Mostrando las entradas con la etiqueta Lancet. Mostrar todas las entradas
Mostrando las entradas con la etiqueta Lancet. Mostrar todas las entradas

27 mayo, 2013

Consejos breves a mujeres victimas de violencia familiar

Martha Cecilia Alzate - Foro - Realidad Etnica...
Martha Cecilia Alzate - Foro - Realidad Etnica y Cultural de RISARALDA (Photo credit: Wikipedia)
Fuente: Salud Juntos
Dr. A.Casi


Utilidad del consejo breve del médico de familia a las mujeres que sufren violencia de pareja -> El consejo breve por el médico de familia a las mujeres que sufren violencia de pareja reduce los síntomas depresivos, aunque no mejora la calidad de vida, la planificación de su seguridad u otros problemas de salud mental después de 12 meses de seguimiento.
Lancet, 16/04/2013 "Screening and counselling in the primary care setting for women who have experienced intimate partner violence (WEAVE): a cluster randomised controlled trial".
La evidencia del beneficio de las intervenciones para ayudar a las mujeres con cribado positivo a violencia del compañero íntimo (VCI) en los entornos de atención de salud es limitado. Se evaluó si el asesoramiento breve de los médicos de familia formados para responder a las mujeres identificadas en la detección de VCI aumentaría la calidad de vida, planificación de la seguridad y el comportamiento, y la salud mental de las mujeres. Métodos: Ensayo controlado aleatorizado, que incluyó a los médicos de familia en las clínicas en Victoria, Australia, y sus pacientes mujeres (edad 16-50 años) que dieron positivo para violencia de su pareja en los últimos 12 meses en una encuesta de salud y estilo de vida. La intervención del estudio consistió en lo siguiente: la formación de los médicos, la notificación a los médicos de las mujeres de detección positiva para la violencia de la pareja, y la invitación a las mujeres a de una a seis sesiones de consejo para la relación y los problemas emocionales. Se utilizó una secuencia de asignación al azar generada por computadora para asignar a los médicos para el control (atención estándar) o la intervención, estratificadas según la ubicación de la práctica de cada médico (urbano vs rural), con tamaños de bloques aleatorios permutados de dos y cuatro dentro de cada estrato. Los datos fueron recolectados mediante una encuesta postal al inicio del estudio y a los 6 y 12 meses después de la invitación (noviembre de 2008). Los investigadores se cegaron a la asignación al tratamiento, pero no lo fueron las mujeres y los médicos inscritos en el ensayo. Los resultados primarios fueron la calidad de vida (Quality of Life-BREF OMS), la planificación de la seguridad y el comportamiento y la salud mental (SF-12) a los 12 meses. Los resultados secundarios incluyeron la depresión y la ansiedad (Hospital Anxiety and Depression Scale, de corte ≥ 8), el informe de las mujeres de una encuesta de su médico acerca de la seguridad de ellas y sus hijos, y la comodidad para hablar sobre la violencia con su médico (cinco puntos de la escala de Likert). Los análisis fueron por intención de tratar, considerando los datos perdidos, y las estimaciones indicadas se ajustaron para la ubicación del médico y las puntuaciones de resultados al inicio. Resultados: Asignamos aleatoriamente a 52 médicos (y 272 mujeres que eran elegibles para su inclusión en el estudio de referencia), para cualquiera de las intervenciones (25 médicos, 137 mujeres) o controles (27 médicos, 135 mujeres). 96 (70%) de 137 mujeres en el grupo de intervención (23 médicos) y 100 (74%) de 135 mujeres en el grupo control (26 médicos) completaron 12 meses de seguimiento. No se detectaron diferencias en la calidad de vida, planificación y comportamiento de seguridad, o la salud mental SF-12 a los 12 meses. No se detectaron diferencias para los resultados secundarios entre los grupos en la ansiedad a los 12 meses o la comodidad para discutir sobre la violencia a los 6 meses, pero los casos de depresión a los 12 meses mejoraron en el grupo de intervención en comparación con el grupo control (odds ratio 0,3, 0 • 1-0 • 7, p = 0,005), así como la consulta del médico  los 6 meses sobre la seguridad de las mujeres (5.1, 1.9 -14 • 0, p = 0,002) y seguridad de los niños (5,5 , 1.6 -19 • 0, p = 0,008). No se registraron efectos adversos. Interpretación: Nuestros hallazgos de la investigación sobre el asesoramiento breve a las mujeres identificadas para la violencia de pareja en los entornos de atención primaria, sugieren que los médicos de familia deben estar capacitados para preguntar acerca de la seguridad de las mujeres y los niños, y proporcionar asesoramiento de apoyo para las mujeres que sufren malos tratos, ya que nuestros resultados sugieren que, si bien no se detectó ninguna mejora en la calidad de vida, el asesoramiento puede reducir los síntomas depresivos.
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04 abril, 2013

