Invited review: Maximizing value and minimizing waste in clinical trial research in dairy cattle: Selecting interventions and outcomes to build an evidence base.

Clinical trials are a valuable study design for evaluating interventions when it is ethical and feasible for investigators to randomly allocate study animals to intervention groups. Researchers may choose to evaluate the comparative efficacy of intervention groups for their effect on outcomes that are relevant to the specific objectives of their trial. However, the results across multiple trials on the same intervention and with the same outcome should be considered when making decisions on whether to use an intervention, because the results of a single trial are subject to sampling error and do not reflect all biological variability. The objective of this review was to provide an overview of important concepts when selecting intervention groups and outcomes within a randomized controlled trial, and when building a body of evidence for intervention efficacy across multiple trials. Empirical evidence is presented to highlight that integrating and interpreting the efficacy of an intervention across trials is hindered by a lack of replication of interventions across trials. Inconsistency in the outcomes and their measurement among trials also limits the ability to build a body of evidence for the efficacy of interventions. The development of core outcome sets for specific topic areas in dairy science, updated as necessary, may improve consistency across trials and aid in the development of a body of evidence for evidence-based decision-making.

Publication and accessibility of results of controlled trials in dairy science.

Research allows for the discovery of new knowledge and is integral to evidence-based decision-making. However, research is only useful if it is available. The aim of this study was to explore publication and accessibility of full-text reports for controlled trials (experimental studies) conducted in dairy cattle. We determined the proportion of controlled trials presented as abstracts at the 2015 Joint Annual Meeting of the American Dairy Science Association and the American Society of Animal Science or the 2015 American Association of Bovine Practitioners Annual Conference that were subsequently published. Factors associated with publication or non-publication in a peer-reviewed journal were evaluated using risk ratios. For trials that were subsequently published, we compared the sample size, numerical results, and inference between the conference abstract and the subsequent publication. Approximately half of the trials (177 out of 380) reported at conferences were subsequently published. Source conference, whether the conference abstract results were described as preliminary, whether there was at least one positive outcome, author affiliation, whether the trial involved deliberate disease induction, and total sample size were not strongly associated with subsequent publication. For trials that were published, the sample size differed between the conference proceedings and full publications for 22%, the numerical results differed in 29%, and the inference differed for 11%. We also evaluated whether trials included in 9 recent systematic reviews were in English and were available without subscription or cost. Of the 390 trials included in recent systematic reviews, approximately 40% were available only through subscription or access fee. These results suggest that publication and accessibility of research results is suboptimal, representing an area of wastage in dairy cattle research. Researchers should ensure that they publish the results of trials comprehensively in searchable publications, even if the results are not novel or do not detect expected differences, and, when possible, make the results available freely.

Modifiable management practices to improve udder health in dairy cattle during the dry period and early lactation: A scoping review.

The objective of this scoping review was to characterize all available literature on modifiable management practices used during the dry period that have been evaluated for their effects on udder health in dairy cattle during the dry period and the subsequent lactation. Five databases and two conference proceedings were searched for relevant literature. Articles published in or after 1990 were eligible for inclusion. Eligible interventions or exposures were restricted to modifiable management practices; however, antimicrobial and teat sealant products were enumerated but not further characterized, as systematic reviews have been published on this topic. Other modifiable management practices were reported in 229 articles. Nutrition (n = 79), which included ration formulation and delivery (n = 44) and vitamin and mineral additives (n = 35), was the most commonly reported practice, followed by vaccines (n = 40) and modification of dry period length (n = 27). Risk of clinical mastitis (CM) was the most commonly reported outcome (n = 151); however, reporting of outcome risk periods varied widely between articles. Cure of existing intramammary infections (IMI) over the dry period (n = 40) and prevention of new IMI over the dry period (n = 54) were most commonly reported with a risk period between calving and 30 d in milk. Future systematic reviews with meta-analyses could target management practices such as nutrition, vaccines, and dry period length to quantify their effects on improving udder health during the dry period and early lactation. However, the variation in reporting of time at risk for CM and other outcomes challenges the ability of future synthesis work to inform management decisions on the basis of efficacy to cure or prevent IMI and CM. Consensus on which core outcomes should be evaluated in mastitis research and the selection of consistent risk periods for specific outcomes in animal trials is imperative.

