Use of Medicare Data to Identify Coronary Heart Disease Outcomes In the Women's Health Initiative (WHI)
Identifieur interne : 000976 ( Main/Exploration ); précédent : 000975; suivant : 000977Use of Medicare Data to Identify Coronary Heart Disease Outcomes In the Women's Health Initiative (WHI)
Auteurs : Mark A. Hlatky ; Roberta M. Ray ; Dale R. Burwen ; Karen L. Margolis ; Karen C. Johnson ; Anna Kucharska-Newton ; Joann E. Manson ; Jennifer G. Robinson ; Monika M. Safford ; Matthew Allison ; Themistocles L. Assimes ; Anthony A. Bavry ; Jeffrey Berger ; Rhonda M. Cooper-Dehoff ; Susan R. Heckbert ; Wenjun Li ; Simin Liu ; Lisa W. Martin ; Marco V. Perez ; Hilary A. Tindle ; Wolfgang C. Winkelmayer ; Marcia L. StefanickSource :
- Circulation. Cardiovascular quality and outcomes [ 1941-7713 ] ; 2014.
Abstract
Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials, or in clinical registry studies. The reliability of claims data for documenting outcomes is unknown.
We linked records of Women's Health Initiative (WHI) participants aged 65 years and older to Medicare claims data, and compared hospitalizations that had diagnosis codes for acute myocardial infarction (MI) or coronary revascularization with WHI outcomes adjudicated by study physicians. We then compared the hazard ratios for active versus placebo hormone therapy based solely on WHI adjudicated events with corresponding hazard ratios based solely on claims data for the same hormone trial participants.
Agreement between WHI adjudicated outcomes and Medicare claims was good for the diagnosis for MI (kappa = 0.71 to 0.74), and excellent for coronary revascularization (kappa=0.88 to 0.91). The hormone:placebo hazard ratio for clinical MI was 1.31 (95% confidence interval (CI) 1.03 to 1.67) based on WHI outcomes, and 1.29 (CI 1.00 to 1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (CI 0.88 to 1.35) based on WHI outcomes and 1.10 (CI 0.89 to 1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1,000 bootstrap replications.
Medicare claims may provide useful data on coronary heart disease outcomes among patients aged 65 years and older in clinical research studies.
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DOI: 10.1161/CIRCOUTCOMES.113.000373
PubMed: 24399330
PubMed Central: 4548886
Affiliations:
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Hlatky</name></author><author><name sortKey="Ray, Roberta M" sort="Ray, Roberta M" uniqKey="Ray R" first="Roberta M" last="Ray">Roberta M. Ray</name></author><author><name sortKey="Burwen, Dale R" sort="Burwen, Dale R" uniqKey="Burwen D" first="Dale R" last="Burwen">Dale R. Burwen</name></author><author><name sortKey="Margolis, Karen L" sort="Margolis, Karen L" uniqKey="Margolis K" first="Karen L" last="Margolis">Karen L. Margolis</name></author><author><name sortKey="Johnson, Karen C" sort="Johnson, Karen C" uniqKey="Johnson K" first="Karen C" last="Johnson">Karen C. Johnson</name></author><author><name sortKey="Kucharska Newton, Anna" sort="Kucharska Newton, Anna" uniqKey="Kucharska Newton A" first="Anna" last="Kucharska-Newton">Anna Kucharska-Newton</name></author><author><name sortKey="Manson, Joann E" sort="Manson, Joann E" uniqKey="Manson J" first="Joann E" last="Manson">Joann E. Manson</name></author><author><name sortKey="Robinson, Jennifer G" sort="Robinson, Jennifer G" uniqKey="Robinson J" first="Jennifer G" last="Robinson">Jennifer G. Robinson</name></author><author><name sortKey="Safford, Monika