From Laws and Court Rulings to Daily Clinical Practice: The Role of Forensic Experts in Modelling Informed Consent Disclosure for Health Treatment

Abstract

Informed consent is a fundamental component of both the right to health and self-determination. Its violation, which occurs when the acquisition process is absent or flawed, can also lead to legal proceedings for isolated harm, regardless of the simultaneous existence of those related to biological and psychological harm. Across Europe, this remains a legal and ethical cornerstone, increasingly important in the context of cross-border care and culturally diverse healthcare settings. Many countries have enacted specific laws to ensure patients receive adequate information, while courts continue to refine its interpretation—often highlighting the inadequacy of informed consent in daily clinical practice. In Italy, in particular, recent rulings underscore the need for clear, comprehensive, and properly documented consent formats for health treatments. This review synthesizes rulings, regulations, and the scientific literature to offer practical guidance for improving informed consent practices in Italy, valuing the role of forensic experts in the integration in healthcare settings of the different interests at stake. The aim is to support both legal compliance and the delivery of high-quality, patient-centred care. Courts and legislation in Italy demand clear and tailored informative disclosure for health treatments, with indications of the treatment and outcomes, to be in written form. Yet, foreseeable risks, more common complications, and alternative treatment options are often poorly communicated in practice—frequently forming the basis of claims for compensation. Integrating team-based consultations and multimedia tools can significantly enhance patient understanding and secure the informed consent process. Those key points are summarized in a brief table, ideally suggesting the minimal requirements for an informed consent form. Investing in standardizing informed consent protocols, and also fostering the sharing of best practices with forensic medicine experts, are crucial steps in ensuring shared decision-making in healthcare and trying to reduce legal disputes.

1. Introduction

Informed consent is a fundamental element of the care process and doctor–patient relationship, forming the very foundation of the right to health [1]. Today, informed consent remains a central topic across Europe, both in terms of clinical practice implementation and courts rulings. Prominent levels of health-related migration, diverse cultural and medical backgrounds, and the growth of cross-border telemedicine have further emphasized the need for comparative analysis and real-practice models [2]. Moreover, to underscore the importance of this topic in Europe, it is worth noting that many countries have enacted specific legislation regulating patient information, the relationship between healthcare professionals and patients, and the expression of patients’ treatment preferences [3]. These regulations reflect a broader commitment to addressing informed consent issues in healthcare, responding to societal demands [4]. Moreover, its significance is reinforced by how frequently courtrooms discuss on its absence, inadequacy, or informative insufficiency, thus strengthening an urgent need for professional training [5,6,7,8,9]. Court rulings help advance the understanding of this process and clarify its limits, shortcomings, and burden-of-proof issues from an impartial, independent, and expert perspective. The various defects in informed consent are therefore a crucial issue in medical liability and have a direct and further impact on claims for medical malpractice across Europe. They are the cornerstone of the doctor–patient trust relationship. In comparison with the broader phenomenon of medical malpractice and, more generally, health negligence, the civil and criminal classification of the sole omission of information and patient’s consent juridically remains not completely solved because it reflects the complex interplay between the right to health and the right to self-determination in health [10,11,12,13,14].

The 2024 ruling by the Italian Court of Cassation has reinforced the principle that a violation of the right to self-determination can occur independently, solely through the omission of information and lack of patient consent. Such an omission constitutes a restriction on the individual’s freedom to make informed decisions about their own care [15]. The prevailing position in Spain appears similar, recognizing the moral damages related to self-determination in consequence of the informed consent violation, either for failing to inform the patient or for failing to obtain—or only partially obtaining—their consent [14]. In the assessment of medical malpractice liability, German High Court case laws seem to overlap the defect/deficit of informed consent with health harm, so as to address errors in obtaining consent during the care process being the same as those during treatment or diagnosis [16]. Liability for failure to obtain informed consent is considered particularly strictly by the Swiss Federal Court as the doctor who proceeds without such consent should be considered liable for all clinical consequences of the medical act, including those simply caused by chance, as the treatment per se was unlawful [17].

This gives rise to interest in managing this process within the broader context of care, ensuring the best possible sharing of information and patient understanding regarding medical treatment. Rulings then offer a valuable insight into informed consent process, including the content of information to be provided and the interplay between specific legislation and case law—even when the latter usually dates back the special law enactment. Comparisons with the European literature further enrich the analysis, shedding light on the broader social and cultural debate surrounding the issue and offering practical guidance for the improvement of the informed consent disclosure and written formats in clinical practice.

