Chronic rhinosinusitis with nasal polyposis and biological agents: the ARIA-ITALY Survey.

Summary: Background. Chronic rhinosinusitis (CRS) is an inflammatory disease that affects the nasal mucosa and the paranasal sinuses. CRS can be associated by nasal polyposis (CRSwNP phenotype) in up to 30% of patients and it is frequently associated with bronchial asthma. CRSwNP shows predominantly an underlying activation of type 2 inflammatory pathways with the involvement of eosinophils, IgE, interleukin (IL)-4, IL-5 and IL-13. Biological drugs that target these inflammatory cytokines are currently a therapeutic option recognized by guidelines for the treatment of uncontrolled form of the disease. Methods. As part of the activity of the "ARIA-Italy" working group, a panel of 255 Italian Ear, Nose and Throat (ENT) specialists, pneumologists and immuno-allergologists actively participated in this national survey and answered a series of questions geared toward understanding the main criteria for patient characterization and therapeutic decision, highlighting multidisciplinarity, and the implementation of the management of CRSwNP patients, as a part of the precision medicine concept and the appropriate use of the biologicals. Results. Two hundred and fifty-five experts and specialists participated in the survey. Conclusions. The results of this survey obtained from an extensive number of active specialists throughout Italy allow some important concluding remarks to be drawn. The main points of agreement were that multidisciplinary care teams provide many benefits but that, once the team is established, meetings and communication between members must be coordinated. Finally, the dissemination of national disease registries and the continuous updating of guidelines and position papers related to CRSwNP and comorbidities should be encouraged.

Severe asthma: follow-up after one year from the Italian Registry on Severe Asthma (IRSA)

Summary: Background. Asthma affects millions of people worldwide, with a subgroup suffering from severe asthma (SA). Biologics have revolutionized SA treatment, but challenges remain in managing different patient traits. This study analyzed data from the Italian Registry on Severe Asthma (IRSA) to investigate changes in SA characteristics and effectiveness of treatments after one year of follow-up, and to identify factors associated with response to treatments in a real-world setting. Methods. Data on SA patients with one year of follow-up were extracted from IRSA. Asthma control, exacerbations, lung function, and treatments, were assessed at follow-up and analyzed against baseline characteristics. Results. After one year of follow-up, notable improvements were observed in all the outcomes of SA of the included patients (n = 570). The effectiveness of biologic therapies was particularly evident, as they contributed significantly to these positive outcomes. Additionally, certain factors were found to be associated with improvement, namely T2 phenotype, baseline eosinophil count (BEC), and area of residence. On the other hand, comorbidities (obesity, gastro-esophageal reflux disease) and poor lung function were risk factors. Notably, poor-responders to biologics exhibited lower level of education, BEC, and exacerbations, and higher frequency of atopy and ACT score ≥ 20. Conclusions. The findings demonstrate the effectiveness of biologics in asthma management, when implemented as part of a planned follow-up strategy aimed at optimizing and fine-tuning the therapy. Moreover, the study highlights the importance of considering key traits such as the T2 phenotype, BEC, education, and comorbidities when tailoring SA treatment. Overall, this study contributes to enhancing our understanding of SA management and guiding the development of personalized treatment approaches for patients with SA.

Severe asthma management in the era of biologics: insights of the Italian Registry on Severe Asthma (IRSA).

Summary: Background. The Italian Registry on Severe Asthma (IRSA) is the most recent and largestregistry in Italy. Objective. To improve the knowledge on the clinical and biological features of severe asthma (SA), and to monitor its treatments. Methods. To analyze clinical,functional, inflammatory, and treatment characteristics of severe asthmatics from the IRSA registry. Results. 851 subjects were enrolled. 31.8% and 64.5% of patients were submitted to oral corticosteroids (OCS), and monoclonal antibodies (MABs), respectively. At least tw ocomorbidities affected 77.4% patients. Asthma was uncontrolled in 62.2% patients. Uncontrolled patients had a higher frequency of exacerbations, and hospitalization, showing a highere osinophilic phenotype, a greater use of OCS, and being treated with MAB less frequently. However, uncontrolled patients treated with MAB had a lower use of OCS and a lower rateof hospitalization. Comparing SA patients with atopy and without atopy, the latter showeda greater use of OCS, and more frequent nasal polyposis and osteoporosis. Among SA patients with atopy treated with MAB, 36% were on a treatment targeting the IL-5 pathway. Conclusions and clinical relevance. This study shows the features of the greatest Italian registryof SA patients, revealing at the time of enrollment a poor disease control, and the use of OCSand MABs in about one third and two thirds of patients, respectively. SA is a complex diseasethat requires a more precise phenotyping and a greater disease control.

