Scope

Given that the prior USPSTF D recommendation was primarily based on the lack of evidence for early treatment of COPD, or treatment in persons with un- or under-recognized symptoms, and not the ability of screening to detect persons with COPD, this targeted update focuses on three key questions to address the important evidence gaps from the prior review. Consistent with the prior review and the primary research, this review focuses on adults age 40 or older given the distribution of COPD in adults. This review newly includes a synthesis of non-pharmacologic interventions, in addition to pharmacologic therapies, in screen-detected or screen-relevant adults with COPD.

Key Questions and Analytic Framework

In consultation with members of the USPSTF, we developed an analytic framework (Figure 1) and three Key Questions (KQs) to guide our targeted evidence update.

Figure 1

Analytic Framework. *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 (more...)

Data Sources and Searches

We conducted a literature search of MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL from January 1, 2015, to January 22, 2021, to identify literature published since the previous review for the USPSTF. We worked with a research librarian to develop our search strategy (Appendix A). Because the previous review did not include non-pharmacologic interventions, we supplemented these searches by examining reference lists of recent reviews and primary studies, and citations provided by experts, to identify major studies prior to 2015. We limited our searches to articles published in English and managed search results using Endnote® version X7 (Thomson Reuters, New York, NY).

Study Selection

We developed specific inclusion criteria to guide study selection (Appendix A Table 1). Two reviewers independently reviewed the title and abstracts of all identified articles using DistillerSR (Evidence Partners, Ottawa, Canada). Two reviewers then independently evaluated the full text of all potentially relevant articles, with differences reviewed by discussion.

To address KQ1 on the effectiveness of screening or risk tailored screening (referred to as active case finding) for COPD on health outcomes, we included randomized controlled trials (RCTs) of any screening method (e.g., spirometry, questionnaire or risk assessment followed by spirometry) in asymptomatic adults, adults who have symptoms that are undetected by the patient or clinician (e.g., mild dyspnea that goes unnoticed), or adults who have nonspecific symptoms (e.g., sporadic sputum production or cough, fatigue) that have gone unreported or unrecognized as related to COPD. We excluded studies conducting surveillance for COPD in populations at very high risk for COPD, i.e., persons with alpha-1 antitrypsin deficiency and workers with known occupational exposures.

To address KQ2 and 3 on the benefits and harms of treatment, we focused on studies that were conducted in persons with screen-detected COPD or screen-relevant patients, meaning adults with mild to moderate COPD by spirometry (or a mean population FEV₁ ≥ 60 percent predicted) and/or low symptom burden as defined by GOLD criteria. Pharmacologic therapies included inhaled bronchodilators (i.e., SABA, SAMA, LABA, LAMA), ICS, or combinations of these treatments. Non-pharmacologic therapies included self-management interventions, case management, behavioral counseling, exercise therapy, and pulmonary rehabilitation. We also included clinician training and education interventions if studies reported patient outcomes. We excluded interventions that are primarily used in persons with more severe or symptomatic disease (e.g., oxygen therapy, oral corticosteroids, phosphodiesterase-4 inhibitors, antibiotics, surgical therapies). Study designs were limited to randomized or non-randomized trials and for harms (KQ3) and large registry studies of drug safety. Treatment trials had to include a minimum of 6 months followup.

Quality Assessment and Data Abstraction

Two reviewers independently assessed the methodologic quality (risk of bias) of each included study using predefined criteria (Appendix A Table 2). We assigned each study a quality rating of “good,” “fair,” or “poor” according to the USPSTF’s study design-specific criteria.³We supplemented these criteria with modified questions from the Newcastle-Ottawa Scale for nonrandomized studies of harms.⁶³ Disagreements were resolved by discussion. One investigator abstracted data into an evidence table and a second investigator checked the accuracy of the abstracted data against the article. We abstracted details on the study’s design, patient characteristics, intervention and comparator characteristics, as well as outcomes specified in the inclusion criteria. Outcomes of interest included mortality, morbidity from COPD, HRQoL, and serious harms as defined by study author or adverse events requiring unexpected medical attention and/or resulting in death. COPD morbidity included objective physical performance measures like the 6-minute walk test (6MWT). Quality of life measures included externally validated generic measures like the Short Form (36) Health Survey (SF-36) or EuroQual (EQ-5D), as well as disease-specific measures like the St. George’s Respiratory Questionnaire (SGRQ), and the COPD Assessment Test (CAT). The SGRQ score can range from 0 to 100, with higher scores indicating more limitations on overall health, daily life, and perceived well-being.⁶⁴ The CAT score can range from 0 to 40, with higher scores representing worse quality of life.⁶⁵ When reported, we also abstracted dyspnea symptom scores and mental well-being outcomes as these were conceptualized as part of HRQoL. Physiologic outcomes of change in FEV₁ were not abstracted.

Data Synthesis and Analysis

This targeted update synthesized the evidence published since the USPSTF last considered this topic in 2016. Therefore, the narrative synthesis does not include older evidence previously considered by the USPSTF. Given the limited number of pharmacologic trials and clinical heterogeneity in the non-pharmacologic trials, we did not conduct any quantitative synthesis. To understand the totality of the evidence for these key questions, we included a summary table comparing the findings of the interval evidence (included in this review) to the previous review supporting the 2016 recommendation.

Expert Review and Public Comment

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 targeted evidence update (as part of the reaffirmation process), particularly regarding the included populations and interventions. In response, the Research Plan was modified to clarify that “asymptomatic” includes persons with yet undetected signs or symptoms of COPD. In addition, text was added to specify that the included population for the KQs related to treatment are persons with mild to moderate COPD, populations with a minimum mean FEV₁ of 60 percent predicted, or both. Last, the uptake of lung cancer screening was added to smoking cessation and recommended immunizations as a preventive service for the Contextual Question. A final research plan was posted on the USPSTF’s Web site on October 8, 2020.

A prior version of this report was reviewed by three content experts and invited representatives of Federal partners. All reviewer comments and their disposition were presented to the USPSTF and revisions in response to comments are reflected in this report. Additionally, a draft of this report was posted November 2nd to December 6th, 2021 for public comment on the USPSTF website along with the accompanying USPSTF draft recommendation statement. Minor edits for clarity and updated citations were added based on public comment.

USPSTF and AHRQ Involvement

The authors consulted with USPSTF members during the development of the research plan, including the analytic framework, KQs, and inclusion criteria. An AHRQ Medical Officer provided project oversight, reviewed the draft and final versions of the evidence update, and assisted with public comment on the research plan and draft report. The USPSTF and AHRQ had no role in the study selection, quality assessment, or writing of the evidence update.