Research Topics
Species | John M LachinSummaryAffiliation: George Washington University Country: USA Publications
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Publications
A review of methods for futility stopping based on conditional powerJohn M Lachin
The Biostatistics Center, Department of Epidemiology and Biostatistics, The George Washington University, Rockville, MD 20852, USA
Stat Med 24:2747-64. 2005..The implementation in conjunction with a group sequential analysis for effectiveness is also described...
Effect of glycemic exposure on the risk of microvascular complications in the diabetes control and complications trial--revisitedJohn M Lachin
The Biostatistics Center, The George Washington University, Rockville, MD 20852, USA
Diabetes 57:995-1001. 2008....
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metforminWilliam C Knowler
Diabetes Prevention Program Coordinating Center, Biostatistics Center, George Washington University, 6110 Executive Blvd, Suite 750, Rockville, MD 20852, USA
N Engl J Med 346:393-403. 2002..9 would have to receive metformin. CONCLUSIONS: Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin...- Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapyJohn M Lachin
The Biostatistics Center, The George Washington University, Rockville, MD 20852, USA
Clin J Am Soc Nephrol 6:1032-40. 2011..Herein, we examine differences in albumin excretion, renal function (estimated GFR), and BP over 5 years between treatment groups... - Operating characteristics of sample size re-estimation with futility stopping based on conditional powerJohn M Lachin
The Biostatistics Center, Department of Epidemiology and Biostatistics and Statistics, The George Washington University, Rockville, MD 20852, USA
Stat Med 25:3348-65. 2006..Sample size re-estimation procedures should be used with caution and the impact on the overall type II error probability should be assessed... - Parametric survival models for interval-censored data with time-dependent covariatesYvonne H Sparling
The Biostatistics Center, Department of Biostatistics and Epidemiology, School of Public Health and Health Services, The George Washington University, Rockville, MD 20852, USA
Biostatistics 7:599-614. 2006.... - Power and sample size evaluation for the Cochran-Mantel-Haenszel mean score (Wilcoxon rank sum) test and the Cochran-Armitage test for trendJohn M Lachin
The Biostatistics Center, Departments of Epidemiology and Biostatistics and Statistics, The George Washington University, Rockville, MD, 20852, USA
Stat Med 30:3057-66. 2011..Herein, it is shown that the power of the test is a function of the slope of the response probabilities over the ordinal scores assigned to the groups that yields simple expressions for the power of the test... - Factors associated with diabetes onset during metformin versus placebo therapy in the diabetes prevention programJohn M Lachin
d, Diabetes Prevention Program Coordinating Center, The Biostatistics Center, George Washington University, 6110 Executive Blvd, Suite 750, Rockville, MD 20852, USA
Diabetes 56:1153-9. 2007.... - A composite design for transition from a preliminary to a full-scale studyJohn M Lachin
The Biostatistics Center, Department of Epidemiology and Biostatistics, The George Washington University, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852, USA
Stat Med 26:5014-32. 2007..We also discuss the practical considerations in the implementation of the design... - Comparison of urinary albumin-creatinine ratio and albumin excretion rate in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications studyNaji Younes
Biostatistics Center, George Washington University, 6110 Executive Boulevard, Suite 700, Rockville, MD 20852 USA
Clin J Am Soc Nephrol 5:1235-42. 2010..The objective of this study was to compare random urine albumin-creatinine ratio (ACR) with timed urine albumin excretion rate (AER) in patients with type 1 diabetes... - Antidepressant medicine use and risk of developing diabetes during the diabetes prevention program and diabetes prevention program outcomes studyRichard R Rubin
Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Diabetes Care 33:2549-51. 2010..To assess the association between antidepressant medicine use and risk of developing diabetes during the Diabetes Prevention Program (DPP) and Diabetes Prevention Program Outcomes Study (DPPOS)... - Differences in A1C by race and ethnicity among patients with impaired glucose tolerance in the Diabetes Prevention ProgramWilliam H Herman
Department of Internal Medicine and Epidemiology, University of Michigan Health System, Ann Arbor, Michigan, USA
Diabetes Care 30:2453-7. 2007..We sought to examine racial and ethnic differences in A1C in individuals with impaired glucose tolerance (IGT)... - Costs associated with the primary prevention of type 2 diabetes mellitus in the diabetes prevention programWilliam H Hernan
