Lessons from Theranos - Restructuring Biomedical Innovation.

After raising more than $700 million, Elizabeth Holmes, the founder and chief executive officer of a healthcare startup once valued at $10 billion, was found guilty on four charges of defrauding investors. Founded in 2003, Theranos Inc. was a privately held corporation that aimed to disrupt the diagnostics industry with rapid, direct-to-consumer laboratory testing using only "a drop of blood" and the company's patented Nanotainer technology. By exploiting gaps in regulatory policy, Theranos brought its panel of laboratory tests to patients without pre-market review or validation from peer-reviewed scientific research. Investigations into Theranos' dubious operations and inaccurate test results exposed the failed venture which had squandered millions of dollars. Theranos affected the lives and health of patients further disrupting an already tenuous relationship between healthcare and the public - the importance of which cannot be understated in the setting of the COVID-19 pandemic. As medical systems address a national public health crisis and pervasive structural inequities, we must align stakeholder incentives between industry and academic biomedical innovation to rebuild trust with our patients.

Resultados y repercusión clínico-anestésica de los exámenes complementarios preoperatorios en pacientes ASA I para cirugía ambulatoria / Results and clinical-anesthetic repercussion of preoperative complementary tests in Asa-I patients scheduled for ambulatory surgery

Introducción: La selección de exámenes laboratorios preoperatorios (test específicos o exámenes por imágenes) debe hacerse como medida complementaria en el caso de sospecha clínica. La solicitud indiscriminada y de rutina es innecesaria e implica costos adicionales para la institución, además de la posibilidad de resultados falsos positivos, con repercusiones más o menos graves para los pacientes. Objetivo: Destacar los resultados y la repercusión clínico-anestésica de los exámenes complementarios preoperatorios en pacientes ASA I para cirugía ambulatoria que llegan a cirugía ambulatoria en el Hospital General Docente Comandante Pinares del municipio de San Cristóbal, Artemisa durante el año 2017. Método: Se realizó un estudio observacional de tipo descriptivo, de corte transversal en el Hospital General Docente Comandante Pinares del municipio de San Cristóbal, Artemisa, durante el año 2017. El universo se representa por 823 pacientes que se sometieron a cirugía ambulatoria, la muestra fue de 394 pacientes, según criterio de selección no probabilístico, intencional. Resultados: El sexo con mayor predominio en las cirugías fue el femenino 65,98 por ciento, las edades más frecuentes fue de 18-30 años. La cirugía electiva que más se realizó fue la colecistectomía 43,18 por ciento. En cuanto a los exámenes paraclínicos realizados, se detectó una baja incidencia de alteraciones, la complicación perioperatoria detectada fue la crisis hipertensiva 0,50 por ciento. Conclusión: Los resultados de los exámenes complementarios fueron normal en la mayoría de los pacientes, sin repercusiones o cambios en la conducta clínico anestésica. Además, generaron un elevado gasto a la institución de salud(AU)

Introduction: The selection of preoperative laboratory tests (specific tests or imaging tests) should be done, as a complementary measure, in the case of clinical suspicion. Indiscriminate and routine request is unnecessary and implies additional costs for the institution, in addition to the possibility of false positive results, with more or less serious repercussions for patients. Objective: To highlight the results and the clinical-anesthetic repercussion of complementary preoperative examinations in ASA-I patients who arrive for ambulatory surgery at Commandant Pinares General Teaching Hospital in San Cristóbal Municipality, Artemisa Province, during the year 2017. Method: An observational, descriptive, cross-sectional study was carried out at Commandant Pinares General Teaching Hospital in San Cristóbal Municipality, Artemisa Province, during the year 2017. The universe was represented by 823 patients who underwent ambulatory surgery. The sample consisted of 394 patients, following nonprobabilistic, intentional selection criteria. Results: The sex with the highest prevalence of surgeries was the female sex (65.98 percent). The most frequent ages were between 18 and 30 years. The most performed elective surgery was cholecystectomy (43.18 percent). Regarding the paraclinical examinations performed, a low incidence of alterations was detected; the perioperative complication detected was hypertensive crisis (0.50 percent). Conclusion: The results of the complementary examinations were normal in most of the patients, without repercussions or changes in the clinical anesthetic behavior. In addition, they generated high expenses for the health institution(AU)

[Ethics and confidentiality of a patient in a medical biology laboratory]. / L'éthique et la confidentialité du patient au laboratoire de biologie médicale.

Confidentiality is based on principles of deontology and ethics, which are included in French regulations and supported by the professional orders. It contributes to the respect and dignity of the patient. If this consideration of the human person is old, it has been updated to build the framework imposed by the accreditation of medical biology laboratories. Confidentiality is thus reflected in a charter of ethics, a model of which we propose here. It reflects the commitments of healthcare professionals in the processing of biological samples from patients. Confidentiality is thus applied, in a practical way, at each phase of the laboratory's activity. In the pre-analytical phase, it organizes the reception of the patient and the taking of samples, taking into account the particular case of minors. In the analytical phase, confidentiality imposes limited access to the technical premises and the organization of the flow of personnel from outside the laboratory. Finally, in the post-analytical phase, the reporting of results is regulated, depending on the type of analyses performed and the person to whom the results are to be reported (patient or prescriber). The particular case of spermiology illustrates all these points. Finally, during these phases of sample processing, document management is also a matter of confidentiality and data protection. Confidentiality is essential to the functioning of a health care structure, but it is restrictive in its day-to-day implementation. Nevertheless, it must be combined with an awareness of all staff to address the ethical issue of human dignity.

Trends in the prevalence of COVID-19 infection in Rio Grande do Sul, Brazil: repeated serological surveys. / Evolução da prevalência de infecção por COVID-19 no Rio Grande do Sul, Brasil: inquéritos sorológicos seriados.

COVID-19, the disease produced by the virus SARS-CoV-2, has spread quickly throughout the world, leading the World Health Organization to first classify it as an international health emergency and, subsequently, declaring it pandemic. The number of confirmed cases, as April 11, surpassed 1,700,000, but this figure does not reflect the prevalence of COVID-19 in the population as, in many countries, tests are almost exclusively performed in people with symptoms, particularly severe cases. To properly assess the magnitude of the problem and to contribute to the design of evidence-based policies for fighting COVID-19, one must accurately estimate the population prevalence of infection. Our study is aimed at estimating the prevalence of infected individuals in the state of Rio Grande do Sul, Brazil, to document how fast the infection spreads, and to estimate the proportion of infected persons who present or presented symptoms, as well as the proportion of asymptomatic infections. Four repeated serological surveys will be conducted in probability samples of nine sentinel cities every two weeks. Tests will be performed in 4,500 participants in each survey, totaling18,000 interviews. Interviews and tests will be conducted at the participants' household. A rapid test for the detection of antibodies will be used; the test was validated prior to the beginning of the fieldwork.

A COVID-19 é uma doença produzida pelo vírus SARS-CoV-2. Esse vírus se espalhou rapidamente pelo mundo, o que levou a Organização Mundial da Saúde a classificar a COVID-19 como uma emergência de saúde internacional e, posteriormente, a declará-la uma pandemia. O número de casos confirmados, no dia 11 de abril de 2020, já passa de 1.700.000, porém esses dados não refletem a real prevalência de COVID-19 na população, visto que, em muitos países, os testes são quase que exclusivamente realizados em pessoas com sintomas, especialmente os mais graves. Para definir políticas de enfrentamento, é essencial dispor de dados sobre a prevalência real de infecção na população. Este estudo tem por objetivos avaliar a proporção de indivíduos já infectados pelo SARS-CoV-2 no Rio Grande do Sul, Brasil, analisar a velocidade de expansão da infecção e estimar o percentual de infectados com e sem sintomas. Serão realizados quatro inquéritos sorológicos repetidos a cada 15 dias, com amostragem probabilística de nove cidades sentinela, em todas as sub-regiões do Estado. As entrevistas e testes ocorrerão no âmbito domiciliar. Serão utilizados testes rápidos para detecção de anticorpos, validados previamente ao início da coleta de dados.

Combating COVID-19 Pandemic in Nepal: Ethical Challenges in an Outbreak.

Pandemic outbreak of COVID-19 is the largest of its kind of this century. All countries throughout the globe are trying their best to contain the disease and eliminate at the earliest. Efforts are continuing to improve the outcome of the infection in terms of minimizing the morbidity and mortality. As a public health strategy every state has the responsibility of protecting the health of the community and such measures includes the preventive measures like social distancing or even lockdown of the state as a whole restricting the movement of the people, diagnostic measures like testing the suspects, contact tracing and isolation of the patients. Treatment of the infected requires decisions in resource constraint situation particularly ICU beds and ventilators. In the meantime, protecting doctors, nurses, other health workers as well as frontline workers need personal protective equipment which is a scarce commodity. While doing so there might be a compromise in the individual autonomy, privacy, confidentiality, and social justice for the beneficence for the larger community. This is an attempt to explore the ethical quandaries in relation to combating COVID-19 in Nepal by relating the issues with the principles of biomedical ethics.

