Publications

JOURNAL ARTICLES

  1. Benkeser D, Diaz I, Luetdke A, Segal J, Scharfstein DO, Rosenblum M: "Improving Precision and Power in Randomized Trials. Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment, for Binary, Ordinal, and Time-to-Event Outcomes (with discussion)," Biometrics. April, 2020.
  2. Reider L, Bai J, Scharfstein DO, Zipuunikov V: "Methods for Step Count Data: Determining `Valid’ Days and Quantifying Fragmentation of Walking Bouts," Gait and Posture. 81: 205-212, 2020.
  3. Xu Y, Scharfstein DO, Muller P, Daniels M: "A Bayesian Nonparametric Approach for Evaluating the Causal Effect of Treatment in Randomized Trials with Semi-Competing Risks," Biostatistics. To Appear.
  4. Hunt L, Murimi IB, Segal JB, Seamans MJ, Scharfstein DO, Varadhan R: "Brand vs. Generic: Addressing Non-Adherence, Secular Trends and Non-Overlap," Journal of Royal Statistical Society – Series A. To Appear.
  5. 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, and METRC: "Perfusion Pressure Lacks Diagnostic Specificity for the Diagnosis of Acute Compartment Syndrome," Journal of Orthopaedic Trauma. 34: 287-293, 2020.
  6. Gitan L, Reider L, Scharfstein DO, O’Toole RV, Bosse MJ, Castillo RC, Jevsevar DS, Pollak A and METRC: "Variability in Discharge Disposition Across US Trauma Centers Following Treatment for High-Energy Lower Extremity Injuries," Journal of Orthopaedic Trauma. 34: e78-e85, 2020.
  7. Duan R, Cao M, Ning Y, Zhu M, Zhang B, McDermott A, Chu H, Zhou X, Moore JH, Ibrahim JG, Scharfstein DO, Chen Y: "Global Identifiability of Latent Class Models with Applications to Diagnostic Test Accuracy Studies," Biometrics. 76: 98-108, 2020.
  8. Magnusson B, Schmidli H, Rouyrre N, and Scharfstein DO: "Bayesian Inference for a Principle Stratum Estimand to Assess the Treatment Effect in a Subgroup Characterized by Post-Randomization Events," Statistics in Medicine, 38:4761-4771, 2019.
  9. Wegener S, Vailier H, Huang Y, Gary J, Pollak A, Bosse M, Archer KR, Newcomb A, Jones C, Sietsma D, Carroll E, Castillo R, Collins S, Frey K, Scharfstein DO, MacKenzie E, and METRC: "Early Effects of the Trauma Collaborative Care Intervention: Results from a Prospective Multicenter Cluster Clinical Trial," Journal of Orthopaedic Trauma, 33:538-546, 2019.
  10. Scharfstein DO: "A Constructive Critique of the Draft ICH E9 Addendum," Clinical Trials, 16:375-380, 2019.
  11. METRC (... Scharfstein DO ...): "A Randomized Controlled Trial Comparing rhBMP2/ACS vs. Autograft for the Treatment of Tibia Fractures with Critical Size Defects," Journal of Orthopaedic Trauma, 33:384-391, 2019.
  12. Castillo RC, Huang Y, Scharfstein DO, Frey K, Bosse MJ, Pollak AN, Vallier HA, Archer KR, Hymes RA, Newcomb AB, MacKenzie EJ, and METRC: “Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopaedic Trauma,” JAMA Surgery, To Appear.
  13. Mitchell S, Obremsky WT, Luly J, Bosse MJ, Frey KP, Hsu J, MacKenzie EJ, Morshed S, O’Toole RV, Scharfstein DO, and Tornetta P: “Inter-Rater Reliability of The Modified Radiographic Union Score for Diaphyseal Tibial (mRUST) Fractures with Bone Defects,” Journal of Orthopaedic Trauma 33:301-307, 2019.
  14. Wang C, Colantuoni EA, Leroux A, and Scharfstein DO: "idem: An R Package for Inferences in Clinical Trials with Death and Missingness," Revised for Journal of Statistical Software, To Appear.