The Diabetes Prevention Program Coordinating Center, Biostatistics Center, George Washington University, Rockville, Maryland 20852, USA
Diabetes Care 26:36-47. 2003..To describe the costs of the Diabetes Prevention Program (DPP) interventions to prevent or delay type 2 diabetes... - Effect of weight loss with lifestyle intervention on risk of diabetesRichard F Hamman
Diabetes Prevention Program Coordinating Center, The Biostatistics Center, George Washington University, 6110 Executive Blvd, Suite 750, Rockville, MD 20852, USA
Diabetes Care 29:2102-7. 2006..We explored the contribution of changes in weight, diet, and physical activity on the risk of developing diabetes among ILS participants... - Sample size requirements for studies of treatment effects on beta-cell function in newly diagnosed type 1 diabetesJohn M Lachin
The Biostatistics Center, The George Washington University, Rockville, Maryland, United States of America
PLoS ONE 6:e26471. 2011..These results provide the information needed to accurately evaluate the sample size for studies of new agents to preserve C-peptide levels in newly diagnosed type 1 diabetes... - The hemoglobin glycation index is not an independent predictor of the risk of microvascular complications in the Diabetes Control and Complications TrialJohn M Lachin
The Biostatistics Center, George Washington University, Rockville, MD 20852, USA
Diabetes 56:1913-21. 2007..The HGI should not be used to estimate risk of complications or to guide therapy... - Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetesCarla J Greenbaum
TrialNet Publications, The Biostatistics Center, Rockville, Maryland, USA
Diabetes Care 31:1966-71. 2008..The Type 1 Diabetes TrialNet Research Group and the European C-peptide Trial (ECPT) Study Group conducted parallel randomized studies to compare the sensitivity, reproducibility, and tolerability of these procedures... - Futility interim monitoring with control of type I and II error probabilities using the interim Z-value or confidence limitJohn M Lachin
The Biostatistics Center, Departments of Epidemiology and Biostatistics, and Statistics, The George Washington University, Rockville 20852, MD, USA
Clin Trials 6:565-73. 2009..Each such assumption will yield a different conditional power value... - Maximum information designsJohn M Lachin
The Biostatistics Center, Department of Epidemiology and Biostatistics, The George Washington University, Rockville, Maryland 20852, USA
Clin Trials 2:453-64. 2005..Thus, the actual information to be accrued and the associated level of power are random variables with sample variation... - TCF7L2 polymorphism, weight loss and proinsulin:insulin ratio in the diabetes prevention programJeanne M McCaffery
The Biostatistics Center, The George Washington University, Rockville, Maryland, United States of America
PLoS ONE 6:e21518. 2011..Here we sought to test whether these effects were apparent in high-risk individuals and modify treatment responses... - Sample size evaluation for a multiply matched case-control study using the score test from a conditional logistic (discrete Cox PH) regression modelJohn M Lachin
Department of Epidemiology and Biostatistics, The Biostatistics Center, The George Washington University, Rockville, MD 20852, USA
Stat Med 27:2509-23. 2008..Examples are presented for a nested case-control study and a multiply matched case-control study... - Conflicts of interest in data monitoring of industry versus publicly financed clinical trialsJohn M Lachin
The Biostatistics Center, Department of Epidemiology and Biostatistics, The George Washington University, Rockville, MD 20857, USA
Stat Med 23:1519-21. 2004..However, the Guidance should heighten the awareness of all investigators in public trials to the potential for the appearance of conflicts and to the need for full and open participation in the management of dualities of interest... - Group sequential large sample T2-like chi2 tests for multivariate observationsJohn M Lachin
The Biostatistics Center, The George Washington University, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852, USA
Stat Med 22:3357-68. 2003..An example is presented using the analysis of repeated cholesterol measurements in a clinical trial... - The role of measurement reliability in clinical trialsJohn M Lachin
The Biostatistics Center, Departments of Epidemiology and Biostatistics and Statistics, The George Washington University, Rockville, MD 20852, USA
Clin Trials 1:553-66. 2004.... - A tribute to Samuel W. GreenhouseJohn M Lachin
The Biostatistics Center, The George Washington University, USA
Stat Med 22:3267-76. 2003 - Over-ruling a group sequential boundary--a stopping rule versus a guidelineK K Gordon Lan
Pfizer Global Research and Development, 50 Pequot Avenue, New London, CT 06320, USA
Stat Med 22:3347-55. 2003..In this sense, one still has a stopping boundary rather than simply a guideline. This concept is discussed relative to monitoring procedures for inferiority or futility, and cases where both an upper and lower boundary are employed... - Insulin therapy, hyperglycemia, and hypertension in type 1 diabetes mellitusIan H De Boer
Division of Nephrology, University of Washington, Box 356521, 1959 NE Pacific St, Seattle, WA 98117, USA
Arch Intern Med 168:1867-73. 2008..Diabetes mellitus and hypertension are closely linked, but the long-term blood pressure effects of glucose-lowering therapy and hyperglycemia are not clear... - A diabetes outcome progression trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetesGiancarlo Viberti
Guy s, King s, and St Thomas School of Medicine, King s College, London, U K
Diabetes Care 25:1737-43. 2002.... - Extension of type 2 diabetes genome-wide association scan results in the diabetes prevention programAllan F Moore
Center for Human Genetic Research, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
Diabetes 57:2503-10. 2008.... - Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT)Steven E Kahn
Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, Washington 98108, USA
Diabetes Care 31:845-51. 2008..The purpose of this study was to examine possible factors associated with the increased risk of fractures observed with rosiglitazone in A Diabetes Outcome Progression Trial (ADOPT)... - Obesity is a major determinant of the association of C-reactive protein levels and the metabolic syndrome in type 2 diabetesSteven E Kahn
Department of Internal Medicine, Division of Metbolism, Endocrinology and Nurtrition, VA Puget Sound Health Care System, 151, 1660 S Columbian Way, Seattle, WA 98108, USA
Diabetes 55:2357-64. 2006..Further, for CRP and fibrinogen this relationship is determined by body adiposity and not by insulin sensitivity or glucose control... - A risk score for type 1 diabetes derived from autoantibody-positive participants in the diabetes prevention trial-type 1Jay M Sosenko
Division of Endocrinology, University of Miami, P O Box 016960 D110, Miami, FL 33101, USA
Diabetes Care 31:528-33. 2008..The accurate prediction of type 1 diabetes is essential for appropriately identifying prevention trial participants. Thus, we have developed a risk score for the prediction of type 1 diabetes... - Multiple superoxide dismutase 1/splicing factor serine alanine 15 variants are associated with the development and progression of diabetic nephropathy: the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications GHussam Al-Kateb
Program in Genetics and Genome Biology, The Hospital for Sick Children, TMDT Building East Tower, Rm 15 707, 101 College St, Toronto, Ontario, Canada
Diabetes 57:218-28. 2008..Despite familial clustering of nephropathy and retinopathy severity in type 1 diabetes, few gene variants have been consistently associated with these outcomes... - Biological variation in HbA1c predicts risk of retinopathy and nephropathy in type 1 diabetes: response to McCarter et alSaul Genuth
Diabetes Care 28:233; author reply 234-5. 2005 - Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetesDavid M Nathan
N Engl J Med 353:2643-53. 2005..We studied whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial (DCCT) affected the long-term incidence of cardiovascular disease... - Glycemic durability of rosiglitazone, metformin, or glyburide monotherapySteven E Kahn
Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle 98108, USA
N Engl J Med 355:2427-43. 2006..The efficacy of thiazolidinediones, as compared with other oral glucose-lowering medications, in maintaining long-term glycemic control in type 2 diabetes is not known... - The effect of intensive glycemic treatment on coronary artery calcification in type 1 diabetic participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) StudyPatricia A Cleary
Diabetes Unit, Massachusetts General Hospital, 32 Fruit St, Boston, MA 02114-2698, USA
Diabetes 55:3556-65. 2006..Prior intensive diabetes treatment during the DCCT was associated with less atherosclerosis, largely because of reduced levels of A1C during the DCCT... - The effect of intensive diabetes treatment on resting heart rate in type 1 diabetes: the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications studyAndrew D Paterson
Program in Genetics and Genomic Biology, The Hospital for Sick Children, TMDT Building East Tower, Room 15 707, 101 College St, Toronto, ON M5G 1L7, Canada
Diabetes Care 30:2107-12. 2007..We hypothesized that intensive diabetes treatment aimed to achieve normal A1C levels has an effect on RHR in individuals with type 1 diabetes... - C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001Jerry P Palmer
Department of Medicine, University of Washington, and DVA Puget Sound Health Care System, Seattle, Washington 98108, USA
Diabetes 53:250-64. 2004..The development of therapies for addressing this important unmet clinical need will be facilitated by trials that are carefully designed with beta-cell function as determined by C-peptide measurement as the primary efficacy outcome...