Medicine and Health Sciences Commons^™

Simulations For Designing And Interpreting Intervention Trials In Infectious Diseases., M Elizabeth Halloran, Kari Auranen, Sarah Baird, Nicole E Basta, Steven E Bellan, +Several Additional Authors

Global Health Faculty Publications

BACKGROUND: Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods.

DISCUSSION: Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, …

Weight Management And Physical Activity Throughout The Cancer Care Continuum., Wendy Demark-Wahnefried, Kathryn H Schmitz, Catherine M Alfano, Jennifer R Bail, Pamela J Goodwin, Cynthia A Thomson, Don W Bradley, Kerry S Courneya, Christie A Befort, Crystal S Denlinger, Jennifer A Ligibel, William H Dietz, Melinda R Stolley, Melinda L Irwin, Marcas M Bamman, Caroline M Apovian, Bernardine M Pinto, Kathleen Y Wolin, Rachel M Ballard, Andrew J Dannenberg, Elizabeth G Eakin, Matt M Longjohn, Susan D Raffa, Lucile L Adams-Campbell, Joanne S Buzaglo, Sharyl J Nass, Greta M Massetti, Erin P Balogh, Elizabeth S Kraft, Anand K Parekh, Darshak M Sanghavi, G Stephen Morris, Karen Basen-Engquist

Global Health Faculty Publications

Mounting evidence suggests that weight management and physical activity (PA) improve overall health and well being, and reduce the risk of morbidity and mortality among cancer survivors. Although many opportunities exist to include weight management and PA in routine cancer care, several barriers remain. This review summarizes key topics addressed in a recent National Academies of Science, Engineering, and Medicine workshop entitled, "Incorporating Weight Management and Physical Activity Throughout the Cancer Care Continuum." Discussions related to body weight and PA among cancer survivors included: 1) current knowledge and gaps related to health outcomes; 2) effective intervention approaches; 3) addressing the …

Nutritional Status Of Infants At Six Months Of Age Following Maternal Influenza Immunization: A Randomized Placebo-Controlled Trial In Rural Nepal., Joanne Katz, Janet A Englund, Mark C Steinhoff, Subarna K Khatry, Laxman Shrestha, Jane Kuypers, Luke C Mullany, Helen Y Chu, Steven C Leclerq, Naoko Kozuki, James M Tielsch

Global Health Faculty Publications

Background

Maternal influenza vaccination has increased birth weight in two randomized trials in South Asia but the impact on infant growth is unknown.

Methods

A randomized placebo-controlled trial of year round maternal influenza immunization was conducted in two annual cohorts in Sarlahi District, southern plains of Nepal, from April 2011 through April 2014. Infants born to women enrolled in the trial had weight, length, and head circumference measured at birth and 6 months of age. The study was powered for the 3 primary trial outcomes but not for stunting and wasting at 6 months of age.

Results

3693 women received …

Pertussis Seroepidemiology In Women And Their Infants In Sarlahi District, Nepal., Michelle M Hughes, Janet A Englund, Kathryn Edwards, Sandra Yoder, James M Tielsch, Mark Steinhoff, Subarna K Khatry, Steven C Leclerq, Joanne Katz

Global Health Faculty Publications

Background

Infants are at greatest risk for pertussis morbidity and mortality. Maternal vaccination during pregnancy has been shown to prevent pertussis in young infants in high- and middle-income countries. However, data on the levels of maternal pertussis antibodies and the efficiency of transplacental transfer in low-income South Asian settings are limited.

Objective

To estimate the prevalence of maternal pertussis antibodies and the efficiency of transplacental transfer in rural southern Nepal.

