A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies.

Harmonized institutional processes and reviewer training are vital to maintain integrity and ethical rigor of the veterinary clinical research pipeline and are a prerequisite to future work that might establish centralized or single-site ethical and regulatory review to ease initiation of multi-center studies. Funded by a CTSA One Health Alliance (COHA) pilot award, a diverse working group of veterinary clinicians and institutional representatives was convened in February 2020 to develop a guidance document detailing broadly agreed upon practices for ethical review and approval of veterinary clinical studies conducted in the United States.The working group defined key areas of need for consensus, developed a set of associated guidelines, and circulated these for review by COHA's fifteen member institutions. Six focus areas were identified by the working group and included vital items of protocol review, composition of the review committee, post-approval monitoring and adverse event reporting, consideration of special circumstances such as satellite sites and the use of healthy veterinary subjects in research, and the informed consent process.This document outlines a broadly agreed-upon framework through which to approach vital items associated with veterinary clinical study protocol review and approval. These approaches represent current best practice in the review and approval of veterinary clinical studies, and can serve as a guidance for veterinary clinician-scientists and regulatory experts, to ensure robust and ethically conducted studies that can contribute to the advancement of both animal and human health.

Bovine trypanosomiasis in tsetse-free pastoral zone of the Far-North region, Cameroon.

BACKGROUND & OBJECTIVES: The Far-North region of Cameroon has been considered free of tsetse and trypanosomiasis for the past three decades. But recent reports by pastoralists indicate its reappearance in the region. This study was aimed to confirm the existence of cattle trypanosomiasis and determine its prevalence, and to establish pastoralists knowledge and practice (KP) of the disease in Ndiyam Shinwa pastoral zone of Cameroon. METHODS: A total of 118 herds were surveyed for a descriptive, cross-sectional study in Ndiyam Shinwa pastoral zone from May to November 2014. Out of these, 110 herds were visited in the beginning of the rainy season, 22 of the 110 herds (suspect cattle) were revisited along with the remaining eight herds in the end of the season. The blood samples of 635 suspect cattle and 135 nonsuspect cattle were collected. Samples were subjected to two diagnostic tests: Buffy coat test (BCT) and packed cell volume (PCV) determination. A survey on pastoralist's (n = 118) KP about trypanosomiasis was also undertaken. RESULTS: Parasitological analyses revealed six infections by Trypanosoma vivax: Four in suspect cattle against two in nonsuspect cattle, corresponding respectively to apparent prevalence of 0.63 and 1.46% and true prevalence of (0.79-3.15%) and (1.82-7.30%). The proportion of cattle found infected in the PCV as well as BCT tests was 33.26% for suspect cattle. More than 75% of followed-up suspects showed persisting symptoms nearly three months after initial examination. The most common diagnostic signs for pastoralists were ruffled hair, lacrimation, anorexia and emaciation. INTERPRETATION & CONCLUSION: Cattle trypanosomiasis has reappeared in the Far-North region and seems to be in the inter-epizootic phase. Pastoralists have a good knowledge of the disease, but their perception of its importance seems to be influenced by the persistence of symptoms attributed to this disease in suspect cattle.

Data-Driven Models of Foot-and-Mouth Disease Dynamics: A Review.

Foot-and-mouth disease virus (FMDV) threatens animal health and leads to considerable economic losses worldwide. Progress towards minimizing both veterinary and financial impact of the disease will be made with targeted disease control policies. To move towards targeted control, specific targets and detailed control strategies must be defined. One approach for identifying targets is to use mathematical and simulation models quantified with accurate and fine-scale data to design and evaluate alternative control policies. Nevertheless, published models of FMDV vary in modelling techniques and resolution of data incorporated. In order to determine which models and data sources contain enough detail to represent realistic control policy alternatives, we performed a systematic literature review of all FMDV dynamical models that use host data, disease data or both data types. For the purpose of evaluating modelling methodology, we classified models by control strategy represented, resolution of models and data, and location modelled. We found that modelling methodology has been well developed to the point where multiple methods are available to represent detailed and contact-specific transmission and targeted control. However, detailed host and disease data needed to quantify these models are only available from a few outbreaks. To address existing challenges in data collection, novel data sources should be considered and integrated into models of FMDV transmission and control. We suggest modelling multiple endemic areas to advance local control and global control and better understand FMDV transmission dynamics. With incorporation of additional data, models can assist with both the design of targeted control and identification of transmission drivers across geographic boundaries.