The Prevalence of Campylobacter in Live Cattle, Turkey, Chicken, and Swine in the United States and Canada: A Systematic Review and Meta-Analysis.

Campylobacter cause gastroenteritis in humans and may be shed in the feces of livestock and poultry species, including cattle, chicken, turkey, and swine. However, a synthesis of the prevalence on farms in the United States and Canada is currently lacking. Thus, our objective was to conduct a systematic review and meta-analysis to estimate the prevalence of Campylobacter coli, Campylobacter jejuni, and Campylobacter spp. on livestock and poultry farms operated under commercial conditions in the United States and Canada. The relevant literature was identified and examined for eligibility based on a priori inclusion and exclusion criteria. Relevant data were extracted, and a meta-analysis was performed. The data were transformed using the Freeman-Tukey arcsine transformation to stabilize the variance. A separate meta-analysis was performed for each animal species, level of sampling (individual versus pooled), and species of Campylobacter, for a total of 29 meta-analyses. C. jejuni and Campylobacter spp. were present in all livestock and poultry species of interest, whereas C. coli was found in all species of interest with the exception of chickens. Furthermore, substantial heterogeneity was observed in most meta-analyses. In an attempt to account for this, subgroup analyses were performed on potential moderators. However, with the exception of beef cattle, where studies in feedlot cattle reported a consistently higher prevalence compared with adult cattle on pasture, significant heterogeneity remained in the majority of meta-analyses after accounting for potential moderators. The results of this review can be used to inform future risk assessment, consumer and producer awareness, and resource allocation, and identify gaps for future research.

Veterinarian barriers to knowledge translation (KT) within the context of swine infectious disease research: an international survey of swine veterinarians.

BACKGROUND: Food animal veterinarians face commodity specific and urgent global challenges yet conditions preventing use of best available knowledge have been sparsely studied. The American Association of Swine Veterinarians (AASV) membership (N = 1289) was surveyed online to benchmark their information priorities and their motivations and sources for keeping current with infectious disease research, and to describe their reported time, skill, access, and process as barriers to knowledge translation (KT). RESULTS: Respondents (n = 80) were mostly from Canada (n = 40) and the U.S.A (n = 31) and demographics approximated the AASV's. Colleagues are the first choice for information on difficult cases (49%, 95%CI: 38-61). Half of respondents (53%, 95%CI: 41-64) spend an hour or less per week keeping up with infectious disease research. The majority reported moderate or less than moderate efficiency (62%, 95%CI: 51-72), and moderate or greater stress (59%, 95%CI: 48-70) with their process for keeping up. Journal article methods sections are commonly not read, almost a third (32%, 95% CI: 22-43) reported either they do not evaluate statistical methods or that they had poor confidence to do so, and half (52, 95%CI: 41-63) could not explain 'confounding bias'. Approximately half (55%, 95%CI: 41-69) with direct oversight of swine herds had full access to 2 or fewer academic journals. Approximately a third of respondents (34%, 95%CI: 24-46) selected only formats involving single research studies (either full text or summaries) as preferred reading materials for keeping current over expert summaries of the body of evidence. CONCLUSION: KT barriers are considerable and a source of stress for many swine veterinarians. Sub-optimal efficiency with keeping up and low confidence to appraise aspects of research are concerns. Results are consistent with previous literature and illustrate need for improved KT infrastructure and for additional training in statistical methods and interpretation of primary research. Further evaluation is warranted of why approximately a third of veterinarians in this study, for the purpose of keeping up, preferentially choose to review individual research studies over choices that would include an expert summary of the body of evidence. Consideration of reasons for this preference will be important in the planning of KT infrastructure improvements.

Weather, environmental conditions, and waterborne Giardia and Cryptosporidium in Iqaluit, Nunavut.

