CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Pharmaceutical intervention in the care of cystic fibrosis patients.

Study design (if review, criteria of inclusion for studies)

prospective, randomised, cross-over study + quality of life

Participants

8 patients were included, out of which 6 completed the original design as a cross-over study, yielding a total of 550 doses of antibiotics. Twenty patients took part in the second part of the study.

Interventions

During a first treatment course the patients received either infusion devices during 5 days or reconstituted the drugs themselves during 5 days, or vice versa. During a second treatment course the order was the reversed. In the second part of the study a modified form of SEIQoL-DW (Schedule for the Evaluation of Individual Quality of Life - Direct Weighting) was used.

Outcome measures

patients preference, direct costs, patients QoL

Main results

The patients preferred infusion devices from the pharmacy prepared according to GMP (Good Manufacturing Practice) as opposed to reconstituting the antibiotics themselves. Points of view presented included no anxiety over the correct dosage of drugs and less disruption of family and social life. In a practical sense, portable devices are more expensive than the preparation of the drugs by the patients themselves. However, when comparing with in-hospital treatment the direct costs for a hospital stay exceed that of the devices. The overall quality of life scores increased significantly when patients received infusion devices compared to reconstituting the drugs themselves.

Keywords: pharmacological_intervention; Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Infection;