Previous clinical exercise interventions have been successfully implemented in trials involving diabetes, cardiovascular disease, smoking cessation, and depression.
We have used a yes-no procedure implemented in trials with four randomly interleaved staircases (each known as 1down-1up).
A second identical Cantek stimulator, implemented in trials that required bilateral stimulation, was fitted with a single 2 mm diameter probe tip and positioned on the hand opposite the TPS in a similar fashion.
Unfortunately, to date, it cannot be easily implemented in multi-center trials since different vendors of MRI scanners have implemented different sequences of acquisition, therefore hindering comparison among sites with different MRI scanners.
Furthermore, the MLU intervention described in the trial protocol and implemented in the trial itself for women allocated to the MLU arm can be regarded as standard practice for MLU care in the two study sites, since the relevant procedures were established in the context of the MidU trial.
Integrating the findings from the qualitative interviews with the modelling thus identified the components of the screening test intervention that could be implemented in a trial from a service perspective.
Costs reflect the interventions as implemented in the trial.
Models of interest were implemented in the trial simulator TS2 version 2.1.2 (Pharsight, Mountain View, CA).
