Shared care planning in people with cognitive disorders and dementia: a survey among patients and caregivers in Italy.

Background: There is wide convergence in the positions of scientific societies, patient associations and public bodies regarding the advisability of advance care planning (ACP) in cognitive disorders and dementia to respect the specificity of the person. Nevertheless, planning in advance for dementia represents a unique challenge. In Italy, law n.

Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians' knowledge, attitudes and practices in four northern Italian health care facilities.

Background: On December 2017 the Italian Parliament approved law n. 219/2017 "Provisions for informed consent and advance directives" regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person's autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives.

[Capacity and right to therapeutic self-determination in law no. 219/2017. The case of persons with psychiatric and cognitive disorder.].

Law no. 219/2017 represents Italy's most comprehensive regulatory framework aimed at enabling the exercise of the right to therapeutic self-determination and ensuring its best expression even for people without legal or natural capacity, through the tools of informed consent, shared care planning and advance care directives. Nevertheless, some criticalities affect the wording of the law, characterised by a promiscuous and heterogeneous use of the terms referring to capacity and by their interpretability.

Italian law n. 219/2017 on consent and advance directives: survey among Ethics Committees on their involvement and possible role.

Background: On December 2017 the Italian Parliament approved law n. 219/2017 "Provisions for informed consent and advance directives" regarding challenging legal and bioethical issues related to healthcare decisions and end-of-life choices. The law does not contain an explicit reference to Ethics Committees (ECs), but they could still play a role in implementing the law.

Assessment of studies based on the use of questionnaires in the time of Covid-19 pandemic.

During the covid-19 pandemic a huge number of research projects have been promoted internationally, nationally and locally. This also happened in Italy which was the first affected European country. Among these studies, research protocols based on the use of online questionnaires to evaluate the reaction of health workers and researchers to the emergency situation and their state of well-being were promoted.

Conflicts of interest and Scientific Societies.

The purpose of this paper is to bring attention to the complex issue of conflicts of interest (COIs) from the point of view of Scientific Societies and their responsibility in managing secondary interests possibly undermining their activities such as improvement of professional quality, research promotion, and development of guidelines. The first publication on the issue of COIs dates back to more than a century, but only in the last decades the related ethical and legal problems have received public and professional attention. The growing role of industry in biomedical research, the significant decrease in public contributions to health, care, training, and research, and the involvement of physicians in industry-funded research have obliged to study how to identify and manage COIs.

Advance directives as a tool to respect patients' values and preferences: discussion on the case of Alzheimer's disease.

Background: The proposal of the new criteria for the diagnosis of Alzheimer's disease (AD) based on biomarker data is making possible a diagnosis of AD at the mild cognitive impairment (MCI) or predementia/prodromal- stage. Given the present lack of effective treatments for AD, the opportunity for the individuals to personally take relevant decisions and plan for their future before and if cognitive deterioration occurs is one the main advantages of an early diagnosis.

Main Body: Advance directives are largely seen as an effective tool for planning medical care in the event the subject becomes incompetent.

Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers.

The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care.

[Conscience clause in end-of-life care.].

The article proposes a critical reflection on issues that appeal to the conscience clause as part of end of life care can produce and what can guarantee freedom of conscience, self-determination of those involved and respect for the dignity of the sick person. After a philosophical and normative analysis, the article is organized on the basis of two important documents for discussion: a position paper of Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI) signed by several scientific societies "Grandi insufficienze d'organo end stage: cure intensive o cure palliative?" and the Design of Law currently being debated "Norme in materia di consenso informato e di disposizioni anticipate di trattamento". In particular, the conscience clause has been discussed in the light of advance care planning (ACP), which represents the instrument to guarantee the shared planning of care and the shared-decision making.

The biomarker-based diagnosis of Alzheimer's disease. 1-ethical and societal issues.

There is great interest in the use of biomarkers to assist in the timely identification of Alzheimer's disease (AD) in individuals with mild symptoms. However, the inclusion of AD biomarkers in clinical criteria poses socioethical challenges. The Geneva Task Force for the Roadmap of Alzheimer's Biomarkers was established to deliver a systematic strategic research agenda (aka roadmap) to promote efficient and effective validation of AD biomarkers and to foster their uptake in clinical practice.

Biomarkers for the diagnosis of Alzheimer's disease in clinical practice: an Italian intersocietal roadmap.

Biomarkers of brain amyloidosis and neurodegeneration/synaptic dysfunction are featured in recent diagnostic criteria for Alzheimer's disease. Several gaps in our knowledge, however, need to be filled before they can be adopted clinically. The aim of this article is to describe a roadmap, developed by a multidisciplinary task force, to rationally implement biomarkers for Italian Memory Clinics.

Genetic Counseling and Testing for Alzheimer's Disease and Frontotemporal Lobar Degeneration: An Italian Consensus Protocol.

