FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
Phase: NA
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Sponsor: University of Sao Paulo

 
 
 
 
 
 
 
 
 
 
FAPO-X: Assisted digital telemonitoring with wearables in patients after 
cardiovascular surgery – a randomized trial 
 
 
financed by samsung 
 
 
 
 
 
 
Researchers: Prof. MD, PhD Fabio Biscegli Jatene 
Prof. MD, PhD Carlos Alberto Pastore 
Prof. PhD Marco Antonio Gutierrez 
Eng. Fabio Pires  
BSc, Phd, Rosangela Monteiro 
Eng. Guilherme Rabello  
BSc, PhD Camila Rodrigues Moreno 
Pietro Colonna 
Nurse, MSc. Matheus Moitinho 
Nurse Bruna Lopes 
 
 
Sao Paulo 
January 07, 2023 

 
 
 
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SUMMARY 
 
Page 
1 
INTRODUCTION 
1 
2 
GOALS 
9 
 
2.1 
goal primary 
9 
 
2.2 
Goals secondary 
9 
3 
METHODOLOGY 
9 
 
3.1 
Study location 
9 
 
3.2 
Inclusion criteria _ 
10 
 
3.3 
Exclusion criteria _ 
10 
 
3.4 
Selection of Volunteers 
10 
 
3.5 
Data collection, clinical examinations and evaluation of 
results 
13 
 
3.6 
Validation of the Measurement Model and Data Analysis 15 
 
3.7 
Anamnesis complete 
15 
 
3.8 
Provision and use of SAMSUNG devices (smartphone 
and smartwatch ) 
16 
 
3.8 
Traditional 
electrocardiography 
(ECG) 
versus 
SAMSUNG smartwatch ECG 
16 
 
3.9 
Measurement of peripheral oxygen saturation (SpO2) by 
SAMSUNG smartwatch versus standard oximetry 
17 
 
3.10 
Blood pressure (BP) measurement by SAMSUNG 
smartwatch versus standard device 
17 
 
 
3.11. 
Definition of alerts - teleassisted group 
18 
 
3.13. 
Aspects ethical 
23 
 
4. 
Timeline Estimated 
24 
 
5. 
Attachments 
25 
 
5.1. 
case report Form (CRF) 
25 
 
5.2. 
Term of Loan Liability 
33 
 
5.3 
Activity Diary 
35 
 
         References  
37 
 

 
 
 
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1. INTRODUCTION 
Noncommunicable diseases are responsible for about 41 million 
deaths/year, which is equivalent to 71% of deaths worldwide 1. It is no different in 
Brazil, chronic diseases represent the main challenge in health, about 72% of 
deaths in the country are due to chronic non-communicable diseases, which 
represent 75% of the expenses of the Unified Health System (SUS) - Figure 1 . 
 
Figure 1 . Chronic diseases represent the main health challenge in Brazil. 
 
The World Health Organization's 2030 Agenda for Sustainable 
Development reveals the commitment of member countries to a 30% reduction in 
premature mortality from non-communicable diseases, especially cardiovascular 
diseases (ischemic heart disease and stroke), cancer, respiratory disease and 
diabetes 2. 

 
 
 
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Cardiovascular diseases represent one of the major causes of morbidity and 
mortality worldwide, which has encouraged numerous researches in different 
areas. Around 17.5 million people die from cardiovascular diseases annually 
worldwide, according to data from the World Health Organization (Figure 2). Only 
in Brazil, diseases related to heart problems correspond to about 300,000 deaths 
per year. They are chronic and can be treated clinically or surgically 3. 
Figure 2 . Leading causes of death worldwide in the year 2019. 
 
A significant portion of cardiovascular diseases require surgical treatments, 
with myocardial revascularization surgeries, correction of valve diseases, followed 
by surgeries to correct aortic diseases and congenital heart diseases, the most 
common in adults and the elderly. These patients are usually referred to the 
operating room with different comorbidities, subject to more complications in the 

 
 
 
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intra and postoperative period, which leads to an increase in hospital stay and 
monetary and technological costs invested in their treatment and recovery 4, 5. 
Brazil is the second country in the world in number of heart surgeries 
performed, totaling around 100,000 surgeries/year, second only to the USA, which 
performs around 300,000 surgeries/year. 
There are over 320 million inpatient surgical procedures performed 
worldwide. Recently, the International Surgical Outcomes (ISOS) Study (ISOS 
Group 2016) highlighted that about 17% of these patients develop one or more 
complications and, among them, 2.8% die as a result of them 6, 7. 
The postoperative period of cardiac surgery requires continuous 
observation from the health team, quick decision-making and highly complex care. 
This period presents many challenges for the multidisciplinary team, due to the 
need for intensive/constant monitoring and the potential postoperative 
complications. In addition to the lives lost, these postoperative complications 
dramatically increase hospital and healthcare costs 8. 
One of the most frequent complications in the postoperative period of 
cardiovascular surgery are arrhythmias, with atrial fibrillation being the most 
frequent arrhythmia in the postoperative period 9. The prevalence of postoperative 
atrial fibrillation (POAF) varies between 15 and 40% in coronary artery bypass 
grafting procedures, 37 to 60% in valve surgery and more than 60% in combined 
interventions and 24% in patients undergoing heart transplantation. 
In 90% of cases, POAF appears in the first four postoperative days 10. The 
average length of the first episode is 7-8 hours. Recurrence occurs in 40% of cases 
and occurs within the first 24 hours. Up to 80% of patients remain in sinus rhythm 

 
 
 
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24 hours after the first episode. About 14% of patients with atrial fibrillation after 
cardiac surgery (AFACS) remain with this rhythmic disorder for up to two weeks 11. 
Other emerging evidence suggests that POAF is associated with long-term 
sequelae such as stroke, heart failure, and all-cause 12mortality.13 
Despite the advances in the area and the different methods for monitoring 
POAF, there is still no method that allows the automated evaluation of fibrillation 
episodes for a very prolonged period. Thus, the detection of POAF becomes an 
important challenge. 
Wearable devices such as smartphones and smartwatches, are a great 
promise for screening and monitoring AF, and can present up to 93% sensitivity 
and 84% specificity when compared to standard ECG 14. In addition, they are easy 
to use and allow evaluating the possible adherence of patients to this new modality 
of assisted telemonitoring. However, to be used as a medical device, these 
wearables need to be accurate in outpatient settings. 
 
