Correspondence
SD reports receiving consulting fees from Osprey Medical and AstraZeneca and lecture fees from Boehringer Ingelheim, Bayer, Maquet, and Terumo. UZ reports holding board membership at Daiichi Sankyo and Lilly, and receiving consulting and lecture fees from Daiichi Sankyo, Lilly, and the Medicines Company. KW reports holding board membership at Biotest and Servier, receiving grant support on behalf of his institution from Biotest and Servier, and lecture fees from Biotest, Brahms, Maquet Cardiovascular, and Servier. HT reports receiving consulting fees from Lilly, grant support on behalf of his institution from Lilly and Terumo, and lecture fees from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Lilly, the Medicines Company, and Terumo.
Steffen Desch, Uwe Zeymer, Karl Werdan, Gerhard Schuler, *Holger Thiele [email protected] University of Leipzig—Heart Centre, Department of Internal Medicine/Cardiology, 04289 Leipzig, Germany (SD, GS, HT); Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen, Germany (UZ); Martin-Luther University HalleWittenberg, Halle, Germany (KW); and University of Lübeck, Department of Internal Medicine/Cardiology/ Angiology and Intensive Care, Lübeck, Germany (HT)
www.thelancet.com Vol 383 February 1, 2014
1
2
Thiele H, Zeymer U, Neumann F-J, et al, on behalf of the Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: final 12 month results of a randomised open-label trial. Lancet 2013; 382: 1638–45. Selker HP, Beshansky JR, Sheehan PR, et al. Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial. JAMA 2013; 307: 1925–33.
Unacceptable commercial interests In his Offline (Nov 30, p 1768), 1 Richard Horton rightly rails against the acceptance of pharmaceutical and nutritional industry funding and promotion at the recent Developmental Origins of Health and Disease meeting in Singapore. In view of the leadership that Horton and The Lancet have shown in raising the profile of global health, the time is ripe for The Lancet to consider its own position on unacceptable promotion and the potential influence of commercial concerns, whose first interest is certainly not the health of the world population. As an example, the US Institute of Medicine sent a copy of the Lancet special issue of the Global Burden of Disease Study (GBD) 2010 to members shrink-wrapped with a sixpage advertising leaflet for an antiobesity drug. Presumably, The Lancet and its publishers benefitted from this advertising being shrink-wrapped with the journal? It is difficult not to be struck by the coincidence of this advert accompanying the GBD 2010 report, which clearly advanced the notion that obesity and related problems are eclipsing issues such as maternal, infant, and child under nutrition as threats to global health and wellbeing. We declare that we have no conflicts of interest.
*George Davey Smith, Shah Ebrahim, SV Subramanian [email protected]
University of Bristol, MRC Integrative Epidemiology Unit, Bristol BS8 2BN, UK (GDS); London School of Hygiene and Tropical Medicine, London, UK (SE); and Harvard School of Public Health, Boston, MA, USA (SVB) 1
Horton R. Offline: DOHaD—coming out, with questions. Lancet 2013; 382: 1768.
WHO guidelines on fluid resuscitation in children with shock Deaths of children in hospitals often occur within 24 h of admission. Many of these deaths could be prevented if very sick children are identified soon after their arrival in the health-care facility and appropriate treatment started immediately. In response to this need, WHO developed and published Emergency Triage Assessment and Treatment guidelines, and included an abbreviated chapter in the Pocket Book of Hospital Care for Children, first edition in 2005. In 2011, the Fluid Expansion as Supportive Therapy (FEAST) study examined the management of children with fever and signs of impaired perfusion in African hospitals and concluded that fluid boluses in children with shock were potentially harmful.1 In a comment published in the BMJ on Jan 14, 2014,2 the researchers involved in the FEAST trial criticised WHO for not revising the relevant guidance— notably the Pocket Book of Hospital Care for Children, second edition.3 The Pocket Book,3 which is a compilation of hundreds of WHO recommendations, is widely used by doctors, nurses, and health-care workers responsible for the care of young children at first-level referral hospitals. The results of the FEAST trial were shared with WHO and the expert group in 2011 (when the reviews for the second edition of the Pocket Book were already well underway). The results were clearly important, but several issues had to be taken into consideration before they could be incorporated into policy
Randy Faris/Corbis
of left ventricular function. Most patients with a final diagnosis of infarct-related cardiogenic shock already present in shock upon arrival in the hospital—ie, shock develops in the ambulatory setting. For obvious reasons, echocardiographic monitoring is not feasible in these patients. For patients who present in the hospital with acute myocardial infarction without shock we believe that the most important step to prevent progression to cardiogenic shock is prompt reperfusion and not serial echocardiographic monitoring with potential IABP insertion. After early reperfusion, close monitoring for signs of developing cardiogenic shock is indeed mandatory. However, once reperfused, progression to cardiogenic shock in a patient who was initially clinically stable is uncommon. It remains speculative if early IABP is beneficial in the small subset of patients who develop shock in the clinical course after reperfusion. Notably, the IABPSHOCK II trial exclusively enrolled patients with overt cardiogenic shock (hypotension and signs of impaired organ perfusion).
