints about your rights as a research participant and/or your experiences 
while participating in this study, contact the University of British Columbia Research Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 

                                                          
 
Version 3 April 2020 
 
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KEMRI Wellcome Trust Research Programme consent form for Saving young lives: Triage and 
management of sepsis in children using the point-of care Paediatric Rapid Sepsis Trigger (PRST) tool 
[Lay Title: Development and testing of a digital tool for recognizing sick children]. Phase III.  
 
 
I, [being a parent/guardian of ________________________________ (name of child),] have had the 
research explained to me. I have understood all that has been read/explained and had my questions 
answered satisfactorily. And I agree to allow my child to take part in the research. 
 
I understand that I can change my mind at any stage, and it will not affect to my child in any way. 
 
Subject/Parent/guardian’s signature: ____________________________Date ___________ 
 
Subject/Parent/guardian’s name:  _____________________________ Time ____________ 
                                                                       (Please print name) 
------------------------------------------------------------------------------------------------------------------------------------------ 
 
Where parent/guardian cannot read, ensure a witness* observes consent process and signs below: 
 
I attest that the information concerning this research was accurately explained to and apparently 
understood by the subject/parent/guardian and that informed consent was freely given by the 
subject/parent/guardian. 
 
Witness’ signature:  _____________________________________ Date _____________ 
 
Witness’ name:       _____________________________________ Time ______________ 
 
*A witness is a person who is independent from the trial or a member of staff who was not involved in 
gaining the consent. 
 
Thumbprint of the parent as named above if they cannot write: _________________________ 
------------------------------------------------------------------------------------------------------------------------------------------ 
 
I have followed the study SOP to obtain consent from the [participant/guardian].  S/he apparently 
understood the nature and the purpose of the study and consents to the participation [of the child] in the 
study. S/he has been given opportunity to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _____________________________Time ____________ 
                                                                        (Please print name) 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 

                                                          
 
Version 3 April 2020 
 
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Appendix H 
 
Makerere University School of Public Health (MUSPH) Higher Degrees, Research and 
Ethics Committee 
 
Participant Information and Assent Form  
(For participants aged over 13 years to under 18 years)  
 
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
Principal Investigators  
Dr. Mark Ansermino 
Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia 
    Dr. Abner Tagoola 
Senior Consultant at Jinja Regional Referral Hospital, Jinja, Uganda 
Co-Investigators 
Samuel Akech  
Kenya Medical Research Institute/Wellcome 
Trust Research Programme
Alishah Mawji  
Department of Anesthesiology, Pharmacology 
& Therapeutics, University of British 
Columbia
Matthew O. Wiens 
Center for International Child Health, BC 
Children’s Hospital Research Institute
Niranjan Kissoon 
Department of Pediatrics, University of British 
Columbia
Edmond Li 
School of Population and Public Health, 
University of British Columbia
Nathan Kenya Mugisha 
Walimu 
 
 
 
 
 
 
 

                                                          
 
Version 3 April 2020 
 
Page 81 of 113 
 
 
 
 
 
 
 
 
 
What is this study about?  
Many children become very sick from infections like malaria, pneumonia and diarrhea. It is very 
important for children with these infections who are very sick to be recognized as early as possible. 
In this study, we want to collect simple information about the health of children coming to the 
hospital.  This information will let us test if we can predict which children are very sick and give 
them treatment earlier, using a computer program that we made.  This information will also help 
us make that computer program better. Sometimes research involves only talking and asking 
questions of different people about what they know, feel or do about something; this can be done 
with one person or a few people at a time. For this research we will ask you questions about your 
health, for example, “Do you have a cough?” 
 
Who is carrying out this study? 
This study is being carried out by the Makerere University School of Public Health (in Jinja), and 
the University of British Columbia (in Canada). These organizations do medical research to find 
better ways of preventing and treating sickness.  
 
You can choose if you want to be in this study: 
We have talked to your parent about this research and they know that we are talking to you. You 
are free to decide whether you want to answer our questions or not, even if your (parent/guardian) 
has said yes. If you say yes, you can change your mind and stop participating in the future and no 
one will be upset with you.  
 
What will happen to the information I give? 
The information you give in this study will only be shared with people who are concerned with 
the research. 
 
The information will be summarised, and all the names of the participants will be removed from 
the documents. This study information may be used for future research; the information will only 
be provided after a national independent committee checks and agrees that you will not be affected 
in any way.  
 
What if I have any questions?  
You are free to talk to your parent/guardian or other people about being in this study. You can ask 
to have time to go talk to them about this. You are free to ask me any questions to any of the staff 
at any time. You can also contact:  

                                                          
 
Version 3 April 2020 
 
Page 82 of 113 
 
Dr. Nathan Kenya-Mugisha 
Walimu Office 
Unit 4, Plot 5, Coral Crescent, Kololo, Kampala 
Tel: 0772-731-751 
Email: kenya@walimu.org 
 
Dr. John Ssempebwa 
Acting Chairperson  
HD Research and Ethics Committee  
Tel: +256-772-963-074 
 
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
 
I, ________________________________ (write your name), have had the study explained to me. 
I have understood everything that was explained to me. And I agree to take part in this study.  
 
I understand that I can change my mind at any time, that if I do, nothing bad will happen to me 
and I will still get medical help. 
 
Child’s signature: ____________________________Date ___________ 
 
Child’s name: _____________________________ Time ____________ 
 
Thumbprint of the child as named above if they cannot write: _________________________ 
 
---------------------------------------------------------------------------------------------------------------------
--------------------- 
 
For the Investigator:  
I certify that I have followed all the study specific procedures for obtaining informed assent from 
this child. 
Investigator’s signature: _______________________________ Date ______________ 
Investigator’s name: ___________________________________Time ______________ 
(Please print name) 
 
THE PARTICIPANT SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 
 
 

                                                          
 
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KEMRI Wellcome Trust Research Programme: Participant Information and Assent Form (For participants 
aged over 13 years to under 18 years) 
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric 
Rapid Sepsis Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing 
sick children]. 
 
Institution 
Investigators 
Kenya Medical Research Institute   
Samuel Akech  
Mike English  
Grace Irimu 
Ambrose Agweyu 
Morris Ogero 
Cynthia Khazenzi 
Jalemba Aluvaala 
Mbagathi Hospital 
David Kimutai 
Jinja Regional Hospital  
Abner Tagoola 
The University of British Columbia/BC 
Children’s Hospital Research Institute  
Mark J. Ansermino  
Niranjan Kissoon 
Matthew Wiens  
Guy Dumont  
Alishah Mawji 
 
What is this study about?  
 
Many children become very sick from infections like malaria, pneumonia and diarrhea. It is very important 
for children with these infections who are very sick to be recognized as early as possible. In this study, we 
want to collect simple information about the health of children coming to the hospital.  This information 
will let us test if we can predict which children are very sick and give them treatment earlier, using a 

                                                          
 
Version 3 April 2020 
 
Page 84 of 113 
 
computer program that we made.  This information will also help us make that computer program better. 
Sometimes research involves only talking and asking questions of different people about what they know, 
feel or do about something; this can be done with one person or a few people at a time. For this research 
we will ask you questions about your health, for example, “Do you have a cough?” 
 
Who is carrying out this study??  
This research is being carried out by KEMRI in collaboration with The University of British 
Columbia (in Canada). KEMRI is a government organization that carries out medical research to 
find better ways of preventing and treating illness in the future for everybody’s benefit.  
You can choose if you want to be in this study: 
We have spoken to your parent about this research and they are aware that we are talking to you. 
You are free to decide whether you want to answer our questions or not, even if your 
(parent/guardian) has agreed. If you agree now, you can change your mind and stop participating 
in the future and no one will be upset with you.  
What will happen to the information I give? 
 
The information you give in this study will only be shared with people who are concerned with 
the research. 
 
The information will be summarised, and all the names of the participants will be removed from 
the documents. This study information may be used for future research; the information will only 
be provided after a national independent committee checks and agrees that you will not be affected 
in any way.  
 
What if I have any questions?  
You are free to discuss your decision about taking part in this study with your parent/guardian or 
other people and you can ask to be given time to go and discuss this with them.  
You are free to ask me any questions to any of the staff at any time. You can also contact:  
 
Dr. Samuel Akech, KEMRI Wellcome Trust Research Programme, P.O, Box 43640-00100 Nairobi, Kenya. 
Telephone: +254 721490166 or +254 20 270163 
If you want to ask someone independent anything about this research please contact: 
Community Liaison Manager, KEMRI – Wellcome Trust, P.O. Box 230, Kilifi.  Telephone: 0723 
342 780 or 041 7522 063         
And 
The Head, KEMRI Scientific and Ethics Review Unit, P. O. Box 54840-00200, Nairobi; 
Telephone numbers: 0717 719477; 0776 399979 Email address: seru@kemri.org 
 
 
 
 

                                                          
 
Version 3 April 2020 
 
Page 85 of 113 
 
 
 
 
 
 
 
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric 
Rapid Sepsis Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing 
sick children]. 
 
I, ________________________________ (write your name), have had the study explained to me. 
I have understood everything that was explained to me. And I agree to take part in this study.  
 
I understand that I can change my mind at any time, that if I do, nothing bad will happen to me 
and I will still get medical help. 
 
Child’s signature: ____________________________Date ___________ 
 
Child’s name: _____________________________ Time ____________ 
 
Thumbprint of the child as named above if they cannot write: _________________________ 
 
-------------------------------------------------------------------------------------------------------------------------------
----------- 
 
For the Investigator:  
I certify that I have followed all the study specific procedures for obtaining informed assent 
from this child. 
Investigator’s signature: _______________________________ Date ______________ 
Investigator’s name: ___________________________________Time ______________ 
(Please print name) 
 
THE PARTICIPANT SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 

                                                          
 
Version 3 April 2020 
 
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Appendix I 
 
Makerere University School of Public Health (MUSPH) Higher Degrees, Research and 
Ethics Committee  
 
Informed Consent Form  
(Usability Testing)  
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
Principal Investigators  
Dr. Mark Ansermino 
Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia 
    Dr. Abner Tagoola 
Senior consultant at Jinja Regional Referral Hospital, Jinja, Uganda 
Co-Investigators 
Samuel Akech  
Kenya Medical Research Institute/Wellcome 
Trust Research Programme
Alishah Mawji  
Department of Anesthesiology, Pharmacology 
& Therapeutics, University of British 
Columbia
 
Matthew O. Wiens 
Center for International Child Health, BC 
Children’s Hospital Research Institute 
Niranjan Kissoon 
Department of Pediatrics, University of British 
Columbia
Edmond Li 
School of Population and Public Health, 
University of British Columbia
Nathan Kenya Mugisha 
Walimu 
 
 
 

                                                          
 
Version 3 April 2020 
 
Page 87 of 113 
 
 
Invitation:  
You are invited to participate in this research study because you are a nurse or student nurse at 
Jinja Regional Referral Hospital.  
 
Your participation is voluntary:  
Your participation is voluntary. You have the right to refuse to participate in this study. If you 
decide to participate, you may still choose to withdraw from the study at any time without any 
negative consequences to the medical care, education, or other services to which you are entitled 
or are presently receiving. Before you decide, it is important for you to understand what the 
research involves. This consent form will tell you about the study, why the research is being 
done, what will happen to you during the study and the possible benefits, risks and discomforts.  
 
If you wish to participate in this study, you will be asked to sign this form. Please take time to 
read this information and ask any questions that may help you understand the study before you 
decide whether to participate. 
 
Who is carrying out this study?  
This study is being done by Makerere University School of Public Health (in Jinja), and the 
University of British Columbia (in Canada). These organizations do medical research to find better 
ways of preventing and treating illness. This study is being funded by Wellcome Trust, which is a 
charity based in the United Kingdom but funds health research worldwide to improve lives. 
 
Background 
There is an urgent need for low-cost, easy-to-use tools that can accurately predict critical illness 
in children. We have developed a digital triage tool comprised of an application on a mobile device 
and attachable pulse oximeter sensors that predicts a critically ill state, or level of risk in a child 
presenting at the hospital. The risk prediction is based on clinical signs and symptoms including 
vital sign measurements. This digital tool is to be used by frontline health workers to identify 
critically ill children (including those with sepsis) and trigger timely treatment administration.  
 
