Stephen R Wisniewski

  • Professor and Co-Director, Epidemiology Data Center
  • Vice Provost for Budget and Analytics, Office of the Provost
  • Faculty in Epidemiology

My primary research interests include the design and analysis of clinical trials. Specifically, multi-center clinical trials. I am currently coordinating multi-center trials of traumatic brain injury, psychiatric disorder, pulmonary disorders and trauma induced coagulopathy.


1994 | University of Pittsburgh, Pittsburgh, PA | PhD, Epidemiology
1988 | The Ohio State University, Columbus, Ohio | MAS, Statistics
1987 | The Pennsylvania State University, University Park, PA | BS, Mathematics


My teaching experience in the Department of Epidemiology has focused on epidemiological methods. Over the course of my career I have been the primary instructor or a visiting lecturer for both Epidemiology 2180 (Epidemiology Method 1) and Epidemiology 2230 (Epidemiology Methods 2).

Selected Publications

From over 400 peer-reviewed publications

The Endohthalmitis Vitrectomy Study Group. Results of the Endophthalmitis Vitrectomy Study: A Randomized Trial of Immediate Vitrectomy and of Intravenous Antibiotics for the Treatment of Post-Operative Bacterial Endophthalmitis.Archives of Ophthalmology, 1995; 113: 1479-1946. PMID 9052630


The Endophthalmitis Vitrectomy Study Group. The Endophthalmitis Vitrectomy Study: Microbiologic Factors in Visual Outcome.American Journal of Ophthalmology, 122; 833-855: 1996.PMID 8659579

Marion DW, Penrod LE, Kelsey SF, Obrist WD, Kochanek PM, Palmer AM,Wisniewski SR and DeKosky ST. Improved Outcome After Traumatic Brain Injury with the Use of Moderate Hypothermia.The New England Journal of Medicine, 336; 540-546; 1997. PMID: 9023090

Wisniewski SR, Hammer ME, Grizzard WS, Kelsey SF, Everett D, Packo KH, Yarian DL, Doft BH for the EVS Study Group. An Investigation of the Hospital Charges Related to the Treatment of Endophthalmitis in the Endophthalmitis Vitrectomy Study.Ophthalmology, 1997; 104: 739-745. PMID: 9160017

Wisniewski SR, Capone A, Kelsey SF, Groer-Fitzgerald S, Lambert HM, and Doft BH for the Endophthalmitis Vitrectomy Study. The Presenting Characteristics of Postoperative Endophthalmitis in the Endophthalmitis Vitrectomy Study.Ophthamology, 2000;107:1274-1282.PMID 10889097

Doft BH,Wisniewski SR, Kelsey SF, Groer-Fitzgerald S for the Endophthalmitis Vitrectomy Study Group. Diabetes and Post-Operative Endophthalmitis in the Endophthalmitis Vitrectomy Study: Implications for Management.Archives of Ophthalmology, 2001;119:650-656. PMID 11346391

Lavori PW, Rush AJ,Wisniewski SR, Alpert J, Fava M. Kupfer DJ, Nierenberg A., Quitkin FM, Sacheim HA, Thase ME, Trivedi M for the STAR*D Group. Strengthening Clinical Effectiveness Trials: Equipoise-Stratified Randomization.Biological Psychiatry, 2001-50:792-801. PMID 11720698

Wisniewski SR, Belle SH, Coon DW, Marcus SM, Ory MG, Burgio L, Burns R, Schulz R. The Resources of Enhancing Alzheimer’s Caregiver Health (REACH): Project Design and Baseline Characteristics.Psychology and Aging, 2003; 18:375-384. PMID 14518801

Wisniewski SR, Stegman D, Trivedi M, Husain MM, Eng H, Shores-Wilson K, Luther J, Biggs MM, Burroughs D, Ritz LA, Fava M, Quitkin F, Rush AJ for the STAR*D Investigators. Methods of testing feasibility for sequenced alternatives to relieve depression (STAR*D).Journal of Psychiatric Research, 2004; 38:241-248. PMID 15003429