Technological resources for health solution 
The use of terms such as Internet of Things or Internet of Things ( IoT ), 
Internet of Everything or Internet of Everything ( IoE ), cloud computing, 
cyberculture, big data, artificial intelligence, neural networks, wearable devices, 
among others , are already part of our daily lives as innovative technological 
contributions in the area of health 15, 16. 
Wearables are proving to be very effective tools with regard to the 
prevention, detection or even management of chronic diseases, according to Baig 
et al 17. The use of wearables to monitor vital signs, such as oxygen saturation 
(SpO2), heart rate, blood pressure and respiratory rate is of fundamental 

 
 
 
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importance 18. In addition, the possibility of generating early warnings in case of 
clinical instability of the patient was associated with a significant decrease in the 
number of cardiac arrests and deaths 19. Statistical data and trend models, even 
generated from non-medical devices such as wearables, are of great value in 
preventive and predictive actions in health care 20, 21. 
The use and implementation of any new technology comes at a cost that 
must be balanced against the potential savings associated with the expected 
improvement in postoperative recovery. Postoperative complications are 
expensive to treat and prolong hospital stays. However, the use of such resources 
as wearables will allow a variety of data to be collected by sensors and allow for 
earlier interventions 22. 
Recent data from a GFK36 global survey on wearables, involving more than 
20,000 people in 16 countries, found that around 33% use tracking to monitor their 
health, through apps, bracelets, smart watches and clips. Among those 
interviewed, 18% had already used the technology some time ago, 45% had never 
used it and 4% were unable to answer. This survey revealed an interest in 
wellness, looking for information about exercise, calorie consumption, and even 
sleep. Another interesting data from this survey is that Brazil occupies, alongside 
the United States, the second position in the use of health and physical condition 
monitoring, losing to China and ahead of Germany and France 23. 
In this context, the use of available technologies can be used as strategies 
for faster dehospitalization, with remote monitoring of the patient, since the initial 
application of wearables in surgery may eventually allow better communication and 
decision-making by the care team through the collection, interpretation and 

 
 
 
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presentation of patient-specific measurements relevant to the context of the 
disease 24. 
Wearable devices, such as smartwatches, can be an innovative and 
relevant alternative, making it possible to reduce hospitalization periods and the 
early return of patients to their routine activities safely, in an assisted way. 
 
Integration of wearable technology health data with the electronic record 
Currently, Information and Communication Technology (ICT) tools are 
present in practically all activities related to the health area, such as teaching, 
research or assistance. 
There is evidence that a feasible and adequate electronic health record 
(EHR) helps professionals in decision-making in patient health care, improving 
safety and efficiency of care 25. In view of this, there has been a progressive 
interest in the medical field in using data captured from the RES, as they contain 
variables with valuable information, such as demographic data, diagnoses, 
medications and laboratory data 26, 27. 
However, although electronic records serve different purposes and utilize 
different IT system architectures, there are many operational challenges and 
technical issues. However, the different needs and subdivisions of the health area, 
without a systematic view, end up using an exaggerated amount of software and 
spreadsheets, without interconnection or integration, making it difficult or even 
preventing the communication and transformation of data into relevant information 
and knowledge in practice. clinic 28, 29. 
InCor's electronic medical record (Integrated Information System InCor - SI3) 
provides integrated data from the Clinical Information System via a standard web 

 
 
 
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interface, which allows independence from the hardware platform used for access, 
in addition to providing better management of health resources in the institution, 
whether in supplies, occupation of beds, laboratory management, medications, 
costs of procedures and information that can be obtained in real-time through 
standardized interfaces 30. Currently, more than 1.4 million patients are registered 
in SI3 with all their care data, resulting in more than 500 Terabytes of data. The 
systems range from scheduling appointments and exams and admitting patients 
to bed control, laboratory management, medication, supplies and billing to the 
SUS. 
In this way, not only the secure integration of the currently existing databases, 
but also the coherent use of the stored information, provide a valuable source of 
knowledge for a better understanding of patients treated by the SUS, thus allowing 
exploratory, prospective and retrospective studies to produce predictive models, 
and facilitating decision-making for better management of public health policies. 
Wearable technology, such as the use of smartwatches, can capture valuable 
bioparameters, and that at the same time, EHR provides practical platforms for 
including these data - the creation of a graphical interface that displays patients' 
health data from these devices could both transform medical care and ensure 
patient privacy. 
In view of the above, the present study aims, through the use of the 
Smartwatch SAMSUNG TM Galaxy Watch5, to validate a measurement model 
and data analysis that early indicate the need for medical assistance due to atrial 
fibrillation (AF) in individuals with heart disease undergoing cardiac surgery, as 
well as to evaluate patients' commitment to a new monitoring routine using regular 

 
 
 
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alerts based on automated readings, in comparison with the traditional 
postoperative routine. 
The use of such devices as predictors of cardiac alterations could save the 
SUS hundreds of millions of reais per year, as it would avoid events in these 
individuals and, consequently, their treatment. To this end, this study will be 
randomized so that 50 patients will use a Smartwatch device SAMSUNG TM 
Galaxy Watch5 and 50 patients will follow the institution's standard treatment (not 
monitored by wearables). 
 
2. OBJECTIVES 
2.1 Primary Purpose 
telemonitoring platform using the Smartwatch SAMSUNG TM Galaxy 
Watch5, validating its applicability in patients with POAF. 
 
