Abstract
BackgroundIn pre-clinical research, systematic reviews have the potential to mitigate translational challenges by facilitating understanding of how pre-clinical studies can inform future clinical research. Yet their conduct is encumbered by heterogeneity in the outcomes measured and reported, and those outcomes may not always relate to the most clinically important outcomes. We aimed to systematically review outcomes measured and reported in pre-clinical in vivo studies of pharmacological interventions to treat high blood glucose in mouse models of type 2 diabetes.MethodsA systematic review of pre-clinical in vivo studies of pharmacological interventions aimed at addressing elevated blood glucose in mouse models of type 2 diabetes was completed. Studies were screened for eligibility and outcomes extracted from the included studies. The outcomes were recorded verbatim and classified into outcome domains using an existing outcome taxonomy. Outcomes were also compared to those identified in a systematic review of registered phase 3/4 clinical trials for glucose lowering interventions in people with type 2 diabetes.ResultsReview of 280 included studies identified 532 unique outcomes across 19 domains. No single outcome, or domain, was measured in all studies and only 132 (21%) had also been measured in registered phase 3/4 clinical trials. A core outcome set, representing the minimum that should be measured and reported, developed for type 2 diabetes effectiveness clinical trials includes 18 core outcomes, of these 12 (71%) outcomes were measured and reported in one or more of the included pre-clinical studies.ConclusionsThere is heterogeneity of outcomes reported in pre-clinical research. Harmonisation of outcomes across the research pathway using a core outcome set may facilitate interpretation, evidence synthesis and translational success, and may contribute to the refinement of the use of animals in research.Systematic review registration: The study was prospectively registered on the PROSPERO Database, registration number CRD42018106831
Highlights
In pre-clinical research, systematic reviews have the potential to mitigate translational challenges by facilitating understanding of how pre-clinical studies can inform future clinical research
In the case of rheumatoid arthritis, a core outcome set has increased the consistency of outcome reporting, and use of the COS has increased over time [3]
We aimed to systematically review outcomes measured in pre-clinical research for type 2 diabetes using a mouse model, and to compare these to outcomes measured in clinical trials of glucose lowering interventions in type 2 diabetes [21]
Summary
In pre-clinical research, systematic reviews have the potential to mitigate translational challenges by facilitating understanding of how pre-clinical studies can inform future clinical research. There is Harman et al J Transl Med (2020) 18:468 often marked variability between trials in the outcomes measured and reported which contributes to research waste through the inability to compare findings and synthesise evidence from multiple trials [1]. These issues can be addressed through the use of a core outcome set (COS), defined as “the minimum [set of outcomes] that should be measured and reported in all clinical trials of a specific condition” [2]. Despite the uptake of COSs in clinical trials, little is known about their relationship to the outcomes measured at other stages of the research pathway
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