Evolução da prevalência de infecção por COVID-19 no Rio Grande do Sul, Brasil: inquéritos sorológicos seriados / Trends in the prevalence of COVID-19 infection in Rio Grande do Sul, Brazil: repeated serological surveys

Resumo A COVID-19 é uma doença produzida pelo vírus SARS-CoV-2. Esse vírus se espalhou rapidamente pelo mundo, o que levou a Organização Mundial da Saúde a classificar a COVID-19 como uma emergência de saúde internacional e, posteriormente, a declará-la uma pandemia. O número de casos confirmados, no dia 11 de abril de 2020, já passa de 1.700.000, porém esses dados não refletem a real prevalência de COVID-19 na população, visto que, em muitos países, os testes são quase que exclusivamente realizados em pessoas com sintomas, especialmente os mais graves. Para definir políticas de enfrentamento, é essencial dispor de dados sobre a prevalência real de infecção na população. Este estudo tem por objetivos avaliar a proporção de indivíduos já infectados pelo SARS-CoV-2 no Rio Grande do Sul, Brasil, analisar a velocidade de expansão da infecção e estimar o percentual de infectados com e sem sintomas. Serão realizados quatro inquéritos sorológicos repetidos a cada 15 dias, com amostragem probabilística de nove cidades sentinela, em todas as sub-regiões do Estado. As entrevistas e testes ocorrerão no âmbito domiciliar. Serão utilizados testes rápidos para detecção de anticorpos, validados previamente ao início da coleta de dados.

Abstract COVID-19, the disease produced by the virus SARS-CoV-2, has spread quickly throughout the world, leading the World Health Organization to first classify it as an international health emergency and, subsequently, declaring it pandemic. The number of confirmed cases, as April 11, surpassed 1,700,000, but this figure does not reflect the prevalence of COVID-19 in the population as, in many countries, tests are almost exclusively performed in people with symptoms, particularly severe cases. To properly assess the magnitude of the problem and to contribute to the design of evidence-based policies for fighting COVID-19, one must accurately estimate the population prevalence of infection. Our study is aimed at estimating the prevalence of infected individuals in the state of Rio Grande do Sul, Brazil, to document how fast the infection spreads, and to estimate the proportion of infected persons who present or presented symptoms, as well as the proportion of asymptomatic infections. Four repeated serological surveys will be conducted in probability samples of nine sentinel cities every two weeks. Tests will be performed in 4,500 participants in each survey, totaling18,000 interviews. Interviews and tests will be conducted at the participants' household. A rapid test for the detection of antibodies will be used; the test was validated prior to the beginning of the fieldwork.

Informed consent and ethics committee approval in laboratory medicine.

Informed consent is a process in which a human subject who is to participate in research needs to give his or her consent after being properly informed of the expected benefits as well as the potential harm of the research that will be performed. The function and purpose of the research ethics committee is to ensure that the research that will take place is in accordance with the relevant ethical standards. This means that the committee must assess the appropriateness of the design of the study reviewed. Research in the field of laboratory medicine has specific features, i.e. the use of samples that remain after routine analysis, data collection from databases containing patient information, data mining, collection of laboratory management data, method/instrument comparisons and validation, etc. As most of such research is either retrospective or not directly associated with patients, the question arises as to whether all types of research require informed consent and ethics committee approval. This article aims to clarify what is specific about obtaining informed consent and ethical approval in laboratory medicine, to provide general guidance on informed consent and ethical approval requirements based on the type of study, and what information should be included in applications for ethical approval and informed consent. This could also provide some guidance for future contributors to the Biochemia Medica.

Potential of big data analytics in the French in vitro diagnostics market.

The new paradigm of the big data raises many expectations, particularly in the field of health. Curiously, even though medical biology laboratories generate a great amount of data, the opportunities offered by this new field are poorly documented. For better understanding the clinical context of chronical disease follow-up, for leveraging preventive and/or personalized medicine, the contribution of big data analytics seems very promising. It is within this framework that we have explored to use data of a Breton group of laboratories of medical biology to analyze the possible contributions of their exploitation in the improvement of the clinical practices and to anticipate the evolution of pathologies for the benefit of patients. We report here three practical applications derived from routine laboratory data from a period of 5 years (February 2010-August 2015): follow-up of patients treated with AVK according to the recommendations of the High authority of health (HAS), use of the new troponin markers HS and NT-proBNP in cardiology. While the risks and difficulties of using algorithms in the health domain should not be underestimated - quality, accessibility, and protection of personal data in particular - these first results show that use of tools and technologies of the big data repository could provide decisive support for the concept of "evidence based medicine".