Temporal and Spatial Analysis of the New World Screwworm (Cochliomyia hominivorax) in Darien and Embera, Panama (2001-2011).

Larvae (maggots) of Cochliomyia hominivorax, the New World Screwworm fly, are voracious consumers of living flesh that have a negative economic impact by decreasing productivity, predisposing to other pathogens, and, in severe cases, causing death of domestic livestock. Screwworm caused extensive financial losses to the livestock industry in North America prior to its eradication. Sterile insect technique (SIT) was used to eradicate screwworm throughout North and Central America and continues to be the main tool to control it in eastern Panama. The goal of this study was to evaluate the temporal and spatial trends of screwworm myiasis cases reported in the Province of Darien and Comarca Embera (border with Colombia), Panama, from 2001 to 2011. We hypothesized that screwworm cases would vary seasonally and be spatially clustered near Colombia as a result of effective eradication strategies in Panama and the presence of an autochthonous population of flies in western Colombia. Temporal and spatial data were retrieved from COPEG-USDA records (Panama) and analysed by anova, Ripley's K function, discrete Poisson spatial statistic scan and Getis-Ord Gi*. No significant temporal trend was found, but cases were spatially distributed in four clusters. One cluster of cases occurred from 2001 to 2003 and was considered a focal temporal and spatial cluster. One cluster occurred in 2001 and 2007 indicating more rare outbreaks in an area with fewer cattle. The two remaining clusters contained cases from 2004 to 2011 and 2001 to 2011 suggesting regular breaks in the control barrier due to occasional failures of the SIT programme, difficulties implementing border quarantine strategies, livestock smuggling or the movement of infested wildlife.

Serotype Diversity of Foot-and-Mouth-Disease Virus in Livestock without History of Vaccination in the Far North Region of Cameroon.

Little information is available about the natural cycle of foot-and-mouth disease (FMD) in the absence of control measures such as vaccination. Cameroon presents a unique opportunity for epidemiological studies because FMD vaccination is not practiced. We carried out a prospective study including serological, antigenic and genetic aspects of FMD virus (FMDV) infections among different livestock production systems in the Far North of Cameroon to gain insight into the natural ecology of the virus. We found serological evidence of FMDV infection in over 75% of the animals sampled with no significant differences of prevalence observed among the sampled groups (i.e. market, sedentary, transboundary trade and mobile). We also found antibodies reactive to five of the seven FMDV serotypes (A, O, SAT1, SAT2 and SAT3) among the animals sampled. Finally, we were able to genetically characterize viruses obtained from clinical and subclinical FMD infections in Cameroon. Serotype O viruses grouped into two topotypes (West and East Africa). SAT2 viruses grouped with viruses from Central and Northern Africa, notably within the sublineage causing the large epidemic in Northern Africa in 2012, suggesting a common origin for these viruses. This research will guide future interventions for the control of FMD such as improved diagnostics, guidance for vaccine formulation and epidemiological understanding in support of the progressive control of FMD in Cameroon.

Detection of Hammondia heydorni DNA in feces collected in and around an Ohio Wildlife Conservation Center.

This study aimed to identify DNA attributed to Hammondia heydorni oocysts in the feces of wild canids in and around an Ohio wildlife conservation center. Two hundred and eighty-five wild canid fecal samples were analyzed using PCR with melting curve analysis to detect coccidian DNA. Coccidia-positive samples were further subjected to H. heydorni-specific and N. caninum-specific PCR assays. Samples positive by the H. heydorni-specific assay were additionally analyzed with a PCR assay to distinguish H. heydorni from Hammondia triffittae. Coccidian DNA was detected in 51 of the 285 (17.9%) wildlife samples. H. heydorni DNA was detected in three of the coccidia-positive wildlife samples (1.1%) and N. caninum was detected in none. Determining the presence of H. heydorni in wild canids will contribute to a greater understanding of the role these hosts play in the ecology of this parasite.

Quantitative assessment of the equine hoof using digital radiography and magnetic resonance imaging.

