This design is more pragmatic than traditional randomized controlled trials since it mirrors the practice of offering a preventive intervention to non-treatment seeking participants and saves the participants from the unnatural and possibly harmful effect of being allocated to a control group after hearing about the details of a potentially beneficial intervention.
To discover which strategies work best in a clinical setting, pragmatic randomized trials may provide a more robust approach than traditional randomized trials because they are not conducted among a specifically screened and/or select volunteer patient population and occur within routine clinical practice settings [ 42].
But such designs create dependency among the collected data, and hence statistical methods for adaptive clinical trials are more complex than those for traditional randomized clinical trials.
Due to their nature and methodological complexity, HEE have particular challenges for adequate reporting, which can be greater than more traditional study designs such as randomized controlled trials.
Second, in a more subtle, but related, situation individuals are randomized in a traditional randomized trial, but naturally fall within a cluster (i.e patients are seen by a single physician) that leads to similarity in behavior (i.e. individual physician practice pattern leads to similar outcomes among patients) [ 43, 44].
They reliably produce improvements in end-of-life care when used alone or in combination with more traditional research methodologies, such as the randomized controlled trial that provided the case for the IPC model [ 30- 32].
ROM data allows the determination of differences in success rate and efficacy between therapies in a more natural context than that of a traditional randomized controlled trial.
For example, designing several large, pivotal trials with reliable measurements and clinically relevant outcomes may yield more reliable information and at a lower cost than traditional randomized trials or trials incorporating expensive omics tests.
Concern Worldwide (an international NGO) is currently conducting a randomized trial in Burundi to compare the more traditional Care Group model where NGO staff members serve as promoters with an "integrated" model where MOH staff members serve as promoters.
In particular, we will see how, in a portfolio setting, it can be advantageous to use a more "risk-seeking" strategy with a high variance in run time, such as a randomized depth-first search approach in mixed integer programming versus the more traditional best-bound approach.
