Daniel O. Scharfstein

Daniel O. Scharfstein, MS, ScD

Languages spoken: English

Academic Information

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

Academic Office Information

Daniel.Scharfstein@hsc.utah.edu

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

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

Selected Publications

Journal Article

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Hernán MA, Scharfstein D (2018). Cautions as Regulators Move to End Exclusive Reliance on Intention to Treat. Ann Intern Med, 168(7), 515-516.
  6. 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.
  7. 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.
  8. 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.
  9. Scharfstein D, McDermott A, Díaz I, Carone M, Lunardon N, Turkoz I (2018). Global sensitivity analysis for repeated measures studies with informative drop-out: A semi-parametric approach. Biometrics, 74(1), 207-219.
  10. Wang C, Scharfstein DO, Colantuoni E, Girard TD, Yan Y (2017). Inference in randomized trials with death and missingness. Biometrics, 73(2), 431-440.
  11. 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.
  12. Egleston BL, Scharfstein DO, MacKenzie E (2009). On estimation of the survivor average causal effect in observational studies when important confounders are missing due to death. Biometrics, 65(2), 497-504.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. Duan R, Cao M, Ning Y, Zhu M, Zhang B, McDermott A, Chu H, Zhou X, Moore JH, Ibrahim JG, Scharfstein DO, Chen Y (2020). Global identifiability of latent class models with applications to diagnostic test accuracy studies: A Gröbner basis approach. Biometrics, 76(1), 98-108.
  18. Colantuoni E, Scharfstein DO, Wang C, Hashem MD, Leroux A, Needham DM, Girard T (2018). Statistical methods to compare functional outcomes in randomized controlled trials with high mortality. BMJ (Clinical research ed.), 360, j5748.
  19. 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. Archives of pediatrics & adolescent medicine, 155(4), 470-9.
  20. Scharfstein DO, McDermott (2019). Global sensitivity analysis of clinical trials with missing patient-reported outcomes. Statistical methods in medical research, 28(5), 1439-1456.
  21. Hogan JW, Scharfstein D (2006). Estimating causal effects from multiple cycle data in studies of in vitro fertilization. Statistical methods in medical research, 15(2), 195-209.
  22. Wolff JL, Giovannetti ER, Boyd CM, Reider L, Palmer S, Scharfstein D, Marsteller J, Wegener ST, Frey K, Leff B, Frick KD, Boult (2010). Effects of guided care on family caregivers. The Gerontologist, 50(4), 459-70.
  23. Skolasky RL, Green AF, Scharfstein D, Boult C, Reider L, Wegener S (2011). Psychometric properties of the patient activation measure among multimorbid older adults. Health services research, 46(2), 457-78.
  24. 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 E (2018). Multisite Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Patients with Residual Disability After Lower-Limb Trauma. The Journal of bone and joint surgery. American volume, 100(20), 1781-1789.
  25. Castillo RC, Scharfstein DO, MacKenzie E (2012). Observational studies in the era of randomized trials: finding the balance. The Journal of bone and joint surgery. American volume, 94 Suppl 1, 112-7.
  26. Scharfstein DO, Hogan J, Herman (2012). On the prevention and analysis of missing data in randomized clinical trials: the state of the art. The Journal of bone and joint surgery. American volume, 94 Suppl 1, 80-4.
  27. Mackenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Egleston BL, Salkever DS, Frey KP, Scharfstein D (2008). The impact of trauma-center care on functional outcomes following major lower-limb trauma. The Journal of bone and joint surgery. American volume, 90(1), 101-9.