Published Online January 22, 2014 http://dx.doi.org/10.1016/ S0140-6736(14)60053-2 For the Emergency Triage Assessment and Treatment guidelines see http://www.who. int/maternal_child_adolescent/ documents/9241546875/en/ index.html
411
Correspondence
Published Online January 23, 2014 http://dx.doi.org/10.1016/ S0140-6736(14)60052-0
For more on the WHO updates see http://www.who.int/ maternal_child_adolescent/ topics/child/en/index.html
412
recommendations; for example of the 3141 children included in the trial, only 65 (2%) met the WHO criteria for shock. WHO recommendations on circulatory shock are used by clinicians managing many disorders not included in the FEAST study, such as severe dehydration, Dengue shock syndrome in Asia, haemorrhagic shock, and bacteraemic septic shock outside Africa. The heterogeneity of shock means that one recommendation will not suit all children, although the FEAST study is very important in highlighting the dangers of rapid intravenous fluid administration in some common febrile disorders in Africa, this finding has wider significance for the diagnosis and management of these disorders everywhere. In the second edition of the Pocket Book (published in August, 2013) a caution was given about the use of rapid fluids in malaria or anaemia, specifically in response to the results of the FEAST study. Whether or not to include a full update presented a dilemma: to delay the finalisation of the second edition by opening up the relevant chapter to revision, or to press ahead with the planned revision as approved by the Guidelines Review Committee (GRC), and take up this chapter in the next round of updates. The Guidelines Development Group decided that, on balance, WHO should not delay the publication of the second edition that was underway (which included guidance for the management of many common disorders, affecting large numbers of children). The revised edition of the Pocket Book clearly indicates which chapters have been updated. All WHO recommendations go through the WHO guidelines development process 4 and are approved by the GRC—the body that ensures that the guidelines are of a high methodological quality and developed through a transparent, evidence-based decision-making process. To revise guidelines WHO convenes a group of international experts to consider the
latest available evidence and decide which areas need to be updated. For the Pocket Book the group defined the priorities for updating in 2010. They included revisions to align the relevant chapters with recently published and GRC-approved WHO guidelines for several common diseases and revisions to incorporate new scientific information that had become available on the management of neonates and young infants, pneumonia, fever, severe acute malnutrition, HIV, and supportive care,5 but no major new data were published for emergency care, hence that chapter was not identified as a priority for updating. Updating of the Pocket Book is an ongoing process because it contains hundreds of recommendations. The review of the chapter on emergency care is currently underway and will include an update of recommendations on fluid therapy and management of shock. WHO held an expert group meeting in 2013, including the Principal Investigator of the FEAST trial, that identified 44 questions on emergency care. Two independent external groups have been commissioned to review all available evidence. This process will include reviews on fluid administration in children with impaired perfusion and other therapies in the management of shock. This review will take into account the FEAST study and other relevant work. The evidence will then be presented to an independent guideline development panel to decide on the appropriate recommendations, culminating in approval by WHO GRC. It is anticipated this process will be completed later this year. Relevant sections of the online version of the Pocket Book will regularly be updated as new scientific knowledge and data with clinical implications emerge but the printed version is published every 5 years. Users are advised to periodically check the WHO website for new updates. We declare that we have no conflicts of interest. TD is Chair of the WHO expert committee on the Pocket Book of Hospital Care for Children.
