Safer discharge from intensive care to hospital wards
BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7297.1261 (Published 26 May 2001) Cite this as: BMJ 2001;322:1261All rapid responses
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Sir,
We completely agree with McPherson's editorial (1) that intensive
therapy (IT) remains largely outside the evidence based paradigm,
particularly so in the field of traumatic brain injury intensive care.
Novel therapeutic or diagnostic approaches are based upon extrapolations
from physiology, their efficacy on outcome is inferred a priori and,
lastly, noted experts pitch them entrepreneurially in papers, meetings and
congresses. When the new approach has taken root, plans for a RCT are
rejected on ethical grounds: patients deserve the best existing treatment,
i.e. the approach in question.
While randomized controlled trials proved that new treatments may be
either harmful or futile- e.g. moderate hypothermia or neuroprotective
agents for head injury (2)-, this has not spurred caution among
propounders of other treatments.
Often new treatments are supported by demonstration that they affect
surrogate end points -e.g. they reduce elevated intracranial pressure
(ICP)- completely ignoring the fact that these latter are no sound proxy
for clinical outcome. For instance, reduction of ICP did not improve
mortality in the hypothermia study (2).
IT-related clinical research seems to have close ties with research in
some fields of surgery: no randomization and no placebo controls (after
all, some pain neurosurgeons never observed a placebo effect in their
undertakings!) (3).
Statistics employed in surgical research approaches the performances of a
comic opera (4). The same can be said of what happens for a slew of IT
clinical research studies.
This deplorable scenario spawns " alternative " guidelines : eminence or
eloquence based and/or vehemence or providence based (5), whose impact on
mortality or outcome are largely unknown.
The risk of a spiraling effect on costs and beds is the logical
consequence.
In fact, this could be a best scenario for some intensivists and many
drug and instrumentation companies.
Vincenzo Bonicalzi MD
Sergio Canavero MD
Department of Neurosciences,
Ospedale Molinette,
Via Cherasco 15,
10126 Torino, Italy
Correspondence to:
Vincenzo Bonicalzi,
Corso Belgio 171,
10153 Torino, Italy
e-mail. vbonica@libero.it
References
1 McPherson K. Safer discharge from intensive care to hospital wards
(editorial). BMJ 2001; 322:1261-1262
2 Narayan RK. Hypothermia for traumatic brain injury - a good idea
proven ineffective (editorial). N Engl J Med 2001; 344:602-603
3 Broggi G, Ferroli P, Franzini A, La Mantia L, Milanese C. Role of
microvascular decompression in trigeminal neuralgia (letter). Lancet 2000;
355: 929
4 Horton R. Surgical research or comic opera: questions but few
answers. Lancet 1996; 347. 984-985
5 Isaacs D. Fitzgerald D. Seven alternative to evidence based
medicine. BMJ 1999; 319: 1618
Competing interests: No competing interests
Sir,
Using an observational dataset of 13,924 patients admitted to 20
intensive care units, Kath Daly and her colleagues have demonstrated1 a
surplus case mix-adjusted mortality amongst patients discharged to the
wards, using a risk index with a cut-point for risk of death of 60%. This
suggests (if the model is correct) that a substantial proportion of
patients must have been discharged from intensive care with a risk of
death higher than this, and indicates the need for prospective studies
which include the circumstances surrounding death in the wards following
ICU discharge. We are planning such a study in the West Midlands.
In his accompanying editorial2 calling for randomised studies,
Professor McPherson states that “intensive care provision at the margin of
possible benefit simply has to be assessed by random allocation like
everything else…” without providing suggestions about how this might be
achieved in the context of emergency care. He implies somewhat
tangentially that the intensive care community is reluctant to expose its
practice to scientific evaluation, using as examples the albumin
controversy and arguments against randomisation on ethical grounds. In
fact, the majority of intensive care practitioners demonstrate enthusiasm
for evaluation of their practice3, but very properly have concerns about
methodological issues.
Prospective randomised evaluation of a predictor of risk is certainly
feasible between hospitals, though the potential for confounding in terms
of variation in structures and processes is considerable. Random
allocation of critically ill patients to different levels of care within
an institution is complicated by ethical difficulties generated by the
likely absence of equipoise4 and the Hawthorne effect, as anyone familiar
with acute medical care will readily understand. Large observational
databases containing validated information from many thousands of patients
provide an important alternative in this context, and may well be more
robust than meta-analyses in terms of the validity of their output5. A
research methodology based on collaborative networks, observational
databases to adjust for case mix, and agreed standards of care should form
the basis for evaluating existing technologies, incorporating prospective
randomised controlled trials where this is possible. As clinical
researchers, we have a duty to find a balance between rigorous scientific
method, and the ethical problems associated with (in this instance)
persuading patients or their relatives that they should be allocated to
early discharge from intensive care to understaffed and overworked
hospital wards.
