Uterus Transplantation as a Surgical Innovation.

Uterus transplantation (UTx) research has been introduced in several countries, with trials in Sweden and the United States producing successful outcomes. The growing interest in developing UTx trials in other countries, such as Spain, the Netherlands, Japan, and Australia, raises important questions regarding the ethics of surgical innovation research in the field of UTx. This paper examines the current state of UTx in the context of the surgical innovation paradigm and IDEAL framework and discusses the ethical challenges faced by those considering the introduction of new trials. We argue that UTx remains an experimental procedure at a relatively early stage of the IDEAL framework, especially in the context of de novo trials, where protocols are likely to deviate from those used previously and where researchers are likely to have limited experience of UTx. We conclude that countries considering the introduction of UTx trials should build on the strengths of the reported outcomes to consolidate the evidence base and shed light on the uncertainties of the procedure. Authorities responsible for the ethical governance of UTx trials are advised to draw on the ethical framework used in the oversight of surgical innovation.

Alternative consent models for biobanks: the new Spanish law on biomedical research.

This article provides an overview of recent contributions to the debate on the ethical use of previously collected biobank samples, as well as a country report about how this issue has been regulated in Spain by means of the new Biomedical Research Act, enacted in the summer of 2007. By contrasting the Spanish legal situation with the wider discourse of international bioethics, we identify and discuss a general trend moving from the traditional requirements of informed consent towards new models more favourable to research in a post-genomic context.

Breast density classification to reduce false positives in CADe systems.

This paper describes a novel weighted voting tree classification scheme for breast density classification. Breast parenchymal density is an important risk factor in breast cancer. Moreover, it is known that mammogram interpretation is more difficult when dense tissue is involved. Therefore, automated breast density classification may aid in breast lesion detection and analysis. Several classification methods have been compared and a novel hierarchical classification procedure of combined classifiers with linear discriminant analysis (LDA) is proposed as the best solution to classify the mammograms into the four BIRADS tissue classes. The classification scheme is based on 298 texture features. Statistical analysis to test the normality and homoscedasticity of the data was carried out for feature selection. Thus, only features that are influenced by the tissue type were considered. The novel classification techniques have been incorporated into a CADe system to drive the detection algorithms and tested with 1459 images. The results obtained on the 322 screen-film mammograms (SFM) of the mini-MIAS dataset show that 99.75% of samples were correctly classified. On the 1137 full-field digital mammograms (FFDM) dataset results show 91.58% agreement. The results of the lesion detection algorithms were obtained from modules integrated within the CADe system developed by the authors and show that using breast tissue classification prior to lesion detection leads to an improvement of the detection results. The tools enhance the detectability of lesions and they are able to distinguish their local attenuation without local tissue density constraints.

An artificial neural network improves the non-invasive diagnosis of significant fibrosis in HIV/HCV coinfected patients.

OBJECTIVE: To develop an artificial neural network to predict significant fibrosis (F≥2) (ANN-SF) in HIV/Hepatitis C (HCV) coinfected patients using clinical data derived from peripheral blood. METHODS: Patients were randomly divided into an estimation group (217 cases) used to generate the ANN and a test group (145 cases) used to confirm its power to predict F≥2. Liver fibrosis was estimated according to the METAVIR score. RESULTS: The values of the area under the receiver operating characteristic curve (AUC-ROC) of the ANN-SF were 0.868 in the estimation set and 0.846 in the test set. In the estimation set, with a cut-off value of <0.35 to predict the absence of F≥2, the sensitivity (Se), specificity (Sp), and positive (PPV) and negative predictive values (NPV) were 94.1%, 41.8%, 66.3% and 85.4% respectively. Furthermore, with a cut-off value of >0.75 to predict the presence of F≥2, the ANN-SF provided Se, Sp, PPV and NPV of 53.8%, 94.9%, 92.8% and 62.8% respectively. In the test set, with a cut-off value of <0.35 to predict the absence of F≥2, the Se, Sp, PPV and NPV were 91.8%, 51.7%, 72.9% and 81.6% respectively. Furthermore, with a cut-off value of >0.75 to predict the presence of F≥2, the ANN-SF provided Se, Sp, PPV and NPV of 43.5%, 96.7%, 94.9% and 54.7% respectively. CONCLUSION: The ANN-SF accurately predicted significant fibrosis and outperformed other simple non-invasive indices for HIV/HCV coinfected patients. Our data suggest that ANN may be a helpful tool for guiding therapeutic decisions in clinical practice concerning HIV/HCV coinfection.

