Why I published

1
Why I published the albumin paper confession
of a buccaneering editor

• Richard Smith
• Editor, BMJ
• October 2001

2
Hypothesis One

• Editors are shadowy, wayward pictures who prefer
  the dark to the light and are happiest consorting
  with les belle de nuits
• They love sensation, any sensation
• Nothing gives them more pleasure than to upset
  solid, upstanding people like intensivists
• The albumin paper provided a momentary fix to
  feed these dubious pleasures

3
Hypothesis two

• The paper asked an important question
• The methods were good enough
• ASIDE the invention of the good enough mother
  may be one of the greatest inventions of the 20th
  century concepts of the good enough editor or
  good enough intensivist follow
• The paper was suitably tentative, even if some of
  the subsequent comments were not

4
What I want to talk about

• The new world of evidence based practice
• My version of the albumin story
• Intensive care in an evidence based world

5
Is evidence based practice
a radical change?

• Combines with other drivers of change
• Consumerism the resourceful patient
• The arrival of the internet
• The desire of owners to manage more the clinical
  process
• Growing gap between what could be done and what
  can be afforded

6
Has EBP changed the world?

• Source of knowledge is systematic review of
  evidence
• Clinical skills can be audited and managed
• Research and evidence go together

• Source of knowledge is expert opinion
• Clinical skills are seen as semimystical
• Research is marginal to practice

7
Has EBP changed the world?

• Analysis of research is haphazard
• Not important to gather new evidence from
  patients routinely

• Analysis of research is systematic
• Patients should be included in trials wherever
  possible

8
Has EBP changed the world?

• Only lip service is paid to keeping up to date
  and learning new skills
• Most medical care is assumed to be beneficial

• Essential to keep learning new skills
• Widespread recognition that the balance between
  doing good and harm is fine

9
Has EBP changed the world?

• Clinical performance is not systematically
  audited
• Managers have little involvement in clinical
  proceses

• Clinical performance is regularly reviewed and
  managed
• Managers are involved in clinical processes

10
Has EBP changed the world?

• Organisational model is hierarchical
• Doctor patient relationship is essentially
  master/pupil

• Organisational model is much more democratic,
  based on ability to use evidence
• Patient partnership is the norm

11
Has EBP changed the world?

• Patients do not have easy access to the knowledge
  base of doctors
• The doctor is smartest

• Patients have as much access to the evidence base
  of medicine as doctors
• Often the patient is smarter

12
The albumin story my view

• Albumin has been used for 50 years to treat the
  critically ill
• The theory behind the treatment was based on
  hypoalbuminaemia being associated with higher
  mortality (undoubtedly true), oedema, and low
  serum oncotic pressure

13
The albumin story my view

• The theory was X being low is bad giving X
  will be good Is this simpleminded?
• Like surgical theory something in the body is
  bad if we cut it out things will be better
  result radical mastectomy hemicorporectomy

14
The albumin story my view

• Respectable intensivists had doubts about the
  effectiveness of albumin
• Currently, the widespread use of albumin has
  more to do with word association and the
  treatment of items that are marked on a pathology
  form with an asterisk than with scientific
  medical management. Neil Soni, BMJ, 1995

15
The albumin story my view

• There was big worldwide variation in the use of
  albumin generally, Commonwealth countries used
  it a lot Americans used it much less
• The story is complicated (as always) by
  commercial factors albumin is expensive, and
  many peoples jobs depend on it

16
The albumin story my view

• Enter some honest Cochraneites/EBMers with no
  particular axe to grind, no money to make, no
  reputation to lose

17
The albumin story my view

• Experience--especially experimentally collected
  data--trumps theory
• The thinking behind the renaissance surely
  intensivists are not medievalists
• Surely intensivists dont want to be associated
  with the chicanery of management consultancy It
  may(not) work in practice, but will it (not) work
  in theory?

