implementing nice guidance and quality standards outcomes strategy
Post on 07-May-2015
2.759 Views
Preview:
DESCRIPTION
TRANSCRIPT
Primary Care management
Chronic obstructive pulmonary disease
Implementing NICE Guidance and Quality Standards
Outcomes StrategyAdditional information can be found at
www.copdeducation.org.uk
On behalf of the Southampton COPD Group
Outcomes strategy
• July 2011• Asthma as well as COPD• Improve Respiratory Health• Reduce number who develop COPD• Reduce premature death• Improve QOL• Safe and effective care• Asthmatics: free of Symptoms; Action Plans• QOF mMRC, SaO2 and PR• NICE quality standards
COPD Main Components
• Smoking
• Immunology
• Microbiology – Bacteria and Virus
• Individual – activity, co morbidities, BMI
NICE STANDARDS
• Diagnostic Quality Standards
• Therapy Quality Standard
• Exacerbation Quality Standard
• Assessment Quality Standard
• Rehabilitation Quality Standard
• End of life Quality Standard
NICE Quality outcome - spiro
• People with COPD have one or more indicative symptoms recorded, and have the diagnosis confirmed by post-bronchodilator spirometry carried out on calibrated equipment by healthcare professionals competent in its performance and interpretation.
Competencies
• What level?• Education for health• Respiratory Education UK• Skills for Health
• http://www.skillsforhealth.org.uk/service-area/copd/
Definition of COPD
• Airflow obstruction is defined as reduced FEV1/FVC ratio (< 0.7)
• It is no longer necessary to have an FEV1 < 80% predicted for definition of airflow obstruction
• If FEV1 is ≥ 80% predicted, a diagnosis of COPD should only be made in the presence of respiratory symptoms, for example breathlessness or cough
FEV1 = forced expiratory volume in 1 second FVC = forced vital capacity
Diagnose COPD: 1
• The presence of airflow obstruction should be confirmed by performing post-bronchodilator spirometry [new 2010]
• All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of the results [2004]
Diagnose COPD: 2
• Assess severity of airflow obstruction using reduction in FEV1
NICE clinical guideline 12
(2004)
ATS/ERS 2004 GOLD 2008 NICE clinical guideline 101
(2010)
Post-bronchodilator
FEV1/FVC
FEV1 % predicted
Post-bronchodilator
Post-bronchodilator
Post-bronchodilator
< 0.7 80% Mild Stage 1 (mild) Stage 1 (mild)*
< 0.7 50–79% Mild Moderate Stage 2 (moderate)
Stage 2 (moderate)
< 0.7 30–49% Moderate Severe Stage 3 (severe) Stage 3 (severe)
< 0.7 < 30% Severe Very severe Stage 4 (very severe)**
Stage 4 (very severe)**
* Symptoms should be present to diagnose COPD in people with mild airflow obstruction** Or FEV1 < 50% with respiratory failure
[new 2010]
Asthma or COPD
• To help resolve cases where diagnostic doubt occurs, or both COPD and asthma are present, the following findings should be used to help identify asthma:
• 1. a large (> 400 ml) response to bronchodilators
• 2. a large (> 400 ml) response to 30 mg oral prednisolone daily for 2 weeks
• 3. Serial peak flow measurements showing 20% or greater diurnal or day-to-day variability. (NICE 2010)
Other tests to confirm the diagnosis in the new patient
CXR – excludes other conditions
BMI – Big predictor in mortality terms but only in moderate and severe disease
FBC - Polycythaemia Anaemia
“It has generally been assumed that individuals with the lowest FEV1 were also progressing the fastest as they had ‘‘clearly’’ lost more function than individuals with more normal lung function. However, evidence is accumulating that this assumption is in error, making it essential to distinguish between severity and activity”
JØRGEN VESTBO 2010
What is the decline in mls/yr ?
TORCH UPLIFT
Gold II 60 49
Gold III 56 41
Gold IV 34 31
ECLIPSEEvaluation of copd longitudinally to identify
predictive surrogate endpoints
NEJM 2011
ECLIPSE
• 2138 Patients• Followed up for 3 years• Baseline, 3,6,12,18, 24, 30, 36 months• Hypothesis was that there was a frequent
exacerbation phenotype• Cost >£300m
Results
• Best predictor of an exacerbation in the first year was
• A treated exacerbation in the year before study entry OR 4.30
• MRC Score OR 1.83• GOLD Stage OR 1.74• Fibrinogen 1.35
FEV1 ECLIPSE
Assessment
• People with COPD have a comprehensive clinical and psychosocial assessment, at least once a year or more frequently if indicated, which includes degree of breathlessness, frequency of exacerbations, validated measures of health status and prognosis, presence of hypoxaemia and comorbidities.
