Evaluation of the efficacy of the Italian guidelines on COPD: a cluster randomized trial.
BACKGROUND
Chronic Obstructive Pulmonary Disease (COPD) is a profoundly disabling disease managed predominantly by General Practitioners (GPs). We planned this prospective trial to evaluate the applicability of Italian GP-directed guidelines in routine practice and whether adherence to them improves treatment efficacy, with respect to decreased exacerbations, hospital admissions, drug use, and out-patient appointments and improved quality of life (QoL).


METHODS
In a cluster randomised trial, 22 GPs were randomly put into two groups: one group was asked to follow the guidelines (YES-GL), the other to continue normal clinical practice (NO-GL). These GPs enrolled 123 patients with COPD and followed them for one year.


RESULTS
Patients managed by the YES-GL GPs had more outpatient appointments and specialist consultations and a higher probability of being classified as having severe COPD. The QoL was fairly low in both groups, and all other clinical outcomes taken into consideration, were not affected by application of the guidelines.


CONCLUSIONS
The guidelines did not substantially alter the clinical evolution of COPD patients, even though some facets of management improved.
Tinelli
C
C
Servizio di Epidemiologia Clinica e Biometria I.R.C.C.S. Policlinico San Matteo, Pavia, Italy. ctinelli@smatteo.pv.it
Rezzani
C
C
Biino
G
G
Marinoni
A
A
Rossi
A
A
Volpini
E
E
Pistorio
A
A
Termini
R
R
Grassi
M
M
D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic / Q000592:standards; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome