Randomised trials in the emergency department are possible and necessary
Editor,
We read with interest Simons' editorial on the emergency treatment of
anaphylaxis.[1] It was a helpful reminder of the limited evidence that
supports the current guidelines. Simons rightly highlights the need for
randomized trials, but we fundamentally do not agree with her that an
emergency department would be an inappropriate place for such studies.
Her concerns include the difficulty obtaining informed consent, the
lack of baseline observations, and the confounding effect of various first
aid treatments administered pre-hospital.
Many anaphylaxis patients arriving at the emergency department will
be considered incompetent to provide informed consent, but in many
countries including the UK, US and Hong Kong, such patients can be
enrolled into randomized trials with consent either waived or deferred.
[2,3]
There will always be heterogeneity in patients' pre-hospital
treatment and physiological status, because this is what emergency
department patients are like in clinical practice. This is not an argument
against using this population for clinical research; indeed, it is a
strong argument not to use any other group. Most hospital interventions
for anaphylaxis will not be carried out in a tightly regulated laboratory,
but in the emergency department, and our clinical practice in the
resuscitation room should be based on high quality evidence obtained from
trials involving resuscitation room patients. Confounding factors such as
the inevitable differences in pre-hospital treatment and
pathophysiological responses are the reason for randomization, they do not
preclude it.
Such studies can be difficult but they are not impossible, and they
will be more reliable both scientifically and ethically.
[1] Simons FER. Emergency treatment of anaphylaxis. BMJ 2008;336:1141
-1142.
[2] Foex BA. The problem of informed consent in emergency medicine
research. Emerg Med J 2001;18:198-204.
[3] CRASH trial collaborators. Effect of intravenous corticosteroids
on death within 14 days in 10 008 adults with clinically significant head
injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet
2004;364:1321-1328.
Competing interests:
None declared
Competing interests:
No competing interests
16 June 2008
Giles N Cattermole
Assistant Professor
Colin A. Graham and Timothy H. Rainer
Accident and Emergency Medicine Academic Unit, Prince of Wales Hospital, Shatin, Hong Kong
Rapid Response:
Randomised trials in the emergency department are possible and necessary
Editor,
We read with interest Simons' editorial on the emergency treatment of
anaphylaxis.[1] It was a helpful reminder of the limited evidence that
supports the current guidelines. Simons rightly highlights the need for
randomized trials, but we fundamentally do not agree with her that an
emergency department would be an inappropriate place for such studies.
Her concerns include the difficulty obtaining informed consent, the
lack of baseline observations, and the confounding effect of various first
aid treatments administered pre-hospital.
Many anaphylaxis patients arriving at the emergency department will
be considered incompetent to provide informed consent, but in many
countries including the UK, US and Hong Kong, such patients can be
enrolled into randomized trials with consent either waived or deferred.
[2,3]
There will always be heterogeneity in patients' pre-hospital
treatment and physiological status, because this is what emergency
department patients are like in clinical practice. This is not an argument
against using this population for clinical research; indeed, it is a
strong argument not to use any other group. Most hospital interventions
for anaphylaxis will not be carried out in a tightly regulated laboratory,
but in the emergency department, and our clinical practice in the
resuscitation room should be based on high quality evidence obtained from
trials involving resuscitation room patients. Confounding factors such as
the inevitable differences in pre-hospital treatment and
pathophysiological responses are the reason for randomization, they do not
preclude it.
Such studies can be difficult but they are not impossible, and they
will be more reliable both scientifically and ethically.
[1] Simons FER. Emergency treatment of anaphylaxis. BMJ 2008;336:1141
-1142.
[2] Foex BA. The problem of informed consent in emergency medicine
research. Emerg Med J 2001;18:198-204.
[3] CRASH trial collaborators. Effect of intravenous corticosteroids
on death within 14 days in 10 008 adults with clinically significant head
injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet
2004;364:1321-1328.
Competing interests:
None declared
Competing interests: No competing interests