Indigenous communities in the Arctic often face unique drinking water quality challenges related to inadequate infrastructure and environmental contamination; however, limited research exists on waterborne parasites in these communities. This study examined Giardia and Cryptosporidium in untreated surface water used for drinking in Iqaluit, Canada. Water samples (n = 55) were collected weekly from June to September 2016 and tested for the presence of Giardia and Cryptosporidium using microscopy and polymerase chain reaction (PCR). Exact logistic regressions were used to examine associations between parasite presence and environmental exposure variables. Using microscopy, 20.0% of samples tested positive for Giardia (n = 11) and 1.8% of samples tested positive for Cryptosporidium (n = 1). Low water temperatures (1.1 to 6.7 °C) and low air temperatures (-0.1 to 4.5 °C) were significantly associated with an increased odds of parasite presence (p = 0.047, p = 0.041, respectively). These results suggest that surface water contamination with Giardia and Cryptosporidium may be lower in Iqaluit than in other Canadian regions; however, further research should examine the molecular characterization of waterborne parasites to evaluate the potential human health implications in Northern Canada.

Invited review: Completeness of reporting of experiments: REFLECTing on a year of animal trials in the Journal of Dairy Science.

Reproducibility is an essential element of the scientific process, and it requires clear and complete reporting of study design, conduct, and analysis. In the human and animal health literature, incomplete reporting is associated with biased effect estimates. Moreover, incomplete reporting precludes knowledge synthesis and undervalues the resources allocated to the primary research. The Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety (REFLECT) statement, published in 2010, is a checklist developed by expert consensus to provide guidance on what study elements should be reported in any intervention trial (designed experiment) involving livestock. The Journal of Dairy Science (JDS) has recently endorsed the use of reporting guidelines. To assess the status of reporting of controlled experiments in JDS and to provide a baseline for future comparison, we evaluated the reporting of 18 items from the REFLECT statement checklist in a sample of 137 controlled trials published in JDS in 2017. Two reviewers independently screened titles and abstracts for relevance and then evaluated a sample of 120 papers reporting controlled trials (experimental studies involving at least one intervention and one comparison or control group), using yes or no questions. Although some items, such as treatment details and statistical analysis, were well reported, other areas, including sample size justification, allocation concealment, blinding, study flow, baseline data, and ancillary analyses, were often not reported or were incompletely described. This work highlights the need for authors and reviewers to take advantage of guidelines and checklists for reporting. Adherence to reporting guidelines can help improve the completeness of reporting of research, expedite and better inform the peer-review process, increase clarity for the reader, and allow for knowledge synthesis, such as meta-analysis, all of which serve to increase the value of the work conducted.

Observational Study Design in Veterinary Pathology, Part 1: Study Design.

Observational studies are the basis for much of our knowledge of veterinary pathology and are highly relevant to the daily practice of pathology. However, recommendations for conducting pathology-based observational studies are not readily available. In part 1 of this series, we offer advice on planning and conducting an observational study with examples from the veterinary pathology literature. Investigators should recognize the importance of creativity, insight, and innovation in devising studies that solve problems and fill important gaps in knowledge. Studies should focus on specific and testable hypotheses, questions, or objectives. The methodology is developed to support these goals. We consider the merits and limitations of different types of analytic and descriptive studies, as well as of prospective vs retrospective enrollment. Investigators should define clear inclusion and exclusion criteria and select adequate numbers of study subjects, including careful selection of the most appropriate controls. Studies of causality must consider the temporal relationships between variables and the advantages of measuring incident cases rather than prevalent cases. Investigators must consider unique aspects of studies based on archived laboratory case material and take particular care to consider and mitigate the potential for selection bias and information bias. We close by discussing approaches to adding value and impact to observational studies. Part 2 of the series focuses on methodology and validation of methods.

Observational Study Design in Veterinary Pathology, Part 2: Methodology.

Observational studies are a basis for much of our knowledge of veterinary pathology, yet considerations for conducting pathology-based observational studies are not readily available. In part 1 of this series, we offered advice on planning and carrying out an observational study. Part 2 of the series focuses on methodology. Our general recommendations are to consider using already-validated methods, published guidelines, data from primary sources, and quantitative analyses. We discuss 3 common methods in pathology research-histopathologic scoring, immunohistochemistry, and polymerase chain reaction-to illustrate principles of method validation. Some aspects of quality control include use of clear objective grading criteria, validation of key reagents, assessing sample quality, determining specificity and sensitivity, use of technical and biologic negative and positive controls, blinding of investigators, approaches to minimizing operator-dependent variation, measuring technical variation, and consistency in analysis of the different study groups. We close by discussing approaches to increasing the rigor of observational studies by corroborating results with complementary methods, using sufficiently large numbers of study subjects, consideration of the data in light of similar published studies, replicating the results in a second study population, and critical analysis of the study findings.