  28. Li T, Hutfless S, Scharfstein DO, Daniels MJ, Hogan JW, Little RJ, Roy JA, Law AH, Dickersin (2014). Standards should be applied in the prevention and handling of missing data for patient-centered outcomes research: a systematic review and expert consensus. Journal of clinical epidemiology, 67(1), 15-32.
  29. Cotter DJ, Stefanik K, Zhang Y, Thamer M, Scharfstein D, Kaufman (2004). Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients. Journal of clinical epidemiology, 57(10), 1086-95.
  30. Boult C, Leff B, Boyd CM, Wolff JL, Marsteller JA, Frick KD, Wegener S, Reider L, Frey K, Mroz TM, Karm L, Scharfstein D (2013). A matched-pair cluster-randomized trial of guided care for high-risk older patients. Journal of general internal medicine, 28(5), 612-21.
  31. Boyd CM, Reider L, Frey K, Scharfstein D, Leff B, Wolff J, Groves C, Karm L, Wegener S, Marsteller J, Boult (2010). 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. Journal of general internal medicine, 25(3), 235-42.
  32. Mitchell SL, Obremskey WT, Luly J, Bosse MJ, Frey KP, Hsu JR, MacKenzie EJ, Morshed S, O'Toole RV, Scharfstein DO, Tornetta P 3rd, Major Extremity Trauma Rehabilitation Consortium (METRC) (2019). Inter-Rater Reliability of the Modified Radiographic Union Score for Diaphyseal Tibial Fractures With Bone Defects. Journal of orthopaedic trauma, 33(6), 301-307.
  33. Wegener ST, Carroll EA, Gary JL, McKinley TO, O'Toole 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. Journal of orthopaedic trauma, 31(8), 427-433.
  34. 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). Journal of orthopaedic trauma, 31 Suppl 1, S3-S9.
  35. O'Toole 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). Journal of orthopaedic trauma, 31 Suppl 1, S18-S24.
  36. O'Toole 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). Journal of orthopaedic trauma, 31 Suppl 1, S25-S31.
  37. Schmidt AH, Bosse MJ, Frey KP, O'Toole RV, Stinner DJ, Scharfstein DO, Zipunnikov V, MacKenzie EJ, METRC (2017). Predicting Acute Compartment Syndrome (PACS): The Role of Continuous Monitoring. Journal of orthopaedic trauma, 31 Suppl 1, S40-S47.
  38. Wegener ST, Pollak AN, Frey KP, Hymes RA, Archer KR, Jones CB, Seymour RB, O'Toole RV, Castillo RC, Huang Y, Scharfstein DO, MacKenzie EJ, METRC (2017). The Trauma Collaborative Care Study: Design and Baseline Characteristics of Study Participants. Journal of orthopaedic trauma, 31 Suppl 1, S78-S87.
  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). Journal of orthopaedic trauma, 31 Suppl 1, S48-S55.
  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. Journal of orthopaedic trauma, 31 Suppl 1, S56-S62.
  41. Obremskey WT, Schmidt AH, O'Toole 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). Journal of orthopaedic trauma, 31 Suppl 1, S32-S38.
  42. 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. Journal of orthopaedic trauma, 31 Suppl 1, S63-S69.
  43. O'Toole 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). Journal of orthopaedic trauma, 31 Suppl 1, S10-S17.
  44. Manson TT, Reider L, O'Toole 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. Journal of orthopaedic trauma, 30(9), 457-62.
  45. Gitajn IL, Reider L, Scharfstein DO, O'Toole RV, Bosse MJ, Castillo RC, Jevsevar DS, Pollak AN, METRC (2020). Variability in Discharge Disposition Across US Trauma Centers After Treatment for High-Energy Lower Extremity Injuries. Journal of orthopaedic trauma, 34(3), e78-e85.
  46. Schmidt AH, Di J, Zipunnikov V, Frey K, Scharfstein DO, O'Toole RV, Bosse MJ, Obremsky WT, Stinner DJ, Hayda RA, Karunaka MA, Hak DJ, Carroll EA, Collins S, MacKenzie E, METR (2020). Is Perfusion Pressure a Reliable Indicator of the Need for Fasciotomy?. Journal of orthopaedic trauma,
