International Public Health Commons^™

Research Support Infrastructure: Implementing A Clinical Research Coordinating Center, Julio A. Ramirez, Paula Peyrani, William A. Mattingly, Forest W. Arnold, Timothy L. Wiemken, Robert R. Kelley, Leslie A. Wolf, Ruth M. Carrico, The Clinical Research Coordinating Center Team

The University of Louisville Journal of Respiratory Infections

Insufficient infrastructure is one of the challenges facing investigators in the field of clinical research. At the University of Louisville (UofL) Division of Infectious Diseases, we developed a multidisciplinary coordinating center with the aim to support investigators in all aspects of the clinical research process. The objective of this article is to describe the composition and the role of the different units of the UofL Clinical Research Coordinating Center. The different components of the Center can serve as a template for institutions interested in developing a clinical research support infrastructure.

Clinical Research: From Idea To Publication, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Julio A. Ramirez, M.D., FACP, Professor of Medicine/Associate Professor of Microbiology and Immunology; Chief, Division of Infectious Diseases; Director, Infectious Diseases Fellowship Training Program and Founding Director, Global Health Initiative at The University of Louisville, presented "Clinical Research: From Idea to Publication" at University of Louisville Department of Medicine Grand Rounds on February 15, 2018. The talk focused on performing an overview of clinical study designs, describing the planning and performing of a clinical study, reviewing the process for statistical and clinical analysis, and presenting the structure of a Clinical Research Coordinating Center.

Research Support Infrastructure: Implementing A Clinical Research Coordinating Center, Julio A. Ramirez, Paula Peyrani, William A. Mattingly, Forest W. Arnold, Timothy L. Wiemken, Robert R. Kelley, Leslie A. Wolf, Ruth M. Carrico, Andrea Reyes-Vega

Faculty and Staff Scholarship

Insufficient infrastructure is one of the challenges facing investigators in the field of clinical research. At the University of Louisville (UofL) Division of Infectious Diseases, we developed a multidisciplinary coordinating center with the aim to support investigators in all aspects of the clinical research process. The objective of this article is to describe the composition and the role of the different units of the UofL Clinical Research Coordinating Center. The different components of the Center can serve as a template for institutions interested in developing a clinical research support infrastructure.

Piloting Carestart™ Rapid Diagnostic Test (Rdt) To Promote Glucose-6-Phosphate Dehydrogenase (G6pd) Screening In Malaria Endemic Community In Cambodia, Bertha Nyagaya-Wojnarski, +Several Additional Authors

GW Research Days 2016 - 2020

Background: Primaquine (PQ) is the only FDA-approved drug for radical cure of Plasmodium vivax (P.v) malaria, but treatment can result in life-threatening hemolysis if given to a glucose-6-phosphate dehydrogenase deficient (G6PDd) patient. Therefore, the G6PD status of the patient with P.v must be known prior to prescribing PQ. However, a patient’s G6PD status in rural malaria endemic settings is generally unknown, illuminating the need for reliable point of care G6PD diagnostic tests as a prerequisite to safely administer PQ. To increase community PQ access in Cambodia, performance of CareStart™ G6PD rapid diagnostic tests (RDTs) needs to …

Designing A Social Norms-Based Intervention To Reduce Anemia In India: A Formative Research Protocol, Aika Aluc, Erica Sedlander, Rajiv N. Rimal, Sameera A. Talegawkar, Hagere Yilma, Wolfgang Munar

GW Research Days 2016 - 2020

Background: Economic and gender inequalities are important determinants of anemia in low and middle income countries. Gender dimensions of food security contribute to the undernutrition among women. More than half of women of reproductive age in India are anemic. Anemia causes increased risk of preterm delivery, higher maternal mortality and contributes to fatigue, which influences women’s work productivity. The World Health Organization (WHO) recommends daily oral iron and folic acid (IFA) supplements during pregnancy and weekly supplements for women of reproductive age. Despite the efforts of government programs and global donors to reduce anemia in India, both initial uptake and …

How Collective Norms And Media Use Affect Attitudes About Violence Against Women And Contraception Use In Sub-Saharan Africa, Erica Sedlander, Rajiv N. Rimal

GW Research Days 2016 - 2020

Background: Contraceptive use and attitudes about violence against women, though enacted at the individual level, are also driven by factors at the interpersonal and social levels. The role of mass media in promoting social norms surrounding these attitudes and behaviors has not received much scholarly attention but can be helpful to illuminate areas for intervention.

