Developing rights-based standards for children having tests, treatments, examinations and interventions: using a collaborative, multi-phased, multi-method and multi-stakeholder approach to build consensus.

Children continue to experience harm when undergoing clinical procedures despite increased evidence of the need to improve the provision of child-centred care. The international ISupport collaboration aimed to develop standards to outline and explain good procedural practice and the rights of children within the context of a clinical procedure. The rights-based standards for children undergoing tests, treatments, investigations, examinations and interventions were developed using an iterative, multi-phased, multi-method and multi-stakeholder consensus building approach. This consensus approach used a range of online and face to face methods across three phases to ensure ongoing engagement with multiple stakeholders. The views and perspectives of 203 children and young people, 78 parents and 418 multi-disciplinary professionals gathered over a two year period (2020-2022) informed the development of international rights-based standards for the care of children having tests, treatments, examinations and interventions. The standards are the first to reach international multi-stakeholder consensus on definitions of supportive and restraining holds.    Conclusion: This is the first study of its kind which outlines international rights-based procedural care standards from multi-stakeholder perspectives. The standards offer health professionals and educators clear evidence-based tools to support discussions and practice changes to challenge prevailing assumptions about holding or restraining children and instead encourage a focus on the interests and rights of the child. What is Known: • Children continue to experience short and long-term harm when undergoing clinical procedures despite increased evidence of the need to improve the provision of child-centred care. • Professionals report uncertainty and tensions in applying evidence-based practice to children's procedural care. What is New: • This is the first study of its kind which has developed international rights-based procedural care standards from multi-stakeholder perspectives. • The standards are the first to reach international multi-stakeholder consensus on definitions of supportive and restraining holds.

Getting personal on overdiagnosis: On defining overdiagnosis from the perspective of the individual person.

How can overdiagnosis be defined, explained, and estimated on an individual level? The answers to this question are essential for persons to be able to make informed choices and give valid consents for tests. Traditional conceptions of overdiagnosis tend to depend on counterfactual thinking and prophetic abilities as you would have to know what would happen in the future if you did not test now. To avoid this, overdiagnosis can be defined in terms of the chance of diagnosing a person with a disease when this does not avoid or reduce manifest disease. To be able to relate this to 1's own life and deliberation, I argue that we need answers to specific questions such as the following: If I am tested, and the test and subsequent test results are positive, but I am not treated, what is the chance that I would not experience and suffer from manifest disease? A definition of overdiagnosis that aims at providing answers to this question is as follows: Prospectively overdiagnosis (of an individual person) is given by the estimated chance that a person having a positive test result would not experience and suffer from manifest disease if not treated or followed up in any way. Getting personal on overdiagnosis directs the attention of overdiagnosis estimates towards what matters in medicine: the experience of individual persons.

Looking for trouble? Diagnostics expanding disease and producing patients.

Novel tests give great opportunities for earlier and more precise diagnostics. At the same time, new tests expand disease, produce patients, and cause unnecessary harm in overdiagnosis and overtreatment. How can we evaluate diagnostics to obtain the benefits and avoid harm? One way is to pay close attention to the diagnostic process and its core concepts. Doing so reveals 3 errors that expand disease and increase overdiagnosis. The first error is to decouple diagnostics from harm, eg, by diagnosing insignificant conditions. The second error is to bypass proper validation of the relationship between test indicator and disease, eg, by introducing biomarkers for Alzheimer's disease before the tests are properly validated. The third error is to couple the name of disease to insignificant or indecisive indicators, eg, by lending the cancer name to preconditions, such as ductal carcinoma in situ. We need to avoid these errors to promote beneficial testing, bar harmful diagnostics, and evade unwarranted expansion of disease. Accordingly, we must stop identifying and testing for conditions that are only remotely associated with harm. We need more stringent verification of tests, and we must avoid naming indicators and indicative conditions after diseases. If not, we will end like ancient tragic heroes, succumbing because of our very best abilities.

Précising definitions as a way to combat overdiagnosis.

