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. 2010 Jan 20;2010(1):CD008285. doi: 10.1002/14651858.CD008285

Chen 1997b.

Methods RCT
1993 to 1994
Participants 60 patients
Stage IIB to IIIB
Interventions Radiotherapy plus hypothermia versus concomitant chemoradiotherapy (Cisplatin) plus hypothermia
Outcomes Survival, disease free survival, local and distant recurrence, acute toxicity, late toxicity
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Data checks on IPD provided suggest adequate sequence generation
Allocation concealment (selection bias) Low risk Sealed envelope
Blinding (performance bias and detection bias) 
 All outcomes High risk Trial was not blinded due to nature of treatment interventions
Incomplete outcome data (attrition bias) 
 All outcomes Low risk IPD provided for all outcomes. NB. Substantial proportion of data missing for late toxicity outcomes
Selective reporting (reporting bias) Low risk N/A (IPD supplied for all outcomes)
Other bias Low risk Data checks on IPD provided suggest study is free of follow‐up bias