Modeling multiple sclerosis using mobile and wearable sensor data.

Multiple sclerosis (MS) is a neurological disease of the central nervous system that is the leading cause of non-traumatic disability in young adults. Clinical laboratory tests and neuroimaging studies are the standard methods to diagnose and monitor MS. However, due to infrequent clinic visits, it is fundamental to identify remote and frequent approaches for monitoring MS, which enable timely diagnosis, early access to treatment, and slowing down disease progression. In this work, we investigate the most reliable, clinically useful, and available features derived from mobile and wearable devices as well as their ability to distinguish people with MS (PwMS) from healthy controls, recognize MS disability and fatigue levels. To this end, we formalize clinical knowledge and derive behavioral markers to characterize MS. We evaluate our approach on a dataset we collected from 55 PwMS and 24 healthy controls for a total of 489 days conducted in free-living conditions. The dataset contains wearable sensor data - e.g., heart rate - collected using an arm-worn device, smartphone data - e.g., phone locks - collected through a mobile application, patient health records - e.g., MS type - obtained from the hospital, and self-reports - e.g., fatigue level - collected using validated questionnaires administered via the mobile application. Our results demonstrate the feasibility of using features derived from mobile and wearable sensors to monitor MS. Our findings open up opportunities for continuous monitoring of MS in free-living conditions and can be used to evaluate and guide the effectiveness of treatments, manage the disease, and identify participants for clinical trials.

Bioethics and advance directives in psychiatric in the hospital context / Bioética y directrices anticipadas en psiquiatría en el contexto hospitalario

Abstract Introduction Mental health services have been a focus of human rights advocates and recent legal reforms in some Latin American countries, which have called for a change from the paradigm of hospitalization to one of accompanying and supporting the person with mental health issues, which make it possible to apply the Advance Directives in Psychiatry (PADs). This change will require time, as well as economic, material, and human resources, and transformations in attitudes, culture, and society, but the implementation of PADs cannot be postponed: they must be used to protect the autonomy of the persons affected, within a bioethical framework. Objective Identify possible bioethical conditions in the prevailing conventional hospital context in Latin America that allow for an implementation of PADs. Method A participant-observer study was carried out in two psychiatric hospital services from June to September 2022. Results A thematic analysis found three themes: 1) clinical care, 2) patient predisposition, and 3) medical-legal questions. This study considered part of theme 2, including the following sub-themes: a) patient self-perception, b) biography/narrative versus diagnostic classification, and c) negotiation. Discussion and conclusion Prominent among the sub-themes discussed are recognition of the values of autonomy and its elements in all of the expressions of the person with mental illness, as well as actions of the physician or health care team in synergy with supported decision-making, a distinctive feature of the anticipatory process of the PAD.

Resumen Introducción La atención de la salud mental se ha visto emplazada por los Derechos Humanos y las recientes reformas legales en algunos países latinos, que instan a cambiar el paradigma asistencial de la hospitalización al del acompañamiento y apoyo en la toma de decisiones de la persona en condición mental, que posibilitan la aplicación de las Directrices Anticipadas en Psiquiatría (DAP). Este cambio implica tiempo, recursos económicos, materiales y humanos, transformaciones actitudinales, culturales y sociales. No obstante, la implementación de las DAP no puede postergarse, deben aplicarse basadas en el respeto a las personas en un marco bioético. Objetivo Identificar las condiciones bioéticas posibles en el contexto hospitalario convencional, imperante en los países de América Latina, que permitan la implementación de las DAP. Método Se llevó a cabo una observación participante en dos servicios de hospitalización psiquiátrica, entre junio y septiembre de 2022. Resultados A través de un análisis temático se obtuvieron tres temas: 1) atención clínica, 2) predisposición de los pacientes y 3) asuntos médicos-legales. Este estudio consideró sólo una parte del tema 2 con sus subtemas: a) Autopercepción de los pacientes, b) biografía/narrativa versus clasificación y c) negociación. Discusión y conclusión En los subtemas discutidos se resalta el reconocimiento a los valores de la autonomía y sus elementos presentes en todas las manifestaciones de la persona con enfermedad mental, se reconoce también el actuar del médico o equipo de salud en sinergia con la toma de decisiones apoyada, que distingue el proceso anticipatorio de las DAP.

Rethinking Benefits in Health Research, Reflections of an Ethics Committee.

The principle of beneficence in health research implies the effort of researchers to minimize risk to participants and maximize benefits to participants and society, which could be considered an abstract definition. Therefore, the benefits are not easily conceived by researchers who fail to achieve their goal, which is to privilege the well-being of participants. The purpose of this work was to describe and discuss the theoretical elements that support the principle of beneficence so that their knowledge allows designing and granting adequate benefits to participants. The present document defines the principle of beneficence. It also analyzes the maximization of benefits, the distinctions between different classifications of benefits, and the differentiation from compensations or incentives. With all this information, researchers must do a critical deliberation to select adequate benefits for participants of their studies, considering the type of study, potential participants, probability of risk, among others. These benefits should not be understood as a charity that researchers grant to the participant; they should be conceived as any form of action in favor of the well-being of participants. Participants must always be considered as moral agents, responsible for deciding whether the benefits would outweigh the possible negative unintended consequences of a particular study. Finally, no risk should be taken if it is not commensurate or proportional to the benefit of the research study.

