Necesidad de información preoperatoria en pacientes intervenidos en el servicio de otorrinolaringología / Need for preoperative information in patients undergoing surgery in the Otorhinolaryngology Department

Resumen Objetivo: determinar las necesidades de información en el preoperatorio de los pacientes atendidos en el servicio de otorrinolaringología del Hospital Nacional Arzobispo Loayza de Lima, Perú. Métodos: investigación de tipo descriptiva y de corte transversal. Se estudiaron 127 pacientes quirúrgicos del servicio de otorrinolaringología. Se utilizó un cuestionario de demandas de información y conocimiento de los pacientes en cuanto a su derecho de decidir una cirugía; contiene preguntas referentes a la descripción de la técnica quirúrgica, complicaciones y riesgos que conlleva la cirugía. Se utilizó una muestra no probabilística por conveniencia, así como el análisis de los datos, el cual se realizó con el paquete estadístico SPSS en versión 25. Para evaluar la correlación entre variables se empleó la prueba chi-cuadrado. Resultados: participaron 127 pacientes, más de 75% de ellos deseaban conocer más información sobre su enfermedad y el tratamiento quirúrgico, 90% manifestaron el deseo de tener una explicación de cómo se realizará la cirugía, 85% necesitaban conocer las complicaciones frecuentes, 20% deseaba ignorar la información sobre posibilidad de muerte. Los adultos jóvenes y el grupo con educación superior demandaban más información (p<0.05), no presentaron diferencias respecto al sexo, salvo en la necesidad de conocer el riesgo de muerte a causa de la cirugía, a favor del sexo femenino (p<0,05). Conclusiones: la mayoría de los pacientes necesitan una información detallada durante la evaluación preoperatoria, principalmente en los grupos de adultos jóvenes y con educación superior. Los médicos debemos brindar información suficiente, clara y con expectativas reales, respetando la autonomía del paciente en la toma de decisiones.

Abstract Aim: To determine the informational needs of preoperative patients being attended at the Otorhinolaryngology Service of the Hospital Nacional Arzobispo Loayza of Lima, Peru. Methods: Using cross-sectional descriptive research, 127 surgical patients from the Otorhinolaryngology Service were studied. A questionnaire asked what information and knowledge the patients had when exercising their right to decide surgery. It contained questions concerning the description of the surgical technique, complications, and risks involved in the surgery. A non probability sample by convenience was used and the data analysis was performed with the SPSS statistical package in version 25 and the chisquare test was used to evaluate the correlation between variables. Results: 127 patients participated, more than 75% of patients wanted to know more information about their disease and the surgical treatment, 90% stated that they needed an explanation of how the surgery would be performed, 85% wanted to know the common complications, and 20% wanted to ignore the possibility of death. Young adults and the group with higher education demanded more information (p<0.05). Concerning sex, there were no differences between the men and women in their answers other than the females needing to know the risk of death due to surgery (p<0.05). Conclusions: Most patients need detailed information during the preoperative evaluation, especially young adults and those with higher education. Physicians should provide sufficient, clear information with realistic expectations, respecting the patient's autonomy in decision-making.

Analysis of the influence of clinical and demographic factors on the understanding of cataract informed consent / Análisis de la influencia de factores clínicos y demográficos en la comprensión del consentimiento informado de cataratas / Análise da influência de fatores clínicos e demográficos na compreensão do consentimento informado para cirurgia de catarata

PURPOSE: To estimate the influence of clinical and demographical information in the understanding of cataract surgery informed consent, identifying less understandable areas. To assess informed consent document concept. METHODS: Multiple-choice questionnaire was designed to collect information and to evaluate the understanding of cataract surgery and informed consent. An ordinary regression model was adjusted to express the effect of clinical and demographic variables to the questionnaire score. RESULTS: The study comprised 180 patients. Sex (female, p=0.404), non-ophthalmologist source of information (p=0.397), previous surgical history (p=0.571), not having a companion (p=0.396) nor the days since the signing of informed consent form (p=0.535) had no influence in the understanding of cataract surgery informed consent. Age (r=-0.083, p<0.001) and educational level (secondary studies r=1.845, p<0.001; tertiary studies r=4.289, p<0.001) showed statistical significance with greater strength of association educational level (OR secondary studies = 6.33, OR tertiary studies = 72.86) than age had (OR = 0.92). CONCLUSION: Patient's knowledge about cataract informed consent is influenced by age and educational level. The purpose and the risks, consequences of not performing surgery and postoperative indications are the least understood topics. Informed consent is seen as a forced legal obligation.

