A Multi-Institutional Informed Consent Proposal As a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk

Overview

Journal J Pers Med

Date 2023 Apr 28

PMID 37108970

Authors

Marina Vinciguerra

Eliano Cascardi

Bruno Lamanna

Maricla Marrone

Fortunato Pititto

Enrica Macorano

Romualdo Sciorio

Giorgio Maria Baldini

Antonio Malvasi

Andrea Ballini

Gerardo Cazzato

Antonella Vimercati

Senthil Kumaran

Ettore Cicinelli

Salvatore Scacco

Miriam Dellino

Affiliations

Soon will be listed here.

Abstract

Methods: The review of relevant literature and international guidelines on prescription of combined oral contraceptives made it possible to create a proposal for informed consent to be used for prescribing.

Results: The several sections of our consent proposal were designed according to a rationale in order to cover all the aspects presented by worldwide guidelines: how to take, adverse effects, advertisements, extra-contraceptive benefits and effects, a checklist for condition at risk of thromboembolism, the signature of the woman.

Conclusions: An informed consent to standardize combined oral contraceptives prescription can improve women's eligibility, mitigate thromboembolic risk, and assure legal protection to healthcare providers. In this systematic review in particular, we refer to the Italian medical-legal scenario, to which our group of researchers belongs. However, the model proposed was designed in the respect of main healthcare organization guidelines, and it could be easily used by any center in the world.

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