Effects of local anesthetic or systemic analgesia on pain associated with cautery disbudding in calves: A systematic review and meta-analysis.

Disbudding is a common management procedure performed on dairy farms and, when done without pain mitigation, is viewed as a key welfare issue. Use of pain control has increased in recent years, but full adoption of anesthesia and analgesia by veterinarians or dairy producers has not been achieved. This may in part be due to the lack of a consistent recommendations of treatment protocols between studies examining pain control methods for disbudding. The objective of this systematic review was to examine the effects of these pain control practices for the most common method of disbudding, cautery, on outcomes associated with disbudding pain in calves. The outcomes were plasma cortisol concentrations, pressure sensitivity of the horn bud area, and validated pain behaviors (ear flick, head shake, head rub, foot stamp, and vocalization). Intervention studies describing cautery disbudding in calves 12 wk of age or younger were eligible, provided they compared local anesthesia, nonsteroidal anti-inflammatory drug (NSAID), or local anesthesia and NSAID to 1 or more of local anesthesia, NSAID, or no pain control. The search strategy used the Agricola, Medline (via OvidSP), and Web of Science databases, as well as the Searchable Proceedings of Animal Conferences (S-PAC), ProQuest Dissertations and Theses Database, and Open Access Theses and Dissertations. Meta-analysis was performed for all outcomes measured at similar time points with more than 2 studies. Local anesthetic was associated with reduced plasma cortisol until 2 h postdisbudding; however, a rise in cortisol was observed in the meta-analysis of studies reporting at 4 h postdisbudding. Heterogeneity was present in several of the analyses for this comparison. The addition of NSAID to local anesthetic showed reduction in plasma cortisol at 4 h, and a reduction in pressure sensitivity and pain behaviors in some analyses between 3 and 6 h postdisbudding. Heterogeneity was present in some meta-analyses, including several using pain behavior outcomes. This may reflect the variation in measurement time periods for behavioral measures between studies, as well as differences among NSAID treatments. Overall, a protective effect of local anesthetic was seen for the acute pain of cautery disbudding, and the delayed rise in cortisol was mitigated by the addition of an NSAID, which also reduced other signs of pain, including pressure sensitivity and pain behaviors. Based on these findings, we recommend use of local anesthetic and an NSAID as best practices for pain mitigation for cautery disbudding of calves 12 wk of age or less. The magnitude and duration of the effect of NSAID treatment was not possible to deduce from the literature because wide variation existed between studies. We recommend consideration of more standardized outcome measurements, especially for pain behaviors. Adherence to reporting guidelines by authors would help ensure more transparent and complete information is available to end users.

Building Data and Information Capacity in Environmental Public Health: A Best-Worst Scaling Experiment.

CONTEXT: Environmental public health practitioners rely on information technology (IT) to maintain and improve environmental health. However, current systems have limited capacity. A better understanding of the importance of IT features is needed to enhance data and information capacity. OBJECTIVE: (1) Rank IT features according to the percentage of respondents who rated them as essential to an information management system and (2) quantify the relative importance of a subset of these features using best-worst scaling. DESIGN: Information technology features were initially identified from a previously published systematic review of software evaluation criteria and a list of software options from a private corporation specializing in inspection software. Duplicates and features unrelated to environmental public health were removed. The condensed list was refined by a working group of environmental public health management to a final list of 57 IT features. The essentialness of features was electronically rated by environmental public health managers. Features where 50% to 80% of respondents rated them as essential (n = 26) were subsequently evaluated using best-worst scaling. SETTING: Ontario, Canada. PARTICIPANTS: Environmental public health professionals in local public health. MAIN OUTCOME MEASURE: Importance scores of IT features. RESULTS: The majority of IT features (47/57) were considered essential to an information management system by at least half of the respondents (n = 52). The highest-rated features were delivery to printer, software encryption capability, and software maintenance services. Of the 26 features evaluated in the best-worst scaling exercise, the most important features were orientation to all practice areas, off-line capability, and ability to view past inspection reports and results. CONCLUSIONS: The development of a single, unified environmental public health information management system that fulfills the reporting and functionality needs of system users is recommended. This system should be implemented by all public health units to support data and information capacity in local environmental public health. This study can be used to guide vendor evaluation, negotiation, and selection in local environmental public health, and provides an example of academia-practice partnerships and the use of best-worst scaling in public health research.

Area-level global and local clustering of human Salmonella Enteritidis infection rates in the city of Toronto, Canada, 2007-2009.

BACKGROUND: Salmonella enterica serotype Enteritidis (S. Enteritidis) remains a major foodborne pathogen in North America yet studies examining the spatial epidemiology of salmonellosis in urban environments are lacking. Our ecological study combined a number of spatial statistical methods with a geographic information system to assess area-level heterogeneity of S. Enteritidis infection rates in the city of Toronto. METHODS: Data on S. Enteritidis infections between January 1, 2007 and December 31, 2009 were obtained from Ontario's surveillance system, and were grouped and analyzed at the forward sortation area (FSA)-level (an area signified by the first three characters of the postal code). Incidence rates were directly standardized using the FSA-level age- and sex-based standard population. A spatial empirical Bayes method was used to smooth the standardized incidence rates (SIRs). Global clustering of FSAs with high or low non-smoothed SIRs was evaluated using the Getis-Ord G method. Local clustering of FSAs with high, low, or dissimilar non-smoothed SIRs was assessed using the Getis-Ord Gi* and the Local Moran's I methods. RESULTS: Spatial heterogeneity of S. Enteritidis infection rates was detected across the city of Toronto. The non-smoothed FSA-level SIRs ranged from 0 to 16.9 infections per 100,000 person-years (mean = 6.6), whereas the smoothed SIRs ranged from 2.9 to 11.1 (mean = 6.3). The global Getis-Ord G method showed significant (p ≤ 0.05) maximum spatial clustering of FSAs with high SIRs at 3.3 km. The local Getis-Ord Gi* method identified eight FSAs with significantly high SIRs and one FSA with a significantly low SIR. The Local Moran's I method detected five FSAs with significantly high-high SIRs, one FSA with a significantly low-low SIR, and four significant outlier FSAs (one high-low, and three low-high). CONCLUSIONS: Salmonella Enteritidis infection rates clustered globally at a small distance band, suggesting clustering of high SIRs in small distinct areas. This finding was supported by the local cluster analyses, where distinct FSAs with high SIRs, mainly in downtown Toronto, were detected. These areas should be evaluated by future studies to identify risk factors of disease in order to implement targeted prevention and control programs. We demonstrated the usefulness of combining several spatial statistical techniques with a geographic information system to detect geographical areas of interest for further study, and to evaluate spatial processes that influenced S. Enteritidis infection rates. Our study methodology could be applied to other foodborne disease surveillance data.

Spatial-temporal epidemiology of human Salmonella Enteritidis infections with major phage types (PTs 1, 4, 5b, 8, 13, and 13a) in Ontario, Canada, 2008-2009.

BACKGROUND: In Ontario and Canada, the incidence of human Salmonella enterica serotype Enteritidis (S. Enteritidis) infections have increased steadily during the last decade. Our study evaluated the spatial and temporal epidemiology of the major phage types (PTs) of S. Enteritidis infections to aid public health practitioners design effective prevention and control programs. METHODS: Data on S. Enteritidis infections between January 1, 2008 and December 31, 2009 were obtained from Ontario's disease surveillance system. Salmonella Enteritidis infections with major phage types were classified by their annual health region-level incidence rates (IRs), monthly IRs, clinical symptoms, and exposure settings. A scan statistic was employed to detect retrospective phage type-specific spatial, temporal, and space-time clusters of S. Enteritidis infections. Space-time cluster cases' exposure settings were evaluated to identify common exposures. RESULTS: 1,336 cases were available for analysis. The six most frequently reported S. Enteritidis PTs were 8 (n = 398), 13a (n = 218), 13 (n = 198), 1 (n = 132), 5b (n = 83), and 4 (n = 76). Reported rates of S. Enteritidis infections with major phage types varied by health region and month. International travel and unknown exposure settings were the most frequently reported settings for PT 5b, 4, and 1 cases, whereas unknown exposure setting, private home, food premise, and international travel were the most frequently reported settings for PT 8, 13, and 13a cases. Diarrhea, abdominal pain, and fever were the most commonly reported clinical symptoms. A number of phage type-specific spatial, temporal, and space-time clusters were identified. Space-time clusters of PTs 1, 4, and 5b occurred mainly during the winter and spring months in the North West, North East, Eastern, Central East, and Central West regions. Space-time clusters of PTs 13 and 13a occurred at different times of the year in the Toronto region. Space-time clusters of PT 8 occurred at different times of the year in the North West and South West regions. CONCLUSIONS: Phage type-specific differences in exposure settings, and spatial-temporal clustering of S. Enteritidis infections were demonstrated that might guide public health surveillance of disease outbreaks. Our study methodology could be applied to other foodborne disease surveillance data to detect retrospective high disease rate clusters, which could aid public health authorities in developing effective prevention and control programs.

Knowledge, attitudes, and practices related to pet contact by immunocompromised children with cancer and immunocompetent children with diabetes.

OBJECTIVE: To compare knowledge, attitudes, and risks related to pet contact in households with and without immunocompromised children. STUDY DESIGN: A questionnaire was distributed to parents of children diagnosed with cancer (immunocompromised; n=80) or diabetes (immunocompetent; n=251) receiving care at the Children's Hospital of Eastern Ontario. Information was collected on knowledge of pets as sources of disease, concerns regarding pet-derived pathogens, and pet ownership practices. Data were analyzed with multivariable logistic regression. RESULTS: The questionnaire was completed by 65% (214 of 331) of the individuals to whom it was given. Pet ownership was common; 45% of respondents had a household pet when their child was diagnosed, and many (households with a child with diabetes, 49%; households with a child with cancer, 20%) acquired a new pet after diagnosis. Most households that obtained a new pet had acquired a pet considered high risk for infectious disease based on species/age (diabetes, 73%; cancer, 77%). Parents of children with cancer were more likely than parents of children with diabetes to recall being asked by a physician/staff member if they owned a pet (OR, 5.9) or to recall receiving zoonotic disease information (OR, 5.3), yet these interactions were reported uncommonly (diabetes, ≤13%; cancer, ≤48%). Greater knowledge of pet-associated pathogens was associated with recalled receipt of previous education on this topic (OR, 3.9). Pet exposure outside the home was reported frequently for children in non-pet-owning households (diabetes, 48%; cancer, 25%). CONCLUSION: Improved zoonotic disease education is needed for pet-owning and non-pet-owning households with immunocompromised children, with ongoing provision of information while the children are at increased risk of disease. Additional efforts from pediatric and veterinary healthcare professionals are required.

Video observation of hand hygiene practices during routine companion animal appointments and the effect of a poster intervention on hand hygiene compliance.

BACKGROUND: Hand hygiene is considered one of the most important infection control measures in human healthcare settings, but there is little information available regarding hand hygiene frequency and technique used in veterinary clinics. The objectives of this study were to describe hand hygiene practices associated with routine appointments in companion animal clinics in Ontario, and the effectiveness of a poster campaign to improve hand hygiene compliance. RESULTS: Observation of hand hygiene practices was performed in 51 clinics for approximately 3 weeks each using 2 small wireless surveillance cameras: one in an exam room, and one in the most likely location for hand hygiene to be performed outside the exam room following an appointment. Data from 38 clinics were included in the final analysis, including 449 individuals, 1139 appointments before and after the poster intervention, and 10894 hand hygiene opportunities. Overall hand hygiene compliance was 14% (1473/10894), while before and after patient contact compliance was 3% (123/4377) and 26% (1145/4377), respectively. Soap and water was used for 87% (1182/1353) of observed hand hygiene attempts with a mean contact time of 4 s (median 2 s, range 1-49 s), while alcohol-based hand rub (ABHR) was used for 7% (98/1353) of attempts with a mean contact time of 8 s (median 7 s, range 1-30 s). The presence of the posters had no significant effect on compliance, although some staff reported that they felt the posters did increase their personal awareness of the need to perform hand hygiene, and the posters had some effect on product contact times. CONCLUSIONS: Overall hand hygiene compliance in veterinary clinics in this study was low, and contact time with hand hygiene products was frequently below current recommendations. Use of ABHR was low despite its advantages over hand washing and availability in the majority of clinics. The poster campaign had a limited effect on its own, but could still be used as a component of a multimodal hand hygiene campaign. Improving the infection control culture in veterinary medicine would facilitate future campaigns and studies in this area, as well as overall patient and staff safety.