Design/methods

Paired maternal-infant blood samples were collected from a subsample of participants in a randomized, controlled trial of maternal influenza immunization (n = 291 pairs). Sera were tested by enzyme-linked …

Impact Of Maternal Vaccination Timing And Influenza Virus Circulation On Birth Outcomes In Rural Nepal., Naoko Kozuki, Joanne Katz, Janet A Englund, Mark C Steinhoff, Subarna K Khatry, Laxman Shrestha, Jane Kuypers, Luke C Mullany, Helen Y Chu, Steven C Leclerq, James M Tielsch

Global Health Faculty Publications

Objective

To describe the effect of maternal vaccination on birth outcomes in rural Nepal, modified by timing of vaccination in pregnancy and influenza virus activity.

Methods

A secondary analysis was conducted using data from two annual cohorts of a randomized controlled trial. A total of 3693 pregnant women from Sarlahi District were enrolled between April 25, 2011, and September 9, 2013. All participants were aged 15–40 years and received a trivalent inactivated influenza vaccine or placebo. The outcome measures included birth weight, pregnancy length, low birth weight (<2500 g), preterm birth, and small‐for‐gestational‐age birth.

Results

Data were available on birth weight for 2741 births and on …

When Is A Randomised Controlled Trial Health Equity Relevant? Development And Validation Of A Conceptual Framework., J Jull, M Whitehead, M Petticrew, E Kristjansson, D Gough, J Petkovic, J Volmink, C Weijer, M Taljaard, S Edwards, L Mbuagbaw, R Cookson, J Mcgowan, A Lyddiatt, Y Boyer, L G Cuervo, R Armstrong, H White, M Yoganathan, T Pantoja, B Shea, K Pottie, O Norheim, S Baird, B Robberstad, H Sommerfelt, Y Asada, G Wells, P Tugwell, V Welch

Global Health Faculty Publications

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.

METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.

RESULTS: A randomised trial can …

When Is A Randomised Controlled Trial Health Equity Relevant? Development And Validation Of A Conceptual Framework., J Jull, M Whitehead, M Petticrew, E Kristjansson, D Gough, J Petkovic, J Volmink, C Weijer, M Taljaard, S Edwards, L Mbuagbaw, R Cookson, J Mcgowan, A Lyddiatt, Y Boyer, L G Cuervo, R Armstrong, H White, M Yoganathan, T Pantoja, B Shea, K Pottie, O Norheim, S Baird, B Robberstad, H Sommerfelt, Y Asada, G Wells, P Tugwell, V Welch

Global Health Faculty Publications

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.

METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.

RESULTS: A randomised trial can …

Natural History Of Hpv Infection Across The Lifespan: Role Of Viral Latency., Patti E Gravitt, Rachel L Winer

Global Health Faculty Publications

Large-scale epidemiologic studies have been invaluable for elaboration of the causal relationship between persistent detection of genital human papillomavirus (HPV) infection and the development of invasive cervical cancer. However, these studies provide limited data to adequately inform models of the individual-level natural history of HPV infection over the course of a lifetime, and particularly ignore the biological distinction between HPV-negative tests and lack of infection (i.e., the possibility of latent, undetectable HPV infection). Using data from more recent epidemiological studies, this review proposes an alternative model of the natural history of genital HPV across the life span. We argue that …

Mhealth Intervention Is Effective In Creating Smoke-Free Homes For Newborns: A Randomized Controlled Trial Study In China., Shaohua Yu, Zongshuan Duan, Pamela B Redmon, Michael P Eriksen, Jeffrey P Koplan, Cheng Huang

Global Health Faculty Publications

Mobile-phone-based smoking cessation intervention has been shown to increase quitting among smokers. However, such intervention has not yet been applied to secondhand smoke (SHS) reduction programs that target smoking parents of newborns. This randomized controlled trial, undertaken in Changchun, China, assessed whether interventions that incorporate traditional and mobile-phone-based education will help create smoke-free homes for infants and increase quitting among fathers. The results showed that the abstinence rates of the fathers at 6 months (adjusted OR: 3.60, 95% CI: 1.41-9.25; p = 0.008) and 12 months (adjusted OR: 2.93, 95% CI: 1.24-6.94; p = 0.014) were both significantly increased in …

