Randomized Controlled Trial Design Based on Patient Cohorts： Methods and Applications of Trials Within Cohorts / 中国实验方剂学杂志

Trials within cohorts （TwiCs） are design methods derived from randomized controlled trials （RCTS）. They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented， some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions"， while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group， the efficacy of intervention measures was evaluated. Within the cohort， the same process could be repeated to carry out multiple RCTS， so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS， TwiCs make it easier to recruit patients from the cohort and have higher external validity， providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However， TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs， including multi-stage informed consent （patients are informed of consent at three stages： entering the cohort， entering the trial group， and after the trial）， randomization procedures （only random sampling of patients from the cohort to receive "trial interventions"）， sample size calculation， and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples， so as to provide new research ideas and methods for clinical researchers.

Hacia la objetividad en la valoración ética: legibilidad como parte de la comprensión de los formatos de consentimiento informado / Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension

Resumen Antecedentes: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. Objetivo: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. Resultados: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. Conclusión: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

Abstract Background: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. Objective: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. Results: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. Conclusion: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

Face, facial recognition technology and personal privacy

The privacy problem of facial recognition technology is that commercial companies obtain people's facial information without the consent of individuals and use facial information to infringe on the privacy of individuals. The importance of human privacy in facial recognition technology is reflected through facial ethics, which requires others to perform corresponding obligations to individuals, such as oral care. Through the analysis of the privacy issues of facial recognition technology, it is found that the two elements of "without personal informed" and "without personal consent" together form the basis for commercial companies to violate personal privacy. The principle of informed consent includes the principle of informed and the principle of consent, which is derived from the principle of informed consent in medical ethics. This paper improves the principles of informed consent in medicine and ethics to better address facial recognition privacy issues.

El problema de la privacidad en la tecnología de reconocimiento facial es que las empresas comerciales obtienen información facial de las personas sin el consentimiento de éstas y utilizan la información facial para vulnerar la privacidad de las personas. La importancia de la privacidad de las personas en la tecnología de reconocimiento facial se refleja a través de la ética facial, que exige que otros cumplan las obligaciones correspondientes con los individuos, como el cuidado bucal. A través del análisis de los problemas de privacidad de la tecnología de reconocimiento facial se descubre que los dos elementos de "sin información personal" y "sin consentimiento personal" juntos forman la base para que las empresas comerciales violen la privacidad personal. El principio de consentimiento informado incluye el de información y el de consentimiento, que se deriva del principio de consentimiento informado de la ética médica. Este artículo mejora los principios del consentimiento informado en medicina y ética para abordar mejor los problemas de privacidad del reconocimiento facial.

A questão da privacidade na tecnologia de reconhecimento facial é que as companhias comerciais obtém informações faciais das pessoas sem seu consentimento e usam informação facial para infringir sua privacidade. A importância da privacidade humana na tecnologia de reconhecimento facial é refletida através da ética facial, que exige que se cumpram obrigações correspondentes para com os indivíduos, da mesma forma como com cuidados orais. Através da análise de aspectos de privacidade na tecnologia de reconhecimento facial, encontrou-se que os dois elementos "sem informação pessoal" e "sem consentimento pessoal" juntos, formam a base para companhias comerciais violarem a privacidade pessoal. O princípio do consentimento informado inclui o princípio de informação e o princípio de consentimento, os quais derivam do princípio do consentimento informado em ética médica. Esse artigo melhora os princípios do consentimento informado em medicina e ética para melhor incluir aspectos de privacidade no reconhecimento facial.

Percepción y prioridades respecto al proceso de consentimiento informado quirúrgico; un análisis mediante métodos mixtos