Monitoreo fetal y resultados perinatales

Fetal-pain
Fetal-pain (Photo credit: Wikipedia)

El monitoreo fetal electrónico al inicio del trabajo de parto no mejora los resultados en mujeres de bajo riesgo.pdf

Impey L, Reynolds M, Maquillan K y col. Admission cardiotocography: a randomised controlled trial. Lancet. 2003; 361: 465 - 70

Fuente: Revista Evidencia 2003. 

 
Objetivo
Evaluar el impacto del monitoreo fetal electrónico (cardiotocograma) al inicio del trabajo de parto sobre los resultados perinatales en mujeres de bajo riesgo.
Diseño
Estudio aleatorizado y controlado.
Lugar
National Maternity Hospital, Dublín, Irlanda.
Pacientes
Sobre 15.163 pacientes que reunían los criterios de inclusión (embarazo único menor de 42 semanas de gestación sin evidencia de compromiso de la salud fetal anteparto, con líquido amniótoco claro y temperatura axilar menor a 37,5°C) fueron aleatorizadas 8.628 mujeres que consintieron participar, 4.320 al grupo de monitoreo electrónico y 4.308 al grupo de manejo habitual (auscultación intermitente).
Intervención
A las pacientes asignadas al grupo experimental, luego de la amniotomía precoz, se les realizó un monitoreo fetal electrónico de 20 minutos. En caso de ser reactivo continuaron sus controles de salud fetal con auscultación intermitente. En caso contrario, el monitoreo fetal electrónico fue continuo hasta el parto.
Medición de resultados principales
El resultado principal se definió como morbilidad neonatal severa o moderada o mortalidad perinatal en ausencia de malformaciones congénitas.
Resultados principales
El resultado principal se observó en 56 (1.3%) de las 4.298 mujeres del grupo monitoreo y en 55 (1.3%) de las 4.282 del grupo de cuidado usual. A pesar de un incremento del uso de monitoreo fetal continuo y de toma de muestras de sangre fetal en el grupo de monitoreo fetal al inicio del trabajo de parto, esto no se asoció a diferencias significativas en la frecuencia de cesárea, de parto instrumental o de episiotomía. Ver tabla.
Tabla: Resultados principales

