North of England evidence based guidelines development project: guideline for the primary care management of dementia
BMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7161.802 (Published 19 September 1998) Cite this as: BMJ 1998;317:802
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SIR - We like to make a critical comment on the recently published
elegant and promising North of England dementia guideline.1 Our point
concerns the emphasis on the use of cognitive screening tests such as the
Mini Mental Status Examination (MMSE) by General Practitioners (GPs) which
was one of the guideline's three summary points. We do not oppose to the
use of screening tests but stress that in a primary care setting GPs have
different and equally effective means to diagnose dementia. To illustrate
this we will report briefly on an evaluation study of the diagnostic
accuracy of GPs who applied the Dutch national dementia guideline for GPs,
which is developed by and for GPs.2
In this evaluation study a cross-sectional comparison was conducted
between the diagnoses of a sample of 64 GPs and an outpatient memory
clinic in the district of Nijmegen in the Netherlands. The GPs were
recruited by mailing. They appeared representative compared to the Dutch
GP population regarding age, sex and practice size.3 A case-finding
approach was used by which suspected elderly patients were diagnosed
according to the national guideline and subsequently referred to the
memory clinic. The dementia guideline held diagnostic criteria of the DSM
(3d edition revised)4 and comprised 29 diagnostic key-recommendations for
a cognitive, physical and behavioural examination. A cognitive screening
test such as the Mini Mental State Examination was optional. The memory
clinic acted as a gold standard and incorporated a multidisciplinary team
using the CAMDEX-protocol.5 We related the GPs' diagnostic accuracy to
whether or not they used the MMSE.
For the analysis of accuracy data on 93 patients were available. In
18 cases the MMSE was applied. The average application rate of the
recommendations was 86% (SD 8,6) and did not differ between the GPs who
used and those who did not use the MMSE (Mann-WhitneyU=683 p=0,3). The
overall GPs' accuracy as expressed in Cohen's kappa appeared to be 0,5
which is moderate. The use of the MMSE by a GP was not associated with a
higher diagnostic accuracy (Pearson r=0,04 p=0,4).
In conclusion, no additional value of the MMSE for achieving better
diagnostic accuracy of dementia was found in a representative group of GPs
who applied the recommendations for a diagnostic examination. Therefore,
to diagnose dementia in a general practice based setting use of the MMSE
might not be necessary when diagnostic recommendations are applied.
1.Eccles M, Clarce J, Livingstone M, Freemantle N, Mason J. North of
England evidence based guideline development project: guideline for
primary care management of dementia. Br Med J 1998;317:802-8.
2.De Bruyne GM, Meyboom-de Jong B, Muskens JB, Weytens JTNM, Wind AW. De
NHG-standaard dementiesyndroom (Guideline on dementia of the Dutch College
of General Practitioners). Huisarts & Wetenschap 1991;34:598-607.
3.Harmsen J, Hingstman L. Cijfers uit de registratie van huisartsen,
peiling 1996 (Numbers of the registration of General Practitioners in the
Netherlands). Utrecht: NIVEL, 1996.
4.DSM-III-R. Diagnostic and statistical manual of mental disorders. (3
revised ed.) Washington, DC: American Psychiatric Association, 1987.
5.Roth M, Tym E, Mountjoy CQ, et al. CAMDEX, a standardized instrument for
the diagnosis of mental disorder in the elderly with special reference to
the early detection of dementia. Br J Psychiatry 1986;149:698-709.
Competing interests: No competing interests
EDITOR – The summary version of the guideline for the primary care
management of dementia by Eccles and colleagues1 is less than adequate in
some respects, and inaccurate in others.
Although the authors stated that they did not aim to cover the area
of differential diagnosis, we believe that this is a major omission, in
view of a) the advent of treatments for Alzheimer's disease, and b) the
need for General Practitioners and other members of the primary health
care team to identify patients with vascular dementia and cognitive
impairment (as many patients with these conditions have treatable risk
factors), as well as Lewy body dementia, for which diagnostic advice is in
fact provided. In the absence of such advice, the guideline should have at
least included recommendations about referral to specialist services,
since distinguishing between the dementias is one of the most important
clinical problems we face at present, and therefore one of the areas where
guidlelines are most urgently required. Similarly, advice about when to
refer to social services is essential.
The section on physical screening failed to recommend a physical
examination, - an essential part of the assessment, eg to identify
treatable vascular risk factors. Recommended routine screening tests
should have included vitamin B12 assay and liver function tests.
