No Difference in Muscle Basal Oxygenation in a Bedridden Population Pre and Post Rehabilitation.

Long periods of bed rest for elderly population, due to a femur fracture event, can cause a deterioration in the muscular capacity. Therefore, monitoring of the muscle oxidative capacity in this fragile population is necessary to define the muscular oxidative metabolism state before and after a rehabilitation period. The time-domain near-infrared spectroscopy (TD-NIRS) technique enables the absolute values to be calculated for hemodynamic parameters such as oxy- (O2Hb), deoxy- (HHb), total- (tHb) haemoglobin, and tissue oxygen saturation (SO2) of the muscular tissue. In this work, we have characterized vastus lateralis muscle hemodynamics during a baseline period at two different time points: after the surgery (PRE) and after 15 days of rehabilitation (POST). The mean values for the absolute values of the hemodynamic parameters were: O2Hb_PRE = 49.1 ± 14.1 µM; O2Hb_POST = 47.1 ± 13.4 µM; HHb_PRE = 28.3 ± 10.3 µM; HHb_POST = 26.7 ± 9.9 µM; tHb_PRE = 77.3 ± 23.6 µM; tHb_POST = 73.8 ± 21.4 µM; SO2_PRE = 63.9 ± 4.0% and SO2_POST = 64.9 ± 5.6%. The hemodynamic parameters did not show significant differences at both group and single subject level. These results suggest that for this kind of population, the baseline of the hemodynamic parameters is not the best one to consider to assess the rehabilitation progresses in terms of muscular oxidative metabolism.

Role of the EEG Theta Network During Software Production: A Connectivity Study.

Software programming is an acquired evolutionary skill originating from consolidated cognitive functions (i.e., attentive, logical, coordination, mathematic calculation, and language comprehension), but the underlying neurophysiological processes are still not completely known. In the present study, we investigated and compared the brain activities supporting realistic programming, text and code reading tasks, analyzing Electroencephalographic (EEG) signals acquired from 11 experienced programmers. Multichannel spectral analysis and a phase-based effective connectivity study were carried out. Our results highlighted that both realistic programming and reading tasks are supported by modulations of the Theta fronto-parietal network, in which parietal areas behave as sources of information, while frontal areas behave as receivers. Nevertheless, during realistic programming, both an increase in Theta power and changes in network topology emerged, suggesting a task-related adaptation of the supporting network system. This reorganization mainly regarded the parietal area, which assumes a prominent role, increasing its hub functioning and its connectivity in the network in terms of centrality and degree.

[The European Medicines Agency rejects the authorization of aducanumab for Alzheimer's disease]. / La Agencia Europea de Medicamentos rechaza la autorización del aducanumab para la enfermedad de Alzheimer.

TITLE: La Agencia Europea de Medicamentos rechaza la autorización del aducanumab para la enfermedad de Alzheimer.

[Aducanumab approval for Alzheimer's disease in the USA: the surrender of science]. / Aprobación del aducanumab para la enfermedad de Alzheimer en Estados Unidos: la claudicación de la ciencia.

TITLE: Aprobación del aducanumab para la enfermedad de Alzheimer en Estados Unidos: la claudicación de la ciencia.

Monitoring the haemodynamic response to visual stimulation in glaucoma patients.

In this paper, we used time-domain functional near infrared spectroscopy (TD-fNIRS) to evaluate the haemodynamic response function (HRF) in the occipital cortex following visual stimulation in glaucomatous eyes as compared to healthy eyes. A total of 98 subjects were enrolled in the study and clinically classified as healthy subjects, glaucoma patients (primary open-angle glaucoma) and mixed subjects (i.e. with a different classification for the two eyes). After quality check data were used from HRF of 73 healthy and 62 glaucomatous eyes. The amplitudes of the oxygenated and deoxygenated haemoglobin concentrations, together with their latencies with respect to the stimulus onset, were estimated by fitting their time course with a canonical HRF. Statistical analysis showed that the amplitudes of both haemodynamic parameters show a significant association with the pathology and a significant discriminating ability, while no significant result was found for latencies. Overall, our findings together with the ease of use and noninvasiveness of TD-NIRS, make this technique a promising candidate as a supporting tool for a better evaluation of the glaucoma pathology.

[Sensitivity and specificity of three complementary methods in the diagnosis of carpal tunnel syndrome]. / Sensibilidad y especificidad de tres métodos complementarios para el diagnóstico de síndrome de túnel carpiano.

INTRODUCTION: Currently there is no universally accepted standard of reference for the diagnosis of carpal tunnel syndrome so it is considered a «latent class¼ pathology, that is, it lacks any diagnostic tests that absolutely certain the presence of disease. METHODS: Prospective, observational and analytical study evaluating the three diagnostic methods used for carpal tunnel syndrome (clinical examination, ultrasound and electromyography). Normality values were set for each diagnostic method. RESULTS: 50 people (14 men and 36 women) were evaluated. The clinical examination showed a positive and significant correlation with the diameter of the affected median nerve (ecography) (R = 0.694, p = 0.032). The values of the under the curve area (UCA) for median nerve conduction speed (MNCS), cubital nerve conduction speed (CNCS), and distal latency (DL) by electromyography were 0.60, 0.519 and less than 0.50 respectively. This states that the diagnostic value of electromyography characteristics is bad. CONCLUSION: Our work establishes clinical examination as a good quality tool being the most sensitive method for diagnosing carpal tunnel syndrome. If there was a need for diagnostic confirmation, the ultrasound proved to be a highly satisfactory study generating less stress, pain and invasion to the patient, decreasing health expenditure and speeding up the process.

INTRODUCCIÓN: Actualmente, no existe un estándar de referencia aceptado universalmente para el diagnóstico del síndrome de túnel carpiano, por lo que se le considera una patología de «clase latente¼, es decir, que carece de alguna prueba diagnóstica que dé certeza absoluta de la presencia de la enfermedad. MÉTODOS: Estudio prospectivo, observacional y analítico en el cual se evaluaron los tres métodos diagnósticos utilizados para el síndrome de túnel carpiano (examen clínico, ecografía y electromiografía). En él, se establecieron valores de normalidad para cada método diagnóstico. RESULTADOS: Se evaluó un total de 50 personas (14 hombres y 36 mujeres). El examen clínico presentó correlación positiva y significativa con el diámetro del nervio mediano afectado (ecografía) (R = 0.694 y p = 0.032). Los valores del área bajo la curva (AUC, por sus siglas en inglés) para la velocidad de conducción del nervio mediano (VCNM), velocidad de conducción de nervio cubital (VCNC) y latencia distal motora (LDM) por electromiografía fueron de 0.60, 0.519 y. CONCLUSIÓN: < 0.50, respectivamente, lo cual determinó que el valor diagnóstico de las características por electromiografía es malo. Nuestro trabajo establece al examen clínico como una herramienta de buena calidad, siendo el método más sensible para el diagnóstico de síndrome de túnel carpiano. Si existiera la necesidad de realizar una confirmación diagnóstica, la ecografía mostró ser un estudio altamente satisfactorio, el cual genera menos estrés, dolor e invasión al paciente, disminuyendo, a su vez, el gasto de salud y agilizando el proceso.

Sensibilidad y especificidad de tres métodos complementarios para el diagnóstico de síndrome de túnel carpiano / Sensitivity and specificity of three complementary methods in the diagnosis of carpal tunnel syndrome

Resumen: Introducción: Actualmente, no existe un estándar de referencia aceptado universalmente para el diagnóstico del síndrome de túnel carpiano, por lo que se le considera una patología de «clase latente¼, es decir, que carece de alguna prueba diagnóstica que dé certeza absoluta de la presencia de la enfermedad. Métodos: Estudio prospectivo, observacional y analítico en el cual se evaluaron los tres métodos diagnósticos utilizados para el síndrome de túnel carpiano (examen clínico, ecografía y electromiografía). En él, se establecieron valores de normalidad para cada método diagnóstico. Resultados: Se evaluó un total de 50 personas (14 hombres y 36 mujeres). El examen clínico presentó correlación positiva y significativa con el diámetro del nervio mediano afectado (ecografía) (R = 0.694 y p = 0.032). Los valores del área bajo la curva (AUC, por sus siglas en inglés) para la velocidad de conducción del nervio mediano (VCNM), velocidad de conducción de nervio cubital (VCNC) y latencia distal motora (LDM) por electromiografía fueron de 0.60, 0.519 y < 0.50, respectivamente, lo cual determinó que el valor diagnóstico de las características por electromiografía es malo. Conclusión: Nuestro trabajo establece al examen clínico como una herramienta de buena calidad, siendo el método más sensible para el diagnóstico de síndrome de túnel carpiano. Si existiera la necesidad de realizar una confirmación diagnóstica, la ecografía mostró ser un estudio altamente satisfactorio, el cual genera menos estrés, dolor e invasión al paciente, disminuyendo, a su vez, el gasto de salud y agilizando el proceso.

