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Background: Delirium is an acute brain dysfunction associated with increased length of hospitalization, mortality, and high healthcare costs especially in patients admitted to the pediatric intensive care unit (PICU). The Cornell Assessment of Pediatric Delirium (CAPD) is a screening tool for evaluating delirium in pediatric patients. This tool has already been used and validated in other languages but not in Italian., Objectives: To test the reliability of the Italian version of the CAPD to screen PICU patients for delirium and to assess the agreement between CAPD score and PICU physician clinical evaluation of delirium., Methods: Prospective double-blinded observational cohort study of patients admitted to a tertiary academic center PICU for at least 48 h from January 2020 to August 2021. We evaluated intra- and inter-rater agreement using the Intraclass Correlation Coefficient (ICC). The ability of the scale to detect delirium was evaluated by comparing the nurses' CAPD assessments with the clinical evaluation of a PICU physician with expertise in analgosedation using the area under the ROC curve (AUC)., Measurements and Main Results: Seventy patients were included in the study. The prevalence of pediatric delirium was 54% (38/70) when reported by a positive CAPD score and 21% (15/70) when diagnosed by the PICU physician. The CAPD showed high agreement levels both for the intra-rater (ICC 1 0.98, 95% CI: 0.97-0.99) and the inter-rater (ICC 2 0.93, 95% CI: 0.89-0.96) assessments. In patients with suspected delirium according to the CAPD scale, the observed sensitivity and specificity of the scale were 0.93 (95% CI: 0.68-1.00) and 0.56 (95% CI: 0.42-0.70), respectively. The AUC observed was 0.75 (95% CI: 0.66-0.8490)., Conclusion: The Italian version of the CAPD seems a reliable tool for the identification of patients at high risk of developing delirium in pediatric critical care settings. Compared to the clinical evaluation of the PICU physician, the use of the CAPD scale avoids a possible underestimation of delirium in the pediatric population., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Fazio, Daverio, Masola, D’Angelo, Frison, Zaggia, Simeone, Pucciarelli, Gregori, Comoretto and Amigoni.)

It is necessary to conduct Clinical Trials in children, including for novel vaccines. Children cannot legally provide valid consent, but can assent to research participation. Informed consent and assent communications are frequently criticized for their lack of comprehensibility and often, researchers do not involve patients in informed consent design. We tested a blended research-design approach to co-design multimedia informed consent prototypes for experimental vaccine studies targeted at the pediatric population. We report details on the methodology utilized, and the insights, ideas, and prototype solutions we generated using social media data analysis, a survey, and workshops. A survey of clinical trial researchers indicated that while the most did not use technology for informed consent, they considered its utilization favorable. Social media analysis enabled researchers to quickly understand where community perspectives were concordant and discordant and build their understanding of the types of topics that they may want to focus on during the design workshops. Participatory design workshops for children and their families reaped insights, ideas, and prototypes for a range of tools including apps and websites. Participants felt that the prototypes were better able to communicate necessary content than the original text document format. We propose using a participatory, mixed-methods approach to design informed consent so that it is better adapted to patients' needs. Such an approach would be helpful in better addressing the needs of different segments of the populations involved in clinical trials. Further evidence should be gained about the impact of this strategy in improving recruitment, decreasing withdrawals and litigations, and improving patient satisfaction during clinical trials., Competing Interests: SLP was employed by the company AND Consulting Group. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Jackson, Daverio, Perez, Gesualdo and Tozzi.)