OBJETIVOS: estimar la influencia de la información clínica y demográfica en la comprensión del consentimiento informado de la cirugía de cataratas, identificando áreas menos comprensibles. Evaluar el concepto de "documento de consentimiento informad". MÉTODOS: el cuestionario de opción múltiple se diseñó para reunir información y evaluar la comprensión de la cirugía de cataratas y el consentimiento informado. Se ajustó un modelo de regresión ordinario para expresar el efecto de las variables clínicas y demográficas en la puntuación del cuestionario. RESULTADOS: El estudio abarcó 180 pacientes. Sexo (femenino, p = 0.404); fuente de información no oftalmológica (p = 0.397); historial quirúrgico previo (p = 0.571); no tener acompañante (p = 0.396), y los días desde la firma del formulario de consentimiento informado (p = 0,535), que no tuvo influencia en la comprensión del consentimiento informado en la cirugía de cataratas. La edad (r = -0.083, p <0.001) y el nivel educativo (estudios secundarios r = 1.845, p <0.001; estudios terciarios r = 4.289, p <0.001) mostraron significación estadística con una mayor fuerza del nivel educativo de asociación (OR estudios secundarios = 6.33, OR estudios terciarios = 72.86) que la edad (OR = 0.92). CONCLUSIÓN: El conocimiento del paciente sobre el consentimiento informado en cirugía de cataratas está influenciado por la edad y el nivel educativo. Los temas menos entendidos son el propósito y los riesgos, las consecuencias de no realizar la cirugía y las indicaciones postoperatorias. El consentimiento informado se considera una obligación legal forzada.

OBJETIVO: Estimar a influência de informações clínicas e demográficas na compreensão do consentimento informado para cirurgia de catarata, identificando áreas menos compreensíveis. Avaliar o conceito do documento de consentimento informado. MÉTODOS: Um questionário de múltipla escolha foi desenvolvido para coletar informações e avaliar a compreensão sobre cirurgia de catarata e de consentimento informado. Um modelo de regressão ordinária foi ajustado para expressar o efeito das variáveis clínicas e demográficas no escore do questionário. RESULTADOS: O estudo envolveu 180 pacientes. Sexo (feminino, p=0,404), fonte de informações não oftalmológica (p=0,397), história cirúrgica prévia (p=0,571), não ter um/a companheiro/a (p=0,396) nem os dias desde a assinatura do formulário de consentimento informado (p=0,535) tiveram influência na compreensão do consentimento informado para cirurgia de catarata. Idade (r=-0,083, p<0,001) e nível educacional (estudos secundários r=1,845, p<0,001; estudos terciários r=4,289, p<0,001) mostraram significância estatística, com maior força de associação para o nível educacional (OR estudos secundários = 6,33, OR estudos terciários = 72,86) que para a idade (OR = 0,92). CONCLUSÃO: O conhecimento do paciente sobre o consentimento informado para cirurgia de catarata é influenciado pela idade e nível educacional. O objetivo e os riscos, consequências, de não fazer a cirurgia e as indicações pós-operatórias são os tópicos menos compreensíveis. O consentimento informado é visto como uma obrigação legal compulsória.

Consentimiento informado en pacientes con epilepsias intratables / Informed consent in patients with intractable epilepsy

La ética médica aborda, entre otros aspectos, la relación médico-paciente, de la cual se deriva el término consentimiento informado como su máxima expresión. La epilepsia afecta al 1-2 por ciento de la población mundial, y en la búsqueda de soluciones a esta enfermedad los sujetos son involucrados en diferentes tipos de estudios. En el presente trabajo se realiza una breve revisión de algunos aspectos éticos relacionados con la aprobación dada por los pacientes que padecen epilepsia o su representante legal para participar en estudios que presuponen la realización de exámenes diagnósticos y el empleo de formas novedosas de tratamiento, lo que se materializa a través del consentimiento informado. Especialmente, se hace referencia a la participación de los pacientes en ensayos clínicos y el manejo de las pacientes que quedan embarazadas en el transcurso del ensayo clínico, los efectos adversos de la medicación y de la cirugía de epilepsia(AU)

Medical Ethics addresses, among other aspects, the doctor-patient relationship from which the term informed consent is derived as its maximum expression. Epilepsy affects 1-2 percent of the world population, and in the search for solutions to this disease the subjects are involved in different types of studies. In the present paper, a brief review of some ethical aspects related to the approval given by patients suffering from epilepsy or their legal representative to participate in studies that presuppose the performance of diagnostic tests and the use of novel forms of treatment. This is materialized through informed consent. Especially, there is a reference to the participation of patients in clinical trials, and the management of patients who become pregnant during the clinical trial, the adverse effects of medication, and epilepsy surgery(AU)

¿Sé y puedo? Toma de decisión y consentimiento informado en los trastornos demenciantes: dilemas diagnósticos y jurídicos en Chile / Decision making and consents given by demented patients. Are they valid?