2.2 Secondary objectives 
• Evaluate the accuracy of the Smartwatch SAMSUNG TM Galaxy Watch5 
in detecting vital signs through optical sensors and, in particular, possible 
heart rhythm irregularities. 
• 
Compare the results of the variables heart rate, blood pressure and 
peripheral oxygen saturation (SpO2) and electrocardiogram provided by the 
Smartwatch SAMSUNG TM Galaxy Watch5 with data obtained from gold 
standard reference equipment. 
 
 
 

 
 
 
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3. METHODOLOGY 
 
3.1 Place of study 
This project will be carried out entirely on the premises of the Instituto do 
Coração of the Hospital das Clínicas of the Faculty of Medicine of the 
University of São Paulo. The sample will consist of 100 outpatients, with heart 
disease undergoing cardiac surgery, and selected during the pre -surgical 
consultation. The sample size was proposed by the contractor because it is 
a pilot study to evaluate the accuracy of the equipment in a sample with 
POAF. 
 
3.2 Inclusion criteria 
•  Be at least 22 years old; 
•  Parameters for surgical indication, in the presence of heart disease (mitral 
or aortic valve disease, coronary artery disease or aortic disease); 
•  Agree to adhere to the study's procedures and requirements; 
•  Be able to consent to their participation in writing; 
• Possess home internet connectivity infrastructure; 
 
3.3 Exclusion criteria 
• 
Not having undergone cardiac surgery; 
• 
Presence of post-surgical complications with prolonged hospital stay for 
more than 14 days from surgery date; 
• 
Presence of a Peripherally Inserted Central Catheter (PICC) or limb 
preservation and cardiac pacemaker in case of impediment to acquisition of 
the ECG (smartwatch); 
• 
Patients with arteriovenous fistula; 
• 
Presence of skin pathology or skin diseases such as vitiligo, lupus and 
atopic dermatitis, as well as tattoos in the wrist region, which may interfere 
with the reading by the optical sensor; 
• 
Show sensitivity or allergic reactions, to any degree, to the component 
materials of the wearable device; 

 
 
 
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Volunteers who meet the research inclusion criteria will participate in the study 
protocols after signing the informed consent form (TCLE). 
3.4 Selection of volunteers 
Patients with heart disease undergoing cardiac surgery, monitored at the 
InCor outpatient clinic. Randomization will be performed 1:1 using an electronic 
randomization system and subsequently stratified from the RedCap platform, 
without knowledge by the team involved in the study. Patients will be randomized 
to intervention group (teleassisted group) or control group (standard follow-up of 
the institution) 
 
1. Control group (N=50): patients with heart disease who underwent a 
surgical procedure with standard outpatient and post-surgical follow-up, 
according to institutional routines and protocols; 
2. Tele-assisted group (N=50): patients with heart disease undergoing a 
surgical procedure remotely monitored through smartwatch and application. 
Adult patients will be included, of both sexes, and ethnic profile 
representative of the Brazilian population, characteristic of the user population of 
the Unified Health System (SUS). 
re-hospitalization 
rate, through scheduled consultations and extra 
intercurrences (clock x institutional standard). As secondary outcomes will be 
evaluated: technological and treatment adherence, through the use of the mobile 
application by patients and development and implementation of the telemonitoring 
platform. 
 
The goal is the inclusion of 40 patients/month (in all, in the 2 study groups: 
Remotely monitored watch group and group without a watch, following the 
institutional standard, following the randomization order generated by a specific 

 
 
 
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system) with 20 in each group of the study. In addition, the inclusion of patients 
will happen gradually and continuously, with 1 patient per group/working day. 
 
Figure 3. Flow of inclusion of patients in each arm of the study. 
 
 
The remote patient monitoring flowchart to be used in this project is shown in 
Figure 3. Briefly, it includes: 
1. Preoperative outpatient consultation with complete anamnesis to verify 
eligibility for using the SAMSUNG TM Galaxy Watch5 Smartwatch; 
2. Hospitalization, surgery and collection of intraoperative data; 
3. Training of the patient and/or family member responsible for the use of 
smartwatch and smartphone to start post-operative remote monitoring; 
4. Upon hospital discharge, the patient will receive guidance for follow-up 
on the platform with the Smartwatch SAMSUNG TM Galaxy Watch5 ; 
5. Remote patient monitoring with SAMSUNG 
TM Galaxy Watch5 
Smartwatch and app for 30 ± 3 days; 
6. Monitoring by InCor's multidisciplinary team of the parameters collected 
using the Smartwatch SAMSUNG TM Galaxy Watch5 and an application 
installed on a smartphone; identifying risks for early interventions in the 
face of any relevant intercurrence; 
Sem 1
Sem 2 
Sem 3 
Sem 4
Sem 5
Sem 6
Sem 7
Sem 8
Sem 9
1 ao 5
6 ao 10
11 ao 15
16 ao 20
21 ao 25
26 ao 30
31 ao 35
36 ao 40
41 ao 45
1 ao 3
4 ao 8
9 ao 13
Sem 10
Sem 11
Sem 12 
Sem 13
Sem 14
Sem 15
Sem 16
Sem 17 
46 ao 50
14 ao 18
19 ao 23
24 ao 28 
29 ao 33
34 ao 38
39 ao 43
44 ao 48
49 ao 50
•  Inclusão •  Retorno

 
 
 
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7. Remote monitoring of the patient by teleconsultation, in case of detection 
of intercurrences. In cases considered serious by the clinical team, 
patients will be instructed to seek the InCor PS; 
8. Face-to-face return to the outpatient clinic 30 ± 3 days after discharge for 
evaluation by the clinical team and conclusion of participation in the 
study. 
 
 
Figure 4. Proposed flowchart for the project. 
 
 
3.5 Data collection, clinical examinations and evaluation of results 
In this project, wearable devices such as the Galaxy Watch will be used. 5 
together with Galaxy series smartphones (A or S line) for the acquisition of blood 
pressure measurements, arterial hemoglobin oxygen saturation (SpO2 ), heart rate 
and ECG . This data will be transmitted to a repository, in a secure cloud 
environment, which meets the requirements of the General Data Protection Act 

 
 
 
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(LGPD) (Figure 5). In addition, data will be transmitted to a platform to be 
developed by InCor's IT team, as part of the project, and integrated into InCor's 
electronic medical record through the WebAdmin tool . 
 
