Check Up: So far, very little flu

CDC Director Gerberding Gives Green Light to G...
CDC Director Gerberding Gives Green Light to Gardasil then Goes to Work for Merck (g1a2d0049c1) (Photo credit: watchingfrogsboil)

Check Up: So far, very little flu

The U.S. Centers for Disease Control and Prevention has confirmed what you already guessed: This has been a remarkably mild flu season.
The influenza virus likes cold weather, so infections normally occur from October through March. But technically, the flu season doesn’t start until labs that test respiratory swabs from sick people find the virus in more than 10 percent of the samples.
This season, that threshold wasn’t reached until the week ended Feb. 11, making this the kindest flu spell in 29 years.
Pennsylvania, for example, had only 80 confirmed cases in all of January – barely more than one achy, feverish, nauseated citizen per county.
What’s going on?
No one really knows.
“With flu, everything is unpredictable,” said immunologist Scott Hensley, a flu expert at the Wistar Institute in Philadelphia. “I don’t think we’re out of the woods; it could just be a delayed season.”
Then again, maybe the flu has been as scarce as snow because snow has been scarce.
“Flu is more easily transmitted in colder temperatures. This has been a mild winter,” Hensley said.
Another theory is that the population has high levels of immunity to the influenza strains now circulating, which include the one that caused the 2009 “swine flu” pandemic. Because the strains have been so stable, people have had time to develop antibodies against them. Vaccination has also boosted immunity.
Although Hensley subscribes to this theory, he adds a caveat: “If that’s true . . . the virus will start mutating” to evade human defenses. “A novel strain might emerge in the next couple of months.”
While there’s no room for complacency, let us celebrate the signs, monitored by the CDC, that the flu has given the nation a respite:
One person per 100,000 has been hospitalized with the flu since October. That’s a 95 percent drop from last season’s rate of 22 people per 100,000.
Only 1 percent to 2 percent of visits to doctors since October have been for flulike illness. The usual rate is 3 percent to 8 percent.
This flu season, there have been three flu-related deaths among children, compared with 122 pediatric deaths last season – and 348 during the 2009 pandemic.
– Marie McCullough

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Biological clock’ is linked to heart attacks

‘Biological clock’ is linked to heart attacks

Abnormal heartbeat occurs most frequently in the morning — and to a lesser degree in the evening hours — and causes a high number of deaths.

BIOLOGICAL CLOCK: The discovery opens up intriguing paths of research, in pinpointing individuals at risk of nocturnal death and devising drugs to shield them. (Photo: Mike Warot/flickr)
Scientists on Wednesday said they had uncovered the first molecular proof that the “biological clock” is linked to a type of sudden, fatal heart attack.
Ventricular arrhythmia, or abnormal heartbeat, occurs most frequently after waking in the morning — and also to a lesser degree in the evening hours — and causes a high number of deaths.
Reporting in the journal Nature, researchers in the United States said they had uncovered the first molecular link between this risk and circadian rhythm, the term by which biological processes vary according to a 24-hour period.
The finger points at levels of a protein called Klf15, they said.

Abnormal heartbeat occurs most frequently in the morning — and to a lesser degree in the evening hours — and causes a high number of deaths.

Previous research has found Klf15 to be a circadian controller — and, startlingly, is also lacking among some patients with heart failure.
The team created mice that had been genetically engineered to either lack Klf15 or make the protein excessively.
In both cases, the rodents had a much higher risk of arrythmias compared to normal counterparts.
“It is the first example of a molecular mechanism for the circadian change in susceptibility to cardiac arrhythmias,” said Xander Wehrens of Baylor College School of Medicine in Houston, Texas.
“If there was too much Klf15 or none, the mice were at risk for developing the arrhythmia.”
Klf15 is only one step in a complex molecular cascade, the researchers believe.
It controls another protein, KChIP2, which affects potassium-generated electrical current that flows though heart muscle cells called cardiac myocytes.
When levels of KChIP2 fluctuate, this causes electrical instability in the myocytes.
As a result, the heart muscle’s action becomes impaired and it takes longer (or conversely, less time) to empty the ventricle — the heart’s pumping chamber. The heart loses the regularity of the beat and labours to pump blood efficiently.
Co-author Mukesh Jain of the Case Western Reserve University School of Medicine in Cleveland,Ohio said that further work could well uncover other circadian-related causes.
The discovery opens up intriguing paths of research, in pinpointing individuals at risk of nocturnal death and devising drugs to shield them, Jain added.
Copyright 2012  AFP Global Edition

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Association of antenatal corticosteroids with mortality and neurodevelopmental outcomes among infants born at 22 to 25 weeks’ gestation.

JAMA. 2011 Dec 7;306(21):2348-58.

Association of antenatal corticosteroids with mortality and neurodevelopmental outcomes among infants born at 22 to 25 weeks’ gestation.


Department of Pediatrics, University of Alabama, 9380 Women and Infants Center, 1700 Sixth Ave S, Birmingham, AL 35249, USA.



Current guidelines, initially published in 1995, recommend antenatal corticosteroids for mothers with preterm labor from 24 to 34 weeks’ gestational age, but not before 24 weeks due to lack of data. However, many infants born before 24 weeks’ gestation are provided intensive care.


To determine if use of antenatal corticosteroids is associated with improvement in major outcomes for infants born at 22 and 23 weeks’ gestation.


Cohort study of data collected prospectively on inborn infants with a birth weight between 401 g and 1000 g (N = 10,541) born at 22 to 25 weeks’ gestation between January 1, 1993, and December 31, 2009, at 23 academic perinatal centers in the United States. Certified examiners unaware of exposure to antenatal corticosteroids performed follow-up examinations on 4924 (86.5%) of the infants born between 1993 and 2008 who survived to 18 to 22 months. Logistic regression models generated adjusted odds ratios (AORs), controlling for maternal and neonatal variables.


Mortality and neurodevelopmental impairment at 18 to 22 months’ corrected age.


Death or neurodevelopmental impairment at 18 to 22 months was significantly lower for infants who had been exposed to antenatal corticosteroids and were born at 23 weeks’ gestation (83.4% with exposure to antenatal corticosteroids vs 90.5% without exposure; AOR, 0.58 [95% CI, 0.42-0.80]), at 24 weeks’ gestation (68.4% with exposure to antenatal corticosteroids vs 80.3% without exposure; AOR, 0.62 [95% CI, 0.49-0.78]), and at 25 weeks’ gestation (52.7% with exposure to antenatal corticosteroids vs 67.9% without exposure; AOR, 0.61 [95% CI, 0.50-0.74]) but not in those infants born at 22 weeks’ gestation (90.2% with exposure to antenatal corticosteroids vs 93.1% without exposure; AOR, 0.80 [95% CI, 0.29-2.21]). If the mothers had received antenatal corticosteroids, the following events occurred significantly less in infants born at 23, 24, and 25 weeks’ gestation: death by 18 to 22 months; hospital death; death, intraventricular hemorrhage, or periventricular leukomalacia; and death or necrotizing enterocolitis. For infants born at 22 weeks’ gestation, the only outcome that occurred significantly less was death or necrotizing enterocolitis (73.5% with exposure to antenatal corticosteroids vs 84.5% without exposure; AOR, 0.54 [95% CI, 0.30-0.97]).


Among infants born at 23 to 25 weeks’ gestation, antenatal exposure to corticosteroids compared with nonexposure was associated with a lower rate of death or neurodevelopmental impairment at 18 to 22 months.





[PubMed – indexed for MEDLINE]

Economic and clinical evaluation of a catch-up dose of 13-valent pneumococcal conjugate vaccine in children already immunized with three doses of the 7-valent vaccine in Italy

Boccalini S, Azzari C, Resti M, Valleriani C, Cortimiglia M, Tiscione E et al. Economic and clinical evaluation of a catch-up dose of 13-valent pneumococcal conjugate vaccine in children already immunized with three doses of the 7-valent vaccine in Italy.Vaccine.2011;28;29:9521-8. D.O.I.: 10.1016/j.vaccine.2011.10.013.

Revisores: Ochoa Sangrador C1, Andrés de Llano JM2

1Servicio de Pediatría. Hospital Virgen de la Concha. Zamora (España).
2Servicio de Pediatría. Hospital General del Río Carrión. Palencia (España). 

Correspondencia: Carlos Ochoa Sangrador. Correo electrónico:
Fecha de recepción: 23/01/2012   Fecha de aceptación: 24/01/2012   Fecha de publicación: 26/01/2012   

Resumen Estructurado

Objetivo: realizar una evaluación clínica y económica de la administración de una dosis
adicional de puesta al día de la vacuna 13-valente en niños de hasta cinco años.
Diseño: análisis de coste-efectividad y coste-utilidad.
Emplazamiento: el entorno del estudio fue tanto hospitalario como en Atención Primaria
 desde la perspectiva del sistema de salud.
Población de estudio: población residente en la provincia de , a 1 de enero de 2010, agrupada por tramos de edad, previamente inmunizada con vacuna 7-valente. Se utilizaron registros del Instituto Nacional de Estadística y registros de un hospital pediátrico de Florencia. Las tasas de hospitalización, costes y mortalidad fueron extraídas de estudios italianos. Los parámetros clínicos y epidemiológicos usados en el modelo principal incluían la eficacia de la vacuna frente a hospitalización por meningitis/sepsis, neumonías hospitalarias y ambulatorias.
Intervención: se evaluaron cuatro posibles estrategias para ponerse al día con la vacuna 13-valente (menores de 24, 36, 48 y 60 meses). Se utilizó un modelo matemático de simulación ya desarrollado para estimar el impacto de la transición de los programas de inmunización.
Medición del resultado: se estimó el impacto en un periodo de 5,5 años tras la inmunización, considerando como resultados de infección por S. pneumoniae:hospitalización por meningitis/sepsis, neumonías bacteriémicas hospitalizadas (complicadas y no complicadas), neumonías no bacteriémicas ingresadas y neumonías ambulatorias. Se asumió la eficacia de ensayos clínicos con vacuna 7-valente (94% para meningitis neumocócica, 87,5% para neumonías hospitalizadas y 20,5% para neumonías ambulatorias). Se calculó el número de casos evitados por tipo de enfermedad neumocócica, el número de muertes evitadas y años de vida ganados, los costes para el tratamiento de la casos prevenidos, el coste de la vacunación, el coste promedio por caso evitado y el coste por año de vida ganado. El análisis no tuvo en cuenta los costes directos no médicos ni los indirectos asociados a la pérdida de productividad. Se realizó un análisis de sensibilidad para coberturas de vacunación, coste de la vacuna, incidencia de las enfermedades neumocócicas, tasas de letalidad y cobertura de serotipos.
Resultados principales: las muertes evitadas con el rescate hasta los 24 meses de edad serían 2,5 por 100 000 niños, que ascenderían, con la ampliación hasta los 60 meses de edad, a 6,6 por 100 000. Los años de vida ganados en este programa hasta los 24, 36, 48 y 60 meses de edad serían 191, 322, 423 y 483 por cada 100 000 niños. El coste medio por caso evitado hasta los 24 meses de edad fue 1674 euros, aumentando a 2522 euros al ampliar hasta los 60 meses. El coste por año de vida ganado fue de 12 250 euros para los niños hasta 24 meses de edad y de 22 093 euros para los niños hasta 60 meses.
Conclusión: vacunar a los niños de hasta 24 meses de edad con un programa de rescate con vacuna neumocócica 13-valente está justificado desde el punto de vista económico. Extenderlo a menores de 60 meses de edad, también está justificado tanto desde el punto de vista económico como clínico.
Conflicto de intereses: los autores declaran la ayuda del laboratorio Pfizer Italia S.r.l.
Fuente de financiación: El trabajo ha sido financiado por Pfizer Italia S.r.l.

