? Core B The goal of the Biostatistics Core B is to provide comprehensive biostatistical and data management support to the Program Project, ?Bridging physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery?. The overarching goal of this program is to study the impact of intra- abdominal pressure, physical activity and muscular strength on pelvic floor support and symptoms and the cultural context in which women experience those changes, in order to develop interventions that will prevent women from developing end-stage pelvic disorders such as pelvic organ prolapse. The scope of this project is relevant to NICHD's described mission and specifically addresses pelvic floor disorders, as emphasized in the portfolio of the Gynecologic Health and Disease Branch. Core B will be responsible for overseeing study design, data collection, database management, and statistical analysis for the Projects. Core Leader Marlene Egger, PhD, Professor in the Department of Family and Preventive Medicine Division of Public Health and biostatistician in the University of Utah Study Design and Biostatistics Center (SDBC), has 35 years' experience in statistical collaboration with medical research projects and direction of Biostatistics Cores, including multi-institutional and single-institution studies. She will be assisted by Core B Associate Director Xiaoming Sheng PhD as well as a master's level statistician and master's level programmer, with additional statistical expertise for specific projects available from the SDBC.
The aims of Core B are to promote high-quality: 1) Study design and implementation; 2) Data management; 3) Statistical analysis; and 4) Dissemination of results. Core B has been integrally involved in assisting each project during preparation with study design, sample size and power calculations, and data analysis planning. Core B will design data collection forms, data entry systems and quality control measures. Core B will use the University of Utah Health Sciences Center's secure computer systems that maximize computational efficiency and speed of access for datasets of all sizes. Core B will work regularly with Core C to oversee data entry, screen validation, produce quality assurance checks, and suggest protocol changes necessary to improve data quality. Core B will operationalize and implement definitions of outcome variables, exposures, and other covariates; perform power analyses and calculate appropriate sample sizes for testing outcome measures; analyze studies; and monitor protocol deviations and assess their potential impact. Core B will conduct statistical analysis of the research hypotheses, tailor or develop new methods as appropriate when traditional methods fail to address the research questions, and support manuscript writing and statistical section writing of reports.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Program Projects (P01)
Project #
5P01HD080629-05
Application #
9746526
Study Section
Special Emphasis Panel (ZHD1)
Project Start
Project End
2021-06-30
Budget Start
2019-07-01
Budget End
2020-06-30
Support Year
5
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Utah
Department
Type
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
Shaw, Janet M; Johnson, Danielle D; Nygaard, Ingrid E (2018) Engaging Undergraduate Kinesiology Students in Clinically-Based Research. Quest 70:292-303
Saltzman, Hanna M; Egger, Marlene J; Bardsley, Tyler et al. (2018) Differences in Pelvic Floor Symptoms During Pregnancy Between Hispanic and Non-Hispanic White Women. Female Pelvic Med Reconstr Surg :
Hsu, Yvonne; Hitchcock, Robert; Niederauer, Stefan et al. (2018) Variables Affecting Intra-abdominal Pressure During Lifting in the Early Postpartum Period. Female Pelvic Med Reconstr Surg 24:287-291
Clark, Lauren; Birkhead, Ana Sanchez; Fernandez, Cecilia et al. (2017) A Transcription and Translation Protocol for Sensitive Cross-Cultural Team Research. Qual Health Res 27:1751-1764
Niederauer, Stefan; de Gennaro, Johanna; Nygaard, Ingrid et al. (2017) Development of a novel intra-abdominal pressure transducer for large scale clinical studies. Biomed Microdevices 19:80
de Gennaro, Johanna Day; de Gennaro, Claire K; Shaw, Janet M et al. (2017) The Relationship Between Intra-Abdominal Pressure and Body Acceleration During Exercise. Female Pelvic Med Reconstr Surg :
Nygaard, Ingrid E; Clark, Erin; Clark, Lauren et al. (2017) Physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery: a protocol for a mixed-methods prospective cohort study. BMJ Open 7:e014252
Shaw, Janet M; Nygaard, Ingrid E (2017) Role of chronic exercise on pelvic floor support and function. Curr Opin Urol 27:257-261
Nygaard, Ingrid E; Shaw, Janet M (2016) Physical activity and the pelvic floor. Am J Obstet Gynecol 214:164-171