The POETIC (PrOcess Evaluation of Trials In Critical care) Framework: A Structured Approach for Designing and Conducting Process Evaluations in Critical Care Trials

Four key process evaluation frameworks and two U.K.-based critical care trials informed initial development. The 2025 update identified five additional U.K. trials, four of which applied POETIC, supporting its relevance and applicability. Expert consensus identified five core dimensions:• Context (Unit Culture, Organizational Structure, Resources, Usual Practice, Attitudes and Perceptions)• Fidelity (extent to which the intervention is delivered as intended)• Dose (amount of the intended intervention delivered and received)• Reach (extent to which the target population is exposed to, or engages with, the intervention)• Quality of Delivery (integrative measure of Fidelity, Dose, and Reach)The framework includes recommended methods such as checklists, interviews, routine trial data, and observations. It was iteratively refined to enhance usability and adaptability and has since been applied in multiple U.K.-based perioperative and critical care trials, demonstrating its utility in U.K. ICU settings. The POETIC framework supports structured evaluation of delivery quality and context in critical care trials, improving trial interpretation and advancing intervention design, delivery, and real-world applicability. Distinctively, POETIC operationalizes ICU-specific Context sub-constructs and provides a prespecified composite Quality of Delivery index to link intervention delivery to outcomes.