Comentario Crítico

Justificación: la generalización de la vacuna neumocócica conjugada en la primera infancia ha permitido reducir el riesgo de infección neumocócica grave. Existe suficiente evidencia sobre la eficacia de la vacuna 7-valente para prevenir infecciones graves, fundamentalmente sepsis y meningitis, aunque la efectividad a medio-largo plazo podría verse reducida por cambios espontáneos o inducidos en el perfil de serotipos. La disponibilidad de nuevas vacunas con mayor cobertura de serotipos ofrece una oportunidad para mejorar la prevención. Para plantear la conveniencia de realizar una campaña de rescate con estas vacunas en población previamente vacunada interesa establecer su coste-efectividad y su coste-utilidad.
Validez o rigor científico: el planteamiento del estudio está bien formulado en cuanto a la intervención evaluada, las medidas de resultado consideradas (coste por episodio evitado, coste por año de vida ganado) y la perspectiva (sistema sanitario). Las estimaciones de costes no se detallan, aunque se refieren a trabajos del mismo entorno que se citan. Sin embargo, las estimaciones de efectividad no están correctamente justificadas. Se ha asumido la eficacia observada en ensayos clínicos de la vacuna 7-valente en población menor de dos años1,2, para un programa de rescate, del que solo se disponen estudios de inmunogenicidad y seguridad, sin justificarse la aplicabilidad de las cifras de efectividad elegidas. Por ejemplo, no se ha valorado la menor eficacia a partir del primer año de vida o las diferencias de eficacia según serotipos2. Esta asunción puede resultar especialmente crítica en cuanto a la eficacia asumida para neumonías ambulatorias (que influirá en el coste por episodio evitado) y para la reducción de mortalidad (no detallada y que influirá en el coste por año de vida ganado). Se ha realizado un ajuste temporal y un análisis de sensibilidad, en el que se explora el efecto de variaciones en varias asunciones del modelo, pero no en las de efectividad.
Importancia clínica: se ha estimado que una campaña de rescate con vacuna antineumocócica 13-valente en niños menores de 60 meses previamente inmunizados frente a siete serotipos permitiría evitar un episodio de infección neumocócica a un coste de 2522 euros. Para juzgar la importancia clínica de esta estimación debería haberse especificado el coste para evitar episodios graves (sepsis/meningitis y neumonías bacteriémicas), presumiblemente mayor. En cuanto al coste por año de vida ganado (22 093 euros), si aceptamos las asunciones de eficacia planteadas en el estudio, estaría bajo el umbral de los 30 000 euros (aceptado para otras intervenciones). No obstante, creemos que las asunciones realizas en cuanto a la reducción de la mortalidad de la campaña de rescate (no demostrada) podrían verse comprometidas por variaciones en la efectividad o cambios en el perfil epidemiológico de serotipos. Un estudio referido a Estados Unidos, que consideraba la prevención de otitis (no contemplada en este estudio) ha estimado un coste de la campaña hasta 60 meses por año de vida ajustado por calidad de 73 564 dólares (solo resultaban rentables las estimaciones en las que se asumía la existencia de protección indirecta sobre población no vacunada)3.
Aplicabilidad en la práctica clínica: las estimaciones aquí referidas al sistema sanitario italiano podrían ser adaptables a nuestro entorno, ajustándolas con datos epidemiológicos propios. Si las estimaciones fueran similares en nuestro entorno parece lógico plantearse la oportunidad de realizar una campaña de rescate, aunque, a falta de estudios de eficacia (no previsibles), deberá supeditarse a su competencia con la financiación de otras intervenciones en función de su coste-utilidad. En este sentido, interesaría saber, mediante la realización de nuevos estudios, si variaciones en las asunciones de eficacia de la intervención o en el perfil de serotipos podrían comprometer su utilidad.
Conflicto de intereses de los autores del comentario: no existe.

Cómo citar este artículo


  1. Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J. 2000;19:187-95.
  2. Black SB, Shinefield HR, Ling S, Hansen J, Fireman B, Spring D et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr Infect Dis J. 2002;21:810-5.
  3. Rubin JL, McGarry LJ, Strutton DR, Klugman KP, Pelton SI, Gilmore KE et al. Public health and economic impact of the 13-valent pneumococcal conjugate vaccine (PCV13) in the United States.Vaccine. 2010;28:7634-43.

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More abut Tamiflu

Cochrane CollaborationImage via Wikipedia

By Michael Smith, North American Correspondent, MedPage Today
Published: January 17, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.
A new review of the influenza drug oseltamivir (Tamiflu) has raised questions about both the efficacy of the medication and the commitment of its maker to supply enough data for claims about the drug to be evaluated by independent experts.

It also raises questions about the entire process of systematic review.

Researchers led by Tom Jefferson, MD, of the Cochrane Collaboration, pored over 15 published studies and nearly 30,000 pages of “clinical study reports.”

But, they reported, the clinical study information – data previously shared only with regulators – was only a part of what internal evidence suggested was available.

And many published studies had to be excluded because of missing or contradictory data, Jefferson and colleagues reported.

Activate MedPage Today’s CME feature and receive free CME credit on medical stories like this one
Action Points  

  • Explain that a new review of an important flu drug has raised questions about the medication and the entire process of systematic review.
  • Point out that the review of oseltamivir showed that there was no evidence of effect on hospital admissions.
The drug’s maker, Switzerland-based Roche, had promised after a previous Cochrane review to make all of its data available for “legitimate analyses.” After a request for the data, Jefferson and colleagues reported, the company sent them 3,195 pages covering 10 treatment trials of the drug.
But, three of the reviewers noted in a parallel report in BMJ, the tables of contents suggested that the data were incomplete.
“What we’re seeing is largely Chapter One and Chapter Two of reports that usually have four or five chapters,” according to theBMJ article’s lead author, Peter Doshi, PhD, of Johns Hopkins University.
Roche did not immediately respond to a telephoned request for comment.
Requests for More Data
The researchers then asked the European Medicines Agency (EMA) for the data, under a Freedom of Information request, and obtained a further 25,453 pages, covering 19 trials.
But that data, too, was incomplete, they said, although the agency said it was all that was available.
The FDA is thought to have the complete reports, but has not yet responded to requests for them, the researchers reported.
Regulatory agencies such as the EMA and FDA routinely see the large clinical study reports, Jefferson and colleagues said in BMJ, but systematic reviewers and the general medical public do not.
“While regulators and systematic reviewers may assess the same clinical trials, the data they look at differs substantially,” they said.
The Cochrane group has been trying for several years to put together a clear-cut systematic review of the evidence on antivirals aimed at flu.
In 2006, the group concluded that the evidence showed that oseltamivir reduced the complications of the flu. But that conclusion was challenged on the basis that a key piece of data was flawed.
An updated review in 2009 – throwing out the flawed study — concluded there wasn’t enough evidence to show that the drug had any effect on complications.
For this analysis, the Cochrane reviewers had originally intended to perform a systematic review on both of the approved neuraminidase inhibitors – oseltamivir and zanamivir (Relenza), using the clinical study reports to supplement published trials.
In the end, they decided that for oseltamivir, they needed more detail in order to perform the review in its entirety. But, they reported, some conclusions could be drawn from published data on the 15 trials and from 16,000 pages of clinical study reports that were available before their deadline.
They also decided to postpone analysis of zanamivir (for which they had 10 trials) because the drug’s maker, GlaxoSmithKline, offered individual patient data which they wanted time to analyze.
The oseltamivir analysis showed:
  • The time to first alleviation of symptoms in people with influenza-like illness was a median of 160 hours in the placebo groups and about 21 hours shorter in those treated with oseltamivir. The difference, evaluated in five studies, was significant at P<0.001.
  • There was no evidence of effect on hospital admissions: In seven studies, the odds ratio was 0.95, with a 95% confidence interval from 0.57 to 1.61, which was nonsignificant atP=0.86.
  • A post-protocol analysis of eight studies showed that oseltamivir patients were less likely to be diagnosed with influenza.
  • The data “lacked sufficient detail to credibly assess” any effect on influenza complications and viral transmission.
Data Discrepancies Found
But discrepancies between the published trial data and the clinical study reports “led us to lose confidence in the journal reports,” Doshi and colleagues wrote in BMJ.
For example, they noted that one journal report clearly said there were no drug-related serious adverse events, but the clinical study report listed three that were possibly related to oseltamivir.
As well, the sheer scope of the clinical study reports meant that much was left out of journal reports. One 2010 study, on safety and pharmacokinetics of oseltamivir at standard and high dosages, took up seven journal pages and 8,545 pages of the clinical study report.
But the researchers were also shaken, they said, by the “fragility” of some of their assumptions.
For instance, they found that the clinical study reports showed that in many trials, the placebo contained two chemicals not found in the oseltamivir capsules.
“We could find no explanation for why these ingredients were only in the placebo,” they wrote in BMJ, “and Roche did not answer our request for more information on the placebo content.”
Jefferson and colleagues also reported they found disparities in the numbers of influenza-infected people reported to be present in the treatment versus control groups of oseltamivir trials.
One possible explanation, they noted, is that oseltamivir affects antibody production – even though the manufacturer says it does not.
Gaps in Knowledge Remain
That question is profoundly important, Doshi told MedPage Today, because it may offer clues to how the drug works – one of the gaps in knowledge about oseltamivir.
“You can’t make good therapeutic decisions if you don’t know how the drugs works,” he said – information that he and his colleagues suspect may be buried in the mass of missing data.
It’s also important, he said, because public health agencies have been making decisions to stockpile oseltamivir without a clear understanding of the facts.
Essentially, he said, those decisions have been based on the flawed study – a Roche-supported meta-analysis – that was thrown out of the 2009 Cochrane review.
“They’re taking the drug manufacturer’s word at face value,” he said.
The results seem unlikely to resolve conflicts over the medical value of the drug, which is a major cash cow for Roche, adding some $3.4 billion to the company’s bottom line in 2009 alone, according to Deborah Cohen, investigations editor of BMJ.
In an accompanying article, Cohen said that “clinicians can be forgiven for being confused about what the evidence on oseltamivir says.”
She noted that the European Centre for Disease Prevention and Control, the CDC, and the World Health Organization “differ in their conclusions about what the drug does.”
As well, those conclusions are often contradicted by claims on the drug labels – themselves allowed by regulators, Cohen argued.
The Cochrane reviewers reported grant support from the U.K. National Institute for Health Research and Jefferson and Doshi reported they had no recent financial links with industry.
Cohen is employed by BMJ.

Anti-platelet drug useful

Patients with coronary stents require medication that inhibits platelet activity and prevents clotting. However, if patients need additional surgery that medication must be stopped several days in advance because it increases the risk of major bleeding during the operation. A new study tested an investigational drug that decreases clotting risk and also leaves the system quicker after it is stopped so surgery can be performed without a major delay. Catherine Dolf has more in this week’s JAMA Report.
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Effect of Aspirin on Vascular and Nonvascular Outcomes Meta-analysis of Randomized Controlled Trials

English: Schematic diagram of a plasma CVD (Ch...Image via WikipediaEffect of Aspirin on Vascular and Nonvascular Outcomes

Meta-analysis of Randomized Controlled Trials
Sreenivasa Rao Kondapally Seshasai, MD, MPhil; Shanelle Wijesuriya, MA, MBBChir; Rupa Sivakumaran, MA, MBBChir; Sarah Nethercott, MA, MBBChir;Sebhat Erqou, MD, PhD; Naveed Sattar, MD, PhD; Kausik K. Ray, MD 
Arch Intern Med. Published online January 9, 2012. doi:10.1001/archinternmed.2011.628
Background  The net benefit of aspirin in prevention of CVD and nonvascular events remains unclear. Our objective was to assess the impact (and safety) of aspirin on vascular and nonvascular outcomes in primary prevention.
Data Sources  MEDLINE, Cochrane Library of Clinical Trials (up to June 2011) and unpublished trial data from investigators.
Study Selection  Nine randomized placebo-controlled trials with at least 1000 participants each, reporting on cardiovascular disease (CVD), nonvascular outcomes, or death were included.
Data Extraction  Three authors abstracted data. Study-specific odds ratios (ORs) were combined using random-effects meta-analysis. Risks vs benefits were evaluated by comparing CVD risk reductions with increases in bleeding.
Results  During a mean (SD) follow-up of 6.0 (2.1) years involving over 100 000 participants, aspirin treatment reduced total CVD events by 10% (OR, 0.90; 95% CI, 0.85-0.96; number needed to treat, 120), driven primarily by reduction in nonfatal MI (OR, 0.80; 95% CI, 0.67-0.96; number needed to treat, 162). There was no significant reduction in CVD death (OR, 0.99; 95% CI, 0.85-1.15) or cancer mortality (OR, 0.93; 95% CI, 0.84-1.03), and there was increased risk of nontrivial bleeding events (OR, 1.31; 95% CI, 1.14-1.50; number needed to harm, 73). Significant heterogeneity was observed for coronary heart disease and bleeding outcomes, which could not be accounted for by major demographic or participant characteristics.
Conclusions  Despite important reductions in nonfatal MI, aspirin prophylaxis in people without prior CVD does not lead to reductions in either cardiovascular death or cancer mortality. Because the benefits are further offset by clinically important bleeding events, routine use of aspirin for primary prevention is not warranted and treatment decisions need to be considered on a case-by-case basis.

