The Declaration of Helsinki in bioethics literature since the last revision in 2013.

The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

A Call to Revise the Declaration of Helsinki's Placebo Guidelines.

Since its introduction in 1964, the World Medical Association's Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects has enshrined the importance of safeguarding the well-being of human subjects in clinical research. The Declaration has undergone seven revisions, often in response to requests for clarification. I want to argue that the Declaration is in need of another revision in light of recent discoveries in placebo research.

Implementación de un cribado de fragilidad desde atención primaria en el Área Sanitaria de Ferrol / Implementation of a frailty screening from primary care in the Health Area of Ferro

Objetivos: Conocer la prevalencia de fragilidad entre los sujetos de 70 o más años que acuden a la consulta de enfermería de atención primaria, así como conocer las variables asociadas a la presencia de fragilidad. Metodología: Estudio observacional transversal en el que, tras un muestreo por conveniencia, se utilizó la Short Physical Performance Battery para realizar un cribado de fragilidad a 114 pacientes. Se utilizó una regresión logística multivariante para conocer las variables asociadas a la fragilidad. Resultados: Un 35,4% de los sujetos estudiados se catalogaron como frágiles tras la realización de las pruebas de función física. Las variables asociadas en el análisis multivariado a la fragilidad fueron la edad, el entorno de residencia, el riesgo de caídas, la toma de anticoagulantes orales y el tratamiento con insulina lenta. Conclusiones: Este estudio ha evidenciado las altas prevalencias existentes de fragilidad, poniendo de relieve la importancia de este tipo de cribados y la pertinencia de que la enfermería de atención primaria contribuya a su detección y manejo.(AU)

Objectives: To know the prevalence of frailty among subjects aged 70 or over who attend the primary care nursing consultation, as well as to know the variables associated with the presence of frailty. Methodology: Cross-sectional observational study in which, after convenience sampling, the Short Physical Performance Battery was used to screen 114 patients for frailty. Multivariate logistic regression was used to determine the variables associated with frailty. Results: 35.4% of the subjects studied were classified as frail after performing the physical function tests. The variables associated with frailty in the multivariate analysis were age, residence environment, risk of falls, taking oral anticoagulants, and slow insulin treatment. Conclusions: This study has evidenced the high existing prevalence of frailty, highlighting the importance of this type of screening and the relevance of primary care nursing contributing to its detection and management.(AU)

A Declaration of Helsinki for animals.

OBJECTIVE: This article examines the ethical principles underlying the Declaration of Helsinki as an internationally agreed justificatory framework for human medical research. The aim of the analysis is to consider the potential usefulness of these principles for defining an internationally agreed ethical 'best practice' in clinical veterinary research (CVR). It is suggested that the specific ethical responsibilities of the clinician to protect the interests of their patient when conducting medical research may be translated into the veterinary setting. Through exploring risk and harm, unproven interventions, vulnerability and informed consent, the article identifies the ethical risks of CVR. It is shown that veterinary regulators in the UK and the European Union have addressed these concerns to varying degrees; however, disagreements over the appropriateness of specific CVR practices are identified. A commitment to collaborative exploration of the benefits and challenges of implementing a Declaration of Helsinki for Animals is proposed.

Research Ethics in the Age of Digital Platforms.

Scientific research is growingly increasingly reliant on "microwork" or "crowdsourcing" provided by digital platforms to collect new data. Digital platforms connect clients and workers, charging a fee for an algorithmically managed workflow based on Terms of Service agreements. Although these platforms offer a way to make a living or complement other sources of income, microworkers lack fundamental labor rights and basic safe working conditions, especially in the Global South. We ask how researchers and research institutions address the ethical issues involved in considering microworkers as "human participants." We argue that current scientific research fails to treat microworkers in the same way as in-person human participants, producing de facto a double morality: one applied to people with rights acknowledged by states and international bodies (e.g., the Helsinki Declaration), the other to guest workers of digital autocracies who have almost no rights at all. We illustrate our argument by drawing on 57 interviews conducted with microworkers in Spanish-speaking countries.

Ethical analysis of cadaver supply and usage processes for research within the scope of the Helsinki Declaration.