Roughly, overdiagnosis (ODx) occurs when people are harmed by receiving diagnoses (often accompanied by interventions) that do not benefit them, usually because the diagnosed conditions do not pose a threat to their health. ODx is a theoretical as well as a practical problem as it relates to definitions of disease. Elsewhere, it has been argued that disease is a vague concept and that this vagueness may contribute to ODx. In response, we develop a stipulative or précising definition of disease, for the specific purpose of decreasing or preventing ODx. We call this diseaseODx , aimed at distinguishing cases where it would be beneficial to identify (and treat the condition) from those where diagnosis is more likely to harm than benefit. A preliminary definition of diseaseODx is that X is a diseaseODx iff there is dysfunction that has a significant risk of causing severe harm. This paper examines the 3 concepts in this definition, using a naturalistic account of function, a Feinbergian account of comparative harm, and a probabilistic understanding of risk. We then test the utility of this approach using examples of clinical conditions that are currently overdiagnosed.

Evaluating diagnostic tests.

Although much has been written on the role of randomized controlled trials and mechanistic reasoning in the evaluation of therapeutic treatments, philosophers of medicine have not yet turned their attention to the question of how diagnostic tests and procedures should be evaluated. I aim to begin to fill this gap by examining each of the following questions: What is the best way to determine the accuracy of a diagnostic test? What is the best way to determine the clinical effectiveness of a diagnostic test? Can an accurate diagnostic test be considered medically valuable even if it is not clinically effective? I argue that while diagnostic accuracy is a minimum requirement for both clinical effectiveness and medical value, accuracy and effectiveness are not sufficient for determining the value of a diagnostic test, because diagnostic value extends beyond patient outcomes.

El síndrome NSLQT / The syndrome of no one knows what the patient has

Se hace una serie de consideraciones a partir de la denominación operativa de síndrome NSLQT: nadie sabe lo que tiene, frase introducida de manera ingeniosa en el Hospital General Universitario de Cienfuegos, para calificar a los pacientes en los que, a pesar de innumerables esfuerzos de todo tipo: clínicos, de indicación de exámenes complementarios, discusiones y rediscusiones diagnósticas, consultas e interconsultas a los más disímiles especialistas, no se puede precisar con claridad el padecimiento de base del enfermo. Esta es una situación estresante para los enfermos, los familiares y el personal a cargo de la atención, con significación no solo en el ámbito asistencial, sino también administrativo, social, ético y posiblemente legal(AU)

This paper presents a series of considerations on the syndrome known as no one knows what the patient has, a phrase ingeniously coined at the University General Hospital of Cienfuegos to refer to those patients whose underlying condition cannot be clearly established despite countless efforts of all sorts: application of clinical methods, investigations, continuous diagnostic discussions, and consultations with the most diverse specialists. This represents a stressful situation for patients, relatives, and medical staff, with a significant impact not only on the health care setting, but also on administrative, social, ethical, and possibly legal spheres(AU)

El papel de la autopsia en la práctica clínica actual / The current role of autopsy in current clinical practice

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A matter of accuracy. Nanobiochips in diagnostics and in research: ethical issues as value trade-offs.

The paper deals with the introduction of nanotechnology in biochips. Based on interviews and theoretical reflections, it explores blind spots left by technology assessment and ethical investigations. These have focused on possible consequences of increased diffusability of a diagnostic device, neglecting both the context of research as well as increased accuracy, despite it being a more essential feature of nanobiochip projects. Also, rather than one of many parallel aspects (technical, legal and social) in innovation processes, ethics is considered here as a ubiquitous system of choices between sometimes antagonistic values. Thus, the paper investigates what is at stake when accuracy is balanced with other practical values in different contexts. Dramatic nanotechnological increase of accuracy in biochips can raise ethical issues, since it is at odds with other values such as diffusability and reliability. But those issues will not be as revolutionary as is often claimed: neither in diagnostics, because accuracy of measurements is not accuracy of diagnostics; nor in research, because a boost in measurement accuracy is not sufficient to overcome significance-chasing malpractices. The conclusion extends to methodological recommendations.

[Clinical and ethical differences between diagnosing and screening].

Screening is often defined as systematic examinations of healthy citizens to identify those with asymptomatic disease. In our modern society many persons have chronic conditions and it is not so easy to draw the line between healthy and unhealthy citizens. Today, many health-care activities aim at detecting conditions at an early non-symptomatic stage of the disease process in order to be able to avoid possible progression to the next stage. On this basis, we suggest to broaden the definition of screening to reflect the realities of modern health care.

