Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative
Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or clinical registry studies. The reliability of claims data for documenting outcomes is unknown. We linked records of Women's Health Initiative (WHI) participants ag...
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| Veröffentlicht in: | Circulation Cardiovascular quality and outcomes 2014-01, Vol.7 (1), p.157-162 |
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| creator | Hlatky, Mark A Ray, Roberta M Burwen, Dale R Margolis, Karen L Johnson, Karen C Kucharska-Newton, Anna Manson, JoAnn E Robinson, Jennifer G Safford, Monika M Allison, Matthew Assimes, Themistocles L Bavry, Anthony A Berger, Jeffrey Cooper-DeHoff, Rhonda M Heckbert, Susan R Li, Wenjun Liu, Simin Martin, Lisa W Perez, Marco V Tindle, Hilary A Winkelmayer, Wolfgang C Stefanick, Marcia L |
| description | Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or 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 to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction 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 of myocardial infarction (κ, 0.71-0.74) and excellent for coronary revascularization (κ, 0.88-0.91). The hormone:placebo hazard ratio for clinical myocardial infarction was 1.31 (95% confidence interval, 1.03-1.67) based on WHI outcomes and 1.29 (95% confidence interval, 1.00-1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (95% confidence interval, 0.88-1.35) based on WHI outcomes and 1.10 (95% confidence interval, 0.89-1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1000 bootstrap replications.
Medicare claims may provide useful data on coronary heart disease outcomes among patients aged ≥65 years in clinical research studies.
URL: www.clinicaltrials.gov. Unique identifier: NCT00000611. |
| doi_str_mv | 10.1161/CIRCOUTCOMES.113.000373 |
| format | Article |
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We linked records of Women's Health Initiative (WHI) participants aged ≥65 years to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction 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 of myocardial infarction (κ, 0.71-0.74) and excellent for coronary revascularization (κ, 0.88-0.91). The hormone:placebo hazard ratio for clinical myocardial infarction was 1.31 (95% confidence interval, 1.03-1.67) based on WHI outcomes and 1.29 (95% confidence interval, 1.00-1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (95% confidence interval, 0.88-1.35) based on WHI outcomes and 1.10 (95% confidence interval, 0.89-1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1000 bootstrap replications.
Medicare claims may provide useful data on coronary heart disease outcomes among patients aged ≥65 years in clinical research studies.
URL: www.clinicaltrials.gov. Unique identifier: NCT00000611.</description><identifier>ISSN: 1941-7713</identifier><identifier>EISSN: 1941-7705</identifier><identifier>DOI: 10.1161/CIRCOUTCOMES.113.000373</identifier><identifier>PMID: 24399330</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Aged, 80 and over ; Centers for Medicare and Medicaid Services, U.S. - statistics & numerical data ; Coronary Disease - diagnosis ; Coronary Disease - epidemiology ; Coronary Disease - therapy ; Estrogens - therapeutic use ; Female ; Hormone Replacement Therapy - statistics & numerical data ; Humans ; Insurance Claim Review ; Medicare - statistics & numerical data ; Myocardial Infarction - diagnosis ; Myocardial Infarction - epidemiology ; Myocardial Infarction - therapy ; Patient Outcome Assessment ; Percutaneous Coronary Intervention - statistics & numerical data ; Progestins - therapeutic use ; Prognosis ; Retrospective Studies ; Treatment Outcome ; United States ; Women's Health - statistics & numerical data</subject><ispartof>Circulation Cardiovascular quality and outcomes, 2014-01, Vol.7 (1), p.157-162</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c443t-7ce1732316b284d078da2dcc28f9ad5f7affa6fc6d34ca1d5c0ef0f8d0db4a383</citedby><cites>FETCH-LOGICAL-c443t-7ce1732316b284d078da2dcc28f9ad5f7affa6fc6d34ca1d5c0ef0f8d0db4a383</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24399330$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hlatky, Mark A</creatorcontrib><creatorcontrib>Ray, Roberta M</creatorcontrib><creatorcontrib>Burwen, Dale R</creatorcontrib><creatorcontrib>Margolis, Karen L</creatorcontrib><creatorcontrib>Johnson, Karen C</creatorcontrib><creatorcontrib>Kucharska-Newton, Anna</creatorcontrib><creatorcontrib>Manson, JoAnn E</creatorcontrib><creatorcontrib>Robinson, Jennifer G</creatorcontrib><creatorcontrib>Safford, Monika M</creatorcontrib><creatorcontrib>Allison, Matthew</creatorcontrib><creatorcontrib>Assimes, Themistocles L</creatorcontrib><creatorcontrib>Bavry, Anthony A</creatorcontrib><creatorcontrib>Berger, Jeffrey</creatorcontrib><creatorcontrib>Cooper-DeHoff, Rhonda M</creatorcontrib><creatorcontrib>Heckbert, Susan R</creatorcontrib><creatorcontrib>Li, Wenjun</creatorcontrib><creatorcontrib>Liu, Simin</creatorcontrib><creatorcontrib>Martin, Lisa W</creatorcontrib><creatorcontrib>Perez, Marco V</creatorcontrib><creatorcontrib>Tindle, Hilary A</creatorcontrib><creatorcontrib>Winkelmayer, Wolfgang C</creatorcontrib><creatorcontrib>Stefanick, Marcia L</creatorcontrib><title>Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative</title><title>Circulation Cardiovascular quality and outcomes</title><addtitle>Circ Cardiovasc Qual Outcomes</addtitle><description>Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or 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 to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction 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 of myocardial infarction (κ, 0.71-0.74) and excellent for coronary revascularization (κ, 0.88-0.91). The hormone:placebo hazard ratio for clinical myocardial infarction was 1.31 (95% confidence interval, 1.03-1.67) based on WHI outcomes and 1.29 (95% confidence interval, 1.00-1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (95% confidence interval, 0.88-1.35) based on WHI outcomes and 1.10 (95% confidence interval, 0.89-1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1000 bootstrap replications.
Medicare claims may provide useful data on coronary heart disease outcomes among patients aged ≥65 years in clinical research studies.
URL: www.clinicaltrials.gov. 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Ray, Roberta M ; Burwen, Dale R ; Margolis, Karen L ; Johnson, Karen C ; Kucharska-Newton, Anna ; Manson, JoAnn E ; Robinson, Jennifer G ; Safford, Monika M ; Allison, Matthew ; Assimes, Themistocles L ; Bavry, Anthony A ; Berger, Jeffrey ; Cooper-DeHoff, Rhonda M ; Heckbert, Susan R ; Li, Wenjun ; Liu, Simin ; Martin, Lisa W ; Perez, Marco V ; Tindle, Hilary A ; Winkelmayer, Wolfgang C ; Stefanick, Marcia L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c443t-7ce1732316b284d078da2dcc28f9ad5f7affa6fc6d34ca1d5c0ef0f8d0db4a383</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Centers for Medicare and Medicaid Services, U.S. - statistics & numerical data</topic><topic>Coronary Disease - diagnosis</topic><topic>Coronary Disease - epidemiology</topic><topic>Coronary Disease - therapy</topic><topic>Estrogens - therapeutic use</topic><topic>Female</topic><topic>Hormone Replacement Therapy - statistics & numerical data</topic><topic>Humans</topic><topic>Insurance Claim Review</topic><topic>Medicare - statistics & numerical data</topic><topic>Myocardial Infarction - diagnosis</topic><topic>Myocardial Infarction - epidemiology</topic><topic>Myocardial Infarction - therapy</topic><topic>Patient Outcome Assessment</topic><topic>Percutaneous Coronary Intervention - statistics & numerical data</topic><topic>Progestins - therapeutic use</topic><topic>Prognosis</topic><topic>Retrospective Studies</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Women's Health - statistics & numerical data</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hlatky, Mark