La Fibromialgia en la jurisprudencia Española. Herramienta FMCheck de Valoración / Fibromyalgia in de Spanish caselaw. FM-Check Assessment Tool

La fibromialgia se define como un estado doloroso generalizado que no afecta a las articulaciones, sino a zonas musculares y raquis con una exagerada sensibilidad a la presión en unos puntos determinados, así lo recoge la Organización Mundial de la Salud desde 1992, incluyéndola en el CIE-10 con el código M79.0.Especialmente compleja es la valoración de sus limitaciones desde el punto de vista clínico, social, laboral o pericial. Esta complejidad trasciende al ámbito médico-legal y se refleja en las cuantiosas sentencias recogidas (más de 30.000), de las que el 96% se corresponden con el área de lo Social y en los conceptos de Limitación e Incapacidad laboral. La herramienta FM-Check puede servir de apoyo para una valoración homogénea, integral y objetiva, evitando inequidades. Puede complementarse con otras en función del destino de la valoración y calificación al que se encamine al paciente/trabajador afectado..(AU)

Fibromyalgia was defined in 1992 by the World Health Organization as a general painful state that does not affect the joints, but muscle areas and rachis with an exaggerated sensitivity to pressure at specific points and was included in the ICD-10 with M79.0 code. Especially complex is the valuation of its limitations both in terms of clinical, social,occupational, or expert view. This complexity transcends the forensic field and is reflected in the substantial sentences collected (over 30,000), of which 96% correspond to the area of the Social and concepts of limitation and disability. The FM-Check tool can support for seamless, omprehensive and objective assessment,avoiding inequities. It can be complemented with other depending on the destination of the assessment and qualification to which the patient / affected worker is heading..(AU)

Discusión ética y legal del asesoramiento genético en paciente portadora de una variación patológica en RAD51D / Ethical and legal discussion on genetic counselling in a carrier of a deleterious variation in RAD51D

En el campo de la genética del cáncer, los avances en innovación tecnológica han ayudado a detectar variaciones patogénicas con baja prevalencia en la población en genes que todavía están en investigación, lo que significa que todavía hay poca evidencia científica disponible sobre el riesgo que estas variaciones podrían conllevar en cuanto a la susceptibilidad de desarrollar cáncer. La difícil tarea de asesorar genéticamente e informar del seguimiento, detección precoz y acciones profilácticas de estos casos, como el aquí expuesto, conlleva importantes implicaciones desde el punto de vista ético y legal sobre las que hay muy poco descrito en la literatura (AU)

In the field of the genetics of the cancer, advances in technological innovation have helped to detect low prevalence deleterious variation in genes within the population that still are under investigation. This means that little scientific evidence is available concerning the risk that these variations might constitute as regards the susceptibility of developing cancer. The difficult task of genetically assessing and reporting on the early detection, the prophylactic actions, and follow-up of these cases, as detailed herein, has important implications from an ethical and legal point of view, but hardly anything about them has been discussed in the literature (AU)

Factores de riesgo cardiovascular en una población de trabajadores del mar de España / Cardiovascular risk among Spanish seafarers

Objetivo: El trabajo a bordo de un buque a menudo se realiza lejos de tierra, lo que dificulta el acceso al tratamiento médico adecuado en caso necesario. Si se produce un evento cardiovascular en un tripulante embarcado, la demora en la atención médica puede dar lugar a graves consecuencias para su salud. Por ello se es importante detectar los factores de riesgo cardiovascular (FRCV) en estos trabajadores. El objetivo del trabajo es analizar la frecuencia de los FRCV en los trabajadores del mar en el Servicio de Sanidad Marítima de Madrid. Métodos: Estudio descriptivo realizado en una población de 334 trabajadores en 2011, analizando la frecuencia de los FRCV, por sexo y por edad, la presencia simultánea de FRCV en un mismo sujeto y el riesgo SCORE total de cada individuo. Resultados: La mayoría de los FRCV estudiados presentó una elevada prevalencia, siendo superior en los varones y en los mayores de 45 años, destacando la tensión arterial en cifras de riesgo (40,1%), la hipercolesterolemia (49,7%), el tabaquismo (33,5%), el sobrepeso (44,6%) y la obesidad (17,4%). Conclusiones: Ante la elevada prevalencia de la mayoría de los factores de riesgo cardiovascular en la población de trabajadores del mar la realización del reconocimiento médico previo a embarque debe tratar de identificarlos

