Daniel O. Scharfstein

Daniel O. Scharfstein, MS, ScD

Languages spoken: English

Academic Information

Departments Primary - Population Health Sciences , Adjunct - Family & Preventive Medicine , Adjunct - Orthopaedics

Visit Dr. Scharfstein's Lab Site

I am chief of the Division of Biostatistics in Department of Population Health Sciences at the University of Utah School of Medicine.

I joined the University of Utah as a Professor in August 2020, after spending 23 years on the faculty of the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health.

I received pre- and post- doctoral training from the Department of Biostatistics at the Harvard School of Public Health under the guidance of Butch Tsiatis (pre) and James Robins (post).

My research is focused in how to report results in randomized trials with informative missing/censored data or irregular assessment times and in observational studies with non-random and time-varying treatment assignment.

I served on the National Academy panel, which issued the report The Prevention and Treatment of Missing Data in Clinical Trials.

I am the principal statistician of the METRC consortium, which is funded by the Department of Defense to conduct multi-center clinical research relevant to the treatment and outcomes of orthopaedic trauma sustained in the military. I have also served as the lead statistician on a number of large evaluation studies including the National Study of the Costs and Outcomes of Trauma (NSCOT), Guided Care for Chronically Ill Older Adults and Healthy Steps for Young Children. For more details, visit my collaborations page.

I was born and raised in Brooklyn, New York, although I have retained little of the classic accent. I am married to Julie Alpher Scharfstein, who was a classmate of mine at Harvard. We have three children: Kayla, Ava, and Nadia.

Education History

Doctoral Training Harvard School of Public Health
 ScD
Graduate Training Harvard School of Public Health
 MS
Graduate Training Georgia Institute of Technology
 MS
Undergraduate University of Pennsylvania
 BS
Undergraduate University of Pennsylvania
 BS

