Core B, Data Management and Biostatistics Core will be responsible for study design, data collection, database management, as well as power and statistical analysis for the Projects. This Core will be headed up by Keith E. Muller, PhD, Professor in the Department of Health Outcomes Policy. He has over 30 years experience leading the biostatistics cores of clinical investigations. Of his 100+ publications, 50% are in sample size research and physiological modeling.
Aim 1. Data Management. The data management activities of this core will be led by Xuerong Wen, a certified Oracle Database Developer and a full time biostatistician at the University of Florida. Data management tasks will include designing the data collection form, data entry and quality control. Data intregity will be ensured through the use of range and logic checking of data at the time of entry. Throughout the entire process of data entiy, Xuerong will work weekly in the Analytical core to oversee data entry, screen validation, producing quality assurance checks, and suggesting any protocol changes necessary to improve data quality. She will work closely with the biostatisticians managing the core to ensure the study designs and objectives are met. We will utilize the University of Florida's Clinical and Translational Research Informatics Program because it has a powerful, reliable and secure computer environment for storing large sets of data.
Aim 2. Biostatistics. In addition to Dr. Muller, additional support will be provided by Wei Hou, PhD, a biostatistician in the Division. The biostatistical team will create operational definitions for outcome variables and other covariates, analyze pilot/exploratory studies to obtain data useful for planning future studies, perform power analyses and calculate appropriate sample sizes for comparing primary outcome measures, monitor and measure protocol deviations and assess the potential impact of any deviations on the studies, conduct statistical analysis for conclusions of research hypotheses, develop new methods when traditional methods fail to address the research questions, and support manuscript writing and statistical section writing for future grant proposals.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Program Projects (P01)
Project #
5P01HD065647-03
Application #
8509748
Study Section
Special Emphasis Panel (ZHD1-DSR-Z)
Project Start
Project End
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$129,120
Indirect Cost
$52,348
Name
University of Florida
Department
Type
DUNS #
969663814
City
Gainesville
State
FL
Country
United States
Zip Code
32611
Floyd, Erin G; von Versen-Höynck, Frauke; Liu, Jing et al. (2016) Collection of pregnancy outcome records following infertility-challenges and possible solutions. J Assist Reprod Genet 33:993-9
Rabaglino, Maria B; Post Uiterweer, Emiel D; Jeyabalan, Arun et al. (2015) Bioinformatics approach reveals evidence for impaired endometrial maturation before and during early pregnancy in women who developed preeclampsia. Hypertension 65:421-9
Baker, Valerie L; Brown, Morton B; Luke, Barbara et al. (2015) Gonadotropin dose is negatively correlated with live birth rate: analysis of more than 650,000 assisted reproductive technology cycles. Fertil Steril 104:1145-52.e1-5
Baker, Valerie L; Brown, Morton B; Luke, Barbara et al. (2015) Association of number of retrieved oocytes with live birth rate and birth weight: an analysis of 231,815 cycles of in vitro fertilization. Fertil Steril 103:931-938.e2
Lathi, Ruth B; Chi, Yueh-Yun; Liu, Jing et al. (2015) Frozen blastocyst embryo transfer using a supplemented natural cycle protocol has a similar live birth rate compared to a programmed cycle protocol. J Assist Reprod Genet 32:1057-62
Andridge, Rebecca R; Shoben, Abigail B; Muller, Keith E et al. (2014) Analytic methods for individually randomized group treatment trials and group-randomized trials when subjects belong to multiple groups. Stat Med 33:2178-90
Simpson, Sean L; Edwards, Lloyd J; Styner, Martin A et al. (2014) Separability tests for high-dimensional, low sample size multivariate repeated measures data. J Appl Stat 41:2450-2461
Conrad, Kirk P; Davison, John M (2014) The renal circulation in normal pregnancy and preeclampsia: is there a place for relaxin? Am J Physiol Renal Physiol 306:F1121-35
Gribbin, Matthew J; Chi, Yueh-Yun; Stewart, Paul W et al. (2013) Confidence regions for repeated measures ANOVA power curves based on estimated covariance. BMC Med Res Methodol 13:57
Conrad, Kirk P; Baker, Valerie L (2013) Corpus luteal contribution to maternal pregnancy physiology and outcomes in assisted reproductive technologies. Am J Physiol Regul Integr Comp Physiol 304:R69-72