How does evidence based guidance influence determinations of medical negligence?
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7473.1024 (Published 28 October 2004) Cite this as: BMJ 2004;329:1024
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Medical negligence and the guidelines
EDITOR-
The author of “ How does evidence based guidance influence
determinations of medical negligence” (BMJ pages 1024-1028) argues to
reject the guidelines in favour of “Responsible body of medical opinion”
the fundamental principle laid down in Bolam test on the standard of care.
1 It is true that 88% of specialty guidelines did not give any
information on searches 2, yet they are accepted by most practitioners as
the yard stick of clinical practice. A change of clinical practice on the
basis of evidence based medicine (EBM) is a recent phenomenon and has just
entered in to its second decade3. In 1957 when Bolam was pronounced,
there was little known on evidence based medicine or specialty guidelines
or existence of similar institution like NICE today. Therefore the
principle laid down in Bolam test i.e. ordinary skilled man exercising and
professing to have that special skill…..” was important to the Courts’
decisions. Let us consider this Bolam test, the second limb of clinical
negligence. A dermatological condition called molluscum contagiosum used
to be treated with phenol cauterisation. The latest UK national guidelines
produced by British Association of Sexual Health and HIV (BASHH) do not
any mere recommend this. There was no reason given. It is probably due
to phenol poisoning. Many GUM physicians still use phenol, but a
minority. If something goes wrong with the patient, will the responsible
body of medical opinion (the Bolam test) help the doctor. Absolutely not
. The court will accept the UK national guidelines. Many women get
genital herpes during pregnancy. Meningitis is a rare complication .
Aciclovir is the drug of choice but not licensed in pregnancy. In
addition, there is a possibility of peri-natal infection with brain
damage in the new born baby. The specialty guidelines dictate that these
patients are treated during pregnancy. Many doctors do not treat because
of its unlicensed position. If there is a damage to the patient or to the
baby, will the Bolam principle rescue the doctor ? The GMC recommends
to follow the guidelines. The Supreme Court of Western Australia rejected
“Responsible body of medical opinion principle” in Bolam test on the
basis of a minority opinion 4. When there is a GMC support, development of
guidelines by a large number of responsible doctors and practice of these
guidelines by the majority, it is very unlikely that the courts will rule
in favour of minority taking the type of damage into consideration, even
though the minority belong to a responsible body of doctors. Courts were
applying the principle of Bolam until 1993 when Balitho test came into
force. Balitho not only strengthened Bolam principle but also emphasised
on causation by weighing the opinions from two conflicting expert
witnesses.5 One expert witness’s evidence was rejected in favour of the
other. After Balitho courts are now studying and analysing carefully many
factors including international and national guidelines, regional
guidelines, Trust guidelines and, NICE guidelines. The author argues “
….guidelines are hearsay “. In my opinion they are not hearsay as
explained above. In law hearsay evidence is not accepted in criminal
courts or criminal jurisdiction but always accepted in civil matters in
civil court proceedings. Since medical negligence is mostly a civil
matter, the hearsay evidence is usually accepted by the courts unless the
negligence is so gross that it is brought under criminal jurisdiction.
Hearsay evidence is not accepted in criminal courts because, the criminal
standard is higher than the civil standard (beyond reasonable doubt v
balance of probabilities).
The second important point is that fortunately the guidelines have
allowed room for Bolam principles. In the following two examples (Table 1
& Table 2) one can see the existence of Bolam;
Table1. Strength of evidence in recommending the guidelines in UK & USA6 Grade A. Substantial clinical benefit with strong evidence Grade B. Limited clinical benefit Grade C. Insufficient efficacy where efficacy does not outweigh the adverseconsequences Grade D. Recommend against use Grade E. Never use Category I. At least one randomised control study Category II. Well designed clinical trial without randomisation Category III. Respected authorities based on clinical experience
Table 2. NICE guidelines with strength of evidence ( Eccles & Mason, 2001)7 Grade A. Directly based Category I Grade B. Directly based Category II Grade C. Directly based Category III Grade D. Directly based Category IV A(NICE) NICE recommendations GPP. Good practice point Category I. Meta-analysis of randomised studies Category II. Central study without randomisation Category III. Comparative studies Category IV. Respected authorities
One can see from the guidelines that each recommendation is followed
by the particular strength of evidence for example AI i.e. substantial
benefit from EBM of randomised control study or recommendation of BIII
limited efficacy may be considered as Bolam principle on respected
authorities based on clinical experience.
In the latest NICE guidelines on the diagnosis and management of
epilepsy in adults and children in primary and secondary care (Clinical
guideline 20, October 2004) one sees a statement to the effect that the
guidance does not over-ride the individual responsibility of health
professionals to make decisions appropriate in the circumstances. The
evidence base in epilepsy guidelines included an audit across the UK of
sudden unexplained death that was carried out in 2002. 8 Whilst
accepting the report of DTB (The Drug and Therapeutic Bulletin)
criticising the guidelines issued by the British Thoracic society and
Scottish Intercollegiate Guideline Network on IV magnesium sulphate in
acute severe asthma,9 it could be emphasised that guidelines are not
written in the tablet of stone, they are constantly under review, often
annual review in some specialties and subject to change on the basis of
EBM. It is sad to see that the implementation of some of the NICE
guidelines are patchy. There is evidence that NICE guidance has been less
influential in surgical procedures and use of medical devices.10 Now
there is no assessment of routine data to see whether the NICE guidelines
are implemented or not.
In medical negligence the courts apply the three limb test i.e. duty
of care, breach of that duty and a causation link for the harm. The third
limb of causation was developed in Balitho 5 where Farquharson LJ said,
“While the judge may be guided by the expert evidence he is not on this
issue to be directed by it”. A responsible medical opinion should be
rejected if it is unreasonable and does not stand up to critical analysis.
Before the court an expert opinion is often examined , cross examined and
re-examined for its validity. Lord Woolf the present Chief Justice
recommended the provision of a single joint expert (SJE) in medical
negligence cases. It is a long way to go to achieve this.
Kailash C Mohanty JP, LL.M
Member of the Employment Appeal Tribunal (High Court), London; Registered
Medical Expert Witness & Consultant Physician
drkcmohanty@yahoo.co.uk
1. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118-
28
2. Grilli R, Magrini N, Penna A, Mura G, Liberti A. Practice guidelines
developed by specialty societies: the need for a critical appraisal.
Lancet 2000;388:103-6
3. Guyatt G, Cook D, Haynes B. Evidence based medicine has come a long
way. BMJ 2004; 329:990-1
4. Cranley v Medical board of Western Australia ( Supreme Court WA)
[1992] 3 Med LR 94-113
5. Balitho v City & hackney Health Authority [1993] Medical LR 381
6. Bartlett J, Gallant JE. 2003 Medical management of HIV of HIV. John
Hopkins University, Baltimore, Maryland, USA adopted by UK National
guidelines by BASHH
7. NICE, Mid City Place, 71 High Holborn, London WC1V ONA
8. Mayor S. NICE guidance on epilepsy recommends specialist diagnosis.
BMJ 2004; 329:995
9. Anonymous. Intravenous magnesium for acute asthma. DTB 2003;41: 79-80
10. SheldonTA, Cullum N, Dawson D, Lankshear A, Lawson K,Watt I, West P,
Wright D, Wright J. What’s the evidence that NICE guidance has been
implemented? BMJ 2004; 329:999-1003
Competing interests:
None declared
Competing interests: Table1. Strength of evidence in recommending the guidelines in UK & USA6Grade A. Substantial clinical benefit with strong evidenceGrade B. Limited clinical benefitGrade C. Insufficient efficacy where efficacy does not outweigh the adverseconsequencesGrade D. Recommend against useGrade E. Never useCategory I. At least one randomised control studyCategory II. Well designed clinical trial without randomisationCategory III. Respected authorities based on clinical experience
The Chambers Dictionary 1993 edition has as part of its definition of
a 'guideline' the following: "an indication of the course that should be
followed". Professor Hurwitz is timely in reminding clinicians under a
charge of negligence that the evidence that may be used in court may come
from established 'guidelines' although such adherence may have to be
substantiated. However, as he clearly identifies there is the thorny issue
of the validation of the information so possessed. One can wonder when
does "information" become "knowledge". From the definition given above the
words 'indication' and 'should' stand out particularly. In other words
these two words soften any prescriptive adherence to the "rules"
(guidelines) laid down by researchers and seniors. This allows clinicians
the clinical freedom to assess and clinically manage the patient both as a
health commodity subservient to the 'guidelines' of care as well as
managing patients as individual hosts of their own disease processes who
are placed under such guidelines. Unless a 'guideline' has a validating
mandate or authority then it is purely indicitative not prescriptive.
