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.

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.

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.

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.

Retrospective multicentre study of methicillin-resistant Staphylococcus aureus infections in 115 horses.

REASONS FOR PERFORMING STUDY: Methicillin-resistant Staphylococcus aureus (MRSA) is an emerging veterinary and zoonotic pathogen, associated with increasing reports of disease in horses. OBJECTIVES: To provide an overview of the characteristics of clinical MRSA infections in horses. METHODS: A retrospective case study was performed on 115 horses admitted to 6 participating veterinary teaching hospitals in Canada and the United States between 2000 and 2006, and diagnosed with clinical MRSA infection. Descriptive statistics, univariate and multivariable analyses for community- (CA) vs. hospital-associated (HA) MRSA infections, and survival vs. nonsurvival at discharge were performed. RESULTS: The age range of MRSA-infected horses was zero (born in hospital) to 31 years. HA (58/114, 50.9%) and CA infections (56/114, 49.1%) were equally common. Infection of surgical incisions was most frequently reported (44/115, 38.0%). Overall 93/111 (83.8%) cases survived to discharge. Previous hospitalisation and treatment with gentamicin were associated significantly with CA-MRSA, whereas infected incision sites were associated significantly with HA-MRSA. Factors significantly associated with nonsurvival included i.v. catheterisation, CA-MRSA infection and dissemination of infection to other body sites. CONCLUSIONS: Equine MRSA infections have a broad range of clinical presentations, appear to be primarily opportunistic and the overall prognosis for survival to discharge is good. POTENTIAL RELEVANCE: These results should help direct future research with regard to investigation of risk factors for equine MRSA infection in community and hospital populations.

Evaluation of the risks of shedding Salmonellae and other potential pathogens by therapy dogs fed raw diets in Ontario and Alberta.

Dogs that participate in animal-assisted interventions (AAIs), often called 'therapy dogs', commonly interact with humans whose immune systems are not functioning optimally. The advisability of feeding raw meat (including poultry) to these animals remains a highly contentious issue, in spite of increasing evidence that raw meat is frequently contaminated with Salmonella. We set out to determine if consuming raw meat influences the risk of therapy dogs shedding Salmonella and other pathogens. Two hundred healthy therapy dogs from Ontario and Alberta were enrolled. Between May 2005 and November 2006, fecal specimens were collected from each dog every 2 months for 1 year, along with a log of places visited, antimicrobial use within the home, dog health status and diet. Specimens were cultured for Salmonella, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), extended-spectrum cephalosporinase (ESC) Escherichia coli and Clostridium difficile. Forty (20%) of the dogs were reported to have been fed raw meat at some point during the year. The incidence rate of Salmonella shedding in the raw meat-fed dogs was 0.61 cases/dog-year, compared with 0.08 cases/dog-year in dogs that were not fed raw meat (P<0.001). Controlling for therapy dog group, the repeated measures, and pig ear consumption and diarrhoea in the 2 months prior to specimen submission, dogs that consumed raw meat were significantly more likely to test positive for Salmonella at least once during the year than dogs that did not eat raw meat [odds ratio (OR) 22.7; 95% confidence interval (CI) 3.1-58.8; P<0.001]. Specific Salmonella serovars were more common among dogs that consumed raw meat versus those that did not include S. Typhimurium, S. Heidelberg and S. Kentucky. Raw meat consumption was also significantly associated with shedding ESC E. coli (OR 17.2; 95% CI 9.4-32.3). No associations between C. difficile, MRSA or VRE and consumption of raw meat were detected. We recommend that dogs fed raw meat should be excluded from AAI programmes, particularly when the programmes involve interaction with humans at high risk of infection or adverse sequelae attributable to infection. Furthermore, although AAI dogs may not be representative of the general population of dogs, we also recommend that feeding of raw meat to dogs is to be avoided in homes where immunocompromised people live.

Prevalence of zoonotic agents in dogs visiting hospitalized people in Ontario: implications for infection control.

Visitation of hospitalized people by dogs is becoming commonplace, but little is known about the potential health risks of introducing dogs to healthcare settings. This cross-sectional study evaluated the prevalence of zoonotic agents in a group of 102 visitation dogs from a variety of sources across Ontario. Between May and July 2004, owners were interviewed by a standardized questionnaire while dogs underwent a standardized physical examination. One specimen of faeces, hair-coat brushings and one rectal, aural, nasal, oral and pharyngeal swab were collected from each dog and tested for 18 specific pathogens. All dogs were judged to be in good health. Zoonotic agents were isolated from 80 out of 102 (80%) dogs. The primary pathogen was Clostridium difficile, which was isolated from 58 (58%) faecal specimens. Seventy-one percent (41/58) of these isolates were toxigenic. Extended-spectrum beta-lactamase Escherichia coli was isolated from one (1%) dog, extended-spectrum cephalosporinase E. coli was isolated from three (3%) dogs, and organisms of the genus Salmonella were isolated from three (3%) dogs. Pasteurella multocida or Pasteurella canis was isolated from 29 (29%) oral swabs, and Malassezia pachydermatis was isolated from eight (8%) aural swabs. Giardia antigen was present in the faeces of seven (7%) dogs, while Toxocara canis and Ancylostoma caninum were detected in two (2%) dogs and one (1%) dog, respectively. Methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, Campylobacter spp., Microsporum canis, group A streptococci, Pseudomonas aeruginosa and Cryptosporidium spp. were not detected. Further information is needed before the full implications of these findings for infection control can be assessed properly.