What is the purpose of this study?  
We would like to evaluate the digital triage tool for ease of interface navigation, functionality, and 
basic workflow. The objective of the training is to ensure health workers understand how to 
correctly collect and interpret patient information and obtain feedback on the digitization of the 
tool. We will recruit 15 health workers for this study.  
 
 
 
 
 
 
 

                                                          
 
Version 3 April 2020 
 
Page 88 of 113 
 
What does the study involve?  
 
You will be asked to perform a simulated clinical scenario to interact with the digital triage tool 
to examine its usability. You will be given a list of tasks to complete. You will be given 
instruction on how to “think aloud” (we will audio record your speech). When the test period is 
completed, you will be asked to fill out a short questionnaire, for your feedback and comments 
on the interface.  The test will be completed in less than one hour and will be audio and video 
recorded.  
 
What are the possible harms and discomforts? 
There are no foreseeable risks in participating in this research study. 
 
What are the potential benefits of participating?  
There is no direct benefit to you for participating in this study. The results of this study will 
determine the usability of the digital triage tool, including possible areas for improvement. This 
will allow us to optimize and update the tool to meet hospital specific needs.   
 
What happens if you decide to withdraw consent to participate?  
Your participation in this research is entirely voluntary.  You may withdraw from this study at any 
time without providing any reasons.   If you decide to enter in the study and withdraw at any time 
in the future, there will be no penalty or loss of benefits to which you are otherwise entitled. 
 
Will my taking part in this study be kept confidential?  
Your confidentiality will be respected. However, research records and health or other source 
records identifying you may be inspected in the presence of the Investigator or her/his designate 
by representative, and the University of British Columbia Research Ethics Board for the purpose 
of monitoring the research. No information or records that disclose your identity will be published 
without your consent, nor will any information or records that disclose your identity be removed 
or released without your consent unless required by law.  
 
You will be assigned a unique study number as a subject in this study. Only this number will be 
used on any research-related information collected about you during the course of this study, so 
that your identity (i.e. your name or any other information that could identify you) as a subject in 
this study will be kept confidential. Information that contains your identity will remain only with 
the Principal Investigator and/or designate. The list that matches your name to the unique study 
number that is used on your research-related information will not be removed or released without 
your consent unless required by law. 
 
Your rights to privacy are legally protected by federal and provincial laws that require safeguards 
to insure that your privacy is respected and also give you the right of access to the information 
about you that has been provided to the sponsor and, if need be, an opportunity to correct any 
errors in this information. Further details about these laws are available on request. 
 

                                                          
 
Version 3 April 2020 
 
Page 89 of 113 
 
What will the study cost?  
There will be no cost to you for your participation in the study. You will not receive any payment 
for participation. 
 
 
 
Who has approved this research? 
All research at MUSPH must be approved before it begins by several national and international 
committees who look carefully at planned work. They must agree that the research is important, 
relevant to Uganda and follows nationally and internationally agreed research guidelines. This 
includes ensuring that all participants’ safety and rights are respected.  
 
Who do I contact if I have questions about the study during my participation?  
You are free to ask questions of any staff at any time. You can also contact the research team using 
these contacts:  
 
Dr. Nathan Kenya-Mugisha 
Walimu Office 
Unit 4, Plot 5, Coral Crescent, Kololo, Kampala 
Tel: 0772-731-751 
Email: kenya@walimu.org 
 
Dr. John Ssempebwa 
Acting Chairperson  
HD Research and Ethics Committee  
Tel: +256-772-963-074 
 
 
Who do I contact if I have any questions or concerns about my rights as a subject? 
If you have any concerns or complaints about your rights as a research subject and/or your 
experiences while participating in this study, contact the Research Subject Information Line in the 
University of British Columbia Office of Research Services by e-mail at  RSIL@ors.ubc.ca or by 
phone at 604-822-8598 (Toll Free: 1-877-822-8598). 
 
 
 
 
 
 
 
 
 
 

                                                          
 
Version 3 April 2020 
 
Page 90 of 113 
 
 
 
 
 
 
 
 
 
 
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
 
 
 
I, ________________________________ (print name), have had the research explained to me. I 
have understood all that has been read/explained and had my questions answered satisfactorily. 
And I consent to participate in this study.  
 
I understand that I can change my mind at any stage, and it will in any way affect the quality of 
care that I receive. 
 
Participant’s signature: ____________________________    Date ___________ 
 
Participant’s name:  _______________________________     Time ___________ 
                                                   (Please print name) 
--------------------------------------------------------------------------------------------------------------------- 
 
I have followed the study SOP to obtain consent from the participant. S/he apparently understood 
the nature and the purpose of the study and consents to the participation in the study. S/he has been 
given opportunity to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _____________________________Time ____________ 
  
 
 
 
 
 (Please print name) 
 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY 
TO KEEP

 
 
    
 
 
Version 3 April 2020 
 
Page 91 of 113
 
KEMRI Wellcome Trust Research Programme: Patient Information and Consent Form  
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric Rapid Sepsis 
Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing sick children]. Usability 
Testing.  
 
Institution
Investigators
Kenya Medical Research Institute  
Samuel Akech 
Mike English  
Grace Irimu 
Ambrose Agweyu 
Morris Ogero 
Cynthia Khazenzi 
Jalemba Aluvaala 
 
Mbagathi Hospital
David Kimutai
Jinja Regional Hospital 
Abner Tagoola
The University of British Columbia/BC Children’s Hospital 
Research Institute  
Mark J. Ansermino 
Niranjan Kissoon 
Matthew Wiens  
Guy Dumont  
Alishah Mawji  
 
Invitation:  
You are invited to participate in this research study because you are a nurse or student nurse at Mbagathi District 
Hospital.  
 
Your participation is voluntary:  
Your participation is voluntary. You have the right to refuse to participate in this study. If you decide to participate, you 
may still choose to withdraw from the study at any time without any negative consequences to the medical care, 
education, or other services to which you are entitled or are presently receiving. Before you decide, it is important for 
you to understand what the research involves. This consent form will tell you about the study, why the research is being 
done, what will happen to you during the study and the possible benefits, risks and discomforts.  
 
If you wish to participate in this study, you will be asked to sign this form. Please take time to read this information and 
ask any questions that may help you understand the study before you decide whether to participate. 
 
Who is carrying out this study?  
This study is being carried out by the Kenya Medical Research Institute (in Nairobi), and the University of British Columbia 
(in Canada). These organizations conduct medical research to find better ways of preventing and treating illness in the 

 
 
    
 
 
Version 3 April 2020 
 
Page 92 of 113
future. This study is being funded by Wellcome Trust, which is a charity based in the United Kingdom but funds health 
research worldwide to improve lives. 
 
Background 
There is an urgent need for low-cost, easy-to-use tools that can accurately predict critical illness in children. We have 
developed a digital triage tool comprised of an application on a mobile device and attachable pulse oximeter sensors 
that predicts a critically ill state, or level of risk in a child presenting at the hospital. The risk prediction is based on clinical 
signs and symptoms including vital sign measurements. This digital tool is to be used by frontline health workers to 
identify critically ill children (including those with sepsis) and trigger timely treatment administration.  
 
What is the purpose of this study?  
We would like to evaluate the digital triage tool for ease of interface navigation, functionality, and basic workflow. The 
objective of the training is to ensure health workers understand how to correctly collect and interpret patient 
information and obtain feedback on the digitization of the tool. We will recruit 15 health workers for this study.  
 
What does the study involve?  
 
 
You will be asked to perform a simulated clinical scenario to interact with the digital triage tool to examine its 
usability. You will be given a list of tasks to complete. You will be given instruction on how to “think aloud” (we will 
audio record your speech). When the test period is completed, you will be asked to fill out a short questionnaire, for 
your feedback and comments on the interface.  The test will be completed in less than one hour and will be audio and 
video recorded. 
 
 
What are the possible harms and discomforts? 
There are no foreseeable risks in participating in this research study. 
 
What are the potential benefits of participating?  
There is no direct benefit to you for participating in this study. The results of this study will determine the usability of 
the digital triage tool, including possible areas for improvement. This will allow us to optimize and update the tool to 
meet hospital specific needs.   
 
What happens if you decide to withdraw consent to participate?  
Your participation in this research is entirely voluntary.  You may withdraw from this study at any time without providing 
any reasons.   If you decide to enter in the study and withdraw at any time in the future, there will be no penalty or loss 
of benefits to which you are otherwise entitled. 
 
Will my taking part in this study be kept confidential?  
Your confidentiality will be respected. However, research records and health or other source records identifying you 
may be inspected in the presence of the Investigator or her/his designate by representative, and the University of British 
Columbia Research Ethics Board for the purpose of monitoring the research. No information or records that disclose 
your identity will be published without your consent, nor will any information or records that disclose your identity be 
removed or released without your consent unless required by law.  
 

 
 
    
 
 
Version 3 April 2020 
 
Page 93 of 113
You will be assigned a unique study number as a subject in this study. Only this number will be used on any research-
related information collected about you during the course of this study, so that your identity (i.e. your name or any 
other information that could identify you) as a subject in this study will be kept confidential. Information that contains 
your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the 
unique study number that is used on your research-related information will not be removed or released without your 
consent unless required by law. 
 
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to insure that your 
privacy is respected and also give you the right of access to the information about you that has been provided to the 
sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are 
available on request. 
 
What will the study cost?  
There will be no cost to you for your participation in the study. You will not receive any payment for participation. 
 
Who has approved this research? 
All research at KEMRI has to be approved before it begins by several national and international committees who look 
carefully at planned work. They must agree that the research is important, relevant to Kenya and follows nationally and 
internationally agreed research guidelines. This includes ensuring that all participants’ safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team using these contacts:  
 
Dr. Samuel Akech, KEMRI Wellcome Trust Research Programme, P.O, Box 43640-00100 Nairobi, Kenya. Telephone: 
+254 721490166 or +254 20 270163 
 
If you want to ask someone independent about this research please contact: 
Community Liaison Manager, KEMRI Wellcome Trust Research Programme, P.O. Box 230, Kilifi.  Telephone: 041 7522 
063, Mobile 0723 342 780 or 0705 154 386 
And 
The Head, KEMRI Scientific and Ethics Review Unit, P. O. Box 54840-00200, Nairobi; Telephone numbers: 0717 719477; 
0776 399979 Email address: seru@kemri.org 
 
Who do I contact if I have any questions or concerns about my rights as a subject? 
If you have any concerns or complaints about your rights as a research subject and/or your experiences while 
participating in this study, contact the Research Subject Information Line in the University of British Columbia Office of 
Research Services by e-mail at  RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll Free: 1-877-822-8598). 
 

 
 
 
Version 3 April 2020 
 
Page 94 of 113
KEMRI Wellcome Trust Research Programme consent form for Saving young lives: Triage and management of sepsis 
in children using the point-of care Paediatric Rapid Sepsis Trigger (PRST) tool [Lay Title: Development and testing of 
a digital tool for recognizing sick children]. Usability Testing.  
 
 
I, ________________________________ (print name),] have had the research explained to me. I have understood all 
that has been read/explained and had my questions answered satisfactorily. And I consent to participate in this study. 
 
I understand that I can change my mind at any stage, and it will in any way affect the quality of care that I receive. 
 
Participant’s signature: ____________________________Date ___________ 
 
Participant’s name:  _____________________________ Time ____________ 
                                                       (Please print name) 
------------------------------------------------------------------------------------------------------------------------------------------ 
 
 
I have followed the study SOP to obtain consent from the participant. S/he apparently understood the nature and the 
purpose of the study and consents to the participation in the study. S/he has been given opportunity to ask questions 
which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _____________________________Time ____________ 
                                                                        (Please print name) 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Version 3 April 2020 
 
Page 95 of 113
 
Appendix J 
 
Makerere University School of Public Health (MUSPH) Higher Degrees, Research and Ethics 
Committee  
 
Informed Consent Form  
(Triage Tool Training Questionnaire)  
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric 
Rapid Sepsis Trigger (PRST) tool 
 
Principle Investigators  
Dr. Mark Ansermino 
Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia 
     Dr. Abner Tagoola 
Senior Consultant at Jinja Regional Referral Hospital, Jinja, Uganda 
Co-Investigators 
Samuel Akech  
Kenya Medical Research Institute/Wellcome 
Trust Research Programme
Alishah Mawji  
Department of Anesthesiology, Pharmacology 
& Therapeutics, University of British Columbia
 
Matthew O. Wiens 
Center for International Child Health, BC 
Children’s Hospital Research Institute 
Niranjan Kissoon 
Department of Pediatrics, University of British 
Columbia
Edmond Li 
School of Population and Public Health, 
University of British Columbia
Nathan Kenya Mugisha 
Walimu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Version 3 April 2020 
 
Page 96 of 113
What you should know about this questionnaire:  
 You are being invited to complete a questionnaire. 
 This consent form explains the nature of the questionnaire and your role when answering the questions. 
 Please read it carefully and take as much time as you need.  
 You are a volunteer. You can choose not to take part and if you join, you may quit at any time. There 
will be no penalty if you decide to quit the study.  
 