The search strategy and synthesis only included the findings of
studies published up until 1996, apart from the two references cited from
1998. Thus many of the statements about drug treatment are now inaccurate,
and the recommendations misleading. Rivastigmine, licensed 6 months ago
for the treatment of Alzheimer's disease, is not even mentioned in this
section. Tacrine is not available in the UK, and velnacrine was never
licensed, - hence their inclusion in the guideline is redundant.
There is now adequate evidence that donepezil has beneficial effects
on cognitive and global functioning in some patients with Alzheimer's
disease, and these improvements may be maintained with long term use2.
Cost-analysis models suggest that overall donepezil is cost neutral3 and
therefore treatment should not be withheld on financial grounds.
The recommendation that general practitioners should not continue hospital
initiated treatment with donepezil would have been contentious in 1996,
but there is no ‘evidence based' support for this in 1998. Specialists
should initiate and supervise treatment with donepezil4, but there is no
reason why general practitioners should not continue to prescribe
donepezil if beneficial effects have been demonstrated. This section
should have been revised and updated to reflect the advances in our
knowledge over the last two years.
The recommendation about respite care includes the comment that it
does not reduce the burden or alter the stress of looking after someone
with a dementing illness. Research commissioned by the Department of
Health found that almost 80% of carers reported that respite care had made
their life better in some way5.
Finally, the guideline should reflect the fact that in many practices
the lead professional for the detection and management of dementia will be
a nurse rather than a doctor.
1 Eccles M, Clarke J, Livingstone M, Freemantle N, Mason J, for the
North of England Evidence Based Dementia Guideline Development Group.
North of England evidence based guidelines development project: guideline
for the primary care management of dementia. BMJ 1998; 317: 802-8.
2 Rogers SL, Friedhoff, LT. Long-term efficacy and safety of
donepezil in the treatment of Alzheimer's disease: an interim analysis of
the results of a US multicentre open label extension study. European
Neuropsychopharmacology, 1998; 8: 67-75.
3 Stewart A, Phillips R, Dempsey G. Pharmacotherapy for people with
Alzheimer's disease: A markov-cycle evaluation of five years therapy using
donepezil. Int J Geriatr Psychiatr 1998; 13: 445-53.
4 Standing Medical Advisory Committee. The use of donepezil for
Alzheimer's disease. 1998.. Levin E, Moriaty J, Gorbach P. Better for the
break. London: HMSO, 1994.
Rebecca Eastley, Clinical Research Fellow
Judy Haworth, Clinical Research Fellow
Gordon Wilcock, Professor in Care of the Elderly, Honorary Consultant
Physician
Department of Care of the Elderly, Frenchay Hospital, Bristol BS16 1LE
Deborah Sharp, Professor of Primary Health Care
University of Bristol, Division of Primary Health Care, Canynge Hall,
Whiteladies Road
Bristol BS8 2PR
Competing interests: No competing interests
Whilst we welcome the publication of evidence based guidelines for
the primary care management of dementia (1) we are concerned that some of
the recommendations are not based directly on the evidence cited, thus
undermining the evidence based approach. Some recommendations are quite
tentative - "General practitioners should consider using formal cognitive
testing", despite good evidence to support the recommendation. In other
sections, quite categorical statements are made - "general practitioners
should not initiate treatment with donepezil" - which are not based on any
published studies of the prescription of donepezil in primary care and
seem completely at odds with the whole purpose of such guidelines. This
advice which is out of step with the SMAC guidelines (2) is also only
based on a judgement made by the authors. The recommendation (cited as
based on category 1 evidence) - that general practitioners should not
continue hospital initiated prescriptions of donepezil is again not
founded on any published evidence. In fact there is evidence from
category I studies (3) that in patients who have responded to donepezil,
discontinuation of medication leads to clinical deterioration. This is
supported by our experience in Southampton Memory Clinic, where we have
used discontinuation of donepezil as a useful adjunct to clinical
assessment and rating scales in some patients where response was
uncertain.
If evidence is lacking, this needs to be made clear. The authors
appear to confuse no evidence of effectiveness with evidence of no
effectiveness - the two are not synonymous. Such statements which are
said to be based on evidence, but are not, lend a spurious scientific
respectability to the recommendations. This blurs the boundary between
evidence and opinion, which the article commendably aims to keep separate.
Yours sincerely
Dr H Matthews*
Consultant in Old Age Psychiatry
Western Community Hospital
Southampton
Dr D Wilkinson#
Consultant in Old Age Psychiatry
Thornhill Research Unit
Southampton
Dr C Holmes
Sen Lect in Old Age Psych
Mental Illness Group
Univ of Southampton
References
1 Eccles M., Clarke J., Livingstone M et al. North of England
evidence based guidelines development project:
guidelines for the primary care management of dementia.
