Although predictive models may be used to provide insight into causality of pathophysiology of the outcome, causality is neither a primary aim nor a requirement for variable inclusion.
From each report, the following information was extracted: patient demographics, co-morbidities, suspected reactions, suspected drug as well as concomitant treatments, dosage, duration of andrographis treatment, date of adverse event onset, clinical outcome, causality assessment, and the source of reports.
The design of this study is cross sectional, which limits the ability to infer causal relationship between nurses' shift length and nurse outcomes causality.
Monitoring for adverse events (AEs) (intensity, duration, outcome, and causality), physical examinations, vital signs, body weight and morphometrics, 12-lead electrocardiograms, and safety laboratory assessments including hematology, serum chemistry, and urinalysis were also performed.
Finally, because this was not a clinical trial with random allocation of known and unknown confounders on the 'exposure-outcome' relationship, causality cannot be conferred.
The empirical analysis follows the potential outcome approach of causality, see e.g. Roy (1951) or Rubin (1974).
Our analyses of the effects of the ICS ALMP use the standard framework of the potential outcome approach to causality or the Roy-Rubin model (Roy, 1951; Rubin, 1974), and they focus on the average treatment effect on the treated (ATT), that is, on the effect the treatment shows for individuals who actually participate in the program.
AEs were evaluated by investigators in terms of seriousness, maximum intensity (mild, moderate or severe), outcome and possible causality with study medication.
Minimal comparison treatments that are less effective than the index treatment can serve as controls for the processes just described, whereas treatments that are equally effective but operate via different mechanisms – as illustrated below – may be used to ensure that change in the putative mediator is not a consequence of change in the outcome variable ("reverse causality").
There is a lack of rigorous research including the methodological challenges of measuring outcomes and attributing causality to these complex, changing, long-term social interventions to healthcare organisations [ 9].
We assessed (1) the unique and combined indirect effects of PF and PC on outcomes, and (2) the causality of relations between PF, PC and the primary outcome pain interference in daily life (MPI) during ACT.