In Chile, more than 180 thousand people (1% of the population) have some form of dementia. The figure should increase to approximately 600,000 (3% of Chileans) by 2050. This disease poses major challenges to the society. One of them is the effective recognition of the autonomy and responsibility of the person living with this condition. This article aims to review the clinical assessment of competence, its agreement with the Chilean legal system and the challenges that the assessment of competence poses in clinical decision-making and the capacity of an individual make decisions, according to the new international obligations subscribed by Chile. It is concluded that inclusion is a pending challenge, reflected among other things, by the non-compliance with binding rules such as Article 12 of the Convention on the Rights of Persons with Disabilities, which affirms that persons with disabilities have the right to be recognized as a person everywhere, before the law.

Conocimiento y aplicación del consentimiento informado en pacientes del Hospital Escuela Universitario/Hospital Materno Infantil / Knowledge and Application of the Informed Consent in the patients of the Univers ity Hospital/ Maternal-Child Hospital

Antecedentes: En Honduras el Consentimiento Informado (CI) no ha sido objeto de estudio ni de publicación. Objetivo: Establecer el grado de conocimiento sobre el diagnóstico, tratamiento y pronóstico de su enfermedad y la aplicación del consentimiento informado en los pacientes ingresados en los servicios de Medicina Interna, Pediatría, Cirugía, Ginecología del Hospital Escuela Universitario (HEU)/Hospital Materno Infantil (HMI) Tegucigalpa en el período de marzo-mayo 2015. M étodos: Estudio cuantitativo, descriptivo, trasversal. La muestra fue 252 pacientes ingresados en las salas de los 4 servicios básicos (63 pacientes por servicio). Utilizando un muestreo no probabilístico. Los datos se recolectaron a través de una entrevista que constó de cuatro secciones: datos generales, conocimiento sobre su enfermedad, personal que le informó y aplicación del consentimiento informado. Para la validación del instrumento se realizó una prueba piloto. Los datos se presentan como frecuencias y porcentajes de las variables estudiadas. Se aplicó el CI a los participantes mayores de 18 años y el asentimiento informado a los mayores de 7 años, se guardó la conidencialidad de la información. Resultados : El 48% (120/252) de los pacientes tenía un grado de conocimiento insuiciente sobre su enfermedad. El Consentimiento Informado se aplicó en el 34% (86/252) de los pacientes entrevistados. El servicio que más aplicó el Consentimiento Informado fue Ginecología, ya que lo aplicó en el 62% (39/63) de sus pacientes. Conclusión: La mayoría de los pacientes tienen un grado de conocimiento insuiciente sobre su enfermedad. El porcentaje de aplicación del Consentimiento Informado por el personal de salud es bajo...(AU)

Perception of the informed consent form by participants in clinical trials / Percepción del término de consentimiento informado por los participantes de los ensayos clínicos / Percepção do termo de consentimento informado pelos participantes dos ensaios clínicos

Objective. To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Methodology. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Results. Some of the participants were aware of the real objective of these studies while others had misperceptions. The reading of the informed consent is not always done and, when it is done, the patient does not understand it. The lack of understanding about the term ''placebo'' was mentioned by some participants. The motivation to participate was the personal benefit. Conclusion. This study shows that obtaining the informed consent in CCTs is complex and that there is the need to adapt the structure and application of this document, in order to protect the participants and improve the quality of clinical trials performed in the country.

Objetivo. Comprender la percepción que tienen los participantes de los ensayos clínicos controlados (ECC) sobre el consentimiento informado y describir el significado de su participación en la investigación. Metodología. Estudio cualitativo que utilizó la técnica de grupo focal. La muestra estuvo constituida por 19 pacientes, quienes participaron en ensayos clínicos sobre hipertensión y enfermedad coronaria en un hospital especializado en cardiología en la ciudad de São Paulo. El referencial metodológico utilizado fue el análisis de contenido. Resultados. Algunos participantes tenían consciencia de la real naturaleza de estas investigaciones mientras otros tenían impresiones equivocadas. La lectura del consentimiento informado no siempre es realizada y cuando esta se hace el paciente no entiende su contenido. La falta de comprensión de lo que era el ''placebo'' fue mencionada por algunos participantes. La motivación en participar se centró en el beneficio personal. Conclusión. Este estudio muestra que la obtención del consentimiento informado en ECC es complejo y que hay necesidad de realizar adecuaciones en la estructura y aplicación del documento, con el fin de proteger a los participantes y mejorar la calidad de las investigaciones clínicas realizadas en el país.

