Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler - Results from a non-interventional study.

OBJECTIVE: Prospective, non-interventional study of fixed-dose inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combination therapy with fluticasone propionate/formoterol fumarate (FP/FORM) across a spectrum of community-based patients with asthma in a real-life setting. METHODS: In FP/FORM-treated patients aged ≥12 years, asthma control (Asthma Control Test™ [ACT]), incidence of severe exacerbations, lung function, quality of life (asthma quality of life questionnaire [AQLQ]) and adverse events (AEs) were assessed over one year. RESULTS: Almost 40% (n = 555) of the full analysis population (N = 1410) were receiving ICS/LABA therapy prior to enrolment; 69.8% completed the study. Asthma control (mean ACT ± standard deviation) improved from 16.3 ± 5.0 at baseline to 19.8 ± 4.5 at study end. ACT scores were significantly (p < 0.0001) higher than baseline at all observation timepoints, including the first assessment at 4-6 weeks. The percentage of patients with asthma control increased (baseline: 30.9%; study end: 62.4%), and the percentage of patients with ≥1 severe asthma exacerbation decreased (12 months before: 35.8%; during study: 5.9%). Lung function (forced expiratory volume in one second, peak expiratory flow) improved from baseline to each observation timepoint (p < 0.0001 for all). Improvement in asthma status was accompanied by ameliorated quality of life: AQLQ scores improved significantly from baseline to all observation timepoints (p < 0.0001 for all). AEs accorded with the summary of product characteristics. After study completion, 70% of patients continued FP/FORM treatment. CONCLUSION: In this one-year study, FP/FORM treatment was associated with clinically relevant improvements in asthma status in a diverse population of patients under real-life conditions.

[Daily care of patients with asthma in the pulmonary practice: changes in asthma - control and therapy depending on the initial level of control]. / Alltagsversorgung von Patienten mit Asthma in der pneumologischen Praxis: Veränderungen des Asthma-Kontrollgrades und der Therapie in Abhängigkeit vom ursprünglichen Kontrollgrad.

To assess the quality of treatment of patients with asthma who were treated jointly by pulmonologists and the family doctor, a data analysis was performed in 13 asthma specialists in 894 asthmatics and a written survey of patients after 3 months of treatment.The data analysis related to the current therapy, the therapy changes and the changes in asthma control test (ACT). One focus of the investigation was placed on the separate analysis of patients with controlled and uncontrolled asthma. Both patient groups show both decrease, as well as increases in the number of points of the ACT. In patients with non-controlled asthma, the proportion of an increase in the number of points in the ACT is above average and indicates an improvement of the disease. This is operated in the patient's subjective assessment. In both patient groups there is a large proportion of patients who report a subjective improvement. An improvement is usually achieved by an improved pharmacotherapy, a deterioration usually occurs due to external influences. The differences for the patient groups are here but less significantly. There is a general satisfaction with both the drug therapy, as well as with the handling. The inhalation drug therapy is performed very stable. In patients with poor asthma control therapy is usually intensified. In oral pharmacotherapy oral steroid therapy has a great dynamic in patients with uncontrolled asthma. In this group, the most frequent increases in the dose of inhaled substances are recorded.

Outbreak of skin and soft tissue infections in a hospital newborn nursery in Italy due to community-acquired meticillin-resistant Staphylococcus aureus USA300 clone.

BACKGROUND: Community-acquired meticillin-resistant Staphylococcus aureus (CA-MRSA) is responsible for severe infections in previously healthy people acquired in the community in different areas of the world. AIM: To report an outbreak of CA-MRSA in a hospital newborn nursery in northern Italy in September-October 2010, its investigation and control measures. METHODS: The epidemiology of the outbreak is reported. The investigation included screening neonates, parents and staff for MRSA carriage. Molecular strain typing was performed on MRSA isolates. FINDINGS: The outbreak affected nine neonates with three severe infections. In addition, four mothers had postpartum mastitis, and three mothers and one father had skin infection. The outbreak strain belonged to the USA300 CA-MRSA clone. Asymptomatic carriage of the outbreak strain was found among neonates, parents and hospital staff. The implementation of appropriate infection control measures in the hospital terminated the outbreak. CONCLUSIONS: To our knowledge, this is the first report of a hospital outbreak caused by the USA300 CA-MRSA clone in Europe. It is important to reinforce infection control measures, particularly in high-risk groups, such as neonates, to prevent USA300 from becoming endemic in European hospitals.

[Patient education in COPD during inpatient rehabilitation improves quality of life and morbidity]. / COPD-Schulung im Rahmen der stationären Rehabilitation verbessert Lebensqualität und Morbidität.