BMJ 1998;317 (7161): 802-8
2. Standing Medical Advisory Committee (SMAC). The use of donepezil
for Alzheimer's disease. UK: Department of Health, April 1998.
3. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT and the
Donepezil study Group. A 24 week, double-blind placebo-controlled trial
of donepezil in patients with Alzheimer's disease. Neurology 1998; 50:
136-45.
* Dr Matthews has received a grant fron Eisai/Pfizer to support the
establishment of a Memory Clinic in Southampton
# Dr Wilkinson has been a member of Advisory boards both Eisai and
Pfizer.
Competing interests: No competing interests
EDITOR - The recent guidelines for the primary care management of
dementia(1) appear to confuse the lack of evidence of benefit with
evidence of lack of benefit regarding the effects of donepezil in
improving function in patients with dementia. Their recommendation that
GPs should not continue hospital initiated donepezil is given a strength
of A (i.e. directly based on evidence from well designed, randomised
controlled trials, meta analyses or systematic reviews). This is clearly
inconsistent with their acknowledgment of the limitations of current
knowledge of the long term benefits of this drug due to the lack
of relevant and high quality research.
We have one patient aged 63 with severe dementia who was prescribed
donepezil with considerable benefits reported by his wife. The
responsible consultant withdrew it after one year to assess whether it was
still useful. His wife reported deterioration in his functioning which
has been reversed by restarting the drug. Whilst not a placebo
controlled individual trial this is one means of assessment in the real
world. Although as gps, we have not yet been asked to prescribe this
drug, I have no doubt that if secondary care were to stop the
prescriptions we would then continue them. To fail to do so would
seriously damage our relationship with his wife, who feels she has
convincing evidence of its benefit from personal experience. To use the
guidelines to claim that "we know better" in the absence of relevant
evidence seems the height of professional arrogance.
To promote evidene based medicine is an admirable aim but loses some
credibility if it attempts to control behaviour in the vast number of
clinical situations for which hard evidence is lacking. As professionals
we must also be prepared to admit to the limits of our knowledge and share
these limitations with our patients.
William G. Tapsfield General practitioner
Collingwood Surgery, Hawkeys Lane, North Shields NE29 0SF
Diana M. Jelley General practitioner
Collingwood Surgery
BMJ 1998; 317: 802-808
Competing interests: No competing interests
Whilst Eccles et al are to be commended in drawing up a guideline for
the primary care management of dementia their stance on Donepezil is
unrealistic.
Whilst many Secondary Care specialists would be happy that General
Practitioners should not initiate treatment with Donepezil and indeed that
GPs should not automatically continue an initial hospital prescription,
there is no doubt that after three to six months some patients will
clearly improve as a result of Donepezil treatment.
Under the proposed guidelines GPs are being given the strongest
recommendation not to prescribe Donepezil for this group of patients
despite their clear response, By contrast GPs can prescribe medication
for other groups of patients in whom a one hundred per cent response to
treatment cannot be expected. Restriction of prescription of Donepezil to
hospital specialists only thus discriminates against the patient.
I would suggest that the final bullet point under the heading "Drug
Treatments" is amended to "General Practitioners should not continue
hospital initiated treatment with Donepezil until individual response
has been demonstrated".
PETER J CONNELLY
Consultant in Old Age Psychiatry
Reference
1 Eccles M, Clarke J, Linvingstone M, Freemantle N, Mason J
North of England evidence based guidelines development project: guidelines
for the primary care management of dementia BMJ 1998; 317: 802-808 (19
September)
Competing interests: No competing interests
Evidence-based guidelines have a responsibility to consider all the
relevant effective treatments and not to concentrate only on those
with which clinicians are currently familiar. In view of this I
was surprised by a serious omission from the North of England
evidence based guidelines for the primary care management of
dementia. (1) There is category I evidence for the effectiveness of
Ginkgo biloba extract (EGb) in dementia. This comes from a large
randomised controlled trial. (2) The NNT for a 4 point improvement in
ADAS-Cog at one year of follow up has been calculated as 7.9 (95% CI
4.2 to 67) and for a significant improvement in GERRI (a daily living
and social behaviour score assessed by family members) was 7.0 (95%
CI 3.3 to 97). The dose of EGb was 120mg a day. (3) It is available
over the counter and the cost of a year's treatment (from one major
supermarket) is £85. Donepezil, by contrast, is licensed only for use
in patients with dementia due to Alzheimer's disease and a year's
treatment costs £891 and £1248 for 5mg and 10mg respectively.