Trevor Duke, *Elizabeth Mason [email protected] Centre for International Child Health University of Melbourne, Royal Children’s Hospital, 3052 Melbourne, VIC, Australia (TD); and Department of Maternal, Newborn, Child and Adolescent Health, WHO, 1211 Geneva, Switzerland (EM) 1
2
3
4
5
Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med 2011; 364: 2483–95. Kiguli S, Akech SO, Mtove G, et al. WHO guidelines on fluid resuscitation in children: missing the FEAST. BMJ 2013; 347: f7003. WHO. Pocket book of hospital care for children, 2nd edn. 2013. Guidelines for the management of common childhood illnesses. http://www.who.int/maternal_child_ adolescent/documents/child_hospital_care/ en/index.html ( accessed Jan 20, 2014). WHO. WHO handbook for guideline development. Geneva: World Health Organization, 2012. WHO. Recommendations for management of common childhood conditions: evidence for technical update of pocket book recommendations. 2012. http://www.who.int/ maternal_child_adolescent/documents/ management_childhood_conditions/en/ index.html (accessed Jan 20, 2014).
©2014 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved.
Department of Error von Birgelen C, Sen H, Lam MK, et al. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet 2014; 383: 413–23—In figure 2 parts A–D, the second last point on the x-axis should have been 330 days, not 360 days. This correction has been made to the online version as of Jan 31, and to the printed Article. Dewachi O, Skelton M, Nguyen V-K, et al. Changing therapeutic geographies of the Iraqi and Syrian wars. Lancet 2014; 383: 449–57— In table 1, under Syria, row Civil War, column Regional, supporting the Syrian Government should read only Hezbollah. This correction has been made to the online version as of Jan 23, 2014, and has been made to the printed Article. El-Zein A, Jabbour S, Tekce B, et al. Health and ecological sustainability in the Arab world: a matter of survival. Lancet 2014; 383: 458–76— In figure 5 of this Series paper, the graph should have been presented as an area graph rather than a line graph, with each shaded area depicting the extent to which the population in that region has grown. This correction has been made to the online version as of Jan 31, 2014, and to the printed Series paper.
www.thelancet.com Vol 383 February 1, 2014
SD reports receiving consulting fees from Osprey Medical and AstraZeneca and lecture fees from Boehringer Ingelheim, Bayer, Maquet, and Terumo. UZ reports holding board membership at Daiichi Sankyo and Lilly, and receiving consulting and lecture fees from Daiichi Sankyo, Lilly, and the Medicines Company. KW reports holding board membership at Biotest and Servier, receiving grant support on behalf of his institution from Biotest and Servier, and lecture fees from Biotest, Brahms, Maquet Cardiovascular, and Servier. HT reports receiving consulting fees from Lilly, grant support on behalf of his institution from Lilly and Terumo, and lecture fees from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Lilly, the Medicines Company, and Terumo.
Steffen Desch, Uwe Zeymer, Karl Werdan, Gerhard Schuler, *Holger Thiele [email protected] University of Leipzig—Heart Centre, Department of Internal Medicine/Cardiology, 04289 Leipzig, Germany (SD, GS, HT); Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen, Germany (UZ); Martin-Luther University HalleWittenberg, Halle, Germany (KW); and University of Lübeck, Department of Internal Medicine/Cardiology/ Angiology and Intensive Care, Lübeck, Germany (HT)
www.thelancet.com Vol 383 February 1, 2014
1
2
Thiele H, Zeymer U, Neumann F-J, et al, on behalf of the Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: final 12 month results of a randomised open-label trial. Lancet 2013; 382: 1638–45. Selker HP, Beshansky JR, Sheehan PR, et al. Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial. JAMA 2013; 307: 1925–33.
Unacceptable commercial interests In his Offline (Nov 30, p 1768), 1 Richard Horton rightly rails against the acceptance of pharmaceutical and nutritional industry funding and promotion at the recent Developmental Origins of Health and Disease meeting in Singapore. In view of the leadership that Horton and The Lancet have shown in raising the profile of global health, the time is ripe for The Lancet to consider its own position on unacceptable promotion and the potential influence of commercial concerns, whose first interest is certainly not the health of the world population. As an example, the US Institute of Medicine sent a copy of the Lancet special issue of the Global Burden of Disease Study (GBD) 2010 to members shrink-wrapped with a sixpage advertising leaflet for an antiobesity drug. Presumably, The Lancet and its publishers benefitted from this advertising being shrink-wrapped with the journal? It is difficult not to be struck by the coincidence of this advert accompanying the GBD 2010 report, which clearly advanced the notion that obesity and related problems are eclipsing issues such as maternal, infant, and child under nutrition as threats to global health and wellbeing. We declare that we have no conflicts of interest.
