[The enormous difference between not rejecting a null hypothesis and stating that it is true]. / La abismal diferencia entre no rechazar la hipótesis nula y afirmar que es cierta.

Assuming that a hypothesis is true because insufficient evidence has been found to reject it is a very common error when interpreting the p-value of a test in biomedical research. For example, a value of p = 0.28 obviously does not mean the null hypothesis should be ruled out, but if we understand what it means (which is not a mathematical issue, but instead a purely logical one) that it is equally obvious that it cannot be stated that it is true. If the samples in a comparison of a new drug with an old one show that the new one has a higher healing percentage and the p-value of the test is 0.0004, for example, the scientific community concludes that the new one is better. However, if for example the p-value of the test is 0.14, the scientific community does not conclude that the new one is as good as the old one. It merely concludes that the new one has not been shown to outperform the other one. It is therefore possible that an extension of the study with more cases may demonstrate that the new one is better.

TITLE: La abismal diferencia entre no rechazar la hipótesis nula y afirmar que es cierta.Un error muy frecuente al interpretar el valor de p del test en la investigación biomédica consiste en asumir que una hipótesis es cierta porque no se ha encontrado suficiente evidencia para rechazarla. Es obvio que un valor de p = 0,28, por ejemplo, no invita a rechazar la hipótesis nula, pero, si se entiende lo que indica (que no es un tema matemático, sino puramente lógico), resulta igualmente obvio que no autoriza a afirmar que es cierta. Si al comparar un nuevo fármaco frente al antiguo encontramos en las muestras que el nuevo presenta mayor porcentaje de curaciones y, por ejemplo, el valor de p del test es = 0,0004, la comunidad científica concluye que el nuevo es mejor. Pero si, por ejemplo, el valor de p del test es = 0,14, la comunidad científica no concluye que el nuevo es igual al antiguo. Sólo concluye que no queda demostrado que el nuevo aventaje al otro. Por ello, queda abierta la puerta a que en una ampliación del estudio con más casos pueda demostrarse que el nuevo es mejor.

El valor de p del test no es un ‘índice matemático’, es simplemente una frecuencia relativa / The p-value of the test is not a ‘mathematical index’, it is simply a relative frequency

Las revistas científicas más importantes en campos como medicina, biología y sociología publican reiteradamente artículos y editoriales denunciando que un gran porcentaje de médicos no entiende los conceptos básicos del análisis estadístico, lo que favorece el riesgo de cometer errores al interpretar los datos, los hace más vulnerables frente a informaciones falsas y reduce la eficacia de la investigación. Este problema se extiende a lo largo de toda su carrera profesional y se debe, en gran parte, a una enseñanza deficiente en estadística que es común en países desarrollados. En palabras de H. Halle y S. Krauss, ‘el 90% de los profesores universitarios alemanes que usan con asiduidad el valor de p de los test no entiende lo que mide ese valor’. Es importante destacar que los razonamientos básicos del análisis estadístico son similares a los que realizamos en nuestra vida cotidiana y que comprender los conceptos básicos del análisis estadístico no requiere conocimiento matemático alguno. En contra de lo que muchos investigadores creen, el valor de p del test no es un ‘índice matemático’ que nos permita concluir claramente si, por ejemplo, un fármaco es más efectivo que el placebo. El valor de p del test es simplemente un porcentaje.(AU)

Abstract. Leading scientific journals in fields such as medicine, biology and sociology repeatedly publish articles and editorials claiming that a large percentage of doctors do not understand the basics of statistical analysis, which increases the risk of errors in interpreting data, makes them more vulnerable to misinformation and reduces the effectiveness of research. This problem extends throughout their careers and is largely due to the poor training they receive in statistics – a problem that is common in developed countries. As stated by H. Halle and S. Krauss, ‘90% of German university lecturers who regularly use the p-value in tests do not understand what that value actually measures’. It is important to note that the basic reasoning of statistical analysis is similar to what we do in our daily lives and that understanding the basic concepts of statistical analysis does not require any knowledge of mathematics. Contrary to what many researchers believe, the p-value of the test is not a ‘mathematical index’ that allows us to clearly conclude whether, for example, a drug is more effective than a placebo. The p-value of the test is simply a percentage.(AU)

[The p-value of the test is not a 'mathematical index', it is simply a relative frequency]. / El valor de p del test no es un 'índice matemático', es simplemente una frecuencia relativa.

