Research Topics
Species | Michael ProschanSummaryAffiliation: National Institutes of Health Country: USA Publications
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How much effect of different antihypertensive medications on cardiovascular outcomes is attributable to their effects on blood pressure?Michael Proschan
National Institute of Allergy and Infectious Diseases, Bethesda, MD, U S A
Stat Med 32:884-97. 2013..The purpose of this paper was to delineate the problems inherent in attempting to answer this question, and to present analyses intended to overcome these problems. Copyright © 2012 John Wiley & Sons, Ltd...
Cluster without fluster: The effect of correlated outcomes on inference in randomized clinical trialsMichael Proschan
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
Stat Med 27:795-809. 2008..It is nonetheless possible to obtain a 'bad' randomization such that members of a cluster tend to be assigned to the same treatment. Conditioned on such a bad randomization, the type 1 error rate is increased...- Sample size re-estimation in clinical trialsMichael A Proschan
National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892 7609, USA
Biom J 51:348-57. 2009..Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexible methods for sample size re-estimation when the outcome is continuous... - Two-stage sample size re-estimation based on a nuisance parameter: a reviewMichael A Proschan
National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA
J Biopharm Stat 15:559-74. 2005..This paper reviews two-stage methods based on estimation of nuisance parameters in either a continuous or dichotomous outcome setting... - Adaptive regressionMichael A Proschan
National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA
J Biopharm Stat 15:593-603. 2005..Are these methods valid? Is there a valid way to analyze such data? These are some of the questions we address... - Estimating the probability of toxicity at the target dose following an up-and-down designMario Stylianou
Office of Biostatistics Research, National Heart, Lung, and Blood Institute NIH, 6701 Rockledge Drive, Room 8220, Bethesda, MD 20892, U S A
Stat Med 22:535-43. 2003..We then derive, using bootstrap methods, an estimate of the probability of toxicity at the recommended dose. Small sample properties of this estimator are also evaluated. Published in 2003 by John Wiley & Sons, Ltd... - Minimize the use of minimization with unequal allocationMichael Proschan
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700A Rockledge Drive, Room 5140, Bethesda, Maryland 20892 7609, USA
Biometrics 67:1135-41. 2011..We show that minimization applied with unequal allocation causes problems that challenge this conventional wisdom... - Normalization of B cell counts and subpopulations after antiretroviral therapy in chronic HIV diseaseSusan Moir
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
J Infect Dis 197:572-9. 2008..However, little is known regarding the effect of antiretroviral therapy (ART)-induced decrease in HIV viremia on B cell numbers and subpopulations... - Conditioning in 2 x 2 tablesMichael A Proschan
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, MSC 7609, Bethesda, Maryland 20892 7609, USA
Biometrics 65:316-22. 2009..We give several biostatistics examples to illustrate the complexities of analyzing what appear to be simple data... 
Evidence for HIV-associated B cell exhaustion in a dysfunctional memory B cell compartment in HIV-infected viremic individualsSusan Moir
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
J Exp Med 205:1797-805. 2008..These data suggest that HIV-associated premature exhaustion of B cells may contribute to poor antibody responses against HIV in infected individuals...- IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infectionIrini Sereti
National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892, USA
Blood 113:6304-14. 2009..Thus, rhIL-7 has a biologic and toxicity profile suggesting a potential for therapeutic trials in HIV infection and other settings of lymphopenia. This clinical trial has been registered at http://www.clinicaltrials.gov under NCT0099671... - Does treatment effect depend on control event rate? Revisiting a meta-analysis of suicidality and antidepressant use in childrenMichael A Proschan
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
Clin Trials 7:109-17; discussion 118-120. 2010..Presenting data from a previously published meta-analysis of the effect of antidepressants in children on suicidality, they suggest a relationship between the control event rate and relative risk... - Practical midcourse sample size modification in clinical trialsMichael A Proschan
National Heart, Lung, and Blood Institute, Bethesda, MD, USA
Control Clin Trials 24:4-15. 2003..We show how to compute the p value and confidence interval for this two-stage procedure. If the original sample size is maintained, analysis of the data is the same as for a fixed sample procedure... - Combining treatment selection and definitive testingMichael A Proschan
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700A Rockledge Drive, Bethesda, MD, USA
Biom J 48:690-2; discussion 693-6. 2006.... - Individual blood pressure responses to changes in salt intake: results from the DASH-Sodium trialEva Obarzanek
Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 8136, MSC 7936, Bethesda, MD 20892 7936, USA
