Final Research Plan
Chronic Obstructive Pulmonary Disease: Screening
October 08, 2020
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.
*Includes asymptomatic adults, adults who have physical symptoms that are undetected by the patient or the clinician, or those who have nonspecific symptoms that have gone unrecognized as being related to COPD.
†Mild (forced expiratory volume in 1 sec [FEV1] ≥80% predicted) to moderate (FEV1 of 50% to 79%).
Abbreviations: COPD=chronic obstructive pulmonary disease; HRQoL=health-related quality of life.
- Does screening for chronic obstructive pulmonary disease (COPD) improve health-related quality of life or reduce morbidity or mortality?
- Does treatment of screen-detected or mild to moderate COPD improve health-related quality of life or reduce morbidity or mortality?
- What are the adverse effects of COPD treatments in this population?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Does identifying asymptomatic adults with COPD improve the delivery and uptake of targeted preventive services (e.g., smoking cessation, recommended immunizations, lung cancer screening)?
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 Review. Criteria are overarching as well as specific to each of the key questions (KQs). The update for this topic will be conducted using rapid synthesis procedures, as described in Section 4.7 of the USPSTF Procedure Manual (available at https://www.uspreventiveservicestaskforce.org/Page/Name/methods-and-processes).This is a targeted update of a subset of key questions that informed the 2015 “D” recommendation on screening for COPD. The proposed three KQs will address the important evidence gaps from the prior review (i.e., effects of screening for or early treatment of COPD on patient health outcomes). Test accuracy and harms of screening questionnaires and pulmonary function tests are not addressed in this update.
| Include | Exclude | |
|---|---|---|
| Populations | KQ 1: Adults age 40 years and older, asymptomatic adults, adults who have physical symptoms that are undetected by the patient or the clinician (e.g., mild dyspnea that goes unnoticed); adults who have nonspecific symptoms (e.g., sporadic sputum production or cough) that have gone unrecognized as being related to COPD
KQs 2, 3: Adults* age 40 years and older with screen-detected fixed airway obstruction; screen-relevant adults such as patients with mild (FEV1 ≥80% predicted) to moderate (FEV1 of 50% to 79%) COPD*; or studies with a mean population FEV1 ≥60% predicted |
KQ 1: Patients with diagnosed COPD or other respiratory conditions; patients with identified alpha-1 antitrypsin deficiency; pregnant women
KQs 2, 3: Patients with severe or very severe COPD; pregnant women; patients with identified alpha-1 antitrypsin deficiency |
| Setting | Primary or specialty care or community-based settings; studies conducted in countries categorized as “Very High” on the Human Development Index (as defined by the United Nations Development Programme) | Inpatient settings |
| Interventions | KQ 1: Any screening method, including pre-bronchodilator screening spirometry; questionnaires or risk assessment tools; peak flow meter; confirmatory post-bronchodilator spirometry
KQs 2, 3: Pharmacotherapy (including short- and long-acting beta-agonists, anticholinergics, inhaled corticosteroids, CXCR2 antagonists, or combinations of these treatments); nonpharmacologic therapy (including case management, behavioral counseling, and exercise therapy) |
KQ 1: Testing used for disease monitoring or management, pulmonary imaging
KQs 2, 3: Oxygen therapy; surgical therapies; lung transplant; treatment of acute exacerbations; systemic corticosteroids; phosphodiesterase-4 inhibitors; mucolytic agents; antibiotics†; acupuncture, herbal, or over-the-counter supplements; whole body vibration therapy |
| Comparisons | Usual care; placebo; no screening/treatment | Active comparator |
| Outcomes | KQs 1, 2: All-cause mortality, disease-specific mortality, and COPD-related morbidity; HRQoL at ≥6 months followup
KQ 3: Serious adverse events requiring unexpected or unwanted medical attention and/or resulting in death (e.g., requiring hospitalization) |
KQs 1, 2: Change in FEV1 |
| Study Designs | KQs 1, 2: RCTs
KQ 3: RCTS included for KQ2, large registry studies of drug safety |
KQs 1, 2: Nonrandomized studies, including cohort studies, case-control studies, and case series |
| Study Quality | Good- and fair-quality studies | Poor-quality studies |
| Language | English | Non-English studies |
*Based on the Global Initiative for Obstructive Lung Disease (GOLD) criteria COPD classifications.
†Patients with severe disease would constitute a very small minority of those identified by asymptomatic screening spirometry, and thus the treatment modalities recommended for these patients will not be considered in this 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 1 sec; HRQoL=health-related quality of life; RCT=randomized, controlled trial.
The draft Research Plan was posted for public comment on the USPSTF website from July 2 to July 29, 2020. The USPSTF received comments regarding clarification of the scope of the reaffirmation review, particularly regarding the included populations and interventions. In response, the USPSTF modified the Research Plan to clarify that “asymptomatic” includes persons with yet undetected signs or symptoms of COPD. In addition, the USPSTF added text to specify that the included population for the KQs related to treatment are persons with mild to moderate COPD, populations with a mean FEV1 of 60% or greater, or both. Last, the USPSTF added lung cancer screening to smoking cessation and recommended immunizations as a preventive service for the Contextual Question.