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EDITORIALS: Klim McPherson Safer discharge from intensive care to hospital wards BMJ 2001; 322: 1261-1262 [Full text]

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The evidence for intensive care

Michael J O'Leary   (29 May 2001)

The ethics of randomisation in intensive care research

Julian Bion   (1 June 2001)

Alternatives to evidence based medicine in neurosurgical ICU

Vincenzo Bonicalzi, Sergio Canavero   (8 June 2001)

Intensive Care Units are also Public Health facilities

A J P Schrijvers   (16 September 2001)

The evidence for intensive care 29 May 2001
Michael J O'Leary, Staff Specialist in Intensive Care St George Hospital, Kogarah, NSW Send response to journal: Re: The evidence for intensive care	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; 356:2139-2143. 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: 318;1099-1103. 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.
The ethics of randomisation in intensive care research 1 June 2001
Julian Bion, Reader in Intensive Care Medicine Birmingham University Send response to journal: Re: The ethics of randomisation in intensive care research	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
Alternatives to evidence based medicine in neurosurgical ICU 8 June 2001
Vincenzo Bonicalzi Dept. of Neurosciences, Ospedale Molinette, Torino, Italy, Sergio Canavero Send response to journal: Re: Alternatives to evidence based medicine in neurosurgical ICU	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
Intensive Care Units are also Public Health facilities 16 September 2001
A J P Schrijvers, professor in public health University Medical Centre Utrecht Send response to journal: Re: 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 1. J. Hautvast c.s., Place in The ICU Tavern, Plaats in de Herberg, report by the Julius Centre for Patient Oriented Research to the Ministry of Health, Welfare and Sport Affairs, University Medical Centre Utrecht, Utrecht, 2001 2. Bion J.F. Rationing intensive care. BMJ 1995; 310:682-683 3. Tarnow-Mordi WO, Hau C., Warden A., Shearer AJ. Hospital mortality in relation to staff workload: a 4-year study in an adult intensive-care unit. Lancet 356 :185-189, 2000) 4. Carson SS, Stocking C, Podsadecki T, Christenson J, Pohlman A, MacRae S, Jordan J, Humphrey H, Siegler M, Hall J: Effects of organizational change in the medical intensive care unit of a teaching hospital: a comparison of ‘open’ and ‘closed’ formats. JAMA 1996;276:322-328. 5. Ghorra S. Reinert SE, Cioffi W, Buczko G, Simms HH. Analysis of the effect of conversion from open to closed surgical intensive care unit. Ann Surg 1999;229:163-171. 6. Franklin C, Rackow EC, Mamdani B, Burke G, Weil MH. Triage considerations in medical intensive care. Arch Intern Med 1990;150:1455- 1459.