BACKGROUND: Pulmonary rehabilitation is recommended for the treatment of COPD in international guidelines. However, patient education as an important part of pulmonary rehabilitation has not been addressed sufficiently to show its benefit. The aim of this study was to find out whether education improves the effectiveness of rehabilitation with regard to quality of life (QoL) and morbidity in the year following rehabilitation. METHODS: COPD patients of multidisciplinary pulmonary inpatient rehabilitation programme participated in this prospective, randomised and controlled trial. To the education group we offered a programme of patient education (4 x 1.5 hours) and an individual action plan on how to cope with exacerbations. Pulmonary function tests and QoL as measured by the Saint George Respiratory Questionnaire (SGRQ) were tested at baseline and at follow-up after 1 year. PATIENTS AND MAIN RESULTS: 90 patients were randomly assigned to the multidisciplinary rehabilitation programme with the usual care (control group, CG) and 94 patients received additional patient education (education group, EG). In both groups the total number of hospital admissions was diminished after 1 year (CG: 24.7% to 11.5%, p = 0.02; EG: 30.8% to 9.9%, p = 0,001). Only the EG needed less intensive care (11.8 days to 2.2, p = 0.02), received less home emergency medical service (18.3 to 5.5%, p = 0.01) and had less emergency hospital admissions (19.6% to 8.7%, p = 0.03). One year after rehabilitation, patients of the EG had a higher chance of improved quality of life (OR = 2.5; CI 1.07-5.84), and they could maintain a longer duration of weekly exercise training (more than 1 hour/week: EG n = 58, CG n = 34, p < 0.01). CONCLUSION: Patient education for COPD has been shown to improve the effectiveness of an inpatient rehabilitation programme regarding quality of life. It also reduces morbidity and supports a change of lifestyle. Therefore, education should be an essential component of rehabilitation in COPD.

[Pulmonary rehabilitation in COPD]. / Rehabilitation bei COPD.

COPD as a widespread disease will need much more attention of all health care providers in future. Otherwise COPD could lead to increasing costs, especially caused by the systemic nature of this disease and the large number of comorbidities as well as an increase of morbidity with reduced personal fitness and quality of life. As a result, the occupational and social participation subsequently decrease. Specific diagnostic in rehabilitation shows these consequences and a multimodal, multi-professional therapeutic management can be started. This means an optimized pharmacotherapy, different steps of intensity of indoor or outdoor rehabilitation with a training for patients, withdrawal therapy, psycho-social support and in severe cases non invasive artificial respiration. The indication for rehabilitation and the legal requirements are shown, as well as the ways to get rehabilitation and the possibilities of a rehabilitation chain including rehabilitation follow up and physical training. It has been proved that rehabilitation improves the symptoms of the disease, the personal fitness and the quality of life. Futhermore, rehabilitation reduces the days and the time spent in hospital and eventually reduces fear and depression. Therefore if consequently followed, rehabilitation in COPD is a valid therapeutic measure that can diminish the epidemiologic burden of this widespread disease.

[Effectiveness of inpatient pulmonary rehabilitation (AHB). Results of a multicenter prospective observation study]. / Effektivität der pneumologischen Anschluss-Rehabilitation (AHB). Ergebnisse einer multizentrischen prospektiven Beobachtungsstudie.

BACKGROUND AND OBJECTIVE: The value of pulmonary rehabilitation in the treatment of chronic obstructive pulmonary disease (COPD) is well accepted. However, there are no data on the efficacy of in-patient rehabilitation instituted within 14 days after an acute disease episode, as practised in Germany. It was the purpose of this multi-centre prospective study to assess changes in lung function, exercise capacity, symptoms and disease-related quality of life (QoL) in patients discharged from hospital for an episode of worsening COPD or asthma, pulmonary embolism, pneumonia or treatment of lung cancer. PATIENTS AND METHODS: 207 patients (mean age 60 13 years) with COPD (n=86), pneumonia (n=42), lung cancer (n=24), asthma (n=14), pulmonary embolism (n=7) or other pulmonary disease (n=34) were included. Measurements of lung function, exercise capacity and disease-related QoL were carried out at the beginning and end of rehabilitation. Socio-economic data and disease-related QoL measurements were recorded again after 2 months. RESULTS: Rehabilitation led to a significant improvement of lung function, exercise capacity and QoL. Patients felt rehabilitation was efficacious (95%), to be recommended (99%) and important (100%). Improvement of QoL was maintained at two 2 months and only 16% of previously working patients had applied for retirement. CONCLUSIONS: The data demonstrate the clinically relevant benefit of in-patient pulmonary rehabilitation immediately after a period of acute illness. In view of these result and the known morbidity and mortality of patients with COPD after hospitalization for a period of acute illness, this form of pulmonary rehabilitation should be considered as standard treatment for these patients.