Objective: Working at sea makes it difficult to receive proper medical attention. Moreover, the prognosis of an acute cardiovascular event often depends on the measures taken in the first few hours after the onset of symptoms, but are often delayed in seamen. Thus, it is very important to detect cardiovascular risk factors in these workers as early as possible. The aim of this study was to measure the prevalence of cardiovascular risk factors among sailors. Methods: Data were on a sample of 334 individuals in the Madrid Maritime Health Service in 2011. We examined the distribution of cardiovascular risk factors, by age and sex, together withthe presence of various risk factors in the same subject and we calculated the global SCORE risk of each individual. Results: Most cardiovascular risk factors were highly prevalent, more frequent among men and individuals older than 45 years, especially risk blood pressure values (40,1%), hypercholesterolemia (49,7%), tobacco use (33,5%), overweight (44,6%) and obesity (17,4%). Conclusions: Since the prevalence of cardiovascular risk factors among this group of seafarers was high, we consider that pre-voyage medical exams must be very detailed in order to detect cardiovascular risk factors in this population

[Cardiovascular risk among Spanish seafarers]. / Factores de riesgo cardiovascular en una población de trabajadores del mar de España.

OBJECTIVE: Working at sea makes it difficult to receive proper medical attention. Moreover, the prognosis of an acute cardiovascular event often depends on the measures taken in the first few hours after the onset of symptoms, but are often delayed in seamen. Thus, it is very important to detect cardiovascular risk factors in these workers as early as possible. The aim of this study was to measure the prevalence of cardiovascular risk factors among sailors. METHODS: Data were on a sample of 334 individuals in the Madrid Maritime Health Service in 2011. We examined the distribution of cardiovascular risk factors, by age and sex, together withthe presence of various risk factors in the same subject and we calculated the global SCORE risk of each individual. RESULTS: Most cardiovascular risk factors were highly prevalent, more frequent among men and individuals older than 45 years, especially risk blood pressure values (40,1%), hypercholesterolemia (49,7%), tobacco use (33,5%), overweight (44,6%) and obesity (17,4%). CONCLUSIONS: Since the prevalence of cardiovascular risk factors among this group of seafarers was high, we consider that pre-voyage medical exams must be very detailed in order to detect cardiovascular risk factors in this population.

El trabajo a bordo de un buque a menudo se realiza lejos de tierra, lo que dificulta el acceso al tratamiento médico adecuado en caso necesario. Si se produce un evento cardiovascular en un tripulante embarcado, la demora en la atención médica puede dar lugar a graves consecuencias para su salud. Por ello se es importante detectar los factores de riesgo cardiovascular (FRCV) en estos trabajadores. El objetivo del trabajo es analizar la frecuencia de los FRCV en los trabajadores del mar en el Servicio de Sanidad Marítima de Madrid. MÉTODOS: Estudio descriptivo realizado en una población de 334 trabajadores en 2011, analizando la frecuencia de los FRCV, por sexo y por edad, la presencia simultánea de FRCV en un mismo sujeto y el riesgo SCORE total de cada individuo.

Hábito tabáquico en trabajadores del mar / Smoke habit in seafarers

Objetivo: estudiar la prevalencia del hábito tabáquico en trabajadores del mar entre 2009 y 2015. Material y método: estudio descriptivo transversal de los datos informatizados de los reconocimientos médicos previos a embarque (RMPE) en los años 2009-2015 en los que se analizó la frecuencia del hábito tabáquico en la población total, así como por sexo, edad (< y ≥ 45 años) y puesto de trabajo (oficiales y no oficiales). Resultados: el tabaquismo resultó más prevalente en los varones, en los sujetos menores de 45 años (con significación estadística en 2014) y en los no oficiales (estadísticamente significativo en 2009 y 2011). Conclusiones: se observó una tendencia a la disminución del hábito tabáquico en los años estudiados, que fue superior a la de la población general española, tal vez por el efecto de las recomendaciones dadas durante los reconocimientos médicos laborales, por lo que recomendamos seguir dándolas durante los RMPE (AU)