The aim of this review is to provide a narrative overview of the key aspects of an informed consent format as established by regulations and court rulings in Italy, discussing it in comparison with the scientific literature on informed consent, with the goal of translating them into a practical guide for clinical application.

Forensic experts play a pivotal role in answering the challenges and limitations of informed consent process, integrating into clinical settings the different interests and minimal requirements. Thus, ensuring that the patient’s valid consent is supported while also allowing for adequate traceability in the health records.

2. Discussion

2.1. Presumed or Explicit Informed Consent and Presumed Dissent

A key aspect regarding the historical and regulatory evolution of consent is the need for its explicit formulation. Implicit consent, in fact, would in some way mean returning to paternalistic forms, which are contrary to shared decision-making. However, the issue remains not yet fully addressed, as current case law deals with cases predating the enactment of consent regulations that formalized its forms and methods, as seen in Italy and Germany [14,15]. Then, case law still concerns the presence or absence of a documented act that discloses the information process and the consent between patient and healthcare providers.

Due to the timing of the trials, the Court of Cassation is currently reviewing cases in which lower-court judges—both at first instance and on appeal—had to infer the presence of information and consent indirectly, relying on legal presumptions. This is because, prior to Law 219/2017, the formal documentation of “informed consent” in writing was not mandatory, except for certain specific medical procedures [18]. This means that, prior to this law, the concept of a presumed and reasonable consent, even obtained orally, was acceptable, and in trial it could be inferred based on other documentary and testimony evidence, reflecting an informative and consenting process by the healthcare professional and the entitled subject that was typically oral. Only after this law came into effect did informed consent have to be explicit, expressed, and documented [5]. The special Italian law made it essential to health treatment to obtain the patient’s consent after being provided information, through procedures, forms, and content strictly defined by the legislation; ultimately, the informative process must be traceable.

On the opposite front, the Italian Supreme Court, deciding on a case where the surgeon had changed the type and invasiveness of the surgical approach instead of the consented one (subtotal resection of the stomach and removal of the gallbladder instead of the planned removal of gastric antireflux plastic with gastrojejunal anastomosis for gastroesophageal reflux), states that actions beyond the consented ones violate a priori the principle of self-determination and affirm the principle of the patient’s presumed dissent, placing the burden of liberating proof entirely on the professional [19].

2.2. Informed Consent

Today, in addition, the Italian law 219/2017 states that every health treatment must be based on the patient’s informed consent. This means that it is the overall treatment process that must be consented to—not each individual medical or care-related act or invasive practice that composes the treatment. Requiring information and consent for every single act would be unfeasible or very demanding from a systemic and organizational point of view [18].

Previously, it was assumed that only more complex, invasive, delicate, or critical procedures required specific and written consent—like HIV testing or blood transfusion. But that approach is no longer valid, because the new law makes no such distinction, unlike in some other European countries, where written consent is still only required for specific procedures (e.g., voluntary interruption of pregnancy, cosmetic procedures, HIV testing, or blood transfusions) [20]. Therefore, it is better to report treatment indication, with an integrated perspective of related complications and risks, than to single procedures/activities, with specific complications and risks. In this way, hospitalization issues (fall risk or delirium risk), care issues (feeding assistance or urinary catheter insertion), intensive care issues (infectious risks, intubation, or monitoring) could also be addressed with in a single comprehensive form.

The issue of correct information and of the documentary evidence of information is even more relevant in those contexts that are less organized or structured, as compared to the hospital context, even from a documentary point of view, i.e., private practices and outpatient clinics. Moreover, since it applies to the entire healthcare sphere and all healthcare professionals, compliance also becomes fundamental to those professions and providers that are typically organized in individual contexts—in the preventive, manipulative, and rehabilitative fields—like physiotherapists or osteopaths, whose actions and roles in the care process are also, in the patients’ perception, less clear.

