In PLoS ONE Carlijn Hooijmans and colleagues describe how the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, the most widely used framework to rate the certainty in the evidence and strength of health care recommendations, could be used to rate the certainty in the evidence of preclinical animal studies in the context of therapeutic interventions.Laboratory animal studies are used in a wide range of human health related research areas, such as basic biomedical research, drug research, experimental surgery and environmental health. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions. Systematic reviews and meta-analyses are important tools to provide robust and informative evidence summaries of these animal studies. Rating how certain we are about the evidence could provide important information about the translational probability of findings in experimental animal studies to clinical practice and probably improve it. Evidence summaries and certainty in the evidence ratings could also be used (1) to support selection of interventions with best therapeutic potential to be tested in clinical trials, (2) to justify a regulatory decision limiting human exposure (to drug or toxin), or to (3) support decisions on the utility of further animal experiments. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is the most widely used framework to rate the certainty in the evidence and strength of health care recommendations. Here we present how the GRADE approach could be used to rate the certainty in the evidence of preclinical animal studies in the context of therapeutic interventions. We also discuss the methodological challenges that we identified, and for which further work is needed. Examples are defining the importance of consistency within and across animal species and using GRADE's indirectness domain as a tool to predict translation from animal models to humans.
Carlijn Hooijmans is assistant professor within the theme of Cancer development and immune defense
Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies. Hooijmans CR, de Vries RBM, Ritskes-Hoitinga M, Rovers MM, Leeflang MM, IntHout J, Wever KE, Hooft L, de Beer H, Kuijpers T, Macleod MR, Sena ES, Ter Riet G, Morgan RL, Thayer KA, Rooney AA, Guyatt GH, Schünemann HJ, Langendam MW; GRADE Working Group. PLoS One. 2018 Jan 11;13(1):e0187271.
SYstematic Review Center for Laboratory animal Experimentation
Related news items
In order to maximize quality of life in pediatric psoriasis reaching for clear skin is necessary12 December 2019
In JAMA Dermatology, Bruins et al showed that greatest improvement in quality of life was achieved with 90% improvement of the Psoriasis Area and Severity Index (PASI) and 90% decrease of affected body surface area in a large cohort of children with psoriasis.read more
Bart-Jan Kullberg appointed as Chair of Health Council12 December 2019
As of 1 January 2020, Bart-Jan Kullberg has been appointed as the Chairperson of the Health Council of the Netherlands.read more
Vote for the Supervisor of the year12 December 2019
Now you have the chance to vote for your preferred candidate. Have fun, and go for it, support and promote the ideal supervisor. Deadline for voting is 5 January 2020. The three nominated finalists are: Joost Drenth, Marien de Jonge and Iris Nagtegaal.read more
Jelle Barentsz's trilogy of educational papers in European Urology12 December 2019
Recently, a trilogy of educational papers by our full professor Jelle Barentsz has been published in European Urology. The publications address what urologists need to know about prostate-MRI.read more
ERC Consolidator Grant for Bousema and Sechopoulos12 December 2019
Teun Bousema and Ioannis Sechopoulos each receive an ERC Consolidator Grant of around two million euros. This European research subsidy will enable them to carry out research for the next five years.read more