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Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome.

Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE et alComponents of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; 336: 999-1003.    TC   PDF


Se han descritos 3 componentes en el efecto placebo: la respuesta a la observación y evaluación (efecto Hawthorne), la respuesta del paciente a la administración de un ritual terapéutico (la prescripción de un fármaco, por ejemplo) y la respuesta del paciente a la interacción-médico paciente. Sin embargo, la importancia relativa de estos 3 componentes no se ha estudiado.


Estudiar si el efecto placebo se puede separar experimentalmente en sus 3 componentes y éstos se pueden combinar gradualmente para producir una mejoría clínica aditiva en pacientes con síndrome del intestino irritable (SII).

Perfil del estudio

Tipo de estudio: Ensayo clínico
Área del estudio: Tratamiento
Ámbito del estudio: Comunitario


Se invitó a participar en el estudio a los pacientes afectos de SII atendidos en un centro, que se reclutaron mediante anuncios en prensa y derivaciones de otros profesionales. Los participantes debían tener ≥18 años, cumplir los criterios diagnósticos de Roma II y tener una puntuación ≥150 en la escala de intensidad de los síntomas. Se excluyó a los pacientes con datos sospechosos de presentar otra enfermedad (pérdida de peso, presencia de sangre en las heces, etc.) y a los que habian recibido acupuntura previamente.
El estudio se dividió en dos periodos de 3 semanas. Durante el primer periodo, los participantes fueron distribuidos aleatoriamente en 3 grupos:
  1. Lista de espera. Sirvió como grupo de control de la evolución natural de la enfermedad, la regresión a la media y el efecto Hawthorne. No recibieron ningún tratamiento, pero fueron valorados a las 3 y 6 semanas.
  2. Interacción limitada. Se le ofrecía al paciente sesiones de acupuntura placebo (sham) con una interacción mínima con el médico. Éste tenía una visita inicial fría de <5 minutos y se le colocaban las agujas y se dejaba al paciente sólo en una habitación durante 20 minutos. Con posterioridad se le administraban 2 sesiones semanales de acupuntura sham durante la duración del estudio.
  3. Interacción potenciada. Además de la acupuntura se permitía una interaccion con el médico más intensa. La visita inicial era más cálida y duraba unos 45 minutos en los que se les ofrecía al paciente mucha más información y se le transmitían ánimos y expectativas positivas sobre el éxito del tratamiento.
Al final del periodo de 3 semanas los pacientes de los grupos 2 y 3 fueron distribuidos de nuevo aleatoriamente sin su conocimiento a continuar con la acupuntura sham o con acupuntura genuina, pero sin cambiar el tipo de relación con el médico que se le había asignado.
Se permitió a los pacientes que siguiesen con su medicación habitual, siempre que esta permaneciese constante antes y durante el estudio. Las valoraciones de los participantes fueron llevadas a cabo por enfermeras que desconocían a qué grupo habían sido asignados los participantes. Las variables de resultado principales fueron una escala de mejoría global de los síntomas en los últimos 7 días comparados con el inicio del estudio (de 1 [mucho peor] a 7 [mucho mejor]) y la respuesta a una pregunta al paciente sobre si en la última semana había notado una mejoría adecuada de sus síntomas. Como variables secundarias se utilizaron los resultados de las escalas de intensidad de los sintomas y de calidad de vida, que se midieron también al inicio del estudio.


Participaron en el estudio 262 pacientes (fig. 1). La composición de los grupos fue parecida. La edad media fue de 38 años. Un 76% eran mujeres. No se encontraron diferencias entre los grupos en las puntuaciones medias de las escalas de ansiedad, depresión y calidad de vida, aunque la intensidad de los síntomas fue ligeramente inferior en el grupo de intervención limitada.
Figura 1. Flujo de los participantes.
Para todas las variables estudiadas la intervención potenciada fue superior a la limitada y ésta superior a la lista de espera (fig. 2).
Figura 2. Resultados de las diferentes intervenciones.
El tratamiento fue bien tolerado y los efectos adversos fueron los típicos de la acupuntura: dolor en el momento de la inserción de las agujas y de su retirada y enrojecimiento de la zona. A las 3 semanas no se detectaron diferencias estadísticamente significativas en la proporción de pacientes de los grupos placebo que creían que habían recibido acupuntura genuina (más del 75% en ambos grupos). En cambio, a las 6 semanas, más participantes del grupo de placebo potenciado creían haber recibido el tratamiento real (84 frente a 56%; P=0,02).


Los autores concluyen que los diferentes componentes del efecto placebo se pueden aislar y combinar progresivamente para conseguir un efecto aditivo y que el componente más robusto es la relación médico-paciente.

Conflictos de interés

Algunos de los autores han recibido honorarios de laboratorios farmacéuticos y de empresas dedicadas a terapias naturales por diferentes conceptos. Financiado por varias agencias de investigación públicas.


El efecto placebo está presente permanentemente en la relación médico-paciente y es muy utilizado por los profesionales: en varios estudios llevados a cabo en diferentes países se observó que una parte importante de los profesionales administran placebos en su práctica habitual y es probable que una parte significativa de los beneficios de los medicamentos recetados se deban a este efecto. Pese a todo, los estudios sobre el tema son escasos y poco conocidos por los médicos en ejercicio. Ello se debe en parte a los problemas éticos de estos estudios, a sus dificultades metodológicas y según algunos autores a la pérdida de prestigio que supone a la profesión médica el estudio exhaustivo de este fenómeno.
Pese a todo, se han producido avances en el tema, como por ejemplo, el hecho de que se haya demostrado que en algunas ocasiones su efecto se vea anulado por la administración de naloxona, lo que sugiere la participación de las endorfinas en el proceso, la importancia que tienen sobre la intensidad del efecto las expectativas del paciente y del médico sobre la eficacia del tratamiento, el efecto que tiene el aspecto físico y el precio del medicamento y el hecho de que cuanto más compleja sea la intervención, más probable es que sea eficaz.
En este estudio, los autores han intentado aislar qué parte del efecto placebo se debe puramente a la intervención y qué parte se debe a la interacción con el medico. Para ello eligieron una enfermedad con una elevada tasa de respuesta al placebo y una intervención (la acupuntura sham) que, al menos en el tratamiento de la dispepsia, se ha mostrado más eficaz como placebo que la utilización de un placebo farmacológico. El principal resultado del estudio es que la intervención resultó eficaz, pero lo fue mucho más la interacción con el médico durante una visita larga y cálida. Esto debería llevarnos a la reflexión sobre el modelo de atención primaria existente en nuestro país en el que la premura de las visitas puede afectar de forma importante a la eficacia de las intervenciones.


  1. Forcades T, Caminal. Núria Rodríguez J, Gutiérrez T, Grupo de investigación en MCAEfecto placebo frente a efecto terapéutico en la práctica clínica y medicinas complementarias y alternativas. Aten Primaria 2007; 39: 99-102.   TC   PDF
  2. González P, de Benedetto MAC, Ramírez IEl arte de curar: el médico como placebo. Aten Primaria 2008; 40: 93-95.   TC   PDF
  3. Skrabanek P, McCormick J. Follies and fallacies in Medicine. Eastbourne: Tarragon Press. 1989.


Manuel Iglesias Rodal. Correo electrónico:
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View more presentations from GETSA

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Wi Fi y esterilidad

Uno de los temas más debatidos que relaciona a la tecnología con la salud es si las ondas emitidas por redes WiFi perjudican la fertilidad de los hombres.Según la revista médica Fertility and Sterility, utilizar dispositivos que reciban este tipo de señal cerca de nuestros genitales podría causar infertilidad.
La revista se baso en un estudio realizado por científicos argentinos que colocaron esperma cerca de computadoras conectadas a WiFi durante 29 horas seguidas. Pasado este tiempo se demostró que el 25% de los espermatozoides dejaron de nadar, mientras que el 9% del ADN quedó completamente dañado.
Por otro lado realizaron el mismo experimento pero con esperma al que no le llega ningún tipo de señal WiFi, en este caso el 14% dejó de nadar y solo el 3% quedó expuesto a distintos tipos de alteraciones genéticas que dañan el ADN.
Según el presidente de la Sociedad de Reproducción Masculina y Urología, Rober Oates, no se puede sacar ningún tipo de conclusiones de este experimento ya que las condiciones fueron dadas en un sistema artificial, por lo que no sería 100% seguro que esto suceda así.
Los factores que afectan la fertilidad masculina son muchos, incluso podría existir mayor riesgo de perder la calidad del esperma por tener apoyada una computadora portátil en nuestras piernas, ya que el calor generado afecta en mayor grado a los espermatozoides que las señales WiFi.
Por otro lado, el urólogo Atanasio Fernández Borrell del Hospital de la Princesa de Madrid menciona que el experimento argentino: “Se trata de un experimento que ha utilizado espermatozoides ‘in vitro’ y no ‘in vivo’, de manera que el resultado es difícilmente aplicable a la realidad”.

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Occult papillary carcinoma of the thyroid. A "normal" finding in Finland. A systematic autopsy study.

Papillary Carcinoma of the Thyroid This illust...Image via Wikipedia

Cancer. 1985 Aug 1;56(3):531-8.

Occult papillary carcinoma of the thyroid. A “normal” finding in Finland. A systematic autopsy study.


The thyroids from 101 consecutive autopsies from Finland were subserially sectioned at 2- to 3-mm intervals. From 36 thyroids, 52 foci of occult papillary carcinoma (OPC) were found, giving a prevalence rate of 35.6%, the highest reported rate in the world. The rate was higher, although not significantly, in males (43.3%) than in females (27.1%), but it did not correlate to the age of the patients. Twenty-six glands contained one tumor focus and ten glands contained two to five tumor foci. Only a minority of the smallest tumors can be detected with the method used. The probable number of OPCs over 0.15 mm in diameter was calculated to be about 300 in this material. The tumor diameter varied from 0.15 mm to 14.0 mm, with 67% of tumors under 1.0 mm. The smallest tumors were usually circumscribed and were composed almost solely of follicles. Larger tumors had more papillary structures and were often invasive. Fibrosis and, in the largest OPCs, lymphocytic reaction were seen around the invasive islands. All tumors were positively stained for thyroglobulin and all but one of the tumors stained positively for epidermal keratin. OPC appears to arise from follicular cells of normal follicles. Apparently the great majority of the tumors remain small and circumscribed and even from those few tumors that grow larger and become invasive OPCs only a minimal proportion will ever become a clinical carcinoma. According to the study, OPC can be regarded as a normal finding which should not be treated when incidentally found. In order to avoid unnecessary operations it is suggested that incidentally found small OPCs (less than 5 mm in diameter) were called occult papillary tumor instead of carcinoma.





