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: 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 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.     

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.     

Explanation and Elaboration Document for the STROBE‐Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary Extension

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers, and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples, and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE‐Vet statement. Thus, this is a companion document to the STROBE‐Vet statement methods and process document (JVIM_14575 “Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary (STROBE‐Vet) Statement” undergoing proofing), which describes the checklist and how it was developed.     

Explanation and Elaboration Document for the STROBE‐Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology – Veterinary Extension

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE‐Vet Statement. Thus, this is a companion document to the STROBE‐Vet Statement Methods and process document, which describes the checklist and how it was developed.     

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.     

Consensus-based reporting standards for diagnostic test accuracy studies for paratuberculosis in ruminants

The Standards for Reporting of Diagnostic Accuracy (STARD) statement (www.stard-statement.org) was developed to encourage complete and transparent reporting of key elements of test accuracy studies in human medicine. The statement was motivated by widespread evidence of bias in test accuracy studies and the finding that incomplete or absent reporting of items in the STARD checklist was associated with overly optimistic estimates of test performance characteristics. Although STARD principles apply broadly, specific guidelines do not exist to account for unique considerations in livestock studies such as herd tests, potential use of experimental challenge studies, a more diverse group of testing purposes and sampling designs, and the widespread lack of an ante-mortem reference standard with high sensitivity and specificity. The objective of the present study was to develop a modified version of STARD relevant to paratuberculosis (Johne's disease) in ruminants. Examples and elaborations for each of the 25 items were developed by a panel of experts using a consensus-based approach to explain the items and underlying concepts. The new guidelines, termed STRADAS-paraTB (Standards for Reporting of Animal Diagnostic Accuracy Studies for paratuberculosis), should facilitate improved quality of reporting of the design, conduct and results of paratuberculosis test accuracy studies which were identified as "poor" in a review published in 2008 in Veterinary Microbiology.     

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative

Background:  To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.  Objective:  To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability.  Methods:  The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.  Results:  The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both.  Conclusions:  Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.     

Completeness of reporting in abstracts from clinical trials of pre-harvest interventions against foodborne pathogens

Abstracts are the most commonly read part of a journal article, and play an important role as summaries of the articles, and search and screening tools. However, research on abstracts in human biomedicine has shown that abstracts often do not report key methodological features and results. Little research has been done to examine reporting of such features in abstracts from papers detailing pre-harvest food safety trials. Thus, the objective of this study was to assess the quality of reporting of key factors in abstracts detailing trials of pre-harvest food safety interventions. A systematic search algorithm was used to identify all in vivo trials of pre-harvest interventions against foodborne pathogens in PubMed and CAB Direct published from 1999 to October 2009. References were screened for relevance, and 150 were randomly chosen for inclusion in the study. A checklist based on the CONSORT abstract extension and the REFLECT Statement was used to assess the reporting of methodological features and results. All screening and assessment was performed by two independent reviewers with disagreements resolved by consensus. The systematic search returned 3554 unique citations; 356 were found to be relevant and 150 were randomly selected for inclusion. The abstracts were from 51 different journals, and 13 out of 150 were structured. Of the 124 abstracts that reported whether the trial design was deliberate disease challenge or natural exposure, 113 were deliberate challenge and 11 natural exposure. 103 abstracts detailed studies involving poultry, 20 cattle and 15 swine. Most abstracts reported the production stage of the animals (135/150), a hypothesis or objective (123/150), and results for all treatment groups (136/150). However, few abstracts reported on how animals were grouped in housing (25/150), the location of the study (5/150), the primary outcome (2/126), level of treatment allocation (15/150), sample size (63/150) or whether study units were lost to follow up (4/150). Forty-eight (48/150) abstracts reported the name, mode of administration, dose and duration of the intervention(s), while 102 (102/150) reported at least one of these elements. Nine (9/150) abstracts specified that allocation of study units to treatments was randomized, and none of the abstracts reported whether blinding was used (0/150). These results reveal gaps in reporting of methodological features and results. Thus, improving reporting quality in abstracts should be a crucial goal to be pursued by authors, reviewers and journal editors.     

