Trial | Description of randomization process | Allocation concealment | Masking | Sample size estimation | Analysis method | Dropouts described | Predefined patient-relevant outcome (defined in trial registry) | Risk of bias |
Beanlands et al. 2007 | Yes | Yes | Partially* | Yes | ITT | Yes | Yes (yes) | Low |
Fischer et al. 2009 | Yes | No | Unclear | Unclear | ITT | Yes | Yes (unclear) | High |
Herder et al. 2006 | Yes | Yes | Unclear | Yes† | ITT | Yes | Yes (unclear) | Low |
Maziak et al. 2009 | Yes | Yes | Unclear | Yes | PP | Yes | Yes (yes) | Low |
Picardi et al. 2007 | Unclear | Unclear | Unclear | Yes | ITT | Yes | Yes (unclear) | High |
Plewnia et al. 2007 | Unclear | Unclear | Unclear | Unclear | ITT | No dropouts | Yes (no) | High |
Ruers et al. 2009 | Yes | Yes | Unclear | Yes | ITT | No dropouts | No (no)‡ | High |
Siebelink et al. 2010 | Yes | Unclear | Partially§ | Yes | ITT | No dropouts | Yes (unclear) | Low |
Sobhani et al. 2008 | Unclear | Unclear | No | Yes | ITT/PP | No dropouts | Yes (unclear) | High |
VanTinteren et al. 2002 | Yes | Yes | Unclear | Yes | ITT | No dropouts | Yes (yes) | Low |
Tsai et al. 2010 | Unclear | Unclear | No | Yes | ITT | Early closure∥ | Yes (yes) | High |
Viney et al. 2004 | Yes | Yes | Partially¶ | Yes | ITT | Yes | Yes (?) | Low |
↵* Events were reviewed and verified by adjudication committee masked to results of 18F-FDG PET scan.
↵† In earlier observational study in 2 participating hospitals, at least 3 (mean ± SD, 3.2 ± 1.6) diagnostic procedures in half of patients were performed in addition to bronchoscopy, chest radiography, laboratory, lung function and cardiovascular tests, and thoracotomy. Here, we considered PET up-front strategy clinically useful if a proportion of patients needing at least 3 tests was reduced from 50% to 30%. Furthermore, we anticipated inclusion of 30% of patients with other histologies (e.g., small cell lung cancer, benign lung diseases) in which PET might have a different impact. Therefore, to assess impact in patient sample of interest with sufficient reliability, its size was increased by 30% to total of 465.
↵‡ Primary outcomes in study protocol were defined as disease-free survival (9 mo) and economic evaluation (9 mo). Primary outcome in publication was number of futile laparotomies.
↵§ Radiologists were not masked. Uniformly masked polar map of heart was used to mask treating physicians. Patients’ masking was unclear.
↵∥ Because of change of equipment and fact that patients declined randomization, study was closed early.
↵¶ In the case of postsurgical pathology, independent review was undertaken masked to randomization.