The consensus-based CINEX guideline for reporting clinical information extraction studies.

OBJECTIVE: Information extraction (IE) from clinical texts has advanced rapidly with recent advances in natural language processing, particularly the advent of large language models (LLMs). However, inconsistent and incomplete reporting of methodologies limits reproducibility, comparability, and clinical translation. We aimed to develop a consensus-based reporting guideline tailored to clinical IE studies. MATERIAL AND METHODS: We developed the Clinical Information Extraction Reporting Guideline (CINEX) through a multi-phase process. The initiative was prospectively registered on the EQUATOR Network as a reporting guideline under development, and a detailed Delphi study protocol was published in advance. A scoping review informed an initial set of items, which was refined through a 3-round electronic Delphi study with 20 international experts, followed by a final consensus meeting. Items were iteratively refined based on predefined inclusion criteria and expert feedback. RESULTS: The final CINEX guideline comprises 29 checklist items grouped into 5 domains: information model, architecture, data, annotation, and outcomes. The 3 eDelphi rounds included 20, 15, and 12 experts, respectively. Two items were added after round one. Consensus for inclusion was reached for a 21 and additional 7 items after rounds 2 and 3, respectively. DISCUSSION: CINEX provides a structured framework to improve transparency, reproducibility, and interpretability in clinical IE research. By standardizing reporting of key methodological components, such as data provenance, annotation processes, and evaluation strategies, it facilitates meaningful comparison across studies and supports safer clinical implementation. CONCLUSION: CINEX complements existing AI reporting standards by addressing domain-specific challenges in clinical IE.