H-Links: Supporting Physicians with Objective Pain Monitoring for

the Comfort of Patients at Homes

Safae Moustakim

, De Jonckheere Julien

, Anna Holubová

, Aditi Shenoy

Daniela Carsch

and Jacques Battaglia

Institut Supérieur d’Ingénieurs de Franche Comté, Univ. Bourgogne Franche-Comté, 25030 Besançon cedex, France

CIT 1403 « Biocapteurs et eSanté », CHU de Lille, 59000 Lille, France

Czech Technical University in Prague, Faculty of Biomedical Engineering, 10000-199 99 Prague, Czech Republic

Health Informatics Department, Karolinska Institute, 171 77 Solna, Sweden

Leibniz-Institut für Polymerforschung, 01067 Dresden, Germany

Université Pierre et Marie Curie, 75000 Paris, France

Keywords: Telemedicine, mHealth, Pain Management, Pain Monitoring, Ambulatory Care, Pediatric Surgery.

Abstract: The following study focus on pain management during post-operative surgery treatment, it describes a

solution for measuring the pain level for pediatric surgery patients at home since hospital care is trending

towards ambulatory care. This solution can decrease the time in pain and optimize dosing of drug intake,

and thus, improve the effectiveness of the treatment, reduce the time of post-surgery recovery and reduce

the risk of chronic pain development. This can, in a global way, increase the overall quality of life of both

patients and their family members. From the parent’s point of view, better acceptance of ambulatory surgery

can be expected together with reduced stress caused by a fear of pain management at home. From the

hospital’s point of view, we expect an increase in the rate of ambulatory surgery, and thus, an increase of

beds availability.

1 INTRODUCTION

In the last couple of years, the hospital care is

trending towards the ambulatory care because of the

hospital charges for patient staying in hospital after

surgery and the bed availability. Indeed, for many

years, the number of hospitals beds available across

the EU has decreased : available beds fell from 2.93

million in 2004 to 2.65 million by 2014, a relative

decrease of 9.6% while the number of beds per 100

000 inhabitants fell from 592 in 2004 to 521 in

2014, a decline of 12% with the EU’s population

growth. Besides, the hospital charges for a patient in

ambulatory care is lesser than the one for a patient in

non-ambulatory care. For example, the patient

having a unicompartmental knee arthroplasty in

ambulatory care is charged $20,500 less than the

patient that is not and who has to pay in average

$46,845. Moreover, the average reimbursement was

55% of charges, or $25,550 for the patient staying in

hospital while it was 47%, or $12,370 for the patient

in ambulatory care (Richter, 2017). But this

tendency gives new challenges. It implies that all the

time that nurses and physicians used to spend with

patients face-to-face for monitoring or guiding them

will lessen, and also that post-operative care at home

should become more usual.In this context, the

communication between patient and physicians

worsen beyond what it already was (Kyle, 2014).

For example, according to a AAOS (American

Academy of Orthopaedic Surgeons) survey, 75% of

the orthopaedic surgeons believed that they

communicated satisfactorily with their patients but

only 21% of the patients reported satisfactory

communication with their doctors. Additionally, the

pain for patient will also worsen since acute pain is

followed by chronic postoperative pain for 10 to

50% of the patients, pain cannot be measured

objectively and there is no standard for feeling pain

and administering appropriate amounts of drugs

(Chou, 2016).

2 STATE OF THE ART

The presented solution is aiming to support post‐

operative surgery treatment in general and for the

first step measuring the pain level for pediatric

Moustakim, S., Julien, D., Holubová, A., Shenoy, A., Carsch, D. and Battaglia, J.

H-Links: Supporting Physicians with Objective Pain Monitoring for the Comfort of Patients at Homes.

DOI: 10.5220/0007696106370644

In Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019), pages 637-644

ISBN: 978-989-758-353-7

637

surgery patients. After Surgery, depending on kind

of surgery, the health care professional will regularly

check the health status of the patient (usually three

times a day). This examination is usually paper

based evaluation of questionnaires or simple

patient ́s observation. When the patients are sent

home, the health care professionals will inform the

patients about the medical prescriptions and arrange

additional appointments to check on the healing

process and to detect possible complications that

could occur. Typically, the nurse will call the patient

regularly and ask about the pain level. In hospitals,

the post‐operative pain level is measured usually by

observation and questionnaires.