Cognitive fatigability assessment test (cFAST): Development of a new instrument to assess cognitive fatigability and pilot study on its association to perceived fatigue in multiple sclerosis.

Background: Fatigue is a common symptom of many diseases, including multiple sclerosis. It manifests as a cognitive or physical condition. Fatigue is poorly understood, and effective therapies are missing. Furthermore, there is a lack of methods to measure fatigue objectively. Fatigability, the measurable decline in performance during a task, has been suggested as a complementary method to quantify fatigue. Objective: To develop a new and objective measurement of cognitive fatigability and investigate its association with perceived fatigue. Methods: We introduced the cognitive fatigability assessment test (cFAST), a novel smartphone-based test to quantify cognitive fatigability. Forty-two people with multiple sclerosis (23 fatigued and 19 non-fatigued, defined by the Fatigue Scale for Motor and Cognitive Functions) took part in our validation study. Patients completed cFAST twice. We used t-tests, Monte Carlo sampling, and area under the receiver operating characteristic curves to evaluate our approach using two sets of proposed metrics. Results: When classifying fatigue, our fatigability metric Δresponse time has a mean area under the receiver operating characteristic curve of 0.74 (95% CI 0.64-0.84), making it the best performing metric for this task. Furthermore, Δresponse time shows a statistically significant difference between the fatigued and non-fatigued groups (t = 2.27, P = .03). Particularly, cognitively-fatigued patients decline in performance, while non-fatigued patients do not. Conclusions: We introduce cFAST, a new instrument to quantify cognitive fatigability. Our pilot study provides evidence that cognitive fatigability assessment test produces a quantifiable drop in cognitive performance in a short period. Furthermore, our results indicate that cFAST may have the potential to serve as a surrogate for subjective cognitive fatigue. cFAST is significantly shorter than the existing fatigability assessments and does not require specialized equipment. Thus, it could enable frequent and remote monitoring, which could substantially aid clinicians in better understanding and treating fatigue.

Continuous monitoring with wearables in multiple sclerosis reveals an association of cardiac autonomic dysfunction with disease severity.

Background: Dysfunction of the autonomic nervous system is common in multiple sclerosis patients, and probably present years before diagnosis, but its role in the disease is poorly understood. Objectives: To study the autonomic nervous system in patients with multiple sclerosis using cardiac autonomic regulation measured with a wearable. Methods: In a two-week study, we present a method to standardize the measurement of heart rate variability using a wearable sensor that allows the investigation of circadian trends. Using this method, we investigate the relationship of cardiac autonomic dysfunction with clinical hallmarks and subjective burden of fatigue and autonomic symptoms. Results: In 55 patients with multiple sclerosis and 24 healthy age- and gender-matched controls, we assessed the cumulative circadian heart-rate variability trend of two weeks. The trend analysis revealed an effect of inflammation (P = 0.0490, SMD = -0.5466) and progressive neurodegeneration (P = 0.0016, SMD = 1.1491) on cardiac autonomic function. No association with subjective symptoms could be found. Conclusions: Trend-based heart rate variability measured with a wearable provides the opportunity for unobtrusive long-term assessment of autonomic functions in patients with multiple sclerosis. It revealed a general dysregulation in patients with multiple sclerosis.

The harmful effects of social research and the Universal Declaration on Bioethics and Human Rights: results of a national survey of social scientists in Mexico / Los efectos nocivos de la investigación social analizados con la Declaración Universal sobre Bioética y Derechos Humanos: resultados de una encuesta nacional a científicos en México

Risks and harms comprise a controversial topic in health sciences social research: they are minimised, denied, or not communicated to study participants. Article 4 of the UNESCO Universal Declaration on Bioethics and Human Rights stipulates the need to minimise harm, but this provision does not appear to refer directly to social sciences. Objectives: 1) to understand the harmful effects in social research; and 2) to describe the application of Article 4 to harm reduction in this field of research. Method: We conducted an internet-based survey with social research investigators, asking about their experience and opinions regarding ethical practices in social research studies. Results: Respondents indicated that harmful effects were considered in terms of the repercussions of certain actions and decisions of the investigator. Discussion: Social researchers observe Article 4, but this study questions aspects of the social and cultural context and their ethical repercussions (AU)

