Ethical issues of human genetic databases : a challenge to classical health research ethics?

[Contents] - Introduction - Selected existing genetic database : distinctive features, ethical problems and the public debate - The ethical debate : principles, values and interests : the ethical foundations of guidelines - Selected issues of consensus and of controversy - Ethical issues of human genetic databases and the future This book compares the new area of biobanking with the tradition of ethically accepted classical research and highlights the distinctive features of existing databases and guidelines

Abstracting qualitative information for process supervision

Supervisory systems evolution makes the obtaining of significant information from processes more important in the way that the supervision systems' particular tasks are simplified. So, having signal treatment tools capable of obtaining elaborate information from the process data is important. In this paper, a tool that obtains qualitative data about the trends and oscillation of signals is presented. An application of this tool is presented as well. In this case, the tool, implemented in a computer-aided control systems design (CACSD) environment, is used in order to give to an expert system for fault detection in a laboratory plant

I-SS: integrated supervision systems approach based on interactive components

Process supervision is the activity focused on monitoring the process operation in order to deduce conditions to maintain the normality including when faults are present Depending on the number/distribution/heterogeneity of variables, behaviour situations, sub-processes, etc. from processes, human operators and engineers do not easily manipulate the information. This leads to the necessity of automation of supervision activities. Nevertheless, the difficulty to deal with the information complicates the design and development of software applications. We present an approach called "integrated supervision systems". It proposes multiple supervisors coordination to supervise multiple sub-processes whose interactions permit one to supervise the global process

Interacting software-agents to support a kind of expert supervision systems

Expert supervision systems are software applications specially designed to automate process monitoring. The goal is to reduce the dependency on human operators to assure the correct operation of a process including faulty situations. Construction of this kind of application involves an important task of design and development in order to represent and to manipulate process data and behaviour at different degrees of abstraction for interfacing with data acquisition systems connected to the process. This is an open problem that becomes more complex with the number of variables, parameters and relations to account for the complexity of the process. Multiple specialised modules tuned to solve simpler tasks that operate under a co-ordination provide a solution. A modular architecture based on concepts of software agents, taking advantage of the integration of diverse knowledge-based techniques, is proposed for this purpose. The components (software agents, communication mechanisms and perception/action mechanisms) are based on ICa (Intelligent Control architecture), software middleware supporting the build-up of applications with software agent features

Expert supervision based on cases

The paper focuses on taking advantage of large amounts of data that are systematically stored in plants (by means of SCADA systems), but not exploited enough in order to achieve supervisory goals (fault detection, diagnosis and reconfiguration). The methodology of case base reasoning (CBR) is proposed to perform supervisory tasks in industrial processes by re-using the stored data. The goal is to take advantage of experiences, registered in a suitable structure as cam, avoiding the tedious task of knowledge acquisition and representation needed by other reasoning techniques as expert systems. An outlook of CBR terminology and basic concepts are presented. The adaptation of CBR in performing expert supervisory tasks, taking into account the particularities and difficulties derived from dynamic systems, is discussed. A special interest is focused in proposing a general case definition suitable for supervisory tasks. Finally, this structure and the whole methodology is tested in a application example for monitoring a real drier chamber

Embryonic and fetal development: fundamental research.

Much progress has been made over the past decades in the development of in vitro techniques for the assessment of chemically induced effects in embryonic and fetal development. In vitro assays have originally been developed to provide information on the mechanism of action of normal development, and have hence more adequately been used in fundamental research. These assays had to undergo extensive modification to be used in developmental toxicity testing. The present paper focuses on the rat whole embryo culture system, but also reviews modifications that were undertaken for the in vitro chick embryo system and the aggregate cultures of fetal rat brain cells. Today these tests cannot replace the existing in vivo developmental toxicity tests. They can, however, be used to screen chemicals for further development or further testing. In addition, these in vitro tests provide valuable information on the mechanisms of developmental toxicity and help to understand the relevancy of findings for humans. In vitro systems, combined with selected in vivo testing and pharmacokinetic investigations in animals and humans, can thus provide essential information for human risk assessment.

Vector biology prospects in dengue research

We argue that using more natural blood feeding methods to study mosquito vector competence for dengue viruses and exploring the effect of viral infection on other mosquito life-history traits that influence vectorial capacity will significantly advance our understanding of dengue epidemiology.

A Thematic Comparison of Eight Frameworks of Quality Criteria in Qualitative Health Research

Background: Despite the increasing incidences of the publication of assessment frameworks intending to establish the "standards" of the quality of qualitative research, the research conducted using such empirical methods are still facing difficulties in being published or recognised by funding agencies. Methods: We conducted a thematic content analysis of eight frameworks from psychology/psychiatry and general medicine. The frameworks and their criteria are then compared against each other. Findings: The results illustrated the difficulties in reaching consensus on the definition of quality criteria. This showed the differences between the frameworks from the point of views of the underlying epistemology and the criteria suggested. Discussion: The aforementioned differences reflect the diversity of paradigms implicitly referred to by the authors of the frameworks, although rarely explicitly mentioned in text. We conclude that the increase in qualitative research and publications has failed to overcome the difficulties in establishing shared criteria and the great heterogeneity of concepts raises methodological and epistemological problems.

Research letter: is neuroticism a risk factor for postpartum depression?

Although the relationship between personality and depressive illness is complex (Shea, 2005), there is empirical evidence that some personality features such as neuroticism, harm avoidance, introversion, dependency, self-criticism or perfectionism are related to depressive illness risk (Gunderson et al. 1999).

