Monitoring
Patient compliance was ascertained via dialysate bag counts during
unscheduled home visits, taking into account the number of bags
delivered and the expected utilization (based on the prescription).
Patient noncompliance was also assessed at each office/clinic visit, in
an interview with the attending nurse or physician. Patients were
asked how many exchanges they had missed in the week before the
current visit, and the results were recorded for analysis. Finally, serum
creatinine levels were recorded as a more objective measure of compliance.
Adverse events and deaths were monitored by a safety committee
and an interim analysis was performed at a scheduled time, to
ensure patient safety.