Estimates Of Burden And Consequences Of Infants Born Small For Gestational Age In Low And Middle Income Countries With Intergrowth-21(St) Standard: Analysis Of Cherg Datasets., Anne Cc Lee, Naoko Kozuki, Simon Cousens, Gretchen A Stevens, Hannah Blencowe, Mariangela F Silveira, Ayesha Sania, Heather E Rosen, Christentze Schmiegelow, Linda S Adair, Abdullah H Baqui, Fernando C Barros, Zulfiqar A Bhutta, Laura E Caulfield, Parul Christian, Siân E Clarke, Wafaie Fawzi, Rogelio Gonzalez, Jean Humphrey, Lieven Huybregts, Simon Kariuki, Patrick Kolsteren, John Lusingu, Dharma Manandhar, Aroonsri Mongkolchati, Luke C Mullany, Richard Ndyomugyenyi, Jyh Kae Nien, Dominique Roberfroid, Naomi Saville, Dianne J Terlouw, James M Tielsch, Cesar G Victora, Sithembiso C Velaphi, Deborah Watson-Jones, Barbara A Willey, Majid Ezzati, Joy E Lawn, Robert E Black, Joanne Katz

Global Health Faculty Publications

Objectives To estimate small for gestational age birth prevalence and attributable neonatal mortality in low and middle income countries with the INTERGROWTH-21st birth weight standard.

Design Secondary analysis of data from the Child Health Epidemiology Reference Group (CHERG), including 14 birth cohorts with gestational age, birth weight, and neonatal follow-up. Small for gestational age was defined as infants weighing less than the 10th centile birth weight for gestational age and sex with the multiethnic, INTERGROWTH-21st birth weight standard. Prevalence of small for gestational age and neonatal mortality risk ratios were calculated and pooled among these datasets at the regional level. …

Bayesian Model Averaging With Change Points To Assess The Impact Of Vaccination And Public Health Interventions., Esra Kürüm, Joshua L Warren, Cynthia Schuck-Paim, Roger Lustig, Joseph A Lewnard, Rodrigo Fuentes, Christian A W Bruhn, Robert J Taylor, Lone Simonsen, Daniel M Weinberger

Global Health Faculty Publications

Background: Pneumococcal conjugate vaccines (PCVs) prevent invasive pneumococcal disease and pneumonia. However, some low-and middle-income countries have yet to introduce PCV into their immunization programs due, in part, to lack of certainty about the potential impact. Assessing PCV benefits is challenging because specific data on pneumococcal disease are often lacking, and it can be difficult to separate the effects of factors other than the vaccine that could also affect pneumococcal disease rates.

Methods: We assess PCV impact by combining Bayesian model averaging with change-point models to estimate the timing and magnitude of vaccine-associated changes, while controlling for seasonality and other …

Lung Ultrasound As A Diagnostic Tool For Radiographically-Confirmed Pneumonia In Low Resource Settings, L E. Ellington, R H. Gilman, M A. Chavez, F Pervaiz, J Marin-Concha, P Compen-Chang, S Riedel, S J. Rodriguez, C Gaydos, J Hardick, J M. Tielsch, M Steinhoff, J Benson, E A. May, D Figueroa-Quintanilla, W Checkley

Global Health Faculty Publications

Background

Pneumonia is a leading cause of morbidity and mortality in children worldwide; however, its diagnosis can be challenging, especially in settings where skilled clinicians or standard imaging are unavailable. We sought to determine the diagnostic accuracy of lung ultrasound when compared to radiographically-confirmed clinical pediatric pneumonia.