Los riesgos y daños de una investigación suele ser un tema discutido en la investigación social en salud, debido a que se llegan a minimizar, negar su existencia, o no comunicar a los participantes. La reducción de los efectos nocivos se estipula en el artículo 4 de la Declaración Universal sobre Bioética y Derechos Humanos, pero esta referencia parece no aludir directamente a las ciencias sociales.Objetivos 1) comprender los efectos nocivos derivados de la investigación social y 2) describir la aplicación del artículo 4 de la Declaración, específicamente en la reducción de los efectos nocivos en los participantes en este campo de la ciencia. Método. Aplicamos una encuesta a investigadores sociales, quienes respondieron un cuestionario electrónico que indagaba la opinión y experiencia en algunas de las prácticas éticas en los estudios sociales. Resultados. Indican que los efectos nocivos se plantean como probabilidad de repercusiones de ciertas acciones y decisiones del investigador; confirma riesgos como el mal uso y/o la manipulación de la información, la generación de falsas expectativas en los participantes, la invasión de sus espacios y de su intimidad. Los daños fueron la revelación de la identidad, la violación de los derechos y la generación de estigma y prejuicios; aporta otro tipo de efectos nocivos como los intereses propios del investigador o de su institución. Discusión. Los investigadores sociales sí aplican el artículo 4 de la Declaración, sin embargo, se cuestionan una serie de aspectos del contexto social y cultural implicado en las repercusiones éticas (AU)

Els riscos i danys d'una recerca sol ser un tema discutit en la recerca social en salut, pel fet que s'arriben a minimitzar, negar la seva existència, o no comunicar als participants. La reducció dels efectes nocius s'estipula en l'article 4 de la Declaració Universal sobre Bioètica i Drets Humans, però aquesta referència sembla no al·ludir directament a les ciències socials. Objectius. 1) comprendre els efectes nocius derivats de la recerca social i 2) descriure l'aplicació de l'article 4 de la Declaració, específicament en la reducció dels efectes nocius en els participants en aquest camp de la ciència. Mètode. Apliquem una enquesta a investigadors socials, els qui van respondre un qüestionari electrònic que indagava l'opinió i experiència en algunes de les pràctiques ètiques en els estudis socials. Resultats. Indiquen que els efectes nocius es plantegen com a probabilitat de repercussions de certes accions i decisions de l'investigador; confirma riscos com el mal ús i/o la manipulació de la informació, la generació de falses expectatives en els participants, la invasió dels seus espais i de la seva intimitat. Els danys van ser la revelació de la identitat, la violació dels drets i la generació d'estigma i prejudicis; aporta un altre tipus d'efectes nocius com els interessos propis de l'investigador o de la seva institució (AU)

Regulation and self-regulation of ethical practices in scientific publication / Regulación y autorregulación de las prácticas éticas en la publicación científica

Abstract Introduction The process of publication is influenced by a pressure on researchers to demonstrate their competence and productivity by publishing large numbers of articles in indexed journals. But there is a great deal of ignorance regarding the ethical obligations in scientific publication; worse, ethical considerations are often seen as mere formalities in the process of publishing an article. Objective This article discusses the ethical practices related to the publication of a scientific article. It encompasses those defined by forms of external regulation and those that might be identified as forms of self-regulation, and it argues for the greater effectiveness of the latter in scientific publication. Method We performed a literature review and a critical analysis of the information. Results There are negative factors that range from plagiarism and the duplication of articles to the fabrication and falsification of data. Researchers look for convenient solutions, taking refuge in practices condoned, paradoxically, by the very scientific community that condemns them. Rather than avoiding these forms of misconduct, the scientific community even justifies them at times, which means that the practices continue. Discussion and conclusion Self-regulation in scientific publication is a preferable goal: it allows participants in the process to assume their obligations freely and with a greater sense of responsibility.

Resumen Introducción Resulta necesario reconocer que el proceso de publicación está influenciado por factores como la presión institucional que se ejerce sobre los investigadores para que publiquen mayor cantidad de artículos en revistas indexadas, lo cual se usa como parámetro de productividad y capacidad. Pero existe un desconocimiento amplio en relación con las obligaciones éticas de la publicación o, peor aún, muchas veces la ética es vista como mero requisito para la aceptación y publicación de un artículo. Objetivo Este trabajo expone las prácticas éticas implicadas en el proceso de publicación de un texto científico, tanto las que se consideran actualmente regulación externa como aquellas que podrían ser identificadas como autorregulativas, a fin de que éstas últimas puedan imperar dentro de las publicaciones. Método Se realizó una revisión de la literatura sobre la materia y un análisis crítico sobre la información. Resultados Existen efectos negativos que van desde la duplicación de artículos y el plagio hasta la fabricación o falsificación de datos. Incluso, se ha buscado una solución cómoda ante las reglas impuestas por la ética de la publicación, pero algunos investigadores han encontrado amparo en prácticas consensuadas dentro de la propia comunidad científica que, paradójicamente, las condena, y a pesar de ello no evita las vejaciones, incluso las llega a "justificar", por lo que siguen presentándose. Discusión y conclusión La autorregulación debería ser razón suficiente para asumir las obligaciones libremente y con mayor responsabilidad dentro del ámbito de la publicación científica.

Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

Elementos circundantes a los comités de ética que dificultan su razonamiento deliberativo / Elementos circundantes aos comitês de ética que dificultam a sua fundamentação deliberativa / Elements surrounding the ethics committees that hinder their deliberative reasoning

Los comités de ética se encuentran entre las manifestaciones más visibles de la bioética. La aceptación que han recibido estas instancias en los últimos años ha sido amplia, pero poco se puede decir acerca de sus funciones y sus metas, principalmente porque se ha rezagado el estudio del trabajo al interior de los comités. El objetivo de este manuscrito es analizar los elementos circunscritos al proceso interno de los comités de ética que están dificultando su razonamiento deliberativo. Elementos como la ausencia de deliberación desde el saber ético, la tensión entre el marco ético y el legal, las particularidades del campo de la salud dentro del discernimiento ético y la consideración de los comités como grupos, deben reconocerse y discutirse en forma permanente y crítica como trabajo autorregulativo de los comités para, de esta manera, conseguir el consenso social e institucional.

