Journal of the National Cancer Institute Advance Access originally published online on August 24, 2009
JNCI Journal of the National Cancer Institute 2009 101(19):1356-1362; doi:10.1093/jnci/djp281
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© The Author 2009. Published by Oxford University Press.
ARTICLES |
Surgeon Training, Protocol Compliance, and Technical Outcomes From Breast Cancer Sentinel Lymph Node Randomized Trial
Affiliations of authors: College of Medicine, University of Vermont, Burlington, VT (DNK, TA, SPH, JMS, DLW); National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA (TBJ, NW); Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA (AMB); Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA (TBJ, NW)
Correspondence to: David N. Krag, MD, Department of Surgery, College of Medicine, University of Vermont, Given Building, Rm E309, 89 Beaumont Ave, Burlington, VT 05405 (e-mail: david.krag{at}uvm.edu).
Background: The National Surgical Adjuvant Breast and Bowel Project B-32 trial was designed to determine whether sentinel lymph node resection can achieve the same therapeutic outcomes as axillary lymph node resection but with fewer side effects and is one of the most carefully controlled and monitored randomized trials in the field of surgical oncology. We evaluated the relationship of surgeon trial preparation, protocol compliance audit, and technical outcomes.
Methods: Preparation for this trial included a protocol manual, a site visit with key participants, an intraoperative session with the surgeon, and prerandomization documentation of protocol compliance. Training categories included surgeons who submitted material on five prerandomization surgeries and were trained by a core trainer (category 1) or by a site trainer (category 2). An expedited group (category 3) included surgeons with extensive experience who submitted material on one prerandomization surgery. At completion of training, surgeons could accrue patients. Two hundred twenty-four surgeons enrolled 4994 patients with breast cancer and were audited for 94 specific items in the following four categories: procedural, operative note, pathology report, and data entry. The relationship of training method; protocol compliance performance audit; and the technical outcomes of the sentinel lymph node resection rate, false-negative rate, and number of sentinel lymph nodes removed was determined. All statistical tests were two-sided.
Results: The overall sentinel lymph node resection success rate was 96.9% (95% confidence interval [CI] = 96.4% to 97.4%), and the overall false-negative rate was 9.5% (95% CI = 7.4% to 12.0%), with no statistical differences between training methods. Overall audit outcomes were excellent in all four categories. For all three training groups combined, a statistically significant positive association was observed between surgeons’ average number of procedural errors and their false-negative rate (
= +0.188, P = .021).
Conclusions: All three training methods resulted in uniform and high overall sentinel lymph node resection rates. Subgroup analyses identified some variation in false-negative rates that were related to audited outcome performance measures.
| CONTEXT AND CAVEATS Prior knowledge The randomized National Surgical Adjuvant Breast and Bowel Project B-32 trial is evaluating whether sentinel lymph node resection can achieve the same outcomes as axillary lymph node resection but with fewer side effects. Study design The ’overall’ relationship of surgeon trial preparation, protocol compliance audit, and technical outcomes was ‘determined and’ compared among surgeons who were trained in one of the three ways. Surgical performance was audited in four categories. Contribution No statistically significant differences were observed between training methods: Overall audit outcomes were excellent in all four categories. Among all surgeons, a statistically significant positive association was observed between the average number of procedural errors and the false-negative rate. Some variation in false-negative rates was observed that was related to audited outcomes. Implications Training methods were effective. Variation in false-negative rates in subgroup analyses indicates the value of the auditing measures and supports the use of similar auditing measures in future trials. Limitations Before randomization, there was only one intraoperative educational session per surgeon to ensure awareness of all the steps involved in protocol compliance. Audits of randomized cases were limited to 20 operations. From the Editors
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Manuscript received June 25, 2009; revised June 25, 2009; accepted July 21, 2009.
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J Natl Cancer Inst 2009 101: 1293.