Valerie L Durkalski
Affiliation: Medical University of South Carolina
- The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomesKyra M Garofolo
Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Charleston, SC 29425, USA
Trials 14:98. 2013..This research aims to investigate the effect of covariate adjustment in the responder analysis framework in order to determine the appropriate analytic method...
- Analysis of clustered matched-pair data for a non-inferiority study designValerie L Durkalski
TCIG STATS, The Clinical Innovation Group, MUSC Foundation for Research Development, Charleston, SC, USA
Stat Med 22:279-90. 2003..This paper proposes a Wald-type test statistic for a non-inferiority hypothesis and applies it to the comparison of two diagnostic procedures...
- Analysis of clustered matched-pair dataValerie L Durkalski
The Clinical Innovation Group TCIG, Medical University of South Carolina, Foundation for Research Development, Charleston, SC 29401, USA
Stat Med 22:2417-28. 2003..Using Monte Carlo simulation, the size and power of the proposed test are compared to those of two currently available methods. To illustrate practical application, clustered matched-pair data from two clinical studies are analysed...
- Challenges in the design and analysis of non-inferiority trials: a case studyValerie Durkalski
Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, SC 29425 8150, USA
Clin Trials 8:601-8. 2011..To date, there has been relatively little in the literature documenting actual experiences with implementing available methodology for non-inferiority trials...
- A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depressionValerie Durkalski
Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA
Clin Trials 7:174-82. 2010..Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost...
- Re-formulating non-inferiority trials as superiority trials: The case of binary outcomesValerie L Durkalski
Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, 29425 8150, USA
Biom J 51:185-92. 2009....
- Measuring episodic abdominal pain and disability in suspected sphincter of Oddi dysfunctionValerie Durkalski
Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, 135 Cannon Street, Ste 303, Charleston, SC 29425, United States
World J Gastroenterol 16:4416-21. 2010..To evaluate the reliability of an instrument that measures disability arising from episodic abdominal pain in patients with suspected sphincter of Oddi dysfunction (SOD)...
- Computed tomographic colonography (virtual colonoscopy): a multicenter comparison with standard colonoscopy for detection of colorectal neoplasiaPeter B Cotton
Department of Gastroenterology, The Digestive Disease Center, Medical University of South Carolina, Charleston 29425, USA
JAMA 291:1713-9. 2004..Computed tomographic colonography (CTC), also known as virtual colonoscopy, has been reported to be reasonably accurate in the diagnosis of colorectal neoplasia in studies performed at expert centers...
- Open-label trial of escitalopram in the treatment of posttraumatic stress disorderSophie Robert
Mental Health Service, Ralph H Johnson VA Medical Center, Charleston, SC 29401, USA
J Clin Psychiatry 67:1522-6. 2006..Its S-enantiomer escitalopram, which may have faster onset and greater magnitude of effect than citalopram in other conditions, has not yet been investigated in PTSD...
- Therapeutic inertia is an impediment to achieving the Healthy People 2010 blood pressure control goalsEni C Okonofua
Medical University of South Carolina, Charleston, SC 29425, USA
Hypertension 47:345-51. 2006..TI has a major impact on BP control in hypertensive subjects receiving regular care. Reducing TI is critical in attaining the Healthy People 2010 goal of controlling hypertension in 50% of all patients...
- Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetesLeonard E Egede
Center for Disease Prevention and Health Interventions for Diverse Populations, Ralph H, Johnson VAMC, Charleston, SC, USA
Trials 11:35. 2010..This study provides a unique opportunity to address this gap in the literature...
- Nosocomial infections due to methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus: relationships with antibiotic use and cost driversPatrick D Mauldin
Department of Clinical Pharmacy and Outcome Sciences, College of Pharmacy, Medical University of South Carolina, Charleston, SC 29425, USA
Ann Pharmacother 42:317-26. 2008....
- The virtual colonoscopy study: a large multicenter clinical trial designed to compare two diagnostic screening proceduresValerie L Durkalski
TCIG STATS, The Clinical Innovation Group, MUSC Foundation for Research and Development, The Medical University of South Carolina, Charleston, SC, USA
Control Clin Trials 23:570-83. 2002..Strategies for the design and implementation of the study are shared as well as the challenges encountered...
- Analysis of trichotomous pharmaceutical endpointsVance W Berger
Biometry Research Group, National Cancer Institute, University of Maryland, Baltimore County, Maryland, USA
J Biopharm Stat 15:739-45. 2005..The purpose of this paper is to fill this gap by offering an objective approach for parameter selection, and to provide real data examples to illustrate the use of this objective approach...