Self Controlled Methodology in Pharmacoepidemiology

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Material Information

Title:
Self Controlled Methodology in Pharmacoepidemiology the Case Time Control and Self Controlled Case Series
Physical Description:
1 online resource (145 p.)
Language:
english
Creator:
Bird, Steven T
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:
SEGAL,RICHARD
Committee Members:
DELANEY,JOSEPH
BRUMBACK,BABETTE A
ETMINAN,MAHYAR

Subjects

Subjects / Keywords:
fluoroquinolones -- pharmacoepidemiology -- self-controlled
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:
Self controlled, within patient methodology has become increasingly common in pharmacoepidemiologic studies, partially attributable to its implicit adjustment for time invariant confounders. Pairing traditional study designs (e.g. case control, cohort) with within patient analysis (e.g. case time control, self controlled case series) can enhance insight into a drug safety question given the contrasting strengths and weaknesses of these designs. The case control and the case time control share a similar sampling strategy and can be conducted using the same cases and controls. We demonstrated pairing of these designs, where both designs observed an approximate two fold increased rate ratio for acute kidney injury with fluoroquinolones. The cohort and self controlled case series also share a similar sampling strategy. We demonstrated pairing of these designs, whereby both techniques identified an approximate two fold increased rate ratio for hypotension during the eight weeks after initiating and restarting tamsulosin therapy. In these studies, concordance of results with two analytic techniques strengthened the robustness of study conclusions. Discordant results however can be challenging to interpret and leave uncertainty for the true association. We provide insight and explore potential explanations for discordance when using between and within patient designs as coanalytic techniques. We also quantified risk window bias in a simulation study to emphasize the importance of basing the duration of selected risk windows on prior clinical knowledge of the safety issue. Some exposure outcome associations will be more amenable to between patient analysis, others will be more applicable to within patient analysis, and many questions will be answerable by both techniques. Within patient analysis should be considered when there is no acceptable active comparator, the drug exposure is transient, the outcome onsets acutely, and between patient confounding is of greater concern than within patient confounding. Conversely, the ideal design is a between patient analysis when an active comparator is available, the exposure is chronic, the outcome is immediate or delayed, and time varying confounding within patients is present to a greater extent than confounding between patients. Selecting an ideal study design is vital to elucidating an accurate exposure outcome association, and when appropriate, pairing within and between patient designs can enhance insight into a drug safety question.
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 Steven T Bird.
Thesis:
Thesis (Ph.D.)--University of Florida, 2014.
Local:
Adviser: HARTZEMA,ABRAHAM G.
Local:
Co-adviser: SEGAL,RICHARD.
Electronic Access:
RESTRICTED TO UF STUDENTS, STAFF, FACULTY, AND ON-CAMPUS USE UNTIL 2015-05-31

Record Information

Source Institution:
UFRGP
Rights Management:
Applicable rights reserved.
Classification:
lcc - LD1780 2014
System ID:
UFE0046450:00001