108 © TOUCH BRIEFINGS 2011
Case Report from the EHR4CR Project—A European Survey on Electronic
Health Records Systems for Clinical Research
Dipak Kalra,1Andreas Schmidt,2HWW Potts,1Danielle Dupont,3M Sundgren4and Georges De Moor,5on behalf of the
EHR4CR Research Consortium
1. Centre for Health Informatics and Multiprofessional Education, University College London; 2. F Hoffman-La Roche, Basel; 3. Data Mining International, Geneva;
4. AstraZeneca, Mölndal; 5. University of Gent
Dipak Kalra is Director of the Centre for Health Informatics and Multiprofessional Education at University College London, and a former
general practitioner. He plays a leading international role in the research and development of electronic health record (EHR) architectures
and systems, covering requirements, information models, representation of clinical meaning, and protection of privacy. He has led the
development of the international standards on EHR interoperability, personal health records, EHR architecture requirements, and several
standards on EHR security and confidentiality. Dr Kalra is a Director of the openEHR foundation, Vice President for Research at the
EuroRec Institute, and an advisor to the European Commission on semantic interoperability.
Andreas Schmidt has been an eHealth systems leader since 2009. He is involved in projects evaluating opportunities around electronic
health record patient level data for F Hoffmann La Roche Pharma Product Development. He has held various roles in clinical development
including cardiac safety, business development, and information management at Novartis Pharma AG and Ciba-Geigy AG in the past
20 years. With more than 10 years of working in public healthcare, Andreas has extensive experience in medical diagnostics and treatment,
scientific research, and patient care.
Danielle Dupont holds a BA in pharmacy, an MSc in sciences (University of Montreal, Canada), and a PhD in health economics (University Claude Bernard Lyon I,
France). She cumulates more than 20 years of international experience, gained in North America and Europe, within leading pharmaceutical companies. She has had
senior leadership roles in the areas of market access, health economics and outcomes research strategy, pricing and reimbursement, value demonstration, and
business model innovation, to optimize access to health technologies across disease areas and life cycles at the global, regional, and local levels. A health economic
expert and opinion leader, she is currently Head of Data Mining America Corporation and Chief Scientific Officer at Data Mining International SA, where she advises
and leads EU and other international projects in collaboration with vast research consortiums across geographies.
Disclosure: Danielle Dupont received direct financial contributions from Data Mining International SA,designated sub-contractor to the EHR4CR
consortium (European Federation of Pharmaceutical Industries and Associations participants). The remaining authors have no conflicts of interest to declare.
Correspondence: email@example.com Citation: iHealth Connections, 2011;1(2):108–13
Acknowledgments: EHR4CR (www.ehr4cr.eu) is sponsored by the Innovative Medicines Initiative, a public-private partnership program of the
European Commission and the European Federation of Pharmaceutical Industries and Associations (www.imi.europa.eu).
Objective: The Electronic Health Records for Clinical Research (EHR4CR) project aims to deliver a new technological
platform and business model to enable the re-use of patient information from electronic health records (EHRs)
for clinical research in Europe. An EU electronic survey (e-survey) was conducted to identify opportunities
and issues pertaining to the development and implementation of cost-effective EHR4CR clinical services.
Methods: The EU e-survey was conducted in two waves: with participating stakeholders from the public and
private sectors involved in the EHR4CR consortium, and with non-participating informed stakeholders.
Results: The results confirm a high interest in re-using EHR data for clinical research with the objective of
optimizing drug development efficiency and access to innovative medicines in Europe. Key challenges include
privacy protection, systems interoperability, patient acceptance, and ethical considerations.
Conclusions: The re-use of EHR data for clinical research represents a unique opportunity. This survey highlights
the importance for the EHR4CR platform and business model to address the respective needs and incentives of
relevant stakeholders to provide sustainable EHR4CR solutions in Europe.
Schmidt_v1_iHC US 13/12/2011 09:28 Page 108
Case Report from the EHR4CR Project
Electronic Health Records for Clinical Research (EHR4CR) is a four-year
project sponsored by European public funds through the Innovative
Medicines Initiative under the 7th Framework Program of the
EU Commission and by in-kind contributions from the European
pharmaceutical industry. This public–private research initiative involves
EU experts from academia and from the European Federation of
Pharmaceutical Industries and Associations.