Doubly robust nonparametric inference on the average treatment effect.

Doubly robust estimators are widely used to draw inference about the average effect of a treatment. Such estimators are consistent for the effect of interest if either one of two nuisance parameters is consistently estimated. However, if flexible, data-adaptive estimators of these nuisance parameters are used, double robustness does not readily extend to inference. We present a general theoretical study of the behaviour of doubly robust estimators of an average treatment effect when one of the nuisance parameters is inconsistently estimated. We contrast different methods for constructing such estimators and investigate the extent to which they may be modified to also allow doubly robust inference. We find that while targeted minimum loss-based estimation can be used to solve this problem very naturally, common alternative frameworks appear to be inappropriate for this purpose. We provide a theoretical study and a numerical evaluation of the alternatives considered. Our simulations highlight the need for and usefulness of these approaches in practice, while our theoretical developments have broad implications for the construction of estimators that permit doubly robust inference in other problems.

Acute disseminated encephalomyelitis in China, Singapore and Japan: a comparison with the USA.

BACKGROUND AND PURPOSE: Ethnicity-related differences in the incidence of acute disseminated encephalomyelitis (ADEM) and other demyelinating diseases including multiple sclerosis and neuromyelitis optica spectrum disorders have been reported. Little is reported on the influence of ethnicity and geographical location in ADEM. METHODS: Medical records of patients who presented with ADEM (ICD-9 323.61 and 323.81) at large referral hospitals in China, Singapore and Japan (years 1992-2015) were retrospectively reviewed and data were collected in a centralized database. Presenting features and outcomes of ADEM were compared between this multi-country Asian cohort and a uniformly collected US cohort using risk differences and risk ratios. Both cohorts were standardized to a 35% pediatric population to facilitate the comparison. RESULTS: There were 83 Asian patients (48 male, 16 pediatric) followed for a median of 2 (25th-75th percentile 1-10) months. Asian patients exhibited a 26% higher prevalence of spinal cord involvement on magnetic resonance imaging [95% confidence interval (CI) 0-52%; P = 0.05; 63% vs. 37%], a 39% lower prevalence of preceding events (95% CI 12-65%; P < 0.01; 33% vs. 72%) and a 23% lower prevalence of corpus callosum involvement (95% CI 7-39%; P < 0.01; 8% vs. 31%). No difference was observed between the two cohorts in the probability of relapse over the first year after disease onset. CONCLUSIONS: It is hypothesized that the high proportion of Asian patients with spinal cord lesions relates to genetic vulnerability or the higher incidence of neuromyelitis optica spectrum disorders in Asia or could be a spurious association. ADEM presentations most probably vary across geographical settings or ethnicities.

Comparing Preliminary and Final Neuroradiology Reports: What Factors Determine the Differences?

BACKGROUND AND PURPOSE: Trainees' interpretations of neuroradiologic studies are finalized by faculty neuroradiologists. We aimed to identify the factors that determine the degree to which the preliminary reports are modified. MATERIALS AND METHODS: The character length of the preliminary and final reports and the percentage character change between the 2 reports were determined for neuroradiology reports composed during November 2012 to October 2013. Examination time, critical finding flag, missed critical finding flag, trainee level, faculty experience, imaging technique, and native-versus-non-native speaker status of the reader were collected. Multivariable linear regression models were used to evaluate the association between mean percentage character change and the various factors. RESULTS: Of 34,661 reports, 2322 (6.7%) were read by radiology residents year 1; 4429 (12.8%), by radiology residents year 2; 3663 (10.6%), by radiology residents year 3; 2249 (6.5%), by radiology residents year 4; and 21,998 (63.5%), by fellows. The overall mean percentage character change was 14.8% (range, 0%-701.8%; median, 6.6%). Mean percentage character change increased for a missed critical finding (+41.6%, P < .0001), critical finding flag (+1.8%, P < .001), MR imaging studies (+3.6%, P < .001), and non-native trainees (+4.2%, P = .018). Compared with radiology residents year 1, radiology residents year 2 (-5.4%, P = .002), radiology residents year 3 (-5.9%, P = .002), radiology residents year 4 (-8.2%, P < .001), and fellows (-8.7%; P < .001) had a decreased mean percentage character change. Senior faculty had a lower mean percentage character change (-6.88%, P < .001). Examination time and non-native faculty did not affect mean percentage character change. CONCLUSIONS: A missed critical finding, critical finding flag, MR imaging technique, trainee level, faculty experience level, and non-native-trainee status are associated with a higher degree of modification of a preliminary report. Understanding the factors that influence the extent of report revisions could improve the quality of report generation and trainee education.

