HEALTH TECHNOLOGY ASSESSMENT, DELIBERATIVE PROCESS, AND ETHICALLY CONTESTED ISSUES.

Healthcare technology assessment (HTA) aims to support decisions as to which technologies should be used in which situations to optimize value. Because such decisions will create winners and losers, they are bound to be controversial. HTA, then, faces a dilemma: should it stay away from such controversies, remaining a source of incomplete advice and risking an important kind of marginalization, or should it enter the controversy? The question is a challenging one, because we lack agreement on principles that are fine grained enough to tell us what choices we should make. In this study, we will argue that HTA should take a stand on ethical issues raised by the technology that is being investigated. To do so, we propose adding a form of procedural justice to HTA to arrive at decisions that the public can regard as legitimate and fair. A fair process involves deliberation about the reasons, evidence, and rationales that are considered relevant to meeting population-health needs fairly. One important way to make sure that there is real deliberation about relevant reasons is to include a range of stakeholders in the deliberative process. To illustrate how such deliberation might work, we use the case of cochlear implants for deaf children.

Expert opinion: Time to ban formal CI selection criteria?

This contribution addresses cochlear implantation (CI) selection criteria as a discussion topic. It expresses a personal viewpoint that challenges the usefulness and necessity of formal selection criteria. Scientifically, it is argued that CI selection must be highly individual, whereas the current criteria are general, not valid, not based on a wide consensus, and not up-to-date. Morally, it is argued that it is not legitimate to presume equality between patients and CI centers, that the current selection criteria create an ethical dilemma, and that an unresolvable contradiction exists between quality of life and measurability. Finally, liberalizing the criteria would probably have only a minimal impact on current practice and budget.

Informed Consent, Deaf Culture, and Cochlear Implants.

While cochlear implantation is now considered routine in many parts of the world, the debate over how to ethically implement this technology continues. One's stance on implantation often hinges on one's understanding of deafness. On one end of the spectrum are those who see cochlear implants as a much needed cure for an otherwise intractable disability. On the other end of the spectrum are those who view the Deaf as members of a thriving culture and see the cochlear implant as an attempt to eliminate this culture. Rather than take a stance in this debate, we will argue that the informed consent process for cochlear implantation must include access to Deaf perspectives. Deaf individuals know best what it is like to be a member of the Deaf community; the reasonable person would put significant weight on the testimony of Deaf individuals when considering whether to undergo cochlear implantation. The reasonable person standard determines what information careproviders must present as part of the informed consent process; thus, informed consent for cochlear implantation requires access to the testimony of Deaf individuals.

Ethics, equity, and human dignity in access to health services: the case of cochlear implants in children and adolescents.

Compare the number of implants performed in the last 12 years for children and adolescents up to 18 years in different regions of mainland Portugal. Study the trend of total implants over the years as well as the percentage held in early ages. Verify to what extent this practice is in line with the values of fairness and justice that underpin European health systems. A retrospective study of cochlear implantation was conducted using a hospital database containing all the episodes with cochlear implant procedures in public hospitals that occurred in Portugal between 2000 and 2012. An analysis by age, year, and region of the implants were performed. The Northern and Central regions, the nearest big center specializing in cochlear implants in Portugal, are those with the largest number of implants: 2.0 and 2.4 per 10,000 children, respectively. The regions of Alentejo and Algarve, which are more rural and remote regions of the center, record the smallest number of implants, 1.1 and 1.5 per 10,000 children, respectively. Over the years, there seems to be an increase of implants implemented in children under 18, most notably from a significant reduction in 2011 and 2012. However, an increase in children implanted before 24 months has been observed from the same zero children at this age in the early years studied to 0.46 per 10,000 inhabitants in 2012. The right to adequate health care must be in accordance with the full respect of fundamental human rights. Economic, social, and educational conditions must also be guaranteed in this process of auditory rehabilitation. Societies must develop a system of ethical health priorities, so that even in situations of financial crisis, the most disadvantaged sectors are not the most penalized ones by the inevitable economic constraints that are implemented.

Hearing the implant debate: therapy or cultural alienation?

Cochlear implants are devices that allow deaf people to hear. Consequently, implanting them in children seems to be a very beneficent intervention. However, some deaf parents have opposed it in the name of the preservation of their culture. For them, deafness is a rich culture with its own language (signing), and implanting their children will prevent them from being members of their parents' culture. For the same reason, other deaf parents have asked for PGD (preimplantation genetic diagnoses) and embryo selection in order to have deaf children. Several arguments can be given in favour of the attitude and of the requests of deaf parents; nevertheless, I conclude that, ultimately, they cannot be morally supported because deafness is a true handicap in our civilization of information.

