Report

DIGITAL HEALTH
AND DATA
COLLECTION
EFCCA
SYMPOSIUM
Vienna 14 February 2020, ECCO Congress
 CONTENTS

3 Foreword

4 Introduction

5 Setting the scene

7 The Patient Perspective

10 The Physicians and Health

Care Professionals’
Perspectives

12 The European Federation

of Pharmaceutical
Industries and Associations
(EFPIA) perspective

14 Discussion points

15 Step forwards

European Federation of
Crohn’s and Ulcerative
Colitis Associations

Rue Des Chartreux, 33-35

Brussels B 1000 - Belgium

Phone: +32 2 540 84 34

Fax: +32 2 540 84 34

www.efcca.org
FOREWORD

Digital tools and technologies are

rapidly transforming healthcare systems
and have a huge potential in patients’
treatments and life.

In the past two years, the European

Federation of Crohn’s & Ulcerative Colitis
Associations (EFCCA) has been in the
forefront of the discussion on how digital
health and big data can contribute in
delivering more personalised care and
offering a higher quality of life for patients
with IBD.

This report summarizes the discussions

made during the symposium on Digital
Health and Data Collection organised It means involving them in the whole
by EFCCA and which took place during process that starts from the design of
the ECCO Congress on 14 February the structure of the data base, goes
2020 (Vienna, Austria). through the data collection and ends
in data analysis. Analysing data from
The symposium convened for the first- the patient’s perspective can become
time representatives from the IBD a powerful and unique way to achieve
patient community, physicians/Health earlier diagnosis, better care strategies
Care Providers and the pharmaceutical and identify patterns in health outcomes
industries to initiate an open discussion in partnership with medical societies and
on how digital technologies can bring all relevant stakeholders.
benefits and opportunities for all.
We are pleased that this first meeting
EFCCA believes that a multi-stakeholder has been such a success, but we must
approach and collaboration can now continue with this important work, we
represent an opportunity to achieve a must widen this stakeholder discussion
more harmonic combination between the involving also representatives from the
quality of care and quality of life data of payers and the regulatory bodies and
IBD patients. we must ensure to bring the entire IBD
community on board. We are confident
Patient centred care, which is considered that together we can make a difference
the standard in Europe, means giving for the lives of people with IBD.
patients a central role in the digital
“revolution” in health care as well as the Isabella Haaf
data collected from patients. EFCCA Deputy Director

3
 Introduction
The IBD patient community is getting Patient data ownership is then the most
increasingly involved in the debate effective answer and patients are the
related to e_health and the proactive role more suitable players to assure equal
they can play in collecting, managing and access to knowledge and information
owning their data could lead to stronger and to avoid discrimination in the use of
empowerment and a more precise outcomes and analysis. By assuming the
definition of unmet needs and patients’ full control of data patients can strongly
priorities. contribute in defining research activities,
Digital health and more importantly reducing the time of diagnosis and
data collection can be the most suitable prioritising key messages and outcomes.
solution. Generally speaking, patients are
willing to share data related to their health It is within this framework that EFCCA
conditions and quality of life, but it is has decided to organise a symposium
crucial that appropriate data protection, on Digital Health and data collection
privacy rules as well as the full control of bringing together representatives from
the whole data collection process is co- the IBD patient community, physicians
designed and defined. and industries to start discussions on this
important issue and to see how a multi-
Empowering patients and patient stakeholders and industry alliances can
associations can lead to more bring benefits and opportunities for all.
commitment and to target that portion
of the IBD patient community that is still
not fully engaged and aware of the role
it can play in research and personalised
medicine.

4
Setting the scene

“
The keynote speaker of the symposium,
Professor Claudio Fiocchi (Cleveland
Clinic, USA) has a longstanding
commitment to research and education “The world’s most
in the field of Inflammatory Bowel
Diseases and has published numerous
valuable resource is no
peer reviewed publications in scientific longer oil, but data.”
journals as well as book chapters and Professor Claudio FiPrrr
abstracts.

Whilst providing the context for the

symposium’s discussion Professor
Fiocchi proposed an integrated,
holistic approach to IBD which holds
significant promise for improving both
our understanding and treatment of
the disease. Only by considering the
complexity of the disease and the
diversity of each patient will we be able
to achieve successful IBD therapies.

More specifically, with the regard to the

topic of digital health and data collection
Professor Fiocchi sees Patient-Reported
outcomes (PROs) as an important
contribution to boost progress in IBD and Professor Claudio Fiocchi
stressed that data including biomedical
big data has become one of our most
valuable resource. Other successful digital interventions
aimed specifically at IBD and involving
By merging computing and medical the collection of patients´ biomedical
technologies, we will see exciting data have allowed physicians to move
breakthroughs for Inflammatory Bowel from traditional generic therapy to a more
Disease. Artificial intelligence (AI), comprehensive precision therapy.
machine learning and deep learning
are the new tools to understand IBD To conclude with his presentation
and advance its therapy. For example, Professor Fiocchi highlighted some
Artificial Intelligence (AI) systems have of the barriers to digital medicine with
shown to improve diagnostic accuracy of interoperability being an important
95% for common ailments. element.

5
 “Interoperability is a The fact that there are a wide range
of databases, compatible systems
prerequisite for the
and proprietary software means that
digital innovations it is difficult to exchange, analyze and
envisioned for future interpret data in a meaningful way,
making “Interoperability a prerequisite
medicine.” for the digital innovations envisioned for
Professor, future medicine.”
Claudio Fiocchi

SYMPOSIUM OPENING

“
Opening of the symposium:
Professor Silvio Danese, ECCO President and
EFCCA Chairman, Salvo Leone

“For the first time

today, an event
organized by the
patient community
takes place during an
important medical
congress. 

This is a signal that

the relationship
between EFCCA and
ECCO is growing
and is taking on a
deeper value and
significance.”
EFCCA Chairman,
Salvo Leone

6
The Patient
Perspective
The IBD patient community is getting It is important that barriers to all-
increasingly involved in the debate inclusive access such as digital illiteracy,
related to e_health and the proactive role economic level, education, chronic
they can play in collecting, managing and conditions, disabilities etc. should be
owning their data could lead to stronger appropriately addressed and overcome
empowerment and a more precise in order to have meaningful and impactful
definition of unmet needs and patients’ digital health solutions.
priorities.
Generally speaking, patients are
Digital health and more importantly willing to share the data related to their
data collection can be the most suitable health conditions and quality of life,
solution to the above-mentioned but it is essential that appropriate data
needs and patients clearly want to be protection, privacy rules as well as the
involved in the development of digital full control of the whole data collection
health solutions. It is important though process is co-designed and defined by
to generate evidence that shows the and with patients.
positive impact that any given digital
solution has on the patients´ quality of life Involving patients in all stages of
and general well-being. the development of digital technology
will better ensure that these tools are
For digital health to be as useful as it successful and impactful.
can be, it needs to involve the widest
range of patients to collect data on health When patients are involved from the early
markers. This will allow scientists with the stages of the development process, they
help of big data systems and artificial can easily flag difficulties that will lead
intelligence to deliver precision medicine. to a slow uptake of a given tool and at
the same time they can show patient
Therefore, ensuring all-inclusive access preferences and real-life needs which will
to these technologies especially by make the device more accessible and
groups of patients that are more reluctant more likely to be used.
to use these is of paramount importance.
Empowering patients and patient Evidence from the following digital health
associations can lead to more projects that have been developed by
commitment and to target that portion patients or that have involved patients
of the IBD patient community that is still from the early design stage show very
not fully engaged and aware of the role positive results and are an encouraging
it can play in research and personalised model to pursue.
medicine.

7
 “
PATIENT PERSPECTIVE

MICI CONNECT (IBD CONNECT) “1 in 2 patients

An excellent example of a digital tool
thought that the (MICI
developed by patients is the MICI Connect) platform had
Connect (IBD Connect) platform.
allowed them to avoid
This platform was created by the French hospitalization.”
Professor Claudio FiPrrr
IBD association AFA Crohn RCH France
and offers services and a support
program from patients, for patients. It is What makes the tool original is the fact
a collection of tools to better understand that it was designed and built by the
and manage the disease. Several paths patients themselves, in answer to their
are proposed allowing each user to own individual problems and needs in
progressively assimilate the information everyday life.
needed daily with the disease.
In a follow up survey to the MICI Connect
The patient may also follow his or her App 84% of its users were satisfied with
progression with the disease through the tool and would recommend it to
some useful scores for consultations someone else. 68 % felt reassured about
with health professionals such as fatigue, their disease and 1 in 2 patients thought
quality of life, number of stools, etc. and that the platform had allowed them to
add this data to his or her health journal. avoid hospitalization.