Abstract: Introduction: Currently there is no universally accepted standard of reference for the diagnosis of carpal tunnel syndrome so it is considered a «latent class¼ pathology, that is, it lacks any diagnostic tests that absolutely certain the presence of disease. Methods: Prospective, observational and analytical study evaluating the three diagnostic methods used for carpal tunnel syndrome (clinical examination, ultrasound and electromyography). Normality values were set for each diagnostic method. Results: 50 people (14 men and 36 women) were evaluated. The clinical examination showed a positive and significant correlation with the diameter of the affected median nerve (ecography) (R = 0.694, p = 0.032). The values of the under the curve area (UCA) for median nerve conduction speed (MNCS), cubital nerve conduction speed (CNCS), and distal latency (DL) by electromyography were 0.60, 0.519 and less than 0.50 respectively. This states that the diagnostic value of electromyography characteristics is bad. Conclusion: Our work establishes clinical examination as a good quality tool being the most sensitive method for diagnosing carpal tunnel syndrome. If there was a need for diagnostic confirmation, the ultrasound proved to be a highly satisfactory study generating less stress, pain and invasion to the patient, decreasing health expenditure and speeding up the process.

Sustained fatigue assessment during isometric exercises with time-domain near infrared spectroscopy and surface electromyography signals.

The effect of sustained fatigue during an upper limb isometric exercise is presented to investigate a group of healthy subjects with simultaneous time-domain (TD) NIRS and surface electromyography (sEMG) recordings on the deltoid lateralis muscle. The aim of the work was to understand which TD-NIRS parameters can be used as descriptors for sustained muscular fatigue, focusing on the slow phase of this process and using median frequency (MF) computed from sEMG as gold standard measure. It was found that oxygen saturation and deoxy-hemoglobin are slightly better descriptors of sustained fatigue, than oxy-hemoglobin, since they showed a higher correlation with MF, while total-hemoglobin correlation with MF was lower.

Potential predatory journals are colonizing the ICMJE recommendations list of followers.

BACKGROUND: The International Committee of Medical Journal Editors (ICMJE) has expressed its concerns about predatory journals using the list of ICMJE Recommendations (ICMJE-R) followers to "gain the appearance of legitimacy." We assessed the presence of potential predatory journals on the ICMJE-R list and their adherence to ICMJE recommendations. METHODS: A random sample of 350 journals from the estimated 3,100-3,200 biomedical journals listed as ICMJE-R followers was chosen. Data collected from the ICMJE and journal webpages in English were: adherence to six ICMJE-R policies/requirements, year of journal's listing as ICMJE-R follower, discipline covered, publisher and its country of origin and existence of article processing charge. Potential predatory journal was considered as one open access journal not being a member of a recognized listing in COPE, DOAJ, OASPA, AJOL and/or INASP. RESULTS: Thirty-one percent of journals were considered to be potentially predatory; 94% of them were included in the ICMJE-R list in 2014-2018. Half were published in the United States and 62% were devoted to medicine. Adherence to five of the six policies/requirements was infrequent, ranging from 51% (plagiarism) to 7% (trial registration). Seventy-two percent of journals mentioned a policy on authors' conflicts of interest. Information on article processing charge was available for 76% journals and could not be found for 22%. Authorship policy/ instructions were significantly more present in journals with publishers from India than from the USA (53% vs 30%; p = 0.047), with no differences in the other five policies. CONCLUSION: Predatory journals should be deleted from the ICMJE-R list of followers to prevent misleading authors. ICMJE-R following journals need to be reevaluated with pre-defined published criteria.

[Easing access to all information should be mandatory to medical journals]. / Facilitar el acceso a toda la informacion debe ser una obligacion para las revistas medicas.

TITLE: Facilitar el acceso a toda la informacion debe ser una obligacion para las revistas medicas.

Existe asociación entre la mención en los medios sociales de los artículos científicos y su número de citas? Análisis de las revistas médicas más influyentes / Are article's social media mentions associated to citation counts? An analysis in highly influential medical journals

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[Patients organizations and new drug approval in the US. Eteplirsen and Duchenne muscular dystrophy case]. / Asociaciones de pacientes y autorizacion de nuevos farmacos en Estados Unidos. El caso del eteplirseno para la distrofia muscular de Duchenne.

INTRODUCTION: In 2016 the US Food and Drug Administration (FDA) granted the marketing authorization for eteplirsen for Duchenne muscular dystrophy. This has been a very controversial decision since it happened after a negative assessment from both the Advisory Committee and the technical FDA evaluation team. The FDA's Center for Drug Evaluation and Research (CDER) director was who ultimately approved the product, while the FDA Commissioner did not overrule that decision. AIM: To report about the most relevant events regarding the approval of eteplirsen by the US FDA. DEVELOPMENT: All relevant facts that occurred during the clinical development and evaluation phase following 'accelerated approval' procedure of eteplirsen are discussed in detail. The technical FDA evaluation team reasons supporting that the drug has not proven clinical benefit, the attitude of patient advocacy groups and the post-approval FDA requirements to the marketing authorization holder are discussed. Finally, we reflect on what is the situation Spanish patients face once eteplirsen is on the US market. CONCLUSIONS: This is a unique case in the history of drug authorizations in western countries, that shows the difficulties that current regulations on accelerated approval of new medicines could have when interpreting scarce and low quality clinical development data, when dealing with rare diseases with no available therapies.

