GP management of community-acquired pneumonia in Italy: the ISOCAP study

Background. Community-Acquired Pneumonia (CAP) is still a significant problem in terms of incidence, mortality rate, particularly in infants and the elderly, and socioeconomic burden. General Practitioners (GPs) are the first reference for patients with this disease, but there are few published studies regarding the outpatient treatment of CAP. Methods. The ISOCAP study aimed to identify the type and outcome of the diagnostic-therapeutic management of CAP by GPs in Italy, within the framework of developing a closer interrelationship between GPs and pulmonary specialists. Thirty-six Pulmonary Divisions throughout Italy each contacted 5 local GPs who agreed to recruit the first 5 consecutive patients who consulted them for suspected CAP within the study’s 1-year observation period. Results. A total of 183 GPs took part in the study and enrolled, by the end of the observation period, 763 CAP patients; of these, complete data was available for 737 patients [males=373, females=364, mean age (±SD) 58.8±19.6 years]. 64.4% of patients had concomitant diseases, mainly systemic arterial hypertension and COPD. Diagnosis of CAP was based by GPs on physical examination only in 41.6% of cases; in the remaining chest X-ray was also performed. In only 4.6% of patients were samples sent for microbiological analysis. All patients were treated with antibiotics: 76.7% in mono-therapy, 23.3% with a combination of antibiotics. The antibiotic class most prevalently used in mono-therapy was cephalosporin, primarily ceftriaxone; the most frequently used combinations were cephalosporin+macrolide and cephalosporin+quinolone. Mono-therapy was effective in 70% of cases, the combination of two or more antibiotics in 91.2% of patients. Overall treatment efficacy was 94.7%; hospitalisation was required in 8.5% of cases. Conclusions. Outpatient management of CAP by GPs in Italy is effective, hospitalisation being necessary only in the most severe cases due to age, co-morbidities or extent of pneumonia. This signifies a very significant savings in national health costs

Costs of chronic obstructive pulmonary disease (COPD) in Italy: The SIRIO study (Social Impact of Respiratory Integrated Outcomes)

SummaryChronic respiratory diseases affect a large number of subjects in Italy and are characterized by high socio-health costs. The aim of the Social Impact of Respiratory Integrated Outcomes (SIRIO) study was to measure the health resources consumption and costs generated in 1 year by a population of patients with chronic obstructive pulmonary disease (COPD) in a real-life setting. This bottom-up, observational, prospective, multicentric study was based on the collection of demographic, clinical, diagnostic, therapeutic and outcome data from COPD patients who reported spontaneously to pneumological centers participating in the study, the corresponding economic outcomes being assessed at baseline and after a 1-year survey. A total of 748 COPD patients were enrolled, of whom 561 [408m, mean age 70.3 years (SD 9.2)] were defined as eligible by the Steering Committee. At the baseline visit, the severity of COPD (graded according to GOLD 2001 guidelines) was 24.2% mild COPD, 53.7% moderate and 16.8% severe. In the 12 months prior to enrollment, 63.8% visited a general practitioner (GP); 76.8% also consulted a national health service (NHS) specialist; 22.3% utilized Emergency Care and 33% were admitted to hospital, with a total of 5703 work days lost. At the end of the 1-year survey, the severity of COPD changed as follows: 27.5% mild COPD, 47.4% moderate and 19.4% severe. Requirement of health services dropped significantly: 57.4% visited the GP; 58.3% consulted an NHS specialist; 12.5% used Emergency Care and 18.4% were hospitalized. Compared to baseline, the mean total cost per patient decreased by 21.7% (p<0.002). In conclusion, a significant reduction in the use of health resources and thus of COPD-related costs (both direct and indirect costs) was observed during the study, likely due to a more appropriate care and management of COPD patients

GOLD severity stratification and risk of hospitalisation for COPD exacerbations

Background and Aim. The Italian Costs for Exacerbations in COPD (“ICE”) study, following a pharmacoeconomic assessment of costs due to COPD exacerbations (primary endpoint), aimed also at evaluating (secondary endpoint) which clinical factors, among those considered for cost-analysis, may, at follow up, present a risk of new exacerbations and re-admission to hospital. Materials and methods. A prospective, multicentre study was carried out on COPD patients admitted to 25 Hospital Centres as a result of an exacerbation from October- December 2002. Following discharge, a 6-month follow- up was performed in each patient via three bi-monthly telephone interviews with a questionnaire administered by an investigator clinician. Results. 570 patients were eligible for data processing, mean age 70.6 years (± 9.5 standard deviation, SD), males 69.2%. According to GOLD, severity stratification was as follows: moderate 36.4%; severe 31.3%; very severe 32.3%. 282 patients experienced at least one exacerbation at follow up, 42% of exacerbations requiring hospitalisation. No significant association was seen between exacerbations and GOLD stage or co-morbidities or treatments except LTOT. Conversely, COPD functional severity influenced hospitalisations very significantly, with relative risks 2.6 (95% Confidence Interval, CI 1.8-3.8) and 2.0 (CI 1.3-2.8) (GOLD very severe versus moderate and severe, respectively), and 1.3 (CI 0.85-2.1) (GOLD severe versus moderate). Hospitalisations were also significantly associated with treatments denoting more severe conditions (oral corticosteroids, oral theophylline, and LTOT). Conclusions. Severity stratification of COPD patients according to respiratory function classes as outlined in GOLD guidelines and need for LTOT are confirmed as important predictors of hospitalisation for an exacerbation

