Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial)

Smith, Michaella J., Gill, P. Grantley, Wetzig, Neil, Sourjina, Tatiana, Gebski, Val, Ung, Owen, Campbell, Ian, Kollias, James, Coskinas, Xanthi, MacPhee, Avis, Young, Leonie, Simes, R. John, Stockler, Martin R. and The Royal Australasian College of Surgeons SNAC Trial Group (2009) Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial). Breast Cancer Research and Treatment, 117 1: 99-109. doi:10.1007/s10549-008-0202-3


Author Smith, Michaella J.
Gill, P. Grantley
Wetzig, Neil
Sourjina, Tatiana
Gebski, Val
Ung, Owen
Campbell, Ian
Kollias, James
Coskinas, Xanthi
MacPhee, Avis
Young, Leonie
Simes, R. John
Stockler, Martin R.
The Royal Australasian College of Surgeons SNAC Trial Group
Title Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial)
Journal name Breast Cancer Research and Treatment   Check publisher's open access policy
ISSN 0167-6806
1573-7217
Publication date 2009-01-01
Year available 2009
Sub-type Article (original research)
DOI 10.1007/s10549-008-0202-3
Volume 117
Issue 1
Start page 99
End page 109
Total pages 11
Place of publication New York, NY, United States
Publisher Springer
Language eng
Abstract The RACS sentinel node biopsy versus axillary clearance (SNAC) trial compared sentinel-node-based management (SNBM) and axillary lymph-node dissection (ALND) for breast cancer. In this sub study, we sought to determine whether patient ratings of arm swelling, symptoms, function and disability or clinicians' measurements were most efficient at detecting differences between randomized groups, and therefore, which of these outcome measures would minimise the required sample sizes in future clinical trials. 324 women randomised to SNBM and 319 randomised to ALND were included. The primary endpoint of the trial was percentage increase in arm volume calculated from clinicians' measurements of arm circumference at 10 cm intervals. Secondary endpoints included reductions in range of motion and sensation (both measured by clinicians); and, patients' ratings of arm swelling, symptoms and quality of life, using the European Organisation for Research and Treatment of Cancer Breast Cancer Module (EORTC QLM-BR23), the body image after breast cancer questionnaire (BIBC) and the SNAC study specific scales (SSSS). The relative efficiency (RE, the squared ratio of the test statistics, with 95% confidence intervals calculated by bootstrapping) was used to compare these measures in detecting differences between the treatment groups. Patients' self-ratings of arm swelling were generally more efficient than clinicians' measurements of arm volume in detecting differences between treatment groups. The SSSS arm symptoms scale was the most efficient (RE = 7.1) The entire SSSS was slightly less so (RE = 4.6). Patients' ratings on single items were 3-5 times more efficient than clinicians' measurements. Primary endpoints based on patient-rated outcome measures could reduce the required sample size in future surgical trials.
Keyword Axillary lymph node dissection
Breast cancer
Lymphoedema
Outcomes assessment
Quality of life
Randomized clinical trial
Relative efficiency statistic
Sentinel node biopsy
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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