Resultado
RR (IC95%)
Morbilidad neonatal severa o moderada o mortalidad perinatal en ausencia de malformaciones congénitas
1,01(0,70 a 1,47)
Uso de
Monitoreo fetal continuo
1,39 (1,33 a 1,45)
Muestras de sangre fetal
1,30 (1,14 a 1,47)
Frecuencia de
Cesáreas
1,13 (0,92 a 1,40)
Parto instrumental
1,03 (0,92 a 1,16)
Episiotomía
1,06 (0,99 a 1,13)
ConclusionesEl monitoreo fetal electrónico de 20 minutos usado en forma rutinaria al inicio del trabajo de parto no mejora los resultados neonatales. No hubo incremento significativo en la frecuencia de cesárea debido, probablemente, al uso liberal de las muestras de sangre fetal.
Fuente de financiamiento: Comité de investigación del Hospital Nacional Materno de Dublín, Irlanda.
Comentario
Según los resultados de este estudio, el monitoreo fetal electrónico al inicio del trabajo de parto en pacientes con embarazos de bajo riesgo no parece estar justificado en función de la falta de impacto en los resultados perinatales.
El monitoreo de la frecuencia cardíaca fetal intraparto fue introducido en los años sesenta con el objetivo de disminuir la incidencia de muerte fetal intraparto y el potencial daño cerebral secundario a hipoxia y acidosis fetal. Sin embargo, como tantas otras tecnologías, fue lanzada al mercado sin la evaluación apropiada. Entre los años setenta y ochenta se realizaron numerosos estudios aleatorizados1, 2, ninguno de los cuales permitió encontrar mejoras en los resultados perinatales. Por ejemplo, a pesar de la generalización del uso del monitoreo fetal intraparto, la incidencia de parálisis cerebral no ha disminuido.
Algunas razones intentan explicar la falta de eficacia del monitoreo fetal electrónico: 1) uso de medidas de resultados que no se relacionan con los patrones de monitoreo observados, 2) falta de interpretaciones estandarizadas, 3) desacuerdo sobre las intervenciones sobre patrones no tranquilizadores, 4) incapacidad para demostrar precisión y validez.
Consideramos que hay que tener precaución con la generalización de los hallazgos de estos estudios, ya que en ellos el grupo control recibió durante el trabajo de parto la atención de una obstétrica o enfermera especializada (una por cada paciente) situación poco habitual en la inmensa mayoría de los nacimientos que ocurren en la República Argentina y el resto de Latinoamérica.
Para concluir agregamos que, si bien en la práctica clínica cotidiana no se realiza el monitoreo fetal de ingreso para categorizar a las mujeres en grupos de riesgo; a pesar de la carencia de sustento científico, el monitoreo fetal “intraparto” se emplea como una forma de “contención” materna y para brindar a los profesionales una falsa sensación de seguridad.
Conclusiones del comentador
El monitoreo fetal electrónico al inicio del trabajo de parto en pacientes con embarazos de bajo riesgo no ha mostrado mejorar los resultados perinatales.

Referencias
1.Thacker, SB; Stroup, D; Chang, M Continuous electronic heart rate monitoring for fetal assessment during labor. Cochrane Database of Systematic Reviews. 1, 2003.
2.Parer JT, King T. Fetal heart rate monitoring: is it salvageable? Am J Obstet Gynecol. 2000; 182(4):982-7.



Autores

Dr. Izbizki, Gustavo
Obstetricia
Obstetricia
Hospital Italiano de Buenos Aires

Dr. Minig, Lucas
Obstetricia
Residente
Hospital Italiano de Buenos Aires

06 marzo, 2013

Knowing its place: mapping as medical investigation

The Lancet
The Lancet (Photo credit: Wikipedia)

