Dr Doug MacMahon

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September 28th 2006
Review of Treatment Guidelines

• Dr Doug MacMahon
• Consultant Physician
• Royal Cornwall Hospitals NHS Trust

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Agenda

• Guidelines, Protocols and Care Pathways
• UK, Europe, USA
• UK
• Primary Care
• Secondary Care
• NICE Guideline
• The Diagnosis and Management of PD
• Relevance/recognition of NMS
• Treatment Options
• Management of PDDementia

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The First Guideline Lord Brains Diseases of
the Nervous System OUP 1969

• The sufferer should be encouraged to lead an
  active life as long as possible but should avoid
  fatigue. A zip fastener on the trousers is a
  convenience.
• L-dopa in doses up to 5 grams looks promising

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So, what is a Guideline?
Clinical guidelines are systematically developed
statements designed to help practitioners and
patients decide on appropriate healthcare for
specific clinical conditions and/or
circumstances Field MJ, Lohr KN. Guidelines for
Clinical Practice from development to use.
Washington DC National Academic Press, 1992.
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Guidelines

• For Whom?
• Generalists / Specialists / Medics / Clinicians
• Patients / Carers
• When produced - how current?
• How Independent?
• Evidence-based, or consensus, or what?
• Utility?

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Protocols and Care Pathways - ways to incorporate
Guidelines into everyday practice - of varying
effectiveness

• Guidelines
• Guidelines reduce unacceptable or undesirable
  variations in practice and provide a focus for
  discussion among health
• professionals and patients. They can
• enable professionals from different disciplines
  to agree treatment and devise a quality framework
  against which practice can be measured
• help commissioners and purchasers to make
  informed decisions
• and provide managers with a useful framework for
  assessing treatment costs.

Protocols Protocols are rigid statements allowing
little or no flexibility or variation. It sets
out a precise sequence of activities to be
adhered to in the management of a specific
clinical condition. It has a logical sequence
and precision of listed activities.
Care Pathways Care pathways determine locally
agreed, multidisciplinary practice, based on
guidelines and evidence where available, for a
specific patient/client group. Care pathways
form all or part of the clinical
record, document the care given and help to
evaluate outcomes for continuous quality
monitoring
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Why Guidelines?

• Decision support- attempting to spread wisdom,
  bring people up to the best practice
• Promulgation of an evidence base- usually
  embedded in Guidelines nowadays
• Set standards to be audited against
• Describe/discourage poor practice

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Parkinson's Disease Guidelines (previous attempts)

• U.S. Algorithms
• CW Olanow,W. Koller et al Neurology 199850S1-57
  
• Olanow CW, Watts RL, Koller WC. Neurology
  200156(supp5)S1-88
• U.K. Guidelines (Specialist)
• K Bhatia, D. Brooks et al. Hospital Medicine,
  June 1998
• Bhatia K, Brooks DJ, et al. Updated guidelines
  for the management of Parkinsons disease.
  Hospital Medicine 2001(Aug) 62(8) 456-470
• Primary Care Guidelines
• PD Aware in Primary Care. PDS,
  London.1998, 1999
• Parkinson's integrating the primary and
  secondary care guidelines
• D MacMahon, D Brooks, R Smith. Practitioner.
  2000244(1609)370-8.

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• Olanow CW, Watts RL, Koller WC. An Algorithm
  (Decision Tree) for the Management of Parkinson's
  Disease (2001). Neurology56(supp5)S1-88
• U.S.A

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Initiation of Treatment for Parkinsons Disease
An Evidence-based Review

• 1993 AAN Practice Parameter levodopa was the
  most effective drug for .. this disorder
• 2002 evidence-based literature review
• The authors conclude
• 1) Selegiline has very mild symptomatic benefit
  (level A, class II evidence) with no evidence for
  neuroprotective benefit (level U, class II
  evidence)

J. M. Miyasaki, W. Martin, O. Suchowersky, W. J.
Weiner, and A. E. Lang. Neurology 20025811-17
Canada / US
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Initiation of Treatment for Parkinsons Disease
An Evidence-based Review

• 2) For PD patients requiring initiation of
  symptomatic therapy, either levodopa or a DA can
  be used (level A, class I and class II evidence).
  Levodopa provides superior motor benefit but is
  associated with a higher risk of dyskinesia.

