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. 2020 May 21;2020(5):CD011475. doi: 10.1002/14651858.CD011475.pub3

Shin 1985.

Study characteristics
Methods Randomised, phase III trial
Treatment period: accrued January 1981 to March 1984; analysis July 1984
Median follow‐up: not described
Participants 124 randomised (71% grade III and 29% IV astrocytoma) from 2 Canadian centres; 62% aged ≥ 60 years and 38% < 60 years; 65% with Karnofsky performance status ≥ 70 and 35% with Karnofsky performance status < 70; percentage men and women not provided
Interventions Arm 1: hyperfractionation: 6141 cGy in 69 fractions given as 89 cGy per fraction 3 times a day
Arm 2: hyperfractionation as arm 1 + misonidazole
Arm 3: conventional fractionation: 5800 cGy in 30 daily fractions
Outcomes Survival (Kaplan‐Meier curve presented up to 600 days)
Progression free survival (median time to progression)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described.
Allocation concealment (selection bias) Unclear risk Protection of treatment allocation before and until assignment was unclear as the method of randomisation was not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Lack of blinding of participants and personnel associated with low risk of bias for the outcome of survival and unclear risk of bias for progression free survival.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Lack of blinding for outcome assessments associated with low risk of bias for survival and unclear risk of bias for progression free survival.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Attrition was not described.
Selective reporting (reporting bias) Unclear risk Publication did not describe the protocol for follow‐up assessment. The degree in which there may have been selective reporting for progression free survival was unknown.
Other bias Unclear risk Size of study bias: 124 randomised.