To illustrate the concept, we can consider patients undergoing dialysis treatment. Patients must be informed about and give consent to various stages of a care process that includes the insertion of a venous catheter or the creation of an arteriovenous fistula, anticoagulant therapy, the performance of haemodialysis, a specific dietary regimen, and ongoing supportive therapy. However, it would be neither feasible nor logical for the patient to sign separate specific informative forms for each of these elements. Rather, a comprehensive informed consent form for the treatment of advanced-stage kidney disease with haemodialysis would be more appropriate, considering treatment benefits, health activities, and overall risks.

2.3. Informed Consent Inadequacy or Insufficiency

Another issue raised by case law is the reference to the forms and modalities used to document the information and consent process focusing on inadequacy or insufficiency [10]. Two crucial issues emerge. On the one hand, there is often an excessive simplification of the informational content. Some forms absurdly reduce the information section to a simple list of topics that should be explained—for example, “the patient was informed about the indication for the procedure, the valid alternatives, main risks, and finally gave consent”—without referencing an informative leaflet or other informative sources. If orally discussed, this evidently is untraceable.

The second problem is the somehow generic nature of the information: a textbook-like description of the pathology or procedure, without indicating how it applies specifically to that patient, or tailoring it to the individual case [21,22,23].

In Spanish and Portuguese law, basic information consists of informing the patient about the relevant or significant consequences that the procedure will produce; the probable risks under normal conditions and the risks related to the patient’s personal or professional circumstances; the contraindications and the current state of the art on the option proposed [14,24]. Therefore, the most significant legal decisions in Spain have placed strong emphasis on the importance of clear documentation and comprehensive information being provided to the patient prior to any procedure. Legal cases in this area mainly involve patients who, although having consented to treatment, were not adequately informed about the risks or available alternatives [6,8,22,25]. Overstating benefits and understating risks is another critical point, as focused on in a British sample [26].

Forensic medicine experts, drawing on their trial experience, must be committed to working within a multidisciplinary team for the proper drafting of informed consent, to reach comprehensiveness in all those points. Given that the information process takes place over several moments, leaving multiple corresponding traces throughout the health record, beyond specific consent forms, as clinical notes, it is essential to monitor the entire documentation, issuing periodic reports to ensure the requirement for completeness is globally met.

2.4. Foreseeable Risks and Complications

In practice, providing adequate and complete information is not an easy task. Simply listing all risks with tiny statistical probabilities (e.g., 0.01%) is only partially helpful, as for drugs brochures, and in fact can create more confusion for the patient. On the contrary, in cases of rare adverse events, this often leads to legal challenges claiming the consent form was incomplete, yet no document can ever cover every natural possible complication [27]. Furthermore, numeric indications of risks and complications are often meaningless or hard to interpret for patients and represent more of a defensive medicine approach than a genuine tool for communication. Statistical percentages or incidence are usually not employed in the information process in Switzerland [17]. That said, a clear description of the most common risks—the material, foreseeable and significant ones—explained in simple terms and related to the patient’s expectations, can be extremely useful [28,29,30].

For example, the treatment of severe hip osteoarthritis with total hip arthroplasty (THA) could be made in a descriptive manner by linking to individual patient characteristics. The potential complications include prosthetic instability/dislocation or wear, periprosthetic fracture, deep vein thrombosis, surgical-site infections, intraoperative nerve injuries, and limb length discrepancies. Considering the patient’s comorbidities (obesity with a BMI of 35–39.9 and spondylarthrosis) and sedentary lifestyle, there is a higher risk of deep vein thrombosis (DVT), i.e., the formation of a blood clot in the veins, typically in the legs. Therefore, anticoagulant therapy will be prescribed and must be continued at home, along with appropriate rehabilitation and regular follow-up with the physician, including wound care. The patient should pay close attention to symptoms such as pain, redness, or swelling in one leg. Adhering to weight-bearing instructions (timing and method) is essential to prevent dislocation or even a periprosthetic fracture.

The French Patients’ Rights Law of 4 March 2002 relaxed the previous jurisprudential standard of disclosure, which does not require the physician to provide exhaustive information but imposes on the physician the obligation to inform the patient about the more frequent risks or the serious but “normally foreseeable” risks. In accordance with the law, courts have ruled that a risk is “normally foreseeable” if it occurs in one case out of a thousand cases (1/1000) [12]. The forensic expert, by also reviewing photographic materials showed to the patient in the case of THA, may recognize the aim of empowering the patient, thus truly enabling them to make an informed choice considering more frequent risks. This holds true even if the patient did not, for instance, report a specific incidence, as the focus remains on the individual case.