Selected Publications

Journal Article

  1. Nabi R, Bonvini M, Kennedy EH, Huang MY, Smid M, Scharfstein DO (2022). Semiparametric sensitivity analysis: unmeasured confounding in observational studies. Biometrics, 80(4). (Read full article)
  2. Nguyen TQ, Stuart EA, Scharfstein DO, Ogburn EL (2024). Sensitivity analysis for principal ignorability violation in estimating complier and noncomplier average causal effects. Stat Med, 43(19), 3664-3688. (Read full article)
  3. Kelley AT, Incze MA, Baumgartner M, Campbell ANC, Nunes EV, Scharfstein DO (2024). Predictors of urine toxicology and other biologic specimen missingness in randomized trials of substance use disorders. Drug Alcohol Depend, 261, 111368. (Read full article)
  4. Chapman AB, Scharfstein DO, Montgomery AE, Byrne T, Suo Y, Effiong A, Velasquez T, Pettey W, Nelson RE (2024). Using natural language processing to study homelessness longitudinally with electronic health record data subject to irregular observations. AMIA Annu Symp Proc, 2023, 894-903. (Read full article)
  5. Patterson JT, OHara NN, Scharfstein DO, Castillo RC, OToole RV, Firoozabadi R, METRC (2022). Do superficial infections increase the risk of deep infections in tibial plateau and plafond fractures? Eur J Orthop Surg Traumatol, 33(7), 2805-2811. (Read full article)
  6. King JB, Berchie RO, Derington CG, Marcum ZA, Scharfstein DO, Greene TH, Herrick JS, Jacobs JA, Zheutlin AR, Bress AP, Cohen JB (2023). New Users of Angiotensin II Receptor Blocker-Versus Angiotensin-Converting Enzyme Inhibitor-Based Antihypertensive Medication Regimens and Cardiovascular Disease Events: A Secondary Analysis of ACCORD-BP and SPRINT. J Am Heart Assoc, 12(17), e030311. (Read full article)
  7. Di Stefano L, Ram M, Scharfstein DO, Li T, Khanal P, Baksh SN, McBee N, Bengtson CD, Gadomski A, Geriak M, Puskarich MA, Salathe MA, Schutte AE, Tignanelli CJ, Victory J, Bierer BE, Hanley DF, Freilich DA, Pandemic Response COVID-19 Research Collaboration Platform for ACEiARB Pooled Analyses (2023). Losartan in hospitalized patients with COVID-19 in North America: An individual participant data meta-analysis. Medicine (Baltimore), 102(23), e33904. (Read full article)
  8. Dahabreh IJ, Matthews A, Steingrimsson JA, Scharfstein DO, Stuart EA (2023). Using Trial and Observational Data to Assess Effectiveness: Trial Emulation, Transportability, Benchmarking, and Joint Analysis. Epidemiol Rev. (Read full article)
  9. Major Extremity Trauma Research Consortium METRC, OToole RV, Stein DM, OHara NN, Frey KP, Taylor TJ, Scharfstein DO, Carlini AR, Sudini K, Degani Y, Slobogean GP, Haut ER, Obremskey W, Firoozabadi R, Bosse MJ, Goldhaber SZ, Marvel D, Castillo RC (2023). Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. N Engl J Med, 388(3), 203-213. (Read full article)
  10. Di Stefano L, Ogburn EL, Ram M, Scharfstein DO, Li T, Khanal P, Baksh SN, McBee N, Gruber J, Gildea MR, Clark MR, Goldenberg NA, Bennani Y, Brown SM, Buckel WR, Clement ME, Mulligan MJ, OHalloran JA, Rauseo AM, Self WH, Semler MW, Seto T, Stout JE, Ulrich RJ, Victory J, Bierer BE, Hanley DF, Freilich D, Pandemic Response COVID-19 Research Collaboration Platform for HCQCQ Pooled Analyses (2022). Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis. PLoS One, 17(9), e0273526. (Read full article)
  11. Obremskey WT, Tornetta P 3rd, Luly J, Morshed S, OToole RV, Hsu JR, Mitchell SL, Mackenzie EJ, Frey KP, Castillo RC, Bosse MJ, Scharfstein DO, METRC (2021). Outcomes of Patients With Large Versus Small Bone Defects in Open Tibia Fractures Treated With an Intramedullary Nail: A Descriptive Analysis of a Multicenter Retrospective Study. J Orthop Trauma, 36(8), 388-393. (Read full article)
  12. Scharfstein DO, Steingrimsson J, McDermott A, Wang C, Ray S, Campbell A, Nunes E, Matthews A (2021). Global sensitivity analysis of randomized trials with nonmonotone missing binary outcomes: Application to studies of substance use disorders. Biometrics, 78(2), 649-659. (Read full article)
  13. Levy JF, Reider L, Scharfstein DO, Pollak AN, Morshed S, Firoozabadi R, Archer KR, Gary JL, OToole RV, Castillo RC, Quinnan SM, Kempton LB, Jones CB, Bosse MJ, MacKenzie EJ, METRC (2022). The 1-Year Economic Impact of Work Productivity Loss Following Severe Lower Extremity Trauma. J Bone Joint Surg Am, 104(7), 586-593. (Read full article)
  14. Fulcher IR, Shpitser I, Didelez V, Zhou K, Scharfstein DO (2021). Discussion on "Causal mediation of semicompeting risks" by Yen-Tsung Huang. Biometrics, 77(4), 1165-1169. (Read full article)
