paul w. stewart - sph.unc.edu...apr 13, 2020 · [email protected] . education 1977-1981 phd...

Last revised 2020-04-13 1

Paul W. Stewart

Business Address 3105G McGavran-Greenberg Hall Department of Biostatistics UNC-CH School of Public Health Campus Box 7420 Chapel Hill, NC 27599-7420 919-966-7276 [email protected] Education 1977-1981 PhD Biostatistics. The University of North Carolina at Chapel Hill. Thesis on a type III bivariate t-distribution for analysis of cross-over designs. Supporting program in Epidemiology and Biomedical Engineering. 1975-1977 MS Statistics. The University of North Carolina at Chapel Hill. Thesis on time-series models for digital analysis of human speech. 1971-1975 BS Mathematics. Furman University, Greenville, South Carolina. Minor in Chemistry, electives in the Medical Sciences and in Visual Arts. Professional Experience 2012-present Research Professor, UNC Biostatistics Department 2016-present Chief Biostatistician on UNC Scientific Review Committee 2009-2016 Chief Biostatistician on UNC Scientific Review Subcommittee of the SOM IRB 1999-2012 Research Associate Professor, UNC Biostatistics Department 1982-1998 Research Assistant Professor, UNC Biostatistics Department 1982-1982 Visiting Research Assistant Professor, UNC Biostatistics Department 1981-1982 Graduate Research Trainee, Pre-Doctoral Award, Directed by Dr. C. E. Davis. UNC Biostatistics Department. 1978-1981 Graduate Research Assistant, CDC-UNC SENIC Project, Directed by Dr. R. J. Carroll and Dr. D. Quade, UNC Biostatistics Department. 1977-1978 Graduate Research Assistant, AID-UNC Guatemala Water and Sanitation Project, Directed by Dr. R. W. Helms, UNC Biostatistics Department. 1975-1977 Graduate Teaching Assistant, Training Grant, Directed by Dr. Ed Wegman, UNC Statistics Department.

Paul W. Stewart

May 25, 2020

Honors 1997 US-EPA Scientific Achievement Award for Publication 1995 Delta Omega Honor Society for Public Health Professionals 1980, 1981 NIH Training Grant 1979 Award for Best Paper on Linear Models at the 4th Annual Conference of SUGI Memberships International Biometric Society, Eastern North American Region (ENAR) American Statistical Association (ASA) Publication Officer of the ASA Section on Statistical Consulting: 2007 and 2008 CTSA Key Function Committee for Biostatistics/Epidemiology/Research Design (BERD): 2011-

2014 Association of GCRC and CTSA Statisticians: 2002-present Association of CFAR Statisticians: 2002-2008, Association founded by Paul Stewart in 2002. Publications 1. Books and Chapters Muller KE and Stewart PW (2006) Linear Model Theory: Univariate, Multivariate, and Mixed Models, Wiley Interscience, NY. 410 pages. Anderson JJB, Switzer BR, Stewart PW, Symons M (2004). “Nutritional Assessment: Analysis of Relationships Between Nutrient Factors and Bone Health.” Chapter 3 in Nutrition and Bone Health, Ed. by Michael F. Holick and Bess Dawson-Hughes. Stewart PW (2000), “Estimation and Comparison of Growth and Dose-Response Curves in the

Presence of Purposeful Censoring”. Book Chapter #10 in the Handbook of Statistics, Vol. 18: Bioenvironmental and Public Health Statistics, Sen PK and Rao (eds.). Elsevier Science Publishing Co., North-Holland / Elsevier, Amsterdam; New York. pp. 325-354.

Stamm JW, Disney JA, Beck JD, Weintraub JA, Stewart PW (1993). "The UNC Caries Risk Assessment Study: Final Results and Some Alternative Modeling Approaches," pages 210-234, in Cariology for the Nineties, edited by Bowen WH and Tabak LA. Rochester, New York: University of Rochester Press.

Paul W. Stewart

May 25, 2020

2. Refereed Publications: Statistical Methods Moore CG, Carter R, Nietert PJ, Stewart PW (2011). Recommendations for Planning Pilot

Studies in Clinical and Translational Research, Clinical and Translational Science 4(5):332-337. PMID 22029804.

( news article about this publication: Willyard C. (2011) “Biostatisticians call for more scientifically rigorous pilot studies” Nature Medicine 17, 1531-1531. www.nature.com/nm/journal/v17/n12/full/nm1211-1531b.html.)

Edwards LJ, Stewart PW, MacDougall JE*, Helms RW (2006). A method for Fitting Regression

Splines with Varying Polynomial Order in the Linear Mixed Model. Statistics in Medicine, 25(3): 513-527.

Bowman, FD*, Stewart PW, Sen PK, Helms RW (2004). Making Inferences about Projected

Completors in Longitudinal Studies. Journal of Biopharmaceutical Statistics 14(4): 947-967. Jiroutek MR, Muller KE, Kupper LL, Stewart PW (2003). A New Method for Choosing Sample

Size for Confidence Interval Based Inferences. Biometrics, 59: 580-590. Edwards LJ, Stewart PW, Muller KE, Helms RW (2001) Linear Equality Constraints in the General

Linear Mixed Model. Biometrics 57, 1185-1190. Stewart PW (1991), Tracking Analysis for Inconsistently Timed Longitudinal Data, Statistics in

Medicine, 11, 2027-2040. Stewart PW (1991). The graphical advantages of finite interval confidence band procedures.

Communication in Statistics, A20, No. 12, 3975-3994. Stewart PW, Stamm JW, (1991). Classification tree prediction of caries using clinical,

microbiological and interview Data, Journal of Dental Research, 70(9), 1239-1251. Stewart PW, Helms RW (1989). Evaluating The Distribution Function Of A Bonferroni Test

Statistic From A Type III Bivariate T Distribution, Journal of Communications in Statistics, A18, No.2, 461-478.

Stewart PW (1989). Extension of the Harrell-Davis quantile estimator to finite populations,

Communications in Statistics, A18, No. 3, 853-876. Stewart PW (1987). Line-segment confidence bands for repeated measures, Biometrics, 43, 629-

640. Stewart PW (1981). Application Of A Bivariate T Distribution To Hypotheses Testing In Crossover

Experiments, Doctoral Dissertation, UNC-CH, December 1981. Institute of Statistics Mimeo Series. The University of North Carolina, Chapel Hill, NC.

--------------------------- * students mentored

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May 25, 2020

3. Refereed Publications: Statistical Application Development and Tutorial Articles Stewart PW, Cachafeiro A, Napravnik S, Eron JJ Jr, Frank I, van der Horst C, Bosch RJ, Bettendorf

D, Bohlin P, Fiscus SA. (2010) Performance Characteristics of the Cavidi ExaVir Viral Load Assay and the Ultra Sensitive P24 Assay Relative to the Roche Monitor HIV-1 RNA Assay. 1

Journal of Clinical Virology. 49; 198–204. PMID 20832356, NIHMS 235094

McDonnell WF, Stewart PW, Smith MV (2013). Ozone exposure-response model for lung function changes: an alternate variability structure. Inhalation Toxicology. 25(6):348-353. PMID 23742111

McDonnell WF, Stewart PW, Smith MV, Kim CS, Schelegle ES (2012), Prediction of Lung Function Response for Populations Exposed to a Wide Range of Ozone Conditions.

Inhalation Toxicology 24(10):619-633. PMID 22906168 McDonnell WF, Stewart PW, Smith MV (2010) Prediction of ozone-induced lung function

responses in humans. Inhalation Toxicology 22(2):160-168. PMID19778178 McDonnell WF, Stewart PW, Smith MV (2009) Modification of a Human Ozone Exposure-

Response Model and Evaluation of Its Performance in Predicting Mean Changes in FEV1 in Independent Data. Inhalation Toxicology 22(2); 160-168.

McDonnell WF, Stewart PW, Smith MV (2007). The temporal dynamics of ozone-induced FEV1

changes in humans: an exposure-response model. Inhalation Toxicology 19(6-7): 483-494. McDonnell WF, Stewart PW, Smith MV, Pan WK*, Pan J (1999) Ozone-induced Respiratory

Symptoms: Exposure-Response Models and Association with Lung Function. European Respiratory Journal, 14: 845-853.

1 In the area of HIV-associated assay research, published comparisons of assay methods had typically relied on inferior statistical methods. The above article explicated innovative use of best statistical methods and strategies within the context of assay comparisons. Such comparisons are of great interest to many investigators.

Paul W. Stewart

May 25, 2020

4. Refereed Publications: Collaborative Biomedical Research Strassle PD, Sickbert-Bennett EE, Klompas M, Lund JL, Stewart PW, Marx AH, DiBiase LM, Weber DJ (2020). Incidence and risk factors of non-device-associated pneumonia in an acute-care

hospital. Infect Control Hosp Epidemiol. 41(1): 73-79. PMID: 31658914 Strassle PD, Sickbert-Bennett EE, Klompas M, Lund JL, Stewart PW, Marx AH, DiBiase LM, Weber

DJ (2019). Incidence and risk factors of non-device-associated urinary tract infections in an acute-care hospital. Infect Control Hosp Epidemiol. 40(11): 1242-1247. PMID: 31475662

Guo C, Brouwer KR, Stewart PW, Mosley C, Brouwer KLR. (2019) Probe Cocktail to Assess

Transporter Function in Sandwich-Cultured Human Hepatocytes. Journal of Pharmacy and Pharmaceutical Sciences. 22(1): 567-575. PMID: 31804919

Leisman, DE, Harhay, MO, Lederer, DJ, Abramson, M, Adjei, AA, Bakker, J, Ballas, ZK, Barreiro, E,

Bell, SC, Bellomo, R, Bernstein, JA, Branson, RD, Brusasco, V, Chalmers, JD, Chokroverty, S, Citerio, G, Collop, NA, Cooke, CR, Crapo, JD, Donaldson, G, Fitzgerald, DA, Grainger, E, Hale, L, Herth, FJ, Kochanek, PM, Marks, G, Moorman, JR, Ost, DE, Schatz, M, Sheikh, A, Smyth, AR, Stewart, I, Stewart PW, Swenson, ER, Szymusiak, R, Teboul, J, Vincent, J, Wedzicha, JA, and Maslove DM. (2019) Development and Reporting of Prediction Models. Critical Care Medicine, doi:10.1097/CCM.0000000000004246.

Lederer DJ, Bell SC, Branson RD, Chalmers JD, Marshall R, Maslove DM, Ost DE, Punjabi NM, Schatz

M, Smyth AR, Stewart PW, Suissa S(← the writing group) and Adjei AA, Akdis CA, Azoulay É, Bakker J, Ballas ZK, Bardin PG, Barreiro E, Bellomo R, Bernstein JA, Brusasco V, Buchman TG, Chokroverty S, Collop NA, Crapo JD, Fitzgerald DA, Hale L, Hart N, Herth FJ, Iwashyna TJ, Jenkins G, Kolb M, Marks GB, Mazzone P, Moorman JR, Murphy TM, Noah TL, Reynolds P, Riemann D, Russell RE, Sheikh A, Sotgiu G, Swenson ER, Szczesniak R, Szymusiak R, Teboul JL, Vincent JL (2019). Control of Confounding and Reporting of Results in Causal Inference Studies. Guidance for Authors from Editors of Respiratory, Sleep, and Critical Care Journals.

Annals of the American Thoracic Society, 16(1), 22-28. PMID: 30230362

Serper M, Evon DM, Stewart PW, Lok AS, Amador J, Reeve BB, Golin CE, Fried MW, Reddy KR,

Sterling RK, Sarkar S, Di Bisceglie AM, Lim JK, Nelson DR, Reau N. (2019) Medication Non-adherence in a Prospective, Multi-center Cohort Treated with Hepatitis C Direct-Acting Antivirals.

J Gen Intern Med. 2019 Oct 28. PMID: 31659661 Evon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, Reeve BB, Serper M, Reau N,

Reddy KR, Di Bisceglie AM, Nelson DR, Golin CE, Lim JK, Fried MW. Reply to: "Patient-reported symptoms during direct-acting antiviral treatment: A real-life study in HIV-HCV coinfected patients (ANRS CO13 HEPAVIH)". Journal of Hepatology. 2020 Mar;72(3):592-593.

Evon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, Reeve BB, Serper M, Reau N,

Rajender Reddy K, Di Bisceglie AM, Nelson DR, Golin CE, Lim JK, Fried MW. (2019). Patient-reported symptoms during and after direct acting antiviral therapies for chronic hepatitis C: The PROP UP Study. Journal of Hepatology. PMID: 31096006

Paul W. Stewart

May 25, 2020

Gustafson SJ, Billings CJ, Hornsby BWY, Key AP (2019). Effect of competing noise on cortical auditory evoked potentials elicited by speech sounds in 7- to 25-year-old listeners.

Hearing Research, 373, 103-112. PMID: 30660965. (Dr. Stewart provided the primary model-based longitudinal analyses critical to the paper. The acknowledgement reads: “Dr. Paul W. Stewart provided statistical consultation, statistical computations, analysis, manuscript text and edits.”)

Evon DM, Stewart PW, Amador J, Serper M, Lok AS, Sterling RK, Sarkar S, Golin CE, Reeve BB,

Nelson DR, Reau N, Lim JK, Reddy KR, Di Bisceglie AM, Fried, M. W. (2018). A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well-being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study. PloS One, 13(8), e0196908. PMCID: 6070182

Evon DM, Amador JC, Stewart PW, Reeve BB, Lok LS, Sterling RK, Di Bisceglie AM, Reau N,

Serper M, Sarkar S, Lim JK, Golin CE, Fried MW. (2018) Psychometric Properties of the PROMIS Short Form Measures in a U.S. Cohort of 961 Patients with Chronic Hepatitis C Prescribed Direct Acting Antiviral Therapy. Alimentary Pharmaceutical & Therapeutics. 47(7): 1001-1011. PMID: 29377191

Ali I, Slizgi JR, Kaullen JD, Ivanovic M, Niemi M, Stewart PW, Barritt AS, Brouwer KLR. (2017).

