The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial
CONTEXT Raloxifene hydrochloride is a selective estrogen receptor modulator that has antiestrogenic effects on breast and endometrial tissue and estrogenic effects on bone, lipid metabolism, and blood clotting. OBJECTIVE To determine whether women taking raloxifene have a lower risk of invasive brea...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 1999-06, Vol.281 (23), p.2189-2197 |
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| creator | Cummings, Steven R Eckert, Stephen Krueger, Kathryn A Grady, Deborah Powles, Trevor J Cauley, Jane A Norton, Larry Nickelsen, Thomas Bjarnason, Nina H Morrow, Monica Lippman, Marc E Black, Dennis Glusman, Joan E Costa, Alberto Jordan, V. Craig |
| description | CONTEXT Raloxifene hydrochloride is a selective estrogen
receptor modulator that has antiestrogenic effects on breast and
endometrial tissue and estrogenic effects on bone, lipid metabolism,
and blood clotting. OBJECTIVE To determine whether women taking raloxifene have a
lower risk of invasive breast cancer. DESIGN AND SETTING The Multiple Outcomes of Raloxifene Evaluation
(MORE), a multicenter, randomized, double-blind trial, in which women
taking raloxifene or placebo were followed up for a median of 40 months
(SD, 3 years), from 1994 through 1998, at 180 clinical centers composed
of community settings and medical practices in 25 countries, mainly in
the United States and Europe. PARTICIPANTS A total of 7705 postmenopausal women, younger than 81
(mean age, 66.5) years, with osteoporosis, defined by the presence of
vertebral fractures or a femoral neck or spine T-score of at least 2.5
SDs below the mean for young healthy women. Almost all participants
(96%) were white. Women who had a history of breast cancer or who were
taking estrogen were excluded. INTERVENTION Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60
mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets. MAIN OUTCOME MEASURES New cases of breast cancer, confirmed by
histopathology. Transvaginal ultrasonography was used to assess the
endometrial effects of raloxifene in 1781 women. Deep vein thrombosis
or pulmonary embolism were determined by chart review. RESULTS Thirteen cases of breast cancer were confirmed among the
5129 women assigned to raloxifene vs 27 among the 2576 women assigned
to placebo (relative risk [RR], 0.24; 95% confidence interval
[CI], 0.13-0.44; P |
| doi_str_mv | 10.1001/jama.281.23.2189 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pasca</sourceid><recordid>TN_cdi_proquest_miscellaneous_17300893</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>190420</ama_id><sourcerecordid>17300893</sourcerecordid><originalsourceid>FETCH-LOGICAL-a283t-ba0c33bd2bd3a9b81d1ec1a8753eb2379a28e9e683487a4d6dbf80115ba1b1f13</originalsourceid><addsrcrecordid>eNpdkdFLw0AMxg9RcE7f9e0Q8a3zcteud77p2FRQJmPiY0nbFDvb3rxrQf3rPVEQzEtI8uP7QsLYMYgJCAEXG2xxIjVMpJpI0GaHjSBROlKJ0btsJITRURrreJ8deL8RIUClI_a2fiE-ryoqem4rvsLGvtcVdcRtx1e1f_3uXjtC3_MZdgU5Xnf80fq-pc5ucfDY8Gcbiku-Ij80vecLZ1veB92H5WoeJLvStvUnlXztamwO2V6Fjaej3zxmT4v5enYb3S9v7mZX9xFKrfooR1EolZcyLxWaXEMJVADqNFGUS5WagJGhqVaxTjEup2VeaQGQ5Ag5VKDG7PxHd-vs20C-z9raF9Q02JEdfAapEkIbFcDTf-DGDq4Lu2USQMmpmKYBOvuF0BfYVC7covbZ1tUtuo8MdCJM-m168oOFb_wNjYilUF9Wwn5k</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>211326067</pqid></control><display><type>article</type><title>The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial</title><source>American Medical Association Journals</source><creator>Cummings, Steven R ; Eckert, Stephen ; Krueger, Kathryn A ; Grady, Deborah ; Powles, Trevor J ; Cauley, Jane A ; Norton, Larry ; Nickelsen, Thomas ; Bjarnason, Nina H ; Morrow, Monica ; Lippman, Marc E ; Black, Dennis ; Glusman, Joan E ; Costa, Alberto ; Jordan, V. Craig</creator><creatorcontrib>Cummings, Steven R ; Eckert, Stephen ; Krueger, Kathryn A ; Grady, Deborah ; Powles, Trevor J ; Cauley, Jane A ; Norton, Larry ; Nickelsen, Thomas ; Bjarnason, Nina H ; Morrow, Monica ; Lippman, Marc E ; Black, Dennis ; Glusman, Joan E ; Costa, Alberto ; Jordan, V. Craig</creatorcontrib><description>CONTEXT Raloxifene hydrochloride is a selective estrogen
receptor modulator that has antiestrogenic effects on breast and