[Inhalation therapy by dose-inhalers: analysis of patients performance and possibilities for improvement]. / Inhalative Therapie mit Dosier-Aerosolen: Fehleranalyse und Varianten der Verbesserung.

Inhalation therapy in chronic obstructive airways disease requires an efficient inhalation technique. This study analyses step by step the mistakes made in the usage of different MDIs, relates these to patient information prior to the testing and examines several teaching procedures for improvement of knowledge and performance of the inhalation technique. 125 patients suffering from COPD were assigned to six different groups according to their background knowledge in the inhalation technique. The performance was assessed in standardized single steps and as overall performance. Furthermore the efficacy of an interactive pc-based-training program was evaluated. The worst performance was seen in patients who only used the suppliers medication leaflet as a guide. Patients trained in outpatient clinics as well as patients trained in small groups during an inpatient stay showed a better performance. A high improvement rate was seen in prior MDI naive patients after they had undergone the interactive pc-based training program. Most problems were detected in the application step "exhalation before inhalation" and in the actuation-inhalation step. Besides the classical and the pc-based training the use of MDI phantoms showed very good results. The practical conclusion of this study is that the ability of patients to use inhalation pharmacotherapy efficiently needs improvement. Training programs of different intensity lead to a different outcome in performance and knowledge depending on prior knowledge. Inhalation pharmacotherapy without adequate training is insufficient.

[Efficacy of a disease management programme in asthma]. / Effizienz eines Disease Management Programmes bei Asthma.

BACKGROUND: Disease Management Programmes (DMP) are intended to improve the quality of the medical care of chronically sick patients and at the same time to keep stable or to reduce the costs to the healthcare system. The effectiveness of a DMP was evaluated by means of an accompanying study. METHOD: Within the framework of the DMP, the patients were managed by case managers who carried out patient instructions, evaluated the symptoms and lung function values (FEV (1)) on a daily basis and supervised treatment goals with the aid of predetermined algorithms. Initially, in collaboration with the family doctor, a treatment schedule was drawn up continuously monitored and adapted. In a 12-month multicentre evaluation study, the quality of life of the patients was determined using the FLA and Euroquol questionnaires. Furthermore, symptoms, lung function (FEV (1)) and the total costs of the treatment were measured. RESULTS: The quality of life (FLA, EuroQuol) of the patients in the Disease Management group was statistically significantly improved compared with the start of the study and with the control group. Inpatient respiratory-related costs were only incurred in the control group ( 320). No significant differences were found in the case of the other direct cost parameters (costs for asthma-related drugs 716 and 720 in the control group and DMP group respectively). The indirect costs were higher in the DMP group due to more frequent disability. With regard to overall symptoms, a pronounced reduction was only achieved in the DMP group. The mean FEV (1) measured in the physicians practice rose in the DMP group from 1.82 l to 1.89 l, whereas in the control group it fell slightly from 1.84 l to 1.78 l. The daily FEV (1) measurements at patient's home showed an increase of about 10 % in the values after 12 months. CONCLUSIONS: The tested DMP for asthmatics brought about a significant improvement in the state of health, asthmatic symptoms and lung function of asthmatics. The direct costs of treatment were also found to be lower.

Optical feedback training of inhalation with Autohaler and Turbuhaler in COPD patients.

The success of inhalation therapy depends on patients inhalation technique and correct handling of the inhalation device. In this study the effort to train correct handling and optimal inhalation technique of patients using Autohaler and Turbuhaler was assessed. The Bad-Reichenhall-Aerosol-Therapy-Trial (BREATH) was a prospective, randomized, cross-over trial in 200 patients who were not familiar with either of the test systems. The correct handling of Autohaler and Turbuhaler was assessed by means of a checklist (observation score). An optimal inhalation maneuver was used evaluated with the computer-based Inhalation Manager (optical feedback, computer score). The Autohaler reached 6.58 +/- 3.64 (mean +/- SD) out of nine points in the observation score and 66.85 +/- 29.84% in the computer score before training. After training the scores increased significantly to 8.33 +/- 2.08 points and 86 +/- 23.40% respectively. The use of the Turbuhaler also significantly improved from 4.28 +/- 4.24 points and 56.67 +/- 42.97% to 7.78 +/- 2.74 points and 85.80 +/- 27.63%, respectively. The significant improvement of patients inhalation technique after training emphasizes the importance of training in inhalation therapy. In addition, it could be demonstrated that the optical feedback given by the Inhalation Manager was a useful tool for improving the inhalation technique of patients using Autohaler and Turbuhaler.

[Physical therapy in COPD--Evidence based medicine?]. / Physikalische Therapie bei COPD - Evidence Based Medicine?