What is this questionnaire about?  
We would like to invite you to complete a questionnaire that aims to learn from healthcare workers who have 
finished training on the PRST tool to help us evaluate the acceptability, usability and feasibility of the tool prior 
to implementation.   
 
Who is carrying out this study?  
This study is being carried out by the Makerere University School of Public Health (in Jinja), and the University 
of British Columbia (in Canada). These organizations conduct medical research to find better ways of 
preventing and treating illness in the future for everybody’s benefit. This study is being funded by the Wellcome 
Trust Innovator Award.  
 
What is the purpose of this questionnaire?   
We will use this information gathered from the questionnaire to (1) ensure healthcare workers understand how 
to correctly collect and interpret patient information, and (2) ensure that healthcare workers are receiving the 
right kind of support from the training of the PRST tool.  
 
Why are you being asked to participate?  
You are being asked to partake in this questionnaire because you are currently a healthcare worker who has 
participated in a training session of the digital PRST tool. It is important that the staff who have received 
training in using the tool are consulted in order to properly evaluate the efficacy of the training for using the 
tool, and the tool itself.  
 
Procedures:  
If you agree to participate, we will ask you to complete a questionnaire form by paper and pen. The questionnaire 
will take less than half an hour. Your personal information will not be collected, so you feedback will not be 
linked back to you as an individual.  
 
You may at any point during the questionnaire decide to withdraw. Feedback is welcome. If you consent to 
participate, and decide to withdraw at a later stage, an opt-out option will be provided.  
 
Risks/Discomforts:  
There are no potential risks associated with completing this questionnaire.  
 
Benefits:  
There are no direct benefits from completing this questionnaire.  
 
Incentives/rewards for participating:  
You will not be paid for completing this questionnaire.  
 

 
 
 
Version 3 April 2020 
 
Page 97 of 113
Protecting data confidentiality:  
The paper copies of the questionnaires will be kept in locked filing cabinets at the research office in the hospital. 
The electronic data obtained from these questionnaires will be stored on secure servers at BC Children’s 
Hospital in Canada for analysis by the Kenyan, Ugandan and Canadian researchers.  
 
Protecting subject privacy during data collection:  
This questionnaire will be held in private. Your information will be kept completely confidential. No 
information that can identify you will be collected. Data that may be reported in scientific journals will not 
include any information that identifies you as a participant in this program. This evaluation is being done by 
researchers from Kenya, Uganda and Canada.  
 
What happens if you refuse to participate? 
All participation in research is voluntary. It is up to you to decide whether or not you are to take part in the 
questionnaire.  If you agree to participate, you will be asked to sign this form.  If you do agree you can change 
your mind at any time and withdraw from the research. If you decide to complete this questionnaire, you are 
still free to withdraw at any time without giving any reasons for your decision.  
 
What happens if you leave the study?  
If you choose not to participate or to withdraw your consent, there will be no penalty or loss of benefits.  
 
Who has approved this research? 
All research at MUSPH has to be approved before it begins by several national [and international] committees 
who look carefully at planned work. They must agree that the research is important, relevant to Uganda and 
follows nationally and internationally agreed research guidelines. This includes ensuring that all participants’ 
safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team using these 
contacts:  
 
Dr. Nathan Kenya-Mugisha 
            Walimu Office 
            Unit 4, Plot 5, Coral Crescent, Kololo, Kampala 
            Tel: 0772-731-751 
Email: kenya@walimu.org 
 
Dr. John Ssempebwa 
Acting Chairperson  
HD Research and Ethics Committee  
            Tel: +256-772-963-074 
 
If you have any concerns or complaints about your rights as a research participant and/or your 
experiences while participating in this study, contact the University of British Columbia Research 
Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 

 
 
 
Version 3 April 2020 
 
Page 98 of 113
What does your signature on this consent form mean? 
 Your signature on this form means:  
 You have been informed about the purpose, procedures, possible benefits and risks of this 
questionnaire.  
 You have been given the chance to ask questions before you sign.  
 You have voluntarily agreed to complete this survey. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Version 3 April 2020 
 
Page 99 of 113
 
 
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric 
Rapid Sepsis Trigger (PRST) tool 
 
 
 
I, ________________________________ (name of participant), have had the research explained to me. I have 
understood all that has been read/explained and had my questions answered satisfactorily. And I agree to take 
part in this questionnaire.   
 
I understand that I can change my mind at any stage, without penalty or loss of benefits.  
 
Participant’s signature: ____________________________Date ___________ 
 
Participant’s name:  ______________________________ Time ____________ 
                                                                       (Please print name) 
------------------------------------------------------------------------------------------------------------------------------------
------ 
 
I have followed the study SOP to obtain consent from the participant. S/he apparently understood the nature 
and the purpose of this questionnaire and consents to participation in the study. S/he has been given opportunity 
to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _______________________________Time ____________ 
                                                                        (Please print name) 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Version 3 April 2020 
 
Page 100 of 113
 
 
 
KEMRI Wellcome Trust Research Programme: Informed Consent Form (Triage Tool Training Questionnaire)  
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric Rapid Sepsis 
Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing sick children].  
 
Institution
Investigators
Kenya Medical Research Institute  
Samuel Akech 
Mike English  
Grace Irimu 
Ambrose Agweyu 
Morris Ogero 
Cynthia Khazenzi 
Jalemba Aluvaala 
 
Mbagathi Hospital
David Kimutai
Jinja Regional Hospital 
Abner Tagoola
The University of British Columbia/BC Children’s Hospital 
Research Institute  
Mark J. Ansermino 
Niranjan Kissoon 
Matthew Wiens  
Guy Dumont  
Alishah Mawji  
 
Introduction: 
 
What you should know about this questionnaire:  
 
You are being invited to complete a questionnaire. 
 
This consent form explains the nature of the questionnaire and your role when answering the questions. 
 
Please read it carefully and take as much time as you need.  
 
You are a volunteer. You can choose not to take part and if you join, you may quit at any time. There will be no 
penalty if you decide to quit the study.  
 
What is this questionnaire about?  
We would like to invite you to complete a questionnaire that aims to learn from healthcare workers who have finished 
training on the PRST tool to help us evaluate the acceptability, usability and feasibility of the tool prior to 
implementation.   
 
Who is carrying out this study?  
This study is being carried out by the Kenya Medical Research Institute (in Nairobi), the Centre for International Child 
Health at the British Columbia Children’s Hospital (in Canada), and the University of British Columbia (in Canada). These 

 
 
 
Version 3 April 2020 
 
Page 101 of 113
organizations conduct medical research to find better ways of preventing and treating illness in the future for 
everybody’s benefit. This study is being funded by the Wellcome Trust Innovator Award.  
 
What is the purpose of this questionnaire?   
We will use this information gathered from the questionnaire to (1) ensure healthcare workers understand how to 
correctly collect and interpret patient information, and (2) ensure that healthcare workers are receiving the right kind 
of support from the training of the PRST tool.  
 
Why are you being asked to participate?  
You are being asked to partake in this questionnaire because you are currently a healthcare worker employed at 
Mbagathi Hospital who has participated in a training session of the digital PRST tool. It is important that the staff who 
have received training in using the tool are consulted in order to properly evaluate the efficacy of the training for using 
the tool, and the tool itself.  
 
Procedures:  
If you agree to participate, we will ask you to complete a questionnaire form by paper and pen. The questionnaire will 
take less than half an hour. Your personal information will not be collected, so you feedback will not be linked back to 
you as an individual.  
 
You may at any point during the questionnaire decide to withdraw. Feedback is welcome. If you consent to participate, 
and decide to withdraw at a later stage, an opt-out option will be provided.  
 
Risks/Discomforts:  
There are no potential risks associated with completing this questionnaire.  
 
Benefits:  
There are no direct benefits from completing this questionnaire.  
 
Incentives/rewards for participating:  
You will not be paid for completing this questionnaire.  
 
Protecting data confidentiality:  
The paper copies of the questionnaires will be kept in locked filing cabinets at the research office in the hospital. The 
electronic data obtained from these questionnaires will be stored on secure servers at BC Children’s Hospital in Canada 
for analysis by the Kenyan, Ugandan and Canadian researchers.  
 
Protecting subject privacy during data collection:  
This questionnaire will be held in private. Your information will be kept completely confidential. No information that 
can identify you will be collected. Data that may be reported in scientific journals will not include any information that 
identifies you as a participant in this program. This evaluation is being done by researchers from Kenya, Uganda and 
Canada.  
 

 
 
 
Version 3 April 2020 
 
Page 102 of 113
What happens if you refuse to participate? 
All participation in research is voluntary. It is up to you to decide whether or not you are to take part in the questionnaire.  
If you agree to participate, you will be asked to sign this form.  If you do agree you can change your mind at any time 
and withdraw from the research. If you decide to complete this questionnaire, you are still free to withdraw at any time 
without giving any reasons for your decision.  
 
What happens if you leave the study?  
If you choose not to participate or to withdraw your consent, there will be no penalty or loss of benefits.  
 
Who has approved this research? 
All research at KEMRI has to be approved before it begins by several national [and international] committees who look 
carefully at planned work. They must agree that the research is important, relevant to Kenya and follows nationally and 
internationally agreed research guidelines. This includes ensuring that all participants’ safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team using these contacts:  
Dr. Samuel Akech, KEMRI Wellcome Trust Research Programme, P.O, Box 43640-00100 Nairobi, Kenya. Telephone: 
+254 721490166 or +254 20 270163 
 
 
If you want to ask someone independent about this research please contact: 
Community Liaison Manager, KEMRI Wellcome Trust Research Programme, P.O. Box 230, Kilifi.  Telephone: 041 7522 
063, Mobile 0723 342 780 or 0705 154 386 
And 
The Head, KEMRI Scientific and Ethics Review Unit, P. O. Box 54840-00200, Nairobi; Telephone numbers: 0717 719477; 
0776 399979 Email address: seru@kemri.org 
 
If you have any concerns or complaints about your rights as a research participant and/or your experiences 
while participating in this study, contact the University of British Columbia Research Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 
 
What does your signature on this consent form mean? 
 Your signature on this form means:  
 
You have been informed about the purpose, procedures, possible benefits and risks of this questionnaire.  
 
You have been given the chance to ask questions before you sign.  
 
You have voluntarily agreed to complete this survey. 

                                                          
 
 
Page 103 of 113 
Version 2 February 2020 
 
 
KEMRI Wellcome Trust Research Programme consent form for Saving young lives: Triage and 
management of sepsis in children using the point-of care Paediatric Rapid Sepsis Trigger (PRST) tool 
[Lay Title: Development and testing of a digital tool for recognizing sick children].  
 
 
I, ________________________________ (name of participant), have had the research explained to me. I 
have understood all that has been read/explained and had my questions answered satisfactorily. And I 
agree to take part in this questionnaire.   
 
I understand that I can change my mind at any stage, without penalty or loss of benefits.  
 
