The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework

The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework
Giuseppe R. Gristina, Lucia Busatta, Mariassunta Piccinni
Minerva Anestesiologica, 2019 April; 85(4) pp 401-11
The Italian Parliament has recently approved a law on informed consent, advance directives and advance care planning. The law also deals with health care proxy and health care decisions for minors and adults who are not able to give consent. The Italian law arrived quite late in comparison with other European countries. After several years of debate on the need to approve such a law, the focus has now shifted to the assessment of the legislative provisions and their impact on clinical practice. In this article, the authors firstly offer an overview of the findings from the empirical research regarding the use of the different legal tools in the field of intensive care medicine; secondly, they present the tools now provided by law no. 219/2017 particularly with regard to the decision-making processes in the Intensive Care Unit (ICU); thirdly, the authors offer a comparison between the new Italian law and other European legal orders, with special reference to France, Spain, Germany and England. The aim of the article is to assess the degree of innovation of the law vis-à-vis the previous framework

Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation

Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation
Gianluca Montanari Vergallo, Antonio G. Spagnolo
The Linacre Quarterly, 29 March 2019  
This article’s authors delve into, and comment on, some of the key provisions within law no. 219, passed in 2017, which came into full effect in 2018. The legislation presents several innovative aspects: (a) communication time is equated to care; (b) patients may turn down lifesaving treatments, yet doctors must put in place all suitable support processes, from a psychological standpoint as well, in order to make sure that patients make informed decisions in full awareness; (c) refusal to treatment may be expressed prior to the onset of the disease making the patient incapable, as long as the advance directive is laid out by a mentally capable adult who has been provided with all relevant medical information available as to the consequence of a refusal to undergo a given treatment; (d) artificial nutrition and hydration are tantamount to treatment; thus, they may not be carried out and kept in place in absence of valid consent; (e) patients may appoint a healthcare proxy holder, tasked with interacting with doctors and caregivers and expressing consent or refusal; (f) patient will, whether current or advance, must be complied with even under emergency or urgency conditions, provided that clinical conditions and circumstances make it possible to acquire it; (g) doctors may disregard advance directives only when specifically provided for by the law; (h) patients may not demand treatment deemed to be illegal or running counter to ethical codes or scientific evidence. The new legislation, therefore, is meant to uphold the right to exercise self-determination as well as the patient’s quality of life, yet ensuring that doctors remain fully capable of making the decisions that they are best positioned to.

Ethics of crisis sedation: questions of performance and consent

Ethics of crisis sedation: questions of performance and consent
Nathan Emmerich, Bert Gordijn
Journal of Medical Ethics, 20 April 2019
This paper focuses on the practice of injecting patients who are dying with a relatively high dose of sedatives in response to a catastrophic event that will shortly precipitate death, something that we term ‘crisis sedation.’ We first present a confabulated case that illustrates the kind of events we have in mind, before offering a more detailed account of the practice. We then comment on some of the ethical issues that crisis sedation might raise. We identify the primary value of crisis sedation as allowing healthcare professionals to provide some degree of reassurance to patients, their families and the professionals who are caring for them. Next we focus on the issue of informed consent. Finally, we ask whether continuous deep sedation might be preferable to crisis sedation in scenarios where potential catastrophic events can be anticipated.

Ethics and Breast Cancer

Ethics and Breast Cancer
Amtul R. Carmichael, Kerstin Sandelin
Surgical Ethics, 27 March 2019; pp 257-264
Enabling, empowering and educating a woman to make the right choice between breast-conserving surgery and mastectomy are aligned with the fundamental principle of bioethics, that is, respect for patient autonomy. A clear understanding of the contemporary ethical and social issues related to genetic testing for breast cancer is necessary to develop a practical approach for counselling, testing and treating patients with genetic disposition to breast cancer. Ethnic inequities, disparities, opportunity and timeliness to treatment and its prognostic significance on breast cancer mortality have been studied in several populations worldwide. While the underutilisation of screening mammography can be attributed to socioeconomic and cultural and geographic barriers, ethical principles must be taken into account. The debate regarding no intervention for low-grade ductal carcinoma in situ and the issue of overdiagnosis are further ethical issues that raise concerns in the informed decision process and the ethical concepts of no harm and autonomy.

Informed Consent For Anaesthesia: Are Our Patients Well Informed?

