Infante 2015.
Study characteristics | ||
Methods |
Trial design: phase 3 RCT Duration of follow‐up: median 8.5 years Number of trial locations: 3 |
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Participants |
Baseline characteristics Number of participants: LDCT arm (N = 1264); control arm (N = 1186) Age: mean age for both groups 65 years old Sex: 100% male Smoking status: LDCT arm (714 active smokers); control (681 active smokers) Performance status: not reported Ethnicity/race: not reported Environmental exposures: LDCT arm (391 participants had occupational exposures including chemical industry, insulation, construction, metallurgy, agriculture, mining); control arm (402 participants had occupational exposures including chemical industry, insulation, construction, metallurgy, agriculture, mining) Inclusion criteria
Exclusion criteria
Preintervention investigations
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Interventions |
Intervention characteristics
Interpretation of scans
Comparison
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Outcomes |
Primary outcomes
Secondary outcomes
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Identification |
Sponsorship source: Italian Association for the fight against cancer Country: Italy Setting: hospital Trial start date: March 2001 Completion of follow‐up: May 2013 Trial registration number: NCT00420862 Corresponding author's name: Maurizio Infante Institution: Instituto Clinico Humanitas, Rozzano, Milano, Italy Email: maurizio.infante@cancercenter.humanitas.it |
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Notes | Conflicts of interest: nil declared | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation of four |
Allocation concealment (selection bias) | Low risk | Allocation stratified by centre according to computer‐generated lists supplied by the data centre |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessors were not blinded to cause of death nor to subjects' allocation. Cause of death was determined by death certificates which were cross‐checked with available medical records. A death review panel blinded to allocation arm was only consulted when there were several competing causes of death. Only 78% of death certificates were cross‐checked, 91% of lung cancer‐related deaths and 80% of non‐pulmonary cancer‐related deaths and 76% of non‐cancer‐related deaths. Active follow‐up was terminated in February 2012, with information regarding death being obtained from registries subsequently. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Final report was revised due to discovery of 20 duplicate registrations and 2 test records (2015 AJRCC). Compliance data‐ 1223 (97%) of participants had ≥ 3 CTs, 1184 (94%) had 5 CT scans. Used intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |
Other bias | High risk | Inappropriate inclusion of 10 participants (kept in trial) with a history of malignancy treated < 10 years before accrual (4 with superficial bladder cancer, 2 with prostate cancer, 1 with chronic lymphocytic leukaemia, 1 with aggressive fibromatosis, 1 with renal cancer and 1 with head and neck cancer). All male participants. Unbalanced baseline between arms with more respiratory comorbidities 35.28% (intervention) versus 31.20% (control) P = 0.032. |