Enterprise Architecture Principles in Research and Practice: Insights from an Exploratory Analysis

Even though architecture principles were first discussed in the 1990s, they are still perceived as an underexplored topic in enterprise architecture management research. By now, there is an increasing consensus about EA principles' nature, as well as guidelines for their formulation. However, the extant literature remains vague about what can be considered suitable EA design and evolution guidance principles. In addition, empirical insights regarding their role and usefulness in practice are still lacking. Accordingly, this research seeks to address three questions: (1) What are suitable principles to guide EA design and evolution? (2) What usage do EA principles have for practitioners? (3) Which propositions can be derived regarding EA principles' role and application? Opting for exploratory research, we apply a research process covering critical analysis of current publications as well as capturing experts' perceptions. Our research ontologically distinguishes between principles from nonprinciples, proposes a validated set of meta-principles, and clarifies principles' application, role, and usefulness in practice. The explored insights can be used as guidelines in defining suitable principles and turning them into an effective bridge between strategy and design and a guide in design decisions.

Prophylactic isolated limb perfusion for localized, high-risk limb melanoma: results of a multicenter randomized phase III trial. European Organization for Research and Treatment of Cancer Malignant Melanoma Cooperative Group Protocol 18832, the World Health Organization Melanoma Program Trial 15, and the North American Perfusion Group Southwest Oncology Group-8593.

PURPOSE: Patients with primary cutaneous melanoma > or = 1.5 mm in thickness are at high risk of having regional micrometastases at the time of initial surgical treatment. A phase III international study was designed to evaluate whether prophylactic isolated limb perfusion (ILP) could prevent regional recurrence and influence survival. PATIENTS AND METHODS: A total of 832 assessable patients from 16 centers entered the study; 412 were randomized to wide excision (WE) only and 420 to WE plus ILP with melphalan and mild hyperthermia. Median age was 50 years, 68% of patients were female, 79% of melanomas were located on a lower limb, and 47% had a thickness > or = 3 mm. RESULTS: Median follow-up duration is 6.4 years. There was a trend for a longer disease-free interval (DFI) after ILP. The difference was significant for patients who did not undergo elective lymph node dissection (ELND). The impact of ILP was clearly on the occurrence-as first site of progression - of in-transit metastases (ITM), which were reduced from 6.6% to 3.3%, and of regional lymph node (RLN) metastases, with a reduction from 16.7% to 12.6%. There was no benefit from ILP in terms of time to distant metastasis or survival. Side effects were higher after ILP, but transient in most patients. There were two amputations for limb toxicity after ILP. CONCLUSION: Prophylactic ILP with melphalan cannot be recommended as an adjunct to standard surgery in high-risk primary limb melanoma.

Unison or cacophony: postgraduate training in pathology in Europe.

With the free movement of people in the European Union, medical mobility has increased significantly. This is notably the case for disciplines for which shortage of well-trained staff has occurred. Pathology is among those specialties and effectively the discipline is confronted with a striking increase in mobility among trainees and qualified specialists. The presumption underlying unlimited mobility is that the competencies of the medical specialists in the European countries are more or less equal, including significant similarities in the postgraduate training programs. In order to assess whether reality corresponds with this presumption, we conducted a survey of the content and practice requirements of the curricula in the EU and affiliated countries. The results indicate a striking heterogeneity in the training program content and practice requirements. To name a few elements: duration of the training program varied between 4 and 6 years; the number of autopsies required varied between none at all and 300; the number of biopsies required varied between none at all and 15,000. We conclude that harmonization of training outcomes in Europe is a goal that needs to be pursued. This will be difficult to reach through harmonization of training programs, as these are co-determined by political, cultural, and administrative factors, difficult to influence. Harmonization might be attained by defining the general and specific competencies at the end of training and subsequent testing them through a test to which all trainees in Europe are subjected.

All-cause mortality in the cohorts of the Spanish AIDS Research Network (RIS) compared with the general population: 1997-2010.

BACKGROUND Combination antiretroviral therapy (cART) has produced significant changes in mortality of HIV-infected persons. Our objective was to estimate mortality rates, standardized mortality ratios and excess mortality rates of cohorts of the AIDS Research Network (RIS) (CoRIS-MD and CoRIS) compared to the general population. METHODS We analysed data of CoRIS-MD and CoRIS cohorts from 1997 to 2010. We calculated: (i) all-cause mortality rates, (ii) standardized mortality ratio (SMR) and (iii) excess mortality rates for both cohort for 100 person-years (py) of follow-up, comparing all-cause mortality with that of the general population of similar age and gender. RESULTS Between 1997 and 2010, 8,214 HIV positive subjects were included, 2,453 (29.9%) in CoRIS-MD and 5,761 (70.1%) in CoRIS and 294 deaths were registered. All-cause mortality rate was 1.02 (95% CI 0.91-1.15) per 100 py, SMR was 6.8 (95% CI 5.9-7.9) and excess mortality rate was 0.8 (95% CI 0.7-0.9) per 100 py. Mortality was higher in patients with AIDS, hepatitis C virus (HCV) co-infection, and those from CoRIS-MD cohort (1997-2003). CONCLUSION Mortality among HIV-positive persons remains higher than that of the general population of similar age and sex, with significant differences depending on the history of AIDS or HCV coinfection.