Exhaustividad y tono crítico de las noticias en la prensa escrita que informan de una innovación médica / Exhaustivity and critical tone of the news in print media reporting medical innovations

Objetivo: Conocer la exhaustividad y el tono crítico de las noticias sobre innovaciones médicas publicadas en la prensa escrita generalista y analizar qué características pueden estar relacionadas. Método: Análisis del contenido de las noticias sobre el descubrimiento, la introducción o la mejora de una innovación médica a través de un cuestionario con diez criterios de exhaustividad que permiten calcular un índice global de exhaustividad. También se analizó el tono crítico de las noticias. Dos investigadores evaluaron de forma independiente las noticias. Resultados: Se analizaron 204 noticias que obtuvieron como puntuación media de exhaustividad 4,5. El 70% se clasificó con un tono crítico optimista. Los criterios de exhaustividad mejor valorados fueron el nivel de detalle sobre la innovación y la correcta diferenciación entre hechos y opiniones. Los criterios peor valorados se refirieron a los posibles conflictos de intereses económicos y a los riesgos potenciales de la innovación. Las variables autor, longitud de la noticia y clasificación de la innovación se relacionaron tanto con la puntuación de exhaustividad como con el tono crítico. El índice de exhaustividad se relacionó además con la patología, el número de fuentes de información y el tono crítico de la noticia, mientrás que el tono crítico se relacionó también con la difusión del periódico y la relevancia de la noticia. Conclusiones: Se identificaron imprecisiones, sesgos o un exceso de optimismo (intencionado o involuntario) en las noticias analizadas. Un mayor detalle en algunos aspectos de las noticias proporcionaría soluciones a muchas de las deficiencias identificadas

Objective: To quantify how exhaustive and critical were stories reporting medical innovations published in print media and to analyze the characteristics that may be related. Method: Content analysis of the newspapers stories related to the discovery, introduction or improvement of a medical innovation through a questionnaire with ten criteria that allows calculating an overall score of exhaustiveness. The critical view was also included. Results: We analyzed 204 newspapers stories that on average obtained a comprehensiveness score of 4.5. Were optimistic 70% of the stories. The most valued criteria were: level of detail of the explanation of the innovation and the correct differentiation between facts and opinions. While the worst-valued criteria were: disclosure of financial conflicts of interest and the quantification of harms. The variables author, length of the story and classification of the innovation were related to both the comprehensiveness score and the critical view. The comprehensiveness score was also related to the pathology, number of sources of information and the critical tone of the story, while the critical view was also related to the newspapers diffusion and the relevance of the news. Conclusions: The analyzed stories presented inaccuracies, biases or an excess of optimism (either intentional or involuntary). Some aspects of the stories discussed in more detail would provide solutions to many of the identified shortcomings

[Exhaustivity and critical tone of the news in print media reporting medical innovations]. / Exhaustividad y tono crítico de las noticias en la prensa escrita que informan de una innovación médica.

OBJECTIVE: To quantify how exhaustive and critical were stories reporting medical innovations published in print media and to analyze the characteristics that may be related. METHOD: Content analysis of the newspapers stories related to the discovery, introduction or improvement of a medical innovation through a questionnaire with ten criteria that allows calculating an overall score of exhaustiveness. The critical view was also included. RESULTS: We analyzed 204 newspapers stories that on average obtained a comprehensiveness score of 4.5. Were optimistic 70% of the stories. The most valued criteria were: level of detail of the explanation of the innovation and the correct differentiation between facts and opinions. While the worst-valued criteria were: disclosure of financial conflicts of interest and the quantification of harms. The variables author, length of the story and classification of the innovation were related to both the comprehensiveness score and the critical view. The comprehensiveness score was also related to the pathology, number of sources of information and the critical tone of the story, while the critical view was also related to the newspapers diffusion and the relevance of the news. CONCLUSIONS: The analyzed stories presented inaccuracies, biases or an excess of optimism (either intentional or involuntary). Some aspects of the stories discussed in more detail would provide solutions to many of the identified shortcomings.

The Use of a Binary Composite Endpoint and Sample Size Requirement: Influence of Endpoints Overlap.