Component costs of foodborne illness: a scoping review.

BACKGROUND: Governments require high-quality scientific evidence to prioritize resource allocation and the cost-of-illness (COI) methodology is one technique used to estimate the economic burden of a disease. However, variable cost inventories make it difficult to interpret and compare costs across multiple studies. METHODS: A scoping review was conducted to identify the component costs and the respective data sources used for estimating the cost of foodborne illnesses in a population. This review was accomplished by: (1) identifying the research question and relevant literature, (2) selecting the literature, (3) charting, collating, and summarizing the results. All pertinent data were extracted at the level of detail reported in a study, and the component cost and source data were subsequently grouped into themes. RESULTS: Eighty-four studies were identified that described the cost of foodborne illness in humans. Most studies (80%) were published in the last two decades (1992-2012) in North America and Europe. The 10 most frequently estimated costs were due to illnesses caused by bacterial foodborne pathogens, with non-typhoidal Salmonella spp. being the most commonly studied. Forty studies described both individual (direct and indirect) and societal level costs. The direct individual level component costs most often included were hospital services, physician personnel, and drug costs. The most commonly reported indirect individual level component cost was productivity losses due to sick leave from work. Prior estimates published in the literature were the most commonly used source of component cost data. Data sources were not provided or specifically linked to component costs in several studies. CONCLUSIONS: The results illustrated a highly variable depth and breadth of individual and societal level component costs, and a wide range of data sources being used. This scoping review can be used as evidence that there is a lack of standardization in cost inventories in the cost of foodborne illness literature, and to promote greater transparency and detail of data source reporting. By conforming to a more standardized cost inventory, and by reporting data sources in more detail, there will be an increase in cost of foodborne illness research that can be interpreted and compared in a meaningful way.

Association between component costs, study methodologies, and foodborne illness-related factors with the cost of nontyphoidal Salmonella illness.

Nontyphoidal Salmonella spp. are one of the most common causes of bacterial foodborne illness. Variability in cost inventories and study methodologies limits the possibility of meaningfully interpreting and comparing cost-of-illness (COI) estimates, reducing their usefulness. However, little is known about the relative effect these factors have on a cost-of-illness estimate. This is important for comparing existing estimates and when designing new cost-of-illness studies. Cost-of-illness estimates, identified through a scoping review, were used to investigate the association between descriptive, component cost, methodological, and foodborne illness-related factors such as chronic sequelae and under-reporting with the cost of nontyphoidal Salmonella spp. illness. The standardized cost of nontyphoidal Salmonella spp. illness from 30 estimates reported in 29 studies ranged from $0.01568 to $41.22 United States dollars (USD)/person/year (2012). The mean cost of nontyphoidal Salmonella spp. illness was $10.37 USD/person/year (2012). The following factors were found to be significant in multiple linear regression (p≤0.05): the number of direct component cost categories included in an estimate (0-4, particularly long-term care costs) and chronic sequelae costs (inclusion/exclusion), which had positive associations with the cost of nontyphoidal Salmonella spp. illness. Factors related to study methodology were not significant. Our findings indicated that study methodology may not be as influential as other factors, such as the number of direct component cost categories included in an estimate and costs incurred due to chronic sequelae. Therefore, these may be the most important factors to consider when designing, interpreting, and comparing cost of foodborne illness studies.

Global incidence of human Shiga toxin-producing Escherichia coli infections and deaths: a systematic review and knowledge synthesis.