The EHR4CR project will deliver an innovative platform and a sustainable
business model to enable the re-use of data from electronic health
records (EHRs) for clinical research purposes in Europe. More
specifically, the EHR4CR project will develop a state-of-the-art
interoperable platform to enable heterogeneous EHR systems to re-use
patient data for clinical research, in full compliance with applicable
legislative, regulatory, ethical, and privacy protection requirements
and policies across Europe. For the first time, the EHR4CR platform and
business model will provide a systematic, structured, and scalable
approach to the re-use of EHRs data for clinical research. Ultimately, the
EHR4CR platform is intended to streamline existing clinical research
processes, attract further research and development investments, and
optimize access to innovative medicines in Europe. As a result, the
re-use of EHR data will benefit healthcare professionals, clinical
researchers, regulators, patients, and society.
However, these solutions will need to address specific needs and
challenges and secure acceptance from patients, the public, and the health
service community. As part of a larger environmental scan initiative, this
article presents the results of an EU electronic survey (e-survey) recently
conducted among EU stakeholders from the public and private sectors to
address the key opportunities and challenges pertaining to the optimal
development and implementation of EHR4CR services in Europe.
The development of new medicines is critical to maintain and advance
improvements in healthcare. However, the discovery of new medicines
has become increasingly challenging. Current unmet medical needs,
ageing populations, long-term management of chronic diseases, and
personalized medicines contribute to an increasing healthcare
demand. The concurrent escalation in healthcare expenditures also
contributes to building unprecedented pressure on healthcare systems
in Europe and around the world.
In parallel, the average cost of conducting clinical trials has increased
three-fold over the last 12 years.1In 2006, the cost of researching,
developing, and achieving regulatory approval for a new chemical or
biological entity was estimated at €1.1 billion.2The total research
and development (R&D) cost across the industry was estimated at
€710–790 billion in 2007, with an annual growth rate of 10.2–13.6 % since
2003.3Clinical research accounts for around 75 % of these R&D costs.
The lengthy clinical development processes (average eight to 10 years)
combined with the ever more challenging market access conditions for
new compounds also negatively impact the pharmaceutical sector.
Furthermore, between 1990 and 2008, R&D investments in the US grew
by 5.6-fold, while in Europe it only grew by 3.5-fold. This confirms
Europe’s relative lack of attractiveness for pharmaceutical R&D
investment. Today, there is rapid growth in the research environment in
emerging economies such as China and India, resulting in closure of
R&D sites in Europe and opening of new sites on the Asian continent.2
Clinical research is also growing in complexity and labor intensity. This
is, in part, attributable to the need to conduct large clinical trials that
provide definitive evidence of clinical efficacy and safety. There is also a
rising demand to assess comparative effectiveness in routine medical
practice, which may require conducting extended non-interventional
studies. Further issues include the difficulty of targeting the right patient
populations, optimizing study protocol designs, identifying suitable
patients for clinical trials, re-entering redundant clinical data manually,
and detecting and reporting infrequent adverse events in a timely
manner. All these factors explain the motivation from developers to
transform current clinical research models to bring innovative medicines
to market faster and at lower cost.
Recent developments in EHRs now increasingly provide opportunities to
re-use the data they contain for clinical research purposes. The
considerable progress made in seamlessly integrating EHRs within
existing healthcare networks offers new possibilities for private- and
academic-sector researchers to conduct clinical trials more efficiently.
However, issues remain. Access to EHRs for research is often limited,
and those that are available are not always representative of the whole
population from which patients may be recruited. It is currently very
difficult to perform research queries across multiple EHRs and
turnaround times are lengthy; this makes rapid, dynamic ‘what-if’
analysis almost impossible.
This is why state-of-the-art, data-driven protocol feasibility has been only
slowly adopted across wide portfolios or entire research organizations.
