Supplementing claims data with outpatient laboratory test results to improve confounding adjustment in effectiveness studies oflipid-lowering treatments

BMC Medical Research Methodology

Jerry Avorn³  Jun Liu³  Kenneth J Rothman⁴  SeoYoung Kim³  Daniel H Solomon³  Joseph Singer²  Gregory W Daniel¹  Jessica Myers³  Robert J Glynn³  Jeremy A Rassen³  Sebastian Schneeweiss³ 

[1] The Brookings Institution, Washington, DC, USA;HealthCore Inc, Wilmington, DE, USA;Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1 Brigham Circle, Suite 3030, Boston, 02120, MA, USA;RTI Health Solutions, RTP, Durham, NC, USA

关键词: Ezetimibe;    Statin;    Lipid lowering therapy;    Pharmacoepidemiology;    Imputation;    Confounding;    Serum lipid levels;    Laboratory test results;    Insurance claims data;   

Others  :  1126436
DOI  :  10.1186/1471-2288-12-180

 received in 2012-05-22, accepted in 2012-10-09,  发布年份 2012

【 摘 要 】

Background

Adjusting for laboratory test results may result in better confounding control when added to administrative claims data in the study of treatment effects. However, missing values can arise through several mechanisms.

Methods

We studied the relationship between availability of outpatient lab test results, lab values, and patient and system characteristics in a large healthcare database using LDL, HDL, and Hb_A1c in a cohort of initiators of statins or Vytorin (ezetimibe & simvastatin) as examples.

Results

Among 703,484 patients 68% had at least one lab test performed in the 6 months before treatment. Performing an LDL test was negatively associated with several patient characteristics, including recent hospitalization (OR = 0.32, 95% CI: 0.29-0.34), MI (OR = 0.77, 95% CI: 0.69-0.85), or carotid revascularization(OR = 0.37, 95% CI: 0.25-0.53). Patient demographics, diagnoses, and procedures predicted well who would havea lab test performed (AUC = 0.89 to 0.93). Among those with test results available claims data explained only14% of variation.

Conclusions

In a claims database linked with outpatient lab test results, we found that lab tests are performed selectively corresponding to current treatment guidelines. Poor ability to predict lab values and the high proportion of missingness reduces the added value of lab tests for effectiveness research in this setting.

【 授权许可】

   
2012 Schneeweiss et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Figure 5.

【 参考文献 】

• [1]Schneeweiss S, Avorn J: A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol 2005, 58:323-337.
• [2]Seeger JD, Walker AM, Williams PL, Saperia GM, Sacks FM: A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarction. Am J Cardiol 2003, 92:1447-1451.
• [3]Mulla ZD, Seo B, Kalamegham R, Nuwayhid BS: Multiple imputation for missing laboratory data: an example from infectious disease epidemiology. Ann Epidemiol 2009, 19:908-914.
• [4]Greenland S, Finkle WD: A critical look at methods for handling missing covariates in epidemiologic regression analyses. Am J Epidemiol 1995, 142:1255-1264.
• [5]Vach W, Blettner M: Biased estimation of the odds ratio in case–control studies due to the use of ad hoc methods of correcting for missing values for confounding variables. Am J Epidemiology 1991, 134:895-907.
• [6]Neri L, Rocca Rey LA, Lentine KL, et al.: Joint association of hyperuricemia and reduced GFR on cardiovascular morbidity: a historical cohort study based on laboratory and claims data from a national insurance provider. Am J Kidney Dis 2011, 58:398-408.
• [7]Laitinen DL, Manthena S: Impact of change in high-density lipoprotein cholesterol from baseline on risk for major cardiovascular events. Adv Ther 2010, 27:233-244.
• [8]McCullough E, Sullivan C, Banning P, Goldfield N, Hughes J: Challenges and benefits of adding laboratory data to a mortality risk adjustment method. Qual Manag Health Care 2011, 20:253-262.
• [9]Schneeweiss S: A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol Drug Saf 2010, 19:858-868.
• [10]Choudhry NK, Levin R, Winkelmayer WC: Statins in elderly patients with acute coronary syndrome: an analysis of dose and class effects in typical practice. Heart 2007, 93:945-951.
• [11]Schneeweiss S, Seeger JD, Maclure M, Wang PS, Avorn J, Glynn RJ: Performance of comorbidity scores to control for confounding in epidemiologic studies using claims data. Am J Epidemiol 2001, 154:854-864.
• [12]Moons KG, Donders RA, Stijnen T, Harrell FE Jr: Using the outcome for imputation of missing predictor values was preferred. J Clin Epidemiol 2006, 59:1092-1101.
• [13]Kiyota Y, Schneeweiss S, Glynn RJ, Cannuscio CC, Avorn J, Solomon DH: Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records. Am Heart J 2004, 148:99-104.
• [14]Kannel WB, Wilson PW: Efficacy of lipid profiles in prediction of coronary disease. Am Heart J 1992, 124:768-774.
• [15]Braunwald E, Antman EM, Beasley JW, et al.: ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on the management of patients with unstable angina). Circulation 2000, 102:1193-1209.
• [16]Kushner FG, Hand M, Smith SC Jr, et al.: 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2009, 120:2271-2306.
• [17]Cannon CP, Braunwald E, McCabe CH, et al.: Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004, 350:1495-1504.
• [18]de Lemos JA, Blazing MA, Wiviott SD, et al.: Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA 2004, 292:1307-1316.