Although composite endpoints (CE) are common in clinical trials, the impact of the relationship between the components of a binary CE on the sample size requirement (SSR) has not been addressed. We performed a computational study considering 2 treatments and a CE with 2 components: the relevant endpoint (RE) and the additional endpoint (AE). We assessed the strength of the components' interrelation by the degree of relative overlap between them, which was stratified into 5 groups. Within each stratum, SSR was computed for multiple scenarios by varying the events proportion and the effect of the therapy. A lower SSR using CE was defined as the best scenario for using the CE. In 25 of 66 scenarios the degree of relative overlap determined the benefit of using CE instead of the RE. Adding an AE with greater effect than the RE leads to lower SSR using the CE regardless of the AE proportion and the relative overlap. The influence of overlapping decreases when the effect on RE increases. Adding an AE with lower effect than the RE constitutes the most uncertain situation. In summary, the interrelationship between CE components, assessed by the relative overlap, can help to define the SSR in specific situations and it should be considered for SSR computation.

El impacto social de la investigación en cardiología: más allá de la gestión / The social impact of cardiology research: beyond management

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Evaluación del impacto de la investigación biomédica: ¿para quién? / Assessing the impact of biomedical research: for whom?

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Prevalencia de angina estable en España. Resultados del estudio OFRECE / Prevalence of stable angina in Spain. Results of the OFRECE study

Introducción y objetivos. El objetivo del estudio OFRECE fue estimar la prevalencia de angina estable en España. Esta es actualmente desconocida por falta de estudios recientes y cambios en la epidemiología y el tratamiento de la cardiopatía isquémica. Métodos. Estudio transversal. Se obtuvo una muestra representativa de la población española de edad mayor o igual a 40 años mediante muestreo aleatorio en dos etapas: la primera fue una selección aleatoria de médicos de atención primaria de cada provincia y la segunda, una selección de 20 individuos de la población asignada a cada médico. La prevalencia se ponderó por edad, sexo y área geográfica. Se clasificó a los participantes como pacientes con angina si cumplían criterios de «angina segura» del cuestionario de Rose y como angina confirmada si además tenían antecedentes de cardiopatía isquémica aguda, revascularización o confirmación tras evaluación cardiológica. Resultados. Se analizó a 8.378 personas (media de edad, 59,2 años), el 71% de las 11.831 invitadas a participar. La prevalencia ponderada de angina segura (Rose) fue del 2,6% (intervalo de confianza del 95%, 2,1-3,1%), mayor en mujeres (2,9%) que en varones (2,2%), y la de angina confirmada, del 1,4% (intervalo de confianza del 95%, 1,0-1,8%) sin diferencias entre varones (1,5%) y mujeres (1,3%). La prevalencia se incrementó con la edad (angina segura, el 0,7% en el grupo de 40-49 años y el 7,1% en el de edad mayor o igual a 70 años), los antecedentes de enfermedad cardiovascular y los factores de riesgo cardiovascular, salvo el tabaquismo. Conclusiones. La prevalencia de angina segura (Rose) en la población española de edad mayor o igual a 40 años es del 2,6% y la de angina confirmada, del 1,4%, y ambas se incrementan con la edad, los factores de riesgo cardiovascular y los antecedentes cardiovasculares (AU)

Introduction and objectives. The objective of the OFRECE study was to estimate the prevalence of stable angina in Spain. This prevalence is currently unknown, due to a lack of recent studies and to changes in the epidemiology and treatment of ischemic heart disease. Methods. This cross-sectional study involved a representative sample of the Spanish population aged 40 years or older, obtained via 2-stage random sampling: in the first stage, primary care physicians were randomly selected from each Spanish province, whereas in the second stage 20 people were selected from the population assigned to each physician. The prevalence was weighted by age, sex, and geographical area. Participants were classified as having angina if they met the 'definite angina' criteria of the Rose questionnaire and as having confirmed angina if the angina was confirmed by a cardiologist or if they had a history of acute ischemic heart disease or revascularization. Results. Of the 11 831 people invited to participate, 8378 (71%) were analyzed (mean age, 59.2 years). The weighted prevalence of definite angina (Rose) was 2.6% (95% confidence interval, 2.1%-3.1%) and was higher in women (2.9%) than in men (2.2%), whereas that of confirmed angina was 1.4% (95% confidence interval, 1.0%-1.8%), without differences between men (1.5%) and women (1.3%). The prevalence of definite angina (Rose) increased with age (0.7% in patients aged 40 to 49 years and 7.1% in those aged 70 years or older), history of cardiovascular disease, and cardiovascular risk factors, except smoking. Conclusions. The prevalence of definite angina (Rose) in the Spanish population aged 40 years or older was 2.6%, whereas that of confirmed angina was 1.4%. Both prevalences increased with age, cardiovascular risk factors, and cardiovascular history (AU)

