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Work Package 9:
Risk-based approaches
WP 9
Risk-based approaches
ISPRO, Italy, co-led by UNICANCER, France
Work Package Summary
The overall objective is to enhance understanding of the concepts of risk and risk-based screening and provide MS with recommendations for assessing the potential integration of these approaches into their screening programs.
Specific objectives are as follows:
1) Review and assess proposed approaches and available tools for risk stratification;
2) Share knowledge, best practices and risk-assessment tools for organising and implementing risk-based interventions;
3) Define relevant scenarios for cost-effectiveness modelling, identify pertinent research questions, and prioritise clinical questions for guideline development;
4) Evaluate available resources per the existing healthcare system and the values, preferences, and social norms of the target population;
5) Propose and develop suitable communication strategies and tools for healthcare professionals and the general public.
ISPRO, Italy,
co-led by UNICANCER, France
Tasks
| Task Nr | Task Name | Description | Participants |
| T9.1 | Development and assessment of methods for promoting informed choice and communication in personalised programs | Methods for measuring informed choices in risk-based screening monitoring systems considering social and individual barriers/facilitators will be developed. Literature review on decision aid tools for risk-tailored screening and risk communication strategies will be performed. Survey (involving European ongoing pilot programs) to assess risk communication practices including written materials, communication campaigns, media approaches will be conducted. Focus groups with screening target populations and use of narrative medicine techniques will be conducted. Task will be led by IRFMN, Italy, co-led by ISPRO, Italy. | ISPRO, NKIP, SCI, OIL IRFMN, ICO, UCY, IRFMN, UNICANCER, NNGYK, CPO, AUSLRE, PAT, RSU, IMIM, NCI, IU NAMSU, DYPEDE, OUS |
| T9.2 | Innovative approaches to risk stratification and available tools | Definitions of risk-stratified screening will be developed. Risk assessment will be conducted and predictive models and risk calculators will be performed sharing results with WP10. Questions relevant for the HTA of the risk-stratified screenings will be identified. WP6 and WP4 tools will be adopted for evaluating barriers and WP4 preparedness to risk-stratified screening. Ethical and privacy concerns (genetic and non-genetic risks) will be addressed. A workshop to share the framework for evaluation with tasks 9.3, 9.4, and 9.5 will be organised. Feedback received from tasks 9.3, 9.4, 9.5 will be used to refine the framework and tools. Task will be led by AUSLRE, Italy, co-led by CPO, Italy. | SCI, CIPH, ISPRO, OIL AUSLRE, CPO UCY, CSF, UNICANCER, BIPS, UCSC, RSU, NCI, IU NAMSU, DYPEDE |
| T9.3 | Individualised cervical cancer screening, including integrating state-ofthe- art triage methods to screening | Survey on existing models, organisational approaches, and member states’ data on risk-based cervical cancer screening will be conducted. Cost-effectiveness scenarios will be defined, informed by the RISCC project and existing pilots, focusing on two risk-stratifications levels: whole population and HPV-positive women. Alignment with existing European recommendations and identification of areas needing new recommendations will be performed defining relevant clinical questions and identifying research priorities. A toolbox will be built for implementing strategies informed by WP4, WP6, and WP10. This task will be led by AUSLRE, Italy, co-led by ISPRO, Italy. | ISPRO, SCI, UZIS, THL, SoS, IOL, PHCI AUSLRE, CSF, NNGYK, DOHI, CPO, PAT, RSU, LSMUKK, OUS, RCC, NCI, IU NAMSU, DYPEDE, HDH |
| T9.4 | Risk-based colorectal cancer screening | Survey of the models and examination of organisational approaches, data sources to stratify the population into risk groups and assessment of data on feasibility, transferability and implementation of tools addressing screening facilitators and barriers will be conducted. Clinical questions for guidelines will be prioritized, including benefits and harms through implementation research, and definitions of cost-effectiveness. Other activities will include coordination of data analysis plans from pilot studies with 2 approaches: individual risk assessment and screening history; analysis of European guidelines for alignment or need for new recommendations; and development of a toolbox for implementation strategies based on existing recommendations, and findings from this task, WP4, WP6 and WP10, to support national/local decision making. This task will be led by CPO, Italy. | LU SoS, CIPH, UZIS, ISPRO, CPO, CSF, BIPS, NNGYK, DOHI, AUSLRE, NIJZ, IMIM, BIOSISTEMAK, IDIVAL, RCC, DYPEDE, NCI, UMIT TIROL, Iasi RIO |