Retraso diagnóstico de la hipertensión arterial en pacientes diabéticos atendidos en atención primaria / Delayed diagnosis of hypertension in diabetic patients monitored in primary care

Introducción y objetivos. El retraso diagnóstico de la hipertensión arterial puede favorecer un control deficiente y el incremento del riesgo cardiovascular. El objetivo es estimar el retraso diagnóstico de la hipertensión en lo diabéticos tipo 2 y la probabilidad de que se los diagnostique en un plazo adecuado (primeros 6 meses) y analizar las características de pacientes y médicos asociadas al retraso diagnóstico. Métodos. Cohorte dinámica retrospectiva, con 7 años de seguimiento en atención primaria, de 8.074 adultos diabéticos a los que se incluyó en el momento de cumplir criterios diagnósticos de hipertensión arterial considerando dos umbrales: 140/90 y 130/80 mmHg. Se estimó el tiempo transcurrido desde el cumplimiento de dichos criterios hasta el registro del diagnóstico la evolución temporal de la probabilidad de que no se diagnosticara mediante análisis de supervivencia de Kaplan-Meier y las variables asociadas al diagnóstico adecuado mediante regresión logística. Resultados. El retraso diagnóstico medio fue 8,9 ± 15,4 meses para pacientes que acudieron con presión arterial ≥ 140/90 mmHg frente a los 15,2 ± 19,6 meses de aquellos con presión < 140/90 mmHg (p < 0,001). Las principales variables asociadas al diagnóstico adecuado fueron presión arterial inicial ≥ 140/90 mmHg (odds ratio = 2,77; intervalo de confianza del 95%, 2,44-3,15), no tener infarto agudo de miocardio previo (odds ratio = 2,23; intervalo de confianza del 95%, 1,67-2,99), obesidad (odds ratio = 1,70; intervalo de confianza del 95%, 1,44-1,99), no sufrir depresión (odds ratio = 1,63; intervalo de confianza del 95%, 1,27-2,08), ser mujer (odds ratio = 1,29; intervalo de confianza del 95%, 1,14-1,46), tener más edad o tratamiento antidiabético más intensivo. La edad del médico mostró relación inversa y su estabilidad laboral, relación directa. Conclusiones. El retraso diagnóstico medio de la hipertensión en diabéticos fue > 6 meses y varió según el umbral diagnóstico utilizado. Los pacientes con presión arterial inicial ≥ 140/90 mmHg presentaron mayor probabilidad de diagnóstico adecuado(AU)

Introduction and objectives. Delayed diagnosis of hypertension may result in inadequate blood pressure control and increased cardiovascular risk. The aim of this study was to estimate the delay in hypertension diagnosis in patients with type 2 diabetes and the likelihood of a diagnosis within a suitable period (first 6 months), and to analyze the patient and physician characteristics associated with delayed diagnosis. Methods. Retrospective dynamic cohort study, with a 7-year follow-up in primary care, of 8074 adult patients with diabetes who met the diagnostic criteria for hypertension. Two thresholds were considered: 140/90 mmHg and 130/80 mmHg. The time elapsed between meeting these criteria and recording the diagnosis was estimated; the time course of the likelihood of a missed diagnosis and the variables associated with correct diagnosis were assessed by Kaplan-Meier survival analysis and logistic regression analysis, respectively. Results. The mean diagnostic delay was 8.9 (15.4) months in patients with blood pressure≥140/90 mmHg compared to 15.2 (19.6) months for those with <140/90 mmHg (P<.001). The main variables associated with correct diagnosis were baseline blood pressure≥140/90 mmHg (odds ratio=2.77; 95% confidence interval, 2.44-3.15), no history of acute myocardial infarction (odds ratio=2.23; 95% confidence interval, 1.67-2.99), obesity (odds ratio=1.70; 95% confidence interval, 1.44-1.99), absence of depression (odds ratio=1.63; 95% confidence interval, 1.27-2.08), female sex (odds ratio=1.29; 95% confidence interval, 1.14-1.46), older age, and taking more intensive antidiabetic therapy. There was an inverse relationship with the age of physicians and a direct relationship with their professional stability. Conclusions. The mean diagnostic delay in hypertension among diabetic patients was greater than 6 months and varied according to the diagnostic threshold used. Patients with baseline blood pressure≥140/90 mmHg were more likely to receive a timely diagnosis(AU)