Yours sincerely
Julian Bion
Reader in Intensive Care Medicine
Birmingham University
B15 2TH.
1. Daly K, Beale R, Chang RWS. Reduction in mortality after
inappropriate early discharge from intensive care unit: logistic
regression triage model. BMJ 2001;322:1274
2. McPherson K. Editorial: Safer discharge from intensive care to
hospital wards. BMJ 2001;322:1261-1262
3. Vella K, Goldfrad C, Rowan K, Bion J, Black N. Use of consensus
development to establish national research priorities in critical care.
BMJ 2000; 320: 976-8
4. Morris AD. Zaritsky AL. LeFever G. Evaluation of ethical conflicts
associated with randomized, controlled trials in critically ill children.
Critical Care Medicine 2000; 28: 1152-6
5. LeLorier J. Gregoire G. Benhaddad A. Lapierre J. Derderian F.
Discrepancies between meta-analyses and subsequent large randomized,
controlled trials. New England Journal of Medicine 1997; 337: 536-42
Competing interests: No competing interests
Sir,
From his editorial, we think that Klim McPherson must
read different journals from us; we know, however, that
the ones he does read he reads superficially (the
Cochrane albumin review was hardly about acute renal
failure!) [1]. Dr McPherson’s assertion that intensive
care is "outside the evidence-based paradigm" simply
does not stand up to the evidence. Patient
management in the ICU is now more evidence based
than ever before, and probably most of the day to day
decisions made by the attending intensive care
specialist have been tested by the rigour of a
randomised controlled trial. For example, we know not
to strive for "supranormal values" of physiology when
resuscitating shocked patients [2]; we know a little
better how to ventilate patients with ARDS [3]; we know
to use enteral rather than parenteral nutrition whenever
possible [4] and which feed to use [5]; and we know
that dopamine is useless in the prevention of SIRS
associated acute renal failure [6]. These represent just
a few of our recent advances. Furthermore, far from
dismissing the Cochrane albumin review the intensive
care community has engaged in vigorous debate on
this issue, as anyone who has attended an
international meeting on intensive care in the last two
years can vouch. Here in Australia we are about to
commence recruitment into a double-blind placebo
controlled trial of albumin in fluid resuscitation under
the auspices of the Australian and New Zealand
Intensive Care Society Clinical Trials Group. This trial
is set to become the largest intensive care trial ever
conducted. In the UK the pulmonary artery catheter is
shortly to be put to trial, thus ending another of the big
controversies of intensive care practice.
Yet it does not appear to be individual intensive care
interventions that McPherson considers as not
evidence based, but rather the very use of intensive
care per se. Again, he is wide of the mark. We would
contend that more than any other discipline the
intensive care specialist and their specialty have been
subject to trial [7]. It is true that often these studies
have been retrospective or "case – control" and thus not
randomised but their results are supported by the
optimisation studies in high-risk surgical patients in
which randomisation has taken place [8]. Again in
Australia moves are advanced for a randomised
controlled trial to look at the effectiveness of the
"Medical Emergency Team" which brings intensive care
management practices to the ward patient.
McPherson’s editorial represents a traditional view in
the UK and is counterproductive to change. As Daly and
colleagues show yet again, there are too few ICU beds
in the NHS, and that is the bottom line [9]. We do not
need further randomised controlled trials to prove the
effectiveness of intensive care as such evidence will
not influence spending. A life lost on the ward costs
much less than one saved in the ICU. What is vital is to
ensure that there are enough beds for those who need
them and that the beds available are used wisely. The
problem we face here in Australia where our bed
numbers more closely approximate clinical need is that
intensive care is recognised as being "highly effective"
and thus everyone wants it and the demand for further
beds becomes insatiable. Unfortunately, as a
profession we are getting worse at saying "no" and
wise use of intensive care beds is probably already
moving out of the intensive care specialists’ control. It is
unfair, therefore, to put the onus of justifying
expenditure on ICU beds onto intensive care
specialists as only a major debate in the general
community about appropriate end of life care can limit
the ballooning intensive care budget. We doubt that this
will happen because the community, both here and in
the UK, just does not have the guts for it.
Michael J. O’Leary
Staff Specialist
The St. George Hospital,
Gray Street,
Kogarah NSW 2217.
David J. Bihari
Associate Professor
Prince of Wales Hospital,
Barker Street,
Randwick NSW 2022.
Australia.
1. Cochrane Injuries Group Albumin Reviewers.
Human albumin administration in critically ill patients:
systematic review of randomised controlled trials. BMJ
1998; 317:235-240.
