Naila Arebi © ECCO
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The level of confidence in evidence generated by research is reflected in various aspects of study design and underpins clinical guidelines in Inflammatory Bowel Disease (IBD). The quality of research study designs, each with inherent strengths and limitations, determines confidence in the results, and it is acknowledged that some ‘robust’ study designs may not be feasible in specific contexts [1, 2]. Experimental designs such as randomised controlled studies that are characterised by methodological rigour, may be unsuitable to study effectiveness owing to their weak external validity, which is attributable to their strict eligibility criteria. Reliance on complementary or alternative evidence from other study designs to address residual gaps in knowledge is not uncommon. Non-experimental observational study designs capture a more diverse population, albeit in a less stringent setting, resulting in several methodological limitations, including high risk of bias and unbalanced confounders [2]. The increasing digitalisation of medicine, in addition to accessible diverse sources of data, is partly responsible for recent intensification of interest in evidence generated by analysing data from observational studies with the purpose of offering new insights into the effectiveness and safety of interventions as well as understanding healthcare delivery and quality of care. The systematic analysis of data from multiple data sources outside a research setting is referred to as real-world studies (RWS), and its subsequent analysis and conclusions as real-world evidence (RWE) [3].