[Proposal of a common model for informed consent for interventional procedures in congenital heart disease patients].

Proposta di un modello comune al consenso informato per le procedure di emodinamica nel cardiopatico congenito.

Journal

Giornale italiano di cardiologia (2006)
ISSN: 1972-6481
Titre abrégé: G Ital Cardiol (Rome)
Pays: Italy
ID NLM: 101263411

Informations de publication

Date de publication:
Jun 2022
Historique:
entrez: 8 6 2022
pubmed: 9 6 2022
medline: 10 6 2022
Statut: ppublish

Résumé

A multidisciplinary study group involving physicians and jurists was established to review and approve an informed consent about the most frequent interventional procedures for congenital heart diseases. The authors worked together with representatives of the Italian Society of Pediatric Cardiology and Congenital Heart Disease (SICP) Council and Jurist's expert in the field of health case-law. The final draft was shared with the major Italian centers involved in congenital interventional procedures and with AICCA, the Italian Patients Association of Congenital Heart Diseases - Adults and Children. At the end of this review process, a final informed consent form was developed for the most frequent procedures performed in our catheterization laboratories. All of them consist of two parts: a general statement and a procedure-related one. The work performed by this multidisciplinary study group, under the supervision of the SICP, resulted in a new dedicated informed consent about interventional procedures in the field of congenital cardiology, taking into account the new legal requests. This informed consent is intended to be both a document that can be used as such and a document from which to derive a specific document for each center. We believe that using similar informed consents in all Congenital Heart Disease Centers or at least have informed consents all inspired by the same setting, could be a further improvement in taking care of the patients and their families.

Sections du résumé

BACKGROUND BACKGROUND
A multidisciplinary study group involving physicians and jurists was established to review and approve an informed consent about the most frequent interventional procedures for congenital heart diseases.
METHODS METHODS
The authors worked together with representatives of the Italian Society of Pediatric Cardiology and Congenital Heart Disease (SICP) Council and Jurist's expert in the field of health case-law. The final draft was shared with the major Italian centers involved in congenital interventional procedures and with AICCA, the Italian Patients Association of Congenital Heart Diseases - Adults and Children.
RESULTS RESULTS
At the end of this review process, a final informed consent form was developed for the most frequent procedures performed in our catheterization laboratories. All of them consist of two parts: a general statement and a procedure-related one.
CONCLUSIONS CONCLUSIONS
The work performed by this multidisciplinary study group, under the supervision of the SICP, resulted in a new dedicated informed consent about interventional procedures in the field of congenital cardiology, taking into account the new legal requests. This informed consent is intended to be both a document that can be used as such and a document from which to derive a specific document for each center. We believe that using similar informed consents in all Congenital Heart Disease Centers or at least have informed consents all inspired by the same setting, could be a further improvement in taking care of the patients and their families.

Identifiants

pubmed: 35674033
doi: 10.1714/3810.37939
doi:

Types de publication

Journal Article Review

Langues

ita

Sous-ensembles de citation

IM

Pagination

433-436

Auteurs

Massimo Chessa (M)

Unità di Cardiologia del Congenito Adulto, Centro di Cardiologia Pediatrica e del Congenito Adulto, IRCCS Policlinico San Donato, San Donato Milanese (MI) - Università Vita Salute San Raffaele, Milano.

Gabriella Agnoletti (G)

S.C. Cardiologia Pediatrica e delle Cardiopatie Congenite, Città della Salute, Torino.

Ilaria Amici (I)

Studio Legale Associato Avv. Rocco Mangia, Milano.

Gabriele Egidy Assenza (G)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - U.O. Cardiologia Pediatrica e dell'Età Evolutiva, Centro per le Cardiopatie Congenite dell'Adulto Dipartimento Cardio-Toraco-Vascolare, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna.

Gianfranco Butera (G)

U.O. Cardiologia Interventistica delle Cardiopatie Congenite, Dipartimento di Cardiologia, Cardiochirurgia, Trapianto Cardio-Polmonare, IRCCS Ospedale Pediatrico Bambino Gesù, Roma.

Biagio Castaldi (B)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - U.O.C. Cardiologia Pediatrica, Azienda Ospedaliera, Università degli Studi, Padova.

Andrea Donti (A)

U.O. Cardiologia Pediatrica e dell'Età Evolutiva, Centro per le Cardiopatie Congenite dell'Adulto Dipartimento Cardio-Toraco-Vascolare, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna.

Angelo Fabio d'Aiello (AF)

Unità di Cardiologia del Congenito Adulto, Centro di Cardiologia Pediatrica e del Congenito Adulto, IRCCS Policlinico San Donato, San Donato Milanese (MI).

Giampiero Gaio (G)

U.O.C. Cardiologia e UTIC Pediatrica, AORN dei Colli, Ospedale Monaldi, Università della Campania "L. Vanvitelli", Napoli.

Luca Giugno (L)

Unità di Cardiologia del Congenito Adulto, Centro di Cardiologia Pediatrica e del Congenito Adulto, IRCCS Policlinico San Donato, San Donato Milanese (MI).

Paolo Guccione (P)

Dipartimento di Cardiologia, Cardiochirurgia, Trapianto Cardio-Polmonare, IRCCS Ospedale Pediatrico Bambino Gesù, Roma.

Giuseppe Limongelli (G)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - U.O. Malattie Rare Cardiovascolari, AORN dei Colli, Ospedale Monaldi Università della Campania "L. Vanvitelli", Napoli.

Giovanni Battista Luciani (GB)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - Unità di Cardiochirurgia Pediatrica e delle Cardiopatie Congenite, Azienda Ospedaliera Universitaria Integrata, Verona.

Rocco Mangia (R)

Studio Legale Associato Avv. Rocco Mangia, Milano.

Maurizio Marasini (M)

U.O.C. Cardiologia, Istituto Giannina Gaslini, Genova.

Gabriele Rinelli (G)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - Dipartimento di Cardiologia, Cardiochirurgia, Trapianto Cardio-Polmonare, IRCCS Ospedale Pediatrico Bambino Gesù, Roma.

Giovannella Russo (G)

U.O.C. Cardiologia e UTIC Pediatrica, AORN dei Colli, Ospedale Monaldi, Università della Campania "L. Vanvitelli", Napoli.

Giuseppe Santoro (G)

U.O.C. Cardiologia Pediatrica e del Congenito Adulto, Dipartimento Pediatrico, Fondazione Monasterio, Massa.

Michele Saitta (M)

Centro Mediterraneo di Cardiologia Pediatrica, Ospedale Pediatrico Bambino Gesù, Taormina.

Laura Soro (L)

Studio Legale Associato Avv. Rocco Mangia, Milano.

Ugo Vairo (U)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - U.O.C. Cardiologia Ospedale Pediatrico Giovanni XXIII, Bari.

Silvia Favilli (S)

Società Italiana di Cardiologia Pediatrica e delle Cardiopatie Congenite - Unità di Cardiologia, Ospedale Pediatrico A. Meyer, Firenze.

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