Ethics for the pediatrician: the evolving ethics of cochlear implants in children.

The story of the ethical controversy over cochlear implants is unique in some ways and paradigmatic in others. It is unique in the ways that it was shaped by the history of deafness, and of cultural responses to deafness, in the United States. The story is paradigmatic in two ways. First, cochlear implantation was an innovative therapy that was introduced into practice without adequate study. Promising early trials led to FDA approval, although long-term outcome data from rigorous studies were lacking. In this respect, the story of cochlear implants is similar to the history of other innovations that were introduced without rigorous evaluation, innovations such as supplemental oxygen, extracorporeal membrane oxygenation, or corticosteroids for bronchopulmonary dysplasia. Cochlear implants also are paradigmatic of a particular type of ethical dilemma in which advocacy groups claim to know better what is best for children than do the children's parents or doctors. This controversy happened during the Baby Doe debate in the 1980s, when advocacy groups claimed that doctors and parents were conspiring to discriminate against children with disabilities. Ultimately, the US Supreme Court invalidated that interpretation of disability rights. Instead, parents and doctors working together are given discretion to make decisions about what is best for children. With regard to cochlear implants for children, the NAD realizes that they are walking a fine line. As one NAD spokesperson said, "We don't say that hearing parents aren't qualified to make decisions about their deaf children. We say that they need to have contact with deaf people if they're going to make educated decisions". The same could be said for pediatricians. There are 4,000 to 8,000 infants born each year in the United States with severe hearing impairment. Their parents will have to make decisions about what is best. Pediatricians need to understand the options and be prepared to help parents sort through the complex data and multiple options in order to arrive at the decision that is best for themselves and their child. Understanding the ethical controversy over cochlear implants will help.

Bioethics and medical/legal considerations on cochlear implants in children.

UNLABELLED: Cochlear implants are the best treatment for congenital profound deafness. Pediatric candidates to implantation are seen as vulnerable citizens, and the decision of implanting cochlear devices is ultimately in the hands of their parents/guardians. The Brazilian Penal Code dictates that deaf people may enjoy diminished criminal capacity. Many are the bioethical controversies around cochlear implants, as representatives from the deaf community have seen in them a means of decimating their culture and intrinsic values. OBJECTIVE: This paper aims to discuss, in bioethical terms, the validity of implanting cochlear hearing aids in children by analyzing their vulnerability and the social/cultural implications of the procedure itself, aside from looking into the medical/legal aspects connected to their criminal capacity. MATERIALS AND METHODS: The topic was searched on databases Medline and Lilacs; ethical analysis was done based on principialist bioethics. RESULTS: Cochlear implants are the best therapeutic option for people with profound deafness and are morally justified. The level of criminal capacity attributed to deaf people requires careful analysis of the subject's degree of understanding and determination when carrying out the acts for which he/she has been charged. CONCLUSION: Cochlear implants are morally valid. Implantations must be analyzed on an each case basis. ENT physicians bear the ethical responsibility for indicating cochlear implants and must properly inform the child's parents/guardians and get their written consent before performing the procedure.

Cochlear implantation for children: opening doors to opportunity.

Cochlear implantation has altered the life-course of thousands of children who have significant hearing loss. Since the United States Food and Drug Administration approved multichannel cochlear implants for children in 1989, growing numbers of parents are choosing this option for their offspring and seeking opportunities to integrate them into the hearing world of our society. When paired with appropriate habilitation, cochlear implantation removes barriers for children who are deaf. This technology affords them the ability to circumvent the effects of deafness and participate academically, socially, culturally, and vocationally with their hearing family and peers.

The future of implantable neuroprosthetic devices: ethical considerations.

From well-established results with cochlear implants to the advent of implantable microelectrode arrays, implantable neuroprosthetic devices have gained increasing attention from health care professionals, scientists, engineers, and the general population. With recent depictions of neuroprostheses in the news media and in movies, confusion about their current state and concern for their future use has increased tremendously among members of the public. Many government agencies and nongovernment organizations are also concerned with the safety and efficacy of these devices. We discuss the present state of development of some of these implantable neuroprostheses, the possible future use of this technology, and the associated ethical issues that can be of concern, including manufacturing, animal experimentation, human trials, scope of use, and individual and societal concerns.