Hypothesis: We proposed and tested the hypothesis that collective norms (defined as a groups aggregate behavior or attitudes) would be associated with individual level attitudes (tolerance towards violence against women) and behaviors (contraception use). This relationship was further hypothesized to vary by media use, such …

Prevalence Of Diabetes Mellitus, Hypertension, And Dyslipidemia In Student-Run Screening Clinics For Rural Communities In The Sierra Norte Of Puebla, Mexico, Sean Navin, Daniel M. Tomaszewski

Pharmacy Faculty Articles and Research

Background: The growing prevalence of hypertension (HTN), diabetes mellitus (DM), and in Mexico highlights the need for preventative health care services. Rural communities worldwide lack access to such services. The purpose of this study was to describe the prevalence of HTN, DM, and dyslipidemia in student-run screening clinics in rural communities of the Sierra Norte of Puebla, Mexico to better understand the role the clinics play for the patients served.

Methods: Data were collected from patients from rural, Mexican towns participating in free pharmacy student-run screening clinics. Patients consented to have their de-identified information pooled for re-search. Screenings …

Designing A Socio-Normative Intervention To Reduce Anemia In Odisha India: A Formative Research Protocol [Version 1; Referees: 2 Approved], Erica Sedlander, Rajiv N Rimal, Sameera A Talegawkar, Hagere Yilma, Wolfgang Munar

Prevention and Community Health Faculty Publications

Background: More than half of women of reproductive age in India are anemic. Anemia is associated with increased risk of preterm delivery, higher maternal mortality and contributes to fatigue, which affects women’s work productivity. The World Health Organization (WHO) recommends daily oral iron and folic acid (IFA) supplements during pregnancy and weekly supplements for women of reproductive age. Government programs and global donors have distributed and promoted IFA supplements in India for over four decades. However, initial intake and compliance remain inadequate.
Objectives: This protocol describes the formative research phase of a larger study, which will test, through a randomized …

Addressing Hydrocephaly In Viet Nam: A Plausible Prevention And Intervention Medical Support Program Proposal, Chelle Mcintyre-Brewer

UNO Student Research and Creative Activity Fair

Families affected by hydrocephalus in Viet Nam have few options for sustainable treatment for a myriad of reasons, primarily centering on barriers to care prevalent to minority, underserved, and economically disadvantaged populations. High morbidity and abandonment rates often result from these circumstances. An interdisciplinary examination of the factors contributing to causal concerns reveals unique cultural considerations, language and literacy barriers, ethnic and geographic differences, as well as economic and governmental issues greatly impacting patient outcome for this condition. The author contends that a program that addresses sociological concerns, along with the medical treatment of the patient, proffers the opportunity for …

Qualitative Evaluation Of The Saleema Campaign To Eliminate Female Genital Mutilation And Cutting In Sudan., Andrea C Johnson, W Douglas Evans, Nicole Barrett, Howida Badri, Tamador Abdalla, Cody Donahue

Prevention and Community Health Faculty Publications

BACKGROUND: Female genital mutilation and cutting (FGM/C, herein FGM) is a widespread and harmful practice. The Government developed a national campaign in Sudan, called Saleema, to change social norms discouraging FGM. Saleema translates to being "whole", healthy in body and mind, unharmed, intact, pristine, and untouched, in a God-given condition. An interim evaluation was conducted using focus groups among Sudanese adults. The primary aim was to explore perceptions of the Saleema poster exemplars and to assess if the desired themes were being communicated. Secondary aims were to understand more about participants' information sources, values, and suggestions for the campaign broadly. …

