Defining post–colon capsule endoscopy colorectal cancer (pCCECRC)—an International Capsule Endoscopy Research (iCARE) group consensus statement

INTRODUCTION AND AIMS: Colon capsule endoscopy (CCE) has seen increased adoption as a large bowel diagnostic test over the past decade. Unlike colonoscopy, the post-test colorectal cancer (CRC) outcomes are yet to be standardised and reported. This international consensus aimed to establish a framework to define pCCECRC. METHODS: A modified Delphi process was conducted in accordance with CREDES guidance. Expert panellists were recruited from the International Capsule Endoscopy Research (iCARE) group and leads of CCE services in the United Kingdom and Ireland. Statements were informed by a systematic literature review and developed by a core steering group. Two rounds of anonymous online voting were undertaken to measure expert agreement on a total of 11 statements. A scale of 1 (strongly disagree) to 5 (strongly agree) was utilised. Agreement was defined as ≥ 75% agree or strongly agree with a maximum IQR of 1. RESULTS: 40 experts participated in round one, with 36 completing round two. Consensus was achieved for all statements. One statement, relating to how pCCECRC should be defined did not reach the consensus threshold in round 1 and was revised before reaching consensus in round 2. pCCECRC was endorsed as an appropriate quality metric, with definitions aligned to PCCRC where feasible. A 6-month post-procedure grace period was agreed, and reporting of a pCCECRC-3-year rate was recommended. Separate unadjusted (service-level) and adjusted (test-specific) pCCECRC rates were defined. A structured "most plausible explanation" framework for attribution is proposed that both aligns with PCCRC methodology and considers the more complex diagnostic pathway of CCE services that usually entails multiple tests. CONCLUSION: This consensus proposes standardised definitions and reporting recommendations for pCCECRC. The proposed framework is intended to support quality assurance and evaluation of CCE services. Validation using real-world service datasets is required.