Some ethical dimensions of cochlear implantation for deaf children and their families.

A major source of controversy between Deaf people and those who support a "social/cultural" view of Deafness as "a life to be lived" and those who see deafness within a "medical model" as a "condition to be cured" has been over the cochlear implantation of young deaf children. Recent research has shown that there are noticeable inequities in access to such procedures in western countries; inequities that give rise to the need for informed public policy discussions. It has also found that parents of newly diagnosed deaf children are not provided with access to all the possibilities for their children-including that of a "Deaf life." How this information can be provided to parents and the public via widespread discussions in the media and elsewhere and involving Deaf people in the implantation counseling process is an issue that needs to be addressed by those responsible for implantation programs.

Theory skepticism and moral dilemmas.

Moral-theory skepticism is not an option in any sort of thinking that could actually be used in resolving dilemmas in applied ethics, since its characteristic doctrines entail positions that in practice often will lead to a kind of paralysis in in moral reasoning, where persons faced with having to decide what to do in particularly difficulty cases are unable to rule out the most implausible conclusions. Moral-theory skepticism thus makes it difficult to formulate decision-making procedures that will provide guidance in action, and, so, seems not to succeed as a fully coherent account of moral reasoning.

Aspectos bioéticos en implantes cocleares pediátricos / Bioethical issues in paediatric cochlear implants

Los aspectos bioéticos implicados en la decisión de realizar una implantación coclear a un niño surgen del hecho de que la utilización de este dispositivo puede cambiar significativamente el modo de estar en el mundo a través de las modificaciones psicológicas, lingüísticas y cognitivas que puede conllevar. El principal aspecto de controversia en este tema es quién tiene el derecho a tomar la decisión de un implante coclear en un menor. Se han estudiado retrospectivamente los niños evaluados en nuestro hospital para considerar la posibilidad de un implante coclear hasta el 31-5-01. Dicha población se desglosa en 37 niños implantados, 10 niños pendientes de cirugía o de completar estudio, y 21 niños excluidos del programa. Se analizan los motivos de exclusión de dichos candidatos y se exponen los problemas bioéticos implicados en dicha selección: Decisión de no implantar en niños pequeños de padres oyentes, problema cultural de las comunidades de sordos, problema del "menor maduro" y adolescentes, problemas socioculturales, patologías asociadas, y responsabilidad del equipo de implantes (AU)

The use of cochlear implants can modify significantly the way in which deaf children relate with the outside world through psychological, linguistic and cognitive changes. The main question about this subject is the ethical controversy with regards to who has the right to make such a decision for a young child. We present the children evaluated at our hospital in order to assess the cochlear implant option. That population was of 37 implanted children, 10 children waiting for surgery and 21 rejected children. We describe and analyze from the bioethical bases and methodology the problems found: decision of no implant in children of hearing parents, the deaf culture point of view, the mature minor doctrine, teenagers, social and cultural problems, multihandicapped children and responsibility of the implants team (AU)

Cochlear implants, the deaf culture, and ethics: a study of disability, informed surrogate consent, and ethnocide.

The use of cochlear implants in born-deaf infants addresses the issues of disability, proxy consent, and potential ethnocide of the Deaf culture. The ethical issues explored in this paper are: 1) the disability versus trait argument of deafness, 2) parents versus Deaf community in proxy consent, 3) justification for surgical intervention in a non-life threatening condition, and 4) justification for ethnocide. Decisions for non-competent individuals should be made to assure the child of an open future, with rights that need to be protected now, so that the child can exercise them later as an adult. Cochlear implants provide the potential of an open future and are morally justified on that basis.

[Bioethical issues in pediatric cochlear implants]. / Aspectos bioéticos en implantes cocleares pediátricos.

The use of cochlear implants can modify significantly the way in which deaf children relate with the outside world through psychological, linguistic and cognitive changes. The main question about this subject is the ethical controversy with regards to who has the right to make such a decision for a young child. We present the children evaluated at our hospital in order to assess the cochlear implant option. That population was of 37 implanted children, 10 children waiting for surgery and 21 rejected children. We describe and analyze from the bioethical bases and methodology the problems found: decision of no implant in children of hearing parents, the deaf culture point of view, the mature minor doctrine, teenagers, social and cultural problems, multihandicapped children and responsibility of the implants team.