Guidelines are there to guide, not to be a slavish representative body of
opinion that must be adhered to. Whilst every doctor should be competent
to perform the tasks asked of them, equally they should ensure that the
knowledge that they impart is validated evidence, and not evidence for the
sake of things. In the coming decade the likely "watchphrases" about the
standards of clinical care will be "Validated Competence" and "Validated
Evidence". Validation embraces a dynamic, not static, process and practice
philosophy around competence. Organisations that issue guidelines should
be quite implicit by what a guideline is and what the provenance and
authority of such a guideline is, along with the review date, to create a
dynamic document.
Competing interests:
None declared
Competing interests: No competing interests
Other issues surrounding Clinical guideline dissemination and Implementation and the Law.
Other issues surrounding Clinical guideline dissemination,
Implementation and the Law.
Dear Sir
I read the issue of the BMJ with great interest. I have been employed
part-time in dissemination and Implementation of SIGN guidelines in a
large hospitals division for the last two years.
Further to the current vogue in the United Kingdom for the creation
of guidelines by authoritative bodies, and their increased use in practice
there are several important issues, which have arisen, the most common of
which are discussed below.
1. How can it be established which guidelines carry the most
authority, particularly when they present a challenge to clinical
discretion or where there is conflict between two sets of
guidelines/protocols?
Frequently the chief focus of interest on the implementation of
clinical guidelines is the initiative to improve the quality of health
care cost-effectively, but the matter is complicated for clinicians
because of the many different guidelines, which they receive, and issues
in relation to their perceived importance in legal and practical terms.
The first problem encountered is one of definition of terms. Is there
a significant difference between terms such as “protocols”, “case
profiles”,“standards”, “guidelines”, “recommendations” or “clinical
practice parameters”? To a legal layman, the term “protocol” might suggest
compulsion whereas the term “guideline” might offer a degree of
flexibility and discretion.
To a health professional however "Guideline" may suggest a set of
documents from some recognised source and "Protocol" may be a document,
which has been developed locally and may therefore carry more weight from
a medical effectiveness point of view.
From a legal point of view, the most important determining factor as to
the effectiveness, of a guidance document, would most likely be, its legal
effect i.e. the legal consequences that any deviation from the guidelines
may attract. In fact the medico-legal lawyers have already attended to
this question. It has been suggested that medical experts must routinely
be asked to consider the existence and relevance of guidelines and
protocols in all clinical negligence cases.
The following is a suggested checklist for lawyers to assist with the
instruction of experts in Clinical Negligence cases:
Guidelines: suggested questions to experts
• How were the guidelines developed?
• When were they published?
• What is the scope of the guidelines?
• Are the guidelines authoritative (e.g. NICE, Royal Colleges,
CMO/Department of Health?)
• Are the guidelines mandatory, or are there permissible exceptions?
• Is there is a responsible/reasonable body of medical opinion which
would advocate a different approach?
• Where a doctor has deviated from guidelines, have the reasons for
this been recorded in the notes?
• Has the doctor considered the risks and benefits of this course of
action, and discussed this with the patient?
• Is the deviation capable of withstanding "logical analysis"? (1)
In fact similar list finds its way around the hospitals published by
the Department of Health giving advice on assessing guidelines.(2)
The very fact that it is thought to be useful to publish such a
detailed list confirms the increasing appreciation of the importance of
guidelines.
When faced with guidelines from different bodies, there is also the inter-
related question of resources. There is a perception that to the extent
that guidelines might be influenced by the cash and management politics of
the NHS there may be a degree of threat to clinical independence and that
guidelines thus tainted could represent a danger to good clinical
practice.
The problems with the guidelines on Beta interferon for Multiple Sclerosis
and Viagra for erectile dysfunction illustrate this.
In R v North Derbyshire HA ex parte Fisher (3), the Secretary of
State advised GPs not to prescribe "Viagra" pending the inclusion of the
drug on the statutory "grey list" of drugs (which may be prescribed in
limited circumstances only). The restriction was challenged by way of
judicial review and held to be unlawful. The court held that the Terms of
Service imposed on GPs a duty to prescribe based on the reasonable
exercise of professional judgment.