endometrial tissue and estrogenic effects on bone, lipid metabolism,
and blood clotting. OBJECTIVE To determine whether women taking raloxifene have a
lower risk of invasive breast cancer. DESIGN AND SETTING The Multiple Outcomes of Raloxifene Evaluation
(MORE), a multicenter, randomized, double-blind trial, in which women
taking raloxifene or placebo were followed up for a median of 40 months
(SD, 3 years), from 1994 through 1998, at 180 clinical centers composed
of community settings and medical practices in 25 countries, mainly in
the United States and Europe. PARTICIPANTS A total of 7705 postmenopausal women, younger than 81
(mean age, 66.5) years, with osteoporosis, defined by the presence of
vertebral fractures or a femoral neck or spine T-score of at least 2.5
SDs below the mean for young healthy women. Almost all participants
(96%) were white. Women who had a history of breast cancer or who were
taking estrogen were excluded. INTERVENTION Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60
mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets. MAIN OUTCOME MEASURES New cases of breast cancer, confirmed by
histopathology. Transvaginal ultrasonography was used to assess the
endometrial effects of raloxifene in 1781 women. Deep vein thrombosis
or pulmonary embolism were determined by chart review. RESULTS Thirteen cases of breast cancer were confirmed among the
5129 women assigned to raloxifene vs 27 among the 2576 women assigned
to placebo (relative risk [RR], 0.24; 95% confidence interval
[CI], 0.13-0.44; P<.001). To prevent 1 case of breast
cancer, 126 women would need to be treated. Raloxifene decreased the
risk of estrogen receptor–positive breast cancer by 90% (RR, 0.10;
95% CI, 0.04-0.24), but not estrogen receptor–negative invasive
breast cancer (RR, 0.88; 95% CI, 0.26-3.0). Raloxifene increased the
risk of venous thromboembolic disease (RR, 3.1; 95% CI, 1.5-6.2), but
did not increase the risk of endometrial cancer (RR, 0.8; 95% CI,
0.2-2.7). CONCLUSION Among postmenopausal women with osteoporosis, the
risk of invasive breast cancer was decreased by 76% during 3 years of
treatment with raloxifene.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.281.23.2189</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Biological and medical sciences ; Breast cancer ; Drug therapy ; Gynecology. Andrology. Obstetrics ; Health risk assessment ; Mammary gland diseases ; Medical research ; Medical sciences ; Tumors ; Women</subject><ispartof>JAMA : the journal of the American Medical Association, 1999-06, Vol.281 (23), p.2189-2197</ispartof><rights>1999 INIST-CNRS</rights><rights>Copyright American Medical Association Jun 16, 1999</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.281.23.2189$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.281.23.2189$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76231,76234</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1850971$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Cummings, Steven R</creatorcontrib><creatorcontrib>Eckert, Stephen</creatorcontrib><creatorcontrib>Krueger, Kathryn A</creatorcontrib><creatorcontrib>Grady, Deborah</creatorcontrib><creatorcontrib>Powles, Trevor J</creatorcontrib><creatorcontrib>Cauley, Jane A</creatorcontrib><creatorcontrib>Norton, Larry</creatorcontrib><creatorcontrib>Nickelsen, Thomas</creatorcontrib><creatorcontrib>Bjarnason, Nina H</creatorcontrib><creatorcontrib>Morrow, Monica</creatorcontrib><creatorcontrib>Lippman, Marc E</creatorcontrib><creatorcontrib>Black, Dennis</creatorcontrib><creatorcontrib>Glusman, Joan E</creatorcontrib><creatorcontrib>Costa, Alberto</creatorcontrib><creatorcontrib>Jordan, V. Craig</creatorcontrib><title>The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial</title><title>JAMA : the journal of the American Medical Association</title><description>CONTEXT Raloxifene hydrochloride is a selective estrogen
receptor modulator that has antiestrogenic effects on breast and
endometrial tissue and estrogenic effects on bone, lipid metabolism,
and blood clotting. OBJECTIVE To determine whether women taking raloxifene have a
lower risk of invasive breast cancer. DESIGN AND SETTING The Multiple Outcomes of Raloxifene Evaluation