2.1 Market Positioning

Automatic physiological pain measurement systems

exist but are exclusively dedicated to pain evaluation

of patients during surgery under general anesthesia

or in intensive care unit (Jeanne, 2014, Broucqsault

Dédrie, 2016). These devices are based on

measurement of heart rate variability, skin

conductivity or pupillary dilatation (De jonckheere,

2015). With respect to the telemonitoring systems

used for post ‐ surgery care, there are already

different solutions on the market available to

connect doctors and patients before and after surgery

(Yoon, 2016). The solutions differ with respect to

the field of activity, the measure of pain level,

hardware integration, degree of doctor interaction

and targeted patients. Examples of competitive

solutions in comparison to the project idea are

SeamlessMD or Kardia. One identified solution,

which addresses this patient group, is “Surgery

Connect”. However, this service focuses only on

informing the parents about the process of surgery.

There is no existing solution on the market for

objective pain assessment, with additional

physiological information from hardware devices for

patients at home after surgery. Products that measure

the pain level rely on information provided by the

patients only. However, at the University Hospital in

Lille the ANI monitoring system used for pain level

measurement in unconscious patients during surgery

has been already tested also on conscious patients

during the first 2 hours right after surgery, and thus,

approved as capable of measuring on conscious

patients as well (Jeanne, 2014). Therefore, the

unique selling proposition of the project idea

addresses the integration of hardware information

together with information from the patient. The

project idea focuses in the first step on children

which undergo surgery.

2.2 Market Potential

Different trends, like the encouragement by

government bodies for digital technology in

healthcare or increasing awareness of mobile based

medical devices support the annual growth of the

mobile health market (CAGR 32.3% until 2025),

which was 33.59 billion dollar in 2018 worldwide.

The market can be segmented by technology

(Telehealthcare, Telecare, Telehealth, mHealth,

Health analytics, Digital health system) but the

project idea includes technologies from many

segments and therefore the number of all patients

undergoing a surgery as well as patients under 14

years in Europe was taken into account to get a

clearer idea of the market. The countries with the

most surgeries performed per year in Europe in

million are 1. Germany (16.8 | 1.4) 2. UK (7.9 | 1.4)

3. France (5.0 | 0.9). To estimate the market volume,

we assumed to collaborate with three hospitals in

France for the first year, 5 in France and one each in

Germany and UK for the second year and for the last

year with 10 hospitals in each country. We identified

the average surgeries performed each year per

hospital and linked them with the cost savings we

could archive with our product. The cost savings are

based on the results of a survey, which indicates a

saving of three days of hospital stay with a mobile

application for postoperative monitoring after

discharge. We assume to archive an acceptance level

for each hospital of 70% (based on results of

SurgeryConnect).

3 SOLUTION SPECIFICATIONS

In order to address the problem with inability to

measure pain objectively among post-operative

surgery patients, the team has identified medical

device management systems from medical device

companies which could provide the software with

suitable physiological signals required to identify

pain level for physicians, who can then monitor

patient ́s health state remotely. Our team would

launch the first product module focused on pain

management with eventually spanning out to other

disease areas and suitable management of those

diseases.

The solution will enable to:

 Provide hospitals sufficient data (both subjective

and objective) related to pain management online

from patients´ homes online,

ClinMed 2019 - Special Session on Designing Future Health Innovations as Needed

638

 Use notifications and reminders for inter and

intra-day situations where needed,

 Reduce the amount of manually register data

needed to be provided by parents hanks to the

connected wearable technology,

 Facilitate communication between

patients/parents and hospital staff,

 Facilitate dosing of pain killers,

 Discover pain level variability both during a day

and during the night also for further research

purposes.

We suspect that from the patient ́s point of view, this

solution can decrease the time in pain and optimize

dosing of drug intake, and thus, improve

effectiveness of the treatment, reduce time of post-

surgery recovery and reduce risk of chronic pain

development. This can, in global way, increase of

overall quality of life of both patients and their

family members. From the parent ́s point of view,

better acceptance of ambulatory surgery can be

expected together with reduced stress caused by a

fear of pain management at home. From the hospital

point of view we expect increase of the rate of

ambulatory surgery, and thus, increase of beds

available for patients. In addition, better awareness

of surgeons (and also other HCP) about patient ́s

post-surgery health state can bring them relief and

reduce time spend on face to face consultations, if

these can be replaced by telemedicine.

4 PROPOSAL OF INNOVATIVE

PRODUCT

4.1 Overview

Our solution will serve as a home-based

telemonitoring platform used primarily for pain

management of children after ambulatory surgery.

The platform will enable the patients (or their

parents, respectively) to collect data needed for

proper control of the post-operative care, i.e.

manually registered information about patient ́s pain

and daily activities, and data automatically collected

through wearables, i.e. patch ECG monitor and

activity tracker (Ooley, 2018, Evenson, 2015), for

objective evaluation of pain level. In addition,

connection with a hospital through a mobile and web

application will be provided. The mobile app will

serve also as a bridge for the data measured by

wearable technology and transferred to a secured

server (Hassan, 2018; Boulos, 2014).

