Abstract
Background
We provide a statistical analysis of the learning phase for sentinel node biopsy.
Methods
Four learning phases were analyzed: 25, 50, 75, and 150 procedures with a corresponding number of 10, 20, 30, and 60 tumor-positive cases. Critical values of nonidentification rate and false-negative rate were defined. The binomial distribution was used to calculate the probabilities of correctly or incorrectly accepting the quality of the performance, given a certain long-term nonidentification or false-negative rate.
Results
The chance of incorrectly reaching a favorable false-negative rate of <10% (critical value) in 20 metastasized patients was 18% for a surgeon with a long-term probability of falsenegative procedures of 15%. This chance was reduced to 10% with a learning phase of 60 tumor-positive cases. When this chance has to be further reduced to 5%, the critical value has to be lower in smaller groups of patients: 5% false-negative rate in 20 tumor-positive procedures.
Conclusions
A learning phase of at least 150 procedures with 60 tumor-positive cases is needed to draw any reliable conclusion about the quality of sentinel node biopsy. In general, a compromise has to be made between the reliability of the results and the practically achievable number of procedures.
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Tanis, P.J., Nieweg, O.E., Hart, A.A.M. et al. The illusion of the learning phase for lymphatic mapping. Annals of Surgical Oncology 9, 142–147 (2002). https://doi.org/10.1007/BF02557365
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DOI: https://doi.org/10.1007/BF02557365