Recent technological developments have considerably transformed the supply, storage, and transportation processes of cadavers, creating new and previously unforeseen ethical challenges regarding cadaver usage. In this study, we analyzed two aspects of the cadaver processing system-cadaver supply and its use in research. Thereafter, we highlighted the major ethical concerns underlying these stages and correlated our search results with the ethical principles outlined in the Declaration of Helsinki (DoH), or Helsinki Declaration. To ensure the reliability and continuity of medical progress, human-especially cadaver-research depends on the ethical priorities as outlined in the DoH: respect for autonomy, privacy/confidentiality, risks/burdens/benefits, and the protection of vulnerable groups. According to our ethics analysis, which also corresponds with the ethics guidelines of the Consensus Panel on Research with the Recently Dead, the most ignored values were respect for autonomy and privacy/confidentiality issues. Based on these ethical concerns, we provide recommendations to address these challenges in anatomy research.

Applicability and usefulness of the Declaration of Helsinki for forensic research with human cadavers and remains.

Bodies of deceased persons and human remains and their specimens (i.e., organs, bones, tissues, or biological samples) are essential in forensic research but ad hoc worldwide-recognized ethical standards for their use are still lacking. Such standards are needed both to avoid possible unethical practices and to sustain research in the forensic field. Pending consensus within the forensic science community regarding this topic, with this article we aim to stimulate a debate as to the applicability and usefulness of the Declaration of Helsinki in the field of forensic research involving human cadavers and remains. Considering the fundamental differences compared to clinical research involving human beings and the different moral obligations involved, we focus on the risks, burdens, and benefits of research, ethics committee approval, and informed consent requirements. The Declaration of Helsinki framework allows forensic researchers to focus on substantial ethical principles promoting the consistency, integrity, and quality of research. Consensus regarding ethical standards and the adoption of national and supranational laws that clearly regulate the use of human cadavers and remains, including those from autopsies, continues to be of primary importance for the forensic science community.

Translation and Construct Validity of the Feeling Scale and the Felt Arousal Scale in Portuguese Recreational Exercisers / Traducción y Validez de Constructo de la Feeling Scale y la Felt Arousal Scale en Ejercitadores Recreativos Portugueses / Tradução e Validade de Constructo da Feeling Scale e Felt Arousal Scale em Praticantes Portugueses de Exercício Recreacional

La Feeling Scale y la Felt Arousal Scale son escalas ampliamente utilizadas en la investigación del deporte. En este estudio, las escalas originales fueron traducidas del inglés al portugués. Posteriormente, se comprobó si las puntuaciones de afecto y activación en el Self-Assessment Manikin, una escala basada en imágenes, predecían las puntuaciones en la Feeling Scale y en la Felt Arousal Scale en 47 deportistas recreativos portugueses, antes y después de una sesión de ejercicio. El Self-Assessment Manikin mostró correlaciones de moderadas a fuertes con la Feeling Scale (r = 0.70 y r = 0.56, p < 0.01) y la Felt Arousal Scale (r = 0.65 y r = 0.72, p < 0.01), y un poder predictivo sustancial sobre la Feeling Scale (R2 = 47% y R2 = 31%) y la Felt Arousal Scale (R2 = 42% y R2 = 52%). En base a este estudio, la Feeling Scale y la Felt Arousal Scale demostraron ser instrumentos válidos para medir el afecto y la excitación en los ejercitantes recreativos portugueses. (AU)

The Feeling Scale and Felt Arousal Scale are widely used in sport research. They provide a practical assessment of self-reported affect and arousal during exercise. The original scales were translated from English to Portuguese. Afterward, it was tested if the affect and arousal scores in the picture-based Self-Assessment Manikin predicted the scores in the Feeling Scale and the Felt Arousal Scale in 47 Portuguese recreational exercisers, before and after an exercise session. Self-Assessment Manikin showed moderate-to-strong correlations with the Feeling Scale (r = 0.70 and r = 0.56, p < 0.01) and the Felt Arousal Scale (r = 0.65 and r = 0.72, p < 0.01), and substantial predictive power over the Feeling Scale (R2 = 47% and R2 = 31%) and the Felt Arousal Scale (R2 = 42% and R2 = 52%). The Feeling Scale and Felt Arousal Scale are valid instruments to measure affect and arousal in Portuguese exercisers. (AU)

