Combining Adverse Perinatal Outcomes for Women Exposed to Antiepileptic Drugs during Pregnancy, Using a Latent Trait Model

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Material Information

Title:
Combining Adverse Perinatal Outcomes for Women Exposed to Antiepileptic Drugs during Pregnancy, Using a Latent Trait Model
Physical Description:
1 online resource (175 p.)
Language:
english
Creator:
Wen, Xuerong
Publisher:
University of Florida
Place of Publication:
Gainesville, Fla.
Publication Date:

Thesis/Dissertation Information

Degree:
Doctorate ( Ph.D.)
Degree Grantor:
University of Florida
Degree Disciplines:
Pharmaceutical Sciences, Pharmaceutical Outcomes and Policy
Committee Chair:
HARTZEMA,ABRAHAM G
Committee Co-Chair:
DELANEY,JOSEPH
Committee Members:
SEGAL,RICHARD
BRUMBACK,BABETTE A
MEADOR,KIMFORD J

Subjects

Subjects / Keywords:
aed -- birth -- combining -- defects -- ltm -- outcomes
Pharmaceutical Outcomes and Policy -- Dissertations, Academic -- UF
Genre:
Pharmaceutical Sciences thesis, Ph.D.
bibliography   ( marcgt )
theses   ( marcgt )
government publication (state, provincial, terriorial, dependent)   ( marcgt )
born-digital   ( sobekcm )
Electronic Thesis or Dissertation

Notes

Abstract:
Application of Latent Variable Models (LVMs) in medical research is becoming increasingly popular. The objective of this study was to employ an LVM in a drug safety study to produce an overall index of adverse perinatal and pregnancy outcome (APO) from four observed component outcomes, including birth defects (BD), abnormal conditions of new borns (ACNB), pregnancy and obstetric complications (PC/OC), and low birth weights (LBW). The validity and reliability of the combined outcome were assessed in accordance with the psychometric theory and the assumptions of the latent variable. Unidimentionality, local independence, internal homogeneity, and construct validity were evaluated using factor analysis, Q3 statistics, and Spearman correlation. The association between infant birth defects and maternal exposure to Antiepileptic drugs (AEDs) or Vaproic Acid (VPA) has been widely investigated. Previous studies reported the significant adverse effects of maternal exposure to AEDs during pregnancy on all four component outcomes, whereas, the significant adverse effects of VPA mainly on one component, BD, specifically neural tube defects. Therefore, AED and VPA, which are representations of two different scenarios of relationships with the component oucomes, were employed in this study to validate the component selection for the combined outcome.  The change of utilization trends for AED polytherapy in 2007 possibly caused by the FDA black box warning for lamortrigine and birth defects was identified in this study. Our findings suggest that combining BD, ACNB, PC/OC, and LBW can generate a valid assessment of overall severity of adverse perinatal and pregnant outcome and the overall adverse effects of AEDs on both mothers and infants. However, caution needs to be taken for combining outcomes. Adding a component outcome that is not associated with the specific drug exposure may mask the relationship between the combined outcome and drug exposure. Therefore, evaluation of the selected components is essential to ensure the validity of the combined outcome.   Future studies are warranted for utilizing the latent variable model with more components, and weighted severity for each component.
General Note:
In the series University of Florida Digital Collections.
General Note:
Includes vita.
Bibliography:
Includes bibliographical references.
Source of Description:
Description based on online resource; title from PDF title page.
Source of Description:
This bibliographic record is available under the Creative Commons CC0 public domain dedication. The University of Florida Libraries, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.
Statement of Responsibility:
by Xuerong Wen.
Thesis:
Thesis (Ph.D.)--University of Florida, 2013.
Local:
Adviser: HARTZEMA,ABRAHAM G.
Local:
Co-adviser: DELANEY,JOSEPH.
Electronic Access:
RESTRICTED TO UF STUDENTS, STAFF, FACULTY, AND ON-CAMPUS USE UNTIL 2014-12-31

Record Information

Source Institution:
UFRGP
Rights Management:
Applicable rights reserved.
Classification:
lcc - LD1780 2013
System ID:
UFE0046207:00001