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      SYRCLE’s risk of bias tool for animal studies


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          Systematic Reviews (SRs) of experimental animal studies are not yet common practice, but awareness of the merits of conducting such SRs is steadily increasing. As animal intervention studies differ from randomized clinical trials (RCT) in many aspects, the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies. The Cochrane Collaboration developed a Risk of Bias (RoB) tool to establish consistency and avoid discrepancies in assessing the methodological quality of RCTs. A similar initiative is warranted in the field of animal experimentation.


          We provide an RoB tool for animal intervention studies (SYRCLE’s RoB tool). This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies. To enhance transparency and applicability, we formulated signalling questions to facilitate judgment.


          The resulting RoB tool for animal studies contains 10 entries. These entries are related to selection bias, performance bias, detection bias, attrition bias, reporting bias and other biases. Half these items are in agreement with the items in the Cochrane RoB tool. Most of the variations between the two tools are due to differences in design between RCTs and animal studies. Shortcomings in, or unfamiliarity with, specific aspects of experimental design of animal studies compared to clinical studies also play a role.


          SYRCLE’s RoB tool is an adapted version of the Cochrane RoB tool. Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies. This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the methodological quality of animal studies.

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          Most cited references24

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          Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

          To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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            Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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              A gold standard publication checklist to improve the quality of animal studies, to fully integrate the Three Rs, and to make systematic reviews more feasible.

              Systematic reviews are generally regarded by professionals in the field of evidence-based medicine as the highest level of medical evidence, and they are already standard practice for clinical studies. However, they are not yet widely used nor undertaken in the field of animal experimentation, even though there is a lot to be gained from the process. Therefore, a gold standard publication checklist (GSPC) for animal studies is presented in this paper. The items on the checklist have been selected on the basis of a literature analysis and the resulting scientific evidence that these factors are decisive in determining the outcome of animal studies. In order to make future systematic reviews and meta-analyses of animal studies possible, to allow others to replicate and build on work previously published, diminish the number of animals needed in animal experimentation (reduction), improve animal welfare (refinement) and, above all, improve the quality of scientific papers on animal experimentation, this publication checklist needs to be used and followed. We have discussed and optimised this GSPC through feedback from interviews with experts in the field of animal experimentation. From these interviews, it became clear that scientists will adopt this GSPC when journals demand it. The GSPC was compared with the current instructions for authors from nine different journals, selected on the basis that they featured a high number of publications on animal studies. In general, the journals' demands for the description of the animal studies are so limited that it is not possible to repeat the studies, let alone carry out a systematic review. By using the GSPC for animal studies, the quality of scientific papers will be improved. The use of the GSPC and the concomitant improvement in the quality of scientific papers will also contribute to decreased variation and increased standardisation and, as a consequence, a reduction in the numbers of animals used and a more reliable outcome of animal studies. It is of major importance that journal editors become convinced of and adopt these recommendations, because only then will scientists follow these guidelines to the full extent. 2010 FRAME.

                Author and article information

                BMC Med Res Methodol
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central
                26 March 2014
                : 14
                : 43
                [1 ]SYRCLE at Central Animal Laboratory, Radboud University Medical Center, Nijmegen, the Netherlands
                [2 ]Centre of Evidence-based Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
                [3 ]Dutch Cochrane Centre, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
                Copyright © 2014 Hooijmans et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                : 10 September 2013
                : 10 March 2014
                Research Article

                risk of bias,methodological quality,animal studies,systematic reviews,tool,translational research


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