10.5826/dpc.1303a181
Introduction: Melanoma is the deadliest of all the skin cancers and its incidence is increasing every year in Europe. Patients with melanoma often present late to the specialist and treatment is delayed for many reasons (delay in patient consultation, misdiagnosis by general practitioners, and/or limited access to dermatologists). Beyond this, there are significant inequalities in skin cancer between population groups within the same country and between countries across Europe. The emergence of the COVID-19 pandemic only aggravated these health deficiencies.
Objectives: The aim was to create an expert opinion about the challenges in skin cancer management in Europe during the post COVID-19 acute pandemic and to identify and discuss the implementation of new technologies (including e-health and artificial intelligence defined as "Smart Skin Cancer Care") to overcome them.
Methods: For this purpose, an ad-hoc questionnaire with items addressing topics of skin cancer care was developed, answered independently and discussed by a multidisciplinary European panel of experts comprising dermatologists, dermato-oncologists, patient advocacy representatives, digital health technology experts, and health technology assessment experts.
Results: After all panel of experts discussions, a multidisciplinary expert opinion was created.
Conclusions: As a conclusion, the access to dermatologists is difficult and will be aggravated in the near future. This fact, together with important differences in Skin Cancer Care in Europe, suggest the need of a new approach to skin health, prevention and disease management paradigm (focused on integration of new technologies) to minimize the impact of skin cancer and to ensure optimal quality and equity.
text/xml
2160-9381
2877
en
Susanna Puig
https://creativecommons.org/licenses/by-nc/4.0
Dermatology Practical & Conceptual
skin cancer
Smart E-Skin Cancer Care in Europe During and After the COVID-19 Pandemic: A Multidisciplinary Expert Consensus
Text.Serial.Journal
https://dpcj.org/index.php/dpc
Original Article
2023-07-31
2022-11-14
2023-07-31
2023-08-24
e2023181
Dermatol Pract Concept
Introduction: Melanoma is the deadliest of all the skin cancers and its incidence is increasing every year in Europe. Patients with melanoma often present late to the specialist and treatment is delayed for many reasons (delay in patient consultation, misdiagnosis by general practitioners, and/or limited access to dermatologists). Beyond this, there are significant inequalities in skin cancer between population groups within the same country and between countries across Europe. The emergence of the COVID-19 pandemic only aggravated these health deficiencies.
Objectives: The aim was to create an expert opinion about the challenges in skin cancer management in Europe during the post COVID-19 acute pandemic and to identify and discuss the implementation of new technologies (including e-health and artificial intelligence defined as "Smart Skin Cancer Care") to overcome them.
Methods: For this purpose, an ad-hoc questionnaire with items addressing topics of skin cancer care was developed, answered independently and discussed by a multidisciplinary European panel of experts comprising dermatologists, dermato-oncologists, patient advocacy representatives, digital health technology experts, and health technology assessment experts.
Results: After all panel of experts discussions, a multidisciplinary expert opinion was created.
Conclusions: As a conclusion, the access to dermatologists is difficult and will be aggravated in the near future. This fact, together with important differences in Skin Cancer Care in Europe, suggest the need of a new approach to skin health, prevention and disease management paradigm (focused on integration of new technologies) to minimize the impact of skin cancer and to ensure optimal quality and equity.
Susanna Puig
2023/07/31
10.5826/dpc.1303a181
e2023181
Dermatology Department. Hospital Clinic of Barcelona; University of Barcelona, Barcelona, Spain. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. Biomedical Research Networking Centre on Rare Diseases (CIBERER), ISCIII, Barcelona, Spain
2160-9381
skin cancer
en
e2023181
Freeman K, Dinnes J, Chuchu N, et al. Algorithm based smartphone apps to assess risk of skin cancer in adults: systematic review of diagnostic accuracy studies. BMJ. 2020;368:m127. DOI: 10.1136/bmj.m127. PMID: 32041693. PMCID: PMC7190019.
Smart E-Skin Cancer Care in Europe During and After the COVID-19 Pandemic: A Multidisciplinary Expert Consensus
https://dpcj.org/index.php/dpc/article/download/2877/2257
                 Smart e-Skin Cancer Care in Europe
               During and after the Covid-19 Pandemic:
                a Multidisciplinary Expert Consensus
    Josep Malvehy1,2, Brigitte Dreno3, Enric Barba4, Thomas Dirshka5, Emilio Fumero6,
Christian Greis7, Girish Gupta8, Francesco Lacarrubba9, Giuseppe Micali9, David Moreno10,
  Giovanni Pellacani11, Laura Sampietro-Colom12, Alexander Stratigos13, Susanna Puig1,2