Somalia: Rift Valley Fever, Alyson Meeks

Global Public Health

This walks readers through the basic demographics of Somalia, a country located in the horn of Africa. After learning about the government in Somalia and the problems that the people of the country face, this focuses on the problem of Rift Valley Fever. Rift Valley Fever is a virus that year after year strikes Somalia and surrounding countries. Weather patterns seem to help predict when Rift Valley Fever will be at the highest risk for an outbreak. This outlines the steps the current government and people are trying to take to help prevent outbreaks of RVF. But the solutions currently …

Microcephaly, Christianne E. Albers

Global Issues in Public Health

Microcephaly is a noncommunicable condition causing the head of an infant to be smaller than what is typical. Microcephaly can cause delays in developmental milestones and/or can cause other conditions such as epilepsy, cerebral palsy, learning disabilities, hearing loss and vision problems. Microcephaly is found more frequently in certain populations of the world than others, specifically those with an increased number of cases with Zika virus. Women need to take preventative measures to ensure their unborn child is safe from the Zika virus. The Zika virus is not the only way microcephaly can occur. Many other causes like exposure to …

Gender-Transformative Bandebereho Couples' Intervention To Promote Male Engagement In Reproductive And Maternal Health And Violence Prevention In Rwanda: Findings From A Randomized Controlled Trial., Kate Doyle, Ruti G Levtov, Gary Barker, Gautam G Bastian, Jeffrey B Bingenheimer, Shamsi Kazimbaya, Anicet Nzabonimpa, Julie Pulerwitz, Felix Sayinzoga, Vandana Sharma, Dominick Shattuck

Prevention and Community Health Faculty Publications

BACKGROUND: Rigorous evidence of the effectiveness of male engagement interventions, particularly on how these interventions impact relationship power dynamics and women's decision-making, remains limited. This study assessed the impact of the Bandebereho gender-transformative couples' intervention on impact on multiple behavioral and health-related outcomes influenced by gender norms and power relations.

METHODS: We conducted a multi-site randomised controlled trial in four Rwandan districts with expectant/current fathers and their partners, who were randomised to the intervention (n = 575 couples) or control group (n = 624 couples). Primary outcomes include women's experience of physical and sexual IPV, women's attendance and men's accompaniment …

Factors Associated With Iron-Folic Acid Supplement Use Among Pregnant Women In Karu, Nasarawa State, Nigeria - A Cross Sectional Study Using Theory Of Planned Behavior, Toyin O. Akomolafe

College of Graduate Studies: Theses & Dissertations

Introduction: Iron-folic acid supplementation is one of the key interventions provided during antenatal care (ANC) services to reduce iron deficiency, maternal anemia, low birthweight and other pregnancy-related complications responsible for maternal and neonatal mortality. However, use of iron-folic acid supplements and adherence with recommended dosage in Nigeria is low. The purpose of this cross-sectional study was to examine factors associated with iron-folic acid supplements use among pregnant women in Karu local government area (LGA), Nasarawa, Nigeria. Methods: Questionnaires were administered in face-to-face interviews with 64 pregnant women (18 – 49 years old) and 19 healthcare providers in selected …

Perceptions Of Health Professionals In Ghana On The Role Of The Community In Chronic Disease Management, Jesuseme Omoruan

College of Graduate Studies: Theses & Dissertations

The prevalence of chronic disease has been on the rise in various developing countries. This study is an exploratory investigation of the perceptions of health professionals in Kumasi, Ghana on the role of the community in chronic disease management. Using the Chronic Care Model as a framework, the objective of the study was to examine the extent of community-healthcare system in chronic disease management and to explore the barriers to and facilitators of community involvement in chronic disease management. By exploring the availability of community resources that positively contribute to the management of these patients, the study fills an existing …