Leading scientific journals in fields such as medicine, biology and sociology repeatedly publish articles and editorials claiming that a large percentage of doctors do not understand the basics of statistical analysis, which increases the risk of errors in interpreting data, makes them more vulnerable to misinformation and reduces the effectiveness of research. This problem extends throughout their careers and is largely due to the poor training they receive in statistics - a problem that is common in developed countries. As stated by H. Halle and S. Krauss, '90% of German university lecturers who regularly use the p-value in tests do not understand what that value actually measures'. It is important to note that the basic reasoning of statistical analysis is similar to what we do in our daily lives and that understanding the basic concepts of statistical analysis does not require any knowledge of mathematics. Contrary to what many researchers believe, the p-value of the test is not a 'mathematical index' that allows us to clearly conclude whether, for example, a drug is more effective than a placebo. The p-value of the test is simply a percentage.

TITLE: El valor de p del test no es un 'índice matemático', es simplemente una frecuencia relativa.Las revistas científicas más importantes en campos como medicina, biología y sociología publican reiteradamente artículos y editoriales denunciando que un gran porcentaje de médicos no entiende los conceptos básicos del análisis estadístico, lo que favorece el riesgo de cometer errores al interpretar los datos, los hace más vulnerables frente a informaciones falsas y reduce la eficacia de la investigación. Este problema se extiende a lo largo de toda su carrera profesional y se debe, en gran parte, a una enseñanza deficiente en estadística que es común en países desarrollados. En palabras de H. Halle y S. Krauss, 'el 90% de los profesores universitarios alemanes que usan con asiduidad el valor de p de los test no entiende lo que mide ese valor'. Es importante destacar que los razonamientos básicos del análisis estadístico son similares a los que realizamos en nuestra vida cotidiana y que comprender los conceptos básicos del análisis estadístico no requiere conocimiento matemático alguno. En contra de lo que muchos investigadores creen, el valor de p del test no es un 'índice matemático' que nos permita concluir claramente si, por ejemplo, un fármaco es más efectivo que el placebo. El valor de p del test es simplemente un porcentaje.

De-escalating axillary management after neoadjuvant chemotherapy in breast cancer: The ratio of positive sentinel lymph nodes matters.

BACKGROUND: De-escalation of axillary surgery in breast cancer (BC) patients diminishes sequelae without compromising cancer outcomes. Surgical management of the axilla is challenging after neoadjuvant treatment. We aimed to identify the factors associated with residual axillary disease amenable to lymphadenectomy in patients with positive sentinel lymph node biopsy (SLNB). METHODS: We conducted a retrospective observational study in Hospital 12 de Octubre (Spain). We included BC patients with positive SLNB who underwent axillary dissection after neoadjuvant chemotherapy. Univariate and multivariate logistic regression models were performed to identify independent predictors of residual axillary disease. We estimated the ratio of positive nodes in SLNB and assessed the diagnostic validity of this ratio in relation to residual axillary disease. RESULTS: We included 103 patients in the study. Residual axillary disease was identified in 54 patients (52.4%). Clinically node positive status at diagnosis (OR = 18.3, 95%CI: 4.0-83.6) and a ratio of positive nodes in SLNB ≥0.5 (OR = 6.5, 95%CI 41.7-23.7) were associated with residual axillary disease. The sensitivity and negative predictive value of a ratio of positive nodes in SLNB ≥0.5 were 87% (95%CI 75.1%-94.6%) and 75% (95%CI 55.1%-89.3%), respectively. CONCLUSIONS: In our study, for patients with positive SLNB after neoadjuvant chemotherapy, stage N+ at diagnosis and a ratio of positive nodes in SLNB ≥0.5 were independent risk factors of positive residual axillary disease. This ratio is a feasible measure with a good diagnostic validity for residual axillary disease and could be used as a guiding factor in the surgical management of these patients.

Clinical study types and guidance for their correct post-pandemic interpretation.