No specification is made in German law, even if it is valorised the specific patient in the specific situation [31]. A rough general standard for the scope and degree of accuracy of the information has been ruled out: the scope and level of detail of the information are inversely proportional to the urgency and the prospects of the success of the intervention. The burden of information thus increases as the urgency of the medical intervention, and its prospects of success decrease, and vice versa [16]. Although in an extremely separate field, such as palliative life-support treatments, it is interesting that the German courts express this by emphasizing that the medical indication circumscribes the area in which patient autonomy can unfold [32]. This seems to reveal the stepwise nature of the informative process from a clinical indication to then a shared reasoning with the patient-user.

In Spain, cosmetic surgery has seen an increase in compensation claims, with a large share specifically regarding poor preoperative information, possible complications, and, of great interest, the potential lack of benefit, with a significant lack of written documentation confirming the information provided [33,34]. Above all, plastic surgeons were sued and complained against regarding consent issues at more than double the rate of any other specialty or surgical subspecialty in the German analysis: the patient’s higher expectation and the surgeon tendency to underestimate the failure of the improvement expected are to be considered [35]. Easy-to-use photo-editing software could effectively simulate the desirable outcomes, their limitations and possible unwanted side effects, like scars [36]. Those considerations are also to be directly translated into the field of dentistry [37].

This patient-specific information is crucial, especially when comorbidities, prior treatments, or unique family, and social contexts are involved. The same treatment can have quite different implications depending on the situation. This risk affects the social aspect of the patient’s life, thus the physician would be found liable for the failure to disclose this serious risk to the patient, as he had knowledge of the patient’s lifestyle and preferences [12].

Following the previous example of THA, the informed consent must disclose that the subject is obese and sedentary, with a high risk of dislocation or DVT, but the goal for this specific subject is to provide through THA minimal pain-free mobility and thereby restore a moderate level of personal autonomy, otherwise determining increasing disability. Moreover, was traced that physiotherapy, anti-inflammatory treatment, intra-articular drug injections, and dietary measures, have not been effective. The informed consent disclosure for a subject with heart failure due to severe aortic valve stenosis, provided as Supplementary Material, includes an option to select a patient-specific risk grading system, selected during discussion. This helps convey a balanced understanding of the treatment’s benefits and risks to the patient and caregivers [38].

2.5. Alternative Options

Regarding alternative options, the issue is more complex. Treatment alternatives are often seen as the exclusive domain of the physician, who makes the recommendation only after already excluding other approaches based on risk–benefit analysis and best available evidence [36,39,40]. However, today, this model must involve the patient as an active participant [41].

The rationale for selecting one option over another should be explained to the patient and documented. Not in every case (like choosing between two similar medications), but in more significant scenarios, the reasoning should be discussed with the patient, allowing them to make a conscious and shared decision, and also leading to better treatment adherence. Informed consent for elective surgery should also include foreseeable changes in surgical plans and should record, when possible, patient consent on the final option or the progressive advance of the surgical schedule [42]. In urgent cases, but those not facing the need for immediate action such as that determined by an emergency, the option of a more invasive surgical approach or a different therapeutic programme must be disclosed, and, in such cases, the patient must be informed of the outcomes resulting from such changes [43].

From an organizational perspective, this suggests that while the core treatment should have a specific information and consent forms, these additional aspects of shared decision-making could be recorded in clinical notes or daily clinical records.

In the exemplificative informed consent disclosure regarding the patient with heart failure due to severe aortic valve stenosis (Supplementary Materials File S1), minimally invasive aortic valve replacement was suggested to the patient as some alternative options were not recommended according to guidelines, while others, irrespective of the specific physiological, occupational, and cardiac medical history, were documented in the medical record.

Just as in certain team-based decision-making contexts for complex cases—from oncology to endocarditis heart teams—a brief multidisciplinary discussion involving the patient and their family would also be warranted in the process of informed consent disclosure [44,45]. Documenting or videorecording these meetings with a short summary report, to be attached to the previously provided informative materials and the specific consent form, would be highly significant—first and foremost for the patient’s understanding, but also in terms of reducing litigation and the risk of unfavourable outcomes in the case of a dispute [38].

