Evidence-based Analysis of Low-dose CT in Management of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of
      chronic morbidity and mortality worldwide. There is debate about diagnosis and management of
      COPD because it was described as complex syndrome accounting for various pulmonary and
      extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation
      and pulmonary function tests (PFTs) data by themselves do not adequately describe the
      complexity of the disease. The chest radiograph is the sole imaging examination recommended
      for the routine evaluation of these patients by the physicians guidelines (GOLD
      guidelines),which, however, are also debating on the utility of computed tomography (CT) in
      this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the
      chest for COPD assessment, in both clinical and research settings. COPD assessment by CT
      seems to improve the accuracy and completeness of the clinical evaluation of these patients.
      Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or
      defined by guidelines.

      Objectives: To evaluate the change in the diagnosis and management of COPD when multiple
      CT-derived information is added to pre-test evaluation.

      Methods: Four pulmonologists with various expertise in the field will review clinical data,
      PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to
      current guidelines. Therefore, after two months from the first evaluation, the pulmonologists
      will review the clinical and PFTs records with comprehensive information about low-dose CT
      (LDCT) previously performed in a week from the chest radiograph. Information about LDCT
      findings will include qualitative assessment by an experienced chest radiologist and
      quantitative analysis by means of an innovative 3D imaging dedicated software. Phenotype
      assessment and patient care decisions (e.g. therapeutic and follow-up strategies, need of
      additional tests etc.) will be recorded before and after assimilation of LDCT data.

      Expected results: This evidence-based prospective study will test the impact of chest LDCT on
      management of COPD patient. In addition, the level of agreement between pulmonologists in
      terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will
      evaluate the need for additional tests referable to LDCT information and their impact on the
      health care system (e.g. in terms of additional costs).
    


Intervention name(s): Low-Dose Computed Tomography
Intervention type(s): Radiation
Intervention description(s): Low-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chronic Obstructive Pulmonary Disease; Diagnostic Imaging; Disease Management; Clinical Decision Support Systems; Cost-Utility Analysis