Study of mitochondrial DNA alteration in the exhaled breath condensate of patients affected by obstructive lung diseases.

Mitochondrial DNA (MtDNA) has been studied as an expression of oxidative stress in asthma, COPD, lung cancer and obstructive sleep apnea, but it has been mainly investigated systemically, although the pathogenetic mechanisms begin in the airways and only later progress to systemic circulation. The aim of this study was to investigate the MtDNA alterations in the exhaled breath condensate (EBC) of patients with asthma, COPD and asthma-COPD overlap syndrome (ACOS). In order to analyze better what happens to mitochondria, both locally and systemically, we compared MtDNA/nDNA in blood and EBC of paired patients. Thirteen (13) COPD patients, 14 asthmatics, 23 ACOS (10 according to Spanish guidelines, 13 in line with GINA guidelines) and 12 healthy subjects were enrolled. Patients underwent clinical and functional diagnostic tests as foreseen by the guidelines. They underwent blood and EBC collection. Content of MtDNA and nuclear DNA (nDNA) was measured in the blood cells and EBC of patients by Real Time PCR. The ratio between MtDNA/nDNA was calculated. For the first time we were able to detect MtDNA/nDNA in the EBC. We found higher exhaled MtDNA/nDNA in COPD, asthmatic and ACOS patients respectively compared to healthy subjects (21.9 ± 4.9 versus 6.51 ± 0.21, p < 0.05; 7.9 ± 2.5 versus 6.51 ± 0.21, p = 0.06; 18.3 ± 3.4 versus 6.51 ± 0.21, p < 0.05). The level of exhaled MtDNA/nDNA was positively correlated with the plasmatic one. The levels of MtDNA/nDNA in the EBC, as expression of oxidative stress, are increased in COPD, asthmatic and ACOS patients compared to healthy subjects. These are preliminary results in a small number of well characterized patients that requires confirmation on a larger population. We support new studies directed toward the analysis of exhaled MtDNA/nDNA as a new exhaled non-invasive marker in other inflammatory/oxidative airways diseases.

Analysis of mitochondrial DNA alteration in new phenotype ACOS.

BACKGROUND: Mitochondria contain their own DNA (MtDNA) that is very sensitive to oxidative stress and as a consequence could be damaged in quantity. Oxidative stress is largely recognized to play a key role in the pathogenesis of asthma and COPD and might have a role in the new intermediate phenotype ACOS (asthma-COPD overlap syndrome). The aim of this study was to investigate MtDNA alterations, as an expression of mitochondrial dysfunction, in ACOS and to verify whether they might help in the identification of this new phenotype and in its differentiation from asthma and COPD. METHODS: Ten (10) ACOS according to Spanish guidelines, 13 ACOS according to GINA guidelines, 13 COPD, 14 asthmatic patients and ten normal subjects were enrolled. They further underwent a blood, induced sputum and exhaled nitric oxide collection. Content of MtDNA and nuclear DNA (nDNA) were measured in the blood cells of patients by Real Time PCR. RESULTS: ACOS patients showed an increase of MtDNA/nDNA ratio. Dividing ACOS according to guidelines, those from the Spanish showed a higher value of MtDNA/nDNA compared to those from GINA/GOLD (92.69 ± 7.31 vs 80.68 ± 4.16). Spanish ACOS presented MtDNA/nDNA ratio closer to COPD than asthma. MtDNA was higher in asthmatic, COPD, GINA and Spanish ACOS patients compared to healthy subjects (73.30 ± 4.47-137.0 ± 19.45-80.68 ± 4.16-92.69 ± 7.31 vs 65.97 ± 20.56). CONCLUSION: We found an increase of MtDNA/nDNA ratio in ACOS subjects that led us to conclude that there is presence of mitochondrial dysfunction in this disease, that makes it closer to COPD than to asthma. Although the MtDNA/nDNA ratio results are a useful marker for differential diagnosis from asthma, COPD and ACOS, further studies are needed to confirm the potentiality of MtDNA/nDNA ratio and to a better characterization of ACOS.