The Lancet, Volume 379, Issue 9819, Pages 887 - 888, 10 March 2012
doi:10.1016/S0140-6736(12)60383-3Cite or Link Using DOITom Koch aEmail Address
Not for the first time—and not for the last—a new disease appeared to ignore the theories of the day. In the 18th century, everyone knew that yellow fever was a climatic illness: “Distempers of very hot southerly countries, and natural to those climes”, wrote one authority in 1755, were “unnatural to other countries situated in a northern latitude”. And yet, during the 18th century yellow fever travelled up the American coast to attack with increasing frequency cities like Boston, New York, and Philadelphia. Figuring out yellow fever was a matter not only of medical urgency but also of economic survival. In one outbreak, in 1793, Philadelphia lost 10% of its population. “Why should cities be erected”, asked Noah Webster in 1796, “if they are only to be the tombs of men?” Some believed this new fever was a plague-like contagion that somehow travelled in the holds of cargo ships. Others insisted it was generated locally in the foul, fetid airs of unsanitary cities built for trade but not for cleanliness. If it was contagious then only quarantine could tame it. If it was, however, a miasmatic illness then, as sanitarian Benjamin Rush wrote in 1797, the medical response was obvious: “Offal matters, especially those which are of a vegetable nature, should be removed from the neighborhood.”
To test the theory of local miasmatic generation, New York physician Valentine Seaman etched on a copperplate map the street location of patient deaths at the epicentre of an outbreak. On a second plate he located the waste sites of “putrid effluvia” that were suspected sources. Published in the inaugural issue of The Medical Repository in 1798, the result revolutionised disease studies. Just as Andre Vesalius’ De Humani Corporis Fabrica challenged 16th-century physicians to see in dissection the real connections between the skeleton and its musculature, Seaman’s mapping invited his contemporaries to see the relation between the environment and a disease generated in it. The miasmatic theory became visible in the apparent correlation of disease incidence and proximate waste sites of odiferous, “furry miasmata”.
This is the unique thing about mapping: it takes a collection of individual cases and makes of them a uniform event class. Each case is related to all others—inviting measures of density and proximity—and to other elements of the mapped environment. In this way medical maps visualise Hippocrates’ great insight in On Airs Waters, and Places that disease events are related, at one or another level, to the environment in which patients live. Of course, the resulting map is only as good as the theory it tests. In applying a miasmatic theory of local disease generation to yellow fever, Seaman assumed it was spawned in the odiferous urban air. In identifying waste sites to be mapped he therefore identified the origin but not the source of the outbreak. He observed dense populations of mosquitoes buzzing at waste sites—“never before known, by the oldest inhabitants, to have been so numerous as at this season”—but, lacking a theory of insect-born illness, Seaman missed the true vector of transmission.
Mapping is also only as good as the technologies of its presentation. Seaman wrote that he regretted the copperplate technology would not permit more than a few of the many reported cases to be imaged. Nor was it possible to overlay his two maps to make clear comparisons. Quickly, however, these problems were overcome as the old copperplate technology gave way to cheaper, faster more precise printing methods that allowed for the inclusion of more data, and greater ease of publication.
Click to toggle image sizeThe mapping techniques developed for yellow fever were later used in myriad attempts to understand the 19th century’s great recurring pandemic, cholera. By mid-century it would become the most studied and the most mapped epidemic in history. In England, the first pandemic killed more than 50 000 citizens between 1831 and 1834, spawning a generation of research papers. The study of this disease necessitated better data and a bureaucracy to administer it. In answer, Parliament created the General Register Office in 1836. Beginning in 1837, the map of the British nation was redrawn into a series of registration districts and subdistricts—each supervised by a Medical Officer—to permit ever more precise collection of mortality and morbidity reports. Under the General Register Office, the first modern census of 1841 created a population database that would provide the population denominator in the future study of disease at every scale. For the first time, density analysis and mortality ratios could be argued across the mapped surface on which individual cases became invisible—the specific subsumed by the general. Still, specificity was important. In 1831 The Lancet published a “Map of the Progress of Cholera” occurring “through 700 irruptions” in 2000 towns to argue cholera’s independence from local environmental conditions; it was a “poison which progresses independently” and thus could not be stopped by quarantine or sanitary measures. From New York City to St Petersburg, others mapped cholera as a local miasmatic illness, a contagion, or both. In all these maps, the graphic argument was increasingly combined with numerical and statistical analytics that were either produced in the map or the commentary accompanying it.