  47. MacKenzie EJ, Weir S, Rivara FP, Jurkovich GJ, Nathens AB, Wang W, Scharfstein DO, Salkever D (2010). The value of trauma center care. The Journal of trauma, 69(1), 1-10.
  48. Mackenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Weir S, Scharfstein D (2007). The National Study on Costs and Outcomes of Trauma. The Journal of trauma, 63(6 Suppl), S54-67; discussion S81-6.
  49. Minkovitz CS, Hughart N, Strobino D, Scharfstein D, Grason H, Hou W, Miller T, Bishai D, Augustyn M, McLearn KT, Guyer (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.
  50. Dattalo M, Giovannetti ER, Scharfstein D, Boult C, Wegener S, Wolff JL, Leff B, Frick KD, Reider L, Frey K, Noronha G, Boyd (2012). Who participates in chronic disease self-management (CDSM) programs? Differences between participants and nonparticipants in a population of multimorbid older adults. Medical care, 50(12), 1071-5.
  51. Varadhan R, Weiss CO, Segal JB, Wu AW, Scharfstein D, Boyd (2010). Evaluating health outcomes in the presence of competing risks: a review of statistical methods and clinical applications. Medical care, 48(6 Suppl), S96-105.
  52. 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. Military medicine, 182(S1), 10-17.
  53. Little RJ, D'Agostino 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 (2012). The prevention and treatment of missing data in clinical trials. The New England journal of medicine, 367(14), 1355-60.
  54. MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Scharfstein D (2006). A national evaluation of the effect of trauma-center care on mortality. The New England journal of medicine, 354(4), 366-78.
  55. Joffe A, McNeely C, Colantuoni E, An MW, Wang W, Scharfstein (2009). Evaluation of school-based smoking-cessation interventions for self-described adolescent smokers. Pediatrics, 124(2), e187-94.
  56. Minkovitz CS, Strobino D, Mistry KB, Scharfstein DO, Grason H, Hou W, Ialongo N, Guyer (2007). Healthy Steps for Young Children: sustained results at 5.5 years. Pediatrics, 120(3), e658-68.
  57. Minkovitz CS, Strobino D, Scharfstein D, Hou W, Miller T, Mistry KB, Swartz (2005). Maternal depressive symptoms and children's receipt of health care in the first 3 years of life. Pediatrics, 115(2), 306-14.
  58. Guyer B, Hughart N, Strobino D, Jones A, Scharfstein (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.
  59. Scharfstein DO, Williams P (1994). Design of developmental toxicity studies for assessing joint effects of dose and duration. Risk analysis, 14(6), 1057-71.
  60. Catalano P, Ryan L, Scharfstein (1994). Modeling fetal death and malformation in developmental toxicity studies. Risk analysis, 14(4), 629-37.
  61. Magnusson BP, Schmidli H, Rouyrre N, Scharfstein D (2019). Bayesian inference for a principal stratum estimand to assess the treatment effect in a subgroup characterized by postrandomization event occurrence. Statistics in medicine, 38(23), 4761-4771.
  62. Shardell M, Scharfstein DO, Vlahov D, Galai (2008). Inference for cumulative incidence functions with informatively coarsened discrete event-time data. Statistics in medicine, 27(28), 5861-79.
  63. Scharfstein DO, Ryea JL, Caffo (2008). Accounting for within-patient correlation in assessing relative sensitivity of an adjunctive diagnostic test: application to lung cancer. Statistics in medicine, 27(12), 2110-26.
  64. Shardell M, Scharfstein DO, Bozzette S (2007). Survival curve estimation for informatively coarsened discrete event-time data. Statistics in medicine, 26(10), 2184-202.
  65. Scharfstein DO, Tsiatis A (1998). The use of simulation and bootstrap in information-based group sequential studies. Statistics in medicine, 17(1), 75-87.