Randomized clinical trials (RCTs) are key to the advancement of medicine and microbiology, but they are not the only option. Observational studies provide information on long-term efficacy and safety, are less expensive, allow the study of rare events, and obtain information more quickly than RCTs. On the other hand, they are more vulnerable to confounding factors. Prospective exploratory pilot studies share many aspects with RCTs but are not subject to supervision by external commissions or mandatory registration. Multitesting can pervert the balance of publications in favor of the desired effect. Bonferroni's reasoning shows that if 10 studies are performed with an ineffective antibiotic, the probability that at least one will show P <0.05 might be 40%. Scenarios in which there is intensive pressure to perform research, such as the recent pandemic, might result in many research teams trying to study the effect of an antimicrobial. Even if the drug has no efficacy, if 100 research teams conduct a study to assess its usefulness, it might be virtually certain that at least one will get a P value <0.05. If the other studies (with P >0.05) are not published, the scientific commu nity would consider that there is strong evidence in favor of its usefulness. In conclusion, RCTs are a very good source of clinical information, but are not the only one. The systematic registration of all research can and should be applied to all types of clinical studies.

[The dramatic loss of statistical power when dichotomising continuous variables]. / La dramática pérdida de potencia estadística al dicotomizar variables continuas.

A very common practice in medical research, during the process of data analysis, is to dichotomise numerical variables in two groups. This leads to the loss of very useful information that can undermine the effectiveness of the research. Several examples are used to show how the dichotomisation of numerical variables can lead to a loss of statistical power in studies. This can be a critical aspect in assessing, for example, whether a therapeutic procedure is more effective or whether a certain factor is a risk factor. Dichotomising continuous variables is therefore not recommended unless there is a very specific reason to do so.

TITLE: La dramática pérdida de potencia estadística al dicotomizar variables continuas.Una práctica muy habitual en la investigación médica, durante el proceso de análisis de los datos, es dicotomizar variables numéricas en dos grupos. Dicha práctica conlleva la pérdida de información muy útil que puede restar eficacia a la investigación. A través de varios ejemplos, se muestra cómo con la dicotomización de variables numéricas los estudios pierden potencia estadística. Esto puede ser un aspecto crítico que impida valorar, por ejemplo, si un procedimiento terapéutico es más efectivo o si un determinado factor es de riesgo. Por tanto, se recomienda no dicotomizar las variables continuas si no existe un motivo muy concreto para ello.

Mitos y realidad en el cálculo del tamaño muestral / Myths and reality about calculating sample size

Cuando decidimos hacer un estudio, una de las primeras cuestiones que se plantea es ¿qué número de individuos debo incluir en la muestra para que sea ‘representativa’ y el estudio sea ‘válido’? Como en otros ámbitos de la vida, hay muchas cuestiones para las que no hay una cantidad ‘adecuada’ y son válidas diferentes cantidades. Aquí ocurre lo mismo. La pregunta ‘¿cuántos euros costó esta bicicleta?’ tiene como respuesta un número concreto. Pero la pregunta ‘¿cuántos euros necesito para comprar una bicicleta?’ admite muchas cifras distintas como respuesta, dependiendo del tamaño y otras características de la bicicleta. Los libros de estadística contienen fórmulas que relacionan el tamaño de la muestra con ciertos parámetros y la mayoría de los médicos cree que una de ellas les dará el tamaño ‘adecuado’ para su investigación, y que usándolas queda ‘justificado el tamaño de la muestra’ ante posibles revisores. En este documento se hace una reflexión sobre el verdadero peso que tienen dichas fórmulas y cuál debe ser el uso adecuado que el investigador haga de ellas. Es necesario mostrar errores y simulaciones que no benefician a nadie y perjudican a muchos restando tiempo y energía.(AU)

When we decide to conduct a study, one of the first questions that arises is what number of individuals should be included in the sample for it to be ‘representative’ and for the study to be ‘valid’? As in other areas of life, there are many matters for which there is no ‘right’ amount and different quantities are valid. The same applies here. When asked the question ‘How many euros did this bicycle cost?’, the answer is a definite number. But the question ‘How many euros do I need to buy a bicycle?’ can be answered in many different ways, depending on the size and other characteristics of the bicycle. Statistics textbooks contain formulas relating sample size to certain parameters and most doctors believe that one of these will give them the ‘right’ size for their research, and that by using them their choice of sample size will be justified in the eyes of potential reviewers. This document reflects on the true value of these formulas and how researchers should make proper use of them. It is necessary to show errors and simulations that benefit no one and hinder many by taking up large amounts of time and energy.(AU)

Potencia estadística en investigación médica. ¿Qué postura tomar cuando los resultados de la investigación son significativos? / Statistical power in medical research. What stance should be taken when the research results are significant?