Hypertension 42:459-67. 2003.... - Multiple outputation: inference for complex clustered data by averaging analyses from independent dataDean Follmann
National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive MSC 7609, Bethesda, Maryland 20892, USA
Biometrics 59:420-9. 2003..It is especially suited to settings where methods for clustered data are impractical, but can also be applied generally as a quick and simple tool... - Chop-lump tests for vaccine trialsDean Follmann
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, MSC 7609, Bethesda, Maryland 20892, USA
Biometrics 65:885-93. 2009..The chop-lump tests are compared to established tests via simulation for planned HIV and malaria vaccine trials. A reanalysis of the first phase III HIV vaccine trial is used to illustrate the method... - Clinical trial results applied to management of the individual cancer patientIsmail Jatoi
Department of Surgery, National Naval Medical Center and The Uniformed Services University, 4301 Jones Bridge Road, Bethesda, Maryland, 20814, USA
World J Surg 30:1184-9. 2006..If the test for subgroup interaction is significant, then the effects of treatment may indeed differ between subgroups of patients, but this should be confirmed in other trials before a treatment is implemented in clinical practice... - Comparison of two or more measurement techniques to a standardMichael A Proschan
National Heart, Lung, and Blood Institute, USA
Contemp Clin Trials 27:472-82. 2006..If two methods have similar and small absolute bias, the one yielding a smaller variance of differences is preferred. We derive methods of comparing absolute biases, variances of errors, and parameters that combine biases and variances... - CD4 and CD8 T cell immune activation during chronic HIV infection: roles of homeostasis, HIV, type I IFN, and IL-7Marta Catalfamo
Clinical and Molecular Retrovirology Section, Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
J Immunol 186:2106-16. 2011..CD4 T cell subsets also showed enhanced STAT1 phosphorylation in response to exogenous IL-7... - HIV/Hepatitis C virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more frequently incur interferon-related adverse events than nonresponders doAnu Osinusi
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
J Acquir Immune Defic Syndr 53:357-63. 2010..This study aimed to assess the relationship between interferon (IFN)-related adverse effects and Hepatitis C virus (HCV) virologic response in HIV/HCV-coinfected individuals treated with pegylated interferon and ribavirin... - Interleukin 7 reduces the levels of spontaneous apoptosis in CD4+ and CD8+ T cells from HIV-1-infected individualsLia Vassena
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
Proc Natl Acad Sci U S A 104:2355-60. 2007..These results provide a further rationale for consideration of IL-7 as an agent of immune reconstitution in HIV-1 infection... - Immunodeficiency and intrinsic IFN resistance are associated with viral breakthrough to HCV therapy in HIV-coinfected patientsVeronique Nussenblatt
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20892, USA
AIDS Res Hum Retroviruses 23:1354-9. 2007..HIV/HCV-coinfected patients have a high rate of VB on PEG-IFN/RBV therapy characterized by higher levels of IFIG expression, immunodeficiency, and hepatic inflammation. Novel strategies are required for the treatment of persons with VB... - Randomized trials of breast-conserving therapy versus mastectomy for primary breast cancer: a pooled analysis of updated resultsIsmail Jatoi
Department of Surgery, National Naval Medical Center and The Uniformed Services University, Bethesda, Maryland, USA
Am J Clin Oncol 28:289-94. 2005..935-1.224; P = 0.33). This pooled analysis confirms that MT and BCT have comparable effects on mortality, even after long-term follow up. However, BCT is associated with a significantly greater risk of locoregional recurrence... - Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristicsLaura P Svetkey
Duke Hypertension Center and Sarah W Stedman Center for Nutritional Studies, Duke University Medical Center, Durham, NC, USA
Ann Epidemiol 13:462-71. 2003..To describe PREMIER, a randomized trial to determine the effects of multi-component lifestyle interventions on blood pressure (BP)... - Effect of the dietary approaches to stop hypertension diet and reduced sodium intake on blood pressure controlLaura P Svetkey
Duke Hypertension Center, Duke University Medical Center, Durham, NC 27710, USA
J Clin Hypertens (Greenwich) 6:373-81. 2004..BP became normal or optimal in 71% of persons consuming the control/lower sodium diet and 77% of persons consuming the DASH/lower sodium diet. Both the DASH diet and reduced sodium intake improved BP control... - Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trialPatricia J Elmer
Kaiser Permanente Northwest, Portland, Oregon 97227, USA
Ann Intern Med 144:485-95. 2006..CONCLUSIONS: Over 18 months, persons with prehypertension and stage 1 hypertension can sustain multiple lifestyle modifications that improve control of blood pressure and could reduce the risk for chronic disease... - Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trialFrans H H Leenen
University of Ottawa Heart Institute, Ottawa, Ontario, Canada
Hypertension 48:374-84. 2006..Some, but not all, of these differences may be explained by less effective blood pressure control in the lisinopril arm...