Figure 5 . Conceptual diagram for the Telemonitoring Platform. 
The division of the study into phases and activities was carried out according to 
the table and description below. 
Phase 
Local 
Activity 
Phase 1 
outpatient 
• 
Inclusion of patients 
• 
Preoperative consultation; 
• 
Meeting with the project coordination team; 
• 
Complete anamnesis; 
• 
Application of the TCLE; 
• 
Collection of additional and contact information; 
Level 2 
hospitalizati
on 
• 
Hospitalization; 
• 
Eventually, some patients may be included in the study after hospitalization, prior 
to surgery, with the application of informed consent at this time; 
phase 3 
surgical 
• Performing the surgical procedure; 
• Intraoperative data collection; 
• Postoperative evaluation and discharge 
• Patient guidelines; 
• 
Signature of the equipment loan liability term (smartphone and smartwatch); and 
the term for using data from the Electronic Health Record; 
• 
Calibration: 
- BP, serial measurements - smartwatch SAMSUNG + traditional auscultatory method; 
- ECG - smartwatch SAMSUNG + traditional ECG; 
- SpO2 - SAMSUNG smartwatch oximetry + traditional oximetry; 
• Questionnaire of events observed during the remote phase; 

 
 
 
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Phase 4 
remote 
collection 
• 
Tracking, monitoring and managing each participant's remote data collection for 30 
± 3 days; these being: 
- Automatically collected: SpO2, heart rate, steps and sleep. 
- Collected manually: blood pressure and ECG. 
• 
Telephone contact, teleconsultations, and unscheduled face-to-face consultations 
in cases of complications; 
Phase 5 
outpatient 
• 
Return outpatient consultation; 
• 
Meeting with the project coordination team; 
• 
Return of equipment used in the remote phase; 
• 
ECG - smartwatch SAMSUNG ; 
• 
SpO2 - smartwatch SAMSUNG + traditional oximetry; 
• 
PA - smartwatch SAMSUNG + traditional auscultatory method; 
• 
Quality of life questionnaire adapted to record the patient's perception during the 
remote monitoring phase; 
• 
Issuance of a report confirming or not the classification of the ECG issued by the 
smartwatch; 
phase 6 
InCor 
• 
Description of tests carried out and compilation of final results; 
• 
Definition, description and justification of the statistical tests chosen and aligned with 
the hypotheses raised at the beginning of the study. 
 
Table 1: Protocol phases, locations and activities. 
 
 
3.6. Validation of the Measurement Model and Data Analysis  
The measurement validity of wearables will be checked against standard 
reference methods used at InCor, in order to verify the effectiveness of using 
wearables using parametric or non-parametric statistical tests, depending on the 
normality distribution pattern of the variables to be studied, considering p values 
<0.05 statistically significant. 
The identification, sociodemographic and clinical data of the patients will be 
registered in the REDCap program, considered as a tool for managing and storing 
research data31 and analyzed using Statistical Package for the Social Sciences 
(SPSS) version 22.0 for Windows. 
 
3.7 Complete anamnesis 
After confirming participation in the study, initial clinical examinations should 
be scheduled. Volunteers will be assessed for family and personal health history, 
and the variables to be collected are described in the case report Form (CRF) of 
the study (Annex 2). 
 

 
 
 
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3.8 Provision and use of SAMSUNG devices (smartphone and 
smartwatch) 
SAMSUNG devices will need to be handed over to participants in phase 3 of 
the study in order for remote data collection to begin. Volunteers must sign a loan 
liability term that guarantees the return of the device, and coverage in case of 
damage, as per Annex 3. Longitudinal data collection will be carried out for a period 
of 30 days ± 3 days, requiring remote monitoring by team. Smartphones and 
smartwatches will be used to monitor adverse events regarding cardiac 
arrhythmia, heart rate and blood pressure. All devices will be delivered with the 
necessary applications for data collection duly installed. However, customization 
(login and initial settings) will be carried out by the Innovation team. During phase 
4, each participant will remain with SAMSUNG devices for 30 days ± 3 consecutive 
days. Participants must use the smartwatch and smartphone throughout the day, 
including while sleeping, and charge the equipment batteries regularly. The data 
will be collected by an application embedded in the equipment. 
During phase 5, the participant must return to InCor for a final consultation of 
the study, and return of borrowed equipment. 
 
 
3.8 
Traditional 
electrocardiography 
(ECG) 
versus 
SAMSUNG 
smartwatch ECG 
Still in phase 3 of the project, resting electrocardiography (ECG) tests will be 
performed in conjunction with ECG collection from the smartwatch SAMSUNG, for 
comparison between the two analysis methods (gold standard vs. device). 
All electrocardiograms will be performed at a speed of 25mm/ sec, with 
1mV/10mm calibration, in a MAC 2000 ECG Machine (GE Medical Systems 
Information Technologies, Inc., WI, USA) on an outpatient basis. The electrodes 
will be placed in the classic way of 12 leads (6 in the frontal plane D 1,D 
2,D3,aVr,aVl,aVf and 6 in the horizontal plane V1,V2,V3.V4,V5,V6 ). The 
parameters will be evaluated by the clinical cardiologist, who will issue a report, 
based on the guidelines of the Brazilian Society of Cardiology on analysis and 
issuance of electrocardiographic reports. 
 

 
 
 
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3.9 Peripheral oxygen saturation (SpO2) measurement by SAMSUNG 
martwatch versus standard oximetry 
SpO2 values will be measured simultaneously by the smartwatch SAMSUNG 
and a digital pulse oximetry equipment (G-TECH 302L). Traditional oximetry, using 
an infrared light beam, simultaneously measures heart rate and peripheral 
oxygenation in percentages of 0-100%, and measurements above 95% will be 
considered normal. This evaluation will be carried out in phases 3 and 5 of the 
project. 
 