Participant’s signature: ____________________________Date ___________ 
 
Participant’s name:  ______________________________ Time ____________ 
                                                                       (Please print name) 
------------------------------------------------------------------------------------------------------------------------------------------ 
 
I have followed the study SOP to obtain consent from the participant. S/he apparently understood the 
nature and the purpose of this questionnaire and consents to participation in the study. S/he has been 
given opportunity to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _______________________________Time ____________ 
                                                                        (Please print name) 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                                          
 
 
Page 104 of 113 
Version 2 February 2020 
 
 
Appendix K 
 
Makerere University School of Public Health (MUSPH) Higher Degrees, Research and 
Ethics Committee  
 
Informed Consent Form  
(Interviews)  
 Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
Principal Investigators  
Dr. Mark Ansermino 
Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia 
     Dr. Abner Tagoola 
Senior Consultant at Jinja Regional Referral Hospital, Jinja, Uganda 
Co-Investigators 
Samuel Akech  
Kenya Medical Research Institute/Wellcome 
Trust Research Programme
Alishah Mawji  
Department of Anesthesiology, Pharmacology 
& Therapeutics, University of British 
Columbia
 
Matthew O. Wiens 
Center for International Child Health, BC 
Children’s Hospital Research Institute 
Niranjan Kissoon 
Department of Pediatrics, University of British 
Columbia
Edmond Li 
School of Population and Public Health, 
University of British Columbia
Nathan Kenya Mugisha 
Walimu 
 
 
 
 
 
 
 
 
 
 
 

                                                          
 
 
Page 105 of 113 
Version 2 February 2020 
 
 
 
 
Invitation: 
You are being invited to take part in a research study that uses interviews to understand more about 
the PRST Digital Triage Tool. We are interested in your experience with the PRST Digital Triage 
Tool.  We would still like to hear from you even if you don’t feel you have the necessary exposure 
or are not comfortable with using the tool.  
 
Your participation is voluntary: 
The following pages explain the study so that you can decide if you want to take part. It is up to 
you whether you would like to participate in an interview, so feel free to ask us any questions. If 
you want to take part you will be asked to sign this form. If you later change your mind you can 
quit at any time without giving a reason.  
 
Who is carrying out this study? 
This study is being done by Makerere University School of Public Health (in Jinja), and the 
University of British Columbia (in Canada). These organizations do medical research to find 
better ways of preventing and treating illness. This study is being funded by Wellcome Trust, 
which is a charity based in the United Kingdom but funds health research worldwide to improve 
lives. 
 
You can take part in this study if you are: 
 A hospital staff, including, doctors, clinicians, nurses, and administrators who have used 
or are familiar with the PRST Digital Triage Tool. 
 Able to spend 60 minutes for an in-person interview on a pre-arranged date. 
 Able to speak, read, and understand English. 
 
We expect that about 30 hospital staff will be interviewed for this study. 
 
What is the purpose of this study? 
This study is part of the ‘Saving young lives: Triage and management of sepsis in children using 
the point-of care Paediatric Rapid Sepsis Trigger (PRST) tool’ project. We would like to conduct 
an interview with you to hear your feedback and experiences with the PRST digital triage tool 
platform so that we can identify areas needing improvement and additional supports that may be 
required.  
 
What happens if I decide to participate? 
 
 You will be interviewed by the research team member at a private office here at the hospital 
facility either by yourself or in a small group. The total time this will take is approximately 
60 minutes (approximately 45-minute interview, plus paperwork).  
 This interview itself will take about 1 hour and will be audio recorded.  

                                                          
 
 
Page 106 of 113 
Version 2 February 2020 
 
 
 We will type up the words from the audio recording and keep that version, called a 
transcript, for use in the study. You will have a chance to check this transcript to make sure 
it is correct and does not contain any information that could identify you. 
 Before you begin the interview, we will ask you to complete a voluntary questionnaire 
about yourself (e.g., age, job position). This will help us understand who is participating in 
this study. 
What are the possible harms and discomforts? 
We do not expect this study to expose you to any risks. You can refuse to answer any question you 
do not wish to answer, and you can stop the interview at any time. You can withdraw from (or 
leave) the study at any time without any negative consequence. Information about you that is 
collected before you quit may still be used in a study report if you withdraw after the report has 
been written.   
 
What are the potential benefits of participating? 
By participating in the study, you will help our team better understand the experiences and feelings 
of hospital staff like yourself about the PRST digital triage tool platform and what additional 
support they may require. 
 
How will you keep my personal information confidential?  
 
 Any information you share with researchers will be kept confidential; all audio files and 
study notes will be kept secure at UBC in Vancouver. No documents or audio files which 
identify you by name or specific personal information will be allowed to leave the study 
team’s offices. 
 Only the UBC and Walimu team will have access to your personal information.  
 You will be assigned a unique study number as a participant in this study. This number 
will not include any personal information that could identify you. Only this number or a 
pseudonym (made up name) will be used on any research related information that goes 
outside the study team. Your real name will not be used in any publications or reports. 
 Your personal information will not be given to anyone outside the research team; however, 
research records identifying you may be inspected in the presence of the Investigator or his 
or her designate by representatives of the UBC Children & Women Research Ethics Board 
and Makerere University School of Public Health (MUSPH) Higher Degrees, Research and 
Ethics Committee  for the purpose of monitoring the research.  
 All original study documents will be kept at UBC or in off-site storage locations in British 
Columbia for 5 years after the study is complete, and then destroyed (documents will be 
shredded, and digital files will be deleted).  
 Transcripts with no names or identifying personal information in them will be kept secure 
at UBC for use in this study and possible future research by members of Mark Ansermino 
and Abner Tagoola’s research team. 
 

                                                          
 
 
Page 107 of 113 
Version 2 February 2020 
 
 
Risks/Discomforts:  
There are no potential risks associated with participating in this interview.   
 
Benefits:  
There are no direct benefits from participating in this interview.   
 
Incentives/rewards for participating:  
You will not be paid for participating in this interview.   
 
Who has approved this research? 
All research at MUSPH must be approved before it begins by several national and international 
committees who look carefully at planned work. They must agree that the research is important, 
relevant to Uganda and follows nationally and internationally agreed research guidelines. This 
includes ensuring that all participants’ safety and rights are respected.  
 
What if I have any questions? 
You are free to ask questions of any staff at any time. You can also contact the research team 
using these contacts:  
 
Dr. Nathan Kenya-Mugisha 
            Walimu Office 
            Unit 4, Plot 5, Coral Crescent, Kololo, Kampala 
            Tel: 0772-731-751 
Email: kenya@walimu.org 
 
Dr. John Ssempebwa 
Acting Chairperson  
HD Research and Ethics Committee  
            Tel: +256-772-963-074 
 
If you have any concerns or complaints about your rights as a research participant and/or 
your experiences while participating in this study, contact the University of British Columbia 
Research Participant Complaint Line:  
e-mail: RSIL@ors.ubc.ca  
Toll Free Tel: 1-877- 822-8598 
 
What does your signature on this consent form mean? 
 Your signature on this form means:  
 You have been informed about the purpose, procedures, possible benefits and risks of this 
questionnaire.  
 You have been given the chance to ask questions before you sign.  
 You have voluntarily agreed to complete this survey.  
 

                                                          
 
 
Page 108 of 113 
Version 2 February 2020 
 
 
 
 
 
 
 
Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool 
 
 
 
I, ________________________________ (name of participant), have had the research explained 
to me. I have understood all that has been read/explained and had my questions answered 
satisfactorily. And I agree to take part in this study.   
 
I understand that I can change my mind at any stage, without penalty or loss of benefits.  
 
Participant’s signature: ____________________________Date ___________ 
 
Participant’s name:  ______________________________ Time ____________ 
                                                                       (Please print name) 
---------------------------------------------------------------------------------------------------------------------
--------------------- 
 
I have followed the study SOP to obtain consent from the participant. S/he apparently understood 
the nature and the purpose of this questionnaire and consents to participation in the study. S/he has 
been given opportunity to ask questions which have been answered satisfactorily. 
 
Designee/investigator’s signature: ____________________________ Date ____________ 
 
Designee/investigator’s name:   _______________________________Time ____________ 
                                                                        (Please print name) 
THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY 
TO KEEP

 
 
 
Version 3 April 2020 
 
Page 109 of 113
 
KEMRI Wellcome Trust Research Programme: Informed Consent Form (Interviews)  
 
Saving young lives: Triage and management of sepsis in children using the point-of care Paediatric Rapid Sepsis 
Trigger (PRST) tool [Lay Title: Development and testing of a digital tool for recognizing sick children].  
 
Institution
Investigators
Kenya Medical Research Institute  
Samuel Akech 
Mike English  
Grace Irimu 
Ambrose Agweyu 
Morris Ogero 
Cynthia Khazenzi 
Jalemba Aluvaala 
 
Mbagathi Hospital
David Kimutai
Jinja Regional Hospital 
Abner Tagoola
The University of British Columbia/BC Children’s Hospital 
Research Institute  
Mark J. Ansermino 
Niranjan Kissoon 
Matthew Wiens  
Guy Dumont  
Alishah Mawji  
 
 
Invitation: 
You are being invited to take part in a research study that uses interviews to understand more about the PRST Digital 
Triage Tool. We are interested in your experience with the PRST Digital Triage Tool.  We would still like to hear from you 
even if you don’t feel you have the necessary exposure or are not comfortable with using the tool.  
 
Your participation is voluntary: 
The following pages explain the study so that you can decide if you want to take part. It is up to you whether you would 
like to participate in an interview, so feel free to ask us any questions. If you want to take part you will be asked to sign 
this form. If you later change your mind you can quit at any time without giving a reason.  
 
Who is carrying out this study? 
This study is being done by the Kenya Medical Research Institute and the University of British Columbia (in Canada). 
These organizations do medical research to find better ways of preventing and treating illness. This study is being funded 
by Wellcome Trust, which is a charity based in the United Kingdom but funds health research worldwide to improve 
lives. 
 
You can take part in this study if you are: 
 A hospital staff, including, doctors, clinicians, nurses, and administrators who have used or are familiar with the 
PRST Digital Triage Tool. 

 
 
 
Version 3 April 2020 
 
Page 110 of 113
 Able to spend 60 minutes for an in-person interview on a pre-arranged date. 
 Able to speak, read, and understand English. 
 
We expect that about 30 hospital staff will be interviewed for this study. 
 
What is the purpose of this study? 
This study is part of the ‘Saving young lives: Triage and management of sepsis in children using the point-of care 
Paediatric Rapid Sepsis Trigger (PRST) tool’ project. We would like to conduct an interview with you to hear your 
feedback and experiences with the PRST digital triage tool platform so that we can identify areas needing improvement 
and additional supports that may be required.  
 
 
What happens if I decide to participate? 
 
 You will be interviewed by the research team member at a private office here at the hospital facility either by 
yourself or in a small group. The total time this will take is approximately 60 minutes (approximately 45 minute 
interview, plus paperwork).  
 This interview itself will take about 1 hour and will be audio recorded.  
 We will type up the words from the audio recording and keep that version, called a transcript, for use in the 
study. You will have a chance to check this transcript to make sure it is correct and does not contain any 
information that could identify you. 
 Before you begin the interview, we will ask you to complete a voluntary questionnaire about yourself (e.g., age, 
job position). This will help us understand who is participating in this study. 
 
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KEMRI Wellcome Trust Research Programme consent form for Saving young lives: Triage and management of 
sepsis in children using the point-of care Paediatric Rapid Sepsis Trigger (PRST) tool [Lay Title: Development 
and testing of a digital tool for recognizing sick children].  
 