Ethics committees are among the most visible manifestations of bioethics. The acceptance these instances have received in recent years has been extensive, but little can be said about their roles and goals, mainly because the analysis of what happens inside the committees has been lagged behind. The aim of this paper is to analyze the elements involved in the inner processes of ethical committees, which are complicating their deliberative reasoning. Elements such as the absence of deliberation from ethical knowledge, the tension between the ethical and legal frameworks, the particularities of the health care field within ethical discernment and the consideration of committees as groups should be permanently and critically recognized and discussed, as self-regulatory work by committees, in order to achieve social and institutional consensus.

Os comitês de ética se encontram entre as manifestações mais visíveis da bioética. A aceitação que tiveram estas instâncias nos últimos anos foi ampla, porém pouco se pode dizer acerca de suas funções e metas, principalmente porque se tem postergado o estudo do trabalho no interior dos comitês. O objetivo deste manuscrito é analisar os elementos circunscritos ao processo interno dos comitês de ética que estão dificultando a sua fundamentação deliberativa. Elementos como a ausência de deliberação a partir do saber ético, a tensão entre o marco ético e o legal, as particularidades do campo da saúde dentro do discernimento ético e a consideração dos comitês como grupos, devem ser reconhecidos e discutidos de forma permanente e crítica como trabalho autorregulativo dos comitês para, desta maneira, conseguir o consenso social e institucional.

Experiencias sobre el impacto del Programa de Formación en Ética de la Investigación Biomédica y Psicosocial en el ámbito de la salud mental y la investigación conductual.

El propósito de este trabajo es presentar el impacto y la integración que los conocimientos adquiridos en el Programa Internacional de Formación en Ética de la Investigación Biomédica y Psicosocial de la Universidad de Chile han tenido en mi experiencia profesional, en el ámbito de la investigación psicosocial en un Instituto de Salud de México. Para este objetivo, expondré tres áreas en las cuales se ha podido evidenciar tal impacto: trabajo en los comités de ética, desarrollo de programas de académicos en bioética e investigación y publicación sobre ética y bioética. El motivo que me llevó a incursionar en el Programa fue que su enseñanza vincula la investigación psicosocial con la ética y la bioética, lo cual me permitió dirigir este tipo de reflexión hacia problemas como violencia, suicidio, adicciones, depresión y salud mental, y a nuevos campos como los estudios comunitarios, con poblaciones en riesgo o vulnerables, en los cuales las diversas implicaciones son difíciles de indagar.

Experiencias sobre el impacto del Programa de Formación en Ética de la Investigación Biomédica y Psicosocial en el ámbito de la salud mental y la investigación conductual / Experiências sobre o impacto do Programa de Formação em Ética da Pesquisa Biomédica e Psicossocial no âmbito da saúde mental e pesquisa comportamental / Experiences about the impact of the Ethics of Biomedical and Psychosocial Research Training Program in mental health and behavioral research field

El propósito de este trabajo es presentar el impacto y la integración que los conocimientos adquiridos en el Programa Internacional de Formación en Ética de la Investigación Biomédica y Psicosocial de la Universidad de Chile han tenido en mi experiencia profesional, en el ámbito de la investigación psicosocial en un Instituto de Salud de México. Para este objetivo, expondré tres áreas en las cuales se ha podido evidenciar tal impacto: trabajo en los comités de ética, desarrollo de programas de académicos en bioética e investigación y publicación sobre ética y bioética. El motivo que me llevó a incursionar en el Programa fue que su enseñanza vincula la investigación psicosocial con la ética y la bioética, lo cual me permitió dirigir este tipo de reflexión hacia problemas como violencia, suicidio, adicciones, depresión y salud mental, y a nuevos campos como los estudios comunitarios, con poblaciones en riesgo o vulnerables, en los cuales las diversas implicaciones son difíciles de indagar.

The purpose of this article is to present the impact and the integration of knowledge acquired in the international ethics of biomedical and psychosocial research training program of the University of Chile has had in my professional experience in the field of psychosocial research at a Mental Health Institute in Mexico. With this purpose, I will develop three areas of clear impact: participation in scientific ethical review committees, development of academic programs in bioethics and research and publication on ethics and bioethics. My motivation to enter in the program was that this training links psychosocial research with ethics and bioethics, which allows me to apply this type of reflection to problems such as violence, suicide, addictions, depression and mental health, and new fields such as community studies with vulnerable or at risk populations, in which the diverse implications are difficult to inquire.