Objetivo: Identificar las principales preocupaciones antes y después de realizarse un procedimiento quirúrgico, e identificar diferencias basadas en género, edad y nivel de escolaridad. Material y Método: Mediante un muestreo no probabilístico incidental se aplicaron 201 encuestas semiestructuradas a personas en la sala de espera del HSJD. Las respuestas fueron procesadas mediante un análisis mixto donde se organizaron categorías por unidades de significancia y se ordenaron de forma decreciente para luego comparar según edad, género y escolaridad. Resultados: Respecto a los aspectos que las personas consideran relevante conocer previo a la cirugía, 4 categorías concentran el 71 % del total: 1. Riesgos, complicaciones y secuelas, 2. Explicación del procedimiento, 3. Beneficios y pronóstico, 4. Cuidados y evaluaciones previas. En relación con lo que le gustaría que le explicaran después, se prioriza: 1. Conocer los resultados del procedimiento (19,3%), 2. Control, derivaciones y cuidados paliativos (15%), 3. Tiempo de recuperación (13,7%). Diferencias significativas: una mayor necesidad de acompañamiento y explicación de la patología expresada por hombres, el interés por conocer y los aspectos relacionados con funcionalidad postoperatoria en personas entre 18-65 años, el interés de conocer los cuidados y evaluaciones previas, conocer los resultados del procedimiento, los cuidados de la herida y la funcionalidad posoperatoria según nivel educacional. Discusión y conclusión: Existen variaciones significativas en contenido prioritario según edad, género y nivel educacional. Finalmente, el presente artículo proporciona evidencia en cuanto a las principales prioridades de pacientes en el sistema público chileno para el consentimiento informado.

Aim: To identify the main concerns before and after undergoing a surgical procedure, and to identify differences based on gender, age and level of education. Material and Method: 201 semi-structured surveys were administered to people in the waiting room of the HSJD by means of incidental non-probabilistic sampling. The responses were processed by means of a mixed analysis in which categories were organized by units of significance and ordered in decreasing order to then compare according to age, gender and schooling. Results: Regarding the aspects that people considered relevant to know before surgery, 4 categories accounted for 71% of the total: 1. Risks, complications and sequels, 2. Explanation of the procedure, 3. Benefits and prognosis, 4. Prior care and evaluations. In relation to what you would like to have explained to you afterwards, priority is given to: 1. knowing the results of the procedure (19.3%), 2. Monitoring, referrals and palliative care (15%), 3. Recovery time (13.7%). Significant differences: a greater need for accompaniment and explanation of the pathology expressed by men, interest in knowing and aspects related to postoperative functionality in persons between 18-65 years of age, interest in knowing the previous care and evaluations, knowing the results of the procedure, wound care and postoperative functionality according to educational level. Discussion and conclusion: There are significant variations in priority content according to age, gender and educational level. Finally, the present article provides evidence regarding the main priorities of patients in the chilean public system for informed consent.

On conducting a study among institutionalised adolescents in Kerala, India: legal and ethical challenges

We report the dilemmas faced by the investigators while conducting a study on the social and environmental factors for protection of the mental health of adolescents placed under State protection in Kerala, India. The proposal received counsel and directives from the Integrated Child Protection Scheme authorities, under the Social Justice Department of Kerala state and the Institutional Ethics Committee of the host institution. The investigator faced and had to reconcile conflicting directives and antithetical field realities, with respect to seeking informed consent from the study participants. The physical act of adolescents signing the consent form, rather than the actual process of assent, received disproportionately more scrutiny. The authorities also questioned the privacy and confidentiality requirements raised by the researchers. Of the 248 eligible adolescents, 26 chose to dissent from participating in the study, demonstrating that choices would be made if they are offered. There is a need for more discourse on achieving steadfast adherence to the principles of informed consent, particularly in research on vulnerable groups such as institutionalised children.

Desafíos a la ética en la investigación frente al envejecimiento poblacional / Ethical challenges in research regarding aging population

El mundo está experimentando un acelerado proceso de envejecimiento poblacional. Este cambio epidemiológico se asocia a la necesidad de incrementar la investigación orientada a mejorar la calidad de vida en las edades avanzadas. Esta investigación requiere de la participación de personas mayores, tanto en áreas del ámbito científico-tecnológico como en el sociocultural. Esta realidad lleva a plantear una serie de interrogantes relacionadas con la forma como se desarrolla esta actividad con las personas mayores, relacionadas con las brechas, desigualdades e inequidades, su vulnerabilidad, su acceso a los productos generados, su capacidad para consentir, entre otros. El objetivo del ensayo es reflexionar acerca de algunas de estas interrogantes, revisando algunos de los preceptos básicos de la ética de la investigación en seres humanos, y plantear algunas necesidades y desafíos para la actualización en las pautas y guías que la orientan. Se espera que las personas mayores que participan en investigación biomédica sean respetadas, se les asegure un adecuado balance riesgo/beneficio y se seleccionen en forma equitativa. Estos principios básicos, aunque reconocidos en términos generales por las guías y regulaciones éticas disponibles, no están completamente garantizados, como evidenció la pandemia de COVID-19. El tema plantea diversos desafíos y amerita su consideración en las pautas y guías éticas para la investigación biomédica con participación de personas mayores.

