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Project title Date Month 2014

Litigation & EBM 22 June 2015

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! Evidence based medicine (EBM):

“the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” Sackett et al 1996

! Clinical practice guidelines (CPGS):

“systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances”

IOM 1990

Definitions

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ü  “Medicine, long recognised as a subtle admixture of science and art, has moved notably in the direction of an exact science as new tools and techniques have been developed to help practitioners of ‘the healing art’ understand better what works in the treatment of patients” (Rosoff 2001)

ü Guidelines are meant to facilitate good medical practice

ü Need to be reviewed and updated regularly

ü  Potentially aid in consistency and quality of healhcare

ü Need to be interpreted and applied in a clinically appropriate manner (Samanta et al 2003)

Why have guidelines?

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Ø  Not a magic bullet Ø  Proliferation of guidelines Ø  Inflexibility

Potential pitfalls

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Tort Law

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! Can guidelines be admitted as evidence of the appropriate standard of care?

! If so, what role do guidelines have?

Key questions

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! Hyams study (1995) ! 259 claims ! 7% (17) involved use of clinical guidelines ! 12 used by claimant ! 4 by the defendant

! 980 lawyers ! 48% had 1 case per year involving guidelines ! Only 36% where they were important ! 22% thought the guideline had influenced the judge or jury

Study

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Vic: Wrongs Act 1958 s 59 A professional is not negligent in providing a professional service if it is established that the professional acted in a manner that (at the time the service was provided) was widely accepted in Australia by a significant number of respected practitioners in the field (peer professional opinion) as competent professional practice in the circumstances. However, peer professional opinion cannot be relied on for the purposes of this section if the court determines that the opinion is unreasonable

Civil Liability Legislation

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Case example

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! Was the Ambulance Service negligent in the preparation and promulgation of the relevant protocol on the basis that !   (a) the protocol was unclear and confusing resulting

in its application in unsuitable circumstances; or !   (b) it should have provided for intramuscular

administration of adrenaline to patients who were not on the point of death.

Ambulance Service of NSW v Worley

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! The claim that the protocol was unclear was not sufficiently pleaded or proved to support a finding of negligence: at [94]

! The evidence did not establish that the dosage and rate at which adrenaline was administered was unreasonable nor that the level of monitoring was not reasonably appropriate: at [145]–[148].

By Basten JA (Tobias JA and McColl JA agreeing):

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! The evidence did not demonstrate that the Ambulance Service failed to exercise due care in its preparation of the protocol. It was not established that its Medical Advisory Committee did not have available up-to-date information, nor was it established that they did not take into account that which was available regarding the use of intramuscular versus intravenous injection of adrenaline. Scientific evidence did not support the view that a change was reasonably required, nor did it support a finding that the Medical Advisory Committee was negligent in maintaining the protocol permitting the use of intravenous adrenaline for the specified indications in October 1998: at [133].

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! Carry varying weight: !   Vary in scope !   Vary in quality !   Source of guideline

! Accompanied by expert testimony !   Relevance !   Use !   Reliability

! Exculpatory ! Inculpatory ! Non-adherance does not necessarily mean an adverse outcome

Use in litigation

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Thank you