Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial)
Identifieur interne : 006823 ( Main/Exploration ); précédent : 006822; suivant : 006824Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial)
Auteurs : Michaella J. Smith [Australie] ; P. Grantley Gill [Australie] ; Neil Wetzig [Australie] ; Tatiana Sourjina [Australie] ; Val Gebski [Australie] ; Owen Ung [Australie] ; Ian Campbell [Nouvelle-Zélande] ; James Kollias [Australie] ; Xanthi Coskinas [Australie] ; Avis Macphee [Australie] ; Leonie Young [Australie] ; R. John Simes [Australie] ; Martin R. Stockler [Australie]Source :
- Breast cancer research and treatment [ 0167-6806 ] ; 2009.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme, Statistique.
English descriptors
- KwdEn :
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.
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Smith</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown</s1><s2>Sydney, NSW 1450</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Sydney, NSW 1450</wicri:noRegion></affiliation></author><author><name sortKey="Grantley Gill, P" sort="Grantley Gill, P" uniqKey="Grantley Gill P" first="P." last="Grantley Gill">P. Grantley Gill</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Breast, Endocrine and Surgical Oncology Unit, Royal Adelaide Hospital</s1><s2>Adelaide, SA</s2><s3>AUS</s3><sZ>2 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide, SA</wicri:noRegion></affiliation></author><author><name sortKey="Wetzig, Neil" sort="Wetzig, Neil" uniqKey="Wetzig N" first="Neil" last="Wetzig">Neil Wetzig</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Wesley Hospital</s1><s2>Brisbane, QLD</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Wesley Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Sourjina, Tatiana" sort="Sourjina, Tatiana" uniqKey="Sourjina T" first="Tatiana" last="Sourjina">Tatiana Sourjina</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown</s1><s2>Sydney, NSW 1450</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Sydney, NSW 1450</wicri:noRegion></affiliation></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown</s1><s2>Sydney, NSW 1450</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Sydney, NSW 1450</wicri:noRegion></affiliation></author><author><name sortKey="Ung, Owen" sort="Ung, Owen" uniqKey="Ung O" first="Owen" last="Ung">Owen Ung</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>New South Wales Breast Cancer Institute, Westmead Hospital, University of Sydney</s1><s2>Sydney</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Campbell, Ian" sort="Campbell, Ian" uniqKey="Campbell I" first="Ian" last="Campbell">Ian Campbell</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Waikato Hospital</s1><s2>Waikato</s2><s3>NZL</s3><sZ>7 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Waikato Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Kollias, James" sort="Kollias, James" uniqKey="Kollias J" first="James" last="Kollias">James Kollias</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Breast, Endocrine and Surgical Oncology Unit, Royal Adelaide Hospital</s1><s2>Adelaide, SA</s2><s3>AUS</s3><sZ>2 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide, SA</wicri:noRegion></affiliation></author><author><name sortKey="Coskinas, Xanthi" sort="Coskinas, Xanthi" uniqKey="Coskinas X" first="Xanthi" last="Coskinas">Xanthi Coskinas</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown</s1><s2>Sydney, NSW 1450</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Sydney, NSW 1450</wicri:noRegion></affiliation></author><author><name sortKey="Macphee, Avis" sort="Macphee, Avis" uniqKey="Macphee A" first="Avis" last="Macphee">Avis Macphee</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Breast Cancer Network</s1><s2>Camberwell, VIC</s2><s3>AUS</s3><sZ>10 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Breast Cancer Network</wicri:noRegion></affiliation></author><author><name sortKey="Young, Leonie" sort="Young, Leonie" uniqKey="Young L" first="Leonie" last="Young">Leonie Young</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Consumer advisory panel, ANZ Breast Cancer Trials Group</s1><s2>New Castle, NSW</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>New Castle, NSW</wicri:noRegion></affiliation></author><author><name sortKey="Simes, R John" sort="Simes, R John" uniqKey="Simes R" first="R. John" last="Simes">R. John Simes</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown</s1><s2>Sydney, NSW 1450</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Sydney, NSW 1450</wicri:noRegion></affiliation></author><author><name sortKey="Stockler, Martin R" sort="Stockler, Martin R" uniqKey="Stockler M" first="Martin R." last="Stockler">Martin R. Stockler</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown</s1><s2>Sydney, NSW 1450</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Sydney, NSW 1450</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Breast cancer research and treatment</title><title level="j" type="abbreviated">Breast cancer res. treat.</title><idno type="ISSN">0167-6806</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Breast cancer research and treatment</title><title level="j" type="abbreviated">Breast cancer res. treat.</title><idno type="ISSN">0167-6806</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anatomic pathology</term><term>Axillary ganglion</term><term>Biopsy</term><term>Breast cancer</term><term>Clinical trial</term><term>Comparative study</term><term>Efficiency</term><term>Evaluation</term><term>Human</term><term>Lymphadenectomy</term><term>Lymphedema</term><term>Node</term><term>Patient</term><term>Prognosis</term><term>Quality of life</term><term>Randomization</term><term>Statistics</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Etude comparative</term><term>Homme</term><term>Malade</term><term>Evaluation</term><term>Pronostic</term><term>Essai clinique</term><term>Noeud</term><term>Biopsie</term><term>Anatomopathologie</term><term>Cancer du sein</term><term>Ganglion axillaire</term><term>Lymphadénectomie</term><term>Randomisation</term><term>Lymphoedème</term><term>Qualité de vie</term><term>Efficacité</term><term>Statistique</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Statistique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Nouvelle-Zélande</li></country><region><li>Nouvelle-Galles du Sud</li></region><settlement><li>Sydney</li></settlement></list><tree><country name="Australie"><noRegion><name sortKey="Smith, Michaella J" sort="Smith, Michaella J" uniqKey="Smith M" first="Michaella J." last="Smith">Michaella J. Smith</name></noRegion><name sortKey="Coskinas, Xanthi" sort="Coskinas, Xanthi" uniqKey="Coskinas X" first="Xanthi" last="Coskinas">Xanthi Coskinas</name><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><name sortKey="Grantley Gill, P" sort="Grantley Gill, P" uniqKey="Grantley Gill P" first="P." last="Grantley Gill">P. Grantley Gill</name><name sortKey="Kollias, James" sort="Kollias, James" uniqKey="Kollias J" first="James" last="Kollias">James Kollias</name><name sortKey="Macphee, Avis" sort="Macphee, Avis" uniqKey="Macphee A" first="Avis" last="Macphee">Avis Macphee</name><name sortKey="Simes, R John" sort="Simes, R John" uniqKey="Simes R" first="R. John" last="Simes">R. John Simes</name><name sortKey="Sourjina, Tatiana" sort="Sourjina, Tatiana" uniqKey="Sourjina T" first="Tatiana" last="Sourjina">Tatiana Sourjina</name><name sortKey="Stockler, Martin R" sort="Stockler, Martin R" uniqKey="Stockler M" first="Martin R." last="Stockler">Martin R. Stockler</name><name sortKey="Ung, Owen" sort="Ung, Owen" uniqKey="Ung O" first="Owen" last="Ung">Owen Ung</name><name sortKey="Wetzig, Neil" sort="Wetzig, Neil" uniqKey="Wetzig N" first="Neil" last="Wetzig">Neil Wetzig</name><name sortKey="Young, Leonie" sort="Young, Leonie" uniqKey="Young L" first="Leonie" last="Young">Leonie Young</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Campbell, Ian" sort="Campbell, Ian" uniqKey="Campbell I" first="Ian" last="Campbell">Ian Campbell</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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