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Optimizing a Disease Severity Scale for Evaluating Travelers' Diarrhea in Adults Nicole Maier Walden University

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Optimizing a Disease Severity Scale for Evaluating Travelers' Diarrhea in Adults Nicole Maier Walden University Walden University ScholarWorks Walden Dissertations and Doctoral Studies Walden Dissertations and Doctoral Studies Collection 2019 Optimizing a Disease Severity Scale for Evaluating Travelers' Diarrhea in Adults Nicole Maier Walden University Follow this and additional works at: https://scholarworks.waldenu.edu/dissertations Part of the Epidemiology Commons This Dissertation is brought to you for free and open access by the Walden Dissertations and Doctoral Studies Collection at ScholarWorks. It has been accepted for inclusion in Walden Dissertations and Doctoral Studies by an authorized administrator of ScholarWorks. For more information, please contact [email protected]. Walden University College of Health Sciences This is to certify that the doctoral dissertation by Nicole Maier has been found to be complete and satisfactory in all respects, and that any and all revisions required by the review committee have been made. Review Committee Dr. Srikanta Banerjee, Committee Chairperson, Public Health Faculty Dr. Aimee Ferraro, Committee Member, Public Health Faculty Dr. Rabeh Hijazi, University Reviewer, Public Health Faculty Chief Academic Officer Eric Riedel, Ph.D. Walden University 2019 Abstract Optimizing a Disease Severity Scale for Evaluating Travelers’ Diarrhea in Adults by Nicole Maier MS, George Washington University, 2007 BS, Mary Washington College, 2004 Dissertation Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy Public Health - Epidemiology Walden University August 2019 Abstract Primary efficacy endpoints for interventional products targeting travelers’ diarrhea (TD) prevention have been predominately based on stool frequency. However, reliance on stool-based endpoints alone may obscure potentially meaningful differences in illness profiles. A single, standardized scoring system optimized for use in adult travelers is needed to accurately measure TD severity and enable more robust estimates of treatment or intervention effectiveness. The purpose of this quantitative secondary data analysis was to describe the variability in TD signs and symptoms across traditional severity metrics such as stool output, identify which symptoms were significantly associated with a negative impact on activity, and determine whether a TD scoring system that considers other symptomology could be optimized for use in future studies using the IRT and CTT frameworks. Data were obtained from two interventional studies: TrEAT TD, a multi-site TD treatment trial, and OEV-118—a placebo-controlled ETEC vaccine efficacy trial in travelers. Correlation, regression and multiple correspondence analyses were performed across multiple signs and symptoms to assess impact on activity and a TD severity score was established. Conclusions were (a) the new TD score significantly benefits the estimation of impact on activity over any individual sign or symptom, and (b) there was a benefit to reduction in overall TD disease severity when applied to a previously conducted vaccine efficacy trial. The use of a single optimized scoring system may better capture illness severity than commonly utilized metrics and moves the field towards current recommendations for TD management. Additionally, the use of the TD severity score may be an improved efficacy metric than stool frequency for future vaccine trials. Optimizing a Disease Severity Scale for Evaluating Travelers’ Diarrhea in Adults by Nicole Maier MS, George Washington University, 2007 BS, Mary Washington College, 2004 Dissertation Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy Public Health - Epidemiology Walden University August 2019 Table of Contents List of Tables ......................................................................................................... iv List of Figures ...................................................................................................... viii Chapter 1: Introduction ............................................................................................1 Study Background ..............................................................................................1 TD Epidemiology...............................................................................................2 TD Interventions ................................................................................................3 Scoring Systems and Challenges .......................................................................4 Problem Statement .............................................................................................6 Purpose ...............................................................................................................7 Research Questions and Hypotheses .................................................................7 Conceptual Framework ......................................................................................8 Nature of the Study ..........................................................................................10 Variables ....................................................................................................10 Definitions........................................................................................................11 Assumptions .....................................................................................................12 Limitations .......................................................................................................12 Delimitations ....................................................................................................14 Significance......................................................................................................14 Chapter 2: Literature Review .................................................................................17 Introduction ......................................................................................................17 Epidemiology .............................................................................................19 i Etiologies/Causative Agents ......................................................................21 TD Costs ....................................................................................................23 Clinical Syndromes/Presentation ...............................................................24 Impact on Activity .....................................................................................25 Prophylaxis and Treatment ........................................................................27 Prevention ..................................................................................................28 Measuring the Severity of TD Gastroenteritis .................................................30 Utility of Additional TD Symptomology ...................................................31 Existing Scoring Systems ................................................................................36 Scoring Systems in Pediatric Populations..................................................36 Scoring System Use in TD Studies ............................................................39 Scoring System Use in Challenge Studies .................................................40 Conceptual Framework ....................................................................................43 Scale Development Theories .....................................................................43 Conclusion .......................................................................................................46 Chapter 3: Research Method ..................................................................................48 Research Design and Rationale .......................................................................48 Research Questions and Hypotheses .........................................................49 Methodology ....................................................................................................50 Participants and Datasets .................................................................................50 Power Calculations ....................................................................................58 Instrumentation and Operationalization of Constructs ..............................58 ii Data Analysis Plan .....................................................................................63 Threats to Validity ...........................................................................................74 Ethical Procedures .....................................................................................76 Summary ..........................................................................................................78 Chapter 4: Results ..................................................................................................79 Secondary Data Analysis .................................................................................80 Quality Control ..........................................................................................80 Precursor Analyses.....................................................................................80 Quantitative Hypothesis Testing Analyses ................................................92 Summary of Results .......................................................................................136 Chapter 5: Summary, Conclusions, and Recommendations ................................137 Overview ........................................................................................................137
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