Propensity score estimators for the average treatment effect and the average treatment effect on the treated may yield very different estimates.

OBJECTIVE: Propensity score matching is typically used to estimate the average treatment effect for the treated while inverse probability of treatment weighting aims at estimating the population average treatment effect. We illustrate how different estimands can result in very different conclusions. STUDY DESIGN: We applied the two propensity score methods to assess the effect of continuous positive airway pressure on mortality in patients hospitalized for acute heart failure. We used Monte Carlo simulations to investigate the important differences in the two estimates. RESULTS: Continuous positive airway pressure application increased hospital mortality overall, but no continuous positive airway pressure effect was found on the treated. Potential reasons were (1) violation of the positivity assumption; (2) treatment effect was not uniform across the distribution of the propensity score. From simulations, we concluded that positivity bias was of limited magnitude and did not explain the large differences in the point estimates. However, when treatment effect varies according to the propensity score (E[Y(1)-Y(0)|g(X)] is not constant, Y being the outcome and g(X) the propensity score), propensity score matching ATT estimate could strongly differ from the inverse probability of treatment weighting-average treatment effect estimate. We show that this empirical result is supported by theory. CONCLUSION: Although both approaches are recommended as valid methods for causal inference, propensity score-matching for ATT and inverse probability of treatment weighting for average treatment effect yield substantially different estimates of treatment effect. The choice of the estimand should drive the choice of the method.

Mesial Temporal Sclerosis: Accuracy of NeuroQuant versus Neuroradiologist.

BACKGROUND AND PURPOSE: We sought to compare the accuracy of a volumetric fully automated computer assessment of hippocampal volume asymmetry versus neuroradiologists' interpretations of the temporal lobes for mesial temporal sclerosis. Detecting mesial temporal sclerosis (MTS) is important for the evaluation of patients with temporal lobe epilepsy as it often guides surgical intervention. One feature of MTS is hippocampal volume loss. MATERIALS AND METHODS: Electronic medical record and researcher reports of scans of patients with proved mesial temporal sclerosis were compared with volumetric assessment with an FDA-approved software package, NeuroQuant, for detection of mesial temporal sclerosis in 63 patients. The degree of volumetric asymmetry was analyzed to determine the neuroradiologists' threshold for detecting right-left asymmetry in temporal lobe volumes. RESULTS: Thirty-six patients had left-lateralized MTS, 25 had right-lateralized MTS, and 2 had bilateral MTS. The estimated accuracy of the neuroradiologist was 72.6% with a κ statistic of 0.512 (95% CI, 0.315-0.710) [moderate agreement, P < 3 × 10(-6)]), whereas the estimated accuracy of NeuroQuant was 79.4% with a κ statistic of 0.588 (95% CI, 0.388-0.787) [moderate agreement, P < 2 × 10(-6)]). This discrepancy in accuracy was not statistically significant. When at least a 5%-10% volume discrepancy between temporal lobes was present, the neuroradiologists detected it 75%-80% of the time. CONCLUSIONS: As a stand-alone fully automated software program that can process temporal lobe volume in 5-10 minutes, NeuroQuant compares favorably with trained neuroradiologists in predicting the side of mesial temporal sclerosis. Neuroradiologists can often detect even small temporal lobe volumetric changes visually.

Daytime PaO2 in OSAS, COPD and the combination of the two (overlap syndrome).

BACKGROUND: OSAS and COPD are often associated with day-time hypoxemia. Overlap Syndrome (OS), the association between both diseases, increases the risk of day-time hypoxemia. The aim of this study was to investigate the mechanisms which could justify the low oxygen level and the effect of CPAP. METHODS: We performed a retrospective analysis in all patients referred to our institutes for suspected OSAS and who also underwent spirometry and blood gas analysis during our evaluation. Thus, 720 patients were selected. According to pulmonary function test parameters they were divided into 3 groups: OSAS (N = 466,65%); OS (N = 168,23%) and COPD (N = 86,12%). In order to evaluate the differences between the three groups, ANOVA analyses were carried out, whereas a multivariate analysis was performed in order to evaluate which factors determine the diurnal PaO(2). In 90 patients we also have the data on blood gas analysis after one year of CPAP treatment, so we evaluate the PaO(2) improvement in accordance with compliance to treatment in these patient subgroups. RESULTS: The OS group showed a lower level of daytime PaO(2) compared with OSAS patients and T90 was higher in OS compared with OSAS. A multivariate analysis showed that in the OS diurnal PaO(2) correlated with age (ß = -0.20) and moreover with FEV(1) (ß = 0.31) and T90 (ß = 0.37), while in the OSAS a correlation was found with FEV(1) (ß = -0.11) and mostly with BMI (ß = 0.25), age and T90. In all patients with good compliance to CPAP day-time PaO(2) improved. CONCLUSIONS: Our data suggest that day-time hypoxemia in OSA patients is largely determined by the increase of body weight and severity of nocturnal hypoxia. However, CPAP therapy has been shown to improve daytime PaO(2) values both in OSAS and in OS.

