Shift-driven action and sustainability plan
This work package aims at securing the project’s effective impact action which is to deliver a system for early diagnosis and treatment of endometriosis. Activities under WP1 delivers the impact action strategy and plan to secure this objective is fully achieved, allow to adjust, foster, and improve actions developed under all other WP via impact monitoring and assessment (IMA) of the aforementioned action’s effectiveness to make change. WP1 secures alignment between operations, methodologies and anticipated results, incorporating a risk and change plans. In addition, WP1 forecast and characterize additional outcomes not planned initially and examine their feasibility without additional resources. Likely all other WP, WP1 foster synergies and coactions mechanisms. WP1 generates synergies with comparable IMA processes from other sources (e.g., EU-funded projects, etc.). All in all, WP1 secures all activities effectively meet each of the call’s 5 expected impact (CEI) with a continued, systemic and digital-based impact monitoring and assessment (IMA) process that generates endometriosis disorder indicators and fact-sheet instruments.
Task 1.1 – Generate the project impact action strategy
Task 1.2 – Development and pilot of cost-effective IMA methods
Ethics, gender, inclusion, RRI and Open Science
This work package’s main aim is to provide a comprehensive framework to secure the project development and results are aligned with the European Union idea of an inclusive, innovative and reflective society. WP generates reflection activities and debates on citizens needs and realities, values and expectations regarding innovation, policies and public affairs, and to a certain extent research and development. Key areas connecting social sciences and humanities key principles, ethics, gender approaches, inclusion, RRI and Open Science are explored to develop a transparent and ethical framework to contribute to early diagnosis and treatment of endometriosis (EDTE) under the perspective of social sciences and humanities, e.g., life course public health, culturally sensitive population health programmes, community-based participatory research, bioethics, inequalities, public engagement, etc.
All in all, WP2 aim at overcoming EDTE barriers related to the society at large, to foster effectiveness in citizen-centered innovation, transparency and participation.
Task 2.1 – Project code guidelines
Task 2.2 – Ethical framework for EDTE
Task 2.3 – Gender-based and inclusion driven framework for EDTE
Task 2.4 – RRI and Open Sciences driven framework for EDTE
D2.2 – White paper on ethical health and care systems
D2.3 – White paper on gender-based and inclusive health and care systems
D2.4 – White paper on RRI-oriented and Open Science health and care systems
Clinical and psychosocial phenotyping
This work package aims to estimate the prevalence and geographical distribution of endometriosis-like symptoms in Denmark and Scotland. This includes the development and comparison of a phenotype description of women reporting endometriosis like symptoms for women with and without an endometriosis diagnosis. The health related and social consequences of diagnostic delay for the individual and the society will be estimated.
Task 3.1 – Development and validation of baseline questionnaire
Task 3.2 – Study on prevalence and geographical distribution
Task 3.3 – Consequences related to diagnostic delay
Risk classifier and biological subtypes
This work package aims to identify subtype-specific risk factors and get insight in possible new drug targets or drug repurposing opportunities. This will be done by validating and refining biological subtypes in two independent cohorts. Based on high-resolution stratification of people with endometriosis, using SMOP, two clinical decision support tools will be developed and demonstrated:
1. risk stratification tool that uses genes to classify women into high and low risk for endometriosis,
2. multi-marker signature that can distinguish biological subtypes and has the potential to facilitate shared decision making and guide treatment choice of endometriosis in combination with other information.
Task 4.1 – Risk classifier
Task 4.2 – Identify endometriosis subtypes
Task 4.3 – Validate and re-fine endometriosis subtypes in independent cohorts
Task 4.4 – Clinical decision support (CDS) tools
D4.2 – Biological markers
D4.3 – Subtype characteristics
D4.4 – Clinical decision support tools
Digital health monitoring and the Lucy App
WP5 aims to identify patterns of lifestyle and environmental factors related with endometriosis in Denmark, Hungary, Scotland, and Sweden. The FEMaLE mobile health app, building of the existing Lucy App, will be used to monitor self-reported endometriosis, mental (e.g. stress, anxiety, and depression) and physical activity and environmental factors in order to classify any behavioural patterns underlying clinical manifestations in people with endometriosis related to stress and infertility issues and nutritional and other lifestyle factors. The main output will be the development of patient profiles and structured clinical data.
Task 5.1 – Translate and validate the Lucy App in Denmark, Scotland, and Sweden
Task 5.2 – Longitudinal study facilitated by the Lucy App
Task 5.3 – Develop the dietary and the lifestyle module
Task 5.4 – Patient risk profile generated by SMOP
D5.3 – Dietary module of the Lucy App
D5.4 – Lifestyle module of the Lucy App
D5.5 – Patient global profile
Surgical phenotyping using machine learning
This work package aims to develop a computer vision tool that enables an automatic and objective confirmation of the diagnosis and assessment of the stage and extension of endometriosis evaluated during laparoscopy. Only complete standardization, using a numeric tool, will allow a reliable definitive assessment. The annotation of the laparoscopic images performed by surgeons will enable machine learning technology to automatize the evaluation of the endometriosis specific score. The algorithm will be integrated in the SurgAR software to allow a real time assessment of the r-ASRM score. The r-ASRM score obtained using the trained algorithm will be compared to the score manually determined by the expert surgeons to validate the algorithm and the numeric tool.
Task 6.1 – Collecting videos with metadata
Task 6.2 – Annotation of laparoscopic videos
Task 6.3 – Developing deep learning algorithm to automatic r-ASRM classification
Task 6.4 – Real time assessment of algorithm
Task 6.5 – Clinical validation of the algorithm
D.6.3 – Deep learning algorithm to automatically determinate the stage of endometriosis
D.6.4 – Computer vision-based software for real time assessment of endometriosis
Augmented reality to improve laparoscopic surgery
This work package aims to create a computer vision tool that enables automatic detection of the division plane around the endometriotic lesion, which requires years of expertise. Only a complete standardization of this determination using a deep learning based numeric tool will allow to develop a reliable automatic real time determination. For this purpose, a large laparoscopic annotated image dataset is mandatory (as in WP6). This will involve various kinds of surgeons to perform during and after the surgery the annotation.
The algorithm will be integrated in the SurgAR software to allow a real time augmented reality guidance tool assisting the surgeon in finding the division planes around the lesion. This facilitates the complete excision of the disease, especially deep endometriosis.
Task 7.1 – Collecting videos with metadata
Task 7.2 – Semantic annotation of laparoscopic videos
Task 7.3 – Deep learning algorithm dedicated to automatic detection of division plane
Task 7.4 – Augmented reality to guide surgeons real time on the laparoscopic screen
Task 7.5 – Integration and clinical validation of the algorithm in SurgAR software
D.7.2 – Dataset of laparoscopic semantic annotated images
D.7.3 – Deep learning algorithm to automatically determinate the division plane
D.7.4 – Computer vision-based software for real time guided surgery of endometriosis
This work package aims to prevent development of chronic pain problems by teaching patients how to manage and reduce the negative physical, psychological and social symptoms by encouraging skills acquisition and adaptive behaviour changes. Ultimately, this could improve the overall quality of life in people with endometriosis.
Task 8.1 – Development of online modules and feasibility testing
Task 8.2 – Conducting a randomized controlled trial
Task 8.3 – Translations of the programme
Task 8.4 – Implementation of the program into the modified Lucy App
D8.2 – Validated English and Hungarian versions of MY-ENDO
D.8.3 – Lucy App MY-ENDO module
Dissemination, communication and synergies
This work package aims at securing the public disclosure of the results of the project with an impact-driven strategy, with a focus on generating momentum at specific stages via synergies with other health and care and societal-related events, initiatives and projects. Also, WP9 will ideate and implement a structured framework of strategic and targeted measures for publicizing dissemination actions to the diverse and comprehensive target audiences. WP9 framework covers dissemination, communication exploitation of results and synergies and develops with two-way exchange mechanisms, driven by the transfer of information from project FEMaLE and by the uptake from targeted audiences to integrate project FEMaLE.
Task 9.1 – Dissemination and communication strategy and tools
Task 9.2 – Synergies action plan
Task 9.3 – Communication implementation and management
Task 9.4 – Dissemination implementation and management
Task 9.5 – Innovation and Intellectual Property management
Task 9.6 – Exploitation of results plan an implementation
D.9.5 – Exploitation of results plan
Management, financial, risk and quality
This work package generates a Lean-Agile project management framework that separates the development process into narrowed iterations to facilitate decision-making and problem solving. WP10 coordinates the project’s implementation as a whole via securing a result-driven assignment of resources, fine-tuning the calendar of activities per the project’s implementation realities, and reporting efficiently to all teams/partners. WP10 secures a sound and transparent knowledge management baseline via practicing the principles of findable, accessible, interoperable and re-usable data (FAIR), to provide the optimized inclusion of all partners engagement, accessibility and space to communicate. WP10 develops with a gender equality driven and ethical-driven approach. WP10 delivers the Correlate FEMaLE, a tailored software as a service (SaaS) giving the users an instant transparent and augmented layer over other online and actionable content, files and pages, stored in and across unconnected and scattered private and public online platforms. WP10 generate the project’s Ethics Requirements formulation. WP10 secure the Ethics Requirements framework of the project, which are guidelines to manage personal data, monitored throughout the duration of the project by activities of different management forums and the project’s Ethics Manager.
Task 10.1 – Project management and implementation strategy and tools
Task 10.2 – Project coordination and partnership internal communication
Task 10.3 – Progress monitoring, quality control and reporting
Task 10.4 – Administrative and financial management
Task 10.5 – Data-driven digital management platform
Task 10.6 – Knowledge management
D.10.1 – Project management and implementation strategy (confidential report)
D.10.2 – Progress monitoring, quality control and briefs (confidential reports)
D.10.3 – Administrative and financial management briefs (confidential reports)
D.10.5 – Knowledge management guidelines and briefs (confidential reports)