J. M. Miyasaki, W. Martin, O. Suchowersky, W. J.
Weiner, and A. E. Lang. Neurology 20025811-17
Canada
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Initiation of Treatment for Parkinsons Disease
An Evidence-based Review

• 3) No evidence was found that initiating
  treatment with sustained-release levodopa
  provides an advantage over immediate-release
  levodopa (level B, class II evidence)

J. M. Miyasaki, W. Martin, O. Suchowersky, W. J.
Weiner, and A. E. Lang. Neurology 20025811-17
Canada
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Treatment Interventions for Parkinson's Disease
an Evidence Based Assessment

• The amount of evidence was sufficient to conclude
  that several interventions were efficacious.
  Frequently, when an intervention was not
  classified as having an established efficacy, the
  primary limitation was the absence of enough data
  from clinical trials to clearly judge.

Rascol O, Goetz C, Koller W, Poewe W, Sampaio C.
Lancet 2002 May 4359(9317)1589-98
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The First U.K. Guidelines Document

• Consensus on four main areas
• Diagnosis and recognition
• Treatment options and algorithm
• Long-term management issues
• Multidisciplinary approach

K Bhatia, D. Brooks et al. Hospital Medicine,
June 1998
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Updated Guidelines for the Management of PD

• New data on diagnosis, drug therapy, surgery and
  psychosocial concerns have emerged since the
  publication of the 1998 Guidelines for the
  Management of Parkinson's Disease.
• This article reviews new data and addresses
  issues left unanswered in the previous guidelines
• Consensus (great good) Sponsored

Bhatia K, Brooks DJ, Burn DJ, Clarke CE, Grosset
DG, MacMahon DG, Playfer J, Schapira AH, Stewart
D, Williams AC Parkinson's Disease Consensus
Working Group. Hosp Med 2001 Aug62(8)456-70 U.K.
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Parkinsons Aware in Primary Care!

• Based on disease management paradigm
• Double-sided A4 laminated sheet
• to all GPs
• followed by revision (1999)
• commissioning guide
• Moving and Shaping PDS 1999
• Aim to heighten awareness
• Information on PD
• Prevalence, Clinical features
• Concepts of team working
• Notes on drug therapy
• and contra-indicated drugs

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4 stage clinical management scale

• Diagnosis
• Maintenance therapy
• Complex
• Palliative care

• MacMahon DG Thomas S J Neurology (1998)
  suppl1S19-22

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How Long do PwPD Live?Duration of Disease

• Stage PD yrs Atypical yrs
• (n59) (n 14)
• Diagnosis 1.6 1.5 1.8 1.8
• Maintenance therapy 5.9 4.8 3.0 2.0
• Complex 4.9 4.4 3.5 3.5
• Palliative care 2.2 2.2 1.5 1.2
• Total 14.6 9.8
• Mean Age at onset 64

So, a long term strategy is required even for
older patients
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Parkinson's Disease Therapy Treatment of Early
and Late Disease

• CONCLUSION
• The medical and surgical treatment of patients
  with PD must be individualized and tailored to
  the needs of the individual patient.

Jankovic J. Chin Med J (Engl) 2001
Mar114(3)227-34
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Ideally, Review Should Be Integral to Design
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A good Guideline would be

• Valid leading to the results expected of them.
• Reproducible if using the same evidence, other
  guideline groups
• would come to the same results.
• Cost-effective reducing the inappropriate use
  of resources.
• Representative/multidisciplinary by involving
  key groups and
• their interests.
• Clinically applicable patient populations
  affected should be
• unambiguously defined.
• Flexible by identifying the expectations
  relating to
• recommendations as well as patient
  preferences.
• Clear unambiguous language, which is readily
  understood by
• clinicians and patients, should be used.
• Reviewable the date and process of review
  should be stated.
• Amenable to clinical audit the guidelines
  should be capable of
• translation into explicit audit
  criteria.