  15. Major Extremity Trauma Research Consortium METRC, OToole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Huang Y, Scharfstein DO, OHara NN, Gary JL, Bosse MJ, Castillo RC, Bishop JA, Weaver MJ, Firoozabadi R, Hsu JR, Karunakar MA, Seymour RB, Sims SH, Churchill C, Brennan ML, Gonzales G, Reilly RM, Zura RD, Howes CR, Mir HR, Wagstrom EA, Westberg J, Gaski GE, Kempton LB, Natoli RM, Sorkin AT, Virkus WW, Hill LC, Hymes RA, Holzman M, Malekzadeh AS, Schulman JE, Ramsey L, Cuff JAN, Haaser S, Osgood GM, Shafiq B, Laljani V, Lee OC, Krause PC, Rowe CJ, Hilliard CL, Morandi MM, Mullins A, Achor TS, Choo AM, Munz JW, Boutte SJ, Vallier HA, Breslin MA, Frisch HM, Kaufman AM, Large TM, LeCroy CM, Riggsbee C, Smith CS, Crickard CV, Phieffer LS, Sheridan E, Jones CB, Sietsema DL, Reid JS, Ringenbach K, Hayda R, Evans AR, Crisco MJ, Rivera JC, Osborn PM, Kimmel J, Stawicki SP, Nwachuku CO, Wojda TR, Rehman S, Donnelly JM, Caroom C, Jenkins MD, Boulton CL, Costales TG, LeBrun CT, Manson TT, Mascarenhas DC, Nascone JW, Pollak AN, Sciadini MF, Slobogean GP, Berger PZ, Connelly DW, Degani Y, Howe AL, Marinos DP, Montalvo RN, Reahl GB, Schoonover CD, Schroder LK, Vang S, Bergin PF, Graves ML, Russell GV, Spitler CA, Hydrick JM, Teague D, Ertl W, Hickerson LE, Moloney GB, Weinlein JC, Zelle BA, Agarwal A, Karia RA, Sathy AK, Au B, Maroto M, Sanders D, Higgins TF, Haller JM, Rothberg DL, Weiss DB, Yarboro SR, McVey ED, Lester-Ballard V, Goodspeed D, Lang GJ, Whiting PS, Siy AB, Obremskey WT, Jahangir AA, Attum B, Burgos EJ, Molina CS, Rodriguez-Buitrago A, Gajari V, Trochez KM, Halvorson JJ, Miller AN, Goodman JB, Holden MB, McAndrew CM, Gardner MJ, Ricci WM, Spraggs-Hughes A, Collins SC, Taylor TJ, Zadnik M (2021). Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial. JAMA Surg, 156(5), e207259. (Read full article)
  16. OToole RV, Stein DM, Frey KP, OHara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC, METRC (2021). PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients. BMJ Open, 11(3), e041845. (Read full article)
  17. Reider L, Bai J, Scharfstein DO, Zipunnikov V, for METRC OUTLET Study Investigators (2020). Methods for Step Count Data: Determining "Valid" Days and Quantifying Fragmentation of Walking Bouts. Gait Posture, 81, 205-212. (Read full article)
  18. Schmidt AH, Di J, Zipunnikov V, Frey KP, Scharfstein DO, OToole RV, Bosse MJ, Obremskey WT, Stinner DJ, Hayda R, Karunakar MA, Hak DJ, Carroll EA, Collins SCJ, MacKenzie EJ, METRC (2020). Perfusion Pressure Lacks Diagnostic Specificity for the Diagnosis of Acute Compartment Syndrome. J Orthop Trauma, 34(6), 287-293. (Read full article)
  19. Wang C, Colantuoni E, Leroux A, Scharfstein DO (2020). idem: An R Package for Inferences in Clinical Trials with Death and Missingness. J Stat Softw, 93. (Read full article)
  20. Duan R, Cao M, Ning Y, Zhu M, Zhang B, McDermott A, Chu H, Zhou X, Moore JH, Ibrahim JG, Scharfstein DO, Chen Y (2019). Global identifiability of latent class models with applications to diagnostic test accuracy studies: A Gröbner basis approach. Biometrics, 76(1), 98-108. (Read full article)
  21. Gitajn IL, Reider L, Scharfstein DO, OToole RV, Bosse MJ, Castillo RC, Jevsevar DS, Pollak AN, METRC (2019). Variability in Discharge Disposition Across US Trauma Centers After Treatment for High-Energy Lower Extremity Injuries. J Orthop Trauma, 34(3), e78-e85. (Read full article)
  22. Magnusson BP, Schmidli H, Rouyrre N, Scharfstein DO (2019). Bayesian inference for a principal stratum estimand to assess the treatment effect in a subgroup characterized by postrandomization event occurrence. Stat Med, 38(23), 4761-4771. (Read full article)
  23. Scharfstein DO (2019). A constructive critique of the draft ICH E9 Addendum. Clin Trials, 16(4), 375-380. (Read full article)
  24. Mitchell SL, Obremskey WT, Luly J, Bosse MJ, Frey KP, Hsu JR, MacKenzie EJ, Morshed S, OToole RV, Scharfstein DO, Tornetta P 3rd, Major Extremity Trauma Rehabilitation Consortium METRC (2020). Inter-Rater Reliability of the Modified Radiographic Union Score for Diaphyseal Tibial Fractures With Bone Defects. J Orthop Trauma, 33(6), 301-307. (Read full article)
  25. Scharfstein DO, McDermott A (2018). Global sensitivity analysis of clinical trials with missing patient-reported outcomes. Stat Methods Med Res, 28(5), 1439-1456. (Read full article)
  26. Castillo RC, Huang Y, Scharfstein D, Frey K, Bosse MJ, Pollak AN, Vallier HA, Archer KR, Hymes RA, Newcomb AB, MacKenzie EJ, Wegener S, Major Extremity Trauma Research Consortium METRC, Hsu JR, Karunakar MA, Seymour RB, Sims SH, Flores E, Churchill C, Hak DJ, Henderson CE, Mir HR, Chan DS, Shah AR, Steverson B, Westberg J, Gary JL, Achor TS, Choo A, Munz JW, Porrey M, Hendrickson S, Breslin MA, McKinley TO, Gaski GE, Kempton LB, Sorkin AT, Virkus WW, Hill LC, Jones CB, Sietsema DL, OToole RV, Ordonio K, Howe AL, Zerhusen TJ Jr, Obremskey W, Boyce RH, Jahangir AA, Molina CS, Sethi MK, Vanston SW, Carroll EA, Drye DY, Holden MB, Collins SC, Wysocki E (2019). Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopedic Trauma. JAMA Surg, 154(2), e184824. (Read full article)
  27. Potter BK, Sheu RG, Stinner D, Fergason J, Hsu JR, Kuhn K, Owens JG, Rivera J, Shawen SB, Wilken JM, DeSanto J, Huang Y, Scharfstein DO, MacKenzie EJ (2018). Multisite Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Patients with Residual Disability After Lower-Limb Trauma. J Bone Joint Surg Am, 100(20), 1781-1789. (Read full article)
  28. Hernn MA, Scharfstein D (2018). Cautions as Regulators Move to End Exclusive Reliance on Intention to Treat. Ann Intern Med, 168(7), 515-516. (Read full article)
