Use of Medicare Data to Identify Coronary Heart Disease Outcomes in the Women's Health Initiative

被引：81

作者：

Hlatky, Mark A. ^{[1
]}

Ray, Roberta M. ^{[2
]}

Burwen, Dale R. ^{[3
]}

Margolis, Karen L. ^{[4
]}

Johnson, Karen C. ^{[5
]}

Kucharska-Newton, Anna ^{[6
]}

Manson, JoAnn E. ^{[7
]}

Robinson, Jennifer G. ^{[8
]}

Safford, Monika M. ^{[9
]}

Allison, Matthew ^{[10
]}

Assimes, Themistocles L. ^{[1
]}

Bavry, Anthony A. ^{[11
]}

Berger, Jeffrey ^{[12
]}

Cooper-DeHoff, Rhonda M. ^{[11
]}

Heckbert, Susan R. ^{[13
]}

Li, Wenjun ^{[14
]}

Liu, Simin ^{[15
]}

Martin, Lisa W. ^{[16
]}

Perez, Marco V. ^{[1
]}

Tindle, Hilary A. ^{[17
]}

Winkelmayer, Wolfgang C. ^{[1
]}

Stefanick, Marcia L. ^{[1
]}

机构：

[1] Stanford Univ, Sch Med, Stanford, CA 94305 USA

[2] Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA

[3] NHLBI, Bethesda, MD 20892 USA

[4] HealthPartners Inst Educ & Res Fdn, Minneapolis, MN USA

[5] Univ Tennessee, Hlth Sci Ctr, Memphis, TN USA

[6] Univ N Carolina, Sch Publ Hlth, Chapel Hill, NC USA

[7] Harvard Univ, Sch Med, Boston, MA USA

[8] Univ Iowa, Coll Publ Hlth, Iowa City, IA USA

[9] Univ Alabama Birmingham, Birmingham, AL USA

[10] Univ Calif San Diego, San Diego, CA 92103 USA

[11] Univ Florida, Gainesville, FL USA

[12] NYU, Med Ctr, New York, NY 10016 USA

[13] Univ Washington, Sch Publ Hlth, Seattle, WA 98195 USA

[14] Univ Massachusetts, Sch Med, Worcester, MA USA

[15] Univ Calif Los Angeles, Los Angeles, CA USA

[16] George Washington Univ, Washington, DC USA

[17] Univ Pittsburgh, Pittsburgh, PA USA

来源：

CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES | 2014年 / 7卷 / 01期

基金：

美国国家卫生研究院;

关键词：

myocardial infarction; patient outcome assessment; pragmatic clinical trials; randomized controlled trials; validation studies; ACUTE MYOCARDIAL-INFARCTION; CLINICAL EVENTS COMMITTEE; POSITIVE PREDICTIVE-VALUE; END-POINTS; LINKING; TRIAL; ADJUDICATION; TRENDS; DIAGNOSIS; ESTROGEN;

D O I：

10.1161/CIRCOUTCOMES.113.000373

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Background 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. Methods and Results 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 (, 0.71-0.74) and excellent for coronary revascularization (, 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. Conclusions Medicare claims may provide useful data on coronary heart disease outcomes among patients aged 65 years in clinical research studies. Clinical Trials Registration Information URL: www.clinicaltrials.gov. Unique identifier: NCT00000611.

引用

页码：157 / 162

页数：6

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