Prerandomization Surgical Training for the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 trial: a randomized phase III clinical trial to compare sentinel node resection to conventional axillary dissection in clinically node-negative breast cancer.
OBJECTIVE
To train surgeons in a standardized technique of sentinel lymph node biopsy and to prepare them for the requirements of a prospective randomized surgical trial.


BACKGROUND
The NSABP B32 trial opened to accrual in May 1999. A significant component of this trial was a prerandomization training phase of surgeons performed by a group of core surgical trainers. The goals of this training phase were to expeditiously instruct surgeons in a standardized technique of sentinel lymph node biopsy and to educate those same surgeons in complete and accurate data collection and source documentation for the trial.


METHODS
This study is a description of the training data collected in a prospective fashion for the training component for surgeon entry into the B32 trial, evaluating the effectiveness of the training program in regards to surgical outcomes and protocol compliance.


RESULTS
Two hundred twenty-six registered surgeons underwent site visit training by a core surgical trainer and 187 completed training and were approved to randomize patients on the trial. The results of 815 training (nontrial) cases demonstrated a technical success rate for identifying sentinel nodes at 96.2% with a false negative rate of 6.7%. A protocol compliance analysis, which included the evaluation of 94 separate fields, showed mean protocol compliance of 98.6% for procedural fields, 95.5% for source documentation fields and 95.0% for data entry fields.


CONCLUSIONS
This training and quality control program has resulted in a large number of surgeons capable of performing sentinel lymph node biopsy in a standardized fashion with a high degree of protocol compliance and pathologic accuracy. This will ensure optimal results for procedures performed on the randomized phase of the trial.
Harlow
Seth P
SP
Department of Surgery, University of Vermont College of Medicine and the Vermont Cancer Center, Burlington 05405, USA. seth.harlow@uvm.edu
Krag
David N
DN
Julian
Thomas B
TB
Ashikaga
Takamaru
T
Weaver
Donald L
DL
Feldman
Sheldon A
SA
Klimberg
V Suzanne
VS
Kusminsky
Roberto
R
Moffat
Frederick L
FL
Noyes
R Dirk
RD
Beitsch
Peter D
PD
D001365:Axilla; D001943:Breast Neoplasms / Q000473:pathology*; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D005260:Female; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D011446:Prospective Studies; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic; D021701:Sentinel Lymph Node Biopsy / Q000592:standards*; D016896:Treatment Outcome