  29. Scharfstein D, McDermott A, Daz I, Carone M, Lunardon N, Turkoz I (2017). Global sensitivity analysis for repeated measures studies with informative drop-out: A semi-parametric approach. Biometrics, 74(1), 207-219. (Read full article)
  30. Colantuoni E, Scharfstein DO, Wang C, Hashem MD, Leroux A, Needham DM, Girard TD (2018). Statistical methods to compare functional outcomes in randomized controlled trials with high mortality. BMJ, 360, j5748. (Read full article)
  31. Wegener ST, Carroll EA, Gary JL, McKinley TO, OToole RV, Sietsema DL, Castillo RC, Frey KP, Scharfstein DO, Huang Y, Collins SCJ, MacKenzie EJ, Major Extremity Trauma Research Consortium METRC (2017). Trauma Collaborative Care Intervention: Effect on Surgeon Confidence in Managing Psychosocial Complications After Orthopaedic Trauma. J Orthop Trauma, 31(8), 427-433. (Read full article)
  32. Wang C, Scharfstein DO, Colantuoni E, Girard TD, Yan Y (2016). Inference in randomized trials with death and missingness. Biometrics, 73(2), 431-440. (Read full article)
  33. Bosse MJ, Murray CK, Carlini AR, Firoozabadi R, Manson T, Scharfstein DO, Wenke JC, Zadnik M, Castillo RC, METRC (2017). Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation With Subsequent Postclosure Deep Wound Infection (Bioburden Study). J Orthop Trauma, 31 Suppl 1, S3-S9. (Read full article)
  34. OToole RV, Gary JL, Reider L, Bosse MJ, Gordon WT, Hutson J, Quinnan SM, Castillo RC, Scharfstein DO, MacKenzie EJ, METRC (2017). A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study). J Orthop Trauma, 31 Suppl 1, S10-S17. (Read full article)
  35. OToole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Scharfstein DO, Gary JL, Bosse MJ, Castillo RC, METRC (2017). Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter, Randomized, Controlled Trial (VANCO Study). J Orthop Trauma, 31 Suppl 1, S18-S24. (Read full article)
  36. OToole RV, Joshi M, Carlini AR, Sikorski RA, Dagal A, Murray CK, Weaver MJ, Paryavi E, Stall AC, Scharfstein DO, Agel J, Zadnik M, Bosse MJ, Castillo RC, METRC (2017). Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study). J Orthop Trauma, 31 Suppl 1, S25-S31. (Read full article)
  37. Obremskey WT, Schmidt AH, OToole RV, DeSanto J, Morshed S, Tornetta P 3rd, Murray CK, Jones CB, Scharfstein DO, Taylor TJ, Carlini AR, Castillo RC, METRC (2017). A Prospective Randomized Trial to Assess Oral Versus Intravenous Antibiotics for the Treatment of Postoperative Wound Infection After Extremity Fractures (POvIV Study). J Orthop Trauma, 31 Suppl 1, S32-S38. (Read full article)
  38. Schmidt AH, Bosse MJ, Frey KP, OToole RV, Stinner DJ, Scharfstein DO, Zipunnikov V, MacKenzie EJ, METRC (2017). Predicting Acute Compartment Syndrome (PACS): The Role of Continuous Monitoring. J Orthop Trauma, 31 Suppl 1, S40-S47. (Read full article)
  39. Bosse MJ, Teague D, Reider L, Gary JL, Morshed S, Seymour RB, Toledano J, Cannada LK, Steverson B, Scharfstein DO, Luly J, MacKenzie EJ, METRC (2017). Outcomes After Severe Distal Tibia, Ankle, and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation (OUTLET). J Orthop Trauma, 31 Suppl 1, S48-S55. (Read full article)
  40. Hsu JR, Owens JG, DeSanto J, Fergason JR, Kuhn KM, Potter BK, Stinner DJ, Sheu RG, Waggoner SL, Wilken JM, Huang Y, Scharfstein DO, MacKenzie EJ, METRC (2017). Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries: The PRIORITI-MTF Study. J Orthop Trauma, 31 Suppl 1, S56-S62. (Read full article)
  41. Bosse MJ, Morshed S, Reider L, Ertl W, Toledano J, Firoozabadi R, Seymour RB, Carroll E, Scharfstein DO, Steverson B, MacKenzie EJ, METRC (2017). Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With and Without a Tibiofibular Synostosis (Ertl) Procedure. J Orthop Trauma, 31 Suppl 1, S63-S69. (Read full article)
  42. Castillo RC, Raja SN, Frey KP, Vallier HA, Tornetta P 3rd, Jaeblon T, Goff BJ, Gottschalk A, Scharfstein DO, OToole RV, METRC (2017). Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study). J Orthop Trauma, 31 Suppl 1, S71-S77. (Read full article)
  43. Wegener ST, Pollak AN, Frey KP, Hymes RA, Archer KR, Jones CB, Seymour RB, OToole RV, Castillo RC, Huang Y, Scharfstein DO, MacKenzie EJ, METRC (2017). The Trauma Collaborative Care Study (TCCS). J Orthop Trauma, 31 Suppl 1, S78-S87. (Read full article)
  44. Stinner DJ, Wenke JC, Ficke JR, Gordon W, Toledano J, Carlini AR, Scharfstein DO, MacKenzie EJ, Bosse MJ, Hsu JR, Major Extremity Trauma Research Consortium METRC (2017). Military and Civilian Collaboration: The Power of Numbers. Mil Med, 182(S1), 10-17. (Read full article)
  45. Manson TT, Reider L, OToole RV, Scharfstein DO, Tornetta P 3rd, Gary JL, Major Extremity Trauma Research Consortium METRC (2016). Variation in Treatment of Displaced Geriatric Acetabular Fractures Among 15 Level-I Trauma Centers. J Orthop Trauma, 30(9), 457-62. (Read full article)
  46. Wu Z, Frangakis CE, Louis TA, Scharfstein DO (2014). Estimation of treatment effects in matched-pair cluster randomized trials by calibrating covariate imbalance between clusters. Biometrics, 70(4), 1014-22. (Read full article)
