A new informed consent form model for cancer patients: Preliminary results of a prospective study by the Italian Association of Medical Oncology (AIOM)

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• 作者：Stefania Gori^a ; ^{stefania.gori@tin.it} ; Maria Teresa Greco^b ; ¹ ; ^{mariateresa.greco@marionegri.it} ; Chiara Catania^c ; ^{chiara.catania@ieo.it} ; Cinzia Colombo^d ; ² ; ^{cinzia.colombo@marionegri.it} ; Giovanni Apolone^e ; ³ ; ^{giovanni.apolone@marionegri.it} ; Vittorina Zagonel^f ; ⁴ ; ^{vittorina.zagonel@ioveneto.it} ; AIOM Group for the Informed Consent in Medical Oncology⁵
• 关键词：Cancer ; Patient information ; New informed consent model form
• 刊名：Patient Education and Counseling
• 出版年：2012
• 期刊代码：217_07383991
• 类别：med
• 出版时间：May, 2012
• 卷：87
• 期：2
• 页码：243-249
• 文件大小：221 K

摘要

Objectives

To document the preliminary validity of a new informed consent form (ICF) model in terms of face/content validity and feasibility, to collect patients鈥?and oncologists鈥?opinions on it, and to explore physicians鈥?and patients鈥?鈥渒nowledge鈥? 鈥渙pinions鈥?about 鈥渢he information exchanged鈥?

Methods

The working group for informed consent promoted by the Italian Association of Medical Oncology developed a new ICF model which was tested in ten Italian cancer centers. Patients and physicians received questionnaires on the new ICF model. Twenty-six independent oncologists were interviewed to collect their opinions.

Results

Seventy eight cancer patients were enrolled: about 90%reported having received information about diagnosis and therapy and 80%about prognosis. About 63%of oncologists had no difficulty in administering the ICF. Oncologists used 鈥渃orrect terms鈥?about diagnosis in 92%of patients with localized disease and in 90%with metastasis and about therapy in respectively 75.7%and 80%. About prognosis, oncologists used 鈥渧ague鈥?and 鈥渘o information-no pertinent terms鈥?in 79%of patients with localized disease and 92.5%of patients with metastasis.

Conclusions

The ICF seemed to have sufficient validity and feasibility.

Practice implication

This ICF model could mean that patients require oncologists to spend more time explaining the diagnosis, prognosis and treatment, increasing patient's opportunities to participate actively in the care process