[25 Years from Di Bella affair: what ethical lessons does it leave us?] / 25 Años del asunto Di Bella: ¿qué enseñanzas éticas nos deja?

Twenty-five years ago, in 1998, the Italian Parliament approved to implement clinical trials in patients with advanced cancer to know the efficacy of an alternative cancer treatment that associated hormones, vitamins and, occasionally, chemotherapy proposed by Professor Luigi Di Bella. It was the answer to people demanding Public Health assume the cost of this therapy. Although parallel phase II trials in various tumors demonstrated the lack of activity, some professionals have continued to use this method since then and have published apparently promising results a few various scientific journals. This real example raises three interesting ethical scenarios. The first one is the ethics of alternative treatments proposed by medical professionals or from the academic field. In these cases, the difficulty in differentiating between hypothesis and real efficacy. This problem impacts on patients and relatives' expectations who must face a potentially fatal disease with little or no hope of a cure with traditional treatments. The second scenario is the design and good practice in the development of clinical trials, which was also the subject of debate in relation to the Di Bella method. And the last one, the ethics of scientific publications. Di Bella's followers published since 2000 12 papers with limited quality on series of patients treated with his method, the majority in a pay-per-publication journal of which Giuseppe Di Bella, son of Professor Di Bella, is included in the board of editors.

Analysis of Regional Palliative Care Strategies: Do Health Policies Influence the Development of Assistance Coverage?

In Spain, health competencies are decentralized, and each autonomous community implements its own plans. Our aim is to determine if the existence of regional palliative care plans implies an improvement in health care coverage. We reviewed regional palliative care plans published in Spain and analyzed the following variables: number and profile of palliative care resources, guidelines and objectives of implementation of resources of these plans, and compliance with European standards. The publication of regional plans is associated with an increase in specific resources in the following years. From 2004 to 2009, the implementation of plans in 6 autonomous communities was associated with an increase in palliative care resources compared to those without a strategy (odds ratio: 1.58, P = .02) or with a settled plan (odds ratio: 1.40, P = .07). The same phenomenon was observed between 2009 and 2015 in 4 autonomous communities and 2 autonomous cities compared with those without a strategy (odds ratio: 2.49, P = .001) and those that implemented a plan before 2009 (odds ratio: 2.62, P < .001). Updating and evaluating these regional plans are also associated with the growth of palliative care resources.

[Theory and Practice of Informed Consent]. / Teoría y Práctica del Consentimiento Informado.

Informed consent is the process of communication between the professional (medical staff and/or investigator) and patient culminating in the decision regarding a particular intervention. However, in our country the concept of informed consent is usually limited to the document that must be signed by the patient to undergo diagnostic or therapeutic procedures riskier. This consent is best understood as a process rather than an event, and also it usually gives consent on care processes rather than on specific events: the acceptance of a process involves a tacitly acceptance of the different components that are usually part of this process. There are many steps in the care process in which a simple permission could be enough, not needing a specific and formal consent... finally, contrary to the usual practice, the acceptance document of consent should be short, clear and understandable, flexible, and with the ability to adapt to the circumstances and the patient's wishes as far as possible and, all in an atmosphere of trust and verbal information that enables the patient, not forced to confront all the information, to delegate decisions on the professional.

[Do we need a more precise definition of what sedation is?]. / ¿Es Necesario Precisar el Concepto de Sedación?

Palliative sedation in defined as the deliberate reduction in the level of consciousness of the patient by administering the appropriate drugs in order to avoid intense suffering caused by one or more refractory symptoms; sedation in the patient who is in his last days or hours of life is assumed to be continuous and as deep as needed. Clinical experience shows specific situations where it is likely that there is some confusion of terms. We could erroneously understand as palliative sedation the cases of symptomatic treatment of hyperactive delirium in a patient in its last days (a situation that sometimes is presented as the first cause of palliative sedation) or those in which it is carried out a progressive increase in the palliative treatment that often have a sedative effect, parallel to the increased severity of symptoms because of disease progression in severe ill patients. In both scenarios, sedating drugs are used to relieve end-of-life clinical complications and suffering but the circumstances of the patient, the goal of these treatments, and the way they are used do not match the definition of sedation.

[Ethical questions in the Spanish journal "Medicina Paliativa": 1994 - 2013]. / Cuestiones éticas en la revista medicina paliativa: 1994 - 2013.

OBJECTIVE: "Medicina Paliativa" is the official journal of the Spanish Society of Palliative Care ("Sociedad Española de Cuidados Paliativos"; SECPAL) and it reflects the interests, also on bioethics, of the professionals caring terminal people. We want to know what the bioethical questions they discuss and their approaches are. METHODS: From all the published articles in "Medicina Paliativa" from 1994 to 2013 we selected those referred to bioethics topics. We analysed: number of publications, author, subtype of article, year of publication, topic, philosophic approach, and the presence of answers and discussion. Qualitative topics were reviewed and agreed by at least two authors. RESULTS: There were 60 (9%) publications with bioethics profile from a total of 672 analyzed articles. A majority were signed by only one author. 31 (51%) were published as letter. The most relevant topics were: euthanasia, dignity, proportionality of treatment and care, sedation, principles of bioethics, and information. The orientation of these papers was, in a majority, according to principles of palliative care. Most bioethics topics have been answered and even answered back. CONCLUSION: Bioethics is an interesting topic in palliative care. The arguments usually fit the principles of palliative care.