Methods |
Methods of randomisation not specified. Application of ITT analysis was not mentioned. |
Participants |
Women with Stage 1 endometrial cancer following TAH and BSO. Also included women with Stage IB and grade 1 tumour. |
Interventions |
All had intravaginal radium. Intervention group received further pelvic RT but not the control group. Follow‐up was 3‐10 years. |
Outcomes |
Pelvic radiotherapy reduced vaginal and pelvic recurrences (1.9% versus 6.9%, P < 0.001 but not overall survival rate/5‐year survival). |
Notes |
Only patients with grade 3 and Stage IC tumour might have benefited from pelvic radiotherapy. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
No details provided. |
Allocation concealment (selection bias) |
Unclear risk |
No details provided. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Histological material "reassessed without reference to the clinical course" suggests that some measure of assessor blinding was applied. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No women lost to follow‐up. Baseline characteristics comparable. |
Selective reporting (reporting bias) |
Unclear risk |
Application of ITT were not described. |
Other bias |
Low risk |
Baseline characteristics comparable. |