Aging; Clinical Trials as Topic; Biostatistics; Patient Preference; Pragmatic Clinical Trials as Topic
Public Health Interests
Aging; Biostatistics; Clinical Trials
Dr. Peduzzi’s primary research interest involves the design, conduct, and analysis of multi-site randomized clinical trials with a particular focus on pragmatic clinical trials. Recent research has focused on issues related to the design and analysis complex clustered randomized trials with recurrent events in the presence of a semi-competing risk of death. Other research is focused on the design of patient preference clinical trials and hybrid Bayesian-frequentist trial designs.
Specialized Terms: Pragmatic Clinical trials; Patient Preference Clinical Trials; Biostatistics; Aging
Extensive Research Description
A major area of current research focus is on the design and analysis of complex clustered randomized clinical trials with time to event outcomes in the presence of a semi-competing risk of death. In particular, we are investigating the estimation of the cluster design effect for these types of complex designs, which has implications for sample size, interim monitoring and power. Because there are no closed form estimates for the design effect, approaches being considered are centered on variance inflation factors and simulation studies. Recently completed work on the analysis of complex cluster randomized trials has focused on the development of a joint model for recurrent events and a semi-competing risk in the presence of multi-level clustering. Future research in this area will include extensions to different types of recurrent events. Another area of current research activity involves patient preference clinical trial designs. Methods have been developed for binary outcomes and future work will include time to event outcomes. This work is being funded by a PCORI methods grant. Plans are in progress to hold a symposium on the design and analysis of patient preference clinical trials involving methodologists and clinical investigators, e.g., those involved in palliative care and end of life research. Past methods work has been in the area of hybrid Bayesian-frequentist designs. In particular, selection of the effect size for sample size determination for a continuous response in a superiority clinical trial using a hybrid classical and Bayesian procedure.
- Peduzzi P, Kyriakides T, O’Connor TZ, Guarino P, Warren SR, Huang GD. Methodological issues in comparative effectiveness research: clinical trials. American Journal of Medicine 12 (supplement December 2010):e8-e15, 2010.
- Peduzzi, P.N., Henderson, W., Hartigan, P., and Lavori, P. Analysis of Randomized Controlled Trials. Epidemiologic Reviews 24: 26-38, 2002.
- Peduzzi, P.N., Concato, J., Kemper, E., Holford, T.R., and Feinstein, A.R. A simulation study of the number of events per variable in logistic regression analysis. Journal of Clinical Epidemiology 49: 1373-1379, 1996.
- Peduzzi, P.N., Wittes, J., Detre, K., and Holford, T.R. Analyses as-randomized and the problem of the nonadherence: an example from the Veterans Affairs Randomized Trial of Coronary Artery Bypass Surgery. Statistics in Medicine 12: 1185-1195, 1993
- Peduzzi, P.N., Concato, J., Holford, T.R., and Feinstein, A.R. The importance of events per independent variable in multivariable analysis. II. Accuracy and precision of regression estimates. Journal of Clinical Epidemiology 48: 1503-1510, 1995
- Peduzzi, P.N., Detre, K.M., Chan, Y-K, Oberman, A., and Cutter, G.R. Validation of a risk function to predict mortality in a VA population with coronary artery disease. Controlled Clinical Trial 3: 47-60, 1982
- Peduzzi, P.N., Hardy, R.J., and Holford, T.R. A stepwise variable selection procedure for nonlinear regression models. Biometrics 36: 511-516, 1980
- Dziura J, Post LA Qing Zhao, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale Journal of Biology and Medicine. 86(3):343-358, 2013.
- Lin H, Han L, Peduzzi PN, Murphy TE, Gill TM, Allore HG. A repeated trajectory class model for intensive longitudinal categorical outcome. Statistics in Medicine. 33(15):2645-2664, 2014. Epub: February 11, 2014.
- Ciarleglio M, Arendt CD, Makuch RM, Peduzzi P. Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure. Contemporary Clinical Trials. 41: 160–171, 2015.
- Ciarleglio M, Arendt CD, Peduzzi P. Selection of the effect size for sample size determination for a continuous response in a superiority clinical trial using a hybrid classical and Bayesian procedure. Clinical Trials. 13(3):275-85, 2016. Epub 2016 Feb 29.