Aging population is a global reality that forces public policies based on transdisciplinary research focused on older adults. This raises a series of issues, such as feasability, inequalities, inequities, vulnerability, access to the products generated, and ability to consent, among others. This essay's objective is to reflect on some of the questions that arise from this reality, review basic precepts of research ethics in human beings, and expose the challenges for updating the current guidelines for ethical biomedical research. Aged adults participating in clinical research should be respected, assured of an adequate risk/benefit balance, and selected fairly. The available guidelines generally recognize these basic principles, but they are not entirely guaranteed, as evidenced during the COVID-19 pandemic. This issue poses various ethical challenges and deserves to be considered in the guidelines and regulations for biomedical research with the participation of older adults.

Ethics of the use of dead human bodies in anatomy teaching in India

The study of the human anatomy predominantly requires the use of remains of the dead. Unclaimed bodies are easily available in India; however, there is a lack of clear ethical guidelines governing their transport and exchange. We raise pertinent questions about the ethical implications of using unclaimed bodies in teaching anatomy, their transport, transfer and storage, ethical and legal issues regarding the voluntary donation of bodies and dry human bones, as well as the commercial aspects of body donation. We also examine existing practices in anatomy departments in India, and explore the available legal safeguards. We detail practical and ethical challenges in the existing practices and safeguards and attempt to provide solutions.

An Assessment of Skin Diseases in People and Their Quality of Life in Bundelkhand Region of Uttar Pradesh

Background: Skin diseases occur in all age groups in developed and developing countries. Various types of skin diseases are found worldwide and depend on factors like environment, surrounding ecology, dietary habits, socioeconomic status, mental health, and literacy. Health-related quality of life (HRQOL) improves after treatment or cure of the diseases. Objectives: To estimate the pattern of skin disease. To find out the quality of life and association of skin disease with sociodemographic factors among patients. Methods: This observational cross-sectional study was done in skin OPD at the tertiary care center, Banda district of Uttar Pradesh, India from May 2022 to July 2022. All patients who attended to skin OPD during study period were included in the study after taking informed verbal consent. Results: Skin diseases had further divided in subcategories which were infectious conditions, pigmentary disorders, inflammatory dermatoses, miscellaneous skin conditions, benign tumor and other lesions with their percentage 44.8, 10.5, 28.6, 7.1, 2.9 and 6.2%, respectively in this study Classes of DQLI where major portion of patients (49.52%) were in ‘Small effect on patient’s life’ category. The relation of age, religion, education and member of household with history of skin disease were found to be highly statistically significant. Conclusion: Infectious skin diseases were found more common in study area. Male populations were more commonly affected. Skin diseases were more common in age group of 18–60 years. Study participants showed no predominant effect on quality of life. But small effect class had major effect on participant’s quality of life.

Challenges in Obtaining Informed Consent in Qualitative Research and Suggestions to Improve It- A Descriptive Qualitative Study

Introduction: The dynamic and flexible nature of qualitative studies is expected to impose new challenges upon the researchers in obtaining informed consent. The study objectives were to explore the challenges per-ceived by the researchers in obtaining informed consent in qualitative research and their suggestions to im-prove it. Material and Methods: It was a descriptive qualitative study in which In-depth interviews were conducted among ten qualitative researchers purposively selected from one medical college in Puducherry. Transcripts prepared from the audio recordings were thematically analyzed manually. Results: The challenges identified were inadequate knowledge of the researcher in designing qualitative con-sent form, reluctance to sign consent document by participant, ensuring confidentiality and risk benefit com-munication. The main suggestions provided by the participants were to use of multimedia tools to improve their understanding and creating a rapport to enhance their trust to participate in the study. Conclusions: Since most of the challenges were related to the reluctance of participants to provide consent due to various reasons and lack of adequate knowledge of the researcher, creating a good rapport with the participants and providing simple information through multimedia approaches and ethical training of qualita-tive researchers will aid us to overcome majority of these challenges.