Informed Consent For Anaesthesia: Are Our Patients Well Informed?
H Y Embu, M G Yilkudi, S I Nuhu
Journal of Biomendical Research & Clinical Practice, 4 April  2019; 2(1)
Patients have the right to be properly informed about procedures to be undertaken on them so that they could make informed decisions. This study was done at the Jos University Teaching Hospital and the University of Abuja Teaching Hospital. Questionnaires on informed consent were administered postoperatively on patients who had undergone elective surgeries under various forms of anaesthesia. The questionnaires sought to find out how much information patients were given about their anaesthesia and how satisfied they were with the information given. 148 patients were interviewed. The mean age was 34.8±13.8 years and the male: female ratio was 1:1.8. Ninety-eight (66.22%) of the procedures were done under general anaesthesia and 50(33.78%) under regional anaesthesia. 104 (70.27%) were told about the type of anaesthesia to be used. Thirty-eight (25.68%) were not told of the possible side effects. Eighty-six (58.1%) understood the information given. 131(88.51%) believed it was necessary to be given information about the anaesthesia. Postoperative pain management was discussed with 10 (6.76%) of respondents. 104 (70.27%) expressed satisfaction with the information given. Information about anaesthesia was given by residents in anaesthesia in 62.16% of cases, by consultant anaesthetists in 8.78% cases, by surgeons in 10.81% of cases and by house officers and nurses in 14.19% of cases. Majority of patients would like information about their anaesthesia procedures but were inadequately informed. Consent for anaesthesia is often obtained by junior residents who have had little training in this aspect. Training on informed consent should be part of the residency program.

Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study

Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study
C.W.E.Younger, S.Moran, C.Douglas, H.Warren-Forward
Radiography, 2 April 2019
Informed consent for ionising radiation medical imaging examinations represents a recent change to medical imaging practice. This practice has not had a definitive and authoritative integration into clinical practice, and lack of direction has caused many health care professionals to be unsure of an appropriate consent methodology. Consent practices have been undertaken inconsistently and sometimes poorly. This research sought to investigate what barriers exist to meaningful informed consent, and what pathways are suggested to overcome these barriers. These views are then discussed in the context of practical health care consent practices.
A semi-structured interview explored the views of radiographers and radiologists on the practice of disclosing the ionising radiation risk of a clinical medical imaging examination. Qualitative data was analysed using a nominal method of quantitative transformation. Responses were reviewed, and a set of definitive themes constructed. Participants considered the influences, logistics and barriers to the informed consent process. Participants were then asked what pathways might be developed that would improve the process.
Twenty-one (21) radiographer participants and nine (9) radiologists were interviewed. The barriers to consent identified issues of time constraints, lack of a unified message, and patient presentations. Pathways suggested included limiting the scope of the consent practice, sharing the consent responsibility, and formulation of definitive consent guidelines.
A unified, definitive series of guidelines for informed consent for ionising radiation examinations would alleviate many of the identified barriers. Having the consent process consistently begin with the referring doctor would facilitate more meaningful consent.

Role of Informed Consent in Andrological Surgery in Adolescents and Adults

Role of Informed Consent in Andrological Surgery in Adolescents and Adults
Mauro Silvani
Psychosexual Counseling in Andrological Surgery, 2 April 2019; pp 81-84
Informed consent for andrological surgery, particularly during adolescence, is a delicate and strategic moment in the success of the patient’s therapeutic path. Informed consent must have certain characteristics:

  • Clarity and simplicity of exposition to allow easy understanding by anyone who reads it, in addition to the patient, for example, his relatives, lawyers, doctors, and magistrates. The information must also be provided with particular delicacy to adolescent children who sometimes are confronting the hospital environment and surgery for the first time.
  • Accompanied by a rich description that allows a better understanding.
  • Must contain a part in which the signer declares that he has clearly understood the pathology that is affecting him and a distinct one from the previous part concerning the type of intervention that the patient will undergo, including a description of the relative complications. In this section of the consent form, other surgical procedures contemplated for the pathology in question should also be described.
  • The collection of the consent form and a signature should always be by the surgeon before the operator, because, more than in any other surgery, this is a surgery in which the doctor-patient relationship of trust is particularly heard and developed.
  • Attendance at the interview with a family member, of the partner if older, or parents if a minor. The signature on the informed consent form results from a clinical diagnostic path divided into multiple periods during which there is a two-way communication between the patient and family practitioner surgeon, especially in the case of a minor patient, to develop a therapeutic alliance that is essential to a successful outcome.