O propósito deste trabalho é apresentar o impacto e a integração que os conhecimentos adquiridos no Programa Internacional de Formação em Ética da Pesquisa Biomédica e Psicossocial da Universidade do Chile tiveram em minha experiência profissional no âmbito da pesquisa psicossocial no Instituto de Saúde do México. Para este objetivo, mostrarei três áreas nas quais foi possível evidenciar tal impacto: trabalho nos comitês de ética, desenvolvimento de programas acadêmicos em bioética e pesquisa e publicação sobre ética e bioética. O motivo que me levou a incursionar no Programa foi que o seu aprendizado vincula a pesquisa psicossocial com a ética e a bioética, o que me permitiu dirigir este tipo de reflexão para problemas como violência, suicídio, toxicofilias, depressão e saúde mental, e a novos campos como os estudos comunitários com populações em risco ou vulneráveis, nas quais as diversas implicações são difíceis de indagar.

[Informed consent: a dialogic praxis for the research]. / Consentimiento informado: una praxis dialógica para la investigación.

The informed consent is a process in which a person agrees to participate in a research, knowing the risks, benefits, problems or consequences that may arise during developing it. The aim of this study is to collect the characteristics of the informed consent process (ICP) so its understanding and compliance allow an ethical dialog, thoughtful and responsible exercise for the researcher. We present the results of an extensive review of the ICP elements from its components to their legal and ethical foundation, including the myths and realities that exist about the format of informed consent as a legal protection. The informed consent is not an established format that researchers reproduce in their research, but its praxis is a daily task in the research with human subjects as critical, deliberative, and committed communication between two moral agents: the researcher and the researched one.

Consideraciones éticas en intervenciones comunitarias: la pertinencia del consentimiento informado / Ethical considerations in community interventions: the pertinence of informed consent

Ethics, understood as the study of moral norms in terms of its assumptions, origins, and changes over time, systematizes similarities and differences between various moral codes. It therefore serves as a meeting point between different perspectives, through dialogue, a fundamental characteristic of this discipline. One of its derivations, as applied ethics, is bioethics, defined by Van Rensselaer Potter as "New knowledge that provides knowledge on how to use knowledge for the good of society". Although bioethics emerged in the 1970s under the imperative of medical discourse, its development as a discipline reflecting human behavior surrounding health has permitted the combination of various types of knowledge, including the contribution of social sciences in this field. Thus bioethics deals with the dilemmas that may arise in social studies on health (such as addictions, violence and migrations). The aims of this manuscript are to systematize and explain some of the implications of the pertinence and adaptation of informed consent (IC) in a bi-national Mexico-United States study on mental health and migration. It also provides elements of analysis for the detection of ethical dilemmas in these community interventions in mental health in Mexico. It therefore attempts to answer the following questions: Within the context of bi-national research, how does one deal with the principle of autonomy and the notion of "voluntariness" included in the requirement of informed consent, in public mental health interventions in Mexican rural communities? Is it possible to respect the way participants in the host country make decisions while at the same time, meeting the demands of the ethics committee of the sponsor country? In order to arrive at the elements of analysis, the authors briefly explain the conceptualization of the terms ethics and bioethics, and explore some of the postulates put forward in both North American (principalism and casuism) ...

A pesar de que la bioética surge en la década de 1970, bajo el imperativo del discurso biomédico, su desarrollo como disciplina que reflexiona sobre el comportamiento humano en torno a la salud ha permitido la reunión de varios saberes, entre ellos, la aportación de las ciencias sociales en dicho campo. De esta forma, la bioética se ocupa de los dilemas que pueden presentarse en los estudios sociales sobre salud (adicciones, violencia, migraciones), incluso en aquellos que, por cuestiones de interés común, son de tipo binacional o multicéntrico. Los objetivos de este artículo son sistematizar y exponer algunas implicaciones de la pertinencia y adecuación del consentimiento informado (CI) en un estudio binacional México-Estados Unidos sobre salud mental y migración. Además, se aportan elementos de análisis para la detección de dilemas éticos en estas intervenciones comunitarias en salud mental en México. De esta forma, se intenta responder a las siguientes preguntas: En el contexto de una investigación binacional, ¿cómo encarar el principio de autonomía y la noción de "voluntariedad", insertos en el requerimiento de un consentimiento informado, en intervenciones de salud mental pública en comunidades rurales mexicanas? ¿Es posible respetar la manera en que los participantes del país anfitrión toman decisiones y cubrir, al mismo tiempo, las exigencias del comité de ética del país patrocinador? Para allegarse los elementos de análisis, se expone someramente la conceptualización de los vocablos ética y bioética, y se abordan algunos postulados planteados tanto de la bioética norteamericana como de la europea, además de aproximarnos a otras posturas bioéticas. Por otro lado, se revisan los principales aportes de los diversos códigos, declaraciones e informes internacionales, incluidas las recomendaciones de la Comisión Nacional de Bioética de México, que norman el proceso del consentimiento informado (CI) en investigación social. El CI es un "proceso social que, a través de un intercambio activo y respetuoso, brinda información sobre la investigación en forma comprensible para el sujeto, permite cerciorarse de que la entienda y tenga opción de preguntar y recibir respuestas a sus dudas, brinde oportunidad para negarse a participar o manifestar voluntad de colaborar y pueda expresarla oralmente o firmar un formulario, sin haber sido sometido a coerción, intimidación ni a influencias o incentivos indebidos". En este sentido, el proceso de consentimiento informado (PCI) protege la libertad de elección del individuo y el respeto de su autonomía. Por ello, también se debe considerar el contexto de desarrollo de grupos culturales diversos al del investigador, sus tradiciones en cuanto a comunicación y decisión, y se deben respetar estos procedimientos. En la investigación social, como en ninguna otra, la puesta en práctica de la normatividad del PCI es muy variada, debido a que se trabaja con sectores dispuestos a participar (prostitutas, usuarios de drogas, primo-delincuentes, etc.) a condición de no firmar ningún consentimiento escrito, lo que otorga prioridad a la calidad de la relación establecida y no sólo al formato. Este documento expone la reflexión sobre algunos dilemas éticos que se presentaron durante una investigación social cuyo objetivo fue identificar los malestares emocionales asociados a la migración internacional México-EUA y la utilización de servicios de salud mental. Específicamente, el análisis ético se centra en la información recabada en el trabajo de campo por medio de la técnica observación participante, en una comunidad rural en el estado de Michoacán.

