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Outcomes and markers in the assessment of chronic obstructive pulmonary disease

P. W. Jones, A. G. N. Agusti
European Respiratory Journal 2006 27: 822-832; DOI: 10.1183/09031936.06.00145104
P. W. Jones
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A. G. N. Agusti
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Tables

  • Table 1—

    Requirements of markers in chronic obstructive pulmonary disease for different groups, some of which, but not all, are shared

    GroupKey requirements
    Family physiciansSimplicity
    Specificity
    Reliability
    Clarity
    Hospital specialistsSensitivity
    Specificity
    Reliability
    Clinical utility
    PayersCost-effective
    Clarity
    Pharmaceutical industryPracticality
    Sensitivity
    Generalisability
    Reliability
    Simplicity
    Regulatory authoritiesSensitivity
    Specificity
    Reliability
    Clarity
    Clinical utility
    Generalisability
    ScientistsReliability
    Sensitivity
    Specificity
    Biological credibility
    PatientsClarity
    Simplicity
  • Table 2—

    Phases of marker validation process for therapeutic trials(modelled on 35)

    ClassificationDescriptionValidation
    Phase 1Natural history markerDemonstration of relationship between frequency/magnitude of marker and clinical outcomes
    Reflect underlying disease mechanisms
    Predict clinical outcomes independent of treatment
    Phase 2Biological activity markerPhase I/II trials demonstrating appropriate effects on the marker with therapeutic intervention
    Responds to therapy
    Change in frequency/magnitude of marker corresponds with therapeutic potencyDose-dependent effects of treatment on the marker
    Phase 3Marker of therapeutic efficacyDemonstration that the marker predicts clinical outcomes and responds to therapy in outcome trials
    An early change in the marker predicts clinical outcome in the context of active therapy
    Ideally, marker could be used as a surrogate endpoint for clinical outcomesValidation should establish whether the marker is applicable to all disease stages and all interventions
  • Table 3—

    Potential markers for the assessment of chronic obstructive pulmonary disease

    Biological markersPhysiological markersSymptomatic markers
    Expectorated cellular markers of inflammationMarkers of lung functionSymptoms
     Neutrophils, macrophages, Inspiratory capacity, DL,CO MRC Respiratory Questionnaire
      eosinophils, mast cells,Physiological tests of small airway obstructionBreathlessness
      lymphocytes Lung hyperinflation MRC Dyspnoea scale, Borg
    Expectorated soluble markers of inflammationRate of decline of lung function  scale, BDI/TDI, UCSD
     TNF-α, IL-8, ECP, MPOExercise testing  dyspnoea scale
    Expired gases 6-min walk testDisease-specific health status (health-
     NO, CO, H2O2Bronchial hyperreactivity related quality of life)
    Expired air condensateSkeletal muscle function CRDQ, SGRQ, BPQ, PFSDQ,
     LTB4, cytokines, aldehydesLean body mass  PFSS, CCQ
    Peripheral blood markersImagingGeneric health status
     Activated neutrophils, TNF-α, CT scan, PET, hyperpolarised SF-36, NHP, EQ-5D
      soluble TNF receptors, IL-6,  gas MRCognitive function
      IL-8, CRPExacerbations
    Sputum protease/anti-protease levels Rate
     HNE, MMPs, α1-AT, SLPI, Type
      TIMPsQuantification of luminal airway mucus
    EGF levels in sputumMeasures of pulmonary hypertension
    Urine markers
     Markers of matrix degradation,
      e.g. desmosine
    • TNF-α: tumour necrosis factor-α; IL: interleukin; ECP: eosinophilic cationic protein; MPO: myeloperoxidase; NO: nitric oxide; CO: carbon monoxide; H2O2: hydrogen peroxide; LTB4: leukotriene B4; CRP: C-reactive protein; HNE: human neutrophil elastase; MMPs: matrix metalloproteinases; α1-AT: α1-antitrypsin; SLPI: secretory leukocyte protease inhibitor; TIMPs: tissue inhibitors of matrix metalloproteinases; EGF: epidermal growth factor; DL,CO: diffusing capacity of the lung for carbon monoxide; CT: computed tomograpy; PET: positron emission tomography; MR: magnetic resonance; MRC: Medical Research Council; BDI/TDI: baseline and transition dyspnoea index; UCSD: University of California, San Diego; CRDQ: Chronic Respiratory Disease Questionnaire; SGRQ: St. George's Respiratory Questionnaire; BPQ: Breathing Problems Questionnaire; PFSDQ: Pulmonary Function Status & Dyspnoea Questionnaire; PFSS: Pulmonary Function Status Scale; CCQ: Clinical COPD Questionnaire; SF-36: Short Form-36; NHP: Nottingham Health Profile; EQ-5D: EuroQol 5D.

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Outcomes and markers in the assessment of chronic obstructive pulmonary disease
P. W. Jones, A. G. N. Agusti
European Respiratory Journal Apr 2006, 27 (4) 822-832; DOI: 10.1183/09031936.06.00145104

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Outcomes and markers in the assessment of chronic obstructive pulmonary disease
P. W. Jones, A. G. N. Agusti
European Respiratory Journal Apr 2006, 27 (4) 822-832; DOI: 10.1183/09031936.06.00145104
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  • Article
    • Abstract
    • DEFINING OUTCOMES AND MARKERS
    • RELATIONSHIP BETWEEN AN OUTCOME AND ITS MARKERS
    • THE NEED FOR NEW MARKERS IN COPD
    • SELECTION AND VALIDATION OF NEW MARKERS IN COPD
    • POTENTIAL NEW MARKERS FOR THE ASSESSMENT OF COPD
    • Acknowledgments
    • References
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More in this TOC Section

  • Living without eosinophils: evidence from mouse and man
  • Increasing physical activity in severe asthma: a systematic review and meta-analysis
  • Asthma management in low- and middle-income countries: case for change
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