 
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THE SUBJECT/PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL
Open Access
Smart triage: triage and management of
sepsis in children using the point-of-care
Pediatric Rapid Sepsis Trigger (PRST) tool
Alishah Mawji1*
, Edmond Li2, Clare Komugisha3, Samuel Akech4, Dustin Dunsmuir5, Matthew O. Wiens6,
Niranjan Kissoon7, Nathan Kenya-Mugisha3, Abner Tagoola8, David Kimutai9, Jeffrey N. Bone10, Guy Dumont11 and
J. Mark Ansermino1
Abstract
Background: Sepsis is the leading cause of death and disability in children. Every hour of delay in treatment is
associated with an escalating risk of morbidity and mortality. The burden of sepsis is greatest in low- and middle-
income countries where timely treatment may not occur due to delays in diagnosis and prioritization of critically ill
children. To circumvent these challenges, we propose the development and clinical evaluation of a digital triage
tool that will identify high risk children and reduce time to treatment. We will also implement and clinically validate
a Radio-Frequency Identification system to automate tracking of patients. The mobile platform (mobile device and
dashboard) and automated patient tracking system will create a low cost, highly scalable solution for critically ill
children, including those with sepsis.
Methods: This is pre-post intervention study consisting of three phases. Phase I will be a baseline period where
data is collected on key predictors and outcomes before implementation of the digital triage tool. In Phase I, there
will be no changes to healthcare delivery processes in place at the study hospitals. Phase II will involve model
derivation, technology development, and usability testing. Phase III will be the intervention period where data is
collected on key predictors and outcomes after implementation of the digital triage tool. The primary outcome,
time to treatment initiation, will be compared to assess effectiveness of the digital health intervention.
Discussion: Smart technology has the potential to overcome the barrier of limited clinical expertise in the identification of
the child at risk. This mobile health platform, with sensors and data-driven applications, will provide real-time individualized
risk prediction to rapidly triage patients and facilitate timely access to life-saving treatments for children in low- and middle-
income countries, where specialists are not regularly available and deaths from sepsis are common.
Trial registration: Clinical Trials.gov Identifier: NCT04304235, Registered 11 March 2020.
Keywords: Sepsis, Triage, Digital triage tool, Resource limited settings
© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give
appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
changes were made. The images or other third party material in this article are included in the article's Creative Commons
licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons
licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain
permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
* Correspondence: alishah.mawji@bcchr.ca
1Department of Anesthesiology, Pharmacology & Therapeutics, University of
British Columbia, 217-2176 Health Sciences Mall, Vancouver, BC V6T 1Z3,
Canada
Full list of author information is available at the end of the article
Mawji et al. BMC Health Services Research          (2020) 20:493 
https://doi.org/10.1186/s12913-020-05344-w

