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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - HarmonicSS (HARMONIzation and integrative analysis of regional, national and international Cohorts on primary SjÃ¶grenâ€™s Syndrome (pSS) towards improved stratification, treatment and health policy making)

Teaser

Summary

HarmonicSS vision is to create an International Network and Alliance of partners and cohorts, entrusted with the mission of addressing the unmet needs in primary SjÃ¶grenâ€™s Syndrome; working together to create and maintain a platform with open standards and tools, designed to enable secure storage, governance, analytics, access control and controlled sharing of information at multiple levels along with methods to make results of analyses and outcomes comparable across centers and sustainable through Rheumatology scientific associations.

The overall concept of the HarmonicSS project is to bring together the largest well characterized regional, national and international longitudinal cohorts of patients with Primary SjÃ¶grenâ€™s Syndrome (pSS) including those participating in clinical trials, and by taking into consideration the ethical, legal, privacy and IPR issues for sharing data from different countries, to semantically interlink and harmonize them. Upon this harmonization, pSS patients will be stratified in disease subsets, open services for big data mining, governance and visual analytics will be integrated, to finally address the identified clinical and health policy pSS unmet needs. Moreover, tools for specific diagnostic procedures (e.g. ultrasonography image segmentation), patient selection for clinical trials and training will be also provided. The users of the HarmonicSS platform are researchers (basic/translational), clinicians, health policy makers and pharmaceutical companies.

OBJECTIVE 1: To establish a unified and semantically enriched knowledge sustainable network of the major clinical and research groups working on pSS and a steering committee for coordination
OBJECTIVE 2: To analyze the ethical, legal, privacy and IPR issues for integrating cohorts from different countries and patient selection for conducting international clinical trials.
OBJECTIVE 3: To achieve individual cohorts data quality and completeness through clinical preparatory actions according to the recent publications sponsored by the European League Against Rheumatism (EULAR).
OBJECTIVE 4: To harmonize the individual cohorts and create the integrative cohort on pSS.
OBJECTIVE 5: To deliver the core ICT services infrastructure for clinicians, researchers and health policy makers.
OBJECTIVE 6: To address the research and clinical unmet needs in pSS.
OBJECTIVE 7: To develop the HarmonicSS tools for patient selection in clinical trials, segmentation of salivary gland ultrasonography and training of general practitioners. OBJECTIVE 8: To deliver evidence and actionable insights for health policies in pSS and pilot application.
OBJECTIVE 9: To achieve sustainability, expandability and exploitation of the platform.

Work performed

WP1
WP1 covers all work related to project coordination, scientific and technical management, result quality assurance and risk management. The project coordinator, assisted by the steering committee, is responsible to monitor the above processes. During the first reporting period, four successful physical meetings were organized and took place to address issues of management and specific task assignment as well as to report current progress and problems arising.
WP2
The objective of the WP2 is to disseminate the activities as well as the results of the project during its lifespan. The work performed during the first reporting period includes the design and development of the project dissemination material. The dissemination actions of the HarmonicSS consortium have been considered through different types of targeted audience.
WP3
The objectives of this WP are to define the requirements of the HarmonicSS platform and the design of the architecture. WP3 deals with the usersâ€™ functional and technical requirements of the HarmonicSS platform and services as well as, with the definition of the legal framework for HarmonicSS data sharing. Finally, the HarmonicSS architecture was designed aiming at covering both the technical requirements and the legal framework.
WP4
The main goal of WP4 is to harmonize the cohorts provided by the HarmonicSS clinical partners. During the first 18 months of the project this WP worked towards establishing the processes and mechanisms for initiating the HarmonicSS cohorts harmonization.
WP5
WP5 addresses the objective 5 of HarmonicSS platform, which is to deliver the core ICT services infrastructure, for clinicians, researchers and health policy makers. This WP consists of 7 tasks, out of which 6 were active in this reporting period. The 7th Task, which is expected to begin at M27 is related to the integration of the above mentioned services in the integrated platform.
WP7
Aim of Task 7.2 was to develop software for ultrasound salivary gland grading system with the aim to ease further advancements in the diagnosis and treatment of pSS. Task 7.3 refers to the HarmonicSS training tool. Prior and on this timeframe, we have worked on finalizing the requirements, performing the analysis of the system and setting the specifications of the training tool.
WP9
WP9 covers the ethics requirements that the project must comply with. Key issues addressed in WP9 deal with criteria for patient inclusion to the HarmonicSS project, all procedures related to patient informed consent, approval of all protocols, data and sample collection, use, and transfer by Ethics Committees, and data pseudonymization.

Final results

During the first reporting period, two amendments have been initiated by the consortium and approved by the EC, relevant to the addition of new clinical partners from Harokopion University and twelve other partners providing in-kind contribution free-of-charge. These additions are anticipated to increase the number of pSS patients and the number of the biological specimens included in the study. Given that the prevalence of pSS in the general population is not high, increasing the number of patients in the study will significantly strengthen the results of the final analysis.
The HarmonicSS project is mainly research oriented, but in the long-term the consortium aims at providing a sustainable support for future research.
The consortium analysed the data sharing and data harmonization requirements, both from technical and legal perspective. The HarmonicSS architecture was defined, taking into account all those requirements and especially those derived by the GDPR. That is the first time a GDPR compliant architecture for data sharing, harmonization and analytics was defined.
The Text-Mining (TM) module developed in the HarmonicSS, introduces a connection between SS and the public-health policy related area. The text-mining component is to be seen as a tool to support the decision-making process in the public health policy area, especially if it uses readily available clinical and demographic features. This permits a more rapid, evidence-based decision-making in public health. However, up until now, there has been limited use of such systems in public health policy making.
The analytics services offer tools for the researchers, medical professionals and health policy makers in order to analyze the cohorts or external data (e.g. costs of SjÃ¶grenâ€™s drugs per country, costs for examination, social media posts, etc). A novel feature addressed, is the distributed learning from federated databases, which has been designed for the genetic analytics and big data mining services.