Objective: The aim of this work was to determine the prevalence of smoke habit in a group of seafarers in the years 2009-2015. Methods: Data obtained of the pre-embarkation medical checkups files finished between January 1st and December 31st of each year were included. Smoke habit’s prevalence was determined in the subjects studied, also by sex, age (< y ≥ 45 years) and job (officers and no officers). Results: Smoking was more prevalent among men, younger than 45 (statistically significant in 2014) and among no officers (significant in 2009 and 2011). Conclusions: We observed a trend to diminish smoke habit along the studied years, higher than in Spanish general population, perhaps due to the beneficial effects of the recommendations given during the medical pre-embarkation checkup to diminish smoking in the studied subjects, so we recommend giving medical advice during pre-embarkation medical examinations (AU)

Improving cardiovascular health in Spanish seafarers.

BACKGROUND AND AIM: There is a high prevalence in the Spanish general population of some cardiovascular risk factors like overweight, obesity and hypercholesterolaemia. But there is lack of research on Spanish seafarers. On the other hand, there is strong evidence of the cardiovascular risk predictive value of some biomarkers. The purpose of this work was to study the convenience of the introduction of detailed diet questionnaires and the measurement of some biomarkers in the pre-embarkation medical examination. MATERIALS AND METHODS: Seafarers undergoing medical checkup during 2011 in Madrid, Spain (n = 334). Overweight and obese subjects received general advice on healthy diet and physical activity. Seventy-four of them were followed up in 2012 and 2013. Glycated haemoglobin (HbA1c), high-sensitivity C-reactive protein (hs-CRP), thyrotropin (TSH) and microalbuminuria were measured in two selected groups of patients in 2011. RESULTS: Overweight and obesity were present in 207 (62%) individuals of the studied population. Those followed up in 2012 and 2013 showed a reduction of body mass index, waist circumference and total cholesterol values. We observed risk value of HbA1c in 60 (35.5%) individuals with significant association to other cardiovascular risk factors. Microalbuminuria appeared in subjects with high blood pressure. High TSH and hs-CRP were not significantly present in our population. CONCLUSIONS: 1. Measurement of HbA1c during medical checkups improves early detection of cardiovascular risk in seafarers. 2. Individuals with overweight and obesity responded positively to medical advice and diminished their risk factors, thus it may be more effective to introduce detailed questionnaires on this issue.

Predicción del riesgo cardiovascular y su relación con el síndrome metabólico y los niveles de marcadores serológicos emergentes en vigilancia de la salud de los trabajadores / Cardiovascular risk prediction and its relationship with metabolic syndrome and ememerging serum markers in occupational health surveillance

Objetivos: Calcular el riesgo cardiovascular según los métodos americano Framingham Coronary Risk Score (FCRS), y europeo Systematic Coronary Risk Evaluation (SCORE) en una población laboral. Comparar los resultados con la presencia de síndrome metabólico (según niveles de glucemia, trigliceridemia, colesterolemia, perímetro abdominal y tensión arterial) y con los niveles de tres marcadores séricos emergentes: proteína C reactiva ultrasensible (PCRus), homocisteina (Hhcy) y lipoproteína (a) (lp(a)).Métodos: Los datos fueron recogidos en los exámenes de salud rutinarios de trabajadores mayoritariamente del sector servicios en FREMAP Prevención Alcobendas entre 2004 y 2006 (n=248). Se siguieron los protocolos de Vigilancia de la Salud del Ministerio de Sanidad, añadiendo a la práctica habitual la obtención de una muestra sérica adicional y la medición del perímetro abdominal. Resultados: Ninguno de los 248 empleados fue considerado de riesgo alto según FCRS, frente al 44,8% según SCORE. Se observó asociación alta (r=0,78, p<0,001) entre los dos métodos predictivos. También entre ambos métodos y la presencia de síndrome metabólico (p=0,043), y solo de FCRS con la PCRus (p=0,021) y la Hhcy séricas (p=0,036). Conclusiones: Según nuestra experiencia, para la prevención de patología cardiovascular en la rutina de la vigilancia de la salud laboral creemos justificada la estimación del riesgo según métodos FCRS y/o SCORE y la medición del perímetro abdominal para evaluar la presencia de síndrome metabólico, por su óptima relación coste-beneficio. Sin embargo, no consideramos justificada la determinación de ninguno de los marcadores biológicos emergentes analizados en este estudio