Cuando el investigador pide subvención y autorización a entidades financieras para llevar a cabo su proyecto, entre las primeras cuestiones que le plantean está: ¿qué potencia estadística tiene este estudio que usted propone? Si el investigador responde, por ejemplo, el 90%, y el evaluador se da por satisfecho, es seguro que no conoce realmente el tema. La potencia de un estudio no es única. Depende de determinados parámetros y ocurre que, en la mayoría de los casos, variando ligeramente los valores de esos parámetros, la potencia toma un valor aceptable. Si no es así, y a pesar de ello se lleva a cabo el estudio, y sus resultados son muy significativos, no ha lugar a cuestionar el éxito encontrado argumentando que el estudio tenía poca potencia. Tan sólo es momento de celebrarlo. (AU)

When researchers request funding and authorisation from financial institutions to carry out their project, one of the first questions they are asked is: what is the statistical power of the study you are proposing? If the researcher answers, for example, 90%, and the evaluator is satisfied, it is certain that he/she is not really familiar with the subject. The power of a study is not unique. It depends on certain parameters and what happens is that, in most cases, by introducing a slight variation in the values of these parameters, the power takes on an acceptable value. If this is not the case and the study is carried out anyway, and its results are very significant, there is no room to question its success by arguing that the power of the study was very low. It is just the time to celebrate. (AU)

[Statistical power in medical research. What stance should be taken when the research results are significant?] / Potencia estadística en investigación médica. ¿Qué postura tomar cuando los resultados de la investigación son significativos?

When researchers request funding and authorisation from financial institutions to carry out their project, one of the first questions they are asked is: what is the statistical power of the study you are proposing? If the researcher answers, for example, 90%, and the evaluator is satisfied, it is certain that he/she is not really familiar with the subject. The power of a study is not unique. It depends on certain parameters and what happens is that, in most cases, by introducing a slight variation in the values of these parameters, the power takes on an acceptable value. If this is not the case and the study is carried out anyway, and its results are very significant, there is no room to question its success by arguing that the power of the study was very low. It is just the time to celebrate.

TITLE: Potencia estadística en investigación médica. ¿Qué postura tomar cuando los resultados de la investigación son significativos?Cuando el investigador pide subvención y autorización a entidades financieras para llevar a cabo su proyecto, entre las primeras cuestiones que le plantean está: ¿qué potencia estadística tiene este estudio que usted propone? Si el investigador responde, por ejemplo, el 90%, y el evaluador se da por satisfecho, es seguro que no conoce realmente el tema. La potencia de un estudio no es única. Depende de determinados parámetros y ocurre que, en la mayoría de los casos, variando ligeramente los valores de esos parámetros, la potencia toma un valor aceptable. Si no es así, y a pesar de ello se lleva a cabo el estudio, y sus resultados son muy significativos, no ha lugar a cuestionar el éxito encontrado argumentando que el estudio tenía poca potencia. Tan sólo es momento de celebrarlo.

[Myths and reality about calculating sample size]. / Mitos y realidad en el cálculo del tamaño muestral.

When we decide to conduct a study, one of the first questions that arises is what number of individuals should be included in the sample for it to be 'representative' and for the study to be 'valid'? As in other areas of life, there are many matters for which there is no 'right' amount and different quantities are valid. The same applies here. When asked the question 'How many euros did this bicycle cost?', the answer is a definite number. But the question 'How many euros do I need to buy a bicycle?' can be answered in many different ways, depending on the size and other characteristics of the bicycle. Statistics textbooks contain formulas relating sample size to certain parameters and most doctors believe that one of these will give them the 'right' size for their research, and that by using them their choice of sample size will be justified in the eyes of potential reviewers. This document reflects on the true value of these formulas and how researchers should make proper use of them. It is necessary to show errors and simulations that benefit no one and hinder many by taking up large amounts of time and energy.

