Transcript REG-Arch-Presentation_15-Feb-13_REG-studies

Studies in progress
Studies already under the REG umbrella:
David Price
REG studies underway
1.
Asthma endpoint validation study
2.
Predictors of asthma risk patient characteristics associated with the
“frequent exacerbator phenotype”
3.
Add-on therapy in paediatric asthma
4.
Mortality risk associated with NRT
5.
UK Department of Health collaborations:
a) Active comorbidities at time of COPD diagnosis
b) “Missed diagnostic opportunities”: Patterns in healthcare resource
utilisations in the years preceding a COPD diagnosis
6.
Trajectories of diagnosis and treatment for obstructive airways disease
following patient presentation
7.
Real-life exploration of disease patterns and management approaches in
idiopathic pulmonary fibrosis
Validation of real-life asthma endpoints
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Aim: to validate a series of objective of asthma control measures that
have been used in published real-life respiratory research.
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The outcome measures will be:
o compared and contrasted to patient-reported outcomes and/or goldstandard, validated asthma control tools and measures (as appropriate).
o Assessed in terms of their relevance, responsiveness and predictive value
o A rank order of outcomes (and possibly hierarchical modelling) will be
established to aid in appropriate outcome selection for future studies.
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Outcomes to be evaluated include composite and proxy measures of:
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Asthma control
Severe exacerbations
Proxies for treatment success (control + no change in therapy)
Hospitalisations
ICS compliance (including medication possession ratio)
Controller-to-reliever ratio
Oral thrush
Predictors of asthma risk
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Hypothesis: there is a frequent-exacerbation phenotype in asthma that results in
increased risk of asthma exacerbations. It may be possible to identify patients with
this phenotype using routine data collected in primary care.
Populations of interest: high risk and low risk
Study design:
o Phase I:
A descriptive analysis of longitudinal patient data. Prescribed oral steroid
courses will be mapped for all asthma patients over a 5-year period.
– Data will be tabulated for all 5 years, but split by year.
– A distribution of oral steroid prescriptions will be produced
– Frequent exacerbators within the population will be identified
– A similar table will be produced for all acute lower respiratory events to
include aggregated steroid courses and antibiotic treated episodes and
disaggregated events
o Phase II: Investigation of individual patient characteristics associated with the
frequent asthma exacerbation phenotype (vs controls)
o Phase III: Multivariate modelling to weight individual characteristics and
identify a possible composite group of characteristics strongly associated with
frequent asthma exacerbations (that could be used to inform a clinical
decision support tool)
Add-on therapy in paediatric asthma (I)
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Objectives: to investigate the relationships between asthma control in
paediatric patients and :
o Primary: therapy step-up (i.e. addition of LABA, LTRA or ICS dose
increase)
o Secondary: change in inhaler type (i.e. DPI to MDI, DPI to MDI)
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Study population: patients with asthma aged 5–12 years
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Outcome period: 12 months
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Data cut / study period: Jan 1990–Dec 2010
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Data source: Clinical Practice Research Database (CPRD) & Optimum
Patient Care Database (OPCRD)
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Outcome measures: Severe exacerbations (ATS/ERS-defined and clinical
definition); rate control (risk domain asthma control impairment; treatment
success; hospitalisations; adherence to ICS; SABA usage; oral thrush)
Mortality risk associated with NRT
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Matched cohort study to evaluate cardiovascular disease risk following
exposure to pharmacological smoking cessation interventions in a real-life
UK primary care population
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Exposed patients:
o Smokers with no past history of CVD whose first recorded smoking cessation
intervention was a cessation attempt assisted by one of the following
pharmacological smoking cessation interventions at NRT as any, or a
combination, of
– transdermal patches
– nasal spray
– gum and tablets
– inhaler
o Other pharmacological smoking cessation interventions (e.g. bupropion,
varenicline).
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Non-exposed patients: smokers with no past history of CVD or prior
cessation attempts whose first recorded smoking cessation intervention
involved receipt of smoking cessation advice (not pharmacological therapy)
Mortality risk associated with NRT
• Matched analyses:
o Smoking cessation advice vs NRT
o NRT vs other pharmacological methods (e.g. bupropion,
varenicline)
o Smoking cessation advice vs other pharmacological (e.g.
bupropion, varenicline)
• Outcomes
o Primary outcome: CV event during 4-week outcome period
o Secondary Outcome: CV event during 52-week outcome period
o Tertiary Outcomes: at any time after IPD
Active comorbidities at the time of
diagnosis of COPD
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Background: A collaborative observational study carried out by the UK
Department of Health and Research in Real Life collaborative and
independent respiratory experts
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Presented: ERS, Amsterdam September 2011
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Rationale: Comorbidities can potentiate the morbidity of chronic obstructive
pulmonary disease (COPD), and vice versa. Patients with COPD often die
as a result of a comorbidities.
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Objectives: Evaluate prevalence of comorbidities at COPD diagnosis in
real-world patients over a 10-yr period.
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Authors: D Price*, R Jones, D Halpin, R Winter, SL Hill, E Bateman, D
Freeman, M Kearney, K Holton, A Moger, A Burden, J von Ziegenweidt, L
Mascarenhas, A Chisholm, D Ryan
Active COPD comorbidities: conclusions (I)
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The data confirm that active comorbidities are common at the time of COPD
diagnosis.
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Trends over the study period suggest:
o Constant diagnosis of asthma
o Increased prevalence of active comorbidities
o Association between presence of comorbidities and milder COPD at
time of diagnosis
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The increased prevalence of active comorbidities at the time of COPD
diagnosis may indicate:
o Increased awareness of comorbidities
o Improved diagnosis of COPD in patients treated for comorbidities
o Effects of national targets, e.g. UK Quality and Outcomes Framework.
Active COPD comorbidities: conclusions (II)
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Close monitoring of patients with existing conditions present opportunity for
earlier COPD identification and diagnosis.
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Decision support prompts:
o Patients with a positive smoking history and either:
– IHD and/or
– Diabetes
o should be evaluated for presence of COPD as part of their reviews
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Integrated, holistic management of patients with COPD (≥GOLD II) is
required to optimise care and minimse the morbidity and mortality of
patients with COPD (e.g. reduce myocardial infractions and strokes for
those COPD patients with comorbid IHD).
Missed opportunities to diagnose COPD
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Background: A collaborative observational study carried out by the UK
Department of Health and Research in Real Life collaborative and
independent respiratory experts
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Presented: ERS, Amsterdam September 2011
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Rationale: Early diagnosis and intervention in the management of
symptomatic chronic obstructive pulmonary disease (COPD) may reduce
the associated impact on patients and economic burden on health systems.
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Objectives: Characterise healthcare utilisation in the yrs preceding a
definitive COPD diagnosis to identify “red flags” that may aid in earlier
diagnosis.
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Authors: D Price*, R Jones, D Halpin, R Winter, SL Hill, E Bateman, D
Freeman, M Kearney, K Holton, A Moger, A Burden, J von Ziegenweidt, L
Mascarenhas, A Chisholm, D Ryan
Missed opportunities to diagnose
COPD: conclusions (I)
Opportunities to diagnose COPD are being missed:
• In UK primary care
o e.g. Chest X-rays rather than spirometry
• In secondary care
o both in respiratory outpatients and admissions
• Further investigations are required on:
o Variability of care in the UK
o Educational deficits
o Key to changing clinical behaviour
Missed opportunities to diagnose
COPD: conclusions (II)
• Be wise before the event
• Current work to improve earlier diagnosis includes:
o Service evaluations of routinely collected data: remote
identification of patients at risk having COPD
o Decision support software: identify patterns around
respiratory consultations, risk factors and prescribing–
prompts assessment automatically generated
o Resource assessment: does improvement in early
diagnosis justify investment by commissioners
Trajectories of diagnosis and treatment
for obstructive airways disease
• Research team:
Hillary Pinnock & Chris Burton, University of Edinburgh
• Data source:
Optimum Patient Care Research Database (OPCD)
• Aim: to map and characterise consultation trajectories from
first presentation with respiratory symptoms and for up to
three years after diagnosis.
Idiopathic pulmonary fibrosis
• Research team:
Andrew Wilson, University of East Anglia
• Data source:
Optimum Patient Care Research Database (OPCRD)
• Research topics:
o Validation work:
– Consistency of IPF coding within primary care
– Prevalence
– Disease progression and life expectancy
o Reflux as a potential cause of IPF: explore the pattern of PPI use
o Impact of steroids on infection rates (pneumonia, LRTIs) in IPF
o Prognostic power of high neutrophil counts in IPF