Data analyses were conducted on the enrolled subjects who met eligibility criteria for participation in the trial (intention-to-treat analysis).
This 10-year, within trial, intention-to-treat economic analysis of the DPP/DPPOS demonstrates that lifestyle, when compared with placebo, is cost-effective, and metformin is marginally cost-saving from a health system and societal perspective.
High quality trial design, with intention-to-analysis, adequate follow-up and baseline similarity, would advance the quality of work in this field.
The current study, a 10-year, within-trial, intention-to-treat analysis of the DPP/DPPOS demonstrates that lifestyle is indeed cost-effective, and metformin is marginally cost-saving or at least cost-neutral compared with placebo.
When analysing data from randomised clinical trials, intention-to-treat analysis provides the highest level of evidence.
Variables were analyzed in accordance with the CONSORT statement for randomized controlled trials intention-to-treat principle; that is, dropouts from the two-week training were invited to participate in the error assessment to avoid selection bias.
Health events for the baseline analysis reflect the trial's intention to treat analyses.
RCT: Randomised controlled trial; ITT: Intention to treat; ME: Method-effectiveness; PP: Per protocol; AT: As-treated; IV: Instrumental variable; IP: Inverse probability; MIA: Multiple imputation analysis.
This is a single (rater) blind, prospective, pragmatic randomised controlled trial, using intention to treat comparing CTCH + TAU with TAU alone.
A rater-blind randomised controlled trial using intention to treat comparing positive memory training (PoMeT) and treatment as usual (TAU) with TAU alone.
Differences between groups in state-trait score were not significant at the start, middle, or end of the trial under intention to treat or adjusted treatment received analyses, although means were consistently lower for the telephone group (table 3).
