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Draft Research Plan

Draft Research Plan for Lung Cancer: Screening

This opportunity for public comment expired on May 30, 2018 at 8:00 PM EST

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 Review will form the basis of the USPSTF Recommendation Statement on this topic.

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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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Moving from left to right, this figure depicts the proposed key questions (KQs) and research approach that will guide the evidence review. The figure illustrates the overarching question (KQ 1): does screening for lung cancer with CT change the incidence of lung cancer and distribution of lung cancer types and stages? On the left, the population of interest is specified as adults at increased risk for lung cancer. Beneath the population of interest is KQ 2: does the use of risk prediction models to identify adults at higher risk of lung cancer mortality improve the balance of benefits and harms of screening compared with the use of trial eligibility criteria? The figure then depicts the pathway from screening to the detection of nodules, asking: what is the accuracy of screening for lung cancer with CT (KQ 3) and what are the associated harms of screening (KQ 4)? Following the detection of nodules, the figure addresses the pathway of workup or surveillance to diagnosis of lung cancer, asking: what are the harms associated with workup or surveillance of nodules (KQ 5)? Following diagnosis of lung cancer, the figure outlines the pathway of treatment to advanced disease, and then to the health outcomes of interest, asking: how effective is surgical resection for the treatment of early (stage I) non-small cell lung cancer (KQ 6) and what are the associated harms of treatment (KQ 7)?  The figure also follows the pathway from diagnosis of lung cancer to health outcomes, asking: what is the magnitude of change in all-cause mortality that results from a specified change in lung cancer incidence and change in distribution of lung cancer stages after screening (KQ 8)?

* The search for evidence on treatment in the systematic review will be limited to studies of surgical resection of stage I non-small cell lung cancer.

Draft: Proposed Key Questions to Be Systematically Reviewed

1. a. Does screening for lung cancer with computed tomography (CT) change the incidence of lung cancer and the distribution of lung cancer types and stages?
    b. Does screening for lung cancer with CT change all-cause mortality, lung cancer mortality, or quality of life?
    c. Does the effectiveness of screening for lung cancer with CT differ for subgroups defined by age, sex, race/ethnicity, presence of comorbid conditions, or risk for lung cancer?
    d. Does the effectiveness of screening for lung cancer with CT differ by the number or frequency of CT scans (e.g., annual screening for 3 years, as used in the National Lung Screening Trial [NLST], vs. other approaches)?
2. Does the use of risk prediction models for identifying adults at higher risk of lung cancer mortality improve the balance of benefits and harms of screening compared with use of trial eligibility criteria (e.g., NLST criteria) or USPSTF recommendations?
3. a. What is the accuracy of screening for lung cancer with CT?
    b. Does the accuracy of screening for lung cancer with CT differ for subgroups defined by age, sex, race/ethnicity, presence of comorbid conditions, or risk for lung cancer?
    c. Does the accuracy of screening for lung cancer with CT differ for various approaches to nodule classification (i.e., those based on nodule size and characteristics)?
4. a. What are the harms associated with screening for lung cancer with CT?
    b. Do the harms of screening for lung cancer differ with the use of Lung-RADS™ (e.g., to reduce false-positive results) or similar approaches?
    c. Do the harms of screening for lung cancer differ for subgroups defined by age, sex, race/ethnicity, presence of comorbid conditions, or risk for lung cancer?
5. a. What are the harms associated with workup or surveillance of nodules detected by screening?
    b. Do the harms of workup or surveillance of nodules differ with the use of Lung-RADS (e.g., to reduce false-positive results) or similar approaches?
    c. Do the harms of workup or surveillance of nodules differ for subgroups defined by age, sex, race/ethnicity, presence of comorbid conditions, or risk for lung cancer?
6. How effective is surgical resection for the treatment of early (stage I) non-small cell lung cancer?
7. What are the harms associated with surgical resection of early (stage I) non-small cell lung cancer?
8. What is the magnitude of change in all-cause and lung cancer mortality that results from a specified change in lung cancer incidence (and change in distribution of lung cancer stages) after screening?

Draft: Proposed Contextual Questions

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

1. What are the barriers to implementation of screening for lung cancer and surveillance in U.S. clinical practice (e.g., barriers to shared decisionmaking, systematically eliciting and documenting a detailed smoking history, systems for tracking nodules and followup, and availability of appropriate low-dose CT protocols)?
2. a. Are the participants of lung cancer screening trials (e.g., NLST) who reported a reduction in all-cause or lung cancer mortality representative of persons eligible for lung cancer screening in the United States (based on USPSTF recommendations or NLST criteria)?
   b. How do the 5-year survival rate and life expectancy of persons eligible for lung cancer screening in the United States (based on USPSTF recommendations or NLST criteria) compare with those of NLST participants?
   c. Are the settings and health care providers in lung cancer screening trials (e.g., NLST) that reported a reduction in all-cause or lung cancer mortality representative of U.S. health care settings and health care providers?
3. Does screening for lung cancer with low-dose CT have unintended benefits from detection of incidental findings (e.g., coronary artery calcium score, chronic obstructive pulmonary disease, or extrapulmonary nodules) leading to interventions that improve health outcomes?

Draft: 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 Review. Criteria are overarching as well as specific to each of the key questions (KQs).

Category Include Exclude
Populations KQs 1–5, 8: Asymptomatic adults (age ≥18 years)

KQs 6, 7: Adults (age ≥18 years) with early (stage I) non-small cell lung cancer

KQs 1–5, 8: Children; persons with symptoms or prior diagnosis of lung cancer

KQs 6, 7: Children; persons with nonprimary lung cancer or other than stage I lung cancer

Risk prediction KQ 2: Externally validated models including demographic variables, clinical variables, or biomarkers intended for identifying persons at increased risk who are more likely to benefit from screening KQ 2: Models including a single variable or biomarker; models not considering smoking and age (i.e., known risk factors for lung cancer)
Screening KQs 1, 3, 4, 8: CT* KQs 1, 3, 4, 8: No screening, chest x-ray, sputum cytology, and other screening methods
Workup or surveillance KQ 5: CT, biopsy, positron emission tomography, or other tests used after screening  
Interventions KQs 6, 7: Surgical resection KQs 6, 7: Chemotherapy, radiation therapy, and natural therapies; immunotherapy; targeted molecular therapy
Comparisons KQs 1, 3, 8: Chest x-ray, no screening, usual care

KQ 2: USPSTF recommendations or criteria used by trials showing benefit (e.g., NLST)

KQs 4, 5: Chest x-ray, no screening, usual care, or no comparison group

KQs 6, 7: No treatment, usual care, or no comparison

KQs 1–3, 8: Studies without a comparison group

KQs 6, 7: Comparative effectiveness studies (i.e., head-to-head studies comparing treatments)

Outcomes KQ 1a: Incidence of lung cancer (all stages), distribution of lung cancer types and stages

KQ 1b: All-cause mortality, lung cancer mortality, and quality of life

KQ 2: Estimated preventable lung cancer deaths or all-cause mortality; estimated screening effectiveness (e.g., number needed to screen); estimated screening harms

KQ 3: Sensitivity, specificity, and predictive value

KQ 4: Radiation exposure, false-positive results, overdiagnosis, smoking cessation rates, psychosocial harms, and incidental findings leading to additional tests and subsequent harms

KQ 5: Radiation exposure, false-positive results, overdiagnosis, smoking cessation rates, psychosocial harms, incidental findings leading to additional tests and subsequent harms, and harms of workup (e.g., adverse events from biopsy)

KQ 6: 5- and 10-year incidence of advanced disease and mortality (i.e., survival rates)

KQ 7: Harms of treatment, including mortality, infection, and bleeding

KQ 8: All-cause and lung cancer mortality

Costs
Study designs All KQs: Controlled trials

KQ 2: Modeling studies; clinical prediction tools are required to include multiple factors

KQ 3: Studies evaluating accuracy

KQs 4, 5, 7 (harms): Prospective cohort studies and case-control studies

KQ 6: Prospective cohort studies

All KQs: All other study designs

KQ 2: Models including a single variable or biomarker; models not considering smoking and age (i.e., known risk factors for lung cancer)

KQs 1–5, 8: Studies with a sample size less than 1,000

KQs 6, 7: Studies with a sample size less than 500

Study duration KQs 1–5, 7, 8: Studies of any length

KQ 6: Studies with at least 5 years of followup

KQ 6: Studies with less than 5 years of followup
Settings Studies published in or after 2001  
Countries Studies conducted in countries categorized as “Very High” on the 2016 Human Development Index (as defined by the United Nations Development Programme) Studies conducted in countries that are not categorized as “Very High” on the 2016 Human Development Index
Language English Languages other than English
Study quality Good- or fair-quality studies Poor-quality studies (according to design-specific USPSTF criteria)

* The evidence review will focus on CT but will also search for and include new trials (published since the search cutoff dates of the last review) of other screening methods. Older studies (from before 2013) of other screening methods will not be carried forward to this update.
Defined as detection of disease that would never progress to produce symptoms or death.
Systematic reviews are excluded from the evidence review. However, separate searches will be conducted to identify relevant systematic reviews and the citations of all studies included in those systematic reviews will be reviewed to ensure that all relevant primary studies have been captured.

Abbreviations: CT=computed tomography; NLST=National Lung Screening Trial.

Draft: Proposed Decision Model

The USPSTF has commissioned a decision model to supplement the systematic evidence review on screening for lung cancer, as it did for the previous topic update in 2014. The decision model is a mathematical simulation that projects the health outcomes that result from alternative interventions for screening, diagnosis, and treatment. In conjunction with the evidence review, the decision model will help the USPSTF examine the benefits and harms of screening for lung cancer at the population level, reflecting current nodule management and followup guidelines, while accounting for the variability in implementation patterns across the United States. The decision model will also evaluate different starting and stopping ages, screening frequencies, and screening strategies based on individual lung cancer risk, particularly for population subgroups at higher risk for lung cancer.

For more information about how the USPSTF uses decision models in formulating its recommendations, please refer to the USPSTF procedure manual, available at https://uspreventiveservicestaskforce.org/Page/Name/procedure-manual.

Current as of: May 2018

Internet Citation: Draft Research Plan: Lung Cancer: Screening. U.S. Preventive Services Task Force. May 2018.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/lung-cancer-screening1

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