Wisniewski SR, Eng H, Meloro L, Gatt R, Ritz L, Stegman D, Trivedi M, Biggs MM, Friedman E, Shores-Wilson K, Warden D, Bartolowits D, Martin JP and Rush AJ. Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project. Clinical Trials, 2004;1:387-398. PMID 16279277

Warden D, Rush AJ, Trivedi M, Ritz L, Stegman D,Wisniewski SR. Quality improvement methods as applied to a multicenter effectiveness trial – STAR*D. Contemporary Clinical Trials, 2005;26:95-112. PMID 15837455

Balasubramani GK,Wisniewski SR, Zhang H, Eng HE. Development of an efficient SAS macro to perform permutation tests for two independent samples. ComputerMethods and Programs in Biomedicine, 2005;79:179-187. PMID 15904990

Trivedi MH, Fava M,Wisniewski SR, Thase ME, Quitkin F, Warden D, Ritz L, Nierenberg A, Lebowitz BD, Biggs MM, Luther JF, Shores-Wilson K, Rush AJ for the STAR*D Study Team. A Comparison of Citalopram Augmentation with Bupropion-SR and Buspirone Following SSRI Failure for Depressed Outpatients: A STAR*D Report. New England Journal of Medicine, 2006;354:1243-1252. PMID 16554526.

Rush AJ, Trivedi MH,Wisniewski SR, Stewart JW, Nierenberg A, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M for the STAR*D Team. A Comparison of Bupropion-SR, Sertraline, and Venlafaxine-XR Following SSRI Failure for Depressed Outpatients: A STAR*D Report. New England Journal of Medicine, 2006;354:1231-1242.&nbsp PMID 16554525

Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA for the STAR*D Investigators. Self-Rated Global Measure of the Frequency, Intensity, and Burden of Side Effects. Journal of Psychiatric Practice, 2006;12:71-79. PMID 16728903

Wisniewski SR, Leon AC, Otto MW, Trivedi MH. Prevention of Missing Data in Clinical Research Studies. Biological Psychiatry, 2006;59:997-100. PMID 16566901

Otto MW, Simon NM,Wisniewski, SR, Miklowitz DJ, Kogan J, Reilly-Harrington NA, Frank E, Nierenberg AA, Marangell L, Sagduyu KA, Weiss RD, Miyahara S, Thase ME, Sachs GS, Pollack MH, for STEP-BD Investigators. One-Year Longitudinal Outcome for Bipolar Patients With Anxiety Disorders: Data from the First 1000 Participants in STEP. British Journal of Psychiatry, 2006;189:20-25. PMID: 16816301

Fava M, Rush AJ,Wisniewski SR, Nierenberg AA, Alpert J, McGrath PJ, Thase ME, Warden D, Biggs MM, Luther JF, Niederehe G, Ritz L, Trivedi MH for the STAR*D Team. A Comparison of Mirtazapine and Nortriptyline Following Two Consecutive Failed Medication Treatments for Depressed Outpatients: A STAR*D Report. American Journal of Psychiatry, 2006; 131:1161-1172. PMID 16816220

Wieland ME, Rosenstock J, Kelsey SF, Ganguli M,Wisniewski SR. Distal Support and Community Living Among Individuals Diagnosed with Schizophrenia and Schizoaffective Disorder. Psychiatry, 70(1); 1-11. PMID 17492907

McGrath PJ, Stewart JW, Fava M, Trivedi MH,Wisniewski SR, Nierenberg AA, Thase ME, Davis L, Biggs MM, Shores-Wilson K, Luther JF, Niederehe G, Warden D, Rush AJ for the STAR*D Study Team. Tranylcypromine Versus Venlafaxine Plus Mirtazapine Following Three Failed Antidepressant Medication Trials for Depression: A STAR*D Report. American Journal of Psychiatry, 2006;1531-1541. PMID 16946177

