Proceedings of the American Thoracic Society
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Comparative Study
An official American Thoracic Society workshop report: the Integrated Care of The COPD Patient.
The optimal care of the patient with chronic obstructive pulmonary disease (COPD) requires an individualized, patient-centered approach that recognizes and treats all aspects of the disease, addresses the systemic effects and comorbidities, and integrates medical care among healthcare professionals and across healthcare sectors. In many ways the integration of medical care for COPD is still in its infancy, and its implementation will undoubtedly represent a paradigm shift in our thinking. This article summarizes the proceedings of a workshop, The Integrated Care of the COPD Patient, which was funded by the American Thoracic Society. ⋯ Our summary describes the concepts of integrated care and chronic disease management, details specific components of disease management as they may apply to the patient with COPD, and provides several innovative examples of COPD disease management programs originating from different healthcare systems. It became clear from the discussions and review of the literature that more high-quality research in this area is vital. It is our hope that the information presented here provides a "call to arms" in this regard.
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Cor pulmonale has long been described in very severe chronic obstructive pulmonary disease (COPD) and emphysema. Cross-sectional results from population-based studies show that left ventricular filling and a variety of vascular measures in the systemic circulation are abnormal in preclinical COPD and emphysema and that a predominant vascular change in COPD and emphysema is endothelial and microvascular dysfunction. ⋯ New imaging-based approaches to the assessment of the pulmonary vasculature are applicable to epidemiologic studies and may help in defining the relationship of pulmonary vascular damage to progression of COPD and emphysema. These measures may also provide imaging-based surrogate markers, and novel therapeutics targeted to the pulmonary vasculature might reduce symptoms and improve function in these common diseases.
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Primary ciliary dyskinesia (PCD) is a rare genetic disorder of ciliary structure and function. The diagnosis can be challenging, particularly when using nongenetic assays. The "gold standard" diagnostic test is ultrastructural analysis of respiratory cilia obtained by nasal scrape or brush biopsy. ⋯ For example, PCD has been confirmed by identifying disease-causing mutations in a heavy dynein chain gene in individuals with normal ciliary ultrastructure but subtle defects in ciliary beat and low nasal NO. Priorities to improve nongenetic diagnostic capability include standardization of nasal NO as a screening test and the development of specialized centers using uniform approaches for the analysis of ciliary ultrastructure and ciliary beat pattern. Another chapter in this issue (see Zariwala and colleagues, pp. 430) addresses the progress toward improved capabilities for definitive genetic testing.
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Review
Novel outcomes and end points: biomarkers in chronic obstructive pulmonary disease clinical trials.
Biomarker development in chronic obstructive pulmonary disease (COPD) is a nascent field, in part because of the complexity underlying COPD pathogenesis. The objective of this review is to provide examples of how biomarkers may be effectively applied in clinical trials of COPD by limiting their use to specific contexts and using them to answer well delineated questions. Types of novel outcomes or "biomarkers" that may be useful in clinical trials in COPD include analyses performed on bronchoscopically obtained samples, sputum, exhaled gases, blood, and urine and "ex vivo" assays performed using biological samples obtained from trial participants. ⋯ Examples given in this review include outcomes used in a phase IIA study of an inhaled small molecule inhibitor of epidermal growth factor receptor. Large observational studies of COPD, including the ECLIPSE, COPDGene, and SPIROMICS studies will further inform our use of biomarkers in COPD clinical trials. To encourage the application of novel biomarkers in clinical trials, the Food and Drug Administration has developed a new process for biomarker "qualification." This process has been designed to be more efficient and to promote consensus building and sharing of preclinical data.