Consideraciones científico tecnológicas y bioéticas relacionadas con el uso indiscriminado del laboratorio clínico / Scientific, technological and bioethical considerations related to the indiscriminate use of the clinical laboratory

Introducción: los avances tecnológicos posibilitan que los profesionales de la salud dispongan de novedosos métodos diagnósticos y terapéuticos cuyo empleo contribuye a aumentar las posibilidades de supervivencia y mejorar la calidad de vida de los pacientes, aunque con los inconvenientes de generar estrés y ansiedad y crear problemas de carácter bioético. Objetivo: exponer algunas consideraciones bioéticas y científico-tecnológicas relacionadas con el uso indiscriminado del laboratorio clínico.Método: se revisó la bibliografía nacional e internacional disponible en formato impreso y en las bases de datos de Internet. Se seleccionaron los trabajos más actualizados y, a partir de ellos, se elaboró una síntesis estructurada del tema desde la perspectiva bioética y de los estudios de ciencia, tecnología y sociedad.Desarrollo: los exámenes de laboratorio posibilitan al especialista confirmar o descartar diagnósticos, establecer pronósticos, controlar el curso de la enfermedad y los resultados del tratamiento, detectar complicaciones, colaborar con estudios epidemiológicos o de grupos de riesgo, participar en protocolos de investigaciones y ensayos clínicos para la introducción de nuevos medicamentos. Pero el sometimiento del criterio médico a los exámenes complementarios en detrimento del empleo del método clínico es un claro ejemplo del avance tecnológico asociado al retroceso intelectual. Conclusiones: el uso indiscriminado del laboratorio clínico implica un dilema ético y científico tecnológico, con un impacto social negativo de la ciencia y la tecnología en la práctica médica(AU)

Introduction: technological advances enable healthcare professionals to have novel diagnostic and therapeutic methods whose use contributes to increase the chances of survival and improve the quality of life of patients, although with the inconveniences of generating stress and anxiety and creating problems of bioethical character. Objective: to expose some bioethical and scientific-technological considerations related to the indiscriminate use of the clinical laboratory. Method: the national and international bibliography available in printed format and in Internet databases was revised. The most updated works were selected and, from them, a structured synthesis of the subject was elaborated from the perspective of the studies of science, technology and society. Development: laboratory tests allow the specialist to confirm or rule out diagnoses, establish prognoses, control the course of the disease and treatment outcomes, detect complications, collaborate with epidemiological studies or risk groups, participate in research protocols and clinical trials for the introduction of new drugs. But the subjection of the medical criterion to the complementary examinations to the detriment of the use of the clinical method is a clear example of the technological advance associated with the intellectual recoil.Conclusions: the indiscriminate use of the clinical laboratory implies an ethical and scientific technological dilemma, with a negative social impact of science and technology in medical practice(AU)

Ethical considerations in the translation of regenerative biofabrication technologies into clinic and society.

Biofabrication technologies have the potential to improve healthcare by providing highly advanced and personalized biomedical products for research, treatment and prevention. As the combining of emerging techniques and integrating various biological and synthetic components becomes increasingly complex, it is important that relevant stakeholders anticipate the translation of biofabricated 3D tissue products into patients and society. Ethics is sometimes regarded as a brake on scientific progress, yet from our perspective, ethics in parallel with research anticipates societal impacts of emerging technologies and stimulates responsible innovation. For the ethical assessment, the biofabrication field benefits from similarities to regenerative medicine and an increasing ethical awareness in the development of tissue-engineered products. However, the novelty of the technology itself, the increase in attainable structural complexity, and the potential for automation and personalization are distinguishing facets of biofabrication that call for a specific exploration of the ethics of biofabrication. This review aims to highlight important points of existing ethical discussions, as well as to call attention to emerging issues specific to 3D biofabrication in bench and bedside research and the translation to society.

[Genomic Tests: From Basic Research to Clinical Practice].