[PubMed – indexed for MEDLINE]

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La enfermedad arterial periférica es una manifestación común de la aterosclerosis cuya prevalencia aumenta con la edad (12% en la población general, alcanzando el 20% en mayores de 70 años) y la presencia de factores de riesgo cardiovascular. El tabaco (más del 80% de los pacientes son o han sido fumadores) y la diabetes mellitus son los principales factores de riesgo1,2.
La mayoría de las personas con esta enfermedad se encuentran asintomáticas y su diagnóstico requiere del cálculo del índice tobillo/brazo junto con una anamnesis y exploración física completa1,3,4.
Alrededor de un tercio de los pacientes con enfermedad arterial de las extremidades inferiores presentan sintomatología5. Dentro de estos síntomas, la claudicación intermitente es el más característico, y se define como un dolor intenso y atenazante en grupos musculares de la extremidad afectada, que aparece al caminar y se alivia con el reposo6.
La enfermedad cardiovascular es la principal causa de muerte en pacientes con claudicación intermitente, por lo que el abordaje de esta patología debe centrarse no solo en mejorar la movilidad y la calidad de vida, sino también en disminuir el riesgo cardiovascular. Para ello han de llevarse a cabo varios tipos de intervenciones1-7:
– Control de los factores de riesgo cardiovascular con especial énfasis en el ejercicio físico y el abandono del tabaco.
– Tratamiento antiagregante.
– Tratamiento farmacológico para el alivio de los síntomas.
– Angioplastia o revascularización cuando la sintomatología es incapacitante a pesar del tratamiento conservador1,3,4.

Las alertas de seguridad y los cambios producidos en la disponibilidad de varios fármacos utilizados en el alivio de los síntomas de la claudicación intermitente hacen necesario actualizar la información disponible y en este aspecto se va a centrar este boletín INFAC
Te recomendamos su lectura haciendo clic aquí 
Equipo de GAPURMED y Excellencis
El boletín INFAC es parte de la Sociedad Internacional de Boletines de Medicamentos, independientes de la industria farmacéutica (ISDB)

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En epocas de ajustes……alguien entenderà esto ?

Health care systemsImage via Wikipedia

The Savings Illusion — Why Clinical Quality Improvement Fails to Deliver Bottom-Line Results

Stephen S. Rauh, M.B.A., C.F.A., Eric B. Wadsworth, Ph.D., C.P.A., William B. Weeks, M.D., M.B.A., and James N. Weinstein, D.O.
December 14, 2011 (10.1056/NEJMp1111662)
It has become a core belief in U.S. health care that improving clinical quality will reduce health care costs. It seems intuitive that reducing readmissions, shortening lengths of stay, and building efficiency into clinical processes will reduce resource utilization and thereby lower costs. Certainly, evidence suggests that there is no association between high quality and high costs.1 Yet true bottom-line savings from improved clinical quality rarely materialize, and costs continue to climb. Manufacturing and service companies around the world have demonstrated the cost benefits of improving product quality and production efficiency. So why haven’t nearly two decades of work on improving health care quality had a measurable effect on health care costs?
The explanation lies in the cost structure of the typical health care setting. Its management and organization create a rigid cost structure that is relatively insensitive to small changes in patient volume, resource use, or the severity of patients’ health conditions. This fixed-cost dilemma leaves most health care costs insensitive to changes in volume and utilization, so clinical quality improvements typically create additional capacity rather than bottom-line savings.2 An examination of the different cost layers highlights the distinction between variable costs, such as supplies and medications, where reduced use produces true savings, and fixed costs, such as facilities and ancillary services, where the costs persist despite reduced use.
To better understand the cost structure of health care delivery, it can be useful to consider how different costs behave depending on the degree to which they are sensitive to changes in resource utilization. The four cost layers we have identified are defined in the tableBehavior of the Various Cost Layers in the Health Care System..
Clinical improvements that reduce layer 1 costs, such as those of supplies and medications, will generally create bottom-line savings, since these are the only truly variable clinical costs in a hospital. To generate savings by reducing use of the resources that account for layer 2 costs, the need for the resource must be reduced enough to allow elimination of a payable unit. For instance, a single nursing unit might have to discharge multiple patients before any savings in hourly nursing labor costs could be captured by allowing an hourly employee to go home early. Reducing layer 3 resources — those for equipment, operating-room time, or physicians’ salaries, for example — almost always produces additional capacity without bottom-line savings. If an intervention reduces operating-room time by 15 minutes, the costs of the equipment and salaried staff required to run the operating room do not change. Nonclinical layer 4 costs are primarily fixed in the short run, but reducing administrative labor costs by achieving administrative efficiency will produce true savings in future operating cycles.
Because of these cost behaviors, quality-improvement efforts that reduce lengths of stay or readmissions or increase radiology throughput do not create substantive bottom-line savings. They generally create capacity to treat additional patients. Similarly, efforts to expand the access of disadvantaged populations to primary care under the assumption that such access will be paid for through avoiding use of high-cost care sites — such as emergency departments — do not generate cost savings. The cost of staffing and equipping an emergency department does not change if there are small reductions in utilization. Indeed, improved access will increase health care costs if new physicians and staff are hired to serve new patients in primary care practices.
Although capacity creation does not generate bottom-line savings, it does create an opportunity to admit another patient and collect additional revenue. Because health care costs are relatively fixed and do not change much at the margin, the cost of admitting a new patient is remarkably low, making volume growth a highly profitable strategy. Volume growth also can give the appearance of reducing costs, since the cost per case decreases when the high fixed costs are spread over a larger number of patients, although total costs will probably continue to rise. Growing volume and increasing revenue, rather than creating true bottom-line savings, are typically at the core of the business case for high-quality care.3
Because of the rigid cost structures, incremental reductions in resource use are unlikely to generate cost savings for either a health care setting or the health care system. The most meaningful way to achieve savings is to focus on overall reductions in utilization rates for health care services and to eliminate the associated unnecessary capacity.
In a recent article, Kaplan and Porter argue that most health care costs are not fixed.4 Postulating that personnel costs can be adjusted and space reallocated on the basis of demand and patient mix, they suggest that cost behaviors are not responsible for the inability to generate cost savings, but “management inattention” is. Although we do not dispute this logic, its practical application is dependent on both procedure volume and the time horizon required for aligning resources with demand. High-volume procedures and treatments for which resource use can be standardized across the cycle of care and for which capacity can be readily adjusted to accommodate appropriate volume appear to be best suited to the aggressive cost management advocated by Kaplan and Porter. Presumably, lower-volume treatments and procedures would have to be consolidated regionally to be more amenable to effective cost management. Until that happens, the fixed-cost dilemma will remain an obstacle. Cost layering provides management with a framework for targeting changes that will generate the most immediate savings.
Whereas quality improvement is producing significant benefits for patients, quality initiatives will continue to produce disappointing bottom-line savings as long as the capacity created is used to support growth in patient volume. As the U.S. health care system begins shifting its focus from volume to value, hospitals will need to adapt their cost structures and capacity to accommodate lower per capita utilization rates as well as reductions in the per-episode intensity of care.
Disclosure forms provided by the authors are available with the full text of this article at
This article (10.1056/NEJMp1111662) was published on December 14, 2011, at


From the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH.

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Top ten drugs in Australia

Top 10 drugs
(Aust Prescr 2011;34:172)
These tables show the top 10 subsidised drugs for the year July 2010 – June 2011.
Table 1
Top 10 drugs supplied by DDD/1000 pop/day *, 
1. atorvastatin 82.87
2. irbesartan 33.02
3. rosuvastatin 32.37
4. perindopril 29.94
5. paracetamol 26.88
6. ramipril 26.16
7. candesartan 25.25
8. simvastatin 23.90
9. esomeprazole 21.32
10. amlodipine 19.92
DDDs in this table include use in combination products
Table 2
Top 10 drugs by prescription counts 
1. atorvastatin 11 020 969
2. esomeprazole 6 099 877
3. rosuvastatin             5 975 902      
4. paracetamol             4 840 331      
5. simvastatin             4 245 616      
6. perindopril             3 995 257      
7. pantoprazole 3 549 374
8. metformin hydrochloride             3 383 078      
9. irbesartan             3 098 162      
10. atenolol             3 070 515      

Table 3
Top 10 drugs by cost to government 
Drug Cost to government DDD/1000/day * Prescriptions
1. atorvastatin 637 426 978 82.87 11 020 969
2. rosuvastatin 334 168 383 32.37             5 975 902      
3. ranibizumab 310 399 773 –  146 272
4. esomeprazole 184 167 326 21.32 6 099 877
5. clopidogrel 173 946 446 10.94             2 774 567      
6. salmeterol and fluticasone 173 934 061 – §             3 065 047      
7. adalimumab 173 892 033 0.33 97 834
8. olanzapine 161 933 986 2.99 950 386
9. simvastatin 139 642 087 23.90             4 245 616      
10. etanercept 122 729 015 0.24 69 742

* The defined daily dose (DDD)/thousand population/day is a more useful measure of drug utilisation than prescription counts. It shows how many people, in every thousand Australians, are taking the standard dose of a drug every day.
Based on date of supply. Does not include private prescriptions or prescriptions under PBS co-payment.
PBS Pharmaceutical Benefits Scheme, RPBS Repatriation Pharmaceutical Benefits Scheme
The World Health Organization has not allocated a DDD for this drug
§ This combination does not have a DDD allocated
Source: Drug Utilisation Sub-Committee (DUSC) Database, as at September 2011. © Commonwealth of Australia.

Guidelines for Breast Cancer

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Time to stop mammography screening

Mammakarzinom, ID T1b. Mammography, breast can...Image via Wikipedia

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Prevención primaria y secundaria con estatinas

Age-standardised disability-adjusted life year...Image via Wikipedia

Boletin INFAC: prevención primaria y estatinas: acuerdos y desacuerdos
Lun 27 Jun, 2011 09:58 Compartir
Si quieres actualizarte sobre el tema “Prevención primaria, estimación del riesgo cardiovascular y estatinas: acuerdos y desacuerdos”, te invitamos a leer el último número del Boletín INFAC  haciendo un clic aquí

“…Desde que se inició el Framingham Heart Study con la finalidad de estudiar la epidemiología de la enfermedad cardiovascular (ECV), la forma de abordar su prevención ha cambiado por completo, y ha pasado a centrarse en la detección y tratamiento de los factores de riesgo modificables mediante la promoción de estilos de vida saludables y también utilizando fármacos de forma preventiva1.
No obstante, la prevención primaria de la ECV sigue siendo objeto de debate, con discrepancias en puntos como los métodos de cálculo del riesgo cardiovascular (RCV), o el establecimiento de los umbrales de riesgo para determinar qué pacientes deben ser tratados y cómo…”

En este número se incluyen los siguientes apartados:
Estimación del riesgo cardiovascular y tablas de predicción del riesgo
¿Cuál es la tabla de riesgo más adecuada en nuestro medio y el punto de corte a considerar?
¿Cuál es la eficacia de las estatinas en prevención primaria?
Efectos adversos de las estatinas
Dosis de estatinas: ¿dosis fijas o según cifras objetivo del c-LDL?
¿Qué estatina?

El objetivo del INFAC es informar sobre los problemas de eficacia y seguridad, analizar su impacto en la práctica clínica y proporcionar las recomendaciones y precauciones a adoptar para el uso de estos fármacos.

El boletín INFAC es miembro de la Sociedad Internacional de Boletines de Medicamentos, independientes de la industria farmacéutica

Esperemos que disfrutes de su lectura.
El equipo de Excellencis y de GAPURMED

Ojo rojo

El ojo rojo en atención primaria 

 En la edición  del 15 de enero 2010 de la American Family Physician  hay una revisión clínica titulada Diagnóstico y tratamiento de ojos rojos en la atención primaria de Holly Cronau, Ramana Reddy Kankanala y Mauger Thomas que comienza: “El ojo rojo es el signo cardinal de inflamación ocular. La condición es generalmente benigna y puede ser manejado por médicos de atención primaria. La conjuntivitis es la causa más común de los ojos rojos. Otras causas comunes incluyen blefaritis, abrasión corneal, cuerpo extraño, hemorragia subconjuntival, queratitis, iritis, glaucoma, quemadura química, y  escleritis. Los signos y síntomas de ojo rojo incluyen secreción ocular, enrojecimiento, dolor, fotofobia, prurito y alteraciones visuales. Generalmente, la conjuntivitis viral y bacteriana son condiciones autolimitadas, y las complicaciones serias son poco frecuentes. Dado que no hay prueba de diagnóstico específica para diferenciar la conjuntivitis viral de la bacteriana, la mayoría de los casos son tratados con antibióticos de amplio espectro. Las alergias o irritantes también pueden causar conjuntivitis. La causa del efecto de ojos rojos se puede diagnosticar a través de una historia detallada del paciente y el examen cuidadoso del ojo, y el tratamiento basado en sobre la etiología subyacente.
El reconocimiento de la necesidad de derivación a un oftalmólogo de emergencia es clave en el manejo de la atención primaria de los ojos rojos. La referencia es necesaria cuando el dolor intenso que no se alivia con anestésicos tópicos, esteroides tópicos son necesarios, o el paciente tiene pérdida de la visión, secreción purulenta abundante, la participación de la córnea, lesión ocular traumática, cirugía ocular reciente, pupila distorsionada, infección por herpes o infecciones recurrentes.  

