A two-ward acute care hospital outbreak of SARS-CoV-2 delta variant including a point-source outbreak associated with the use of a mobile vital signs cart and sub-optimal doffing of personal protective equipment.

BACKGROUND: The arrival of the Delta variant of SARS-CoV-2 was associated with increased transmissibility and illness of greater severity. Reports of nosocomial outbreaks of Delta variant COVID-19 in acute care hospitals have been described but control measures varied widely. AIM: Epidemiological investigation of a linked two-ward COVID-19 Delta variant outbreak was conducted to elucidate its source, risk factors, and control measures. METHODS: Investigations included epidemiologic analysis, detailed case review serial SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) testing of patients and healthcare workers (HCWs), viral culture, environmental swabbing, HCW-unaware personal protective equipment (PPE) audits, ventilation assessments, and the use of whole genome sequencing (WGS). FINDINGS: This linked two-ward outbreak resulted in 17 patient and 12 HCW cases, despite an 83% vaccination rate. In this setting, suboptimal adherence and compliance to PPE protocols, suboptimal hand hygiene, multi-bedded rooms, and a contaminated vital signs cart with potential fomite or spread via the hands of HCWs were identified as significant risk factors for nosocomial COVID-19 infection. Sudden onset of symptoms, within 72 h, was observed in 79% of all Ward 2 patients, and 93% of all cases (patients and HCWs) on Ward 2 occurred within one incubation period, consistent with a point-source outbreak. RT-PCR assays showed low cycle threshold (CT) values, indicating high viral load from environmental swabs including the vital signs cart. WGS results with ≤3 SNP differences between specimens were observed. CONCLUSION: Outbreaks on both wards settled rapidly, within 3 weeks, using a `back-to-basics' approach without extraordinary measures or changes to standard PPE requirements. Strict adherence to recommended PPE, hand hygiene, education, co-operation from HCWs, including testing and interviews, and additional measures such as limiting movement of patients and staff temporarily were all deemed to have contributed to prompt resolution of the outbreak.

The REFLECT statement: reporting guidelines for randomized controlled trials in livestock and food safety: explanation and elaboration.

Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision-making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996 with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies, the use of a deliberate challenge model in some trials, and common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies.

The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A two-day consensus meeting was held on November 18-19, 2008 in Chicago, Ill, United States of America, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety (LFS) and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

Quality of reporting of clinical trials of dogs and cats and associations with treatment effects.

BACKGROUND: To address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials. HYPOTHESIS: The reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects. ANIMALS: Dogs and cats used in 100 randomly selected reports of clinical trials. METHODS: Data related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models. RESULTS: There were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence (P < .001), the use of double blinding (P < .001), the inclusion criteria for study subjects (P = .003), baseline differences between treatment groups (P = .006), the measurement used for all outcomes (P = .002), and possible study limitations (P = .03). CONCLUSIONS AND CLINICAL IMPORTANCE: Many clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need.

The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18-19, 2008 in Chicago, IL, to achieve the objective. Before the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

Q fever in Alberta, Canada: 1998-2011.

Establishing the diagnosis of Q fever (Coxiella burnetii) is important in directing the application of therapy to prevent severe manifestations of the infection. In Alberta, Canada, the presence of high livestock density creates a significant risk of infection, but to date, there has been no comprehensive analysis of local Q fever epidemiological trends and exposure patterns. Between 1998 and 2011, there were 39 cases and an overall adjusted case rate of 0.087 per 100 000 person-years. Cases were identified most commonly during the May-June season (Figure 2). The median age at date of diagnosis was 49.0 (range: 8.7-71.5) with slightly higher percentage of cases in men (56.4%) than in women (43.6%). There was an apparent geographical clustering of cases. The majority of these cases, with exposure data (n = 31), reported contact with farms and/or livestock, predominantly cattle (6), sheep (5) and goats (5). Cases tended to occur in census divisions with higher density of sheep, goats and cattle. Our findings suggest the need for an increase in targeted messages about Q fever to those in the livestock industry, as more targeted case finding among patients with a high index of suspicion for Q fever. In addition, widespread implementation of a standard questionnaire for cases would enhance surveillance of Q fever in Alberta.

A survey of Canadian public health personnel regarding knowledge, practice and education of zoonotic diseases.

