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The initial telephone screening procedure implemented in this trial was appropriate, and only one patient required attendance for further screening before a descision could be made; furthermore only one patient refused consent to participate in the trial.
However, the adaptive two-stage design implemented in this trial allows a data-driven modification of the sample size of the second stage based on the results of the interim analysis or on external information while the specified significance level is controlled when the decision rules defined above are adhered to [ 35].
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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).
Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures.
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.
The implementation of standards into clinical routine in our study was not satisfactory and still needs improvement; however, taken both mediators together, treatment standards were more strictly implemented in trial hospitals than in non-trial hospitals.
In addition, TNM staging should be implemented in clinical trial stratification and in tumor registry accession in order to allow future refinement of appropriate therapeutic options (Table 1).
ISRCTN: ISRCTN93576146 Understanding how interventions are implemented in trial settings is important for interpreting the main trial results and indicating how the intervention might function beyond the trial [ 1, 2].
This strategy was posteriorly implemented in the CUPID trial (see below).
This review examines how interventions encouraging this engagement have been implemented in controlled trials.
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