Bastien Corsat representing MICI Connect

8
 PATIENT PERSPECTIVE

MYIBDCOACH

Another good example of showing the The result showed a high satisfaction and
importance of patient involvement in the compliance of patients and health care
design and development of digital health providers. Interestingly, the results also
tools is myIBDcoach. MyIBDcoach was showed a 36% reduction in outpatient
developed in partnership with patients, visits, a 31% reduction in telephone
dietitians, IBD nurse-specialists, and consultations and a 50% reduction in
gastroenterologists. hospitalisations and increased adherence
to medication.
MyIBDcoach enables continuous home-
monitoring of patients with IBD and
enhances disease knowledge and
communication between patients and
health care providers.

A feasibility study of myIBDcoach was

carried out in order to evaluate the effects
of myIBDcoach compared to standard
care on healthcare utilisation and patient-
reported quality of care PRQoC.

Dr Marieke Pierick, Maastricht University Hospital

9
 The Physicians
and Health Care
Professionals’
Perspectives
In her presentation made at the physicians and HCPS rely heavily on
Symposium, MD Catarina Fidalgo quality data to decide where there are
(Hospital Beatriz Ângelo & Hospital da high value interventions and where not.
Luz, Portugal) provided some interesting
reflections and viewpoint on the issue of Unfortunately, getting good quality data
digital health and data collection from the is not easy.
physicians´ viewpoint.
Sometimes it is a lack of access to such
Given the huge financial costs around IBD data (be it government, insurance or
care from diagnosis to risk stratification, clinical trial data) or there is data that is
treatment, complications and recovery, conflicting or unclear.

Dr Catarina Fidalgo, Hospital Beatriz Ângelo & Hospital da Luz

10
 “ There is a lack of
clear definitions or
outcome
measures available
to establish quality
of care standards for
IBD patients
“
This lack of clear definitions or outcome An initiative of ECCO, the “United
measures available to establish quality Registries for Clinical Assessment
of care standards for IBD patients and Research” (UR-CARE) database is
has led the European Crohn’s and an online international registry capturing
Colitis Organisation (ECCO) to work IBD patients’ records in an easy and
on the construction of a list of criteria comprehensive way. 
summarising current standards of care in
IBD. UR-CARE is designed for daily clinical
practice and research studies and is
The list is based on scientific evidence, available to study groups as well as
interdisciplinary expert consensus to individual centres. 
and patient-oriented perspectives.
It represents the position of ECCO Another issue MD Fidalgo highlighted
regarding the optimum quality of care was the incompatibility of Clinician Rated
that should be available to patients. Outcome Measures (CROMS), Patient
Reported Outcome Measures (PROMs)
Considering that healthcare systems and and Patient Reported Experience
regulations vary between countries it measures (PREMs). Furthermore, none
might be necessary to adapt it at local and of the 20 existing PRO tools for disease
national levels and it is recognised that activity meet the FDA criteria for tool
not all criteria that have been identified quality and only 2 of them involved patient
as optimal will be available in every unit. representatives in the process.

11
 The European Federation
of Pharmaceutical
Industries and
Associations (EFPIA)
perspective
Pharmaceutical companies in Europe The project will empower patients
are recognizing that digital technologies with tools to measure their outcomes
are driving a radical transformation of in a standardised manner creating
our healthcare systems and that in order transparency of health outcomes.
to support health innovations there is a
need for connecting and collaborating The overall objectives of H2O will be to
with all relevant stakeholders. make health outcomes transparent to
patients and other stakeholders in order to
In its manifesto “Building a healthier improve clinical care, to enhance medical
future for Europe” the EFPIA calls for research and to support moves to value-
the need to “drive the evolution towards based healthcare while also creating an
patient-centered and outcomes-focused ethically and legally appropriate model
healthcare systems to allow national for the collection and management of
governments to recognise and reward patient health data.
innovation based on the value it brings
to patients and society. This includes Patients will create information and use
assessing and benchmarking EU Health this with their health care professionals
Systems by using patient-relevant in routine clinical care; researchers and
outcomes, with the support of digital policy makers will use the new data to
solutions and a European harmonised improve policy and decision making.
distributed health data network”.
An umbrella organization at the European
Speaking on behalf of the European level will ensure interoperability and
Federation of Pharmaceutical Industries reproducibility at international level.
and Associations (EFPIA) Ms Meni
Styliadou and Pr Tanja Stamm, PhD
(Head of Section for Outcomes Research
at Vienna University) presented the
H20 (Health Outcomes Observatory)
a European project funded by the
Innovative Medicines Initiative.

