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
Regional hospitals invest in joint research Four new projects have been granted29 October 2020
Four more research projects have been granted in the promotion fund of the Radboudumc and the regional hospitals.read more
Two studies show potential of trained immunity for the treatment of cancer Radboudumc makes Cell twice in one issue29 October 2020
Mihai Netea: "These studies show that stimulating trained immunity can have an important anti-cancer effect. In combination with current immunotherapy with 'checkpoint inhibitors', boosting trained immunity has the potential to significantly improve cancer treatment"read more
Research should facilitate discontinuation of antidepressants29 October 2020
How do you reduce the use of antidepressants safely and without major problems? That is a question that concerns many patients and physicians. Radboudumc and Amsterdam UMC in the Netherlands are going to investigate this with a ZonMw grant of 1.5 million euros.read more
Cum Laude PhD defense for Vincent Aengevaeren29 October 2020
We congratulate Vincent Aengevaeren! After defending his thesis entitled: ‘Potential Detrimental Effects of Exercise on the Heart’ on 28 October, Vincent attained his PhD degree with honors. Vincent had been appointed on a RIHS Junior Researcher grant.read more
Polyisocyanide Hydrogels as a Tunable Platform for Mammary Gland Organoid Formation28 October 2020
A multidisciplinary team of RIMLS and Radboud University researchers published in Advanced Science that Polyisocyanide Hydrogels as a Tunable Platform for Mammary Gland Organoid Formation.read more