Risk-stratified cancer screening: A consensus-based conceptual framework from EUCanScreen

BACKGROUND: Cancer screening is a cornerstone of effective cancer prevention. The 2022 European Council Recommendation on cancer screening encourages risk-based approaches, including risk stratification, when appropriate, to improve the balance of screening benefits, harms, and resource use. To address conceptual heterogeneity and fragmented guidance across cancer sites and countries, the EUCanScreen Joint Action convened a multidisciplinary working group from 22 European countries to develop a shared conceptual framework for risk-stratified cancer screening, as a specific operational approach. METHODS: We conducted a scoping review to identify definitions, key outcomes, benefits and harms, and ethical considerations relevant to risk-stratified screening. The findings informed a structured brainstorming session and a two-round Delphi survey among EUCanScreen participants. A consultation phase and plenary discussion were used to finalize the framework in May 2025. RESULTS: The core elements defining risk-stratified screening are (1) the availability of validated information to estimate individual risk (i.e., the different probability of disease or its natural history), (2) the definition of stratification criteria (i.e., risk thresholds defining groups with similar risk that can be managed similarly), and (3) the presence of evidence-based stratum-specific management protocols. The framework clarifies how risk stratification can be applied across the screening pathway, from eligibility and screening intensity to referral and follow-up. Crosscutting organizational and ethical, legal, and social considerations were identified, including data governance, privacy and data protection, management of genetic information, psychological impacts, equity and access, and training and communication needs. Conclusions This collaborative, consensus-based framework identifies essential elements and crosscutting issues for designing, implementing, monitoring, and evaluating risk-stratified cancer screening. The rationale of risk-stratified screening is to modulate screening intensity in both directions, intensifying it for those at higher risk and reducing it for those at lower risk.