 1 Dermatology Department. Hospital Clinic of Barcelona, Spain
 2 University of Barcelona, Barcelona, Spain. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
   Biomedical Research Networking Centre on Rare Diseases (CIBERER), ISCIII, Barcelona, Spain
 3 Department of Dermatolo-Cancerology, CHU Nantes, CIC 1413, CRCINA, University Nantes, Nantes, France
 4 Spanish Melanoma Association, Barcelona, Spain
 5 Centroderm Clinic, Wuppertal, and Faculty of Health, University Witten-Herdecke, Witten, Germany
 6 Almirall R&D, St. Feliu de Llobregat, Spain
 7 Department Dermatology, University Hospital of Zurich, Zurich, Switzerland
 8 University Department of Dermatology, Edinburgh Royal Infirmary, Lauriston Building, Edinburgh, UK
 9 Dermatology Clinic, University of Catania, Catania, Italy
10 Dermatology Department, University Hospital Virgen Macarena, Seville, Spain
11 Dermatology Department. Università degli Studi di Roma La Sapienza. Roma, Italy
12 Assessment of Innovations and New Technologies Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain
13 Department of Dermatology-Venereology, Andreas Sygros Hospital, National and Kapodestrian University of Athens, Athens, Greece



Key words: artificial intelligence, COVID-19, e-Health, melanoma, skin cancer
Citation: Malvehy J, Dreno B, Barba E, et al. Smart e-Skin Cancer Care in Europe During and after the Covid-19 Pandemic: A
Multidisciplinary Expert Consensus. Dermatol Pract Concept. 2023;13(3):e2023181. DOI: https://doi.org/10.5826/dpc.1303a181
Accepted: February 27, 2023; Published: July 2023
Copyright: ©2023 Malvehy et al. This is an open-access article distributed under the terms of the Creative Commons Attribution-
NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use,
distribution, and reproduction in any medium, provided the original authors and source are credited.
Funding: Funded by Almirall S.A., in accordance with Good Publication Practice guidelines.
Competing Interests: BE has received payment/honoraria from Pierre Fabre Dermo-Cosmetique. FE is employee of Almirall. GC has
received Stock/ stock options from Derma2go AG. MJ has received payment/honoraria for lectures from Sun Pharma, and participation on
an advisory board from Sun Pharma and Almirall. PS has received grants/contracts from La Roche Posay and ISDIN, payment/honoraria
from Almirall, Novartis, ISDIN, Leo Pharma, BMS, La Roche Posay, Sanofi, Roche Pfizer, Regeneron, and Sun Pharma, participation on
Data Safety Monitoring Board/Advisory Board from ISDIN, Roche, Jansen, Sun Pharma, Sanofi, Regeneron, and Almirall and receipt of
equipment or other services from Abbyie. SA has received grants/contracts from Novartis, Abbie, and Regeneron and payment/honoraria
from BMS, Janssen Cilag, Sanofi, Genesis Pharma and Regeneron. The rest of authors declare no conflicts of interest.
Authorship: All authors have contributed significantly to this publication.
Corresponding Author: Josep Malvehy, Dermatology Department, Hospital Clínic of Barcelona, Barcelona, Spain. E-mail: jmalvehy@clinic.cat
Acknowledgments: Manuscript writing support was provided by Montse Sabaté, PhD from TFS HealthScience.




Original Article | Dermatol Pract Concept. 2023;13(3):e2023181                                                                         1
    ABSTRACT         Introduction: Melanoma is the deadliest of all the skin cancers and its incidence is increasing every
                     year in Europe. Patients with melanoma often present late to the specialist and treatment is delayed
                     for many reasons (delay in patient consultation, misdiagnosis by general practitioners, and/or limited
                     access to dermatologists). Beyond this, there are significant inequalities in skin cancer between pop-
                     ulation groups within the same country and between countries across Europe. The emergence of the
                     COVID-19 pandemic only aggravated these health deficiencies.
                     Objectives: The aim was to create an expert opinion about the challenges in skin cancer management
                     in Europe during the post COVID-19 acute pandemic and to identify and discuss the implementa-
                     tion of new technologies (including e-health and artificial intelligence defined as “Smart Skin Cancer
                     Care”) to overcome them.
                     Methods: For this purpose, an ad-hoc questionnaire with items addressing topics of skin cancer care
                     was developed, answered independently and discussed by a multidisciplinary European panel of ex-
                     perts comprising dermatologists, dermato-oncologists, patient advocacy representatives, digital health
                     technology experts, and health technology assessment experts.
                     Results: After all panel of experts discussions, a multidisciplinary expert opinion was created.
                     Conclusions: As a conclusion, the access to dermatologists is difficult and will be aggravated in the near
                     future. This fact, together with important differences in Skin Cancer Care in Europe, suggest the need of
                     a new approach to skin health, prevention and disease management paradigm (focused on integration
                     of new technologies) to minimize the impact of skin cancer and to ensure optimal quality and equity.




