Development status and prospects of international standardization of medical devices of Traditional Chinese Medicine.

As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.

Cultivo mediante hisopado superficial versus cultivo de la biopsia de tejidos profundos en la infección del pie diabético / Culture through superficial swab versus deep tissue biopsy in the diabetic foot infection

RESUMEN Introducción: para lograr el adecuado y precoz diagnóstico de la infección en pie diabético, es necesario la obtención de una muestra bacteriológica de calidad para la identificación del germen causal. Objetivo: identificar posibles relaciones entre los resultados obtenidos, en el cultivo realizado mediante hisopado superficial versus el obtenido mediante biopsia de los tejidos profundos en la infección del pie diabético. Materiales y métodos: se realizó un estudio explicativo observacional, longitudinal, prospectivo en el Servicio Provincial de Angiología y Cirugía Vascular del Hospital Provincial Clínico Quirúrgico Universitario "Comandante Faustino Pérez", durante un periodo de 3 años desde enero del 2016 hasta diciembre del 2018. Una selección muestral no probabilística determinó una muestra constituida por 138 extremidades en 132 pacientes con diagnóstico clínico de pie diabético infectado, que requirieron cirugía para desbridamiento de la lesión. Aceptaron ser incluidos en la investigación y para el aislamiento del germen causal fueron empleados ambos métodos de cultivo: hisopado superficial y biopsia de los tejidos profundos. Resultados: el promedio de microorganismos aislados se incrementó en relación con la severidad de la infección del pie diabético, con mayor incremento en el aislamiento hecho por el hisopado superficial. El hisopado superficial posee pobre correlación con los gérmenes aislados mediante el cultivo de la biopsia de los tejidos profundos. Conclusiones: las muestras deben ser obtenidas preferentemente por curetaje. En el diagnóstico de la infección del pie diabético es de gran utilidad, por su rapidez y concordancia con los resultados del cultivo, efectuar siempre una tinción de Gram a partir del mismo sitio (AU).

ABSTRACT Introduction: to arrive to an adequate and precocious diagnosis of the diabetic foot infection, it is necessary to obtain a qualitative bacteriological sample to identify the causing germ. Objective: to identify possible relationships between the results obtained both, in the culture made through superficial swab and the culture obtained from deep tissues biopsy in the diabetic foot infection. Materials and methods: a prospective, longitudinal, observational, explicative study was carried out in the Provincial Service of Angiology and Vascular Surgery of Provincial University Clinical Surgical Hospital "Comandante Faustino Pérez", in a period of three years, from January 2016 to December 2018. A non-probabilistic sampling choose a sample of 138 lower limbs in 132 patients with clinical diagnosis of infected diabetic foot, who required surgery for lesion debridement. They gave their consent to be included in the research; for the isolation of the casual germ were used both culture methods, superficial swab and deep tissues biopsy. Results: the average of isolated microorganism increased in relation to the severity of the diabetic food infection, with higher increase in the isolation obtained by superficial swab. The superficial swab shows poor correlation with the germ isolates by the culture the deep tissue biopsy. Conclusions: the samples should be gathered preferably by curettage. In the diagnosis of the diabetic foot infection, it is very useful, due to its speed and concordance with the culture results, to make always a Gram staining beginning from the same place (AU).

Investigating health information systems-induced errors.

PURPOSE: The purpose of this paper is to present a review of health information system (HIS)-induced errors and its management. This paper concludes that the occurrence of errors is inevitable but it can be minimised with preventive measures. The review of classifications can be used to evaluate medical errors related to HISs using a socio-technical approach. The evaluation could provide an understanding of errors as a learning process in managing medical errors. DESIGN/METHODOLOGY/APPROACH: A literature review was performed on issues, sources, management and approaches to HISs-induced errors. A critical review of selected models was performed in order to identify medical error dimensions and elements based on human, process, technology and organisation factors. FINDINGS: Various error classifications have resulted in the difficulty to understand the overall error incidents. Most classifications are based on clinical processes and settings. Medical errors are attributed to human, process, technology and organisation factors that influenced and need to be aligned with each other. Although most medical errors are caused by humans, they also originate from other latent factors such as poor system design and training. Existing evaluation models emphasise different aspects of medical errors and could be combined into a comprehensive evaluation model. RESEARCH LIMITATIONS/IMPLICATIONS: Overview of the issues and discourses in HIS-induced errors could divulge its complexity and enable its causal analysis. PRACTICAL IMPLICATIONS: This paper helps in understanding various types of HIS-induced errors and promising prevention and management approaches that call for further studies and improvement leading to good practices that help prevent medical errors. ORIGINALITY/VALUE: Classification of HIS-induced errors and its management, which incorporates a socio-technical and multi-disciplinary approach, could guide researchers and practitioners to conduct a holistic and systematic evaluation.