Background
The global burden of pediatric mortality in low- and
middle-income countries (LMICs) remains high, with
4.9 million deaths in children under 5 in 2016 [1]. Most
of these deaths are due to sepsis, which is defined as the
body’s response to an infection (such as pneumonia,
diarrhea, or malaria) leading to organ damage and ultim-
ately morbidity and mortality [2]. Sepsis is common
worldwide, but countries in Africa report substantially
higher case fatality rates (adjusted odds ratios: Africa,
7.89 [95% confidence interval (CI), 6.02–10.32]) as com-
pared to the United States [3]. Recognizing the enormity
of the global burden of sepsis (death, disability, social,
and economic) led to a 2017 World Health Assembly
resolution highlighting the need to prioritize prevention,
recognition, and early treatment of sepsis [4].
Sepsis disproportionately affects socioeconomically dis-
advantaged populations in LMICs. Encouragingly, most
deaths from sepsis are preventable by early detection and
treatment. The majority of deaths occurring in health fa-
cilities happen occur as a result of delayed, inadequate, or
inappropriate treatment. Every hour of delay in therapy is
associated with an escalating risk of morbidity and mortal-
ity [5]. Simple, highly effective interventions to treat sepsis,
including antimicrobials and intravenous (IV) fluids, are
available at care facilities in LMICs. Yet availability and
readiness to provide treatment is not always enough [6]—
timely treatment may not occur because the sickest chil-
dren are not prioritized.
The World Health Organization (WHO) advocates the
use of Emergency Triage Assessment and Treatment
(ETAT) guidelines to triage children in resource limited
settings [7]. Although the ETAT system is widely
adopted in LMICs, successful implementation of the
guidelines into clinical practice is not always the case
[8]. In LMICs, patients are frequently admitted and
treated on a first-come, first-serve basis, leading to de-
layed care for children who are in need of urgent treat-
ment.
These
priority
children
can
receive
faster
treatment if every child is rapidly triaged upon arrival to
identify danger and priority signs of sepsis [9]. However,
sepsis is a syndrome that mimics many conditions and
few health workers can confidently triage and diagnose
sepsis. Evidence-based trigger tools and protocols may
be useful in skilled hands, but require complex decision-
making based on physiological, clinical, social, and la-
boratory parameters.
The purpose of this study is to develop and clinically
evaluate a digital triage tool that can be used rapidly and
reliably, without the need for extensive memorization or
training, by frontline health workers (including nurses
and non-physician clinicians) to identify critically ill chil-
dren (including those with sepsis). The digital platform
consists of a mobile application integrating a pulse
oximetry sensor attached to the device, with embedded
smart algorithms that predict a critically ill state, or level
of risk in a child presenting at the hospital. The platform
also includes an interactive dashboard located in stra-
tegic locations (e.g., laboratory, consultation rooms),
which connects to the mobile application through a se-
cure local network and displays the triage data to pro-
vide
real-time
monitoring
for
the
physicians
who
manage the patients.
Over the past 10 years, we have developed, imple-
mented, and evaluated the core technology of the Digital
Triaging Platform including vital sign measurement de-
vices (PhoneOx [10] and RRate [11]) and the mobile appli-
cation and dashboard [12–14]. We have already identified
candidate predictor variables using a modified Delphi
process [15], and developed a risk prediction model based
on the need for admission using predictors collected in
over 1000 children at a Kenyan hospital [16].
Methods/design
This protocol was developed with adherence to Standard
Protocol Items: Recommendations for Interventional
Trials (SPIRIT) guidelines.
Objectives
Objective 1
To develop and clinically validate a digital triage tool
and dashboard for improving hospital wait times to
treatment administration in critically ill children, includ-
ing those with sepsis.
This will involve:
a.
Collecting a pre-selected list of clinical variables
(Additional file 1) from participants to develop a
prediction model based on the need for hospital
admission.
b. Developing digital triage tool by implementing the
derived prediction model along with ETAT triage
guidelines (currently followed at study hospitals)
into the Digital Triaging Platform.
c.
Evaluating the usability/feasibility of the digital
trigger tool prior to implementation and routine
use at the study hospitals.
d. Determining effectiveness of the triage tool by
comparing hospital wait times to treatment
administration for children before and after
implementation of the digital triage tool.
Objective 2
To validate the use of an automated Radio-Frequency
Identification (RFID) method to track timeliness of in-
terventions (see RFID system section more information).
This will involve:
Mawji et al. BMC Health Services Research          (2020) 20:493 
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a.
Simultaneously having trained Timekeepers track
patient wait times manually, and an RFID system
track patient wait times automatically.
b. Comparing time data obtained from the
Timekeepers with time data obtained from the
RFID system to evaluate accuracy of the RFID
system.
c.
Achieving routine use of a clinically evaluated RFID
system to automate tracking of patient wait times in
the study hospitals.
Trial design
This
is
a
pre-post
intervention
study
concerning
pediatric patients presenting to the study hospitals in
seek of medical care for an acute illness. The study will
take place over a period of 24 months. Participant re-
cruitment will be initiated in April 2020 and continue
for approximately 12 months. Statistical analysis, results
presentation and dissemination will be conducted in the
remaining months.
Study procedures can be divided into three phases: (I)
pre-intervention (baseline), (II) interphase, (III) interven-
tion (Table 1).
Phase I: pre-intervention (baseline)
This will be a period of baseline data collection at Mba-
gathi County Hospital, Jinja Regional Referral Hospital,
and Kiambu County Referral Hospital. There will be no
changes to healthcare delivery procedures in the hospi-
tals. Triage in the pediatric outpatient department will
continue as per usual by hospital nurses using ETAT
guidelines [7]. Research nurses will consent participants
and collect health data (see Additional file 1) in the tri-
age waiting area, where patients are waiting to be seen
by the hospital triage nurses. The control site, Kiambu
County Referral Hospital will participate in Phase I for
an elongated period of time (see Table 1) and will not
participate in Phase II or Phase III.
Phase II: interphase
Model derivation and technology development A risk
prediction model will be derived using the data collected
in Phase I and implemented in a Digital Triaging Plat-
form, along with a digitized version of the ETAT+
guidelines. The Digital Triaging Platform, including vital
sign measurement devices (PhoneOx [10] and RRate
[11]) and the mobile application and clinical dashboard
[12–14] has already been developed and evaluated. Once
the digital triage tool has been developed, it will be eval-
uated in potential users using simulated patient scenar-
ios and a ‘Think Aloud’ method.
Usability testing and training The digital triage tool will
be evaluated for ease of interface navigation, functionality
and basic workflow. A sample of 15 health workers in the
study hospitals to represent the primary user groups will
be selected for participation in the 60-min-long usability
testing initiatives. Participants will be recruited through
word of mouth as there is a very small cadre of potential
participants. The objective of the training is to (1) ensure
healthcare workers understand how to correctly collect
and interpret patient information, and (2) to obtain feed-
back on the digitization of the tool. Training will use a
framework that meets key international norms for testing
digital tools, including, the think-aloud method and a
questionnaire. Each training session will be conducted by
a moderator and observer. During the evaluation, the ob-
server will be seated next to the participant and will rec-
ord user interaction with each interface, comments,
errors, and duration of each task. Participants will be given
3–5 patient scenarios which will list hypothetical informa-
tion to be entered into the app. This information will be
designed to represent routine data collected during triage
examination at the study hospitals. The moderator will
provide the fictional charts to participants and instruct
them throughout the tasks. During the simulated patient
Table 1 Study Schema
Experimental
Sites:
Phase I Baseline (3–5
months)
Phase II Interphase (1–3
months)
Phase III Intervention (5–6 months)
Post-Data
Collection (9–14
months)
1. Mbagathi
County
Hospital,
Nairobi
2. Jinja
Regional
Referral
Hospital, Jinja
Data collection of
predictors and outcomes
by study nurses.
Model derivation,
technology development,
usability testing.
Data collection continues as done in Phase I by
study nurses. Routine use of digital triage tool by
hospital nurses.
Analysis, results
presentation and
dissemination.
Control Site:
Phase I (12 months)
1. Kiambu
County
Hospital,
Nairobi
Ongoing baseline data collection.
Mawji et al. BMC Health Services Research          (2020) 20:493 
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scenarios, participants will be asked to think aloud, in
order to assess their thought process as they used the app.
Participants will be specifically instructed to comment on
the layout of the app screen, the dialogue on each inter-
face, the order of tasks, and any additional observations or
opinions. After learning the basics of the digital platform,
the participants will be read the think aloud instructions
and asked to perform the list of tasks and answer ques-
tions. The observer will complete a checklist to ensure
that all tasks were completed, questions will be asked to
evaluate task comprehension, and notes will be taken
about whether help was needed in completing each task.
At the end of the training session, participants will
complete a triage tool training questionnaire to provide an
understanding of the practical benefits and drawbacks of
incorporating the digital triage tool into a clinical context.
The questionnaire will utilize open ended questions and
comment responses. From this evaluation. Responses
from the survey will be anonymous. The data generated
from the training phase is fictitious and will not be linked
to any individual subject. Transcriptions and Think Aloud
observations will be analyzed using the Framework
Method [17] to assess attitudes of health workers. Re-
sponses will be transcribed and coded using NVivo [18],
for the identification, examination and interpretation of
emerging themes and patterns. Results from the analysis,
feedback from the questionnaires, and comments on the
observer checklists will be used to generate a report with
suggested improvements to be shared with the quality im-
provement implementation team prior to Phase III.
Phase III: intervention
Phase III will be an interventional period involving rou-
tine use of the digital triage tool by the hospital triage
nurses at Mbagathi County Hospital in Nairobi, Kenya,
and Jinja Regional Referral Hospital in Jinja, Uganda.
The digital triage tool will not replace triage policies in
place at the study hospitals, but rather it will strengthen
existing systems by integrating ETAT guidelines and a
data-driven risk prediction model into the application.
As done in Phase I, study nurses will consent partici-
pants and collect health data in the triage waiting area
while patients are waiting to be seen by the hospital tri-
age nurses (who will be using the digital triage tool).
Continued collection of predictor variables will allow
comparison of participant characteristics in the pre-
intervention cohort and the post-intervention cohort.
Methods: participants, interventions, and
outcomes
Study setting
This multi-site study will take place at one hospital in
Uganda, and two hospitals in Kenya. In Uganda, the
study will be conducted at Jinja Regional Referral
Hospital in Jinja. Jinja, a city of approximately 90,000
people, is located in the Eastern region of Uganda. The
Jinja Regional Referral Hospital pediatric ward admits
approximately 5000 patients per year and the outpatient
department sees approximately 100 patients per day. In
Kenya, the study will be conducted at Mbagathi County
Hospital and Kiambu County Referral Hospital, both lo-
cated in Nairobi. A typical outpatient department (OPD)
in the Kenyan study hospitals serves approximately 20,
000 children per year and is staffed by one or two nurses
who conduct triage and administer treatment, two or
three clinicians who review patients and issue prescrip-
tions, and one additional nurse who administers treat-
ment and provides counselling to caregivers of children.
The
Kenyan
hospitals
admit
approximately
2000
pediatric patients per year.
Study sites
1. Jinja Regional Referral Hospital, Jinja, Uganda
(experimental site)
2. Mbagathi County Hospital, Nairobi, Kenya
(experimental site)
3. Kiambu County Referral Hospital, Nairobi, Kenya
(control site)
Eligibility criteria
Inclusion Criteria:
1. All pediatric outpatients seeking medical treatment
of an acute illness. The lower age limit will include
children aged from 0 days, and the upper age limit
will be in accordance to respective hospitals’
practice for pediatric admissions (this may be 12, 15
or 19 years).
2. Informed parental/guardian consent provided.
3. Assent from children older than 8 years (Uganda
site) or 13 years (Kenya sites) in addition to
parental/guardian consent provided.
Exclusion Criteria:
1. Patients presenting to the outpatient department
for elective cases (e.g. elective surgery or change of
dressing) or for clinical review appointment.
2. Informed consent or assent (when applicable) not
provided.
Interventions
PRST (digital triage tool)
The PRST is a triage tool hosted on a digital platform
that will enable frontline health workers in LMICs to
identify critically ill children (i.e. severe infections,
sepsis)
early,
so
that
life-saving
treatment
can
be
Mawji et al. BMC Health Services Research          (2020) 20:493 
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administered in a timely manner. The digital platform
will consist of a mobile application hosted on an An-
droid tablet integrating a pulse oximetry sensor attached
to the tablet, with embedded smart algorithms that pre-
dict a critically ill state, or level of risk in a child present-
ing to the hospital. The platform will also include an
interactive dashboard which will display the triage data
to provide real-time monitoring for the clinicians who
manage the patients. The dashboard will be imple-
mented as a password protected website accessible by
registered medical staff on any computer or tablet on
the local network, allowing for easy and non-disruptive
integration into health systems with existing electronic
health records. ETAT+ criteria for triage will be incor-
porated as part of the digital platform (in addition to
model identified from data obtained in Phase I).
RFID system
Timing tracking will be automated using customised
RFID. RFID uses radio-frequency electromagnetic fields
to identify the location of patients carrying special tags,
with the help of readers located in key locations around
the hospital, including the registration area, triage exam-
ination rooms, and treatment rooms. We intend to use
Low Energy Bluetooth (BLE) tags that have a diameter
of approximately 3 cm and weigh < 20 g. These tags will
be inserted into a custom, washable arm, wrist or leg
band. The tag could also be retained by the caregiver if
the child was not willing to have the tag attached to
them. When in close vicinity to a reader (for example, in
the same room), the tag (location beacon) sends a mes-
sage to a strategically located receiver to track the time
at which the patient was in that precise location. The
Bluetooth frequency is no different to that used by mo-
bile phones and is not expected to interfere with other
processes in the hospital. The RFID system will allow
health workers to keep track of patients with ease and
has the potential to increase organization in fast-paced,
overburdened healthcare facilities.
Outcomes
Primary outcomes
For model development Hospital admission (within 5
days of assessment) status determined from hospital re-
cords, and a follow up call 7 days post discharge. This
will inform development of a clinical prediction model
based on need for hospital admission.
For effectiveness evaluation of digital triage tool An
increase of at least 20% in the proportion of critically ill
children (emergency and priority cases) receiving an ap-
propriate bundle of care within 60 min of arrival at the
hospital. An appropriate bundle of care is defined as at
least one of antibiotics, intravenous fluids, or oxygen as
appropriate for age and clinical syndrome as determined
and administered by hospital staff.
Secondary outcomes
1. Length of hospitalization determined from hospital
records, and a follow up call 7 days post-discharge.
2. Final diagnosis determined from hospital records.
3. 7-day post-discharge mortality status determined
from a follow up call 7 days post-discharge.
4. 7-day readmission status determined from a follow
up call 7 days post-discharge.
a.
Facility of readmission.
b. Treatment received during readmission.
Participant involvement
Total study participation time is estimated to be a max-
imum of 60 min per participant in both the baseline
(phase I) and intervention (phase III) periods.
Participant involvement in phase I and phase III
Potential participants will be recruited by study nurses
while they are waiting in line to be seen by the hospital
triage nurses. Participants can anticipate study proce-
dures (including consent, clinical examination, and inter-
view) to take between 35 to 50 min. The study nurses
will conduct study procedures in the triage waiting area,
while the participant is waiting in line to be seen by the
hospital triage nurses. If it is the participant’s turn to be
seen by the hospital triage nurses, study procedures will
stop and there will be no interference or delays in acces-
sing standard care. Participants will also engage in a
short (10 min) follow up call 7-days post-discharge.
Additional procedures in phase III
In the intervention period, the hospital triage nurses will
be conducting triage using the digital triage tool (which
will include a digitized version of the triage guidelines in
already place at the study hospitals). It is important to
understand that the digital triage tool will NOT be re-
placing standard care, but rather it will be integrated
into standard care to supplement and strengthen exist-
ing triage systems.
To reiterate, the study nurses will conduct the same
study procedures (consent, clinical examination, and
interview) in both the baseline (Phase I) and intervention
(Phase III) periods. These procedures are conducted
while the participants are waiting in line to be seen by