TITLE: Mitos y realidad en el cálculo del tamaño muestral.Resumen. Cuando decidimos hacer un estudio, una de las primeras cuestiones que se plantea es ¿qué número de individuos debo incluir en la muestra para que sea 'representativa' y el estudio sea 'válido'? Como en otros ámbitos de la vida, hay muchas cuestiones para las que no hay una cantidad 'adecuada' y son válidas diferentes cantidades. Aquí ocurre lo mismo. La pregunta '¿cuántos euros costó esta bicicleta?' tiene como respuesta un número concreto. Pero la pregunta '¿cuántos euros necesito para comprar una bicicleta?' admite muchas cifras distintas como respuesta, dependiendo del tamaño y otras características de la bicicleta. Los libros de estadística contienen fórmulas que relacionan el tamaño de la muestra con ciertos parámetros y la mayoría de los médicos cree que una de ellas les dará el tamaño 'adecuado' para su investigación, y que usándolas queda 'justificado el tamaño de la muestra' ante posibles revisores. En este documento se hace una reflexión sobre el verdadero peso que tienen dichas fórmulas y cuál debe ser el uso adecuado que el investigador haga de ellas. Es necesario mostrar errores y simulaciones que no benefician a nadie y perjudican a muchos restando tiempo y energía.

Top ten errors of statistical analysis in observational studies for cancer research.

Observational studies using registry data make it possible to compile quality information and can surpass clinical trials in some contexts. However, data heterogeneity, analytical complexity, and the diversity of aspects to be taken into account when interpreting results makes it easy for mistakes to be made and calls for mastery of statistical methodology. Some questionable research practices that include poor analytical data management are responsible for the low reproducibility of some results; yet, there is a paucity of information in the literature regarding specific statistical pitfalls of cancer studies. In addition to proposing how to avoid or solve them, this article seeks to expose ten common problematic situations in the analysis of cancer registries: convenience, dichotomization, stratification, regression to the mean, impact of sample size, competing risks, immortal time and survivor bias, management of missing values, and data dredging.

Most advisable strategy in search of asymptomatic target organ damage in hypertensive patients / Estrategia óptima de búsqueda de daño de órgano diana asintomático en el hipertenso

Objective: To evaluate the diagnostic potential of seven examinations in order to define the most suitable strategy for target organ damage (TOD) search in hypertensive patients. Methods: This is a descriptive, cross-sectional study. 153 consecutive treated and essential hypertensive patients were enrolled. Patients with established cardiovascular or chronic renal disease (stage ≥ 4) were excluded. TOD search was assessed by: glomerular filtration rate (GFR), albumin/creatinine ratio (ACR), electrocardiogram (ECG), echocardiogram (ECO), ankle-brachial index (ABI), pulse wave velocity (PWV), and carotid ultrasound (intima media thickness and presence of plaques). The rationale of our strategy ought to determine the performance of applying a set of the most widely available tests (GFR, ACR, ABI, ECG) and advise about the optimal sequence of the remaining tests. Results: The sample was 64.4 ± 7.9 years old, 45.8% males. 82.6% of the sample had any TOD at all. The resulting algorithm found a 37% TOD in relation to GFR, ACR, ABI and ECG values. Adding carotid ultrasound added up to 70% of the studied population and properly classified (TOD+/TOD−) 89% of the cohort. When performing PWV, 78% of the patients had been identified as TOD+ and 96% of the population was correctly identified. Contribution of ECO was minor. Conclusion: After running the more widely available explorations (GFR, ACR, ABI, ECG), a step-by-step strategy that included carotid ultrasound, PWV and ECO could be the best sequence for TOD search in asymptomatic hypertensive patientsien