¿Qué saber para optimizar el uso de medios diagnósticos en la clínica? / What to know for optimizing the use of diagnostic means in the clinical practice?

Introducción: la eficacia de un medio diagnóstico se refiere a la capacidad para detectar al verdadero paciente enfermo. La sensibilidad, especificidad y valores predictivos positivo y negativo son indicadores de la validez de un medio diagnóstico. Otra manera de obtener la probabilidad de enfermar es a través de la estimación de las razones de verosimilitud positiva y negativa. Objetivo: describir conceptos generales e interpretación de sensibilidad, especificidad, valores predictivos y umbrales diagnósticos. Métodos: se realizó una revisión de artículos y libros sobre las propiedades básicas de un medio diagnóstico para poder interpretarlos de manera correcta y con ello optimizar su uso en el ámbito clínico. Conclusiones: trabajo que servirá como guía para los profesionales de la salud que se debaten constantemente con la necesidad de hacer un diagnóstico correcto para tratar oportunamente a los pacientes y evitarles complicaciones y cuando sea posible evitar la muerte(AU)

Introduction: The effectiveness of a diagnostic means refers to the ability to detect the true sick patient. The sensitivity, specificity and positive and negative predictive values are indicators of the validity of a diagnostic means. Another way to obtain the probability of getting sick is through the estimation of positive and negative likelihood ratios. Objective: To describe general concepts and interpretation of sensitivity, specificity, predictive values and diagnostic thresholds. Methods: A review of articles and books on the basic properties of a diagnostic means was made in order to interpret them correctly and thereby optimize their use in the clinical setting. Conclusions: Our paper will serve as a guide for health professionals who are constantly debating the need to make correct diagnosis to treat patients timely and to avoid complications and, to avoid death when possible(AU)

¿Qué saber para optimizar el uso de medios diagnósticos en la clínica? / What to know for optimizing the use of diagnostic means in the clinical practice?

Introducción: la eficacia de un medio diagnóstico se refiere a la capacidad para detectar al verdadero paciente enfermo. La sensibilidad, especificidad y valores predictivos positivo y negativo son indicadores de la validez de un medio diagnóstico. Otra manera de obtener la probabilidad de enfermar es a través de la estimación de las razones de verosimilitud positiva y negativa. Objetivo: describir conceptos generales e interpretación de sensibilidad, especificidad, valores predictivos y umbrales diagnósticos. Métodos: se realizó una revisión de artículos y libros sobre las propiedades básicas de un medio diagnóstico para poder interpretarlos de manera correcta y con ello optimizar su uso en el ámbito clínico. Conclusiones: trabajo que servirá como guía para los profesionales de la salud que se debaten constantemente con la necesidad de hacer un diagnóstico correcto para tratar oportunamente a los pacientes y evitarles complicaciones y cuando sea posible evitar la muerte(AU)

Introduction: The effectiveness of a diagnostic means refers to the ability to detect the true sick patient. The sensitivity, specificity and positive and negative predictive values are indicators of the validity of a diagnostic means. Another way to obtain the probability of getting sick is through the estimation of positive and negative likelihood ratios. Objective: To describe general concepts and interpretation of sensitivity, specificity, predictive values and diagnostic thresholds. Methods: A review of articles and books on the basic properties of a diagnostic means was made in order to interpret them correctly and thereby optimize their use in the clinical setting. Conclusions: Our paper will serve as a guide for health professionals who are constantly debating the need to make correct diagnosis to treat patients timely and to avoid complications and, to avoid death when possible(AU)

Optoacoustic diagnostic modality: from idea to clinical studies with highly compact laser diode-based systems.