In that place, the data can be processed,

analyzed, and further displayed with a specific

interface to both the healthcare provider and the

patient/family member via the mobile or web

application. Notifications and reminders will be

included. Fig. 1 illustrates the whole concept

proposal.

Figure 1: System workflow and components diagram.

4.2 Connected Technology

The main wearable technology includes a patch

ECG monitor used (in connection with a pain

management system algorithm) for the objective

evaluation of patient´s pain, and an activity tracker

for automatic evaluation of patient´s intensity of

physical activity throughout a day and their sleeping

efficiency.

4.3 Data Collection and Analysis

For the patient's monitoring, both manually entered

and automatically registered data via wearable

sensors will be tracked.

Manually registered data contain the following

parameters:

 Subjective pain evaluation (using standardized

scales for kids and adolescents)

 Mood information

 Acute pain detection needed to be immediately

suppressed by medication

 Type of activity the patient performs during a

day and its duration (resting, playing, sleeping,

eating, walking)

 Medication intake (dose, datetime)

Automatically registered data are displayed in Tab 1

together with the explanation of their role in pain

management. Based upon the results from the

clinical study during which all the parameters are to

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639

be measured, the final composition of the sensors

needed to be tracked will be proposed.

Table 1: List of automatically collected data using

connected devices.

Parameter

Possible

device

Role in homecare

pain management

Heart rate

-Patch holter

-SmartWatch (if

the accuracy is

proved to be

sufficient)

Pain level monitoring

via pain management

systems ‘algorithms

Physical

activity

-Activity tracker

Automatic evaluation

of intensity of

patient´s daily activity

and sleep efficiency

Among to the data provided by healthcare

provide, the following informations are included:

 Type of drug administration and its timing,

 Drug prescription,

 Visit appointments scheduling,

 Notifications and comments on treatment.

The data transmitted to the server will be processed

using certain algorithms and displayed in form of

graphs and tables to the doctor via web portal. The

doctor will have the opportunity to go from the

general overview on the data collected into more

detailed characteristics.

Values out of the target range will be highlighted

and alarms implemented. Download of a report

(PDF) for upload into EMR capable of importing

PDF documents, or raw data (CSV) for further

analysis will be also an option for the web user.

4.4 Communication

The healthcare provider will be able to send a

notification to the patient through the connected web

app. Depending on the importance of the message,

three levels of notifications can be used (urgent

message, treatment change recommendation, general

information), whereas the notifications are

differentiated by a specific colour both on the

mobile app and web app the patient/parent can

connect to, using their unique credentials.

In case of emergency situation which needs to be

treated immediately, direct call can be performed by

both either the hospital or the parent.

4.5 Interoperability and Third-party

Integration

The data from wearable devices will be transmitted

to the server either directly (in case the

communication protocol is available) or through API

of given company. To create a secure and

interoperable health data exchange, the Continua

Design Guidelines will be followed. Following the

standards, the FHIR configuration will be

implemented for potential future connection with an

EMR system of a hospital.

4.6 Data Security

Three main principles will be followed to ensure

protection of the data: confidentiality, integrity and

availability.

5 PROJECT RISK ASSESSMENT

 External Risks:

External risks include all influence which is

resulting from the environmental influence. One risk

is the development of the competitive landscape

during the project time and new technical solutions.

To address this risks a constant market analysis will

be implemented, to allow a imitate response and

agile adjustments in the project objectives, if

necessary.

 Internal Risks:

The project requires certain competences to address

e.g. certification regulations but also knowledge

about country specific health care regulations and

systems. During the project period the specific

requirements will be identified and addressed by

external consulting services or the employment of

the suitable positions.

 Financial Risks:

In the first time period to the breakeven point the

development of finance strategies for the project will

be necessary. This includes the identification and

implementation of the relevant financing options.

- Hospitals will not be willing to participate on the

expenses for the system

- Medical insurances will not participate on the

cost reimbursement

6 DEVELOPMENT PLAN

The development plan consists of 6 work packages

(WPs) summarized below, whereas each WP

consists of objectives, description and deliverables.

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WP1: Project Management

The management part goes across the whole project

lifecycle period and is responsible for leading the

whole project and its team members and

achievement of each particular WP to be done as

required and on time. In addition, financial and

administrative roles are included into this process, as

a subcategories.

To ensure seamless development of the project,

weekly report of the project monitoring evaluation

and control will be done.