  66. Catalano PJ, Scharfstein DO, Ryan LM, Kimmel CA, Kimmel G (1993). Statistical model for fetal death, fetal weight, and malformation in developmental toxicity studies. Teratology, 47(4), 281-90.
  67. Epstein JI, Sanderson H, Carter HB, Scharfstein D (2005). Utility of saturation biopsy to predict insignificant cancer at radical prostatectomy. Urology, 66(2), 356-60.
  68. Reshef S, Fried L, Beauchamp N, Scharfstein D, Reshef D, Goodman (2011). Diastolic blood pressure levels and ischemic stroke incidence in older adults with white matter lesions. The journals of gerontology. Series A, Biological sciences and medical sciences, 66(1), 74-81.
  69. Wolff JL, Rand-Giovannetti E, Palmer S, Wegener S, Reider L, Frey K, Scharfstein D, Boult (2009). Caregiving and chronic care: the guided care program for families and friends. The journals of gerontology. Series A, Biological sciences and medical sciences, 64(7), 785-91.
  70. Boult C, Reider L, Frey K, Leff B, Boyd CM, Wolff JL, Wegener S, Marsteller J, Karm L, Scharfstein (2008). Early effects of "Guided Care" on the quality of health care for multimorbid older persons: a cluster-randomized controlled trial. The journals of gerontology. Series A, Biological sciences and medical sciences, 63(3), 321-7.
  71. Scharfstein DO, Tsiatis AA, Gilbert P (1998). Semiparametric efficient estimation in the generalized odds-rate class of regression models for right-censored time-to-event data. Lifetime data analysis, 4(4), 355-91.
  72. McLearn KT, Strobino DM, Hughart N, Minkovitz CS, Scharfstein D, Marks E, Guyer (2004). Developmental services in primary care for low-income children: clinicians' perceptions of the Healthy Steps for Young Children program. Journal of urban health, 81(2), 206-21.
  73. Leff B, Reider L, Frick KD, Scharfstein DO, Boyd CM, Frey K, Karm L, Boult (2009). Guided care and the cost of complex healthcare: a preliminary report. The American journal of managed care, 15(8), 555-9.
  74. Dodd-O JM, Hristopoulos M, Scharfstein D, Brower R, Hassoun P, King LS, Becker P, Liu M, Wang W, Hassoun HT, Rabb (2009). Interactive effects of mechanical ventilation and kidney health on lung function in an in vivo mouse model. American journal of physiology. Lung cellular and molecular physiology, 296(1), L3-L11.
  75. Bozzette SA, Ake CF, Tam HK, Phippard A, Cohen D, Scharfstein DO, Louis T (2008). Long-term survival and serious cardiovascular events in HIV-infected patients treated with highly active antiretroviral therapy. Journal of acquired immune deficiency syndromes (1999), 47(3), 338-41.
  76. Needham DM, Dennison CR, Dowdy DW, Mendez-Tellez PA, Ciesla N, Desai SV, Sevransky J, Shanholtz C, Scharfstein D, Herridge MS, Pronovost P (2006). Study protocol: The Improving Care of Acute Lung Injury Patients (ICAP) study. Critical care (London, England), 10(1), R9.
  77. Minkovitz CS, Strobino D, Hughart N, Scharfstein D, Hou W, Miller T, Bishai D, Guyer (2003). Developmental specialists in pediatric practices: perspectives of clinicians and staff. Ambulatory pediatrics, 3(6), 295-303.
  78. Wang C, Daniels MJ, Scharfstein DO, Land (2010). A Bayesian Shrinkage Model for Incomplete Longitudinal Binary Data with Application to the Breast Cancer Prevention Trial. Journal of the American Statistical Association, 105(492), 1333-1346.
  79. Li X, Caffo B, Scharfstein (2007). On the potential for illogic with logically defined outcomes. Biostatistics (Oxford, England), 8(4), 800-4.
  80. Egleston BL, Scharfstein DO, Freeman EE, West S (2007). Causal inference for non-mortality outcomes in the presence of death. Biostatistics (Oxford, England), 8(3), 526-45.