TITLE: Asociaciones de pacientes y autorizacion de nuevos farmacos en Estados Unidos. El caso del eteplirseno para la distrofia muscular de Duchenne.Introduccion. En 2016, la Agencia de Medicamentos y Alimentos (FDA) estadounidense autorizo la comercializacion del eteplirseno para el tratamiento de la distrofia muscular de Duchenne. Este hecho ha sido muy controvertido, por cuanto la autorizacion se produjo tras una evaluacion negativa por parte del comite asesor de la FDA y de sus propios tecnicos. Fue la directora del Centro de Investigacion y Evaluacion de Farmacos quien autorizo el medicamento, decision que no revoco el director de la FDA. Objetivo. Informar sobre los acontecimientos mas relevantes que han conducido a la autorizacion del eteplirseno por la FDA. Desarrollo. En el articulo se exponen pormenorizadamente los hechos relevantes que acontecieron durante el desarrollo clinico y la evaluacion reguladora del eteplirseno siguiendo la via de la 'autorizacion acelerada'. Se comentan las razones por las que los tecnicos de la FDA entienden que este medicamento no ha mostrado producir beneficio clinico, la actitud de las asociaciones de pacientes y las exigencias postautorizacion que la FDA ha impuesto a la compañia propietaria del medicamento. Por ultimo, se reflexiona sobre la situacion en que quedan los pacientes espanoles una vez que el eteplirseno esta comercializado en Estados Unidos. Conclusiones. Este caso, unico en la historia de autorizacion de medicamentos en el mundo occidental, pone de manifiesto las dificultades que las regulaciones actuales de autorizacion acelerada de nuevos medicamentos pueden tener en la interpretacion de datos del desarrollo clinico, cuando estos son escasos y de poca calidad, y cuando se trata de enfermedades raras sin terapias disponibles.

La cohabitación de la academia y la industria: ¿qué postura toman las revistas médicas en relación con los artículos de opinión? / The cohabitation of academia and industry: what position do the medical journals take regarding opinion articles?

¿Deben las revistas médicas publicar editoriales y artículos de carácter educativo escritos por autores que presentan conflictos de intereses financieros con las industrias farmacéutica y biotecnológica de cuyos productos (o sus competidores) opinan? En los últimos 18 meses se ha desatado una polémica entre The New England Journal of Medicine y BMJ, que plantean 2 posturas opuestas: la primera entiende que el prejuicio negativo contra autores con conflicto de intereses con la industria es excesivo y, por tanto, acepta artículos de cualquier experto procurando que presenten el mínimo sesgo posible. BMJ, por el contrario, prohíbe publicar ese tipo de artículos por autores que tienen conflicto de intereses financieros con la industria. En este artículo se desarrollan las actitudes de ambas (y otras) revistas y se reflexiona sobre este tipo de conflicto en la profesión médica (AU)

Should medical journals publish editorials and educational articles written by authors who have financial conflicts of interest with pharmaceutical and biotechnology industries on whose products (or their competitors) they discuss? In the last 18 months, a controversy was sparked between The New England Journal of Medicine and BMJ, who took 2 opposite positions: the former stated that the negative bias against authors with conflicts of interest with industry is excessive and therefore accept articles from any expert, ensuring that they have the minimum possible bias. BMJ, in contrast, prohibits the publication of these types of article by authors who have financial conflicts of interest with industry. This article discusses the approaches of the 2 journals (and those of others) and reflects on this type of conflict in the medical profession (AU)

The cohabitation of academia and industry: What position do the medical journals take regarding opinion articles? / La cohabitación de la academia y la industria: ¿qué postura toman las revistas médicas en relación con los artículos de opinión?

Should medical journals publish editorials and educational articles written by authors who have financial conflicts of interest with pharmaceutical and biotechnology industries on whose products (or their competitors) they discuss? In the last 18 months, a controversy was sparked between The New England Journal of Medicine and BMJ, who took 2 opposite positions: the former stated that the negative bias against authors with conflicts of interest with industry is excessive and therefore accept articles from any expert, ensuring that they have the minimum possible bias. BMJ, in contrast, prohibits the publication of these types of article by authors who have financial conflicts of interest with industry. This article discusses the approaches of the 2 journals (and those of others) and reflects on this type of conflict in the medical profession.