- Lin H, Guo Z, Peduzzi P, Gill T, Allore HG. A semiparametric transition model with latent traits for longitudinal multistate data. Biometrics 64(4):1032-42, 2008. Epub March 19, 2008.
- Han L, Allore H, Murphy T, Gill T, Peduzzi P, Lin H. Dynamics of functional aging based on latent-class trajectories of activities of daily living. Annals of Epidemiology 23:87-92, 2013.
Full List of PubMed Publications
- Dominitz JA, Robertson DJ, Ahnen DJ, Allison JE, Antonelli M, Boardman KD, Ciarleglio M, Del Curto BJ, Huang GD, Imperiale TF, Larson MF, Lieberman D, O'Connor T, O'Leary TJ, Peduzzi P, Provenzale D, Shaukat A, Sultan S, Voorhees A, Wallace R, Guarino PD: Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM): Rationale for Study Design. Am J Gastroenterol. 2017 Nov; 2017 Oct 10. PMID: 29016565
- Bhasin S, Gill TM, Reuben DB, Latham NK, Gurwitz JH, Dykes P, McMahon S, Storer TW, Duncan PW, Ganz DA, Basaria S, Miller ME, Travison TG, Greene EJ, Dziura J, Esserman D, Allore H, Carnie MB, Fagan M, Hanson C, Baker D, Greenspan SL, Alexander N, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace R, Casteel C, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Margolis S, Eder R, McGloin JM, Skokos E, Wiggins J, Garber L, Clauser SB, Correa-De-Araujo R, Peduzzi P: Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods. J Gerontol A Biol Sci Med Sci. 2017 Oct 14; 2017 Oct 14. PMID: 29045582
- Juthani-Mehta M, Van Ness PH, Peduzzi P: Cranberry Capsules for bacteriuria Plus Pyuria in Nursing Home Residents-Reply. JAMA. 2017 Mar 14. PMID: 28291888
- Juthani-Mehta M, Van Ness PH, Bianco L, Rink A, Rubeck S, Ginter S, Argraves S, Charpentier P, Acampora D, Trentalange M, Quagliarello V, Peduzzi P: Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial. JAMA. 2016 Nov 8. PMID: 27787564
- Wu X, Guarino P, Lo AC, Peduzzi P, Wininger M: Long-term Effectiveness of Intensive Therapy in Chronic Stroke. Neurorehabil Neural Repair. 2016 Jul; 2015 Oct 8. PMID: 26450442
- Ciarleglio MM, Arendt CD, Peduzzi PN: Selection of the effect size for sample size determination for a continuous response in a superiority clinical trial using a hybrid classical and Bayesian procedure. Clin Trials. 2016 Jun; 2016 Feb 29. PMID: 26928986
- Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR, IRIS Trial Investigators.: Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7; 2016 Feb 17. PMID: 26886418
- Perkins SM, Bacchetti P, Davey CS, Lindsell CJ, Mazumdar M, Oster RA, Peduzzi PN, Rocke DM, Rudser KD, Kim M: Best Practices for Biostatistical Consultation and Collaboration in Academic Health Centers. Am Stat. 2016; 2016 Jun 9. PMID: 27777443
- Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ: A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15; 2014 Dec 16. PMID: 25520333
- Ciarleglio MM, Arendt CD, Makuch RW, Peduzzi PN: Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure. Contemp Clin Trials. 2015 Mar; 2015 Jan 9. PMID: 25583273
- Rabinowitz PM, Slizovskiy IB, Lamers V, Trufan SJ, Holford TR, Dziura JD, Peduzzi PN, Kane MJ, Reif JS, Weiss TR, Stowe MH: Proximity to natural gas wells and reported health status: results of a household survey in Washington County, Pennsylvania. Environ Health Perspect. 2015 Jan; 2014 Sep 10. PMID: 25204871
- Murphy TE, Allore HG, Han L, Peduzzi PN, Gill TM, Xu X, Lin H: A longitudinal, observational study with many repeated measures demonstrated improved precision of individual survival curves using Bayesian joint modeling of disability and survival. Exp Aging Res. 2015. PMID: 25978444
