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. 2012 Apr 18;2012(4):CD005007. doi: 10.1002/14651858.CD005007.pub3

Sause 1979

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
  • Control: total dose 6250 rads in 25 fractions over 6 weeks

  • HBOT: total dose 4800 rads in 12 fractions over 5 weeks while breathing oxygen at 3 ATA for about 30 minutes

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