Critical features of veterinary field trials

Elbers, A.R.W.; Schukken, Y.H.

doi:10.1136/vr.136.8.187

Cited by 30 publications

(18 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Exposure to infectious agents probably results in a more-homogeneous serological status of animals within clusters as measured by the intra-cluster correlation coefficient (Donald and Donner, 1987;Rothman, 1990), because the interrelatedness of incidence and prevalence is the very characteristic that defines infectious diseases (Koopman et al, 1991;Susser, 1994a;De Jong, 1995). Consequently, it cannot be assumed that the animals are independent units (Schukken et al, 1991;Elbers and Schukken, 1995;Cameron and Baldock, 1998), because compared to other population members, animals within clusters have a higher chance of becoming infected once the infection is introduced into the herd.…”

Section: Introductionmentioning

confidence: 99%

Risk factors for bovine herpesvirus-1 seropositivity

Boelaert

Speybroeck

Kruif

et al. 2005

Preventive Veterinary Medicine

View full text Add to dashboard Cite

This paper reports the investigation of risk factors for bovine herpesvirus-1-seropositivity, based on a cluster-sample survey of the Belgian cattle population. This serosurvey was carried out in 1998 in 309 randomly selected unvaccinated herds of all types (dairy, mixed and beef) were all bovids (N = 11,284) were sampled.Older and male cattle had higher seroprevalence. Origin (homebred or purchased) and herd size interacted; for smaller herds ( 50 cattle on the premises), purchase status and larger herd size were risk factors, whereas these effects were not observed for larger herds. #

show abstract

Section: Introductionmentioning

confidence: 99%

Risk factors for bovine herpesvirus-1 seropositivity

Boelaert

Speybroeck

Kruif

et al. 2005

Preventive Veterinary Medicine

View full text Add to dashboard Cite

show abstract

“…However, despite the availability of these criteria, the quality of reporting of intervention trials remains poor. An assessment of the quality of RCTs published in one journal revealed that although some of the trials provided information on methodological features, many others failed to do so (Elbers and Schukken, 1995). These trials lacked information related to the method of treatment allocation, the grouping of animals relative to treatment allocation, the use or non-use of blinding and the method of statistical analysis (Elbers and Schukken, 1995).…”

Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

“…An assessment of the quality of RCTs published in one journal revealed that although some of the trials provided information on methodological features, many others failed to do so (Elbers and Schukken, 1995). These trials lacked information related to the method of treatment allocation, the grouping of animals relative to treatment allocation, the use or non-use of blinding and the method of statistical analysis (Elbers and Schukken, 1995). Further, several systematic reviews in pre-harvest food safety (Denagamage et al, 2007;O'Connor et al, 2008) and animal health (O'Connor et al, 2006;Wellman and O'Connor, 2007;Burns and O'Connor, 2008) have noted a lack of reporting of group allocation methods; blinding and details related to intervention protocols, outcome assessments and statistical analysis methods in some published clinical trials.…”

Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Sargeant

O’Connor

Gardner

et al. 2010

Journal of Food Protection

View full text Add to dashboard Cite

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 that 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 deliberate challenge models in some trials and the 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. KeywordsRandomized trials, livestock, challenge studies and standards RightsWorks produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted. AbstractConcerns 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 that 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...

show abstract

“…However, previous studies have illustrated substantive issues related to the reporting of clinical trials in the small animal literature 1 and in veterinary medicine in general. 2 Authors of systematic reviews of therapeutic interventions in dogs and cats also have reported shortcomings in the reporting of key features in the published research. [3][4][5][6] Numerous studies have reported shortcomings in the reporting of important methodological features of clinical trials in human clinical research.…”

mentioning

confidence: 99%

Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment Effects

Sargeant

Thompson²,

Valcour

et al. 2010

Veterinary Internal Medicne

View full text Add to dashboard Cite

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 o .001), the use of double blinding (P o .001), the inclusion criteria for study subjects (P 5 .003), baseline differences between treatment groups (P 5 .006), the measurement used for all outcomes (P 5 .002), and possible study limitations (P 5 .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.

show abstract

Critical features of veterinary field trials

Cited by 30 publications

References 0 publications

Risk factors for bovine herpesvirus-1 seropositivity

Risk factors for bovine herpesvirus-1 seropositivity

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment Effects

Contact Info

Product

Resources

About