  81. Scharfstein DO, Halloran ME, Chu H, Daniels M (2006). On estimation of vaccine efficacy using validation samples with selection bias. Biostatistics (Oxford, England), 7(4), 615-29.
  82. Scharfstein DO, Daniels MJ, Robins J (2003). Incorporating prior beliefs about selection bias into the analysis of randomized trials with missing outcomes. Biostatistics (Oxford, England), 4(4), 495-512.
  83. Scharfstein DO, Liang KY, Eaton W, Chen L (2001). The quadratic cumulative odds regression model for scored ordinal outcomes: application to alcohol dependence. Biostatistics (Oxford, England), 2(4), 473-83.
  84. 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. Journal of the Royal Statistical Society. Series C, Applied statistics, 60(4), 475-496.
  85. Marsteller JA, Hsu YJ, Reider L, Frey K, Wolff J, Boyd C, Leff B, Karm L, Scharfstein D, Boult (2010). Physician satisfaction with chronic care processes: a cluster-randomized trial of guided care. Annals of family medicine, 8(4), 308-15.
  86. Hauschild A, Chen SC, Weichenthal M, Blum A, King HC, Goldsmith J, Scharfstein D, Gutkowicz-Krusin (2014). To excise or not: impact of MelaFind on German dermatologists' decisions to biopsy atypical lesions. Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology, 12(7), 606-14.
  87. Bobb JF, Scharfstein DO, Daniels MJ, Collins FS, Kelada (2011). Multiple imputation of missing phenotype data for QTL mapping. Statistical applications in genetics and molecular biology, 10(1), Article 29.
  88. Scharfstein D (2019). A constructive critique of the draft ICH E9 Addendum. Clinical trials (London, England), 16(4), 375-380.
  89. Marsteller JA, Hsu YJ, Wen M, Wolff J, Frick K, Reider L, Scharfstein D, Boyd C, Leff B, Schwartz L, Karm L, Boult (2013). Effects of Guided Care on providers' satisfaction with care: a three-year matched-pair cluster-randomized trial. Population health management, 16(5), 317-25.
  90. Paryavi E, Stall A, Gupta R, Scharfstein DO, Castillo RC, Zadnik M, Hui E, O'Toole R (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. The journal of trauma and acute care surgery, 74(6), 1521-7.
  91. 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, O'Toole 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 (2019). Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopedic Trauma. JAMA surgery, 154(2), e184824.
  92. Nabi R, Bonvini M, Kennedy EH, Huang MY, Smid M, Scharfstein D (2024). Semiparametric sensitivity analysis: unmeasured confounding in observational studies. Biometrics, 80(4),
  93. Nguyen TQ, Stuart EA, Scharfstein DO, Ogburn E (2024). Sensitivity analysis for principal ignorability violation in estimating complier and noncomplier average causal effects. Statistics in medicine, 43(19), 3664-3688.
  94. Kelley AT, Incze MA, Baumgartner M, Campbell ANC, Nunes EV, Scharfstein D (2024). Predictors of urine toxicology and other biologic specimen missingness in randomized trials of substance use disorders. Drug and alcohol dependence, 261, 111368.
  95. Chapman AB, Scharfstein DO, Montgomery AE, Byrne T, Suo Y, Effiong A, Velasquez T, Pettey W, Nelson R (2024). Using natural language processing to study homelessness longitudinally with electronic health record data subject to irregular observations. AMIA ... Annual Symposium proceedings. AMIA Symposium, 2023, 894-903.
  96. Patterson JT, O'Hara NN, Scharfstein DO, Castillo RC, O'Toole RV, Firoozabadi R, METR (2023). Do superficial infections increase the risk of deep infections in tibial plateau and plafond fractures?. European journal of orthopaedic surgery & traumatology, 33(7), 2805-2811.
  97. King JB, Berchie RO, Derington CG, Marcum ZA, Scharfstein DO, Greene TH, Herrick JS, Jacobs JA, Zheutlin AR, Bress AP, Cohen J (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. Journal of the American Heart Association, 12(17), e030311.