Women's Lives In Times Of Zika, Ana Rosa Linde, Carlos Eduardo Siqueira

Gastón Institute Publications

Zika virus infection during pregnancy is a cause of congenital brain abnormalities. Its consequences to pregnancies has made governments, national and international agencies issue advices and recommendations to women. There is a clear need to investigate how the Zika outbreak affects the decisions that women take concerning their lives and the life of their families, as well as how women are psychologically and emotionally dealing with the outbreak. We conducted a qualitative study to address the impact of the Zika epidemic on the family life of women living in Brazil, Puerto Rico, and the US, who were affected by it …

Preliminary Evaluation Of An Lyta Pcr Assay For Detection Of Streptococcus Pneumoniae In Urine Specimens From Hospitalized Patients With Community-Acquired Pneumonia, Subathra Marimuthu, James T. Summersgill, Kuldeep Ghosh, Leslie A Wolf

The University of Louisville Journal of Respiratory Infections

Community acquired pneumonia (CAP) due to Streptococcus pneumoniae still occurs in at risk populations, despite the availability of effective vaccines. Laboratory confirmation of S. pneumoniae remains challenging in cases of CAP despite advances in blood culture techniques and the availability of nucleic acid amplification tests such as PCR-based methods. Urine specimens are an attractive sample type because they are non-invasive compared to bronchial washes or whole blood specimens for patients with CAP. While urine specimens have been used successfully in antigen detection assays, they have not been extensively evaluated for PCR-based assays. In this preliminary study, we evaluated the potential …

Distributing Data And Analysis Software Containers For Better Data Sharing In Clinical Research, William A. Mattingly Phd, Stephen Furmanek, Christopher M. Sinclair, Timothy L. Wiemken Phd

The University of Louisville Journal of Respiratory Infections

Introduction: Data sharing in clinical research is critical for increasing knowledge discovery. Data and software tools should be FAIR: Findable, Accessible, Inter-operable and Re-usable. Many bottlenecks exist in the process of a clinical investigator using shared data including data acquisition and statistical analysis. The objective of this project is to develop a structure for sharing data and providing rapid automated statistical analysis through creation of a pre-packaged, open-source software container.

Methods: We use the open source software container technologies VirtualBox and Vagrant to create a template for sharing clinical data and analysis scripts as a single container. We use …

Rationale And Methods Of The Study Protocol: Streptococcus Pneumoniae Serotypes In Adults 18 Years And Older With Radiographically-Confirmed Community-Acquired Pneumonia (Cap), Ronika Alexander, Paula Peyrani, Julio A. Ramirez, Wesley H. Self Md, Mph, Carlos Grijalva, Francis Counselman, Gregory A. Volturo, Heidi Kabler, Luis Ostrosky-Zeichner, Richard Wunderink, Robert L. Sherwin, Senen Pena, Thomas File, Timothy L. Wiemken, Sharon Gray, Michael Pride, Kimbal D. Ford, Qin Jiang, Raul Isturiz

The University of Louisville Journal of Respiratory Infections

This study was an active, prospective surveillance study of adults 18 years and older hospitalized with community-acquired pneumonia (CAP) due to Streptococcus pneumoniae conducted at 21 hospitals in ten cities across the United States. This report describes the surveillance methodology applied between October 7, 2013 and September 30, 2016, including the identification and description of surveillance areas and populations at-risk for CAP hospitalization for estimation of incidence rates for selected study sites.

Streptococcus Pneumoniae Antigen, Missing Opportunities Of A Promising Point Of Care Diagnostic Test, Magdelina Słomka, Ruby Gupta, Baltej Singh, Venkatesh Gondhi, Siddartha Bhandary, Ekezie Francis, Jose Bordon

The University of Louisville Journal of Respiratory Infections

Background: The etiologic diagnosis of community acquired pneumonia (CAP) and community-acquired meningitis (CAM) are still far from optimal accuracy and turnaround time. The most common bacterial pathogen identified in both CAP and CAM is Streptococcus pneumoniae.

