Background 

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in Europe, with significant disparities in care across EU-Member States. In response, the European Commission Initiative on Colorectal Cancer (ECICC) was conceived to enhance CRC prevention, screening and care and to provide a unified approach to quality assessment. Quality indicators (QI) and performance measures (PMs) are essential tools to evaluate healthcare quality and inform quality assurance schemes (QAS). 

Objectives 

To map and assess clinical laboratory QIs and PMs for the European QA scheme for colorectal cancer services, focusing on their scientific soundness, responsiveness, and feasibility to support evidence-based decision-making and standardised, high-quality cancer care. 

Methods 

A systematic review was conducted by the systematic review team (SRT) in accordance with PRISMA guidelines and Cochrane methodology. Search strategies were developed for five quality aspects prioritised by the ECICC Screening & Diagnosis Topic-Specific Group (TSG): stool sample collection; sample submission and transport; Fecal Immunochemical test (FIT) analytical performance; clinical performance; and reporting of results. MEDLINE and EMBASE were searched without language restrictions, complemented by grey literature from professional organizations and European health initiatives. Studies of any design were included if they involved adults at any risk of CRC and reported FIT-related clinical laboratory QIs with associations to relevant outcomes, including false-negative and false-positive results, adherence to follow-up, interval colorectal cancer, and early-stage colorectal cancer. The SRT extracted and summarised the evidence, while the TSG assessed and selected candidate QIs based on scientific soundness, responsiveness to change, and feasibility of implementation. 

Results 

Of 5,041 unique records, 322 studies met the inclusion criteria. Clear stool sample collection instructions for FIT (n = 51) were feasible and responsive QIs, with low-certainty evidence of associations with FIT positivity and follow-up adherence, but not early-stage cancer detection; evidence for laboratory verification was limited. Sample submission and transport (n = 23) were critical for FIT performance, as delays and temperature affected accuracy; clear transport instructions were considered feasible, good-practice QIs despite very low-certainty evidence and no directly measurable impact on early-stage CRC. FIT analytical (n = 83) and clinical performance indicators (n = 144), including positivity, detection, and interval cancer rates, were essential for screening and feasible for monitoring, but supported by low or very low-certainty evidence. Reporting FIT results (n = 21) was critical for screening, with clear and timely communication associated with improved follow-up adherence; data transfer systems and comprehensive laboratory reporting were considered essential and feasible despite limited direct evidence on clinical outcomes. 

Conclusions/Implications for practice or policy

Clinical laboratory QIs for CRC quality assurance schemes show substantial gaps of research supporting the scientific soundness. Strengthening the evidence linking these indicators to meaningful outcomes is essential for harmonised, evidence-based quality assessment across Europe.