Inappropriate 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.METHODS: While 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.RESULTS: Current 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: o Inappropriate ionising medical imaging is widespread and increasing worldwide. o This trend leads to noteworthy damage to health and is linked to the issue of patient autonomy. o Some authors have argued that informed consent often falls short of improving patient autonomy. o Process-based informed consent can deal with scientific uncertainties to contrast inappropriateness. o Informed consent is still a distinctive process in defence of both patients and physicians.

Informed consent in the hospital as in any other healthcare setting is - before anything else - a process of communication and relationship which must involve the patient in a decision directly affecting his/her health. In this article, we focus our attention on the bi-directionality existing among an informed consent process and the instrument of alternative dispute resolution constituted by mediation applied to healthcare conflicts. The link between the two legal institutions is bidirectional because informed consent is a fundamental premise of a good mediation and mediation - in turn - can be an important stimulus to continuously improve the process of informed consent. This bi-directionality for both legal institutions is fueled by the element of "trust". While trust in informed consent is the result of a continuous dialogue and listening between the doctor, the staff and the patient, in mediation it represents the crucial element to be renovated.Therefore, mediation in healthcare is an effective tool for managing conflicts tothe extent that goes to latch on to a real and previous communicative relationshipthat actually materialized between the parties around the relationship of care.The emotional reality of the patient and his family - as well as that one regardinghealth professionals themselves - can emerge in an effective way during mediation,through the co-presence of the parties in a facilitated dialogue. This same realitycan motivate health professionals to acquire a thorough and in-depth trainingon the values, techniques and tools necessary for the realization of a genuine process-based informed consent within an effective doctor-patient communication. All this can and must be done - in an organization sensitive to these issues - according to a virtuous cycle that feeds on itself and creates a renewed wellness for physicians as well as for patients in their inseparable relationship of care.

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.

Inappropriate use of ionizing tests in medicine represents an increasing trend, which causes noteworthy damages to health, as well as a huge increment of health expenditures, waiting lists, organizational conflicts, judicial disputes, and insurance compensations. This phenomenon is strictly related to the keybioethical and legal issue of patient's autonomy, which is protectable by means of a correct implementation of informed consent. The current practice of the passive signature on incomplete and unreadable informed consent templates belongs to the so-called "event-based" approach. This practice mortifies the patient's right to decide freely and deliberately, being him unaware of the biological consequencesof diagnostic-therapeutic interventions on himself and on his progeny's health. On the other hand, physicians themselves are not protected, since they can generate arbitrary clinical acts more frequently, with heavy deontological and legal consequences. Conversely, a "process-based" approach is necessary,which conveys informed consent in a series of other clinical and organisational processes towards a full therapeutic alliance among physician and patient. Actually, in both the presence and absence of the inauspicious event recurring also in the area of imaging as well as in other specialist areas, an arbitrary informed consent is the cause of deep conflicts, especially at relational level, between physician and patient. The authors suggest - in both juridical and communication perspectives - that these conflicts deserve to be properly analyzed and brought to the surface by the parties through the tool of mediation in healthcare, provided by Legislative Decree n. 28/2010. This tool is oriented not so much towards a technical solution at all costs, as towards a reconstruction of the care relationship, which unfortunately is lacking in the current way of conceiving and managing informed consent.

Guidelines on informed consent for clinical practice and research trials recommend the use of standard plain language to enhance patient comprehension and to facilitate shared decision-making. Aim: To assess readability of our current informed consent forms used in cardiology.

The phenomenon of inappropriateness in ionizing imaging and medical interventions is large-scale and increasing. This tendency causes noteworthy damages to health and to patient's autonomy. Moreover, this trend causes a huge increment of health expenditures, waiting lists, organizational conflicts, judicial disputes, insurance compensations. The actual passive signature on unreadable templates of informed consent in the Italian hospital context constitutes, by a matter of facts, a central node of inappropriateness problem. This way to manage informed consent "event" model mortifies the patient's right to decide freely and deliberately, being him unaware of biological consequences of clinical-therapeutical interventions on himself and his progeny's health. Physician himself can generate arbitrary clinical acts, with heavy deontological and legal consequences. Hence, informed consent in ionizing imaging necessitates a particular"process" management, useful to convey a series of other clinical and organisational processes towards a full realisation of therapeutic alliance among physician and patient. This review aims at highlighting in a juridical and communicative key a range of tools which are applicable to contrasting the hospital abuse of ionizing radiations, for defending both patients' health and patients' dignity, being them primarily persons and citizens of a rule-of-law State.