Prevalence of Stable Angina in Spain. Results of the OFRECE Study.

INTRODUCTION AND OBJECTIVES: The objective of the OFRECE study was to estimate the prevalence of stable angina in Spain. This prevalence is currently unknown, due to a lack of recent studies and to changes in the epidemiology and treatment of ischemic heart disease. METHODS: This cross-sectional study involved a representative sample of the Spanish population aged 40 years or older, obtained via 2-stage random sampling: in the first stage, primary care physicians were randomly selected from each Spanish province, whereas in the second stage 20 people were selected from the population assigned to each physician. The prevalence was weighted by age, sex, and geographical area. Participants were classified as having angina if they met the "definite angina" criteria of the Rose questionnaire and as having confirmed angina if the angina was confirmed by a cardiologist or if they had a history of acute ischemic heart disease or revascularization. RESULTS: Of the 11 831 people invited to participate, 8378 (71%) were analyzed (mean age, 59.2 years). The weighted prevalence of definite angina (Rose) was 2.6% (95% confidence interval, 2.1%-3.1%) and was higher in women (2.9%) than in men (2.2%), whereas that of confirmed angina was 1.4% (95% confidence interval, 1.0%-1.8%), without differences between men (1.5%) and women (1.3%). The prevalence of definite angina (Rose) increased with age (0.7% in patients aged 40 to 49 years and 7.1% in those aged 70 years or older), history of cardiovascular disease, and cardiovascular risk factors, except smoking. CONCLUSIONS: The prevalence of definite angina (Rose) in the Spanish population aged 40 years or older was 2.6%, whereas that of confirmed angina was 1.4%. Both prevalences increased with age, cardiovascular risk factors, and cardiovascular history.

La experimentación animal y el progreso de la medicina / Animal experimentation and progress in medicine

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Prevalence of atrial fibrillation in Spain. OFRECE study results.

INTRODUCTION AND OBJECTIVES: Atrial fibrillation is associated with substantial morbidity and mortality and both its incidence and prevalence are high. Nevertheless, comprehensive data on this condition in Spain are lacking. The aim of this study was to estimate the prevalence of atrial fibrillation in Spain. METHODS: A cross-sectional study was conducted in the general Spanish population older than 40 years. Two-stage random sampling was used, in which first-stage units were primary care physicians randomly selected in every Spanish province and second-stage units were 20 randomly selected persons drawn from each participating physician's assigned population. The reported prevalence was standardized for the age and sex distribution of the Spanish population. The electrocardiogram recordings were read centrally. RESULTS: Overall, 8343 individuals were evaluated. The mean age was 59.2 years (95% confidence interval, 58.6-59.8 years), and 52.4% of the participants were female. The overall age-adjusted prevalence of atrial fibrillation was 4.4% (95% confidence interval, 3.8-5.1). Prevalence was similar in both sexes, men 4.4% (3.6-5.2) and women 4.5% (3.6-5.3), rising with increasing age older than 60 years. In patients older than 80 years, the prevalence was 17.7% (14.1-21.3). In 10% of patients an unknown atrial fibrillation was diagnosed. CONCLUSIONS: The prevalence of atrial fibrillation in the general Spanish population older than 40 years is high, at 4.4%. The prevalence is similar in both sexes and rises steeply above 60 years of age. It is estimated that there are over 1 million patients with atrial fibrillation in the Spanish population, of whom over 90,000 are undiagnosed.

