Slovenia 1988.
Methods | 1988 to 1992 RCT | |
Participants | 74 patients
Stage III Trial data used in subgroup analyses for sex, age, histology, stage and nodal status |
|
Interventions | Surgery + radiotherapy vs surgery alone RT details 30 Gy in 10 to 12 fractions in 2 weeks Prescription technique: central axis, at the midplane Machine used: linac Average field size (cm): 9 × 12 Clinical target volume: hilum, mediastinum Technique: oblique fields, lateral fields | |
Outcomes | Survival | |
Notes | Sealed envelope randomisation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation |
Allocation concealment (selection bias) | Low risk | Quote: "randomisation carried out via sealed envelope" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: individual participant data obtained and checked for all outcomes |
Selective reporting (reporting bias) | Low risk | Comment: individual participant data obtained and checked for all outcomes |
Other bias | Low risk | Comment: study apparently free of other sources of bias |
All trials supplied individual participant data for analysis and therefore are defined as unpublished data, even though most are published.
IPD = individual participant data. RCT = randomised controlled trial. RT = radiotherapy.1G