Methods: We reviewed the literature on S. pneumoniae antigen to highlight opportunities to optimize its use as a point of care diagnostic test to maximize quality of patient care, antimicrobial stewardship outcomes and cost saving. A PubMed search was performed using key words “S. pneumoniae antigen; rapid diagnostic tests for S. pneumoniae”. We selected articles in English and sorted into randomized …

Level Of Recall Bias Regarding Pneumococcal Vaccination History Among Adults Hospitalized With Community-Acquired Pneumonia: Results From The University Of Louisville Pneumonia Study, Sarah Van Heiden, Ruth Carrico, Timothy L. Wiemken, Ronika Alexander, John M. Mclaughlin, Qin Jiang, Paula Peyrani, William A. Mattingly, Stephen P. Furmanek, Connor L. English, Senen Pena, Raul Isturiz, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Background: Recall bias is likely to occur in vaccine effectiveness studies using self-reported vaccination history. The validity of patient-reported vaccination status for adults is not well defined. The objective of this study was to evaluate the validity of self-reported pneumococcal vaccination history among patients hospitalized with community-acquired pneumonia (CAP).

Methods: Prospective ancillary study of a population-based observational study of hospitalized patients with CAP in the city of Louisville. To be included in the analysis, patients had to (i) be reached by phone 30-days after discharge from the hospital and (ii) report that they remembered whether or not they received a …

One-Year Mortality In Patients With Community-Acquired Pneumonia, Paula Peyrani, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Pneumonia remains a common cause of morbidity and mortality in the US. Although, communityacquired pneumonia (CAP) has traditionally been considered an acute process, more recently, data have emerged showing that patients surviving an episode of CAP are at increased risk of death long after hospital discharged. In this descriptive review, we examine the current knowledge of long-term mortality and propose a hypothesis explaining the pathogenesis of long-term mortality in patients with CAP.

Most Common Statistical Methodologies In Recent Clinical Studies Of Community-Acquired Pneumonia, Stephen Furmanek, Connor L. English, Thomas Chandler, Timothy L. Wiemken Phd

The University of Louisville Journal of Respiratory Infections

Background: Training new individuals in pneumonia research is imperative to produce a new generation of clinical investigators with the expertise necessary to fill gaps in knowledge. Clinical investigators are often intimidated by their unfamiliarity with statistics. The objective of this study is to define the most common statistical methodologies in recent clinical studies of CAP to inform teaching approaches in the field.

Methods: Articles met inclusion criteria if they were clinical research with an emphasis on incidence, epidemiology, or patient outcomes, searchable via PubMed or Google Scholar, published within the timeframe of January 1st 2012 to August 1st 2017, …

Pneumonia Pathogenesis And The Lung Microbiome: Back To The Drawing Board, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

No abstract provided.

Antimicrobial Stewardship In Hospitalized Patients With Respiratory Infections: Ten-Year Experience From The Robley Rex Louisville Va Medical Center, Leslie A. Beavin, Forest W. Arnold, Paula Peyrani, Anupama Raghuram, David Newman, Ronald Smith, Carmen Sciortino, Stephen P. Furmanek, Ruth M. Carrico, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Rationale: Antibiotic stewardship has been defined as coordinated interventions designed to improve and measure the appropriate use of antibiotic agents. Respiratory infections are the most common infectious reason for hospitalization in the United States. Therefore, one could extrapolate that respiratory infections are then also the most common reason for hospital antibiotic use and possess the highest potential for hospital antibiotic misuse. The primary objective of this article was to evaluate the role of antimicrobial stewardship on improving antibiotic use for respiratory infections in hospitalized patients on intravenous (IV) antibiotics at the Robley Rex Louisville VAMC over a 10-year period.

