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J Thorac Cardiovasc Surg 2001;122:430-439
© 2001 The American Association for Thoracic Surgery
Statistics for the Rest of Us (STATS) |
From the Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio.
Received for publication May 8, 2001. Accepted for publication May 23, 2001. Address for reprints: Eugene H. Blackstone, MD, The Cleveland Clinic Foundation, 9500 Euclid Ave, Desk F25, Cleveland, OH 44195 (E-mail: blackse@ccf.org).
Three barriers to effective, helpful, and accurate analysis of clinical outcomes for which breakthrough technology has just emerged include: (1) general analysis of repeated follow-up measures, (2) treatment comparisons from nonrandomized clinical experiences, and (3) scientific risk factor identification. The three barriers have in common workarounds, that is, unsatisfactory and inadequate temporary, but simple, solutions in the absence of a real solution. Our expectations may be so low that we run the risk of preferring the workarounds for their simplicity rather than rejoicing that breakthrough has occurred! Therefore, the purpose of this article is to acquaint you with the breakthrough methods in a nontechnical fashion so that you may read reports more knowledgeably, interact with your statistical collaborators more closely, or encourage your statistician to consider these methods if they are applicable to your clinical research.
Barriers
Follow-up assessment
Clinical question:
How does aortic valve regurgitation progress after heart valve replacement with a bioprosthesis, and what factors influence that change?
Available data:
Aortic regurgitation grade (0 to 4+) by echocardiography at periodic clinic visits.
Simple workaround:
Tabulation of aortic regurgitation grade at latest clinic visit. Simple. But it does not answer the question!
Attempts have been made to depict the time-related change in graded outcomes after cardiac surgery, but the display appears complex at first glance. Even those attempts used the status only at last follow-up, not the status assessed periodically across time.
1,2
Clinical question:
How do pressure gradients across bioprostheses progress with time?
Available data:
Echocardiographic estimates of pressure gradient at irregular clinic visits.
Simple workaround:
Lacking methods to analyze serial echocardiographic data, we simply provide a global mean value. We may go a bit further and group the measurements into a few time intervals, then average all values within those intervals, perhaps stratified by prosthesis size.
Simple, but just as in the case of repeated assessment of functional status, the workaround does not
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A. M. Gillinov, C. Faber, P. L. Houghtaling, E. H. Blackstone, B.-K. Lam, R. Diaz, B. W. Lytle, J. F. Sabik III, and D. M. Cosgrove III Repair versus replacement for degenerative mitral valve disease with coexisting ischemic heart disease J. Thorac. Cardiovasc. Surg., June 1, 2003; 125(6): 1350 - 1362. [Abstract] [Full Text] [PDF] |
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A. M. Gillinov, E. H. Blackstone, D. M. Cosgrove III, J. White, P. Kerr, A. Marullo, P. M. McCarthy, and B. W. Lytle Mitral valve repair with aortic valve replacement is superior to double valve replacement J. Thorac. Cardiovasc. Surg., June 1, 2003; 125(6): 1372 - 1387. [Abstract] [Full Text] [PDF] |
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A. M. Gillinov, E. H. Blackstone, J. M. Alster, J. M. Craver, W. A. Baumgartner, S. A. Brewster, L. H. Kleinman, and N. G. Smedira The Carbomedics Top Hat supraannular aortic valve: a multicenter study Ann. Thorac. Surg., April 1, 2003; 75(4): 1175 - 1180. [Abstract] [Full Text] [PDF] |
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V. A. Ferraris and S. P. Ferraris Risk Stratification and Comorbidity Card. Surg. Adult, January 1, 2003; 2(2003): 187 - 224. [Full Text] |
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J. P. Umana, D. C. Miller, and R. S. Mitchell What is the best treatment for patients with acute type B aortic dissections--medical, surgical, or endovascular stent-grafting? Ann. Thorac. Surg., November 1, 2002; 74(5): S1840 - 1843. [Abstract] [Full Text] [PDF] |
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N. C. Patel, A. P. Deodhar, A. D. Grayson, D. M. Pullan, D. J.M. Keenan, R. Hasan, and B. M. Fabri Neurological outcomes in coronary surgery: independent effect of avoiding cardiopulmonary bypass Ann. Thorac. Surg., August 1, 2002; 74(2): 400 - 406. [Abstract] [Full Text] [PDF] |
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M. K. Banbury, D. M. Cosgrove III, J. D. Thomas, E. H. Blackstone, J. Rajeswaran, J. E. Okies, and R. M. Frater Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis Ann. Thorac. Surg., May 1, 2002; 73(5): 1460 - 1465. [Abstract] [Full Text] [PDF] |
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E. H. Blackstone and T. W. Rice Clinical-pathologic conference: Use and choice of statistical methods for the clinical study, ""Superficial adenocarcinoma of the esophagus"" J. Thorac. Cardiovasc. Surg., December 1, 2001; 122(6): 1063 - 1076. [Full Text] [PDF] |
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