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Another possible reason for difficulties in enrolment of trial participants is the patients' reluctance.
An adequate communication on these aspects should minimize difficulties in enrolment and losses to follow up.
This information allowed to identify some possible areas to work on to try to minimize difficulties in enrolment and to reduce the risk of loss to follow up.
This broad definition partly relates to uncertainties on actual CHF demographics, and as the yearly admission is unlikely to exceed 500, will not lead to significant difficulties in enrolment.
The results of this observational study confirm the difficulties in enrolment and the risk of loss to follow up related to newborn cohort studies: only 900 of 1204 women eligible (75%) decide to participate and, of these, only 70% were in follow up 18 months after child birth.
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This requirement led to serious difficulties in the enrolment of subjects; consequently, the study was prematurely suspended.
The difficulty in enrolling cases and controls may reflect the type of enrolment procedure used.
The Xtravent study was conducted in 10 centres over 40 months and yet only 79 patients were enrolled [ 19], underlining the difficulties of enrolment in this patient population.
Secondary outcomes included a reduction in the seizure burden (reduction in the mean number of clusters of head nods and/or convulsive seizures per unit time), the proportions of patients with independence in basic self-care, resolution of behaviour and emotional difficulties and enrolment in school.
The survey reveals that despite the difficulties, overall enrolment surged in the 2003/2004 school year.
The decision was based upon logistic difficulties of early enrolment in many cases, and the consensus clinical experience of the researchers who felt that HBO could still offer significant effects even if started up to 48 h.
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