  47. Hauschild A, Chen SC, Weichenthal M, Blum A, King HC, Goldsmith J, Scharfstein D, Gutkowicz-Krusin D (2014). To excise or not: impact of MelaFind on German dermatologists' decisions to biopsy atypical lesions. J Dtsch Dermatol Ges, 12(7), 606-14. (Read full article)
  48. Li T, Hutfless S, Scharfstein DO, Daniels MJ, Hogan JW, Little RJ, Roy JA, Law AH, Dickersin K (2013). Standards should be applied in the prevention and handling of missing data for patient-centered outcomes research: a systematic review and expert consensus. J Clin Epidemiol, 67(1), 15-32. (Read full article)
  49. Marsteller JA, Hsu YJ, Wen M, Wolff J, Frick K, Reider L, Scharfstein D, Boyd C, Leff B, Schwartz L, Karm L, Boult C (2013). Effects of Guided Care on providers' satisfaction with care: a three-year matched-pair cluster-randomized trial. Popul Health Manag, 16(5), 317-25. (Read full article)
  50. Paryavi E, Stall A, Gupta R, Scharfstein DO, Castillo RC, Zadnik M, Hui E, OToole RV (2013). Predictive model for surgical site infection risk after surgery for high-energy lower-extremity fractures: development of the risk of infection in orthopedic trauma surgery score. J Trauma Acute Care Surg, 74(6), 1521-7. (Read full article)
  51. Boult C, Leff B, Boyd CM, Wolff JL, Marsteller JA, Frick KD, Wegener S, Reider L, Frey K, Mroz TM, Karm L, Scharfstein DO (2013). A matched-pair cluster-randomized trial of guided care for high-risk older patients. J Gen Intern Med, 28(5), 612-21. (Read full article)
  52. Dattalo M, Giovannetti ER, Scharfstein D, Boult C, Wegener S, Wolff JL, Leff B, Frick KD, Reider L, Frey K, Noronha G, Boyd C (2012). Who participates in chronic disease self-management (CDSM) programs? Differences between participants and nonparticipants in a population of multimorbid older adults. Med Care, 50(12), 1071-5. (Read full article)
  53. Little RJ, DAgostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitzky A, Scharfstein D, Shih WJ, Siegel JP, Stern H (2012). The prevention and treatment of missing data in clinical trials. N Engl J Med, 367(14), 1355-60. (Read full article)
  54. Scharfstein DO, Hogan J, Herman A (2012). On the prevention and analysis of missing data in randomized clinical trials: the state of the art. J Bone Joint Surg Am, 94 Suppl 1, 80-4. (Read full article)
  55. Castillo RC, Scharfstein DO, MacKenzie EJ (2012). Observational studies in the era of randomized trials: finding the balance. J Bone Joint Surg Am, 94 Suppl 1, 112-7. (Read full article)
  56. Wang W, Scharfstein D, Wang C, Daniels M, Needham D, Brower R, the NHLBI ARDS Clinical Network (2011). Estimating the Causal Effect of Low Tidal Volume Ventilation on Survival in Patients with Acute Lung Injury. J R Stat Soc Ser C Appl Stat, 60(4), 475-496. (Read full article)
  57. Skolasky RL, Green AF, Scharfstein D, Boult C, Reider L, Wegener ST (2010). Psychometric properties of the patient activation measure among multimorbid older adults. Health Serv Res, 46(2), 457-78. (Read full article)
  58. Boult C, Reider L, Leff B, Frick KD, Boyd CM, Wolff JL, Frey K, Karm L, Wegener ST, Mroz T, Scharfstein DO (2011). The effect of guided care teams on the use of health services: results from a cluster-randomized controlled trial. Arch Intern Med, 171(5), 460-6. (Read full article)
  59. Reshef S, Fried L, Beauchamp N, Scharfstein D, Reshef D, Goodman S (2010). Diastolic blood pressure levels and ischemic stroke incidence in older adults with white matter lesions. J Gerontol A Biol Sci Med Sci, 66(1), 74-81. (Read full article)
  60. Bobb JF, Scharfstein DO, Daniels MJ, Collins FS, Kelada S (2014). Multiple imputation of missing phenotype data for QTL mapping. Stat Appl Genet Mol Biol, 10(1), Article 29. (Read full article)
  61. Wang C, Daniels MJ, Scharfstein DO, Land S (2011). A Bayesian Shrinkage Model for Incomplete Longitudinal Binary Data with Application to the Breast Cancer Prevention Trial. J Am Stat Assoc, 105(492), 1333-1346. (Read full article)
  62. Wolff JL, Giovannetti ER, Boyd CM, Reider L, Palmer S, Scharfstein D, Marsteller J, Wegener ST, Frey K, Leff B, Frick KD, Boult C (2009). Effects of guided care on family caregivers. Gerontologist, 50(4), 459-70. (Read full article)
  63. MacKenzie EJ, Weir S, Rivara FP, Jurkovich GJ, Nathens AB, Wang W, Scharfstein DO, Salkever DS (2010). The value of trauma center care. J Trauma, 69(1), 1-10. (Read full article)
  64. Marsteller JA, Hsu YJ, Reider L, Frey K, Wolff J, Boyd C, Leff B, Karm L, Scharfstein D, Boult C (2010). Physician satisfaction with chronic care processes: a cluster-randomized trial of guided care. Ann Fam Med, 8(4), 308-15. (Read full article)
  65. Varadhan R, Weiss CO, Segal JB, Wu AW, Scharfstein D, Boyd C (2010). Evaluating health outcomes in the presence of competing risks: a review of statistical methods and clinical applications. Med Care, 48(6 Suppl), S96-105. (Read full article)