A population-based case-control study of 1250 stroke deaths in rural Bangladesh.

BACKGROUND AND PURPOSE: There are limited population-based studies to determine the risk factors for stroke in Bangladesh. METHODS: A health and demographic surveillance system has been maintained in Matlab, Bangladesh (population 223 886, 142 villages in 2008). All adult stroke and injury deaths (2005-2008) were monitored by verbal autopsy. Risk factors for stroke deaths were calculated using a multivariable logistic regression model with adult injury deaths as controls. RESULTS: A total of 1250 stroke deaths (51% women; mean age 72.3 years, range 20-101) occurred out of 4955 total deaths and were compared with 246 adult injury deaths (47% women, mean age 55.8 years, range 20-100). The population-attributable mortality of stroke was 25.2% based on the verbal autopsy instrument and 17.8% when accounting for the reported sensitivity and specificity of a similar verbal autopsy instrument that has been validated for stroke death. Risk of stroke death was significantly increased with hypertension (OR 7.94, 95% CI 4.44-15.54, P < 0.001), diabetes mellitus (OR 2.54, 1.21-6.21, P = 0.02), and betel consumption (OR 2.36, 1.45-3.80, P < 0.001) when adjusted for age and sex. An increased risk was not observed with heart disease (OR 1.37, 0.45-5.95, P = 0.62), cigarette smoking (OR 1.41, 0.82-2.45, P = 0.22), tobacco powder (OR 1.15, 0.30-7.64, P = 0.86), or cigar/hookah pipe smoking 0.94 (0.45-2.18, P = 0.88) when adjusted for age and sex. There were more strokes in winter (December-March) than summer (June-September) (P < 0.001). CONCLUSIONS: There is a high modifiable burden of risk factors for adult stroke deaths in rural Bangladesh, most notably including hypertension. Betel consumption may be an under-recognized risk factor for stroke death.

Quality control in neuroradiology: impact of trainees on discrepancy rates.

BACKGROUND AND PURPOSE: Prior studies have found a 2%-8% clinically significant error rate in radiology practice. We compared discrepancy rates of studies interpreted by subspecialty-trained neuroradiologists working with and without trainees. MATERIALS AND METHODS: Subspecialty-trained neuroradiologists reviewed 2162 studies during 41 months. Discrepancies between the original and "second opinion" reports were scored: 1, no change; 2, clinically insignificant detection discrepancy; 3, clinically insignificant interpretation discrepancy; 4, clinically significant detection discrepancy; and 5, clinically significant interpretation discrepancy. Faculty alone versus faculty and trainee discrepancy rates were calculated. RESULTS: In 87.6% (1894/2162), there were no discrepancies with the original report. The neuroradiology division had a 1.8% (39/2162; 95% CI, 1.3%-2.5%) rate of clinically significant discrepancies. In cases reviewed solely by faculty neuroradiologists (16.2% = 350/2162 of the total), the rate of discrepancy was 1.7% (6/350). With fellows (1232/2162, 57.0% of total) and residents (580/2162, 26.8% of total), the rates of discrepancy were 1.6% (20/1232) and 2.2% (13/580), respectively. The odds of a discrepant result were 26% greater (OR = 1.26; 95% CI, 0.38-4.20) when reading with a resident and 8% less (OR = 0.92; 95% CI, 0.35-2.44) when reading with a fellow than when reading alone. CONCLUSIONS: There was a 1.8% rate of clinically significant detection or interpretation discrepancy among academic neuroradiologists. The difference in the discrepancy rates between faculty only (1.7%), fellows and faculty (1.6%), and residents and faculty (2.2%) was not statistically significant but showed a trend indicating that reading with a resident increased the odds of a discrepant result.