Ética de la investigación psicosocial

resumen está disponible en el texto completo

Summary: The aim of this manuscript is to open up a space for thinking about and debating the issue of ethics in psychosocial research. The ethics of research is put forward in order to identify, deliberate and to a certain extent mitigate the dilemmas arising during the process of generating knowledge. In research, the main questioning focuses on how to behave ethically at the various stages of research, in one's relationships with other scientists and in considering the social responsibility of science. The ethics of research in human beings becomes important when one admits that all kinds of studies contain dilemmas that constitute risks for those that participate in it. However, not all research in human beings is the same; the risks and benefits of biomedical experimentation differ from those that arise in studies in the psychosocial area. Social science research, including psychosocial research, generally entails emotional risks that may trigger mental health disorders and social risks, such as the discrimination or stigmatization of the subjects involved. The ethical dilemmas of social studies are different because they are conceived of in a morally heterogeneous context; in the relativist essence of social sciences; in the canons of scientific objectivity and methodological rigor; in the primacy of subjectivity and the recognition of otherness; in the processes of individuation and the social order; in historicity and culture; in the exercise of power and in the will to know. In other words, in the elements those represent and are inherent to social research. In general, these conflicts are expressed when researchers begin to wonder what to prioritize at the moment of choosing a research issue and the way the latter is undertaken. They also arise over the issue of what to publish and when considering the importance of the problem for the community, mainly at the time of giving back the information to those that participated in the study. As a result of the above, first must be questioned both the design of the work, the method and techniques to be used in achieving objectives and the impact of the study for the scientific and social community. The latter is crucial, since it determines whether or not social intervention policies that are important in people's lives can be implemented. The dissemination of information has often been an issue of great interest and ethical debate, since it involves confidentiality as well as the need for publication and the dissemination of results. In this respect, intellectual honesty and the guarantee that the results of the study will be properly used by researcher are crucial. It is therefore essential to take ethical reflection to other fields of action, where the different ethical implications are difficult to deal with, such as community studies, at-risk or minority populations, as well as the various research methods, such as the qualitative approach. At the same time, ethical problems encountered by social researchers tend to be avoided, perhaps because they are not interpreted as such or because, in the majority of cases, they can be regarded as mistakes or deficiencies by the researcher himself, who is not prepared to reveal them to the scientific community or perhaps because the recognition of a dilemma may influence the acceptance of a research project. Thus social scientists usually only recognize those displayed in biomedical experimentation as ethical dilemmas and therefore do not subject themselves to the ethical codes of these disciplines. It may also be because psychosocial research should not really have to apply ethical standards applied in other disciplines, whose object of study is different from that of social sciences. If it did so, it would be a non-reflexive way of understanding the construction of knowledge derived from social research. On the contrary, the ethics of psychosocial research attempts to problematize and generate reflection and interpretation, from the epistemological and ontological consistency characteristic of the social disciplines, where the ethical conflicts represented in everyday practices are obviated and become unquestionable in research, which is why one has to rethink the responsibility and commitment involved in social science. Thus, psychosocial research should propose its own ethical requirements, without having to make declarations or establishing principles that end up as ethical codes. The point is not to establish norms for the critical behavior of researchers or to recommend universal ethical guidelines. The point is for ethical requirements to arise from the inherent needs of social research, through constant dialog and consensus, the recognition of the ethical dilemmas that emerge and the critical work conducted in this area. The point is to provide rather than establish knowledge, skills and abilities in the interaction with people, to understand the duties of professionals and the rights of participants and to develop the sensitivity to be able to recognize the different cultural nuances, the expressions of group diversity and the vulnerability of the human condition. Unless the issue is examined in depth, ethics in the social field will be threatened by an ethical imperialism that imposes unilateral evaluation criteria on psychosocial research. It would be an ethics whose requirements would become excessively bureaucratic and complied with solely for the purpose of obtaining grants for research. At present, ethical concerns are only entrusted to institutions (Ethical committees) or financing organizations, whether national or foreign, since researchers regard them merely as an imposition that happens to be in vogue, rather than assuming that they are the ones that have the capacity and sensitivity, based on their experience, to identify and mitigate ethical dilemmas. This shows the importance of ensuring that researchers accept the rigorous, ethical review of their work during the entire research process, even at the time of the publication and presentation of results. Hence the need for an ethics committee, whose dialogic function operates with a variety of visions and opinions, that do not prevent debate and instead promote reflection, and which is far removed from belief, intuition, dogma, doctrine and fundamentalism, which would hamper dialog and tolerance and the creation of a space where moral and above all, ethical responsibility should prevail. Ethical dilemmas are inherent to psycho-social research, which is why the main challenge would be to ensure respect for autonomy, bearing in mind the fact that informed consent must be voluntary, individual and/or collective, verbal or written, but above all, a process that only ends after research has been completed. At the same time, researchers must protect the confidentiality, privacy and common good of those being researched, and avoid damage, discrimination and stigmatization. In short, efforts must be made to maximize benefits, in other words, to protect the rights and well-being of research subjects. In psychosocial research, one is ethically obliged to problematize and critically reflect on one's work and the way one behaves, in other words, one's ethos as researchers, with responsibility and moral commitment towards those being researched.

Self-esteem, depressive symptomatology, and suicidal ideation in adolescents: results of three studies / Autoestima, sintomatología depresiva e ideación suicida en adolescentes: resultados de tres estudios

Summary: Suicidal behavior has different levels: ideation, contemplation, planning and preparation, attempt, and consummation. Likewise, suicidal behavior comprises all the actions aimed at achieving suicide. During adolescence there is a tendency to a reduction of emotional well-being. Thus, adolescents may engage in dangerous behavior, extreme narcissism and individualization, exclusion and social isolation. Another element playing an important role during adolescence is self-esteem. Low self-esteem could lead to apathy, isolation, and passivity. Conversely, high self-esteem is associated with more active lives, a greater control over circumstances, less anxiety and greater capacity to cope with internal and external stress. Although there are other factors that could predispose adolescents towards suicidal behavior, certain studies have identified depressive symptomatology as the most powerful and independent risk factor in suicidal ideation and it has been argued that it should be regarded as an expression of severe depression. The purpose of this study is to explore the existence of a relationship between low self-esteem and depressive symptomatology with suicidal ideation and to explore if gender has an effect in this interaction. Data were obtained from three different samples of Mexican adolescent students. The instruments used were the Rosenberg Self-Esteem Scale, the CES-D, and the Roberts Suicidal Ideation Scale. Women showed a higher frequency of low self-esteem than men in two studies. In another, men had a significantly higher frequency of low self-esteem. Regarding depressive symptomatology, women obtained higher scores than men. No significant differences were found in one study. The percentages of high suicidal ideation displayed greater variability by gender and by study. Among the subjects who reported high suicide ideation, a greater proportion of women tended to have low self-esteem, though these differences were not significant in any study. Over half of the women in each study reported higher suicidal ideation and depressive symptomatology than men, with significant differences only among junior high students in two studies. The exploration of the link between depressive symptomatology and high suicidal ideation showed significant differences by gender, a finding which might be linked to the fact that women are more allowed to express their depressive or fatalistic feelings and thoughts or death wishes, whereas among men this type of ideas are perceived as a sign of weakness. Gender-related differences in low self-esteem were only found in one study; men had a higher percentage than women. The comparison of low self-esteem in subjects with high suicidal ideation did not reveal any statistical difference by gender, despite it has been identified as a risk factor for suicidal behavior. In the other hand, results of depressive symptomatology concurred with international literature about this being a determinant factor in the presence of suicidal ideation in women. Considering the objective of this study, three main conclusions can be suggested. First, low self-esteem is not significantly linked to suicidal ideation, perhaps because it is a risk factor more associated with suicidal behavior. Second, depressive symptomatology was related to suicidal ideation, and although this relationship and the one between depressive symptomatology and self-esteem have been reported before, it is important to note that there seems to be a domino effect among these problems. This effect could begin with depressive symptoms linked to suicidal ideation, which in turn could affect self-esteem, and subsequently trigger suicidal behavior. And third, differences between men and women raise the question of whether these are caused by intrinsic characteristics in a biological-genetic substrate inherent to each gender or whether they are determined by the cultural context and the formative patterns existing in the groups to which the subjects belong.