- Viscoli CM, Brass LM, Carolei A, Conwit R, Ford GA, Furie KL, Gorman M, Guarino PD, Inzucchi SE, Lovejoy AM, Parsons MW, Peduzzi PN, Ringleb PA, Schwartz GG, Spence JD, Tanne D, Young LH, Kernan WN, IRIS Trial investigators.: Pioglitazone for secondary prevention after ischemic stroke and transient ischemic attack: rationale and design of the Insulin Resistance Intervention after Stroke Trial. Am Heart J. 2014 Dec; 2014 Jul 28. PMID: 25458644
- Lin H, Han L, Peduzzi PN, Murphy TE, Gill TM, Allore HG: A dynamic trajectory class model for intensive longitudinal categorical outcome. Stat Med. 2014 Jul 10; 2014 Feb 11. PMID: 24519416
- Tinetti ME, Han L, Lee DS, McAvay GJ, Peduzzi P, Gross CP, Zhou B, Lin H: Antihypertensive medications and serious fall injuries in a nationally representative sample of older adults. JAMA Intern Med. 2014 Apr. PMID: 24567036
- Tinetti ME, Han L, McAvay GJ, Lee DS, Peduzzi P, Dodson JA, Gross CP, Zhou B, Lin H: Anti-hypertensive medications and cardiovascular events in older adults with multiple chronic conditions. PLoS One. 2014; 2014 Mar 10. PMID: 24614535
- Lee DS, Markwardt S, McAvay GJ, Gross CP, Goeres LM, Han L, Peduzzi P, Lin H, Dodson JA, Tinetti ME: Effect of β-blockers on cardiac and pulmonary events and death in older adults with cardiovascular disease and chronic obstructive pulmonary disease. Med Care. 2014 Mar. PMID: 24561758
- Fried LF, Emanuele N, Zhang JH, Brophy M, Conner TA, Duckworth W, Leehey DJ, McCullough PA, O'Connor T, Palevsky PM, Reilly RF, Seliger SL, Warren SR, Watnick S, Peduzzi P, Guarino P, VA NEPHRON-D Investigators.: Combined angiotensin inhibition for the treatment of diabetic nephropathy. N Engl J Med. 2013 Nov 14; 2013 Nov 9. PMID: 24206457
- Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P: Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013 Sep; 2013 Sep 20. PMID: 24058309
- Han L, Allore H, Murphy T, Gill T, Peduzzi P, Lin H: Dynamics of functional aging based on latent-class trajectories of activities of daily living. Ann Epidemiol. 2013 Feb. PMID: 23305692
- Van Ness PH, Peduzzi PN, Quagliarello VJ: Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: methodological insights from a pneumonia prevention trial. Contemp Clin Trials. 2012 Nov; 2012 Aug 11. PMID: 22917599
- Nunez-Smith M, Ciarleglio MM, Sandoval-Schaefer T, Elumn J, Castillo-Page L, Peduzzi P, Bradley EH: Institutional variation in the promotion of racial/ethnic minority faculty at US medical schools. Am J Public Health. 2012 May; 2012 Mar 15. PMID: 22420820
- Carling T, Carty SE, Ciarleglio MM, Cooper DS, Doherty GM, Kim LT, Kloos RT, Mazzaferri EL Sr, Peduzzi PN, Roman SA, Sippel RS, Sosa JA, Stack BC Jr, Steward DL, Tufano RP, Tuttle RM, Udelsman R, American Thyroid Association Surgical Affairs Committee.: American Thyroid Association design and feasibility of a prospective randomized controlled trial of prophylactic central lymph node dissection for papillary thyroid carcinoma. Thyroid. 2012 Mar; 2012 Feb 7. PMID: 22313454
- Tinetti ME, McAvay G, Chang SS, Ning Y, Newman AB, Fitzpatrick A, Fried TR, Harris TB, Nevitt MC, Satterfield S, Yaffe K, Peduzzi P: Effect of chronic disease-related symptoms and impairments on universal health outcomes in older adults. J Am Geriatr Soc. 2011 Sep; 2011 Aug 24. PMID: 21883120
- Tinetti ME, McAvay GJ, Chang SS, Newman AB, Fitzpatrick AL, Fried TR, Peduzzi PN: Contribution of multiple chronic conditions to universal health outcomes. J Am Geriatr Soc. 2011 Sep; 2011 Aug 30. PMID: 21883118
