Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial).
Identifieur interne : 006350 ( Main/Exploration ); précédent : 006349; suivant : 006351Comparing 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 ; Neil Wetzig ; Tatiana Sourjina ; Val Gebski ; Owen Ung ; Ian Campbell ; James Kollias ; Xanthi Coskinas ; Avis Macphee ; Leonie Young ; R John Simes ; Martin R. StocklerSource :
- Breast cancer research and treatment [ 1573-7217 ] ; 2009.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Amplitude articulaire, Biopsie de noeud lymphatique sentinelle (effets indésirables), Bras (anatomopathologie), Enquêtes et questionnaires, Femelle, Humains, Lymphadénectomie (effets indésirables), Lymphoedème (anatomopathologie), Lymphoedème (étiologie), Qualité de vie, Résultat thérapeutique, Sujet âgé, Tumeurs du sein (), Tumeurs du sein (diagnostic).
- MESH :
- anatomopathologie : Bras, Lymphoedème.
- diagnostic : Tumeurs du sein.
- effets indésirables : Biopsie de noeud lymphatique sentinelle, Lymphadénectomie.
- étiologie : Lymphoedème.
- Adulte d'âge moyen, Amplitude articulaire, Enquêtes et questionnaires, Femelle, Humains, Qualité de vie, Résultat thérapeutique, Sujet âgé, Tumeurs du sein.
English descriptors
- KwdEn :
- Aged, Arm (pathology), Breast Neoplasms (diagnosis), Breast Neoplasms (surgery), Female, Humans, Lymph Node Excision (adverse effects), Lymphedema (etiology), Lymphedema (pathology), Middle Aged, Quality of Life, Range of Motion, Articular, Sentinel Lymph Node Biopsy (adverse effects), Surveys and Questionnaires, Treatment Outcome.
- MESH :
- adverse effects : Lymph Node Excision, Sentinel Lymph Node Biopsy.
- diagnosis : Breast Neoplasms.
- etiology : Lymphedema.
- pathology : Arm, Lymphedema.
- surgery : Breast Neoplasms.
- Aged, Female, Humans, Middle Aged, Quality of Life, Range of Motion, Articular, Surveys and Questionnaires, Treatment Outcome.
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.
DOI: 10.1007/s10549-008-0202-3
PubMed: 18925434
Affiliations:
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Michaella.Smith@ctc.usyd.edu.au</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Gill, P Grantley" sort="Gill, P Grantley" uniqKey="Gill P" first="P Grantley" last="Gill">P Grantley Gill</name></author><author><name sortKey="Wetzig, Neil" sort="Wetzig, Neil" uniqKey="Wetzig N" first="Neil" last="Wetzig">Neil Wetzig</name></author><author><name sortKey="Sourjina, Tatiana" sort="Sourjina, Tatiana" uniqKey="Sourjina T" first="Tatiana" last="Sourjina">Tatiana Sourjina</name></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name></author><author><name sortKey="Ung, Owen" sort="Ung, Owen" uniqKey="Ung O" first="Owen" last="Ung">Owen Ung</name></author><author><name sortKey="Campbell, Ian" sort="Campbell, Ian" uniqKey="Campbell I" first="Ian" last="Campbell">Ian Campbell</name></author><author><name sortKey="Kollias, James" sort="Kollias, James" uniqKey="Kollias J" first="James" last="Kollias">James Kollias</name></author><author><name sortKey="Coskinas, Xanthi" sort="Coskinas, Xanthi" uniqKey="Coskinas X" first="Xanthi" last="Coskinas">Xanthi Coskinas</name></author><author><name sortKey="Macphee, Avis" sort="Macphee, Avis" uniqKey="Macphee A" first="Avis" last="Macphee">Avis Macphee</name></author><author><name sortKey="Young, Leonie" sort="Young, Leonie" uniqKey="Young L" first="Leonie" last="Young">Leonie Young</name></author><author><name sortKey="Simes, R John" sort="Simes, R John" uniqKey="Simes R" first="R John" last="Simes">R John Simes</name></author><author><name sortKey="Stockler, Martin R" sort="Stockler, Martin R" uniqKey="Stockler M" first="Martin R" last="Stockler">Martin R. 