  15. 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, and METRC PRIORITI-MTF Team: "Multi-Site Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Lower Limb Trauma Patients with Residual Disability," Journal of Joint and Bone Surgery 100:1781-1789, 2018.
  16. Hernan M and Scharfstein DO: "Cautions as Regulators Move to End Exclusive Reliance on Intention-To-Treat," Annals of Internal Medicine 168:515-516, 2018.
  17. Scharfstein DO and McDermott A: "Global Sensitivity Analysis of Randomized Trials with Missing Patient Reported Outcomes," Statistical Methods in Medical Research 28:1439-1456, 2019.
  18. Scharfstein DO, McDermott A, Diaz I, Carone M, and Turkoz I: "Global Sensitivity Analysis for Repeated Measures Studies with Informative Drop-out: A Semi-Parametric Approach," Biometrics 74:207-219, 2018.
  19. Colantuoni EA, Scharfstein DO, Wang CG, Hashem MD, Leroux A, Needham DM, and Girard TD: "Statistical Methods to Compare Functional Outcomes in RCTs with High Mortality," British Medical Journal 360:j5748, 2018.
  20. Wegener S, Carroll E, Gary J, McKinley T, O'Toole R, Sietsema D, Castillo R, Frey K, Scharfstein DO, Huang Y, Collins S, Wysocki E, Mackenzie E, and METRC: "Trauma Care Collaborative Intervention: Effect on Provider Confidence in Managing Psychosocial Complications Following Orthopaedic Trauma," Journal of Orthopaedic Trauma 31:427-433, 2017.
  21. Bosse MJ, Murray CK, Carlini AR, Firoozabadi R, Manson T, Scharfstein DO, Wenke JC, Zadnik M, Castillo RC, and METRC: "Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation with Subsequent Post-Closure Deep Wound Infection (Bioburden Study)," Journal of Orthopaedic Trauma 31:S3-S9, 2017.
  22. O'Toole RV, Joshi M, Carlini AR, Murray CK, Weaver MJ, Allen L, Scharfstein DO, Gary J, Bosse MJ, Castillo RC, and METRC: "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:S18-S24, 2017.
  23. 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, and METRC: "Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study)," Journal of Orthopaedic Trauma 31:S25-S31, 2017.
  24. Schmidt AH, Frey KP, Bosse MJ, O'Toole RV, Stinner DJ, Scharfstein DO, Zipunnikov V, Mackenzie EJ, and METRC: "Predicting Acute Compartment Syndrome (PACS): The Role of Continuous Monitoring," Journal of Orthopaedic Trauma 31:S40-S47, 2017.
  25. Wegener S, O'Toole R, Hymes R, Archer K, Jones C, Seymour R, Castillo R, Rey K, Huang Y, Scharfstein DO, Mackenzie E, and METRC: "The Trauma Collaborative Care Study: Design and Baseline Characteristics of Study Participants," Journal of Orthopaedic Trauma 31:S78-S87, 2017.
  26. Bosse MJ, Gary J, Reider L, Teague D, Morshed S, Toledano J, Cannada L, Seymour R, Steverson B, Scharfstein DO, Luly J, Mackenzie EJ, and METRC: "Outcomes Following Severe Distal Tibia, Ankle, and/or Foot Trauma: Comparison of Limb Salvage vs. Transtibial Amputation (OUTLET)," Journal of Orthopaedic Trauma 31:S48-S55, 2017.
  27. Hsu JR, Owens JG, Stinner DJ, Potter BK, Kuhn K, Sheu RG, Fergason J, Waggoner S, Huang Y, Scharfstein DO, DeSanto J, Mackenzie EJ, and METRC: "Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries: The PRIORITI-MTF Study," Journal of Orthopaedic Trauma 31:S56-S62, 2017.
  28. Obremskey WT, O'Toole RV, Morshed S, Tornetta P 3rd, Murray CK, Jones CB, Scharfstein DO, Castillo RC, Taylor TJ, Carlini AR, DeSanto J, and METRC: "A Prospective Randomized Trial to Assess Oral (PO) versus Intravenous (IV) Antibiotics for the Treatment of Post-op Wound Infection after Extremity Fractures (POvIV)," Journal of Orthopaedic Trauma 31:S32-S38, 2017.