Objetivo. Compreender a percepção que têm os participantes dos ensaios clínicos controlados (ECC) sobre o consentimento informado e descrever o significado de sua participação na investigação. Metodologia. Estudo qualitativo que utilizou a técnica de grupo focal. A mostra esteve constituída por 19 pacientes que participaram em ensaios clínicos sobre hipertensão e doença coronária num hospital especializado em cardiologia na cidade de São Paulo. O referencial metodológico utilizado foi a análise de conteúdo. Resultados. Alguns participantes tinham consciência da real natureza destas investigações enquanto outros tinham impressões equivocadas. A leitura do consentimento informado não é sempre realizada e quando esta se faz o paciente não entende. A falta de entendimento do que era o ''placebo'' foi mencionada por alguns participantes. A motivação em participar se centrou no benefício pessoal. Conclusão. Este estudo mostra que a obtenção do consentimento informado em ECC é complexo e que há necessidade de realizar adequações na estrutura e aplicação do documento, com o fim de proteger aos participantes e melhorar a qualidade das investigações clínicas realizadas no país.

El consentimiento informado en el tratamiento integral del niño con fisura labio-alveolo-palatina / Informed consent in the comprehensive treatment of children with labial-alveolar-palatal clefts

Introducción: el Servicio de Cirugía Maxilofacial del Hospital Pediátrico Universitario Juan Manuel Márquez de La Habana adoleció de un proceso estandarizado de consentimiento informado. Se tuvo además como propósito el analizar los criterios de los representantes válidos sobre la información que le brindaría el consentimiento informado. Métodos: se estudió a los 32 integrantes del equipo multidisciplinario y a 9 representantes válidos de los pacientes para así constatar el grado de conocimiento sobre los principios de Ética Médica y Bioética. Resultados: se mostró que la mayoría tuvo un nivel bajo en cuanto a Ética Médica y niveles medio o alto en la Bioética. Los representantes válidos presentaron un nivel bajo. Se confirmó el reconocimiento de la necesidad e importancia del consentimiento informado aunque el equipo de salud refirió que no lo utiliza adecuadamente. Se elaboró una propuesta metodológica del proceso de consentimiento informado. Conclusiones: el nivel de conocimiento sobre los principios de la Ética Médica y la Bioética de los profesionales no se correspondió con la percepción que ellos tuvieron ni con la expresión práctica de dichos elementos(AU)

Introduction: the Maxillofacial Surgery Service at Juan Manuel Marquez Children's University Hospital in Havana did not have a standardized informed consent procedure. Another purpose was to analyze the opinions of valid representatives about the information to be provided by such informed consent. Methods: a study was conducted of the 32 members of the multidisciplinary team and 9 valid representatives of the patients to verify their awareness of the principles of medical ethics and bioethics. Results: most showed low awareness of medical ethics, and medium to high awareness of bioethics. Valid representatives showed a low level of awareness. Acknowledgement of the importance of and need for informed consent was confirmed, but the medical team admitted that they do not use it appropriately. A methodological proposal was developed for the process of informed consent. Conclusions: awareness of the principles of medical ethics and bioethics by professionals was not consistent with their perception of such principles or their implementation(AU)

El comité de bioética, instancia deliberativa, académica y científica / The bioethics committee: a deliberative, academic, and scientific instance

A continuación se postulan Los Comités de Bioética como organismos de carácter deliberativos, axiológicos y deontológicos, fruto de la conciencia y el compromiso ético-critico de la población académica y científica para aportar de una forma pragmática y concreta a problemáticas que tocan directamente al hombre de hoy y su repercusión global futura. Presenta su acción imprescindible y incidencia en el debate bioético actual, sus características, dificultades, compromisos educativos y sus desafíos.

This article sets outs Bioethics Committees as organisms of deliberative, axiological, and deontological nature, as a result of the awareness and ethical-critical commitment of the academic and scientific population in order to contribute, in a pragmatic and concrete manner, to issues which directly deal with today´s man and their future global impact. It presents their essential action and incidence in the current bioethical debate, their characteristics, difficulties, educational commitments and challenges.