Introduction                                                      expenditure [7,8]. According to data from recent studies in
                                                                  Europe, a large percentage of patients have restricted ac-
Skin cancer and particularly keratinocyte skin cancer is diag-    cess to innovative medicines for metastatic melanoma [9].
nosed more commonly than all other malignancies combined.         Moreover, there is limited number of dermatologists in many
A systematic review showed a 33% increase in keratinocyte         European regions. There are tight health budgets and this
skin cancer cases between 2007 and 2017. Most of this in-         situation is unlikely to improve in the next few years. The
crease (20%) could be attributed to a change in the popula-       public healthcare pathways in many E
                                                                                                     ­ uropean countries rely
tion age structure, and 13% to population growth [1].             on general practitioners triaging patients before referral to
    Patients with melanoma often go late to the specialist.       dermatologists with patients in private healthcare having the
Moreover, treatment is delayed for many reasons (delay in         ability to go directly to dermatologists.
patient consultation, misdiagnosis by general practitioners,         In 2019 a document of the EuroHealthNet highlighted
and/or limited access to dermatologists). These facts, to-        the need for health policies that guarantee universal ac-
gether with the increase of the cost-of-illness of melanoma       cess to high-quality care and eradicate health inequalities
in Europe [2,3], remark the importance to enhance preven-         in the ­European Union (EU), which are estimated to cost
tion (ie, primary prevention: reduction of ultraviolet light      €980 b
                                                                       ­ illion per year [10].
exposure, and secondary prevention: earlier detection of             The emergence of the COVID-19 pandemic and the post
melanoma).                                                        COVID-19 acute pandemic has postponed planned medical
    In addition to these necessary improvements, relevant in-     and surgical activities, may lead to delays in the diagnosis
equalities in skin cancer between population groups within        and treatment of skin cancer and could aggravate the health
the same country and between countries across the European        deficiencies previously described [11-13].
region have been reported. Limitation in the number of skin
cancer experts and access to dermatologists, access to skin
                                                                  Objectives
cancer centers, availability of diagnostic techniques (ie, der-
moscopy, digital monitoring, reflectance confocal micros-         The aim of this study was to describe the challenges in skin
copy, optical coherence tomography), availability of Mohs         cancer management in Europe during the post COVID-19
surgery in complex skin carcinoma, availability of systemic       acute pandemic and to identify and discuss the implemen-
therapies, reimbursement constrains, among others [4-6].          tation of new technologies (including e-health and artificial
    The notable disparity in the prognosis of melanoma across     intelligence defined as “Smart Skin Cancer Care”) to over-
Europe is correlated with significant differences in healthcare   come them.




