Ethical Legal Aspects Research Articles

Foot health and quality of life in women with breast cancer undergoing chemotherapy: a cross-sectional study

Background Chemotherapy is one of the most widely used therapies for breast cancer, triggering important repercussions on people’s quality of life. However, little research has been undertaken about podiatric adverse effects. This study aimed was to determine the prevalence of podiatric pathology developed in people with breast cancer who receive chemotherapy.MethodsObservational, descriptive, and cross-sectional study was conducted in the Oncology service of the A Coruña University Hospital (northwest Spain). People with breast cancer and undergoing chemotherapy treatment of legal age (≥ 18), who signed the informed consent (n = 117) were included. Sociodemographic, comorbidity, disease and foot health variables, as well as two self-administered questionnaires (Foot Health Status Questionnaire and Foot Function Index) were studied. The current ethical-legal aspects were followed.ResultsFoot health problems were highly prevalent, highlighting nail color changes (59.8%), onychocryptosis (39.7%), xerosis (62.4%), plantar fasciitis (12.8%), and neuropathic symptoms (75.2%). Some foot pain was presented in 77.8% of the sample, predominantly at nail level (15.4%) or sole of the foot and nail (14.5%). Most participants described their foot health as fair or poor (56.4%) and felt limited in walking (65.8%). The lowest score for the Foot Health Status Questionnaire was footwear (30.6(33.5)).ConclusionsFoot health adverse effects represent worrisome problems in women with breast cancer undergoing chemotherapy, due to their high prevalence and negative implications on quality of life. These problems are critical as they may have implications for stopping or reducing chemotherapy. All these results call for the development of more research to contribute to the care and wellbeing of people with cancer who receive treatments such as chemotherapy. Thus, this line of research is a new path to be developed by the podiatry community.

Ethical-legal aspects of organoids and their use in research. Manage risks and legal constraints for the development of ethical research

Organoids, briefly and simply stated, are miniature replicas of human organs and tissues: they derive from induced pluripotent stem cells (iPSC) or from adult cells and tissues, including tumors. They represent an important tool for personalized medicine and drug testing in general. At the moment the legal framework is incomplete and the focus is rather on ethical issues and the protection of privacy. The essay focuses on the legal framework looking for qualifying answers that can combine research development and protection of the person.

Nível de conhecimento ético-legal dos graduandos em Medicina: estudo transversal no ano de 2020

Abstract: Introduction: Complaints about medical malpractice are frequent. Therefore, investigating how the medical student formation is made concerning the ethical and legal aspects, can contribute to its improvement. Objective: To evaluate and compare the level of knowledge of medical students from a university about ethical and legal aspects of the profession, based on their formation in the disciplines of the related axis (Medical Ethics and Bioethics; Legal Medicine and Deontology/Medical Forensics and Good Practice). Method: Cross-sectional study carried out through the application of an online questionnaire (August-November/2020) based on the Code of Medical Ethics (CME) and the Code of Ethics for Medical Student- 10 sociodemographic and 12 objective questions (Topics: “Professional Confidentiality”, “Medical student’s Interpersonal Relations”, “Medical Publicity”, “Relations with Patients and Families”, “Human Rights”, “Fundamental Principles”, “Medical Activity” and “Telemedicine”). A total of 116 students were evaluated at the start, middle and end of the medical course. The Kruskal-Wallis and Dunn tests were used for comparisons. The Chi-Square and Fisher’s exact tests were used for the association of categorical variables. Results: The performance increased throughout the course, with statistical significance between the average number of correct answers in the 1st, 6th and 10th/12th periods: 5.1; 6.7 and 7.8, (p-value <0.001). The analysis by thematic blocks, on the other hand, did not show a statistical association of correct answers with progress in the medical course (p-value >0.05) for broad-reaching topics and development of competences from the basic cycle, such as “Medical Publicity”, “Relations with Patients and Families”, “Telemedicine” and “Medical Student’s Interpersonal Relations” - with emphasis on the student’s limitations in providing care. As for topics that required competences inherent to the disciplines of the ethical-legal axis, this association was identified (p-value <0.05), as follows: “Professional Confidentiality”, “Human Rights”, “Fundamental Principles”, “Medical Activity” and “Medical Student’s Interpersonal Relations” - specifically on the use of electronics. Finally, the highest percentage of correct answers (95.7%) is associated with “Medical Student’s Interpersonal Relations”, with an emphasis on the student’s limitations. While the lowest rates were found in “Professional Confidentiality” (18.1%), “Medical Activity” (33.6%) and “Human Rights” (25%)”. Conclusion: There is an association between the medical formation proposed by the ethical-legal axis, and the effective increase of the medical student’s level of knowledge concerning the ethical-legal aspects of the profession.