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Full-size image (129K) Wellcome Library, London
Detail from Valentine Seaman’s map of cases of yellow fever in New York, published in The Medical Repository (1798)
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Detail from The Lancet‘s map of the progress of the cholera in Asia, Europe, Africa published in 1831
Famously, John Snow argued that cholera might be spread by contaminated water. He sought to prove his thesis in two studies, one of a ferocious outbreak in St James, Westminster, in 1854, and the other across South London. In the first he created a non-statistical dot map centred on a single water source: the Broad Street pump. In the second he attempted to assign cases of cholera in south London to water supply company jurisdictions in an attempt to show a correspondence between water quality and disease intensity. Most of Snow’s contemporaries agreed water seemed to be implicated, but that did not mean foul miasmatic odours were irrelevant. Since the Broad Street map, like Seaman’s map, was devoid of statistics or statistical arguments, it left room for other interpretations. Worse, his more ambitious south London study lacked—as Snow would later admit—a solid statistical base. Even with one, as John Simon of the Board of Health concluded in 1856, the maths of the day was incapable of a definitive analysis of the problem. Robert Koch finally settled the question of cholera’s nature when, applying the methods of his new bacteriology, he identified the waterborne Vibrio cholerae in 1883.
If bacteria were the cause of disease, mapping remained the means by which its local source was most easily identified. In the late 19th and 20th centuries, mapping became the tool public health experts used to identify the probable source of a range of outbreaks including cholera, typhoid, typhus, and yellow fever. The map also served to identify new, non-bacterial epidemics. In the 1870s, Alfred Haviland mapped cancer rates in Britain to argue a national epidemic. Within 20 years, maps of cancer mortality from across the British Empire were being published in national health surveys and medical journals. Cancer replaced cholera as the disease to study at every scale, from that of the neighbourhood to the nation. New statistical methods were developed—including confidence ratios, which allowed ever more precise renderings of its prevalence. Once again, these maps served only as well as the theories they embodied. US public health physician W H Frost, for example, attempted to map influenza and poliomyelitis epidemics in the early 20th century. These maps did not serve because, as we now know, viral disease has a different profile from diseases that are bacterially based. It was not until the computer revolution of the 1960s that complex statistical models capable of describing—and thus mapping—viral progression were possible. Finally, predictive models to map viral progression could be constructed. In the 1980s, for example, geographer Peter Gould married gravity and distance decay models with data on HIV/AIDS incidence in the USA to create the first powerfully predictive model of the disease. The resulting maps were disseminated as a video. Still, the old dot map of incidence remained important; it was through mapping the individual geographies of his patients that Abraham Verghese came to see the dynamic of HIV as it affected the rural Tennessee population he served.
By the first decade of the 21st century, maps of a range of new conditions—from H1N1 influenza to West Nile virus—were presented as statistical surfaces in which disease variances were embedded in regional, national, and international geographies. Often presented on the internet, these were typically maps of maps, aggregates of local case studies collected by regional authorities that formed the basis of national investigations. Irrespective of the nature of the disease mapped, or the scale of its presentation, the old Hippocratic insight remained: where cases aggregate its origin is likely to be found in the human and geographical environment. To understand disease, therefore, we map its community of incidence and its environment.

