Andrea Virdis

Health technology assessment (HTA): ethical aspects

Abstract“HTA is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused, and seek to achieve best value” (EUnetHTA 2007). Even though the assessment of ethical aspects of a health technology is listed as one of the objectives of a HTA process, in practice, the integration of these dimensions into reports remains limited. The article is focused on four points: 1. the HTA concept; 2. the difficult HTA-ethics relationship; 3. the ethical issues in HTA; 4. the methods for integrating ethical analysis into HTA.

Heterologous assisted reproduction and kernicterus: The unlucky coincidence reveals an ethical dilemma

Secrecy and anonymity related to heterologous assisted reproduction may hide basic newborn data to neonatologists. Secrecy and anonymity are discussed in view of their possible consequences on relational dynamics and on developmental psychology. Nevertheless, they can also involve the offsprings genetic status regarding inheritable diseases. International guidelines have been recently published on this topic. Because no guidelines are ‘ideal’ unfortunate and possibly dramatic consequences can occur. We aimed to embark on a debate about this matter starting with a real clinical experience. In our case a rarely fatal but widespread disease, together with the lack of knowledge about parental status led, in a fast succession of clinical events, to the unavoidable insurgence of kernicterus.

Cryopreservation of ovarian tissue in pediatrics: what is the child's best interest?

In paediatric female patients the only option for restoring fertility after chemotherapy and radiotherapy is ovarian tissue banking. Even if this procedure is considered the most promising available, anyway it is still an experimental option due to the paucity of data. The possibility to offer an experimental preventive technique with potential benefits but with known risks arises a dilemma: what is the best interest for suffering child? Is it most important to minimize risk of the disease or to preserve the future fertility? However, if it is right to propose fertility preservation when physical and psychic risks are acceptable, we think it is not in the child’s best interest to retrieve ovarian tissue from very young patients whose ovaries are small and for whom surgery is a high risk procedure. Moreover fertility preservation should not be offered if this could increase the risk of disease worsening.

Electronic Medical Diary (EMD): Ethical Analysis in a HTA Process

Ethical analysis within Health Technology Assessment (HTA) – a comprehensive form of health policy research that examines the short- and long- term consequences of the application or use of technologies (in a broad meaning) – aims at analysing the moral questions raised by the technology itself and by the consequences of implementing or not a health technology as well as ethical issues that are inherent in the HTA process. The work intends to assess, within a HTA process, the ethical consequences of implementing the Electronic Medical Diary (EMD) in health care systems. The EMD is a device for supporting the daily registration and collection of clinical events related to a certain patient. The storage of these patient-specific clinical data constitutes the patient database (PDB) that may be connected with the many online tools which can improve the flow of information within the hospital information system. Such devices should be able to replace the traditional paper record.

Congenital rubella syndrome: seeking damages to be born. Ethical, medical and public health considerations

A case of congenital rubella syndrome has been the reason to seek damages but a Civil Court of Rome sentenced against this and in favor of sued doctors. We discussed the high level of social attention and the feeling present in our western culture behind the request for damages. Legal considerations above the Italian abortion Law is provided to understand the framework of the court decision. Ethical, medical, and public health issues are commented and compared with the Perruches case.

Incapacità di alimentazione ed idratazione autonoma: un confronto fra il neonato, il lattante e il soggetto in stato vegetativo

Within the broad framework of the care for the person in vegetative state (VS), artificial nutrition and hydration have a fundamental importance, similarly to what happens in the assistance given to newborns and to unweaned infants. As the absence of physiological functions or relationships with the outside world are often given to justify the assistance withdrawal in subjects in VS, the article aims to address the issue of artificial nutrition and hydration dutifulness in these persons, through a comparison between the various vital, physiological “functions”or behavioral and social skills present both in the subject in VS and in newborns and infants. By the light of this comparison, it appears that the only reason that can wrongly support the legality of the nutrition withdrawal in the subjects in VS is ideological and not scientific.