A Feeling Scale e a Felt Arousal Scale são amplamente utilizadas na investigação em desporto. Fornecem uma avaliação prática dos estados psicológicos de afeto e da ativação durante o exercício. Neste estudo, as escalas originais foram traduzidas do inglês para português. Posteriormente, testou-se se a pontuação do afeto e da ativação na Self-Assessment Manikin, uma escala baseada em imagens, previa a pontuação na Feeling Scale e na Felt Arousal Scale em 47 desportistas recreativos portugueses, antes e depois de uma sessão de exercício. A Self-Assessment Manikin mostrou correlações moderadas a fortes com a Feeling Scale (r = 0.70 e r = 0.56, p < 0.01) e com a Felt Arousal Scale (r = 0.65 e r = 0.72, p < 0,01), e um poder preditivo substancial sobre a Feeling Scale (R2 = 47% e R2 = 31%) e a Felt Arousal Scale (R2 = 42% e R2 = 52%). A Feeling Scale e a Felt Arousal Scale são instrumentos válidos para medir o afeto e a ativação em desportistas recreativos portugueses (AU)

El paciente tratado de hepatitis C como fuente potencial de derivación de nuevos casos / Hepatitis C-treated patients as a potential source for referral of new cases

Introducción: Los antivirales de acción directa (AAD) representan una oportunidad para la eliminación del virus de la hepatitis C (VHC) por su simplicidad. No obstante, se precisan estrategias dirigidas a diagnosticar nuevos pacientes y a atraer diagnosticados sin evaluación. En este sentido, los pacientes con otras enfermedades virales crónicas que reciben un trato satisfactorio promueven la derivación a consulta de otros pacientes. Nuestro objetivo fue evaluar en qué grado los pacientes que han sido tratados con AAD recomendarían seguimiento y tratamiento a otros pacientes, así como las características de los pacientes que influyen en esta decisión. Pacientes y métodos: Se incluyó a 202 pacientes infectados por VHC tratados con AAD. Se les preguntó sobre conocimiento de otros infectados y deseos de compartir su experiencia, y se realizó encuesta de satisfacción general (cuestionario Baker) y específica de VHC (cuestionario HCVTSat). Además, se registraron variables demográficas, socioeconómicas y de la infección por VHC. Resultados: A pesar de que el 54,4% de los pacientes refería conocer a otros afectados, un 34,2% no estaría totalmente de acuerdo en compartir su experiencia global en consulta. El análisis de satisfacción general y específica mostró que los pacientes que compartirían su experiencia referían una percepción de mayor atención por parte del especialista (4,7±0,4 vs. 4,3±0,6, p=0,001), tenían más información sobre el tratamiento (4,6±0,5 vs. 4,0±0,7, p=0,001) y mayor apoyo social (4,5±0,7 vs. 4,0±0,8, p=0,001). Conclusiones: La percepción por parte del paciente tratado sobre satisfacción general del proceso de atención sanitaria e información de beneficios influye en el grado de recomendación a otros infectados. Se debe prestar atención y mejorar el conocimiento del tratamiento y la percepción de mejora en salud de los pacientes tratados, ya que puede contribuir a aumentar las derivaciones a consulta especializada.(AU)

Introduction: Direct-acting antivirals (DAAs) are an opportunity for hepatitis C virus (HCV) elimination. Strategies are needed to diagnose new patients and to attract those diagnosed without evaluation. Patients with other chronic viral diseases who receive satisfactory treatment promote referral of other patients for evaluation. Our aim was to evaluate whether patients who have been treated with DAAs would recommend follow-up and treatment to other patients as well as the characteristics that influence this decision. Patients and methods: Two-hundred and 2HCV-infected patients treated with DAAs were included. Patients were asked about whether they knew other infected people and their willingness to share their experience. A general satisfaction survey and a specific HCV satisfaction survey were carried out. Demographic, socioeconomic and HCV infection variables were recorded. Results: Despite the fact that 54.4% of the patients reported knowing others infected, 34.2% would not fully agree to share their experience. The analysis of general and specific satisfaction showed that patients who shared their experience mentioned a perception of greater care from the specialist (4.7±0.4 vs. 4.3±0.6, P=.001) and had more information on treatment expectations (4.6±0.5 vs. 4.0±0.7, P=.001) and social support (4.5±0.7 vs. 4.0±0.8, P=.001). Conclusions: The perception by treated patients of general satisfaction with the healthcare process and information about benefits influences the degree of recommendation to other infected people. Knowledge about treatment and perception of improvement in health of treated patients should be enhanced as it can contribute to increasing referrals to specialized consultation.(AU)

Giving and taking: ethical treatment assignment in controlled trials.

