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From the Departments of Surgery (PJT, OEN, BBRK) and Radiotherapy (AAMH), The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Correspondence: Address correspondence and reprint requests to: P. J. Tanis, MD, Department of Surgery, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands; Fax: 31-20-512-2554; E-mail: ptanis{at}nki.nl
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 false-negative 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.
Key Words: Sentinel node Learning phase Sensitivity Identification rate Binomial distribution Critical value
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