The consequences of not optimizing protocols are: increased protocol
amendments, slower than expected enrolment, costly changes to add
new sites and countries, and, sometimes, even failed trials. Almost half
of all trial delays are caused by participant recruitment problems4and
the percentage of studies that complete enrolment on time is extremely
low across all clinical trial markets: 18 % in Europe, 17 % in Asia-Pacific,
15 % in Latin America, and 7 % in the US.5
Today, clinical trial data are entered into dedicated electronic clinical
trial systems and the same information is often also entered into the
institution’s EHR system. Connecting healthcare and clinical trial systems
for data exchange could reduce or even avoid the redundant data entry
occurring today. Various studies have established that over 40 % of
clinical trial data are entered into the patient’s health record, the clinical
trial EDC system, and, possibly, a third paper copy.6,7 Investigational sites
estimate that over 70 % of data are duplicated between EHR and clinical
There is now a growing realization that the ability to effectively integrate
and interoperate advanced EHR systems within healthcare networks
represents a unique opportunity to enhance academic research, to
speed up existing processes, and to build greater efficiency. These
advances promise to address significant unmet medical needs more
expediently, to improve patient safety, and to optimize access to
innovative medicines for better health outcomes.
Schmidt_v1_iHC US 08/12/2011 16:49 Page 109
To that end, the EHR4CR platform will be tested in pre-defined disease
areas for relevant applications of interest which include clinical trial
feasibility, patient recruitment, clinical trial execution, and adverse event
reporting. This will be achieved by combining areas of previously
isolated medical informatics progress (e.g. semantic interoperability,
privacy-enhancing techniques and standards) in an entirely new
integrated approach with the aim of enabling the re-use of EHRs for
clinical research through optimal data extraction and aggregation,
de-identification, linkage, and security. To ensure the delivery of
high-quality and cost-effective solutions, the EHR4CR platform will also
be supported by specific governance (including advanced accreditation
and certification programs) and by a sustainable business model.
There are other projects investigating better approaches to re-using
EHR data for clinical research. TRANSFoRm is an EU project developing
computational services to enable the re-use of general practice EHR
data for clinical research. PONTE (Efficient Patient Recruitment for
Innovative Clinical Trials of Existing Drugs to other Indications) is a
three-year EU research project (2010–2013) developing a platform for
automatic identification of patients eligible to participate within
specified clinical trials. PACeR (Partnership to Advance Clinical
electronic Research) is a new US-sponsored project aiming to design
processes to help to more quickly and easily match patients to clinical
trials. All of these projects expect to undertake some business modeling
investigations, but none has as yet been published.
Among the multiple ongoing environmental scan initiatives and
evidence-based approaches being deployed, this article presents the
methods and results of an EU e-survey conducted with informed
European stakeholders to address key opportunities and challenges in
developing and implementing a sustainable pan-EU EHR4CR capability.
An EU e-survey was conducted with informed stakeholders to scan the
environment relevant to the EHR4CR project, with the objectives being to:
• collect further insights on the advantages and value of EHR4CR
• uncover potential key issues to address and opportunities to explore;
• identify key drivers and challenges for delivering/implementing/
using EHR4CR services;
• detect early signals to guide the development of innovative
customized services; and
• inform the design of a sustainable business model for EHR4CR
services in Europe.
This survey consisted of a self-administered electronic questionnaire
which was developed, piloted, and validated by a designated task force
within the EHR4CR consortium. The questionnaire included a brief
description of the EHR4CR project (background, rationale, and research
environment), and comprised 30 multiple-choice questions covering
three themes, namely:
• about you and your organization;
• about the EHR4CR platform and services; and
• factors affecting the EHR4CR platform and services.
The survey was conducted in two successive waves. Using an ‘internal’
perspective, the first wave was conducted from June 22, 2011 to July 4,
2011 with participating EU EHR4CR partners already involved in
the EHR4CR project. Two electronic reminders were sent to the
participants prior to the survey deadline and 78 respondents
completed the survey. Using an ‘external’ perspective, the second
wave was conducted from July 5, 2011 to September 16, 2011 with
informed external stakeholders and collaborators not participating in
the EHR4CR project. Two electronic reminders were sent to the
participants prior to the survey deadline and 125 respondents
completed the survey.
The results from both waves were analysed separately and then
compared to identify main areas for improvement in clinical research,
key opportunities and challenges, and expected benefits from
Respondents to this survey comprised stakeholders from academic
centers (n=42), the pharmaceutical industry (n=), information technology
(IT) providers and EHR and electronic data capture (EDC) system
vendors (n=38), clinical research organizations and research sites (n=28),
patient advocacy groups (n=4), health agencies (n=4), and other relevant
sectors (n=20). One-third of the academic centers and almost all of the
pharma respondents were members of the EHR4CR consortium (i.e.
internal stakeholders), whereas most of the other respondent categories
were external. Most respondents had been involved in their respective
field for over 15 years, and so these survey results reflect substantial
experience from these sectors.