The use of mechanical restraint in critical care units: Characterisation, application standards and related factors. Results of a multicentre study

ObjectivesTo describe and characterise the use of mechanical restraint (MR) in critical care units (CCU) in terms of frequency and quality of application and to study its relationship with pain/agitation-sedation/delirium, nurse:patient ratio and institutional involvement. MethodMulticentre observational study conducted in 17 CCUs between February and May 2016. The observation time per CCU was 96 h. The main variables were the prevalence of restraint, the degree of adherence to MR recommendations, pain/agitation-sedation/delirium monitoring and institutional involvement (protocols and training of professionals). ResultsA total of 1070 patients were included. The overall prevalence of restraint was 19.11%, in patients with endotracheal tube (ETT) 42.10% and in patients without ETT or artificial airway it was 13.92%. Adherence rates between 0% and 40% were obtained for recommendations related to non-pharmacological management and between 0% and 100% for those related to monitoring of ethical-legal aspects. The lower prevalence of restraint was correlated with adequate pain monitoring in non-communicative patients (P < .001) and with the provision of training for professionals (P = .020). An inverse correlation was found between the quality of the use of MR and its prevalence, both in the general group of patients admitted to CCU (r = −.431) and in the subgroup of patients with ETT (r = −.521). ConclusionsRestraint is especially frequently used in patients with ETT/artificial airway, but is also used in other patients who may not meet the use profile. There is wide room for improvement in non-pharmacological alternatives to the use of MC, ethical and legal vigilance, and institutional involvement. Better interpretation of patient behaviour with validated tools may help limit use of MR.

Uso de contenciones mecánicas en unidades de cuidados críticos: caracterización, estándares de aplicación y factores relacionados. Resultados de un estudio multicéntrico

ObjectivesTo describe and characterise the use of mechanical restraint (MR) in critical care units (CCU) in terms of frequency and quality of application and to study its relationship with pain/agitation-sedation/delirium, nurse:patient ratio and institutional involvement. MethodMulticentre observational study conducted in 17 CCUs between February and May 2016. The observation time per CCU was 96h. The main variables were the prevalence of restraint, the degree of adherence to MR recommendations, pain/agitation-sedation/delirium monitoring and institutional involvement (protocols and training of professionals). ResultsA total of 1070 patients were included. The overall prevalence of restraint was 19.11%, in patients with endotracheal tube (ETT) 42.10% and in patients without ETT or artificial airway it was 13.92%. Adherence rates between 0% and 40% were obtained for recommendations related to non-pharmacological management and between 0% and 100% for those related to monitoring of ethical-legal aspects. The lower prevalence of restraint was correlated with adequate pain monitoring in non-communicative patients (P<.001) and with the provision of training for professionals (P=.020). An inverse correlation was found between the quality of the use of MR and its prevalence, both in the general group of patients admitted to CCU (r=−.431) and in the subgroup of patients with ETT (r=−.521). ConclusionsRestraint is especially frequently used in patients with ETT/artificial airway, but is also used in other patients who may not meet the use profile. There is wide room for improvement in non-pharmacological alternatives to the use of MC, ethical and legal vigilance, and institutional involvement. Better interpretation of patient behaviour with validated tools may help limit use of MR.

The Andalusian Registry of Donors for Biomedical Research: Five Years of History.

The mission of the Andalusian Public Health System Biobank is to offer the best options for biological samples of human origin and associated clinical information, protecting the rights of citizens who donate their samples for research. Since the Andalusian Biobank provides high-quality biological samples of all types in a specified format, adapting the preanalytical phase according to the requirements of the research, prospective collection and distribution of samples are being prioritized in order to contribute to the sustainability of the Biobank. The Andalusian Registry of Donors for Biomedical Research is a tool for the recruitment of donors and the prospective collection of samples. Its operation is based on the informed consent of donors for their incorporation into the Registry and contact with possible donors under request from specific projects. An additional advantage of this unique initiative is to ensure that societal actors work together throughout the entire research process, establishing alliances with patient associations and groups to develop joint actions and promote biomedical research. Here, we describe the creation, ethical–legal aspects, management and results of the Andalusian Registry of Donors for Biomedical Research after five years of operation.