WP2: Definition of User Requirements,

Technical, Clinical and Ergonomic Evaluations

Using a user-centred design approach, the user needs

would be evaluated using focus groups and creation

of personas. This would be done collectively for

each of the stakeholders of this application. Since

current standards of pain measurement are not well

defined, a proof of concept with a software

prototype would be designed for stakeholder’s

feedback. The application would initially be

developed for an Android OS to be freely available

for download for patients and their families. The

application designed for the healthcare professionals

would be connected with the hospital systems which

would enable a single e-health system.

WP3: Preclinical Study

During the analysis of suitable sensors that could be

used for monitoring of given parameter, the

following factors will be taken into consideration:

compatibility of medical device with software

application, quality of signal, wireless data

transmission, size of the device, it´s price and

duration of battery used to charge the device.

To get sufficient data for development of

algorithm, preclinical study will be performed on

20-30 subjects (children in post-operative state, age

of 2-8 years) for 2 days. In these patients heart rate

variability and physical activity will be monitored

via selected wearable devices.

In parallel to the automatic data transfer from the

wearables, patient´s manually registered information

about the pain and daily activities will be registered

using usual tool.

WP4: Development

First step of the development stage the software

architecture will be performed. Based upon the data

obtained from WP2 the design, concrete

functionalities and final interface of both the mobile

and web application will be made, before conducting

the validation phase of clinical study.

As a first concept of the telemonitoring system

we will implement the software part only, without

the data evaluation obtained from connected

devices.

After the validation of the accuracy of the

devices and the final device composition is resolved,

the upgrade version of the system, including the

hardware part of the project, will be implemented,

processed through the regulatory, and marketed in

parallel to the software solution already approved.

The algorithm used for automatic evaluation of

pain level will be developed in cooperation with the

company producing the pain management system.

The automatic evaluation of physical activity level

will be created in accordance to the data analysis

made after the preclinical study.

During the whole development period, we will

also actively consult particular issues with software

experts and regulatory affairs to ensure the final

product will meet all the essential requirements.

Requirements for quality management system will

be followed based upon the ISO 9001 standard.

Each update of the software versions will be

tested based on the testing processes described

within the Risk assessment section. As a final

control of the software testing phase, the verification

and validation is performed based on the IEC 62304.

WP5: Regulatory Assessment

Certification and Standards

The commercial product we create would have to be

classified as Class IIa medical device (COUNCIL

DIRECTIVE 93/42/EEC, Annex IX, Rule 10).

After receiving clinical validation, we would

improve the functionalities of our application to

produce automatic recommendation of medication

dosage to assist decision making based on multi

sensor data. This might require us to move to Class

IIb medical device certification (Directive

93/42/EEC, Annex IX, Rule 11).

Risk Analysis

For the methodology, the FMEA-based method is

used and ISO 13485 is applied.

The protection of personal data will be treated

based upon the EU legal framework, GDPR

(General Data Protection Regulation).

Identification of characteristics of a medical

device related to a usage that could have an impact

on safety are treated based upon the international

standard IEC 62366.

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WP6: Validation and Usability Studies

A series of formative and summative evaluations

will be conducted for this project. The formative

evaluations planned for this prototype were selected

from ‘Product planning methods’ and ‘User research

and validation’ method. For analysing how the

system was designed, evaluating which aspects of

the system are lacking and identifying usability

problems, a heuristic evaluation will be used.

Subsequently, focus groups and observation

studies will help us identify the problems with

usability of the application for the physicians and the

patients before the first prototype is created and also

during the testing phase of the system.

For the technical part of the solution, validation

and verification will be performed during the last

phase of the development period.

As a part of the validation, clinical study will be

performed.

Deliverables:

Proof that our product can be used as intended,

brings benefit to the end user as expected and is ease

to use enough to encourage the end user for its long-

term use.

7 CLINICAL STUDY

The clinical study aim to evaluate the usability and

effectiveness of the whole system and the workflow

process, the main evaluations of this study are:

 Comparison of the manually registered pain level

data with the automatic data obtained through the

wearables

 Patient level of pain

 Treatment adaptation

 Physicians and parents feedback

 Family quality of life

7.1 Criteria for Acceptance

- Age: 2-8 years old

- Orthopedic post-surgery

- No cardiac disease

- No neuropathic disorder

7.2 Clinical Study Performance

2 arms of patients (50-60 children, 2-8 years of age)

who undergo an ambulatory orthopedic surgery will

be recruited to the study, i.e. intervention and

control group.