Análisis de los formatos de consentimiento informado en los establecimientos de salud Reflexiones bioéticas y jurídicas en el contexto peruano

en la actividad asistencial desarrollada por los profesionales de la salud, el consentimiento informado (CI) instrumentaliza la aquiescencia otorgada por el paciente respecto al procedimiento y/o intervención quirúrgica. Existe una regulación dispersa en el ordenamiento legal peruano en relación con el CI. En el ámbito del sistema interamericano se resuelven precedentes importantes que establecen el contenido mínimo que se debe informar al paciente previo al consentimiento. Se evalúo el cumplimiento de 22 elementos necesarios y nueve deseables en los formatos de CI, en atención al ordenamiento normativo vigente y a lo previsto a nivel supranacional por la Corte Interamericana de Derechos Humanos (Corte IDH). Dichas categorías fueron validadas mediante el juicio de expertos abogados y profesionales de la salud. La población objetivo estuvo conformada por 456 formatos de consentimiento aplicados en los establecimientos de salud públicos de Lima Metropolitana, durante los años 2019-2021. En todos los formatos se cumplen los elementos necesarios asociados con datos del paciente, el profesional de la salud y el nombre del procedimiento o intervención quirúrgica. No hay elemento deseable que se cumpla en la totalidad de estos formatos. En ese sentido, se advierten brechas en el contenido de los esos formatos en los establecimientos de salud peruanos, por lo que se debe reivindicar el aspecto informativo para lograr actos de consentimiento plenamente eficaces.

in the healthcare activity carried out by health professionals, informed consent (IC) instrumentalizes the acquiescence of the patient concerning the procedure and/or surgical intervention. There is a scattered regulation in the Peruvian legal system about IC. In the Inter-American system, essential precedents establish the minimum content the patient should be informed of before consent. Compliance with 22 necessary elements and nine desirable elements in the IC forms was evaluated under the current legal system and the supranational provisions of the Inter-American Court of Human Rights (IACHR Court). These categories were validated through the judgment of expert lawyers and health professionals. The target population consisted of 456 consent forms applied in public health facilities in Metropolitan Lima from 2019-2021. In all the formats, the necessary elements associated with patient data, the health professional, and the name of the procedure or surgical intervention are fulfilled. There is no desirable element that is fulfilled in all of these formats. In this sense, there are gaps in the content of these forms in Peruvian health facilities, so the informative aspect should be vindicated to achieve fully effective acts of consent.

na atividade assistencial desenvolvida pelos profissionais da saúde, o consentimento informado (CI) instrumentaliza a aquiescência outorgada pelo paciente a respeito do procedimento e/ou intervenção cirúrgica. Existe uma regulamentação dispersa no ordenamento legal peruano com relação ao CI. No âmbito do sistema interamericano, são resolvidos precedentes importantes que estabelecem o conteúdo mínimo que deve ser informado ao paciente prévio ao consentimento. Foi avaliado o cumprimento de 22 elementos necessários e nove desejáveis nos modelos de CI, em atenção ao ordenamento normativo vigente e ao previsto no âmbito supranacional pela Corte Interamericana de Direitos Humanos (Corte IDH). Essas categorias foram validadas mediante o julgamento de especialistas advogados e profissionais da saúde. A população-alvo esteve conformada por 456 formulários de consentimento aplicados nos estabelecimentos de saúde públicos de Lima Metropolitana, durante 2019-2021. Em todos os formulários, são cumpridos os elementos necessários associados com dados do paciente, o profissional da saúde e o nome do procedimento ou intervenção cirúrgica. Não há elemento desejável que se cumpra na totalidade desses formulários. Nesse sentido, são apresentadas lacunas no conteúdo desses formulários nos estabelecimentos de saúde peruanos, por isso o aspecto informacional deve ser reivindicado para conseguir atos de consentimento plenamente eficazes.

Ética e integridad académica en la formación doctoral: el caso de los doctorados en educación en las universidades chilenas / Ethics and academic integrity in doctoral training: the case of doctorates in education in Chilean universities / Ética e integridade acadêmica na formação pós-graduada: o caso dos doutorados em educação nas universidades chilenas

El presente artículo analiza, a partir de una revisión documental de planes y programas de curso de los doctorados en Educación activos en Chile, en qué medida y cómo los programas de formación de futuros investigadores en educación doctoral abordan el desafío de integrar la educación ética en su diseño curricular. Mediante un análisis temático de la documentación oficial de los programas se identificaron y analizaron diversos elementos relacionados con ética de la investigación e integridad académica abordados en la formación doctoral, su enfoque prevalente (normativo o de discernimiento ético), su orientación (propositiva o de prevención) y la profundidad con que son tratados esos aspectos. Los resultados muestran que solo un tercio de los actuales programas abordan de manera explícita la formación ética en investigación, y que, en estos casos, su abordaje tiende a subrayar aspectos más formales que de fondo, acotados fundamentalmente al cumplimiento del protocolo de consentimiento informado.

