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 |
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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 |
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Outcomes | Survival (Kaplan‐Meier curve presented up to 600 days) Progression free survival (median time to progression) |
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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. |