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September 28th 2006. Review of Treatment Guidelines. Dr Doug MacMahon Consultant Physician Royal Cornwall Hospitals NHS Trust. Agenda. Guidelines, Protocols and Care Pathways UK, Europe, USA UK Primary Care Secondary Care NICE Guideline The Diagnosis and Management of PD

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Dr doug macmahon consultant physician royal cornwall hospitals nhs trust l.jpg

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 PD+Dementia


The first guideline lord brain s diseases of the nervous system oup 1969 l.jpg

The First ‘Guideline’ Lord Brain’s 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 1998;50:S1-57

    Olanow CW, Watts RL, Koller WC. Neurology 2001:56(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 Parkinson’s 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. 2000;244(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). Neurology:56(supp5);S1-88

U.S.A


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Initiation of Treatment for Parkinson’s Disease: An Evidence-based Review

  • 1993: AAN Practice Parameter ‘levodopa wasthe most effective drug for ….. this disorder’

  • 2002: evidence-based literature review

    The authors conclude

  • 1) Selegiline has very mild symptomaticbenefit (level A, class II evidence) with no evidence for neuroprotectivebenefit (level U, class II evidence)

J. M. Miyasaki, W. Martin, O. Suchowersky, W. J. Weiner, and A. E. Lang. Neurology 2002;58:11-17 Canada / US


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Initiation of Treatment for Parkinson’s Disease: An Evidence-based Review

2) For PD patients requiringinitiation of symptomatic therapy, either levodopa or a DA canbe used (level A, class I and class II evidence). Levodopa providessuperior motor benefit but is associated with a higher riskof dyskinesia.

J. M. Miyasaki, W. Martin, O. Suchowersky, W. J. Weiner, and A. E. Lang. Neurology 2002;58:11-17 Canada


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Initiation of Treatment for Parkinson’s Disease: An Evidence-based Review

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

J. M. Miyasaki, W. Martin, O. Suchowersky, W. J. Weiner, and A. E. Lang. Neurology 2002;58:11-17 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 4;359(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 Aug;62(8):456-70 U.K.


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Patient  Carers

Role of Specialist Nurse/Key Worker

Monitor & Review

Provide information/education

Provide continuity of care

Are drugs working well?

Evidence of complications?

Is support sufficient?

G P Role

Alert for parkinsonism

Referral to specialist team

Monitor disease progression

(refer to primary care guidelines)

Specialist Role

Confirm/refute diagnosis

Monitor disease progression and drug therapy and/or surgery

(refer to secondary care guidelines)


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Parkinson’s 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) [suppl1]:S19-22


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How Long do PwPD Live?Duration of Disease

Stage PD yrs Atypical yrs

(n=59)(n= 14)

Diagnosis 1.6 ± 1.5 1.8 ± 1.8

Maintenance therapy 5.9 ± 4.8 3.0 ± 2.0

Complex4.9 ± 4.4 3.5 ± 3.5

Palliative care 2.2 ± 2.21.5 ± 1.2

Total14.6 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 Mar;114(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 Parkinson’s 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

IaSystematic review of RCTs

IbOne or more RCTs

2a One or more controlled but non-randomised study

2bOne or more quasi-experimental study

3Descriptive study(s) such as case-control study

4Expert committee reports or opinions or clinical experience of respected authorities


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Grading of Guideline Recommendations

ADirectly based on Category 1 evidence

BDirectly based on Category 2 evidence or extrapolated from Category 1 evidence

CDirectly based on Category 3 evidence or extrapolated from Category 1 or 2 evidence

DDirectly 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 <10% 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

National Collaborating Centre for Chronic Conditions30


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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 6–12 months to review their diagnosis.

National Collaborating Centre for Chronic Conditions33


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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

  • AgeChronological 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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National Collaborating Centre for Chronic Conditions38


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The Management of Parkinson’s 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 Parkinson’s 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). Neurology:56(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

Rasagiline

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 Parkinson’s disease nurse specialist (PDNS)

National Collaborating Centre for Chronic Conditions44


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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.

National Collaborating Centre for Chronic Conditions45


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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

National Collaborating Centre for Chronic Conditions46


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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

National Collaborating Centre for Chronic Conditions47


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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

National Collaborating Centre for Chronic Conditions48


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NSF – LTC Quality Requirements

  • A person centred service                        

  • Early recognition, prompt diagnosis and treatment

  • Emergency and acute management

  • Early and specialist rehabilitation

  • Community rehabilitation and support

  • Vocational rehabilitation

  • Providing equipment and accommodation

  • Providing personal care and support

  • Palliative care

  • Supporting family and carers

  • Caring for people with neurological conditions in hospital or other health and social care settings


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National Collaborating Centre for Chronic Conditions


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Implementation Tools

Plus: Audit Criteria see: www.NICE.org.uk


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