Objectives: To calculate cardiovascular risk according to the American Framingham Coronary Risk Score (FCRS) and the European Systematic Coronary Risk Evaluation (SCORE) methods. To correlate the results with the presence of metabolic syndrome (glycemia, triglyceridemia, cholesterolemia, abdominal circumference and blood pressure) and with serum levels of three emerging biomarkers [ultrasensitive reactive C protein (PCRus), homocysteine (Hcy) and lipoproteín (a)(lp (a)].Methods: Data were gathered during routine medical surveillance of mostly white collar workers in FREMAP Alcobendas from 2004 to 2006 (n=248).We followed standardized health surveillance protocols as established by the Spanish Health Ministry, along with inclusion of an additional blood sample and measurement of the abdominal circumference. Results: None of the 248 workers included in our sample was classified as having high or very high risk according to FCRS in contrast to 44.8 % according to SCORE. We observed a strong correlation (r=0.78, p<0.001) between both predictive methods. We also found associations between both methods and metabolic syndrome (p=0.043), and between the FCRS and PCRus (p=0.021) and Hcy (p=0.036). Conclusions: Our results suggest that the inclusion of risk predictions based on FCRS and/or SCORE could be recommended for the primary prevention of cardiovascular disease, because of their excellent cost-benefit relationship. However, we do not recommend routine measurement of the biological markers included in this study

[Cardiovascular risk prediction and its relationship with metabolic syndrome and emerging serum makers in occupational health surveillance]. / Predicción del riesgo cardiovascular y su relación con el síndrome metabólico y los niveles de marcadores serológicos emergentes en vigilancia de la salud de los trabajadores.

OBJECTIVES: To calculate cardiovascular risk according to the American Framingham Coronary Risk Score (FCRS) and the European Systematic Coronary Risk Evaluation (SCORE) methods. To correlate the results with the presence of meta-bolic syndrome (glycemia, triglyceridemia, cholesterolemia, abdominal circumference and blood pressure) and with serum levels of three emerging biomarkers [ultrasensitive reactive C protein (PCRus), homocysteine (Hcy) and lipoproteín (a) (lp (a)]. METHODS: Data were gathered during routine medical surveillance of mostly white collar workers in FREMAP Alcobendas from 2004 to 2006 (n=248).We followed standardized health surveillance protocols as established by the Spanish Health Ministry, along with inclusion of an additional blood sample and measurement of the abdominal circumference. RESULTS: None of the 248 workers included in our sample was classified as having high or very high risk according to FCRS in contrast to 44.8 % according to SCORE.We observed a strong correlation (r=0.78, p<0.001) between both predictive methods.We also found associations between both methods and metabolic syndrome (p=0.043), and between the FCRS and PCRus (p=0.021) and Hcy (p=0.036). CONCLUSIONS: Our results suggest that the inclusion of risk predictions based on FCRS and/or SCORE could be recommended for the primary prevention of cardiovascular disease, because of their excellent cost-benefit relationship. However, we do not recommend routine measurement of the biological markers included in this study.