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• Parkinson's disease diagnosis, management and
  treatment of Parkinson's disease in primary and
  secondary care
• First Guidelines Meeting March 2004
• Issued June 2006 www.NICE.org.uk

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Full Guideline - for reference
Quick Reference Guide - what everyone actually
reads
For patients!
NICE Parkinsons Disease Guidelines website

http//www.nice.org.uk/
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PD Guideline ProcessDevelopment

• Follows principles of evidence-based medicine
• Systematic review of literature in each area
• Classify evidence according to hierarchy of
  evidence
• Appraise evidence using meta-analysis if
  appropriate
• Use Guideline Development Group to develop
  opinion leader advice to fill the gaps in the
  evidence but explicitly label as such

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Hierarchy of Evidence

• Ia Systematic review of RCTs
• Ib One or more RCTs
• 2a One or more controlled but non-randomised
  study
• 2b One or more quasi-experimental study
• 3 Descriptive study(s) such as case-control
  study
• 4 Expert committee reports or opinions or
  clinical experience of respected
  authorities

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Grading of Guideline Recommendations

• A Directly based on Category 1 evidence
• B Directly based on Category 2 evidence or
  extrapolated from Category 1 evidence
• C Directly based on Category 3 evidence or
  extrapolated from Category 1 or 2 evidence
• D Directly based on Category 4 evidence or
  extrapolated from Category I, 2 or 3 evidence

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Diagnosis and Early Advice

• Aims to secure an accurate diagnosis plan
  management including drugs, and
  education to maintain good health
• On suspicion of diagnosis - what to do?
• The task force recommends referral for
• confirmation of the diagnosis
• ongoing planning of appropriate management,
  including drugs and review arrangements primary
  or secondary care
• To whom?
• What not to do - start treatment

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Is the Diagnosis Easy?

• 50 error rate in primary care
• 25 error in secondary care
• Reduced to lt10 with use of UKPDS BB criteria
• (plus retrospectoscope!)

Meara Hughes, Lees
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KEY PRIORITIES FOR IMPLEMENTATION

• Referral to expert for accurate diagnosis
• People with suspected PD should be referred
  quickly and untreated to a specialist with
  expertise in the differential diagnosis of this
  condition.
• The GDG considered that people with suspected
  mild PD should be seen within 6 weeks but new
  referrals in later disease with more complex
  problems require an appointment within 2 weeks

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Guidelines for Primary Care (UK) Referral

• Refer to local specialist with interest and
  knowledge of the disease to confirm diagnosis
• This may be
• a local neurologist,
• a local geriatrician or,
• a local physician with an interest or,
• a more distant specialist in the disease
• Key point is the expertise of the specialist and
  availability and accessibility of the
  multi-disciplinary team, especially in the later
  stages of the disease

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Differential Diagnosis

• Presence of red-flags
• early bulbar or gait disorder
• early autonomic failure, cerebellar, eye signs
• cognitive ?, hallucinations
• lack of therapeutic response
• Alert for overlapping conditions
• essential tremor
• drug-induced parkinsonism
• Is imaging useful?
• Sometimes CT, MRI, SPET, PET, DATSCAN

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KEY PRIORITIES FOR IMPLEMENTATION

• Diagnosis and expert review
• The diagnosis of PD should be reviewed regularly
  and reconsidered if atypical clinical features
  develop.
• Acute levodopa and apomorphine challenge tests
  should not be used in the differential diagnosis
  of parkinsonian syndromes.
• The Guideline Development Group considered
  that people diagnosed with PD should be seen at
  regular intervals of 612 months to review their
  diagnosis.

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With what?
NICE PD Guidelines 2006
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Guidelines Recommendation

• It is prudent to delay treatment with levodopa
  provided that adequate relief can be achieved
  with other treatment strategies
• Dopamine agonists are recommended as a
  first-line alternative to levodopa in appropriate
  patients

• K Bhatia, D. Brooks et al. Hospital Medicine,
  June 1998

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Factors - Selection of Drug Regimen

• Age Chronological or Biological?
• Physical Impairment, Disability, or Handicap?
• Neuroprotection
• Avoidance of Dyskinesia, Fluctuations
• Urgency of Need versus Long Term Result
• Concomitant Disease Treatment
• Coprescribed drugs
• Cardiovascular
• Neuro-psychiatric
• Anxiety, Hallucinations, Confusion, Dementia