Overall, 23 EU countries were represented in this survey. The majority of
respondents came from the UK (n=39), Germany (n=36), Belgium (n=24),
Sweden (n=21), Switzerland (n=15), and France (n=14).
Importantly, the results from both waves of respondents showed a high
degree of consistency across most aspects surveyed.
Main Areas for Improvement in Conducting
For internal and external respondents, the greatest aspects of current
clinical trials practice needing improvement are identifying patients for
participation in clinical trials (70 %), optimizing the time currently
required to conduct clinical trials (59 %), reducing the costs (54 %) and
workload of conducting clinical trials (54 %), and evaluating clinical trial
protocol feasibility (50 %).
Most respondents proposed the highest priority for EHR4CR platform
services to be evaluating patient populations and identifying patients for
clinical trials. Exchanging data between EHRs and clinical trials was also
considered a priority. The detection and reporting of adverse events
was considered a lower priority by pharma but the highest priority by the
small number of patient advocacy representatives who participated in
this survey. These results are not surprising: safety is often viewed as a
secondary end-point, while targeting the right patient population and
recruiting patients is a prerequisite to demonstrating efficacy (the
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Case Report from the EHR4CR Project
A large proportion (44 %) of the respondents had noted a strong or
increasing societal or cultural trend towards the re-use of EHR data for
clinical research. This trend largely being perceived as new and not yet
wide-scale is one of the key motivations behind the Innovative
Medicines Initiative call topic that EHR4CR is addressing.
Nearly all the respondents (95 %) were personally in favor of re-using EHR
data for research. However, a small sub-group of external stakeholders
(eight of 125, 6 % of the external survey respondents) were not at all in
favor of this. This sub-group was not significantly associated with any
specific industry sector or country. Further understanding about the
reservations perceived by certain stakeholder types may emerge through
the in-depth interviews planned in the next phase of this project.
Regarding the opportunity of new technological developments, the
majority of academic (74 %), clinical research (82 %), and vendor
respondents (92 %) classified themselves as innovators or early adopters
of new information technology, whereas only 57 % of pharma
respondents did so. These classifications did not differ significantly by
country. This late adoption by pharma may be explained by large size
organizations (which likely require more time and resources for
implementation), by other organizational priorities or movements, or by
the need to be extra cautious for risk management purposes.
Most respondents (67 %) indicated that they find it challenging to attract
the human or financial resources needed for new clinical research
applications within their organizations. Most considered that their
organization was in a position to implement and use EHR4CR services
(44 % ‘good’ and ‘excellent’; or 81 % ‘fair’, ‘good’, or ‘excellent’);
however, a significant difference was observed between IT providers and
clinical research sites, which considered themselves to be in a good
position on average (median), and academic centers and pharma, which
only considered themselves in a fair position. This suggests that training
may be needed in some sectors to support the implementation of
The research domains perceived by respondents as areas that could
benefit the most from EHR4CR services are listed in Figure 1. Regarding
the opportunity to develop partnerships with specific stakeholders,
respondents considered the groups shown in Figure 2 to be essential to
achieve the full potential of the EHR4CR platform. Fifty-seven percent
of respondents were keen to see the creation of an EU network of
excellence for the use of EHRs for clinical research. Customized training
for end users of the EHR4CR services, with ready access to experts who
could guide on its use for specific application domains, was also
considered important, as was a helpdesk. Assigning EHR4CR champions
at each research facility was also perceived as potentially helpful.
When considering who should fund EHR4CR services, by far the most
nominated candidate was governments (90 %), indicating that the
majority see this service as a public resource even if used by pharma.
