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Istituto di fisiologia clinica

Torna all'elenco Contributi in rivista anno 2012

Contributo in rivista

Tipo: Articolo in rivista

Titolo: Low Quality and Lack of Clarity of Current Informed Consent Forms in Cardiology: How to Improve Them

Anno di pubblicazione: 2012

Formato: Elettronico Cartaceo

Autori: Terranova, 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:


Lingua: inglese

Abstract: Guidelines 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 abstract: inglese

Pagine da: 649

Pagine a: 655

Pagine totali: 7


Paese di pubblicazione: Stati Uniti d'America
Lingua: inglese
ISSN: 1936-878X

Numero volume: 5

Numero fascicolo: 6

DOI: 10.1016/j.jcmg.2012.03.007

Referee: Sì: Internazionale

Stato della pubblicazione: Published version

Indicizzato da:

  • ISI Web of Science (WOS) [000305462300011]
  • Scopus [2-s2.0-84862196166]
  • PubMed [22698536]
  • PUMA [/cnr.ilc/2012-A0-004]
  • Google Scholar [QEcrdUYAAAAJ:ns9cj8rnVeAC]

Parole chiave:

  • bioethics; imaging risk communication; informed consent; patient rights

URL: http://www.sciencedirect.com/science/article/pii/S1936878X1200321X

Strutture CNR:


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