Looking ahead, there is the idea that patients themselves could participate in creating this documentation, for instance by signing off on these decision-making steps [46]. This would help maintain shared understanding and participation throughout the course of care and in case of withdrawal, changes, or updates. A remaining major limitation in the health service space is the implementation and complete integration of the patient’s signature in electronic health records, even if significant experience is present from clinical trials and remote consenting [47]. This is especially relevant in long-term care or rehabilitation, where ongoing decisions must be made. However, in everyday practice, this is very complex—especially with elderly patients or those with multiple conditions, whose mental capacity may fluctuate. Still, even in the absence of formal support figures like health guardianship, it is possible to take advantage of the patient’s clearer moments to confirm treatment decisions.

Essentially, this means that a mixed standard should require the physician to disclose information relevant to the particular patient, not to a hypothetical reasonable patient, especially when the physician knows or reasonably should have known that a specific risk is important to that patient [12].

2.6. Complexities and Barriers

For instance, in Switzerland, the doctrine of informed consent is limited by the so-called and acknowledged therapeutic privilege, meaning that a doctor need not (and indeed must not) give information which might induce a state of anxiety in the patient such as to injure the patient’s health [17]. On the contrary, what is proposed in the psychological care field is quite interesting. The professional, apart from ethical reasons, highlights the option for either party to terminate the care relationship, providing and documenting specific motivations, while still ensuring continuity of care [48,49]. The patient moreover agrees to attend a final session aimed at summarizing the psychotherapeutic work carried out, while the professional commits to recommending a colleague who can continue the therapy based on the patient’s characteristics, interests, and conditions. Treatments goals and fees are also usually mentioned and agreed upon in writing [50].

Linguistic readability and topographical readability are essential for patient comprehension and informed consent validity [27,51]. Images, schemes, and explanatory video recordings are important, in particular in complicated, highly technologized procedures [52]. The multimedia informed consent programme, integrated with the overall path for undergoing bariatric surgery, gives patients an opportunity to access detailed, high-quality information regarding their upcoming surgery, combined with pertinent details of their hospitalization and treating surgeon [53]. In case of trial, all this information must be properly acknowledged and weighed by the forensic expert.

However, it is important to consider the need to integrate these methods of information delivery and consent acquisition within an ecosystem that is not yet advanced in terms of digitalization—ranging from the aforementioned digital signature of the patient to the video recording of the information and its subsequent archiving in health records.

The complexity of the topic, with the particular issues and context, could explain the limitations of an automatic generative system for informed consent forms, which nowadays simply mechanistically elaborate the data [54]. Another issue that is also relevant for training purposes, as well as for the validity and effectiveness of information and consent, is the relationship between the person who informs and receives the consent and the person who actually performs the healthcare activities. This is for several reasons: it makes it possible to inform the patient of the real risks and the specificities of the activity, as well as of the surgical technique; the professional has knowledge of the most frequent criticalities in the execution of the activity, and doctor–patient trust is strengthened. This is compared to a practice in which it is the residents who inform the patients, thus distorting first of all the user’s entrustment process [55].

2.7. Key Points of an Informed Consent Form

To design a truly effective model, building on the various insights from the previous discussion, it is helpful to include a standardized informational base—organized, for example, by disease or treatment—alongside a free-text section where the healthcare provider can add key information tailored to the specific case, including references to the patient’s personal, medical history and lifestyle habits, and the patient’s or proxies’ considerations [24,56,57]. Some key points are synthetically described in the table that follows integrating clinical and forensic needs (

Table 1. Key Points for Effective Informed Consent Forms.