Transporter-mediated Alterations in Patients with NASH Increase Systemic and Hepatic Exposure to an OATP and MRP2 Substrate. Clin Pharmacol Ther. 2017 Dec 22. [Epub ahead of print] PMID: 29271075

Evon DM, Golin CE, Stewart PW, Fried MW, Alston S, Reeve B, Lok AS, Sterling RK, Lim JK, Reau

N, Sarkar S, Nelson DR, Reddy KR, Di Bisceglie AM. (2017). Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment. Contemporary Clinical Trials. 57: 58-68. PMID: 28342989

Feins RH, Burkhart HM, Conte JV, Coore DN, Fann JI, Hicks GL Jr, Nesbitt JC, Ramphal PS, Schiro

SE, Shen KR, Sridhar A*, Stewart PW, Walker JD, Mokadam NA. (2017) Simulation-Based Training in Cardiac Surgery. Ann Thorac Surg. 103(1): 312-321. PMID 27570162 (* biostatistics student)

2016 Aug 20. pii: S0003-4975(16)30773-1. doi: 10.1016/j.athoracsur.2016.06.062. [Epub ahead of print]

Sterling RK, Kuo A, Rustgi VK, Sulkowski MS, Stewart TG*, Fenkel JM, El-Genaidi H, Mah'moud

MA, Abraham GM, Stewart PW, Akushevich L, Nelson DR, Fried MW, Di Bisceglie AM (2015). Virological outcomes and treatment algorithms utilization in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir. Aliment Pharmacol Ther. 41(7): 671-85. PMID: 25627020

(* biostatistics student) Ferslew BC, Xie G, Johnston CK, Su M, Stewart PW, Jia W, Brouwer KL, Sidney Barritt A 4th (2015).

Altered Bile Acid Metabolome in Patients with Nonalcoholic Steatohepatitis. Dig Dis Sci. 60(11): 3318-3328. PMID: 26138654

Ferslew BC, Johnston CK, Tsakalozou E, Bridges AS, Paine MF, Jia W, Stewart PW, Barritt AS 4th,

Brouwer KL (2015). Altered morphine glucuronide and bile acid disposition in patients with nonalcoholic steatohepatitis. Clin Pharmacol Ther. 97(4): 419-427. PMID: 25669174

Hill AM, Stewart PW, Fung MK, Kris-Etherton PM, Ginsberg HN, Tracy RP, Pearson TA, Lefevre M,

Reed RG, Elmer PJ, for the DELTA Investigators. (2014) Monthly haemostatic factor variability in women and men. European Journal of Clinical Investigation. 44(3):309-318. PMID: 24382103

Paul W. Stewart

May 25, 2020

LaMantia MA, Stewart PW, Platts-Mills TF, Biese KJ, Forbach C, Zamora E, McCall BK, Shofer FS, Cairns CB, Busby-Whitehead J, Kizer JS. (2013) Predictive value of initial triage vital signs for critically ill older adults. Western Journal of Emergency Medicine. 14(5):453-460. PMID: 24106542

Köck K, Ferslew BC, Netterberg Ida, Yang K, Urban TJ, Swaan PW, Stewart PW, Brouwer KLR

(2014). Risk factors for development of cholestatic drug-induced liver injury: Inhibition of hepatic basolateral bile acid transporters multidrug resistance-associated proteins 3 and 4.

Drug Metabolism and Disposition. 42(4):665-674. PMID: 24154606 Yang K, Pfeifer ND, Hardwick RN, Yue W, Stewart PW, Brouwer KLR (2014) An experimental

approach to evaluate the impact of impaired transport function on hepatobiliary drug disposition using Mrp2-deficient TR- rat sandwich-cultured hepatocytes in combination with Bcrp knockdown.

Molecular Pharmaceutics. 11(3): 766-775. PMID: 24410402 Gribbin MJ, Chi YY, Stewart PW, Muller KE (2013). Confidence regions for repeated measures

ANOVA power curves based on estimated covariance. BMC Medical Research Methodology. 13(1):57. PMID 23586676 Dong B, Stewart PW, Egan TM (2013). Postmortem and ex vivo carbon monoxide ventilation

reduces injury in rat lungs transplanted from non-heart-beating donors. Journal of Thoracic Cardiovascular Surgery. S0022-5223(12):01382-7. PMID 23260460 Tian Z, Dong B, Blackwell JW, Stewart PW, Egan TM (2013). Effect of a vascular endothelial

cadherin antagonist in a rat lung transplant model. Ann Thoracic Surg. 95(3):1028-33. PMID 23333062 Ilic K, Hawke RL, Thirumaran RK, Schuetz EG, Hull JH, Kashuba AD, Stewart PW, Lindley CM,

Chen ML (2013). The influence of sex, ethnicity, and CYP2B6 genotype on bupropion metabolism as an index of hepatic CYP2B6 activity in humans. Drug Metab Dispos. 41(3):575-581. PMID 23238783

Dosal JC, Stewart PW, Lin J-A*, Williams CS, Morrell DS (2014), Cantharidin for Treatment of

Molluscum Contagiosum: A Prospective, Double-Blinded, Placebo-Controlled Trial. Pediatric Dermatology. 31(4):440–449. PMID 22897595 (* biostatistics student) Kipp AM, Pungrassami P, Stewart PW, Chongsuvivatwong V, Strauss RP, VanRie A (2011). Study of tuberculosis and AIDS stigma as barriers to tuberculosis treatment adherence using

validated stigma scales. Int J Tuberc Lung Dis. 15(11):1540-1545. PMID 22008770 Noah TL, Ivins SS, Abode KA, Stewart PW, Michelson PH, Harris WT, Henry MM, Leigh MW. (2010) Inhaled versus systemic antibiotics and airway inflammation in children with cystic fibrosis

and Pseudomonas. Pediatric Pulmonology. 45(3):281-290. PMID 20146365 Joy MS, Boyette T, Hu Y, Wang J, La M, Hogan SL, Stewart PW, Falk RJ, Dooley MA, Smith PC

(2010) Effects of uridine diphosphate glucuronosyltransferase 2B7 and 1A7 pharmacogenomics and patient clinical parameters on steady-state mycophenolic acid PK in glomerulonephritis.

European Journal of Clinical Pharmacology (2010) 66:1119–1130. PMID 20567810 Pungrassami P, Kipp AM, Stewart PW, Chongsuvivatwong V, Strauss RP, Van Rie A. (2010)

Tuberculosis and AIDS stigma among patients who delay seeking care for tuberculosis symptoms. International Journal of Tuberculosis and Lung Disease 14(2):181-187. PMC 2875178 PMID 20074409

Paul W. Stewart

May 25, 2020

Napravnik S, Cachafeiro A, Stewart PW, Eron JJ Jr, Fiscus SA. (2010) HIV-1 viral load and phenotypic antiretroviral drug resistance assays based on reverse transcriptase activity in comparison to amplification based HIV-1 RNA and genotypic assays.

J Clin Virol. 47(1):18-22. Epub 2009 Nov 5. PMID 19896416

Van Rie A, Dow A, Mupuala A, Stewart PW (2009) Neurodevelopmental trajectory of HIV-infected

children accessing care in Kinshasa, Democratic Republic of Congo. J Acquir Immune Defic Syndr. 52(5):636-42. PMID 19730268 Rosen DL, Schoenbach VJ, Wohl DA, White BL, Stewart PW, Golin CE (2009). Characteristics

and behaviors associated with HIV infection among inmates in the NC prison system. American Journal of Public Health. 99(6):1123-1130. PMID 19372527

Rosen DL, Schoenbach VJ, Wohl DA, White BL, Stewart PW, Golin CE. (2009). An evaluation of

HIV testing among inmates in the North Carolina prison system. American Journal of Public Health. 99 Suppl 2: S452-S459. PMID 19797758 Mukherjee N, Morrell DS, Duvic M, Stewart PW, Goldsmith LA. (2009) Attitudes of

dermatologists in the southeastern United States regarding treatment of alopecia areata: a cross-sectional survey study. BMC Dermatol. 12:9-11. PMID 19909522

Fischer LM, daCosta KA, Kwock L, Stewart PW, Lu T-S*, Stabler SP, Allen RH, Zeisel SH (2007).

Sex and menopausal status influence human dietary requirements for the nutrient choline. Am J Clin Nutr. 85(5): 1275-1285. (* biostatistics student) Dumond JB, Yeh RF, Patterson KB, Corbett AH, Jung BH, Rezk NL, Bridges AS, Stewart PW, Cohen MS, Kashuba AD. (2007) Antiretroviral drug exposure in the female genital tract: implications

for oral pre- and post-exposure prophylaxis. AIDS 21(14): 1899-1907. Pilcher CD, Joaki G, Hoffman IF, Martinson FEA, Mapanje C, Stewart PW, Powers KA, Galvin S,

Chilongozi D, Gama S, Price MA, Fiscus SA, Cohen MS, for the UNC Project in Malawi (2007). Amplified Transmission of HIV-1: Comparison of HIV-1 Concentrations in Semen and Blood During Acute and Chronic Infection AIDS 20;21(13): 1723-1730.

Richey LM, George JR, Couch ME, Kanapkey BK, Yin X, Cannon T, Stewart PW, Weissler MC,

Shores CG. (2007) Defining cancer cachexia in head and neck squamous cell carcinoma. Clinical Cancer Research. 13(22 Pt 1): 6561-6567. Berglund L, Lefevre M, Ginsberg HN, Kris-Etherton PM, Elmer PJ, Stewart PW, Ershow A, Pearson TA, Dennis BH, Roheim PS, Ramakrishnan R, Reed R, Stewart K, Phillips KM, for the DELTA Investigators. (2007) Comparison of monounsaturated fat with carbohydrates as a replacement for saturated fat in subjects

with a high metabolic risk profile: studies in the fasting and postprandial states. American Journal of Clinical Nutrition. 86(6):1611-1620. Golin CE, Earp J, Tien H-C*, Stewart PW, Porter C, Howie L. (2006) A 2-arm, randomized,

controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (ART) among patients failing or initiating ART.

J Acquired Immune Deficiency Syndrome. 42(1): 42-51.

Paul W. Stewart

May 25, 2020

Watkins PB, Kaplowitz N, Slattery JT, Colonese CR, Colucci SV, Stewart PW, Harris SC. (2006) Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. JAMA 296(1): 87-93.

{#1 on the "50 Most Frequently Read Articles" list accessed from the web site during July 2006.} Watkins PB, Kaplowitz N, Colucci SV, Stewart PW, Harris SC. (2006) Reply: Acetaminophen and Aminotransferase Elevations. JAMA 296(23): 2798-2799. Mouly SJ, Matheny C, Paine MF, Lambda Smith G, Lamba J, Lamba V, Pusek SN, Schuetz EG, Stewart PW, Watkins PB (2005). Variation in oral clearance of saquinavir is predicted by

CPY3A5*1 genotype but not by enterocyte content of cytochrome P450 3A5. Clinical Pharmacology Therapy, 78(6): 605-618. Napravnik S, Edwards D, Stewart PW, Stalzer B, Matteson E, Eron JJ Jr. (2005). HIV-1 Drug

Resistance Evolution Among Patients on Potent Combination Antiretroviral Therapy with Detectable Viremia. Journal of Acquired Immune Deficiency Syndrome. 40:34-40.

Paine MF, Ludington SS, Chen M-L, Stewart PW, Huang S-M, Watkins PB (2005). Do Men and

Women Differ in Proximal Small Intestinal CYP3A or P-Glygoprotein Expression? Drug Metabolism and Disposition 33: 426-433. Wohl DA, Zeng D, Stewart PW, Glomb N, Alcorn T, Jones S, Handy J, Fiscus S, Weinberg A,

Gowda D, van der Horst C (2005). Cytomegalovirus, Mortality and CMV End-Organ Disease Among Patients with AIDS Receiving Potent Antiretroviral Therapies.

Journal of Acquired Immune Deficiency Syndrome 38(5): 538-544. Girdler SS, Maixner W, Naftel HA, Stewart PW, Moretz RL, Light KC. (2005) Cigarette smoking, stress-induced analgesia and pain perception in men and women. Pain. 114(3): 372-385. PMID15777863 Stephenson BL, Wohl DA, Golin CE, Tien H-C*, Stewart PW, Kaplan AH (2005) Effect of Release from Prison and Re-incarceration on the Viral Loads of HIV-infected individuals.

Public Health Reports 120:84-88. Mouly SJ, Matheny C, Paine MF, Lambda Smith G, Lamba J, Lamba V, Pusek SN, Schuetz EG, Stewart PW, Watkins PB (2005). Variation in oral clearance of saquinavir is predicted by CPY3A5*1 genotype but not by enterocyte content of cytochrome P450 3A5. Clinical Pharmacology Therapy, 78(6): 605-618. Napravnik S, Edwards D, Stewart PW, Stalzer B, Matteson E, Eron JJ Jr. (2005). HIV-1 Drug Resistance Evolution Among Patients on Potent Combination Antiretroviral Therapy with Detectable Viremia. Journal of Acquired Immune Deficiency Syndromes. 40: 34-40. Paine MF, Ludington SS, Chen M-L, Stewart PW, Huang S-M, Watkins PB (2005). Do Men and Women Differ in Proximal Small Intestinal CYP3A or P-Glycoprotein Expression? Drug Metabolism and Disposition 33: 426-433. Wohl DA, Zeng D, Stewart PW, Glomb N, Alcorn T, Jones S, Handy J, Fiscus S, Weinberg A, Gowda D, van der Horst C (2005) JAIDS 38(5): 538-544.

Paul W. Stewart

May 25, 2020

Girdler SS, Maixner W, Naftel HA, Stewart PW, Moretz RL, Kathleen CL (2005) Cigarette

Smoking, Stress-Induced Analgesia and Pain Perception in Men and Women. Pain 114(3): 372-385. Stephenson BL, Wohl DA, Golin CE, Tien H-C*, Stewart PW, Kaplan AH (2005) Effect of Release from Prison and Re-incarceration on the Viral Loads of HIV-infected individuals. Public Health Reports 120:84-88. Pilcher CD, Tien HC, Eron JJ, Vernazza PL, Leu S-Y, Stewart PW, Goh LE, Cohen MS (2004). Brief but Efficient: Acute HIV Infection and the Sexual Transmission of HIV. Journal of Infectious

Disease. 189:1785-1792. Shefali MK, Paine MF, Stewart PW, Watkins PB (2004) 6’7’-Dihydroxyberamottin Contributes to

the Grapefruit Juice Effect. Clinical Pharmacology and Therapeutics 75: 569-579. Givens RC, Lin YS, Dowling ALS, Thummel KE, Lamba JK, Schuetz EG, Stewart PW, Watkins

PB (2003). CYP3A5 Genotype Predicts Renal CYP3A Activity and Blood Pressure in Healthy Adults. Journal of Applied Physiology. 95: 1297-1300.