Methods

Between January 2012 and September 2013, we consecutively enrolled children aged 2–59 months with primary respiratory complaints at the outpatient clinics, emergency department, and inpatient wards of the Instituto Nacional de Salud del Niño in Lima, Peru. All participants underwent clinical evaluation by a pediatrician and lung ultrasonography by one of three …

Financing Of International Collective Action For Epidemic And Pandemic Preparedness., Gavin Yamey, Marco Schäferhoff, Ole Kristian Aars, Barry Bloom, Dennis Carroll, Mukesh Chawla, Victor Dzau, Ricardo Echalar, Indermit Singh Gill, Tore Godal, Sanjeev Gupta, Dean Jamison, Patrick Kelley, Frederik Kristensen, Ceci Mundaca-Shah, Ben Oppenheim, Julie Pavlin, Rodrigo Salvado, Peter Sands, Rocio Schmunis, Agnes Soucat, Lawrence H Summers, Anas El Turabi, Ron Waldman, Ed Whiting

Global Health Faculty Publications

The global pandemic response has typically followed cycles of panic followed by neglect. We are now, once again, in a phase of neglect, leaving the world highly vulnerable to massive loss of life and economic shocks from natural or human-made epidemics and pandemics. Quantifying the size of the losses caused by large-scale outbreaks is challenging because the epidemiological and economic research in this field is still at an early stage. Research on the 1918 influenza H1N1 pandemic and recent epidemics and pandemics has shown a range of estimated losses (panel).^{1; 2; 3; 4; …}

Risk And Burden Of Adverse Intrapartum-Related Outcomes Associated With Non-Cephalic And Multiple Birth In Rural Nepal: A Prospective Cohort Study., Naoko Kozuki, Joanne Katz, Subarna K Khatry, James M Tielsch, Steven C Leclerq, Luke C Mullany

Global Health Faculty Publications

OBJECTIVES: Intrapartum-related complications are the second leading cause of neonatal death worldwide. We estimate the community-level risk and burden of intrapartum-related fetal/neonatal mortality and morbidity associated with non-cephalic and multiple birth in rural Sarlahi District, Nepal.

DESIGN: Community-based prospective cohort study.

SETTING: Rural Sarlahi District, Nepal.

PARTICIPANTS: Pregnant women residing in the study area.

METHODS: We collected data on maternal background characteristics, conditions during labour and delivery, fetal presentation and multiple birth during home visits. We ran log-binomial regression models to estimate the associations between non-cephalic/multiple births and fresh stillbirth, early neonatal mortality and signs of neonatal encephalopathy, respectively, and …

Population-Based Pertussis Incidence And Risk Factors In Infants Less Than 6 Months In Nepal., Michelle M Hughes, Janet A Englund, Jane Kuypers, James M Tielsch, Subarna K Khatry, Laxman Shrestha, Steven C Leclerq, Mark Steinhoff, Joanne Katz

Global Health Faculty Publications

Background.

Pertussis is estimated to cause 2 percent of childhood deaths globally and is a growing public health problem in developed countries despite high vaccination coverage. Infants are at greatest risk of morbidity and mortality. Maternal vaccination during pregnancy may be effective to prevent pertussis in young infants, but population-based estimates of disease burden in infants are lacking, particularly in low-income countries. The objective of this study was to estimate the incidence of pertussis in infants less than 6 months of age in Sarlahi District, Nepal.

Methods.

Nested within a population-based randomized controlled trial of influenza vaccination during pregnancy, infants …

Challenges To Estimating Vaccine Impact Using Hospitalization Data., Cynthia Schuck-Paim, Robert J Taylor, Lone Simonsen, Roger Lustig, Esra Kürüm, Christian A W Bruhn, Daniel M Weinberger

Global Health Faculty Publications

Because the real-world impact of new vaccines cannot be known before they are implemented in national programs, post-implementation studies at the population level are critical. Studies based on analysis of hospitalization rates of vaccine-preventable outcomes are typically used for this purpose. However, estimates of vaccine impact based on hospitalization data are particularly prone to confounding, as hospitalization rates are tightly linked to changes in the quality, access and use of the healthcare system, which often occur simultaneously with introduction of new vaccines. Here we illustrate how changes in healthcare delivery coincident with vaccine introduction can influence estimates of vaccine impact, …

Monthly Food Insecurity Assessment In Rural Mkushi District, Zambia: A Longitudinal Analysis, Muzi Na, Bess Caswell, Sameera A Talegawkar, Amanda C Palmer

Global Health Faculty Publications

Background

Perception-based scales are widely used for household food insecurity (HFI) assessment but were only recently added in national surveys. The frequency of assessments needed to characterize dynamics in HFI over time is largely unknown. The study aims to examine longitudinal changes in monthly reported HFI at both population- and household-level.

