The Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) has recently launched the multicenter observational transversal study “Quality evaluation of the informative booklets for patients involved in the DEEP-2 trial” (QuBo). The overall aim of this study is to investigate the quality of the informative material addressed to paediatric patients involved in DEEP-2, in order to evaluate the level of comprehension and the likeability of the informative documents proposed in the clinical trial to paediatric patients.
Particularly, QuBo will foresee the filling in of a an age-tailored structured questionnaire (one for 6-11 years old patients and another one for 11-18 patients) that will be used to directly collect the children’s and adolescents’ opinion on the DEEP-2 informative material.
The study will involve centres adhering to DEEP-2 and all patients receiving the DEEP-2 informative material, who will not undergo any other intervention, treatment, visit or procedure besides the ones belonging to the standard clinical practice. Children will only be asked to provide their feedback about the age-appropriate informative documents produced to explain key aspects of the clinical study.
The study is coordinated by Dr. Lorella Pitrolo, medical director at Unità Operativa di Pediatria –servizio Talassemia of the hospital Villa Sofia Cervello, Palermo, coordinating centre of the study. It has been approved in Albania and Italy and will soon involve other centres on a voluntary base.