Consiglio Nazionale delle Ricerche

Tipo di prodottoArticolo in rivista
TitoloLow Quality and Lack of Clarity of Current Informed Consent Forms in Cardiology: How to Improve Them
Anno di pubblicazione2012
Formato
  • Elettronico
  • Cartaceo
Autore/iTerranova, Giuseppina [ 2 ]; Ferro, Marcello [ 3 ]; Carpeggiani, Clara [ 1 ]; Recchia, Virginia [ 1 ]; Braga, Larissa [ 4 ]; Semelka, Richard C. [ 4 ] ; Picano, Eugenio [ 1 ]
Affiliazioni autori[ 1 ] Consiglio Nazionale delle Ricerche (CNR), Inst Clin Phys, I-56124 Pisa, Italy [ 2 ] Azienda Sanit Locale ASL 5 Pisa, Risk Management Unit, Pisa, Italy [ 3 ] Consiglio Nazionale delle Ricerche (CNR), Ist Linguist Computaz, I-56124 Pisa, Italy [ 4 ] University of North Carolina Chapel Hill, Dept Radiol, Chapel Hill, NC USA
Autori CNR e affiliazioni
  • VIRGINIA RECCHIA
  • MARCELLO FERRO
  • CLARA CARPEGGIANI
  • EUGENIO PICANO
Lingua/e
  • inglese
AbstractGuidelines on informed consent for clinical practice exhort physicians to use standard plain language to enhance patient comprehension and facilitate shared decision making. The aim of this study was to assess and improve quality and readability of current informed consent forms used in cardiology. We evaluated the currently used informed consent forms, previously written in Italian and English, of 7 common imaging examinations, according to the recommendations of scientific societies. For each text, we also developed a revised informed consent form according to reference standards, including Federal Plain Language guidelines. Regarding readability scores, we analyzed each text (standard and revised) with Flesch-Kincaid (F-K) grade level (higher numbers indicating harder-to-read text) and the Italian language-tailored Gulpease level (from 0 [difficult] to 100 [easy]). Overall quality and readability was poor for both the original English and Italian versions, and readability was improved with the revised form, with higher readability evidenced by changes in both F-K grade level (standard 10.2 ± 2.37% vs. revised 6.5 ± 0.41%; p < 0.001) for English and Gulpease (standard 45.7 ± 2% vs. revised 84.09 ± 2.98%; p < 0.0001) for Italian. In conclusion, current informed consent forms are complex, incomplete, and unreadable for the average patient. Substantial quality improvement and higher readability scores can be achieved with revised forms that explicitly discuss risks and are prepared following standard recommendations of plain writing.
Lingua abstractinglese
Altro abstract-
Lingua altro abstract-
Pagine da649
Pagine a655
Pagine totali7
RivistaJACC-CARDIOVASCULAR IMAGING
Editore: ELSEVIER SCIENCE INC - NEW YORK, USA
Paese di pubblicazione: Stati Uniti d'America
Lingua: inglese
ISSN: 1936-878X
Titolo chiave: JACC-CARDIOVASCULAR IMAGING
Numero volume della rivista5
Fascicolo della rivista6
DOI10.1016/j.jcmg.2012.03.007
Verificato da refereeSì: Internazionale
Stato della pubblicazionePublished version
Indicizzazione (in banche dati controllate)
  • ISI Web of Science (WOS) (Codice:000305462300011)
  • Scopus (Codice:2-s2.0-84862196166)
  • PubMed (Codice:22698536)
  • PUMA (Codice:/cnr.ilc/2012-A0-004)
  • Google Scholar (Codice:QEcrdUYAAAAJ:ns9cj8rnVeAC)
Parole chiavebioethics; imaging risk communication; informed consent; patient rights
Link (URL, URI)http://www.sciencedirect.com/science/article/pii/S1936878X1200321X
Titolo parallelo-
Data di accettazione-
Note/Altre informazioni-
Strutture CNR
  • IFC — Istituto di fisiologia clinica
  • ILC — Istituto di linguistica computazionale "Antonio Zampolli"
Moduli CNR
    Progetti Europei-
    Allegati
    • Low Quality and Lack of Clarity of Current Informed Consent Forms in Cardiology - How to Improve Them

    Dati associati a vecchie tipologie
    I dati associati a vecchie tipologie non sono modificabili, derivano dal cambiamento della tipologia di prodotto e hanno solo valore storico.
    Editore
    • Elsevier Science Inc., New York (Stati Uniti d'America)