Does using anatomical models improve patient satisfaction in orthopaedic consenting? Single-blinded randomised controlled trial

Does using anatomical models improve patient satisfaction in orthopaedic consenting? Single-blinded randomised controlled trial
K.Sugand, H.H.Malik, S.Newmana, D.Spicer, P.Reilly, C.M.Gupte
The Surgeon, 1 April 2019
Patient satisfaction in consenting is a major pillar of clinical governance and healthcare quality assessment. The purpose was to observe the effect of using 3D anatomical models of knee and shoulder joints on patient satisfaction during informed consent in the largest single-blinded randomised controlled trial in this field.
52 patients undergoing elective knee or shoulder surgery were randomised into two groups when being consented. The intervention group (n = 26) was shown an anatomical model of the knee/shoulder joint while the control group (n = 26) was given only a verbal explanation without a model. Patients rated their satisfaction on the validated Medical Interview Satisfaction Scale (MISS-26) questionnaire. Semi-structured interviews were analysed for specific themes to determine key factors that influenced patient satisfaction. The mean score ±SD were calculated with significance set at p < 0.05.
There was a significant difference in the overall satisfaction between the control and intervention cohorts (MISS-26 score 4.33 [86.6%] ± 0.646 vs 4.70 [94.0%] ± 0.335 respectively, 7.4% improvement, 8.5% difference, p = 0.01). Behavioural criteria showed a 13% increase in satisfaction (p = 0.02). Semi-structured interviews determined that the factors influencing satisfaction included the surgeon’s interpersonal manner, the use of the visual aid and seeing the consultant surgeon in clinic. All patients in the intervention cohort identified factors contributing to their satisfaction, whereas a fifth of the control cohort claimed nothing at all made them feel satisfied.
Anatomical models as visual aids significantly increased patient satisfaction during the consenting process and played an integral part of the surgeon’s explanation. Patients exposed to anatomical models also claimed to be more satisfied with the surgeon’s inter-personal skills. This study recommends the use of anatomical models, which are both cost-effective and easily implementable, during explanation and consent for orthopaedic procedures.

Incorporating fetal archival tissues into undergraduate medical education

Incorporating fetal archival tissues into undergraduate medical education
Kaylin Jeanne Beiter, Sophie Elise Fourniquet, Jason C Mussell
Federation of American Societies for Experimental Biology, 1 April 2019; 33(1)
[The bolded sections have been added by the editor]
A great deal of time is spent in undergraduate medical education preparing students for death and also the importance of informed consent. Missing from these preparations are the differences students may feel when encountering the death of an elderly individual versus the death of an infant and how the different informed consent processes came to be. Purposeful incorporation of fetal specimens in at various time points throughout the first year may be able to help solve these problems simultaneously.
The Louisiana State University Health Sciences Center at New Orleans (LSUHSC-NO) has in its possession a large repository of fetal specimens, many of which were collected prior to the era of IRB protocols, preventing informed consent from being secured for their use. These fetal specimens are used in anatomy education at LSUHSC-NO annually. We identified appropriate time points throughout the first year of training to insert discussions of informed consent and to examine emotions coincident with dealing with fetal and neonatal death and how they might contrast to student emotions about their cadavers, i.e. adult death, as well as how these feelings evolve over the year. Thematic analyses of self-reflections were used to assess differences in students emotions when confronting death. They will also be used to examine changes in student attitudes regarding death during the entire first year.
Using archival material as the centerpiece for principled discourse challenges students to contextualize the practice of medical ethics socially and historically, heightening awareness of their own cultural and social biases. This experience also provided an outlet for students to share their thoughts on the ethical principles that will guide their future practice and to share their emotional reactions to the fetal specimens. Preliminary results showed themes of anxiety and reverence predominating before students entered the adult cadaver lab while sadness, informed consent, and impropriety predominated student reflections before exposure to fetal specimens.
Providing medical students with an example thought process allows students to begin developing their own methods of incorporating respectful pragmatism into their own careers. Incorporation of fetal collections and discussions of their origins enables undergraduate medical students to think critically and examine their own ethical mores in addition to mastering high volumes of content knowledge.

Informed consent in spinal surgery

Informed consent in spinal surgery
V. Todd, N. C. Birch
The Bone & Joint Journal, 31 March 2019; 101B(4) pp 355-360
Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery.