Table 2.
Characteristics of included studies and participants
| Author, year [reference] | Country | Lung-RADS version |
Study design | Inclusion period | No. of included patients | Age (y) | Sex (male) | Smoking status | Lung nodule (type and no.) | Reference standard | Eligibility criteria | Lung cancer prevalence |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pinsky 2015 [11] | USA | 1.0 | Retrospective cohort | 2002–2004 | 26,455 | Range 55–74 | 59% | 48.1% current and 51.9% former smokers | All types; unknown number | Histopathology | NLST selection criteria* | 1.1% (292) |
| McKee 2015 [35] | USA | 1.0 | Retrospective cohort | January 2012–May 2014 | 1603 | 64 | 53% | 45.8% current and 54.2% former smokers | All types; unknown number | Histopathology, PET, suspicious growth rate, or multidisciplinary consensus | NCCN high-risk criteria# | 1.8% (29) |
| Halpenny 2016 [36] | USA | 1.0 | Retrospective cohort | May 2011–September 2014 | 139 | 66 | 43% | 99.3% current or former smokers | 57.1% (4) malignant SN, 28.6% (2) malignant PSN, and 14.3% (1) malignant GGN | Histopathology | A previous history of malignancy | 5.0% (7) |
| Guichet 2017 [37] | USA | 1.0 | Prospective cohort | July 2015–April 2017 | 275 | 59 | 52% | 81.1% current and 18.9% former smokers | All types; unknown number | Histopathology, FU | NCCN high-risk criteria# | 0.7% (2) |
| Jacobs 2017 [38] | USA | 1.0 | Prospective cohort | June 2014–December 2015 | 680 | 64 | 55% | 48.3% current and 51.7% former smokers | All types; unknown number | Histopathology | Age 55–77, ≥ 30 pack-year smoking, quit < 15 years | 2.4% (16) |
| Marshall 2017 [39] | Australia | 1.0 | Retrospective cohort | December 2007–December 2010 | 256 | 65 | 67% | 47.3% current and 52.7% former smokers | All types; 136 patients with 301 nodules | Histopathology | NLST selection criteria* | 2.0% (5) |
| Hsu 2018 [40] | China, Taiwan | 1.0 | Retrospective cohort | August 2013–October 2014 | 1978 | 57 | 55% | 10.7% current, 16.5% former, and 72.8% never smokers | All types; unknown number | Histopathology | Age 40–80 years | 1.6% (32) |
| Kang 2018 [41] | South Korea | 1.0 | Retrospective cohort | March 2003–June 2016 | 28,807 | 52 | 71% | 57.8% current or former smokers, and 42.2% never smokers | 1218 never smokers with nodules: 34.3% (418) with SN, 10.1% (123) with PSN, and 55.5% (677) with GGN; unknown no. for smokers | Histopathology | No special | 0.7% (198) |
| Kim 2018 [42] | South Korea | 1.0 | Retrospective cohort | August 2002–December 2007 | 4365 | 51 | 0% | 100% never smokers | 18.2% (4) malignant SN, 50% (11) malignant PSN, 18.2% (4) malignant GGN | Histopathology | Age 40–79 years, never smokers, female | 0.5% (22) |
| Bhandaria 2019 [43] | USA | 1.0 | Retrospective cohort | 2016–2017 | 4500 | 62 | 46% | 69.0% current and 31.0% former smokers | All types; unknown number | Histopathology | USPSTF criteria& | 1.6% (70) |
| Healey 2019 [44] | USA | 1.0 | Prospective cohort | January 2015–January 2017 | 952 | NA | NA | 100% current or former smokers | All types; unknown number | Histopathology | NLST selection criteria* | 1.9% (18) |
| Kaminetzky 2019 [45] | USA | 1.0 | Prospective cohort | 2012–2016 | 1181 | 64 | 48% | 71.4% current and 28.6% former smokers | All types; unknown number | Histopathology, or imaging, National Death Index | NLST selection criteria* | 2.5% (30) |
| Meier-Schroers 2019 [46] | Germany | 1.0 | Prospective cohort | NA | 224 | 59 | NA | 100% current or former smokers | All types; unknown number | Histopathology | Age 50–70, ≥ 15 cigarettes/day for ≥ 25 or ≥ 10 cigarettes/day for ≥ 30 years, current or former quit < 10 years | 3.6% (8) |
| Ouyang 2019 [47] | China | 1.0 | Prospective cohort | 2018 | 1372 | 59 | 37% | NA | 69.6% (955) participants without nodules, 25.0% (343) with SN, 4.2% (57) with PSN, and 1.2% (17) with GGN | Histopathology | Age ≥ 45 years | 0.7% (9) |
| Teles 2019 [48] | Brazil | 1.0 | Prospective cohort | May 2015–April 2016 | 472 | 51 | 76% | 60.0% current and 40% former smokers | All types; unknown number | Histopathology | Age > 45, current or former smoker | 0.6% (3) |
| Tremblay 2019 [49] | Canada | 1.0 | Retrospective cohort | June 2015–December 2017 | 775 | 63 | 50% | 45.2% current and 54.8% former smokers | All types; unknown number | Histopathology | NLST criteria*, or age 55–80 with estimated 6-year risk (PLCOm2012) ≥ 1.5% | 2.8% (22) |
| Barbosa 2020 [50] | USA | 1.0 | Retrospective cohort | May 2014–July 2019 | 260 | 65.5 | 48% | 55.0% current and 45.0% former smokers | 33% participants without nodules, 62% with SN, 1% with PSN, and 4% with GGN | Histopathology | Age 55–80, ≥ 30 pack-year smoking, quit < 15 years | 1.5% (4) |
| Hsu 2020 [51] | China, Taiwan | 1.0 | Prospective cohort | February 2017–August 2018 | 836 | NA | 43% | NA | All types; unknown number | Histopathology | Age 40–80 | 3.2% (27) |
| Kessler 2020 [52] | USA | 1.0 | Prospective cohort | December 2012–June 2016 | 486 | 63 | 46% | 66.7% current and 33.3% former smokers | All types; unknown number | Histopathology | NLST selection criteria* | 7.8% (38) |
| Kim 2020 [53] | South Korea | 1.0 | Prospective cohort | April 2017–December 2018 | 11,394 | 62 | 97% | 53.3% current and 46.7% former smokers | All types; unknown number | Histopathology | NLST selection criteria* | 0.6% (65) |
| Maller 2020 [54] | USA | 1.1 | Retrospective cohort | 2011–2019 | 454 | 65 | 49% | 29.5% current and 61.5% former smokers | All types; unknown number | Histopathology | NCCN high-risk criteria# | 2.4% (11) |
| O’Dwyer 2020 [55] | USA | 1.0 | Prospective cohort | May 2011–November 2018 | 543 | 66 | 43% | 100% current or former smokers | 74.3% (26) malignant SN, 11.4% (4) malignant PSN, and 14.3% (5) malignant GGN | Histopathology | NCCN high-risk criteria#, and a previous history of malignancy | 6.4% (35) |
| White 2020 [56] | USA | 1.0 | Retrospective cohort | September 2013–September 2018 | 962 | 66 | 70% | 100% current or former smokers | All types; unknown number | Histopathology or FU | USPSTF criteria& | 4.4% (42) |
| Darling 2021 [57] | Canada | 1.0 | Prospective cohort | June 2017–May 2018 | 1624 | NA | 51% | 58.9% current and 41.1% former smokers | All types; unknown number | Histopathology | 6-year risk (PLCOm2012) ≥ 2% | 1.7% (28) |
| Erkmen 2021 [58] | USA | 1.0 | Prospective cohort | October 2015–March 2018 | 496 | 64 | 50% | 61.0% current and 39.0% former smokers | All types; unknown number | Histopathology or repeat CT | Age 55–77, ≥ 30 pack-year smoking, quit < 15 years | 3.2% (16) |
| Kastner 2021ǂ [21] | USA | 1.0, and 1.1 | Retrospective cohort | August 2002–April 2004 | 2813 | 62 | 61% | 100% current or former smokers | Only non-calcified nodules: 92.5% (4078) SN, 1.9% (82) PSN, and 5.6% (248) GGN | Histopathology | NLST selection criteria* | 3.9% (110) |
| Parang 2021 [59] | India | 1.0 | Retrospective cohort | January 2016–January 2019 | 350 | 61 | 96% | 100% current or former smokers | All types; unknown number | Histopathology | Smoker, current or former quit < 15 years | 2.0% (7) |
| Regis 2021 [60] | USA | 1.1 | Retrospective cohort | January 2012–December 2018 | 4301 | 63.1 | 56% | 47.4% current and 52.6% former smokers | All types; unknown number | Histopathology, nodule growth, PET/CT, or multidisciplinary consensus | NCCN eligibility criteria# | 2.0% (85) |
| Silva 2021 [61] | Italy | 1.1 | Retrospective cohort | NA | 1248 | Range 55–74 | 72% | 66.3% current and 33.7% former smokers | 57.3% (715) participants without nodules, 31.0% (387) with SN, 2.4% (30) with PSN, and 9.3% (116) with GGN | Histopathology | NLST selection criteria* | 2.6% (32) |
| Oshiro 2022 [62] | USA | 1.0 | Retrospective cohort | January 2015–December 2019 | 838 | 65.5 | 61% | 100% current or former smokers | All types; unknown number | Histopathology | Age 55–79, ≥ 30 pack-year smoking, quit < 15 years | 1.6% (13) |
| Panina 2022 [63] | Kazakhstan | 1.0 | Prospective cohort | June 2018–May 2020 | 3671 | Range 40–75 | 43% | 26.1% current, 14.2% former, and 59.9% never smokers | 83.8% (62) malignant SN, and 16.2% (12) malignant PSN | Histopathology | Age 40–75 | 2.0% (74) |
NLST National Lung Screening Trial; NCCN National Comprehensive Cancer Network; USPSTF US Preventive Services Task Force; PLCOm2012 risk prediction models including Tammemägi’s modified Prostate, Colorectal, Lung, and Ovarian Cancer Screening Trial 2012; NA not applicable; FU follow-up; SN solid nodule; PSN part-solid nodule; GGN ground-glass nodule
*NLST selection criteria: age 55–74, 30 pack-ear smoking history, quit within 15 years
#NCCN high-risk criteria: (1) age 55–74 years, ≥ 30 pack-year smoking history, quit within 15 years; (2) age > 50 years, ≥ 30 pack-year smoking history
&USPSTF criteria: age 55–80 years, ≥ 30 pack-year smoking history, quit within 15 years
ǂThe study by Kastner [21], which evaluated both versions 1.0 and 1.1, used the same database (NLST data) as the one by Pinsky [11], which only evaluated version 1.0, but with a smaller population. Therefore, we only extracted the result of the diagnostic performance of Lung-RADS version 1.1 from the study by Kastner