2                                                                     Original Article | Dermatol Pract Concept. 2023;13(3):e2023181
Methods                                                           Statement 2
                                                                  A more equitable health system should be developed by
A panel of multidisciplinary European experts (total of 12        implementing new strategies and technology (e-health and
experts) comprising 4 dermatologists (UK N = 1, Germany           others) (that will improve efficiency and reduce costs), pro-
N = 1, and Italy N = 2), five dermato-oncologists (Italy          viding high-quality skin cancer care and ensuring transpar-
N = 1, Spain N = 2, Greece N = 1, and France N = 1), pa-          ency. Artificial intelligence applications in some healthcare
tient advocacy representatives (Spain N = 1), digital health      systems may entrench existing social and economic biases
technology experts (Switzerland N = 1), and health technol-       and perpetuate inadvertent discriminatory practices [14].
ogy assessment (Spain N = 1) experts was selected for the         Thus, appropriate EU policies should be promoted to de-
formulation of this document. The experts were selected by        crease inequalities among different populations and coun-
the study coordinator and this selection was done based on        tries in Europe.
their expertise in the different disciplines.
    The experts countries were France, Germany, Greece,           Statement 3
Italy, Spain, and the UK. It has been considered that the ex-
                                                                  A fast implementation of digital medicine in clinical prac-
perts represent countries with different provisions for skin
                                                                  tice is crucial to overcome the scenario of shortage of der-
cancer care in Europe.
                                                                  matologists in most European countries. Smart Skin cancer
    An ad hoc questionnaire with items addressing chal-
                                                                  care consists of e-Health (electronic health) technologies in-
lenges and opportunities that the post COVID-19 pandemic
                                                                  cluding m-Health (mobile health) services, electronic record
offer in skin cancer management was developed (see Appen-
                                                                  management, smart home services, and intelligent and con-
dix 1) and was answered independently by all the experts in
                                                                  nected medical devices for patients and health professionals
three meetings on-line.
                                                                  in skin cancer (see Figures 1 and 2). Deep learning, which
    During the three meetings on-line, the question-
                                                                  leverages artificial neural networks and learn complex map-
naire was answered and the discussions were set up in
                                                                  pings between inputs (eg images) and outputs (eg diagnosis)
June 2020. As a result of these discussions, a multidisci-
                                                                  [15,16] has shown an accuracy non-inferior to dermatolo-
plinary expert opinion about challenges and opportunities
                                                                  gists and superior to primary care physicians [17-21]. The
during the post COVID-19 pandemic in skin cancer man-
                                                                  involvement of dermatologists in the development of these
agement was created and reviewed by all the experts in
                                                                  digital technologies, together with other disciplines such as
October-November 2020.
                                                                  anthropologists or sociologists should be also considered to
                                                                  help associate them with human perspectives and values,
Results                                                           while ensuring good acceptance when launched. Moreover,
                                                                  the collaboration of general practitioners with teledermatol-
Challenges and opportunities that the post COVID-19 pan-          ogy is also needed since it has shown similar clinical out-
demic offer in skin cancer management in Europe: clinical         comes to conventional consultation in dermatology clinics,
statements.                                                       and improved satisfaction from both patients and care pro-
                                                                  viders [22-24].
Statement 1
A universal access of the European Union (EU) citizens to         Statement 4
specialists, modern diagnostics and treatments, skin cancer       A more proactive disease management by the citizen/
centres, and personalized medicine is needed, especially,         patient should be encouraged. The use of “smart” digital
in a situation of overload of health care systems and re-         heath technologies offers new opportunities to educate
stricted health budgets, which has been aggravated by the         citizens and patients to improve their care without con-
COVID-19 pandemic. Some of these changes include better           straints of distance, location, and time, while expanding
predictive genotypic and phenotypic biomarkers or a combi-        the patient/citizen’s capabilities and empowerment, which
nation of them (deep phenotyping) to help selecting individ-      is recognized as an important part of the integrated care
uals more accurately for screening, diagnosis, treatment, and     provision. Ensuring proper education in digital health for
follow-up. Moreover, more efficient clinical trials guided by     their conditions can improve clinical care, treatment adher-
translational research and the collaboration of pharmaceu-        ence, patient satisfaction, and health outcomes [19]. The
tical companies are required. The development of networks         new strategies for education will require the introduction
of referral centers in coordination with local hospitals to im-   of online learning settings in skin cancer and new digital
prove effective translational research and to facilitate enrol-   technologies. Effective policies to support empowerment of
ment of patients is crucial.                                      patients are needed.




Original Article | Dermatol Pract Concept. 2023;13(3):e2023181                                                                3
Figure 1. Big data for smart skin cancer health. Industry (pharma, biomarkers, devices for diagnosis of skin cancer), Health services and
infrastructures, Health (Skin Cancer) Technology Assessment, Artificial Intelligence/Augmented Intelligence (Natural language processing,
Diagnosis using images and pathology, prognosis, precision medicine, epidemiology), Health informatics (Standards for e-Health), e-Health
(Telemedicine, prescription, monitoring, etc.), m-Health (Skin cancer Apps: education, triage, diagnosis, monitoring of patients).
Adapted from https://ec.europa.eu/info/sites/info/files/mazzucato_report_2018.pdf