- Peduzzi P, Kyriakides T, O'Connor TZ, Guarino P, Warren SR, Huang GD: Methodological issues in comparative effectiveness research: clinical trials. Am J Med. 2010 Dec. PMID: 21184867
- Concato J, Peduzzi P, Huang GD, O'Leary TJ, Kupersmith J: Comparative effectiveness research: what kind of studies do we need? J Investig Med. 2010 Aug. PMID: 20479661
- Lin H, Guo Z, Peduzzi PN, Gill TM, Allore HG: A semiparametric transition model with latent traits for longitudinal multistate data. Biometrics. 2008 Dec; 2008 Mar 19. PMID: 18355385
- Murphy TE, Agostini JV, Van Ness PH, Peduzzi P, Tinetti ME, Allore HG: Assessing multiple medication use with probabilities of benefits and harms. J Aging Health. 2008 Sep; 2008 Jul 14. PMID: 18625759
- Agostini JV, Tinetti ME, Han L, Peduzzi P, Foody JM, Concato J: Association between antihypertensive medication use and non-cardiovascular outcomes in older men. J Gen Intern Med. 2007 Dec; 2007 Sep 25. PMID: 17899299
- Concato J, Aslan M, Palmisano MM, Doebbeling CC, Peduzzi P, Ofek K, Soreq H, Doebbeling B: Acetylcholinesterase activity in veterans of the first Gulf War. J Investig Med. 2007 Nov. PMID: 18062897
- Marottoli RA, Ness PH, Araujo KL, Iannone LP, Acampora D, Charpentier P, Peduzzi P: A randomized trial of an education program to enhance older driver performance. J Gerontol A Biol Sci Med Sci. 2007 Oct. PMID: 17921424
- Marottoli RA, Allore H, Araujo KL, Iannone LP, Acampora D, Gottschalk M, Charpentier P, Kasl S, Peduzzi P: A randomized trial of a physical conditioning program to enhance the driving performance of older persons. J Gen Intern Med. 2007 May. PMID: 17443366
- Peduzzi P, Guo Z, Marottoli RA, Gill TM, Araujo K, Allore HG: Improved self-confidence was a mechanism of action in two geriatric trials evaluating physical interventions. J Clin Epidemiol. 2007 Jan; 2006 Sep 28. PMID: 17161760
- Guarino P, Lamping DL, Elbourne D, Carpenter J, Peduzzi P: A brief measure of perceived understanding of informed consent in a clinical trial was validated. J Clin Epidemiol. 2006 Jun; 2006 Mar 24. PMID: 16713523
- Concato J, Wells CK, Horwitz RI, Penson D, Fincke G, Berlowitz DR, Froehlich G, Blake D, Vickers MA, Gehr GA, Raheb NH, Sullivan G, Peduzzi P: The effectiveness of screening for prostate cancer: a nested case-control study. Arch Intern Med. 2006 Jan 9. PMID: 16401808
- Guarino P, Elbourne D, Carpenter J, Peduzzi P: Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding. Clin Trials. 2006. PMID: 16539087
- Allore H, Tinetti ME, Araujo KL, Hardy S, Peduzzi P: A case study found that a regression tree outperformed multiple linear regression in predicting the relationship between impairments and Social and Productive Activities scores. J Clin Epidemiol. 2005 Feb. PMID: 15680749
- Allore HG, Tinetti ME, Gill TM, Peduzzi PN: Experimental designs for multicomponent interventions among persons with multifactorial geriatric syndromes. Clin Trials. 2005. PMID: 16279575
- Gill TM, Baker DI, Gottschalk M, Peduzzi PN, Allore H, Van Ness PH: A prehabilitation program for the prevention of functional decline: effect on higher-level physical function. Arch Phys Med Rehabil. 2004 Jul. PMID: 15241748
- Byers AL, Allore H, Gill TM, Peduzzi PN: Application of negative binomial modeling for discrete outcomes: a case study in aging research. J Clin Epidemiol. 2003 Jun. PMID: 12873651
- Gill TM, Baker DI, Gottschalk M, Peduzzi PN, Allore H, Byers A: A program to prevent functional decline in physically frail, elderly persons who live at home. N Engl J Med. 2002 Oct 3. PMID: 12362007