El consentimiento informado en el campo de la salud / Informed consent in the health field

Este material se fundamenta en la necesidad de proveer a estudiantes y profesionales de la salud una herramienta que pueda guiarlos en la redacción del consentimiento informado antes de la realización de los trabajos, pero para ello, deberían darle valor. El consentimiento informado del paciente es un derecho humano y una exigencia ética-legal del profesional. Es utilizado en varios ámbitos de la salud, tratamiento de pacientes , estudios complejos que podrían ocasionar reacciones adversas, utilización de fármacos, investigación en humanos, trasplante de órganos. Su incumplimiento podría generar responsabilidad ( por eso es un acto jurídico). Debe preceder a la presentación del documento la información suficiente, en lo posible también expresar por escrito, y una vez aceptado y firmado el documento, el paciente puede replantearse la sustitución aún en plena ejecución del plan, y rechazar su continuidad (revocación del consentimiento).

Obstáculos subjetivos en el acceso al test VIH: aportes desde el psicoanálisis / Subjective barriers in access to HIV test: contributions from psychoanalysis

El test de VIH es un sencillo análisis de sangre, sin embargo prejuicios, creencias, representaciones no conscientes sobre la enfermedad, así como una serie de fantasías y temores, dificultan la realización de la prueba. el test es simple, pero la decisión de hacerlo es compleja. Esa complejidad es arrasada si se lo plantea como obligatorio y queda avasallada también en la estrategia de opt-out. El cuestionamiento a tal metodología está basado en: a) hacerse el test con consecuencias sobre la conducta del sujeto es una decisión (diferenciación teórico-clínica: opción/elección/decisión; b)respeto del tiempo subjetivo (3 tiempos lógicos: instante de ver, tiempo de comprender, momento de concluir), c) abordaje de los aspectos pulsionales que en el sujeto permean sus conocimientos y acciones. La promoción del testeo voluntario con consentimiento informado es una herramienta indispensable, resulta imprescindible comprender los obstáculos subjetivos racionales y no racionales que interfieren, en la población y en los equipos de salud.

The HIV test is a simple blood test, however prejudices, believes, not aware representations about the disease, and a series of fantasies and fears hinder taking the test. The test is simple, but the decision to do so is complex. That complexity is destroyed if it is presented as required and also subdued the opt-out strategy. The controversy about this methodology is bases on: a) taking the test with implications for the person's behaviour is a decision (theoretical and clinical differentiation: option/choice/decision), b) respect of subjective time (3 logical times: the instant of seeing, the time for understanding, the moment of concluding), b) respect of subjective time (3 logical times: the instant of seeing, the time for understanding, the moment of concluding), c) approaching pulsional aspects that permeate the subject's knowledge and actions. The promotion of voluntary testing with informed consent is an indispensable tool, it is imperative to understand the rational and nonrational subjective obstacles that interfere in the population and in health teams.

Entendimento do termo de consentimento por pacientes partícipes em pesquisas com fármaco na cardiologia / Informed consent as viewed by patients participating in cardiology drug trial / La comprensión del formulario de consentimiento por los pacientes que forman parte de investigaciones con fármaco en la cardiología

Fundamento: Em ensaios clínicos, o Termo de Consentimento Livre e Esclarecido (TCLE) é fundamental para preservar a ética, mas pela sua complexidade ele pode não ser entendido completamente. Neste estudo, avaliamos o entendimento do TCLE pelo paciente. Objetivo: Abordamos a questão sobre o nível de compreensão dos pacientes em relação aos estudos baseados no Consentimento Informado. Métodos: Convidamos participantes de pesquisa ambulatorial fases II, III e IV, com fármacos, para responder um questionário estruturado com 29 questões, tais como: por que aceitou participar? Leu o TCLE antes de assinar? Ao assiná-lo, estava certo de tê-lo entendido? Oitenta indivíduos (20 mulheres e 60 homens) compareceram, num universo de 106 pacientes. As variáveis de cada questão foram consideradas por frequência de ocorrência. A comparação entre as médias entre os grupos foi realizada pelos testes t de Student ou Wilcoxon; e para associações, o Qui-quadrado ou Razão de Verossimilhança, ou teste exato de Fisher. Resultados: A média das idades foi de 58,7 ± 9,3 anos. Das motivações para participar da pesquisa, 66,2 por cento apontaram seu próprio benefício; 42,5 por cento, o bem da ciência; 25,0 por cento alegaram atender a um pedido de seu médico; 50 por cento não entenderam corretamente o TCLE; e 32,9 por cento sequer o leram, mas o assinaram. Dentre os que receberam placebo após a randomização (n = 47), 66,7 por cento não entenderam o significado deste termo. Houve forte correlação entre o não entender o significado de placebo com a escolaridade (p = 0,02), evidenciando que quanto menor o nível de instrução, menor este entendimento. Conclusão: O TCLE é pouco compreendido pelos pacientes e para alguns deles a confiança no médico teve impacto na decisão de participar do ensaio clínico com fármaco, havendo também influência do nível de instrução dos sujeitos no entendimento do termo "placebo".

Background: In clinical tests, the Informed Consent is critical to preserve the ethics, but due to its high complexity level, it cannot be fully understood. This study assesses the Informed Consent as viewed by patients. Objective: We addressed the issue of what do patients understand about the studies based on the IC. Methods: We invited participants of outpatient clinical drug trials phase II, III and IV to answer a questionnaire with 29 questions, such as: why have you accepted to participate? Did you read the Informed Consent before signing it? By signing it, were you sure you have fully understood it? Eighty individuals (20 women and 60 men) showed up, from 106 patients. The variables of each question were considered as often as they appeared. The comparison of the averages among the groups was made by t tests of Student or Wilcoxon; and for associations, Chi-square or Likelihood Ratio, or Fisher's exact test. Results: Ages averaged 58.7 ± 9.3 years. Concerning their reasons to taking part in the survey, 66.2 percent pointed out their own benefit; 42.5 percent, for science's sake; 25.0 percent claimed they were doing so at their doctor's request; 50 percent did not understand the Informed Consent properly; and 32.9 percent did not read it, but signed it. Among those who were administered placebo after randomization (n = 47), 66.7 percent did not understand the meaning of the informed consent. A strong correlation between failure to understand the meaning of placebo with literacy level (p = 0,02) was verified, which is an evidence that the smaller is the literacy level, the smaller is the understanding level. Conclusion: The Informed Consent is poorly understood by patients and for some of them, trusting a doctor affected their decision in taking part in the clinical trial with drugs. Their literacy level also influenced their understanding of the term "placebo".

Fundamento: En ensayos clínicos, el Formulario de Consentimiento Informado (FCI) es fundamental para que se preserve la ética, sin embargo por su complexidad él puede no comprenderse completamente. En este estudio, evaluamos la comprensión del FCI por parte del paciente. Objetivo: Abordamos la cuestión sobre el nivel de comprensión de los pacientes respecto a los estudios basados en el Consentimiento Informado. Métodos: Invitamos a los participantes de investigación clínica fase II, III y IV con fármacos para responder un cuestionario estructurado con 29 cuestiones, tales como: ¿Por qué aceptó participar?¿Leyó el FCI antes de firmarlo?¿Al firmarlo estaba seguro de haberlo entendido? Ochenta individuos (20 mujeres y 60 varones) comparecieron, en un total de 106 pacientes. Las variables de cada cuestión se llevaron a cabo por frecuencia de ocurrencia. La comparación entre los promedios entre los grupos se realizó mediante las pruebas t de Student o Wilcoxon; y para asociaciones, el Chi-cuadrado o Razón de Verosimilitud, o prueba exacta de Fisher. Resultados: El promedio de las edades fue de 58,7 ± 9,3 años. De las motivaciones para participar en la investigación, el 66,2 por ciento señaló su propio beneficio; un 42,5 por ciento, el bien de la ciencia; un 25,0 por ciento alegó atender a una petición de su médico; el 50 por ciento no comprendió correctamente el FCI; y un 32,9 por ciento tampoco leyó el formulario, pero lo firmó. Entre los que recibieron placebo tras la randomización (n = 47), un 66,7 por ciento no entendió el significado de este término. Hubo una fuerte correlación entre las personas que no entendían el significado de placebo con la escolaridad (p = 0,02), evidenciando que cuanto menor era el nivel de instrucción, menor era la comprensión. Conclusión: EL FCI es poco comprendido por los pacientes y para algunos de ellos la confianza en el médico tuvo impacto en la decisión de participar en el ensayo clínico con fármaco, habiendo...

Acceptance and Understanding of the Informed Consent Procedure Prior to Gastrointestinal Endoscopy by Patients: A Single-Center Experience in Korea

BACKGROUND/AIMS: Only a few reports have examined informed consent for gastrointestinal endoscopy in Korea. The aim of this study was to evaluate the appropriateness of the informed consent procedure in Korea. METHODS: A total of 209 patients who underwent endoscopy were asked to answer a self-administered structured questionnaire on the informed consent procedure for gastrointestinal endoscopy. RESULTS: One hundred thirteen patients completed questionnaires and were enrolled. In the survey, 91.2% answered that they understood the procedure, and the degree of understanding decreased with age; 85.8% were informed of the risks of the procedure, and the proportion was higher for inpatients and for those receiving therapeutic endoscopy or endoscopic retrograde cholangiopancreatography; 60.2% were informed of alternative methods, and the proportion was higher in older patients; 76.1% had the opportunity to ask questions during the informed consent procedure, and the proportion was higher in inpatients. The understanding of the risks of the endoscopic procedure was better in the younger and more highly educated groups. About 80% had sedation before endoscopy, and only 56% were informed of the risks of sedation during endoscopy. CONCLUSIONS: The current informed consent process may be reasonably acceptable and understandable to the patients. However, the understanding of the risks of endoscopy was insufficient especially in the cases of older, poorly educated patients and outpatients. The information about alternatives, the opportunity to ask for additional information, and the information about the risks of sedation during endoscopy were also insufficient in the current consent process.

