Cost-Effectiveness of Lung Volume Reduction Surgery

Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema
• Intervention / Treatment: Procedure: Effectiveness of Lung Reduction Therapy

Detailed Description

Background:

Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Objectives:

Evaluate cost-effectiveness of LVRS compared to current therapy for COPD.

Methods:

This is a case control study in which veterans undergoing LVRS at VA Puget Sound Health Care System (VAPSHCS) are compared to patients with a similar severity of disease at Boise VAMC who are not undergoing LVRS. Changes in health related quality of life are being evaluated using three instruments: the SF-36, the St. George�s Respiratory Questionnaire, and the Quality of Well-Being Scale, the latter to calculate utility associated with different health states. Costs will be determined using utilization data on outpatient visits, medications, oxygen use, inpatient days, radiology tests, laboratory tests, and emergency room visits are being collected for the twelve months before and after surgery. Costs will be calculated according to VA and community standards.

Status:

Complete.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of >165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1	Procedure: Effectiveness of Lung Reduction Therapy

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Stephan D. Fihn, MD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA; Principal Investigator: Hugh F Huizenga, MD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications and helpful links

General Publications

• Huizenga HF, Ramsey SD, Albert RK. Estimated growth of lung volume reduction surgery among Medicare enrollees: 1994 to 1996. Chest. 1998 Dec;114(6):1583-7. doi: 10.1378/chest.114.6.1583.

Study record dates

Study Major Dates

• Study Completion (Actual): March 1, 2000

Study Registration Dates

• First Submitted: March 14, 2001
• First Submitted That Met QC Criteria: March 15, 2001
• First Posted (Estimate): March 16, 2001

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
• Other Study ID Numbers: IIR 96-024