  66. Boyd CM, Reider L, Frey K, Scharfstein D, Leff B, Wolff J, Groves C, Karm L, Wegener S, Marsteller J, Boult C (2009). The effects of guided care on the perceived quality of health care for multi-morbid older persons: 18-month outcomes from a cluster-randomized controlled trial. J Gen Intern Med, 25(3), 235-42. (Read full article)
  67. Joffe A, McNeely C, Colantuoni E, An MW, Wang W, Scharfstein D (2009). Evaluation of school-based smoking-cessation interventions for self-described adolescent smokers. Pediatrics, 124(2), e187-94. (Read full article)
  68. Leff B, Reider L, Frick KD, Scharfstein DO, Boyd CM, Frey K, Karm L, Boult C (2009). Guided care and the cost of complex healthcare: a preliminary report. Am J Manag Care, 15(8), 555-9. (Read full article)
  69. Wolff JL, Rand-Giovannetti E, Palmer S, Wegener S, Reider L, Frey K, Scharfstein D, Boult C (2009). Caregiving and chronic care: the guided care program for families and friends. J Gerontol A Biol Sci Med Sci, 64(7), 785-91. (Read full article)
  70. Egleston BL, Scharfstein DO, MacKenzie E (2008). On estimation of the survivor average causal effect in observational studies when important confounders are missing due to death. Biometrics, 65(2), 497-504. (Read full article)
  71. Dodd-O JM, Hristopoulos M, Scharfstein D, Brower R, Hassoun P, King LS, Becker P, Liu M, Wang W, Hassoun HT, Rabb H (2008). Interactive effects of mechanical ventilation and kidney health on lung function in an in vivo mouse model. Am J Physiol Lung Cell Mol Physiol, 296(1), L3-L11. (Read full article)
  72. Shardell M, Scharfstein DO, Vlahov D, Galai N (2008). Sensitivity analysis using elicited expert information for inference with coarsened data: illustration of censored discrete event times in the AIDS Link to Intravenous Experience (ALIVE) Study. Am J Epidemiol, 168(12), 1460-9. (Read full article)
  73. Shardell M, Scharfstein DO, Vlahov D, Galai N (2008). Inference for cumulative incidence functions with informatively coarsened discrete event-time data. Stat Med, 27(28), 5861-79. (Read full article)
  74. Brotman RM, Klebanoff MA, Nansel TR, Andrews WW, Schwebke JR, Zhang J, Yu KF, Zenilman JM, Scharfstein DO (2008). A longitudinal study of vaginal douching and bacterial vaginosis--a marginal structural modeling analysis. Am J Epidemiol, 168(2), 188-96. (Read full article)
  75. Brotman RM, Ghanem KG, Klebanoff MA, Taha TE, Scharfstein DO, Zenilman JM (2008). The effect of vaginal douching cessation on bacterial vaginosis: a pilot study. Am J Obstet Gynecol, 198(6), 628.e1-7. (Read full article)
  76. Scharfstein DO, Ryea JL, Caffo B (2007). Accounting for within-patient correlation in assessing relative sensitivity of an adjunctive diagnostic test: application to lung cancer. Stat Med, 27(12), 2110-26. (Read full article)
  77. Bozzette SA, Ake CF, Tam HK, Phippard A, Cohen D, Scharfstein DO, Louis TA (2008). Long-term survival and serious cardiovascular events in HIV-infected patients treated with highly active antiretroviral therapy. J Acquir Immune Defic Syndr, 47(3), 338-41. (Read full article)
  78. Rivara FP, Mackenzie EJ, Jurkovich GJ, Nathens AB, Wang J, Scharfstein DO (2008). Prevalence of pain in patients 1 year after major trauma. Arch Surg, 143(3), 282-7; discussion 288. (Read full article)
  79. Boult C, Reider L, Frey K, Leff B, Boyd CM, Wolff JL, Wegener S, Marsteller J, Karm L, Scharfstein D (2008). Early effects of "Guided Care" on the quality of health care for multimorbid older persons: a cluster-randomized controlled trial. J Gerontol A Biol Sci Med Sci, 63(3), 321-7. (Read full article)
  80. Mackenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Egleston BL, Salkever DS, Frey KP, Scharfstein DO (2008). The impact of trauma-center care on functional outcomes following major lower-limb trauma. J Bone Joint Surg Am, 90(1), 101-9. (Read full article)
  81. Mackenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Weir S, Scharfstein DO (2007). The National Study on Costs and Outcomes of Trauma. J Trauma, 63(6 Suppl), S54-67; discussion S81-6. (Read full article)
  82. Li X, Caffo B, Scharfstein D (2007). On the potential for illogic with logically defined outcomes. Biostatistics, 8(4), 800-4. (Read full article)
  83. Eaton WW, Kalaydjian A, Scharfstein DO, Mezuk B, Ding Y (2007). Prevalence and incidence of depressive disorder: the Baltimore ECA follow-up, 1981-2004. Acta Psychiatr Scand, 116(3), 182-8. (Read full article)
  84. Minkovitz CS, Strobino D, Mistry KB, Scharfstein DO, Grason H, Hou W, Ialongo N, Guyer B (2007). Healthy Steps for Young Children: sustained results at 5.5 years. Pediatrics, 120(3), e658-68. (Read full article)
  85. Egleston BL, Scharfstein DO, Freeman EE, West SK (2006). Causal inference for non-mortality outcomes in the presence of death. Biostatistics, 8(3), 526-45. (Read full article)
  86. Shardell M, Scharfstein DO, Bozzette SA (2006). Survival curve estimation for informatively coarsened discrete event-time data. Stat Med, 26(10), 2184-202. (Read full article)
  87. Scharfstein DO, Halloran ME, Chu H, Daniels MJ (2006). On estimation of vaccine efficacy using validation samples with selection bias. Biostatistics, 7(4), 615-29. (Read full article)
