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. 2017 Jan 4;2017(1):CD004561. doi: 10.1002/14651858.CD004561.pub3

WSSA Glasgow.

Methods Study design: 3‐arm RCT
Country: Scotland
Study period: 1972‐1977
Inclusion criteria: aged ≤ 76 years, operable breast cancer, no deep fixation or skin involvement, no fixation of axillary lymph nodes
Exclusion criteria: none reported
Length of follow‐up: 5 years in EBCTCG 1990
Participants Simple mastectomy with radiotherapy to the chest wall but not to nodal areas (Arm A) vs simple mastectomy with radiotherapy to both chest wall and nodal areas (Arm B) vs simple mastectomy with axillary clearance and radiotherapy to the chest wall but not to nodal areas (Arm C)
No. in trial arm: Arm A: N = 123; Arm B: N = 94; Arm C: N = 118
Age median and range: not reported
Stage distribution: not reported
Proportion node positive: Arm A: N = 16/123; Arm B: N = 9/94; Arm C: N = 17/118
Pathological type of breast cancer: not reported
Interventions Simple mastectomy with radiotherapy to the chest wall but not to nodal areas (Arm A) vs simple mastectomy with radiotherapy to both chest wall and nodal areas (Arm B) vs simple mastectomy with axillary clearance and radiotherapy to the chest wall but not to nodal areas (Arm C)
Outcomes Overall survival, local recurrence
Axillary node surgery Minimum no. nodes to be removed according to protocol: see the next 3 lines
Arm A: Protocol specifies no disturbance of nodes.
Arm B: Protocol specifies no disturbance of nodes.
Arm C: Axillary contents were removed.
Method of node pathological analysis: not reported
Further treatment for node‐positive cases: no
Radiotherapy Arm A: Radiotherapy to chest wall (42 Gy in 2.1 Gy fractions)
Arm B: Radiotherapy to chest wall (42 Gy in 2.1 Gy fractions) and nodal areas, including axilla and supraclavicular fossa (42 Gy in 2.1 Gy fractions)
Arm C: Radiotherapy to chest wall (42 Gy in 2.1 Gy fractions)
RT same in all trial arms? no
Hormone and chemotherapy Not reported
Notes Study included 3 arms:
1. Simple mastectomy with RT to chest wall but not to nodal areas;
 2: Simple mastectomy with RT to both chest wall and nodal areas, including axilla and supraclavicular fossa; and
 3: Simple mastectomy with axillary clearance plus RT to chest wall but not to nodal areas: results derived from arms 1 and 3 only. Data from meta‐analysis forest plot only
 Central randomisation
 Sealed cards
Baseline differences? not reported
Intention‐to‐treat analyses? not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Numbered envelopes: It is unclear how sequence was generated.
Allocation concealment (selection bias) Unclear risk Sealed envelopes: It is unclear whether envelopes were opaque.
Blinding of outcome assessment (detection bias) 
 Disease control in the axilla Unclear risk This was not reported.
Blinding of outcome assessment (detection bias) 
 Breast cancer recurrence Unclear risk This was not reported.
Blinding of outcome assessment (detection bias) 
 Short term adverse events Unclear risk Outcome was not reported.
Blinding of outcome assessment (detection bias) 
 Long term adverse events Unclear risk Outcome was not reported.
Incomplete outcome data (attrition bias) 
 Survival Low risk Data appear to be available for all included participants.
Incomplete outcome data (attrition bias) 
 Axillary recurrence Low risk Data appear to be available for all included participants.
Incomplete outcome data (attrition bias) 
 Breast cancer recurrence Low risk Data appear to be available for all included participants.
Incomplete outcome data (attrition bias) 
 Short term adverse events Unclear risk Outcome was not reported.
Incomplete outcome data (attrition bias) 
 Long term adverse events Unclear risk Outcome was not reported.
Selective reporting (reporting bias) Unclear risk Short‐term and long‐term adverse events were not reported.