| T9.5 | Breast cancer screening based on individual risk characteristics | The following activities will be carried out: survey of existing, ongoing, and planned risk assessment experimentations and evaluation of their impact on benefits; review of guidelines and identification of research gaps and implementation, and prioritised clinical questions for guideline updates; systematic review and multidisciplinary analysis (consensus method) of cost-effectiveness models and socio-psychological impact, and Patient Reported Outcomes (PROMS); collection and analysis of data on feasibility, transferability, and challenges in different screening approaches; and development of a toolbox for critical analysis of screening strategies to support decision makers at national/local level (expected benefits, costs, cost-effectiveness). This task will be led by Unicancer, France, co-led by CPO, Italy. | ISPRO, OIL, Unicancer, CPO, UCY, CSF, ISS, AUSLRE, LoR, LSMUKK, OUS, BIOSISTEMAK, IOCN, APHP, NCI, NNGYK, UMIT TIROL |
| T9.6 | Integrating primary, secondary and tertiary prevention with screening | The following activities will be carried out: map ongoing primary, secondary, and This task will be led by SCI, Belgium, co-led by Unicancer, France | SCI, ISPRO, OIL, ICO, CIPH, TAI Unicancer, CCRef, CvKO, BRUPREV, AUSLRE, CPO, UCSC, OUS, RSU, NCI |
| T9.7 | The role of risk stratification in new screenings (lung, prostate, gastric) | The following activities will be carried out: survey of risk stratification models and organisational approaches for new screening; analysis of European guidelines and options; definition of cost-effectiveness scenarios and conduction of pooled data analysis from pilot studies. with feedback fromWP10 for relevant models; systematic reviews and multidisciplinary analyses (consensus method) to identify knowledge and research gaps in risk-stratified screening for lung, prostate, and gastric cancers (informed by 8.1, 8.2, 8.3, 8.4, 8.5); feedback provision to WP10 on costeffectiveness analysis. This task will be led by Unicancer, France, co-led by ISPRO, Italy. | ISPRO, PHC, INCa, NKIP Unicancer, CPO, BIOSISTEMAK, IDIVAL, OIL, AUSLRE, LoR, NCI, IU NAMSU, AP-HP |
| Task Nr | Task Name | Description | Participants | Role | In-kind Contributions/Subcontracting |
| T9.1 | Development and assessment of methods for promoting informed choice and communication in personalised programs | Methods for measuring informed choices in risk-based screening monitoring systems considering social and individual barriers/facilitators will be developed. Literature review on decision aid tools for risk-tailored screening and risk communication strategies will be performed. Survey (involving European ongoing pilot programs) to assess risk communication practices including written materials, communication campaigns, media approaches will be conducted. Focus groups with screening target populations and use of narrative medicine techniques will be conducted. Task will be led by IRFMN, Italy, co-led by ISPRO, Italy. | ISPRO, NKIP, SCI, OIL IRFMN, ICO, UCY, IRFMN, UNICANCER, NNGYK, CPO, AUSLRE, PAT, RSU, IMIM, NCI, IU NAMSU, DYPEDE, OUS | BEN AE | Yes (subcontracting) |
| T9.2 | Innovative approaches to risk stratification and available tools | Definitions of risk-stratified screening will be developed. Risk assessment will be conducted and predictive models and risk calculators will be performed sharing results with WP10. Questions relevant for the HTA of the risk-stratified screenings will be identified. WP6 and WP4 tools will be adopted for evaluating barriers and WP4 preparedness to risk-stratified screening. Ethical and privacy concerns (genetic and non-genetic risks) will be addressed. A workshop to share the framework for evaluation with tasks 9.3, 9.4, and 9.5 will be organised. Feedback received from tasks 9.3, 9.4, 9.5 will be used to refine the framework and tools. Task will be led by AUSLRE, Italy, co-led by CPO, Italy. | SCI, CIPH, ISPRO, OIL AUSLRE, CPO UCY, CSF, UNICANCER, BIPS, UCSC, RSU, NCI, IU NAMSU, DYPEDE | BEN AE | No |