Intervention Group:

The intervention group will get the sensors to

measure HR and physical activity. All the data will

be automatically transmitted wirelessly to the

connected mobile app, synchronized with the server

and displayed to a doctor in a hospital. In addition,

parents of the kids will provide manually registered

information to the app.

Both the parents and the doctor will have an

access to the data collected through a mobile/web

app.

The doctor will be able to send a notification to

the patient based upon the data obtained through the

connected web app.

The doctor will check the data approx. 30 mins

before patient ́s scheduled medication, and in

case of the need of the dosage change, he will

send the patient a message with the recommended

dosage.

The phone call can be used in case of emergency

situation.

Control Group:

As a control group the patients ́ results from the

preliminary study will be used. In case the treatment

processes will be changed until the beginning of the

clinical study the new arm of control group will be

performed.

The control group will be following the standard

healthcare methods used for ambulatory surgery.

The parents will follow the doctor's medications

prescriptions and will be able to contact a nurse 2

times a day to check the patient's health state. Paper-

based questionnaires and information about patient ́s

daily activities will be provided by the parents and

consulted at the face to face consultation with the

doctor.

8 BUSINESS PERSPECTIVE AND

ECONOMIC MODEL

The business model involves the software

application for patients and doctors, which is

connected to the database and also includes

information from wearable devices. The market

entrance strategy focuses primarily on the promotion

of the software to enhance the connection between

healthcare professionals and patients based on

subjective data.

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642

For the market entrance of the business model

the end user group will be parents, whose children

are under 14 years and underwent surgery.

Additionally to subjective information the main

hardware information will be an objective pain

measurement, which is already used during surgery.

For future portfolio-expansion different solutions in

different field of surgery and specifically chronic

pain monitoring will be considered. For the

expansion of the field of areas additional hardware

devices could be implemented and the related

information included into the database.

The main targeted customer groups will be

hospitals and health systems, where the biggest

benefit will be generated due to cost savings

regarding the reduce of the length of stay in

hospitals by around three days. There also exists

evidence, showing that 110 clinic spots became

available due to monitored patients at home after

surgery. Based on the saving of three hospital stays

per day a potential savings for Germany (1 billion

€), France (450 million €), and UK (3.5 billion €)

could be calculated. The main business core activity

will be to develop the software application but also

to manage the data transfer and storage. To process

and analyse the received data different algorithm

will be applied, which will be licensed. For the

provision of the hardware devices corporations with

manufacture of already existing medical device

solutions on the market will be targeted.

The marketing strategy will primary rely on

doctors as influencers. Therefore, the main efforts of

communication will target this group. Studies, which

quantify the benefits of the project solutions, will

have a high priority to raise the awareness level and

building trust. Nevertheless, the patients will be the

user to decide to download the software and will

therefore have a direct influence of the selling

outcome.

The most important geographical markets where

identified according to the number of surgeries

performed per year in Europe. As a first stage the for

the market launch the first customer will be the

leading hospitals in France (e.g. Centre Hospitalier

Régional Universitaire de Lille). For the following

year the market entrance to one hospital each in

Germany and France will be addressed. After

showing evident of the quantified data for the

financial benefit of the products health systems (e.g.

APICIL in France) can be addressed to cover the

costs. As a last step and long-time goal the data shall

be provided to research institutes and companies.

9 CONCLUSIONS

Opening the doors for both subjective and objective

evaluation of pain in homecare enables us to collect

big data related to pain management and explore our

solution to other healthcare sectors. The data

collected from both home and hospital environment

can give us the opportunity to explore our solution

and involve machine learning algorithms enabling to

provide better decision support and make some so

far manual processes fully automatic (e.g. automatic

recommendation of drug dose adjustment). This

could significantly reduce time spent on data

analysis on the side of HCP.

Healthcare providers can profit from the data in

order to proof their high quality and efficient

treatment practices. Researchers can get an

opportunity to discover new methods for pain

management treatment, and manufacturers can

obtain evaluation of effectiveness of their products

and tips for their further improvement.

Proving that the objective pain evaluation can

work for treatment of post-surgery homecare of

children, our future aim is to explore the solution to

adults -considering software adjustment due to a bit

different treatment procedures- and moreover, focus

on its potential use also in chronic pain

management, which represents a huge market

opportunities.

ACKNOWLEDGEMENTS

This work was supported by The EIT Health

Summer School CLINMED, INSERM CIC- IT 1403

of Lille, Bourgogne Franche-Comté University,

Karolinska Institute and Pierre and Marie Curie

University and Charles University.

The authors would like to thank the surgery

department at the University Hospital of Lille, and

Mdoloris Medical Systems based in Lille, France for

their collaboration.

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