 
3.10 Blood pressure (BP) measurement by SAMSUNG smartwatch 
versus standard device 
smartwatch will first be calibrated SAMSUNG for BP measurement following 
the instructions of the equipment itself. From then on, 8 consecutive 
measurements will be taken, at rest, alternating between using the smartwatch 
SAMSUNG and the arm pressure gauge (Brand Welch) standard, which uses 
aneroid meter and pulse auscultation (stethoscope littman clinic). Measurements 
with the standard device will be performed with the patient in the supine position, 
after 10 minutes of rest with 3 consecutive measurements. Additionally, a 
measurement will be performed in a sitting position and another measurement in 
an orthostatic position with a 30-second difference between measurements. 
This assessment will be repeated in phase 5 of the project, following the 
same methodology described above. 
 
 
 

 
 
 
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3. 11 Definition of alerts – teleassisted group 
The multidisciplinary team will receive alerts through the application 
platform, according to pre-established limits of blood pressure, heart rate and 
blood oxygen saturation.  
• Blood pressure 
Normal Parameters: Systolic [100 – 140 mmHg] and diastolic [70-90 mmHg] 
Yellow Alert: Systolic [100 – 180 mmHg] and diastolic [90 – 110 mmHg] 
Red Alert: Systolic [<90 and >180 mmHg] and diastolic [<60 mmHg and 
>100 mmHg]. 
 
• Heart Rate: 
Normal parameters: HR detection between 60-100 bpm. 
Red Alert: Detection of HR < 50 bpm outside sleep period; or HR > 100 
bpm (concurrently assessed by watch) 
• Oxygen Saturation: 
Normal parameters: 95 – 100% 
Yellow Alert: 91 – 95% 
Red Alert: <90% 
 
The conduct and actions planned to be taken by the clinical team after 
receiving the alerts through the Si3 platform (on D+1), as well as the guidelines 
that teleassisted patients will receive at the time of hospital discharge, are 
described in the table below: 
   

 
 
 
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Table 2. Flow of care for patients in the study (alerts, guidelines, interventions and actions) 

 
 
 
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The institutional electronic medical record (Si3) software modeling that will be used in the project to access clinical and 
functional information regarding patient data, are exemplified in the figures below: 
 
Figure 6. Institutional Electronic Health Record: Macro view of the alerts referring to the teleassisted group . 
 
MODELO DE TELA SI3 

 
 
 
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MODELO DE TELA SI3 

 
 
 
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Figure 7. Institutional Electronic Medical Record : Macro view of the alerts referring to each patient that makes up the teleassisted group . 
 
Figure 8. Institutional Electronic Medical Record : Visualization of alerts referring to the variable and to each patient that makes up the teleassisted group . 
MODELO DE TELA SI3 

 
 
 
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3.1 2 Ethical Aspects 
 The researcher in charge will ensure that obtaining the TCLE (Annex 1) is 
conducted in accordance with the specifications and international regulatory 
requirements of the ICH (International Council for Humanization of Technical 
Requirements for Pharmaceuticals for Human Use) for good clinical practices 
based on the ethical principles established by the resolution of the National 
Health Council (CNS, Resolution nº 466/2012). 
be submitted to the CAPPesq Research Ethics Committee, via Plataforma 
Brasil. The ethical aspects of research involving human beings will be considered, 
as recommended by Resolution 466/2012. All data collected from volunteers will 
be treated ensuring confidentiality and meeting the other requirements 
established by the LGPD. The patients will be monitored by the multidisciplinary 
team via SI3, and any intercurrence verified by the multidisciplinary team in a “ 
near real time” period and the patient will be consulted and guided in the face of 
the detected intercurrences. 
After completing the survey, the data will be anonymized and analyzed by 
the InCor team. The raw data will be made available to the contracting company 
without any identification of the patient. After processing and analyzing the data, 
publication of the results in scientific databases is expected. 
 
 
 
 
 

 
 
 
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4. ESTIMATED SCHEDULE 
ACTIVITIES 
1st 
month 
2nd 
month 
3rd-7th 
month 
 
8th 
month 
 
9th 
month 
10th-
12th 
month 
Clinical PT submission to 
the Scientific Committee 
and CAPPesq 
x 
 
 
 
 
 
Analysis of the Clinical PT 
by the Research Ethics 
Committee 
x 
x 
 
 
 
 
Device Software 
Installation and Testing 
 
 
x 
 
 
 
Execution of the Clinical 
Protocol  
(inclusion of patients and 
remote monitoring) 
 
 
x 
 
 
 
Compilation and analysis 
of results 
 
 
 
x 
 
 
Final report 
 
 
 
x 
x 
 
Accountability 
 
 
 
 
x 
 
Submission of scientific 
articles 
 
 
 
 
 
x 
 
 
 

 
 
 
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5. ANNEXES 
 
5.1. Case Report Form (CRF) 
 
CASE REPORT FORM 
Study Title 
Wearable -assisted digital telemonitoring of post-cardiovascular surgery patients 
 
Study Samsung FAPO-x 
 
 
 
CLINICAL TRIAL/UNIT: INOVA InCor 
 
PRINCIPAL INVESTIGATOR: Dr. Fabio Biscegli Jatene 
EXECUTING RESEARCHER: Dr. _________________________ 
 
 
 
 
 
I am confident that the information provided on this case registration form is complete and 
accurate. I confirm that the study was conducted in accordance with the protocol and any 
changes to the protocol and that written informed consent was obtained prior to the study . 
 
 
Investigator Signature: 
 
 
 
Patient Name 
 
_____________________________________________________ 
 
Patient Signature: 
------------------------------------------------- _ -------------------------------------------------- 
 
 
 
Signing date: 
 
 
 
 
 
 
 
 
 
 
 
 
D 
d 
m 
m 
m 
Th
Th
Th
Th
 
 
 
 
 

 
 
 
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Inclusion criteria 
 
Yes 
 No 
1 
Is the subject older than 22 years old with heart disease ? 
 