[Consent, biobanks and biomedical research law]. / Consentimiento, biobancos y ley de investigación biomédica.

This article provides an overview of recent contributions to the ethical and legal debate on the use of previously collected human biobank samples. It reports how this issue has been regulated in Spain by means of the new Law on Biomedical Research as well as in the international bioethical discourse. By contrasting both approaches we identify and critically discuss a general trend moving from the traditional requirements of informed consent towards models more favourable to research in a post-genomic context.

Cultura de la confidencialidad en los hospitales del norte de España / The culture of confidentiality in Northern Spain hospitals

No disponible

Consentimiento, biobancos y Ley de Investigación Biomédica / No disponible

El artículo se ocupa de algunas contribuciones recientes al debate ético y jurídico sobre el uso de muestras biológicas humanas (MBH) en biobancos. Examina el tratamiento de esta cuestión en España a través de la reciente Ley de Investigación Biomédica (LIB) y en el panorama internacional. La comparación de ambos contextos permite constatar y analizar críticamente la aparición de nuevos modelos de consentimiento, distintos de los modelos tradicionales y más favorables a la investigación en un contexto post-genómico (AU)

This article provedes an overview of recent contributions to the ethical and legal debate on the use of previously collected human biobank samples. It reports how this issue has been regulated in Spain by means of the new law on Biomedical Research as well as in the international bioethical discourse. By contrasting both approaches we indentify and critically discuss a general trend moving from the traditional requirements of informed consent towards models more favourable to research in a post-genomic context (AU)

La reserva de las anotaciones subjetivas: ¿derecho o privilegio? / Restricted access to subjective notes: right or privilege?

La Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica ha supuesto un hito en el reconocimiento legal de la autonomía de los pacientes. En su artículo 18.3 aborda el tema de las anotaciones subjetivas de un modo poco claro y que merece ser objeto de debate. El artículo revisa la argumentación ética y jurídica relacionada con este tema, en que se vislumbra un giro autonomista que supone que el enfermo pasa de sujeto paciente a sujeto agente. Finalmente se analizan los argumentos a favor y en contra de las limitaciones de disponibilidad de las anotaciones subjetivas, y se concluye que no debe existir un derecho de reserva exclusivo de los profesionales sanitarios, diferente de los mecanismos de tutela de la confidencialidad y de los derechos disponibles para cualquier ciudadano. Aun admitiendo la existencia de anotaciones subjetivas, en ningún caso puede justificarse el reconocimiento de un derecho de reserva de los profesionales, que parece más bien un privilegio propio de otros tiempos y modelos, lo cual no impide la necesaria reflexión acerca de cómo los pacientes deberían disponer de su historia clínica

Law 41/2002, of November 14th, concerning patient autonomy and rights and responsibilities regarding clinical information is a landmark in the legal recognition of patient autonomy. Article 18.3 of this law, which deals with the topic of subjective notes, is insufficiently clear and warrants further discussion. The present article reviews the ethical and legal arguments related to this topic, in which an autonomous twist can be discerned, implying an essential change in the patient's role: from patient to agent. Finally the arguments for and against restricted access to subjective notes are examined. The conclusion is that there is no justification for a special right for health professionals different from the rights enjoyed by any citizen and from the general legal resources for guaranteeing confidentiality. Even acknowledging the existence of subjective notes, the authors argue that a professional legal right to restricted access is unjustifiable; such a right would be more a privilege than a right and seems to belong to former times and ethical and legal frameworks. This criticism does not preclude further and necessary reflection about how patients should access their clinical records