9 per 1,000 person-years in controls, for a highly significant 35 percent relative risk reduction in a fully adjusted multivariate
intention to treat analysis. During follow-up, 15 percent of patients switched from low-dose aspirin to no aspirin or vice versa, prompting investigators to perform a per protocol analysis of the data.
Second, they did not comment in the
intention to treat analysis. In addition, no sample size calculated for the significant conclusion.
Of the 394 individuals assessed for eligibility, 179 participants were enrolled and had a least some study drug, and were accordingly used in the
intention to treat analysis. A total of 151 completed the 8 weeks of treatment.
The
intention to treat analysis covered all randomised patients who received treatment (50 per group), while patients who discontinued or did not have a repeat biopsy were treated as non-responders.
The non-inferiority of the fixed-dose regimen was shown in the per protocol analysis and a post hoc modified
intention to treat analysis, but not in the prespecified modified
intention to treat analysis, where 83.3% (570/684) of patients had a favourable outcome (negative culture result at 18 months) in the fixed-dose group compared with 84.8% (563/664) in the separate drugs group (risk difference -1.5%, 90% CI: 4.7 - 1.8%).
In the
intention to treat analysis, there were 39,601 pregnancies and 138 pregnancy-related deaths in the vitamin A supplementation group (348 deaths per 100,000 pregnancies) compared with 39,234 pregnancies and 148 pregnancy-related deaths in the placebo group (377 per 100,000 pregnancies), (adjusted odds ratio 0.92, p=0.51).
In an
intention to treat analysis, the rate of relapse flares during the first year of follow-up was virtually identical in the two treatment arms: a rate of 40.2 flares/1,000 patient-months of follow-up in 183 patients withdrawn after 6 months, and 40.3 flares/1,000 patient-months in 181 patients withdrawn after 12 months.
This chapter is very informative, covering important concepts including
intention to treat analysis, subgroup analysis, interactions between subgroups and ethical issues related to research in critical care.
Intention to treat analysis in clinical trials when there are missing data.
Results: In the
intention to treat analysis of the entire sample, no group differences were observed in increments in BMC or bone dimensions during or after supplementation.
Intention to treat analysis is related to methodological quality.
Random-effects regression analysis of subjects as randomized (
intention to treat analysis) showed that clozapine was significantly more effective than haloperidol on two single-domain measures: symptoms (p = .02) and side effects (p [less than] .0001).