  88. Nathens AB, Rivara FP, MacKenzie EJ, Maier RV, Wang J, Egleston B, Scharfstein DO, Jurkovich GJ (2006). The impact of an intensivist-model ICU on trauma-related mortality. Ann Surg, 244(4), 545-54. (Read full article)
  89. Hogan JW, Scharfstein DO (2006). Estimating causal effects from multiple cycle data in studies of in vitro fertilization. Stat Methods Med Res, 15(2), 195-209. (Read full article)
  90. Needham DM, Dennison CR, Dowdy DW, Mendez-Tellez PA, Ciesla N, Desai SV, Sevransky J, Shanholtz C, Scharfstein D, Herridge MS, Pronovost PJ (2005). Study protocol: The Improving Care of Acute Lung Injury Patients (ICAP) study. Crit Care, 10(1), R9. (Read full article)
  91. MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Scharfstein DO (2006). A national evaluation of the effect of trauma-center care on mortality. N Engl J Med, 354(4), 366-78. (Read full article)
  92. Epstein JI, Sanderson H, Carter HB, Scharfstein DO (2004). Utility of saturation biopsy to predict insignificant cancer at radical prostatectomy. Urology, 66(2), 356-60. (Read full article)
  93. Minkovitz CS, Strobino D, Scharfstein D, Hou W, Miller T, Mistry KB, Swartz K (2005). Maternal depressive symptoms and children's receipt of health care in the first 3 years of life. Pediatrics, 115(2), 306-14. (Read full article)
  94. Cotter DJ, Stefanik K, Zhang Y, Thamer M, Scharfstein D, Kaufman J (2004). Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients. J Clin Epidemiol, 57(10), 1086-95. (Read full article)
  95. McLearn KT, Strobino DM, Hughart N, Minkovitz CS, Scharfstein D, Marks E, Guyer B (2004). Developmental services in primary care for low-income children: clinicians' perceptions of the Healthy Steps for Young Children program. J Urban Health, 81(2), 206-21. (Read full article)
  96. Scharfstein DO, Manski CF, Anthony JC (2004). On the construction of bounds in prospective studies with missing ordinal outcomes: application to the good behavior game trial. Biometrics, 60(1), 154-64. (Read full article)
  97. Minkovitz CS, Hughart N, Strobino D, Scharfstein D, Grason H, Hou W, Miller T, Bishai D, Augustyn M, McLearn KT, Guyer B (2003). A practice-based intervention to enhance quality of care in the first 3 years of life: the Healthy Steps for Young Children Program. JAMA, 290(23), 3081-91. (Read full article)
  98. Minkovitz CS, Strobino D, Hughart N, Scharfstein D, Hou W, Miller T, Bishai D, Guyer B (2003). Developmental specialists in pediatric practices: perspectives of clinicians and staff. Ambul Pediatr, 3(6), 295-303. (Read full article)
  99. Scharfstein DO, Daniels MJ, Robins JM (2003). Incorporating prior beliefs about selection bias into the analysis of randomized trials with missing outcomes. Biostatistics, 4(4), 495-512. (Read full article)
  100. Scharfstein DO, Irizarry RA (2003). Generalized additive selection models for the analysis of studies with potentially nonignorable missing outcome data. Biometrics, 59(3), 601-13. (Read full article)
  101. Scharfstein DO, Liang KY, Eaton W, Chen LS (2003). The quadratic cumulative odds regression model for scored ordinal outcomes: application to alcohol dependence. Biostatistics, 2(4), 473-83. (Read full article)
  102. Scharfstein D, Robins JM, Eddings W, Rotnitzky A (2001). Inference in randomized studies with informative censoring and discrete time-to-event endpoints. Biometrics, 57(2), 404-13. (Read full article)
  103. Minkovitz C, Strobino D, Hughart N, Scharfstein D, Guyer B, Healthy Steps Evaluation Team (2001). Early effects of the healthy steps for young children program. Arch Pediatr Adolesc Med, 155(4), 470-9. (Read full article)
  104. Rotnitzky A, Scharfstein D, Su TL, Robins J (2001). Methods for conducting sensitivity analysis of trials with potentially nonignorable competing causes of censoring. Biometrics, 57(1), 103-13. (Read full article)
  105. Guyer B, Hughart N, Strobino D, Jones A, Scharfstein D (2000). Assessing the impact of pediatric-based development services on infants, families, and clinicians: challenges to evaluating the Health Steps Program. Pediatrics, 105(3), E33. (Read full article)
  106. Scharfstein DO, Tsiatis AA (1998). The use of simulation and bootstrap in information-based group sequential studies. Stat Med, 17(1), 75-87. (Read full article)
  107. Scharfstein DO, Tsiatis AA, Gilbert PB (1999). Semiparametric efficient estimation in the generalized odds-rate class of regression models for right-censored time-to-event data. Lifetime Data Anal, 4(4), 355-91. (Read full article)
  108. Scharfstein DO, Williams PL (1994). Design of developmental toxicity studies for assessing joint effects of dose and duration. Risk Anal, 14(6), 1057-71. (Read full article)
  109. Catalano P, Ryan L, Scharfstein D (1994). Modeling fetal death and malformation in developmental toxicity studies. Risk Anal, 14(4), 629-37. (Read full article)
  110. Catalano PJ, Scharfstein DO, Ryan LM, Kimmel CA, Kimmel GL (1993). Statistical model for fetal death, fetal weight, and malformation in developmental toxicity studies. Teratology, 47(4), 281-90. (Read full article)

