Table 3 Eligibility criteria for key question 3 on the comparative effects between (a) trial-based selection criteria and use of risk prediction models, and (b) trial-based nodule classification and different nodule classification systems

Population

Adults aged 18 years and older are not suspected to have lung cancer

Studies that focused on people under age 18 or that targeted adults 18 years and older who were either suspected of having lung cancer or were previously diagnosed with lung cancer

Intervention(s)

For risk prediction models used for screening eligibility:

Risk prediction models that include factors (laboratory tests, other assessments) that are not available or feasible in primary care

Risk prediction models are used for screening eligibility that incorporate nodule characteristics

Externally validated risk prediction models intended for identifying persons who may benefit from screening

The subsequent screening process must be similar to trials included in KQ1 (e.g. LDCT, nodule classification)

Note: The purpose of the study may be to provide external validation

For nodule classification systems: any nodule classification system. Other elements of screening must be similar to the trial included in KQ1

Comparison(s)

For risk prediction models:

Trial-based eligibility criteria (similar to that used by trials included in KQ1 (e.g., NLST, NELSON))

For nodule classification systems:

Nodule classification system is similar to those used by trials included in KQ1 (e.g., NLST, NELSON)

Outcomes

Benefits:

False positive selections (individual is positive for “increased risk” using model [i.e. is selected for screening with CT or other modality] but does not get cancer or die from lung cancer during follow-up)

1. All-cause mortality*

2. Lung cancer mortality*

3. Health-related quality of life

Harms:

4. Overdiagnosis of lung cancer*

5. Major complications or morbidity from invasive testing as a result of screening

6. Death from invasive testing as a result of screening

7. False positives

8. Psychosocial consequences of the screening process (i.e., before or right after screening, receiving a false positive result)

9. Incidental findings

*Rated as critical outcomes; others rated as important

See Table 1. Note: outcome may be reported as a relative measure between benefit(s) and harm, e.g., number of overdiagnosed cancers per prevented death

Delivery setting

Any setting relevant to primary care

Study design(s) and publication status

Nonrandomized clinical trials, prospective or retrospective controlled observational studies (including analyses using data from screening arms in RCTs), modeling studies

• RCTs (captured in KQ1)

• Editorials

• Commentaries

• Case reports and series

Journal articles

Letters, abstracts, and grey literature (e.g., government reports, results in trial registries) if information on study design (e.g., eligibility criteria, participant characteristics, presentation of scenarios) is sufficient to assess study and results are confirmed as final (accessible online or via author contact)

Countries

Studies conducted on populations from countries categorized as “Very High” on the 2016 Human Development Index (as defined by the United Nations Development Programme)

Studies conducted on populations from countries not categorized as “Very High” on the 2016 Human Development Index (as defined by the United Nations Development Programme)

Priority will be given to studies relevant to the Canadian context

Language of full text

English or French

Languages other than English and French

Dates of publication

2012 (publication of first RCT showing the benefit of lung cancer screening was Aug 2011)