Methods

A total of 157 households in rural Mkushi District whose children were enrolled in the non-intervened arm of an efficacy trial of biofortified maize were included in the analysis. HFI was assessed by a validated 8-item perception-based Likert scale on a monthly basis from October 2012 to March …

Risk And Burden Of Adverse Intrapartum-Related Outcomes Associated With Non-Cephalic And Multiple Birth In Rural Nepal: A Prospective Cohort Study, Naoko Kozuki, Joanne Katz, Subarna Khatry, James M. Tielsch, Steven Leclerq, Luke C. Mullany

Global Health Faculty Publications

Objectives Intrapartum-related complications are the second leading cause of neonatal death worldwide. We estimate the community-level risk and burden of intrapartum-related fetal/neonatal mortality and morbidity associated with non-cephalic and multiple birth in rural Sarlahi District, Nepal.

Design Community-based prospective cohort study.

Setting Rural Sarlahi District, Nepal.

Participants Pregnant women residing in the study area.

Methods We collected data on maternal background characteristics, conditions during labour and delivery, fetal presentation and multiple birth during home visits. We ran log-binomial regression models to estimate the associations between non-cephalic/multiple births and fresh stillbirth, early neonatal mortality and signs of neonatal encephalopathy, respectively, and …

Febrile Rhinovirus Illness During Pregnancy Is Associated With Low Birth Weight In Nepal., Erin K Philpott, Janet A Englund, Joanne Katz, James Tielsch, Subarna Khatry, Stephen C Leclerq, Laxman Shrestha, Jane Kuypers, Amalia S Magaret, Mark C Steinhoff, Helen Y Chu

Global Health Faculty Publications

BACKGROUND: Adverse birth outcomes, including low birth weight (LBW), defined as <2500 >grams, small-for-gestational-age (SGA), and prematurity, contribute to 60%-80% of infant mortality worldwide and may be related to infections during pregnancy. The aim of this study was to assess whether febrile human rhinovirus (HRV) illness is associated with adverse birth outcomes.

METHODS: Active household-based weekly surveillance was performed for respiratory illness episodes in pregnant women as part of a community-based, prospective, randomized trial of maternal influenza immunization in rural Nepal. Rhinovirus (HRV) febrile illness episodes were defined as fever plus cough, sore throat, runny nose, and/or myalgia with HRV detected …

A Peer Evaluation Of The Community-Based Education Programme For Medical Students At The University Of Zimbabwe College Of Health Sciences: A Southern African Medical Education Partnership Initiative (Mepi) Collaboration, D. Michaels, I. Couper, M. Mogodi, J. Hakim, Zohray M. Talib, +Several Additional Authors

Global Health Faculty Publications

Background. The University of Zimbabwe College of Health Sciences (UZCHS), Harare, which has a long tradition of community-based education (CBE), has not been evaluated since 1991. An innovative approach was used to evaluate the programme during 2015.

Objectives. To evaluate the CBE programme, using a peer-review model of evaluation and simultaneously introducing and orientating participating colleagues from other medical schools in southern Africa to this review process.