Zoonoses, diseases that can spread under natural conditions between humans and other animals, are become a major public health concern in many countries including Canada. In Canada, investigations of zoonotic disease incidents are often conducted by public health inspectors (PHIs). However, little is known about PHIs' knowledge of transmission of zoonotic pathogens, their perceptions of zoonotic disease importance or their education regarding zoonotic diseases. The objective of this study was therefore to assess the knowledge, perceptions and education of Canadian PHIs regarding zoonotic diseases. Data were collected from December 2008-January 2009 using an internet-based survey distributed to members of the Canadian Institute of Public Health Inspectors national listserv. Responses were received from 229 PHIs in four provinces, with a response rate of approximately 20%. The majority of respondents reported at least 10 years of experience in the public health sector, 80% (181/225) were in frontline positions, and 62% (137/222) were routinely involved in investigations of infectious diseases. Two-thirds believed that the importance of zoonotic diseases with regards to public health would increase in the next 5 years. Whilst most respondents were able to correctly identify animals capable of directly transmitting common zoonotic pathogens, there were gaps in knowledge, particularly with regard to rabies and transmission of gastrointestinal pathogens by companion animals. PHIs tended to feel that their training on zoonotic diseases prior to working as PHIs was deficient in some areas, or left some room for improvement. Their responses also suggested that there is a need for improvement in both the quantity and the quality of continuing education on zoonotic diseases. In particular, less than one-third of PHIs received ongoing continuing education regarding zoonotic diseases, and of those that did, nearly two-thirds rated the quantity and quality as only fair.

A systematic review of vaccinations to reduce the shedding of Escherichia coli O157 in the faeces of domestic ruminants.

The objective of this study was to conduct a systematic review and meta-analysis of the published literature to evaluate the efficacy of vaccines in reducing faecal shedding of Escherichia coli O157 in ruminants. A systematic search of eight databases and land-grant university research reports using an algorithm adapted from a previous systematic review of pre-harvest interventions against E. coli O157 was conducted to locate all reports of in vivo trials of E. coli O157 vaccines in ruminants published between 1990 and 2010. All located references were screened by two independent reviewers, and data were extracted from all relevant papers, with treatment effect measured in odds ratios. For trials with a faecal prevalence outcome that did not involve mixing of treated and untreated cattle in the same pen, efficacy was explored using random-effects meta-analysis. Funnel plots were used to evaluate publication bias, and random-effects meta-regression was performed to explore heterogeneity. The search located 20 relevant manuscripts which detailed 24 trials and 46 treatment comparisons; all but one trial involved cattle. There were 9 deliberate challenge trials (19 comparisons), and 15 natural exposure trials (27 comparisons). For Type III protein vaccines, there were 9 natural exposure trials detailing 17 comparisons, and meta-analysis of 8 comparisons revealed that vaccine treatment resulted in a statistically significant reduction in E. coli O157 faecal prevalence [odds ratio (OR)=0.38, 95% confidence interval (CI)=0.29, 0.51]. Siderophore receptor and porin protein (SRP) vaccines (three trials/four comparisons) also reduced faecal prevalence (OR=0.42, 95% CI=0.20, 0.61); however, none of the bacterin vaccine trials (n=3, six comparisons) resulted in a statistically significant reduction in prevalence. The results suggest that Type III protein and SRP vaccines significantly reduce faecal shedding in cattle; however, caution should be taken in interpreting the results because of the heterogeneity in the results.

The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A two-day consensus meeting was held on November 18-19, 2008 in Chicago, IL, United States of America, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock-production specialists, journal editors, assistant editors, and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines For Randomized Control Trials) statement for livestock and food safety (LFS) and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety by modifying the CONSORT statement.

The conduct of randomized controlled trials in livestock with production, health and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on 18-19 November 2008 in Chicago, IL, USA, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock-production specialists, journal editors, assistant editors and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health and food-safety outcomes.

Methodological quality and completeness of reporting in clinical trials conducted in livestock species.

Randomized controlled trials (RCTs) are the gold standard for evaluating efficacy of treatments under real world conditions and, as such, it is important that they are conducted with methodological rigour to prevent biased results. Many medical journals have adopted a standard checklist for reporting of RCTs, the CONSORT statement. The objective of this study was to evaluate clinical trials in livestock populations to assess methodological quality and completeness of reporting and to investigate the association between these criteria and treatment effects. A total of 100 clinical trials published between 2006 and 2008 in the English language were randomly selected. For each trial, 2 reviewers independently completed a checklist based on the CONSORT statement and a different 2 reviewers completed a standard template describing the outcomes used and the statistical significance of all reported treatment effects. Disagreements among reviewers were resolved by consensus. The results showed that there were substantive deficiencies in the reporting of many of trial features, both related to methodological quality and completeness of reporting. Details on key features such as randomization, double blinding, and the number of subjects lost to follow-up were reported in only 67, 4, and 62% of trials, respectively. Reporting of random allocation to treatment group was associated with a lower proportion of positive treatments effects within trials, as was reporting of inclusion/exclusion criteria for study subjects, details on the intervention, animal signalment, significance tests of baseline differences for at least one variable, and the methods used to measure all outcomes. The results suggest that there are deficiencies in the current reporting of important features of RCTs conducted in livestock species and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for trial reporting in livestock could aid authors, reviewers, and editors in ensuring that necessary trial details are reported in all published trials.