Prevalencia de fibrilación auricular en España. Resultados del estudio OFRECE / Prevalence of Atrial Fibrillation in Spain. OFRECE Study Results

Introducción y objetivos: La fibrilación auricular se asocia con elevadas morbilidad y mortalidad, y tanto su incidencia como su prevalencia son altas. No obstante, hay escasos datos poblacionales sobre su epidemiología en España. El objetivo de este estudio es estimar la prevalencia de fibrilación auricular en España. Métodos: Estudio transversal en población española de 40 o más años. Se realizó un muestreo en dos etapas, una primera selección aleatoria de médicos de atención primaria de cada provincia española y, en segundo lugar, se seleccionó aleatoriamente a 20 individuos de la población asignada a cada médico participante. La prevalencia se ponderó por edad, sexo y área geográfica. Se realizó una lectura centralizada de los registros electrocardiográficos. Resultados: Se evaluó a 8.343 personas (media de edad, 59,2 [intervalo de confianza del 95%, 58,6-59,8] años; el 52,4% mujeres). La prevalencia total de fibrilación auricular fue del 4,4% (intervalo de confianza del 95%, 3,8-5,1). La prevalencia fue similar en varones (4,4% [3,6-5,2]) y mujeres (4,5% [3,6-5,3]) y se incrementa progresivamente a partir de los 60 años de edad. En los mayores de 80 años, la prevalencia fue del 17,7% (14,1-21,3). En un 10% de pacientes se diagnosticó una fibrilación auricular no conocida. Conclusiones: La prevalencia de fibrilación auricular en la población general española mayor de 40 años es elevada, del 4,4%. La prevalencia es similar en varones y mujeres y se incrementa escalonadamente a partir de los 60 años. Se estima en más de 1 millón de pacientes con fibrilación auricular en la población española, de los que más de 90.000 están sin diagnosticar (AU)

Introduction and objectives: Atrial fibrillation is associated with substantial morbidity and mortality and both its incidence and prevalence are high. Nevertheless, comprehensive data on this condition in Spain are lacking. The aim of this study was to estimate the prevalence of atrial fibrillation in Spain. Methods: A cross-sectional study was conducted in the general Spanish population older than 40 years. Two-stage random sampling was used, in which first-stage units were primary care physicians randomly selected in every Spanish province and second-stage units were 20 randomly selected persons drawn from each participating physician's assigned population. The reported prevalence was standardized for the age and sex distribution of the Spanish population. The electrocardiogram recordings were read centrally. Results: Overall, 8343 individuals were evaluated. The mean age was 59.2 years (95% confidence interval, 58.6-59.8 years), and 52.4% of the participants were female. The overall age-adjusted prevalence of atrial fibrillation was 4.4% (95% confidence interval, 3.8-5.1). Prevalence was similar in both sexes, men 4.4% (3.6-5.2) and women 4.5% (3.6-5.3), rising with increasing age older than 60 years. In patients older than 80 years, the prevalence was 17.7% (14.1-21.3). In 10% of patients an unknown atrial fibrillation was diagnosed. Conclusions: The prevalence of atrial fibrillation in the general Spanish population older than 40 years is high, at 4.4%. The prevalence is similar in both sexes and rises steeply above 60 years of age. It is estimated that there are over 1 million patients with atrial fibrillation in the Spanish population, of whom over 90 000 are undiagnosed (AU)

Características de artículos españoles de «calidad científica» citados en las guías de práctica clínica en salud mental / Characteristics of Spanish articles of “scientific quality” cited in clinical practice guidelines on mental health

Introducción: Se quiere ilustrar el impacto de la investigación española en la toma de decisiones clínicas y sanitarias. Con este fin se formula la cuestión de cómo son las publicaciones científicas españolas más citadas en las guías de práctica clínica (GPC) en salud mental. Material y método: Se plantea un estudio de tipo descriptivo-cualitativo sobre las características de 10 artículos originales españoles citados en la GPC sobre trastornos mentales y seleccionados por su «calidad científica». Se analizó el contenido de los artículos según las características siguientes: tema, diseño, centros de investigación, relevancia científica y práctica, tipo de entidad financiadora y posición de la referencia o influencia del contenido en la GPC. Resultados: Entre los estudios que han alcanzado notoriedad figuran algunos de ciencia básica que examinan el establecimiento de asociaciones genéticas en la patogenia de las enfermedades mentales y otros sobre la eficacia de las intervenciones educativas. El contenido de estos últimos es el que más influencia ha tenido en la GPC, citándose en el resumen de la evidencia o en recomendaciones. Algunas de las características que destacan en los artículos seleccionados son los diseños sofisticados (experimentales o analíticos) y el carácter multicéntrico, especialmente con colaboraciones internacionales. La confirmación o refutación de hallazgos previos en temas polémicos puede haber igualmente contribuido a la amplia citación de los trabajos. Conclusiones: La inclusión de estudios en las GPC no es una condición de «calidad» suficiente pero, sin embargo, su descripción puede ser ilustrativa para el diseño de futuras líneas de investigación o publicación (AU)