 
 
 
 
 
 
 
2 
Did the subject voluntarily give written informed consent? 
 
 
 
 
 
 
 
 
3 
Does the subject agree to adhere to the study procedures? 
 
 
 
 
 
 
 
 
4 
Does the subject have surgical indication in the presence of heart 
disease? 
 
 
 
 
 
 
 
 
5 
 
 
 
 
 
*If any inclusion criteria is marked as no, the patient is not eligible for the 
study. 
 
 
 
 
Exclusion criteria 
 
Yes* 
 
No 
 
 
Did the subject have post-surgical complications with an extension of 
the hospital stay for more than 14 days? 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
Does the subject have any skin pathology or skin diseases? ( ex : 
vitiligo, lupus and/or atopic dermatitis) 
 
 
 
 
 
 
 
 
3 
Does the subject have allergies to the material components of the 
mobile device? 
 
 
 
 
 
 
 
 
4 
Does the subject have significant abrasions on the body? 
 
 
 
 
 
 
 
 
5 
For some reason did the patient not undergo cardiac surgery? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

 
 
 
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VISIT 1 (TRIAGE) 
Date: _______________ 
 
 
 
 
 
 
 
 
 
 DD MMM YYYY 
  
 
 
DEMOGRAPHIC DATA 
Age years): 
 
 
 
Fri: 
Feminine  
Masculine  
 
 
 
Height (m): 
 
•  
 
 
 
 
 
 
Weight (Kg): 
 
 
•  
 
 
 
 
 
BMI (BMI = Weight ÷ (Height × Height)): 
 
 
•  
 
 
 
 
 
 
Race: 
 
Education Grade: 
 
 
CLINICAL EVALUATION: 
 
( ) Altered heart rhythm ( ) Signs of HF ( ) Dizziness/feeling faint 
 
( ) Decrease in exercise tolerance, dyspnea ( ) Transient Ischemic Attack 
 
( ) Stroke ( ) Chest pain ( ) Dyspnea at rest 
 
( ) Exercise intolerance 
 
  Date of Symptom Onset: _______________ 
 
 
 
                DD MMM YYYY 
 
other, please 
specify 
-------------------------------------------------- ------------ 
 
 
 
 
 
INFORMED CONSENT 
Note: Written informed consent must be given before any study-specific procedures occur or 
any current therapy is discontinued for the purposes of participation in this study. 
Did the subject freely give written informed consent? 
Yes 
 
No 
 
 
 

 
 
 
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COMBITIES: 
 
( ) Valvular Heart Disorder ( ) Diabetes Mellitus ( ) Hypertension 
( ) COPD ( ) Hyperthyroidism ( ) TIA/CVA (history) 
( ) Sudden cardiac death in FH 
  
 
PREVIOUS PROCEDURES: 
( ) No Procedures 
( ) Coronary Angioplasty ( ) Revascularization Surgery ( ) Pacemaker 
( ) Cardiac Resynchronization Therapy ( ) Valve Prosthesis 
( ) Implantable cardiodefibrillator ( ) Ventricular Assist Device 
( ) Heart Transplantation ( ) Chemical Cardioversion ( ) Electrical Cardioversion 
 
  
 
SMOKING: 
 
       Yes 
 
No 
 
 
 
( ) Current (Consumer for a period not less than 6 months) 
( ) Past (If you have smoked at some point in your life, but have not smoked for more 
than 6 months) 
 
 
DRINKING: 
 
 
       Yes 
 
No 
 
 
 
( ) Current (Consumer for a period not less than 6 months) 
( ) Past (If you have smoked at some point in your life, but have not smoked for more 
than 6 months) 
 
The report or record of consumption of alcoholic beverages, alcoholism and/or alcohol 
intoxication will be considered in this study. According to the World Health Organization 
(WHO) acceptable consumption is up to: 15 drinks/week for men and 10 drinks/week for women 
 
 
 
 

 
 
 
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ILLICIT DRUGS : 
 
 
       Yes 
 
No 
 
 
 
Specify: 
------------------- ------------------------------- ------------------ 
 
 
 
PHYSICAL EXERCISE: 
 
 
       Yes 
 
No 
 
 
 
Specify: 
------------------- ------------------------------- ------------------ 
 
 
 
 
INGESTION OF MEDICINES 
Is the subject currently or previously taking any medications, including vitamins and/or 
supplements? 
 
       Yes 
 
No 
 
 
* Record all medications on the Concomitant Medications page 
 
 
MEDICAL HISTORY 
Is there any relevant medical history on the following systems? 
Code 
System 
*Yes 
No 
 
Code 
System 
*Yes 
No 
1 
Cardiovascular 
 
 
 
9 
neoplasm 
 
 
two 
Respiratory 
 
 
 
10 
Neurological 
 
 
3 
Hepatobiliary 
 
 
 
11 
Psychological 
 
 
4 
Gastrointestinal 
 
 
 
12 
Immunological 
 
 
5 
genito-urinary 
 
 
 
13 
Dermatology 
 
 
6 
Endocrine 
 
 
 
14 
allergies 
 
 
7 
Hematological 
 
 
 
15 
Eyes, ear, nose, throat 
 
 
8 
Skeletal muscle 
 
 
 
00 
Other 
 
 
 
 
* If YES to any of the above, please enter the code for each condition in the boxes 
below, provide further details (including dates) and indicate whether the condition is 

 
 
 
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currently or potentially active. If providing details of surgery, specify underlying cause. 
Use a separate line for each condition. 
 
Currently active? 
Code 
Details (including dates) 
Yes 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PHYSICAL EXAMINATION (To be performed only by the medical team) 
Code 
System 
*Not 
normal 
Normal 
1 
General appearance 
 
 
two 
Cardiovascular 
 
 
3 
Respiratory 
 
 
4 
Gastrointestinal / Abdomen 
 
 
5 
extremities 
 
 
 
* If ABNORMAL , enter the code for each condition in the boxes below and provide brief details. 
Please use one _ line separate for each condition . 
 