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Smith</name><affiliation wicri:level="1"><nlm:affiliation>NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia. Michaella.Smith@ctc.usyd.edu.au</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Gill, P Grantley" sort="Gill, P Grantley" uniqKey="Gill P" first="P Grantley" last="Gill">P Grantley Gill</name></author><author><name sortKey="Wetzig, Neil" sort="Wetzig, Neil" uniqKey="Wetzig N" first="Neil" last="Wetzig">Neil Wetzig</name></author><author><name sortKey="Sourjina, Tatiana" sort="Sourjina, Tatiana" uniqKey="Sourjina T" first="Tatiana" last="Sourjina">Tatiana Sourjina</name></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name></author><author><name sortKey="Ung, Owen" sort="Ung, Owen" uniqKey="Ung O" first="Owen" last="Ung">Owen Ung</name></author><author><name sortKey="Campbell, Ian" sort="Campbell, Ian" uniqKey="Campbell I" first="Ian" last="Campbell">Ian Campbell</name></author><author><name sortKey="Kollias, James" sort="Kollias, James" uniqKey="Kollias J" first="James" last="Kollias">James Kollias</name></author><author><name sortKey="Coskinas, Xanthi" sort="Coskinas, Xanthi" uniqKey="Coskinas X" first="Xanthi" last="Coskinas">Xanthi Coskinas</name></author><author><name sortKey="Macphee, Avis" sort="Macphee, Avis" uniqKey="Macphee A" first="Avis" last="Macphee">Avis Macphee</name></author><author><name sortKey="Young, Leonie" sort="Young, Leonie" uniqKey="Young L" first="Leonie" last="Young">Leonie Young</name></author><author><name sortKey="Simes, R John" sort="Simes, R John" uniqKey="Simes R" first="R John" last="Simes">R John Simes</name></author><author><name sortKey="Stockler, Martin R" sort="Stockler, Martin R" uniqKey="Stockler M" first="Martin R" last="Stockler">Martin R. Stockler</name></author></analytic><series><title level="j">Breast cancer research and treatment</title><idno type="eISSN">1573-7217</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Arm (pathology)</term><term>Breast Neoplasms (diagnosis)</term><term>Breast Neoplasms (surgery)</term><term>Female</term><term>Humans</term><term>Lymph Node Excision (adverse effects)</term><term>Lymphedema (etiology)</term><term>Lymphedema (pathology)</term><term>Middle Aged</term><term>Quality of Life</term><term>Range of Motion, Articular</term><term>Sentinel Lymph Node Biopsy (adverse effects)</term><term>Surveys and Questionnaires</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Amplitude articulaire</term><term>Biopsie de noeud lymphatique sentinelle (effets indésirables)</term><term>Bras (anatomopathologie)</term><term>Enquêtes et questionnaires</term><term>Femelle</term><term>Humains</term><term>Lymphadénectomie (effets indésirables)</term><term>Lymphoedème (anatomopathologie)</term><term>Lymphoedème (étiologie)</term><term>Qualité de vie</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Tumeurs du sein ()</term><term>Tumeurs du sein (diagnostic)</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Lymph Node Excision</term><term>Sentinel Lymph Node Biopsy</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Bras</term><term>Lymphoedème</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Biopsie de noeud lymphatique sentinelle</term><term>Lymphadénectomie</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Lymphedema</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Arm</term><term>Lymphedema</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Lymphoedème</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Female</term><term>Humans</term><term>Middle Aged</term><term>Quality of Life</term><term>Range of Motion, Articular</term><term>Surveys and Questionnaires</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Amplitude articulaire</term><term>Enquêtes et questionnaires</term><term>Femelle</term><term>Humains</term><term>Qualité de vie</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Tumeurs du sein</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></country></list><tree><noCountry><name sortKey="Campbell, Ian" sort="Campbell, Ian" uniqKey="Campbell I" first="Ian" last="Campbell">Ian Campbell</name><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="Gill, P Grantley" sort="Gill, P Grantley" uniqKey="Gill P" first="P Grantley" last="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></noCountry><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></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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