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The Management of Parkinsons Disease
Cognitive impairment or comorbidities ABSENT
Cognitive impairment or comorbidities PRESENT
Full Page Slide at Rear of Section
Adapted from Olanow CW, Watts RL, Koller WC. An
algorithm (decision tree) for the management of
Parkinsons disease (2001) Treatment guidelines.
Neurology 2001 56 (11, Suppl 5).
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Wearing Off

• Definition of Wearing Off - poorly recognised
• Distinction from Dyskinesia, Dystonia, on-off
• Patients often clearer than Generalist Doctors
  Nurses
• Importance of Patient Education

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• Olanow CW, Watts RL, Koller WC. An Algorithm
  (Decision Tree) for the Management of Parkinson's
  Disease (2001). Neurology56(supp5)S1-88

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Rx Is Even more difficult in Late disease!
Adapted from Draft NICE Guidelines March 2006
Options Include Agonists MAO(b)I Selegiline Ra
sagiline COMTI Entacapone Tolcapone (NB LFTs)
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KEY PRIORITIES FOR IMPLEMENTATION

• Regular access to specialist nursing care
• People with PD should have regular access to the
  following
• Clinical monitoring and medication adjustment
• A continued point of contact for support,
  including home visits, when appropriate
• A reliable source of information about clinical
  and social matters of concern to people with PD
  and their carers,
• which may be provided by a Parkinsons disease
  nurse specialist (PDNS)

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KEY PRIORITIES FOR IMPLEMENTATION

• Access to physiotherapy
• Physiotherapy should be available for people
  with PD. Particular consideration should be given
  to
• Gait re-education, improvement of balance and
  flexibility
• Enhancement of aerobic capacity
• Improvement of movement initiation
• Improvement of functional independence, including
  mobility and activities of daily living
• Provision of advice regarding safety in the home
  environment.

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KEY PRIORITIES FOR IMPLEMENTATION

• Access to occcupational therapy
• Occupational therapy should be available for
  people with PD. Particular consideration should
  be given to
• Maintenance of work and family roles, employment,
  home care and leisure activities
• Improvement and maintenance of transfers and
  mobility
• Improvement of personal self-care activities such
  as eating, drinking, washing and dressing
• Environmental issues to improve safety and motor
  functions
• Cognitive assessment and appropriate intervention

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KEY PRIORITIES FOR IMPLEMENTATION

• Access to speech and language therapy
• Speech and language therapy should be available
  for people with PD. Particular consideration
  should be given to
• Improvement of vocal loudness and pitch range,
  including speech therapy programmes such as Lee
  Silverman Voice Treatment (LSVT)
• Teaching strategies to optimise speech
  intelligibility
• Ensuring an effective means of communication is
  maintained throughout the course of the disease,
  including use of assistive technologies
• Review and management to support the safety and
  efficiency of swallowing and to minimise the risk
  of aspiration

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KEY PRIORITIES FOR IMPLEMENTATION

• Palliative care
• Palliative care requirements of people with PD
  should be considered throughout all phases of the
  disease.
• People with PD and their carers should be given
  the opportunity to discuss end-of-life issues
  with appropriate healthcare professionals

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NSF LTC Quality Requirements

1. A person centred service                        
2. Early recognition, prompt diagnosis and treatment
   
3. Emergency and acute management
4. Early and specialist rehabilitation
5. Community rehabilitation and support
6. Vocational rehabilitation
7. Providing equipment and accommodation
8. Providing personal care and support
9. Palliative care
10. Supporting family and carers
11. Caring for people with neurological conditions in
    hospital or other health and social care settings

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Implementation Tools
KEY REQUIREMENT Assessment Action by whom/when
1 People with suspected PD should be referred quickly (lt6/52) and untreated to a specialist with expertise in the differential diagnosis of this condition.
2 The diagnosis of PD should be reviewed regularly (612 months to review their diagnosis) and reconsidered if atypical clinical features develop.
3 People with PD should have regular access to .. Parkinsons disease nurse specialist (PDNS)
4 Physiotherapy should be available for people with PD. Locations?? 1y, 2y
5 Etc.Palliative
Plus Audit Criteria see
www.NICE.org.uk
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