Debating the mathematical model to validate the sentinel lymph biopsy techniques in breast cancer patients. The danger of bias and its practical implications.
BACKGROUND
Sentinel node biopsy (SNB) is an effective alternative to axillary lymph node dissection (ALD) for axillary staging. SNB (test) needs a validation period in which ALD (the gold standard) is always performed. Sensitivity, specificity and predictive values (PV) are used to define the accuracy of the procedure. We hypothesise that, during the period of validation, a bias is produced if the result of SNB is included as a part of the ALD.


METHODS
A hypothetical population of 350 patients was analysed. First analyses were performed by including the sentinel lymph node as a part of 'the rest of the axilla'. Second analyses were re-done according to our theory, and sentinel lymph node was considered outside 'the rest of the axilla'. Sensitivity, specificity and PV were compared for both models.


RESULTS
First group (classic) - sensitivity: 94%; specificity: 100%; positive PV: 100%; negative PV: 97%. Second group (new proposed model) - sensitivity: 87%; specificity: 81%; positive PV: 44%; negative PV: 97%.


CONCLUSIONS
The classic concept of sentinel lymph node to calculate sensitivity, specificity and positive PV can result in a bias. The magnitude of this bias will vary in terms of the obtained values, but its direction is always optimistic.
Martinez-Ramos
David
D
General and Digestive Surgery Department, Castellon General Hospital, Castellon, Spain, Europe. davidmartinez@comcas.es
Escrig-Sos
Javier
J
Alcalde-Sanchez
Miguel
M
Hoashi
Jane S
JS
Salvador-Sanchis
Jose Luis
JL
D001365:Axilla; D015982:Bias; D001943:Breast Neoplasms / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology*; D008954:Models, Biological; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D021701:Sentinel Lymph Node Biopsy