Statement 5                                                           model confidence calibration (to assess the probability of
Digital health education for health professionals is an effi-         being correct, with every prediction), and model interpret-
cient and convenient learning mode, a promising solution              ability (to understand the decision-making process) are
to enhance patient-related outcomes, to support health                needed [15]. There is a lack of benefit evidence in most
care staff by reducing their workload, to improve the ca-             cases, a risk of missing melanoma and a limited specificity
reers coordination, meet the increasing demand and ad-                with the risk of overdiagnosis [27]. Therefore, prospective
dress the shortage of highly trained dermatologists. The              studies including large cohorts with different populations
results of a survey targeted toward European medical stu-             and ethnicities in clinical practice are urgently needed to
dents showed that 85% of them consider that more digital              validate them [30,31].
health education should be implemented in the medical
curriculum. This study concluded that there is a lack of              Statement 7
digital health-related formats in medical education and a             Confidentiality and data privacy protection should ensure
perceived lack of digital health literacy among European              patient/citizen safety [28]. There are important ethical con-
medical students [25]. Therefore, implementation of digital           cerns regarding patient confidentiality, informed consent,
Health education in the medical curriculum is essential to            transparency, and data privacy protection. Although some
enable a meaningful digital transformation of healthcare              applications require users to consent to their data policies,
systems [26].                                                         the process of how a patient data (including sensitive digital
                                                                      body images) are accessed, used, and externally shared is of-
Statement 6                                                           ten not transparent. Adequate definition of data protection
Validated applications using artificial intelligence for              policies and guidelines for the consumers, companies, and
the assessment of skin cancer are requested. Good qual-               health professionals to guide the fast implementation of new
ity standards metrics (for reporting model performance),              smart skin cancer technologies is needed.



4                                                                          Original Article | Dermatol Pract Concept. 2023;13(3):e2023181
Figure 2. Global components of smart skin cancer care. Global components include Research and Health Technologies, Health Care system
and Population (care givers, citizens, and patients). The main areas in skin cancer to be considered in the global model are: primary preven-
tion (e-education, identification of risk factors, behaviors, sun-protection, treatment of pre-cancer,…); access to early diagnosis (access to
dermatologists, dermoscopy, advanced diagnostic tools such as RCM) and stratification of risk population for specific follow-up in skin can-
cer centers using deep phenotyping and other strategies) and access to complex treatment when necessary (surgery–Mohs, complex surgery;
innovative systemic therapies).


Statement 8                                                              property. Post-marketing quality assurance must be agreed
Adequate pre- and post-marketing certification is also re-               among stakeholders including the society, health policy mak-
quired. The new regulation of medical devices in the EU                  ers, companies, clinicians, and patients/citizens. This cultural
implemented since May 2021 includes software programs                    shift will ensure the overall quality of digital solutions.
for diagnosis (Medical Device Directives (MDD): AIMDD
90/385/EEC; MDD 93/42/EEC; IVDMDD 98/79/EC). It                          Limitations of the Study
is expected that a strict evaluation of applications for skin            Some bias in the selection of the experts may have been as
cancer will be implemented for EU certification. Actually,               not all European countries were represented.
some applications licensed in Europe for risk assessment of
tumours (based on photography) for citizens using artificial
                                                                         Conclusions
intelligence are Class I marked certified, which are not in-
tended for diagnostic purposes [29].                                     In the 4th industrial revolution and specially during the post
    A cultural shift is needed in digital health and particu-            COVID-19 pandemic and in a diverse European environment
larly in the implementation of applications using artificial             with significant differences in Skin Cancer Care and diffi-
intelligence by developers, stakeholders, policy-makers, and             culty in accessing the dermatologist, a new approach to skin
Dermatology and Oncology scientific societies. Digital tech-             health, prevention and disease management paradigm (fo-
nology is complex, and it changes constantly due to fast                 cused on integration of new technologies) in needed to mini-
technical development of the algorithms re-trained with new              mize the impact of skin cancer and to ensure optimal quality
data provided by the users. By contrast, both clinical val-              and equity. This new approach must be accompanied by a
idation and regulatory audits are expensive and time con-                cultural change in the implementation of new technologies to
suming. Developers should support trustworthy third-party                adequately overcome the crisis and deficiencies in skin cancer
access to data and codes within the parameters of techni-                management. This implementation needs to go hand-in-hand
cal feasibility, while respecting ownership of intellectual              with education of citizens/patients and health professionals.



Original Article | Dermatol Pract Concept. 2023;13(3):e2023181                                                                              5
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