Nierenberg AA, Fava M, Trivedi MH,Wisniewski SR, Tahse ME, McGrath PJ, Alpert JE, Warden D, Luther JF, Niederehe G, Lebowitz B, Shores-Wilson K, Rush AJ for the STAR*D Study Team. A Comparison of Lithium and T3Augmentation Following Two Failed Medication Treatments for Depression: A STAR*D Report. American Journal of Psychiatry, 2006;163:1519-1530. PMID 16946176

Rush AJ, Trivedki MH,Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum J, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several treatment Steps: A STAR*D Report. American Journal of Psychiatry, 2006;163:1905-1917. PMID 17074942

Wisniewski SR, Rush AJ, Bryan C, Shelton R, Trivedi MH, Marcus S, Husain MM, Hollon SD, Fava M for the STAR*D Investigators. Comparison of Quality of Life Measures in a Depressed Population. The Journal of Nervous and Mental Disease, 2007;195:219-225. PMID 1746881

Wisniewski SR, Fava M, Trivedi MH, Thase ME, Warden D, Niederehe G, Friedman ES, Biggs MM, Sackeim HA, Shores-Wilson K, McGrath PJ, Lavori PW, Miyahara S, Rush AJ. Acceptability of Second-Step Treatments to Depressed Outpatients: A STAR*D Report. American Journal of Psychiatry, 2007;164:753-760. PMID 17475734

Warden D, Rush AJ, Trivedi MH, Fava M,Wisniewski SR. The STAR*D project results: A comprehensive review of findings. Current Psychiatry Reports, 2007;9:449-459. PMID 18221624

Cook IA, Balasubramani GK, Eng H, Friedman E, Young EA, Martin J, Nay WT, Ritz L, Rush AJ, Stegman D, Warden D, Trivedi MH,Wisniewski SR.&nbsp Electronic source materials in clinical research: Acceptability and validity of symptom self-rating in major depressive disorder. Journal of Psychiatric Research, 2007;41:737-743. PMID 17275840

Miklowitz DJ, Otto MW, Frank E, Reilly-Harrington NA, Kogan JN, Sachs GS, Thase ME, Calabrese JR, Marangell LB, Ostacher MJ, Patel J, Thomas MR, Araga M, Gonzalez JM,Wisniewski SR.&nbsp Intensive psychosocial intervention enhances functioning in patients with bipolar depression: Results from a 9-month randomized controlled trial. American Journal of Psychiatry, 2007;164:1340-1347. PMID 17728418

Bryan CJ, Songer TJ, Brooks MM, Thase ME, Gaynes BN, Klinkman M, Rush AJ, Trivedi MH, Fava M,Wisniewski SR. A comparison of baseline sociodemographic and clinical characteristics betwemajor depressive disorder patients with and without diabetes: A STAR*D report. Journal of Affective Disorders, 2008;108:113-120. PMID 18037497

Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF, McGrath PJ, Lavori PW, Thase ME, Fava M, Trivedi MH. Can Phase III Trial Results of Antidepressant Medications be Generalized to Clinical Practice? A STAR*D Report. American Journal of Psychiatry, 2009;166;599-607. PMID 19339358

Kocsis JH, Gelenberg AJ, Rothbaum BO, Klein DN, Trivedi MH, Manber R, Keller MB, Leon AC,Wisniewski SR, Arnow BA, Markowitz JC, Thase ME; REVAMP Investigators. Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP Trial. Archives of General Psychiatry, 2009;66(11):1178-88. PMID 19884606

Wisniewski SR, Chen CC, Kim E, Kan HJ, Guo Z, Carlson BX, Tran QV, Pikalov A.Global benefit-risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder. Pharmacoepidemiology and Drug Safety, 2009;18(10):965-72. PMID 19662630

Barkin JL, Wisner KL, Bromberger JT, Beach SR,Wisniewski SR. Assessment of functioning in new mothers.Journal of Women's Health, 12010;9:1493-1499. PMID 21054183

Rush AJ, Trivedi MH, Stewart JW, Nierenberg AA, Fava, M, Warden D, Morris DW, Luther JF, Husain MM, Cook IA, Shelton RC, Lesser IM, Kornstein SG,Wisniewski SR. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study. American Journal of Psychiatry, 2011; 168:689-701. PMID: 21536692

