Evidence-based Analysis of Low-dose CT in Management of COPD

Impact of Low-dose Computed Tomography on the Management of Chronic Obstructive Pulmonary Disease Patients: an Evidence-based Study

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Radiation: Low-Dose Computed Tomography

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD diagnosis according to ATS/ERS criteria (post-bronchodilator FEV1 to FVC ratio < 0.7);
• clinical stability, namely no acute exacerbation in the previous 4 weeks;
• clinical indication for low-dose computed tomography (LDCT) to investigate bronchiectasis, interstitial lung disease, or pulmonary hypertension.

Exclusion Criteria:

• pregnancy;
• patients with congenital or acquired immune deficit;
• patients with lung transplantation;
• patients under oxygen therapy;
• patients with diagnosis of asthma or other clinically relevant pulmonary disease other than COPD.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MulticenterRecruitment; COPD phenotypization by Low-Dose Computed Tomography	Radiation: Low-Dose Computed Tomography; Low-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire)	To quantify the refinement of the diagnosis of COPD patients when LDCT data are added to standard evaluation, namely, conventional clinical-functional assessment and chest radiography.	Up to 3 years
Clinical management of COPD in relation to therapy adjustment (questionnaire)	To describe the change in management of COPD patients when LDCT data are added to standard evaluation, namely, conventional clinical-functional assessment and chest radiography.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-observer agreement before and after disclosure of LDCT features (questionnaire)	To assess the intra-observer agreement of pulmonologists before and after assimilation of LDCT data.	Up to 3 years
Inter-observer agreement (questionnaire)	To assess changes in inter-observer agreement between pulmonologist before and after assimilation of LDCT data.	Up to 3 years
Additional costs derived from change in management of COPD after disclosure of LDCT features (comparison of costs)	To evaluate additional costs for the regional health care system deemed by assimilation of LDCT data.	Up to 3 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Parma
• Investigators: Principal Investigator: Nicola Sverzellati, MD, PhD, Universita di Parma

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Estimate): November 9, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Diagnostic Imaging; Clinical Decision Support Systems; Disease Management; Cost-Utility Analysis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ImagingCOPD_Multicenter