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WHO guidance 'risks killing children' WHO guidance 'risks killing children'
(about 13 hours later)
Thousands of children in Africa may die if the World Health Organisation does not change its guidance on the treatment of children arriving in hospital with shock as a result of conditions such as acute malaria or septicaemia, according to a group of highly-respected researchers. Thousands of children in Africa may die if the World Health Organisation does not change its guidance on the treatment of children arriving in hospital with shock as a result of conditions such as acute malaria or septicaemia, according to a group of highly respected researchers.
The doctors and scientists are dismayed that the WHO has not yet revised its advice, in spite of a very large and convincing trial they carried out, the results of which were published in May 2011 in the New England Journal of Medicine. The trial showed that the practice of giving rapid fluid resuscitation to children in shock, which is common practice in more affluent countries, did more harm than good. All the children in the trial across six sites in Africa - more than 3,000 - were severely ill, but a greater proportion of those given emergency intravenous fluids when they arrived in hospital died than those who were not. The doctors and scientists are dismayed that the WHO has not yet revised its advice, in spite of a very large and convincing trial they carried out, the results of which were published in May 2011 in the New England Journal of Medicine. The trial showed that the practice of giving rapid fluid resuscitation to children in shock, which is common practice in more affluent countries, did more harm than good. All the children in the trial across six sites in Africa – more than 3,000 – were severely ill, but a greater proportion of those given emergency intravenous fluids when they arrived in hospital died than those who were not.
The results of the trial, called FEAST (Fluid Expansion as Supportive Therapy), stunned even the doctors who were carrying it out. I wrote about it here. They were trying to introduce a therapy that, it was assumed, was partly responsible for saving lives in Europe and the US. But it had never been properly trialled. The objective of the trial, funded by the UK Medical Research Council, was to see what was possible in an Africa setting and whether one type of fluid worked better than another.The results of the trial, called FEAST (Fluid Expansion as Supportive Therapy), stunned even the doctors who were carrying it out. I wrote about it here. They were trying to introduce a therapy that, it was assumed, was partly responsible for saving lives in Europe and the US. But it had never been properly trialled. The objective of the trial, funded by the UK Medical Research Council, was to see what was possible in an Africa setting and whether one type of fluid worked better than another.
Kathryn Maitland, professor of tropical paediatric infectious disease at the Wellcome Trust Centre for Clinical Tropical Medicine, St Mary's in London, could not believe it when she got a call from the independent data monitoring committee, which had looked at the interim results and decided the outcome was very clear even though the trial had not been completed. Kathryn Maitland, professor of tropical paediatric infectious disease at the Wellcome Trust Centre for Clinical Tropical Medicine, St Mary's in London, could not believe it when she got a call from the independent data monitoring committee, which had looked at the interim results and decided the outcome was very clear, even though the trial had not been completed.
Three years ago today I got the phone call saying we are going to stop your trial and they told me the reason why. I was devastated. The rest of the investigators were extremely surprised.Three years ago today I got the phone call saying we are going to stop your trial and they told me the reason why. I was devastated. The rest of the investigators were extremely surprised.
But there was no doubt what they had found. Children given what is known as a "bolus" - a drip delivering a large amount of fluid over just 15 minutes - wake up and appear to have made a miraculous recovery. But 89.4% of those survived, compared to 92.7% who were not given a bolus. In Uganda, some of whose hospitals participated in the trial, 50,000 to 80,000 children arrive in shock every year. That small percentage difference can be measured in lives. But there was no doubt what they had found. Children given what is known as a "bolus" – a drip delivering a large amount of fluid over just 15 minutes – wake up and appear to have made a miraculous recovery. But 89.4% of those survived, compared to 92.7% who were not given a bolus. In Uganda, some of whose hospitals participated in the trial, 50,000 to 80,000 children arrive in shock every year. That small percentage difference can be measured in lives.
Maitland says their analysis showed children given the bolus made a quick recovery and then had a rapid relapse. Within hours they went back into lethal shock. The bolus was responsible for deaths.Maitland says their analysis showed children given the bolus made a quick recovery and then had a rapid relapse. Within hours they went back into lethal shock. The bolus was responsible for deaths.
They shared their findings with the WHO even before the paper was published. There has been resistance to the results from some doctors, who have always used rapid fluid resuscitation. In affluent countries, if there are problems they may be masked by ventilation and other sophisticated medical practices. But the trial in Africa has been applauded for its methodology and won the BMJ Research Paper of the Year in 2012. Médecins Sans Frontières has changed its practice as a result. Doctors in a number of African countries, led by the Kenyan Paediatric Association, want to change their practice but want WHO to alter the guidance which their countries follow.They shared their findings with the WHO even before the paper was published. There has been resistance to the results from some doctors, who have always used rapid fluid resuscitation. In affluent countries, if there are problems they may be masked by ventilation and other sophisticated medical practices. But the trial in Africa has been applauded for its methodology and won the BMJ Research Paper of the Year in 2012. Médecins Sans Frontières has changed its practice as a result. Doctors in a number of African countries, led by the Kenyan Paediatric Association, want to change their practice but want WHO to alter the guidance which their countries follow.
But the WHO 2013 edition of the Pocket Book of Hospital Care for Children continues to recommend a 20 ml/kg bolus for children in shock, with up to two more if that does not work. In a new paper in the BMJ, the scientists say:But the WHO 2013 edition of the Pocket Book of Hospital Care for Children continues to recommend a 20 ml/kg bolus for children in shock, with up to two more if that does not work. In a new paper in the BMJ, the scientists say:
We are concerned that, given results of FEAST and their consistency across subgroups, including in those meeting the strict WHO definition of shock, these recommendations might expose substantial numbers of children to harm.We are concerned that, given results of FEAST and their consistency across subgroups, including in those meeting the strict WHO definition of shock, these recommendations might expose substantial numbers of children to harm.
About 10% of children on the Kenya coast are admitted with shock, they say, which suggests the numbers are in the millions. Around 2% would meet the WHO definition of shock and be given a bolus. More who do not meet the strict WHO definition could be treated in the same way. About 10% of children on the Kenyan coast are admitted with shock, they say, which suggests the numbers are in the millions. Around 2% would meet the WHO definition of shock and be given a bolus. More who do not meet the strict WHO definition could be treated in the same way.
Treatment with rapid fluid resuscitation may therefore result in hundreds or thousands of excess deaths.Treatment with rapid fluid resuscitation may therefore result in hundreds or thousands of excess deaths.
The failure of WHO to take account of the FEAST data is disappointing and puzzling, particularly given its commitment to systematic assessment of evidence. We call on WHO to urgently reassess the evidence for bolus fluid resuscitation and revise their guidelines in accordance with this assessment.The failure of WHO to take account of the FEAST data is disappointing and puzzling, particularly given its commitment to systematic assessment of evidence. We call on WHO to urgently reassess the evidence for bolus fluid resuscitation and revise their guidelines in accordance with this assessment.
WHO told the BMJ that it has commissioned two external groups to look at all the evidence to see whether the guidance needs updating and that it would be premature to comment on the FEAST trial until then.WHO told the BMJ that it has commissioned two external groups to look at all the evidence to see whether the guidance needs updating and that it would be premature to comment on the FEAST trial until then.
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