Further reading

Gould, 1993 Gould P. The slow plague: a geography of AIDS. Oxford: Blackwell, 1993.
Koch, 2011 Koch T. Disease maps: epidemics on the ground. Chicago, IL: University of Chicago Press, 2011.
Koch, 2005 Koch T. Cartographies of disease: maps, mapping, and medicine. Redlands, CA: ESRI Press, 2005.
Maxcy, 1941 In: Maxcy KF, ed. Papers of Wade Hampton Frost, MD. A contribution to epidemiological method. New York: Commonwealth Fund, 1941.
The Lancet, 1831 The Lancet. History of the rise, progress, ravages, &c. of the blue cholera of India. Lancet 1831; 1: 241-284.PubMed
Verghese et al., 1989 Verghese A, Berk SL, Sarubbi F. Urbs in rure: human immunodeficiency virus infections in rural Tennessee. J Infect Dis 1989; 160: 1051-1055. PubMeda Department of Medical Geography, University of British Columbia, Vancouver, BC, Canada
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07 marzo, 2012

Meta-analysis and New Knowledge

Cochrane Collaboration
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Source: http://www.typepad.com/services/trackback/6a0120a692721d970b0120a90cc76f970b

When hierarchies of evidence are listed for the EBM world, meta-analyses of randomized trials generally sit at the pinnacle.
And yet, the actual meta-analyses that you encounter when researching a clinical question can be far less enlightening. Even if we grant a pass to the many systematic reviews at The Cochrane Collaboration that conclude with the a priori obvious fact that no high quality RCTs addressing a question have been performed, and another pass to the reviews that find a single RCT and publish its results as the results of the systematic review, we are still left with the innumerable meta-analyses that seem to provide less of a window on truth than the underlying trials.
Frequently such meta-analyses are either driven by the single large RCT that everyone would have cited anyway or, worse, a number of small, poorly-performed RCTs are combined with a moderate-sized, well-performed RCT and alter the results away from what was likely the best estimate of reality: the results of the well-performed RCT.
Meta-analysts often seem to either be too removed from their subject area and thus lack the expertise to really understand what went clinically right and wrong in the underlying RCTs (or be unwilling to use that knowledge to discriminate among the trials), or be too cozy with a single trial (typically as an author) and thus too willing to ding trials that found conflicting results.
Ultimately, meta-analysis only rarely seems to importantly advance our knowledge of an issue beyond where we would have found ourselves by just reading through the RCTs.
So with that background it is always interesting to me when a meta-analysis comes along that really seems to shed new light on a subject such that we seem to know something that we somehow didn't know when we just had the underlying trials.
An example came along in The Lancet last week.
Despite the enormous number of patients participating in randomized trials of statins, it has been uncertain what effect statins have on the development of diabetes. Some biochemical and animal studies suggested that statins might prevent diabetes. Clinical trials have been conflicting with some showing protection and other showing increased risk. In reviewing the underlying trials, it has been hard to figure out what is going on:
  • Are some statins protective while others are harmful?
  • Are hydrophilic statins having different effects than lipophilic statins?
  • Was the observation of increased diabetes risk in the JUPITER Trial just a random event that became noticeable because of reporting bias (where positive or interesting secondary outcomes are more likely to show up in a paper than negative results).
  • Are the varying results of the statin trials due to random variation around a single truth, or do the results suggest that the underlying trials differed from each other in some important way (perhaps because of the population studied, the way the statin was administered, or the way diabetes was assesses?
A month ago, anyone simply looking at the collection of trials would have had a hard time giving a coherent answer to the above questions. Now, after a nicely done meta-analysis by Prof. Naveed Sattar et al., there are reasonable answers to all these questions. And thinking about these questions also sheds light on how to read and judge a meta-analysis.
The new analysis found that patients treated with statins had about a 9% higher risk of diabetes than those treated with placebo or other agents. When I started reading the analysis, I had the questions in the list above already in mind and so was prepared to challenge the meta-analysis on several fronts. The authors of the analysis had appropriately anticipated my concerns and, to the extent the data allowed, answered them:
1) Was this really a chance finding driven by JUPITER? Before JUPITER found an increased risk of diabetes, there had been little discussion of statins and diabetes risk. JUPITER's findings could have been due to chance, but the publicity around the result could have triggered the meta-analysis. JUPITER was large enough to sway the results in the meta-analysis and perhaps lead to a self-fulfilling conclusion based in random variation. The meta-analysis, though, did a secondary analysis that excluded JUPITER, and found that the results were essentially the same.
2) Were the varying results in the trials due to random variation or true differences? The meta-analysis found little need to invoke anything more than randomness (as measured by a statistic called the I2). What had seemed to be conflicting results was likely nearly entirely due to random variation around a likely single true effect of slightly increased risk of diabetes.
3) Are some statins protective while others cause diabetes? The finding of little heterogeneity suggests the answer is no, but ultimately this is a hard question to answer definitively because of the more limited data about each individual statin. The meta-analysis found that the confidence intervals of the effects for individual statins overlapped such that it seemed unlikely that there were important differences among the statins, but it's hard to be certain. Additionally, lipophilic and hydrophilic statins showed the same effects on diabetes. And beyond that, the meta-analysis found that one of the main trials that had suggested a protective effect of pravastatin on diabetes had used an unusual definition of diabetes, and the effect was not seen when they substituted a standard definition.
While no new trials were published, as a result of this meta-analysis we have a much better feel for the effect of statins on diabetes than we had a few weeks ago. So, if after hours of trying to answer clinical questions by reading Cochrane you find yourself wondering whether meta-analyses are ever worth the effort that seems to go into them, remember this one and how much we learned about diabetes and statins from a new analysis of existing data.

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16 diciembre, 2011

2011: was the year that…


Lancet, Volume 378, Issue 9809, Pages 2062 - 2063, 17 December 2011
doi:10.1016/S0140-6736(11)61889-8Cite or Link Using DOI

2011: was the year that…

This year had a heady mix of health reforms, revolutions, groundbreaking research in HIV and spinal cord medicine, and a world population milestone. Udani Samarasekera reports.