In R (on the application of Pfizer Ltd) v Secretary of State for
Health (4) ,when a health authority refused to provide beta-interferon
treatment for a man with multiple sclerosis, the High Court in England
concluded that the health authority had acted unlawfully, because it had
disregarded guidance on such treatment issued by the Department of Health.
However, it might have been lawful to depart from the policy in the
guidance, since it did not bear the badge of mandatory requirement, had
the authority at least considered the guidance and formulated clear
reasons for the departure from it. But this it had not done.
Therefore although guidelines generally do not have the force of law
yet and their non-observance may reflect adversely on the person who fails
to follow them, there does not appear to be simple advice to any clinician
who must decide between conflicting guidelines Even if there is support
from the courts for one set of guidelines a breach of contract with an
employer for failing to follow a different set of guidelines could have
very serious consequences.
It is submitted however that increased co-operation between the
guideline producing bodies is necessary. An example of good practice is
the National Asthma Guideline (5) in which the BMA, The Royal College of
physicians, SIGN, The British Thoracic Society, The National Asthma
campaign, The General Practice Airways Group, the British Association for
Accident and Emergency Medicine, The Royal College of Paediatrics and
Child Health and The British Paediatric Respiratory Society all
collaborated.
This should be encouraged as it creates a unified approach i.e. there
is one guideline, which covers the management of Asthma covering its
management in the community and in hospitals. The advantages of this type
of guideline include:
· A wide ranged consultation which means there is less chance of
missing out an aspect of management
· It is most likely to be the best practice as so many bodies have
reviewed the evidence.
· A large body of responsible people has approved it therefore from a
legal point of view, deviation from it would be difficult to justify.
If they hadn’t collaborated, each of these bodies would probably have
produced separate guidelines. This would mean, practically, a barrage of
guidelines from well-respected sources being in circulation. Clinicians
would need to consider more guidelines, which could lead to an increased
risk of confusion on the wards as well as in court if presented as
evidence.
The above National Asthma Guideline is referred to Dr Hurwitz’s
article (6) regarding the change of evidence regarding the single dose of
Magnesium Sulphate in Acute Asthma. It is submitted that if this
recommendation was to be revised and after an exhaustive review needed to
be changed, the change would need to be made on the one national
guideline.
It follows that to answer the question on which guidelines should be
a priority, the advice may be they need to be proven through evidence-
based research, disseminated, accepted and adopted before there is legal
or medical basis for doctors to follow it. It is also submitted that due
to the robust methodologies of review of evidence such as that of SIGN
Guidelines, which is now internationally renowned, deviation from these
guidelines would be difficult to justify. (As far as I am aware , there
has been as yet no case law involving SIGN guidelines in Scotland to
support this).
2. Would a health professional be expected to know all the latest
guidelines/evidence?
The doctors' predicament with regard to the profusion of published
materials was appreciated by Lord Denning nearly fifty years ago, in
Crawford v Charing Cross Hospital(7). The case concerned the claimant
developing brachial palsy as a result of his arm being kept in an extended
position on the operating table. The anaesthetist had failed to read an
article in the Lancet concerning the best position of an arm when using a
drip.
In finding the anaesthetist who had not kept up to date with this
latest article in the medical literature on a particular area of expertise
not guilty of negligence, he went on to say:
“It would be putting too high a burden on a medical man to say he has
read every article in the medical press..... [but] the time may come in a
particular case when a new recommendation may be so well proved and so
well known and so well accepted that it should be adopted”.
As has been pointed out by JH Tingle (8) "Crawford was a case in the
late 1950s, before the information technology age, an age which we are now
in…the Crawford approach needs to be considered in the light of the above
revolution. Whilst it is now easier to obtain information, there is also
much more of it".
The Crawford case was referred to in another case (Gascoigne v Ian
Sheridan and Co and Latham )(9). This was primarily a case of failure to
diagnose cancer. However, the responsibility of an Obstetrician to keep
informed of developments in his field was another issue considered.