OBJETIVOS: Calcular el riesgo cardiovascular según los métodos americano Framingham Coronary Risk Score (FCRS), y europeo Systematic Coronary Risk Evaluation (SCORE) en una población laboral. Comparar los resultados con la presencia de síndrome metabólico (según niveles de glucemia, trigliceridemia, colesterolemia, perímetro abdominal y tensión arterial) y con los niveles de tres marcadores séricos emergentes: proteína C reactiva ultrasensible (PCRus), homocisteina (Hhcy) y lipoproteína (a) (lp(a)). MÉTODOS: Los datos fueron recogidos en los exámenes de salud rutinarios de trabajadores mayoritariamente del sector servicios en FREMAP Prevención Alcobendas entre 2004 y 2006 (n=248). Se siguieron los protocolos de Vigilancia de la Salud del Ministerio de Sanidad, añadiendo a la práctica habitual la obtención de una muestra sérica adicional y la medición del perímetro abdominal. RESULTADOS: Ninguno de los 248 empleados fue considerado de riesgo alto según FCRS, frente al 44,8% según SCORE. Se observó asociación alta (r=0,78, p<0,001) entre los dos métodos predictivos. También entre ambos métodos y la presencia de síndrome metabólico (p=0,043), y solo de FCRS con la PCRus (p=0,021) y la Hhcy séricas (p=0,036). CONCLUSIONES: Según nuestra experiencia, para la prevención de patología cardiovascular en la rutina de la vigilancia de la salud laboral creemos justificada la estimación del riesgo según métodos FCRS y/o SCORE y la medición del perímetro abdominal para evaluar la presencia de síndrome metabólico, por su óptima relación coste-beneficio. Sin embargo, no consideramos justificada la determinación de ninguno de los marcadores biológicos emergentes analizados en este estudio.

Adjusting the dose of tamoxifen in patients with early breast cancer and CYP2D6 poor metabolizer phenotype.

BACKGROUND: CYP2D6 is a key enzyme in tamoxifen metabolism, transforming it into its main active metabolite, endoxifen. Poor CYP2D6 metabolizers (PM) have lower endoxifen plasma concentrations and possibly benefit less from treatment with tamoxifen. We evaluated tamoxifen dose adjustment in CYP2D6 PM patients in order to obtain plasma concentrations of endoxifen comparable to patients with extensive CYP2D6 metabolism (EM). PATIENTS AND METHODS: Comprehensive CYP2D6 genotyping and plasma tamoxifen metabolite concentrations were performed among 249 breast cancer patients in adjuvant treatment with tamoxifen. Tamoxifen dose was increased in PM patients to 40 mg and to 60 mg daily for a 4-month period each, repeating tamoxifen metabolite measurements on completion of each dose increase. We compared the endoxifen levels between EM and PM patients, and among the PM patients at each dose level of tamoxifen (20, 40 and 60 mg). RESULTS: Eleven PM patients (4.7%) were identified. The mean baseline endoxifen concentration in EM patients (11.30 ng/ml) was higher compared to the PM patients (2.33 ng/ml; p < 0.001). In relation to the 20 mg dose, increasing the tamoxifen dose to 40 and 60 mg in PM patients significantly raised the endoxifen concentration to 8.38 ng/ml (OR 3.59; p = 0.013) and to 9.30 ng/ml (OR 3.99; p = 0.007), respectively. These concentrations were comparable to those observed in EM patients receiving 20 mg of tamoxifen (p = 0.13 and p = 0.64, respectively). CONCLUSION: In CYP2D6 PM patients, increasing the standard tamoxifen dose two-fold or three-fold raises endoxifen concentrations to levels similar to those of patients with EM phenotype.

Case-control study of semicircular lipoatrophy, a new occupational disease in office workers.

OBJECTIVES: Semicircular lipoatrophy (SL) is an emerging occupational pathology. Its etiology is poorly understood. We intend to establish the probable risk factors and estimate the relative risk. METHODS: A case-control study was performed. Our company had 55 diagnosed cases. As controls, we used the 3 closest healthy coworkers to each case. We calculated the chi square, odds ratio and logistic regression for different exposures, during the 3 years from September 2007 to August 2010. RESULTS: There was 100% participation for the cases and 70.9% for the controls (ratio 1 : 2.1 case-control). The only risk variables found were female gender (p<0.02) and exposure to leaning on the edge of a table (p<0.01). In addition, a breakdown by sex objectifies a much stronger association with leaning on the edge of a table in women (p<0.01) than men (p 0.67). CONCLUSIONS: Female gender and leaning on the edge of a table (repeated microtrauma), especially in women, are risk factors for development of SL. Other variables seem to be confounding factors associated with female gender. There were no SL cases showing statistically significant relations with history of cancer or autoimmune diseases. There was also no significance with regard to wearing jeans. There is therefore a new risk for office staff in addition to the more traditional disorders (musculoskeletal, ocular, and psychosocial). Further studies are necessary to evaluate what we consider an underdiagnosed condition, since there is a large percentage of people that are potentially exposed and we found very little information in the literature on the matter.