Goodbye NHS

On Jan 19, UK Health Secretary Andrew Lansley unveiled the Health and Social Care Bill. The legislation dictated a massive shake-up of the National Health Service (NHS), which included putting general practioners in charge of commissioning health services and allowing price competition between state and private health-care providers. Many health professionals felt reforms of the speed and scale outlined in the bill were unnecessary, damaging, and tantamount to privatisation of the NHS. The hugely unpopular bill united health-care professionals in England in protest, with many taking to the streets throughout the year. Minor changes were made to the draft legislation after a public “listening exercise” in June. In October, in a letter in The Telegraphrepublished in The Lancet, more than 400 of the country's leading public health experts urged the House of Lords to reject the legislation. As The Lancet went to press, the bill continued its passage through parliament.

Au revoir French drug scandals?

The fallout from France's Mediator (benfluorex) scandal continued this year, with the publication of a damning report in January by accountability organisation Inspection Générale des Affaires Sociales. The report criticises drug manufacturer Servier for deceptive marketing of Mediator and the French drug regulator for being an ineffective and overworked bureaucracy. Mediator, used as an adjuvant for diabetes, might have contributed to the deaths of 500 people from valvular heart disease in its 33 years on the market by conservative estimates. France pulled the drug in November, 2009, years after other countries had made the move. From March to May this year, a national consultation about the regulation of prescription drugs culminated in a bill by French Health Minister Xavier Bertrand in August to overhaul the drug regulatory system. The legislation called for a crackdown on conflicts of interest, restructuring of the French drug regulator, and improvements in drug licensing processes and post-approval monitoring.

Arab Spring

Starting on Dec 18, 2010, the wave of uprisings across the Arab world has been a defining event of 2011. This year has seen revolutions in Tunisia and Egypt, civil war in Libya, and major uprisings in Bahrain, Syria, and Yemen. Smaller protests have also occurred in other Arab countries. Health and humanitarian concerns remain high in the region. According to WHO, at least 50 000 people are thought to have been wounded during the Libya conflict, 20 000 of them seriously. Conflict-related injuries remain the country's main health priority, followed by non-communicable diseases—due to lack of health staff, drugs, and medical supplies—and mental health. In Bahrain, health professionals have been targeted in crackdowns by government forces whereas hospitals have become places of torture in Syria, according to a recent report by Amnesty.
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Full-size image (53K) AFP/Getty Images

Disaster in Japan

At 05:46 GMT on March 11 a magnitude 9·0 earthquake struck off the coast of northeast Japan—the country's most powerful earthquake in recorded history. The large tsunami that followed caused widespread destruction to buildings and communications and transport infrastructure. The Fukushima Daiichi nuclear power plant, 240 km north of Tokyo, was damaged and all six reactors had failures of their cooling systems, releasing radioactive material into the area. Several hospitals were also destroyed and other health services faced challenging circumstances such as loss of electricity and lack of essential supplies. The disaster killed more than 16 000 people, and displaced more than 100 000 others. Many of the displaced survivors were elderly people who were housed in temporary accommodation as temperatures plummeted during the Japanese winter.

HIV treatment as prevention

In May, results from the phase 3 HPTN052 trial provided definitive proof that highly active antitretroviral therapy (HAART) can prevent the sexual transmission of HIV in serodiscordant couples when one is HIV positive and the other negative. The study involved 1763 couples at 13 sites in nine countries in Africa, the USA, and Asia. The trial was stopped early by the international data and safety monitoring board after it showed that immediate HAART given to the HIV- infected partners at a CD4 cell count between 350 and 550 cells per μL could reduce the sexual transmission of HIV by 96%—the primary endpoint. Immediate HAART was also associated with a 30% decrease in the combined endpoint of disease progression and death and an 83% reduction in incidence of pulmonary tuberculosis.

Small steps, giant leap

In May, Susan Harkema and colleagues reported in The Lancet that electrostimulation of the spinal cord of a patient with paraplegia along with task-specific training led to several minutes of standing and fairly coordinated stepping without any input from the brain. 23-year-old Rob Summers became paraplegic after being hit by a motor vehicle in 2006 and showed no spine-controlled leg movement despite 2 years of rehabilitation. However, continual direct electrical stimulation from a surgically implanted epidural array in his lower spinal cord was able to mimic signals that the brain normally transmits to initiate movement. As noted in an accompanying Comment, the level of recovery achieved in this case study was “unprecedented”.