Prioritize the overall treatment indication.	Refrain from single activities/procedure consenting, except for particularly complex or high-risk procedures.
Mention the alternative options, including conservative ones, different surgical approaches, new approaches and technology-driven approaches, and rehabilitative ones.	Refrain from presenting multiple surgical or medical/surgical options in the disclosure without clearly identifying the chosen one and the rationale behind it.
Include any foreseeable changes in treatment/surgical plans and explain the reasoning clearly; consider modular forms for updates.	Refrain from changes to treatment or surgical plans without accurately recording an update of the consent and clinical justification—especially in cases where a prior exploratory procedure is required.
Mention the failure of preventive, conservative, or rehabilitative treatments, also indicating specific patient conditions or preferences.	Refrain from suggesting that the current treatment is the only viable one without explaining the context of failed previous approaches.
Prioritize the description of more relevant complications and thoroughly explain those that are more frequent to the patient (due to comorbidities, previous surgery, and social and habit conditions).	Refrain from listing adverse events/complications and excessive references to percentages; do not overwhelm with rare, statistical risks.
Prioritize simple wording and brief sentences.	Refrain from subordinations, medical jargon, adverbs (usually, often, and always); avoid negative or passive phraseology, and ambiguous language.
Ensure the availability of translations into major languages or access to interpreters, and ensure the delivery of adapted versions for patients with sensory, cognitive, or literacy difficulties.	Refrain from assuming comprehension without assessment or tailored support.
Incorporate descriptive images and/or videos, neutral/figurative anatomical images, and flowcharts of processes. Ensure multimedia content is version-controlled and integrated into quality systems.	Refrain from overloading patients with uncontextualized technical material or overly detailed schematics.
Provide the informative part for reading prior to consenting and accurately record it (e.g., in the pre-hospitalization visit).	Refrain from form signature the same day as the treatment or hospitalization, especially for complex and long informative forms.
Clearly outline consistent guidelines, best evidence, or consistent literature, preferably national or international and regularly updated.	Refrain from reference to limited or personal or single-centre case series.
Briefly report the patients’ considerations, expectations, or questions discussed during the visit/colloquium.	Refrain from disregarding individual patient’s preferences, goals, and psychosocial background.
While respecting the autonomy and wishes of the entitled individual, involve proxies, family members, or other trusted figures—especially in complex cases or when dealing with fragile or vulnerable individuals—as sources of support and witnesses to the process.	Refrain from excluding caregivers or trustees when appropriate, particularly if they support comprehension or continuity of care.
Incorporate the option of withdrawing consent along with a concise explanation of the potential implications, and accurately record any withdrawal discussions in the medical record.	Refrain from implying consent is permanent or irrevocable.
In cosmetic and plastic surgery, also including dentistry, clearly outline possible esthetic outcomes.	Refrain from outcome magnification; do not apply unrealistic visual examples or promises that lack realistic support.
Ensure the relationship between those who inform and receive consent and those who perform the health activities.	Refrain from informing the patient if not involved directly in the care path or surgical procedure.

). Those points are briefly addressed in an example of an informative form for the treatment of heart failure due to severe aortic valve stenosis (Supplementary Materials File S1).

The issue arising from Italian and foreign case law regarding the completeness and thoroughness of information for consent to healthcare treatment, as well as some more deficient aspects, partly stems from rulings that discuss facts dating back well before current clinical practice. This well-known legal delay, coupled with the fact that the courts often handle the most critical cases, highlights the need to carefully weigh the conclusions drawn. However, this also offers an important critical perspective on the right to health and its interaction with the right to self-determination, which are exercised precisely in the everyday healthcare context and in practice, partially orally and partially with standardized informative brochures.

Forensic medicine experts, operating in both healthcare and judicial settings and capable of translating legal findings into healthcare training, documentation, and routine practice, can help ensure, together with clinicians, chief medical officers, and health managers, that informed consent forms are comprehensive, legally sound, and tailored to individual patients.

3. Conclusions

Despite differences between legal systems, there is a growing trend toward strengthening the protection of patients’ self-determination rights, driven by the recognition that adequate informed consent is essential for high-quality medical care. Although many countries have made significant progress in regulating and implementing informed consent for health treatment, the analyzed data provide valuable insights for further improvement and the development of effective clinical models for obtaining informed consent. To ensure the validity of informed consent throughout the care process, it is critical to provide information that is accurate, up-to-date, complete, traceable, and understandable. This is key to supporting the patient’s informed participation and decision-making, particularly regarding risks, alternative treatment options, and expected outcomes—especially relevant in fields such as plastic and cosmetic surgery. Moreover, a well-documented consent process serves as essential legal evidence in the case of disputes, thereby offering protection not only to patients but also to healthcare professionals and facilities.

Some essential and other critical elements drawn from Italian and European case law and the scientific literature have been integrated to provide a basis for the standardization of an informed consent model.

Investing in doctor–patient communication and training, standardizing consent protocols, integrating forensic experts into clinical settings, and promoting informative transparency in healthcare interactions are vital steps toward reducing litigation risks and ensuring ethical, high-quality care.