However, we do argue that balancing pragmatism and systematisation are structural to all pragmatic trials, although this may take different forms in other pragmatic trials.
Pragmatic trials can improve our understanding of how treatments will perform in routine practice.
In this series, we integrate the theoretical design options with the practice of conducting pragmatic trials.
Rather, pragmatic trials are guided by their end goal: informing practice".
As pragmatic trials are often open label, a less subjective outcome can reduce bias.
The three central ethical questions identified for pragmatic trials are: (i) what level of oversight should pragmatic trials require; (ii) do randomized patients face additional risks; and (iii) is a waiver of informed consent ethically defensible?
As a result, there has been a recent push towards pragmatic trials that better mimic real-world conditions.
In particular, the central role of pragmatic trials and qualitative research in CAMs' field has to be stressed and justified.
Selecting the setting, study population, mode of intervention, comparator, and outcome are crucial in designing pragmatic trials.
We performed a review of the literature to identify the ethical challenges thus far related to pragmatic trials.
Pragmatic trials aim to inform clinical decision making by measuring the effect of a treatment in clinical practice.