OBJECTIVES: Shiga toxin-producing Escherichia coli (STEC) are an important cause of foodborne disease, yet global estimates of disease burden do not exist. Our objective was to estimate the global annual number of illnesses due to pathogenic STEC, and resultant hemolytic uremic syndrome (HUS), end-stage renal disease (ESRD), and death. MATERIALS: We searched Medline, Scopus, SIGLE/OpenGrey, and CABI and World Health Organization (WHO) databases for studies of STEC incidence in the general population, published between January 1, 1990 and April 30, 2012, in all languages. We searched health institution websites for notifiable disease data and reports, cross-referenced citations, and consulted international knowledge experts. We employed an a priori hierarchical study selection process and synthesized results using a stochastic simulation model to account for uncertainty inherent in the data. RESULTS: We identified 16 articles and databases from 21 countries, from 10 of the 14 WHO Sub-Regions. We estimated that STEC causes 2,801,000 acute illnesses annually (95% Credible Interval [Cr.I.]: 1,710,000; 5,227,000), and leads to 3890 cases of HUS (95% Cr.I.: 2400; 6700), 270 cases of ESRD (95% Cr.I.: 20; 800), and 230 deaths (95% Cr.I.: 130; 420). Sensitivity analyses indicated these estimates are likely conservative. CONCLUSIONS: These are the first estimates of the global incidence of STEC-related illnesses, which have not been explicitly included in previous global burden of disease estimations. Compared to other pathogens with a foodborne transmission component, STEC appears to cause more cases than alveolar echinococcosis each year, but less than typhoid fever, foodborne trematodes, and nontyphoidal salmonellosis. APPLICATIONS: Given the persistence of STEC globally, efforts aimed at reducing the burden of foodborne disease should consider the relative contribution of STEC in the target population.

Exposure variables in veterinary epidemiology: are they telling us what we think they are?

This manuscript summarizes a presentation delivered by the first author at the 2024 symposium for the Calvin Schwabe Award for Lifetime Achievement in Veterinary Epidemiology and Preventive Medicine, which was awarded to Dr. Jan Sargeant. Epidemiologic research plays a crucial role in understanding the complex relationships between exposures and health outcomes. However, the accuracy of the conclusions drawn from these investigations relies upon the meticulous selection and measurement of exposure variables. Appropriate exposure variable selection is crucial for understanding disease etiologies, but it is often the case that we are not able to directly measure the exposure variable of interest and use proxy measures to assess exposures instead. Inappropriate use of proxy measures can lead to erroneous conclusions being made about the true exposure of interest. These errors may lead to biased estimates of associations between exposures and outcomes. The consequences of such biases extend beyond research concerns as health decisions can be made based on flawed evidence. Recognizing and mitigating these biases are essential for producing reliable evidence that informs health policies and interventions, ultimately contributing to improved population health outcomes. To address these challenges, researchers must adopt rigorous methodologies for exposure variable selection and validation studies to minimize measurement errors.

What question are we trying to answer? Embracing causal inference.

This study summarizes a presentation at the symposium for the Calvin Schwabe Award for Lifetime Achievement in Veterinary Epidemiology and Preventive Medicine, which was awarded to the first author. As epidemiologists, we are taught that "correlation does not imply causation." While true, identifying causes is a key objective for much of the research that we conduct. There is empirical evidence that veterinary epidemiologists are conducting observational research with the intent to identify causes; many studies include control for confounding variables, and causal language is often used when interpreting study results. Frameworks for studying causes include the articulation of specific hypotheses to be tested, approaches for the selection of variables, methods for statistical estimation of the relationship between the exposure and the outcome, and interpretation of that relationship as causal. When comparing observational studies in veterinary populations to those conducted in human populations, the application of each of these steps differs substantially. The a priori identification of exposure-outcome pairs of interest are less common in observational studies in the veterinary literature compared to the human literature, and prior knowledge is used to select confounding variables in most observational studies in human populations, whereas data-driven approaches are the norm in veterinary populations. The consequences of not having a defined exposure-outcome hypotheses of interest and using data-driven analytical approaches include an increased probability of biased results and poor replicability of results. A discussion by the community of researchers on current approaches to studying causes in observational studies in veterinary populations is warranted.