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

Seth P. Harlow, David N. Krag, Thomas B. Julian, Takamaru Ashikaga, Donald L. Weaver, Sheldon A. Feldman, V. Suzanne Klimberg, Roberto Kusminsky, Frederick L Moffat, R. Dirk Noyes, Peter D. Beitsch

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

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. Summary Background Data: 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.

Original languageEnglish
Pages (from-to)48-54
Number of pages7
JournalAnnals of Surgery
Volume241
Issue number1
DOIs
StatePublished - Jan 1 2005
Externally publishedYes

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Phase III Clinical Trials
Dissection
Breast
Randomized Controlled Trials
Guideline Adherence
Breast Neoplasms
Sentinel Lymph Node Biopsy
Documentation
Information Storage and Retrieval
Surgeons
cyhalothrin
Quality Control
Education

ASJC Scopus subject areas

  • Surgery

Cite this

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. / Harlow, Seth P.; Krag, David N.; Julian, Thomas B.; Ashikaga, Takamaru; Weaver, Donald L.; Feldman, Sheldon A.; Klimberg, V. Suzanne; Kusminsky, Roberto; Moffat, Frederick L; Noyes, R. Dirk; Beitsch, Peter D.

In: Annals of Surgery, Vol. 241, No. 1, 01.01.2005, p. 48-54.

Research output: Contribution to journalArticle

Harlow, Seth P. ; Krag, David N. ; Julian, Thomas B. ; Ashikaga, Takamaru ; Weaver, Donald L. ; Feldman, Sheldon A. ; Klimberg, V. Suzanne ; Kusminsky, Roberto ; Moffat, Frederick L ; Noyes, R. Dirk ; Beitsch, Peter D. / 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. In: Annals of Surgery. 2005 ; Vol. 241, No. 1. pp. 48-54.
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abstract = "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. Summary Background Data: 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.",
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AU - Krag, David N.

AU - Julian, Thomas B.

AU - Ashikaga, Takamaru

AU - Weaver, Donald L.

AU - Feldman, Sheldon A.

AU - Klimberg, V. Suzanne

AU - Kusminsky, Roberto

AU - Moffat, Frederick L

AU - Noyes, R. Dirk

AU - Beitsch, Peter D.

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