Andersen 1978.
Study characteristics | ||
Methods | Randomised, phase III trial Treatment period: 1963–1967 Follow‐up: 3 years |
|
Participants | 108 adults with glioblastoma (grade IV astrocytoma) from 4 US medical centres; 73% aged 50–70 years; baseline performance status not described; 64% men and 36% women | |
Interventions | Arm 1: postoperative radiotherapy: 4500 cGy in daily fractionation over 4.5–5.0 weeks Arm 2: no postoperative radiotherapy |
|
Outcomes | Crude survival presented as survival curves up to 20 months | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Participants born on odd dates received postoperative radiotherapy whereas those born on even dates did not. |
Allocation concealment (selection bias) | High risk | Randomisation was based on odd or even dates of birth. The protection of treatment allocation before and until assignment was deemed to be at high risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and personnel was not possible due to the nature of radiation delivery. However, blinding would not have biased the outcome of survival. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Although there was no blinding of the outcome (survival), blinding would not have biased the assessment of this outcome. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition not described. |
Selective reporting (reporting bias) | Low risk | The study's prespecified outcome (survival) that was of interest in this review was reported in the prespecified way. |
Other bias | Unclear risk | Size of study bias: 108 participants. |