  29. Bosse MJ, Ertl W, Firoozabadi R, Morshed S, Toledano J, Carroll E, Scharfstein DO, Seymour SB, Steverson B, Reider L, Mackenzie EJ, and METRC: "Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation with and without a Tibia-fibula Synostosis (Ertl) Procedure," Journal of Orthopaedic Trauma 31:S63-S69, 2017.
  30. O'Toole RV, Gary JL, Hutson J, Quinnan S, Bosse MJ, Gordon W, Castillo R, Scharfstein DO, Reider L, Mackenzie EJ, and METRC: "A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators vs. Internal Fixation (FIXIT Study)," Journal of Orthopaedic Trauma 31:S10-S17, 2017.
  31. Stinner DJ, Wenke JC, Ficke JR, Gordon W, Toledano J, Carlini AR, Scharfstein DO, Mackenzie EJ, Bosse MJ, Hsu JR, and METRC: "Military and Civilian Collaboration: The Power of Numbers," Journal of Military Medicine 182:10-17, 2017.
  32. Wang CG, Scharfstein DO, Colantuoni EA, Girard T, and Yan Y: "Inference in Randomized Trials with Death and Missingness," Biometrics 73:431-440, 2017.
  33. Manson T, Reider L, O'Toole RV, Scharfstein DO, Tornetta P, Gary J, and METRC: "Variation in Treatment of Displaced Geriatric Acetabular Fractures Among 15 Level I Trauma Centers," Journal of Orthopaedic Trauma 30:457-462, 2016.
  34. The Major Extremity Trauma Research Consortium (METRC): "Building a Clinical Research Network for Orthopaedic Trauma: The Major Extremity Trauma Research Consortium (METRC)," Journal of Orthopaedic Trauma 30:353-361, 2016.
  35. Scharfstein DO, Rotnitzky A, Abraham M, McDermott A, Chaisson R, Kim J, and Geiter L: "On the Analysis of Tuberculosis Studies with Missing Data," Annals of Applied Statistics 9:2215-2236, 2015.
  36. Scharfstein DO, McDermott A, Olson W, and Wiegand F: "Global Sensitivity Analysis for Repeated Measures Studies with Informative Drop-out: A Fully Parametric Approach," Statistics in Biopharmaceutical Research 6:338-348, 2014.
  37. Wu Z, Frangakis CE, Louis TA, and Scharfstein DO: "Estimation of Treatment Effects in Matched-Pair Cluster Randomized Trials by Calibrating Covariate Imbalance Between Clusters," Biometrics 70:1014-1022, 2014.
  38. Hauschild A, Chen S, Weichenthal M, Blum A, King H, Goldsmith J, Scharfstein DO, and Gutkowicz-Krusin: "To Excise or Not: The impact of MelaFind on German Dermatologists’ Decisions to Biopsy Lesions That May Be Melanoma," Journal der Deutschen Dermatologischen Gesellschaft 12:606-614, 2014.
  39. Li T, Hutfless S, Scharfstein DO, Daniels M, Hogan J, Little R, Roy J, and Dickerson K: "Standards in the Prevention and Handling of Missing Data for Patient Centered Outcome Research," Journal of Clinical Epidemiology 67:15-32, 2014.
  40. Paryavi E, Stall A, Gupta R, Scharfstein DO, Castillo RC, Zadnik M, Hui E, and O'Toole RV: "A Predictive Model for Surgical Site Infection Risk after Surgery for High-Energy Lower Extremity Fractures: Development of the Risk of Infection in Orthopaedic Trauma Surgery (RIOTS) Score," Journal of Trauma 74:1521-1527, 2013.
  41. Marsteller JA, Hsu Y-J, Wen M, Wollf J, Frick K, Reider L, Scharfstein DO, Boyd C, Leff B, Schwartz L, Karm L, and Boult C: "Effects of Guided Care on Physician, Nurse and Practice Staff Satisfaction with Care: A Three-Year Cluster-Randomized Trial," Population Health Management 16:317-325, 2013.