Objetivo: Evaluar el rendimiento diagnóstico de un panel de siete pruebas de determinación de daño de órgano diana (DOD) aplicadas de forma sistemática, a fin de sugerir la estrategia óptima para la búsqueda de DOD en el hipertenso. Método: Estudio descriptivo y transversal. Se incluyeron 153 pacientes diagnosticados de hipertensión esencial bajo tratamiento farmacológico. Se excluyeron pacientes con enfermedad cardiovascular establecida o enfermedad renal crónica estadio ≥4. Se realizó una búsqueda de DOD mediante filtrado glomerular estimado (FGe), índice albúmina creatinina (IAC), hipertrofia ventricular por electrocardiograma (ECG) y ecocardiograma (ECO), índice tobillo brazo (ITB), velocidad de la onda de pulso (VOP) y ecografía carotídea (placas y grosor íntima media). Se propuso una estrategia de búsqueda de DOD en la que tras la realización de las exploraciones más accesibles (FGe, IAC, ITB y ECG) se sugiere la secuencia de exploraciones a realizar con mayor eficacia diagnóstica. Resultados: La edad media fue 64.4 ± 7.9 años, siendo el 45.8% varones. El 82.6% presentó algún tipo de DOD. Según el algoritmo propuesto, las pruebas de mayor accesibilidad diagnosticaron un 37% de DOD en la muestra. Tras añadir la ecografía carotídea, se detectó DOD en el 70%, y el 89% de la población fue apropiadamente clasificada en DOD+/DOD−. La realización de VOP incrementó la prevalencia de DOD hasta el 78%, y el 96% de la muestra fue correctamente clasificada. La contribución de la ECO fue menor. Conclusión: Tras la realización de las exploraciones más accesibles (FGe, IAC, ITB y ECG), la realización sistemática de ecografía carotídea, VOP y ECO podría ser la estrategia óptima para la búsqueda de DOD en el hipertenso

Most advisable strategy in search of asymptomatic target organ damage in hypertensive patients.

OBJECTIVE: To evaluate the diagnostic potential of seven examinations in order to define the most suitable strategy for target organ damage (TOD) search in hypertensive patients. METHODS: This is a descriptive, cross-sectional study. 153 consecutive treated and essential hypertensive patients were enrolled. Patients with established cardiovascular or chronic renal disease (stage ≥4) were excluded. TOD search was assessed by: glomerular filtration rate (GFR), albumin/creatinine ratio (ACR), electrocardiogram (ECG), echocardiogram (ECO), ankle-brachial index (ABI), pulse wave velocity (PWV), and carotid ultrasound (intima media thickness and presence of plaques). The rationale of our strategy ought to determine the performance of applying a set of the most widely available tests (GFR, ACR, ABI, ECG) and advise about the optimal sequence of the remaining tests. RESULTS: The sample was 64.4±7.9 years old, 45.8% males. 82.6% of the sample had any TOD at all. The resulting algorithm found a 37% TOD in relation to GFR, ACR, ABI and ECG values. Adding carotid ultrasound added up to 70% of the studied population and properly classified (TOD+/TOD-) 89% of the cohort. When performing PWV, 78% of the patients had been identified as TOD+ and 96% of the population was correctly identified. Contribution of ECO was minor. CONCLUSION: After running the more widely available explorations (GFR, ACR, ABI, ECG), a step-by-step strategy that included carotid ultrasound, PWV and ECO could be the best sequence for TOD search in asymptomatic hypertensive patients.

Control de la anticoagulación en pacientes con fibrilación auricular no valvular en práctica clínica de atención primaria en las diferentes comunidades autónomas. Estudio PAULA / Control of anticoagulation in patients with non-valvular atrial fibrillation in a primary care clinical practice setting in the different autonomous communities. PAULA study

Objetivos. Conocer las diferencias entre comunidades autónomas en el grado de control de los pacientes con fibrilación auricular no valvular, tratados con antagonistas de la vitamina K, incluidos en el estudio PAULA. Métodos. Estudio observacional retrospectivo/transversal. Participaron 139 investigadores de 99 centros de salud de todas las Comunidades Autónomas (excepto La Rioja). El grado de control se determinó mediante tiempo en rango terapéutico, por método directo (mal control<60%), y por Rosendaal (mal control<65%). Resultados. Fueron incluidos 1.524 pacientes. Se observaron pequeñas diferencias entre las características basales de los pacientes. Se apreciaron diferencias en el porcentaje de tiempo en rango terapéutico, según el método Rosendaal (media 69,0±17,7%), desde 78,1%±16,6 (País Vasco) a 61,5%±14 (Baleares), según método directo (media 63,2±17,9%), desde 73,6%±16,6 (País Vasco) al 57,5%±15,7 (Extremadura). Al comparar comunidades, donde el médico de familia asume de forma integral el control y no existen restricciones a la prescripción, el porcentaje de tiempo en rango terapéutico por el método directo fue 63,89 frente 60,95%, en las que sí existen (p=0,006), por Rosendaal, del 69,39% frente al 67,68% (p=0,1036). Conclusiones. Existen diferencias significativas en el grado de control entre comunidades siendo inadecuado en algunas. Comunidades donde el médico de familia asume la gestión integral de la anticoagulación, el tiempo en rango terapéutico es algo superior y muestra una tendencia favorable a mejor control. Estos hallazgos pueden tener implicación clínica, merecen una reflexión y un análisis específico (AU)