Advanced genomic analytical technologies are developing and challenging the current framework of clinical laboratory testing. However, most genomic tests have been devised as laboratory-developed tests (LDTs) without sufficient validation of their analytical validity. Quality assurance (QA) of tests is mandatory for routine clinical practice. External quality management systems such as ISO add QA. Other than QAs of pre-analysis, analytical procedures, reports, and laboratory personnel should be regularly assessed using appropriate best practices and guidelines for analytical validity. Moreover, ethical, legal, and social issues concerning genomic information should be resolved in genomic tests. Taken together, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient's clinical status and the risks and benefits resulting from test use. Genomic tests in current use vary in terms of their accuracy and potential to improve health outcomes. Recently, high-throughput analysis using next-generation sequencing and microarrays is being developed and introduced into clinical practice. As analysis of these data sets is a huge challenge, it requires novel analytical processes that include data quality assessment, comprehensive analysis, interpretation of the results, and presenting the results to users. Especially, human resources are required to develop genome informatics to interpret large amounts of data. Another issue is to regulate Direct To Consumers (DTC) genetic tests by medical institutions as a salutary health service. Although advanced genomic analytical technologies present some issues, they are useful and powerful tools in clinical practice. Thus, they will be properly introduced into clinical practices in a step by step manner.

El control de la diabetes a distancia. ¿Cuánto hay de verdaderamente útil bajo el término telemedicina? / Remote diabetes monitoring. What is really useful under the term telemedicine?

El uso de los sistemas de telemedicina es cada vez más común y ha demostrado ser una estrategia segura, efectiva y no inferior a la visita presencial, en relación con el control metabólico (HbA1c), en la calidad del tratamiento de la diabetes, en términos de confianza en la autogestión y mayor calidad de vida. Un factor crucial para su aplicación en la práctica clínica habitual es una selección óptima de la frecuencia de la transmisión de datos, y la necesidad de herramientas de fácil uso, intuitivas y con mínimos problemas técnicos. También es importante determinar las características de los pacientes que más pueden beneficiarse del uso de la telemedicina y, consecuentemente, tratar de definir la mejor estrategia para su aplicación en la práctica clínica diaria

The use of telemedicine systems is increasingly common and has proven to be a safe and effective and not inferior to face-to-face visits in relation to metabolic control (HbA1c) and quality of diabetes treatment in terms of trust in self-management and improved quality of life. A crucial factor for their application in clinical practice is the optimal selection of the frequency of data transmission, and the need for tools which are easy to use, intuitive and with minimal glitches. It is also important to determine the characteristics of patients who can benefit most from the use of telemedicine, and consequently, try to define the best strategy for its implementation in daily clinical practice

Variability of ethics education in laboratory medicine training programs: results of an international survey.

BACKGROUND: Ethical considerations are increasingly important in medicine. We aimed to determine the mode and extent of teaching of ethics in training programs in clinical chemistry and laboratory medicine. METHODS: We developed an on-line survey of teaching in areas of ethics relevant to laboratory medicine. Reponses were invited from directors of training programs who were recruited via email to leaders of national organizations. RESULTS: The survey was completed by 80 directors from 24 countries who directed 113 programs. The largest numbers of respondents directed postdoctoral training of scientists (42%) or physicians (33%), post-masters degree programs (33%), and PhD programs (29%). Most programs (82%) were 2years or longer in duration. Formal training was offered in research ethics by 39%, medical ethics by 31%, professional ethics by 24% and business ethics by 9%. The number of reported hours of formal training varied widely, e.g., from 0 to >15h/year for research ethics and from 0 to >15h for medical ethics. Ethics training was required and/or tested in 75% of programs that offered training. A majority (54%) of respondents reported plans to add or enhance training in ethics; many indicated a desire for online resources related to ethics, especially resources with self-assessment tools. CONCLUSION: Formal teaching of ethics is absent from many training programs in clinical chemistry and laboratory medicine, with heterogeneity in the extent and methods of ethics training among the programs that provide the training. A perceived need exists for online training tools, especially tools with self-assessment components.

Repercusión social de iatrogenias por el uso de recursos de diagnóstico en el laboratorio clínico / Social impact of iatrogenesis due to the use of diagnostic resources in the clinical laboratory

Se entiende como iatrogenia el efecto desfavorable sobre la salud de los pacientes, provocado por la institución médica como resultado de errores de omisión o comisión por profesionales sanitarios y como consecuencia de las acciones que se realizan con fines preventivos, diagnósticos y terapéuticos, por lo cual en este artículo se comenta en torno a la repercusión social de posibles tendencias iatrogénicas en un hospital, a través del uso de recursos de diagnóstico en el laboratorio clínico(AU)

Iatrogenesis is defined as the adverse effect on the health of patients caused by the medical institution as a result of omission or commission errors committed by heath professionals and as a consequence of actions taken for preventive, diagnostic and therapeutic ends, for which this article discusses about social impact of possible iatrogenic trends in a hospital through the use of diagnostic resources in the clinical laboratory(AU)