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

Sargeant, Jan M.; Elgie, Rodney; Valcour, James; Saint-Onge, J.; Thompson, Alastair; Marcynuk, Pasha; Snedeker, Kate

doi:10.1016/j.prevetmed.2009.06.002

Cited by 81 publications

(96 citation statements)

References 26 publications

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“…Approximately two-third of items was inadequately reported; indeed, several items (title indicating the study as randomized, randomization, blinding, number randomized, number analyzed, trial registration, and funding) were completely not reported in RCT or non RCT abstracts or both (Table 4). Our finding that both RCT and non RCT abstracts did not report title indicating the study as randomized was consistent with that of previous studies in livestock species (Sargeant et al 2009;Snedeker et al 2012). However, this was different from previous studies in human subjects that reporting title indicating the study as randomized was found more than half of the included abstracts (Ghimire et al 2014;Mbuagbaw et al 2014).…”

Section: Discussionsupporting

confidence: 91%

“…Research especially a controlled trial is needed to reduce the cost, to improve the production, and to solve health's problems in commercially raised chickens. Although a large number of controlled trials for livestock species have been published in each year and readers expect to read RCTs rather than non-RCTs, unfortunately, substantial proportions of non-RCTs have been reported in literature of livestock research (Sargeant et al 2009;Snedeker et al 2012). …”

Section: Introductionmentioning

confidence: 99%

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Reporting quality of randomized and non-randomized controlled trial abstracts from chicken research

Sukon

Kongpechr

Bubpahou

et al. 2016

Preprint

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In publication of a controlled trial article from health science research, the abstract is an important part that readers usually read first and then decide whether to read the whole article; therefore, information provided in the abstract should be adequate. The CONSORT (consolidated standards of reporting trials) for Abstracts checklist has been developed and used as a guideline for authors to prepare their manuscripts. This checklist has also been used as a tool to evaluate published abstracts. The objectives of this study were to evaluate reporting quality of randomized controlled trial (RCT) and non-RCT abstracts from chicken research and to determine factors associated with the reporting quality. We searched PubMed for RCT and non-RCT abstracts involving chicken research published between 2006 and 2015. The included abstracts were evaluated using the modified CONSORT for Abstracts checklist. The primary outcome was a mean overall quality score (OQS), which, for each abstract, was a sum of items reported in the modified CONSORT for Abstracts checklist. In addition, some pre-specified factors were evaluated for their association with the reporting quality using simple and multiple linear regression analyses.A total of 949 abstracts (n=262 for RCT and n=687 for non-RCT abstracts) were included and evaluated. Although OQS was significantly greater in RCT than in non-RCT abstracts (mean ± SD, 6.7 ± 0.9 vs 3.3 ± 1.1; P-value<0.001), both mean scores were still less than half of the full score of 15. Only 2 items-objective and conclusions-were adequately reported (>80%) in both types of the abstracts. Items concerning trial design, participants, interventions, randomization, and number randomized were adequately reported only in the RCT abstracts. In contrast, items concerning the study as randomized in the title, clearly defined primary outcome, blinding, numbers analyzed, estimated effect size and its precision for the primary outcome, trial registration, and funding were not reported or reported less than 5% in both RCT and non-RCT abstracts. In this study, 4 factors-year of publication, number of trials reported, number of experimental groups reported, and sample size reported-were associated with OQS. That is, abstracts with higher OQS were published more recently, reported a single trial rather than multiple trials, reported number of experimental groups rather than not reported, and reported sample size rather than not reported. These factors explained about 37.5% of the variance of OQS. In AbstractIn publication of a controlled trial article from health science research, the abstract is an important part that readers usually read first and then decide whether to read the whole article; therefore, information provided in the abstract should be adequate. The CONSORT (consolidated standards of reporting trials) for Abstracts checklist has been developed and used as a guideline for authors to prepare their manuscripts. This checklist has also been used as a tool to evaluate published abstracts. The objective...

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Reporting quality of randomized and non-randomized controlled trial abstracts from chicken research

Sukon

Kongpechr

Bubpahou

et al. 2016

Preprint

View full text Add to dashboard Cite

show abstract

“…This lack of consistency in reporting makes it almost impossible to summarize sufficient data appropriately, thereby affecting the ability to arrive at an overall conclusion on a particular intervention or outcome. For example, in 100 randomly selected trials on animal health or production outcomes, only 67% reported random allocation to intervention group, 35% clearly described the number of animals housed together in a group, 4% reported the use of double blinding where blinding was feasible and 62% reported the number of study units lost to follow-up during the trial (Sargeant et al, 2009a). In an evaluation of 100 pre-harvest food-safety trials, randomization, double blinding and the number of subjects lost to follow-up were reported in 46%, 0% and 43% of trials respectively, and the number of animals housed together was stated in 52% of the trials (Sargeant et al, 2009b).…”

Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

“…In a review of trials of antibiotic therapy for bovine respiratory disease, 25 of 35 studies reported multiple outcomes, and none indicated the primary outcome (O'Connor et al, 2010f). In a study evaluating reporting in food-animal trials with health or production outcomes, 91 of 100 trials reported multiple outcomes, with only four trials identifying the primary outcome (Sargeant et al, 2009a). Of 100 pre-harvest food-safety trials evaluated in a similar study, 91 reported the use of multiple outcomes, with none of the trials identifying the primary outcome (Sargeant et al, 2009b).…”

Section: Explanationmentioning

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

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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...

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“…30 The participants were also provided with a complete list of the comments from the Web-based survey and a list describing how often each CONSORT item had been reported in a study of 100 livestock trials reporting production or health outcomes, and 100 trials reporting preharvest food-safety outcomes. 33,34 The meeting began with several presentations about the CONSORT statement, the results from the reviews of livestock-trial reporting, and a discussion of the approach to reaching consensus that would be used. Three voting criteria were suggested and discussed as indicators of consensus: 100% of participants must agree, 480% of participants must agree, or a simple majority (450%).…”

Section: The Consensus Meetingmentioning

confidence: 99%

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety

O’Connor¹,

Lefebvre²,

Keefe³

et al. 2010

Veterinary Internal Medicne

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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.

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

Cited by 81 publications

References 26 publications

Reporting quality of randomized and non-randomized controlled trial abstracts from chicken research

Reporting quality of randomized and non-randomized controlled trial abstracts from chicken research

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

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety

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