| Methods | Study design: open‐label, multicentre, randomised study. Source of funding: Programme Hospitalier de Recherche Clinique (French Department of Health). |
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| Participants | Country: France. Setting: hospital. Number of centres: 4. Number of participants: 394. Age (mean (range)): screening group: 64 (48‐77) years; limited screening group: 62 (50‐75) years. Sex: screening group: 105 M/92 F; limited screening group: 102 M/95 F. Inclusion criteria: aged ≥ 18 years, diagnosed with unprovoked VTE. VTE defined as objectively confirmed proximal deep vein thrombosis or pulmonary embolism. Unprovoked VTE defined as VTE not provoked by major inherited or acquired risk factor including surgery, trauma or fracture during 3 months before VTE event, known antiphospholipid antibody syndrome or known deficiency in antithrombin, protein C or protein S. Exclusion criteria: ongoing pregnancy, active malignant disease (defined as known malignant disease which was active or treated during previous 5 years), not insured under French National Social Security programme, hypersensitivity to 18F‐FDG or any of the excipients according to summary of product characteristics in France, or unable or unwilling to give consent. |
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| Interventions | Screening procedure: screening strategy consisting of limited strategy + 18F‐FDG PET/CT scan of chest, abdomen and pelvis. Control: limited screening strategy (physical examination, usual laboratory tests and basic radiographs). Duration: 2 years. |
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| Outcomes | Primary outcomes: proportion of people with a cancer diagnosis in each group after the initial screening assessment. Secondary outcomes: subsequent cancer diagnosis in people with negative initial screening, proportion of early‐stage versus advanced‐stage tumours at initial screening and during follow‐up, overall mortality and cancer‐related mortality during follow‐up. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The randomisation list was created centrally using computer‐generated block sizes of six, stratified by centre, and concealed from investigators. We used a secure, dedicated, central web‐based randomisation system (Clinsight)." |
| Allocation concealment (selection bias) | Low risk | Quote: "The randomisation list was created centrally using computer‐generated block sizes of six, stratified by centre, and concealed from investigators. We used a secure, dedicated, central web‐based randomisation system (Clinsight). A unique study participant number and study group allocation was given after patients’ basic information and eligibility criteria were entered by the study personnel." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Participants and physicians giving the intervention, assessing outcomes, and analysing the data were not masked to study group assignment." Comment: blinding of participants and study personnel not done but review authors judged that outcome and outcome measurement not likely to be influenced by lack of blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Physicians giving the intervention, assessing outcomes, and analysing the data were not masked to study group assignment." Comment: outcome assessors not blinded to outcome assessment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all losses to follow‐up accounted for. |
| Selective reporting (reporting bias) | Low risk | Comment: primary and secondary outcomes clearly prespecified and reported. |
| Other bias | Low risk | Comment: study appeared free from other sources of bias. |
CT: computed tomography; F: female; FDG: fluorodeoxyglucose; M: male; Pap: Papanicolaou; PET: positron emission tomography; PSA: prostate‐specific antigen; SD: standard deviation; TNM: tumour‐node‐metastasis; VTE: venous thromboembolism.