Para la revisión completa, haga click aquí . 

American Family Physician  81 (2):137-144 © 2010 Academia Americana de Médicos de Familia
Diagnóstico y tratamiento de ojos rojos en la Atención Primaria. Holly Cronau, Ramana Reddy Kankanala y Mauger Thomas. Correspondencia a Holly Cronau: holly.cronau @ 

Obesity Treatment in Primary Care — Are We There Yet?

Weightloss pyramid.Image via Wikipedia

The U.S. Preventive Services Task Force recommends that clinicians arrange for their obese patients to receive intensive, multicomponent behavioral weight-loss counseling.1 However, less than 50% of primary care physicians (PCPs) report that they consistently provide diet and weight-control advice to their adult patients with weight-related disease, and less than 25% regularly refer patients for further management or track their weight-control behaviors over time.2
Recognizing the need for effective weight-management treatments that can be implemented in the primary care setting, the National Heart, Lung, and Blood Institute funded the Practice-based Opportunities for Weight Reduction consortium,3 a group of independent but coordinated comparative-effectiveness trials of weight-loss interventions delivered in primary care settings to obese patients with cardiovascular risk factors. The primary outcome was weight change at 2 years. In this issue of the Journal, the results of two of these studies4,5 are presented.
In the study by Wadden et al.,4 usual care (counseling provided at quarterly PCP office visits) was compared with the addition of brief lifestyle counseling (monthly, 15-minute, in-person counseling visits by trained medical assistants) and with enhanced lifestyle counseling (brief lifestyle counseling plus a toolbox that included meal replacements and weight-loss medications). Although weight loss in the brief-lifestyle-counseling group (2.9 kg) and the usual-care group (1.7 kg) did not differ significantly at 2 years, participants in the enhanced-lifestyle-counseling group lost significantly more weight (4.6 kg) than did those in either of the other two groups and were more likely to lose at least 5% of their initial body weight (35% in the enhanced-lifestyle-counseling group, vs. 26% in the brief-lifestyle-counseling group and 22% in the usual-care group).
In the study by Appel et al.,5 participants from six primary care practices were randomly assigned to a self-directed weight-loss program (control group); to in-person individual sessions plus group sessions, along with electronic and telephone contacts delivered by office-based lifestyle coaches (in-person support); or to a commercial call center–directed group in which coaches delivered all lifestyle interventions by telephone, Internet, and e-mail (remote support). Physicians supported the delivery of the interventions, reviewed participants’ weight status, and at routine medical visits encouraged participants to be engaged with the weight-loss treatment. Weight loss at 2 years was similar in the groups that received in-person support (5.1 kg) and remote support (4.5 kg) and was significantly greater than the weight loss in the control group (0.8 kg). Participants assigned to either the in-person or the remote lifestyle intervention were twice as likely as those assigned to the control group to have lost 5% or more of their initial body weight at 2 years (41% for the in-person group and 38% for the remote group, vs. 19% for the control group).
A well-recognized issue that affects the sustainability of behavioral interventions is that attendance at face-to-face counseling sessions decreases substantially over time. In the study by Wadden et al., participants in both the brief-lifestyle-counseling and the enhanced-lifestyle-counseling groups attended fewer than half the scheduled counseling visits during year 2. Similarly, in the study by Appel et al., those assigned to the in-person group participated in only 2 of 24 recommended face-to-face individual and group sessions between month 7 and the end of the trial. In contrast, those assigned to the remote group participated in a median of 16 of 18 recommended telephone contacts during that time. Given that remotely delivered coaching resulted in weight-loss outcomes similar to those of in-person visits, the use of mobile technologies to deliver behavioral weight-loss treatment in primary care appears to be promising. Such interventions may present fewer barriers to adherence than interventions delivered in person, since they allow for greater scheduling flexibility, decreased travel time, and lower transportation costs. In addition, a telephone-based coaching program has the potential for widespread implementation in multiple practice settings, including geographically isolated areas.
Both these studies provide evidence that PCPs can deliver safe and effective weight-loss interventions in primary care settings. However, there are important caveats. Although described as “effectiveness” rather than “efficacy” studies, both studies provided treatments (including lifestyle coaching, counseling, and, in the case of the Wadden study, meal replacements and medications) at no cost to the participants. Whether patients would be willing to pay for these therapies, or insurers would be willing to reimburse for them, is not known. Determining the costs and cost-effectiveness of these and other treatments in primary care settings is crucial. In addition, these two studies were not powered to detect differences in cardiovascular risk reduction, and there were no consistent between-group differences with respect to lipid levels, glucose levels, or blood pressure at 2 years. Particularly when one is augmenting behavioral treatments with medication, it is critical to assess the impact of such interventions on obesity-related coexisting conditions.
Finally, although more than one third of patients may respond to lifestyle counseling with weight loss of at least 5% of their baseline weight, many obese persons do not successfully achieve or maintain weight losses sufficient to improve their health by means of lifestyle changes alone. Some patients will require additional treatments (e.g., medications or bariatric surgery) as an adjunct to, but not a replacement for, lifestyle interventions. Continued research on ways to enhance patients’ adherence to long-term lifestyle changes should improve the reach and effectiveness of behavioral treatments for obesity in primary care settings.
The opinions expressed herein are those of the author and do not necessarily reflect the views of the National Institutes of Health or the Department of Health and Human Services.
Disclosure forms provided by the author are available with the full text of this article at
This article (10.1056/NEJMe1111487) was published on November 15, 2011, at


From the Office of Obesity Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.

Cochrane Neonatal Group: revisiones sistemáticas aliadas para el mejor cuidado de los prematuros

Cochrane Neonatal Group: revisiones sistemáticas aliadas para el mejor cuidado de los prematuros

Fuente: Pediatria Basada en Pruebas.

The Cochrane Collaboration (CC) se autodefine como una organización internacional sin ánimo de lucro cuya misión es ayudar en la toma de decisiones en materia de salud proveyendo la mejor información disponible. El objetivo de la CC es analizar, mantener y divulgar revisiones sistemáticas (RS) de los efectos de la asistencia sanitaria por medio de ensayos clínicos (y, si no estuvieren disponibles ensayos clínicos, revisiones de la evidencia más fiable derivada de otras fuentes).

Las RS de CC se publican en The Cochrane Library. Actualmente están disponibles alrededor de 4.600 RS (y unos 2.000 protocolos), que experimentan un continuocrecimiento cada año. El factor de impacto de Cochrane Database of Systematic Reviews (CDSR), la base de datos de RS en The Cochrane Library, es 6,186 en el año 2010.

Un elemento fundamental en la organización de CC radica en el establecimiento de grupos colaboradores de revisión (Collaborative Review Groups, CRG). En la CC cada revisor es miembro del CRG, que está formado por profesionales de distintas disciplinas que comparten un interés específico sobre un tema determinado. Estos CRG no coinciden necesariamente con las especialidades médicas tradicionales, sino que están dirigidos a problemas o conjuntos de afecciones específicas. Los CRG son actualmente 50; de éstos, los que tradicionalmente cuentan con una mayor actividad están relacionados con la perineonatología, concretamente Cochrane Pregnancy and Childbirth y Cochrane Neonatal Group. De hecho, es conocido que el logotipo de CC refleja una RS perineonatológica: el tratamiento con corticoesteroides en mujeres gestantes con amenaza de parto prematuro.

En el momento actual Cochrane Neonatal Group tiene publicadas 280 RS. Los 5 temas prioritarios son: infección neonatal (44 RS), ventilación mecánica (37 RS), alimentación en el recién nacido de bajo peso (33 RS), síndrome de distrés respiratorio (24 RS) y displasia broncopulmonar (19 RS).
Realizamos un análisis bibliométrico de la RS del Cochrane Neonatal Group en el año 2003 (ver artículo anexo), que nos permitió conocer la dinámica de este activo CRG. Al comparar estos resultados, comprobamos que en estos 7 años el número de RS se ha duplicado y que las patologías asociadas al recién nacido prematuro y/o menor de 1500 gramos siguen siendo prioritarias. Y las actualizaciones y novedades son continuas. Como ejemplo estas dos recientes RS sobre dos intervenciones (pentoxifilinalactoferrina oral) para la sepsis y enterocolitis necrotizante.

La CC es una gran aliada para la toma de decisiones basada en pruebas en neonatología. La CC se ha convertido en un recurso indispensable en los cuidados del prematuro, para obtener mejor resultados en salud, con un mejor cociente beneficios-riesgos-costes. Una excelente fuente de información que conviene recordar en vísperas del Día del Niño Prematuro, que se celebrará mañana.

Cochrane Neonatal Group: revisiones sistemáticas aliadas para el mejor cuidado de los prematuros

David Pencheon: Good general practice is sustainable general practice and vice versa

Source: BMJ blogs

2 Nov, 11 | by BMJ Group
David Pencheon
Once again the RCGP’s Annual conference last week in Liverpool produced a wealth of stimulating and topical debates – from the ethics of whether doctors should take a lead in commissioning (why do we always feel the need to “take the lead?”), to what constitutes sustainable general practice. The groups considering the latter issue, chaired by Tim Ballard and Trevor Thompson, concluded that when done well general practice and primary care is, by its very nature, sustainable: keeping people healthy, independent, empowered, and out of hospital. However, these worthy aspirations don’t always inspire and direct individuals to more specific action. Of course, there is the usual list of ways in which we can do the day job in a more environmentally sensitive way: declutter, go even more paperless, measure and reduce energy consumption, more teleconsultations (did I hear correctly that one Cornish practice has exceeded 50% here?), better procurement, fewer and more integrated collection of specimens, visits on foot, by bike, on a (electric) scooter.
However, the group felt that if we really wanted to be truly sustainable, there should be a focus on the models of care for its population that really would keep people healthy, independent, empowered, and out of hospital. What was needed, the group felt, was a specific list of clinical and health related areas where significant action (or research if necessary) should be commissioned and/or implemented. What are the known knowns (or even the known unknowns) where systematic and exemplary action would have the most effect to immediate and long term patient care and population health? 
Five areas emerged, neatly summarised by Peter Cawston, a GP from Glasgow:
  1. Helping people eat better and move better (where some of the most significant co-benefits for health can be made. Over eating red processed meat is not good for immediate health or for longer term environmental survival and the use of fossil fuel to travel is good neither for our own health nor our children’s – as well as being dangerously carbon intensive).
  2. Enabling women to have control over their fertility (especially pertinent as we welcome the 7 billionth citizen to the planet).
  3. Targeting prescribing on those most likely to benefit (in particular moving from target driven medication lists to therapy tailored to the individual, with consequent improvements in safety and effectiveness as well as reductions in financial and environmental costs arising from the manufacture and use of drugs).
  4. Promoting a greater sense of belonging (helping people to connect more and consume less, building on the personal trusting relationships at the core of general practice).
  5. Helping people manage a better death (where the avoidance of death and promotion of longevity as signs of success need to be recalibrated to what is a much more humane and dignified approach to helping people manage their end of life, and end of life care).
David Pencheon is a UK trained public health doctor and is currently director of the NHS Sustainable Development Unit (England).