Imaging characteristics of oligodendrogliomas that predict grade.

BACKGROUND AND PURPOSE: Oligodendrogliomas are tumors that have variable WHO grades depending on anaplasia and astrocytic components and their treatment may differ accordingly. Our aim was to retrospectively evaluate imaging features of oligodendrogliomas that predict tumor grade. MATERIALS AND METHODS: The imaging studies of 75 patients with oligodendrogliomas were retrospectively reviewed and compared with the histologic grade. The presence and degree of enhancement and calcification were evaluated subjectively. rCBV and ADC maps were measured. Logistic linear regression models were used to determine the relationship between imaging factors and tumor grade. RESULTS: Thirty of 75 (40%) tumors enhanced, including 9 of 46 (19.6%) grade II and 21 of 29 (72.4%) grade III tumors (P < .001). Grade III tumors showed lower ADC values compared with grade II tumors (odds ratio of a tumor being grade III rather than grade II = 0.07; 95% CI, 0.02-0.25; P = .001). An optimal ADC cutoff of 925 10(-6) mm(2)/s was established, which yielded a specificity of 89.1%, sensitivity of 62.1%, and accuracy of 78.7%. There was no statistically significant association between tumor grade and the presence of calcification and perfusion values. Multivariable prediction rules were applied for ADC < 925 10(-6) mm(2)/s, the presence of enhancement, and the presence of calcification. If either ADC < 925 10(-6) mm(2)/s or enhancement was present, it yielded 93.1% sensitivity, 73.9% specificity, and 81.3% accuracy. The most accurate (82.2%) predictive rule was seen when either ADC < 925 10(-6) mm(2)/s or enhancement and calcification were present. CONCLUSIONS: Models based on contrast enhancement, calcification, and ADC values can assist in predicting the grade of oligodendrogliomas and help direct biopsy sites, raise suspicion of sampling error, and predict prognosis.

Long-term cognitive outcomes following out-of-hospital cardiac arrest: a population-based study.

OBJECTIVE: To report the neurologic outcomes in long-term survivors of out-of-hospital cardiac arrest with ventricular fibrillation as the presenting rhythm (OHCA VF) at a population level. METHODS: All adults who experienced OHCA VF in Olmsted County, MN, from 1990 to 2008, survived more than 6 months postarrest, and were alive at the time of study recruitment were invited to participate in structured neuropsychological testing and a neurologic examination. Cognitive test results were compared to the normal population using the Mayo's Older Adults Normative Studies. Linear regression models were fit to evaluate each neuropsychological test result in relation to call-to-shock time, sex, age at cardiac arrest, time elapsed since event, witnessed vs unwitnessed arrest, and administration of bystander cardiopulmonary resuscitation. RESULTS: Of 332 OHCA VF arrests, 140 people (42.2%, 95% confidence interval 36.9%-47.5%) survived to discharge. No patient entered a minimally conscious or permanent vegetative state. Long-term survivors (n = 47, median survival 7.8 years postarrest) had lower scores on measures of long-term memory and learning efficiency (p = 0.001) but higher than average scores on verbal IQ (p = 0.001). Nearly all survivors were functionally independent and scored high on the Mini-Mental State Examination (MMSE) (median Barthel Index 100/100, median MMSE 29/30). CONCLUSIONS: Long-term survivors of OHCA VF have long-term memory deficits compared to the normal population at the same age and education level. These findings provide a baseline for cognitive outcomes studies of OHCA VF as new techniques are developed to improve survival.

[Questionnaires for occupational disability evaluation in patients with chronic respiratory diseases]. / Questionari per la valutazione della disabilità occupazionale in pazienti con malattie respiratorie croniche.

Chronic Obstructive Pulmonary Disease (COPD) represents a model of respiratory degenerative chronic disabling disorder. In Pulmonary Rehabilitation (PR), occupational approach is aimed at restoring patient's abilities at best in the social, familiar and working scenarios, and it is an essential part of a good PR Programme. To evaluate first occupational disability and then the occupational outcome of a PR programme, we need appropriate tools. London Chest Activity of Daily Living (LCADL) ed il Manchester Respiratory Activities of Daily Living (MRADL) are two questionnaires with such characteristics available in the literature. Our aim was to translate into Italian and adapt to the Italian social reality these two questionnaires. This may be a preliminary albeit necessary step to obtain reliable data on the occupational outcome of PR programmes in Italy.

