Low quality and lack of clarity of current informed consent forms in cardiology: how to improve them.
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.
Azienda Sanitaria Locale ASL 5 Pisa-Risk Management Unit, Pisa, Italy.
Giuseppina
G
Terranova
Marcello
M
Ferro
Clara
C
Carpeggiani
Virginia
V
Recchia
Larissa
L
Braga
Richard C
RC
Semelka
Eugenio
E
Picano
D000328:Adult; D000368:Aged; D002309:Cardiology / Q000941:ethics / Q000592:standards; D032882:Comprehension; D032962:Consent Forms / Q000941:ethics / Q000592:standards; D005260:Female; D005568:Forms and Records Control / Q000941:ethics / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards; D007558:Italy; D007802:Language; D008297:Male; D008875:Middle Aged; D011786:Quality Control; D014956:Writing