Beers SR,Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-extended. Journal of Neurotrauma, 2012;29:1126-1139. PMID: 22220819

Stark JH, Sharma R, Ostroff S, Cummings DAT, Ermentrout B, Stebbins S, Burke DS,Wisniewski SR. Local spatial and temporal processes of influenza in Pennsylvania, USA: 2003-2009. PloS ONE, 2012;7:e34245. PMID: 22470544

Otto MW,Wisniewski SR. CBT for treatment resistant depression. The Lancet, 2013;381:352-353.

Adelson PD,Wisniewski SR, Beca J, Brown SD, Bell M, Muizelaar JP, Okada P, Beers SR, Balasubramani GK, Hirtz D.Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomized controlled trial.The Lancet Neurology, 2012;75:6546-553.

Wisner KL, Bogen DL, Sit D, McShea M, Hughes C, Rizzo D, Confer A, Luther J, Eng H,Wisniewski SW. Does fetal exposure to SSRIs or maternal depression impact infant growth? American Journal of Psychiatry, 2013;170:485-493.

Kolko DJ, Campo J, Kilbourne AM, Hart J, Sakolsky D,Wisniewski SR. Collaborative care outcomes for pediatric behavioral health problems: A cluster randomized trial. Pediatrics, 2014;133:e981-e982.

Zimmerman RK, Rinaldo CR, Nowalk MP, Balasubramani GK, Moehling KK, Bullotta A, Eng HF, Raviotta JM, Sax TM,Wisniewski SR. Viral infections in outpatients with medically attended acute respiratory illness during the 2012-2013 influenza season. BMC Infectious Diseases, 2015;15:art. no. 87. PMID: 25887948

Bell MJ, Wisniewski SR. Severe Traumatic Brain Injury in Children: A Vision for the future. Intensive Care Medicine, 2016;42:1618-20. PMID: 27256038.

Kochanek PM, Jackson TC, Jha RM, Clark RSB, Okonkwo DO, Bayir H, Polyac SM, Wagner AK, Empey PE, Conley YP, Bell MJ, Kline AE, Bondi CO, Simon DW, Carlson SW, Puccio AM, Horvat CM, Au AK, Elmer J, Treble-Barna A, Ikonomovic MD, Shutter LA, Taylor DL, Stern AM, Graham SH, Kagan VE, Jackson EK,Wisniewski SR, Dixon CE.Paths to Successful Translation of New Therapies for Severe Traumatic Brain Injury in the Golden Age of Traumatic Brain Injury Research:A Pittsburgh Vision.Journal of Neurotrauma, 2019 PMID:30520681

Forno E, Bacharier LB, Phipatanakul W, Guilbert TW, Cabana MD, RossK, Covar R, Gern JE, Rosser FJ, Blatter J, Curraini S, Han Y-Y,Wisniewski SR, Celedon JC. Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children with Asthma and Low Vitamin D Levles. Journal of the American Medical Association, 2020;324:752-760.

Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT,Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I, CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults with Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. Journal of the American Medical Association,325:1841-1851.

Kochanek PM, Adelson PD, Hutchison J, Ferguson NM, Ferrazzano P, O’Brien N, Beca J, Sarnaik A, LaRovere K, Bennett TD, Deep A, Gupta D, Willyerd FA, Gao S, Rosario BL,Wisniewski SR, Bell MJ D for the Investigators of the ADAPT Trial. Comparison of Intracranial Pressur Measurements Before and After Hypertonic Saline or Mannitol Treatment in Children with Severe Traumatic Brain Injury. JAMA Open Network,2022;5:e220891. doi:10.1001/jamanetworkopen.2022.0891

Brooks MM,Wisniewski SR. Assessing Unexpected Circumstances That Lead to Modifications in Clinical Trial Design, Conduct, or Analysis: Application of the CONSERVE Reporting Guideline. Journal of the American Medical Association,2022;327:868–869. doi:10.1001/jama.2022.1748