12a. Rationale
What to write
Include sufficient scientific background to understand the rationale and context for the study, and explain the experimental approach.
Explanation
Scientific background information for an animal study should demonstrate a clear evidence gap and explain why an in vivo approach was warranted. Systematic reviews of the animal literature provide the most convincing evidence that a research question has not been conclusively addressed, by showing the extent of current evidence within a field of research. They can also inform the choice of animal model by providing a comprehensive overview of the models used along with their benefits and limitations1–3.
Describe the rationale and context of the study and how it relates to other research, including relevant references to previous work. Outline evidence underpinning the hypothesis or objectives and explain why the experimental approach is best suited to answer the research question.
Example
‘For decades, cardiovascular disease has remained the leading cause of mortality worldwide… and cardiovascular research has been performed using healthy and young, non-diseased animal models. Recent failures of cardioprotective therapies in obese insulin-resistant …, diabetic …, metabolic syndrome-affected… and aged… animals that were otherwise successful in healthy animal models has highlighted the need for the development of animal models of disease that are representative of human clinical conditions…. The majority of laboratory-based studies investigating cardiovascular disease and myocardial tolerance to ischemia-reperfusion (I-R) are currently conducted using normogonadic models with either genetically-induced… or diet-induced… obesity and metabolic syndrome (MetS). In the clinical setting, elderly male patients often present with both testosterone deficiency (TD) and MetS…. A strong and compounding association exists between metabolic syndrome and testosterone deficiency which may have significant impact on cardiovascular disease and its outcomes which is not addressed by current models…. Although laboratory investigations generally rely on animal models of isolated metabolic syndrome or hypogonadism, their mutual presentation in the clinical setting warrants the development of appropriate animal models of the MetS with hypogonadism, especially in the context of cardiovascular disease research’4.
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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