  98. 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 ACEi/ARB Pooled Analyse (2023). Losartan in hospitalized patients with COVID-19 in North America: An individual participant data meta-analysis. Medicine, 102(23), e33904.
  99. Major Extremity Trauma Research Consortium (METRC), O'Toole RV, Stein DM, O'Hara 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 R (2023). Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. The New England journal of medicine, 388(3), 203-213.
  100. 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, O'Halloran 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 HCQ/CQ Pooled Analyse (2022). Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis. PloS one, 17(9), e0273526.
  101. Obremskey WT, Tornetta P 3rd, Luly J, Morshed S, O'Toole RV, Hsu JR, Mitchell SL, Mackenzie EJ, Frey KP, Castillo RC, Bosse MJ, Scharfstein DO, METR (2022). 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. Journal of orthopaedic trauma, 36(8), 388-393.
  102. Scharfstein DO, Steingrimsson J, McDermott A, Wang C, Ray S, Campbell A, Nunes E, Matthews (2022). Global sensitivity analysis of randomized trials with nonmonotone missing binary outcomes: Application to studies of substance use disorders. Biometrics, 78(2), 649-659.
  103. Levy JF, Reider L, Scharfstein DO, Pollak AN, Morshed S, Firoozabadi R, Archer KR, Gary JL, O'Toole RV, Castillo RC, Quinnan SM, Kempton LB, Jones CB, Bosse MJ, MacKenzie EJ, METR (2022). The 1-Year Economic Impact of Work Productivity Loss Following Severe Lower Extremity Trauma. The Journal of bone and joint surgery. American volume, 104(7), 586-593.
  104. Fulcher IR, Shpitser I, Didelez V, Zhou K, Scharfstein D (2021). Discussion on "Causal mediation of semicompeting risks" by Yen-Tsung Huang. Biometrics, 77(4), 1165-1169.
  105. Colantuoni E, Li X, Hashem MD, Girard TD, Scharfstein DO, Needham D (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. Journal of clinical epidemiology, 137, 126-132.
  106. Major Extremity Trauma Research Consortium (METRC), O'Toole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Huang Y, Scharfstein DO, O'Hara 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 (2021). Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial. JAMA surgery, 156(5), e207259.
  107. O'Toole RV, Stein DM, Frey KP, O'Hara 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, METR (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.
  108. Dahabreh IJ, Matthews A, Steingrimsson JA, Scharfstein DO, Stuart E (2023). Using Trial and Observational Data to Assess Effectiveness: Trial Emulation, Transportability, Benchmarking, and Joint Analysis. Epidemiologic reviews,
  109. Pullenayegum EM, Scharfstein D (2022). Randomized Trials With Repeatedly Measured Outcomes: Handling Irregular and Potentially Informative Assessment Times. Epidemiologic reviews, 44(1), 121-137.
  110. Reider L, Bai J, Scharfstein DO, Zipunnikov V, for METRC OUTLET Study Investigator (2020). Methods for Step Count Data: Determining "Valid" Days and Quantifying Fragmentation of Walking Bouts. Gait & posture, 81, 205-212.
  111. Schmidt AH, Di J, Zipunnikov V, Frey KP, Scharfstein DO, O'Toole RV, Bosse MJ, Obremskey WT, Stinner DJ, Hayda R, Karunakar MA, Hak DJ, Carroll EA, Collins SCJ, MacKenzie EJ, METR (2020). Perfusion Pressure Lacks Diagnostic Specificity for the Diagnosis of Acute Compartment Syndrome. Journal of orthopaedic trauma, 34(6), 287-293.
  112. Wang C, Colantuoni E, Leroux A, Scharfstein D (2020). idem: An R Package for Inferences in Clinical Trials with Death and Missingness. Journal of statistical software, 93,