CYP2D6*4 allele and breast cancer risk: is there any association?

BACKGROUND: CYP2D6 is an important cytochrome P450 enzyme. These enzymes catalyse the oxidative biotransformation of about 25% of clinically important drugs as well as the metabolism of numerous environmental chemical carcinogens. The most frequent null allele of CYP2D6 in European populations, CYP2D6*4, has been studied here in order to elucidate whether a relationship exists between this allele and the risk of developing breast cancer in a Spanish population. MATERIALS AND METHODS: Ninety-six breast cancer Spanish patients and one hundred healthy female volunteers were genotyped for the CYP2D6*4 allele using AmpliChip CYP450 Test technology. RESULTS: Homozygous CYP2D6*4 frequency was significant lower in breast cancer patients than in the control group (OR=0.22, p=0.04). The heterozygous CYP2D6*4 group also displayed lower values in patients than in controls but the difference was not significant (OR=0.698, p=0.28). Therefore, the presence of the CYP2D6*4 allele seems to decrease susceptibility to breast carcinoma in the selected population. CONCLUSIONS: A possible decreased transformation of procarcinogens by CYP2D6*4 poor metabolisers could result in a protective effect against carcinogens.

Implicaciones éticas y legales de la investigación biomédica / Ethical and legal implications of biomedical research

Los grandes avances de la investigación biomédica sitúan a los investigadores, las instituciones y las empresas responsables ante problemas éticos y legales. Esta nueva mirada a su quehacer profesional resulta de la necesaria protección de los derechos y deberes de los pacientes, que se refleja en documentos internacionales y legislaciones específicas en los diferentes países, que de forma globalizada están asumiendo la investigación transnacional, a su vez vinculada a la traslacional. El carácter multidisciplinario de la investigación biomédica actual encuentra reflejo en el ámbito de los derechos y deberes que hay que proteger. Así, la ética, la bioética y el derecho inician un diálogo obligado e intenso que incluso da nombre a nuevas áreas de conocimiento, como son el derecho sanitario y el bioderecho. La medicina personalizada dibuja un nuevo criterio asistencial, y la farmacogenética puede ser un buen modelo de estudio, capaz de promover la deliberación y la prudencia en las decisiones. Finalmente, la economía de la salud resulta imprescindible no sólo por su experiencia técnica, sino para redescubrir la ética que le dio origen (AU)

The major advances in biomedical research pose ethical and legal problems for the researchers, institutions and companies responsible for these advances. This new vision of their professional task results from the necessary protection of patients’ rights and responsibilities, reflected in international documents and specific legislation in distinct countries, which are globally being adopted by transnational research, linked —in turn— to translational research. The pluridisciplinary nature of current biomedical research is reflected in the field of the rights and responsibilities to be protected. Thus, Ethics, Bioethics and the Law started an ineludible and intense dialogue that has even given rise to new areas of knowledge such as Healthcare Law and Biolaw. Personalized medicine constitutes a new healthcare criterion while pharmacogenetics may be a good study model, able to promote deliberation and prudence in decisions. Finally, Health Economics is essential, not only to benefit from its technical experience but also to rediscover the ethics that gave rise to this discipline (AU)

[Ethical and legal implications of biomedical research]. / Implicaciones éticas y legales de la investigación biomédica.

The major advances in biomedical research pose ethical and legal problems for the researchers, institutions and companies responsible for these advances. This new vision of their professional task results from the necessary protection of patients' rights and responsibilities, reflected in international documents and specific legislation in distinct countries, which are globally being adopted by transnational research, linked -in turn- to translational research. The pluridisciplinary nature of current biomedical research is reflected in the field of the rights and responsibilities to be protected. Thus, Ethics, Bioethics and the Law started an ineludible and intense dialogue that has even given rise to new areas of knowledge such as Healthcare Law and Biolaw. Personalized medicine constitutes a new healthcare criterion while pharmacogenetics may be a good study model, able to promote deliberation and prudence in decisions. Finally, Health Economics is essential, not only to benefit from its technical experience but also to rediscover the ethics that gave rise to this discipline.