Background 

Health literacy is increasingly recognised as a determinant of access, informed decision-making and equity in colorectal cancer (CRC) screening programmes (1). European evidence indicates that limited health literacy is associated with lower participation and persistent socioeconomic inequalities (2,3). Beyond uptake, inadequate comprehension of invitations, screening procedures and test results may introduce avoidable patient safety risks along the screening pathway, including inappropriate decision-making, delayed diagnostic follow-up and loss of screening continuity. Despite this evidence, health literacy is rarely operationalised as a measurable dimension of quality and patient safety within organised CRC screening programmes. Current quality assurance frameworks primarily focus on participation rates and clinical outcomes, with limited attention to communication quality, navigability and system-level support for informed and safe participation across diverse European contexts. 

Objectives 

To explore how health literacy can be assessed as a quality dimension within organised colorectal cancer screening programmes and to propose a set of indicators applicable across European settings. 

Methods 

This study is embedded within a European Joint Research Centre (JRC) project of the European Commission Initiative on Colorectal Cancer (ECICC), aimed at the development of a quality assurance scheme for colorectal cancer (CRC) screening. As part of this work, a systematic review of peer-reviewed and grey literature was conducted to identify health literacy–related concepts, measures, and practices relevant to CRC screening. 

In this context, a deep and mapping approach was used to explore how health literacy can be operationalised as a quality dimension within CRC screening programmes.  Evidence was mapped piloting the Health Literacy Responsiveness (HLR) Framework across the screening pathway and aligned with ECICC quality principles (4). Based on this mapping, a set of context-specific health literacy indicators was selected and qualitatively assessed for responsiveness, sensitivity to change and feasibility by a multidisciplinary expert group. 

Results 

Following title/abstract screening and full-text review, 51 studies were included. Clear stool sample collection instructions for faecal immunochemical testing (FIT) were identified as feasible and health literacy–responsive quality indicators. Evidence of associations with FIT positivity and follow-up adherence was of low certainty, and no evidence was found for associations with early-stage cancer detection. The HLR Framework was used to map indicators across six interconnected organisational domains: external policy and funding environment; leadership and culture; systems, processes and policies; access to services and programmes; community engagement and partnerships; and communication practices and standards. 

Conclusions

Health literacy was rarely addressed as a formal quality or safety indicator within existing evidence. By applying the HLR Framework, this study is expected to propose a preliminary set of feasible, context-specific health literacy indicators, highlighting important gaps in the systematic assessment of communication quality and patient safety within CRC screening programmes.