A meta-analysis of the milk-production response after anthelmintic treatment in naturally infected adult dairy cows

Meta-analysis was used to estimate the effects of anthelmintic treatment on milk production in dairy cows. The literature search included peer-reviewed journals (both full articles and abstracts), conference proceedings and theses and included documents written in English, Spanish, French, Portuguese or Italian. The study outcome was defined as the difference in milk production (kg/cow per day) between treated and untreated cows. Random effect meta-analyses were performed on 75 trials published between 1972 and 2002. The combined estimate after controlling for publication bias and/or small-study effect was of 0.35 kg/cow per day. Significant variation among studies was detected and although several variables were associated with the study outcome, they did not significantly reduce the unexplained variability among trials. Trials reporting the use of endectocides had higher milk-production response compared with trials using older anthelmintics. Similarly, whole-herd treatment trials or trials which applied the treatment in mid-lactation or strategically throughout the year had higher response compared with calving or dry-period treatment trials. Trials reporting the results as total 305-day milk production had lower response compared with trials which measured production as daily milk weight. Primiparous cows trials had lower responses compared with multiparous cows trials.     

Randomization,blinding, data handling and sample size estimation in papers published in Veterinary Anaesthesia and Analgesia in 2009 and 2019

ObjectiveTo evaluate reporting of items indicative of bias and weak study design.Study designLiterature survey.PopulationPapers published in Veterinary Anaesthesia and Analgesia.MethodsReporting of randomization, blinding, sample size estimation and data exclusion were compared for papers published separated by a 10 year interval. A reporting rate of more than 95% was considered ideal. The availability of data supporting results in a publicly accessible repository was also assessed. Selected papers were randomized and identifiers removed for review, with data from 59 (57 in 2009, two in 2008) and 56 (52 in 2019, four in 2018) papers analyzed. Items were categorized for completeness of reporting using a previously published operationalized checklist. Two reviewers reviewed all papers independently.ResultsFull reporting of randomization increased over time from 13.6% to 85.7% [95% confidence interval (CI), 57.8–86.6%; p < 0.0001], as did sample size estimation (from 0% to 20%; 95% CI, 7.6–32.4%; p = 0.002). Reporting of blinding (49.2% and 50.0%; 95% CI, –18.3% to 20.0%; p = 1.0) and exclusions of samples/animals (39.0% and 50.0%; 95% CI, –8.8% to 30.8%; p = 0.3) did not change significantly. Data availability was low (2008/2009, zero papers; 2018/2019, two papers). None of the items studied exceeded the predetermined ideal reporting rate.Conclusions and clinical relevanceThese results indicate that reporting quality remains low, with a risk of bias.     

Novel approaches for the control of helminth parasites of livestock VI: summary of discussions and conclusions

Gastrointestinal helminth parasites impact on livestock production systems throughout the world, and the use of anthelmintics to control this problem has lead to the inevitable development of populations of helminths resistant to these treatments. This, coupled with consumer desires for minimal chemical inputs into food and fibre production, has prompted research into non-chemical approaches to helminth control. Scientists of the "Novel Approaches to the Control of Helminth Parasites of Livestock" group met for the 6th time in August 2010 and this paper summarises that meeting. Six scientific sessions addressed current approaches and topics of interest through formal presentations and discussion of issues raised by the contributing authors. Close interaction between researchers and extension specialists during the meeting has contributed to enhanced prospects for field application of research outcomes in the future.     

