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 |