A</creatorcontrib><creatorcontrib>Ray, Roberta M</creatorcontrib><creatorcontrib>Burwen, Dale R</creatorcontrib><creatorcontrib>Margolis, Karen L</creatorcontrib><creatorcontrib>Johnson, Karen C</creatorcontrib><creatorcontrib>Kucharska-Newton, Anna</creatorcontrib><creatorcontrib>Manson, JoAnn E</creatorcontrib><creatorcontrib>Robinson, Jennifer G</creatorcontrib><creatorcontrib>Safford, Monika M</creatorcontrib><creatorcontrib>Allison, Matthew</creatorcontrib><creatorcontrib>Assimes, Themistocles L</creatorcontrib><creatorcontrib>Bavry, Anthony A</creatorcontrib><creatorcontrib>Berger, Jeffrey</creatorcontrib><creatorcontrib>Cooper-DeHoff, Rhonda M</creatorcontrib><creatorcontrib>Heckbert, Susan R</creatorcontrib><creatorcontrib>Li, Wenjun</creatorcontrib><creatorcontrib>Liu, Simin</creatorcontrib><creatorcontrib>Martin, Lisa W</creatorcontrib><creatorcontrib>Perez, Marco V</creatorcontrib><creatorcontrib>Tindle, Hilary A</creatorcontrib><creatorcontrib>Winkelmayer, Wolfgang C</creatorcontrib><creatorcontrib>Stefanick, Marcia L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Circulation Cardiovascular quality and outcomes</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hlatky, Mark A</au><au>Ray, Roberta M</au><au>Burwen, Dale R</au><au>Margolis, Karen L</au><au>Johnson, Karen C</au><au>Kucharska-Newton, Anna</au><au>Manson, JoAnn E</au><au>Robinson, Jennifer G</au><au>Safford, Monika M</au><au>Allison, Matthew</au><au>Assimes, Themistocles L</au><au>Bavry, Anthony A</au><au>Berger, Jeffrey</au><au>Cooper-DeHoff, Rhonda M</au><au>Heckbert, Susan R</au><au>Li, Wenjun</au><au>Liu, Simin</au><au>Martin, Lisa W</au><au>Perez, Marco V</au><au>Tindle, Hilary A</au><au>Winkelmayer, Wolfgang C</au><au>Stefanick, Marcia L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative</atitle><jtitle>Circulation Cardiovascular quality and outcomes</jtitle><addtitle>Circ Cardiovasc Qual Outcomes</addtitle><date>2014-01</date><risdate>2014</risdate><volume>7</volume><issue>1</issue><spage>157</spage><epage>162</epage><pages>157-162</pages><issn>1941-7713</issn><eissn>1941-7705</eissn><abstract>Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or 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 to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction 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 of myocardial infarction (κ, 0.71-0.74) and excellent for coronary revascularization (κ, 0.88-0.91). The hormone:placebo hazard ratio for clinical myocardial infarction was 1.31 (95% confidence interval, 1.03-1.67) based on WHI outcomes and 1.29 (95% confidence interval, 1.00-1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (95% confidence interval, 0.88-1.35) based on WHI outcomes and 1.10 (95% confidence interval, 0.89-1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1000 bootstrap replications.
Medicare claims may provide useful data on coronary heart disease outcomes among patients aged ≥65 years in clinical research studies.
URL: www.clinicaltrials.gov. Unique identifier: NCT00000611.</abstract><cop>United States</cop><pmid>24399330</pmid><doi>10.1161/CIRCOUTCOMES.113.000373</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Aged Aged, 80 and over Centers for Medicare and Medicaid Services, U.S. - statistics & numerical data Coronary Disease - diagnosis Coronary Disease - epidemiology Coronary Disease - therapy Estrogens - therapeutic use Female Hormone Replacement Therapy - statistics & numerical data Humans Insurance Claim Review Medicare - statistics & numerical data Myocardial Infarction - diagnosis Myocardial Infarction - epidemiology Myocardial Infarction - therapy Patient Outcome Assessment Percutaneous Coronary Intervention - statistics & numerical data Progestins - therapeutic use Prognosis Retrospective Studies Treatment Outcome United States Women's Health - statistics & numerical data |
| title | Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative |
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