  113. Castillo RC, Raja SN, Frey KP, Vallier HA, Tornetta P 3rd, Jaeblon T, Goff BJ, Gottschalk A, Scharfstein DO, O'Toole RV, METR (2017). Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study). Journal of orthopaedic trauma, 31 Suppl 1, S71-S77.
  114. Allen HM, Holena MM, Allen LE, Zhao S, Castillo RC, Cohen SP, Hurley RW, Scharfstein DO, Haythornthwaite JA, Raja SN, Wegener ST, Rini CM, Keefe FJ, Bridges J, Reeder R, Thompson RE, Hanley D, Campbell CM, SKOAP Consortiu (2025). Study design and protocol of a randomized, pragmatic, comparative effectiveness trial evaluating a sequenced strategy for improving outcomes in people with knee osteoarthritis pain (SKOAP): Conservative treatment evaluation. Seminars in arthritis and rheumatism, 75, 152834.
  115. Jones BE, Chapman AB, Ying J, Nevers MR, Munro S, Klompas M, Valderrama AL, Scharfstein D (2025). Evaluating the impact of an oral care initiative on the risk of non-ventilator-associated hospital-acquired pneumonia using electronic clinical data and diagnostic coding surveillance criteria. Infection control and hospital epidemiology, 46(12), 1-9.
  116. Derington CG, Berchie RO, Scharfstein DO, Andrews RM, Greene TH, Xu Y, King JB, Supiano MA, Sonnen JA, Williamson J, Pajewski NM, Pruzin JJ, Cohen JB, Bress A (2025). Effect of Initiation and Continuous Adherence to ARBs Versus ACEIs on Risk of Adjudicated Mild Cognitive Impairment or Dementia. The journals of gerontology. Series A, Biological sciences and medical sciences, 80(7),
  117. Major Extremity Trauma Research Consortium (METRC), Obremskey WT, O'Toole RV, Morshed S, Tornetta P 3rd, Murray CK, Jones CB, Scharfstein DO, Taylor TJ, Carlini AR, DeSanto JM, Castillo RC, Bosse MJ, Karunakar MA, Seymour RB, Sims SH, Weinrib DA, Churchill C, Carroll EA, Pilson HT, Goodman JB, Holden MB, Miller AN, Sietsema DL, Stahel PF, Mir H, Schmidt AH, Westberg JR, Mullis B, Shively KD, Hymes RA, Konda SR, Vallier HA, Breslin MA, Smith CS, Crickard CV, Reid JS, Baker M, Eglseder WA, LeBrun C, Manson T, Mascarenhas DC, Nascone J, Pollak AN, Schloss MG, Sciadini MF, Degani Y, Miclau T, Weiss DB, Yarboro SR, McVey ED, Firoozabadi R, Agel J, Burgos EJ, Gajari V, Rodriguez-Buitrago A, Tummuru RR, Trochez K (2025). Oral vs Intravenous Antibiotics for Fracture-Related Infections: The POvIV Randomized Clinical Trial. JAMA surgery, 160(3), 276-284.
  118. Smith BB, Gao Y, Yang S, Varadhan R, Apter AJ, Scharfstein D (2024). Semi-parametric sensitivity analysis for trials with irregular and informative assessment times. Biometrics, 80(4),
  119. Hunt L 3rd, Murimi IB, Segal JB, Seamans MJ, Scharfstein DO, Varadhan (2020). Brand versus generic: addressing non-adherence, secular trends and non-overlap. Journal of the Royal Statistical Society. Series A, (Statistics in Society), 183(4), 1461-1478.

Editorial

  1. Kharrazi H, Wang C, Scharfstein (2014). Prospective EHR-based clinical trials: the challenge of missing data. Journal of general internal medicine, 29(7), 976-8.

Letter

  1. Lunardon N, Scharfstein (2017). Comment on 'Small sample GEE estimation of regression parameters for longitudinal data'. Statistics in medicine, 36(22), 3596-3600.
  2. 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 D (2020). Aggregating data from COVID-19 trials. Science (New York, N.Y.), 368(6496), 1198-1199.
  3. Apter A, Barg FK, Basu S, Federman A, Hamilton WJ, Krishnan JA, Li T, Localio R, Pindle C, Scharfstein DO, Smith JD, Sumino (2024). Irregular assessment times in pragmatic randomized clinical trials. Trials, 25(1), 841.

Report

  1. O'Toole RV, Stein DM, O'Hara 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 R (2023). Comparing Two Medicines to Prevent Blood Clots after Treatment for Fractures – The PREVENT CLOT Study.