Equilibrio ético para toma de decisiones asistenciales en pacientes críticos / Ethical balance for healthcare decision-making in critical patients

Los pacientes graves son enfermos en los cuales se presentan dificultades para la obtención del consentimiento informado. Por un lado tienen tendencia a sufrir muchos procedimientos invasores, incluso de soporte vital, y por otro la naturaleza de su enfermedad o su tratamiento los limita de participar en el proceso de consentimiento en ocasiones, a fin de caracterizar el comportamiento del proceso de toma de decisiones asistenciales en el paciente crítico en la Unidad de Cuidados Intensivos, se realizó un estudio prospectivo, longitudinal y de intervención, en el cual se estudiaron dos cohortes consecutivas de pacientes (280 cada una). Se registraron todas las decisiones asistenciales y procedimientos realizados en el primer periodo y la toma de decisiones alegórica al consentimiento informado e implicado. En un segundo período de intervención, con técnicas estratégicas especializadas, se solicitó a pacientes (que tuviesen puntaje inferior a 50 puntos en la escala de Karnofsky), a familiares y allegados su consentimiento informado y se volvió a registrar el número de procedimientos y de consentimientos informados individuales obtenidos. Siempre que pudo ser posible, se le consultó el procedimiento a realizar al paciente y las acciones médicas y de enfermería. Cuando esto no fue posible, se tomó el criterio del familiar o allegado competente. En tercera instancia, se tomó el criterio del consenso absoluto de todo el equipo asistencial de trabajo, el consentimiento implicado. Se obtuvo un trànsito en el protagonismo de las decisiones asistenciales en el paciente crítico, donde inicialmente primaba casi absolutamente el consentimiento implicado para pasar al consentimiento informado de pacientes y familiares. Ademàs se incrementó en la medida de lo posible la participación de los pacientes graves y familiares al proceso asistencial. Las enfermedades cardiovasculares agudas fueron las situaciones clínicas que permitieron màs autonomía en el consentimiento informado, y la falla múltiple de órganos donde el consentimiento implicado predominó(AU)

Serious patients are ill people in which there are difficulties to obtain the informed consent. On the one hand they have a trend to underwent many invasive procedures, even of vital support, and by the other hand, the origin of its disease or its treatment limit them to participate sometimes in the consent process to characterize the behavior of healthcare decision-making in critical patient in Intensive Care Unit, thus we conducted a prospective, longitudinal and interventional study to study two consecutive cohorts of patients (280 each). All healthcare assistances and procedures carried out during the first period and the decision-making related to informed and implicated consent. During a second intervention period using specialized techniques we requested to patients (with a score under 50 points in Karnofsky scale), family and relatives the informed consent and the procedures number and of individual informed consent was registered again obtained. As much as we can the procedure to be performed was asked patient about the procedure and the medical and nursing actions. When it was not possible, we considered the family or competent relatives criterion. In third case, we took the absolute consensus criterion of all the working healthcare staff, the implicated consent. A transit in leading role of healthcare decisions in critical patient was obtained where initially the implicated consent was a almost absolute priority to pass to the informed consent of patients and relatives. Also, as much as it was possible the participation of critical patients and relatives in healthcare process was increased. Acute cardiovascular diseases were the clinical situations allowed more autonomy in informed consent and the failure of multiple organs where the implicated consent was predominant(AU)

O consentimento informado para além da medicina defensiva / The informed consent beyond the defensive medicine

O consentimento informado é uma exigência ética e legal na assistência médica. Na perspectiva da Medicina Defensiva, o consentimento informado é visto como documento que visa a proteger os interesses do médico. Na perspectiva da Bioética, é um processo que visa a proteger os interesses do paciente. Numa visão jurídica fundamentada na Bioética, conclui-se que o consentimento informado é processo, que pode ser expresso na forma escrita, que visa proteger interesses tanto de médicos quanto de pacientes.

The informed consent is a legal and ethical requirement in medical care. In the perspective of Defensive Medicine, informed consent is regarded as a document to protect the doctor. On the Bioethics standpoint, informed consent is a process which aims the protection of the patient. In a legal stance based on Bioethics informed consent is a process that can be expressed in written form, to protect both doctors and patients.

