The authors also thank Renata Todeschini, Francesca Diodati, and Eliana Valerani for their secretarial support and Kevin Smart (Link Srl, Milan, Italy) for his linguistic help in preparing the article.

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This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.

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