Book Review: Bad Blood – Secrets and Lies in a Silicon Valley Startup

This book review appraises John Carreyrou’s non-fiction book Bad Blood. The text provides penetrating insights on Theranos, an American laboratory diagnostics company that promised to revolutionize laboratory medicine. The author’s award-winning prose relays the events leading to the eventual discovery of fraud at Theranos as well as the subsequent collapse of the company. The book can be faulted for being unripe. Publication prior to a full resolution to the Theranos affair precludes analysis of the longer-term impacts of this fraud. Notwithstanding Bad Blood’s imperfect timing, the book remains a seminal text amidst journalistic chronicles of medical innovation gone wrong.

Avaliação no contexto do Laboratório Latino-Americano de Avaliação da Qualidade da Educação

<p>O objetivo deste artigo é analisar a concepção de avaliação adotada pelo Laboratório Latino-Americano de Avaliação da Qualidade da Educação (LLECE), órgão ligado à Organização das Nações Unidas Para a Educação, a Ciência e a Cultura (Unesco). A metodologia se constitui na interpretação dos documentos resultantes das atividades do Laboratório. Com o intuito de organizar a discussão, quatro tópicos são apresentados. Inicialmente, breves considerações sobre o histórico e a organização do LLECE. Na sequência, apontamentos referentes ao Primeiro Estudo Regional Comparativo e Explicativo (1997), as atividades do Segundo Estudo Regional Comparativo e Explicativo (2007) e, por fim, a síntese do Terceiro Estudo Regional Comparativo e Explicativo (2014). Como resultado, sinalizou-se que a avaliação em larga escala, no Brasil, converge com as orientações do LLECE nas últimas décadas. Constata-se a consolidação de um perfil meritocrata e gerencial para as práticas avaliativas.</p><p><strong>Palavras-chave:</strong> Avaliação em Larga Escala; Qualidade da Educação; Equidade; LLECE.</p><p> </p><p><strong>Evaluación en el marco del Laboratorio Latinoamericano de Evaluación de la Calidad de la Educación</strong></p><p>El objetivo de este artículo es analizar la concepción de evaluación adoptada por el Laboratorio Latinoamericano de Evaluación de la Calidad de la Educación (LLECE), organismo vinculado a la Organización de las Naciones Unidas Para la Educación, la Ciencia y la Cultura (Unesco). La metodología se refiere a la interpretación de los documentos resultantes de las actividades del Laboratorio. Con el propósito de organizar la discusión se presentan cuatro tópicos. Inicialmente, breves consideraciones sobre el historial y la organización del LLECE. A continuación, consideraciones relativas al Primer Estudio Regional Comparativo y Explicativo (1997), a las actividades del Segundo Estudio Regional Comparativo y Explicativo (2007) y, por fin, la síntesis del Tercer Estudio Regional Comparativo y Explicativo (2014). Como resultado, señalamos que la evaluación en gran escala en Brasil converge con las orientaciones del LLECE en las últimas décadas. Se constata la consolidación de un perfil gerencial y basado en la meritocracia para las prácticas evaluativas.</p><p><strong>Palabras-clave:</strong> Evaluación en Gran Escala; Calidad de la educación; Equidade; LLECE.</p><p> </p><p><strong>Evaluation in the context of the Latin American Laboratory for the Assessment of Quality Education</strong></p><p>This article aims to analyze the concept of evaluation adopted by the Latin American Laboratory for the Assessment of Quality Education (LLECE), an agency linked to the United Nations for Education, Science and Culture Organization (Unesco). The methodology consists in interpreting the documents resulting from the Laboratory activities. In order to organize the discussion, four topics are presented, starting with brief considerations on the LLECE history and organization. Then, some notes will follow on the First Regional Comparative and Explanatory Study (1997), the activities of the Second Regional Comparative and Explanatory Study (2007) and, finally, we will discuss the synthesis of the Third Regional Comparative and Explanatory Study (2014). As a result, we observed that, in Brazil, large-scale assessment has converged with the LLECE guidelines in the last decades. A consolidation of a merit-based and managerial profile of assessment practices was also noted.</p><p><strong>Keywords:</strong> Large-Scale Assessment; Quality Education; Equity; LLECE.</p>

What Alert Thresholds Should Be Used to Identify Critical Risk Results: A Systematic Review of the Evidence

BACKGROUND Pathology laboratories are required to immediately report results which indicate a patient is at critical risk, but there is little consensus about what values are deemed critical. The aim of this review was to systematically review the literature on alert thresholds for common chemistry and hematology tests in adults and to provide an explicit and ranked source of this evidence. METHODS The literature search covered the period of 1995–2014. Evidence sources were critically appraised and ranked using the 1999 Stockholm hierarchy for analytical performance specifications in laboratory medicine modified for establishing decision limits. RESULTS The 30 most frequently reported laboratory tests with alert thresholds are presented with evidence rankings. Similar thresholds were reported in North America, Europe and Asia. Seventy percent of papers reported thresholds set by individual institutions, while 18% contained thresholds from surveys of laboratories or clinicians. Forty-six percent of the papers referred to 1 or both of the 2 American laboratory surveys from the early 1990s. “Starter sets” of alert thresholds were recommended by 6 professional bodies, 3 of which were collaborations between pathologists and clinicians. None of the 9 outcome studies identified dealt with confounding factors. CONCLUSIONS Recommendations by professional bodies based on outdated surveys of the former state of the art or consensus are currently the best sources of evidence for laboratories to build their alert list. Well-designed outcome studies and greater collaboration between clinicians and the laboratory are needed to identify the most appropriate alert thresholds that signify actionable, critical or significant risk to patient well-being.