Lindesmith L, Moe CL, Marionneau S, Ruvoen N, Jiang X, Lindblad L, Stewart PW, LePendu J, Baric R (2003). Human Susceptibility and Resistance to Norwalk Virus Infection. Nature Medicine 9: 548 - 553. Hoffman IF, Martinson FEA, Stewart PW, Chilongozi1 DA, Leu S-Y, Kazembe PN, Banda T,

Dzinyemba W, Joshi1 P, Cohen MS, Fiscus SA (2003). HIV-1 RNA in Breast Milk Components. Journal of Infectious Disease. 188: 1209-1212. Davenport ML, Punyasavatsut N, Stewart PW, Gunther DF. Savendahl L. Sybert VP. (2002) Growth failure in early life: an important manifestation of Turner syndrome. Hormone Research. 57(5-6):157-64. Quinlivan EB, Zhang C, Stewart PW, Komoltri C*, Davis MG, Wehbie RS (2002). Elevated Virus Loads Of Kaposi's Sarcoma-Associated Human Herpesvirus 8 Predict Kaposi's Sarcoma

Disease Progression, But Elevated Levels Of Human Immunodeficiency Virus Type 1 Do Not. Journal of Infectious Diseases, 185(12):1736-44. Quinlivan EB, Wang RX, Stewart PW, Komoltri C*, Regamey N, Erb P, Vernazza PL (2001).

Longitudinal sero-reactivity to human herpesvirus 8 (KSHV) in the Swiss HIV Cohort 4.7 years before KS. Journal of Medical Virology. (64):157-166.

Jere C, Cunliffe NA, Hoffman IF, Stewart PW, Kilaru K*, Boradhead RL, Molyneux ME, Hart CA,

Fiscus FA (2001). Plasma HIV Burden in Malawian Children Co-Infected with Rotavirus. AIDS 15(11): 1439-1442. Reed R, Stewart PW, Kris-Etherton PM, Pearson T, for the DELTA Investigators (2000). Effects of Menstrual Cycle on Lipids and Hemostasis. Metabolism. 49: 1101-1105. (Acknowledgment to Szu-Yun Leu, Biostatistics GRA.) Davenport ML, Punyasavatsut N, Gunther D, Savendahl L, Stewart PW (1999)

Paul W. Stewart

May 25, 2020

Turner syndrome: a pattern of early growth failure. Acta Paediatr Suppl 88(433):118-21 Muhlebach MS, Stewart PW, Leigh MW, Noah TL (1999). Inflammatory Responses to Bacteria in Young Cystic Fibrosis and Control Patients. American Journal of Respiratory and Critical Care Medicine 160: 186-191. Dennis B, Champagne C, Ershow A, Karmally W, Kris-Etherton P, Phillips K, Stewart K, Stewart

PW, Van Heel N, Wang CH, Windhauser M, Farhat-Wood A, for the DELTA Investigators (1998). Diet Design for Multicenter Controlled Feeding Trials: DELTA I. Journal of the American Dietetic Association. 98(7): 766-776. Ginsberg H, Dennis B, Elmer P, Ershow AP, Lefevre M, Pearson T, Roheim P, Ramakrishnan R, Reed RG, Anderson N, Stewart K, Philllps K, Stewart PW, Kris-Etherton PK, for the DELTA

Investigators (1998), Diet Effects on Lipids and Thrombogenic Activity: Effects of Reducing Dietary Total and Saturated Fat on Plasma Lipids and Lipoproteins.

Arteriosclerosis, Thrombosis, and Vascular Biology, 18: 441-449. Lefevre M, Ginsberg HN, Kris-Etherton PM, Elmer PJ, Stewart PW, Ershow A, Pearson TA, Roheim PS, Ramakrishnan R, Derr J, Gordon D, Reed R, for the DELTA Investigators (1997). ApoE genotype does not predict lipid response to changes in dietary saturated fatty acids in a heterogeneous normolipidemic population. Arteriosclerosis, Thrombosis, and Vascular Biology. 17: 2914-2923. Herman-Giddens ME, Kotch JB, Browne DC, Ruina E, Winsor JR, Jung JW, Stewart PW (1997).

Childbearing Patterns in a Cohort of Women Sexually Abused as Children, Journal of Interpersonal Violence. 13(4): 504-513. McDonnell WF, Stewart PW, Andreoni S, Seal E Jr, Kehrl R, Horstman DH, Folinsbee LJ, Smith

MB (1997) Prediction of Ozone-induced FEV1 Changes: Effects of Concentration, Duration, and Ventilation. American Journal of Respiratory and Critical Care Medicine, 156: 715-722.

Quinlivan, EB, Ye D, Wehbie RS, Stewart PW, Flepp M, Vernazza PI. (1997) Kaposi's Sarcoma Patients in the Swiss HIV Cohort Study with and without Detectable Human Herpesvirus 8 in Peripheral Blood Mononuclear Cells, AIDS 11: 1893-1895. Kotch JB, DuFort V, Stewart PW, Fieberg J, McMurry M, O’Brian S, Ngui EM, Brennan M

(1997). Injuries Among Children in Home and Out-of-Home Care, Journal of Injury Prevention 3: 267-271. Kotch JB, Browne DC, Ringwalt CL, DuFort V, Ruina E, Stewart PW, Jung JW (1997). Stress, Social Support and Substantiated Maltreatment in the Second and Third Year of Life, Journal of Child Abuse and Neglect 21: 1025-1037. McDonnell WF, Stewart PW, Andreoni S, Smith MB (1995) Proportion of Moderately

Exercising Individuals Responding to Low-level, Multi-hour Ozone Exposure. American Journal of Respiratory and Critical Care Medicine, 152: 589-596. Kotch JB, Browne DC, Ringwalt CL, Stewart PW, Ruina E, Holt K, Lowman B, JW Jung (1995). Risk of Child Abuse and Neglect in a Cohort of Low Income Children.

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Journal of Child Abuse and Neglect, 19: 1115-1130. Henderson FH, Henry MM, Ivins SS, Morris R, Neebe EC, Leu S, Stewart PW (1995). Correlates of Recurrent Wheezing in School Age Children American Journal of Respiratory and Critical Care Medicine, 151: 1786-1793. Hillis SD, Weigle K, Miranda CM, McCann M, Bender D, Stewart PW (1995). Supplementary Feeding in Colombian Child-Care Centers and Growth Velocity, Pediatrics, 94: 1066-1069. Margolis MQ, Hunt RJ, Vann WF, Stewart PW (1994). Distribution of primary tooth caries in first-

grade children from two nonfluoridated US communities. Pediatric Dentistry, 16: 200-205. Henderson FH, Stewart PW, Voter KZ, Strope GL, Burchinal MR, Ivins SS, Morris R, Ou-Li Wang, Henry MM (1992). Respiratory allergy and the relationship between early childhood

lower respiratory illness experience and subsequent lung function American Review of Respiratory Disease, 145, 283-290 Strope G, Stewart PW, Henderson F, Henry M, (1991). Respiratory allergy and the relationship

between early childhood lower respiratory illness experience and subsequent lung function. American Review of Respiratory Disease, 144, 655-662. Stamm JW, Stewart PW, Bohannan HM, Disney JA, Graves RC, Abernathy JR (1991). Risk Assessment for Oral Diseases, Advances in Dental Research, 5, 4-17. Scruggs RR, Stewart PW, Samuels MS, Stamm JW (1991). Clinical evaluation of seven anti-calculus dentifrice formulations, Journal of Clinical Periodontology, 13, 23-27. Stamm JW, Disney JA, Graves R, Cancro L, Payonk G, Stewart PW (1988). An Evaluation of six dentifrice formulations for anticalculus activity, Journal of Clinical Periodontology, 16, 101-111 Voter K, Henry M, Stewart PW, Strope G, Henderson F, (1987). Methacholine sensitivity and lung function related to pre-school lower respiratory illness in children in Chapel Hill, NC.

American Review of Respiratory Disease1, 137, 302-307. Carson JL, Collier AM, Hu SS, Smith CA, Stewart PW (1987). The appearance of compound cilia

in the nasal mucosa of normal human subjects following acute environmental exposure to sulfur dioxide. Environmental Research, 42, 155-165.

Glueck C, Laskarzewski P, Suchindran C, Chambless W, Stewart PW, Heiss H, Tyroler A (1986).

Progeny's lipid levels by parental mortality, Circulation. Part 2, 73, 51-61. Kwiterovich P, Stewart PW, for the LRC Investigators (1986). Detection of dyslipoproteinemia

using plasma total cholesterol and triglyceride levels, Circulation, Part 2, 73, 30-39.

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5. Manuscripts in Review or in Revision Stewart PW, Benignus V “Nonlinear models for summary dose-response data.” Submitted to American Statistician. 14 pages. 6. Publications: Book Reviews Review of "Time Series: A Biostatistical Introduction", Diggle PJ (Author); Stewart PW

(Reviewer). JASA, 1992; 87: 255-255. Review of "Linear Mixed Models in Practice: A SAS-oriented Approach", Verbeke G and

Molenberghs G (Editors); Stewart PW (Reviewer). Technometrics, 1999; 41(1): 79-79. 7. Publications: Monographs Stewart PW (1990), "Classification Tree Prediction of Caries Using Clinical, Microbiological and

Interview Data," The 1990 Transactions of The Task Force on Design and Analysis: 49-63. Edited by Neal W. Chilton. Stewart PW (1977). “Some Properties of the Linear Prediction Estimator for the Power Spectrum of a Speech Wave: Original Results for Autoregressive Processes,” Master's Thesis, UNC-CH, Institute of Statistics Mimeo Series: 57 pages. The University of North Carolina, Chapel Hill, NC. Stewart PW, “The Thrill of Theory: Foundations for the Joy of Modeling”, Lecture notes for BIO263, Advanced Linear Models Theory: 485 pages. Available from UNC Custom Publishing. Stewart PW, “Matrix Results Useful in Statistics", Lecture notes for BIOS107 and BIOS108 one-hour review courses: 165 pages. Distributed by UNC Custom Publishing. Stewart PW, "The LINMOD GCMPACK User's Guide for Growth-Curve Model Analysis," Used in BIOS267 from 1979-1986: 12 pages. Stewart PW (2008) “What is a Pilot Study: GCRC Protocols Which Propose Pilot Studies”: 5 pages. www.cincinnatichildrens.org/research/divisions/c/ctrc/protocol/pilot-studies/

/Small_or_Pilot_Studies.htm { Cited in Connelly LM (2008) "Pilot Studies". Medsurg Nursing, 17: 411-412. } 8. Presentations 8.1 Statistical Presentations 2017 “Pilot Study Design and Review” NC TraCS Institute, Chapel Hill, NC. November 3, 2017. 2017 “Designing Your Research Study: Essential Concepts, Best Practices, Speedy IRB Approval”

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UNC Dept of Pediatrics, Chapel Hill, NC. January 6, 2017. 2016 "Choosing a Sample Size and the Design and Purpose of Pilot Studies" UNC Dept of Anesthesiology, Chapel Hill, NC. May 11, 2016. 2015 "Biostatistics Seminar: Design and Purpose of Pilot Studies" NC TraCS Institute, Chapel Hill, NC. August 28, 2015. 2015 "Review of IRB Applications: Design and Analysis of Pilot Study Proposals " Seminar for IRB Staff Members, Chapel Hill, NC. June 24, 2015. 2014 "Speedy IRB Approval: Strategic Statistical Considerations in Preparation of IRB

Applications " IRB Workshop for Investigators, Chapel Hill, NC. September 15, 2014. 2014 "Speedy IRB Approval: Strategic Statistical Considerations in Preparation of IRB

Applications " IRB Workshop for Investigators, Chapel Hill, NC. March 28, 2014. 2014 "Pediatric Research Using Pilot Studies" Pediatric Pulmonology, UNC School of Medicine, Chapel Hill, NC. Sept. 5, 2014. 2013 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies" Pediatric Pulmonology, UNC School of Medicine, Chapel Hill, NC. April 19, 2013. 2012 “Nonlinear Mixed-Effects Models for Ozone Exposure-Response” Joint Statistical Meetings (JSM), August 2012. 2012 “Nonlinear Models for Meta-Analysis of Summary Exposure-Response Data” Meeting of the IBS / ENAR. March 2012. 2011 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies" UNC Clinical Research Scholars , UNC School of Medicine, Chapel Hill, NC. 2011 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies" EPID 690, UNC School of Public Health, Chapel Hill, NC. January 27, 2011. 2010 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies" UNC Clinical Research Scholars , UNC School of Medicine, Chapel Hill, NC. 2009 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies" UNC Clinical Research Scholars , UNC School of Medicine, Chapel Hill, NC. 2008 “Directing Biostatistics Cores in Biomedical Research.” Invited session at the Joint Statistical Meetings, Denver, CO 2008 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies" UNC Clinical Research Scholars , UNC School of Medicine, Chapel Hill, NC. 2007 "Pilot Studies, Feasibility Studies, and Small Exploratory Studies"

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UNC Clinical Research Scholars , UNC School of Medicine, Chapel Hill, NC. 2006 “A Bernoulli / Left-Censored Lognormal Mixture Model for Activity of the Protease of HIV-1 as a Function of Amino Acid Characteristics.” Invited presentation at the Joint Statistical Meetings, Seattle, WA. 2005 "Introduction to Power Analysis," UNC General Clinical Research Center (GCRC), Doris-Duke Research Fellows, UNC School of Medicine, Chapel Hill, NC. 2004 "Introduction to Power Analysis," UNC General Clinical Research Center (GCRC), Doris-Duke Research Fellows, UNC School of Medicine, Chapel Hill, NC. 2003 "Introduction to Power Analysis," UNC General Clinical Research Center (GCRC), Doris-Duke Research Fellows, UNC School of Medicine, Chapel Hill, NC. 2002 "Introduction to Power Analysis," UNC General Clinical Research (GCRC), UNC School of Medicine, Chapel Hill, NC. 1998 "Longitudinal Analysis of Menstrual Cycle Variation in Hormones, Lipids, Lipoproteins, and Hemostatic Factors in a Three-Period Crossover Study," Presented at March 1998 Meeting of the IBS / ENAR. 1995 "Risk Modeling of EPA Clinical Research Branch Ozone Response Data," EPA - UNC Cooperative Agreement Program, U.S. EPA, Chapel Hill, NC. 1995 "Longitudinal Analysis of Pulmonary Function for Cystic Fibrosis Patients," Biostatistics Dept., Genentech Inc., South San Francisco, CA. 1995 "Longitudinal Analysis of Long-term Benefits of Pulmozyme (R) for Cystic Fibrosis Patients," Biostatistics Dept., Genentech Inc., S. San Francisco, CA. 1993 "Simultaneous Confidence Bands for Nonlinear Longitudinal Models," Presented at August 1993 Joint Meeting of the ASA, IBS, and the IMS. 1993 "Simultaneous Confidence Bands for Non-Linear Longitudinal Models," Biostatistics Department, UNC, Chapel Hill, NC. 1992 "Methods for Tracking Analysis for Inconsistently Timed Longitudinal Data," Presented at August 1992 Joint Meeting of the ASA, IBS, and the IMS. 1991 "Analysis of Dose-Response Curves for Censored Repeated Measures," Presented at August 1991 Joint Meeting of the ASA, IBS, and IMS. 1991 "Tracking Analysis for Inconsistently Timed Longitudinal Data," Presented at June 1991 ASA Symposium on Longitudinal Data Analysis, 1991 "Methods for Informatively Right-Censored Longitudinal Data," Biostatistics Department, UNC, Chapel Hill, NC.

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1991 "Methods for Right-Censored Longitudinal Data," Biostatistics Section, Bowman Gray School of Medicine, Winston-Salem, NC. 1991 "Tree-Structured Models for Classification and Regression," Biostatistics Department, UNC, Chapel Hill, NC. 1990 "Methods for the Analysis of Tracking in Inconsistently-Timed Longitudinal Data," Presented at Aug.'90 Joint Meeting of the ASA, Biometric Society, and the IMS. 1990 "Classification Tree Prediction of Caries Using Clinical, Microbiological and Interview Data," Presented to November 1990 Meeting of The Task Force on Design and Analysis for Dental Research. New Brunswick, NJ. 1990 "Classification Tree Prediction of Caries Using Clinical, Microbiological and Interview Data," Presented at Mar.'90 Meetings of the International Association of Dental Research. 1989 "The Graphical Advantages of Finite Interval Confidence Band Procedures," Presented at Aug.'89 Joint Meetings of the ASA, Biometric Society, and IMS. 1987 "Methods for Evaluation of Once-Repeated Measures for Evidence of Tracking," Presented at Aug.'87 joint Meetings of the ASA, Biometric Society, and IMS. 1987 "Finite Interval Confidence Bands for Repeated Measures," Mathematics Department, East Carolina University, Greenville, NC. 1985 "Finite Interval Confidence Bands for Repeated Measures," Biostatistics Department, Glaxo, Inc. 1985 "Finite Interval Confidence Bands for Repeated Measures," Biometrics Department, Medical University of South Carolina. 1985 "Finite Interval Confidence Bands for Repeated Measures," Statistics Department, University of Florida, Gainesville, FL. 1985 "Finite Interval Confidence Bands for Repeated Measures," Biostatistics Department, Vanderbilt University, TN. 1985 "Finite Interval Confidence Bands for Repeated Measures," Biostatistics Department, Emory University, Atlanta, GA. 1984 "Extension of the quantile estimator proposed by Harrell and Davis to finite populations," Presented at Mar.'85 Meetings of the International Biometric Society. 1979 "The Analysis of Growth and Dose-Response Curves," Presented at Aug.'79 Joint Meetings of the ASA, Biometric Society, and IMS. (Published in ASA Proceedings of Statistical Computation Section, 130-135.)

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1979 "LINMOD Analysis of Growth and Dose-Response Curves," Presented at Aug.'79 The Conference of SAS Users Group International. (Published in Proceedings of the 4th Annual Conference of the SUGI, 266-271.) Award for Best Paper on Linear Models at this annual conference. 8.2 Statistical Presentation Collaborations (substantial contributions other than presentation) McDonnell WF, Stewart PW, Smith M (2012) “Identification and Evaluation of a Dynamic Ozone-

FEV1 Exposure-Response Model for Use in Conducting Risk Assessment in Support of the NAAQS for Ozone.” Presentation to U.S. Environmental Protection Agency, Clean Air Scientific Advisory Committee (CASAC), Jan 9, 2012.

Edwards LJ, Muller KE, Gurka MJ, Stewart PW (2005) “ Selecting the Best Linear Mixed Model:

The State of the Art for Longitudinal Data Analysis.” Presented at the 2005 JSM. Stewart PW and DeMuth G (2002). “Estimation in Longitudinal Studies of Continuous Measures

that are Subject to Purposeful Censoring”. Presented at the March 2002 Meeting of the IBS / ENAR.

Kilaru R, Stewart PW (2001) “Application of a Monte Carlo EM Algorithm to Left-Censored Bivariate Normal Data”. Presented at the March 2001 Meeting of the IBS / ENAR. Bowman D, Sen PK, Stewart PW (1999) “Statistical Methods for Obtaining Inferences about Projected Completors in Longitudinal Studies with Non-ignorable Dropout”. Presented at 1999 JSM. Cox T and Stewart PW (1997), "Evaluation of the Performance of Mixed-Model Procedures for

Ophthalmologic Data,"Presented at March 1997 Meeting of the IBS / ENAR. Cox T and Stewart PW (1997), "Evaluation of the Performance of GEE Procedures for

Ophthalmologic Data," Presented at March 1997 Meeting of the IBS / ENAR. Burchinal, MR., Stewart PW, Pekow, PS, Helms, RW. (1991), "Tracking in Inconsistently-Timed

Longitudinal Pulmonary Function Data: Empirical Results," Presented at the 1991 JSM. Helms RW, McCanless I, Christiansen DH, Hosking JD, Muller KE, Stewart PW (1979), "Using GLMM5 for general linear models analysis: A tutorial", Presented at 4th Annual SAS Users

Group International Conference. (Published in Proceedings of the SUGI Conference, pp 234- 271.) 8.2 Biomedical Presentation Collaborations Serper M, Evon DM, Stewart PW, Sulbaran JCA, Reddy R “Factors associated with baseline and on-treatment sleep disturbance and cognitive concerns among

patients with and without cirrhosis treated for chronic hepatitis C (HCV) with direct acting antivirals (DAAs): Interim results from the PROP UP Study” Submitted to AASLD, 2017.

Sterling R, Evon DM, Stewart PW, Sulbaran JCA “HIV testing in patients starting HCV treatment and factors associated with adherence to

AASLD-IDSA Guidelines” Submitted to AASLD, 2017.

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Evon DM, Stewart PW, Sulbaran JCA, Golin CE, Fried MW, Alston S “Baseline Characteristics and Patient-Reported Outcomes from PROP UP: A Large US Multi-site

Observational Study of Patients with Chronic Hepatitis C Infection Initiating Direct Acting Antiviral Therapy” submitted for AASLD, 2017.

Masuodi S, Blackwell J, Stewart PW, Egan TM. (2017) Cytokine levels in Steen Solution perfusate

increase during ex‐vivo lung perfusion (EVLP) of lungs from conventional donors (Conv) and uncontrolled Donation after Circulatory Determination of Death donors (uDCDDs) (Abstract).

International Society for Heart and Lung Transplantation; April 5‐8, 2017; San Diego, CA. The Journal of Heart and Lung Transplantation. 2017;36(4S):S311. Egan TM, Haithcock B, Long J, Birchard K, Lobo J, Stewart PW, Blackwell J, Yuan D, Thys C,

Karb D, Miller S, Hartwig M. Interim results of a Phase II clinical trial comparing outcomes of recipients of lungs recovered from uncontrolled donation after circulatory determination of death donors (uDCDDs) assessed by ex-vivo lung perfusion (EVLP) and CT scan to outcomes of recipients of lungs from brain-dead donors (BDDs). (Abstract). The Journal of heart and lung transplantation. 2016;35(4S):S372.

Egan TM, Requard JJ, Stewart PW, Thys C. Obstacles to lung transplant from uncontrolled donation

after circulatory determination of death donors (uDDCDDs) (Abstract). The Journal of Heart and Lung Transplantation. 2016;35 (4S):S66.

Stewart PW, Yankaskas J, Egan TM. (2014) The growing impact of lung transplant (LTX) on

survival for patients with cystic fibrosis (CF) (Abstract). Presented to the International Society for Heart and Lung Transplantation on 2014-04-11 in San Diego, California. The Journal of Heart and Lung Transplantation;33(4):S227-S8.

Egan T, Haithcock B, Long J, Noone P, Blackwell J, Forrest L, Gazda S, Reddy S, Davis R, Birchard

K, Stewart PW (2014). Preliminary results of a Phase II trial comparing outcomes of patients transplanted with lungs from uncontrolled donation after cardiac death donors (uDCDDs) assessed with ex-vivo lung perfusion (EVLP) to lungs from conventional brain-dead donors (Abstract). The Journal of Heart and Lung Transplantation 14;33(4):S17. Presented to the International Society for Heart and Lung Transplantation on 2014-04-11 in San Diego, California.

Egan TM, Blackwell J, Forrest L, Gazda S, Requard JJ, Haithcock B, Birchard K, Stewart PW,

Randell S, Venkataraman A, Beamer S, Reddy S, Myers B, Bachman M, Casel N, Niedfeldt D. (2014) Evaluation of human lungs from uncontrolled donation after cardiac death donors (uDCDDs) with ex-vivo lung perfusion (EVLP) [Abstract]. Presented to the International Society for Heart and Lung Transplantation on 2014-04-11 in San Diego, California. The Journal of Heart and Lung Transplantation. 33(4):S47.

Egan TM, Dong B, Blackwell J, Birchard K, Stewart PW, Funkhouser W, et al. Assessing human

lungs unsuitable for transplant by ex-vivo lung perfusion (EVLP) and ex-vivo CT scan; Does EVLP cause inflammation? (Abstract) Presented to the International Society for Heart and Lung Transplantation on 2014-04-11 in San Diego, California. The Journal of Heart and Lung Transplantation 34 (4S):S139.

Egan TM, Gazda S, Stewart PW (2014). If I had a million lungs: Impact of uncontrolled donation

after cardiac death donors (uDCDDs) on the number of potential lung donors in the U.S. (Abstract).

Paul W. Stewart

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Presented to the International Society for Heart and Lung Transplantation on 2014-04-11 in San Diego, California. The Journal of Heart and Lung Transplantation 33(4):S47.

Köck K , Ferslew B, Netterberg I, Yang K, Urban TJ, Stewart PW, Brouwer KLR (2012) “Inhibition

of the hepatic basolateral bile acid transporter MRP4 predicts cholestatic drug-induced liver injury” Presented at 2012 AALSD Conference. Egan T, Dong B, Blackwell J, Simmons W, Jernigan E, Nicotra W, Haithcock J, Haithcock B, Tian Z,

Reddy S, Birchard K, Stewart PW, Noone P. (2011) Ex-vivo lung perfusion (EVLP) of human lungs: a preclinical study to assess transplant suitability (Abstract). Chest. 2011;140(4)

McDonnell W, Stewart PW, Smith M (2008) “Modification of a Human Ozone Exposure-Response

Model and Evaluation of Its Performance in Predicting Mean Changes in FEV1 in Independent Data.” U. S. Environmental Protection Agency Workshop on Ozone, October, 2008.

Kipp AM, Stewart PW, Pungrassami P, Chongsuvivatwong V, van Rie A. (2008) “TB stigma

trajectory among patients completing TB treatment in Southern Thailand”. AIDS Conference, Mexico City, 2008.

Dow A, Mupuala A, Stewart PW, van Rie A. (2008) “The Effects of Provision of HIV care on

Neurodevelopment of Preschool children. AIDS Conference, Mexico City, 2008 Hoffman IF, Martinson FEA, Fiscus SA, Sohoni P, Komoltri C*, Chilangozi DA, Kazembe PN,

Stewart PW, and Cohen MS. (2007) “Factors Affecting the Detection of HIV-1 RNA in Breast Milk.” 14th Conference on Retrovirus and Opportunistic Infections (CROI), Los Angeles, CA, February 25-28, 2007.

Sigounas D, Stewart PW, Samer E, Bullitt E, Kilpatrick M, Ewend (2007) "A New Measurement

Criterion For Volumetric Evaluation Of Metastatic Brain Tumors”. Presented to the Society of Neuro-Oncology, Dallas, Texas, November 15-18, 2007.

Pilcher C, Tien H-C, Stewart PW, Vernazza P, Chakraborty H, Eron J Jr, Cohen M (2007).

“Estimating Transmission Probabilities over Time in Acute HIV Infection from Biological Data” 14th Conference on Retrovirus and Opportunistic Infections (CROI), Los Angeles, CA, Feb 25-28, 2007.

Dumond JB, Yeh RF, Patterson KB, Corbett AH, Jung BH, Rezk NL, Bridges AS, Stewart PW,

Cohen MS, Kashuba ADM (2007). Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxis. 14th Conference on Retrovirus and Opportunistic Infections (CROI), Los Angeles, CA, February 25-28, 2007.

Fiscus SA, Cachafeiro A, Stewart PW, Napravnik S, Frank I, Eron J Jr, and the AACTG NWCS 227

Team (2007). “Cavidi Exavir Viral Load and Phenotype Assays” 14th Conference on Retrovirus and Opportunistic Infections (CROI), Los Angeles, CA, February 25-28, 2007.

Hoffman IF, Martinson FEA, Fiscus SA, Sohoni P, Komoltri C, Chilangozi DA, Kazembe PN,

Stewart PW, and Cohen MS. (2007) “Factors Affecting the Detection of HIV-1 RNA in Breast Milk.” 14th Conference on Retrovirus and Opportunistic Infections (CROI), Los Angeles, CA, February 25-28, 2007.

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Fiscus SA, Cachafeiro A, Stewart PW, Napravnik S, Frank I, Eron J Jr, and the Adult ACTG

NWCS 227 Team. (2006). Cavidi Exavir Viral Load and Phenotype Assays. Presented at the 13th Annual Conference on Retroviruses and Opportunistic Infections.

Pilcher C, Tien H-C, Stewart PW, Vernazza P, Chakraborty H, Eron JJ Jr, Cohen MS. (2006)

Estimating Transmission Probabilities over Time in Acute HIV Infection from Biological Data. Presented at the 13th Annual Conference on Retroviruses and Opportunistic Infections.

Hoffman I, Martinson FEA, Fiscus SA, Sohoni C, Komoltri C, Chilangozi DA, Kazembe PN,

Stewart PW, Cohen MS. (2006). Factors Affecting the Detection of HIV-1 RNA in Breast Milk. Presented at the 13th Annual Conference on Retroviruses and Opportunistic Infections.

Paine MF, Ludington SS, Chen ML, Stewart PW, Huang SM, Watkins PB (2005). Does sex

influence proximal small intestinal cyp3a or p-gp expression? Presented at the ASCPT meetings March, 2005.

Paine MF, Ludington SS, Chen ML, Stewart PW, Huang SM, Watkins PB (2005). Does sex

influence proximal small intestinal cyp3a or p-gp expression? Presented at the FDA Science Forum, April 2005.

McDonnell WF, Stewart PW, Smith MV (2003). A Dynamic Nonlinear Model of Ozone-Induced

FEV1 Response Under Changing Exposure Conditions. Presented at the 99th Conference of the American Thoracic Society, Seattle, May 21, 2003.

Moe CL, Stewart PW, Savitz D, Koltai D, Loomis D, Hutton S, Bell P (2003). NC Study of

Estuaries and Rivers and Cohort Health (NC SEARCH): Preliminary Results. Presented to CDC, Wilmington, NC, October 31, 2003.

Stewart PW, Moe CL, Savitz D, Koltai D, Loomis D, Hutton S, Bell P (2003). NC Study of

Estuaries and Rivers and Cohort Health (NC SEARCH): Statistical Methods and Preliminary Results. Presented to CDC, Atlanta, GA, January 29, 2003.

Stewart PW, Moe CL, Savitz D, Koltai D, Loomis D, Hutton S, Bell P (2003). NC Study of

Estuaries and Rivers and Cohort Health (NC SEARCH): Illustrated Methods and Plans for Statistical Analysis of Study Data. Presented to CDC, Richmond, VA, April 16, 2003.

Pilcher CD, Tien HC, Stewart PW, Vernazza PL, Cohen MS. (2002) Estimating Transmission

Probabilities over Time in Acute HIV Infection from Biological Data. (CFAR-supported). Abstract 366-M. Presented at the 9th Conference on Retroviruses and Opportunistic Infections, Seattle, Feb 24-28, 2002.

Pilcher CD, Tien HC, Vernazza P, Stewart PW, Chakraborty H, Eron J, Cohen M (2002). Semen

Viral Dynamics In Acute HIV Infection: Implications for Sexual Transmission. (CFAR-supported). Abstract 367-M. Presented at XIV International Conference on AIDS

Lindesmith L, Moe CL, Stewart PW, Baric RS (2001) “Evidence of Protective Mucosal Immune

Response to NV Infection.” (Acknowledged student, Lauren Lindblad.) Presented at a symposium of the US EPA, RTP, NC. July 2001.

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Jere CS, Hoffman I, Stewart PW, Kilaru R, Broadhead RL, Molyneux ME, Hart CA, Cunliffe NA, and Fiscus SA. (2000) “HIV Viral Loads in HIV Infected Malawian infants Co-infected with Rotavirus.” (CFAR-supported.) XIII International AIDS Conference, Durban, S. Africa, July 2000.

Hoffman IF, Martinson FEA, Fiscus SA, Sohoni P, Komoltri C, Chilongozi DA, Kazembe PN,

Stewart PW, Cohen MS (2000) “Factors Affecting the Detection of HIV RNA in Breast Milk.” (CFAR-supported) XIII International AIDS Conference, Durban S. Africa, July 2000.

Stephenson B, Wohl D, Kiziah N, et al. (2000) “Release from Prison is Associated with Increased HIV RNA at Time of Reincarceration”, XIII International AIDS Conference, Durban, South Africa, July 2000.(Acknowledgements to CFAR Bios Core support.) McDonnell WF with Stewart PW, Smith M, Pan W (2000) "Ambient Ozone: Development of

Exposure-Response Models for the Acute Respiratory Effects of Inhaled Irritants in Humans: Effects of Concentration, Minute Ventilation, and Duration” invited paper at U.S. EPA Symposium, “Indictators of Health and Ecological Risk Assessment” June 2000, RTP, NC.

Moe C, Stewart PW (2000), “Nonlinear Mixed-Effects Models for Norwalk Virus Dose Response” Presented at the W.H.O. Workshop on Hazard Characterization of Pathogens in Food and Water, June 2000, Bilthoven, Netherlands. McDonnell WF, Stewart PW (1999). “Exposure-response modeling of ozone-induced FEV1 changes in humans: Effects of concentration, duration, minute ventilation, & age.” Presented at Workshop on Quality Assurance of Environmental Models; Sponsored by National Center for Statistics and the Environment (NRCSE) and by the U.S.E.P.A.” Seattle, September 7-10, 1999. Davenport ML, Punyasavatsut N, Gunther D, Savendahl L, Stewart PW (1999) “Turner syndrome: a pattern of early growth failure.” Presented at Endocrinology Workshop sponsored by Pharmacia & UpJohn, Nice, France, April 15, 1999. Fiscus SA, Hoffman IF, Stewart PW, Kilaru R, Broadhead RL, Molyneux ME, Hart CA, and Cunliffe NA. (1999) HIV viral loads in HIV-infected Malawian infants co-infected with rotavirus. 2nd Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants, Montreal, Canada, September 1999. Kris-Etherton PM, Stewart PW, for the DELTA Investigators (1998), "Prediction Equations for Hemostatic Factors." Presented at April '98 Meeting of the Fed. of Am. Societies of Exper. Biology. (FASEB) DuFort V, Kotch J, Stewart PW, Harb M, McMurray M (1998), “Are home-care children different from out-of-home care children?” Presented to the 4th World Conference on Injury Prevention & Control, Amsterdam. Moe C, Stewart PW, Harb M (1998), “Norwalk Virus Dose Response” Presented to the U.S. Environmental Protection Agency, RTP, NC. Davenport M, Punyasavatsut N, Stewart PW, (1998), “Growth in Infancy and Childhood in Turner’s Syndrome: New Growth Charts” Presented at the Endocrine Society Conference, June 1998. Kotch JB, Fieberg J, Brennan M, Dufort V, McMurray M, Stewart PW (1996), “Injuries

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Among Children In Home And Out-Of-Home Care” Presented at the National Head Start Research Conference, Washington, DC. McDonnell B, Stewart PW, Smith M, (1995), "Respiratory Response to Varying Levels of Ozone as a Function of Minute Ventilation Rate". Presented at May'95 Meetings of the American Thoracic Society. Abstract published in Proceedings of the ATS, (1995). Henry MM, Stewart PW, Henderson FW, (1994), "Longitudinal study of, allergy, wheezing illnesses, and lung function in a population of children in Raleigh, NC." Presented at May'94 Meetings of the American Thoracic Society. Margolis MQ, Hunt RJ, Vann WF, Stewart PW (1993), "Caries Risk Assessment in Primary Teeth of First Grade Children", (Masters' Thesis), Presented at Mar.'93 Meetings of International Association of Dental Research. Stamm JW, Stewart PW (1992). "Risk Factor Models for Caries Prediction." Presented at Jul.'92 International Conference on Oral Biology, Edinburgh, Scotland. Stamm JW, Disney JA, Beck JD, Weintraub JA, Stewart PW (1991), "Caries Risk Assessment for Children According to Prior Caries Experience." Presented at Jun.'91 Conference on Cariology For the Nineties, Rochester, NY. Weintraub JA, Kaste LM, Beck JD, Stewart PW, Abernathy J, Disney JA (1991), "Caries Risk Assessment for Children According to Prior Caries Experience." Presented at Jul.'91 Meetings of International Association of Dental Research, Stamm JW, Stewart PW, Bohannan HM, Disney JA, Graves RC, Abernathy JR (1990), "Risk Assessment for Oral Disease." Presented at Prevention Revisited: A Special Symposium, Seventy-Fifth Anniversary Celebration, Eastman Dental Center, Rochester, NY; Sep.'90. Scruggs RR, Stewart PW, Samuels MS, Stamm JW (1990), "Attitudinal assessment of students with curriculum changes." Presented at '89 Meeting of American Association of Dental Schools, New Orleans. Scruggs RR, Stewart PW, Samuels MS, Stamm JW, (1989), "Clinical evaluation of six anti-calculus dentifrice formulations." Presented at Mar.'89 Meetings of International Association of Dental Research. Piazza FM, Henry MM, Muelenaer AA, Ivins SS, Stewart PW, Henderson FW, Voter KZ, Strope GL (1988), "Wheezing associated lower respiratory illness in early childhood and later lung function in non-asthmatic black children". Presented at May'88 Meetings of the American Thoracic Society. Muelenaer AA, Henry MM, Piazza FM, Ivins SS, Stewart PW, Henderson FW, Voter KZ, Strope GL (1988), "Bronchial responsiveness to isoetharine and methacholine in healthy, non-asthmatic black children". Presented at May'88 Meetings of the American Thoracic Society.

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8.3 Presentations with Acknowledgement: the NIH DELTA Study (Dr. Stewart designed the analysis strategy and co-authored the abstracts, papers, &

presentations.) Kris-Etherton PM, for the DELTA Investigators* (1996), "Cholesterol Lowering Diet Effects on Biologic Covariation Among Plasma Total Cholesterol, Triglyceride, & Factor VIIc Levels." Presented at Apr.'97 Meeting of the Fed. of Am. Societies of Exper. Biology. Dennis BH, for the DELTA Investigators* (1996), "Diet Design for Multicenter Studies of Diet and Lipoproteins in Humans." Presented at Nov.'96 Meeting of the American Heart Association. Berglund L, for the DELTA Investigators* (1996), "HDL Subclass Pattern During Reduction of Dietary Saturated Fatty Acids in Healthy Subjects." Presented at Nov.'96 Meeting of the American Heart Association. Ershow A, for the DELTA Investigators* (1996), "Dietary Effects on Lipoproteins and Thrombogenic Activity in Subjects with Markers for Insulin Resistance (DELTA2): Study Design and Recruitment." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Phillips K, for the DELTA Investigators* (1996), "Diet Composition Validation and Monitoring as Part of a Multicenter Clinical Feeding Trial of Step 1, High Mono-Unsaturated Fat, and Average American Diets." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Kris-Etherton PM, for the DELTA Investigators* (1996), "Effects of Replacing Saturated Fat (SFA) with Mono-Unsaturated Fat (MUFA) or Carbohydrate (CHO) on Plasma Lipids and Lipoproteins in Individuals with Markers for Insulin Resistance." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Elmer PT, for the DELTA Investigators* (1996), "Effects of a Step1 Diet and a High Mono-Unsaturated (MUFA) Fat Diet on Hemostatic Factors in Individuals with Markers for Insulin Resistance." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Lefevre M, for the DELTA Investigators* (1996), "Do ApoB & ApoA-IV Polymorphisms Affect Lipid Response to Reductions in Dietary Saturated Fat in Humans." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Ginsberg HN, for the DELTA Investigators* (1996), "Step1 Diet and a High Mono-Unsaturated Fat-Modified Step1 Diet Have Equal [or Similar] Effects on Post-Prandial Lipids and Glucose Levels in Patients with Markers for Insulin Resistance." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Berglund L, for the DELTA Investigators* (1996), "Variation of HDL Subclass Pattern During Dietary Intervention in Subjects with Markers for Insulin Resistance." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Reed RG, for the DELTA Investigators* (1996), "Cyclic Variability of Plasma Lipids,

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Lipoproteins, and Thrombogenic Factors in Premenopausal Women." Presented at Apr.'96 Meeting of the Fed. of Am. Societies of Exper. Biology. Reed RG, for the DELTA Investigators* (1995), "Variance in Serum Lipids and Lipoproteins with Menstrual Cycle in Premenopausal Women." Presented at May'95 Meetings of the American Association for Clinical Chemistry. Abstract published in Clin. Chem. 41, S136 (1995). Reed RG, for the DELTA Investigators* (1995), "Variance in Lipids & Lipoproteins With Menstrual Cycle in Premenopausal Women Is No Greater Than Variance in Postmenopausal Women or Men". Presented at Mar.'95 Confer. on Cardiovascular Disease Epidemiology & Prevention. Abstract published in Circulation 91, 923 (1995). Reed RG, for the DELTA Investigators* (1995), "Dietary Fat in Women: Do Effects on Lipids Vary with Menstrual Status?" Presented at Apr.'95 Meetings of the Fed. of Am. Societies of Exper. Biology. Abstract published in the FASEB Journal 9, A290 (1995). Elmer PT, for the DELTA Investigators* (1995), "Dietary Effects on Lipoproteins & Thrombogenic Activity: Effects of Reducing Dietary Total & Saturated Fats on Hemostatic Factors" Presented at Apr.'95 Meeting of the Fed. of Am. Societies of Exper. Biology. Ginsberg HN, for the DELTA Investigators* (1995), "Diet Effects on Lipids & Thrombogenic Activity: Effects of Reducing Dietary Total & Saturated Fat on Plasma Lipids and Lipoproteins", Presented at Apr.'95 Meeting of the Fed. of Am. Societies of Exper. Biology. Lefevre M, for the DELTA Investigators* (1995), "Relationship Between ApoE Genotype and Lipid Response to Dietary Saturated Fat", Presented at Apr.'95 Meeting of the Fed. of Am. Societies of Exper. Biology. Ershow A, for the DELTA Investigators* (1995), "Dietary Effects on Lipoproteins and Thrombogenic Activity: Rationale and Design", Presented at Apr.'95 Meeting of the Fed. of Am. Societies of Exper. Biology. NIH / NCBI “MyBibliography” Complete List of Published Work in MyBibliography

http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/40409685/?sort=date&direction=ascending

http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/40409685/?sort=date&direction=ascending

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Teaching Experience Dr. Stewart maintains a teaching portfolio that is available upon request. It addresses the following

three components of his experience in teaching. 1. The Process – How, When, and Where One Teaches 2. The Content – Peer Review of What One Teaches 3. The Outcomes – The Effects of Teaching on the Student 1. Supervision and Training of Graduate Student Assistants Dr. Stewart's teaching experience has been in a variety of settings including the School of Public

Health. Most of his experience teaching students of biostatistics has occurred in the process of training and supervising the many students who have worked with him on collaborative biomedical research projects as “graduate research assistants” (GRAs).