The current version of the Declaration of Helsinki states that 'the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention(s) … '. This wording implies that it is acceptable for patients to be assigned to receive an unproven new intervention and to be denied a best current proven intervention. We assert that patients being invited to participate in controlled trials cannot, ethically, be expected to forego proven beneficial forms of care. Patients being treated in controlled trials should not knowingly be disadvantaged compared with similar patients being treated in usual clinical care, where they have access to beneficial care. In this article, we have tried to separate for discussion 'the withholding of effective care from trial participants', 'informed consent to treatment', 'blinding' and 'use of placebos'.

A call for urgent action to safeguard our planet and our health in line with the helsinki declaration.

In 2015, the Rockefeller Foundation-Lancet Commission launched a report introducing a novel approach called Planetary Health and proposed a concept, a strategy and a course of action. To discuss the concept of Planetary Health in the context of Europe, a conference entitled: "Europe That Protects: Safeguarding Our Planet, Safeguarding Our Health" was held in Helsinki in December 2019. The conference participants concluded with a need for action to support Planetary Health during the 2020s. The Helsinki Declaration emphasizes the urgency to act as scientific evidence shows that human activities are causing climate change, biodiversity loss, land degradation, overuse of natural resources and pollution. They threaten the health and safety of human kind. Global, regional, national, local and individual initiatives are called for and multidisciplinary and multisectorial actions and measures are needed. A framework for an action plan is suggested that can be modified for local needs. Accordingly, a shift from fragmented approaches to policy and practice towards systematic actions will promote human health and health of the planet. Systems thinking will feed into conserving nature and biodiversity, and into halting climate change. The Planetary Health paradigm ‒ the health of human civilization and the state of natural systems on which it depends ‒ must become the driver for all policies.

Relación Transversal, Vertical y Sagital en Sujetos con Deformidad Facial Candidatos a Cirugía Ortognática / Transverse, Vertical and Sagittal Relationship in Subjects with Facial Deformity Candidates for Orthognathic Surgery

RESUMEN: El objetivo de este estudio fue evaluar la relación entre la clase esqueletal sagital y las condiciones transversales o verticales en sujetos con deformidad facial sin presencia de asimetría facial; Se realizó un análisis cefalomét rico de la clase esqueletal sagital, transversal y vertical en 115 sujetos con indicaciones de cirugía ortognática. Se consideró algunos datos del análisis cefalométrico de Steiner y el análisis cefalométrico de Ricketts en sentido sagital para determinar la clase esqueletal facial. A nivel transversal se determinó la dimensión transversal facial, dimensión transversal maxilar y dimensión transversal mandibular. A nivel vertical se determinó la dimensión vertical oclusal y dimensión vertical total. Al comparar las mediciones transversales y verticales entre sujetos de sexo femenino y masculino, se observó que los hom- bres presentaban mayores dimensiones que las mujeres (p=0,0001) en todos los análisis realizados. Los sujetos clase III presentaron mayor dimensión transversal facial (p=0,0002) y transversal mandibular (p=0,001) que los sujetos clase II. Además, se observó que los sujetos clase III presentaban mayor dimensión vertical total (p=0,002) que los sujetos clase II; Es posible concluir que existe características faciales transversales y verticales que se pueden relacionar con la posición sagital de las estructuras maxilo-mandibulares.

ABSTRACT: The aim of this study is to evaluate the relationship between sagittal skeletal class and transverse or vertical conditions in subjects with facial deformity without presence of facial asymmetry; A comparative study was conducted between the results of the cephalometric analysis of the sagittal, transverse and vertical skeletal class in 115 subjects with indications for orthognathic surgery. The Steiner cephalometric analysis in the sagittal direction was used to determine the facial skeletal class and the Ricketts cephalometric analysis in the sagittal analysis. At the transverse level it was determined the facial transverse dimension, maxillary transverse dimension and mandibular transverse dimension. At a vertical level it is determined the occlusal vertical dimension and total vertical dimension. When comparing cross-sectional and vertical measurements between female and male subjects, it was observed that male subjects presented greater dimensions than female subjects (p=0.0001). Class III subjects present greater facial transverse dimension (p=0.0002) and mandibular transverse dimension (p=0.001) than class II subjects. Also, it was observed that class III subjects had a greater total vertical dimension (p=0.002) than class II subjects; It is possible to conclude that there are facial characteristics transverse and vertical that can be related with the sagittal position of the maxillo-mandibular structures.