M" sort="Safford, Monika M" uniqKey="Safford M" first="Monika M" last="Safford">Monika M. Safford</name></author><author><name sortKey="Allison, Matthew" sort="Allison, Matthew" uniqKey="Allison M" first="Matthew" last="Allison">Matthew Allison</name></author><author><name sortKey="Assimes, Themistocles L" sort="Assimes, Themistocles L" uniqKey="Assimes T" first="Themistocles L" last="Assimes">Themistocles L. Assimes</name></author><author><name sortKey="Bavry, Anthony A" sort="Bavry, Anthony A" uniqKey="Bavry A" first="Anthony A" last="Bavry">Anthony A. Bavry</name></author><author><name sortKey="Berger, Jeffrey" sort="Berger, Jeffrey" uniqKey="Berger J" first="Jeffrey" last="Berger">Jeffrey Berger</name></author><author><name sortKey="Cooper Dehoff, Rhonda M" sort="Cooper Dehoff, Rhonda M" uniqKey="Cooper Dehoff R" first="Rhonda M" last="Cooper-Dehoff">Rhonda M. Cooper-Dehoff</name></author><author><name sortKey="Heckbert, Susan R" sort="Heckbert, Susan R" uniqKey="Heckbert S" first="Susan R" last="Heckbert">Susan R. Heckbert</name></author><author><name sortKey="Li, Wenjun" sort="Li, Wenjun" uniqKey="Li W" first="Wenjun" last="Li">Wenjun Li</name></author><author><name sortKey="Liu, Simin" sort="Liu, Simin" uniqKey="Liu S" first="Simin" last="Liu">Simin Liu</name></author><author><name sortKey="Martin, Lisa W" sort="Martin, Lisa W" uniqKey="Martin L" first="Lisa W" last="Martin">Lisa W. Martin</name></author><author><name sortKey="Perez, Marco V" sort="Perez, Marco V" uniqKey="Perez M" first="Marco V" last="Perez">Marco V. Perez</name></author><author><name sortKey="Tindle, Hilary A" sort="Tindle, Hilary A" uniqKey="Tindle H" first="Hilary A" last="Tindle">Hilary A. Tindle</name></author><author><name sortKey="Winkelmayer, Wolfgang C" sort="Winkelmayer, Wolfgang C" uniqKey="Winkelmayer W" first="Wolfgang C" last="Winkelmayer">Wolfgang C. Winkelmayer</name></author><author><name sortKey="Stefanick, Marcia L" sort="Stefanick, Marcia L" uniqKey="Stefanick M" first="Marcia L" last="Stefanick">Marcia L. Stefanick</name></author></analytic><series><title level="j">Circulation. Cardiovascular quality and outcomes</title><idno type="ISSN">1941-7713</idno><idno type="eISSN">1941-7705</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials, or in clinical registry studies. The reliability of claims data for documenting outcomes is unknown.</p></sec><sec id="S2"><title>Methods and Results</title><p id="P2">We linked records of Women's Health Initiative (WHI) participants aged 65 years and older to Medicare claims data, and compared hospitalizations that had diagnosis codes for acute myocardial infarction (MI) or coronary revascularization with WHI outcomes adjudicated by study physicians. We then compared the hazard ratios for active versus placebo hormone therapy based solely on WHI adjudicated events with corresponding hazard ratios based solely on claims data for the same hormone trial participants.</p><p id="P3">Agreement between WHI adjudicated outcomes and Medicare claims was good for the diagnosis for MI (kappa = 0.71 to 0.74), and excellent for coronary revascularization (kappa=0.88 to 0.91). The hormone:placebo hazard ratio for clinical MI was 1.31 (95% confidence interval (CI) 1.03 to 1.67) based on WHI outcomes, and 1.29 (CI 1.00 to 1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (CI 0.88 to 1.35) based on WHI outcomes and 1.10 (CI 0.89 to 1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1,000 bootstrap replications.