Mitchell J said that a “shop floor gynaecologist” had a responsibility to
keep himself generally informed about mainstream changes in diagnosis,
treatment and practice through the mainstream literature, such as leading
textbooks and the journal of Obstetrics and Gynaecology, but it was
unreasonable to expect him to acquaint himself with the content of the
more obscure journals.
To quote from Bolam (10) , a professional person "cannot obstinately
and pig headedly carry on with some old technique if it has been proved to
be contrary to what is really substantially the whole of informed
[professional] opinion." In other words it will only be negligence not to
adopt it, when it is a proved and accepted practice of the profession. The
question of at which point in time during which a doctor may be held
negligent for not managing a patient using treatment that has been proven
through randomised trials and the eventual issue of clinical guidelines is
as yet unresolved.
This is now an era in the medical sense where revalidation,
continuous professional development, appraisals are now all commonly used
and applied. It is now a requirement for professionals to prove that they
are continuously updating their knowledge and skills.
Finally, an issue to consider is the delay between the availability
of strong scientific evidence and the subsequent dissemination of clinical
guidelines, which imply the expected standard of care.
A case in point is the introduction of antenatal corticosteroids for
the prevention of morbidity in premature infants. Corticosteroids were
first shown to be effective in reducing serious neonatal mortality and
morbidity more than 20 years ago and the same findings were strengthened
by at least 13 subsequent randomised trials. However, it was not until
1993 that the Royal College of Obstetrics and Gynaecology recommended to
all obstetric units to consider the use of such therapy when the delivery
of an infant is likely to be before 34 weeks gestation. The implication
here is that even clinical guidelines may be slow to develop and keep pace
with the current scientific evidence and professional bodies must
therefore be responsive enough to develop guidelines that reflect current
best practice.
Guidelines must also be reviewed and updated regularly in view of the
available evidence from scientific studies.
A related question, which may arise, is who could be held responsible if
the guideline once produced, has not reached the practitioner? If the
Trust/Hospital the practitioner works for, has taken responsibility for
disseminating guidelines could the Trust be held responsible for them not
reaching their intended recipients? This question is somewhat related to
the next section and practical connotations as can be seen from the
example below.
A recent guideline (11) contained a slight error in the dose of drug
recommended for management of Epilepsy in pregnancy (If the drug dose is
given according to the typographical error, it would have no effect). This
typographical error was found after the guidelines had been widely
disseminated. Although the error page was sent round to those on the
database, there are those who picked up the guideline from a collection
area in the hospital and these doctors may not get informed of the error.
In this case however the doctor would be following a guideline
disseminated to him by the Trust. It could be argued of course that it is
the doctor’s responsibility to check the website to update
himself/herself, (the corrected version is on the website) however this is
an illustration of a problem that could potentially arise.
3. Flawed Guidelines
It is a generally held view that it is the health professional rather
than the authors of the guideline that will be held responsible for
implementing faulty guidelines. Further to a case search on this issue, it
is submitted that as yet no case has been brought against authors for
faulty guidelines in the U.K.
Significantly, the TOFT report investigating the circumstances
leading up to a fatal intra-thecal, rather than intravenous injection of
Vincristine into a patient at the Queen’s Medical Centre Nottingham,
highlighted that as well as the ,local guidelines being unclear, there
were two guidelines in circulation. One version had an important omission
in the last line of text:
“It (intrathecal chemotherapy) should never be given on the same day IV
Vincristine”. Thus, anyone reading that particular edition of the
guidelines would be unaware that intrathecal injections should not be
given on the same day as IV Vincristine.(12)
This had no direct effect on the adverse incident, however one
version of the guidelines was incomplete or defective and it also brings
to our attention the risks involved of having different versions of
guidelines on the same subject in the same area.
In relation to guidelines on the ward, the TOFT report recommended
that all of the old guidelines be removed, A document version control and
recording system must be introduced to ensure that only the latest
editions of guidelines and procedures are available to staff and that
copies of all departmental procedures relating to chemotherapy must be
lodged in every location where they may be required for consultation (13).
The position of defective guidelines was considered in an American
case of Wickline versus State of California (14) where it was held that it
could be quite possible that guideline developers could be held negligent
if a patient suffered injury as a result of inadequate or erroneous
guidelines. In this landmark case, the California Medicaid (Medi-Cal)
programme refused a doctor’s request for additional days of patient
monitoring on the basis that they were not required under the clinical
algorithms developed by Medi-Cal. The patient was discharged and
subsequently developed complications. Cost-saving reasons had overridden
the doctor’s better clinical judgement. The patient in turn sued Medi-Cal
for medical negligence in requiring the doctor to discharge the patient
against the doctor’s better judgement for cost-containment reasons.
