Faries, Mark B., Nicola Mozzillo, Mohammed Kashani-Sabet, John F. Thompson, Mark C. Kelley, Ronald C. DeConti, Jeffrey E. Lee, et al. 2017. “Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases.” Annals of Surgical Oncology, October, 1–10. http://doi.org/10.1245/s10434-017-6072-3.
Added by: Thomas Eigentler
The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials
| Topic | Judgment | Risk of bias (low, unclear or high risk of bias) |
|---|---|---|
| Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups | Random permuted block design (block size = 20) with stratification by site of metastasis (soft tissue or nonvisceral lymph nodes [stage IV M1a] or visceral sites [stage IV M1b]) and number of metastatic lesions (1, 2–3, or 4–5). | Low Risk |
| Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen before or during enrolment | No information about the creation of the randomisation list provided | Unclear Risk |
| Describe all measures used, if any, to blind trial participants and researchers from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective | The identity of the investigational agent was masked to investigators and study personnel. | Low Risk |
| Describe all measures used, if any, to blind outcome assessment from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective | Open label | High Risk |
| Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomised participants), reasons for attrition or exclusions where reported, and any reinclusions in analyses for the review | Losses to follow-up were disclosed and the analyses were conducted using a intention to treat analysis | Low Risk |
| State how selective outcome reporting was examined and what was found | All prespecified outcomes were reported | Low Risk |
| State any important concerns about bias not covered in the other domains in the tool | No | Unclear Risk |
Reviewed by: Thomas Eigentler