He has supervised and trained more than 40 GRAs. This teaching opportunity has involved

thousands of hours of direct, practical training and instruction in statistical methods, research strategy, database management, statistical computing, consulting skills, and scientific writing.

Dr. Stewart has also supervised the required practical consulting experiences of 18 students in the

UNC Biostatistics Department. Dr. Stewart’s research projects involving GRAs usually result in co-authorships for both Dr.

Stewart and the GRA. In other cases, Dr. Stewart has provided oversight on “solo” collaborations of the GRA which resulted in publications such as this one for Dr. Tsui-Shan Lu while a graduate student:

Engmann C, Adanub R, Lu T-S, Bose C, Lozoff B (2008). Anemia and iron deficiencyin pregnant Ghanaian women from urban areas, International Journal of Gynecology and Obstetrics, 101(1):62-66. 2. Biostatistics Courses in the Classroom In the classroom Dr. Stewart has also provided hundreds of student credit hours of instruction. Dr. Stewart is currently teaching BIOS 841 “Principles of Statistical Consulting” during 2014, 2015, 2016, 2017, 2018, 2019, 2020. For ten semesters (1987-1997) he taught BIOS 263 “Advanced Theory of Linear Models” and

produced the following text book: Muller KE, Stewart PW (2006) Linear Model Theory: Univariate, Multivariate, and Mixed Models, Wiley Interscience, NY. 410 pages. He also taught BIOS 267, BIOS 107, BIOS 108, and guest lectures in other biostatistics

courses.

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3. Guest Lectures, Conference Presentations, Seminars In addition to conference presentations, Dr. Stewart has provided guest lectures, tutorials, and

seminars to groups and clients in the Schools of Medicine, Dentistry, Pharmacy, and Public Health and to other groups apart from the UNC system.

4. Teaching During Consultation and Collaboration with Biomedical Investigators Last, but certainly not least, statistical consultation is rich in teaching opportunities. Consultation

with biomedical investigators involves clarification of fundamental statistical concepts, tutorial explications, and dissemination of methods innovations. Collaboration is a two-way learning (teaching) experience.

These face-to-face teaching opportunities are especially important for improving the quality of research undertaken by investigators who are junior faculty.

5. Direction of Dissertation and Master’s Thesis Research Dr. Stewart has directed the thesis research of students of biostatistics and has served as an active member of thesis committees. 5.1 Doctoral Research Directed Jipcy Amador 2018, “High Dimensional Causal Inference” (UNC-CH Biostatistics Dept.) Jamie Powers 2011, “ROC Generalized Linear Model Methods for Longitudinal Analysis of Psychiatric Pharmaceutical Clinical Trials” with Dr. John Preisser, in progress. (Quintiles, Inc.) Steven Enck 2009, “Latent Class Hierarchical Linear Models for Multivariate Longitudinal Data” (SAS Institute) George Demuth 2005, “Purposeful Censoring in Longitudinal Study Designs” (Founding CEO of StatTech Inc.) Dubois Bowman 2000, “Mixed Model Methods for Non-ignorably Missing Data". with Dr. P. K. Sen. (Emory U., Biostatistics Dept.) Penny Pekow 1991, “The Analysis of Tracking in Longitudinal Data.” (U. Conn., Biostatistics Dept.) 5.2 Doctoral Research Committee Member Bradley Saul 2018, “Applications of and Tools for Causal Inference” (UNC, Biostatistics) Paula Strassle 2018, “Non-device-associated hospital-acquired infections” (UNC, Epidemiology)

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Izna Ali 2018, “Impact of Genetics, Medications, and Liver Disease on the Function of Hepatic Efflux Transporters” (UNC, School of Pharmacy) Ashley Buchanan 2014, “Causal Inference in HIV/AIDS Research: Generalizability and Applications ” (Harvard U, Biostatistics) Annie-Green Howard 2012, “Missing Data in Non-parametric Tests of Correlated Data with One Covariate of Interest” (UNC-CH, Biostatistics) Aaron M. Kipp 2009, “Social Stigma and the New Tuberculosis” (Vanderbilt U., Epidemiology) Sean Simpson 2008, “General Linear Models with Generalized AR(1) Covariance Structure for Longitudinal and Spatial Data” (Wake Forest U., Biostatistics) Anita Abraham 2008, “Model Selection Methods in the Linear Mixed Model for Longitudinal Data “ (US FDA, Biostatistics) Hae-Young Kim 2007, “Operating characteristics of group testing algorithms for case identification in the presence of test error” (NERI, Biostatistics) Jean Orelien 2007, “Assessing Goodness-of-Fit in the Linear Mixed Model” (CEO of Scimetrika, Inc.) David Rosen 2007, “Factors Associated with Voluntary HIV Testing and Serostatus Among North Carolina State Prisoners” (UNC Epid. Dept. and UNC School of Med.) Matt Gurka 2004, “The Box-Cox Transformation in the General Linear Mixed Model for Longitudinal Data” (U. Virginia, Biostatistics) Michael Jiroutek 2002, “Exact Coverage & Sample Size of a Linear Model for an for an Internal Pilot Design (final oral exam 08/16/02) (Salix Pharmaceuticals, Inc.) Chris Coffee 2000, “Internal Pilot Study Design and Analysis” (U. Alabama, Birmingham, Biostatistics) Laura Helms 2000, “Multiple Imputation in Clinical Trials” (CEO of Rho, Inc.) Jim MacDougal 2000, "Non-Parametric Models for Multivariate Longitudinal Data" (new england pharmaceutical industry) Lynnette Keyes 1999, “Linear Mixed-Effects Models”

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(UNC, FPG Center Biostatistics) Diane Catellier 1998, “GLMM Methods of Missing Data". (UNC, Biostatistics) Solange Andreoni 1997, "Repeated Measurements on Diagnostic Variables in Multi-Visit Clinical Studies." (Universidade Federal de São Paulo) Jin-Whan Jung 1997,“Multivariate Methods for Measures of Association for Quantifying Variation Among Two or More Groups in Longitudinal or Crossover Studies.” (SAS Institute) Szu-Yun Leu 1996, "Informative Censoring in Non-linear Models". (UC-SD, Biostatistics) John Preisser 1995, “Robust Multivariate Regression for Discrete and Continuous Outcomes." (UNC Biostatistics) Yi-Hsin Connie Yang 1996, "Interim Analysis for Continuous Repeated Measurements". (Statistics Director, KMU Hospital, Taiwan ) Cheryl A. Roe 1996, "ML Estimation and Testing in Small Samples for Repeated Covariate Linear Models with Missing Data." Deborah Glueck 1996,"Power Analysis for Designs with Fixed and Random Predictors." (U. Colorado, Denver, Biostatistics ) Bob Lyles 1996, "Statistical Methods for Environmental Exposure Data." (Emory U., Biostatistics) Suzy Eberling 1994, "Preschool Dental Treatment & Risk of Future Caries” (Dentist and Epidemiologist with Bristol Bay Area Health Corporation Dillingham, AK) Scott Hamilton 1994, "Partially Linear Nonparametric Smoothing." (CEO of Biometrics and Randomization Technologies) Glenn Davies 1994, "Survey Sampling Methods in Dental Research." Anne R. Meibohm 1993, “Analysis of Survival with Imputed Covariate Data." Emilia Sakurai 1993, "Simultaneous Nonparametric Tests for 2-Way Layouts" Fraser Smith 1993, "Mixed Model Analysis of Censored Normal Distributions." (US FDA, Biostatistics) James Grady 1993, "Structured Covariance Matrices for Incomplete Longitudinal Data." (U. Conn., Biostatistics)

Paul W. Stewart

May 25, 2020

Claudine Legault 1991, “Comparison of Sequential Methods for Clinical Trials.” (Wake Forest U., Biostatistics) Susan Hillis 1991, “Effects of daycare on the children of Sincelejo, Colombia.” (Emory U., Epidemiology) Peg Burchinal 1986, “Comparison of growth curve models in application to human developmental functions” (UNC, FPG Center, Biostatistics) Dalton Andrade 1985, “MLE and Likelihood Ratio Tests in the Multivariate Normal Distribution with Incomplete Data and Patterned Mean and Covariance Matrix” (Universidade Federal do Ceara , Brazil) 5.3 Master’s Research Directed Amaanti Sridhar 2017, Masters Paper on “Regularization via Feature Filtering: PC, PLS, Ridge, and Lasso regression methods” Reader only. (UNC Biostatistics Department) Meichen Dong 2016, Masters Paper on “Randomized Clinical Trials Subject to Patients Switching Treatment Regimens at Baseline” (UNC Biostatistics Department) Jieni Xu 2015, “Power Analysis of Study Designs in Environmental Studies” Reader only. (UNC Biostatistics) Lauren Lindblad 2002, “Statistical Models for Longitudinal Analysis of Menstrual Cycle Variation in Hormones, Lipids, Lipoproteins, and Hemostatic Factors in a Three-Diet Crossover Study” (Duke U., DCRI Biostatistics) Mike Despirito 2002, “Nonlinear Models Establishing Standard Growth Curve Charts for Girls with Turners Syndrome. (StatTech Services) Rakhi Kilaru 2000, “Application of the EM Algorithm to Left Censored Bivariate Normal Data” (Duke U., DCRI Biostatistics) Michelle Harb 1999, "Comparison of Model-Based Analysis Methods in an Exposure-Response Study of Norwalk Virus Infection”. (Rho, Inc., Biostatistics ) Tonya Stancil 1996, "Pediatric Respiratory Illness History: Concordance Between Parental Report and Medical Chart Review". 5.4 Statistical Mentoring of Doris Duke Foundation Fellows in the UNC GCRC / CTRC (Selected third-year medical students nation-wide) 2001 Lisa Schweigler, Peter Farkas, Ray Givens

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2002 Kelly Fogelman, Julie Dombrowski, Christie Kistler, Jackson Hamilton, Neeta Ventepalli 2003 Anup Parikh, Raval Mehul, Kate Lawrence, David Edwards, Medina Miguel 2004 Scott Cameron, Maren Show, Leeza Park, Scott Genshaft, Arun Aneja, Victor Lai, Sheela Agarwal, Kris Gunn 2005 Michelle McCrain, Luke Richey, Jonathan George, Margaret Kosnar, Erik Kouba, Michelle Kiser 2006 Dimitri Sigounas, Sara Schultz, Sara Peterson, Emmanuel Thomas, Brian Alder, Farhad Ardeshirpour, JaVar Mayatt-Jones, Jessica Wiser, Kamal Kolappa 2007 Jackie Dosal, Andrea Tsai, Anjana Lal, Ethan Munzinger, Michael Hudson, Niyati Mukherjee, Sarah Graboski, Than-Thu Tran 2008 Ahmed Zihini, Alan Woodruff, Chloe Hill, Ermias Abebe, Raj Kurpad

Paul W. Stewart

May 25, 2020

Contracts and Grants 1. Overview of Collaborative Research 2014-present Co-Investigator and Biostatistician. HCV-PRIORITIZE Multi-Center Multi-Arm Randomized Clinical Trial of Treatment Regimens for Hepatitis C Virus.* University of Florida and UNC-CH School of Medicine 2014-present Co-Investigator and Biostatistician. HCV-PROP_UP Multi-Center Observational and Studies of Patient-

Reported Outcomes During Treatment for Hepatitis C Virus.* UNC-CH School of Medicine 2011-present Co-Investigator and Biostatistician. HCV-TARGET Multi-Center Registry and Studies of Treatments for Hepatitis C Virus.* UNC-CH School of Medicine and HCV-TARGET Consortium 2008-present Co-Investigator and Biostatistician. Biostatistics Core* of NC TraCS Institute and CTSA Initiative. UNC-CH Biostatistics Department and the UNC-CH School of Medicine 2009-2016 Co-Investigator and Biostatistician. Ex-vivo Perfusion and Ventilation of Lungs from Non-Heart-Beating Donors to Assess Transplant Suitability.* UNC School of Medicine and Duke University School of Medicine 2008-2014 Co-Investigator and Biostatistician. Study of CYP3A Activity Measures. UNC School of Pharmacy. 2007-2012 Co-Investigator and Biostatistician. Study of CYP2B6 Genotype and Phenotype UNC School of Pharmacy. 2011-2013 Co-Investigator and Biostatistician. Vital Signs in the Elderly: Predictive Value of Triage in the Emergency Dept UNC School of Medicine 2008-2012 Co-Investigator and Biostatistician. Randomized Clinical Trial of Cantharidin vs. Placebo for Treatment of Molluscum Contagiosum in Pediatric Practice. UNC School of Medicine (* provides support for graduate research assistants)

Paul W. Stewart

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1997-2008 Director of GCRC Biostatistics Core and Mentor in K12/K30 Program, General Clinical Research Center (GCRC)* UNC School of Medicine. 1998-2008 Director of CFAR Biostatistics Core, UNC Center for AIDS Research (CFAR)* 1999-2011 Co-Investigator and Biostatistician, Adult Pulmonary Ozone Studies of Exposure-Response. US-EPA, RTP, NC. 2001-2008 Co-Investigator and Biostatistician, Study of Pulmonary Inflammation in Cystic Fibrosis, UNC Department Pediatrics. 1999-2008 Co-Investigator and Biostatistician, Intervention to Improve Patient Compliance* UNC CFAR 1996-2006 Co-Investigator and Biostatistician, Longitudinal NC SEARCH Project* A prospective cohort study of estuary-associated syndrome in NC. CDC, NC, and UNC Department of Epidemiology. 2001-2006 Co-Investigator and Biostatistician, Gender, Nicotine and Stress-Induced Analgesia, UNC Department of

Psychiatry.

1998-2007 Co-Investigator and Biostatistician, Study of Choline as an Essential Dietary Nutrient, UNC Department of Nutrition. 2002-2003 Co-Investigator and Biostatistician, Study of Inflammatory Bowel Disease, UNC Department of Medicine. 2001-2003 Co-Investigator and Biostatistician, Cytomegalovirus in HIV Patients* CFAR and UNC School of Medicine. 2002-2003 Co-Investigator and Biostatistician, Modeling Acute HIV Dynamics* CFAR and UNC School of Medicine. 1996-2002 Co-Investigator and Biostatistician, US-EPA Norwalk Virus Study of Exposure-Response. UNC Departments of Biostatistics and Epidemiology. 1999-2003 Consulting Biostatistician, Center for Inflammatory Disease, UNC School of Dentistry. (* provides support for graduate research assistants)

Paul W. Stewart

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2000-2003 Consulting Biostatistician, Department of Orthodontics, UNC School of Dentistry. 1996-2003 Principal Investigator, Coordinating Center of NHLBI DELTA Program. Randomized multicenter collaborative trials for effects of experimental isocaloric diets on lipids, lipoproteins, and hemostatic factors. UNC Biostatistics Department. 1992-1999 Principal Investigator, Adult Pulmonary Ozone Studies of Exposure-Response.* US-EPA air quality research funded via UNC Cooperative Agreement. UNC Departments of Epidemiology and Biostatistics. 1997-2000 Consulting Biostatistician, UNC Thurston Arthritis Research Center (TARC). * 1996-1998 Principle Investigator of subcontract, Penn. State Univ., Chocolate Manufacturers Association Study* UNC Biostatistics Department. 1997-1999 Principal Investigator, Coordinating Center for the ACTA Study in the TARC.* Randomized multicenter collaborative trial comparing Arthrotec and Acetaminophine in arthritis patients. (Searle, Inc.) 1990-1997 Investigator, The Long-Scan Study* A Longitudinal Study of Risk of Abuse / Neglect. UNC Department Maternal & Child Health. 1993-1997 Co-Principal Investigator, Longitudinal Study of Injuries Among Children During Daycare.* UNC Department of Maternal & Child Health. 1992-1997 Co-Investigator, Biometry Core of NHLBI Duke-UNC Sickle Cell Center.* UNC Department of Biostatistics. 1992-1996 Co-Principal Investigator, Coordinating Center of NHLBI DELTA Program.* UNC Department of Biostatistics. 1986-1995 Biostatistician, Dental Research Center, UNC Department of Dental Ecology. (* provides support for graduate research assistants)

Paul W. Stewart

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1986-1993 Investigator, NIDR Caries Risk Assessment Study.* UNC Department of Dental Ecology. 1992-1994 Co-Principal Investigator, NHLBI-UNC Study of Pediatric Lung Function, Viral Illness, Allergy, Environmental Tobacco Smoke in African-American Girls. * UNC Frank Porter Graham Child Development Research Center. 1992-1993 Consulting Statistician, CSCC- NHLBI "Study of Left Ventricular Dysfunction" (SOLVD). * UNC Biostatistics Department. 1982-1991 Co-Investigator and Director of Biostatistics Unit, Biometry Core of the NHLBI-UNC Pediatric Pulmonary SCOR. * UNC Departments of Biostatistics Department and Pediatrics. 1982-1991 Co-Investigator on Multiple Projects, NHLBI-UNC Pediatric Pulmonary SCOR. * Longitudinal Studies of Lung Function and Respiratory Illness. UNC Departments of Biostatistics and Pediatrics. 1982-1982 Investigator on NHLBI Lipid Research Clinics (LRC) Program, Biostatistics Department, School of Public Health, The University of North Carolina, Chapel Hill. (* provides support for graduate research assistants)

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3. Research Grants Project Title HCV-PRIORITIZE Description Multi-Center Multi-Arm Randomized Clinical Trial of Treatment Regimens for Hepatitis C Virus. Prin. Investigator David Nelson Role of PW Stewart Chief Biostatistician Graduate Assistants Amaanti Sridhar Funded 2016-present Funding Agency PCORI Award 25% effort for biostatistics collaboration Project Title HCV-PROP-UP Description Multi-Center Observational Study of Patient-Reported Outcomes Before,

During, and After Treatment for Hepatitis C Virus. Prin. Investigator Donna Evon Role of PW Stewart Chief Biostatistician Graduate Assistants Jipcy Amador Sulbaran Funded 2016-present Funding Agency PCORI Award 20% effort for biostatistics collaboration Project Title HCV-TARGET Description Multi-Center Registry and Studies of Treatments for Hepatitis C Virus. Prin. Investigator Michael Fried Role of PW Stewart Chief Biostatistician Graduate Assistants Tom Stewart and Meichen Dong Funded 2012-present Funding Agency Industry consortium Award 15% effort for biostatistics collaboration Project Title NC TraCS Biostatistics Core Description Clinical and Translational Science Award (CTSA). Prin. Investigator Michael Kosorok, UNC Biostatistics Dept. Role of PW Stewart Biostatistician for “Collaboration”, “Methods Research”, “Training” Graduate Assistants Ja-An Lin, Thomas Stewart, Meichen Dong, and others Funded 19 May 2008 − present Fun ding Agency NIH Award NIH and UNC support for CTSA Initiative Project Title More And Better Lungs: Ex-Vivo Perfusion of Lungs from Non-Heart-Beating Donors Description NIH GO Grant. Prin. Investigator Thomas Egan, UNC Department of Surgery Role of PW Stewart Co-Investigator and Biostatistician Graduate Assistants Thomas Stewart Funded 1 September 2013 − 30 June 2016 Funding Agency NIH-NHLBI Award 20% effort for biostatistical collaboration Project Title Ex vivo Perfusion/Ventilation of Lungs to Assess Transplant Suitability

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Description NIH GO Grant. Prin. Investigator Thomas Egan, UNC Department of Surgery Role of PW Stewart Co-Investigator and Biostatistician Graduate Assistants Ja-An Lin Funded 1 January 2010 − 31 December 2012 Funding Agency NIH-NHLBI Award 20% effort for biostatistical collaboration Project Title Evaluation of a Simulation-Based Cardiac Surgery Curriculum Description Evaluation of a simulation-based training curriculum in cardiac surgery Prin. Investigator Richard Feins Role of PW Stewart Co-Investigator and Biostatistician Graduate Assistants Amaanti Sridhar Funded 2015-2016 Funding Agency AHRQ Award 65% effort for biostatistics collaboration Project Title Human Cytochrome P450 4F Enzymes and Drug Interactions Description NIH R01 Prin. Investigator Michael Wang Role of PW Stewart Co-investigator and Biostatistician Graduate Assistants none Funded 6 September 2010 – 30 June 2015 Funding Agency NIH Project Title CFAR Biostatistics Core Description NIH Center for AIDS Research: Core F. Prin. Investigator PW Stewart, UNC Biostatistics Dept. Role of PW Stewart Chief statistician, Director. Other Co-Investigators Francoise Seillier-Moiseiwitsch Graduate Assistants Chula Komoltri, Rakhi Kilaru, Anita Shanker Funded 1 Sep 1998 – 31 Aug 2001, 1 Sep 2001 – 31 Aug 2006, 1 Sep 2006 – 31 Aug 2011. Funding Agency NIH Award Core: $99,130 total per year plus cost recovery fees Project Title GCRC: Biostatistics Unit of UNC General Clinical Research Center Description Biostatistics Core of the UNC GCRC. Prin. Investigator Eugene Orringer, UNC School of Medicine. Role of PW Stewart Director of Biostatistics Core. Consultation / collaboration in design of biomedical research, comparison of competing statistical methods, selection/development of statistical methodology, grant writing, etc. for 156 projects in year 2003. Biostatistics Department liaison. Other Co-Investigators David Weber. Graduate Assistants Steve Cohen, Cathy Jenkins, Szu-Yun Leu. Funded 1 Dec 1997 - 30 Nov 2006, 1 Dec 2007 - 30 Nov 2010 Web verne.med.unc.edu Funding Agency NIH GCRC Program Award Increased from 50%FTE to 110% FTE: 75% of Dr. Stewart + 50% of GRA. Project Title Human Requirements for the Nutrient Choline

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May 25, 2020

Description A longitudinal feeding GCRC-related study in experimental subjects (eating different amounts of choline) with control subjects (eating matched diet) to experimental subjects that has been adjusted to a fixed amount of choline. Prin. Investigator S Zeisel, UNC Nutrition Dept. Chairman Role of PW Stewart Co-investigator and chief statistician. Funded 07/01/2000 - 6/30/2005 Funding Agency NIDDK (1 R01 DK55865-01A2) Award $3,682,329 per five years. Project Title NC Study of Estuary & River Cohort Health (NC-SEARCH) Description Longitudinal study relevant to concerns by CDC, EPA, and NIEHS about Pfiesteria. Involves biostatistical collaboration, design, longitudinal analysis, and publication of methods papers and study results. Prin. Investigator Christine Moe. www.cdc.gov, www.schs.state.nc.us/epi/hab/research.htm Role of PW Stewart Chief Statistician. Other Co_Investigators Dana Loomis, Deborah Koltai-Attix, Steve Hutton, Paula Bell. Graduate Assistants Szu-Yun Leu. Funded 1 Jul 1997 - 30 Jun 2001, plus 4 month extension. Funding Agency CDC & NC DHHS “Harmful Algal Blooms” Program Award 10% support for Dr. Stewart. Project Title Dental Research: UNC Orthodontics Department Description Collaborative project development, grant preparation, consultation, and methodological research in the UNC Orthodontics Department. Prin. Investigator Ceib Phillips, PhD, MPH Role of PW Stewart Trial Statistician. Web ortho.dent.unc.edu/MainUNCPage/orthopro.htm#Research Funded 1/1/2000 - 12/31/2005. Funding Agency NIH - NIDCR Award 5% for Dr. Stewart. Project Title CF BALF Study of Surfactant Proteins and Inflammation: Description GCRC-related collaboration on design, grant application, experimentation, analysis, and publication. Part of a Pulmonary SCORE. Funding Agency NHLBI SCORE Program Prin. Investigator Terry Noah Role of PW Stewart Trial Statistician. Dates 1 Dec 2000 - 31 Nov 2003 Award 9% FTE for Paul Stewart. Project Title Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis: Description GCRC-related collaboration on design, grant application, experimentation, analysis, and publication. Prin. Investigator Scott Donaldson Role of PW Stewart Trial Statistician. Dates 1 Jul 2000 - 30 Jun 2002 Funding Agency Cystic Fibrosis Foundation (CFF) Award 5% FTE for Paul Stewart Project Title Gender, Nicotine and Stress-Induced Analgesia: Description GCRC-related collaboration on design, grant application, experimentation,

Paul W. Stewart

May 25, 2020

analysis, and publication. Prin. Investigator Susan Girdler Role of PW Stewart Trial Statistician. Dates 1 Aug 2001 - 30 Apr 2005 Funding Source NIH-NIDA Award 5% FTE for Paul Stewart Project Title Prediction Equations II: Dietary Effects on Hemostasis & Lipids Description Subcontract from Penn. State Univ. for biostatistical collaboration. Combines data from DELTA 1 & 2, the Dairy Study, and Judd Study. Prin. Investigator PW Stewart, UNC Biostatistics Dept. Role of PW Stewart Chief statistician, co-author. Other Co-Investigators Penny Kris-Etherton, Tom Pearson, et al. Graduate Assistants Chula Komoltri, Burton Levine Dates 1 July 1998 - 31 June 1999 Funding Agency Chocolate Manufacturers Association Award $25,000 total for 1 year. Project Title Prediction Equations I: Dietary Effects on Hemostasis & Lipids Description Subcontract from Penn. State Univ. for biostatistical collaboration. Combines data from DELTA 1 & 2. Prin. Investigator PW Stewart, UNC Biostatistics Dept. Role of PW Stewart Chief statistician, co-author. Other Co-Investigators Penny Kris-Etherton, Tom Pearson, et al. Graduate Assistants Chula Komoltri Dates 1 November 1996 - 31 December 1997 Funding Agency Chocolate Manufacturers Association Award $12,400 total for 1 year. Project Title Norwalk Virus Exposure-Response Description Experimental research relevant to US-EPA water quality standards. Prin. Investigator Christine Moe, UNC Epidemiology Dept. Role of PW Stewart Biostatistician Graduate Assistants Michelle Harb Dates 1 July 1997 - 30 June 1999 Funding Agency U.S Environmental Protection Agency Award $10,000 direct over 2 years for the biostatistical component. Project Title DELTA-I Closeout: Dietary Effect on Lipids and Thrombogenic Activity, Studies of Specific Fatty Acids in the American Diet Description Coordinating Center for Multicenter Clinical Trials Prin. Investigator PW Stewart, UNC Biostatistics Dept. Role of PW Stewart P.I., Author of grant, Chief Statistician. Other Co-Investigators BH Dennis, CW Wang, S Blackwell, CE Davis, JD Hosking, et al. Graduate Assistants Michelle Harb, Burton Levine, Chula Komoltri Dates 1 August 1997 - 30 September 1998 Funding Agency National Heart Lung and Blood Institute Award $112,674 total. Project Title DELTA-II: Dietary Effect on Lipids and Thrombogenic Activity, Studies of Specific Fatty Acids in the American Diet Description Coordinating Center for Multicenter Clinical Trials Prin. Investigator PW Stewart, UNC Biostatistics Dept.