Methods: …

Community-Based Distribution Of Iron-Folic Acid Supplementation In Low- And Middle-Income Countries: A Review Of Evidence And Programme Implications., Justine A Kavle, Megan Landry

Prevention and Community Health Faculty Publications

The present literature review aimed to review the evidence for community-based distribution (CBD) of iron–folic acid (IFA) supplementation as a feasible approach to improve anaemia rates in low- and middle-income countries.

The literature review included peer-reviewed studies and grey literature from PubMed, Cochrane Library, LILAC and Scopus databases.

Low- and middle-income countries.

Non-pregnant women, pregnant women, and girls.

CBD programmes had moderate success with midwives and community health workers (CHW) who counselled on health benefits and compliance with IFA supplementation. CHW were more likely to identify and reach a greater number of women earlier in pregnancy, as women tended to …

Building Healthy Futures: Two Students’ Experiences With Global Health In Rural Ecuador, Varsha Kumar, Daniel Shyu

Purdue Journal of Service-Learning and International Engagement

This article highlights two students’ experience on Timmy Global Health’s medical brigade to Quito, Ecuador. Timmy is a nonprofit, Indiana-based organization dedicated to advocacy, service, and fundraising on a domestic and global scale. Every year, Timmy sends a group of sixteen students and medical professionals to Quito, Ecuador, over Purdue’s spring break to treat people in underserved communities who otherwise would not have access to quality health care. On this medical brigade, Timmy students travel to a different location each day for a week, set up clinic, and diagnose, treating nearly 100 patients a day. Those with conditions too complex …

Lung Cytokines And Systemic Inflammation In Patients With Copd, Alessandra Morello Gearhart, Rodrigo Cavallazzi, Paula Peyrani, Timothy L. Wiemken, Stephen P. Furmanek, Andrea Reyes-Vega, Umair Gauhar, Hiram Rivas-Perez, Jesse Roman, Julio A. Ramirez, Rafael Fernandez-Botran

The University of Louisville Journal of Respiratory Infections

Rationale: Chronic obstructive pulmonary disease (COPD) is characterized by lung and systemic inflammation. The role of cytokines in local and systemic inflammation in COPD is not well understood. This study aimed to compare plasma and bronchoalveolar lavage (BAL) fluid cytokine levels in COPD and non-COPD subjects with the intent of better understand their potential roles in driving local and systemic inflammation.

Methods: This cross-sectional study analyzed data from 65 subjects: 31 with COPD confirmed by spirometry and 34 non-COPD controls. All subjects underwent spirometry, plasma sample collection, and bronchoscopy/BAL. Levels of 21 inflammatory cytokines were measured in the plasma (systemic …

Using Steroids In Patients With Community-Acquired Pneumonia At The University Of Louisville Hospital: Who, What, And When, Rodrigo Cavallazzi, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

No abstract provided.

Lung Cytokines And Systemic Inflammation In Patients With Copd., Alessandra Morello Gearhart, Rodrigo Cavallazzi, Paula Peyrani, Timothy L. Wiemken, Stephen P. Furmanek, Andrea Reyes-Vega, Umair Gauhar, Hiram Rivas-Perez, Jesse Roman, Julio A. Ramirez, Rafael Fernandez-Botran

Faculty and Staff Scholarship

Rationale: Chronic obstructive pulmonary disease (COPD) is characterized by lung and systemic inflammation. The role of cytokines in local and systemic inflammation in COPD is not well understood. This study aimed to compare plasma and bronchoalveolar lavage (BAL) fluid cytokine levels in COPD and non-COPD subjects with the intent of better understand their potential roles in driving local and systemic inflammation.

Methods: This cross-sectional study analyzed data from 65 subjects: 31 with COPD confirmed by spirometry and 34 non-COPD controls. All subjects underwent spirometry, plasma sample collection, and bronchoscopy/BAL. Levels of 21 inflammatory cytokines were measured in the plasma (systemic …