Pharma was itself the second most proposed candidate (68 %) to fund
EHR4CR services, and public health agencies the third (50 %). There was
a high degree of consistency between the two groups surveyed. Moving
forward, different funding schemes will nonetheless have to be
prototyped to identify the most relevant and sustainable EHR4CR
Figure 3 illustrates the groups identified by respondents as being
the expected contributors of data, resources, and services for the
Figure 1: Research Domains of Interest for EHR4CR Services
Health economics and outcomes research
Public health research
Comparative effectiveness research
Non-interventional (observational) research
Medical informatics research
Figure 2: Groups/Organizations with Whom It Was
Perceived Essential for EHR4CR to Build Partnerships
General and specialized medias
Trusted third parties
Public health agencies
Clinical research sites
Patients advocacy groups
Figure 3: Groups Expected to Be Contributors (of Data,
Resources, and Services) to EHR4CR Services
Public health agencies
Trusted third parties
Patient advocacy groups
Clinical research sites
Schmidt_v1_iHC US 13/12/2011 09:29 Page 111
Respondents from all sectors and countries, both internal and external
to the project, all rated complying with legislative, regulatory, ethical,
and privacy protection requirements as the strongest driving force for
successfully implementing, delivering, and using EHR4CR services (95 %
rating it highest or highest equal). This may be because respondents
clearly recognized that significant ethical and confidentiality concerns
have to be overcome if EHR data are to be re-used for research,
especially across countries. Tackling these issues is a key component of
the EHR4CR work plan. Systems interoperability and demonstrating
value for money were the next two high-priority drivers for all
Responses to the next question highlighted similar concerns, also across
all respondent types. Among the main challenges, gaining acceptance
from patients and all stakeholders was considered to be EHR4CR’s
greatest hurdle (93 % rating this highest or highest equal). Delivering
services to a high quality in real-life settings, having a platform that is
generic and comprehensive enough to address multiple clinical research
scenarios, and flexibility of services were the other challenges
considered most important to address.
Twenty-two percent of respondents considered improved efficiency to
be the most important gain to clinical research from EHR4CR solutions.
Standardization was also ranked highly (18 %), but a higher proportion of
respondents (34 %) indicated that improved efficiency, standardization,
quality, time optimization, and faster access to innovative medicines
were all equally essential benefits.
When asked about the most distinctive advantages of the EHR4CR
platform to their organization, the majority response across both internal
and external stakeholders (68 %) was unequivocally the delivery of
reliable, high-quality, and cost-effective services for the re-use of EHR
data for clinical research. Other frequently chosen advantages were the
optimization of clinical research processes for the public and private
sectors (42 %) and the elimination of non-value-added tasks, such as
re-entry of data and trial-specific paperwork (42 %). Improved patient
safety from early detection and reporting of adverse events (30 %) was
also considered important.
When asked to indicate the same advantages of the platform, but this
time to clinical researchers, the same three factors were ranked most
highly, with elimination of non-value-added tasks coming top (56 %).
Improved patient safety from early detection and reporting of adverse
events (31 %) and clarification of the source of data used for clinical
research (30 %) were also nominated as important.
When asked about the same advantages, this time to patients, faster
access to safe and effective medicines (75 %) and improved patient
safety from early detection and reporting of adverse events (75 %) were
overwhelmingly the most popular advantages, with similar high rankings
across all respondents.
When asked finally about advantages to society, most responded
similarly to the advantages to patients. However, the optimization of
clinical research processes for the public and private sectors (38%),
the establishment of EU best practices in e-clinical research (34%),
and the opening of new opportunities for the public sector from
innovative clinical services (32 %) were also highlighted as an
Science today offers greater promise for finding better treatments than
ever before, thanks to new knowledge, innovative medicines, and
technologies.2However, the increasing healthcare demand, the
emerging personalized medicine era, and the escalating healthcare
costs require better integration of three main drivers: biological
sciences, information management, and healthcare collaboration. The
main opportunity consists of optimizing information exploitation to
enable scientific knowledge discovery and efficiency of new drug
development platforms. The corresponding challenge resides in how to
best access, connect, manage, and exploit the relevant health
information available within and beyond clinical trials, including clinical
research legacy data, external research databases, biomedical literature,
and EHRs. All these environments contribute to defining a vast
information landscape.9This addresses the need to realize a substantial
transformation of existing platforms and systems to enable their
evolution, in compliance with relevant legal, ethical, privacy protection,
and regulatory considerations and frameworks.