Vivien Theodore Thomas (1910–1985): An African-American laboratory technician who went on to become an innovator in cardiac surgery

Vivien Theodore Thomas (1910–1985) was an African-American laboratory technician and instructor of surgery at Johns Hopkins University, Baltimore. He was born as the grandson of a slave in Lousiana, working as a carpenter and subsequently as a laboratory technician after the great depression and the loss of his savings derailed his plans to become a doctor. In his role as a laboratory technician, he overcame challenging personal circumstances to become an innovator in paediatric cardiac surgery, despite having no formal college education. He played an important role in assisting Alfred Blalock and Helen Taussig in the development of the ‘Blalock-Taussig’ shunt, a procedure used to improve the survival of children with cyanotic congenital heart defects. He also contributed to major breakthroughs in research covering a spectrum of disorders such as traumatic shock, coarctation of the aorta and transposition of the great arteries. He acted as a teacher and mentor to a generation of surgical residents and technicians who went on to become leaders in their field across the USA. A television film based on his life was premiered by HBO in 2004 titled ‘Something the Lord made’.

Human hair cortisol analysis: Comparison of the internationally-reported ELISA methods

Purpose: Recently, hair cortisol has become a topic of global interest as a biomarker of chronic stress. Different research groups have been using different methods for extraction and analysis, making it difficult to compare results across studies. A critical examination of the reported analytical methods is important to facilitate standardization and allow for a uniform interpretation. Methods: This study qualitatively compared four published procedures from laboratories in Germany, the Netherlands, USA and Canada. Multiple aspects of their procedures were compared. Results: A major difference among the laboratories was the ELISA kit used: the Canadian laboratory used the kit from ALPCO Diagnostics (Salem, MA, USA), the American laboratory used the kit from DRG International (Springfield, NJ, USA), the German laboratory used the kit from DRG Instruments GmbH (Marburg, Germany), or IBL (Hamburg, Germany), and the Dutch used the kit from Salimetrics (Suffolk, UK). In addition, there are noted differences in hair mass used as well as washing and extraction procedures. The range of hair cortisol levels determined in healthy volunteers by the four groups was within 2.3-fold: Koren, 46.1 pg/mg; Van Rossum, 29.72 pg/mg; Kirschbaum, 20 pg/mg and Laudenslager ~ 27 pg/mg. Conclusions: The relative similarities in hair cortisol values in volunteers among the four laboratories should facilitate a quality assurance exchange program, as a necessary step toward clinical use of this novel test.

Empathy in Translation: Movement and Image in the Psychological Laboratory

ArgumentThe new English term “empathy” was translated from the GermanEinfühlungin the first decade of the twentieth century by the psychologists James Ward at the University of Cambridge and Edward B. Titchener at Cornell. At Titchener's American laboratory, “empathy” was not a matter of understanding other minds, but rather a projection of imagined bodily movements and accompanying feelings into an object, a meaning that drew from its rich nineteenth-century aesthetic heritage. This rendering of “empathy” borrowed kinaesthetic meanings from German sources, but extended beyond a contemplation of the beautiful to include a variety of experimental stimuli and everyday objects in the laboratory. According to Titchener's structural psychology, all higher thought could be reduced to more elemental aspects of mind, and experimental introspection showed empathy to be constituted of kinaesthetic images. The existence of kinaesthetic images, Titchener argued, formed an incisive critique of the view that thought could take place without images, held by one of Titchener's major psychological rivals, the school of thought-psychologists in Würzburg, Germany. The new term “empathy” in early American academic psychology therefore delineated a kinaesthetic imaginative projection that took place on the basis of ontological difference between minds and things.

Homogeneous, Nonradioactive, Enzymatic Assay for Plasma Pyridoxal 5-Phosphate

Background: Pyridoxal 5′-phosphate (PLP) is the biologically active form of vitamin B6. Clinical studies suggest that low PLP concentrations are an independent risk factor for cardiovascular and other diseases. However, PLP concentrations are not routinely diagnosed because of the lack of a homogeneous, nonradioactive assay. We describe a homogeneous, nonradioactive, enzymatic PLP assay that uses the apo form of the PLP-dependent recombinant enzyme, homocysteine-α,γ-lyase (rHCYase). Methods: PLP was removed from holoenzyme rHCYase by incubation with hydroxylamine to obtain apo-rHCYase. The restoration of enzymatic activity by reconstitution of the holoenzyme was linearly related to the amount of PLP bound to the enzyme. The amplification principle of the assay allowed nanomolar concentrations of PLP to be measured by the conversion (by reconstituted holo-rHCYase) of millimolar concentrations of homocysteine to H2S. N,N-Dibutylphenylenediamine (DBPDA) was used for determination of H2S, the combination of which forms a chromophore with high absorbance. The assay was initiated by incubation of 5 μL of plasma with apo-rHCYase in a binding buffer for 60 min at 37 °C. Homocysteine (2.5 mmol/L) was added to the assay buffer and incubated at 37 °C for 20 min. The DBPDA reaction was allowed to progress for 10 min and then read at 675 nm. Results: The PLP enzymatic assay has a lower limit of detection of 5 nmol/L and is linear to 200 nmol/L. The recovery of PLP was 98%. The mean within- and between-run CVs were 9.6% and 12%, respectively. Correlation of 45 samples in the PLP enzymatic assay and the B63H radioenzymatic assay (American Laboratory Products Co., Ltd.) yielded: y = 0.9367x + 10.569 (R2 = 0.9201). Conclusions: This new PLP assay is the first homogeneous, nonradioactive, vitamin B6 diagnostic method. The assay is applicable to chemistry automated analyzers and may have wide clinical use.