Evidence-Based Medicine in the EMR Era

Students working with an artificial patient (F...Image via Wikipedia

Evidence-Based Medicine in the EMR Era

Jennifer Frankovich, M.D., Christopher A. Longhurst, M.D., and Scott M. Sutherland, M.D.
November 2, 2011 (10.1056/NEJMp1108726)

Many physicians take great pride in the practice of evidence-based medicine. Modern medical education emphasizes the value of the randomized, controlled trial, and we learn early on not to rely on anecdotal evidence. But the application of such superior evidence, however admirable the ambition, can be constrained by trials’ strict inclusion and exclusion criteria — or the complete absence of a relevant trial. For those of us practicing pediatric medicine, this reality is all too familiar. In such situations, we are used to relying on evidence at Levels III through V — expert opinion — or resorting to anecdotal evidence. What should we do, though, when there aren’t even meager data available and we don’t have a single anecdote on which to draw?
We recently found ourselves in such a situation as we admitted to our service a 13-year-old girl with systemic lupus erythematosus (SLE). Our patient‘s presentation was complicated by nephrotic-range proteinuria, antiphospholipid antibodies, and pancreatitis. Although anticoagulation is not standard practice for children with SLE even when they’re critically ill, these additional factors put our patient at potential risk for thrombosis, and we considered anticoagulation. However, we were unable to find studies pertaining to anticoagulation in our patient’s situation and were therefore reluctant to pursue that course, given the risk of bleeding. A survey of our pediatric rheumatology colleagues — a review of our collective Level V evidence, so to speak — was equally fruitless and failed to produce a consensus.
Without clear evidence to guide us and needing to make a decision swiftly, we turned to a new approach, using the data captured in our institution’s electronic medical record (EMR) and an innovative research data warehouse. The platform, called the Stanford Translational Research Integrated Database Environment (STRIDE), acquires and stores all patient data contained in the EMR at our hospital and provides immediate advanced text searching capability.1 Through STRIDE, we could rapidly review data on an SLE cohort that included pediatric patients with SLE cared for by clinicians in our division between October 2004 and July 2009. This “electronic cohort” was originally created for use in studying complications associated with pediatric SLE and exists under a protocol approved by our institutional review board.
Of the 98 patients in our pediatric lupus cohort, 10 patients developed thrombosis, documented in the EMR, while they were acutely ill. The prevalence was higher among patients who had persistent nephrotic-range proteinuria and pancreatitis (see tableResults of Electronic Search of Patient Medical Records (for a Cohort of 98 Pediatric Patients with Lupus) Focused on Risk Factors for Thrombosis Relevant to Our 13-Year-Old Patient with Systemic Lupus Erythematosus.). As compared with our patients with lupus who did not have these risk factors, the risk of thrombosis was 14.7 (95% confidence interval [CI], 3.3 to 96) among patients with persistent nephrosis and 11.8 (95% CI, 3.8 to 27) among those with pancreatitis. This automated cohort review was conducted in less than 4 hours by a single clinician. On the basis of this real-time, informatics-enabled data analysis, we made the decision to give our patient anticoagulants within 24 hours after admission.
Our case is but one example of a situation in which the existing literature is insufficient to guide the clinical care of a patient. But it illustrates a novel process that is likely to become much more standard with the widespread adoption of EMRs and more sophisticated informatics tools. Although many other groups have highlighted the secondary use of EMR data for clinical research,2,3 we have now seen how the same approach can be used to guide real-time clinical decisions. The rapid electronic chart review and analysis were not only feasible, but also more helpful and accurate than physician recollection and pooled colleague opinion. Such real-time availability of data to guide decision making has already transformed other industries,4 and the growing prevalence of EMRs along with the development of sophisticated tools for real-time analysis of deidentified data sets will no doubt advance the use of this data-driven approach to health care delivery. We look forward to a future in which health information systems help physicians learn from every patient at every visit and close the feedback loop for clinical decision making in real time.
Did we make the correct decision for our patient? Thrombosis did not develop, and the patient did not have any sequelae related to her anticoagulation; truthfully, though, we may never really know. We will, however, know that we made the decision on the basis of the best data available — acting, as the fictional detective Nero Wolfe would say, “in the light of experience as guided by intelligence.”5 In the practice of medicine, one can’t do better than that.
Disclosure forms provided by the authors are available with the full text of this article at
This article (10.1056/NEJMp1108726) was published on November 2, 2011, at


From the Division of Rheumatology (J.F.), the Division of Systems Medicine (C.A.L.), and the Division of Nephrology (S.M.S.), Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA.


  1. 1
    Lowe HJ, Ferris TA, Hernandez PM, Weber SC. STRIDE — an integrated standards-based translational research informatics platform. AMIA Annu Symp Proc 2009;14:391-395
  2. 2
    Prokosch HU, Ganslandt T. Perspectives for medical informatics: reusing the electronic medical record for clinical research. Methods Inf Med 2009;48:38-44
    Web of Science | Medline
  3. 3
    Gunn PW, Hansen ML, Kaelber DC. Underdiagnosis of pediatric hypertension — an example of a new era of clinical research enabled by electronic medical records. AMIA Annu Symp Proc 2007;11:966-966
  4. 4
    Halevy A, Norvig P, Pereira F. The Unreasonable Effectiveness of Data. IEEE Intelligent Systems, March/April 2009:8-12.
  5. 5
    Stout R. In the best families. New York: Viking Press, 1950:71.

Mamografías: más daños que beneficios. Los riesgos de la excesiva prevención

Front page of The New York Times July 29, 1914...Image via Wikipedia

Con cierta frecuencia los medios de comunicación suelen hablarnos de la bondad de las mamografías para detectar cáncer de mama. Pero esto ha sido cuestionado por la ciencia y una parte de la comunidad médica. Lo último publicado sobre ello es un texto enArchives of Internal Medicine, de H. Gilbert Welch, sobre el escaso-nulo impacto del cribado con mamografía. También lo ha comentado el New York Times: El cribado (screening) del cáncer de mama es absurdo, produce más daños que beneficios.
Especialmente por los medicamentos que se utilizan en los casos de sobre-diagnóstico(más del 40%; es decir, casi la mitad de las mamas extirpadas con cáncer de mamanunca darían metástasis y se sobretratan con cirugía-anestesia, radioterapia y quimioterapia).
“Diversos protocolos y programas recomiendan, en España, que los profesionales insistan en el auto-examen de mamas como medida de aplicación universal para la detección precoz del cáncer de mama; también, que se ofrezca la mamografía a mujeres de menos de 50 años y mayores de 69, especialmente en la práctica privada. ¿Disminuyen estas dos recomendaciones la mortalidad por cáncer de mama? La respuesta es negativa“.
En 2006 volvían a reciordar que el afán de prevenir puede ser peligroso. La prevención del cáncer de mama mediante mamografía es un programa muy popular pero quecarece de fundamento científico y que puede producir más daño que beneficios. Las mujeres deberían tener la información que se propone en este artículo para decidir. Además, como se publica también estos días el 40% del cáncer de mama no necesita quimioterapia.

Why hospitals and physicians should get serious about patient-centered care

QuikSCAT image of Hurricane Katrina on August ...Image via Wikipedia

Source: Kevin MD

Health care professionals are a cynical lot.   We joke about the “fad or buzzword of the month,” usually some vague concept heralded by the powers on high.   Our job is to promote the idea, knowing full well that the “next big thing” is probably right around the corner.
Take “patient-centered.” It sure feels like a buzz word.   I suspect most hospital and physician executives, and their ad agency partners, would agree.  But this time things are very different.
Here are reasons why hospitals and physicians should get serious about patient-centered care.
1. Patients are starting to discover that their doctors and hospitals are not nearly as good as they should be.
“Pay no attention to that man behind the curtain.” This line comes from the Wizard of Oz where little Toto rips the curtain back to show the great and powerful Oz is merely an old medicine show marketer from Kansas.
The analogy is a good one.  Patients across the U.S., and other countries, are “doing a Toto” as they pull back the curtains on doctors and hospitals only to learn that they are often not getting the quality of care they expected.
People every day hear about some story that undermines their confidence in the health care system.  Doctor Smith at XYZ hospital amputated the wrong limb again, Sally down the street was given the wrong medication, Mr. Patel’s opinion was ignored by his doctor, and so on.  Unlike years past when such stories were infrequent and seemed to occur in some other city… stories now appear daily, occur in my city, and are instantly shared with people around the world via the internet.
2. Patient-centered care is the right thing to do, and it’s not that hard
I think most would agree that today’s health care system is still very provider-driven.  That means that the care that is delivered, how it is delivered, who delivers it, and how outcomes are measured are all defined from the providers’ perspective (physicians, hospitals and payers ).   Patient-centered care simply means looking at these same issues but from the perspective of individual patients.   Notice nowhere here did I equate patient-centered care with smile training, customer service training or pianos in attractive lobbies.  Patient-centered care means involving patients in the planning, delivery and evaluation of health care where it really counts in terms of outcomes, patient adherence, cost reduction and fewer re-hospitalizations.
Being patient-centered is like doing a market research study and then implementing the findings.  Patient-centered care does not give absolute control to patients, it simply invites them into the party and gives them a place at the table.  As providers, we don’t do a good job of listening to patients.  We do an even worse job when it comes to acting on what patients tell us they want.
3. Patient-centered care will make any hospital or doctor stand out from the crowd.
Like a beautiful rainbow, patients and providers will recognize patient-centered care when they see it.   Like rainbows, example of patient-centered care are few and far between, but here are some tell-tale signs:
  • Providers and patients know each others’ names
  • Patients’ opinions are actively sought, listened to and honored where possible (no, a suggestion box, patient satisfaction survey or mission statement constitute being patient-centered — if you think they are then you aren’t patient-centered)
  • Patients tell you that their doctors and other team members really listened to what they had to say (again if you think satisfaction surveys qualify you aren’t there yet)
  • Patients are treated as the most important member of their health care team and taught how they can best contribute to the team’s success
  • Providers feel that their patients are actively involved in their own care
  • You see a significant improvement in patient health status, adherence, engagement, level of utilization and patient/provider experience
If these aren’t good enough reasons to give patient-centered care another look at your organization then just think about this.  Beginning in 2013, 30% of hospital Medicare reimbursement will be determined based upon patient experience.  Eventually commercial payers will follow suit.
Steve Wilkins is a former hospital executive and consumer health behavior researcher who blogs atMind The Gap.

(CMAJ) Eficacia de las estatinas en prevención primaria en sujetos de bajo riesgo. ¿Café para todos?

