Screening for Chronic Obstructive Pulmonary Disease Using Spirometry
Note: This is a draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF.
The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report will form the basis of the USPSTF Recommendation Statement on this topic.
This draft Research Plan is available for comment from February 20 until March 19, 2014 at 5:00 p.m., ET. You may wish to read the entire Research Plan before you comment.
I. Proposed Analytic Framework
Abbreviations: COPD = chronic obstructive pulmonary disease; HRQoL = health-related quality of life.
II. Proposed Key Questions to Be Systematically Reviewed
- Does screening asymptomatic adults age 40 years and older for chronic obstructive pulmonary disease (COPD) using prebronchodilator screening spirometry improve health-related quality of life or reduce morbidity or mortality?
- Does the effect of screening in asymptomatic adults vary across strategy (i.e., selective subgroups [such as age, presence of certain comorbid conditions, sex, race/ethnicity, smoking history, or others] vs. the general population)?
- Can high-risk asymptomatic adults who are more likely to screen positive for COPD be reliably identified (i.e., by prescreening with nonsymptom–oriented questionnaires or other maneuvers, such as peak flow testing; or by identification of certain patient characteristics, such as age; exposure to tobacco smoke, cooking/heating oils, or occupational dusts/chemicals; family history of COPD; comorbid conditions; sex; or race/ethnicity)?
- What is the test performance of prebronchodilator screening spirometry in predicting diagnosis of COPD, based on confirmation using postbronchodilator spirometry to identify fixed airflow obstruction in asymptomatic adults?
- Are there other modalities to screen for COPD in asymptomatic adults besides prebronchodilator spirometry (e.g., peak flow testing), and what are the test performance characteristics of such tests?
- What are the adverse effects of screening for COPD using prebronchodilator spirometry?
- Does identifying asymptomatic adults with fixed airflow obstruction through screening improve the delivery and uptake of targeted preventive services?
- Does screening for COPD increase smoking cessation rates in asymptomatic adults compared with usual care?
- Does screening for COPD increase relevant immunization rates in asymptomatic adults compared with usual care?
- What are the adverse effects of screening for COPD, including the effect of targeted preventive services, in asymptomatic adults (e.g., false reassurance for screen-negative smokers)?
- Does treatment of COPD in screen-detected asymptomatic adults improve health-related quality of life or reduce morbidity or mortality?
- What are the adverse effects of treatment of COPD in screen-detected asymptomatic adults?
III. Proposed Contextual Question
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the yield and distribution of COPD disease severity identified by screening asymptomatic adults age 40 years and older for COPD using prebronchodilator screening spirometry?
IV. Proposed Research Approach
The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Report. Criteria are overarching as well as specific to each of the key questions (KQs).
|Populations||KQs 1–4: Asymptomatic adults age 40 years and older*
KQs 5–8: Asymptomatic adults age 40 years and older with screen-detected fixed airway obstruction; patients with mild (FEV1 ≥80% normal) to moderate (FEV1 50%–79% normal) COPD**
|KQs 1–4: Patients with diagnosed COPD or other respiratory conditions; patients with COPD-related symptoms; patients with identified alpha-1 antitrypsin deficiency; pregnant women
KQs 5–8: Patients with severe (FEV1 30%–49% normal) or very severe (FEV1 <30% normal) COPD**; pregnant women; patients with COPD-related symptoms; patients with identified alpha-1 antitrypsin deficiency
|Setting||Primary or specialty care or community-based settings; developed countries (i.e., categorized as “very high” on the Human Development Index, as defined by the United Nations)||Inpatient settings; countries not categorized as “very high” on the Human Development Index|
|Interventions||KQs 1–4: Prebronchodilator screening spirometry, questionnaires, or risk assessment tools; peak flow meter; confirmatory postbronchodilator spirometry
KQs 5–8: Pharmacotherapy, targeted preventive services (i.e., smoking cessation, pneumococcal and/or influenza immunizations)
|KQs 1–4: Spirometry or other modalities used for disease monitoring or management
KQs 5–8: Treatment offered to symptomatic patients, oxygen therapy, surgical therapies, lung transplant, pulmonary rehabilitation†
|Comparisons||KQs 1–4: Usual care; no screening; comparative test performance within the same screening population
KQs 5–8: Usual care; placebo; no treatment
|Outcomes||KQ 1: All-cause mortality, disease-specific mortality, COPD-related morbidity; health-related quality of life
KQ 2: Fixed airflow obstruction requisite for COPD diagnosis as determined by established diagnostic standards (i.e., FEV1/FVC ratio <0.70)
KQ 3: Fixed airflow obstruction requisite for COPD diagnosis as determined by established diagnostic standards (i.e., FEV1/FVC ratio <0.70); test performance, including sensitivity and specificity (per person); positive and negative predictive value (per person); diagnostic yield by disease severity
KQs 4, 6, 8: Serious adverse events requiring unexpected or unwanted medical attention and/or resulting in death (e.g., requiring hospitalization), adverse events reported by ≥5% of the study population, false reassurance for screen-negative smokers
KQ 5: Self-reported or biologically validated smoking abstinence rates, sustained abstinence over the course of the study, number of quit attempts; immunization rates
KQ 7: All-cause mortality, disease-specific mortality, COPD-related morbidity; health-related quality of life; disease progression as measured by pulmonary function (i.e., stable FEV1; reduced exacerbations)
|Study Designs||KQs 1, 5, 7: RCTs, systematic reviews (of included study designs)
KQs 2, 3: RCTs, cohort studies, systematic reviews (of included study designs)
KQs 4, 6, 8: RCTs, large screening registry or database observational studies, cohort studies, systematic reviews (of included study designs)
|KQs 1, 5, 7: Cohort studies, case-control studies, case series|
|Study Quality||Good and fair quality||Poor quality|
* Recent survey data shows that the prevalence of COPD is highest in adults age 65 to 84 years (8.3% in men ages 65 to 74 years; 11.2% in women ages 75 to 84 years). Epidemiological surveys suggest an incidence of 3% to 5% in adults age 45 years and younger. Based on these data, the evidence review will focus on adults age 40 years and older.
** Based on the GOLD criteria for COPD classification.
† Patients with severe disease would constitute a very small minority of those identified by asymptomatic screening spirometry; thus, the treatment modalities recommended for these patients will not be considered in the evidence review (i.e., pulmonary rehabilitation, oxygen therapy, surgical treatment to reduce lung volume, and lung transplantation).
Abbreviations: COPD = chronic obstructive pulmonary disease; FEV1 = forced expiratory volume in one second; FVC = forced vital capacity; GOLD = Global Initiative for Chronic Obstructive Lung Disease; RCT = randomized, controlled trial.
AHRQ Publication No. 14-05205-EF-5
Current as of February 2014
U.S. Preventive Services Task Force. Screening for Chronic Obstructive Pulmonary Disease Using Spirometry: Draft Research Plan. AHRQ Publication No. 14-05205-EF-5. http://www.uspreventiveservicestaskforce.org/draftresplan.htm