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

UNLABELLED: While 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.

Maugeri Respiratory Failure questionnaire reduced form: a method for improving the questionnaire using the Rasch model.

PURPOSE: The Maugeri Respiratory Failure questionnaire (MRF-28) is the first instrument specifically developed for use with chronic respiratory failure (CRF) patients. The 28 items were selected using classical test theory. The purpose of the current analysis was to further refine the questionnaire using item response theory, specifically, the Rasch model analysis. METHODS: Three hundred and seventeen CRF patients (mean aged 66.7 yrs; Male 219, Female 98) completed the MRF-28 health status measure. Data were collected through the self-report questionnaire and analyzed using 1-parameter logistic models by means of RUMM software. RESULTS: The 28-item questionnaire has good psychometric properties in terms of discriminant power because the Person Separation Index is 0.896. However, the item-trait interaction was not good as shown by the total-item Chi-square (chi(2)(112), p<0.001). Removing two items that did not fit the Rasch model well, produced a minor improvement in Person Separation Index to 0.899 and the item-trait interaction improved (chi(2)(104), p = NS). In the preliminary analysis we identified 21 patients who were outliers; when they were excluded the distribution of the residuals, according to the Kolmogorov-Smirnov statistics, was normal and factor analysis of the item residuals showed that the components had similar eigenvalues and no strong correlation with items. These results suggest that the MRF-26 is a unidimensional measure of health-related quality of life impairment for chronic respiratory failure patients. CONCLUSIONS: A combination of classical psychometric tests and Rasch analysis produced an instrument of moderate size that covers a wide range of effects of CRF and has interval scaling properties.

Degree of control of physician-diagnosed asthma and COPD in Italy.

BACKGROUND: It is important for the Italian National Health Service to obtain data on the degree of control of asthma and chronic obstructive pulmonary disease (COPD) in the general population in Italy in order for balanced planning of future investments in these diseases to be made. Currently, precise estimates of these parameters are not available in literature. OBJECTIVES: In collaboration with the Italian Academy of General Practitioners (SIMG; www.simg.it) we have investigated the degree of control of physician-diagnosed asthma and COPD in Italy. METHODS: A standardised questionnaire on asthma and COPD has been self-administered to a sample of 1937 Italian family physicians (representing around 5% of all the Italian doctors involved in general practice) chosen to cover all the Italian counties. RESULTS: We have collected questionnaire data from 19,917 patients with asthma and COPD followed in their practice and 12,438 (62.4%) were correctly filled in enabling evaluation. We selected the number of emergency room visits, hospitalisations and intensive care unit admissions for asthma and COPD in the last 12 months as objective measures of the degree of asthma and COPD morbidity in these patients. The figures were respectively 12.4% (emergency room visits), 17.3% (hospitalisations) and 1.2% (intensive care unit admissions) of all patients with physician-diagnosed asthma and COPD. CONCLUSIONS: This data suggests that in Italy the morbidity of asthma and COPD remains high; representing a significant burden for the Italian National Health Service. There is a clear necessity for further studies to investigate the causes of this incomplete control.

A new questionnaire specifically designed for patients affected by chronic obstructive pulmonary disease; The Italian Health Status Questionnaire.

The aim of this study was to develop a specific and valid questionnaire for Italian COPD patients, living on the north or the south of Italy-which are two culturally distinct areas. The project consisted in three steps: (1) initial item set generation to identify items relevant to both genders, all ages and both regions; (2) item reduction including tests of regional specificity; (3) tests of internal validity using item-response theory using Rasch one-parameter modelling. Ninty-six COPD patients (mean aged 69 yr; 78 Male) completed the original set of 124 items of the Italian Health Status Questionnaire (IHSQ). Item reduction was carried out using an established standardised approach employing classical psychometric test theory. The internal construct validity of the 47 items that survived this process were tested to determine whether they constituted a unidimensional construct "impaired health due to COPD" using Rasch analysis. This showed that the questionnaire had very good psychometric properties, with an excellent Person Separation Index of 0.95 and no evidence of bias due to item-trait interaction (chi104(2)=127.1, P=n.s.). The combination of classical test theory and modern item-response methodology has produced a questionnaire with excellent measurement properties suitable for COPD patients whether from the north or south of Italy.