Aims. To determine the differences between regions in the level of control of patients with non-valvular atrial fibrillation treated with vitamin K antagonists, included in the PAULA study. Methods. Observational, and coss-sectional/retrospective study, including 139 Primary Care physicians from 99 Health Care centres in all autonomous communities (except La Rioja). Anticoagulation control was defined as the time in therapeutic range assessed by either the direct method (poor control <60%), or the Rosendaal method (poor control <65%). Results. A total of 1,524 patients were included. Small differences in baseline characteristics of the patients were observed. Differences in the percentage of time in therapeutic range were observed, according to the Rosendaal method (mean 69.0±17.7%), from 78.1%±16.6 (Basque Country) to 61.5±14% (Balearic Islands), by the direct method (mean 63.2±17.9%) from 73.6%±16.6 (Basque Country) to 57.5±15.7% (Extremadura). When comparing regions, in those where the Primary Care physicians assumed full control without restrictions on prescription, the percentage of time in therapeutic range by the direct method was 63.89 vs. 60.95% in those with restrictions (p=.006), by Rosendaal method, 69.39% compared with 67.68% (p=.1036). Conclusions. There are significant differences in the level of control between some regions are still inadequate. Regions in which the Primary Care physicians assumed the management of anticoagulation and without restrictions, time in therapeutic range was somewhat higher, and showed a favourable trend for better control. These findings may have clinical implications, and deserve consideration and specific analysis (AU)

[Control of anticoagulation in patients with non-valvular atrial fibrillation in a primary care clinical practice setting in the different autonomous communities. PAULA study]. / Control de la anticoagulación en pacientes con fibrilación auricular no valvular en práctica clínica de atención primaria en las diferentes comunidades autónomas. Estudio PAULA.

AIMS: To determine the differences between regions in the level of control of patients with non-valvular atrial fibrillation treated with vitamin K antagonists, included in the PAULA study. METHODS: Observational, and coss-sectional/retrospective study, including 139 Primary Care physicians from 99 Health Care centres in all autonomous communities (except La Rioja). Anticoagulation control was defined as the time in therapeutic range assessed by either the direct method (poor control <60%), or the Rosendaal method (poor control <65%). RESULTS: A total of 1,524 patients were included. Small differences in baseline characteristics of the patients were observed. Differences in the percentage of time in therapeutic range were observed, according to the Rosendaal method (mean 69.0±17.7%), from 78.1%±16.6 (Basque Country) to 61.5±14% (Balearic Islands), by the direct method (mean 63.2±17.9%) from 73.6%±16.6 (Basque Country) to 57.5±15.7% (Extremadura). When comparing regions, in those where the Primary Care physicians assumed full control without restrictions on prescription, the percentage of time in therapeutic range by the direct method was 63.89 vs. 60.95% in those with restrictions (p=.006), by Rosendaal method, 69.39% compared with 67.68% (p=.1036). CONCLUSIONS: There are significant differences in the level of control between some regions are still inadequate. Regions in which the Primary Care physicians assumed the management of anticoagulation and without restrictions, time in therapeutic range was somewhat higher, and showed a favourable trend for better control. These findings may have clinical implications, and deserve consideration and specific analysis.

[Prevalence of multiple sclerosis in the Region of Murcia]. / Prevalencia de la esclerosis multiple en la Region de Murcia.