2. Hayes MA, Timmins AC, Yau EH et al. Elevation of
systemic oxygen delivery in the treatment of critically ill
patients. N Engl J Med 1994; 330:1717-22.
3. The Acute Respiratory Distress Syndrome Network.
Ventilation with lower tidal volumes as compared with
traditional tidal volumes for acute lung injury and the
acute respiratory distress syndrome. N Engl J Med
2000; 342:1301-1308.
4. Heyland DK. MacDonald S. Keefe L. Drover JW. Total
parenteral nutrition in the critically ill patient: a
meta-analysis. JAMA 1998; 280:2013-2019.
5. Zaloga GP. Immune-enhancing enteral diets:
where's the beef? Crit Care Med 1998; 26:1143-1146.
6. ANZICS Clinical Trials Group. Low-dose dopamine
in patients with early renal dysfunction: a
placebo-controlled randomised trial. Lancet 2000;
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7. Vincent JL. Need for intensivists in intensive-care
units. Lancet 2000; 356:695-696.
8. Wilson J, Woods I, Fawcett J, et al. Reducing the risk
of major elective surgery: randomised controlled trial of
preoperative optimisation of oxygen delivery. BMJ 1999:
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9. Daly K, Beale R, Chang RWS. Reduction in mortality
after inappropriate early discharge from intensive care
unit: logistic regression triage model. BMJ 2001;
322:1274-1276.
Competing interests: No competing interests
Intensive Care Units are also Public Health facilities
Dear Sir,
We do not agree with your statement that appropriateness of intensive
care has to be proven, simply by random allocation of patients like
everything else about which is legitimate doubt. This is jumping to
conclusions and “too sharp in the bend” as we say in Holland.
We agree with this statement as far as concerned to intensive care
treatment, once a patient is admitted to the intensive care unit (ICU).
Then random allocation to different therapies should be done to bring
intensive care more than now within the domain of Evidence Based Medicine.
However, treatment is not the only function of ICU’s. They have also
two public health functions: 1. to assess if patients are appropriate
referred and 2. to give immediate admission in cases of emergency. These
two types of functions are comparable with those of police forces and fire
brigades. These agencies screen also the appropriateness of referred cases
and give immediate support in case of emergency.
For the two public health functions the scientific questions are: 1.
What is an acceptable risk to refuse a referred case which was appropriate
to admit? 2. What is the most efficient organisation of intensive care
units in a society to meet that level of acceptable risk? To answer these
questions we arrive in the domain of screening and diagnostic methods and
of cost effectiveness studies. Appropriate designs are observational as
well as experimental studies. In both approaches the daily incidence of
appropriate referred and refused Intensive Care patients is an important
outcome indicator.
This daily incidence is firstly related to an 24 hours availability
of a registered intensive care physician at the Intensive Care Unit (ICU)
and secondly to an online website at regional ICU’s and the ambulance
dispatch center which shows available IC beds in the region. This
conclusion is based on our observational study [1] of 6341 appropriately
referred ICU patients during four months in 2000, in 18 Dutch general non-
university hospitals with more than 500 beds. The median incidence of
appropriate referred and refused patients was 0.26 per day and per ICU.
Capacity problems were recorded for 1051 or 16.6 % of the mentioned 6.341
patients. Of these 1051 persons 618 were refused, 266 admitted with
improvisation and 167 prematurely discharged. In 42% of the refused cases
one or more ICU beds were closed due to shortage of ICU nursing staff
(75%), medical staff (14%), equipment (1%) and multi-resistant nosocomial
infections in the ICU (10%).
The percentage of study period days with one or more refusals was
related to the 24 hours availability of a registered intensive care
physician (17% vs 25%, p=0,054 Confidence Interval (CI) = 0% – 16%). This
relation is also found in other studies [2-5]. The participation of an ICU
in an online database of available beds tended to be associated with a
reduced percentage of study period days with one or more refusals,
although not reaching statistical significance (17.6% vs 21.1%, difference
3,5% p=0.5 CI= 0% -14%).
Augustinus J.P. Schrijvers, PhD, professor of public health
Jeannine Hautvast, MD PhD, fellow in health care research
Diederick E Grobbee, MD PhD professor of clinical epidemiology
Jan Bakker, MD PhD, director of Intensive Care Department Isala Hospitals
in Zwolle
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of Health, Welfare and Sport Affairs, University Medical Centre Utrecht,
Utrecht, 2001
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comparison of ‘open’ and ‘closed’ formats. JAMA 1996;276:322-328.
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effect of conversion from open to closed surgical intensive care unit. Ann
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Competing interests: No competing interests