  42. Boult C, Leff B, Boyd CM, Wolff JL, Marstellar JA, Frick KD, Wegener S, Reider L, Frey K, Mroz T, Karm L, and Scharfstein DO: "A Matched-Pair Cluster-Randomized Trial of Guided Care for Multi-Morbid Older Patients," Journal of General Internal Medicine 28:612-621, 2013.
  43. Dattalo M, Rand-Giovanetti E, Scharfstein DO, Boult C, Wegener S, Wolff J, Leff B, Frick K, Noronha G, Reider L, Frey K, and Boyd C: "Who Participates in Chronic Disease Self-Management (CDSM) Programs? Differences between Participants and Non-Participants in a Population of Multi-Morbid Older Adults," Medical Care 50:1071-1075, 2012.
  44. Little R, D'Agostino R, Cohen M, Dickerson K, Emerson S, Farrar J, Frangakis C, Hogan J, Molenberghs G, Murphy S, Neaton J, Rotnitzky A, Scharfstein DO, Shih W, siegel J, and Stern H: "The Prevention and Treatment of Missing Data in Clinical Trials," New England Journal of Medicine 367:1355-1360, 2012.
  45. Castillo R, Scharfstein DO, and Mackenzie E: "Observational Studies in the Era of Randomized Studies," Journal of Bone and Joint Surgery 94:112-117, 2012.
  46. Scharfstein DO, Hogan J, and Herman A: "On the Prevention and Treatment of Missing Data in Randomized Clinical Trials: The State of the Art," Journal of Joint and Bone Surgery 94:80-84, 2012.
  47. Bobb JF, Scharfstein DO, Daniels MJ, Collins FS, and Kelada S: "Multiple Imputation of Missing Phenotype Data for QTL Mapping," Statistical Applications in Genetics and Molecular Biology 10:Article 29, 2011.
  48. Scharfstein DO, Onicescu G, Goodman S, and Whitaker R: "On the Analysis of Subgroup Effects in Randomized Trials When Subgroup Membership is Missing: Application to the MADIT II Study," Applied Statistics 60:607-617, 2011.
  49. Wang W, Scharfstein DO, Wang CG, Daniels M, Needham D, and Brower R: "Estimating the Causal Effect of Lower Tidal Volume Ventilation on Survival in Patients with Acute Lung," Applied Statistics 60:475-496, 2011.
  50. Skolasky R, Green A, Scharfstein DO, Boult C, Reider L, and Wegener S: "Psychometric Properties of the Patient Activation Measure Among Multi-Morbid Older Adults," Health Services Research 46:457-478, 2011.
  51. Reshef S, Fried L, Beauchamp N, Scharfstein DO, Reshef D, and Goodman S: "Diastolic Blood Pressure Levels and Ischemic Stroke Incidence in Older Adults with White Matter Lesions," Journal of Gerontology: Medical Sciences 66:74-81, 2011.
  52. Boult C, Reider L, Leff B, Frick KD, Boyd CM, Wolff JL, Frey K, Karm L, Wegener ST, Mroz T, and Scharfstein DO: "The Effect of Guided Care Teams on the Use of Health Services: Results from a Cluster-Randomized Controlled Trial," Archives of Internal Medicine 171:460-466, 2011.
  53. Wang CG, Daniels MJ, Scharfstein DO, and Land S: "Bayesian Shrinkage Model for Incomplete Longitudinal Binary Data with Application to a Breast Cancer Prevention Trial," Journal of American Statistical Association: Case Studies and Applications 105:1333-1346, 2010.
  54. Varadhan R, Weiss C, Segal J, Wu A, Scharfstein DO, and Boyd C: "Evaluating Health Outcomes in the Presence of Competing Risks: A Review of Statistical Methods and Clinical Applications," Medical Care 28:S96-S105, 2010.
  55. Martseller J, Hsu Y-J, Reider L, Frey K, Wolff J, Boyd C, Leff B, Karm L, Scharfstein DO, and Boult C: "Physician Satisfaction with Chronic Care Processes: A Cluster-Randomized Trial of Guided Care," Annals of Family Medicine 8:308-315, 2010.
  56. Mackenzie E, Weir S, Rivara F, Jurkovich G, Nathens A, Wang W, Scharfstein DO, and Salkever D: "The Value of Trauma Center Care," Journal of Trauma 69:1-10, 2010.