INTRODUCTION: Multiple sclerosis (MS) is a demyelinating inflammatory disease of the central nervous system with immune-mediated pathogenesis. Recent research points to an increase in its prevalence, and a number of studies relate Epstein-Barr virus (EBV) with its aetiology. AIMS: This study seeks to analyse the prevalence of MS in the Region of Murcia, and includes a description of the clinical characteristics at the time of onset of the disease, and of the EBV serological status of patients with MS. PATIENTS AND METHODS: We conducted a retrospective epidemiological study based on a sample consisting of the population living within the central-west healthcare area of the Region of Murcia (257,865 inhabitants). Clinical and serological data extracted from different sources were analysed. RESULTS: Prevalence of MS in the population under study: 88 cases/100,000 inhabitants. Prevalence of MS together with isolated demyelinating syndrome: 98.4 cases/100,000 inhabitants. Mean incidence of MS: 5.8 cases/100,000 inhabitants/year. At the onset of MS, 67.8% were females, 81.9% presented a relapsing-remitting course, the mean age was 31.4 years, the sensory system was the most frequently compromised (45.1%), onset was monofocal in 55.4% and the degree of disability on the Expanded Disability Status Scale was 2.1 points. The seroprevalence of EBV was 99.3%. The reactivation of EBV infection was related to the clinical activity of MS in 10 patients (45.4%). CONCLUSIONS: Currently, the prevalence of MS in the Region of Murcia is similar to that estimated in other Spanish autonomous regions. The study confirms the trend of increased prevalence observed over the last few decades.

TITLE: Prevalencia de la esclerosis multiple en la Region de Murcia.Introduccion. La esclerosis multiple (EM) es una enfermedad inflamatoria desmielinizante del sistema nervioso central con patogenia inmunomediada. Recientes estudios indican un aumento de su prevalencia, y numerosos trabajos relacionan el virus de Epstein-Barr (VEB) con su etiologia. Objetivo. Analisis de prevalencia de la EM en la Region de Murcia, incluyendo la descripcion de las caracteristicas clinicas en el momento del inicio de la enfermedad, y del estado serologico del VEB de los pacientes con EM. Pacientes y metodos. Estudio epidemiologico retrospectivo, tomando como muestra la poblacion residente en el area sanitaria centro-oeste de la Region de Murcia (257.865 habitantes). Se analizan datos clinicos y serologicos extraidos de diferentes fuentes. Resultados. Prevalencia de la EM en la poblacion estudiada: 88 casos/100.000 habitantes. Prevalencia de la EM junto con el sindrome desmielinizante aislado: 98,4 casos/100.000 habitantes. Incidencia media de la EM: 5,8 casos/100.000 habitantes/año. En el inicio de la EM, el 67,8% eran mujeres, el 81,9% presentaba un curso recurrente-remitente, la edad media era de 31,4 años, el sistema funcional mas frecuentemente afectado era el sensitivo (45,1%), el inicio fue monofocal en el 55,4% y el grado de discapacidad en la Expanded Disability Status Scale era de 2,1 puntos. La seroprevalencia del VEB fue del 99,3%. La reactivacion de la infeccion por VEB se relaciono con actividad clinica de EM en 10 pacientes (45,4%). Conclusiones. Actualmente, la prevalencia de la EM en la Region de Murcia es similar a la estimada en otras comunidades autonomas españolas. El estudio confirma la tendencia de incremento de prevalencia observada en las ultimas decadas.

Objeciones que invalidan las conclusiones del estudio de efectividad, tolerabilidad y calidad de vida de tapentadol LP vs. oxicodona/naloxona LP / Objections that invalidate the conclusions of the study of effectiveness, tolerability and quality of life of tapentadol LP vs. oxycodone/naloxone LP

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The challenges of managing a complex stoma with NPWT.

This paper reports the clinical experience of a 71-year-old female with resection of the colon, who subsequently developed postoperative complications. A colostomy was carried out; necrosis of the colostomy edges and stoma retraction complicated optimal stoma appliance placement. It was possible to treat the resulting cavity with negative pressure wound therapy (NPWT) by isolating the stoma and treating the peristomal wound area. The wound was treated with NPWT for 30 days; at day 20, the patient was discharged to home to continue with NPWT for a further 10 days by community nurses, with regular follow-up visits in the outpatient clinic. The patient improved steadily and achieved complete closure of the wound.