Diseño y validación de un modelo de gestión del capital intelectual para la calidad de Instituciones de Educación Superior, Colombia

Se muestran los resultados del diseno y validacion de un Modelo de Gestion de Capital Intelectual (CI) para la calidad de IES, Colombia 2014-2016. Investigacion aplicada, de caracter mixta. El abordaje cualitativo fue a partir de la confrontacion de la teoria con las condiciones especificas del objeto abordado (sus caracteristicas y necesidades) lo que permitio el diseno del modelo. El abordaje de los datos cuantitativos fue estadistico. Se disenaron siete encuestas las cuales fueron validadas por expertos. Fue denominado Modelo Sistemico-Dinamico de Gestion del Capital Intelectual para la Calidad de Instituciones de Educacion Superior (SIDIGCIES), su diseno estuvo fundamentado en tres teorias: la Teoria de las Organizaciones Inteligentes de Senge, la Teoria de las Capacidades Dinamicas en el Mundo Empresarial de Teece, Pisano y Shuen, y la Teoria de Creacion del Conocimiento de Nonaka y Takeuchi. Tambien se tuvieron en cuenta los lineamientos del Consejo Nacional de Acreditacion (CNA) de Colombia tanto para programas como instituciones. Esta estructurado por cuatro Subsistemas - Dinamicos: Talento Humano, Investigacion e Innovacion, Academico Administrativo y Reconocimiento Social. La validacion del modelo en un programa de Medicina mostro la pertinencia de SIDIGCIES, con las exigencias establecidas a nivel nacional e internacional para la acreditacion de programas y de instituciones. Se logro el diseno de 92 indicadores para la medicion distribuidos en cada uno de los subsistemas y de siete instrumentos para cada uno de los actores del proceso de ensenanza-aprendizaje debidamente validados, contando de esta manera con herramientas fiables de medicion de la gestion del capital intelectual.

Patients with hepatitis C lost to follow-up: ethical-legal aspects and search results.

data on the prevalence and characteristics of hepatitis C patients lost to follow-up are lacking. In addition, the identification of this population clashes with data protection regulations. the identification and contact protocol was submitted to the Health Care Ethics Committee. The protocol was based on anti-HCV serology test results for 2010-2018, which were obtained from the Microbiology Department. In addition, the situation of the patients in the hospital and regional database was analyzed, based on the following classification: a) chronic hepatitis C, if the last HCV RNA determination was positive; b) cured hepatitis C, if the last HCV RNA determination was negative after 12 weeks of treatment; and c) possible hepatitis C, if anti-HCV antibodies were positive with no result for HCV RNA. Lost patients were defined as those with chronic or possible hepatitis C and no follow-up in the Digestive Diseases or Internal Medicine Departments. The patients were contacted by postal mail and then by telephone, so that they could be offered treatment. the Ethics Committee considered that the protocol fulfilled the bioethical principles of autonomy, beneficence, non-maleficence and justice and that contact was ethically desirable. From 4,816 positive anti-HCV serology results, 677 patients were identified who were lost to follow-up (14.06 %; 95 % CI, 13.2-15.2). The mean age was 54 years, 61 % were male, 12 % were foreign born and 95 % were mono-infected. The study of each serology result took 1.3 minutes. One-quarter (25 %) of the losses corresponded to the Digestive Diseases and Internal Medicine Departments. Of the 677 losses, serology testing had only been ordered for 449 patients (66.3 %) and the remaining 228 (33.7 %) also had a positive HCV RNA result. a large number of patients with hepatitis C are lost to follow-up. Searching for and contacting these patients is legally and ethically viable.

Construction of hypermedia to support the systematization of the nursing care education.

To describe the process of hypermedia construction to support the teaching of the Systematization of the Nursing Care (SNC). Methodological research of educational technology development. The hypermedia construction stages were conducted from February 2015 to March 2016 and integrated theoretical studies, focus group with professors and educational technology development process in the light of the referential Theory of Significant Learning. Hypermedia consists of interactive content and shows a splash screen with a concept map that guides a free way of learning about four structuring aspects in the SNC learning: concept, history and benefits; ethical-legal aspects; operationalization; and nursing process: steps and technical integration in nursing. It was concluded that it is essential that the educational technologies are built from a pedagogical rationale to support your incorporation into educational environments.