the hospital triage nurses. The difference in Phase III is
that the hospital triage nurses (that the participants are
waiting in line to see) will be using the digital triage tool
to triage participants.
Mawji et al. BMC Health Services Research          (2020) 20:493 
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Sampling and recruitment
Sample size
Model development considerations The sample size
for model development is based on two components: the
number of predictors expected in the final model (effect-
ive variables), n, and the outcome event rate, I. We em-
ploy the typical minimum standard of 10 events per
effective variable and calculate the sample size as
N = (n x 10)/I. Based on our previous study at a Kenyan
hospital [16], we estimate the admission rate as I = 12%,
and thus, to allow for a model with 10 predictors we re-
quire a minimum sample of 833 children.
Power to detect difference considerations Based on
an assumed pre-intervention rate of 27% of children
who receive a bundle of care within 1 h, an assumed
20% relative increase due to the intervention, and an
alpha of 0.05, an estimate of 750 children per group is
needed for 80% power. The assumed pre-intervention
rate is consistent with previous studies [19] and con-
firmed in our feasibility trial of the application and dash-
board in Uganda.
Selected sample size Based on the uncertainty com-
monly present in these smaller sample sizes [20], the de-
sire to include the possibly of modelling non-linearities
in our models (using machine learning methods) and
the clinical feasibility (large case load) we plan to target
a larger sample of 4000 at each site, with a minimum
sample size of 1000 participants enrolled in Phase I.
Based on the activity at our selected sites this would re-
quire no more than a 60% recruitment rate during a six-
month period.
Sampling strategy
A systematic method for participant selection based on
time cut-offs will be adopted to minimize sampling bias.
The study nurses will be instructed to screen the first
patient arriving after each time cut-off (i.e. first patient
to arrive after every 30-min cut-off). If the patient is not
eligible, the next patient arriving after the time cut-off
will be selected, and so on. The interval between time
cut-offs will reflect the time a study nurse spends with
each participant (35–50 min) to maximize efficiency.
When there is more than one study nurse on a given
shift, the time intervals will be staggered.
Methods: data collection, management, and
analysis
Data collection
Predictors, hospital outcomes, 7-day follow-up calls
All study nurses will be trained and well versed on the
standard operating procedures to facilitate standardization
of all measurements. Study nurses will collect data using a
custom-built Android application on a Samsung Galaxy
Tablet A8. The list of predictors to be collected include
clinical signs and symptoms, demographic/sociodemo-
graphic data, and pregnancy/birth information (see Add-
itional file 1). Similarly, designated study nurses will
obtain hospital outcomes (see Additional file 1) from
patient records and enter them into the application on the
Samsung Galaxy Tablet. Study nurses will conduct 7-day
follow up calls in accordance with the standard operating
procedures and enter the data into the application on the
Samsung Galaxy Tablet.
Time outcomes
Timing tracking will be automated using customised
RFID (see RFID system section for details).
Usability testing data
Think Aloud transcriptions and observer checklists will be
entered into a computer and uploaded to REDCap. The
Triage Tool Training Questionnaire (Additional file 2) will
be captured on paper and stored in a locked cabinet, in a
locked room in our research spaces nearby the study sites.
Post-study healthcare worker satisfaction survey
After completion of Phase III of the study, healthcare
workers that participated in the usability testing initia-
tive will be invited to complete a Healthcare Worker
Satisfaction Survey (Additional file 3). This will be used
to generate a report that provides insight on the overall
perception of health worker’s experiences with the
digital triage tool.
Data management
Data collection infrastructure
Study Nurses will collect data using a custom-built An-
droid application, created using LambdaNative (lambda-
native.org),
the
open-source
cross-platform
toolkit
developed internally at BC Children’s Hospital Research
institute. All data entered into the mobile application is
stored in an encrypted database using the encryption ci-
pher Rabbit. Access to the tablet and application is se-
cured by passwords; without using the application, the
encrypted files are not readable. The Masimo iSpO2®
Pulse Oximeter with Micro USB Connector will be used
to collect pulse oximetry and heart rate (including 30 s
of raw plethysmographic data) and the Masimo Care-
giver™non-contact thermometer will be used to measure
core temperature. The data collection application also
contains complex error checking specific to the survey
questions such as date inconsistency checks and ensures
only relevant data items are collected, by dynamically
hiding redundant questions.
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Due to the complex nature of a large multi-center
study, data will be uploaded directly from the Android
tablets to REDCap (Research Electronic Data Capture,
https://projectredcap.org/). REDCap is a secure web-
based application designed to support data capture for
research studies and it has been used for over 300,000
projects, in over 100 countries, including prior studies in
Uganda [13]. Encrypted data will be stored for less than
14 days after completion of data collection on the tab-
lets. In Kenya, the data will be directly uploaded weekly
(depending on internet availability) over a secured inter-
net connection to KTWRP servers, where it will be
stored. A deidentified copy will be sent to the central
study server at the BC Children’s Hospital Research in-
stitute where data will be checked for completeness and
consistency with data definitions. In Uganda, the data
will be sent to the central study server at the BC Chil-
dren’s Hospital Research Institute. After this upload, the
data on the tablets will be deleted. Each subject will be
given a unique number and all data will be connected to
this unique number. Using REDCap limits the amount
of paper-based data, further ensuring data integrity and
safety. The uploaded data will be accessible to only study
team members with secure access to the server.
Data collected during follow-up interviews conducted
by phone or in person will also be collected electronic-
ally and shared in the same secured manner. Personal
identifiers are required for the collection of admission
data and follow-up data. The data collection application
contains several forms. All identifiers are collected on a
single form, separate from the other forms containing
non-identifying information, and stored in a separate
and restricted REDCap form. Access to identifiers will
be limited to those requiring this data for follow-up (i.e.
only study personnel involved in follow-up or data verifi-
cation). No analysts, co-investigators or principal investi-
gators not directly involved in the follow-up or data
verification will have access to this data. Access to RED-
Cap will require 2-way authentication: in addition to the
normal password process, a secure code (sent via SMS
to the user) will be required for access to this data.
Paper based data collection items include consent
forms and research assistant field notes (which do not
contain identifiers). These will be stored in a locked cab-
inet, in a locked at our research spaces next to each
study site.
Health intervention infrastructure
The bundle of care during the intervention will include
triage in the OPD using an additional custom Android
web-app, running locally on the device with no required
Internet connection. As with the data collection app, this
application will be password protected and data will be
stored encrypted on the device. Following each triage, the
triage data will be sent to a local low-cost Unix server
Soekris box based in a secure room at each site. Data will
be sent through encrypted HTTPS requests to server-side
PHP scripts, which insert it within MySQL tables.
The clinician dashboard that will be used to clinically
manage all children in the OPD who have been triaged
will be implemented as a password protected website ac-
cessible by registered medical staff on any computer or
tablet on the local network. As with the triage app, this
website runs completely locally, independent of an out-
side Internet connection and is not accessible from off-
site. The dashboard is implemented using the Laravel
(https://laravel.com), a PHP
web
framework, which
queries the MySQL server tables securely. Personal iden-
tifiers will be collected in the triage app and sent to the
server for display on the dashboard as is necessary for
correct identification of patients, but such information
will never leave the hospital site. As the study hospitals
already have computers in their OPDs, use of the clinical
dashboard will not be extra work for the hospital staff or
interfere with other tasks.
Statistical analysis
Model development
The predictive model for severe infection and sepsis in
children will be developed based on the need for hospital
admission of 24 h or longer. To find the best performing,
and most parsimonious model, a variety of model build-
ing techniques will be compared. These will include but
are not limited to: stepwise regression based on Akaike’s
Information Criterion (AIC), penalized regression via
elastic net, and random forest [21]. Models will be com-
pared based on the area under the receiver operating
curve, and the specificity achieved at high (80–90%) sen-
sitivity thresholds. Models within 10% of the best per-
forming model will be considered. Final model selection
will depend on parsimony, availability of predictors
across sites (based on resources, cost and feasibility of
collection), discrimination and calibration. All model
comparisons will take place within an internal validation
resampling framework such as cross validation or boot-
strapping. Risk thresholds to stratify participants into tri-
age categories (emergency, priority, and queue) be
selected based on sensitivity analysis and expert opinion.
To account for geographical differences and disparities
in disease prevalence (high malaria prevalence in Jinja,
Uganda), we will use net reclassification improvement to
optimize and re-calibrate (if required) the prediction
model [22].
RFID system validation
We will validate the RFID technology against a human
timekeeper control for the time to bundle of care out-
come by investigating bias and accuracy using a Bland
Mawji et al. BMC Health Services Research          (2020) 20:493 
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Altman analysis. The RFID technology will be consid-
ered as interchangeable with a human timekeeper if the
95% limits of agreement fall within +/−5 min. We chose
this cut off as delays in bundle of care delivery below
this threshold is unlikely to be of clinical significance.
We will use the first 100 pairs of RFID and human mea-
surements to calculate a mean difference and standard
deviation of difference between the two measurements.
Using these two values and a clinically acceptable limit
of 5 min, with an alpha of 0.05 and beta of 0.2, we will
calculate the sample size required for the Bland Altmann
analysis by methods previously described [23]. If the 95%
limits of agreement fall outside of 5 min, the same Bland
Altman analysis will be done for the patient arrival time
and time of bundle of care delivery; these comprise of
the start and end time components of the time to bundle
of care outcome. These secondary analyses serve to as-
certain which of the two components contains the larger
discrepancy between RFID and human measurement.
Should these secondary analyses be necessary, imple-
mentation issues in the RFID technology will be brain-
stormed in focus groups with the technology team and
addressed on the ground, and we will repeat the same
validation process as described. After successful logistical
improvements and validation of the RFID technology to
within 5 min of a human timekeeper, we will utilize the
RFID technology for data collection with a human time-
keeper as backup as needed.
Outcomes analysis
We will be conducting our primary analysis using a dif-
ference in differences method. For our primary analysis,
a logistic regression model for receipt of bundle of care
within 1 h will be fit including: 1) phase of study (pre vs.
post PRST) and 2) group (intervention versus control) as
independent dummy variables and 3) their interaction.
The interaction term corresponds to the difference in
log-odds between groups in baseline vs intervention and
it’s exponent as the ratio of odds ratios. We will sum-
marise this difference by estimating the marginal effect
(risk difference) of phase in both the control and inter-
vention groups. The difference of these marginal effects
is the so-called ‘difference in difference’ for a binary out-
come [24]. Confidence intervals will be based on the
delta-method, or bootstrapping, where appropriate. A
similar approach will be used for binary secondary out-
comes (mortality, readmission), or quantile regression
for median time to bundle of care, a non-parametric
outcome.
Subgroup analyses specified a priori include Ugandan
vs. Kenyan intervention site, young infant (under 2
months old) vs. children under 5 vs. older children, and
presentation during day-shift hours versus night-shift
hours (if applicable). We will also perform subgroup
analyses on each triage category (emergency, priority,
queue); patients from the pre-intervention phase will be
retroactively categorized into these subgroups for this
analysis. These subgroup analyses will be conducted with
the inclusion of a three-way interaction between said
variable, phase, and group. Statistical significance will be
based on a likelihood ratio test comparing models with
and without this term. This three-way interaction term
would represent potential interactions between different
subgroups and our difference in odds ratio obtained in
our primary analysis, and results will again be presented
on the risk difference scale based on marginal effects.
This method of subgroup analysis sometimes termed a
difference in difference in differences method.
Although none are expected, if there are any time
varying confounders identified during the study that dif-
fer between intervention and control (health system or
policy changes, natural events, changes in patient popu-
lations etc.) they will be included in above models as
sensitivity analyses.
As we are continually collecting data regarding predic-
tors for admission alongside the clinical team, there is
the possibility that our research activities may interact
with the efficiency of delivering the sepsis bundle of
care. Although the possibility of such interaction is mini-
mized by our use of dedicated research personnel who
would not approach patients who are actively receiving
clinical care, any such interactions could potentially limit
the external validity of our study to non-research-
controlled settings. Therefore, to assess this potential
interaction, we will pause the collection of predictor data
1 month before and after implementation of the PRST
program. This pause will also occur in the control group
in order to replicate any bias caused by changes in our
primary outcome attributable to the pause rather than
the PRST program. To investigate the potential for this
bias, we will treat the collection or non-collection of pre-
dictors as a dummy variable for subgroup analysis using
the difference in difference in differences method de-
scribed above.
All analyses will be conducted using R statistical soft-
ware [25], and an alpha level of 0.05 will be considered
statistically significant for all outcome analyses.
Methods: monitoring
Data monitoring
Internal monitoring of study processes will be done
regularly by the study coordinators at each hospital site.
During monitoring, data and consent forms for 10% of
enrolled participants will be reviewed for compliance.
Retraining of study staff will be done to correct for any
inconsistencies noted during monitoring and follow-up
will be subsequently done by the study coordinator to
ensure compliance. Given that the digital triage tool is
Mawji et al. BMC Health Services Research          (2020) 20:493 
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community and health system level intervention, a data
monitoring committee was not deemed necessary.
Data completeness will be continuously monitored
using daily, weekly and monthly reports. Accuracy of
data will be verified using an audit of 5% of cases by a
data manager who will not be involved in enrolling sub-
jects. Preliminary data quality checks and analysis will be
performed throughout the data collection stage to en-
sure that data collected is valid and secure. These data
quality checks will include checking the quality of pulse
oximetry waveform data via implementing a Signal
Quality Index (SQI) algorithm and checking for com-
pleteness and validity of input data. Further data quality
checks will inspect the number of patients enrolled, the
number of patients admitted, and the timed outcome
data. Upon completion of data collection, a summary of
the data collected will be compiled and will be discussed
by the investigators and the study nurses to ensure that
data is clean, correct and useful.
Ethics and dissemination
Research ethics approval/protocol amendments
Ethical approval has been obtained from Makerere
University School of Public Health (MUSPH) Higher
Degrees, Research and Ethics Committee, Kenya Medical
Research Institute (KEMRI) Scientific & Ethics Review
Unit (SERU), and The University of British Columbia/
Children’s
and
Women’s
Health
Centre
of
British
Columbia Research Ethics Board (UBC C&W REB).
MUSPH provided approval for the study to be con-
ducted at Jinja Reginal Referral Hospital in Jinja, Uganda.
KEMRI SERU provided approval for the study to be con-
ducted on behalf of both Mbagathi County Hospital and
Kiambu County Referral Hospital in Nairobi, Kenya. A
copy of the protocol proposed informed consent forms,
other written participation information, and any pro-
posed advertising material will be submitted for written
approval. The investigators will submit and, where ne-
cessary, obtain approval from the Institutional Review
Board (IRB) for any major protocol amendments and
changes to the informed consent document. The study
team are responsible for assuring that this protocol and
the associated informed consent documents and study-
related documents are approved prior to implementation
of the protocol. Any major amendments to the protocol,
informed consents, or other study- related documents
must be approved by the IRB prior to implementation.
Informed consent and assent
All consent materials will be approved by all three
IRBs listed in the section above prior to use.
The study nurses will be responsible for screening and
consenting participants. This would be the norm in
Kenya and Uganda. The study nurses will be certified
and trained to ensure that the caregiver has a complete