This article analyzes to what extent and how training programs for future researchers in doctoral education address the challenge of integrating ethical training in their curricular design. Based on a documentary review of course plans and postgraduate programs in education active in Chile, the explicit presence of ethical aspects and academic integrity in their training plans was examined. Through a thematic analysis of the official documentation of the programs, we identified and analyzed various elements related to research ethics and academic integrity addressed in doctoral training, their prevalent approach normative or ethical discernment, their orientation proactive or preventive and the depth with which these aspects are treated. The results show that only one-third of the current programs explicitly address ethical training in research and that in these cases, their approach tends to emphasize more formal than substantive aspects, mainly limited to compliance with the informed consent protocol.

O presente artigo analisa, a partir de uma revisão documental de planos e programas de curso dos doutorados em Educação ativos no Chile, em que medida e como os programas de formação de futuros investigadores em educação pós-graduada abordam o desafio de integrar a educação ética em seu plano curricular. Mediante uma análise temática da documentação oficial dos programas se identificaram e analisaram diversos elementos relacionados com ética da investigação e integridade acadêmica abordados na formação pós-graduada, seu enfoque prevalente (normativo ou de discernimento ético), sua orientação (propositiva ou de prevenção) e a profundidade com que são tratados esses aspectos. Os resultados mostram que só um terço dos atuais programas abordam de maneira explícita a formação ética em investigação, e que, nestes casos, sua abordagem tende a ressaltar aspectos mais formais que substanciais, limitados fundamentalmente ao cumprimento do protocolo de consentimento informado.

Radiographers' knowledge and attitude toward informed consent / Conocimientos y actitud de los radiógrafos hacia el consentimiento informado / Conhecimento e atitudes de radiologistas sobre consentimento informado

Health professionals are obliged to provide the patient and/or his or her guardian with information about examinations and treatment. In the case of examinations involving the use of ionizing radiation, informed consent is essential to weigh the associated benefits and risks. This study evaluates the knowledge and attitude of radiographers regarding informed consent in the radiology department. It is a descriptive cross-sectional study using an online questionnaire, divided into three sections and containing 19 questions, detailing the demographics, knowledge, and attitude of radiographers. Participant responses were scored between 1 and 3, then calculated and averaged to determine mean scores. Student's t-test was used to determine the statistical significance between means. Mean scores for knowledge and attitudes ranged from 11.60 ±1.72 to 18.73 ±1.84. Radiographers with more experience showed a statistically significant difference (17.45 ±1.23) (p < 0.00) with those with less experience (15.34 ±1.52). Twenty-one percent of the respondents did not seek consent from patients prior to examination. This study demonstrated that these professionals are knowledgeable about informed consent; however, more emphasis should be placed on practice by providing training courses and disseminating correct practice.

Los profesionales sanitarios están obligados a facilitar al paciente y/o a su tutor información sobre los exámenes y el tratamiento. En el caso de los exámenes que implican el uso de radiaciones ionizantes, el consentimiento informado es esencial para sopesar los beneficios y riesgos asociados. Este estudio evalúa los conocimientos y la actitud de los radiógrafos en relación con el consentimiento informado en el departamento de radiología. Se trata de un estudio descriptivo transversal en el que se utilizó un cuestionario en línea, dividido en tres secciones y que contenía 19 preguntas, en las que se detallaban los datos demográficos, los conocimientos y la actitud de los radiógrafos. Las respuestas de los participantes se puntuaron entre 1 y 3, y luego se calcularon y promediaron para determinar las puntuaciones medias. Se utilizó la prueba t de Student para determinar la significación estadística entre las medias. Las puntuaciones medias de los conocimientos y las actitudes oscilaron entre 11,60 ±1,72 y 18,73 ±1,84. Los radiógrafos con más experiencia mostraron un mayor nivel de conocimientos y actitudes. Los radiógrafos con más experiencia mostraron una diferencia estadísticamente significativa (17,45 ±1,23) (p < 0,00) con los que tenían menos experiencia (15,34 ±1,52). El 21% de los encuestados no solicitó el consentimiento de los pacientes antes de la exploración. Este estudio demostró que estos profesionales tienen conocimientos sobre el consentimiento informado; sin embargo, se debería hacer más hincapié en la práctica impartiendo cursos de formación y difundiendo la práctica correcta.

