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.

Sexually transmitted diseases (STDs) among adolescents and young people represent a significant public health problem that generates a pressing requirement of effective evidence-based education to promote primary and secondary prevention. The objective of the study is to evaluate how knowledge, information needs, and risk perception about HIV and STDs can change after targeted education interventions for students. A total of 436 subjects aged 15–24 attending high school (134 biomedical and 96 non-biomedical fields) and university courses (104 scientific and 102 non-scientific disciplines) were enrolled to respond to a questionnaire before and after the intervention. An improvement in knowledge was found in all groups, with statistically significant knowledge score differences between the four groups in 60% of the items. More than 94% of the students consider it useful to promote information on these issues. Receiving this information generated awareness and safety in more than 85% of high-school students and 93% of University students. Students widely perceived a great risk being infected with HIV/STDs, although pregnancy was seen as a more hazardous consequence of unprotected sex. This study shows that educational interventions are effective in improving knowledge, apart from findings about key knowledge topics, information needs, and risk perception, which provide significant insights to design future targeted education programs.

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BackgroundInappropriate ionising medical imaging has been escalating in the last decades. This trend leads to potential damage to health and has been associated to bioethical and legal issues of patient autonomy.MethodsWhile the doctrine underlines the importance of using informed consent to improve patient autonomy and physician-patient communication, some researchers have argued that it often falls short of this aim. There are basically two different informed consent practices. The first — the so-called “event-based model” — regards informed consent as a passive signature of a standard unreadable template, performed only once in each medical pathway. The second — the so-called “process-based model” — integrates information into the continuing dialogue between physician and patient, vital for diagnosis and treatment.ResultsCurrent medical behaviour often embraces the event-based model, which is considered ineffective and contributes to inappropriateness. We sought, in this review, to analyse from juridical and communication standpoints whether process-based informed consent can deal with scientific uncertainties in radiological decision-making. The informed consent is still a distinctive process in defence of both patients’ and physicians’ health and dignity in rule-of-law states and consequently in curtailing the abuse of ionising medical radiation.Main Messages• Inappropriate ionising medical imaging is widespread and increasing worldwide.• This trend leads to noteworthy damage to health and is linked to the issue of patient autonomy.• Some authors have argued that informed consent often falls short of improving patient autonomy.• Process-based informed consent can deal with scientific uncertainties to contrast inappropriateness.• Informed consent is still a distinctive process in defence of both patients and physicians.