Review

  1. Pullenayegum EM, Scharfstein DO (2022). Randomized Trials With Repeatedly Measured Outcomes: Handling Irregular and Potentially Informative Assessment Times. [Review]. Epidemiol Rev, 44(1), 121-137. (Read full article)
  2. Colantuoni E, Li X, Hashem MD, Girard TD, Scharfstein DO, Needham DM (2021). A structured methodology review showed analyses of functional outcomes are frequently limited to "survivors only" in trials enrolling patients at high risk of death. [Review]. J Clin Epidemiol, 137, 126-132. (Read full article)

Editorial

  1. Kharrazi H, Wang C, Scharfstein D (2014). Prospective EHR-based clinical trials: the challenge of missing data. J Gen Intern Med, 29(7), 976-8. (Read full article)

Letter

  1. Ogburn EL, Bierer BE, Brookmeyer R, Choirat C, Dean NE, De Gruttola V, Ellenberg SS, Halloran ME, Hanley DF Jr, Lee JK, Wang R, Scharfstein DO (2020). Aggregating data from COVID-19 trials. [Letter to the editor]. Science, 368(6496), 1198-1199. (Read full article)
  2. Lunardon N, Scharfstein D (2017). Comment on 'Small sample GEE estimation of regression parameters for longitudinal data'. [Letter to the editor]. Stat Med, 36(22), 3596-3600. (Read full article)