*George Davey Smith, Shah Ebrahim, SV Subramanian [email protected]
University of Bristol, MRC Integrative Epidemiology Unit, Bristol BS8 2BN, UK (GDS); London School of Hygiene and Tropical Medicine, London, UK (SE); and Harvard School of Public Health, Boston, MA, USA (SVB) 1
Horton R. Offline: DOHaD—coming out, with questions. Lancet 2013; 382: 1768.
WHO guidelines on fluid resuscitation in children with shock Deaths of children in hospitals often occur within 24 h of admission. Many of these deaths could be prevented if very sick children are identified soon after their arrival in the health-care facility and appropriate treatment started immediately. In response to this need, WHO developed and published Emergency Triage Assessment and Treatment guidelines, and included an abbreviated chapter in the Pocket Book of Hospital Care for Children, first edition in 2005. In 2011, the Fluid Expansion as Supportive Therapy (FEAST) study examined the management of children with fever and signs of impaired perfusion in African hospitals and concluded that fluid boluses in children with shock were potentially harmful.1 In a comment published in the BMJ on Jan 14, 2014,2 the researchers involved in the FEAST trial criticised WHO for not revising the relevant guidance— notably the Pocket Book of Hospital Care for Children, second edition.3 The Pocket Book,3 which is a compilation of hundreds of WHO recommendations, is widely used by doctors, nurses, and health-care workers responsible for the care of young children at first-level referral hospitals. The results of the FEAST trial were shared with WHO and the expert group in 2011 (when the reviews for the second edition of the Pocket Book were already well underway). The results were clearly important, but several issues had to be taken into consideration before they could be incorporated into policy
Randy Faris/Corbis
of left ventricular function. Most patients with a final diagnosis of infarct-related cardiogenic shock already present in shock upon arrival in the hospital—ie, shock develops in the ambulatory setting. For obvious reasons, echocardiographic monitoring is not feasible in these patients. For patients who present in the hospital with acute myocardial infarction without shock we believe that the most important step to prevent progression to cardiogenic shock is prompt reperfusion and not serial echocardiographic monitoring with potential IABP insertion. After early reperfusion, close monitoring for signs of developing cardiogenic shock is indeed mandatory. However, once reperfused, progression to cardiogenic shock in a patient who was initially clinically stable is uncommon. It remains speculative if early IABP is beneficial in the small subset of patients who develop shock in the clinical course after reperfusion. Notably, the IABPSHOCK II trial exclusively enrolled patients with overt cardiogenic shock (hypotension and signs of impaired organ perfusion).
