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.     

Bulk tank milk selenium and its association with milk production parameters in Canadian dairy herds

An observational study was conducted in 63 Canadian dairy farms to evaluate the association of bulk tank milk selenium (Se) concentration (BTSe) with average daily milk yield, milk fat and milk protein, bulk tank somatic cell count (BTSCC), and the probability of being a Staphylococcus aureus-positive herd. Bulk tank milk samples collected between March 2007 and February 2008 were evaluated for BTSCC, S. aureus culture status, and BTSe. Mean BTSe was 0.51 ± 0.15 μmol/L; no herds were classified as deficient or marginal based on BTSe. Bulk tank milk Se was unconditionally associated with milk production; however, adjusting by region indicated a confounding effect of this variable. There was no relationship between BTSe and BTSCC. Higher values of BTSe were associated with lower risk of being a S. aureus-positive herd, possibly as a result of a more robust udder immune response, or as a result of providing Se at a higher rate as one component of an udder health program that reduces risk of being S. aureus positive.     

Comparison of sampling techniques for measuring the antimicrobial susceptibility of enteric Escherichia coli recovered from feedlot cattle

OBJECTIVE: To evaluate the effectiveness of various sampling techniques for determining antimicrobial resistance patterns in Escherichia coli isolated from feces of feedlot cattle. SAMPLE POPULATION: Fecal samples obtained from 328 beef steers and 6 feedlot pens in which the cattle resided. PROCEDURE: Single fecal samples were collected from the rectum of each steer and from floors of pens in which the cattle resided. Fecal material from each single sample was combined into pools containing 5 and 10 samples. Five isolates of Escherichia coli from each single sample and each pooled sample were tested for susceptibility to 17 antimicrobials. RESULTS: Patterns of antimicrobial resistance for fecal samples obtained from the rectum of cattle did not differ from fecal samples obtained from pen floors. Resistance patterns from pooled samples differed from patterns observed for single fecal samples. Little pen-to-pen variation in resistance prevalence was observed. Clustering of resistance phenotypes within samples was detected. CONCLUSIONS AND CLINICAL RELEVANCE: Studies of antimicrobial resistance in feedlot cattle can rely on fecal samples obtained from pen floors, thus avoiding the cost and effort of obtaining fecal samples from the rectum of cattle. Pooled fecal samples yielded resistance patterns that were consistent with those of single fecal samples when the prevalence of resistance to an antimicrobial was > 2%. Pooling may be a practical altemative when investigating patterns of resistance that are not rare. Apparent clustering of resistance phenotypes within samples argues for examining fewer isolates per fecal sample and more fecal samples per pen.     

Increase in milk yield following eprinomectin treatment at calving in pastured dairy cattle

Gastrointestinal nematodes rarely cause signs of clinical disease in adult cattle. However, they have been shown to exert a negative impact on production in lactating animals, as seen by improved production following elimination of the worms using anthelmintics. A double blind, randomized clinical trial was performed in 28 dairy herds in Canada. The objective of the study was to evaluate the effect of treatment with eprinomectin pour-on solution (IVOMEC EPRINEX) at calving on production, in cattle that have had some exposure to pasture. Cows were randomly allocated to treatment or placebo in blocks of 10, based on calving date, and treated with eprinomectin or placebo on the day of calving.Information on milk production was obtained from all animals, as well as recorded cases of selected diseases. Milk production results from the Canadian dairy herd management system database were analysed using a mixed model with herd as a random effect and test within-cow as a repeated measurement. Test day milk yields from the first six tests after treatment were included in the model, representing a period of between 180 and 200 days in milk (dim). Treated cows produced an additional 0.94 kg of milk per day when compared to the controls over this period. The production effect was independent of calving season, age of the animal and geographical location. No effect of treatment was seen on milk composition, somatic cell count (scc) or on the selected health parameters that were recorded for all included animals.Monthly fecal egg counts (FEC) were performed for eight randomly selected animals in each herd. The observed FEC were low in this study, with a range from 0 to 419 trichostrongyle type eggs per 5g (ep5g) of feces in animals not yet treated with the anthelmintic. The average count was 9.8 and the median was 1.0. FECs dropped immediately after calving and stayed lower for at least 100 days in treated animals when compared to controls.In conclusion, gastrointestinal nematodes appear to have an effect on milk production in Canadian dairy cows that have had some degree of pasture exposure. Eliminating the present subclinical parasite burdens produced a consistent increase in milk production that can yield economic benefits for the dairy producer.     