The court warned that doctors could be held liable where they
disregard good clinical judgement by following cost-containment guidelines
when the outcome may adversely affect the patient. It is now common to put
disclaimers on guidelines that protect the authors such as:
“This guideline is not intended to be construed or to serve as a
standard of medical care. Standards of care are determined on the basis of
all clinical data available for an individual case and are subject to
change as scientific knowledge and technology advance and patterns of care
evolve. These parameters of practice should be considered guidelines only.
Adherence to them will not ensure a successful outcome in every case, nor
should they be construed as including all proper methods of care or
excluding other acceptable methods of care aimed at the same results. The
ultimate judgement regarding a particular clinical procedure or treatment
plan must be made by the doctor, following discussion of the options with
the patient, in light of the diagnostic and treatment choices available.
However, it is advised that significant departures from the national
guideline or any local guidelines derived from it should be fully
documented in the patient’s case notes at the time the relevant decision
is taken” (15).
It can be seen that statements such as the above cover most
eventualities and offer good protection from being held ultimately
responsible for the content of the guidelines. It is submitted that it is
unlikely in the near future in the U.K. that guideline developers will be
sued.
Conclusion
Although the legal status of clinical guidelines has, to date, never
been definitively clarified by the courts, their non - observance will
reflect adversely on the person who fails to follow them. Departure from
an accepted course of practice or guideline should be justifiable,
withstand logical analysis which should probably be documented.
The test of the Standard of Care is unlikely to be superseded by a
legal standard entirely determined by the wording of a guideline without
reference to expert medical witnesses as a responsible body of medical
practitioners.
It is likely that widespread adoption of locally agreed guidelines
which reflect customary standards of care could result in clinical care
informed by guidelines becoming viewed as the norm. It is unlikely however
that, in the near future, departure from guidelines could be seen as prima
facie evidence of a case to answer.
Developments in the government's NHS strategy, particularly in
relation to health quality, means that guidelines will have a greater
influence in court in clinical negligence cases in the future.
It is submitted however that clinical practice would be safer if the
quality rather than the quantity of guidelines was addressed. As can be
surmised from the above, the quantity of guideline producing bodies has a
detrimental effect on the quality of health care and in itself increases
the risk of medical error.
Collaborative efforts by different bodies, reviewing the evidence together
and producing good quality guidelines with flexibility to apply the
guideline to the care of the individual patient is the best way forward.
Dr Farida Hamza Mohamed MD, LLM
SIGN Implementatation Co-rdinator
Lothian University Hospitals Division
Farida.Hamza-Mohamed@luht.scot.nhs.uk
1. Ellis Peter, Clinical practice Guidelines and the Law, Lamb
Chambers website, http:// www.lambchambers.co.uk/docs.art6.pdf
2.Department of Health. Clinical guidelines: using clinical
guidelines to improve patient care within the NHS. London: DOH, 22 May
1996.
3.[1997] 8 Med. L.R. 327
4.[2002] EWCA Civ 1566)
5.British Guideline on the management of Asthma January 2003
6.Hurwitz B.How does evidence based guidance influence determinations
of medical negligence?.BMJ 2004:329:1024
7.(1953) The Times, 8 December (C.A.)
8. The developing role of Clinical Guidelines, Clinical guidelines ,
Law Policy and Practice Cavendish Publishing 2002 at p 108.
9.[1994] Med LR 437
10. Bolam vs. Friern Hospital Management Committee, 2 All ER,
1957:118-28 at p 122
11.SIGN 70 Management of Epilepsy in Adults. Royal college of
Physicians of Edinburgh
12.External Inquiry into the adverse incident that occurred at
Queen’s Medical Centre, Nottingham, 4th January 2001 at P19
13.External Inquiry into the adverse incident that occurred at
Queen’s Medical Centre, Nottingham, 4th January 2001 at p46
14.1986.30
15. Statement of intent, SIGN 70, Management of Eplilepsy
Competing interests:
None declared
Competing interests: No competing interests