Young 1980.
Methods | Randomised, parallel group, two arm, active controlled, open label, two‐centre trial | |
Participants |
Inclusion: tissue diagnosis of a malignant tumour not of central nervous system origin; the presence of clinical symptoms of cord compression; and a myelogram showing extradural lesion or block that correlated with clinical presentation Exclusion: prior radiotherapy, unfit for surgery, more than one lesion, presence of only spinal or radicular pain. Age: 19 to 83 years Gender: not stated Pretreatment ambulant: laminectomy plus radiotherapy versus radiotherapy alone: 6 versus 5 Performance status: not stated Type of primary tumours: all types Visceral metastasis: not stated Duration and rapidity of cord compression: not stated Spinal level: not stated Spinal instability: not stated |
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Interventions |
Intervention laminectomy with radiotherapy: 30 Gy in 10 fractions over 14 days + steroids* (N = 16) Control radiotherapy: 30 Gy in 10 fractions (4 Gy/day first 3 days, then 18 Gy in 7 fractions over 14 days) + steroids* (N = 13) Timing of intervention in relation to development of cord compression ‐ not stated Concomitant medications: *Dexamethasone 12 mg stat followed by 4 mg four times daily till radiotherapy completion; other medications ‐not reported |
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Outcomes |
Outcomes reported and used:
Outcomes reported but not used:
Outcomes sought but not reported:
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Notes |
Setting: two centres in USA Period of study: not reported Provision for rehabilitation: not reported Source of funding: not reported Comments: radiotherapy alone: mortality ‐ 24% (due to underlying disease) duration of follow‐up: participants were followed up at regular intervals until death; duration unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was carried out using a "table of random numbers" |
Allocation concealment (selection bias) | High risk | Not stated; there were also baseline imbalances in prognostic variables that might have occurred due to lack of stratification |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of blinding could have led to differential interventions in terms of pain medication; though no differences were noted with interventions |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Ambulatory status was clearly defined and minimised the possibility of observer bias |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | While subjective outcomes were operationally defined, detection bias cannot be ruled out in this open label trial |
Incomplete outcome data (attrition bias) Efficacy outcomes | Low risk | There was no attrition |
Incomplete outcome data (attrition bias) Adverse events | Low risk | As above |
Selective reporting (reporting bias) | Low risk | The trial protocol was not available but all relevant outcomes were reported |
Other bias | Low risk | No other sources of bias were identified |
MRI ‐ magnetic resonance imaging CT‐ computed tomography ECOG ‐ Eastern Co‐operative Oncology Group SD ‐ standard deviation Gy ‐ Gray