REASONS FOR PERFORMING STUDY: Evaluation of laminitis cases relies on radiographic measurements of the equine foot. Reference values have not been established for all layers of the foot. OBJECTIVES: To establish normal hoof wall and sole measurements using digital radiography (DR) and magnetic resonance imaging (MRI) and to document tissue components present in the dorsal hoof wall and solar layers seen on DR. STUDY DESIGN: Prospective observational case-control study. METHODS: Digital radiography and MRI were performed on 50 cadaver front feet from 25 horses subjected to euthanasia for nonlameness-related reasons. Four observers measured hoof wall (dorsal, lateral and medial) and sole thickness (sagittal, lateral and medial) using DR and magnetic resonance images. One observer repeated the measurements 3 times. Inter- and intraobserver correlation was assessed. RESULTS: Digital radiography and MRI measurements for the normal hoof wall and sole were established. Inter- and intraobserver pairwise Pearson's correlation for DR (r>0.98) and MRI measurements (r>0.99) was excellent. Based on MRI, the less radiopaque layer on DR is comprised of the stratum lamellatum and stratum reticulare. CONCLUSIONS: Normal DR and MRI measurements for the hoof wall and sole were established. On DR images, the less radiopaque layer of the foot observed corresponds to the critical tissues injured in laminitis, the strata lamellatum and reticulare. These reference measurements may be used by the clinician to detect soft-tissue changes in the laminitic equine foot and provide a foundation for future research determining changes in these measurements in horses with laminitis.

Use of expert opinion for animal disease decisions: an example of foot-and-mouth disease status designation.

When data representing a preferred measurement of risk cannot be obtained, as is often the case for global animal diseases, decisions that affect millions of people and their animals are typically made based on expert opinion. Expert opinion can be and has been used to address the critical lack of data existing for prevalence and incidence of many global diseases, including foot-and-mouth disease (FMD). However, when a conclusion based on expert opinion applies to a topic as sensitive as FMD, which has tremendous economic, political, and social implications, care should be taken to understand the accuracy of and differences in the opinion data. The differences in experts' opinions and the relative accuracy of an expert opinion elicitation for "diagnosing" country-level FMD presence were examined for the years 1997-2003 using Bayesian methods. A formal survey of eight international FMD experts revealed that individual experts had different opinions as to the probability of finding FMD in a country. However, a weighted average of the experts' responses was relatively accurate (91% sensitivity and 85% specificity) at identifying the FMD status of a country, compared to using a method that employed information available from World Organization for Animal Health (OIE). The most apparent disagreements between individual experts and available information were found for Indonesia, South Korea, and South America, and, in general, the experts seemed to believe that countries in South Asia were more likely to be positive than other countries that reported FMD cases to OIE. This study highlights new methodology that offers a standardized, quantitative, and systematic means by which expert opinion can be used and assessed.

Analytical epidemiology of genomic variation among Pan Asia strains of foot-and-mouth disease virus.

Genetic data from field isolates of foot-and-mouth disease virus (FMDV) have been used to trace the source of recent outbreaks of FMD, to design better vaccines and diagnostic tests for FMDV, and to make conclusions regarding the general variability in the FMDV genome. Though epidemiologic data associated with FMDV isolates are available, these data have been used rarely to explore possible associations of epidemiologic factors with evolution or variation of the FMDV genome. In this study, factors associated with variation in the primary immunogenic peptide gene of FMDV (VP1), for a sample of 147 serotype O, Pan Asia strain sequences were explored using traditional analytical epidemiologic methods: logistic regression and multinomial-response logistic regression. Hypothesized factors included host type (bovine, ovine, buffalo, or porcine) and geographical region (Middle East, South Asia, East Asia, Southeast Asia, and Europe). Results of two regression analyses suggest that host type and region, considered to be possible surrogates for host management, may be associated with selection in the VP1 amino acid sequence in FMDV. For example, isolates from cattle and sheep in South Asia appear to converge with a proposed ancestor sequence, whereas isolates from the same species in the Middle East and Southeast Asia appear to diverge. The methods demonstrated here could be used on a more detailed dataset to explore the selective pressure of host immunity on the evolution of FMDV antigens in an endemic setting. More broadly, epidemiologic methods could be applied extensively to molecular data to explore the causes of genomic variation in disease-causing organisms.