Yours sincerely,
Tom Marshall,
Honorary Lecturer in Public Health Medicine,
Department of Public Health and Epidemiology,
University of Birmingham,
Edgbaston,
Birmingham,
B15 2TT.
1. Eccles M., Clarke J Livingston M., Freemantle N., Mason J. North
of England evidence based guidelines development project: guideline for
the primary care management of dementia. British Medical Journal
1998;317:802-808.
2. Le Bars P.L., Katz M.M., Berman N. et al. A
placebo-controlled, double-blind, randomized trial of an extract of Ginkgo
biloba for dementia. Journal of the American Medical Association 1997;
278: 1327-32.
3. Dementia - diagnosis and treatment. Bandolier 1998; 48-2.
Conflicts of interest: none
Competing interests: No competing interests
Disputable diagnostic value of the Mini Mental Status Examination in general practice
SIR - We like to make a critical comment on the recently published
elegant and promising North of England dementia guideline.1 Our point
concerns the emphasis on the use of cognitive screening tests such as the
Mini Mental Status Examination (MMSE) by general practitioners which was
one of the guideline's three summary points. We do not oppose to the use
of screening tests but stress that in a primary care setting general
practitioners have different and equally effective means to diagnose
dementia. To illustrate this we report briefly on an evaluation study of
the diagnostic accuracy of general practitioners who applied the Dutch
national dementia guideline for general practitioners.2
In this evaluation study a cross-sectional comparison was conducted
between the diagnoses of a sample of 64 general practitioners and an
outpatient memory clinic in the district of Nijmegen in the Netherlands.
The general practitioners were recruited by mailing. They were
representative compared to the Dutch population of general practitioners
regarding age, sex and practice size.3 A case-finding approach was used by
which suspected elderly
patients were diagnosed according to the national guideline and
subsequently referred to the memory clinic. The dementia guideline held
diagnostic criteria of the Diagnostic Statistical Manual of Mental
Disorders (DSM-III-R)4 and comprised 29 diagnostic key-recommendations for
a cognitive, physical and behavioural examination. A cognitive screening
test such as the Mini Mental State Examination was optional. The memory
clinic's diagnosis acted as a gold standard. We related the general
practitioners' diagnostic accuracy to whether or not they used the Mini
Mental State Examination.
For the analysis of accuracy, data on 93 patients were available. In 18
cases the Mini Mental State Examination was applied. The average
application rate of the recommendations was 86% (SD 8,6) and did not
differ between general practitioners who used and those who did not use
the Mini
Mental State Examination (Mann-WhitneyU=683 p=0,3). The overall accuracy
as expressed in Cohen's kappa was 0,5 which is moderate. The use of the
Mini Mental State Examination was not associated with a better diagnostic
accuracy (Pearson r=0,04 p=0,4).
In conclusion, no additional value of the Mini Mental State
Examination for achieving better diagnostic accuracy of dementia was found
in a representative group of general practitioners who applied diagnostic
recommendations. Therefore, to diagnose dementia in general practice the
use of the Mini Mental State Examination may not be necessary when
diagnostic recommendations are applied.
Hein van Hout
Health scientists, research fellow
Myrra Vernooij-Dassen, PhD
Senior lecturer
Willibrord Hoefnagels, MD,
Professor in Geriatric Medicine
Richard Grol, PhD,
Professor in General Practice
Centre for Quality of Care Research
Department of General Practice and Social Medicine, and Department of
Geriatric Medicine,
University of Nijmegen,
Postbox 9101,
6500 HB Nijmegen
The Netherlands
References
1. Eccles M, Clarce J, Livingstone M, Freemantle N, Mason J. North of
England evidence based guideline development project: guideline for
primary
care management of dementia. Br Med J 1998;317:802-8.
2. De Bruyne GM, Meyboom-de Jong B, Muskens JB, Weytens JTNM, Wind AW. De
NHG-standaard dementiesyndroom [Guideline on dementia of the Dutch College
of General Practitioners]. Huisarts & Wetenschap 1991;34(13):598-607.
3. Harmsen J, Hingstman L. Cijfers uit de registratie van huisartsen,
peiling 1996 [Numbers of the registration of General Practitioners in the
Netherlands]. Utrecht: NIVEL, 1996.
4. DSM-III-R. Diagnostic and statistical manual of mental disorders. (3
revised edition) Washington, DC: American Psychiatric Association, 1987.
Competing interests: No competing interests