| T9.3 | Individualised cervical cancer screening, including integrating state-ofthe- art triage methods to screening | Survey on existing models, organisational approaches, and member states’ data on risk-based cervical cancer screening will be conducted. Cost-effectiveness scenarios will be defined, informed by the RISCC project and existing pilots, focusing on two risk-stratifications levels: whole population and HPV-positive women. Alignment with existing European recommendations and identification of areas needing new recommendations will be performed defining relevant clinical questions and identifying research priorities. A toolbox will be built for implementing strategies informed by WP4, WP6, and WP10. This task will be led by AUSLRE, Italy, co-led by ISPRO, Italy. | ISPRO, SCI, UZIS, THL, SoS, IOL, PHCI AUSLRE, CSF, NNGYK, DOHI, CPO, PAT, RSU, LSMUKK, OUS, RCC, NCI, IU NAMSU, DYPEDE, HDH | BEN | Yes (subcontracting) |
| T9.4 | Risk-based colorectal cancer screening | Survey of the models and examination of organisational approaches, data sources to stratify the population into risk groups and assessment of data on feasibility, transferability and implementation of tools addressing screening facilitators and barriers will be conducted. Clinical questions for guidelines will be prioritized, including benefits and harms through implementation research, and definitions of cost-effectiveness. Other activities will include coordination of data analysis plans from pilot studies with 2 approaches: individual risk assessment and screening history; analysis of European guidelines for alignment or need for new recommendations; and development of a toolbox for implementation strategies based on existing recommendations, and findings from this task, WP4, WP6 and WP10, to support national/local decision making. This task will be led by CPO, Italy. | LU SoS, CIPH, UZIS, ISPRO, CPO, CSF, BIPS, NNGYK, DOHI, AUSLRE, NIJZ, IMIM, BIOSISTEMAK, IDIVAL, RCC, DYPEDE, NCI, UMIT TIROL, Iasi RIO | COO BEN AE | No |
| T9.5 | Breast cancer screening based on individual risk characteristics | The following activities will be carried out: survey of existing, ongoing, and planned risk assessment experimentations and evaluation of their impact on benefits; review of guidelines and identification of research gaps and implementation, and prioritised clinical questions for guideline updates; systematic review and multidisciplinary analysis (consensus method) of cost-effectiveness models and socio-psychological impact, and Patient Reported Outcomes (PROMS); collection and analysis of data on feasibility, transferability, and challenges in different screening approaches; and development of a toolbox for critical analysis of screening strategies to support decision makers at national/local level (expected benefits, costs, cost-effectiveness). This task will be led by Unicancer, France, co-led by CPO, Italy. | ISPRO, OIL, Unicancer, CPO, UCY, CSF, ISS, AUSLRE, LoR, LSMUKK, OUS, BIOSISTEMAK, IOCN, APHP, NCI, NNGYK, UMIT TIROL | BEN AE | No |
| T9.6 | Integrating primary, secondary and tertiary prevention with screening | The following activities will be carried out: map ongoing primary, secondary, and This task will be led by SCI, Belgium, co-led by Unicancer, France | SCI, ISPRO, OIL, ICO, CIPH, TAI Unicancer, CCRef, CvKO, BRUPREV, AUSLRE, CPO, UCSC, OUS, RSU, NCI | BEN AE | No |
| T9.7 | The role of risk stratification in new screenings (lung, prostate, gastric) | The following activities will be carried out: survey of risk stratification models and organisational approaches for new screening; analysis of European guidelines and options; definition of cost-effectiveness scenarios and conduction of pooled data analysis from pilot studies. with feedback fromWP10 for relevant models; systematic reviews and multidisciplinary analyses (consensus method) to identify knowledge and research gaps in risk-stratified screening for lung, prostate, and gastric cancers (informed by 8.1, 8.2, 8.3, 8.4, 8.5); feedback provision to WP10 on costeffectiveness analysis. This task will be led by Unicancer, France, co-led by ISPRO, Italy. | ISPRO, PHC, INCa, NKIP Unicancer, CPO, BIOSISTEMAK, IDIVAL, OIL, AUSLRE, LoR, NCI, IU NAMSU, AP-HP | BEN AE | No |
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Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HADEA). Neither the European Union nor HADEA can be held responsible for them.
The general objective of EUCanScreen is to assure sustainable implementation of high-quality screening for breast, cervical and colorectal cancers, as well as implementation of the recently recommended screening programs – for lung, prostate and gastric cancers. EUCanScreen will facilitate the reduction of cancer burden and achieving equity across the EU.
This project has received funding from the European Union’s EU4HEALTH Programme under the Grant Agreement no 101162959