Profissionais da saúde são obrigados a fornecer ao paciente ou seu guardião informações sobre exames e tratamentos. No caso de exames envolvendo o uso de radiação ionizante, consentimento informado é essencial para balancear os benefícios e riscos associados. Esse estudo avalia o conhecimento e atitudes de radiologistas a respeito do consentimento informado no departamento de radiologia. É um estudo transversal usando um questionário online, dividido em três seções e contendo 19 perguntas, detalhando a demografia, conhecimento e atitudes de radiologistas. As respostas dos participantes foram classificadas entre 1 e 3, e então calculadas e calculadas as médias para determinar os escores médios. O teste t de Student foi usado para determinar a significância estatística entre as médias. Escores médios para conhecimento e atitudes variaram de 11,60 ±1,72 a 18,73 ±1,84. Radiologistas com mais experiência mostraram uma diferença estatisticamente significante (17.45 ±1.23) (p < 0.00) daqueles com menos experiência (15.34 ±1.52). 21% dos respondentes não buscaram consentimento dos pacientes antes do exame. Esse estudo demonstrou que esses profissionais estão cientes do consentimento informado; entretanto, mais ênfase deve ser dada na prática ao fornecer cursos de treinamento e disseminando práticas corretas.

Percepciones y prácticas de clínicos sobre la autonomía del paciente quirúrgico durante el proceso de toma del consentimiento informado. Santo Domingo de los Tsáchilas, Ecuador / Perceptions and practices of clinicians on the autonomy of the surgical patient during the process of taking informed consent. Santo Domingo de los Tsáchilas, Ecuador / Percepções e práticas dos clínicos sobre a autonomia do paciente cirúrgico durante o processo de consentimento informado. Santo Domingo de los Tsáchilas, Equador

La forma como el clínico percibe al paciente y sus conocimientos sobre el consentimiento informado (CI) se reflejan en prácticas de respeto hacia el paciente, con relación a su autonomía y privacidad, desde un marco ético, deontológico y legal. El objetivo fue analizar las percepciones y prácticas de cirujanos en relación con el respeto de la autonomía del paciente durante el proceso de toma del CI en un hospital de la ciudad de Santo Domingo de los Tsáchilas, Ecuador. Metodología Cualitativa. La muestra fue por saturación, aplicando una entrevista semiestructurada. Los datos se analizaron por medio del programa Atlas Ti 8.0®, utilizando rastreo de categorías estructuradas. La mayoría de los médicos asume el consentimiento como un documento legal y obligatorio, por el miedo a procesos sancionatorios. Además, suele delegar su responsabilidad a otros profesionales, desconociendo componentes estructurales y éticos de la toma del consentimiento informado. Concluimos que la falta de conocimiento sobre CI lleva a percepciones y, por ende, a prácticas que vulneran la autonomía y la confidencialidad, además del respeto de recibir la información por parte del clínico que realiza la intervención.

The way in which the clinician perceives the patient and his knowledge about informed consent (IC) are reflected in practices of respect for the patient, in relation to their autonomy and privacy from an ethical, deontological and legal framework. Objective. Analyze the perceptions and practices by surgeons in relation to the respect of the autonomy of the patient during the process of taking the IC in a hospital in the city of de Santo Domingo de los Tsáchilas / Ecuador. Methodology. Cualitattivo. The sample was by saturation applying a semi-structured interview. The data were analyzed using the Atlas Ti 8.0 ® program using structured category tracking. Result. Most doctors take consent as a legal and mandatory document, for fear of sanctioning processes. In addition, they usually delegate their responsibility to other professionals ignoring structural and ethical components of taking informed consent. Conclusion. It is evident that the lack of knowledge about IQ leads to perceptions, and therefore, to practices that violate autonomy and confidentiality, in addition to the respect of receiving information from the clinician who performed the intervention.