Acurácia da biópsia de congelação no câncer de pele não-melanoma / Accuracy of frozen section biopsy in non-melanoma skin cancer

Os carcinomas basocelular e espinocelular juntos respondem por mais da metade dos casos novos de câncer. A biópsia de congelação é frequentemente usada em áreas como cabeça e pescoço, nas quais uma margem ampla poderia ocasionar cicatrizes desfigurantes ou dificuldades de reconstrução, porém o resultado da biópsia de congelação nem sempre corresponde ao da parafina. O presente trabalho tem como objetivo fazer uma revisão bibliográfica sobre a correlação do resultado da biópsia de congelação intraoperatória e o resultado final do exame anatomopatológico da peça cirúrgica (exame de parafina), pela sua importância na ressecção curativa e na reconstrução do local acometido. Foi realizado levantamento bibliográfico, tendo como base artigos científicos publicados a respeito da acurácia da biópsia de congelação nos últimos 10 anos. A biópsia de congelação é um método eficiente e confiável, que deve ser aplicado em áreas em que a ressecção deve ser a mais econômica possível. Em áreas com tumor pequeno e sobra de pele a biópsia de congelação é pobre, dispensável e não altera resultados. A biópsia de congelação se mostrou um método eficiente, de custo acessível e de boa reprodutibilidade quando realizada por profissionais experientes e em casos bem indicados.

Together, basal cell and squamous carcinomas account for more than 50% of all new cases of cancer. Frozen section biopsy is often used in areas such as the head and neck, in which a wide margin could cause disfiguring scars or difficulties with reconstruction, but the results of frozen biopsy do not always correspond to the results of paraffin sections. This paper aims to review existing literature on the correlation between the results of intraoperative frozen biopsy and final pathological examination of surgical specimens (examination of paraffin sections), because of the importance of frozen biopsy in curative resection and reconstruction of affected sites. A literature review was conducted, based on scientific articles published over the previous 10 years about the accuracy of intraoperative frozen sections. Frozen section biopsy is an efficient and reliable method that should be applied in areas where resection should be as economical as possible. However, in cases with small tumors and excess skin, the results of frozen biopsy are poor, dispensable, and not meaningful. Frozen biopsy is an efficient, affordable, and reproducible method when performed by experienced staff in well-selected cases.

Wish-fulfilling medicine in practice: a qualitative study of physician arguments.

There has been a move in medicine towards patient-centred care, leading to more demands from patients for particular therapies and treatments, and for wish-fulfilling medicine: the use of medical services according to the patient's wishes to enhance their subjective functioning, appearance or health. In contrast to conventional medicine, this use of medical services is not needed from a medical point of view. Boundaries in wish-fulfilling medicine are partly set by a physician's decision to fulfil or decline a patient's wish in practice. In order to develop a better understanding of how wish-fulfilling medicine occurs in practice in The Netherlands, a qualitative study (15 semistructured interviews and 1 focus group) was undertaken. The aim was to investigate the range and kind of arguments used by general practitioners and plastic surgeons in wish-fulfilling medicine. These groups represent the public funded realm of medicine as well as privately paid for services. Moreover, GPs and plastic surgeons can both be approached directly by patients in The Netherlands. The physicians studied raised many arguments that were expected: they used patient autonomy, risks and benefits, normality and justice to limit wish-fulfilling medicine. In addition, arguments new to this debate were uncovered, which were frequently used to justify compliance with a patient's request. Such arguments seem familiar from conventional medicine, including empathy, the patient-doctor relationship and reassurance. Moreover, certain arguments that play a significant role in the literature on wish-fulfilling medicine and enhancement were not mentioned, such as concepts of disease and the enhancement-treatment dichotomy and 'suspect norms'.