18
The albumin story my view

• The Cochraneites follow their usual method
• They pose a question, systematically search for
  all relevant studies, set some quality criteria,
  perhaps combine the data statistically, and see
  what the data say
• A crucial observation is that the data are poor
  the big, randomised, double blind study that
  should have been done has not been done

19
The albumin story my view

• The data suggested--to their surprise but fairly
  consistently--that albumin kills more people than
  it saves
• They write up the study with a suitably tentative
  conclusion

20
The albumin story my view

• There is no evidence that albumin administration
  reduces mortality in critically ill patients with
  hypovolaemia, burns, or hypoalbuminaemia and a
  strong suggestion that it may increase mortality.
  These data suggest that use of human albumin in
  critically ill patients should be urgently
  reviewed and that it should not be used outside
  the context of rigorously conducted randomised
  controlled trials.

21
The albumin story my view

• The study is submitted to the BMJ
• We decline to fast track the study
• The peer review of the study is even more
  extensive than usual, generating pages of
  comments and revisions
• The clinical reviewer is against
  publication--partly because of unhappiness with
  the whole methodology (garbage in, garbage
  out--but this is all the evidence we have)

22
An aside problems with peer review

• No evidence of effectiveness
• Ineffective doesnt detect errors
• A lottery
• A black box
• Slow
• Expensive
• Biased
• Easily abused
• Cant detect fraud

23
An aside on peer review

• The benefit of peer review probably comes not
  from sorting out what to reject and what to
  publish but rather from improving what is
  eventually published.

24
Who makes the final decision at the BMJ?

• Two practising doctors (mostly physicians) with
  extensive experience of peer review
• One or possibly two editors
• A statistician
• Everybody reads every word
• A majority vote carries the day
• The buck stops with the editor (me)

25
The albumin story my view

• A heavily revised paper is published
• An editorial written by an intensivist is
  generally supportive
• A scientific commentary provides modern
  pathophysiological explanations of why albumin
  might make things worse rather than better
• A TWIB overdoes it Albumin administration
  increases mortality in critically ill patients

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The albumin story my view

• 30 rapid responses
• For the Editorial Board of the BMJ to sanction a
  headline-grabbing press release on this paper is
  nothing short of scaremongering, and further
  justifies my decision three years ago to resign
  my membership of the BMA.
• Keith Judkins, intensivist

28
The albumin story my view

• A reasonable test is to ask what I would want for
  myself, as a patient, or for someone I cared for.
  In brief, I would attempt to sue anyone who gave
  me an albumin infusion. And, as for any attempt
  to secure my informed consent to take part in a
  randomised trial (or my assent on behalf of
  someone I cared for who was unable to give
  informed consent) - forget it!
• Sir, wow Iain Chalmers, head of the UK Cochrane
  Centre

29
The aftermath

• A moderate editorial argues that rather than
  fulminating we seek to answer the questions
  raised
• FDA advises that the results deserve serious
  attention
• A trial is proposed
• Use of albumin drops

30
The aftermath

• Authors and editor get gently roasted at British
  intensive care meeting
• Intensivists seem to argue that A question like
  whether albumen works is not useful. What matters
  is the whether the individual intensivist can
  compensate for the individual patients seriously
  dreranged physiology
• Editor says this is exactly the argument used by
  psychoanalysts

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32
Intensivists and evidence

• Albumen
• Low dose dopamine to prevent renal failure
• Pulmonary artery catheters
• Ranitidine to prevent GI bleeding
• Various antesepsis regimens

33
Why the problem?

• RCTs are especially hard to do in intensive care
  urgency, very sick patients, multiple pathology,
  each patient is unique, consent
• It must be hard to do nothing
• Good surgeons know how to operate. Better
  surgeons know when to operate. The best surgeons
  know when not to operate. True as well for
  intensivists?

34
Conclusion

• The albumen story has posed important questions
  that are now being answered
• Its prompted understanding (and
  misunderstanding--they always go together) of EBM
  among intensivists
• We all got a little carried away
• Cue music Je ne regret rien