Introduction: The study aims to illustrate the impact of Spanish research in clinical decision making. To this end, we analysed the characteristics of the most significant Spanish publications cited in clinical practice guidelines (CPG) on mental health. Material and methods: We conducted a descriptive qualitative study on the characteristics of ten articles cited in Spanish CPG on mental health, and selected for their ‘‘scientific quality’’. We analysed the content of the articles on the basis of the following characteristics: topics, study design, research centres, scientific and practical relevance, type of funding, and area or influence of the reference to the content of the guidelines. Results: Among the noteworthy studies, some basic science studies, which have examined the establishment of genetic associations in the pathogenesis of mental illness are included, and others on the effectiveness of educational interventions. The content of those latter had more influence on the GPC, because they were cited in the summary of the scientific evidence or in the recommendations. Some of the outstanding features in the selected articles are the sophisticated designs (experimental or analytical), and the number of study centres, especially in international collaborations. Debate or refutation of previous findings on controversial issues may have also contributed to the extensive citation of work. Conclusions: The inclusion of studies in the CPG is not a sufficient condition of ‘‘quality’’, but their description can be instructive for the design of future research or publications (AU)

Investigación en ciencias de la salud, corresponsabilidad e impacto social / Research in health sciences, co-responsibility and social impact

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Impact of clinical and health services research projects on decision-making: a qualitative study.

BACKGROUND: This article reports on the impact assessment experience of a funding program of non-commercial clinical and health services research. The aim was to assess the level of implementation of results from a subgroup of research projects (on respiratory diseases), and to detect barriers (or facilitators) in the translation of new knowledge to informed decision-making. METHODS: A qualitative study was performed. The sample consisted of six projects on respiratory diseases funded by the Agency for Health Quality and Assessment of Catalonia between 1996 and 2004. Semi-structured interviews to key informants including researchers and healthcare decision-makers were carried out. Interviews were recorded, transcribed verbatim and analysed on an individual (key informant) and group (project) basis. In addition, the differences between achieved and expected impacts were described. RESULTS: Twenty-three semi-structured interviews were conducted. Most participants indicated changes in health services or clinical practice had resulted from research. The channels used to transfer new knowledge were mainly conventional ones, but also in less explicit ways, such as with the involvement of local scientific societies, or via debates and discussions with colleagues and local leaders. The barriers and facilitators identified were mostly organizational (in research management, and clinical and healthcare practice), although there were also some related to the nature of the research as well as personal factors. Both the expected and achieved impacts enabled the identification of the gaps between what is expected and what is truly achieved. CONCLUSIONS: In this study and according to key informants, the impact of these research projects on decision-making can be direct (the application of a finding or innovation) or indirect, contributing to a more complex change in clinical practice and healthcare organization, both having other contextual factors. The channels used to transfer this new knowledge to clinical practice are complex. Local scientific societies and the relationships between researchers and decision-makers can play a very important role. Specifically, the relationships between managers and research teams and the mutual knowledge of their activity have shown to be effective in applying research funding to practice and decision-making. Finally the facilitating factors and barriers identified by the respondents are closely related to the idiosyncrasy of the human relations between the different stakeholders involved.

Characteristics of Spanish articles of "scientific quality" cited in clinical practice guidelines on mental health.