Paul W. Stewart

May 25, 2020

Role of PW Stewart P.I., Author of grant, Chief Statistician. Other Co-Investigators BH Dennis, CW Wang, S Blackwell, CE Davis, JD Hosking, et al. Graduate Assistants Michelle Harb Dates 1 April 1997 - 31 March 2001 Funding Agency National Heart Lung and Blood Institute Requested Award $3,636,902 direct to UNC over 4 years. Note 6.8 percentile priority score awarded by IRG in October 1996. Funding not approved by NHLBI Council in February 1997. Appeal entered February 1997 to NIH Director and the Council. Funding not approved by NHLBI Council in March 1997. Award $112,674 total to UNC for 1 year: 1 Sep. 1997 - 31 Aug. 1998. Project Title DELTA-I: Dietary Effect on Lipids and Thrombogenic Activity, Studies of Nutrient Profile Strategies Description Coordinating Center for Multicenter Clinical Trials Prin. Investigator PW Stewart beginning June 1, 1996; BH Dennis prior to June 1, 1996. Role of PW Stewart Co-author of grant, P.I./Co-PI, Chief Statistician. Other Co-investigators CW Wang, NY Anderson, S Blackwell, CE Davis, JD Hosking, et al. Graduate assistants Szu-Yun Leu, Michelle Harb Dates 1 September 1992 - 31 August 1996 Funding Agency National Heart Lung and Blood Institute Award $2,200,000 direct over 4 years. Project Title Statistical Models & Methods for Ozone Exposure-Response Data Description Pulmonary experimental research relevant to revision of the US-EPA air quality standards. One of several projects in the UNC-EPA Cooperative Agreement. Prin. Investigator PW Stewart, UNC Biostatistics Dept. Role of PW Stewart Author of grant, Chief statistician Other Co-Investigators WR McDonnell, MV Smith Graduate Assistants Solange Andreoni, Elaine B. Hoffman, Paul Rathouz, Jean Pan Dates Renewed annually: 1 July 1992 - 30 June 1997 Funding Agency U.S. Environmental Protection Agency Award $375,000 direct over 5 years. Project Title Combined Behavioral/Pharmacologic Treatment of Alcoholism Project Description Coordinating center for a multicenter clinical trial. Prin. Investigator J Hosking, UNC Biostatistics Dept. Role of PW Stewart Author of the statistical methods section “Appendix C” (16 pages.) Dr. Stewart has chosen not to participate in the study. Other Co-Investigators JC Garbutt, M Youngblood, et al. Dates 1 October 1997 - 31 September 2003 Funding Agency NIAAA Award $3,407,169 direct over 6 years.

Paul W. Stewart

May 25, 2020

Project Title Thurston Arthritis Research Center Description Center, Projects, and Cores for interrelated basic and clinical research. Prin. Investigator John Winfield, UNC School of Medicine. Role of PW Stewart Chief Biostatistician in the Numerical Sciences Core, and Co-Investigator on Clinical Projects; for example, --Numerical Science Core (Blalock), --Self-Management Strategies and Health Outcomes (Callahan), --Johnston County Osteoarthritis Project (Jordan), --Osteoporosis Prevention in Women (Blalock), --Emotional Contagion (DeVellis), --Beta2-Glycoprotein I in Apoptosis (Reap), --Anti-nRNP/Sm Auto-Antibody Spreading Mech. (Satoh), and --Signaling Mech. in Myotendinous Junction Formation (Peng). Graduate Assistants George Luta Dates 1 July 1998 - 30 June 2002 Funding Agency NIH Award $3,770,782 direct over 4 years. Project Title Injuries Among Children in Home and Out-of-Home Care Description Longitudinal study of prospectively documented injuries based on a random sample of families in the research triangle area. Prin. Investigator JB Kotch, UNC MCH Dept. Role of PW Stewart Co-Principal Investigator, Project Statistician Other Co-Investigators Marsha McMurry, Vincent Dufort, et al. Graduate Assistants John Fieberg, Michelle Harb Dates 1 July 1994 - 31 June 1996, with no-cost extensions. Funding Agency Bureau of Maternal & Child Health in the Department of Health and Human Services Award $300,000 direct over two years. Project Title Biometry Core II: Duke-UNC Comprehensive Sickle Cell Center Description Core unit providing professional services in design, analysis, and data management to about 15 projects Prin. Investigator RW Helms, UNC Biostatistics Dept. Role of PW Stewart Co-author of grant, Co-investigator, Statistician on multiple projects Other Co-Investigators MR Burchinal, M Helms Graduate Assistants Elaine B. Hoffman Dates 1 April 1993 - 31 March 1998 Funding Agency National Heart Lung and Blood Institute Award $1,065,000 direct (prior to Gram-Rudman-Hollings budget cuts) Project Title Biometry Core I: Duke-UNC Comprehensive Sickle Cell Center Description Core unit providing professional services in design, analysis, and especially data management to about 15 projects Prin. Investigator RW Helms, UNC Biostatistics Dept. Role of PW Stewart Co-author of proposed design for new Biometry Core, Co-Investigator Other Co-Investigators MR Burchinal, M Helms Graduate Assistants Elaine B. Hoffman Dates 1 April 1991 - 31 March 1992 Funding Agency National Heart Lung and Blood Institute Award $200,000 direct per two years (via rebudgeting to accommodate Core.) Project Title Longitudinal Analysis of Spirometry in Black Children

Paul W. Stewart

May 25, 2020

Description R03 Grant for analysis of existing database using new statistical methods for longitudinal data. Prin. Investigator FW Henderson, UNC Frank Porter Graham Child Development Center Role of PW Stewart Grant (R03) author, chief statistician, co-author Other Co-Investigators MM Henry, E Neebe Graduate Assistants Scott Hamilton Dates 1 April 1992 - 30 June 1994 Funding Agency National Heart Lung and Blood Institute Award $100,000 direct over two years Project Title SCORE Biometry Core: Lung Injury by Childhood Infection Description Providing biomedical research services in UNC Pediatric-Pulmonary Specialized Center of Research (SCOR). Prin. Investigator RW Helms, UNC Biostatistics Dept. Role of PW Stewart Co-investigator & Director of the biostatistics component Other Co-Investigators K Fendt (Director of the data management component), FW Henderson (Director of the epidemiology component) Graduate Assistants L Helms, D Fairclough, K McCarroll, P Pekow Dates 1 December 1986 - 30 November 1991 Funding Agency National Heart Lung and Blood Institute Award $1,318,155 direct over five years Project Title SCOR Project #1: Lung Function, Lower Respiratory Illness, Allergy, and Tobacco Smoke Description UNC Pediatric-Pulmonary Specialized Center of Research (SCOR) Prin. Investigator FW Henderson, UNC Pediatrics Dept. Role of PW Stewart Co-author of grant, Project Statistician Other Co-Investigators MM Henry, MR Burchinal, RW Helms Graduate Assistants CS Kleoudis, L Maxwell, GG Dahiya, A Kenan, G Davis, M Hunt, Lynn Bressler, S McNulty, M Martin, M Abulata, M Chen Dates 1 December 1986 - 30 November 1991 Funding Agency National Heart Lung and Blood Institute Award $550,000 direct over five years Project Title SCOR Project #2: Analysis of Incomplete Longitudinal and Mulitvariate Data Description UNC Pediatric-Pulmonary Specialized Center of Research (SCOR) Prin. Investigator RW Helms, UNC Biostatistics Dept. Role of PW Stewart Co-investigator Graduate Assistants DL Fairclough, J Rochon, K McCarroll, SC Murray Dates 1 December 1986 - 30 November 1991 Funding Agency National Heart Lung and Blood Institute Award $501,500 direct over five years

Paul W. Stewart

May 25, 2020

Project Title Development of Anthropometric Strategies Description New Methods for Defining Patterns of Growth-Failure in Infants Prin. Investigator PW Stewart Co-Investigators JK Whitt, MG Busby, Penny Pekow(GRA) Dates 1 January 1990 - 31 April 1991 Funding Agency The Institute of Nutrition Award $4000 total, seed grant Project Title Developmental Tracking Description New Analysis Methods for Spirometric Performance in Childhood Prin. Investigator PW Stewart Co-Investigators PS Pekow, MR Burchinal , Penny Pekow (GRA) Dates 1 January 1988 - 31 December 1988 Funding Agency FPG Child Development Center Award $5000 total, Innovative Research Awards Program

Paul W. Stewart

May 25, 2020

Service 1. Journal Referee Dr. Stewart has served as a referee of manuscripts submitted to the following journals: Biometrics Technometrics Environmental Statistics Statistics and Computing Statistics in Medicine The American Statistician Communications in Statistics Journal of the American Statistical Association Journal of Dental Research Neurosurgery (an Associate Editor since 2011) Pediatric Pulmonology (an Associate Editor since 1992) American Journal of Respiratory and Critical Care Medicine 2. Department of Biostatistics 2014-present Member Alumni Activities and Social Committee 2014-present Member Biostatistics Faculty Mentoring Committeee 2009-2010 Member Publication Point System Committee 2006-2014 Member Information Technology 2003-2003 Chairman Continuation of Business / Emergency Response 1992-2006 Chairman Information Technology 1991-1993 Chairman Seminar Committee 1990-1991 Member Advisory Committee on Information Technology 1989-1997 Member Seminar Committee 1985-1991 Member Examinations Committee 1985-1986 Member Linear Models Courses Committee (ad hoc) 1982-1992 Member Statistical Computing and Data Management Committee 3. School of Public Health 1996-1996 Member SPH Dean's Committee for Review of Information Technology 1994-1995 Member SPH Dean's Computer & Data Processing Advisory Committee 4. University of North Carolina 2016-present Biostatistician UNC Scientific Review Committee 2009-2016 Biostatistician UNC Scientific Review Subcommittee of the SOM IRB

Committee 2015-present Biostatistician TraCS Institute Committee on Recruitment Liason Services, RICs and TICs 2005-present Biostatistician TraCS Institute Biostatistics Core 4. Service to Professional Societies 2007-2008 Publication Officer of the ASA Section on Statistical Consulting 2002 Founder of the Association of CFAR Statisticians

Paul W. Stewart

May 25, 2020

5. Service as a Consultant TARGET Pharma Solutions: observational studies in liver disease research. Dr. Michael Fried, MD For clinical trials protocols, formulation and writing of sections on study design and analysis plans. Dr. Beth Fetterman, PharmaLink FHI, RTP, NC Pulmonary function, cystic fibrosis, and missing-data methods Dr. S. Hamilton, Genentech, Inc., South San Francisco, CA Clinical trials protocols and sequential methods: hepatic metabolism and liver disease research. Dr. Michael Fried, MD Methods for nonlinear random effects models in meta-analysis of human exposure-response data: derivation, validation and publication of statistical methods for clustered Toluene data. Dr. Vernon Benignus, US EPA, RTP, NC Pulmonary function, brochodilators, and longitudinal methods Drs. J. Ward and I. McCanless, Glaxo, Inc., Research Triangle Park, NC Longitudinal prediction of financial performance, data warehousing, data mining Mr. D. Thomas, Chief Auditor, ITT Sheraton World Headquarters, Boston, MA Oral contraceptives, galactose, heart disease, and crossover designs Dr. E. Bisgrove, Family Health International, RTP, NC Correlates of infant mortality in Africa, and graphical methods Mr. P. Roark, US-AID: WASH Project, Arlington, VA Dentistry and the prediction of caries in children Dr. N. W. Chilton, Task Force on Design and Analysis, Lawrenceville NJ Detection of child abuse, prediction intervals, and tolerance intervals Dr. David Ingram, Wake County Medical Center, Raleigh, NC Growth-curve analysis methodology and algorithms Dr. S. L. Lee, National Institutes of Health, Washington, DC Longitudinal designs, GEE methods, and hair growth cycles Dr. R. Anderson, Harvard U., Boston, MA Longitudinal analysis of infrared laser clinical trials Dr. M. Moore, Palomar Medical Technologies, Boston, MA

Paul W. Stewart

May 25, 2020

6. Computer Software Made Available 2005: IML_CENSAD.SAS: a set of SAS macros derived from a translation of the

CENSAD FORTRAN algorithm for fitting linear mixed-effects models to left censoring longitudinal data. The new code uses SAS / PROC IML.

2000: BIV_EM.SAS: a set of modules for longitudinal analysis of bivariate or trivariate

outcomes that are subject to left-censoring; e.g., censored below a lower limit of detection. 1996: LM_MACRO.SAS: a set of modules for longitudinal analysis of multi-dimensional

responses. Comprises over 12,000 lines of code. 1992: TRACKING.IML: a set of modules for analysis of longitudinal “tracking” analysis

via mixed-model analysis of growth curves (dose-response) curves. The modules include approximately 1000 statements in the SAS PROC IML language; about half are internal documentation.

1990: CPUSERVER: system software allowing users on a local area network to share

remote batch processors. SAS programs and other programs enter a queue and run in batch mode. SAS programs are placed in the queue by simply copying the program file into the network directory named “q:\”. All results appear with the program file in directory “r:\” when the results are ready for review.

1980: LINMOD/GCMPACK: a module for analysis of Dose-Response Curves and Growth

Curves: The current version of the LINMOD software system for the analysis of univariate and multivariate data by general linear models was provided by Keith Muller and was initially developed by R.W. Helms, J.D. Hosking, and D.H. Christiansen with later assistance by K. E. Muller and P. W. Stewart. LINMOD is a software system for the analysis of multivariate and univariate data by general linear models. The LINMOD system originally included 4,500 statements in the SAS / PROC MATRIX language. In 1996 and again in 1997 K.E.Muller translated the code to SAS / PROC IML language and made needed revisions. Drs. Stewart and Muller used LINMOD in BIOS263 and BIOS163 for instruction and discovery. The LINMOD system (including GCMPACK) has been used by several of the National Institutes of Health, by several pharmaceutical companies, and at universities in the U.S., Canada, Brazil, and Chile.

Professional Interests Research, Collaboration, and Teaching Design and Analysis Strategies for Biomedical Research Analysis of Incomplete/Coarsened Longitudinal and Multivariate Data Linear and Nonlinear Statistical Models for Repeated Measures Simultaneous Confidence Regions and Graphical Representations Clinical and Environmental Studies Statistical Computing for Reproducible Analysis Graphical Methods in Statistical Computations for Model Fitting Causal Inference Methods

paul w. stewart - sph.unc.edu...apr 13, 2020 · [email protected] . education 1977-1981 phd...

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