12
 Meni Styliadou (left) and Tanja Stamm

“ Drive the evolution

towards patient-centered
and outcomes-focused
healthcare systems
to allow national
governments to recognise
and reward innovation
based on the value it
brings to patients and
society...
“
13
 kkkkkkk

Discussion
points
Following these presentations and discussions during the Question and Answers
session we have identified the following elements/barriers that we aim to further discuss
with all multi stakeholders and industry alliances.

INTEROPERABILITY

The interoperability of digital medicine. to encourage greater use of the most

The fact that there are a wide range impactful technologies. Data collection
of databases, compatible systems and protection under institutional
and proprietary software means that umbrella.
it is difficult to exchange, analyse and
interpret data in a meaningful way.
Interoperability is seen as one of the key ALL INCLUSIVENESS
elements to ensure meaningful digital
health outcomes. In order for digital technologies to have a
meaningful impact on the improvement of
TRUST health and healthcare these technologies
need to be accessible to everyone.
Concerns about user’s data privacy, the Digital literacy, economic income level
ownership data and data protection need and education are some of the aspects
to be taken into consideration in order that need to be taken into consideration.

14
DISCUSSION POINTS

PATIENTS AS EQUAL PARTNERS STANDARDISATION

Digital solutions that are “made by There is a need for standardized dataset
patients” are more likely to address for IBD that should be endorsed by ECCO,
these barriers and to be used by patients EFCCA and CCFA as well as agreed and
and therefore it makes sense to involve accepted outcome measures including
patients early and in a systematic CROs / PROMs / PREMs for benchmark
manner in the development of digital and outcome research.
technologies.

DATA COLLECTION AND DATA SLOW UPTAKE

OWNERSHIP
In many countries across Europe the
Patients’ engagement can be of uptake of digital solutions is slow and
paramount importance not only in the HCPs are reluctant to use them in daily
collection of their data. Patients can practise. Patients do not yet see any
also play a crucial role when it comes direct benefits which often results in
to data analysis issued from quality of desisting from using such tools.
care and patient-reported outcomes. The
ownership of these date combined with There is a need to engage and raise
a greater involvement in the analysis of awareness with health care providers
clinical data may be a possible path and and the patient community to ensure
lead to a more patient-centred approach that they are well informed of the benefits
and deliver more personalised care. that digital health can deliver.

Step forwards
The Symposium has been a unique meeting in bringing together major stakeholders
to discuss the issues around digital health and data collection. It has provided us
very useful insights into the variety of aspects of this topic and will allow us to foster a
meaningful exchange of ideas and common strategies.

It is foreseen to continue with this dialogue, and we will look into involving further
stakeholders such as the payers (through the International Association of Mutual Benefit
Societies (AIM) as well as the regulators such as the European Medicines Agency.

We strongly believe that such a multi stakeholder approach is needed in order to create
synergies and ensure that digital technologies are developed in the most efficient and
effective way whilst taking into consideration their relevance to patients.
EFCCA wishes to thank the
Congress partners and sponsors:

EFCCA Contact Details

Rue des Chartreux 33-35 Chairman: Treasurer:
B -1000 Brussels Belgium Salvo Leone Marko Perovic
Tel/Fax: +32 2 540 8434 [email protected] [email protected]
Deputy Director:
Registration: 1096/97 Honorary Secretary and CEO: Luisa Avedano Isabella Haaf
Revised 22/2/2006 Vice President: Ciara Drohan Tel: +32 483 371 194 Tel: +34 606 849 937
No. 459814543 [email protected] [email protected] [email protected]