• CAT • BODE• mMRC• BMI
• SaO2
Nice outcomes - therapy
• People with COPD have a current individualised comprehensive management plan
• People with COPD are offered inhaled and oral therapies, in accordance with NICE guidance, as part of an individualised comprehensive management plan
Promote effective inhaled therapy
• In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as required, offer the following as maintenance therapy:
• if FEV1 ≥ 50% predicted: either LABA or LAMA
• if FEV1 < 50% predicted: either LABA+ICS in a combination inhaler, or LAMA
• Offer LAMA & LABA+ICS to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS,
• Triple therapy not dependent on FEV1
• Inhaler technique and ability to activate the device
ICS = inhaled corticosteroidLABA = long-acting beta2 agonist
LAMA = long-acting muscarinic agonist[new 2010]
Therapy
New treatment
New documents
Self Management plan
Self Management plan
• Target airflow limitation → bronchodilating by altering airway smooth muscle tone
• Improve emptying of the lung
• Ideally: reduce hyperinflation at rest and during exercise
GOLD 2011. Available from: www.goldcopd.org Spencer et al. Cochrane Database Syst Rev 11;10:CD007033
Bronchodilators are the cornerstoneof COPD treatment
GOLD 2011: Pharmacologic management of COPD*‡
(C) (D)
LABA+ICS or LAMA LABA+ICS or LAMA
LABA and LAMALABA+ICS and LAMA or
LABA+ICS and PDE4-inh orLABA and LAMA orLAMA and ICS or
LAMA and PDE4-inh
SABA or SAMA prn LABA or LAMA
LABA or LAMA orSABA and SAMA
LABA and LAMA
(A) (B)
GOLD 1
GOLD 2
GOLD 3
GOLD 4
mMRC ≥2CAT ≥10
mMRC 0−1 CAT <10
Exacerbations per year
≥2
First choice; Second choice
0
1
GOLD 2011
Bronchodilators
Long acting bronchodilators are beneficial in not just in terms of improving FEV1 and reducing exacerbations but also by reducing resting and dynamic hyperinflation
There is a potential benefit in combining long acting bronchodilators from different pharmacological classes in COPD patients (LABA and LAMA)
Dynamic Hyperinflation
Exercise
Overview of bronchodilators approved in the last 5 years and in development for treatment of COPD
QD = once daily; BID = twice daily
Drug Class Route Company Development stage
Indacaterol LABA Inhaled, QD Novartis Approved
Olodaterol LABA Inhaled, QD BI Phase III
Vilanterol LABA Inhaled, QD Theravance/GSK Phase II
Aclidinium LAMA Inhaled, BID Almirall/Forest Approved
Glycopyrronium LAMA Inhaled, QD Novartis Approved
The role of inhaled corticosteroids in COPD
Where do they fit?
GOLD 2011: Pharmacologic management of COPD*‡
(C) (D)
LABA+ICS or LAMA LABA+ICS or LAMA
LABA and LAMALABA+ICS and LAMA or
LABA+ICS and PDE4-inh orLABA and LAMA orLAMA and ICS or
LAMA and PDE4-inh
SABA or SAMA prn LABA or LAMA
LABA or LAMA orSABA and SAMA
LABA and LAMA
(A) (B)
GOLD 1
GOLD 2
GOLD 3
GOLD 4
mMRC ≥2CAT ≥10
mMRC 0−1 CAT <10
Exacerbations per year
≥2
First choice; Second choice
0
1
GOLD 2011
Inhaled Corticosteroids
• Recommended prescription in combination with LABA in patients with FEV1<50% and exacerbations
• Reduce exacerbation frequency by approximately 25% in most studies in patients of this phenotype
• They are however overprescribed in COPD (often as monotherapy where there is limited evidence of efficacy)
Clinical trial data show that many patients with moderate COPD are receiving ICS (1)
GOLD
I II III IV
Long-acting bronchodilators 61.8 67.3 69.3 65.1
SAMA 41.7 50.7 59.9 47.6
SABA 68.8 76.3 78.9 73.2
ICS 63.7 67.2 72.5 66.2
Theophyllines 24.7 34.9 36.1 30.5
Tashkin, et al. ATS 2006SAMA = short-acting muscarinic antagonist SABA = short-acting β2-agonist; ICS = inhaled corticosteroid
*Total includes six Stage I (mild) patients
Secondary endpoint:Change from baseline post-bronchodilator FEV1 (L)
-2 10 22 34 46 58 70 82 94 106
Chan
ge in
Pos
t-do
se F
EV1 (
L)
Treatment
TIO
SFC
P=0.2180.01
0.03
0.05
0.07
0.09
0.1
0.02
0.04
0.06
0.08
Wedzicha et al AJRCCM 2008
Time to First Pneumonia adverse event
Cox Hazard Ratio 95% CI p-valueSFC vs TIO 1.94 (1.19, 3.17) 0.008
0 13 26 39 52 65 78 91 104
01
23
456
78
1112
Pro
bab
ility
of
Eve
nt (
%)
Time to Event (Weeks)
Treatment
910
TIO
SFC
Wedzicha et al AJRCCM 2008
Nice outcome - smoking
• People with COPD who smoke are regularly encouraged to stop and are offered the full range of evidence-based smoking cessation support.
Stop smoking
• Encouraging patients with COPD to stop smoking is one of the most important components of their management
• All COPD patients still smoking, regardless of age, should be encouraged to stop, and offered help to do so, at every opportunity
• Record a smoking history, including pack years smoked
• Offer nicotine replacement therapy, varenicline or bupropion (unless contraindicated) combined with a support programme to optimise quit rates [2010]
[2004]
Intervention Stop Smoking
FRESH
• http://www.freshne.com/
• http://www.freshne.com/everybreath/
Nice Outcomes - oxygen
•People with COPD potentially requiring long-term oxygen therapy are assessed in accordance with NICE guidance by a specialist oxygen service.
•People with COPD receiving long-term oxygen therapy are reviewed in accordance with NICE guidance, at least annually, by a specialist oxygen service as part of the integrated clinical management of their COPD
Long term oxygen therapy –who?
•FEV1 < 30% predicted
•Cyanosis
•Polycythaemia.
•Peripheral oedema.
•Raised jugular venous pressure.
•Oxygen saturations < 92% on air.
Ambulatory
• For people with LTOT
• Maximises the hours of oxygen
• Some use in significant de-saturators
• May have use in exercise classes
Nebulisers
• Mainstay of therapy should be by a conventional inhaled route.
• Majority of patients get little added benefit from nebulisers.
• Consider nebulisers if:• Patient lacks dexterity to use
inhalers.• Patient has cognitive
impairment.• Patient has severe COPD and is
still symptomatic despite high dose inhaled bronchodilator therapy.
Nice outcome - rehab
• People with COPD meeting appropriate criteria are offered an effective, timely and accessible multidisciplinary pulmonary rehabilitation programme.
Provide pulmonary rehabilitation
Pulmonary rehabilitation
An individually tailored multidisciplinary programme of care to optimise patients’ physical and social performance and autonomy
Tailor multi-component, multidisciplinary interventions to individual patient’s needs
Hold at times that suit patients, and in buildings with good access
Offer to all patients who consider themselves functionally disabled by COPD
Make available to all appropriate people, including those recently hospitalised for an acute exacerbation
[new 2010]
What does it achieve ?
• Pulmonary rehabilitation• Reduces the number of hospital days• Reduces health-care utilization • Increases exercise tolerance• Reduces need for 02• Reduces exacerbation frequency
NICE outcome - exacerbations
• People who have had an exacerbation of COPD are provided with individualised written advice on early recognition of future exacerbations, management strategies (including appropriate provision of antibiotics and corticosteroids for self-treatment at home) and a named contact.
• People admitted to hospital with an exacerbation of COPD are cared for by a respiratory team, and have access to a specialist early supported- discharge scheme with appropriate community support.
• People admitted to hospital with an exacerbation of COPD and with persistent acidotic ventilatory failure are promptly assessed for, and receive, non-invasive ventilation delivered by appropriately trained staff in a dedicated setting.
• People admitted to hospital with an exacerbation of COPD are reviewed within 2 weeks of discharge.
Managing exacerbations
• Minimise impact of exacerbations by:
•- giving self-management advice on responding promptly to symptoms of exacerbation
•- starting appropriate treatment with oral steroids and/or antibiotics
• The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, and vaccinations
[2004]
End of life outcome
•People with advanced COPD, and their carers, are identified and offered palliative care that addresses physical, social and emotional needs.
top related