</p></sec><sec id="S3"><title>Conclusion</title><p id="P4">Medicare claims may provide useful data on coronary heart disease outcomes among patients aged 65 years and older in clinical research studies.</p></sec><sec id="S4"><title>Clinical Trials Registration Information</title><p id="P5"><ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>, Trial Number NCT00000611</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Allison, Matthew" sort="Allison, Matthew" uniqKey="Allison M" first="Matthew" last="Allison">Matthew Allison</name><name sortKey="Assimes, Themistocles L" sort="Assimes, Themistocles L" uniqKey="Assimes T" first="Themistocles L" last="Assimes">Themistocles L. Assimes</name><name sortKey="Bavry, Anthony A" sort="Bavry, Anthony A" uniqKey="Bavry A" first="Anthony A" last="Bavry">Anthony A. Bavry</name><name sortKey="Berger, Jeffrey" sort="Berger, Jeffrey" uniqKey="Berger J" first="Jeffrey" last="Berger">Jeffrey Berger</name><name sortKey="Burwen, Dale R" sort="Burwen, Dale R" uniqKey="Burwen D" first="Dale R" last="Burwen">Dale R. Burwen</name><name sortKey="Cooper Dehoff, Rhonda M" sort="Cooper Dehoff, Rhonda M" uniqKey="Cooper Dehoff R" first="Rhonda M" last="Cooper-Dehoff">Rhonda M. Cooper-Dehoff</name><name sortKey="Heckbert, Susan R" sort="Heckbert, Susan R" uniqKey="Heckbert S" first="Susan R" last="Heckbert">Susan R. Heckbert</name><name sortKey="Hlatky, Mark A" sort="Hlatky, Mark A" uniqKey="Hlatky M" first="Mark A" last="Hlatky">Mark A. Hlatky</name><name sortKey="Johnson, Karen C" sort="Johnson, Karen C" uniqKey="Johnson K" first="Karen C" last="Johnson">Karen C. Johnson</name><name sortKey="Kucharska Newton, Anna" sort="Kucharska Newton, Anna" uniqKey="Kucharska Newton A" first="Anna" last="Kucharska-Newton">Anna Kucharska-Newton</name><name sortKey="Li, Wenjun" sort="Li, Wenjun" uniqKey="Li W" first="Wenjun" last="Li">Wenjun Li</name><name sortKey="Liu, Simin" sort="Liu, Simin" uniqKey="Liu S" first="Simin" last="Liu">Simin Liu</name><name sortKey="Manson, Joann E" sort="Manson, Joann E" uniqKey="Manson J" first="Joann E" last="Manson">Joann E. Manson</name><name sortKey="Margolis, Karen L" sort="Margolis, Karen L" uniqKey="Margolis K" first="Karen L" last="Margolis">Karen L. Margolis</name><name sortKey="Martin, Lisa W" sort="Martin, Lisa W" uniqKey="Martin L" first="Lisa W" last="Martin">Lisa W. Martin</name><name sortKey="Perez, Marco V" sort="Perez, Marco V" uniqKey="Perez M" first="Marco V" last="Perez">Marco V. Perez</name><name sortKey="Ray, Roberta M" sort="Ray, Roberta M" uniqKey="Ray R" first="Roberta M" last="Ray">Roberta M. Ray</name><name sortKey="Robinson, Jennifer G" sort="Robinson, Jennifer G" uniqKey="Robinson J" first="Jennifer G" last="Robinson">Jennifer G. Robinson</name><name sortKey="Safford, Monika M" sort="Safford, Monika M" uniqKey="Safford M" first="Monika M" last="Safford">Monika M. Safford</name><name sortKey="Stefanick, Marcia L" sort="Stefanick, Marcia L" uniqKey="Stefanick M" first="Marcia L" last="Stefanick">Marcia L. Stefanick</name><name sortKey="Tindle, Hilary A" sort="Tindle, Hilary A" uniqKey="Tindle H" first="Hilary A" last="Tindle">Hilary A. Tindle</name><name sortKey="Winkelmayer, Wolfgang C" sort="Winkelmayer, Wolfgang C" uniqKey="Winkelmayer W" first="Wolfgang C" last="Winkelmayer">Wolfgang C. Winkelmayer</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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