Algunos desafíos bioéticos de la predicción y prevención secundaria en oncología / Bioethics challenges in prediction and secondary prevention in oncology

Los avances en tecno-ciencia nos han permitido cambiar el clásico concepto de enfermedad desde el evidente estado de disminución física y debilitamiento, por conceptos más complejos y dinámicos, entre los cuales destacan las enfermedades asintomáticas o “silenciosas”, los marcadores tumorales y recientemente la incorporación de anomalías en los genes como predictores de enfermedades. Tales marcadores y genes de predisposición genética aumentan día a día y muchos de ellos ya se utilizan en la práctica clínica. Los profesionales sanitarios debemos conocer a cabalidad sus indicaciones, comprender sus beneficios así como también debemos saber reconocer sus limitaciones y aspectos controversiales como herramientas de diagnóstico y como elementos predictivos. Los datos genéticos pueden llegar a ser extremadamente delicados por cuanto su difusión inapropiada puede vulnerar la dignidad y los derechos de las personas. Su divulgación puede significar discriminación y estigmatización para quien es portador de defectos del código genético, por lo que los médicos debemos ser los primeros garantes de la privacidad y confidencialidad de esta información. En general se recomienda su utilización en la identificación de grupos de riesgo sólo cuando se pueden ofrecer terapias o estrategias que mejoren el curso natural de la enfermedad pues de lo contrario, sólo contribuirán a generar ansiedad y angustia sin ningún beneficio evidente para el paciente.

Advances in techno-science have allowed us to change the classical concept of disease from the spectrum of signs of physical decline and weakness, for more complex and dynamic concepts, such as asymptomatic or "silent" diseases and recently the incorporation of abnormal genes as predictors of disease. Among these predictors, tumor markers are growing continuously and many of them are already used in clinical practice. Healthcare professionals must understand their benefits as well as should be able to recognize its controversial aspects such as diagnostic tools and predictors. Genetic data can be extremely sensitive because its disclosure could undermine the dignity and rights of individuals. Its information can result in risk of discrimination and stigmatization and for these reasons doctors should be the first guarantee of privacy and confidentiality of this information. Its use in the identification of risk groups is acceptable only when they can provide therapies or strategies to improve the natural course of the disease.

The challenges of oral-based diagnostics in extending the role of dentistry as a health care profession: property rights, privacy, and informed consent.

Saliva may be a legal and ethical counterpart of other bodily fluids in diagnostic testing to blood and urine, with regard to its role in diagnostic testing. Two paradigms that have been proposed in the literature to address these challenges are reviewed in this paper. The first is centered on ownership and property rights to saliva, including financial compensation from commercially developed products using saliva. The commodification of saliva as property is also discussed. The second paradigm is related to privacy and the potential for genetic discrimination, given the unwarranted disclosure of confidential information. The management of saliva specimens from dental patients and research participants will also require the implementation of innovative approaches to obtain informed consent.

Una reflexión ética desde la práctica clínica sobre los exámenes y procedimientos de ayuda diagnóstica / An ethical reflection from clinical practice on the examinations and diagnostic support procedures

El acto médico por excelencia es la atención del paciente; este es un proceso complejo, marcado por la relación entre dos personas en razón de una enfermedad que agrede a una de ellas y que la otra pretende aliviar. En este marco de peculiaridad existen directrices comunes en la relación médico paciente y que tienen que ver con la ética. Normalmente la atención se inicia con la historia o anamnesis, para seguir con el examen físico y luego con la solicitud de exámenes de laboratorio o procedimientos de diversa índole cuya finalidad es sustentar la hipótesis diagnóstica y permitir iniciar una acción terapéutica adecuada. Esta última parte, la de la ayuda tecnológica, requiere atención porque allí pueden generarse omisiones o desviaciones del recto proceder. El método de análisis se desarrolla contrastando los príncipios básicos de la ética: beneficencia, no maleficencia, justicia y autonomía con los distintos elementos envueltos en el acto de solicitar exámenes de ayuda diagnóstica. Para facilitar la reflexión, la petición de exámenes se desglosa, en: a) selección de los test; b) petición o solicitud propiamente tal; c) direccionamiento del paciente y d) análisis y comunicación de resultados. Cada uno de estas etapas requiere atención porque, muchas veces tras el automatismo con que se ejecutan se malogran algunos de estos principios éticos. Estas reflexiones pretenden hacer presente estas zonas de conflicto. La repercusión ética puede hacerse más compleja cuando el acto médico de petición de exámenes se realiza bajo el prisma de la enseñanza de la medicina.

