In the transition phase, both poorer performance on the baseline 400 m walk and presence of a pacemaker were significant predictors of percent attendance in the composite model, whereas predictors in the maintenance phase for this model included the presence of a pacemaker and higher levels of self-reported fatigue.
The maintenance phase of the economic model (Fig. 2) is designed to follow hypothetical patients for 5 years after the index mixed episode, irrespective of whether they did or did not respond to treatment during the acute phase.
The outcome for the third objective of this study was all-cause mortality within 1, 2 or 3 years following the expected completion date of CR (ie, end of prescheduled visits as per programme model including maintenance phase), regardless of whether or not the patient actually enrolled or fully participated in the programme.
The maintenance phase sample was included in models of scores from maintenance phase visits (i.e., Week 8 and Month 12) and in models of scores from both acute and maintenance phase visits (i.e., Baseline, Week 3, Week 8, and Month 12).
The maintenance phase is designed using a Markov model, and it follows patients for four-week cycles for a five-year follow-up period as their condition stabilizes and the goal of treatment shift into relapse prevention.
Each PRO domain and summary score within the maintenance phase sample were analyzed using a MMRM model, with subject as a random effect and with maintenance phase visit (Week 8, Month 12), sustainer status at Month 12 (remission, not in remission), and the visit * sustainer status interaction as fixed effects.
A pre and post CST groups comparison was undertaken to evaluate the open trial first phase and an ANCOVA model used to analyse the maintenance phase with its controlled comparison.
Compared to a model with single regressors for the maintenance phase (i.e., load 4 maintenance, load 5 maintenance, load 6 maintenance, and baseline maintenance), the present design helped to minimize correlations between the regressors of interest and the other predictors of the model.
For the primary efficacy analysis, serum phosphorus from randomization to each visit of maintenance phase was assessed by an analysis of covariance (ANCOVA) model, and the 95%CI was calculated.
The model comprises an acute phase and a maintenance phase.
