Methods |
RCT of previously untreated head and neck SCC with allocation concealment not clear, method of randomisation not stated. Patient, outcome assessors and treating team all aware of allocation. No indication of power calculation |
Participants |
50 adults with SCC of the head and neck where radiotherapy was the treatment of choice. Group allocation unclear but six dropouts and 21 analysed in HBOT group, 23 in control |
Interventions |
|
Outcomes |
Death at 2 to 8 years, local tumour control and late radiation tissue injury |
Notes |
5 participants excluded from analysis because they died from 'intercurrent disease' prior to 2 year follow‐up Schulz rating: randomisation: C; allocation concealment: B; selection bias: B; blinding: C |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |