The conventional therapy intervention was assumed to be implemented for the 2-year trial period.
The resulting customized adherence support program (referred to as ASP) was then implemented for the remainder of the trial.
In order to test effectiveness of the half hour relaxation, he recommends that the change be implemented for a trial period of two years.
Patients undergoing the clinical treatment with QUART, who were not included in a randomised clinical trial and who met the same criteria implemented for trial cases [ 16], were included in the study (out-trial patients).
At the institutional level, this often included combining the expertise of experienced trialists, methodologists, and the staff that would be responsible for implementing the trial; however, this integration was more common at sites with more support for research.
As independent interpretation with exact duplication of reading conditions for multiple radiologists are not implemented in the trial, for the purposes of our analyses we assume that the paired arms of the study for 2D alone (Arm A plus B) and 2D + 3D (Arm C plus D) constitute sufficiently similar reading conditions to be considered double readings.
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.
While these guidelines have been widely implemented for assessing trials, considerably less is known about the acceptability and utility of sub-group analysis within RCTs, and there is little guidance for researchers who wish to pool data from trials that have already carried out sub-group analysis.
Each site had a local WSD Project Team with responsibility for implementing the trials in their region in line with the protocols provided by the WSD Evaluation Team.