КОНЦЕПТУАЛЬНЫЕ ОСНОВЫ ИССЛЕДОВАНИЯ ГЕРМЕНЕВТИКИ КАТЕГОРИИ ЭФФЕКТИВНОСТИ С ПОЗИЦИИ ЭВОЛЮЦИИ НАУЧНОГО ЗНАНИЯ

Currently, in economics, there can be seen a generation of different models, mechanisms and methodologies for analyzing the content of the efficiency category. In these conditions, many researchers are still trying to justify the need to unify approaches to its definition. The article shows the differentiation of approaches to the hermeneutic of the effectiveness category determined by the stages of the evolution of scientific knowledge (classical, nonclassical, post-nonclassical) and by complication of the object of study (the development of a simple, self-regulating and self-developing complex systems). For this purpose, the following approaches to epistemology are used: hermeneutical, systemic, and dialectical. The author states that mechanical picture of the world, which is the basis of the categorical grid of the description of simple systems, typical of the classical stage of the science evolution, has determined the development of the reductionist idea about the effectiveness as the effectivity (Walras approach). The emergence of the ideas of probabilistic and objective causality at neo-classical stage of the development of scientific knowledge made it possible to complement the concept of efficiency as the effectivity by using interpersonal comparisons of utility (Pigou approach) and methodological relativity principle (Pareto approach). The determination by objective reality, characteristic of the modern (post-nonclassical) stage of the development of scientific knowledge, predetermined including social and ethical-legal aspects in the content of the efficiency category and the possibility of applying two approaches to its hermeneutics: efficiency as effectivity and efficiency as effectiveness. The application of efficiency category as an integrated element of management system (performance), which synthesizes the categories of effectivity, effectiveness and quality, is associated with the necessity to reflect scientific concepts, which is the second feature of the post-nonclassical stage. The selection of various types of efficiency (internal and external, potential and actual, static and dynamic) is associated with the complication of the research object - the development of complex self-developing systems. The conclusion is that at the present time the determinant of quality is the defining element in the interpretation of the efficiency category (performance), characterized by the quantitative certainty.

Female genital mutilations: genito-urinary complications and ethical-legal aspects.

Many women in the world are still undergoing female genital mutilations (FGMs) even if in almost all the countries, the practice of FGM is illegal. The increase of immigration, particularly from African Countries, to Europe, and Italy too, led to consider this phenomenon with particular attention and skill. All the operators in health services need to know the different types of FGMs and the related complications and the psychological and sexual sequels. Urological complications, in particular, are not rare and the changing anatomy of the external genital apparatus can also make the catheter insertion sometimes difficult. This review analyzes the epidemiology of FGMs, the reasons why the practice is still made, the complications, the ethical, and the principal legal aspects of this practise that must be hopefully early banned.

The Intego database: background, methods and basic results of a Flemish general practice-based continuous morbidity registration project.

BackgroundIntego is the only operational computerized morbidity registration network in Belgium based on general practice data. Intego collects data from over 90 general practitioners. All the information is routinely collected in the electronic health record during daily practice.MethodsIn this article we describe the design and methods used within the Intego network together with some of its basic results. The collected data, the quality control procedures, the ethical-legal aspects and the statistical procedures are discussed.ResultsIntego contains longitudinal information on 285 357 different patients, corresponding to over 2.3% of the Flemish population representative in terms of age and sex. More than 3 million diagnoses, 12 million drug prescriptions and 29 million laboratory tests have been recorded.ConclusionsIntego enables us to present and compare data on health parameters, incidence and prevalence rates, laboratory results, and prescribed drugs for all relevant subgroups on a routine basis and is unique in Belgium.

Acupuntura como instrumento de trabalho do enfermeiro: revisão integrativa da literatura

It is an integrative review that aims to synthesize the knowledge about use of acupuncture as a tool for nurse’s work between 2007 and 2011, in the bases: Bdenf, Cinahl, Lilacs, Scielo and Redalyc. Among the nine references analyzed were drawn three thematic categories: Experiences of nursing care with the use of acupuncture; Ethical-legal aspects of the use of acupuncture as a tool for the work of nurses and the insertion of acupuncture in the nursing curriculum. Were declined the needs about research in the practice of nurses and acupuncture, as well as expansion in training, since graduation to post-graduate classes, as well the increase of its offer in the Unified Health System.

Endoscopic removal of an endodontic file accidentally swallowed: Clinical and legal approaches

The use of a rubber dam is an essential procedure when treating root canals, and not using it may compromise the success of the treatment, as well as the patient's health. This report presents a case in which a K-file was accidentally swallowed during an endodontic procedure, performed without the use of a rubber dam. Given the absence of immediate clinical complications, the subject underwent a chest radiograph. The file was located at the oesophagogastric junction and was later removed by endoscopy. In addition to the clinical repercussions, this example also illustrates the ethical-legal aspects of this type of accident.