Resumen: El problema del suicidio ha cobrado mayor relevancia en años recientes. Esto se debe a la magnitud que ha alcanzado. El suicidio tiene un carácter multifactorial, es complejo, dinámico y creciente en nuestro país. A su vez, la autoestima baja y el malestar depresivo se han vinculado con la conducta suicida en la adolescencia; los individuos vulnerables enfrentados a factores estresantes o que implican riesgo pueden llegar a presentar ideación o alguna conducta suicida. El malestar depresivo se ha identificado como el factor de riesgo más importante para la ideación suicida. Esta se presenta de manera diferente en hombres y en mujeres, por lo que se cree que su impacto está matizado por las características de los roles de género. El propósito de este estudio es explorar si la autoestima baja y la sintomatología depresiva se relacionan con la ideación suicida, y si el sexo surte un efecto sobre esta interacción. Los datos se obtuvieron de tres estudios con adolescentes estudiantes mexicanos. En el primero (secundaria, 1992-1993, Delegación Tlalpan), se utilizó un muestreo no probabilístico. La muestra incluyó a 423 adolescentes (56% hombres y 44% mujeres, con una media de edad de 13.86±1.2 años). En el segundo (secundaria y bachillerato, 1996-1997, Delegación Coyoacán) participaron 816 adolescentes: 406 de secundaria (49% hombres y 51% mujeres, con una media de edad de 13.27±1.1 años), y 410 de bachillerato (51% hombres y 49% mujeres, con una media de edad de 17±4.3 años). El muestreo fue no probabilístico. El tercero (secundaria, 1998-1999, Centro Histórico) incluyó a 936 estudiantes (54% hombres y 46% mujeres, con una media de edad de 13.7±1.8 años). El muestreo fue no probabilístico. Los tres estudios fueron transversales. El instrumento incluyó la Escala de Autoestima de Rosenberg, la CES-D y la Escala de Ideación Suicida de Roberts. Se calcularon los puntos de corte para cada escala por sexo para identificar a los sujetos con baja autoestima, sintomatología depresiva e ideación suicida alta. En dos estudios, las mujeres alcanzaron frecuencias más altas de autoestima baja, aunque las diferencias no fueron significativas. En el de 1999, los hombres tuvieron una frecuencia de autoestima baja significativamente más elevada que las mujeres. A su vez éstas alcanzaron puntajes significativamente más altos de sintomatología depresiva en los estudios de 1996 y 1999. En el caso de la ideación suicida, sólo hubo diferencias significativas en el estudio de 1999. Las mujeres con ideación suicida mostraron porcentajes más elevados de autoestima baja (diferencia no significativa) y de sintomatología depresiva (con diferencias significativas en los estudios de 1996 y 1999) que los hombres. La comparación de autoestima baja en los sujetos con ideación suicida no reveló diferencias significativas por sexo, a pesar de que éste se ha identificado como un factor de riesgo importante para la conducta suicida. Por otro lado, los resultados de sintomatología depresiva coinciden con lo reportado a nivel internacional en el sentido de considerar el sexo como un elemento determinante para la presencia de ideación suicida en las mujeres. Teniendo en consideración el objetivo de este trabajo, se pueden señalar tres conclusiones: la autoestima baja no se asoció significativamente con la ideación suicida; esto se puede deber a que ésta es un factor de riesgo más relacionado con la conducta. Asimismo, la sintomatología depresiva se asoció con la ideación suicida, y aunque ésta y la que se da entre la sintomatología y la autoestima ya se han reportado, es importante señalar que parece haber un efecto en cadena entre estas problemáticas. Este efecto se originaría en los síntomas depresivos ligados con la ideación suicida, la cual puede afectar a la autoestima y ésta, a su vez, dispararía la conducta suicida. Finalmente, las diferencias entre hombres y mujeres dejan abierto el debate sobre si éstas se originan en factores biológicos inherentes al sexo o si están determinadas por los patrones de formación influidos por su parte por elementos contextuales caracterizados culturalmente.

Outpatient cleft lip repair.

The emphasis on cost reduction and increased efficiency in health care delivery has prompted an increase in outpatient (ambulatory) surgical procedures. A retrospective review of the perioperative management of patients undergoing cleft lip repair at two urban tertiary pediatric hospitals was performed to assess the safety of outpatient cleft lip repair. The hospital database at Childrens Hospital Los Angeles was searched to find all patients who had been operated on for cleft lip repair during calendar years 1999 and 2000. Two groups were identified from Childrens Hospital Los Angeles: the outpatient cleft lip repair group (patients discharged the same day as the operation; n = 91) and the inpatient cleft lip repair group (n = 14). A data set was acquired from the Royal Children's Hospital in Melbourne, Australia, using the same criteria, for fiscal years 1998 to 2000 (n = 50). All patients from Royal Children's Hospital had operations as inpatients. Parameters considered for each group were age, sex, race, ethnicity, length of hospital stay, preexisting medical conditions or diagnoses, complications, and readmissions or presentation to the emergency department within 4 weeks of operation. The Childrens Hospital Los Angeles outpatient group had three readmissions that were considered to be complications of the operation. The Childrens Hospital Los Angeles inpatient group had one readmission attributable to a complication. The Royal Children's Hospital group also had one readmission for a complication. There was no significant difference in the complication rate of the Childrens Hospital Los Angeles outpatient group and the Royal Children's Hospital group (p > 0.05). There was also no significant difference in the complication rate of both of the Childrens Hospital Los Angeles groups compared with the Royal Children's Hospital group (p > 0.05). This study indicates that cleft lip repair performed in an outpatient setting may be a safe alternative to the inpatient operation. Certain preexisting medical conditions, however, may dictate the need for inpatient hospitalization after repair.