  57. Boyd CM, Reider L, Frey K, Scharfstein DO, Leff B, Wolff J, Groves C, Karm L, Wegener S, Marsteller J, and Boult C: "The Effects of Guided Care on Perceived Quality of Health Care for Multi-morbid Older Persons: 18 Month Outcomes from a Cluster Randomized Trial," Journal of Gerontology: Medical Sciences 25:235-242, 2010.
  58. Scharfstein DO and Achy-Brou A: "Global Sensitivity Analysis of Randomized Trials with Informative Drop-out: A Semi-parametric Perspective," Drug Information Journal 43:441-445, 2009.
  59. Wollf JL, Rand-Giovanetti E, Boyd CM, Reider L, Palmer S, Scharfstein DO, Marsteller J, Wegener S, Frey K, Leff B, Frick K, and Boult C: "Effects of Guided Care on Family Caregivers," The Gerontologist 50:459-470, 2010.
  60. Wang W, Scharfstein DO, Tan Z, and Mackenzie EJ: "Causal Inference in Observational Studies with Outcome Dependent Sampling," Journal of Royal Statistical Society, Series B 71:947-969, 2008.
  61. Leff B, Reider L, Frick K, Scharfstein DO, Boyd C, Frey K, Karm L, and Boult C: "The Early Effects of ‘Guided Care’ on Multi-Morbid Older Patient’s Use and Cost of Health Services: A Randomized Controlled Trial," American Journal of Managed Care 5:555-559, 2009.
  62. Wolff JL, Rand-Giovanetti E, Palmer S, Wegener S, Rieder L, Frey K, Scharfstein DO, and Boult CB: "Caregiving and Chronic Care: The Guided Care Program for Families and Friends," Journal of Gerontology: Medical Sciences 64:785-791, 2009.
  63. Joffe A, McNeely C, Colantuoni E, An M, Wang W, and Scharfstein DO: "Evaluation of School-Based Multi- versus Single-Session Group Smoking Cessation Interventions for Adolescent Smokers," Pediatrics 124:e187-e194, 2009.
  64. Dodd-o J, Hristopoulos M, Scharfstein DO, Brower R, Hassoun P, Becker P, Liu M, Wang W, King L, and Rabb H: "Interactive Effects of Mechanical Ventilation and Kidney Health on Lung Function in an In Vivo Mouse Model (with Editorial)," American Journal of Physiology: Lung Cellular and Molecular Pysiology 196:L3-L11, 2009.
  65. Egleston BL, Scharfstein DO, and Mackenzie EJ: "On Estimation of the Survivors Average Causal Effect in Observational Studies when Important Confounders are Missing Due to Death," Biometrics 65:497-504, 2009.
  66. Shardell M, Scharfstein DO, Vlahov D, and Galai N: "Sensitivity Analysis Using Elicited Expert Information for Inference with Coarsened Data: Illustration of Censored Discrete Event Times in ALIVE," American Journal of Epidemiology 168:1460-1469, 2008.
  67. Shardell M, Scharfstein DO, Vlahov D, and Galai N: "Inference for Cumulative Incidence Functions with Informatively Coarsened Discrete Event-Time Data," Statistics in Medicine 27:5861-5879, 2008.
  68. Brotman RM, Klebanoff MA, Nansel T, Andrews WW, Zhang J, Schwebke JR, Kai FY, Zenilman JM, and Scharfstein DO: "A Longitudinal Study of Vaginal Douching and Disruption of Vaginal Flora - A Marginal Structural Modeling Analysis," American Journal of Epidemiology 168:188-196, 2008.
  69. Brotman RM, Ghanem KG, Klebanoff MA, Taha TE, Scharfstein DO, and Zenilman JM: "The Effect of Vaginal Douching Cessation on Bacterial Vaginosis: A Pilot Study," American Journal of Obstetrics and Gynecology 198:628.e1-628.e7, 2008.
  70. Bozzette SA, Ake CF, Tam HK, Phippard A, Cohen D, Scharfstein DO, and Louis TL: "Long term Survival and Serious Cardiovascular Events in HIV Patients Treated with Highly Active Antiretroviral Therapy," Journal of AIDS 47:338-341, 2008.
  71. Boult C, Reider L, Frey K, Leff B, Boyd CM, Wolff J, Wegener S, Marsteller J, Karm L, and Scharfstein DO: "The Early Effects of "Guided Care" on the Quality of Health Care for Multi-Morbid Older Persons: A Cluster-Randomized Controlled Trial," Journal of Gerontology: Medical Sciences 63A:321-327, 2008.
  72. Scharfstein DO, Ryea JL, and Caffo B: "Accounting for Within Patient Correlation in Assessing Relative Sensitivity of an Adjunctive Diagnostic Test," Statistics in Medicine 27:2110-2126, 2008.
  73. Mackenzie EJ, Rivara FP, Jukovich GJ, Nathens AB, Egleston BL, Salkever DS, and Scharfstein DO: "The Impact of Trauma Center Care on One-Year Functional Outcomes Following Major Lower Limb Trauma," Journal of Bone and Joint Surgery 90:101-109, 2008.
  74. Rivara FP, Mackenzie EJ, Jurkovich GJ, Nathens AB, Wang J, and Scharfstein DO: "Prevalence of pain in patients one year following major trauma," Archives of Surgery 143:282-287, 2008.
  75. Mackenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Weir S, and Scharfstein DO: "The National Study of the Costs and Outcomes of Trauma (with discussion)," Journal of Trauma 63:S54-67, 2007.
  76. Eaton WW, Kalaydijan A, Scharfstein DO, Mezuk B, and Ding Y: " Prevalence and Incidence of Depressive Disorder: the Baltimore ECA Follow-up, 1981-2204," Acta Psychiatrica Scandinavica 116:182-188, 2007.
  77. Minkovitz CS, Strobino D, Mistry KB, Scharfstein DO, Grason H, Hou W, Ialongo N, and Guyer B: "Healthy Steps for Young Children: Sustained Results at 5 ½ Years," Pediatrics 120:e658-e668, 2007.
  78. Li X, Caffo B, and Scharfstein DO: "On the Potential for Ill-logic with Logically Defined Outcomes," Biostatistics 8:800-804, 2007.
  79. Rotnitzky A, Farall A, Bergesio A, and Scharfstein DO: "Analysis of failure time data under competing censoring mechanisms," Journal of the Royal Statistical Society, Series B 69:307-327, 2007.
  80. Shardell M, Scharfstein DO, and Bozzette SA: "Survival Curve Estimation for Informatively Coarsened Discrete Time-to-Event Data," Statistics in Medicine 26:2184-2202, 2007.
  81. Egleston B, Scharfstein DO, Freeman E, and West S: "Causal Inference for Non-morbidity Outcomes in the Presence of Death," Biostatistics 8:526-545, 2007.
  82. Nathens AB, Rivera FP, Mackenzie EJ, Maier RV, Wang J, Egleston B, Scharfstein DO, and Jurkovich GJ: "The Impact of an Intensivist-Model ICU on Trauma-Related Mortality," Annals of Surgery 244:545-554, 2006.
  83. Scharfstein DO, Halloran ME, Chu H, and Daniels MJ: "On Estimation of Vaccine Efficacy Using Validation Samples with Selection Bias," Biostatistics 7:615-629, 2006.
  84. Hogan J and Scharfstein DO: "Estimating Causal Effects from Multiple Cycle Data in Studies of in vitro Fertilization (IVF)," Statistical Methods in Medical Research 15:195-209, 2006.
  85. Needham DM, Dennison CR, Dowdy DW, Mendez-Tellez PA, Ciesla N, Desai SV, Sevransky J, Shanholtz C, Scharfstein DO, Herridge MS, and Pronovost PJ: "Study Protocol: The Improving Care of Acute Lung Injury Patients (ICAP) Study," Critical Care 10:R9, 2006.
  86. Mackenzie EJ, Rivera FP, Jurkovich, Nathens AB, Frey KP, Egleston BJ, Salkever DS, and Scharfstein DO: "A National Evaluation of the Effect of Trauma Center Care on Mortality," New England Journal of Medicine 354: 366-378, 2005.