(MORE), a multicenter, randomized, double-blind trial, in which women
taking raloxifene or placebo were followed up for a median of 40 months
(SD, 3 years), from 1994 through 1998, at 180 clinical centers composed
of community settings and medical practices in 25 countries, mainly in
the United States and Europe. PARTICIPANTS A total of 7705 postmenopausal women, younger than 81
(mean age, 66.5) years, with osteoporosis, defined by the presence of
vertebral fractures or a femoral neck or spine T-score of at least 2.5
SDs below the mean for young healthy women. Almost all participants
(96%) were white. Women who had a history of breast cancer or who were
taking estrogen were excluded. INTERVENTION Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60
mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets. MAIN OUTCOME MEASURES New cases of breast cancer, confirmed by
histopathology. Transvaginal ultrasonography was used to assess the
endometrial effects of raloxifene in 1781 women. Deep vein thrombosis
or pulmonary embolism were determined by chart review. RESULTS Thirteen cases of breast cancer were confirmed among the
5129 women assigned to raloxifene vs 27 among the 2576 women assigned
to placebo (relative risk [RR], 0.24; 95% confidence interval
[CI], 0.13-0.44; P<.001). To prevent 1 case of breast
cancer, 126 women would need to be treated. Raloxifene decreased the
risk of estrogen receptor–positive breast cancer by 90% (RR, 0.10;
95% CI, 0.04-0.24), but not estrogen receptor–negative invasive
breast cancer (RR, 0.88; 95% CI, 0.26-3.0). Raloxifene increased the
risk of venous thromboembolic disease (RR, 3.1; 95% CI, 1.5-6.2), but
did not increase the risk of endometrial cancer (RR, 0.8; 95% CI,
0.2-2.7). CONCLUSION Among postmenopausal women with osteoporosis, the
risk of invasive breast cancer was decreased by 76% during 3 years of
treatment with raloxifene.</description><subject>Biological and medical sciences</subject><subject>Breast cancer</subject><subject>Drug therapy</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Health risk assessment</subject><subject>Mammary gland diseases</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Tumors</subject><subject>Women</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><recordid>eNpdkdFLw0AMxg9RcE7f9e0Q8a3zcteud77p2FRQJmPiY0nbFDvb3rxrQf3rPVEQzEtI8uP7QsLYMYgJCAEXG2xxIjVMpJpI0GaHjSBROlKJ0btsJITRURrreJ8deL8RIUClI_a2fiE-ryoqem4rvsLGvtcVdcRtx1e1f_3uXjtC3_MZdgU5Xnf80fq-pc5ucfDY8Gcbiku-Ij80vecLZ1veB92H5WoeJLvStvUnlXztamwO2V6Fjaej3zxmT4v5enYb3S9v7mZX9xFKrfooR1EolZcyLxWaXEMJVADqNFGUS5WagJGhqVaxTjEup2VeaQGQ5Ag5VKDG7PxHd-vs20C-z9raF9Q02JEdfAapEkIbFcDTf-DGDq4Lu2USQMmpmKYBOvuF0BfYVC7covbZ1tUtuo8MdCJM-m168oOFb_wNjYilUF9Wwn5k</recordid><startdate>19990616</startdate><enddate>19990616</enddate><creator>Cummings, Steven R</creator><creator>Eckert, Stephen</creator><creator>Krueger, Kathryn A</creator><creator>Grady, Deborah</creator><creator>Powles, Trevor J</creator><creator>Cauley, Jane A</creator><creator>Norton, Larry</creator><creator>Nickelsen, Thomas</creator><creator>Bjarnason, Nina H</creator><creator>Morrow, Monica</creator><creator>Lippman, Marc E</creator><creator>Black, Dennis</creator><creator>Glusman, Joan E</creator><creator>Costa, Alberto</creator><creator>Jordan, V. Craig</creator><general>American Medical Association</general><scope>IQODW</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7T2</scope><scope>7U1</scope><scope>7U2</scope></search><sort><creationdate>19990616</creationdate><title>The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial</title><author>Cummings, Steven R ; Eckert, Stephen ; Krueger, Kathryn A ; Grady, Deborah ; Powles, Trevor J ; Cauley, Jane A ; Norton, Larry ; Nickelsen, Thomas ; Bjarnason, Nina H ; Morrow, Monica ; Lippman, Marc E ; Black, Dennis ; Glusman, Joan E ; Costa, Alberto ; Jordan, V. 