In its ideal form, the EHR is a longitudinal electronic record of patient
health information generated by one or more encounters in any care
delivery setting. The adoption of EHRs in hospitals, community
centers, and private practices has been steadily increasing and offers
new possibilities to improve the delivery, quality, and continuity of
clinical care.10–13 However, there are obvious obstacles to using EHRs in
clinical research, including EHR fragmentation, diverse and
independent systems that to not adhere to standards, and substantial
technological and implementation challenges. In particular, such
ambition requires enabling interoperability (encompassing technical,
functional, legal, and organizational aspects) to ensure seamless
cross-border connectivity for optimal electronic data collection and
exchange between systems.
Importantly, it is worth mentioning that the findings of this EHR4CR
e-survey are strongly consistent between internal and external
stakeholders. Both confirm a high level of interest in re-using EHR
patient-level data for clinical research purposes. The results also
highlight the real challenge for the pharmaceutical industry and
research organizations to recruit patients in sufficient numbers for
clinical trials, as well as the well-recognized significant duplication of
efforts in collecting patient data. The clinical scenarios identified by
the EHR4CR project (clinical trial feasibility, patient recruitment, clinical
trial execution, and adverse event reporting) were rated as key
priorities by all stakeholders surveyed.
Ethical considerations, privacy protection issues, and acceptance of the
EHR4CR solution by patients were ranked by the stakeholders as being
the most critical challenges that the project will have to address. Other
challenges identified include the interoperability of EHR data between
diverse hospital systems and the quality and granularity of routinely
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Case Report from the EHR4CR Project
collected clinical data, which may limit the suitability of the data for use
in clinical trials.
Notably, the results of this e-survey clearly reveal the expectation for the
EHR4CR platform to be value-driven rather than cost-driven. This means
that its services need to be demonstrably of a high quality and deliver
added benefits, improved efficiency, and value for money to its customers
and end users. In particular, the most significant benefits for research
organizations, patients, and society of re-using EHR data for clinical
research were identified by the respondents as the delivery of high-quality
and cost-effective solutions, optimization of clinical research processes,
and elimination of non-value-added tasks (redundant data entry). The
results also revealed that such improvements were expected to lead to
greater drug development efficiency, faster access to safe and effective
medicines, enhanced patient safety, and best practices in e-clinical
research through the proposed accreditation and certification programs.
While the results of this EU e-survey provide useful information, they are
nonetheless limited in scope. They will be complemented by
supplemental environmental scan initiatives undertaken by the EHR4CR
consortium, including semi-structured interviews with EU academic
experts, as well as an ongoing consultative process with public and
private EU stakeholders over the duration of the project.
There is increasing societal acceptance of the need for clinical
research and of the potential value of re-using EHR patient-level data
to optimize research efforts. In parallel, society in general, healthcare
systems and the pharmaceutical industry are critically concerned
about managing costs more efficiently and providing timely access to
safe and effective innovative medicines.
The rapid advancement of health information technologies (including
EHRs) now offers remarkable opportunities to optimize clinical research
potential, to streamline existing processes, and to enhance overall drug
development efficiency and access to innovative medicines in Europe.
In this context, the EHR4CR project intends to meet the ambitious
objective of establishing a scalable pan-European platform to enable
the re-use of EHR data to support the design and execution of clinical
trials and the monitoring of the safety of medicines.
This survey confirms the high interest and relevance of the EHR4CR
project with regard to EU stakeholders’ respective needs and incentives
for delivering sustainable and cost-effective solutions in Europe. These
promising possibilities and the complexity inherent to the EHR4CR
platform also require carefully addressing current opportunities and
challenges with continuous support and input from all relevant
stakeholders to enable the successful implementation of a pan-EU
EHR4CR capability and sustainable business model at project completion.
Considering that the EHR4CR platform will need to be deployed and
interface with a wide range of systems and services to support an
end-to-end user experience, this EU e-survey provides valuable
information towards achieving the development and implementation
of EHR4CR services and of a sustainable and scalable business model.
The results of this e-survey also address the many opportunities and
significant challenges ahead, including ensuring interoperability in
compliance with privacy protection, regulatory, legal, and ethical
requirements, and policies across Europe. Another challenge is the
near-universal downscaling of many national e-health programs, which
may limit the opportunity to extend the richness and interoperability of
EHR systems and of the infrastructure to enable them to communicate
at a regional or national level. ■
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