  87. Epstein JI, Sanderson H, Carter HB, Scharfstein DO: "The Utility of Saturation Biopsy to Predict Insignificant Cancer at Radical Prostatectomy," Urology 66:356-360, 2005.
  88. Minkovitz CS, Strobino D, Scharfstein DO, Hou W, Miller T, Mistry KB, and Schwartz K: "Maternal Depressive Symptoms and Children’s Receipt of Health Care in the First Three Years of Life," Pediatrics 115:306-314, 2005.
  89. Cotter DJ, Stefanik K, Zhang Y, Thamer M, Scharfstein DO, and Kaufman J: "Hematocrit was Not Validated as a Surrogate End Point for Survival Among Epoetin-treated Hemodialysis Patients," Journal of Clinical Epidemiology 57:1086-1095, 2004.
  90. McLearn KT, Strobino DM, Hughart N, Minkovitz CS, Scharfstein DO, Marks E, and Guyer B: "Developmental Services in Primary Care for Low-Income Children: Clinicians' Perceptions of the Healthy Steps for Young Children Program," Journal of Urban Health 81:206-221, 2004.
  91. Lin H, Scharfstein DO, and Rosenheck RA: "Analysis of Longitudinal Data with Irregular, Informative Follow-up," Journal of the Royal Statistical Society, Series B 66:791-813, 2004.
  92. Scharfstein DO, Manski CF, and Anthony JC: "On the Construction of Bounds in Prospective Studies with Missing Ordinal Outcomes: Application to the Good Behavior Game Trial," Biometrics 60:154-164, 2004.
  93. Minkovitz CS, Hughart N, Strobino D, Scharfstein DO, Grason H, Hou W, Miller T, Bishai D, Augustyn M, McLearn KT, and Guyer B: "A Practice-Based Intervention to Enhance Quality of Care in the First Three Years of Life: Results from the Healthy Steps for Young Children Program," Journal of the American Medical Association 290:3081-3091, 2003.
  94. Minkovitz C, Strobino D, Hughart N, Miller T, Scharfstein DO, Bishai D, and Guyer B: "Introduction of Developmental Specialists in Pediatrics Practices: Provider Perspectives from Healthy Steps," Ambulatory Pediatrics 3:295-303, 2003.
  95. Scharfstein DO and Irizarry R: "Generalized Additive Selection Models for the Analysis of Non-ignorable Missing Data," Biometrics 59:601-613, 2003.
  96. Scharfstein DO, Daniels M, and Robins JM: "Incorporating Prior Beliefs About Selection Bias in the Analysis of Randomized Trials with Missing Data," Biostatistics 4:495-512, 2003.
  97. Scharfstein DO and Robins JM: "Estimation of the Failure Time Distribution in the Presence of Informative Right Censoring," Biometrika 89:617-635, 2002.
  98. Scharfstein DO, Liang K-Y, Eaton W, and Chen L-S: "The Quadratic Cumulative Odds Regression Model for Scored Ordinal Outcomes: Application to Alcohol Dependence," Biostatistics 2:473-483, 2001.
  99. Minkovitz C, Strobino D, Hughart N, Scharfstein DO, and Guyer B: "Healthy Steps for Young Children Program," Archive of Pediatrics and Adolescent Medicine 155:475-479, 2001.
  100. Scharfstein DO, Robins JM, Eddings W, and Rotnitzky A: "Inference in Randomized Studies with Informative Censoring and Discrete Time-to-Event Endpoints," Biometrics 57:404-413, 2001.
  101. Rotnitzky A, Scharfstein DO, Su TL, and Robins JM: "A Sensitivity Analysis Methodology for Randomized Trials with Potentially Non-ignorable Cause-Specific Censoring," Biometrics 57:103-113, 2001.
  102. Robins JM, Rotnitzky A, and Scharfstein DO: "Sensitivity Analysis for Selection Bias and Unmeasured Confounding in Missing Data and Causal Inference Models," Statistical Models for Epidemiology 1-94, 2000.