Escribimos este post durante el vuelo Sevilla-Bilbao de las 21:10, camino del XVI Congreso de la SEFAP, cuyo contenido tuitearemos, junto a otros compañeros, en los próximos días, utilizando elhashtag #16Bsefap. Su lectura es garantía de que el iPad y su propietario, llegaron sin novedad a la capital guipuzcoana. Como muchos sabéis, hace unos días se publicó en el Canadian Medical Association Journal un meta-análisis cuyo objetivo ha sidoevaluar la eficacia y riesgos de las estatinas en personas con un riesgo cardiovascular bajo. La forma en la que están redactadas las conclusiones puede dar pie a que más de uno piense que por fin, hay un respaldo evidencial para prescribir (más) estatinas, en la prevención primaria de la enfermedad cardiovascular. ¿Así de fácil? A la vista de lo leído, no tanto…
Material y método: revisión sistemática (se describe la estrategia de búsqueda) y meta-análisis de ensayos clínicos aleatorizados de al menos 6 meses de duración y n>30, que compararon un tratamiento con estatinas vs un placebo o un tratamiento distinto en personas de bajo riesgo cardiovascular (<20% a 10 años, calculado por extrapolación del riesgo observado en el grupo control de cada ensayo).
Resultados: 29 estudios (n=80.711) cumplieron los criterios de inclusión. Se observó una reducción de la mortalidad (RR: 0,90; IC95% 0,84-0,97; RRA: 0,42; IC95% 0,13-0,67; NNT: 239; IC95% 149-796) en personas con un riesgo <20% (análisis primario) y de 0,83 (IC95% 0,73-0,94) si el riesgo era <10% (resultado del análisis de sensibilidad realizado). El beneficio también fue estadísticamente significativo en los IAM no mortales (RR: 0,64; RRA: 0,66; NNT: 153) y los ACV no mortales (RR:0,81; RRA: 0,30; NNT: 335). La mediana de seguimiento fue de 2 años (0,5-3 años). No se observaron diferencias estadísticamente significativas entre estatinas en función de su potencia o la mayor reducción del colesterol. Tampoco se observaron diferencias entre grupos en relación a los efectos adversos graves (RR: 1,01; IC95% 0,96-1,07).
Conclusión de los autores: las estatinas se mostraron eficaces en la prevención de la mortalidad y la morbilidad cardiovascular en personas con bajo riesgo. Las reducciones de los riesgos relativos fueron similares a las observadas en pacientes con antecedentes de coronariopatía.
Fuente de financiación: Canadian Agency for Drugs and Technology in Health y Alberta Heritage Foundation.
Comentario: al tratamiento con estatinas, le dedicamos un densopost hace ahora un año. Desde entonces, lo más novedoso sobre este tema ha sido, si no nos falla la memoria, la publicación de una revisión de la Cochrane y el estudio de hoy. La primera incluye solo 14 ensayos clínicos aleatorizados y no hace la fina -y por otra parte artificial– distinción entre bajo o alto riesgo. Además, sus conclusiones incluyen un mensaje nítido a los clínicos, del que adolece el estudio del CMAJ: Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.
¿Por qué pensamos que el meta-análisis del CMAJ no debe cambiar las recomendaciones sobre el uso de estatinas en prevención primaria incluido en nuestras guías de cabecera? Podríamos hablar de las limitaciones metodológicas reconocidas por sus autores y otras derivadas de la menor exigencia de los criterios de inclusión utilizados, con respecto a la revisión de la Cochrane. Sobre este punto, os animamos a leer con fruición el artículo del BMJ sobre laherramienta para evaluar el riesgo de sesgos en los ensayos clínicos incluidos en este tipo de revisiones. También podríamos referirnos a los notables conflictos de interés de sus autores. O a la peculiar forma de expresar las conclusiones en el resumen, en términos de riesgosrelativos, antes que de riesgos absolutos (que aparecen, junto a los NNT en la farragosa tabla de la página 4) lo que dio pie a un airado comentario no exento de razón, ya que como todos sabéis, ir por ciudad a 200 km/h en una moto confiere un riesgo extraordinario de convertirse en donante de órganos, respecto a quien va a la velocidad reglamentaria,  independientemente de que la reducción del riesgo relativo conferida por los cascos utilizados por ambos sujetos sea similar.
No obstante, lo más criticable de este artículo es la inspiracióncolesterolocéntrica que lo alumbra, que invita, de forma implícita, a olvidarnos del abordaje multifactorial de la prevención cardiovascular, modificación de hábitos de vida inclusive. También es criticable que se eliminaran de un plumazo a todos los diabéticos, considerados de alto riesgo, sin más, independientemente, por ejemplo, de su edad, sexo, hábitos de vida, peso o presión arterial.
En relación a los resultados, por revisiones previas sabíamos que las estatinas tienen cierto beneficio (y ciertos perjuicios) en las personassanas, con factores de riesgo de sufrir una enfermedad cardiovascular. Según el estudio, necesitaríamos tratar ≈240 pacientes de bajo riesgo durante 3 años para salvar una vida. O dicho de otro modo: en un cupo pesado, de 1.500 personas sanas desde un punto de vista cardiovascular, tratarlos a todos con estatinas -independientemente de su nivel de riesgo- durante dicho período salvaría ≈6 vidas. Este sinsentido terapéutico -que da en la línea de flotación del mercado OTC de las estatinas- nos hace preguntarnos una vez más ¿qué personas con factores de riesgo cardiovascular, se podrían beneficiar del tratamiento con estatinas? Y la respuesta, una vez más, permanece inalterable: las de mayor riesgo, intentandoindividualizar el tratamiento, farmacológico o no, en función de las características de cada persona, apoyándonos, como herramienta queorienta la toma de decisiones en el cálculo del riesgo cardiovascular individual. ¿Café para todos? de momento no. Cafés hay muchos. Y no todos gustan…

Fuente: el rincón de Sisifo

FDA Says Chantix Benefits Outweigh The Risks or were you expeting another end ?

Ed Silverman in Pharmalot

cigarette-smoke-flickrAfter reviewing the results of two epidemiological studies that compared the controversial Chantix smoking-cessation pill with NicoDerm patches, the FDA has decided that the benefits of the Pfizer pill continue to outweigh the risks. The decision comes three years after the drugmaker added warnings its anti-smoking drug is connected to suicidal thoughts and behavior (back story).
Due to the myriad reports linking Chantix to psychiatric side effects, the FDA had sponsored two observational studies of neuropsychiatric adverse events with Chantix. One was conducted by the Department of Veterans Affairs’ Center for Medication Safety and the other by the Department of Defense’s US Army Medical Command’s Pharmacovigilance Center.
The VA study population included 14,131 Chantix users and an equal number of NRT users. The DoD study was also a retrospective cohort study comparing 30-day rates of hospitalizations for neuropsychiatric adverse events among 19,933 new Chantix users and 15,867 NRT patch users who started therapy from August 1, 2006 to August 31, 2007 in the Military Health System. Patients were drawn from active duty military personnel, military retirees and their dependents.
“Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy,” the FDA says in a statement. “However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events.
“Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix…(But) based on FDA’s assessment of currently available data, the agency continues to believe that the drug’s benefits outweigh the risks and the current warnings in the Chantix drug label are appropriate.”
The verdict is a big win for Pfizer, which has struggled to promote Chantix against a rising mound of studies that its pill is more trouble than it’s worth. In addition to concerns about suicide, studies have suggested Chantix can be responsible for violent behavior and cause serious cardiovascular risks (see herehere and here). The European Medicines Agency, however, recently ruled that Chantix benefits outweigh any heart risks (see this).

Top ten medical blogs

Universal health careImage via Wikipedia

Source: Medical Island
Of course, the post deals only with english written blogs.  
Blogging has of late become a regular past-time among various professionals and the medical profession is no exception. Medical Blogging requires serious consideration of the audience and the topics to be covered. Medical Professionals across the globe keep themselves updated through various electronic media and the internet has become the ultimate source of medical information for most of them.
Medical blogs make up a major chunk of the information available on the internet. They cover a range of topics from providing regular medical updates to the peculiar blog that talks about mundane medical terms and nuances. Medical Blogs are either started by individuals, run by some companies and organisations or an amalgamation of both. The vast number of medical blogs made the task of finding the “BEST” a serious business.
It is only true that no single blog could be the same for the entire audience, hence the ranking provided here is arbitrary based on my personal preferences. Without much ado, here is my list of the “TOP 10 MEDICAL BLOGS
I enjoyed reading many other medical blogs, but the ones mentioned here really caught my attention. I hope you too enjoy reading and following these blogs.
You will have suggestions to make about the selection or your own collection of favourite medical blogs. If so, post them in the comments section so that I can create another list of “The Best 100 Medical Blogs”.

Estimating treatment effects for individual patients based on the results of randomised clinical trials

BMJ 2011; 343:d5888 doi: 10.1136/bmj.d5888 (Published 3 October 2011)

Cite this as: BMJ 2011; 343:d5888

  • Research

Estimating treatment effects for individual patients based on the results of randomised clinical trials

Free via Creative Commons: OPEN ACCESS

  1. Johannes A N Dorresteijn, epidemiologist and medical doctor1,
  2. Frank L J Visseren, professor of vascular medicine, epidemiologist, and internist1
  3. Paul M Ridker, Eugene Braunwald professor of medicine, epidemiologist, and cardiologist2
  4. Annemarie M J Wassink, internist and postdoctoral researcher1
  5. Nina P Paynter, assistant professor of epidemiology2
  6. Ewout W Steyerberg, professor of medical decision making, and methodologist3
  7. Yolanda van der Graaf, professor of epidemiology and imaging4
  8. Nancy R Cook, associate professor of biostatistics and epidemiology2
Author Affiliations

  1. 1Department of Vascular Medicine, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands

  2. 2Division of Preventive Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

  3. 3Department of Public Health, Erasmus Medical Center, Rotterdam, Netherlands

  4. 4Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands

  1. Correspondence to: F L J Visseren
  • Accepted 12 August 2011


Objectives To predict treatment effects for individual patients based on data from randomised trials, taking rosuvastatin treatment in the primary prevention of cardiovascular disease as an example, and to evaluate the net benefit of making treatment decisions for individual patients based on a predicted absolute treatment effect.
Setting As an example, data were used from the Justification for the Use of Statins in Prevention (JUPITER) trial, a randomised controlled trial evaluating the effect of rosuvastatin 20 mg daily versus placebo on the occurrence of cardiovascular events (myocardial infarction, stroke, arterial revascularisation, admission to hospital for unstable angina, or death from cardiovascular causes).
Population 17 802 healthy men and women who had low density lipoprotein cholesterol levels of less than 3.4 mmol/L and high sensitivity C reactive protein levels of 2.0 mg/L or more.
Methods Data from the Justification for the Use of Statins in Prevention trial were used to predict rosuvastatin treatment effect for individual patients based on existing risk scores (Framingham and Reynolds) and on a newly developed prediction model. We compared the net benefit of prediction based rosuvastatin treatment (selective treatment of patients whose predicted treatment effect exceeds a decision threshold) with the net benefit of treating either everyone or no one.
Results The median predicted 10 year absolute risk reduction for cardiovascular events was 4.4% (interquartile range 2.6-7.0%) based on the Framingham risk score, 4.2% (2.5-7.1%) based on the Reynolds score, and 3.9% (2.5-6.1%) based on the newly developed model (optimal fit model). Prediction based treatment was associated with more net benefit than treating everyone or no one, provided that the decision threshold was between 2% and 7%, and thus that the number willing to treat (NWT) to prevent one cardiovascular event over 10 years was between 15 and 50.
Conclusions Data from randomised trials can be used to predict treatment effect in terms of absolute risk reduction for individual patients, based on a newly developed model or, if available, existing risk scores. The value of such prediction of treatment effect for medical decision making is conditional on the NWT to prevent one outcome event.
Trial registration number NCT00239681.

Critical Moments — Doctors and Patients

Lenore M. Buckley, M.D., M.P.H.
N Engl J Med 2011; 365:1270-1271October 6, 2011

I lost myself in the very properties of [my patients‘] minds, for the moment at least, I actually became them . . . so that when I detached myself from them at the end of intense concentration over an illness that was affecting them, it was as though I was awakening from sleep. For the moment I myself did not exist, nothing of myself affected me. As a consequence, I came back to myself as if from any other sleep, rested.

William Carlos Williams, M.D.