The essential medical action is patient care. This is a complex process, in which one subject tries to relieve another, that suffers an illness. This particular relationship is governed by ethical principles. Medical care starts with history taking, followed by physical examination and the request of laboratory tests to confirm a diagnostic hypothesis and provide an appropriate treatment. When laboratory tests are requested, a series of ethical issues can arise. The basic ethical principles of avoiding harm, beneficence, non maleficence, justice and autonomy must be taken into account at the moment of requesting laboratory tests. The stages of this act can be divided in selection of the adequate test, requesting them, educating the patient and finally the analysis and communication of results. Each of these stages, if carried out automatically and without a proper discern, can violate some of the above mentioned ethical principles. The ethical repercussions can become more complex if these medical acts are done while teaching medicine.

Una reflexión ética, desde la práctica clínica, sobre los exámenes clínicos y los procedimientos de apoyo diagnóstico / Ethic reflection from the medical practice, about the diagnosis procedures

El acto médico por excelencia es la atención del paciente; este es un proceso complejo, marcado por la relación entre dos personas en razón de una enfermedad que agrede a una de ellas y la otra pretende aliviar. En este marco de peculiaridad existen directrices comunes en la relación médico paciente y que tienen que ver con la ética. Normalmente la atención se inicia con la historia o anamnesis, para seguir con el examen físico y luego con la solicitud de exámenes de laboratorio o procedimientos de diversa índole cuya finalidad es sustentar la hipótesis diagnóstica y permitir iniciar una acción terapéutica adecuada. Esta última parte, la de la ayuda tecnológica, requiere atención porque allí puede haber omisiones o desviaciones del recto proceder. El método de análisis se desarrolla contrastando los principios básicos de la ética: Beneficencia, No maleficencia, Justicia y Autonomía con los distintos elementos envueltos en el acto de solicitar exámenes de ayuda diagnóstica. Para facilitar la reflexión, la petición de exámenes se desglosa, en: a) selección de los test; b) petición o solicitud propiamente tal; c) direccionamiento del paciente y d) análisis y comunicación de resultados. Cada uno de estas etapas requiere atención porque, muchas veces tras el automatismo con que se ejecutan se malogran algunos de esos principios éticos. Estas reflexiones pretenden hacer presente estas zonas de conflicto. La repercusión ética puede hacerse más compleja cuando el acto médico de petición de exámenes se realiza bajo el prisma de la enseñanza de la medicina

The essential medical action is patient care. This is a complex process, in which one subject tries to relieve another, that suffers an illness. This particular relationship is governed by ethical principles. Medical care starts with history taking, followed by physical examination and the request of laboratory tests to confirm a diagnostic hypothesis and provide an appropriate treatment. When laboratory tests are requested, a series of ethical issues can arise. The basic ethical principles of avoiding harm, beneficence, non maleficence, justice and autonomy must be taken into account at the moment of requesting laboratory tests. The stages of this act can be divided in selection of the adequate test, requesting them, educating the patient and finally the analysis and communication of results. Each of these stages, if carried out automatically and without a proper discern, can violate some of the above mentioned ethical principles. The ethical repercussions can become more complex if these medical acts are done while teaching medicine

Property and privacy paradigms of "marketable spit": an ethical and legal counterpart to blood?

Major advances in the testing of oral fluid (e.g., saliva) may lead to the diagnosis and treatment of previously undiagnosed conditions and may enable dentists to manage oral disease more effectively. Such use of another body fluid, blood, is already well established. Blood is a complex tissue that has been extensively researched and is now used for a wide variety of diagnostic tests. It is also regarded as a form of property with ethical and legal dimensions. If saliva is to fulfill a similar role, it should perhaps be granted those same protections. This paper advances the concept that saliva should be considered a form of property, possibly within personal biological materials law. The emerging potential for the development of marketable products from oral fluids raises the issue of protecting the research participant's ethical and legal rights. In particular, violation of privacy and genetic discrimination may arise from the testing of salivary DNA. Respect for autonomy requires that the clinician inform a patient or research participant about his or her rights to property and privacy as these may pertain to oral fluid.