SAEs will be classified according to intensity (mild, moderate, severe, life-threatening, death), outcome (recovered completely, recovered with sequelae, not recovered with or without therapy of SAE, death, unknown), and causality (doubtful, possibly related, probably related, definitely related, not assessable).
However, due to the cross-sectional design of the study, the direction of the correlation is unknown and causality cannot be proven.
Unsupervised learning does not assure the causality implications of links between the events but allows the exploration of unknown sequences and a predefined model does not need to be built [21].
Given the cross-sectional, observational design of the study, the direction of causality is unknown.
However, the direction of causality remains unknown as prospective studies of cognitive function in subjects without diabetes have suggested that hippocampal dysfunction potentially causes elevated cortisol levels (22).
Whilst the directions of causality are unknown, these findings nonetheless highlight the importance of asking service users about the elements of COC that they deem essential.
Although quality of life has been shown to be associated with fatigue in previous studies [ 8, 9], direction of causality is unknown.
Again, the direction of causality is unknown; it may be that service users who are experiencing psychosis begin to disengage with services affecting their quality of life, or that service users with poor continuity of care have poorer quality of life and poorer mental health as a result.
Of course, there is no clear sense of the direction of causality in this relationship.
Variations in definitions of the environment, the health effects, and the scenarios assessed, unknown impacts of multi-causality and co-morbidity, lacking consensus about causality, controversial views about model structures, and many other sources of uncertainty may affect eBoD assessments, but cannot be easily quantified, and are usually not fully addressed.