Aspectos ético-legais da equipe de enfermagem em saúde do trabalhador: reflexões necessárias

This article had as objective to reflect on table II of the Official Resolution NR4 (OR), under the Law n. 7498/86 and the ethical-legal aspects of the insertion of nursing professionals in Brazilian companies. It is a descriptive and reflective study based upon the theoretical characteristics of the workers’ field which includes the description, analysis and comprehension of the established goals. The official sites of the Ministry of Work, of the Nursing Federal Advice, and the Occupational Nursing National Association were used as foundation of the research. The NR4 determines the rules of the Occupational and Security Health Services and the process of hiring auxiliary nurses without occupational nurse supervision is against the Law n. 7498/86. The reflections on this study may clarify some aspects of the illegal and unethical practices, as well as propose the professional councils a new way to monitor irregular institutions, in accordance to each experience.

Aspectos ético-legais do controle da infecção hospitalar: algumas reflexões relativas ao enfermeiro

Hospital infection is responsible for indirect and direct costs on the health system. Damages caused by the lack of personal productivity as well as those related to aspects such as pain, suffering and hospital infection sequels are variants that come from ethical-legal processes. This study aims at considering some reflections about the ethical-legal aspects in hospital infection control so as to provide safety to the nursing working process on what this subject is concerned.

O uso de equipamentos de proteção individual entre graduandos de cursos da área da saúde e a contribuição das instituições formadoras

Study accomplished with objective of verify handling and use’s indications of Personal Protective Equipment (PPE) and to identifying the contribution of the institutions for the students' formation on this theme. They participated in the study 777 graduated of the area of health in University of the State of Goiás – Brazil. The data were obtained through questionnaire observing the ethical-legal aspects. The obtained results reveal the fragility in the student's knowledge about handling and use’s indications in spite of most to affirm to use the PPE routinely in their practical activities. It was verified that several disciplines along the graduation approach the theme. However, in a punctual way, out of context and without coherence. And for a same PPE different indications and use forms were adopted. We identified fragility of the process teaching-learning in University as the knowledge’s construction on the use of PPE. It’s brings a relationship among the knowledge, the practice and the teaching of the same ones.

Ethical legal aspects in assisted reproductive technologies

Ethical legal aspects in assisted reproductive technologies

O PAPEL DAS INSTITUIÇÕES DE ENSINO SUPERIOR NA PREVENÇÃO DAS DOENÇAS IMUNOPREVENÍVEIS

ABSTRACT: This is a descriptive study peformed with the undergraduating students (last graded) in the health field. We aimed at characterizing the performance of the Higher Educational Institutions (HEI) in orientating such students concerning vaccination, immunepreventable diseases of high importance to heath care professionals (HCP), in Goias. A sample test was carried out using Epi-Info 2004 Software, n=651, which corresponds to 54,0% of the studied population, reliability interval of 95%. The ethical-legal aspects of the research were observed. Data was collected through questionnaire, shown in figures and tables, and assessed by descriptive statistics. Of the students, 92, 0% reported having been orientated towards vaccination. lnformation was obtained by the means of curricular subject in 32,3%, and the faculty directors accounting for 13,6% of reports. Vaccines which are known as recommended to such professionals are: anti-hepatitis B in 94,8%, anti-diphtheria and anti-tetanus in 77,3% of the citations. Although the HEI in Goias have been discussing such issue, they do that in a fragmented and little consistent way. KEY WORDS: Occupational Exposure; Occupational Health; Immunization.

Should Anencephalic Infants be Used as Organ Donors?

The frontiers of organ transplantation and its scientific and ethical-legal aspects have advanced to the arena of pediatrics. The technical advances bring with them the problem of organ procurement, with estimates that the discrepancy between supply and demand for pediatric organs will be even more pronounced than in adults. In partial response to this anticipated shortage, it has been proposed that newborns with anencephaly be used as organ donors. 1 In this article the essential elements of this proposal will be briefly described and some of the underlying ethical and legal controversies will be highlighted in the hope that pediatricians will be stimulated to participate with health lawyers, policymakers, and transplantation surgeons in the debate. MEDICAL ASPECTS Significant progress has been made in the transplantation of small organs and the use of immunosuppressive agents in growing children. 2 The prospect now exists that annually in the United States 300 to 450 children with end stage renal disease, 400 to 800 children with liver failure, and 400 to 600 children with complex congenital heart disease may be helped with organ transplantation. 1,3 The supply of usable organs may be limited by asphyxial damage related to the common causes of death in infants, however. Each year, approximately 1,800 babies are born in the United States with anencephaly. 4 Available data suggest that 25% to 45% are live born and at least 95% die within the first week. 5 Apart from their fatal neurologic malformation, their organs are presumed suitable for transplantation. 4 Moreover, prenatal α-fetoprotein and ultrasonographic screening can identify almost all anencephalics with a high level of certainty. 6