A systematic review of randomized controlled trials for prevention or treatment of atopic dermatitis in dogs: 2008–2011 update

Background – The management of atopic dermatitis (AD) in dogs relies mainly on the use of interventions to reduce pruritus and skin lesions. Objectives – To provide a critical analysis of recent clinical trials reporting the efficacy and safety of interventions for canine AD. Methods – Systematic review of randomized controlled trials (RCTs) published, presented or completed between 2008 and 2011, which enrolled dogs with AD. The search was done using electronic databases, reviewing published meeting abstracts and sending queries to professional email lists. Trials reporting the efficacy of interventions aimed at treating, preventing or reducing glucocorticoid usage in atopic dogs were selected. Results – Twenty‐one RCTs were included. We found further moderate‐quality evidence of efficacy and safety of oral glucocorticoids and ciclosporin for treatment of canine AD. There was additional moderate‐quality evidence of the efficacy of a topical glucocorticoid spray containing hydrocortisone aceponate. Low‐quality evidence was found for the efficacy and safety of injectable recombinant interferons, a budesonide leave‐on conditioner, a ciclosporin topical nano‐emulsion and oral fexofenadine. There is low‐quality evidence of efficacy of oral masitinib, with a need for monitoring for protein‐losing nephropathy. Finally, we uncovered low‐quality evidence of efficacy of a commercial diet as a glucocorticoid‐sparing intervention and of a glucocorticoid spray as a flare‐delaying measure. Very low‐quality evidence was found for the efficacy of other interventions. Conclusions and clinical importance – Topical or oral glucocorticoids and oral ciclosporin remain the interventions with highest evidence for efficacy and relative safety for treatment of canine AD.     

全面收益报告的借鉴及应用形式探析

新《企业会计准则》突破“历史成本原则”、“收入实现原则”、“稳健原则”等传统利润确认原则的束缚，使净利润中包含了部分“其他全面收益”的内容。自上世纪90年代以来，英美各国及国际会计准则委员会在传统财务会计报告利润的基础上增加“其他全面收益”，并呈现出不同的报告方式。全面收益报告在我国的应用已具有其必要性和可行性。文中在借鉴国外经验的基础上，初步探讨分析各种“全面收益报告”模式的利弊，主张采用渐进模式，逐步推行全面收益报告。     

Teaching international animal agriculture

Students who major in animal science at U.S. institutions are generally exposed to a curriculum that emphasizes commercial, large-scale production of the few traditional food animals: cattle, poultry, sheep, and swine. Globally, most farmers live in lesser-developed countries under limited-resource conditions of land, feed supplies, equipment, and capital. The promotion of commercial animal production enterprises may not be appropriate for such farms because it can subject farmers to considerable economic risk. Rather, use of limited numbers of large livestock, locally adapted breeds, or smaller livestock (e.g., ducks, goats, guinea pigs, and rabbits) may be more appropriate under subsistence, integrated farming systems. In this global context, a course in international animal agriculture has been taught for 15 yr to undergraduate and graduate students. The course consists of a review of traditional and potential livestock species well suited for impoverished families on small farms and methods to implement sustainable livestock projects, including feasibility, design, implementation, monitoring, and evaluation stages. To enhance student understanding, global food issues and challenges are illustrated with case studies. A term paper is also assigned for which students choose three suitable livestock species or local breeds that would be complementary on a small crop farm (< 5 ha). Daily dietary requirements of protein and energy per family member are calculated. Itemized enterprise budgets and production tables are prepared. Early in the course, the general consensus of students was that people who are malnourished and live in poverty have low personal ambition and motivation, and that their problems should be amenable to solution by application of American technology and expertise. The course modifies such attitudes and enhances a student's critical thinking and problem-solving abilities and communication skills. Course evaluations indicated that students believed that it is important to acquire some international knowledge and understanding when seeking a job, and that certain animal science courses should contain some international content. Students gain an understanding of global animal agriculture and an appreciation of the complexity of food production and hunger issues.     

Veterinary Randomized Clinical Trial Reporting: A Review of the Small Animal Literature

The randomized clinical trial (RCT) is a valuable research method for the evaluation of new treatment and prevention regimens in veterinary medicine. Reporting of clinical trials in other disciplines has not been complete. Without complete information on the conduct and results of a clinical trial, readers cannot optimize their use of the information presented. This report represents an objective review of randomized clinical trials in the veterinary small animal literature from 1986 to 1990. Results indicate that RCT reports in the small animal veterinary literature are incomplete. The importance of reporting on particular aspects of RCT research is described.