Several therapeutical options of physical therapy in COPD show significant effects on the organism. Some of those effects are verified, but there is still an uncertainty about the exact influences on the disease and the beneficial outcome, especially because different trials describe contradictory results. Existing studies observed an improved respiratory mechanism with a more economical ventilatory work and a better gas exchange by use of physical therapy. Therefore the right indication for certain options of physical therapy should be defined, so that the outcome can be controlled and a benefit can be drawn from the effects. Sufficient data of existing trials for the whole physical therapy in COPD is still deficient. Due to an inappropriate study design and/or the number of observed patients a lot of clinical studies are not qualified to lead to significant results and recommendations. For the future it is necessary to investigate the exact effects of physical therapy with controlled, randomised, clinical trials further on. Hereby an improvement of the care of patients with COPD can be achieved and the beneficial effects and the outcome with physical therapy can better be estimated.

[The education program for patients with COPD from Bad Reichenhall]. / Das Bad Reichenhaller Patientenverhaltenstraining bei chronisch obstruktiver Bronchitis/Lungenemphysem - Prävention und Rehabilitation -

An education program for patients with COPD is presented. This program was created for inpatient pulmonary rehabilitation at the Klinik Bad Reichenhall. We intend to improve the patients' acceptance of disease and their understanding of therapy. Furthermore we want to impart basic knowledge about COPD and its treatment. The patients should be motivated to manage the disease in an active and more independent way: They should control the natural course of their disease by learning preventive and restorative health care behaviours and self-help activities in case of acute exacerbations. The aim is to attain the acceptance of changing life-style.

[Methods for the costing process in the field of economic evaluation of a rehabilitation program for patients with chronic obstructive lung diseases]. / Methoden zur Kostenerfassung im Rahmen der ökonomischen Evaluation einer Rehabilitationsmassnahme bei chronischen Atemwegserkrankungen.

Studies in health economics especially economic evaluations of health care technologies and programmes are getting more and more important. However, in Germany there are no established, validated and commonly used instruments for the costing process. For the economic evaluation of a rehabilitation programme for patients with chronic lung diseases such as asthma and chronic bronchitis we developed methods for identification, measurement and validation of resource use during the inpatient rehabilitation programme and during the outpatient follow-up period. These methods are based on methodological considerations as well as on practical experience from conducting a pilot study. With regard to the inpatient setting all relevant diagnostic and therapeutic resource uses could be measured basing on routine clinical documentation and validated by using the cost accounting of the clinic. For measuring the use of resources during the follow-up period in an outpatient setting no reliable administrative data are accessible. Hence, we compared a standardised retrospective patient questionnaire used in a 20-minute interview (n = 50) and a cost diary for the continuing documentation by the patient over a period of 4 weeks (n = 50). Both tools were useful for measuring all relevant resource uses in sufficient detail, but because of higher participation rates and lower dropouts the structured interview appears to be more suitable. Average total costs per month were 1591 DM (interview), respectively 1867 DM (cost diary). Besides productivity loss, costs for medication and GP visits caused the relatively highest resource uses. Practicable instruments were developed for the costing process as part of an economic evaluation in a German rehabilitation setting for pulmonary diseases. After individual modification, these could also be used for different indications and in other institutional settings.

[Fear of cortisone: in pulmonary rehabilitation it is less than expected. Results of a patient survey]. / Kortisonangst: In der pneumologischen Rehabilitation geringer als erwartet. Ergebnisse einer Patientenbefragung.

BACKGROUND: The treatment of diseases of the upper and lower respiratory tracts can't be imagined without corticoids, applied systemically of locally. In specialist literature one can find indications of a certain reservation towards this kind of medication on the part of many patients. Sometimes, this reservation is so strong that it can be referred to as a regular fear of cortison. Bad compliance and with it, frequently, a deterioration of the symptoms, are inevitable consequences. The aim of the study was to find out how distinct the fear of cortison is with patients in pneumological rehabilitation and wether there are any relations with other spheres of attitude. METHOD: Patients with COPD and asthma with inhalative and/or systemic corticoid medication received an extensive questionnaire during their rehabilitation as in-patients for four weeks. 102 questionnaires were evaluated. RESULTS: The statements of the patients indicated high compliance regarding corticoid medication. As to the fear of such preparation, only 5/102 (4.9%) of those questioned produced results which suggest strong fear of cortison. Fear of cortison is, among other things, slightly related to general psychic-stress and a general negative attitude towards medicine. There is a negative correlation between compliance at the taking of medicine and fear of cortison. CONCLUSIONS: Contrary to statements in specialist literature of wide-spread reservations and fear towards cortison, we have found out that these play only a minor part, at least with the mostly elderly clientele of pneumological rehabilitation. Different explanations are discussed.