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A Journal on Pediatrics, Neonatology, Adolescent Medicine,
Child and Adolescent Psychiatry

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Minerva Pediatrica 2009 October;61(5):483-8


language: English

A project for the evaluation of awareness of under-aged patients involved in clinical trials. Development of the IGG- Awareness Scale

Massimo L. M. 1, Calcagno A. 2, Battaglia T. 2, Pistorio A. 3

1 Department of Pediatric Hematology and Oncology, G. Gaslini Scientific Children’s Hospital, Genoa, Italy 2 Pediatric Clinic University of Genoa, G.Gaslini Scientific Children’s Hospital Genoa, Italy 3 Epidemiology and Biostatistics Unit, G. Gaslini Scientific Children’s Hospital, Genoa, Italy


Aim. Most very sick, under-aged children express a desire or need for information about their illness and therapy. Most of them are being treated with experimental trials, and their parents/ tutors have been requested to provide informed consent. The need to understand, mostly by the older patients, may differ depending on age and gender, but it always involves psychology. Although the literature is full of guidelines and papers about assent of under-aged patients, there is a lack of data about their awareness.
Methods. The authors report a project for the evaluation of awareness of under-aged patients in their involvement in clinical trials; a simple investigative instrument that consists of a short, simple, semistructured interview which includes a questionnaire of 11 items is presented. A preliminary investigation was performed with a convenience sample of 15 school-aged children with cancer. The interview project was accomplished after this evaluation. The main aim was to evaluate the degree of awareness of sick youngsters between 11 and 18 years of age with regards to the experimental trial they are undergoing.
Results and conclusion. The study is a monocentric, transversal and descriptive survey, approved by the Research Ethics Committee of our institution. A complete analysis of the total scores of awareness will be performed.

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