Published Online January 22, 2014 http://dx.doi.org/10.1016/ S0140-6736(14)60053-2 For the Emergency Triage Assessment and Treatment guidelines see http://www.who. int/maternal_child_adolescent/ documents/9241546875/en/ index.html
411
Correspondence
Published Online January 23, 2014 http://dx.doi.org/10.1016/ S0140-6736(14)60052-0
For more on the WHO updates see http://www.who.int/ maternal_child_adolescent/ topics/child/en/index.html
412
recommendations; for example of the 3141 children included in the trial, only 65 (2%) met the WHO criteria for shock. WHO recommendations on circulatory shock are used by clinicians managing many disorders not included in the FEAST study, such as severe dehydration, Dengue shock syndrome in Asia, haemorrhagic shock, and bacteraemic septic shock outside Africa. The heterogeneity of shock means that one recommendation will not suit all children, although the FEAST study is very important in highlighting the dangers of rapid intravenous fluid administration in some common febrile disorders in Africa, this finding has wider significance for the diagnosis and management of these disorders everywhere. In the second edition of the Pocket Book (published in August, 2013) a caution was given about the use of rapid fluids in malaria or anaemia, specifically in response to the results of the FEAST study. Whether or not to include a full update presented a dilemma: to delay the finalisation of the second edition by opening up the relevant chapter to revision, or to press ahead with the planned revision as approved by the Guidelines Review Committee (GRC), and take up this chapter in the next round of updates. The Guidelines Development Group decided that, on balance, WHO should not delay the publication of the second edition that was underway (which included guidance for the management of many common disorders, affecting large numbers of children). The revised edition of the Pocket Book clearly indicates which chapters have been updated. All WHO recommendations go through the WHO guidelines development process 4 and are approved by the GRC—the body that ensures that the guidelines are of a high methodological quality and developed through a transparent, evidence-based decision-making process. To revise guidelines WHO convenes a group of international experts to consider the
latest available evidence and decide which areas need to be updated. For the Pocket Book the group defined the priorities for updating in 2010. They included revisions to align the relevant chapters with recently published and GRC-approved WHO guidelines for several common diseases and revisions to incorporate new scientific information that had become available on the management of neonates and young infants, pneumonia, fever, severe acute malnutrition, HIV, and supportive care,5 but no major new data were published for emergency care, hence that chapter was not identified as a priority for updating. Updating of the Pocket Book is an ongoing process because it contains hundreds of recommendations. The review of the chapter on emergency care is currently underway and will include an update of recommendations on fluid therapy and management of shock. WHO held an expert group meeting in 2013, including the Principal Investigator of the FEAST trial, that identified 44 questions on emergency care. Two independent external groups have been commissioned to review all available evidence. This process will include reviews on fluid administration in children with impaired perfusion and other therapies in the management of shock. This review will take into account the FEAST study and other relevant work. The evidence will then be presented to an independent guideline development panel to decide on the appropriate recommendations, culminating in approval by WHO GRC. It is anticipated this process will be completed later this year. Relevant sections of the online version of the Pocket Book will regularly be updated as new scientific knowledge and data with clinical implications emerge but the printed version is published every 5 years. Users are advised to periodically check the WHO website for new updates. We declare that we have no conflicts of interest. TD is Chair of the WHO expert committee on the Pocket Book of Hospital Care for Children.
Trevor Duke, *Elizabeth Mason [email protected] Centre for International Child Health University of Melbourne, Royal Children’s Hospital, 3052 Melbourne, VIC, Australia (TD); and Department of Maternal, Newborn, Child and Adolescent Health, WHO, 1211 Geneva, Switzerland (EM) 1
2
3
4
5
Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med 2011; 364: 2483–95. Kiguli S, Akech SO, Mtove G, et al. WHO guidelines on fluid resuscitation in children: missing the FEAST. BMJ 2013; 347: f7003. WHO. Pocket book of hospital care for children, 2nd edn. 2013. Guidelines for the management of common childhood illnesses. http://www.who.int/maternal_child_ adolescent/documents/child_hospital_care/ en/index.html ( accessed Jan 20, 2014). WHO. WHO handbook for guideline development. Geneva: World Health Organization, 2012. WHO. Recommendations for management of common childhood conditions: evidence for technical update of pocket book recommendations. 2012. http://www.who.int/ maternal_child_adolescent/documents/ management_childhood_conditions/en/ index.html (accessed Jan 20, 2014).
©2014 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved.
Department of Error von Birgelen C, Sen H, Lam MK, et al. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet 2014; 383: 413–23—In figure 2 parts A–D, the second last point on the x-axis should have been 330 days, not 360 days. This correction has been made to the online version as of Jan 31, and to the printed Article. Dewachi O, Skelton M, Nguyen V-K, et al. Changing therapeutic geographies of the Iraqi and Syrian wars. Lancet 2014; 383: 449–57— In table 1, under Syria, row Civil War, column Regional, supporting the Syrian Government should read only Hezbollah. This correction has been made to the online version as of Jan 23, 2014, and has been made to the printed Article. El-Zein A, Jabbour S, Tekce B, et al. Health and ecological sustainability in the Arab world: a matter of survival. Lancet 2014; 383: 458–76— In figure 5 of this Series paper, the graph should have been presented as an area graph rather than a line graph, with each shaded area depicting the extent to which the population in that region has grown. This correction has been made to the online version as of Jan 31, 2014, and to the printed Series paper.
www.thelancet.com Vol 383 February 1, 2014
