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Table 2 Risk of bias in the included studies

From: Axillary surgery in women with sentinel node-positive operable breast cancer: a systematic review with meta-analyses

  ATTRM-048-13-2000 IBCSG-23-01 ACOSOG Z0011 AMAROS OTOASOR
Random sequence generation (selection bias) Unclear Low Low Low Unclear
Allocation concealment (selection bias) Unclear Low Low Low Unclear
Blinding of outcome assessment (detection bias): Disease control in the axilla Unclear High—no blinding Unclear High—no blinding Unclear
Blinding of outcome assessment (detection bias): Breast cancer recurrence Unclear High—no blinding Unclear High—no blinding Unclear
Blinding of outcome assessment (detection bias): Short term adverse events Outcome not reported High—no blinding Unclear Outcome not reported Unclear
Blinding of outcome assessment (detection bias): Long term adverse events Outcome not reported High—no blinding Unclear High—no blinding Unclear
Incomplete outcome data (attrition bias): Survival Low Low Low Low Low
Incomplete outcome data (attrition bias): Disease control in the axilla Low Low Low Low Unclear—data not reported in sufficient detail to be able to ascertain whether all patients are included
Incomplete outcome data (attrition bias): Breast cancer recurrence Low Low Low Low Low
Incomplete outcome data (attrition bias): Short term adverse events Outcome not reported Unclear—denominator not reported Unclear—data reported at 30 days for 371/411 ALND and 373/399 SLND + ALND Outcome not reported Outcome not reported
Incomplete outcome data (attrition bias): Long term complications Outcome not reported Unclear—14 patients allocated to surgery alone received ALND and 17 patients allocated to ALND did not receive ALND; all excluded from the analyses High—data missing from progressively larger proportions of patients as follow up progressed; possibly more pronounced in the SLND group. Outcome data reported at 1 year for 242/411 ALND and 226/399 SLND +ALND High—data available from 655/744 ALND and 586/681 aRT patients at baseline; progressively higher rates of missing data at 1, 3 and 5 years for lympoedema. Unclear how much data were available for shoulder mobility Outcome not reported
Selective reporting (reporting bias) High—adverse events not reported Low Low High—only lymphedema and should mobility reported as morbidity outcomes High—morbidity not reported
  1. SLND sentinel lymph node dissection, ALND axillary lymph node dissection, aRT axillary radiotherapy