A forma como o médico percebe o paciente e seus conhecimentos sobre o consentimento informado (IC) se refletem nas práticas de respeito ao paciente, em relação à sua autonomia e privacidade a partir de um arcabouço ético, deontológico e jurídico. Objetivo. Analise as percepções e práticas dos cirurgiões em relação ao respeito à autonomia do paciente durante o processo de tomada do IC em um hospital na cidade de Santo Domingo de los Tsáchilas/Equador. Metodologia. Qualitativo. A amostra foi por saturação aplicando uma entrevista semiestruturada. Os dados foram analisados utilizandose o programa Atlas Ti 8.0 ® utilizando rastreamento estruturado de categorias. Resultado. A maioria dos médicos toma o consentimento como documento legal e obrigatório, por medo de sancionar processos. Além disso, eles geralmente delegem sua responsabilidade a outros profissionais ignorando componentes estruturais e éticos de obter consentimento informado. Conclusão. É evidente que a falta de conhecimento sobre o QI leva a percepções e, portanto, a práticas que violam autonomia e confidencialidade, além do respeito ao recebimento de informações do médico que realizou a intervenção.

Reproductive rights of women with intellectual disability in India.

The reproductive rights of women with intellectual disability (WID) are a matter of concern for all stakeholders, including the woman herself, caregivers, guardians and her treating physicians. The judicial system often calls upon psychiatrists to opine regarding the “capacity to consent” of a WID to procedures such as medical termination of pregnancy and permanent sterilisation. Apart from physical and obstetric examinations, assessment of mental status and intelligence quotient (IQ) are also carried out to facilitate an understanding of the above issue. The Rights of Persons with Disabilities Act, 2016, (RPwD) and the Mental Healthcare Act, 2017, elucidate what constitutes free and informed consent as well as how to assess capacity. The assessment process of “capacity to consent” to reproductive system procedures among WID is important and can guide clinicians. Before assessing capacity, the treating physicians should educate a WID with appropriate information on the proposed procedure, its risks and benefits through various means of communication and then evaluate the “capacity to consent” to the procedure. This article summarises the provisions of the existing legislations on the reproductive rights of WID and puts forward guidance for clinicians on how to approach the issue.

Financial toxicity and dialysis: Autonomy and truth-telling in resource-limited settings

From an ethical perspective, resource limitations provide a challenge for healthcare providers. Handling disclosure of the financial details of treatment options in a way that empowers patients, even in the face of extreme poverty, requires careful consideration of the personal preferences and motivations of each patient. This article will consider the high costs of dialysis for patients experiencing extreme poverty in light of various ethical principles, including informed consent and truth-telling. It will conclude that a graduated method of disclosing the physical and financial burdens of each treatment option is the best way forward, particularly for healthcare workers engaged in resource-limited settings.

Missed and Lost to Follow-up Cases in HIV Positive Patients and the Impact of Lockdown During COVID-19 Pandemic on Adherence to Anti-retroviral Therapy at ART Center, Jhansi, Uttar Pradesh

Background: Anti-retroviral therapy (ART) for HIV has changed a highly fatal disease to a chronic manageable condition. National technical guidelines by NACO say that adherence of >95%(optimal) is required for optimal viral load suppression which is a challenge both for the patient and the health system. Objectives: This study was conducted to determine the reasons for missed and lost to follow-up (LFU) cases and to assess the impact of the COVID pandemic on ART adherence. Settings and Design: Cross-sectional study conducted at ART center, Jhansi. Methods and Material: 357 patients were administered a self-designed questionnaire after taking informed consent to enquire about the reasons for missing doses and LFU and whether they missed treatment during the lockdown. Statistical analysis used: the results were expressed in frequencies and percentages and appropriate statistical tests were applied. Results: 72% HIV patients had optimal adherence and 6.7% were on second-line treatment. Out of 357 patients, 56 had missed treatment and 10 were LFU. The main reasons for the missing were run out of pills, busy with other things and being away from home. The number of episodes of missed and LFU increased during the pandemic. The main problems faced were lack of transport (24), fear of catching the disease (7), no money to hire a vehicle (5). Conclusions: Constant monitoring and handholding of those with suboptimal adherence is required. Travel allowance to such patients and regular counseling will help to ensure adherence. Long-term solutions include vocational rehabilitation and awareness programs to reduce stigma and discrimination.