Methods. An international team of medical educators, convened through the Medical Education Partnership Initiative, worked collaboratively to modify an existing peer-review assessment method. Data collection took the form of pre-visit surveys, on-site and …

Decentralised Training For Medical Students: Towards A South African Consensus, Marietjie De Villiers, Julia Blitz, I. Couper, Athol Kent, Kalavani Moodley, Zohray Talib, Susan Van Schalkwyk, Taryn Young

Global Health Faculty Publications

Introduction: Health professions training institutions are challenged to produce greater numbers of graduates who are more relevantly trained to provide quality healthcare. Decentralised training offers opportunities to address these quantity, quality and relevance factors. We wanted to draw together existing expertise in decentralised training for the benefit of all health professionals to develop a model for decentralised training for health professions students.
Method: An expert panel workshop was held in October 2015 initiating a process to develop a model for decentralised training in South Africa. Presentations on the status quo in decentralised training at all nine medical schools in South …

From Sea To Shining Sea, And The Great Plains To Patagonia: A Review On Current Knowledge Of Diabetes Mellitus In Hispanics/Latinos In The U.S. And Latin America, Larissa Aviles-Santa, Uriyoán Colon-Ramos, Nangel Lindberg, Joseimer Mattei, Francisco Pasquel, Cynthia Perez

Global Health Faculty Publications

The last two decades have witnessed many advances in the prevention, treatment, and control of diabetes mellitus and its complications. Increased screening has led to a greater recognition of Type 2 diabetes mellitus (Type 2 DM) and prediabetes; however, Hispanics/Latinos, the largest minority group in the U.S., have not fully benefited from these advances. The Hispanic/Latino population is highly diverse in ancestries, birth places, cultures, languages, and socioeconomic backgrounds, and it populates most of the Western Hemisphere. In the U.S., the prevalence of diabetes mellitus varies among Hispanic/Latino heritage groups, being higher among Mexicans, Puerto Ricans, and Dominicans, and lower …

Perspectives On Model Forecasts Of The 2014–2015 Ebola Epidemic In West Africa: Lessons And The Way Forward, Gerardo Chowell, Cecile Viboud, Lone Simonsen, Stefano Merler, Alessandro Vespignani

Global Health Faculty Publications

The unprecedented impact and modeling efforts associated with the 2014–2015 Ebola epidemic in West Africa provides a unique opportunity to document the performances and caveats of forecasting approaches used in near-real time for generating evidence and to guide policy. A number of international academic groups have developed and parameterized mathematical models of disease spread to forecast the trajectory of the outbreak. These modeling efforts often relied on limited epidemiological data to derive key transmission and severity parameters, which are needed to calibrate mechanistic models. Here, we provide a perspective on some of the challenges and lessons drawn from these efforts, …

Interrelationship Between Climatic, Ecologic, Social, And Cultural Determinants Affecting Dengue Emergence And Transmission In Puerto Rico And Their Implications For Zika Response., Angela Matysiak, Amira Roess

Global Health Faculty Publications

Objective

The global resurgence of dengue has been attributed to rapid population growth, urban expansion, increased air travel, globalization, and climate change. Dengue is now endemic in Puerto Rico. Puerto Rico is at risk for Zika, another emerging arbovirus. The interrelationship between climatic, ecological, social, and cultural factors that affect dengue and other arboviruses' transmission is understudied.

Design

The objective of this systematic review is to examine the interrelationship between climatic, ecological, social, and cultural factors on dengue transmission in Puerto Rico and to draw lessons for Zika response.

Results

A comprehensive search of peer-reviewed journal articles was performed, producing …

Regulatory Elements On Marijuana, For The Effective Population Health Protection, C Santos-Burgoa

Global Health Faculty Publications

When discussing the public health approach to the use of marijuana, the complexity of rigorous regulatory interventions for population protection is omitted. Using the experience of governments where these practices already exist, regulation is introduced as an essential public health function, spelling out seven purposes for controlling marijuana. The technical elements of institutional capacity -including the technical and financial capacity- and of governance that must be covered by any rigorous regulation of its use are detailed below. The difficulty of regulating psychoactive substances is addressed when considering the capacity to control other legal substances manifested with their increased consumption. It …

When Is A Randomised Controlled Trial Health Equity Relevant? Development And Validation Of A Conceptual Framework, J. Jull, M. Whitehead, M. Petticrew, E. Kristjansson, D. Gough, Sarah Baird, +Several Additional Authors

Global Health Faculty Publications

Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.

Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.

Results A randomised trial can …