A pale, thin, anxious 9-year-old boy sits in front of me. As I start to talk to him, I realize that he is in pain, stoic, and not very verbal. I glance down and notice a markedly swollen ankle. He has been losing weight and uncomfortable for months, his anxious parents report. The pain seems to come and go, but now it’s so severe that he has trouble getting off the bus.
I gently probe for more information. “Have you had diarrhea?” I ask the boy. Yes, he nods. His mother looks startled; he has obviously never mentioned it to her. “Any blood in the diarrhea?” He nods again, and now we’re both startled. The boy looks even more anxious, and I’m aware of his parents’ escalating panic. It’s then that I realize that this is one of those critical moments. I’ll confess that most of the time, I’m not the slow, thoughtful, organized, wise physician with an endless fund of knowledge that I always imagined I’d become. More often, I’m the harried, absent-minded doctor who rushes into the room an hour late and tries to organize her thoughts in front of you as you remind her who you are and why you’re there. But at moments like this, I become completely focused. William Carlos Williams, the poet and primary care physician, eloquently described these moments and the intensity of the relationship between doctors and patients as they embark on the treatment of a serious illness.
Such moments occur at most a few times a month, usually when I least expect them. I walk into an exam room prepared to hear about a straightforward problem or to see a child with pain “everywhere” who’s struggling with the social challenges of middle school, and then, as I listen, I realize that the person in front of me is seriously ill. Sometimes the patient or the parents already know; sometimes they have no idea. The dawning of this realization is followed by a call to full attention. In the next hour and over the next few months, what I do (or don’t do) will change the life of this child and family; what I say and how I say it will be critical, providing the information, reassurance, and hope to keep everyone moving forward.
With this boy, Sam, my questions and exam follow the usual order, and then it’s time to talk. I remind myself of my responsibilities — education, treatment, support, advocacy. I look into Sam’s eyes and try to describe, in language he can understand, general concepts that will give him a sense of what’s happening in his body. This basic explanation is usually adequate for the parents as well, who are often in a state of shock; we’ll have more time to talk later.
I explain it to Sam first, respecting the fact that it’s his body and he is able to understand — and needs to know — what’s happening. It’s an important step in showing him respect and giving him back some control. We’re beginning a relationship, and obtaining his trust will be key to getting his cooperation. I want him to know that I see who he is, care about what he thinks, and will be his ally.
As I talk, I envision myself building a protective wall around him and his parents to hold back the wave of fear, vulnerability, and loss of control that is rushing in as they realize something serious has occurred. I look into his eyes and explain with confidence and reassurance that things will get better. I offer hope: “We know what this is, and together we will get you better.” We are now a team, and he’s the most important team member. We discuss the possible diagnoses, treatment, the need for a GI referral, and how to reach me over the next few days.
As I leave the room, I feel like I’m rising to the surface of the water after a deep dive. I have been in another world, where outside sounds are muffled and time slows. Now I reemerge in the noisy, fast-paced world of outpatient medicine. I’m an hour behind schedule, and the nurses — and my next patient — are understandably annoyed. A long day awaits. But somehow the rest of the day is easier. The world comes into better focus. I have been reminded of why I’m here and how lucky I am to be doing what I do.
In the afternoon, I pass the pediatric gastroenterologist, who reassures me he will see Sam quickly, and within a week he’s diagnosed with Crohn’s disease and starts treatment.
I see Sam regularly over the next few months. I smile when I go into the room, look at him first as I say hello, and ask how things are going. I’ve learned to warn my patients about the ups and downs of glucocorticoid treatment: first, there’s relief when the medicine finally controls the symptoms, then there’s discouragement about side effects and changes in appearance and mood, followed by the struggle to discontinue them as the other medications begin to work. It’s an emotional roller coaster, and it’s my job to prepare them.
Sam has followed this path. There’s the visit at 4 weeks when the diarrhea has stopped and the joints are not painful. He is still quiet but looks relieved. When he returns at 8 weeks, he is markedly cushingoid, embarrassed, and dejected — it’s not easy to have a pumpkin face with acne in elementary school. Again, I sit next to him and look directly into his eyes. Sometimes this is not so easy with teens and preteens, who tend to stare down at the floor. In an attempt at humor, I bend down and turn my head up so I can see his face. “It will be better,” I reassure him. “A few more weeks.” He smiles. I walk him through the treatment plan again. I explain what’s happening to his body and go over the timelines.
By the 12th week, he is still cushingoid but surprisingly chatty and looks straight into my eyes as he reports what’s happened since the last visit. He seems to understand now that I am here to see and talk to him, and he is proud of his role in managing the illness. He looks more hopeful. The prednisone dose has been reduced, and he knows the tapering schedule well enough to correct his father, who is momentarily confused about the gastroenterologist’s treatment plan. He sees the light at the end of the tunnel.
Sam and his parents are at the beginning of a long journey. This illness will influence who Sam will become — affecting his self-image, relationships, and aspirations. His parents face one of life’s most difficult challenges. The course of their lives and their relationship shifted, almost imperceptibly, at that first visit. How their story will play out is still unclear to me, although I’ve seen hundreds of other versions of it over the years.
This time, I’ve been lucky enough to be there from that critical moment at the beginning, to be a part of the story’s evolution and, I hope, acceptable resolution. All physicians experience these moments. They shape our lives, inform our values, and educate and prepare us for the next patient who needs our help. The expectation of these moments and the satisfaction they bring keep us moving forward through difficult times. The challenge is to continue to notice them — to remember the personal impact of the diagnoses we make and our ability and obligation to soften the blows, to build that protective wall.
The name of the patient has been changed to protect his privacy.
Disclosure forms provided by the author are available with the full text of this article at


From Virginia Commonwealth University School of Medicine, Richmond.

The New Language of Medicine

Pamela Hartzband, M.D., and Jerome Groopman, M.D.
N Engl J Med 2011; 365:1372-1373October 13, 2011

During our first year of medical school, we spent countless hours learning new words, memorizing vocabulary as if we were studying a foreign language. We discovered that some words that sounded foreign actually represented the familiar: rubeola was measles, pruritus meant itching. Now, we find ourselves learning a new language of medicine filled with words that seem familiar yet feel foreign. Patients are no longer patients, but rather “customers” or “consumers.”1 Doctors and nurses have been transmuted into “providers.” These descriptors have been widely adopted in the media, medical journals, and even on clinical rounds. Yet the terms are not synonymous. The word “patient” comes from patiens, meaning suffering or bearing an affliction. Doctor is derived from docere, meaning to teach, and nurse from nutrire, to nurture. These terms have been used for more than three centuries.
What precipitated the increasing usage of this new vocabulary in medicine? We are in the midst of an economic crisis, and efforts to reform the health care system have centered on controlling spiraling costs. To that end, many economists and policy planners have proposed that patient care should be industrialized and standardized.2 Hospitals and clinics should run like modern factories, and archaic terms such as doctor, nurse, and patient must therefore be replaced with terminology that fits this new order.
The words we use to explain our roles are powerful. They set expectations and shape behavior. This change in the language of medicine has important and deleterious consequences. The relationships between doctors, nurses, or any other medical professionals and the patients they care for are now cast primarily in terms of a commercial transaction. The consumer or customer is the buyer, and the provider is the vendor or seller. To be sure, there is a financial aspect to clinical care. But that is only a small part of a much larger whole, and to people who are sick, it’s the least important part. The words “consumer” and “provider” are reductionist; they ignore the essential psychological, spiritual, and humanistic dimensions of the relationship — the aspects that traditionally made medicine a “calling,” in which altruism overshadowed personal gain. Furthermore, the term “provider” is deliberately and strikingly generic, designating no specific role or type or level of expertise. Each medical professional — doctor, nurse, physical therapist, social worker, and more — has specialized training and skills that are not recognized by the all-purpose term “provider,” which carries no resonance of professionalism. There is no hint of the role of doctor as teacher with special knowledge to help the patient understand the reasons for his or her malady and the possible ways of remedying it, no honoring of the work of the nurse as a nurturer with unique expertise whose close care is essential to healing. Rather, the generic term “provider” suggests that doctors and nurses and all other medical professionals are interchangeable. “Provider” also signals that care is fundamentally a prepackaged commodity on a shelf that is “provided” to the “consumer,” rather than something personalized and dynamic, crafted by skilled professionals and tailored to the individual patient.
Business is geared toward the bottom line: making money. A customer or consumer is guided by “caveat emptor” — “let the buyer beware” — an adversarial injunction and hardly a sentiment that fosters the atmosphere of trust so central to the relationship between doctor or nurse and patient. Reducing medicine to economics makes a mockery of the bond between the healer and the sick. For centuries, doctors who were mercenary were publicly and appropriately castigated, the subjects of caustic characterization in plays by Moliere and stories by Turgenev. Such doctors betrayed their calling. Should we now be celebrating the doctor whose practice, like a successful business, maximizes profits from “customers”?
Beyond introducing new words, the movement toward industrializing and standardizing all of medicine (rather than just safety and emergency protocols) has caused certain terms that were critical to our medical education to all but disappear. “Clinical judgment,” for instance, is a phrase that has fallen into disgrace, replaced by “evidence-based practice,” the practice of medicine based on scientific data. But evidence is not new; throughout our medical education beginning more than three decades ago, we regularly examined the scientific evidence for our clinical practices. On rounds or in clinical conferences, doctors debated the design and results of numerous research studies. But the exercise of clinical judgment, which permitted assessment of those data and the application of study results to an individual patient, was seen as the acme of professional practice. Now some prominent health policy planners and even physicians contend that clinical care should essentially be a matter of following operating manuals containing preset guidelines, like factory blueprints, written by experts.2 These guidelines for care are touted as strictly scientific and objective. In contrast, clinical judgment is cast as subjective, unreliable, and unscientific. But there is a fundamental fallacy in this conception. Whereas data per se may be objective, their application to clinical care by the experts who formulate guidelines is not. This truth, that evidence-based practice codified in clinical guidelines has an inescapable subjective core, is highlighted by the fact that working with the same scientific data, different groups of experts write different guidelines for conditions as common as hypertension and elevated cholesterol levels3 or for the use of screening tests for prostate and breast cancers.4 The specified cutoffs for treatment or no treatment, testing or no testing, the weighing of risk versus benefit — all necessarily reflect the values and preferences of the experts who write the recommendations. And these values and preferences are subjective, not scientific.5
What impact will this new vocabulary have on the next generation of doctors and nurses? Recasting their roles as those of providers who merely implement prefabricated practices diminishes their professionalism. Reconfiguring medicine in economic and industrial terms is unlikely to attract creative and independent thinkers with not only expertise in science and biology but also an authentic focus on humanism and caring.
When we ourselves are ill, we want someone to care about us as people, not as paying customers, and to individualize our treatment according to our values. Despite the lip service paid to “patient-centered care” by the forces promulgating the new language of medicine, their discourse shifts the focus from the good of the individual to the exigencies of the system and its costs. Marketplace and industrial terms may be useful to economists, but this vocabulary should not redefine our profession. “Customer,” “consumer,” and “provider” are words that do not belong in teaching rounds and the clinic. We believe doctors, nurses, and others engaged in care should eschew the use of such terms that demean patient and professional alike and dangerously neglect the essence of medicine.
Disclosure forms provided by the authors are available with the full text of this article at


From Beth Israel Deaconess Medical Center and Harvard Medical School — both in Boston.

California Gov Signs Controversial Vaccine Law

California Gov Signs Controversial Vaccine Law

vaccine-flickr1Following months of controversy, California Governor Jerry Brown late last week signed into law a bill that removes parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although state law already allows children 12 and older to consent to treatment for sexually transmitted diseases without parental involvement, the new law expands that right to immunizations.
The bill (read here) had been strongly opposed by several organizations that argued minors do not have adequate judgment to make a decision about vaccination (back story). The legislation also figured into the wider national debate in recent weeks over HPV vaccines, concern among social conservatives about teenage sex and the extent to which drugmakers have worked to influence introduction and passage of such bills (see here andhere).
At issue is a furor that has plagued Merck and its Gardasil vaccine. The FDA approved the shot five years ago to protect girls and women ages 9 to 26 against four strains of the human papillomavirus, or HPV, which can lead to cervical cancer. Social conservatives and some parents, however, are concerned that teenagers may interpret vaccination as a green light to engage in premarital sex. Brown did not issue a statement upon signing the bill (look here), but one group is spitting mad.
“By signing AB 499 to coerce minors into risky Gardasil shots, Jerry Brown is deceptively telling preteen girls it will protect them from HPV, giving them a false sense of security that they can have all the sexual activity they want without risking developing cervical cancer or a raft of other negative consequences,” says Randy Thomasson, president of, in a statement.
In contrast to such sentiments, public health officials have recommended HPV vaccination – including the Cervarix vaccine sold by GlaxoSmithKline – as a useful tool to thwart the advent of cervical cancer. Nonetheless, Gardasil has been dogged by questions over side effects, cost and long-term effectiveness. Meanwhile, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention (read here). To some extent, the concerns over Gardasil reflect the wider controversy over vaccine safety, in general.
Merck, however, fueled the debate over HPV vaccination by employing a surreptitious marketing campaign several years ago in which the drugmaker backed Women In Government, a non-profit group of state legislators, in hopes that mandatory vaccination bills for school-age children would be introduced nationwide. The effort backfired, though, and Merck ended its lobbying (back story).
But the issue re-emerged last month, when Texas Governor and Republican presidential candidate Rick Perry said his decision to sign an executive order to create a mandate. The state legislature later overturned the order, but Perry’s ties to Merck at the time became campaign fodder. These included Merck donations in the years prior to his order (read here).
The unexpected attention cast a bigger spotlight on the bill in California, where many members of the state senate and assembly who voted to approve the legislation also received money last year from Merck. This group included representative Toni Adkins, who introduced the bill and earlier this summer denied that she ever received money from the drugmaker (see here).
vaccine pic thx to lulu on flickr

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