Europe's E coli outbreak

The European summer was seriously disrupted this year by a novel strain of Shiga-toxin-producing Escherichia coli. On May 22, Germany first reported a substantial increase in patients with haemolytic uraemic syndrome and bloody diarrhoea caused by enterohaemorrhagic E coli O1O4:H4. Between May 22 and July 21, the virulent strain caused 4075 cases of infection and led to the deaths of 50 people, mainly in Germany with some cases elsewhere in Europe and in North America. The source of the outbreak was eventually traced to bean sprouts produced at a German farm but only after several vegetables were erroneously blamed, including raw tomatoes, lettuce, and Spanish cucumbers. As an Editorial in The Lancet put it: “communication surrounding the outbreak has been haphazard at best, dismal at worst.”

Donors give to GAVI

There was good news for the GAVI Alliance in June when donors committed substantial new funds to the organisation during apledging meeting in London, UK. The meeting, attended by UK Prime Minister David Cameron, raised US$4·3 billion, exceeding the $3·7 billion target. The funds will allow GAVI to expand its portfolio to include vaccines such as those against the human papillomavirus that causes cervical cancer. Meanwhile, for other multilaterals, it was a disappointing year: the Global Fund to Fight AIDS, Tuberculosis and Malaria announced suspension of its latest funding round because of a lack of donor support.

Famine declared

The worst drought in 60 years in the Horn of Africa, coupled with conflict in Somalia, left more than 13 million people in need of food or humanitarian assistance in July. On July 20, the UN declared famine in two regions of Somalia, southern Bakool and Lower Shabelle. It was the first time that the UN had declared famine in a part of Somalia since 1991—92. Across the country, nearly half the Somali population—3·7 million people—remain in crisis. In October, the UN Office for the Coordination of Humanitarian Affairs stated: “The famine in the Horn of Africa remains the biggest crisis in the world today…The regional aid effort will need to continue well into 2012, both to meet immediate needs and—in the longer-term—to tackle the underlying problems and vulnerabilities which have put so many people in danger.”

New York, New York

On Sept 20, heads of state and governments made progress on global efforts to tackle non-communicable diseases (NCDs) at the UN High-Level Meeting of the General Assembly of the UN in New York, NY, USA. Countries approved the Political Declaration on the Prevention and Control of Non-communicable Diseases. However, many health experts and observers were disappointed that no time-bound targets appeared in the final document, not even the very broad one proposed by the NCD Alliance, of a 25% decrease in NCD deaths by 2025. WHO is now charged with developing voluntary targets for member states to reduce the burden of NCDs and for establishing a process to monitor progress by the end of 2012.

A vaccine for malaria

Promising interim results from a phase 3 trial of GlaxoSmithKline's experimental vaccine against malaria were published in theNew England Journal of Medicine in October. The study showed that the RTS,S/AS01 vaccine roughly halved the risk of clinical and severe malaria in African infants aged 5—17 months a year after vaccination. However, meningitis and generalised convulsive seizures occurred more frequently in those receiving the RTS,S/AS01 vaccine than in the control group, and the vaccine did not reduce deaths from malaria. The data for 6—12-week-old infants are due to be reported next year, and the full trial results in 2014.
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Full-size image (38K) Corbis

7 billion and counting

The end of October saw the world's population hit 7 billion people, according to the UN Population Fund (UNFPA). The planet's human population has almost doubled during the past 50 years. Average life expectancy has increased from about 48 years in the early 1950s to about 68 years in the first decade of the new century. Infant deaths have decreased from about 133 in 1000 births in the 1950s to 46 per 1000 between 2005 to 2010. The number of children a woman has also fell from about 6·0 to 2·5. But despite these successes, UNFPA note that poverty gaps between rich and poor people are widening everywhere. Things are only set to get bigger (and hopefully better): the UN foresees a global population of 9·3 billion people in 2050, and more than 10 billion by the end of this century.
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Full-size image (21K) Reuters

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