Efficacy of pulmonary rehabilitation in chronic respiratory failure (CRF) due to chronic obstructive pulmonary disease (COPD): The Maugeri Study.

14noWhile the effectiveness of pulmonary rehabilitation (PR) in chronic obstructive pulmonary disease (COPD) is well established, its effectiveness in the most severe category of COPD, i.e. patients with chronic respiratory failure (CRF), is less well known. OBJECTIVE: To verify the effects of PR in patients with CRF, and compare the level of improvement with PR in these patients to that of COPDs not affected by CRF. METHODS: A multi-centre study was carried out on COPD patients with versus without CRF. The PR program included educational support, exercise training, and nutritional and psychological counselling. Lung function, arterial gases, walk test (6MWT), dyspnoea (MRC; BDI/TDI), and quality of life (MRF(28); SGRQ) were evaluated. RESULTS: Thousand forty seven consecutive COPD inpatients (327 with CRF) were evaluated. In patients with CRF all parameters improved after PR (0.001). Mean changes: FEV(1), 112 ml; PaO(2), 3.0 mmHg; PaCO(2), 3.3 mmHg; 6MWT, 48 m; MRC, 0.85 units; MRF(28) total score, 11.5 units. These changes were similar to those observed in patients without CRF. CONCLUSIONS: This study, featuring the largest cohort so far reported in the literature, shows that PR is equally effective in the more severe COPD patients, i.e. those with CRF, and supports the prescription of PR also in these patients.nonemixedCARONE M; PATESSIO A; AMBROSINO N; BAIARDI P; BALBI B; BALZANO G; CUOMO V; DONNER CF; FRACCHIA C; NAVA S; NERI M; POZZI E; VITACCA M; SPANEVELLO A.Carone, M; Patessio, A; Ambrosino, N; Baiardi, P; Balbi, B; Balzano, G; Cuomo, V; Donner, Cf; Fracchia, C; Nava, S; Neri, M; Pozzi, E; Vitacca, M; Spanevello, Antoni

Standards of care and clinical predictors in patients hospitalised for a COPD exacerbation - The Italian SOS (Stratification Observational Study)

Background and aims. Hospitalisations for chronic obstructive pulmonary disease (COPD) exacerbations are major events in the natural history of the disease in terms of survival, quality of life and risk of further episodes of exacerbation. The aims of study were to evaluate: 1. adherence to recommended standards of care; and 2. clinical factors influencing major outcomes during hospitalisation for an episode of COPD exacerbation and within a 6-month follow-up. Methods. An observational, prospective study was conducted in 68 centres. Assessment of standards of care included diagnostic procedures (such as pulmonary function tests and microbiology) and management options (such as drug therapies, vaccinations and rehabilitation). Outcome measures relevant to the hospitalisation were: survival, need for mechanical ventilation, and length of stay (LOS). Outcomes at 6-months were: survival, exacerbations and hospitalisations for an exacerbation. Multivariate logistic regression was applied to evaluate the relation between clinical factors and outcomes. Results. 931 patients were enrolled. Only 556 patients (59.7%) were diagnosed COPD and stratified for severity with the support of spirometry (FEV1/VC ≤0.7) and were considered for outcome analysis. Among treatments, pulmonary rehabilitation and anti-smoking counselling were applied infrequently (14.5 and 8.1% of patients, respectively). Within six months 63 COPD patients (17.7%) had at least one episode of exacerbation prompting a further hospitalisation and 19 died (5.3%). Predictor of mortality was the co-morbidity Charlson index (odds ratio, OR 10.3, p=0.03 CI:1.25-84.96). A further hospitalisation was predicted by hospitalisation for an exacerbation in the previous 12 months (OR 3.59, p=0.003 CI:1.54-8.39). Conclusions. Standards of care were far lower than recommended, in particular 40% of patients were labelled as COPD without spirometry. COPD patients with a second hospitalisation in 12 months for an exacerbation had about 3 times the risk of suffering a new episode and hospitalisation in the following six months