Management factors related to seroprevalences to bovine viral-diarrhoea virus,bovine-leukosis virus,Mycobacterium avium subspecies paratuberculosis,and Neospora caninum in dairy herds in the Canadian Maritimes

Bovine viral-diarrhoea (BVD), enzootic bovine leukosis (EBL), Johne's disease (JD), and neosporosis lower on-farm productivity, reduce export competitiveness, and increase consumer concerns regarding safety. Our purpose was to examine the relationship between 27 control practices and the estimated true seroprevalences for these four diseases for 2604 cattle in 90 dairy herds in the Maritimes provinces of Canada. Overall, 37.8, 20.4, 3.4, and 19.2% of all sampled cattle were truly exposed to the agents of BVD, EBL, JD, and neosporosis, respectively. The median within-herd true prevalences were 0, 9.3, 0, and 12.3%, respectively. Factor analysis reduced the 27 control practices to two highly correlated factors. Tobit-regression analyses determined that vaccination practices were associated with reduced prevalence of exposure for Bovine viral-diarrhoea and EBL. Also, farms that tended to purchase their dairy animals were associated with higher seroprevalence for Johnes' disease. Neither of these two factors was associated with the seroprevalence of Neospora caninum infection. The few routine biosecurity measures that were investigated in this study were generally not related to the seroprevalences of these farms.     

Comparison of two enzyme-linked immunosorbent assays for diagnosis of Mycobacterium avium subsp. paratuberculosis.

Enzyme-linked immunosorbent assays (ELISAs) are used in Johne's disease (JD) control programs as a first screening for presence of the disease in a herd. A high sensitivity of the ELISA is therefore important, yet the commonly used ELISAs have relatively low sensitivity. The inclusion of an absorption phase, although improving specificity, potentially decreases sensitivity. Sera and feces of 383 adult dairy cows in 8 herds were used to compare the test characteristics of an absorbed and a nonabsorbed indirect ELISA for the detection of JD. The absorbed ELISA is based on a protoplasmic antigen, whereas the nonabsorbed uses a lipoarabinomannan-based antigen. The potential advantage of the nonabsorbed ELISA is that it may be less specific and more sensitive. Two herds certified free of JD were used to compare the specificity of the ELISAs. The other herds used to compare sensitivity were either infected with Mycobacterium avium subsp. paratuberculosis or had unknown status. Using fecal culture as a gold standard, the diagnostic specificity for the absorbed and nonabsorbed ELISAs were 98.4% and 87.9%, respectively. The diagnostic sensitivity was 72.4% and 65.5% for the absorbed and the nonabsorbed ELISA, respectively. Furthermore, a comparison using a fecal DNA probe as the comparison standard resulted in both ELISAs having a sensitivity of 61.9%. Agreement between the 2 ELISAs was moderate, with a kappa statistic of 0.58. The nonabsorbed ELISA did not have a higher sensitivity and had a lower specificity than the absorbed ELISA. Therefore, in this population, there was no advantage gained with using the nonabsorbed ELISA.     

Airborne particle concentration and meteorologic conditions associated with pneumonia incidence in feedlot cattle

To elucidate the role of air quality on the occurrence of pneumonia in feedlot cattle, the following environmental values were measured at a feedlot: suspended particulates in 5 particle-size fractions, relative humidity, air temperature, and barometric pressure. Pneumonia incidence data were classified by the number of days the cattle had been at the feedlot (days on feed). The concentration of airborne particles, range of temperature, days on feed, and season of the year were associated with incidence of pneumonia in cattle. Pneumonia incidence rates were greatest both within 15 days of arrival at the feedlot and during the fall sampling periods. The incidence of pneumonia in the 16 to 30 days-on-feed group was closely associated with the concentration of particles 2.0 to 3.3 microns in diameter and the range of daily temperature when exposure occurred 15 days before the onset of disease in the fall and 10 days before in the spring.     