Code 
Details 
 
 
 
 
 
 
 
 
 
 
   
VITAL SIGNS 
Pulse 
 
 
 
bpm 
Pressure Sanguine ( 
sitting ) 
 
 
 
 
 
 
 
mmHg 
 
 
  

 
 
 
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ECG 
 
Normal 
 
Not normal 
 
** 
** 
Description
____________________________________________________________ 
( ) Sinus ( ) Atrial Fibrillation ( ) Atrial Flutter ( ) Nodal or Atrioventricular Reentry 
Tachycardia ( ) Wide QRS Tachycardia ( ) Bradyarrhythmias  
 
Store the signed and dated dash in the plastic sleeve on the back of the CRF 
 
 
  
LABORATORY ANALYSIS 
 
Initials 
Blood for hematology and biochemistry 
harvested by 
 
✓ 
 
Collection Date ( dd mmm yyyy ) 
 
 
Hematology 
  
 
 
 
 
 
 
 
 
 
 
 
Biochemistry 
  
 
 
 
 
 
 
 
 
 
 
Please insert a copy of all results in the plastic sleeve on the back of the CRF. 
 
CONCOMITANT MEDICATION 
 
Medication 
Daily 
Dose 
(total) 
Items 
Reason 
Start date 
(MM/DD/YYYY) 
End Date 
(MM/DD/YYYY) 
Continuous 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 

 
 
 
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STUDY CLOSURE FORM 
 
 
Reason for Terminating Study  (Please tick main reason only. Reasons other than 
Completed Study require explanation next to answer) 
 Study Concluded  
Adverse Event/Severe Adverse Event (complete the Adverse Event form, if 
applicable) 
_________________________________________________________________ 
 Lost to follow 
 
_______________________________________________________
_________________________________________ 
 Participant no compatible 
 
_______________________________________________________
_______________________________ 
 Medication Concurrent 
 
_______________________________________________________
_______________________________ 
 Medication Contraindicated 
 
_______________________________________________________
_______________________________ 
 To remove consent 
 
_______________________________________________________
_______________________________ 
 Death __ 
____________________________________________________________________ 
Other 
 
_______________________________________________________
___________________________________________________ 
 
 
 
 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
 
 
 
 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
___ ___ / ___ 
___ / ___ ___ 
___ ___ 
 
Study End Date: ___ ___ / ___ ___ / ___ ___ ___ ___ 
(MM/DD/YYYY) 

 
 
 
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5. 2. Term of Loan Responsibility 
 
I,______________________________________________________, 
bearer 
of 
RG 
No._____________________UF 
_______, 
resident 
and 
domiciled 
at 
Address________________________________________________, 
No._____Bairro_____________________, City_________________, State _______ Tel. 
With.: __________________, Tel. Answer: ___________________. 
I 
inform, 
for 
the due 
purposes, 
that 
I 
received 
from 
INSTITUTO 
DO 
CORAÇÃO/FUNDAÇÃO ZERBINI registered with CNPJ under no. 50.644.053/0001-13, the 
equipment described below, owned by SAMSUNG ELETRÔNICA DA AMAZÔNIA LTDA ., 
registered with CNPJ 23.209.756/0001-40, for exclusive use in the FAPO-X Samsung project 
of InovaInCor - InCor, for the term from 30 to 33 day(s) from this date, committing myself to 
return it in perfect condition at the end of this period. 
I declare responsibility for their conservation, in accordance with the manufacturer's 
recommendations; committing myself not to lend or entrust to another person; and 
communicate, immediately to the InovaInCor via message to us nº 11 XXXXXXXX, 11 
XXXXXXXX any incident and occurrence with the equipment(s); as well as ensuring the 
necessary precautions for the proper functioning and integrity of the assigned equipment, it 
being important to point out that the change of address (equipment) is not authorized without 
the knowledge and authorization of Inova InCor. 
At the end of the monitoring period or, in case of withdrawal from the project, I 
will return the complete equipment and in perfect condition, considering the time of 
use, to the competent sector. 
 
Gadgets 
Model 
Accessories 
Serial number 
Smartwatch 
galaxy 5 
 
Induction Charger 
 
smartphone 
 
USB Cable + Power Sup
 

 
 
 
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São Paulo, ______ of __________________ of 20____ 
 
_______________________________ 
Studies Coordinator 
 
 
_______________________________ 
Research Subject 
 
 
 
 

 
 
 
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5.3. 
Activity Diary 
 
Notes until lunch 
Hour 
Activities 
Symptoms 
Medicines 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Notes after lunch until dinner 
Hour 
Activities 
Symptoms 
Medicines 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Notes after dinner (don't forget times you slept and woke up) 
Hour 
Activities 
Symptoms 
Medicines 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Time you slept: ____________ Time you woke up: __________ 
Date 
Hour 
Symptoms (palpitations, chest pains, 
fainting, dizziness, vertigo, etc. ) 
Comments 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

 
 
 
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Blood Pressure Monitoring 
Date 
Hour 
max 
mine 
Frequency 
Therapy 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 

 
 
 
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6. REFERENCES 
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Chronic non-communicable diseases and the use of health services: analysis of 
the National Health Survey in Brazil. Rev. Public Health . 2017; 51( Suppl 1): 4s. 
2 Polanczyk CA. Epidemiology of cardiovascular diseases in Brazil: the truth 
hidden in the numbers. Arch bras Cardiol . 2020; 115(2):161-2. 
 
3Oliveira GMM, Brant LCC, Polanczyk CA, Biolo A, Nascimento BR, MDC et al. 
Cardiovascular Statistics – Brazil 2020. Arq. Bras. Cardiol . 2020; 115(3): 308-
439. 
 
4Feitosa ACR, Marques AC, Caramelli B, Ayub B, Polanczyk CA., Jardim C et al. 
II Guideline for Perioperative Assessment of the Brazilian Society of Cardiology. 
Arch. Bras. Cardiol.2011; 96 (3 Suppl 1): 1-68. 
 