  103. Guyer B, Hughart N, Stronbino D, Jones A, and Scharfstein DO: "Assessing the Impact of Pediatric-Based Developmental Services on Infants, Families, and Clinicians: Challenges to Evaluating the Healthy Steps Program," Pediatrics, 105:e33, 2000.
  104. Scharfstein DO, Rotnitzky A, and Robins JM: "Adjusting for Non-ignorable Drop-out Using Semiparametric Non-response Models (with discussion)," Special Invited Paper for the Theory and Methods Section of Journal of the American Statistical Association 94:1096-1146, 1999.
  105. Rotnitzky A, Robins JM, and Scharfstein DO: "Semiparametric Regression for Repeated Outcomes with Non-ignorable Non-response," Journal of the American Statistical Association 93:1321-1339, 1998.
  106. Scharfstein DO, Tsiatis AA, and Gilbert P: "Semiparametric Efficient Estimation in the Generalized Odds‑Rate Class of Regression Models for Right‑Censored Time to Event Data," Lifetime Data Analysis 4:355-392, 1998.
  107. Scharfstein DO and Tsiatis AA: "The Use of Simulation and Bootstrap in Information‑Based Group Sequential Studies," Statistics in Medicine 17:75-87, 1998.
  108. Scharfstein DO, Tsiatis AA and Robins JM: "Semiparametric Efficiency and Its Implication on the Design and Analysis of Group Sequential Studies," Journal of the American Statistical Association 92:1342-1350, 1997.
  109. Scharfstein DO and Williams PL: "Design of Developmental Toxicity Studies for Assessing the Joint Effects of Dose and Duration," Risk Analysis 14:1057-1071, 1994.
  110. Catalano PJ, Ryan LM, and Scharfstein DO: "Modeling Fetal Death and Malformation in Developmental Toxicity Studies," Risk Analysis 14:629-637, 1994.
  111. Catalano PJ, Scharfstein DO, Ryan LM, Kimmel CA, and Kimmel GL: "Statistical Model for Fetal Death, Fetal Weight, and Malformation in Developmental Toxicity Studies," Teratology 47:281-290, 1993.

MONOGRAPHS

  1. The Prevention and Treatment of Missing Data in Clinical Trials, Panel on Handling Missing Data in Clinical Trials, Committee on National Statistics, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies, Washington, DC, 2010.

BOOK CHAPTERS

  1. Scharfstein DO, Zhu Y, Tsiatis AA: "Survival Analysis" in Handbook of Statistical Methods for Randomized, Controlled Trials, K. Kim, F. Bretz, K. Cheung, L. Hampson, Editors, Chapman & Hall, 2016.

LETTERS TO THE EDITOR

  1. Ogburn EL, Bierer BE, Brookmeyer R, Choirat C, Dean NE, DeGruttola V, Ellenberg SS, Halloran ME, Hanley DF, Lee JK, Wang R, Scharfstein DO: "Aggregating Data from COVID-19 Trials,"" Science 368: 1198-1199, 2020.
  2. Lunardon N and Scharfstein DO: Comment on "Small Sample GEE Estimation of Regression Parameters for Longitudinal Data," Statistics in Medicine 36:3596-3600, 2017.
  3. Kharrazi H, Wang C, Scharfstein DO: "Prospective EHR-Based Prospective Clinical Trials: The Challenge of Missing Data," Journal of General Internal Medicine 29:976-978, 2014.
  4. Scharfstein DO, Boyd CM, Wolff JL, and Boult C: Comment on Peikes et al. "Early Evaluations of the Medical Home: Building on a Promising Start," The American Journal of Managed Care 18:2012.

SOFTWARE

  1. McDermott A and Scharfstein DO: SAMON – Sensitivity Analysis Tool for Analyzing Repeated Measures Studies with Missing Data. Available at http://www.missingdatamatters.org. Also available on CRAN.
  2. Wang C, Colantuoni EA, Leroux A, Scharfstein DO: idem – An R Package for Inferences in Clinical Trials with Death and Missingness. Available on CRAN.

OTHER

  1. Scharfstein DO: "Analytical Performance Measures for the Miniload Automated Storage and Retrieval Systems," Masters Thesis, Georgia Institute of Technology, 1990.