Optoacoustic (photoacoustic) diagnostic modality is a technique that combines high optical contrast and ultrasound spatial resolution. We proposed using the optoacoustic technique for a number of applications, including cancer detection, monitoring of thermotherapy (hyperthermia, coagulation, and freezing), monitoring of cerebral blood oxygenation in patients with traumatic brain injury, neonatal patients, fetuses during late-stage labor, central venous oxygenation monitoring, and total hemoglobin concentration monitoring as well as hematoma detection and characterization. We developed and built optical parametric oscillator-based systems and multiwavelength, fiber-coupled highly compact, laser diode-based systems for optoacoustic imaging, monitoring, and sensing. To provide sufficient output pulse energy, a specially designed fiber-optic system was built and incorporated in ultrasensitive, wideband optoacoustic probes. We performed preclinical and clinical tests of the systems and the optoacoustic probes in backward mode for most of the applications and in forward mode for the breast cancer and cerebral applications. The high pulse energy and repetition rate allowed for rapid data acquisition with high signal-to-noise ratio from cerebral blood vessels, such as the superior sagittal sinus, central veins, and peripheral veins and arteries, as well as from intracranial hematomas. The optoacoustic systems were capable of automatic, real-time, continuous measurements of blood oxygenation in these blood vessels.

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

No disponible

[Systematic review of diagnosis criteria on drug induced liver injury in China from 2005 to 2012].

OBJECTIVE: To summarize the application of diagnosis criteria on drug induced liver injury in China from 2005 to 2012 in China. METHOD: We systematically searched the journals included in four commonly accepted Chinese electronic databases for medical research, i.e. CNKI, CBM, VIP and Wanfang database, for articles published from 2005 to 2012. The articles meeting the inclusion criteria were considered eligible for our analysis. Relevant information was extracted using a standardized form in Excel 2007. RESULT: Overall,273 studies were included for the present review. 199 Case Series and 74 Case Report. There are 15 various standard of diagnosis using in 199 Case Series for DILI. Chinese general standard, 1997 Maria Criteria, and Medical records are generally used. The use of the three standard has no trend with time and various journals in 199 Case Series. 74 Case Report all use medical records as criteria on DILI diagnosis. CONCLUSION: We don't have the consolidate criteria on DILI diagnosis at present, so when we choose the standard of diagnosis, we should consider many factors in order to avoid missed diagnosis and misdiagnosis.

La calidad de la codificación diagnóstica: una necesidad formativa en atención primaria / The quality of diagnostic coding: A training need in primary care

No disponible

Assessing patient management plans of doctors and medical students: an illness script perspective.

INTRODUCTION: Illness script theory offers explanations for expert-novice differences in clinical reasoning. However, it has mainly focused on diagnostic (Dx) performance, while patient management (Mx) has been largely ignored. The aim of the present study was to show the role of Mx knowledge in illness script development and how it relates to diagnostic knowledge in the course of development toward expertise. METHODS: The participants were 10 fourth-year and 10 sixth-year medical students, and 10 experienced physicians (ie, internists). Participants were asked to study 4 written clinical cases and provide management plans. Based on propositional analysis the management plans were examined for accuracy and elaborateness as well as the number of Mx and Dx items. RESULTS: Providing accurate Mx plans that concurrently pay attention to Dx and Mx was a characteristic of doctors' performance. The Mx plans of sixth-year students were as accurate as fourth-year students, but the format and the size of sixth-year students' plans was more similar to those of doctors. While sixth-year students generated plans with an Mx focus, the plans of fourth-year students were characterized by a Dx focus. DISCUSSION: The experienced physicians' accurate management plans are characterized by a high number of the Mx and Dx items. For sixth-year students the management plans are still incomplete, which leads to generic as well as inaccurate Mx orders. For fourth-year students, the Mx focus is lacking, and hence they seem to treat an Mx task as if it were a Dx task.

Clinical tests for screening and diagnosis of cervical spine myelopathy: a systematic review.

OBJECTIVE: The purpose of this review was to investigate the diagnostic accuracy for screening and confirmation of clinical tests for cervical spine myelopathy (CSM) and to investigate the quality of the studies that have investigated these values. METHODS: This study was a systematic review that used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Search terms for PubMed included myelopathy; diagnosis, differential; sensitivity and specificity; and physical examination. Search terms for Cumulative Index to Nursing and Allied Health Literature were limited to myelopathy and sensitivity and specificity. Qualitative assessment included report of diagnostic accuracy metrics (sensitivity, specificity, and positive and negative likelihood ratios) and quality scores using the Quality Assessment of Diagnostic Accuracy Studies tool. Scores were created for single tests and clustered test findings. RESULTS: After evaluation, 12 full-text articles were selected, scored, and tabulated. Nearly all of the 18 tests demonstrated high levels of specificity and low levels of sensitivity, suggesting that they are poor screening tools. Only one study was scored as high quality. One study involved clustering of test findings but was considered low quality. CONCLUSION: Nearly all of the clinical tests for CSM seem to be poor screening tools, which implies that manually oriented clinicians may perform treatment methods in a situation of doubt or uncertainly. More high-quality studies are needed, and manual therapists need to be cognizant that the current clinical tests for CSM lack strong diagnostic accuracy measures that are necessary for clinical decision making.

Evaluation of diagnostic accuracy in detecting ordered symptom statuses without a gold standard.

Our research is motivated by 2 methodological problems in assessing diagnostic accuracy of traditional Chinese medicine (TCM) doctors in detecting a particular symptom whose true status has an ordinal scale and is unknown-imperfect gold standard bias and ordinal scale symptom status. In this paper, we proposed a nonparametric maximum likelihood method for estimating and comparing the accuracy of different doctors in detecting a particular symptom without a gold standard when the true symptom status had an ordered multiple class. In addition, we extended the concept of the area under the receiver operating characteristic curve to a hyper-dimensional overall accuracy for diagnostic accuracy and alternative graphs for displaying a visual result. The simulation studies showed that the proposed method had good performance in terms of bias and mean squared error. Finally, we applied our method to our motivating example on assessing the diagnostic abilities of 5 TCM doctors in detecting symptoms related to Chills disease.

The systematical analysis of oriental pulse waveform: a practical approach.

With the view to set up the oriental pulse database as well as objective diagnosis standards, this study has designed and manufactured a digital pulse diagnosis system that uses a high-performance microprocessor on the basis of systematic pulse diagnosis methodology. The algorithm for extracting significant points has been proposed to precisely interpret the pulse signals that have various kinds of noises, and pulse measurement tests were conducted on many patients at a hospital. Much of the clinical data attained by the digital pulse diagnosis system has been compared with the clinical findings made by the doctors in charge of patients. As a result of this comparison and analysis, the study has found out that the two findings showed almost identical opinions. On this basis, an objective diagnostic parameter clinical diagnosis has been presented.

Biobanking for better healthcare.

Translational cancer research is highly dependent of large series of cases including high quality samples and their associated data. Comprehensive Cancer Centers should be involved in networks to enable large-scale multi-center research projects between the centers [Ringborg, U., de Valeriola, D., van Harten, W., Llombart-Bosch, A., Lombardo, C., Nilsson, K., Philip, T., Pierotti, M.A., Riegman, P., Saghatchian, M., Storme, G., Tursz, T., Verellen, D, 2008. Improvement of European translational cancer research. Collaboration between comprehensive cancer centers. Tumori 94, 143-146.]. Combating cancer knows many frontiers. Research is needed for prevention as well as better care for those who have acquired the disease. This implies that human samples for cancer research need to be sourced from distinct forms of biobanking. An easier access to these samples for the scientific community is considered as the main bottleneck for research for health, and biobanks are the most adequate site to try to resolve this issue [Ozols, R.F., Herbst, R.S., Colson, Y.L., Gralow, J., Bonner, J., Curran Jr., W.J., Eisenberg, B.L., Ganz, P.A., Kramer, B.S., Kris, M.G., Markman, M., Mayer, R.J., Raghavan, D., Reaman, G.H., Sawaya, R., Schilsky, R.L., Schuchter, L.M., Sweetenham, J.W., Vahdat, L.T., Winn, R.J., and the American Society of Clinical Oncology, 2007. Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening: a report from the American Society of Clinical Oncology. J. Clin. Oncol. 25, 146-162.]. However, biobanks should not be considered a static activity. On the contrary, biobanking is a young discipline [Morente, M.M., Fernandez, P.L., de Alava, E. Biobanking: old activity or young discipline? Semin. Diagn. Pathol., in press.], which need continuously evolve according to the permanent development of new techniques and new scientific goals. To accomplish current requirements of the scientific community biobanks need to face some essential challenges including an appropriate design, harmonized and more suitable procedures, and sustainability, all of them in the framework of their ethic, legal and social dimensions. This review therefore presents an overview on these issues, based on the works and discussions of the Marble Arch International Working Group on Biobanking for Biomedical Research, integrated by experts in biobanking from five continents.