Background: In 2012 and 2013, a quality improvement program was launched in 14 Cystic Fibrosis centres in France to improve care and patient outcomes. The PHARE-M performance study, funded by the French Ministry of Health, was designed to assess the impacts of the program. One goal was to determine whether the undertaking aimed at developing a culture of quality among care teams would result in limiting lung function decline in patients and/or would present improved BMI evolution results when compared with control centres.
Methods: A quantitative experimental study was designed using repeated data on forced expiratory volume in 1 second (FEV1) and on body mass index (BMI) over time. Two groups of patients were included in a closed cohort: one group took part in the PHARE-M program while the other did not participate. Patients were paired (1-1) based on age range and type of centre. The annual values collected in the French Patient Registry for the years 2012, 2013, 2014 and 2015 were used as data. In the case of transplanted and deceased patients, data were replicated up to year 2015 using the last available value in the registry before death or transplantation.
Results: In 2012, 1077 patients were included in each of the two paired groups. By 2015, 155 patients and their pairs had left the cohort due to them changing centres during the study. The sex ratio was different in the two paired groups. Before controlling for the sex ratio, no significant differences regarding the 3-year evolution of the mean FEV1 and BMI data were observed between the two groups, except for a significant difference in adolescents (13-17 years of age) for the mean BMI Z-score (control population: +0.04, Std error=0.01, p<0.0001; PHARE-M group: -0.034, Std error=0.014, p=0.018).
Conclusion/Discussion: In the context of the PHARE-M performance study, when comparing centres trained in the QI program and nonparticipating centres, significant impacts on the evolution of patient outcomes were not identified after three years. However, changes in the organization of care had a local impact on the outcomes of a select number of patients, as reported in previous articles.