Informed consent & ethical issues in paediatric psychopharmacology.

Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.

Como consentir sem entender? / How consent without knowing?

INTRODUÇÃO: Termo de Consentimento Livre e Esclarecido (TCLE) é o documento que informa sobre os benefícios e riscos de um estudo. Alguns autores concluíram que os TCLE são de difícil compreensão. OBJETIVO: Correlacionar grau de dificuldade dos TCLE, pelos índices de Flesch (IF) e Flesch-Kincaid (ILFK), utilizados num ambulatório de oncologia ao perfil de escolaridade dos usuários desse mesmo serviço, bem como verificar a legibilidade e a presença das informações obrigatórias segundo o item IV.1 da Resolução 196/96 do Conselho Nacional de Saúde. RESULTADOS: Foram obtidos 10 TCLE; segundo o IF e ILFK, a média foi de 38,5 e 18,16 respectivamente, mostrando ser necessário aproximadamente 18 anos de estudo para a compreensão, dado incompatível com a realidade de nossa população, em que mais de 50 por cento tem menos de oito anos de estudos. Em relação à qualidade dos termos, estes eram bem elaborados tecnicamente, contendo a maior parte dos itens necessários. Ao correlacionarmos o ILFK com a qualidade dos TCLEs, pôde-se observar que a qualidade dos termos não apresentou correlação com a legibilidade (p= 0.884, coeficiente de correlação de Pearson 0.053). CONCLUSÃO: O grau de dificuldade dos TCLE é incompatível com a escolaridade de nossa população e nossos TCLE apresentavam informações suficientes. Esperávamos relacionar a quantidade de informações ao grau de dificuldade de compreensão do texto, não sendo confirmada, mostrando a possibilidade de um TCLE ser completo ao mesmo tempo fácil de ler.

BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50 percent have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

The informed consent status for surgery patients in eastern Turkey: a cross-sectional study.

This study assesses the quality of the informed consent process and satisfaction with the informed consent process, for surgery patients in Turkey. Four hundred and eighty three patients were interviewed after their surgeries. More than half of the patients were satisfied with the information on eight issues that pertained to the informed consent process. A majority of patients (91 per cent) were satisfied with the information regarding why an operation necessary. However, only 205 of 483 patients(42 per cent) indicated that they had received sufficient information on the potential side effects and complications of surgery. Patients' educational level and the type of surgery--urgent or elective--were associated with the satisfaction status.

Informed consent in an antiretroviral trial in Nigeria.

We examined the process of informed consent in an antiretroviral trial in Nigeria. A semi-structured questionnaire was administered to 88 out of 180 people enrolled in the trial. This covered all aspects of the information disclosed in the leaflet of the antiretroviral trial. We found that 75 (85 per cent) of the respondents knew that the purpose of the research was to test a new drug and 13 (14 per cent) believed that they were receiving free treatment for HIV. Participants understood certain aspects of the research, especially the benefits and duration. Their understanding of the trial's risks and their right to refuse to participate and to withdraw was low. Their level of understanding was significantly related to age but not to gender, marriage, education, religion, employment and occupation. Signed informed consent is not a guarantee that participants have understood the information given to them and therefore made a voluntary decision to participate. Researchers should make sure that the process of obtaining informed consent achieves the desired outcome. This is especially important in the developing world where access to health care is limited, potential participants are poor and literacy levels are low.

Factors related to volunteer comprehension of informed consent for a clinical trial.

The informed consent process has become a universal requirement for research involving human subjects. Its goal is to inform volunteers regarding research in order to make decision to participate or not. This study aimed to measure volunteers' comprehension levels concerning the clinical trial and to find out factors associated with that comprehension levels. Eighty-one volunteers who enrolled in a malaria clinical trial were recruited into the study. A semi-structured questionnaire was used to collect the information. Non-participant observation was used to observe the process of informed consent. Volunteers were interviewed three days after being recruited into the trial. The results show the volunteers' comprehension was low. Only 44% of volunteers had an acceptable level of comprehension. It also revealed that 20 volunteers were not aware of being volunteers. Most volunteers knew about the benefits of participating in the trial and realized that they had the right to withdraw from the study, but not many knew about the risks of the trial. The results indicated the method of informing about the trial affected the volunteers' comprehension level. No relationship was found between comprehension level and volunteers' socio-demographic characteristics and their attitude toward the consent process. The findings from this study demonstrate volunteers who participated in the clinical trial were not truly informed. Further studies regarding enhancing volunteers' understanding of the trial are needed.