INTRODUCTION: The study aims to illustrate the impact of Spanish research in clinical decision making. To this end, we analysed the characteristics of the most significant Spanish publications cited in clinical practice guidelines (CPG) on mental health. MATERIAL AND METHODS: We conducted a descriptive qualitative study on the characteristics of ten articles cited in Spanish CPG on mental health, and selected for their "scientific quality". We analysed the content of the articles on the basis of the following characteristics: topics, study design, research centres, scientific and practical relevance, type of funding, and area or influence of the reference to the content of the guidelines. RESULTS: Among the noteworthy studies, some basic science studies, which have examined the establishment of genetic associations in the pathogenesis of mental illness are included, and others on the effectiveness of educational interventions. The content of those latter had more influence on the GPC, because they were cited in the summary of the scientific evidence or in the recommendations. Some of the outstanding features in the selected articles are the sophisticated designs (experimental or analytical), and the number of study centres, especially in international collaborations. Debate or refutation of previous findings on controversial issues may have also contributed to the extensive citation of work. CONCLUSIONS: The inclusion of studies in the CPG is not a sufficient condition of "quality", but their description can be instructive for the design of future research or publications.

Drug-eluting stents for off-label indications in real clinical world: evidence based or 'intuition' based clinical practice?

BACKGROUND: The use of drug-eluting stents (DES) is an example of the disparity between recommendations given by regulatory agencies and the real clinical world. Such disparity might lead cardiologists to adopt different routines in the use of DES. We aimed to assess variability of off-label DES use between hospitals and to what extent it can be explained by differences in patient or hospital characteristics. METHODS: Characteristics of consecutive patients receiving DES in 29 hospitals were recorded. Individual and hospital determinants of receiving DES for off-label indications were assessed by multilevel logistic regression. RESULTS: 1903 patients were recruited and 1188 (62.4%) received DES for off-label indications. Individual variables associated with off-label use were age (OR 1.01 (1-1.02)), previous percutaneous (OR 2.24 (1.68-2.97)) or surgical (2.41 (1.52-3.84)) revascularization, repeated procedure at the same admission (OR 4.66 (2.7-8.05)), receiving two (OR 4.17 (3.24-5.37)) or three or more DES (OR 14.12 (9.08-21.96)) vs one. Adjusting for individual variables, the Odds of receiving DES for off-label indication was higher in public funding hospitals with surgery availability vs private hospitals: 1.49 (0.86-2.6), and in public hospitals without surgery vs public with surgery availability: OR 1.76 (1.02-3.03). Interhospital variability reminded significant after adjustment for individual and contextual variables. CONCLUSION: Off-label DES use is highly variable between centers. Although this variability is partially determined by hospital type of funding and cardiac surgery availability, the substantial interhospital variability after multilevel adjustment suggests heterogeneity in the process of care.

Prevalence of calcific aortic valve disease in the elderly and associated risk factors: a population-based study in a Mediterranean area.

AIMS: To determine the prevalence of aortic valve sclerosis (ASC) and stenosis (AS) in the elderly in a Mediterranean area and to identify associated clinical factors. METHODS AND RESULTS: Population cross-sectional study in a random sample of 1068 people ≥65 years in a Mediterranean area. ASC was categorized as absent, mild-to-moderate, or moderate-to-severe depending on the severity of thickening and calcification. The relation between the severity of ASC and potential risk factors was assessed by multinomial logistic regression analysis. Some degree of thickening and/or calcification was present in 45.4%, of the sample, 73.5% in >85 years. AS prevalence was 3% for the total cohort and 7.4% in >85 years. Adjusting for gender it was found that age, smoking habit, hypertension, waist circumference, and ankle-brachial index <0.9 were associated with degrees of ASC. Except for waist circumference, there was a gradient between the magnitude of association and the severity of ASC. The OR for age was 1.56 (95% CI 1.39-1.76) for mild-to-moderate ASC and 2.03 (95% CI 1.72-2.4) for moderate-to-severe ASC, and for smoking habit 1.59 (95% CI 1.08-2.34) for mild-to-moderate ASC and 2.13 (95% CI 1.19-3.78) for moderate-to-severe ASC. Diabetes and renal impairment were associated with advanced but not with early stages of ASC. CONCLUSIONS: The prevalence of ASC and AS in people ≥65 years is similar to that reported in other regions. The gradient in the association of cardiovascular risk factors with the severity of ASC suggests that they may be causally implied in the pathogenesis of the disease.