Statistics and Methodology

Dr. Mark has had the great fortune to work closely with some of the leading biostatisticians and methodologists working in cardiovascular diseases over the last 30 years, and these partnerships have led to some widely cited methodological papers. The 1996 paper with Frank Harrell and Kerry Lee is one of the highest citation papers in the field. The paper with Eisenstein and Anstrom is generally credited with introducing the landmark analysis to cardiovascular outcomes research.

Statistical and Methodology Publications

Understanding the Role of P Values and Hypothesis Tests in Clinical Research.

Mark DB, Lee KL, Harrell FE Jr.

JAMA Cardiol. 2016 Oct 12. doi: 10.1001/jamacardio.2016.3312. [Epub ahead of print] PMID: 27732700

SCD-HeFT: Use of R-R interval statistics for long-term risk stratification for arrhythmic sudden cardiac death.

Au-Yeung WT, Reinhall PG, Poole JE, Anderson J, Johnson G, Fletcher RD, Moore HJ, Mark DB, Lee KL, Bardy GH.

Heart Rhythm. 2015 Oct;12(10):2058-66. doi: 10.1016/j.hrthm.2015.06.030. Erratum in: Heart Rhythm. 2015 Dec;12(12):2520.

PMID: 26096609 Free PMC Article

Empirical estimation of life expectancy from large clinical trials: use of left-truncated, right-censored survival analysis methodology.

Nelson CL, Sun JL, Tsiatis AA, Mark DB.

Stat Med. 2008 Nov 20;27(26):5525-55. doi: 10.1002/sim.3355. PMID: 18613251

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation.

Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM.

JAMA. 2007 Jan 10;297(2):159-68. PMID: 17148711

Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.

Reed SD, Anstrom KJ, Bakhai A, Briggs AH, Califf RM, Cohen DJ, Drummond MF, Glick HA, Gnanasakthy A, Hlatky MA, O’Brien BJ, Torti FM Jr, Tsiatis AA, Willan AR, Mark DB, Schulman KA.

Am Heart J. 2005 Mar;149(3):434-43. PMID: 15864231

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM.

N Engl J Med. 2002 Oct 24;347(17):1335-41. PMID: 12397192 Free Article

Using observational data to estimate prognosis: an example using a coronary artery disease registry.

DeLong ER, Nelson CL, Wong JB, Pryor DB, Peterson ED, Lee KL, Mark DB, Califf RM, Pauker SG.

Stat Med. 2001 Aug 30;20(16):2505-32. PMID: 11512139

Comparing risk-adjustment methods for provider profiling.

DeLong ER, Peterson ED, DeLong DM, Muhlbaier LH, Hackett S, Mark DB.

Stat Med. 1997 Dec 15;16(23):2645-64. Review. PMID: 9421867

Tutorial in Biostatistics: Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors.

Harrell FE Jr, Lee KL, Mark DB.

Stat Med. 1996 Feb 28;15(4):361-87. Review. PMID: 8668867 Free Article

Comparison of analytic models for estimating the effect of clinical factors on the cost of coronary artery bypass graft surgery.

Dudley RA, Harrell FE Jr, Smith LR, Mark DB, Califf RM, Pryor DB, Glower D, Lipscomb J, Hlatky M.

J Clin Epidemiol. 1993 Mar;46(3):261-71. PMID: 8455051

Comparison of predictions based on observational data with the results of randomized controlled clinical trials of coronary artery bypass surgery.

Hlatky MA, Califf RM, Harrell FE Jr, Lee KL, Mark DB, Pryor DB.

J Am Coll Cardiol. 1988 Feb;11(2):237-45. PMID: 3276752 Free Article

Rethinking sensitivity and specificity.

Hlatky MA, Mark DB, Harrell FE Jr, Lee KL, Califf RM, Pryor DB.

Am J Cardiol. 1987 May 1;59(12):1195-8. No abstract available. PMID: 3554956

Clinical data bases. Accomplishments and unrealized potential.

Pryor DB, Califf RM, Harrell FE Jr, Hlatky MA, Lee KL, Mark DB, Rosati RA.

Med Care. 1985 May;23(5):623-47. Review. No abstract available. PMID: 3892181

Tying clinical research to patient care by use of an observational database.

Hlatky MA, Lee KL, Harrell FE Jr, Califf RM, Pryor DB, Mark DB, Rosati RA.

Stat Med. 1984 Oct-Dec;3(4):375-87. No abstract available. PMID: 6396793