Critical appraisal:Porceddu SV, Bressel M, Poulsen MG, Stoneley A, Veness MJ, Kenny LM, et al 2018 2
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Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)
Random sequence generation
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
- Participants were randomly assigned in a ratio of 1:1 to RT or CRT. Stratified random assignment was used to balance the arms according to high-risk nodal disease and advanced primary/in-transit disease and institution.In cases where participants had both risk categories, patients were stratified to the high-risk nodal group
What was the risk of bias from the random sequence generation?
- High
Allocation concealment
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of or during, enrolment.
- Participants were randomly assigned in a ratio of 1:1 to RT or CRT. Stratified random assignment was used to balance the arms according to high-risk nodal disease and advanced primary/in-transit disease and institution.In cases where participants had both risk categories, patients were stratified to the high-risk nodal group
What was the risk of bias from the allocation concealment?
- High
Blinding
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
- Not described
What was the risk of bias from the blinding of participants and personnel and outcome assessors?
- Unclear
Incomplete outcome data
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
- Freedom from loco-regional relapse: as reported
Overall Survival: as reported
Adverse events: as reported
Quality of life: additional outcome not reported in initial report
What was the risk of bias from incomplete outcome data?
- Low
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
- quality of life as an additional outcome reported by the authors that was not in the original study description
What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).
- Low
Other sources of bias
Describe any other sources of bias
- Non found
What was the risk of bias from other sources?
- Low
Overall risk of bias
| Unclear risk of bias | Additional comments: |
This appraisal has been completed.
- Article
- Porceddu SV, Bressel M, Poulsen MG, Stoneley A, Veness MJ, Kenny LM, et al. Postoperative Concurrent Chemoradiotherapy Versus Postoperative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: The Randomized Phase III TROG 05.01 Trial. J Clin Oncol 2018 May 1;36(13):1275-1283 Available from: http://www.ncbi.nlm.nih.gov/pubmed/29537906.
- Assigned to
- User:Annika.stollery
- Topic area
- Guidelines:Keratinocyte carcinoma
- Clinical question
- Form
- Form:Quality appraisal rct-cochrane
- Outcomes
- Freedom from locoregional relapse; Locoregional relapse; Disease-free survival; Overall Survival; Adverse events
Section below only relevant for Cancer Council Project Officer