Background: Genetic testing of familial Alzheimer's disease (AD) and frontotemporal lobar degeneration (FTLD) is attracting interest thanks to innovative primary prevention clinical trials and increased request for information by at-risk individuals. However, ethical, social, and psychological implications are paramount and genetic testing must be supported by structured genetic counseling. In Italy, practice parameters and guidelines for genetic counseling in dementia are not available.

Ethical Process Reporting in Indian Dental Journals.

Aim: To study the proportion of articles reporting ethical review board (ERB) approval and informed consent process (ICP) in articles published in dental journals in India.

Methods: A descriptive study was designed, and ten Indian dental journals published by different dental specialty professional associations were selected. Among 702 retrieved articles, from 40 issues of the 10 selected journals published in 2008 and 2011, 428 meet the inclusion criteria, and they were analyzed.

Research involving subjects with Alzheimer's disease in Italy: the possible role of family members.

Background: Alzheimer's disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder's causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer's disease.

Public's attitudes on participation in a biobank for research: an Italian survey.

Background: The creation of biobanks depends upon people's willingness to donate their samples for research purposes and to agree to sample storage. Moreover, biobanks are a public good that requires active participation by all interested stakeholders at every stage of development. Therefore, knowing public's attitudes towards participation in a biobank and biobank management is important and deserves investigation.

Biomarker-based diagnosis of mild cognitive impairment due to Alzheimer's disease: how and what to tell. A kickstart to an ethical discussion.

New criteria for the diagnosis of Alzheimer's disease (AD) based on biomarker results have recently been developed and are currently undergoing extensive validation. The next few years may represent a time window where the diagnostic validity of biomarkers will be studied in highly specialized research settings. Biomarkers results will be used to direct clinical diagnosis and, whenever appropriate, therapy and management.

Participation in biobanks for research by incapacitated adults: review and discussion of current guidelines.

Objective: Biobanks for research and genetic research are important opportunities to create new understanding of complex disorders, such as psychiatric disorders and dementia. The management of biobanks for subjects with psychiatric disorders or dementia raises additional challenges because of the ethical issues regarding the potentially impaired decision-making capacities of the subjects. The aim of this paper is to study (i) how guidelines address the matter and (ii) how they can be implemented in real research situations with patients suffering from psychiatric disorders and dementia.

The policies of ethics committees in the management of biobanks used for research: an Italian survey.

Gaps in regulations pertaining to the collection and storage of biological materials in a biobank, at least in the European context, have made the writing of local guidelines essential from an ethical point of view. Nevertheless, until recently, the elaboration of local guidelines for the collection, use and storage of biological materials in a biobank has been the exception in Italy and all European countries. In this context, it is of value to know the policies, even if they are unwritten, of local ethics committees (ECs) engaged in the evaluation of research protocols involving biobanks and biological materials.

Genetics and psychiatry: a proposal for the application of the precautionary principle.

The paper suggests an application of the precautionary principle to the use of genetics in psychiatry focusing on scientific uncertainty. Different levels of uncertainty are taken into consideration--from the acknowledgement that the genetic paradigm is only one of the possible ways to explain psychiatric disorders, via the difficulties related to the diagnostic path and genetic methods, to the value of the results of studies carried out in this field. Considering those uncertainties, some measures for the use of genetics in psychiatry are suggested.

Persistent vegetative state: an ethical reappraisal.

New knowledge from scientific research on vegetative state (VS) and its consequences in clinical practice are reviewed. The ambiguity of the concept of consciousness and the difficult issue of its moral significance are then examined. The Authors stress the need for longitudinal prognostic studies, the promotion of an expert widespread use of standardized behavioural scales, and recommend that the ethical debate about VS rely upon the widest consensus of the scientific community.

Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines.

Diagnosis disclosure of prodromal Alzheimer disease-ethical analysis of two cases.

Background: According to a recent proposal for revised diagnostic criteria for Alzheimer disease, the diagnosis could be made even in the absence of impairment of social function or daily life activities, provided positivity of one or more abnormal biomarkers. The use of the new proposed diagnostic criteria raises ethical issues and needs to be carefully evaluated.

Method: We describe two clinical cases of prodromal Alzheimer's disease and discuss the diagnosis disclosure, taking into consideration several issues: (i) the issue of the boundary between well founded research procedures and clinical practice, (ii) the issue of the fuzziness of the concepts of scientific evidence and scientific uncertainty, (iii) the issue of patient's autonomy and patient's best interest, and (iv) the issue of the patients' specific personal and social context.

Understanding information on clinical trials by persons with Alzheimer's dementia. A pilot study.

Background: Because of the growing value attributed to informed consent, competence assessment has become an important task for physicians and researchers, particularly when treatment and research involve persons who may be cognitively impaired, such as those with Alzheimer's dementia.

Methods: We developed and validated a 12-item questionnaire to assess the understanding of information about clinical trials by research subjects (score 0 to 24). The 12 questions were selected from a larger pool of 16 through internal consistency validity testing.