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Final Research Plan

Chronic Obstructive Pulmonary Disease: Screening

May 15, 2014

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from February 20 until March 19, 2014 at 5:00 p.m., ET.

The figure is an analytic framework that depicts eight key questions described in the final Research Plan. In general, it illustrates the overarching questions: whether screening asymptomatic adults age 40 years and older for COPD using prebronchodilator screening spirometry leads to improved health outcomes or potential harms. The analytic framework also illustrates key questions related to screening modalities used to identify adults who are more likely to test positive upon screening and the test performance of prebronchodilator screening spirometry in predicting COPD diagnostic confirmation. In addition, the analytic framework outlines intermediate key questions investigating whether identifying asymptomatic adults with fixed airway obstruction results in improved delivery of targeted preventive services, specifically smoking cessation interventions and/or influenza or pneumococcal immunizations, and the potential related harms. Also, it outlines whether treatment of screen-detected adults age 40 years and older with asymptomatic COPD improves health outcomes and what harms are associated with COPD treatment in this population.

Abbreviations: COPD = chronic obstructive pulmonary disease; HRQoL = health-related quality of life.

  1. 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?
    1. Does the effect of screening in asymptomatic adults vary across strategy (e.g., selective subgroups [such as age, presence of certain comorbid conditions, sex, race and ethnicity, smoking history, or others] vs. the general population)?
  2. 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)?
  3. 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?
    1. Are there other modalities to screen asymptomatic adults for COPD besides prebronchodilator spirometry (e.g., peak flow testing) and what are the performance characteristics of such tests?
  4. What are the adverse effects of screening for COPD using prebronchodilator spirometry?
  5. Does identifying asymptomatic adults with fixed airflow obstruction through screening improve the delivery and uptake of targeted preventive services?
    1. Does screening for COPD increase smoking cessation rates in asymptomatic adults compared with usual care?
    2. Does screening for COPD increase relevant immunization rates in asymptomatic adults compared with usual care?
  6. What are the adverse effects of screening for COPD, including the impact of targeted preventive services in this population (e.g., false reassurance for screen-negative smokers)?
  7. Does treatment for asymptomatic adults identified with mild to moderate COPD through screening improve health-related quality of life or reduce morbidity or mortality?
  8. What are the adverse effects of COPD treatment in this population?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. 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?
  2. If there is sufficient evidence of a net benefit found in screening for COPD using spirometry in asymptomatic adults age 40 years and older, at what time interval should patients who initially screened negative be rescreened?

The 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).

  Include Exclude
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 (e.g., persistent dyspnea, chronic sputum production, and/or cough); patients with identified alpha-1 antitrypsin deficiency
Settings Primary or specialty care or community-based settings; countries categorized as “Very High” by the Human Development Index (as defined by the United Nations Development Program) Inpatient settings; countries not categorized as “very high”
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 (e.g., 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 and 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 and disease-specific mortality, COPD-related morbidity, health-related quality of life, disease progression as measured by pulmonary function (e.g., 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
Language English Non-English studies

* We will consider asymptomatic patients to be made up of individuals in one of the following states: those who are free of the disease; those in whom the disease is present but who have physical symptoms that are undetected by the patient or the clinician (e.g., have mild dyspnea that goes unnoticed); or those who have nonspecific symptoms (e.g., sporadic sputum production or cough) that have gone unrecognized as being related to COPD.
† 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, this 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.

The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from February 20 to March 19, 2014. The USPSTF received comments requesting that asymptomatic adults be more clearly defined. In the proposed research approach, asymptomatic adults are now defined as: persons free of the disease; persons who have the disease but have undetected physical symptoms (e.g., mild dyspnea); or persons with nonspecific symptoms (e.g., sporadic sputum production or cough) that have gone unrecognized as being related to COPD. Further, the USPSTF received a comment requesting that evidence related to the spirometry screening interval be considered. In response, a contextual question on the rescreening interval was added; the rescreening interval is contingent upon finding sufficient evidence of the efficacy and probable net benefit to COPD screening using spirometry. Additionally, minor changes were made to clarify the inclusion and exclusion criteria in response to a variety of comments.