Healthcare Seeking Behaviour of Hospitalised COVID-19 Patients During Second Wave in Tertiary Care Hospital of Northern India

Background: The Coronavirus Disease (COVID-19) pandemic continues its deadly reign all over the world. Devising effective strategies for detecting and controlling the infection has become ever more critical. Effective prevention and control of the pandemic is entirely dependent on human behavior in terms of practicing preventive and curative measures. During the second wave of COVID-19, people’s perceptions of preventive and curative measures changed. Objective: To study healthcare-seeking behavior of hospitalized COVID-19 patients. Methods: Hospitalized patients due to COVID-19 in the month of March, April and May of 2021 were included in the study. Their attendants/close relatives were contacted telephonically to know about the admitted patients’ healthcare-seeking behavior. Verbal consent was taken from attendants before the commencement of the interview, followed by informing them about the purpose of the interview. Results: Amongst the subjects, there were more males than females (67.5 vs 32.4%), age ranged between 18 to 88 with a mean value of 56.61 ± 14.7 years. Self-medication was significantly associated with study subjects’ mortality (p=0.03). Conclusion: Elderly people were having higher mortality rate than their younger counterparts. People were hesitant to visit primary care physicians after having symptoms of COVID-19.

Prevalence, Socio-cultural Restrictions and Determinants of School Absenteeism during Menstruation among Adolescent School Girls in Bangalore

Introduction: Menstrual-related problems are one of the most common problems among adolescent girls and might adversely affect their performance in academic and other activities of daily life. Aims & Objectives: 1. To determine the prevalence of school absenteeism among adolescent school girls during menstruation. 2. To assess the restrictions which are imposed on adolescent school girls during menstruation. 3. To evaluate the various factors associated with school absenteeism during menstruation. Methods: A study was conducted by carrying out a questionnaire and focus group discussion between October 2019-January 2020 in seven schools of Bangalore city after obtaining the assent and informed consent signed by their parents. Result: The mean age of the girls was 14.45 ± 1.71. The proportion of school absenteeism during menstruation was (30.25%). The majority (89.25%) of the students among the school absentees missed one day of school during menstruation. Among the school absentees, pain/discomfort was one of the main reasons for missing school, accounting for (69.42%). (46.25%) of the students were restricted from any kind of religious activities. Pain during menstruation, shame, fear of leakage, lack of toilet or water supply, lack of a place to dispose of sanitary pads and absence of a private place to manage periods were some factors that were associated with school absenteeism during menstruation. Conclusion: Considerably high school absenteeism among adolescent girls due to menstruation was noted in this study, highlighting the need for improved interventions that reach girls at a young age.

A Study on Internet and Gaming Addiction, Hikikomori Trait and Insomnia Status among Medical Undergraduates at one of Cities of Western India

Background: College students appear more vulnerable in developing a dependence on the internet. Individuals with hikikomori are frequently reported to have social contact predominantly via the internet. Objectives: To find the prevalence of Internet addiction, gaming Addiction, Hikikomori Trait and Insomnia amongst medical undergraduates and to study their association with various determinants. Methodology: The present Cross-Sectional study was conducted among first to final-year medical students studying at various medical colleges in Indian City from February to May 2021. Data collection was done after obtaining the ethical permission of the Institute. A total of 400 students who gave consent were sent an electronic questionnaire. Results: The mean age of study participants was 20 ± 1.58 years. Internet addiction was present in 189(47.2%) participants, gaming addiction in 128 (32%) students and Hikikomori Trait was found in 98(24.5%) students. There was a statistically significant association between different grades of insomnia and internet, gaming addiction, and hikikomori trait (<?0.0001) in the present study. Conclusion: Internet addiction was present in almost half of the medical students while gaming addiction was seen in nearly one third of the students. Male gender and hostel stay had a statistically significant association with internet addiction, gaming addiction, insomnia and hikikomori trait.

An Exploratory Study on Quality of Life among Road Traffic Accident Victims in India

Background: Road traffic accidents are India’s sixth leading cause of mortality, with a substantial share of physical, psychosocial and economic losses in the productive age group. Objectives: To explore the victims’ and stakeholders’ perceptions on quality of life among road traffic accident victims in India. Methods: A qualitative study incorporating in-depth interviews among road traffic accident victims and key informant interviews among stakeholders was conducted from June to August 2019 (3 months) in Puducherry. Participants were selected using purposive sampling. Data was collected till the point of saturation with a semi-structured interview guide through six in-depth interviews among accident victims and six key informant interviews among stakeholders. Content analysis of the data was performed, and a conceptual framework was developed. Written informed consent from each participant was sought. Ethical clearance was obtained from the Institute Ethics Committee. Results: Four themes were identified: reasons for road traffic accidents, problems faced by the victims, problems faced by the caretaker or family member, and preventive measures for road traffic injuries. Conclusion: Physical, psychological, and financial problems were encountered by the victims, caretakers, and family members after a major road traffic accident. Accident victims felt that support from family members was indispensable in returning to normal life.