Evaluation of Digital and Optical Refractometers for Assessing Failure of Transfer of Passive Immunity in Dairy Calves

Background

Failure of transfer of passive immunity (FTPI) is the underlying predisposing risk factor for most early losses in dairy calves. Refractometers, either optical or digital, can be used to assess FTPI as a part of calf health monitoring program on dairy operations.

Objectives

To evaluate the performance of and differences between digital Brix and optical refractometers for assessing FTPI in dairy calves.

Animals

Two hundred Holstein calves from 1 to 11 days of age.

Methods

A cross‐sectional study was designed to measure serum IgG concentration by radial immunodiffusion (RID) assay, digital Brix and optical refractometers. The correlation coefficients (r) between the 2 refractometers were plotted against each other and against the measured IgG concentration from RID. The Se, Sp, and accuracy of digital Brix and optical refractometers for assessing FTPI using previously recommended cut‐offs were calculated. A receiver operating characteristic curve was created and used to identify the optimal cut‐off for this dataset.

Results

The RID IgG concentration was positively correlated with digital Brix (r = 0.79) and optical (r = 0.74) refractometers. The best combination of Se (85.5%), Sp (82.8%), and accuracy (83.5%) of digital Brix refractometer was at 8.3%Brix. For optical refractometer, the best combination of Se (80%), Sp (80.7%), and accuracy (80.5%) was at 5.5 g/dL.

Conclusions and Clinical Importance

Both refractometers exhibited utility in assessing FTPI in dairy calves.     

Effects of meloxicam on severity of lameness and other clinical signs of osteoarthritis in dogs

OBJECTIVE: To evaluate effects of meloxicam on severity of lameness and other clinical signs in dogs with osteoarthritis (OA). DESIGN: Randomized, controlled, multicenter clinical trial. ANIMALS: 217 client-owned dogs with clinical and radiographic signs of OA. PROCEDURE: Dogs were randomly assigned to be treated with meloxicam (n = 105; 0.2 mg/kg [0.09 mg/lb], SC, once on day 1, then 0.1 mg/kg [0.045 mg/lb], PO, q 24 h, for 13 days) or a placebo (n = 112). A general clinical score was assigned by investigators on days 1 (ie, prior to initiation of treatment), 8, and 15 on the basis of severity of lameness, extent of weight bearing, and severity of signs during palpation of the affected joint. Owners and investigators provided overall evaluations on days 8 and 15. RESULTS: Dogs treated with meloxicam had significantly greater improvements in general clinical scores, compared with baseline scores, on days 8 and 15 than did dogs treated with placebo. On days 8 and 15, percentages of dogs treated with meloxicam in which owners and investigators considered treatment to be successful were significantly higher than percentages of control dogs in which treatment was considered to be successful. No abnormalities in hematologic and serum biochemical test results were detected. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that compared with administration of a placebo, administration of meloxicam for 14 days significantly improved the clinical condition of dogs with OA without causing adverse effects.     

Risk factors for milk off-flavours in dairy herds from Prince Edward Island, Canada

A sudden increase in the incidence of milk off-flavours in bulk tank milk from Prince Edward Island (Canada) dairy farms in the late 1990s prompted an investigation of potential herd-level risk factors. A prospective case-control study was conducted from 2000 to 2002. Data on herd management were obtained by questionnaire and field investigation from all the 62 identified off-flavour positive farms (cases) and 62 loosely matched (for data-collection convenience) off-flavour negative farms (controls). Forty-three of the 62 cases (69%) of milk off-flavours identified during the study period were classified as “transmitted” (feed) off-flavours, and 9 (15%), 6 (10%), and 4 (6%) as “rancid”, “oxidized” and “malty” off-flavours, respectively. Given this evidence and the relatively low incidence of other flavour defects in milk, only transmitted-flavour cases were considered in the analyses of risk factors. Poor air quality in the lactating cows’ barn (OR = 40.8), using baled silage as the main forage (OR = 10.6), as well as feeding roughage before milking (OR = 253.3) or as a free choice (OR = 3.2) all were significantly (P < 0.05) associated with the incidence of transmitted flavours in bulk-tank milk. Clipping the hair on the cows’ udder (OR = 0.07) and changing the bedding material more than once a day (OR = 0.12) were protective. The finding about feeding baled silage before milking has raised hypotheses about silage composition (in particular the off-flavour compounds or their precursors) and also about the process of silage making itself.