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Real-world research and its importance in respiratory medicine

David Price, Guy Brusselle, Nicolas Roche, Daryl Freeman, Alison Chisholm
Breathe 2015 11: 26-38; DOI: 10.1183/20734735.015414
David Price
1Respiratory Effectiveness Group, Cambridge, UK
2University of Aberdeen, Aberdeen, UK
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  • For correspondence: david@rirl.org
Guy Brusselle
1Respiratory Effectiveness Group, Cambridge, UK
3Department of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium
4Departments of Epidemiology and Respiratory Medicine, Erasmus MC, Rotterdam, The Netherlands
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Nicolas Roche
1Respiratory Effectiveness Group, Cambridge, UK
5Respiratory and Intensive Care Medicine, GH Cochin, Site Val de Grace, Paris, France
6Université Paris-Descartes (EA2511), Sorbonne Paris Cité, Paris, France
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Daryl Freeman
1Respiratory Effectiveness Group, Cambridge, UK
7East of England Strategic Clinical Network, Norfolk, UK
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Alison Chisholm
1Respiratory Effectiveness Group, Cambridge, UK
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    Figure 1

    Studies have shown that classical efficacy RCTs exclude about 90% for a) asthma and 95% for b) COPD routine care populations due to strict inclusion and exclusion criteria. a) For asthma clinical-trial patients criteria included: visual analogue scale (VAS) <2; historical reversibility in FEV 12% within the last 12 months; absence of significant co-morbidity; nonsmoker or if previous smoker (XS) a smoke burden <10 pack-years; regular use of ICS; symptomatic asthma (defined as either the use of short acting β2-agonist daily or nocturnal awakening due to asthma at least once a week). b) For COPD clinical-trial patients criteria included: VAS >7.5, absence of significant co-morbidity; smoker (S) or XS; a smoke burden of >15 pack-years; no history of hay fever indicating presence of atopy. Reproduced from [5] with permission from the publisher.

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    Figure 2

    Integrated research framework, bounded by population and ecology of care axes running from highly selected to managed care populations (Y-axis) and from highly interventional to observational study design approaches (X-axis). Adapted from [10] with permission from the publisher.

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    Figure 3

    Long-term adherence to ICS. Short-term cRCTs will miss the interaction between real-life adherence and treatment outcomes. Reproduced from [20] with permission from the publisher.

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    Figure 4

    The COMPACT study demonstrated the difference in outcomes associated with management of only lower airways inflammation (budesonide) compared with systemic (upper and lower airways) inflammation management (montelukast) in asthmatic patients without (a) and with (b) rhinitis. Reproduced from [31, 32] with permission from the publishers.

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    Figure 5

    Mean (95% CI) difference between non-smokers and smokers with asthma, Suggesting alternatives to higher-dose ICS may be required. *: p≤0.01 for smokers versus non-smokers. Reproduced from [36] with permission from the publisher.

Tables

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  • Table 1

    Common similarities and differences between the design of classical and pragmatic RCTs

    Feature of trial designClassical RCTPragmatic RCT
    RandomisationYesYes
    Control groupYesYes
    Setting/ecology of care• Highly controlled
    • Specialised centres (secondary or tertiary)
    • Pragmatically controlled
    • Usual care (> primary care)
    Patient population• Highly selected
    • Confirmed diagnosis
    Narrow (“pure”) population
    • Pragmatically selected
    • Clinical diagnosis
    Broad (“real-life”) population
    Inclusion/exclusion criteriaManyFew
    AdherenceVery good (stimulated and monitored)Low (real-world adherence)
    Therapy• Blinded (single- or double-blind); or
    • Open-label
    Usually open-label to allow for effects of different technologies e.g. device or mode of administration
    ComparatorPlacebo; and/or active treatmentActive treatment
    OutcomeEfficacyReal-life effectiveness (comparative effectiveness)
    SafetyUsually short-termShort-term and long-term
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Real-world research and its importance in respiratory medicine
David Price, Guy Brusselle, Nicolas Roche, Daryl Freeman, Alison Chisholm
Breathe Mar 2015, 11 (1) 26-38; DOI: 10.1183/20734735.015414

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Real-world research and its importance in respiratory medicine
David Price, Guy Brusselle, Nicolas Roche, Daryl Freeman, Alison Chisholm
Breathe Mar 2015, 11 (1) 26-38; DOI: 10.1183/20734735.015414
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  • Article
    • Abstract
    • Introduction
    • What sort of evidence 'do we have?
    • What do cRCTs tell us?
    • What can real-life research tell us?
    • Using real-life evidence to improve asthma management
    • Conclusions
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