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Obstetrics</topic><topic>Health risk assessment</topic><topic>Mammary gland diseases</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Tumors</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cummings, Steven R</creatorcontrib><creatorcontrib>Eckert, Stephen</creatorcontrib><creatorcontrib>Krueger, Kathryn A</creatorcontrib><creatorcontrib>Grady, Deborah</creatorcontrib><creatorcontrib>Powles, Trevor J</creatorcontrib><creatorcontrib>Cauley, Jane A</creatorcontrib><creatorcontrib>Norton, Larry</creatorcontrib><creatorcontrib>Nickelsen, Thomas</creatorcontrib><creatorcontrib>Bjarnason, Nina H</creatorcontrib><creatorcontrib>Morrow, Monica</creatorcontrib><creatorcontrib>Lippman, Marc E</creatorcontrib><creatorcontrib>Black, Dennis</creatorcontrib><creatorcontrib>Glusman, Joan E</creatorcontrib><creatorcontrib>Costa, Alberto</creatorcontrib><creatorcontrib>Jordan, V. Craig</creatorcontrib><collection>Pascal-Francis</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cummings, Steven R</au><au>Eckert, Stephen</au><au>Krueger, Kathryn A</au><au>Grady, Deborah</au><au>Powles, Trevor J</au><au>Cauley, Jane A</au><au>Norton, Larry</au><au>Nickelsen, Thomas</au><au>Bjarnason, Nina H</au><au>Morrow, Monica</au><au>Lippman, Marc E</au><au>Black, Dennis</au><au>Glusman, Joan E</au><au>Costa, Alberto</au><au>Jordan, V. Craig</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><date>1999-06-16</date><risdate>1999</risdate><volume>281</volume><issue>23</issue><spage>2189</spage><epage>2197</epage><pages>2189-2197</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT Raloxifene hydrochloride is a selective estrogen
receptor modulator that has antiestrogenic effects on breast and
endometrial tissue and estrogenic effects on bone, lipid metabolism,
and blood clotting. OBJECTIVE To determine whether women taking raloxifene have a
lower risk of invasive breast cancer. DESIGN AND SETTING The Multiple Outcomes of Raloxifene Evaluation
(MORE), a multicenter, randomized, double-blind trial, in which women
taking raloxifene or placebo were followed up for a median of 40 months
(SD, 3 years), from 1994 through 1998, at 180 clinical centers composed
of community settings and medical practices in 25 countries, mainly in
the United States and Europe. PARTICIPANTS A total of 7705 postmenopausal women, younger than 81
(mean age, 66.5) years, with osteoporosis, defined by the presence of
vertebral fractures or a femoral neck or spine T-score of at least 2.5
SDs below the mean for young healthy women. Almost all participants
(96%) were white. Women who had a history of breast cancer or who were
taking estrogen were excluded. INTERVENTION Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60
mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets. MAIN OUTCOME MEASURES New cases of breast cancer, confirmed by
histopathology. Transvaginal ultrasonography was used to assess the
endometrial effects of raloxifene in 1781 women. Deep vein thrombosis
or pulmonary embolism were determined by chart review. RESULTS Thirteen cases of breast cancer were confirmed among the
5129 women assigned to raloxifene vs 27 among the 2576 women assigned
to placebo (relative risk [RR], 0.24; 95% confidence interval
[CI], 0.13-0.44; P<.001). To prevent 1 case of breast
cancer, 126 women would need to be treated. Raloxifene decreased the
risk of estrogen receptor–positive breast cancer by 90% (RR, 0.10;
95% CI, 0.04-0.24), but not estrogen receptor–negative invasive
breast cancer (RR, 0.88; 95% CI, 0.26-3.0). Raloxifene increased the
risk of venous thromboembolic disease (RR, 3.1; 95% CI, 1.5-6.2), but
did not increase the risk of endometrial cancer (RR, 0.8; 95% CI,
0.2-2.7). CONCLUSION Among postmenopausal women with osteoporosis, the
risk of invasive breast cancer was decreased by 76% during 3 years of
treatment with raloxifene.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><doi>10.1001/jama.281.23.2189</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 1999-06, Vol.281 (23), p.2189-2197 |
| issn | 0098-7484 1538-3598 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_17300893 |
| source | American Medical Association Journals |
| subjects | Biological and medical sciences Breast cancer Drug therapy Gynecology. Andrology. Obstetrics Health risk assessment Mammary gland diseases Medical research Medical sciences Tumors Women |
| title | The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial |
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