5Stevens B, Pezzullo L, Verdian L, Tomlinson J, George A, Bacal F. The Costs 
of Heart Disease in Brazil. Arch . Bras. Cardiol . 2018; 111(1): 29-36. 
 
6The International Surgical Outcomes Study group. Global patient outcomes after 
elective surgery: prospective cohort study in 27 low-, middle- and high-income 
countries.British Journal of Anesthesia . 2016; 117(5): 601-609. 
 
7 Michael F. Innovations in monitoring from smartphones to wearables. ICU 
Management & Practice 3 – 2017;148-50 
 
8da Silva PLN, Damasceno RF. Nosocomial infections in patients undergoing 
cardiac surgery: a review of incidences regarding post-surgery risk factors. J 
Manag Prim Health Care . 2020; 12:1-23. 
 
9 Baeza-Herrera LA, Rojas-Velasco G, Márquez-Murillo MF, Portillo-Romero 
ADR, Medina-Paz L, Álvarez-Álvarez R et al. Atrial fibrillation in cardiac surgery. 
Arch Cardiol Mex. 2019;89(4):348-359. 
 
10 Filardo G, Damiano RJ, Ailawadi G, Thourani VH, Pollock BD, Sass DM, et al. 
Epidemiology of new-onset atrial fibrillation following coronary artery bypass 
graft surgery. Heart. 2018;104(12):985–92. 
 
11 Ronsoni RM, Souza AZM, Leiria TLL, Lima GG. Update on management of 
postoperative atrial fibrillation after cardiac surgery. Braz J Cardiovasc Surg 
2020;35(2):206-10. 
 
12 Goyal, P., Kim, M., Krishnan, U., Mccullough, SA, Cheung, JW, Kim, LK, ... & 
Kamel, H. (2022). Post-operative atrial fibrillation and risk of heart failure 
hospitalization. European heart journal, 43(31), 2971-2980 . 
 

 
 
 
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13 A lTurki , A., Marafi , M., Proietti , R., Cardinale, D., Blackwell, R., Dorian, P., 
... & Huynh, T. (2020). Major adverse cardiovascular events associated with 
postoperative atrial fibrillation after noncardiac surgery: a systematic review and 
meta-analysis. Circulation: Arrhythmia and Electrophysiology, 13(1), e007437. 
 
14 Chon, KH, & McManus, DD (2018). Detection of atrial fibrillation using a 
smartwatch. Nature Reviews Cardiology , 15(11), 657-658. 
 
15 Verzani RH, Serapiao ABS. Technological contributions to health: look at 
physical activity. Science _ health collective . 2020; 25(8): 3227-3238. 
 
16 Businesswire . UCSF and Sage Bionetworks Announce Stress Research Study 
Leveraging New Sensor Technologies on the Samsung Galaxy S9 ans S9+. 
https://www.businesswire.com/news/home/20180315005916/en/UCSF-Sag 
 
17 Baig MM, Gholam HH, Moqeem AA, Mirza F, Linden MA. Systematic Review 
of Wearable Patient Monitoring Systems - Current Challenges and Opportunities 
for Clinical Adoption. J Med Syst 2017; 41:115. 
 
18Dias D, Paulo Silva Cunha J. Wearable Health Devices-Vital Sign Monitoring, 
Systems and Technologies. Sensors (Basel). 2018;18(8):2414. 
 
19 Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for 
deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. 
 
20Bove LA. Increasing Patient Engagement Through the Use of Wearable 
Technology. Journal for Nurse Practitioners. 2019; 15:535-9. 
 
21 Bayoumy K, Gaber M, Elshafeey A et al. Smart wearable devices in 
cardiovascular care: where we are and how to move forward. Nat Rev Cardiol 
(2021). 
 
22Kolovos P. Wearable Technologies in Post-Operative Recovery: Clinical 
Applications and Positive Impacts. Intl J Caring Sciences. 2020;13(2):1474. 
23GFK. The technologies shaping consumers' lives now and next. Report GfK: 
Tech Trends 2017. 
 
24Slade SJA, Veillette CJ. The application of wearable technology in surgery: 
ensuring the positive impact of the wearable revolution on surgical patients. Front 
Surg. 2014; 1:39. 
 
25Adler-Milstein, J., Holmgren, AJ, Kralovec , P., Worzala , C., Searcy, T., & Patel, 
V. (2017). Electronic health record adoption in US hospitals: the emergence of a 
digital “advanced use” divide. Journal of the American Medical Informatics 
Association, 24(6), 1142-1148. 
 
26 Vuppalapati , C., Ilapakurti , A., & Kedari , S. (2016, March). The role of big 
data in creating sense ehr , an integrated approach to creating next generation 
mobile sensor and wearable data driven electronic health record ( ehr ). In 2016 
 

 
 
 
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IEEE second international conference on big data computing service and 
applications ( BigDataService ) (pp. 293-296). IEEE. 
 
27Sutton, RT, Pincock , D., Baumgart, DC, Sadowski, DC, Fedorak , RN, & 
Kroeker , KI (2020). An overview of clinical decision support systems: benefits, 
risks, and strategies for success. NPJ digital medicine, 3(1), 1-10. 
 
28 Alcade PR, Kirsztajn GM. Expenditures of the Brazilian Unified Health System 
with Chronic Kidney Disease . Braz. J. Nephrol . 2018;40(2):122-129 
 
29Bittar OJN, Biczyk M, Serinolli MI, Novaretti MCZ, Moura MMN. Health 
information systems and their complexity. Rev ADM in Health. 2018; 18:70. 
30Gutierrez MA, Rabelo MFS, Silva UTA, Furuie SS, Pires FA. InCor's experience 
in Health Information Systems. Goldbook of the 50th HUPE Scientific Congress. 
2012. 
 
31 Harris, PA, Taylor, R., Thielke , R., Payne, J., Gonzalez, N., & Conde, JG 
(2009). Research electronic data capture ( REDCap )—a metadata-driven 
methodology and workflow process for providing translational research 
informatics support. Journal of biomedical informatics , 42(2), 377-381.