understanding of the consent processes, the consent
form, and that the caregiver is of legal age (18 years old)
and competent to provide consent.
In obtaining and documenting informed consent,
the site investigators and their designees will comply
with applicable local and domestic regulatory require-
ments. This clinical study will have a paper-based in-
formed consent form (ICF) for enrollment developed
for local use that are in accordance with applicable
guidelines. The consent form will include the purpose
of the study, a description of the procedures to be
followed and the risks and benefits of participation.
The informed consent process will give individuals all
of
the
relevant
information
they
need
to
decide
whether to participate, or to continue participation, in
this study. Potential research participants’ caregivers
will be encouraged to ask questions and to exchange
information freely with the study team. Participants
will be informed on who to contact (Principal Investi-
gator) should they have any questions during, or after
the study period. If the caregiver providing consent is
illiterate, an independent witness will be present to
verify to the caregiver that all the information read
aloud is contained in the ICF. In this instance, both
the caregiver and witness will sign the ICF. The care-
giver
will
voluntarily
sign,
thumbprint
and
date
(thumbprint acceptable if illiterate who will also re-
quire a witness) the consent form if they wish to par-
ticipate in the study and will be provided with a copy
of the consent form. A signed and dated copy of the
consent form will be kept in the documentation file
at all times.
There will be consent forms specific to Phase I and
Phase III. Assent will be sought for children aged 13 and
older in Kenya, and for children aged 8 and older in
Uganda. The lower age limit for assent was selected
based on site-specific requirements, which differ in
Kenya and Uganda. Consent will also be sought for par-
ticipation in usability testing initiatives, the Triage Tool
Training Questionnaire, and the Healthcare Worker Sat-
isfaction Survey. Consent forms will be made available
in English and the local language of the catchment
population at each study site, which is Kiswahili in
Kenya and Luganda in Uganda.
In emergency cases, consent will be deferred until the
child is stable and study procedures will only begin after
initiation of emergency treatment. Study procedures will
not delay or interfere with access to standard care. If
consent is not granted, the data will be deleted. This de-
ferred consent procedure is to avoid introduction of bias
by neglecting to obtain data from the most severely ill
children while avoiding delays in providing care to the
child. This procedure has been used in previous studies
Mawji et al. BMC Health Services Research          (2020) 20:493 
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involving children with severe illness, including use by
the Fluid Expansion As Supportive Therapy (FEAST)
study [26].
Confidentiality
Data will be stored and distributed using password pro-
tected locations and secure data transfer. All data en-
tered into the digital triage tool is stored in an encrypted
database using the encryption cipher Rabbit. Access to
the digital tool is secured by passwords and without
using the application, the encrypted files are not read-
able. Encrypted data will be stored for a maximum of 2
weeks on the tablets before being directly uploaded and
stored stored in a secure research server at MUSPH
(Uganda), or KEMRI (Kenya), and UBC. After this up-
load, the data on the devices will be deleted. Data will be
entered into the digital triage tool using a REDCap elec-
tronic data collection form. REDCap is a secure, web-
based application designed to support data capture for
research studies. Each subject will be given a unique
number and data will be connected to this unique num-
ber. Using REDCap limits the amount of paper-based
data; further ensuring data integrity and safety. The
uploaded data will be accessible to any team member
with secure access to the server, including investigators
from MUSPH, KEMRI, and UBC. Standard operating
procedures will be implemented for the security of data,
physical devices and networks. All research staff will be
well trained and understand that privacy and confidenti-
ality are imperative. All paper forms used for consent
will not contain the study number. These forms will be
stored in our research spaces near the study sites under
lock and key, for the duration of the study and for any
additional time required by the local and/or national
guidelines at the time.
Risks/adverse events
We do not anticipate any adverse events directly attrib-
utable to the study. The most significant risk in this
study is a small delay in treatment administration due to
inappropriate triage by the digital triage tool. This delay
would not be significantly different from the baseline
standard of care. The risk of an adverse event is minimal
as the digital triage tool will only be used to guide the
frontline health workers in identifying critically ill chil-
dren in need of prompt assessment. All subjects will still
be assessed by a healthcare provider regardless of triage
status assigned by the digital tool.
All children enrolled into this study will receive stand-
ard care according to local, regional and national guide-
lines. No study procedures will take place which in any
way interfere with the prescribed care. Study procedures
will be delayed, when necessary, to ensure that these
procedures will not impact recommended care.
Other potential risks include:
RFID tagging
The RFID tag is a new and unfamiliar piece of technol-
ogy that needs to be worn or attached to participants
who may not feel comfortable with it. We will ensure
that participants/caregivers are fully aware of the pur-
pose of wearing the RFID tag and how the system works.
Further, the tag is a tiny piece of plastic that can be eas-
ily concealed and will not cause any discomfort to par-
ticipants. This has been discussed with our local PI’s and
local ethics committees in Kenya and Uganda. This has
been approved by both the local and national ethics
committees.
Blood sampling
Blood sampling will only be conducted when clinically
indicated are already routine hospital procedures. This
will not be done by research staff for research purposes,
but rather we will be ensuring the resources are available
to the hospital nurses to do this testing if indicated.
These will be communicated by the consultant during
the consultation that follows the triage process.
Coercion
Caregivers may feel coerced to enroll in the study in
order to receive care for their child within a research
setting, which may be perceived as of a higher quality
than the standard of care. This will be minimized by en-
suring that study nurses emphasize that the child will re-
ceive medical care whether enrolled in the study or not.
Access to data
After the study period, a de-identified copy of the data
will be prepared for deposition in a repository with open
access with proper governance mechanisms. We will
make every effort to prevent re-identification of subjects
by coding data that has the potential of being identifi-
able. For example, we will convert all dates into mean-
ingful decimal numbers (date of birth into days since
birth and date of recruitment will be reduced to month
of recruitment) and all locations will coded into data
that is useful but not specific (such as address converted
to distance and direction from facility). We will ensure
that data elements with small numbers of subjects (less
than 10) will be coded or lumped to avoid identification.
The de-identified study data will be made publicly avail-
able using the Harvard Dataverse (https://dataverse.har-
vard.edu/), which is the data repository for KWTRP, and
a URL will be made accessible. To enhance visibility,
sharing and collating datasets with other collaborating
sites for increased usability/re-use, de-identified will also
be shared availed to reputable data hosting service such
as the INDEPTH Data Repository (http://www.indepth-
Mawji et al. BMC Health Services Research          (2020) 20:493 
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ishare.org/index.php/home), or through the newly estab-
lished Pediatric Sepsis CoLab (sponsored by the World
Federation of Pediatric Critical and Intensive care Soci-
eties). Sharing and access will be managed and subject
to institutional agreements (KEMRI and UBC) that will
set terms for how requests and access will be managed.
We will ensure that a rigorous data governance structure
is used by the data hosting service. The distribution will
only occur with agreement from Principal Investigators
and the investigators at all of the study sites. Data will
also be shared through peer reviewed publications and
through the Wellcome Trust open data initiatives. Data
will be made available within 12 months following com-
pletion of the study.
Presentation and dissemination of results
Results presentation
The results of this research will be primarily presented
through at least one published manuscript with detailed
description of the background, methods, results, and
conclusion. The specific format and details of this manu-
script will be in accordance with the requirements of the
publishing journal. All usage of data for publications and
other forms of data dissemination will occur jointly be-
tween collaborative institutions and include authors
from both sites in all publications.
Dissemination
Results will be disseminated to local hospital teams and
key stakeholders such as at the annual conference held
by the Kenya Pediatric Association (KPA). A robust
knowledge translation approach is a key aspect of our
transition and scale-up. An integrated equity-oriented
cascade approach [27] will be used to guide knowledge
translation across the duration of the project. We will
engage the “6 Ps” stakeholder groups (public, patients/
caregivers, policymakers, practitioners, press, and private
sector), all of which are critical to the successful out-
come of our project. Our key knowledge translation ac-
tivities will employ a rich range of communication
channels and will be multifaceted: academic, govern-
mental, policy-driven, and public-facing. Methods of dis-
semination will include social media, radio, websites,
progress reports, workshops, community meetings, ex-
ecutive summaries, technical reports, verbal presenta-
tions
to
key
stakeholders,
peer-reviewed
scientific
publications and conference presentations. All relevant
reports, publications and data will be freely available
online.
Discussion
Our team has demonstrated that simple and affordable
technology can circumvent the lack of training and assist
in identification and follow-up of high-risk children
following treatment for infections [28]. Our technology
aims to improve the quality of care, defined as the de-
gree to which health services for individuals and popula-
tions increase the likelihood of desired health outcomes
and are consistent with current professional knowledge.
Quality of care is suboptimal in many LMICs, where
more than 8 million people die yearly from conditions
that should be treatable by the health system [9]. Nearly
60% of these deaths are from conditions that should re-
spond to appropriate health care but occur due to poor-
quality care [29].
The PRST will facilitate data-driven and evidence-
based improvements to the quality of care provided to
children with critical illness (i.e., sepsis). The digital plat-
form consists of a mobile application integrating a pulse
oximetry sensor attached to the device, with embedded
smart algorithms (which include ETAT guidelines) that
predict a critically ill state, or level of risk for children
presenting to the outpatient department. The platform
also includes an interactive dashboard located in stra-
tegic locations (e.g., laboratory, consultation rooms),
which connects to the mobile application through a se-
cure local network and displays the triage data to pro-
vide
real-time
monitoring
for
the
physicians
who
manage the patients. Additionally, an RFID method for
tracking patients will be used to automatically collect
data on the timeliness of interventions. The dashboard
and RFID tracking system will increase data accuracy
and completion, enhance communication and empower
health workers, and improve resource allocation.
Using the PRST, each child presenting to the health-
care facility is rapidly triaged based on clinical symp-
toms, signs, and vital signs, which are captured by front-
line health worker in less than 5 min. Based on these
data, smart algorithms in the mobile application assign a
level of risk (emergency, priority, queue) to each child.
Following identification of risk, we target the expedited
administration of evidence-based, low-cost interventions
such as antibiotic, fluid, and oxygen therapy. The timely
administration of this life-saving bundle of care is driven
by the triage data displayed on the dashboard.
The main objective of the PRST is to enable frontline
health workers to recognize the most urgent children
more rapidly and allocate necessary resources more effi-
ciently. We designed the PRST specifically for use in
low-resource settings. The mobile application, integrated
pulse oximetry sensors, and dashboard are easily access-
ible, affordable, robust to internet and power interrup-
tions (system includes a secure local network that does
not require an active internet connection) and do not
rely on sophisticated expertise to operate.
Performance of the PRST may vary depending on geo-
graphical location, season, and with different disease
prevalence and severity. Standardized measurements will
Mawji et al. BMC Health Services Research          (2020) 20:493 
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be collected at sites in both Kenya and Uganda in order
to explore these differences and optimize performance
of the PRST at each site. External validation will be ne-
cessary to determine generalizability in other LMICs.
Supplementary information
Supplementary information accompanies this paper at https://doi.org/10.
1186/s12913-020-05344-w.
Additional file 1. Smart Triage Data Dictionary.
Additional file 2. Triage Tool Training Questionnaire.
Additional file 3. Healthcare Worker Satisfaction Survey.
Abbreviations
AIC: Akaike’s Information Criterion; BC: British Columbia; BLE: Low-energy
Bluetooth; CI: Confidence interval; ETAT: Emergency Triage and Treatment;
FEAST: Fluid Expansion As Supportive Therapy; HTTPS: Hypertext Transfer
Protocol Secure; ICF: Informed consent form; IEC : Independent Ethics
Committee; INDEPTH: The International Network for the Demographic
Evaluation of Populations and Their Health; IRB: Institutional Review Board; IV
: Intravenous; KEMRI : Kenya Medical Research Institute; KPA: Kenya Pediatric
Association; KWTRP: KEMRI-Wellcome Trust Research Programme; LMIC: Low-
and middle-income countries; MUSPH: Makerere University School of Public
Health; OPD: Outpatient Department; PHP: Hypertext Preprocessor; PRST
: Pediatric Rapid Sepsis Trigger; REDCap: Research Electronic Data Capture;
RFID: Radio-Frequency Identification; SERU: Scientific & Ethics Review Unit;
SMS: Short Message Service; SQI: Signal Quality Index; UBC: University of
British Columbia; UBC C&W REB: University of British Columbia/ Children’s
and Women’s Health Centre of British Columbia Research Ethics Board;
URL: Uniform Resource Locator; USB: Universal Serial Bus; WHO: World Health
Organization
Acknowledgements
The authors would like to thank collaborators from KEMRI, WALIMU, and Jinja
Regional Referral Hospital.
Authors’ contributions
UBC affiliated investigators AM, EL, JMA, NK, MOW, and GD conceived and
designed this study with significant contributions from investigators in
Kenya, SA and DK, and in Uganda, CK, AT, and NKM. EL, JNB, and AM
developed the analytic approach. DD was responsible for software
development, data collection systems, and data management. AM led the
principal drafting of the protocol. All authors read, reviewed, and approved
the final protocol.
Funding
This study has been funded by the Wellcome Trust Innovator Award (ID:
215695/B/19/Z). Study sponsors do not have a role in study design;
collection, management, analysis, and interpretation of data; writing of the
report; or the decision to submit the report for publication. They will not
have ultimate authority over any of these activities. This study has been
independently peer reviewed by the funding body.
Availability of data and materials
Within 12 months of study completion, de-identified study data will be made
publicly available. The de-identified study data will be made publicly avail-
able using the Harvard Dataverse (https://dataverse.harvard.edu/), which is
the data repository for KWTRP, and a URL will be made accessible. To en-
hance visibility, sharing and collating datasets with other collaborating sites
for increased usability/re-use, de-identified will also be shared availed to rep-
utable data hosting service such as the INDEPTH Data Repository (http://
www.indepth-ishare.org/index.php/home), or through the newly established
Pediatric Sepsis CoLab (sponsored by the World Federation of Pediatric Crit-
ical and Intensive care Societies).
Ethics approval and consent to participate
Ethical approval has been obtained from Makerere University School of
Public Health (MUSPH) Higher Degrees, Research and Ethics Committee,
Kenya Medical Research Institute (KEMRI) Scientific & Ethics Review Unit
(SERU), and The University of British Columbia/ Children’s and Women’s
Health Centre of British Columbia Research Ethics Board (UBC C&W REB).
MUSPH provided approval for the study to be conducted at Jinja Reginal
Referral Hospital in Jinja, Uganda. KEMRI SERU provided approval for the
study to be conducted on behalf of both Mbagathi County Hospital and
Kiambu County Referral Hospital in Nairobi, Kenya. Written informed consent
will be obtained from all caregivers/participants prior to enrollment.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Author details
1Department of Anesthesiology, Pharmacology & Therapeutics, University of
British Columbia, 217-2176 Health Sciences Mall, Vancouver, BC V6T 1Z3,
Canada. 2School of Population and Public Health, University of British
Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada. 3Walimu, P.O. Box
9924, Plot 5-7, Coral Crescent, Kololo, Kampala, Uganda. 4Kenya Medical
Research Institute/Wellcome Trust Research Programme, P.O. Box
43640-00100, Nairobi, Kenya. 5Digital Health Innovation Lab, BC Children’s
Hospital Research Institute, 948 W 28th Ave, Vancouver, BC V5Z 4H4, Canada.
6Center for International Child Health, BC Children’s Hospital Research
Institute, 948 W 28th Ave, Vancouver, BC V5Z 4H4, Canada. 7Department of
Pediatrics, University of British Columbia, Rm B2W, 4480 Oak Street,
Vancouver, BC V6H 3V4, Canada. 8Jinja Reginal Referral Hospital, Jinja,
Uganda. 9Mbagathi County Hospital, P.O. Box 20725-00202, Nairobi, Kenya.
10Department of Obstetrics and Gynaecology, University of British Columbia,
1125 Howe Street, Vancouver, BC V6Z 2K8, Canada. 11Electrical and
Computer Engineering, The University of British Columbia, 5500 - 2332 Main
Mall, Vancouver, BC V6T 1Z4, Canada.
Received: 30 April 2020 Accepted: 20 May 2020
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